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Bypass versus angioplasty in severe ischaemia of the leg (BASIL): Multicentre, randomised, controlled trial
... The main treatments for severe PAD are endovascular or open surgical revascularisation [1]. As endovascular interventions are minimally invasive, they might be expected to be associated with less need for readmission to hospital than open surgery [2][3][4][5]. Readmission after revascularisation is common. A recent systematic review reported that approximately 15% of people treated by peripheral revascularisation are readmitted to hospital within 30 days of discharge [6]. ...
... Recent reports, however, suggest this extra expense may be offset by shorter hospital stays compared with open revascularisation [10,17]. Many previous economic analyses have not however taken readmission costs into account when comparing endovascular and open surgery [5,18]. Furthermore, previous studies have been mainly performed in the United States where specialisation in vascular and endovascular surgery occurred later than in some other countries, such as Australia [2]. ...
... Improved quality control following endovascular revascularisation could play a role in reducing these costs. The cost-effectiveness of endovascular procedures compared to traditional open surgical revascularisation has been extensively studied [5,11,18,35]. Findings from previous studies have been contradictory and due to changes in practice the applicability of earlier studies to modern vascular surgical practice is unclear. Many earlier studies, such as the Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) trial, compared simple balloon angioplasty to bypass [4]. ...
Objective: This study examined the costs of both index admissions and 30-day readmissions for people undergoing revascularization at a single centre in Australia.
Methods: This was a retrospective analysis of prospectively collected data. Eligible participants were those presenting with chronic limb ischemia requiring revascularization between 2002 and 2017. Generalised linear modelling was used to estimate mean (95% CI) costs for index and readmission hospital stays, and total hospital costs.
Results: 302 participants presenting with intermittent claudication (n=219; 72.5%) or critical limb ischemia (n=83; 27.5%) treated by open (n=116; 38.4%) or endovascular (n=186; 61.6%) revascularization were included. 48 (15.9%) participants were readmitted within 30-days of discharge from their index admission. The mean index admission hospital cost was AUD$13 827 (95% CI, $11 935- $15 818) per person. This cost was significantly greater for open as compared to endovascular revascularization (p<0.001). The mean readmission cost was AUD$15 324 ($10 944- $19 966) per person readmitted. When comparing before and after 2010, total costs decreased, mainly due to decreased lengths of hospital stay for open procedures.
Conclusions: Hospital costs were less for endovascular than open revascularization of chronic limb ischemia. Costs decreased over time. Readmission is an important contributor to overall costs of peripheral revascularization.
... The current evidence base underpinning the treatment of severe limb ischaemia is extremely poor with very few randomised clinical trials [4] and no available systematic reviews or meta-analysis. The National Institute of Health and Care Excellence clinical guideline (CG) 147 on Peripheral Arterial Disease recommended that a randomised controlled trial be undertaken to answer the following question which BASIL-2 aims to answer: namely, 'What is the clinical and cost effectiveness of a 'bypass surgery first' strategy compared with an 'angioplasty first' strategy for treating people with critical limb ischaemia caused by disease of the infrageniculate (below the knee) arteries?' [5] Aims The original BASIL-1 trial, on which BASIL-2 is based, randomised 452 patients with severe limb ischaemia, mainly due to femoro-popliteal disease (in the thigh), to either an angioplasty first or a bypass surgery first revascularisation strategy [4]. ...
... The current evidence base underpinning the treatment of severe limb ischaemia is extremely poor with very few randomised clinical trials [4] and no available systematic reviews or meta-analysis. The National Institute of Health and Care Excellence clinical guideline (CG) 147 on Peripheral Arterial Disease recommended that a randomised controlled trial be undertaken to answer the following question which BASIL-2 aims to answer: namely, 'What is the clinical and cost effectiveness of a 'bypass surgery first' strategy compared with an 'angioplasty first' strategy for treating people with critical limb ischaemia caused by disease of the infrageniculate (below the knee) arteries?' [5] Aims The original BASIL-1 trial, on which BASIL-2 is based, randomised 452 patients with severe limb ischaemia, mainly due to femoro-popliteal disease (in the thigh), to either an angioplasty first or a bypass surgery first revascularisation strategy [4]. The Bypass vs. Angioplasty in Severe Ischaemia of the Leg -2 (BASIL-2) Trial is a UK National Institute of Health Research, Health Technology Assessment funded, multi-centre randomised controlled trial (http://www.nets.nihr.ac.uk/projects/hta/123545) that will now compare, at the point of clinical equipoise, the clinical and cost-effectiveness of a 'vein bypass first' with a 'best endovascular treatment first' revascularisation strategy for severe limb ischaemia due to infra-popliteal (below the knee) disease (Fig. 1). ...
... Recruitment is aiming to take place over 3 years with 20 % recruited in the first year and 40 % recruited in each subsequent year. Non-event rates for amputation-free survival are assumed to be 0.72, 0.62, 0.53, 0.47 and 0.35 at years 1 to 5 based on data from the original BASIL-1 trial [4]. Allowing for a conservative estimate of 10 % drop-out rate for the primary outcome, a trial of 600 patients will have 90 % power to detect a reduction in amputation-free survival of one third (HR = 0.66 equivalent to an absolute difference of 12 % in amputation free survival at Year 3) with a 5 % significance level. ...
... Due to the advancement of PAD disruption of blood supply occurs from several weeks to months [3]. For PAD patients, Risk factor control, antiplatelet and statin drugs and excersie training [4][5][6][7] are the common conventional treatments at an early stage. But the Reconstruction of the blood circulation using endovascular or open surgical approaches will be required in more advanced stages of PAD [8,9]. ...
Peripheral Arterial Disease (PAD) is still a challenging condition affecting millions of people and leading to amputation or death. In patients with non reconstructable disease or failed revascularization, stem cell therapy (SCT) could help in promoting angiogenesis and limb salvage. However, there is limited data about the long-term benefits of SCT in such patients. Aim of this study is to evaluate the long-term survival and clinical outcomes in PAD patients who underwent stem cell therapy. All patients who underwent stem cell therapy using intramuscular injections of autologous bone-marrow mononuclear cells (BM-MNCs) for the treatment of PAD between January 2011 and November 2020 were include in the study. Electronic medical records (EMRs) and Telephonic phone follow up was used to get baseline clinical characteristics and follow up data. Out of 3627 PAD patient, 41 patients underwent stem cell therapy procedure between January 2011 to November 2020. Mean age was 48 years (range, 21 to 75 years) and 37 patients (90.24%) were males. The median follow-up period was 4.66 years (range, 6 months – 9.9 years). Indication for SCT was rest pain, gangrene or non-healing ulcer due to either non reconstructable disease or failed revascularization. All patients were given antiplatelets and statin therapy. Out of 41 PAD patients, 7 patients were lost to follow up. In the remaining, 34 patients, 29 (70.73%) patients were alive, and 5 patients were dead. Overall, 10 (24.39%) patients underwent ipsilateral amputation and 4 patients had persistent claudication pain. In the remaining patients’ ulcers healed and has no residual pain. Amputation free survival was 75.61%. The benefits of Autologous BM-MNCs stem cell therapy are sustained even in the long term with overall survival rate was 85.29% and the amputation free survival was 75.61% and should be considered for all CLI patients irrespective of age.
... 12 Additionally, a majority of diabetic patients who are not candidates for revascularization undergo major amputation within 12 months. 29 Non-revascularization therapies such as prostaglandin treatment, 30 mesenchymal stromal cells, 31 wound management, 32 and neuromodulation therapies such as spinal cord stimulation (SCS) [33][34][35] and dorsal root ganglion stimulation (DRG-S) 36 have been proposed to help patients avoid major amputations and related morbidity. ...
Introduction: Spinal cord stimulation (SCS) or Dorsal root ganglion stimulation (DRG-S) can improve limb salvage, microcirculatory blood flow, and pain relief in patients with peripheral arterial disease (PAD) who are not candidates for revascularization or who have persistent ischemic-related pain after revascularization This retrospective analysis presents 10-year data on the effectiveness and safety outcomes of neuromodulation for PAD at a single center.
Objective: This study evaluated the survival and amputation outcome of subjects who received neuromodulation therapy for the management of PAD. Descriptive outcomes such as Walking distance (m), pain intensity (NRS), opioid consumption (MME [morphine milligram equivalents]/d), and self-rated health (EQ-VAS) were also analysed.
Methods: This study retrospectively reviews the health data of a single cohort of 51 patients who received an SCS or DRG-S from 2007 to 2022 in a single German center. Survival rate was determined using the Kaplan Meier (KM) curve and major amputation was determined as the amputation of a major limb above the ankle. Patients who received a toe amputation were excluded from the amputation analysis. Pain, quality of life, walking distance, and opioid usage were assessed before implantation (baseline), 1, 6, and 12 months after implantation, and then annually.
Results: 51 patients (37 men [mean age 68.9 ± 10.2], 14 women [mean age (68.7 ± 14.6]) underwent SCS (n = 49) or DRG-S (n = 2) implantation due to persistent ischemic pain. The follow-up mean years ± SD is 4.04 ± 2.73. At baseline, patients were classified as Rutherford's Category 3 (n = 23), Category 4 (n = 15), or Category 5 (n = 9). At 24M, 42/47 patients did not require a major amputation following the implant. All patients reported complete pain relief from pain at rest. A total of 75% of patients were able to walk more than 200m and 87% of patients who used opioids at baseline were off this medication at 24 months. Overall, 93% of patients reported an improvement in their overall health assessment. These improved outcomes were sustained through years 3-10 for patients who have reported outcomes.
Conclusions: Our single center data supports the efficacy of spinal neuromodulation for improvements in limb salvage, pain relief, mobility, and quality of life. Also, the data show that neuromodulative therapy has a long-term therapeutic effect in patients with chronic limb pain with Rutherford class 3, 4, and 5 peripheral arterial disease (both reconstructable and non-reconstructable).
... The incidence of non-traumatic LE amputations among ESRD patients is thought to be 10 times higher than in the general population, even when controlled for diabetes [16,17]. ESRD is a significant poor prognostic factor for limb salvage and overall survival in patients with limb ischemia [18]. Survival in ESRD patients after open revascularization at one and three years is only 60% and 18%, respectively [3][4][5]. ...
Objective:
To analyze whether the rate of lower extremity (LE) ischemia is higher on the ipsilateral side after kidney transplantation.
Methods:
Our institutional transplant database was retrospectively queried for all patients who received a kidney transplant and underwent subsequent LE revascularization or major limb amputations between January 2004 and July 2020. The one-sample binomial test was used to test whether the LE ipsilateral to the transplanted kidney was at higher risk of peripheral arterial disease (PAD) complications necessitating intervention (major amputation or revascularization).
Results:
There were 1,964 patients who received a kidney transplant during the study period. Of these, 51 patients (3%) had subsequent LE arterial revascularizations or major amputations. The mean age was 58 ± 10 years, and 37 patients (73%) were male. A total of 33 patients had ipsilateral LE vascular interventions (26 major amputations and seven revascularizations) while 18 patients had contralateral vascular interventions (14 major amputations and four revascularizations) (P = 0.049). The average interval between transplantation and subsequent vascular intervention was 52 months for the ipsilateral intervention group and 41 months for the contralateral intervention group (P = 0.33).
Conclusions:
In patients who received kidney transplantation and required subsequent LE surgical intervention, we observed an association between the side of transplantation and the risk of future ipsilateral LE arterial insufficiency. Further studies are needed to determine the etiology of this association.
... Technological advancements in procedural materials and the minimally invasive nature of endovascular intervention have allowed for the provision of this service as a day-case, with a recent surge in this practice over recent years. 3 Spiliopoulos et al. demonstrated the feasibility of day-case procedures with a particular focus on balloon angioplasty. 4 In addition, Lin et al., successfully showed safety of endovascular intervention in office-based setting. ...
Background:
We aimed to investigate the safety of endovascular procedures undertaken in a single outpatient center located in a rural, underserved area. Endovascular procedures for Peripheral Arterial Disease (PAD) have become increasingly common in outpatient settings; their safety is yet to be determined in a rural, underserved area with no stand-by vascular surgeon on site.
Methods:
We undertook a retrospective case review of endovascular procedures for the investigation and management of lower extremity PAD between December 2012 and August 2015. Patients were classified by Rutherford score, degree of stenosis and length of lesions. Complications were major (requiring hospitalization) or minor, including perforation, distal embolization, hematoma, and allergic reactions, which could be treated immediately in the catheterization laboratory with no sequelae. Patients were monitored in the facility and followed up using clinical, biochemical and radiological parameters at 24 h and 1 month.
Results:
A total of 692 patients underwent endovascular procedures for the investigation and/or treatment of PAD, of which 608 were interventional. Of these patients, 10.20% experienced procedural complications, of which 0.66% were classified as major, including wire retention and retroperitoneal hemorrhage. In total, 99.34% were discharged safely on the same day as the procedure. No adverse events were reported at follow up.
Conclusion:
Endovascular procedures for PAD can be performed safely in a rural outpatient setting with low complication rates. Most complications are minor and do not require hospitalization. Outpatient procedures for PAD are safe and may widen access to specialist procedures in areas of socio-economic deprivation.
... PAD is another clinical manifestation of atherosclerosis which also includes coronary artery disease (CAD) and cerebrovascular disease, which further increase morbidity and mortality in the specific population [2]. Minimally invasive, endovascular interventions, when indicated, are preferred over surgical repair for the treatment of PAD in terms of efficacy, cost, and safety [3,4]. The mainstay of treatment for PAD remains balloon angioplasty either as a primary intervention or as an adjacent therapy for stents and other devices [5]. ...
