No full-text available
To read the full-text of this research,
you can request a copy directly from the authors.
Excimer Laser-Assisted Recanalization of Long, Chronic Superficial Femoral Artery Occlusions
Abstract
To examine the safety and efficacy of excimer laser-assisted angioplasty (ELA) for recanalization of superficial femoral artery (SFA) occlusions.
Data were analyzed from 318 consecutive patients (207 men; mean age 64.2 +/- 10.7 years, range 33-91) who underwent ELA of 411 SFAs with chronic occlusions averaging 19.4 +/- 6.0 cm in length. More than 75% of patients had severe claudication (category 3). Critical lower limb ischemia with rest pain or minor tissue loss was present in 6 and 15 patients, respectively. The mean ankle brachial index (ABI) before and after exercise was 0.62 +/- 0.15 and 0.40 +/- 0.18, respectively.
The initial attempt (crossover approach 89.7%, antegrade 6.6%, transpopliteal 3.6%) to cross the occlusion with an excimer laser catheter was successful in 342 (83.2%) of 411 limbs. A secondary attempt performed in 44 of 69 failed cases was successful in 30 limbs, increasing the technical success rate to 90.5% (372/411). Complications included acute reocclusion (4, 1.0%), perforation (9, 2.2%), and distal thrombosis/embolization (16, 3.9%). Postprocedurally, 219 (68.8%) patients were asymptomatic; mild (category 1) or moderate (category 2) claudication remained in 53 (16.6%) and 26 (8.2%) patients, respectively. The primary patency at 1 year was 33.6%. In the majority of patients, reocclusion was treatable on an outpatient basis. The 1-year assisted primary and secondary patency rates were 65.1% and 75.9%, respectively.
Long SFA occlusions can be recanalized safely and successfully by ELA. However, to maintain patency and quality of life, intensive surveillance using objective testing followed by prompt repeat intervention are mandatory.
... In a study conducted by Scheinert et al. (29), 411 chronic occlusions of the superficial femoral artery, with an average length of 19.4±6 cm, were managed using ELA with adjunctive PTA or stenting. The technical success rate was reported to be 90.5%. ...
... In order to critically assess the impact of peripheral laser angioplasty in the percutaneous treatment of peripheral arterial disease, its benefits and drawbacks must be discussed. ELA is as safe as standard PTA (29,32,(34)(35)(36) Probably easier passage through chronic and calcified occlusions in ELA than with a conventional guidewire (22,32,37,38) Positive results for avoiding amputations in patients with critical limb ischemia (Note that randomized studies with standard PTA are missing) (32, 33) ...
... Better short-and medium-term outcomes in femoropopliteal in-stent restenoses than in standard PTA (randomized study and meta-analysis) (34,39) Drawbacks Need for adjunctive balloon dilatation in most cases due to a narrow channel created by current laser catheters (21,23,28,(29)(30)(31)(32)(33)(34) Higher cost than in standard PTA/stenting (38) ELA, excimer laser angioplasty; PTA, percutaneous transluminal balloon angioplasty. ...
Percutaneous transluminal angioplasty (PTA) is a routine procedure for the treatment of peripheral arterial disease. However, its main limitation is late restenosis occurring at a 1-year rate of 6%-60%. Restenosis arises from injury to the arterial wall including overstretching, compression and rupture of the atherosclerotic plaque during balloon inflation. It is hypothesized that better long-term angioplasty results are observed if atherosclerotic plaques are removed rather than compressed and fractured. Laser angioplasty is one method to remove atherosclerotic plaques. We discuss the principles of lasers, physical properties of laser light, history of laser angioplasty and effects of laser radiation on tissues. Large clinical studies using laser angioplasty are critically assessed. In comparison to conventional PTA, there are some advantages of laser angioplasty: easier passage through chronic and calcified occlusions and according to some studies, better short- and medium-term results regarding limb salvage and management of in-stent restenoses. The main drawback of laser angioplasty is that current laser catheters are not able to create a sufficiently wide channel in the occlusion, meaning that adjunctive balloon dilatation is still required. Thus, long-term data may be misleading. Basic and applied research should continue to focus on enlargement of plaque ablation.