Introduction: Percutaneous transluminal angioplasty (PTA) currently remains the endovascular treatment of choice in a large percentage of patients suffering from peripheral artery disease (PAD). However, the mechanism of angioplasty itself can cause some extent of arterial dissection leading to early vessel restenosis/reocclusion. Current endovascular imaging studies have reported a higher rate of arterial dissection than previously reported in literature and advocated the correlation of dissection with poor patency. Thus, there is the need of developing devices to minimize dissection and bailout stenting.
Areas covered: The present review focuses on newly-developed balloon angioplasty technologies designed to minimize arterial wall distress and consequently the rate of dissections. Available literature regarding three new specialty balloons is being reviewed, highlighting their value and limitations. Authors’ future perspective about the benefits of utilizing specialty balloons towards a metal free and dissection free future is also provided.
Expert opinion: By understanding the mechanism of angioplasty and thus developing devices which cause minimal or no arterial wall distress, the rate of dissections and bailout stenting can be minimized and long-term clinical outcomes of endovascular therapy can be optimized.
... No entanto, essa opção terapêutica pode estar relacionada a uma alta morbimortalidade, bem como demandar recursos substanciais. Além disso, tal durabilidade depende diretamente de uma constante vigilância do enxerto, de retornos ambulatoriais frequentes e de exames de imagem como o ultrassom Doppler vascular, além de requerer, muitas vezes, reintervenções repetidas 3 . ...
Resumo Contexto O stent primário é uma opção de tratamento bem estabelecida para a doença arterial periférica em território femoropoplíteo. Estudos nacionais são escassos. Objetivos Avaliar desfechos clínicos e radiológicos em curto e médio prazo em pacientes classificados como Rutherford 3-6, tratados com o uso de stent em lesões femoropoplíteas. Métodos A análise foi realizada com base em um banco de dados prospectivamente mantido de doentes tratados entre julho de 2012 e julho de 2015. O objetivo primário foi a perviedade. Os objetivos secundários foram melhora na classificação de Rutherford, índice tornozelo/braço, revascularização do vaso-alvo, taxa de salvamento do membro e óbito em até 24 meses. Resultados Foram incluídos 64 pacientes, sendo 61 com lesões TASC II A/B (95%). A taxa de perviedade primária em 6, 12 e 24 meses foi de 95,2%, 79,1% e 57,9%, respectivamente. A análise de regressão de Cox revelou uma menor perviedade em pacientes com doença oclusiva (RR, 6,64, IC 95%, 1,52-28,99, p = 0,02), bem como uma perda de perviedade cerca de seis vezes maior em doentes TASC B do que TASC A (RR, 5,95, IC 95%, 1,67-21,3, p = 0,0061). Em 12 meses, 90,38% dos doentes permaneceram assintomáticos. A taxa de salvamento do membro em 24 meses foi de 94,3% (IC 95%, 87,9-100%). A ausência de revascularização do vaso-alvo em 24 meses foi de 90,5% (IC 95%, 82,8-98,9%). Conclusões Os resultados foram compatíveis com estudos internacionais, apesar do estágio mais avançado da doença vascular observada em nosso grupo. Piores desfechos foram associados a doença oclusiva e lesões complexas.
... This diagnosis is associated with greater than 50% mortality at 5 years. [1][2][3] The prognosis for limb salvage is poor without revascularization as major amputation rates approach 50% and serve as an independent predictor of mortality. [4][5][6][7] In addition to advanced age and non-ambulatory status, many studies have also identified other co-morbidities as independent risk factors for increased mortality and/or major amputation in CLI patients, including heart failure (HF), end-stage renal disease (ESRD), coronary artery disease (CAD), and diabetes mellitus (DM). ...
The impact of heart failure (HF) on long-term survival in patients with critical limb ischemia (CLI) has not been well described. Outcomes stratified by left ventricular ejection fraction (EF) are also unknown. A single center retrospective chart review was performed for patients who underwent treatment for CLI from 2006 to 2013. Baseline demographics, procedural data and outcomes were analyzed. HF diagnosis was based on appropriate signs and symptoms as well as results of non-invasive testing. Among 381 CLI patients, 120 (31%) had a history of HF and 261 (69%) had no history of heart failure (no-HF). Within the HF group, 74 (62%) had HF with preserved ejection fraction (HFpEF) and 46 (38%) had HF with reduced ejection fraction (HFrEF). The average EF for those with no-HF, HFpEF and HFrEF were 59±13% vs 56±9% vs 30±9%, respectively. The likelihood of having concomitant coronary artery disease (CAD) was lowest in the no-HF group (43%), higher in the HFpEF group (70%) and highest in the HFrEF group (83%) ( p=0.001). Five-year survival was on average twofold higher in the no-HF group (43%) compared to both the HFpEF (19%, p=0.001) and HFrEF groups (24%, p=0.001). Long-term survival rates did not differ between the two HF groups ( p=0.50). There was no difference in 5-year freedom from major amputation or freedom from major adverse limb events between the no-HF, HFpEF and HFrEF groups, respectively. Overall, the combination of CLI and HF is associated with poor 5-year survival, independent of the degree of left ventricular systolic dysfunction.
... endovascular interventions are thought to carry a lower risk of morbidity and mortality. 4 in the last decade, new treatment options have been explored for patients with Cli for whom a surgical or endovascular revascularization is not an option. These include stem cell therapy, spinal cord stimulation, and ...
Patients with critical limb ischemia have a poor life expectancy, and aggressive revascularization is accepted to maintain their independence in the end stage of life. Bypass surgery and, more recently, endovascular interventions with angioplasty and stenting have become the treatment of choice to prevent amputation and resolve rest pain. Up to 20% of patients with critical limb ischemia are not suitable candidates for a vascular intervention because of extensive occlusions of the outflow in the crural and pedal vessels. This "desert foot" can be treated with a venous arterialization. In this review, we discuss the mechanism, the techniques, outcome, and complications of venous arterialization.
... Endovascular therapy was the first choice for patients with a limited life expectancy and those who required prosthetic grafts for a bypass. [14] Endovascular techniques have, however, evolved at a rapid pace since the BASIL study and drug‑eluting stents and balloons have improved the success rates of endovascular therapy for tibial disease. [15] ...
Fifteen percent of people with diabetes develop an ulcer in the course of their lifetime. Eighty-five percent of the major amputations in diabetes mellitus are preceded by an ulcer. Management of ulcers and preventing their recurrence is important for the quality of life of the individual and reducing the cost of care of treatment. The main causative factors of ulceration are neuropathy, vasculopathy and limited joint mobility. Altered bio-mechanics due to the deformities secondary to neuropathy and limited joint mobility leads to focal points of increased pressure, which compromises circulation leading to ulcers. Ulcer management must not only address the healing of ulcers but also should correct the altered bio-mechanics to reduce the focal pressure points and prevent recurrence. An analysis of 700 patients presenting with foot problems to the Diabetic Clinic of Ganga Hospital led to the stratification of these patients into four classes of incremental severity. Class 1 – the foot at risk, Class 2 – superficial ulcers without infection, Class 3 – the crippled foot and Class 4 – the critical foot. Almost 77.5% presented in either Class 3 or 4 with complicated foot ulcers requiring major reconstruction or amputation. Class 1 foot can be managed conservatively with foot care and appropriate foot wear. Class 2 in addition to measures for ulcer healing would need surgery to correct the altered bio-mechanics to prevent the recurrence. The procedures called surgical offloading would depend on the site of the ulcer and would need an in-depth clinical study of the foot. Class 3 would need major reconstructive procedures and Class 4 would need amputation since it may be life-threatening. As clinicians, our main efforts must be focused towards identifying patients in Class 1 and offer advice on foot care and Class 2 where appropriate surgical offloading procedure would help preserve the foot.
... The treatment of DFU combined with PAD is usually a challenge. Although revascularization such as percutaneous transluminal angioplasty or bypass surgery has become the prime therapy to decrease major amputations and promote ulcer healing, [24,25] sometimes the applications are limited because of the poor tolerance of contrast medium resulting from poor We demonstrated the immediate effects on foot peripheral circulation after Buerger exercise and a cohort follow-up that can help us to understand more about the long-term effects on patients with diabetes feet by continuing doing this exercise. Moreover, as a pilot-study evidence, we have quantitatively identified the immediate SPP increase after Buerger exercise and proved the physiologic hypothesis which easy-learning exercise can be beneficial to patients with diabetic feet. ...
Buerger exercise can improve the peripheral circulation of lower extremities. However, the evidence and a quantitative assessment of skin perfusion immediately after this exercise in patients with diabetes feet are still rare.
We recruited 30 patients with unilateral or bilateral diabetic ulcerated feet in Chang Gung Memorial Hospital, Chia-Yi Branch, from October 2012 to December 2013. Real-time dorsal foot skin perfusion pressures (SPPs) before and after Buerger exercise were measured and analyzed. In addition, the severity of ischemia and the presence of ulcers before exercise were also stratified.
A total of 30 patients with a mean age of 63.4 ± 13.7 years old were enrolled in this study. Their mean duration of diabetes was 13.6 ± 8.2 years. Among them, 26 patients had unilateral and 4 patients had bilateral diabetes foot ulcers. Of the 34 wounded feet, 23 (68%) and 9 (27%) feet were classified as Wagner class II and III, respectively. The real-time SPP measurement indicated that Buerger exercise significantly increased the level of SPP by more than 10 mm Hg (n = 46, 58.3 vs 70.0 mm Hg, P < 0.001). In terms of pre-exercise dorsal foot circulation condition, the results showed that Buerger exercise increased the level of SPP in severe ischemia (n = 5, 22.1 vs 37.3 mm Hg, P = 0.043), moderate ischemia (n = 14, 42.2 vs 64.4 mm Hg, P = 0.001), and borderline–normal (n = 7, 52.9 vs 65.4 mm Hg, P = 0.028) groups, respectively. However, the 20 feet with SPP levels more than 60 mm Hg were not improved significantly after exercise (n = 20, 58.3 vs 71.5 mm Hg, P = 0.239). As to the presence of ulcers, Buerger exercise increased the level of SPP in either unwounded feet (n = 12, 58.5 vs 66.0 mm Hg, P = 0.012) or wounded feet (n = 34, 58.3 vs 71.5 mm Hg, P < 0.001). The majority of the ulcers was either completely healed (9/34 = 27%) or still improving (14/34 = 41%).
This study quantitatively demonstrates the evidence of dorsal foot peripheral circulation improvement after Buerger exercise in patients with diabetes.
... Estimation of the risk of adverse postoperative outcome is of paramount importance in surgery. Even more, in patients with critical limb ischemia (CLI), in whom revascularization is needed, postoperative prognosis is crucial [3,4] . The prognosis of CLI is even compared to that of some malignant diseases as the mortality reaches 20%. ...
In patients with critical limb ischemia who undergone revascularization procedures, the assessment of risk factors that may affect the postoperative outcome is of great importance. The main objective in this study is to assess the utility of two specific risk scores, the Finnvasc score and the modified Prevent III score.
: We evaluated the applicability of these two risk scores in 150 patients who undergone an unilateral infrainguinal surgical revascularization procedure. The receiver operating characteristic curve analysis was used to estimate the predictive value of the scoring methods. A comparison between the risk scores, determine the areas under the curve. Medium-term prediction ability was analyzed for both scoring methods.
: The area under the curve of Finnvasc score for predicting amputation was 0.739 (95%CI:0.661-0.807) and of the modified PIII score 0.713 (95%CI:0.633-0.784); for restenosis we obtained 0.528 (95%CI:0.444-0.611), respectively 0.529 (95%CI:0.445-0.612) and for thrombosis 0.628 (95%CI:0.544-0.706) and 0.556 (95%CI:0.472-0.638), demonstrating that the Finnvasc score performs better in overall prediction. Heart failure is a strong independent predictor of amputation (p=0.0001, OR=26.90; 95%CI:5.81-124.2), restenosis (p=0.0003, OR=4.80; 95%CI:1.96-11.8) and mortality (p=0.01, OR=7.16; 95%CI:1.33-38.52).
: The accuracy of the two risk scoring methods in predicting the medium-term outcome of patients undergoing surgical infrainguinal revascularization is acceptable. The Finnvasc score is easier to be applied to the characteristics of our patients.
... [1,13] Endovascular intervention has many advantages over surgical management in whom medical treatment fail, it offers rapid convalescence less morbidity; (exposure to anesthesia and wound infection) and preserving the chance of future open vascular intervention if these techniques failed. [14] The a wire of the distal access. The two balloons abutted each other with 1 mm in between, and then both wires were pulled back in the shaft to be just below the balloon. ...
Context: Chronic total occlusions (CTOs) sometimes are a challenge for endovascular intervention, especially in developing countries where new devices used to cross CTOs are either unavailable or too expensive. Using basic endovascular tools remains the only solution in such cases when patients were at high risk for open surgical intervention. We present our experience of using double balloon technique to cross CTO lesions in the femoropopliteal segment after failure of known traditional techniques, i.e. intraluminal, subintimal angioplasty, and subintimal arterial flossing with antegrade–retrograde intervention (SAFARI technique). We looked for technical success of double balloon technique in such difficult CTO.
Aims: To assess the safety and applicability of double balloon technique in crossing long and complex CTOs lesions, where new crossing re-entry devices are unavailable.
Subjects and Methods: This is a retrospective study to look into cases between November 2013 and October 2015, in Kasr Ani Hospital, Cairo University, Egypt.
Results: The success rate of the technique was 100%.
Conventional Methods: Intraluminal, subintimal angioplasty, and SAFARI technique for crossing CTOs in the femoropopliteal territory were used in 350 lesions, but it failed in 30 where double balloon technique was used. The technical success rate of the technique was 100%.
Conclusions: Double balloon technique was safe and cheap. It should replace the use of new re-entry devices keeping them only in bail-out cases after the failure of this technique.
... Yaşam beklentisi <2 yıl, eşlik eden risk faktörleri yüksek, distal baypas için uygun safen veni bulunmayan olgularda endovasküler tedavi yeğlenebilir. Yaşam beklentisi >2 yıl, genel durumu iyi, uygun safen ven grefti bulunan olgularda uzun dönem sonuçları daha iyi olduğu için ekibin deneyimine göre cerrahi tedavi yeğlenebilir (110,111). Stenozu ya da oklüzyonu 10 cm uzunluğa kadar sınırlı olan, yüksek riskli olgularda PTA'nın uygulanması yeğlenebilir (112). PTA sonucunun suboptimal ve rezidü stenoz oranının >%50 olduğu, yinelenen PTA'lara karşın distal akıma engel olacak biçimde diseksiyon gelişen olgularda ise infrapopliteal stent yeğlenmelidir. ...
Study Group for Diabetic Foot Infections of the Turkish Society of Clinical Microbiology and Infectious Diseases has called for collaboration of the relevant specialist societies and the Ministry of Health to issue a national consensus report on the diagnosis, treatment and prevention of diabetic foot (DF) wounds and diabetic foot infections (DFIs) in Turkey. In the periodical meetings of the assigned representatives from all the parties, various questions as to pathogenesis, microbiology, assessment and grading, treatment, prevention and control of diabetic foot were identified. Upon reviewing related literature and international guidelines, these questions were provided with consensus answers. Several of the answers provided in the report are listed below: [1] Although there are many reasons for the development of DF wounds, the main reason is the combined effect of diabetes-related vascular disease and neuropathy. [2] Aerobic Gram-positive cocci are mostly responsible for superficial DFIs in patients with cellulitis and no history of antibiotic use. [3] Pseudomonas aeruginosa is one of the commonly encountered agents when between the toes of the patient are moist. [4] When the other potential reasons are eliminated, DFIs should be considered in presence of at least two of the classical signs of inflammation including redness, warmth, swelling, tenderness, and pain, or purulent discharge in the foot lesion. [5] Infections are classified into mild, moderate, or severe groups according to some criteria such as the depth and width of the wounds, and the presence of systemic findings of infection. [6] PEDIS system should be preferred as a classification system for its high predictive value in diabetes-related foot complications. [7] Culture samples from the DF wound should only be obtained when infection is clinically considered and, where possible, before starting antibiotic treatment. [8] Inflammatory biomarkers such as leukocyte count, C-reactive protein, erythrocyte sedimentation rate, and procalcitonin may be useful in distinguishing between colonization with infection. [9] Magnetic resonance imaging is a sensitive and specific method in patients unresponsive to treatment when osteomyelitis and deep soft tissue abscesses are considered. [10] The gold standard in the diagnosis of osteomyelitis is histopathological examination. [11] To provide wound healing and to save the limb, removal of dead and infected tissue with urgent and aggressive debridement, appropriate antibiotic therapy, metabolic control, and off-loading of pressure, the diagnosis and proper treatment of peripheral arterial disease, and restoration of the foot function are necessary. [12] A lot of different factors playing a role in etiopathogenesis complicate the approach to be developed in this type of lesions, and therefore it requires a team concept. [13] In the empirical treatment, the objective should be treating only the potential agents. Adequate tissue levels, low side effects and patient compliance must be observed; effective drugs should be used in specified doses and duration. [14] Debridement is an essential and integral part of wound treatment and is an important tool allowing the formation of healthy granulation tissue. [15] When the infected tissue cannot be completely cleared with the debridement and in cases when the patient could not cope with the remaining infection load, performing a limb amputation on a safe level of infection would be lifesaving. [16] If an arterial insufficiency is considered in a patient with a DF wound, early diagnosis and interventional treatment is necessary. [17] Hyperbaric oxygen therapy is used as an adjunctive treatment in combination with other treatments in DFI patients. [18] Topical negative pressure therapy is a useful adjunctive measure in selected patients. [19] Growth factors can be used in selected patients other than wounds that can be treated with cheaper and safer methods. [20] Maggot therapy may be considered as a debridement method in DF wound cases. [21] Patients with more than ten years of diabetes history have an increased risk of wound development or amputation. [22] DF problem is the only complication of diabetes that can be prevented through education.
... Despite the advances in access and lesion treatment, current procedural success using femoral access in CLI interventions remains disappointing at 80–90% [54], with historic failure rates reported up to 20–40% [10,[55][56][57]. Procedural failure may be due to inability to obtain access, inadequate access, or to lesion characteristics such as calcified and diffuse occlusive lesions that frequently extend to the popliteal artery or SFA [58]. ...
... In addition, the risk profile with this procedure is much less than that with more extensive open procedures [9]. Comparable outcomes have been obtained when PTA and bypass surgery are compared [10] The use of PTA has increased in the management of patients with CLI [11,12]; however, there is little data regarding outcomes of this intervention in the management of diabetic patients with CLI. ...
Purpose: This study sought to establish the outcome following percutaneous transluminal angioplasty (PTA) in patients with critical limb ischemia (CLI) and how diabetes may influence that outcome.
Method: A retrospective study included 49 consecutive patients with CLI who were managed by PTA between 2008 and 2011, with a follow-up period of 12 month. Analysis of data was done using the SPSS version 19 software. The χ² test , t-test , Z test, simple and multiple logistic regression analyses were performed.
Results: The study included 22 diabetic and 27 non-diabetic patients. The technical success was almost similar in both diabetic and non-diabetic groups (91% and 88% respectively). In the diabetic and non-diabetic groups, the limbs salvage rates were (72.7% and 88.9% respectively), rates of major amputation were (22.7% and 7.4% respectively), rates of minor amputation were (4.6% and 3.7% respectively) and ulcer healing rates were (90.0% and 93.3% respectively). There was higher percentage of ulcer or advance tissue necrosis among diabetics (P=0.014).
Conclusions: The technical success of angioplasty was almost similar in both groups. In both groups, having gangrene on initial clinical assessment is associated with seven folds increase in the risk of amputation when other factors are adjusted for.
The aim of this chapter is to provide an overview of patients with arteriopathy, especially in the infrapatellar segment, which is the most affected in diabetic patients. In this sense, we always try to analyze the degree of disease of the patient and, if limb salvage intervention is necessary, to evaluate the new technologies that promote higher rates of technical success with less tissue aggression. In addition to the TASK classification, which provides an idea of the degree of obstruction and thus facilitates therapeutic decision-making, the use of various classifications has been demonstrated, which aims to promote better communication between physicians about the state of ischemia and the degree of injury. The different techniques used were presented, thanks to the development of new materials, with more and more possibilities for saving limbs.
To compare the computed tomography (CT) number and the radiation dose between the 64 (group A) and 80-detector row (group B) during lower extremity computed tomography angiography (LE-CTA). We enrolled 144 patients underwent LE-CTA and compared the CT number for the popliteal arteries, radiation dose and the rate of the optimal CT number during the LE-CTA exceeding 200 HU between the two groups. The CT number for the popliteal arteries and mean dose-length product was significantly higher in Group A than in Group B (P < 0.01). The rate of the optimal CT number for the popliteal arteries was 23.6% with Group B scanner and 56.9% with Group A (P < 0.05). The 64-detector row CT was significantly higher in the CT number for the popliteal arteries, radiation dose and rate of the optimal CT number during the LE-CTA than the 80-detector row. Depiction ability did not improve by using a high CT scanner with a wider detector during LE-CTA.
Objectives:
The OPEN study evaluated the safety and efficacy of the S.M.A.R.T.® Flex Vascular Stent System in patients with femoropopliteal arterial disease.
Background:
Long-term data on endovascular treatments of femoropopliteal arterial disease are required to establish the repair durability.
Methods:
The OPEN study was a multicenter, single-arm, prospective study comparing primary safety and efficacy outcomes to performance goals (PG) developed for bare nitinol stents. Patients with symptoms due to a single, ≤180 mm length, de novo femoropopliteal arterial lesion with >70% stenosis were enrolled were enrolled and followed for 36 months. Subjects with lesions ≤150 mm served as the initial comparison cohort for the PG (other cohorts were analyzed if the PG was met).
Results:
257 subjects with lesions ≤180 mm were enrolled. The mean lesion length was 71 ± 46, and 52.5% had severe claudication. The primary safety endpoint (freedom from all-cause death, index limb amputation, and target lesion revascularization [TLR] through 30 days) was met in 98.8% (96.5%, 99.6%) of subjects in the comparison cohort, meeting the PG (88.0%). The primary efficacy endpoint (comparison cohort vessel patency at 12 months) was 68.4% (61.1%, 74.8%), where the lower limit of the 95% confidence interval did not meet the 66.0% PG. Freedom from TLR in the per-protocol cohort at 12-, 24-, 36-month was 84.7%, 74.6%, and 72.8%, respectively. The 24-month stent fracture rate was 4.3%, with no new fractures identified at 36 months.
Conclusion:
The results show promising long-term safety and effectiveness for the S.M.A.R.T.® Flex Vascular Stent System in patients with femoropopliteal arterial disease.
Acute limb ischemia (ALI) is a vascular emergency associated with high rates of limb loss and mortality. Management of these patients is challenging given the severe systemic illness resulting from tissue ischemia and the high incidence of preexisting comorbid conditions and underlying peripheral arterial disease. Expeditious diagnosis, anticoagulation, and revascularization are of utmost importance in reducing morbidity. Revascularization may be accomplished using open, endovascular, or hybrid techniques. Approach to revascularization depends on the severity of ischemia, location of occlusion, cause, chance of recovery, comorbidities, and available resources.
Objective:
To review quality of life (QOL) instruments for chronic limb-threatening ischemia (CLTI) patients and informal carers, and their use in QOL and cost-utility analysis (CUA) studies.
Background:
CLTI is a global health problem with significant morbidity affecting patients and informal carers. QOL is increasingly measured for holistic outcomes assessment and CUA. However, measurement instruments in CLTI are poorly understood.
Methods:
MEDLINE, EMBASE, PsycINFO, CINAHL, COSMIN, PROQOLID, CEA registry, and NHS EED databases were searched for all English language studies up to May 2021. Features of instruments, evidence of measurement property appraisal, and trends in use were assessed. Prospective protocol registration (Open Science Framework: https://doi.org/10.17605/OSF.IO/KNG9U).
Results:
A total of 146 studies on QOL instruments (n=43), QOL outcomes (n=97), and CUA (n=9) were included. Four disease-specific QOL instruments are available for lower extremity arterial disease (intermittent claudication or CLTI). VascuQoL-25 and VascuQoL-6 have been used in CLTI. There is no CLTI-specific instrument. Of 14 generic instruments, SF-36, EQ-5D-3L, NHP, and WHOQOL-BREF were most common. Studies reporting partial measurement property appraisal favored VascuQoL-25, VascuQoL-6, and SF-36. Feasibility considerations include mode of administration and responder burden. None of 4 available carer-specific instruments have been used in CLTI. Since 1992, the number of QOL studies has increased considerably, but CUA studies are scarce. Informal carers have not been assessed.
Conclusions:
This review provides a comprehensive reference for QOL measurement in CLTI that helps end-users with instrument selection, use, and interpretation. However, a CLTI-specific instrument is needed. There is an opportunity to benefit society through future CUA studies and evaluation of QOL in informal carers.
Background and objectives:
Endovascular therapy (EVT) first strategy has been widely adopted for the treatment of chronic limb threatening ischemia (CLTI) patients in real-world practice. This study aimed to investigate long-term outcomes of CLTI patients who underwent EVT and identify prognostic factors.
Methods:
From the retrospective cohorts of a Korean multicenter endovascular therapy registry, 1,036 patients with CLTI (792 men, 68.8 ± 9.5 years) were included. The primary endpoint was amputation-free survival (AFS) defined as the absence of major amputation or death. Secondary endpoints were major adverse limb events (MALE; a composite of major amputation, minor amputation, and reintervention).
Results:
Five-year AFS and freedom from MALE were 69.8% and 61%, respectively. After multivariate analysis, age (hazard ratio [HR], 1.476; p<0.001), end-stage renal disease (ESRD; HR, 2.340; p<0.001), Rutherford category (RC) 6 (HR, 1.456; p=0.036), and suboptimal EVT (HR, 1.798; p=0.005) were identified as predictors of major amputation or death, whereas smoking (HR, 0.594; p=0.007) was protective. Low body mass index (HR, 1.505; p=0.046), ESRD (HR, 1.648; p=0.001), femoropopliteal lesion (HR, 1.877; p=0.004), RC-6 (HR, 1.471; p=0.008), and suboptimal EVT (HR, 1.847; p=0.001) were predictors of MALE. The highest hazard rates were observed during the first 6 months for both major amputation or death and MALE. After that, the hazard rate decreased and rose again after 3-4 years.
Conclusions:
In CLTI patients, long-term outcomes of EVT were acceptable. ESRD, RC-6, and suboptimal EVT were common predictors for poor clinical outcomes.
Trial registration:
ClinicalTrials.gov Identifier: NCT02748226.
Objective:
To investigate the clinical effect of extracorporeal circulation compression perfusion (ECCP) in the treatment of diabetic foot.
Methods:
We retrospectively evaluated 89 patients with diabetic foot admitted from January 2017 to April 2019. The patients were grouped according to whether they received ECCP treatment; experimental group: 27 patients, controls: 62 patients. After applying the inclusion criteria and exclusion criteria, there were 21 patients in the experimental group and 21 patients in the control group. Foot microcirculation was evaluated by measuring the percutaneous oxygen partial pressure (TcPO2) and infrared thermography (IRT). Wound healing time and ulcer recurrence rate 1 year after discharge were compared between the groups.
Results:
TcPO2 and IRT values in the experimental group differed significantly compared with the control group. Foot ulcer healing time in the experimental group was shorter than that in the control group (17.10 ± 3.08 days vs 25.38 ± 4.40 days, respectively), and the recurrence rate after 1 year in the experimental group was lower than that in the control group (2/21, 9.5% vs 9/21, 42.8%, respectively).