... Table 3. practice such as re-entry devices. 5,[9][10][11]31,32 In cases of failure of the antegrade approach, crossing the lesion in a retrograde fashion represents a safe and effective alternative. 9,12-15 Retrograde crossing of occlusive femoro-popliteal lesions is associated with a high (>90%) technical success rate and a low rate of procedural complications. ...
... retrograde access after the failure of the antegrade approach is higher than that of the primary antegrade approach11,31 and is comparable to other retrograde access sites such as distal SFA, popliteal and pedal artery. The lesion crossing rate slightly higher than that of previous studies is probably due to the presence in our study of some shorter femoral-popliteal occlusions compared to theCTOs treated in the aforementioned studies. ...
Background:
Despite the development in endovascular technologies and the introduction of new tools in clinical practice, the endovascular crossing of femoropopliteal occlusions is not always possible with the antegrade approach, with a failure rate that can be up to 20%. This study aims to assess the feasibility, safety, and efficacy in terms of acute outcome of the endovascular retrograde crossing of femoro-popliteal occlusions with tibial access.
Methods:
This study is a single-centre, retrospective analysis of prospectively collected data of 152 consecutive patients, who had undergone, from September 2015 to September 2022, endovascular treatment of femoro-popliteal arterial occlusions with retrograde tibial access after the failure of the antegrade approach.
Results:
The median lesion length was 25 cm and 66 patients (43.4%) had a calcium grading according to the peripheral arterial calcium scoring system of 4. Angiographically, 44.7% of the lesions were TASC II category D. In all cases, successful cannulation and sheath introduction were performed with an average cannulation time of 150.4 s. Femoropopliteal occlusions were successfully crossed with the retrograde route in 94.1% of cases; the intimal approach was performed in 114 patients (79.7%). The mean time from puncture to retrograde crossing was 20.5 min. Acute vascular access-site complications were noted in 7 (4.6%) patients. Thirty-day major adverse cardiovascular events rate and 30-day major adverse limb events rate of 3.3% and 2%, respectively, were observed.
Conclusions:
The results of our study indicate that retrograde crossing of femoro-popliteal occlusions with tibial access is a feasible, effective, and safe approach in case of failed antegrade approach. The results presented represent one of the largest investigations ever published on tibial retrograde access and contribute to the small body of literature present on this topic to date.
... However, studies have confirmed that percutaneous transluminal angioplasty (PTA) below the knee can effectively treat CLI; although the limb rescue rate is high (84-89%), the patency rate is low (31-51%) [5][6][7]. Excimer laser (308 nm) atherectomy (ELA) combined with drug-coated balloon (DCB) has significant effect on the treatment in-stent restenosis or reocclusion of femoropopliteal artery [8,9]. By removing and reducing the volume of plaque and thrombus, excimer laser (308 nm) ablation reduces the thickness of target vessel wall and increases the uptake of paclitaxel by the vessel wall, thus enhancing the effect of DCB and improving the long-term patency rate [10]. ...
... The landmark multicenter trial conducted by Laird JR et al. showed low rates of complication with laser in infrapopliteal disease (4% major dissection, 3% acute thrombosis, 3% distal embolization, 2% perforation) [21]. Other studies have similarly shown low rates of procedural complications with laser (2.2% perforation, 3.9% distal embolization) [9,22]. The study by Steinkamp et al. also showed that the incidence of distal embolization in laser angioplasty was lower compared with balloon dilatation alone (0.8% vs. 9%) [23]. ...