Conclusion:
ECCP improved foot microcirculatory perfusion in diabetic foot treatment. ECCP has clinical practicality and may accelerate wound healing speed and reduce ulcer recurrence.
Objetivo:
La terapia endovascular ofrece menor costo y reducción en la morbimortalidad. El uso del stent medicado Zilver PTX muestra resultados prometedores con permeabilidad del 89.9% a un año. El objetivo es analizar la permeabilidad a 6 meses y la presencia de complicaciones con el uso del stent medicado Zilver PTX en comparación a la derivación femoropoplítea sintética.
Métodos:
Estudio retrospectivo que abarca dos grupos de 15 pacientes cada uno, con una edad promedio de 66 años, todos presentan diagnóstico de enfermedad arterial periférica (EAP) sintomática. El grupo control fue sometido a revascularización con injerto sintético, mientras el grupo de estudio fue tratado con stent medicado Zilver PTX. Ambos grupos fueron vigilados por un periodo de 6 meses.
Resultados:
En comparación, ambos métodos son eficaces en el tratamiento de la EAP del sector femoropoplíteo. Para el grupo tratado con stent medicado, se encontró disminución en días de estancia intrahospitalaria y tendencia a incrementar la clase funcional. La permeabilidad primaria fue del 87 vs. el 93% en la derivación abierta y grupo manejado con stent medicado Zilver PTX, respectivamente. Como permeabilidad secundaria se encontró 93% vs. 100%.
Conclusiones:
Ambos métodos son eficaces para tratar la enfermedad femoropoplítea. Nuestros resultados favorecen el uso de stent medicado en comparación a derivación con injerto sintético.
The most morbid form of peripheral arterial disease (PAD) remains critical limb ischemia (CLI) associated with rest pain, gangrene or limb loss. This chapter reviews the basic epidemiology of distal tibial and forefoot disease, outlines the indications for percutaneous therapy of this vascular territory, and explores procedural considerations for modern distal extremity endovascular interventions. Patients with history and physical exam findings concerning for CLI should generally have non‐invasive testing to establish a diagnosis. The ankle‐brachial index (ABI) is a simple yet powerful tool and usually the first test of choice to detect PAD. Contralateral femoral access remains the most common approach to treat infrainguinal PAD, but may have limitations when trying to treat infrapopliteal lesions. To address the limitations of percutaneous transluminal angioplasty (PTA), stenting has been employed to treat flow‐limiting dissections or persistent restenosis. To combat the risk of restenosis, antineoproliferative therapy has been explored in both drug‐eluting stents (DESs) and drug‐eluting balloons (DEBs).
Increasingly stringent restrictions of duty hours for residents have led to decreasing experience with complex open vascular interventions; simulation is a promising avenue for both skills training and skill assessment. Various different forms of simulation are now available including benchtop models, animal models, cadavers, and high-fidelity simulators. This chapter reviews the available modalities, the evidence supporting their use in both open and endovascular surgical training, components of a successful simulation training program, and the application of simulation training in the context of two academic centers – LSU and OHSU.
The evolving demands of surgical training have led to the successful implementation of skills examinations in the areas of laparoscopic and endoscopic surgery. Currently, there is no similar formal skills assessment in vascular surgery, despite endovascular intervention replacing open surgery in treatment of many vascular conditions. The adoption of less invasive techniques to treat aneurysm and occlusive disease has resulted in new training paradigms and technical challenges for trainees. The duty hour restriction for trainees and declining numbers of complex open vascular interventions have added to the challenges of vascular surgery training. Simulation is a promising avenue for both skills training and assessment. The ability to evaluate the fundamental skills of trainees would be an important step to ensure a degree of uniformity in trainees' technical abilities. The role of simulation-based training in acquiring, testing, and refining these skills is still in its infancy in the vascular surgery training paradigm. This article aims to impart a deeper understanding of the conditions for developing and implementing the fundamentals of vascular and endovascular surgery, and to provide guidance regarding the role of simulation-based training in a rapidly evolving specialty. There are various forms of simulation available, including benchtop models, high-fidelity simulators, and virtual-reality simulators, and each requires a different method of proficiency assessment. Both open surgery and endovascular skills can be assessed and the application of successful implementation in academic vascular surgery training program is presented.
With growing use of drug-coated balloons (DCB) for femoropopliteal (FP) artery interventions, there is limited information on rates of real-world adjunctive stent use and its association with short and long-term outcomes. We report on 225 DCB treated FP lesions in 224 patients from the Excellence in Peripheral Artery Disease (XLPAD) registry (NCT01904851) between 2014 and 2016. Cochran–Mantel–Haenszel and Wilcoxon rank sum statistics were used to compare stented (planned or ‘bail-out’) versus non-stented DCB treated lesions. Stents were implanted in 31% of FP DCB interventions. Among the 70 stents implanted, 46% were for ‘bail-out’ indications and 54% were planned. Lesions treated with stents were longer (mean 150 mm vs 100 mm; p < 0.001) and less likely to be in-stent restenosis lesions (10% vs 28%; p=0.003). Stenting was significantly more frequent in complex FP lesions, including chronic total occlusions (66% vs 34%; p < 0.001). For bail-out stenting, interwoven nitinol stents were the most common type (50%) followed by drug-eluting stents (34%) and bare-metal stents (22%). There were no differences in peri-procedural complication rates or 12-month target limb revascularization rates (18.6% vs 11.6%; p=0.162) or 12-month amputation rates (11.4% vs 11%; p=0.92) between lesions where adjunctive stenting was used versus lesions without adjunctive stenting, respectively. In conclusion, in a contemporary ‘real-world’ adjudicated multicenter US registry, adjunctive stenting was necessary in nearly a third of the lesions, primarily for the treatment of more complex FP lesions, with similar short and intermediate-term clinical outcomes compared with non-stented lesions.
Objectives
There is paucity of information regarding critical limb ischemia-related readmission rates in patients admitted with critical limb ischemia. We studied 30-day critical limb ischemia-related readmission rate, its predictors, and clinical outcomes using a nationwide real-world dataset.
Methods
We did a secondary analysis of the 2013 Nationwide Readmissions Database. We included all patients with a primary diagnosis of extremity rest pain, ulceration, and gangrene secondary to peripheral arterial disease. From this group, all patients readmitted with similar diagnosis within 30 days were recorded.
Results
Of the total 25,111 index hospitalization for critical limb ischemia, 1270 (5%) were readmitted with a primary diagnosis of critical limb ischemia within 30 days. The readmission rate was highest (9.5%) for the group that did not have any intervention (revascularization or major amputation) and was lowest for surgical revascularization and major amputation groups (2.6% and 1.3%, P value <0.001 for all groups). Severity of critical limb ischemia at index admission was associated with a significantly higher rate of 30-day readmission. Critical limb ischemia-related readmission was associated with a higher rate of major amputation (29.6% vs. 16.2%, P<0.001), a lower rate of any revascularization procedure (46% vs. 62.6%, P<0.001), and a higher likelihood of discharge to a skilled nursing facility (43.2% vs. 32.2%, P<0.001) compared to index hospitalization.
Conclusions
In patients with primary diagnosis of critical limb ischemia, 30-day critical limb ischemia-related readmission rate was affected by initial management strategy and the severity of critical limb ischemia. Readmission was associated with a significantly higher rate of amputation, increased length of stay, and a more frequent discharge to an alternate care facility than index admission and thus may serve as a useful quality of care metric in critical limb ischemia patients.
Background
Society for Vascular Surgery practice guidelines for the medical treatment of intermittent claudication give a GRADE 1A recommendation for smoking cessation. Active smoking is therefore expected to be low in patients suffering from intermittent claudication selected for vascular surgical intervention. The aim of this study is to evaluate the prevalence of smoking in patients undergoing intervention for intermittent claudication at the national level and to determine the relationship between smoking status and intervention.
Methods
The Vascular Quality Initiative (VQI) registries for infra-inguinal bypass, supra-inguinal bypass, and peripheral vascular intervention (PVI) were queried to identify patients who underwent invasive treatment for intermittent claudication. Patient factors, procedure type (bypass versus PVI), and level of disease (supra-inguinal versus infra-inguinal) were evaluated for associations with smoking status (active smoking or nonsmoking) by univariate and covariate analysis.
Results
Between 2010 and 2015, 101,055 procedures were entered in the 3 registries, with 40,269 (40%) performed for intermittent claudication. Complete data for analysis were present in 37,632 cases. At the time of intervention, 44% of patients were active smokers, with wide variation by regional quality group (16–53%). In covariate analysis, active smoking at treatment was associated with age <70 years (prevalence ratio [PR] 2.42), male gender (PR 1.03), chronic obstructive pulmonary disease (PR 1.35), absence of prior cardiovascular procedures (PR 1.15), poor medication usage (PR 1.10), preoperative ankle-brachial index (ABI) <0.9 (PR 1.19), and supra-inguinal disease (PR 1.14). Invasiveness of treatment (PVI versus bypass procedures) was not significantly associated with smoking status. During follow-up, 36% of patients had quit smoking. Predictors of smoking cessation included age ≥70 years (RR 1.45), ABI ≥0.9 (RR 1.12), and bypass procedures (RR 1.22).
Conclusions
At the time of treatment, 44% of patients undergoing intervention for intermittent claudication in the VQI were active smokers and there was a wide regional variation. Prevalence of active smoking was greater in the presence of younger age, fewer comorbidities, lower ABI, and supra-inguinal disease. Type of procedure performed, and in turn level of invasiveness required, did not appear to be influenced by smoking status. Elderly patients and those undergoing open procedures were more likely to quit smoking during follow up. These findings suggest opportunities for greater smoking cessation efforts before invasive therapies for intermittent claudication.
Objective:
Although an increasing number of patients with peripheral arterial disease undergo multiple revascularization procedures, the effect of prior interventions on outcomes remains unclear. The purpose of this study was to evaluate perioperative outcomes of bypass surgery in patients with and those without prior ipsilateral treatment.
Methods:
Patients undergoing nonemergent infrainguinal bypass between 2011 and 2014 were identified in the National Surgical Quality Improvement Program Targeted Vascular module. After stratification by symptom status (chronic limb-threatening ischemia [CLTI] and claudication), patients undergoing primary bypass were compared with those undergoing secondary bypass. Within the secondary bypass group, further analysis compared prior bypass with prior endovascular intervention. Multivariable logistic regression analysis was used to establish the independent association between prior ipsilateral procedure and perioperative outcomes.
Results:
A total of 7302 patients were identified, of which 4540 (62%) underwent primary bypass (68% for CLTI), 1536 (21%) underwent secondary bypass after a previous bypass (75% for CLTI), and 1226 (17%) underwent secondary bypass after a previous endovascular intervention (72% for CLTI). Prior revascularization on the same ipsilateral arteries was associated with increased 30-day major adverse limb event in patients with CLTI (9.8% vs 7.4%; odds ratio [OR], 1.4 [95% confidence interval (CI), 1.1-1.7]) and claudication (5.2% vs 2.5%; OR, 2.1 [95% CI, 1.3-3.5]). Similarly, secondary bypass was an independent risk factor for 30-day major reintervention (CLTI: OR, 1.4 [95% CI, 1.1-1.8]; claudication: OR, 2.1 [95% CI, 1.3-3.5]), bleeding (CLTI: OR, 1.4 [95% CI, 1.2-1.6]; claudication: OR, 1.7 [95% CI, 1.3-2.4]), and unplanned reoperation (CLTI: OR, 1.2 [95% CI, 1.0-1.4]; claudication: OR, 1.6 [95% CI, 1.1-2.1]), whereas major amputation was increased in CLTI patients only (OR, 1.3 [95% CI, 1.01-1.8]). Postoperative mortality was not significantly different in patients undergoing secondary compared with primary bypass (CLTI: 1.7% vs 2.2% [P = .22]; claudication: 0.4% vs 0.6% [P = .76]). Among secondary bypass patients with CLTI, those with prior bypass had higher 30-day reintervention rates (7.8% vs 4.9%; OR, 1.5 [95% CI, 1.0-2.2]) but fewer wound infections (7.3% vs 12%; OR, 0.6 [95% CI, 0.4-0.8]) compared with patients with prior endovascular intervention.
Conclusions:
Prior revascularization, in both patients with CLTI and patients with claudication, is associated with worse perioperative outcomes compared with primary bypass. Furthermore, prior endovascular intervention is associated with increased wound infections, whereas those with prior bypass had higher reintervention rates. The increasing prevalence of patients undergoing multiple interventions stresses the importance of the selection of patients for initial treatment and should be factored into subsequent revascularization options in an effort to decrease adverse events.
Unlabelled:
Since 1980, the American College of Cardiology (ACC) and American Heart Association (AHA) have translated scientific evidence into clinical practice guidelines with recommendations to improve cardiovascular health. These guidelines, based on systematic methods to evaluate and classify evidence, provide a cornerstone of quality cardiovascular care. In response to reports from the Institute of Medicine, and a mandate to evaluate new knowledge and maintain relevance at the point of care, the ACC/AHA Task Force on Clinical Practice Guidelines (Task Force) modified its methodology.– The relationships among guidelines, data standards, appropriate use criteria, and performance measures are addressed elsewhere.