There are few studies on excimer laser (308 nm) atherectomy in the treatment of infrapopliteal artery disease. The purpose of this retrospective clinical study was to assess the efficacy and safety of excimer laser atherectomy (ELA) in combination with adjuvant drug-coated balloon angioplasty (DCB) compared to DCB for infrapopliteal arterial revascularization in patients with ischemic diabetic foot. From September 2018 to February 2019, a total of 79 patients with diabetic foot were treated for infrapopliteal arterial revascularization at Tianjin First Central Hospital (Tianjin, China). In this project, 35 patients were treated with ELA combined with DCB angioplasty, and 44 patients were treated with DCB angioplasty. The patients’ baseline characteristics were similar between the 2 groups. The primary efficacy endpoints through 24 months were clinically driven target lesion revascularization (CD-TLR), wound healing rate, major amputation rate, and target vessel patency rate. The primary safety endpoint through 24 months was all-cause mortality. The primary efficacy results at 24 months of ELA + DCB versus DCB were CD-TLR of 14.3% versus 34.1% (p = 0.044), wound healing rate of 88.6% versus 65.9% (p = 0.019), target vessel patency rate of 80.0% versus 52.3% (p = 0.010), and major amputations rate of 5.7% versus 22.7% (p = 0.036). The safety signal at 24 months of all-cause mortality rate was 2.9% for ELA + DCB group and 4.5% for DCB group (p = 0.957). ELA combined with DCB angioplasty is more effective than DCB in the treatment of infrapopliteal artery disease in patients with ischemic diabetic foot, which can improve the wound healing rate and target vessel patency rate. There was no statistical difference in the safety results between the two groups.
... In cases where CTO crossing with standard guidewires was unsuccessful after 5 min of continuous attempt, patients were then enrolled in the trial and treated with the Wingman catheter (Reflow Medical, San Clemente, CA) prior to endovascular revascularization. The time period for attempted crossing with a standard guidewire was based off of precedent set by previous crossing catheter trials (usually 3 min in previous trials) 4,5,[9][10][11][12][13][14][15][16][17] . ...
... The primary endpoints of the trial were statistically compared to performance goals that were calculated based on results from other CTO crossing catheters. 4,5,[9][10][11][12][13][14][15][16][17] Study success required the lower one-sided 95% confidence limit of the primary efficacy endpoint to exceed 70.7%, which was derived assuming an 83.2% crossing rate and a 12.5% margin. Similarly, the upper one-sided 95% confidence limit of the primary safety endpoint was not to exceed 13.0%, assuming an observed rate of 8.0% plus a 5.0% margin. ...
Objectives
To determine the safety and effectiveness of a peripheral artery chronic total occlusion (CTO) crossing catheter following failed crossing attempts with standard guidewires.
Background
CTO crossing remains a challenge during peripheral artery interventions.
Methods
In this prospective, international, single‐arm study, patients with a peripheral artery CTO that was uncrossable with standard guidewires were treated with a crossing catheter (Wingman, Reflow Medical). The primary efficacy endpoint of CTO crossing success was compared to a performance goal of 70.7%. The primary composite safety endpoint (major adverse event [MAE], clinically significant perforation or embolization, or grade C or greater dissection) was assessed over a 30‐day follow‐up period and compared to a performance goal of 13.0%.
Results
A total of 85 patients were treated using the Wingman catheter for peripheral artery CTO crossing. Key patient characteristics were mean age of 71±9 years, 66% male, and mean lesion length of 188±94 mm in the superficial femoral artery (71%), popliteal artery (15%), or infrapopliteal arteries (14%). Both primary endpoints of the trial were met¾CTO crossing success was 90% (lower confidence limit=82.5%) and 5 primary safety events occurred in 4 (4.8%) patients (upper confidence limit=10.7%). Over 30 days of follow‐up, Rutherford score decreased by at least 2 categories in 74% patients; the percentage of patients with normal hemodynamics assessed with the ankle‐brachial index increased from 1% to 51%.
Conclusions
Among patients with a CTO that was unable to be crossed with a standard guidewire, the Wingman catheter was able to cross 90% of occlusions with a favorable safety profile.
... The photochemical, photothermal and photomechanical energy delivered by the excimer laser interacts with tissue, breaks down molecular bonds and creates vapor bubbles that generate kinetic energy. Long total superficial femoral artery (SFA) occlusions, as in the Peripheral Excimer Laser Angioplasty trial, as well as below-the-knee lesions in critical limb ischemia patients have been treated with excimer laser, providing improved results over those obtained with standard PTA alone, as well as excellent limb-salvage rates (11)(12)(13). The excimer laser probe is capable of 'step-by-step' debulking and hence, excimer laser atherectomy (ELA) outperforms other mechanical atherectomy treatments (14). ...