Intended use:
Practice guidelines provide recommendations applicable to patients with or at risk of developing cardiovascular disease. The focus is on medical practice in the United States, but guidelines developed in collaboration with other organizations may have a broader target. Although guidelines may be used to inform regulatory or payer decisions, the intent is to improve quality of care and align with patients' interests. Guidelines are intended to define practices meeting the needs of patients in most, but not all, circumstances, and should not replace clinical judgment. Guidelines are reviewed annually by the Task Force and are official policy of the ACC and AHA. Each guideline is considered current until it is updated, revised, or superseded by published addenda, statements of clarification, focused updates, or revised full-text guidelines. To ensure that guidelines remain current, new data are reviewed biannually to determine whether recommendations should be modified. In general, full revisions are posted in 5-year cycles.–
Modernization:
Processes have evolved to support the evolution of guidelines as “living documents” that can be dynamically updated. This process delineates a recommendation to address a specific clinical question, followed by concise text (ideally <250 words) and hyperlinked to supportive evidence. This approach accommodates time constraints on busy clinicians and facilitates easier access to recommendations via electronic search engines and other evolving technology.
Evidence review:
Writing committee members review the literature; weigh the quality of evidence for or against particular tests, treatments, or procedures; and estimate expected health outcomes. In developing recommendations, the writing committee uses evidence-based methodologies that are based on all available data.– Literature searches focus on randomized controlled trials (RCTs) but also include registries, nonrandomized comparative and descriptive studies, case series, cohort studies, systematic reviews, and expert opinion. Only selected references are cited. The Task Force recognizes the need for objective, independent Evidence Review Committees (ERCs) that include methodologists, epidemiologists, clinicians, and biostatisticians who systematically survey, abstract, and assess the evidence to address systematic review questions posed in the PICOTS format (P=population, I=intervention, C=comparator, O=outcome, T=timing, S=setting).,– Practical considerations, including time and resource constraints, limit the ERCs to evidence that is relevant to key clinical questions and lends itself to systematic review and analysis that could affect the strength of corresponding recommendations.
Guideline-directed management and treatment:
The term “guideline-directed management and therapy” (GDMT) refers to care defined mainly by ACC/AHA Class I recommendations. For these and all recommended drug treatment regimens, the reader should confirm dosage with product insert material and carefully evaluate for contraindications and interactions. Recommendations are limited to treatments, drugs, and devices approved for clinical use in the United States.
Class of recommendation and level of evidence:
The Class of Recommendation (COR; ie, the strength of the recommendation) encompasses the anticipated magnitude and certainty of benefit in proportion to risk. The Level of Evidence (LOE) rates evidence supporting the effect of the intervention on the basis of the type, quality, quantity, and consistency of data from clinical trials and other reports (Table 1).– Unless otherwise stated, recommendations are sequenced by COR and then by LOE. Where comparative data exist, preferred strategies take precedence. When >1 drug, strategy, or therapy exists within the same COR and LOE and no comparative data are available, options are listed alphabetically.
Relationships with industry and other entities:
The ACC and AHA sponsor the guidelines without commercial support, and members volunteer their time. The Task Force zealously avoids actual, potential, or perceived conflicts of interest that might arise through relationships with industry or other entities (RWI). All writing committee members and reviewers are required to disclose current industry relationships or personal interests, from 12 months before initiation of the writing effort. Management of RWI involves selecting a balanced writing committee and assuring that the chair and a majority of committee members have no relevant RWI (Appendix 1). Members are restricted with regard to writing or voting on sections to which their RWI apply. For transparency, members' comprehensive disclosure information is available online. Comprehensive disclosure information for the Task Force is also available online. The Task Force strives to avoid bias by selecting experts from a broad array of backgrounds representing different geographic regions, sexes, ethnicities, intellectual perspectives/biases, and scopes of clinical practice, and by inviting organizations and professional societies with related interests and expertise to participate as partners or collaborators.
Individualizing care in patients with associated conditions and comorbidities:
Managing patients with multiple conditions can be complex, especially when recommendations applicable to coexisting illnesses are discordant or interacting. The guidelines are intended to define practices meeting the needs of patients in most, but not all, circumstances. The recommendations should not replace clinical judgment.
Clinical implementation:
Management in accordance with guideline recommendations is effective only when followed. Adherence to recommendations can be enhanced by shared decision making between clinicians and patients, with patient engagement in selecting interventions on the basis of individual values, preferences, and associated conditions and comorbidities. Consequently, circumstances may arise in which deviations from these guidelines are appropriate. The reader is encouraged to consult the full-text guideline for additional guidance and details with regard to lower extremity peripheral artery disease (PAD) because the executive summary contains limited information.
Without formal guidelines, physicians currently must resort to a combination of “trial-and-error” and a “use what’s in stock” approach to patient, wire, and device selection. This has been implicated in poor outcomes, including high technical failure and reintervention rates. In this article, we speculate on how plaque pathophysiology and morphology might facilitate an objective, tailored approach to wire, drug, and device selection. Yahagi et al recently updated their modified American Heart Association classification scheme for atherosclerotic lesions. Using this clas- sification scheme, we take a mechanistic approach to
discussing adjunctive wire, drug, and device selection considerations for specific plaque morphologies.
Background Estimating sample size is an integral requirement in the planning stages of quantitative studies. However, although abundant literature is available that describes techniques for calculating sample size, many are in-depth and have varying degrees of complexity. Aim To provide an overview of four basic parameters that underpin the determination of sample size and to explain sample-size estimation for three study designs common in nursing research. Discussion Researchers can estimate basic sample size if they have a comprehension of four parameters, such as significance level, power, effect size, and standard deviation (for continuous data) or event rate (for dichotomous data). In this paper, these parameters are applied to determine sample size for the following well-established study designs: A comparison of two independent means, the paired mean study design and a comparison of two proportions. Conclusion An informed choice of parameter values to input into estimates of sample size enables the researcher to derive the minimum sample size required with sufficient power to detect a meaningful effect. An understanding of the parameters provides the foundation from which to generalise to more complex size estimates. It also enables more informed entry of required parameters into sample size software. Implications for practice Underpinning the concept of evidence-based practice in nursing and midwifery is the application of findings that are statistically sound. Researchers with a good understanding of parameters, such as significance level, power, effect size, standard deviation and event rate, are enabled to calculate an informed sample size estimation and to report more clearly the rationale for applying any particular parameter value in sample size determination.
Purpose
To investigate the clinical outcomes of endovascular therapy (EVT) in octogenarians and nonoctogenarians with peripheral arterial disease.
Methods
A retrospective analysis of 511 patients (654 affected legs) who underwent EVT between July 2005 and December 2013 was conducted in a prospectively maintained database. Immediate results and long-term vascular outcomes were analyzed and compared between octogenarians and nonoctogenarians.
Results
Octogenarians were more likely to be female and have atrial fibrillation (AF), whereas nonoctogenarians had higher rates of obesity, claudication, and medical comorbidities. There were no differences in the rates of EVT success, 30-day major adverse vascular events, and 6-month functional improvement between groups. Over the 10-year follow-up period, the rates of 3-year limb salvage, sustained clinical success, freedom from major cerebrovascular and cardiovascular events, and composite vascular events were similar between groups, but the survival rate was better in nonoctogenarians than in octogenarians (73% vs 63%, respectively, P=0.004). In Cox regression analysis, dependence on dialysis and AF were significant predictors of death (odds ratio [OR] 4.44 in dialyzed and 2.83 in AF patients), major cerebrovascular and cardiovascular events (OR 3.49 and 2.45), and composite vascular events (OR 3.14 and 2.25).
Conclusion
EVT in octogenarians was feasible, without an increased risk of periprocedural complications. The rates of limb salvage, sustained clinical success, and long-term vascular events were comparable between groups. Dialysis dependence and AF are independent predictors for poor prognosis in patients with peripheral arterial disease. However, these observations require further confirmation in larger scale studies.
Mikrochirurgie bei Patienten mit peripherer arterieller Verschlusskrankheit (pAVK) zeichnet sich durch einige Besonderheiten im Vergleich zu Gewebetransplantationen bei gefäßgesunden Patienten aus. Von Relevanz sind hier besonders die Problematik des kompromittierten Einstroms, der Gefäßwandbeschaffenheit mit unterschiedlichen Verkalkungen und Wandverdickungen sowie die Strömungswiderstände im abführenden Gefäßschenkel. Während in der Anfangszeit der Mikrochirurgie die Anastomosierung von Mikrogefäßen an atherosklerotisch veränderte Empfänger- oder Spendergefäße als relative Kontraindikation angesehen wurde, gelten heute durch die zunehmende Standardisierung des Vorgehens und die Verbreitung der Mikrochirurgie auch fortgeschrittene Gefäßveränderungen bei kritisch kranken Patienten nicht mehr als eine Kontraindikation gegen mikrochirurgische Rekonstruktionen. Hierzu wurden mittlerweile vermehrt interdisziplinäre Konzepte entwickelt, die in diesem Abschnitt beleuchtet werden sollen.
Objective:
This study aimed to examine acellular extracellular matrix based hydrogels as potential therapies for treating peripheral artery disease (PAD). We tested the efficacy of using a tissue specific injectable hydrogel, derived from decellularized porcine skeletal muscle (SKM), compared to a new human umbilical cord derived matrix (hUC) hydrogel, which could have greater potential for tissue regeneration because of its young tissue source age.
Background:
The prevalence of PAD is increasing and can lead to critical limb ischemia (CLI) with potential limb amputation. Currently there are no therapies for PAD that effectively treat all of the underlying pathologies, including reduced tissue perfusion and muscle atrophy.
Methods:
In a rodent hindlimb ischemia model both hydrogels were injected 1-week post-surgery and perfusion was regularly monitored with laser speckle contrast analysis (LASCA) to 35 days post-injection. Histology and immunohistochemistry were used to assess neovascularization and muscle health. Whole transcriptome analysis was further conducted on SKM injected animals on 3 and 10 days post-injection.
Results:
Significant improvements in hindlimb tissue perfusion and perfusion kinetics were observed with both biomaterials. End point histology indicated this was a result of arteriogenesis, rather than angiogenesis, and that the materials were biocompatible. Skeletal muscle fiber morphology analysis indicated that the muscle treated with the tissue specific, SKM hydrogel more closely matched healthy tissue morphology. Short term histology also indicated arteriogenesis rather than angiogenesis, as well as improved recruitment of skeletal muscle progenitors. Whole transcriptome analysis indicated that the SKM hydrogel caused a shift in the inflammatory response, decreased cell death, and increased blood vessel and muscle development.
Conclusion:
These results show the efficacy of an injectable ECM hydrogel alone as a potential therapy for treating patients with PAD. Our results indicate that the SKM hydrogel improved functional outcomes through stimulation of arteriogenesis and muscle progenitor cell recruitment.
Purpose
To investigate the prevalence and the current status of treatment of diabetic foot in Korea using Medicare claim data provided by the Health Insurance Review and Assessment Service.
Materials and Methods
Diabetic foot patients were selected from the 2011 one-year data with disease classification code based on the Korean Statistical Classification of Disease and Related Health Problems-6 system. Diabetic foot patient was defined as an adult (> 19-year-old) with specific disease codes of diabetic foot or with disease codes of diabetes, with foot ulcer/gangrene. Treatments for diabetic foot from the 5-year data between 2007 and 2011 focused on wound care including orthopedic foot surgery, lower extremity (LE) arterial revascularization procedure and major LE amputation.
Results
Diabetic patients in 2011 were 3763445, and diabetic foot patients were 108346 (2.9%). In the treatment details for the diabetic foot patients, local wound care alone were included in 104430 patients (96.4%), LE revascularization procedures were included in 2782 patients (2.6%) and major LE amputation were included in 1260 patients (1.2%). Of patients with major LE amputation, 1134 (90.1%) had no record of LE revascularization procedure. Of patients who had LE revascularization procedure, 126 (4.5%) had major LE amputation.
Conclusion
The annual prevalence of diabetic foot in 2011 in South Korea was 2.9%, which was similar to findings of other prevalence study of western countries. LE arterial revascularization procedure was performed in only a minority of diabetic foot patients. There is lack of awareness of LE arterial occlusive disease and the necessity of revascularization in treatments of diabetic foot.
Background:
Critical limb ischemia (CLI) is a life- and limb-threatening condition affecting 1% to 10% of the population with peripheral arterial disease. Traditional revascularization options are not possible for up to 50% of CLI patients, in which case, the use of cellular therapies, such as bone marrow-derived mesenchymal stem cells (MSCs), hold great promise as an alternative revascularization therapy. However, no randomized, controlled phase 3 trials to date have demonstrated an improvement in limb salvage with cellular therapies. This may be due to poor cell quality (ie, inability to generate a sufficient number of angiogenic MSCs) or to the inadequate retention and viability of MSCs after delivery, or both. Because concerns remain about the expansion and angiogenic potential of autologous MSCs in the CLI population, the objective of this study was to examine the effect of our novel culture media supplement, pooled human platelet lysate (PL), in lieu of the standard fetal bovine serum (FBS), to improve the expansion potential of MSCs from CLI patients. We also characterized the in vitro angiogenic activity of MSCs from the tibia of amputated CLI limbs compared with MSCs from healthy donors.
Methods:
MSCs were obtained from the tibia of four CLI patients (ISC) and four ISC patients with diabetes mellitus (ISC+DM) undergoing major amputation. Healthy MSCs were aspirated from the iliac crest of four young and healthy donors. MSCs were isolated and expanded in culture with PL or FBS. MSCs from passage 3 to 6 were used for phenotypic marker expression and for adipogenic and osteogenic differentiation and were tested for their in vitro angiogenic activity on human microdermal endothelial cells. In parallel MSCs were cultured to passage 11 for population-doubling calculations.
Results:
MSCs from ISC and ISC+DM patients and from healthy patients exhibited appropriate expression of cell surface markers and differentiation capacity. Population doublings were significantly greater for PL-stimulated compared with FBS-stimulated MSCs in all groups. Biologically active amounts of angiogens were identified in the secretome of all MSCs without consistent trends among groups. PL expansion did not adversely affect the angiogenic activity of MSCs compared with FBS. The ISC and ISC+DM MSCs demonstrated angiogenic effects on endothelial cells similar to those of healthy and ISC MSCs.