... ELA involves employing photochemical, photomechanical and photothermal processes to debulk and ablate tissue (thrombi, atherosclerotic plaques) and has been proven to be a useful supplement to chronic obstructive arterial treatment (11,34). The patency rates of successfully treated lesions (freedom from target lesion revascularization) have been reported to be 96.6% at 12 and 82.7% at 24 months (14). ...
The aim of the present retrospective study was to evaluate the feasibility, safety and the primary results following application of excimer laser atherectomy (ELA) combined with adjunctive drug-coated balloon angioplasty (DCBA) as the first-line endovascular treatment for patients with chronic obstructive femoropopliteal arterial disease. The baseline characteristics and angiographic variables of all patients who underwent ELA for stable chronic obstructive femoropopliteal arterial disease at Tianjin First Central Hospital (Tianjin, China) between May and December 2017 were collected. Information on clinical characteristics, including the 12-month primary patency rate, technical success rate, procedural success rate, bailout stenting rate, target lesion revascularization and major adverse events, was obtained following review of the patients' medical records. A descriptive analysis was performed on all variables. Kaplan-Meier curves were plotted for the primary patency rate. The present study included 17 consecutive patients (age, 68.9±7.4 years; 94.1% males) who were followed up for 12 months after the intervention. Adjunctive BA was performed in 100% of the cases. The occlusion length was 23.3±8.9 cm (range, 5.6-40.5 cm). The technical success rate was 100% and the procedural success rate was 88.2%. Bailout stenting was required in 5 of the 17 patients (29.4%) and the 12-month primary patency rate was 82.4%. The clinically driven target lesion revascularization rate was 5.9% at 12 months. An embolic protection device was used in 23.5% of the patients. The following adverse events were reported: Distal embolization requiring treatment, 5.9% (1 patient with embolic protection device); and flow-limiting dissection requiring treatment, 5.9%. In the present study, there were no major adverse events (all-cause death, unplanned major amputation or target lesion revascularization) at 30 days after the intervention. Therefore, ELA combined with adjunctive DCBA for the treatment of chronic obstructive femoropopliteal arterial disease appears to be safe, practicable and associated with a high procedural success rate; furthermore, endoluminal-driven atherectomy may effectively reduce the requirement for stent placement in the lower limb arteries and is associated with long-term patency.
... In order to achieve satisfactory success, the operator must be experienced in various recanalization methods, inclusive antegrade and retrograde techniques to reduce surgery time and contrast agent dose, and to minimize complications. In approximately 20-25% of cases, even experienced operators in big centres may fail to treat long occlusive femoropopliteal lesions with an antegrade approximation, or re-entry apparatus may be required after subintimal passage associated with sequential multiple stent implantation [10][11][12]. In the long run, this results in excess costs and perhaps less open patency rates. ...
Aim: In this study, the aim was to investigate whether antegrade or retrograde approaches are superior in the endovascular treatment of femoropopliteal chronic total occlusions (CTO). Material and Methods: A total of 437 patients who were diagnosed with CTO in the femoropopliteal region and who subsequently underwent endovascular procedures between February 2019 and April 2022 were evaluated retrospectively. The patients were grouped as antegrade access and retrograde access. All patients were classified according to the Rutherford and TASC (Transatlantic Intersociety Consensus II) classification. The patients were followed for 2 years. Above-ankle amputation and >50% stenosis in the target vessel were considered a failure. ABI, improvement in clinical symptoms, and limb salvage were evaluated in controls. Results: Antegrade approach was performed in 218 of the endovascular procedures. Antegrade recanalization was successful in 201 patients (92.2%), and failed antegrade attempt was seen in 17 because the lesion could not be crossed. Retrograde approach was used in 197 of endovascular interventions. Successful retrograde recanalization was unsuccessful in 185 patients (93.9%), and retrograde intervention was unsuccessful in 12 patients because the lesion could not be crossed. When the two-year restenosis numbers were examined, it was 61 (30.3%) in the antegrade group, while it was 49 (25.5%) in the retrograde group, and there was a significant difference between the groups. When the one-year stent occlusions between the groups were examined, it was 14 (6.9%) in the antegrade group and 8 (4.1%) in the retrograde group, and there was a statistically significant difference between the groups. Conclusion: The retrograde approach is as effective and safe as the antegrade approach in the treatment of femoropopliteal CTO. It should be noted that it can be used as an alternative method without the need for any support device, especially in cases where the antegrade approach is unsuccessful.
... Excimer laser-assisted recanalization is one of the most frequently used methods for the recanalization of chronic total occlusions. Although this technique was used in many studies in the 1990s and early 2000s (25)(26)(27)(28) and achieved early successful results, it is no longer used nowadays, as it was found to have high restenosis rates due to severe vascular inflammation in long-term follow-up compared with other recanalization techniques in later studies (29) . In a series of 48 patients, published in 1999, all stents were placed successfully, and no major complications occurred. ...
Objectives:
This study aimed to present our mid-term experience in the endovascular treatment of aortoiliac occlusive disease using the kissing balloon technique.
Materials and Methods:
This two-center, retrospective study included 36 patients (male, n=23; female, n=13; mean age 62.7±9.7 years) with an aortoiliac occlusive disease, who received intervention using the kissing balloon technique between January 2017 and December 2019.
Results:
Thirty-six patients with aortoiliac occlusive disease underwent percutaneous intervention. The procedure could not be continued in three patients because of technical failure. Hence, 33 patients were successfully treated using the kissing balloon technique. The technical success rate was 91.6% and the one year patency rate was 83.3%. Of the 33 patients, 3 underwent surgery because of stent occlusion. After 1-year follow-up, in all 30 patients, all the vessels and stents were patent and no re-stenosis, no occlusion and no procedure related morbidity and mortality occurred.
Conclusion:
The endovascular treatment of aortoiliac occlusive diseases with kissing balloon technique demonstrated high success and patency rates in appropriate cases. However, in some patients technical failure may occure and the procedure could not be completed. The use of newer recanalization devices, materials or techniques, enrollment of larger cohort and more than 1 year of follow-up may clarify the long-term results of the kissing balloon technique.
... The successful intervention for peripheral artery disease (PAD) is limited by complex lesion morphology including long CTOs and severe calcification (Ingle et al., 2002). Conventional PVI failed in up to 25% femoropopliteal CTOs (Scheinert et al., 2001), and lower success rate in below-the-knee artery (BKA) lesions due to the background of patients with critical limbthreatening ischemia was reported (Tan et al., 2021). ...
Background
The successful intervention for peripheral artery disease is limited by complex chronic total occlusions (CTOs). During CTO wiring, without the use of intravascular or extravascular ultrasound, the guidewire position is unclear, except for calcified lesions showing the vessel path. To solve this problem, we propose a novel guidewire crossing with plaque modification method for complex occlusive lesions, named the “Direct tip Injection in Occlusive Lesions (DIOL)” fashion.
Main text
The “DIOL” fashion utilizes the hydraulic pressure of tip injection with a general contrast media through a microcatheter or an over-the-wire balloon catheter within CTOs. The purposes of this technique are 1) to visualize the “vessel road” of the occlusion from expanding a microchannel, subintimal, intramedial, and periadventitial space with contrast agent and 2) to modify plaques within CTO to advance CTO devices safely and easily. This technique creates dissections by hydraulic pressure. Antegrade-DIOL may create dissections which extend to and compress a distal lumen, especially in below-the-knee arteries. A gentle tip injection with smaller contrast volume (1–2 ml) should be used to confirm the tip position which is inside or outside of a vessel. On the other hand, retrograde-DIOL is used with a forceful tip injection of moderate contrast volume up to 5-ml to visualize vessel tracks and to modify the plaques to facilitate the crossing of CTO devices. Case-1 involved a severe claudicant due to right superficial femoral artery occlusion. After the conventional bidirectional subintimal procedure failed, we performed two times of retrograde-DIOL fashion, and the bidirectional subintimal planes were successfully connected. After two stents implantation, a sufficient flow was achieved without complications and restenosis for two years. Case-2 involved multiple wounds in the heel due to ischemia caused by posterior tibial arterial occlusion. After the conventional bidirectional approach failed, retrograde-DIOL was performed and retrograde guidewire successfully crossed the CTO, and direct blood flow to the wounds was obtained after balloon angioplasty. The wounds heeled four months after the procedure without reintervention.