Conclusion:
PL promotes the rapid expansion of MSCs from CLI and healthy persons. Importantly, MSCs expanded from CLI patients demonstrate the desired angiogenic activity compared with their healthy counterparts. We conclude that autologous MSCs from CLI patients can be sufficiently expanded with PL and be expected to deliver requisite angiogenic effects in vivo. We expect the improved expansion of ISC and ISC+DM with PL to be helpful in improving the successful delivery of autologous MSCs to patients with CLI.
DOI: 10.5152/kd.2015.29
Diyabetik Ayak Yarası ve İnfeksiyonunun Tanısı, Tedavisi ve
Önlenmesi: Ulusal Uzlaşı Raporu
Diagnosis, Treatment and Prevention of Diabetic Foot Wounds and Infections:
Turkish Consensus Report
Neşe Saltoğlu1, Önder Kılıçoğlu2, Selçuk Baktıroğlu3, Zeynep Oşar-Siva4, Şamil Aktaş3,5, Muzaffer Altındaş6,
Caner Arslan7, Turan Aslan1, Selda Çelik8, Aynur Engin1, Haluk Eraksoy1, Önder Ergönül1, Bülent Ertuğrul1,
Serdar Güler9, Ayten Kadanalı1, Lütfiye Mülazımoğlu1, Nermin Olgun8, Oral Öncül1, Ali Öznur2, İlhan Satman10,
İrfan Şencan11, Özlem Tanrıöver12, Özge Turhan1, Abdullah Kemal Tuygun7, Hasan Tüzün7, Ahmet Çınar Yastı13, Temel Yılmaz14
1 Türk Klinik Mikrobiyoloji ve İnfeksiyon Hastalıkları Derneği, Diyabetik Ayak İnfeksiyonları Çalışma Grubu (İstanbul Üniversitesi,
Bezmiâlem Vakıf Üniversitesi, Cumhuriyet Üniversitesi, Koç Üniversitesi, Adnan Menderes Üniversitesi, Kafkas Üniversitesi /
Ümraniye Eğitim ve Araştırma Hastanesi, Marmara Üniversitesi), İstanbul, Türkiye
2 Türk Ortopedi ve Travmatoloji Birliği Derneği (İstanbul Üniversitesi), Ankara, Türkiye
3 Yara Bakımı ve Doku Onarımı Derneği (İstanbul Üniversitesi), Ankara, Türkiye
4 Türk Diyabet Cemiyeti (İstanbul Üniversitesi), İstanbul, Türkiye
5 Sualtı ve Hiperbarik Tıp Derneği (İstanbul Üniversitesi), İstanbul, Türkiye
6 İstanbul Diyabetik Ayak Derneği (İstanbul Üniversitesi), İstanbul, Türkiye
7 Ulusal Vasküler ve Endovasküler Cerrahi Derneği (İstanbul Üniversitesi, Dr. Siyami Ersek Göğüs Kalp ve Damar Cerrahisi
Eğitim ve Araştırma Hastanesi), Ankara, Türkiye
8 Diyabet Hemşireliği Derneği (İstanbul Üniversitesi, Hasan Kalyoncu Üniversitesi), İstanbul, Türkiye
9 Sağlık Bakanlığı Türkiye Diyabet Önleme ve Kontrol Programı Koordinatörü (Hitit Üniversitesi / Ankara Numune Eğitim ve
Araştırma Hastanesi), Ankara, Türkiye
10 Türkiye Endokrinoloji ve Metabolizma Derneği (İstanbul Üniversitesi), Ankara, Türkiye
11 Sağlık Bakanlığı Müsteşar Yardımcısı (Sakarya Üniversitesi / Dışkapı Yıldırım Beyazıt Eğitim ve Araştırma Hastanesi / Türkiye
Halk Sağlığı Kurumu), Ankara, Türkiye
12 Türkiye Aile Hekimleri Uzmanlık Derneği (Yeditepe Üniversitesi), Ankara, Türkiye
13 Kritik Bakım Derneği, Kronik Yara Çalışma Grubu (Hitit Üniversitesi / Ankara Numune Eğitim ve Araştırma Hastanesi), Ankara,
Türkiye
14 Türkiye Diyabet Vakfı (İstanbul Üniversitesi), İstanbul, Türkiye
Moderatörlüğü üstlenmiş olan ilk dört yazarın ardından 11 Uzmanlık Derneğinin, Sağlık Bakanlığı’nın ve Türkiye Diyabet Vakfı’nın temsilcileri,
çalıştıkları Üniversite ya da Eğitim ve Araştırma Hastaneleri de gösterilerek alfabetik sırayla belirtilmiştir.
Abstract
Study Group for Diabetic Foot Infections of the Turkish Society
of Clinical Microbiology and Infectious Diseases has called
for collaboration of the relevant specialist societies and the
Ministry of Health to issue a national consensus report on
the diagnosis, treatment and prevention of diabetic foot (DF)
wounds and diabetic foot infections (DFIs) in Turkey. In the periodical
meetings of the assigned representatives from all the
parties, various questions as to pathogenesis, microbiology,
assessment and grading, treatment, prevention and control of
diabetic foot were identified. Upon reviewing related literature
and international guidelines, these questions were provided
Özet
Türk Klinik Mikrobiyoloji ve İnfeksiyon Hastalıkları Derneği Diyabetik
Ayak İnfeksiyonları Çalışma Grubu, ülkemiz koşullarında
diyabetik ayak (DA) yarasının ve DA infeksiyonu (DAİ)’nun
tanısı, tedavisi ve önlenmesine yönelik bir ulusal uzlaşı raporu
hazırlamak üzere ilgili ulusal uzmanlık derneklerine ve Sağlık
Bakanlığı’na işbirliği çağrısında bulunmuştur. Görevlendirilen
temsilcilerin periyodik olarak yaptığı toplantılarda ilgili literatür
ve uluslararası kılavuzlar gözden geçirilerek, patogenez,
mikrobiyoloji, değerlendirme ve derecelendirme, tedavi, korunma
ve kontrol konularında yanıt verilmesi gereken sorular
saptanmış ve bu sorulara üzerinde uzlaşılan yanıtlar verilmişSaltoğlu
N et al. Diyabetik Ayak Yarası ve İnfeksiyonunun Tanısı, Tedavisi ve Önlenmesi 3
with consensus answers. Several of the answers provided in
the report are listed below: [1] Although there are many reasons
for the development of DF wounds, the main reason is the
combined effect of diabetes-related vascular disease and neuropathy.
[2] Aerobic Gram-positive cocci are mostly responsible
for superficial DFIs in patients with cellulitis and no history of
antibiotic use. [3] Pseudomonas aeruginosa is one of the commonly
encountered agents when between the toes of the patient
are moist. [4] When the other potential reasons are eliminated,
DFIs should be considered in presence of at least two of
the classical signs of inflammation including redness, warmth,
swelling, tenderness, and pain, or purulent discharge in the
foot lesion. [5] Infections are classified into mild, moderate, or
severe groups according to some criteria such as the depth and
width of the wounds, and the presence of systemic findings of
infection. [6] PEDIS system should be preferred as a classification
system for its high predictive value in diabetes-related foot
complications. [7] Culture samples from the DF wound should
only be obtained when infection is clinically considered and,
where possible, before starting antibiotic treatment. [8] Inflammatory
biomarkers such as leukocyte count, C-reactive protein,
erythrocyte sedimentation rate, and procalcitonin may be useful
in distinguishing between colonization with infection. [9]
Magnetic resonance imaging is a sensitive and specific method
in patients unresponsive to treatment when osteomyelitis and
deep soft tissue abscesses are considered. [10] The gold standard
in the diagnosis of osteomyelitis is histopathological examination.
[11] To provide wound healing and to save the limb,
removal of dead and infected tissue with urgent and aggressive
debridement, appropriate antibiotic therapy, metabolic control,
and off-loading of pressure, the diagnosis and proper treatment
of peripheral arterial disease, and restoration of the foot function
are necessary. [12] A lot of different factors playing a role
in etiopathogenesis complicate the approach to be developed
in this type of lesions, and therefore it requires a team concept.
[13] In the empirical treatment, the objective should be treating
only the potential agents. Adequate tissue levels, low side effects
and patient compliance must be observed; effective drugs
should be used in specified doses and duration. [14] Debridement
is an essential and integral part of wound treatment and
is an important tool allowing the formation of healthy granulation
tissue. [15] When the infected tissue cannot be completely
cleared with the debridement and in cases when the patient
could not cope with the remaining infection load, performing
a limb amputation on a safe level of infection would be lifesaving.
[16] If an arterial insufficiency is considered in a patient
with a DF wound, early diagnosis and interventional treatment
is necessary. [17] Hyperbaric oxygen therapy is used as an
adjunctive treatment in combination with other treatments in
DFI patients. [18] Topical negative pressure therapy is a useful
adjunctive measure in selected patients. [19] Growth factors
can be used in selected patients other than wounds that can be
treated with cheaper and safer methods. [20] Maggot therapy
may be considered as a debridement method in DF wound cases.
[21] Patients with more than ten years of diabetes history
have an increased risk of wound development or amputation.
[22] DF problem is the only complication of diabetes that can be
prevented through education.
Klimik Dergisi 2015; 28(Suppl. 1): 2-34.
Key Words: Diabetic foot, diabetic foot infection, diabetes mellitus,
diagnosis, treatment, prevention.
tir. Rapordaki yanıtlardan birkaçı aşağıda sıralanmıştır: [1]
DA yarası gelişmesinin pek çok nedeni olmakla birlikte başlıca
neden diyabetle ilişkili vasküler hastalığın ve nöropatinin
kombine etkisidir. [2] Selüliti olan ve daha önce antibiyotik
kullanmamış hastalarda gelişen yüzeysel DAİ’lerden daha çok
aerop Gram-pozitif koklar sorumludur. [3] Pseudomonas aeruginosa,
hastanın ayak parmak aralarının ıslak kaldığı durumlarda
yaygın olarak karşılaşılan etkenlerden biridir. [4] Diğer
nedenler dışlandıktan sonra, ayak lezyonunda kızarıklık, sıcaklık
artışı, şişlik, duyarlılık veya ağrı gibi inflamasyonun klasik
bulgularından en az ikisinin varlığında ya da pürülan akıntı söz
konusu olduğunda DAİ düşünülmelidir. [5] DAİ tanısı konulan
hastalar öncelikle yaranın derinlik ve genişliği, infeksiyonun
sistemik bulgularının olup olmaması gibi ölçütlere dayanılarak
infeksiyon şiddeti açısından hafif, orta derece veya şiddetli
infeksiyon olarak sınıflandırılır. [6] Diyabetle ilişkili ayak komplikasyonlarını
öngörme değeri yüksek bir sınıflandırma sistemi
olarak PEDIS sistemi yeğlenmelidir. [7] DA yarasında kültür
örneği yalnız klinik olarak infeksiyon düşünüldüğü zaman ve
mümkünse antibiyotik tedavisi başlanmadan önce alınmalıdır.
[8] İnflamasyon göstergeleri olan lökosit sayısı, C-reaktif protein,
eritrosit sedimantasyon hızı ve prokalsitonin gibi biyobelirteçler,
infeksiyonla kolonizasyonun ayırt edilmesinde yararlı
olabilir. [9] Manyetik rezonans görüntülemesi, tedaviye yanıt
alınamayan, osteomyelit ya da derin yumuşak doku apsesi
düşünülen hastalar için duyarlı ve özgül bir yöntemdir. [10]
Osteomyelit tanısında altın standard histopatolojik incelemedir.
[11] Yara iyileşmesini sağlayabilmek ve bacağı kurtarmak
için gerekenler, acil ve agresif debridmanlarla ölü ve infekte
dokuların uzaklaştırılması, uygun antibiyotik tedavisi, metabolik
kontrol, ayağın yükten ve basıdan kurtarılması, periferik
arter hastalığının tanısı ve uygun şekilde tedavisi ve ayağın işlevinin
kazandırılmasıdır. [12] Etyopatogenezinde rol oynayan
faktörlerin çok farklı olması, gelişen lezyonları karmaşık hale
getirmekte ve bu tip hastalara yapılacak yaklaşımlarda bir ekip
anlayışını gerektirmektedir. [13] Ampirik tedavide yalnız etken
olabilecek bakterilerin kapsanması hedeflenmeli; yeterli doku
düzeyi, düşük yan etki ve hasta uyumu gözetilmeli; etkin ilaçlar
belirlenmiş dozlarda ve sürede kullanılmalıdır. [14] Debridman,
yara tedavisinin temel ve ayrılmaz bir parçasıdır ve
sağlıklı granülasyon dokusu oluşmasını sağlayan önemli bir
araçtır. [15] Debridmanla infekte dokunun tamamen temizlenmesi
mümkün olmadığında ve hastanın kalan infeksiyon yüküyle
başa çıkamayacağı durumlarda, infeksiyon bulunmayan
güvenli bir düzeyden ampütasyon yapılması yaşam kurtarıcı
olacaktır. [16] DA yarası olan bir hastada önemli bir arteriyel
yetersizlik olduğu düşünülüyorsa, bunun erken tanınması ve
girişimsel tedavisi gerekir. [17] Hiperbarik oksijen tedavisi,
DAİ’lerde tek başına değil, diğer tedavilerle birlikte bir yardımcı
tedavi yöntemi olarak kullanılır. [18] Negatif basınçlı yara
kapama yöntemi, seçilmiş olgularda yararlı bir yardımcı tedavi
yöntemidir. [19] Büyüme faktörleri, daha ucuz ve güvenli
yöntemlerle kapanabilecek yaralar dışında, seçilmiş olgularda
kullanılabilir. [20] Kurtçuk tedavisi, DA yarası olgularında
bir debridman yöntemi olarak değerlendirilebilir. [21] On yılı
aşkın süredir diyabeti olan hastalarda yara gelişmesi ya da
ampütasyon riski artmaktadır. [22] DA sorunları diyabetin eğitimle
önlenebilir tek komplikasyonudur.