Conclusions
The DIOL fashion is a useful and effective method to facilitate CTO treatment.
... Vascular calcification are major contributors to interventional revascularization failure in up to 25% for femoropopliteal chronic total occlusions (CTOs) (Scheinert et al., 2001). Severe calcified plaques negatively affect postprocedural minimal lumen area and patency (Fujihara et al., 2019). ...
Background
Vascular calcification is a predictor of poor clinical outcome during and after endovascular intervention. Guidewire crossing techniques and devices have been developed, but chronic total occlusions (CTOs) with severe calcification often prevent subintimal re-entry. We propose a novel guidewire crossing approach combined needle rendezvous with balloon snare technique, named the “needle re-entry” technique, for treatment of complex occlusive lesions.
Main text
A 73-year-old female with severe claudication in her right calf with ankle brachial index of 0.62, and a computed tomography angiogram showed a long occlusion with diffuse calcification in superficial femoral artery. She was referred to our department to have peripheral interventions. Since the calcified vascular wall of the lesion prevented the successful re-entry, the “needle re-entry” was performed. First, a retrograde puncture of the SFA, distally to the occlusion, was performed and an 0.018-in. guidewire with a microcatheter was inserted to establish a retrograde fashion. Second, an antegrade 5.0-mm balloon was advanced into a subintimal plane and balloon dilation at 6 atm was maintained. Third, an 18-gauge needle was antegradely inserted from distal thigh to the dilated 5.0-mm balloon. After confirming a balloon rupture by the needle penetration, we continued to insert the needle to meet the retrograde guidewire tip. Then, a retrograde 0.014-in. guidewire was carefully advanced into the needle hole, named the “needle rendezvous” technique. After further guidewire advancement to accomplish a guidewire externalization, the needle was removed. Finally, since the guidewire was passing through the 5.0-mm ruptured balloon, the balloon was withdrawn, and the guidewire was caught with the balloon and successfully advanced into the antegrade subintimal space, named the “balloon snare” technique. After the guidewire was advanced into the antegrade guiding sheath and achieved a guidewire externalization, an endovascular stent graft and an interwoven stent were deployed to cover the lesion. After postballoon dilation, an angiography showed a satisfactory result without complications. No restenosis, reintervention, and limb loss have been observed for one year follow-up period after this technique.
Conclusions
The “needle re-entry” technique is a useful guidewire crossing technique to revascularize femoropopliteal complex CTOs with severe calcification which prevent the achievement of guidewire crossing with the conventional procedures.
... For these cases, balloon dilatation may prove insufficient for this type of lesions and the risk of recoil and restenosis is remarkably high. 8 Furthermore, applying high pressures during balloon angioplasty of pelvic arteries may lead to vessel rupture. In this regard, the 'pave-and-crack' technique proved to be useful for the treatment of severely calcified femoropopliteal lesions. ...
Background
Leriche syndrome is the result of the atherosclerotic occlusion of the distal aorta that may also involve pelvic arteries. The standard treatment for this condition is considered surgical with various techniques available for establishing appropriate flow to both limbs. However, due to the technical advances in the last decades, endovascular approaches are now also capable to tackle such lesions. The ‘pave-and-crack’ technique enables the treatment of severely calcified lesions. This two-step procedure consists of firstly placing a covered stent prothesis (VIABAHN) into the severely calcified segment, which is afterwards aggressively dilated with high-pressure balloons. Subsequently, an interwoven nitinol SUPERA stent with high radial forces is placed within the prothesis.
Case summary
Herein, we describe the case of an 81-year-old male patient, who presented with critical limb-threatening ischaemia of his right leg. Doppler ultrasound revealed a long occlusion of the right external iliac artery, common femoral, superficial femoral, and deep femoral artery. The lesion was successfully tackled using antegrade and retrograde punctures and the ‘pave-and-crack’ technique.
Discussion
The ‘pave-and-crack’ technique is an endovascular approach for the treatment of severe circumferential calcified lesions. Based on this technique covered stents are initially placed to prevent vessel rupture, which might occur during the aggressive balloon dilatation. Subsequently, the covered stents are relined by interwoven Supera stents, which provide high radial force preventing recoil and restenosis.