Klimik Dergisi 2015; 28(Özel Sayı 1): 2-34.
Anahtar Sözcükler: Diyabetik ayak, diyabetik ayak infeksiyonu,
diabetes mellitus, tanı, tedavi, önleme.
Background Diabetes mellitus continues to grow in global prevalence and to consume an increasing amount of health care resources. One of the key areas of morbidity associated with diabetes is the diabetic foot. To improve the care of patients with diabetic foot and to provide an evidence-based multidisciplinary management approach, the Society for Vascular Surgery in collaboration with the American Podiatric Medical Association and the Society for Vascular Medicine developed this clinical practice guideline. Methods The committee made specific practice recommendations using the Grades of Recommendation Assessment, Development, and Evaluation system. This was based on five systematic reviews of the literature. Specific areas of focus included (1) prevention of diabetic foot ulceration, (2) off-loading, (3) diagnosis of osteomyelitis, (4) wound care, and (5) peripheral arterial disease. Results Although we identified only limited high-quality evidence for many of the critical questions, we used the best available evidence and considered the patients' values and preferences and the clinical context to develop these guidelines. We include preventive recommendations such as those for adequate glycemic control, periodic foot inspection, and patient and family education. We recommend using custom therapeutic footwear in high-risk diabetic patients, including those with significant neuropathy, foot deformities, or previous amputation. In patients with plantar diabetic foot ulcer (DFU), we recommend off-loading with a total contact cast or irremovable fixed ankle walking boot. In patients with a new DFU, we recommend probe to bone test and plain films to be followed by magnetic resonance imaging if a soft tissue abscess or osteomyelitis is suspected. We provide recommendations on comprehensive wound care and various débridement methods. For DFUs that fail to improve (>50% wound area reduction) after a minimum of 4 weeks of standard wound therapy, we recommend adjunctive wound therapy options. In patients with DFU who have peripheral arterial disease, we recommend revascularization by either surgical bypass or endovascular therapy. Conclusions Whereas these guidelines have addressed five key areas in the care of DFUs, they do not cover all the aspects of this complex condition. Going forward as future evidence accumulates, we plan to update our recommendations accordingly.
Infrapopliteal percutaneous transluminal angioplasty (PTA) is currently indicated in patients with critical limb ischaemia (CLI). It may be performed after femoral angioplasty or bypass surgery, to improve outflow and hence patency of the proximally treated segment. Patients with CLI are typically elderly with multiple co-morbidities and limited life expectancy and therefore, a procedure, which is minimally invasive with reduced morbidity and mortality but lesser long-term patency, may be more appropriate than a more invasive procedure with better long-term patency. Clinical success is superior to angiographic patency, because once healing has occurred, should the artery restenose or occlude, collateral flow can be sufficient to preserve tissue integrity if there is no further injury. Although no prospective randomized trials have been performed, the reported limb-salvage rates of PTA are comparable with surgery. As PTA carries a lower morbidity and mortality, shorter hospital stay and does not preclude surgery, it is ideal for this group of patients who are high-risk surgical candidates. Improvements in guide-wire and catheter technology and recanalization techniques mean that very long stenoses or occlusions, and multiple lesions can be treated successfully. At the current time, PTA is the treatment of choice for infrapopliteal occlusive disease; experience with the use of stents in this territory is increasing but currently insufficient to justify their primary use.
People with diabetes develop foot ulcers because of neuropathy (sensory, motor, and autonomic deficits), ischaemia, or both. The initiating injury may be from acute mechanical or thermal trauma or from repetitively or continuously applied mechanical stress. Patients with clinically significant limb ischaemia should be assessed by a vascular surgeon to determine the need for angioplasty, stenting, or femorodistal bypass. When infection complicates a foot ulcer, the combination can be limb or life-threatening. Infection is defined clinically, but wound cultures reveal the causative pathogens. Tissue specimens are strongly preferred to wound swabs for wound cultures. Antimicrobial therapy should be guided by culture results, and should aim to cure the infection, not to heal the wound. Alleviation of the mechanical load on ulcers (off-loading) should always be a part of treatment. Neuropathic ulcers typically heal in 6 weeks with total contact casting, because it effectively relieves pressure at the ulcer site and enforces patient compliance. The success of other approaches to off-loading similarly depends on the patients' adherence to the effectiveness of pressure relief. Surgery to heal ulcers and prevent recurrence can include tenotomy, tendon lengthening, reconstruction, or removal of bony prominences. However, these procedures may result in secondary ulceration and other complications. Ulcer recurrence rates are high, but appropriate education for patients, the provision of posthealing footwear, and regular foot care can reduce rates of re-ulceration.
the purpose of this study was to assess the quality of life (QOL) in patients with critical lower limb ischaemia (CLI), and its modification after three types of therapeutical outcomes.
between January and December 2000 52 patients (36 male, mean age 68 years) treated for critical limb ischaemia (CLI) completed the Short Form (SF)-36 on admission and then 6 and 12 months later. Patients were divided in the 3 groups: Group I: revascularisation; Group II: major amputation; Group III: conservative treatment. Trends for each dimension over the follow-up and the effect of treatment group were assessed by an analysis of variance with repeated measurements.
on admission, patients with CLI had a significantly worse health-related quality of life than a control population. Although some domains improved, some also deteriorated between baseline and 12 months and there was no significant difference between the three treatment groups.
our results suggest that changes in dimensions of QOL obtained by limb revascularisation do not differ from those of other therapeutic approaches.
To examine the level of agreement among vascular surgeons and interventional radiologists regarding their preference for the surgical or endovascular management of severe limb ischaemia.
Delphi consensus study using 596 different hypothetical patient scenarios.
Delphi consensus group for the Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) trial.
Twenty consultant vascular surgeons and 17 interventional radiologists completed both rounds of the study. The scenarios detailed the anatomical extent of disease, whether the patients had rest pain only or had tissue loss, and whether or not a suitable vein for bypass was available. Panellists were asked to score their treatment preference for either surgery or angioplasty on an eight-point scale. Outliers (top 10% and bottom 10% responses) were removed. If the remaining 80% of responses fell within a 3-point range, this was defined as "agreement". If they did not, this was considered "disagreement".
There was substantial disagreement in 484 (81%) of scenarios in round 1 and 401 (67%) in round 2. This disagreement was greater among surgeon than radiologists in both round 1 (83 vs 65%) and round 2 (69 vs 42%). Surgeons also demonstrated less convergence between rounds.
There is substantial disagreement between and among surgeons and radiologists with regard to the appropriateness of surgery or angioplasty for severe limb ischaemia. This lack of consensus stems from the absence of an evidence base and means that the same patient may receive entirely different treatment depending on which hospital and consultant they attend. Not only may this unexplained variation be clinically unsatisfactory, it has major implications for the planning and use of health service resources.
Modifiable patient factors that contribute to graft occlusion may be addressed after surgery. To determine risk factors associated with reverse vein graft (RVG) occlusion, we examined the characteristics and duplex scan surveillance (DS) patterns of patients with RVGs.
Patients treated with RVG from January 1996 through December 2000 were identified from a prospective registry. The study population consisted of all patients with RVGs performed during the study period with grafts that subsequently occluded. Patients whose grafts remained patent served as age-matched and gender-matched control subjects. The prescribed DS regimen was every 3 months for the first postoperative year and every 6 months thereafter. Early DS failure was defined as having no DS within the first 3 months. Cox proportional hazards analysis was used to compare the two groups. Hazard ratios were calculated.
During the study period, 674 patients underwent RVG. Fifty-five patients with occluded RVGs were compared with 118 with patent RVGs. The follow-up period for occluded grafts was 13.40 +/- 12.59 months and for patent grafts was 32.40 +/- 15.61 months. Dialysis therapy, a known hypercoagulable state, continued smoking, and DS failure were independent factors associated with RVG occlusion. The hazards ratio for dialysis was 6.45 (95% CI, 3.07 to 13.51; P <.001), for current smoking was 4.72 (95% CI, 2.5 to 8.85; P <.001), for hypercoagulable state was 2.99 (95% CI, 1.47 to 6.10; P =.003), and for early DS failure was 2.43 (95% CI, 1.29 to 4.59; P =.006).
Continued smoking and failure to undergo DS within the first three postoperative months are modifiable factors associated with RVG occlusion. Smoking cessation and graft surveillance must be stressed to optimize patency of infrainguinal RVGs.
to determine the incidence of early complications following percutaneous transluminal angioplasty and to describe their management and outcome.
five hundred and fifty consecutive patients undergoing angioplasty of 648 limbs, containing 1053 anatomical segments during a two year period were reviewed retrospectively.
early complications affected 109 segments (10%) in 92 limbs (14%) of 84 patients (15%). Of the 109 segments affected by early complications, 106 (97%) were managed by endovascular techniques with surgery being required on only three (3%) occasions. There were no deaths attributable to angioplasty.
although early complications occur in 14% of limbs undergoing percutaneous transfemoral angioplasty, the majority (97%) can be managed by endovascular techniques.
Few will debate that infrainguinal arterial reconstruction increases limb salvage. However, numerous reports describe a difference in results in coronary and peripheral arterial reconstructions between men and women. In this study, we analyze the outcome of infrainguinal bypasses performed over 30 years and stratify the results by gender.
We reviewed our vascular registry from 1968 to 1999 for all infrainguinal arterial reconstructions. Demographics, indications, and adverse outcomes were analyzed. Patency, limb salvage, and survival rates were determined with life-table analysis. The chi2, log-rank, and Student t tests were used to determine statistical significance.
Five thousand eight hundred eighty procedures were performed, with 2161 in women (37%). Women were significantly older (71 versus 66 years), more often diabetic (53% versus 50%), and less often smokers (27% versus 44%) and more often had surgery for limb salvage (89.8% versus 81.0%). Mortality, complications, and need for revision did not differ. Primary patency rate was 44% versus 47%, secondary patency rate was 55% versus 58%, and survival rate was 39% versus 34% in men and women, respectively, at 10 years (all P >.05). Limb salvage rate in women exceeded that in men (93% versus 88%) at 10 years. Subgroup analysis by conduit also revealed no difference in patency.
Infrainguinal arterial reconstruction can be performed safely with comparable results in women and men. Although women may present older and more often for limb salvage, outcomes do not appear to be adversely affected.
We describe the outcome of revascularization procedures used to treat peripheral arterial occlusive disease (PAOD), using population-based administrative data.
A retrospective population-based cohort study utilizing administrative databases in Ontario, Canada, was conducted for fiscal years 1991 to 1998 to identify patients who underwent arterial bypass surgery and percutaneous transluminal angioplasty to treat PAOD. The Kaplan-Meier method was used to calculate cumulative survival rate and amputation-free survival rate. To analyze factors that affect these rates, multivariate analysis was performed with Cox proportional hazard models.
Over the study period 15,824 patients underwent bypass operations and 11,548 underwent angioplasty. For patients who underwent bypass surgery, 5-year cumulative survival rate was 61.5% and major amputation-free survival rate was 83.4%, compared with 69% and 92.2%, respectively, for patients who underwent angioplasty. Male sex, older age, diabetes, and heart disease were associated with increased risk for death after revascularization procedures. Increased risk for major amputation after revascularization procedures was associated with male sex, older age, and diabetes, whereas hypertension was linked to decreased risk.
To evaluate the long-term outcome of revascularization procedures for PAOD at the population level, survival and major amputation-free survival rates should be used, because they provide more clinically accepted estimates compared with the correlation between utilization rates for revascularization and amputation procedures, which have been used to describe outcome in previously published reports in the literature.
There is continuing controversy as to whether surgical bypass or angioplasty should be first-line treatment of severe limb ischemia. We undertook this study to examine angiographic and clinical factors that influence the treatment of severe limb ischemia by vascular surgeons and interventional radiologists.
Twenty consultant vascular surgeons and 17 consultant vascular interventional radiologists evaluated 596 hypothetical clinical or angiographic scenarios, and recorded whether, in their opinion, the most appropriate first-line treatment was surgical bypass, angioplasty, or primary amputation. Stepwise multiple linear regression was used to identify the factors that significantly affected responses from the entire group and from surgeons and radiologists separately.
There were significant differences between surgeons and radiologists with regard to how clinical and angiographic variables determined treatment preferences. Increasing disease severity, absence of runoff into the foot, presence of a suitable vein, and tissue loss as opposed to rest pain only (the latter only significant to surgeons) all increased the response score toward surgery. However, surgeons and radiologists weighted each of these factors quite differently. Even in the most complex statistical model, 19% of surgical and 13% of radiologic response variations remained unexplained.
Individual surgeons and radiologists vary considerably in their views of the relative merits of surgery and angioplasty in patients with severe limb ischemia. This broad gray area mandates the need for randomized controlled trial data to inform joint decision-making and to optimize patient outcome.
Subintimal angioplasty has been suggested as a treatment option for occlusive disease and has become an established practice in some centres, reducing their operative workload considerably. Others have concerns about the safety and durability of the procedure. This review will focus on the evidence for the use of subintimal angioplasty in lower limb occlusive disease. A systematic review of the literature from a Medline search has been carried out. Despite a paucity of trial data, subintimal angioplasty is now an established technique for the treatment of lower limb occlusive disease. The results for femoro-popliteal disease are well documented, with excellent technical and clinical success rates and low complication rates. The results for iliac disease are less well documented and demand caution. For infra-popliteal disease with critical ischaemia, the technique is again safe with good short and long-term results in a group of patients in whom distal bypass surgery is often risky. Subintimal angioplasty has a definite learning curve and those wishing to take it up should visit an experienced centre first. To achieve widespread acceptance it is likely to require large scale randomised controlled trials.
To determine the early and late outcome of percutaneous transluminal angioplasty (PTA) for critical limb ischaemia (CLI) in patients aged 80 years and over.
Retrospective case note review of all patients aged 80 years and over who underwent attempted PTA for CLI between 1st January 1999 and 31st December 2000. Minimum follow-up was 12 months with a maximum of 42 months.
One hundred and twenty-eight PTAs were attempted in 113 severely ischaemic limbs of 98 patients (36 men and 62 women of median age 84, range 80-97, years). Seventy patients had significant co-morbidity. The indication for revascularisation was rest pain in 47 procedures, ulceration in 66 and digital gangrene in 15. The anatomical segments involved were iliac (n=19), superficial femoral (n=92), popliteal (n=91) and infrapopliteal (n=72). The technical success rate was 108 of 128 (84%) procedures. Early technical complications occurred in 24 (19%) procedures: four major, 20 minor. The 30-day operative mortality rate was six of 128 (5%). The median (range) in-hospital stay was two (1-72) days. Early or delayed surgical revascularisation was required in 11 limbs and there were six major limb amputations during the study period. The 24-month patient survival rate was 59%. The 24-month primary and secondary symptomatic patency and secondary limb salvage rates were 52, 69 and 95%, respectively.
PTA is safe, requires a short hospital stay, and is clinically effective in the majority of very elderly patients with CLI. Although minimally invasive, the relatively high peri-procedural mortality rate and low 24-month survival rate reflect the high co-morbidity of this group of patients.
To evaluate the feasibility and efficacy of subintimal infrapopliteal angioplasty (SIA) as a method for recanalization of occluded tibial arteries in the treatment of critical limb ischaemia (CLI).
Between January 2002 and September 2003, 20 patients with CLI were submitted to SIA; of these, 16 had diabetes mellitus. All patients had foot ulceration or gangrene and ten had rest pain. All patients were treated with SIA of one or more vessels of the popliteal district. Overall, thirty-four arteries of the infrapopliteal district underwent revascularization; in 9 cases, SIA of superficial femoral artery occlusions was associated. Technical success was evaluated on angiography at the end of the procedure: revascularization of at least one of the 3 leg vessels with re-establishment of arterial flow to the foot was regarded as a technical success. Pain relief (when pain was present) and healing of foot ulceration, without above-the-ankle major amputation (limb salvage), were defined as clinically successful. During the follow-up (mean: 9 months; range: 6-21 months) all patients were checked 6 months after the procedure by clinical examination and colour-Doppler ultrasound.
The technical success rate of SIA in the revascularization of the infrapopliteal vessels was 85%. In the 17 technically successful cases, pain had entirely resolved in 9/10 cases and trophic lesions of the foot healed in 14/17 cases. In this group, 9 patients underwent minor amputation; 2 underwent major above-the-ankle amputation; one underwent to surgery 20 days after the SIA and required a femoro-tibial by-pass. In the 3 cases of technical failure (15%), revascularization of the entire occluded tract could not be achieved. Of these, one patient subsequently underwent major amputation. Nine months after SIA, the cumulative limb salvage rate was 85% (17/20 clinically successful cases) and the survival rate was 90%. Colour-Doppler US at 6 months showed 70% primary patency. No major complication occurred during the procedure. Five minor complications in four patients were managed endovascularly or healed spontaneously.
SIA is a feasible and effective technique for foot revascularization in patients with CLI. Long occlusions or diffusely calcified arteries are suitable indications. Technical failure does not preclude conventional surgery. In patients treated with SIA, the risk of major amputation is low and mortality rate is nil. Minor complications can be managed using endovascular techniques.
We sought to determine the long-term results of revision procedures performed for repair of stenotic lesions in infrainguinal vein bypass grafts.
A retrospective review of 188 vein grafts, from a total series of 1260 bypasses, undergoing revision of stenotic lesions between January 1, 1987, and December 31, 2002, at Brigham & Women's Hospital was undertaken. Lesions were identified by recurrence of symptoms, change in examination findings, or with routine duplex ultrasound graft surveillance. Demographic and medical risk factors, and surgical variables were analyzed with respect to patency outcomes after the initial graft revision, with descriptive statistics, logistic regression, and life table analysis. Primary and secondary patency rates were determined from the time of graft revision.
Patients included 108 men (57%) and 80 women (42%) who underwent revision at a mean age of 67.8 years. One hundred thirty grafts required only a single revision, whereas 58 required subsequent additional revisions. Revision procedures included 99 vein patches (52.7%), 23 jump grafts (12.2%), 23 interposition grafts (12.2%), 8 transpositions to new outflow vessels (4.3%), and 35 balloon angioplasty procedures (18.6%). During a mean follow-up of 1535 days, 5-year primary patency rate was 49.3% +/- 4.5% (SE) and 5-year secondary patency rate was 80.3% +/- 3.6%. There was no difference in patency rate for different revision procedures, type of vein graft, indication for the original procedure, or for patients with diabetes mellitus or renal disease. The overall limb salvage rate was 83.2% +/- 3.5% 5 years after graft revision. With COX proportional hazard analysis of time to failure of the revision procedure, the outflow level of the original bypass and the time of revision proved to be an important predictor of durability of the graft revision. Revision of popliteal bypass grafts resulted in a 60% 5-year primary patency rate, whereas revision of tibial grafts resulted in a 42% 5-year primary patency rate (P = .004; hazard ratio [HR], 2.06). Five-year secondary patency rates were 90% and 76%, respectively (P = .009; HR = 3.43). The timing of the graft revision proved an additional predictor. Grafts revised within 6 months of the index operation had lower primary patency than those with later revisions (42.9% vs 80.7%, respectively; HR = 1.754; P = .0152).
Vein graft revisions offer durable patency and limb salvage rates after repair of stenotic infrainguinal bypass grafts. Vigilant ongoing surveillance is essential, because 30.9% of revised grafts will develop additional lesions that will require repair. Tibial level bypass grafts that require early repeat intervention to treat graft stenosis are at particular risk for development of subsequent lesions.
Elderly patients with extensive infrainguinal peripheral vascular disease and critical chronic limb ischemia (CCLI) are poor surgical candidates. Our purpose was to evaluate angiographic and clinical results of popliteal, infrapopliteal, and multi-level disease percutaneous transluminal angioplasty (PTA) in such patients.
Retrospective study of angiographic and clinical files in selected group.
Between 1996 and 2002, 38 elderly patients aged 80-94 years old (mean age 83.3) with critical leg ischemia were treated with PTA. All patients were at high surgical risk. 31/38 (81.5%) patients had chronic non-healing wounds, and 14/38 (37%) had multi-level disease of superficial femoral, popliteal and crural arteries. One hundred and two lesions were treated by angioplasty. Immediate angiographic and 1 year clinical results were retrospectively analyzed.
The overall procedural success rate was 32/38 (84.2%). There were three major complications (7.9%), but no deaths, and three technical failures, all were of infrapopliteal lesions. After 1 year, 27 patients could be followed, five patients died during the first year of unrelated causes. Twenty-three patients (85.2%), were clinically re-occluded within 1 year, but complete and partial wound healing was achieved in 80% (16/20) and rest pain improvement in 57% (4/7), so that overall limb salvage was 74% (20/27).
Elderly patients with multi-level CCLI have a short patency term following angioplasty of 14.8% after 1 year. Nevertheless, this temporary vascular patency enables wound healing or improvement in 74% of these patients, thus such endovascular interventions are recommended in this age group.
Although up to a half of patients undergoing abdominal aortic aneurysm (AAA) repair suffer myocardial injury, as indicated by a rise in cardiac troponin I (cTnI), this is infrequently accompanied by a rise in creatine kinase (CK)-MB fraction or electrocardiogram (ECG) changes. This study compares for the first time peri-operative cTnI, CK-MB and ECG changes in patients undergoing surgery for critical lower limb ischaemia (CLI).
Twenty-nine patients (20 men, median age 75 [range, 57-95] years) were studied prospectively. cTnI, CK/CK-MB ratio and ECG were performed pre-operatively and on post-operative days 1, 2 and 3.
Eleven (38%) patients had an elevated cTnI >0.5 ng/ml. Five (17%) patients had an elevated CK-MB fraction >4% and all of these patients had an elevated cTnI. Eleven (38%) patients had ischaemic changes on ECG including seven of 11 (64%) patients with elevated cTnI and all five patients with elevated CK-MB fraction. There was no relationship between pre-operative cardiac status, antiplatelet use or type of anaesthesia and post-operative cTnI rise. Patients with a cTnI rise were younger (p=0.01), and were more likely to have presented with gangrene (p=0.04) and have a longer operation time (p=0.01) than patients who did not demonstrate a cTnI rise. Four patients developed clinically apparent cardiac complications: cardio-pulmonary arrest (n=1), cardiogenic shock (n=1), acute CCF (n=1) and rapid atrial fibrillation (n=1). Survival at 6 months was 26 of 29 (90%) patients.
These data demonstrate that over a third of patients operated for CLI sustain peri-operative myocardial injury, many of which are not clinically apparent. Pre-operative medical optimisation may improve prognosis in this group of patients.
The greater saphenous vein is assessed as part of the workup for femorodistal bypass surgery in our unit. The aim of this study was to determine whether the minimum internal diameter (MID) of the vein predicted graft patency and limb salvage in femorodistal bypass surgery, independently of the quality of the runoff. A consecutive series of 67 infrainguinal vein bypass grafts were performed on 62 patients with critical lower limb ischemia. All were followed for at least 1 year. The MID of the greater saphenous vein was calculated from preoperative saphenograms, and all of the arteriograms were scored for their runoff using an ad hoc method approved by the Society for Vascular Surgery. The cumulative patency of all vein grafts at 3 years was 59 +/- 7% (SE), and the limb salvage was 85 +/- 5%. All femoropopliteal bypass grafts were patent at 3 years if the MID of the vein was greater than 3.0 mm. The crural bypass patency was 66 +/- 12% for an MID greater than 3.0 mm and only 27 +/- 12% for an MID less than 3.0 mm. Every extra point on the runoff score increased the hazard of bypass failure by 16% (95% CI 1.0-34; p < .05). Vein diameter and runoff score were independent of one another (r2 = -.106). The MID of the greater saphenous vein is a major determinant of outcome in infrainguinal vein bypass surgery independent of the arterial runoff.
The purpose of this study was to assess the technical feasibility and early outcome of tibial angioplasty for a subset of patients with limb-threatening ischemia who were not candidates for bypass grafting. A retrospective analysis was conducted of 19 patients (7 male, 12 female) who underwent crural angioplasty for limb-threatening ischemia using 0.018- or 0.014 inch-based systems. Contraindications to bypass were insufficient conduit in 7 patients and severe comorbid illness in 12. Concurrent treatment of inflow lesions was performed in 12 of 20 limbs via either angioplasty alone (5) or combined with stenting (12). Outcome measures were ankle-brachial indices (ABI), relief of rest pain, and healing or healed wounds. Twenty-three vessels were treated, including 14 tibial occlusions and 9 stenoses. The average length of diseased segment was 11 cm (range, 3-25 cm). Thirteen of 14 occlusions were treated with subintimal recanalization, the remainder with laser recanalization. Technical success was achieved in 22 of 23 treated vessels. Mean preoperative ABI was 0.53 and mean postoperative ABI was 0.85. Palpable pulses were present in 11 of 20 limbs (55%). There was one perioperative mortality (5.2%). Mean follow-up was 3 months. Three failures occurred requiring amputation (15.8%). The remaining 16 patients were improved with healing (8) or healed (4) wounds and relief of rest pain (4). These results indicate that technical success may be achieved with outflow lesion angioplasty in the majority of patients encountered. The durability of this method of therapy is unknown, and our length of follow-up is not sufficient to answer this question. However, an attempt at angioplasty appears justified before primary amputation and before surgical bypass in those patients at high risk for intervention.
Objective:
To assess outcomes of percutaneous infrainguinal arterial angioplasty for treatment of chronic limb-threatening ischemia (CLI) in poor surgical candidates.
Methods:
A retrospective clinical analysis of 67 consecutively treated patients (76 limbs) with CLI over a 33-month period was performed. Patients were considered poor surgical candidates because of absent distal target vessels (31 limbs), severe comorbid conditions (36 limbs), or lack of an autologous vein for distal bypass (9 limbs). Limb salvage was defined as preservation of a functional foot without the need for a prosthesis. Technical success was defined as the ability to percutaneously recanalize the arterial segment with less than 30% residual stenosis. Clinical success was healing of ulcers or minor amputation sites, resolving rest pain, or avoiding a major amputation. Successful technical and clinical outcomes were correlated with patient demographics, clinical presentation, and TransAtlantic Inter-Society Consensus arterial lesion characteristics by using the Fisher exact test.
Results:
Seventy-six limbs were treated for rest pain (n = 12), gangrene (n = 22), or nonhealing ulcers (n = 42). There were 40 men and 27 women. The mean age was 70 years (range, 36-94 years). Lesions were located in tibial (n = 55), popliteal (n = 6), and superficial femoral (n = 15) arteries. Arterial recanalization and limb salvage was achieved in 64 (83.5%) limbs. Technical failure (n = 12) correlated with TransAtlantic Inter-Society Consensus D lesions ( P = .009) and the presence of occlusion ( P = .027). Clinical failure (major amputation, n = 12) correlated with the presence of gangrene ( P = .032) or the combination of diabetes, arterial occlusion, and gangrene ( P = .018). The single variables of age, sex, diabetes, and renal failure did not adversely affect outcomes. There was one mortality (myocardial infarction), and there were two major morbidities (femoral artery pseudoaneurysm and sepsis).
Conclusions:
Peripheral arterial angioplasty should be considered as an alternative to primary amputation in selected patients with CLI who are poor candidates for traditional surgical bypass.