... Intervention endovascular treatment (EVT) is a good choice in treating chronic total occlusion of the superficial femoral artery (SFA). The initial success rate of this therapeutics was reported between 81% and 94% recently [1] as compared with 75% in 2001 [2] . Among the 2 ways of approaching the lesion Abbreviations: EVT, endovascular treatment; SFA, superficial femoral artery; ABI, ankle-brachial index; TASC, Trans-Atlantic Inter-Society Consensus. ...
A 55-year-old male was admitted with numbness in the left foot and intermittent claudication. Doppler ultrasound and digital subtraction angiography presented chronic total occlusion in the ostial of left superficial femoral artery and reperfusion flow at one-third below from collateral channels of deep femoral artery. Thus, we decided to perform an endovascular intervention for this patient. First, we used contralateral transfemoral approach technique, but the microwire could not reach to the occluded superficial femoral artery lesion. Then, we approached the chronic total occlusion lesion retrogradely. A wire was passed successfully from the popliteal artery to ostial superficial femoral artery. Finally, 2 stents were implanted. This case highlights that popliteal retrograde approach is effective and safe for total occlusion of superficial femoral artery.
... Vascular calcification is a common finding in peripheral artery disease (PAD) and may represent a significant challenge for endovascular therapy. 1 The length of disease and degree of calcification are thought to be major contributors to technical failure rates, which may have an incidence as high as 25% for chronic total occlusions (CTOs) of the femoropopliteal segment. 2,3 Moreover, severe calcification can compromise the intraluminal passage of guidewires and balloon catheters, forcing them into a subintimal plane that may result in reentry failure. It may also act as a physical impediment to stents and antirestenotic therapies such as drug-coated balloons (DCBs), as evidenced by worse patency outcomes in this group. ...
Vascular calcification is a frequent finding in peripheral arterial disease and remains an additional challenge to endovascular treatment in both recanalization and durability of interventions. The lack of standardization in the classification of peripheral artery calcification has led to a defective characterization of the performance of endovascular devices in the subgroup of calcified lesions of the femoropopliteal sector. The objective of this review is to make a survey of the available evidence regarding the current options in the endovascular treatment of highly calcified lesions of the femoropopliteal sector.
... 2,3 Mais ainda, a calcificação vascular parece influenciar a própria resposta à intervenção terapêutica: na doença arterial periférica, a extensão da calcificação contribui para uma elevada taxa de falência técnica durante a recanalização percutânea de oclusões femoro-poplíteas crónicas. 4,5 À semelhança da calcificação das artérias coronárias, verificou-se que também a calcificação aórtica (CA) estava associada a eventos cardiovasculares num estudo que utilizou um sistema de pontuação subjetivo para avaliar a CA em radiografias lombares de indivíduos do Framingham Heart Study. 6 Neste estudo longitudinal, mais de 2500 indivíduos foram acompanhados por mais de 22 anos. ...
Abdominal aortic aneurysm (AAA) remains a relevant cause of mortality in Western countries. There is a need for continuous identification of risk factors for aneurysmal progression and predictors of treatment response to optimize the therapeutic strategy to be offered to these patients. Vascular calcification has been studied in several capillary beds as a cardiovascular risk factor. However, the importance of abdominal aortic calcification (AC) in AAA remains incompletely clarified, and the available evidence is scattered and heterogeneous. The objective of this review is to describe the possible impact of AC on aneurysmal progression and rupture, as well as on the response to endovascular correction. It should be noted that the establishment of a validated, quick and easy to use method for assessing AC would be of great clinical and/or research utility.
... Vascular calcification is a common finding in peripheral artery disease (PAD) and may represent a significant challenge for endovascular therapy. 1 The length of disease and degree of calcification are thought to be major contributors to technical failure rates, which may have an incidence as high as 25% for chronic total occlusions (CTOs) of the femoropopliteal segment. 2,3 Moreover, severe calcification can compromise the intraluminal passage of guidewires and balloon catheters, forcing them into a subintimal plane that may result in reentry failure. It may also act as a physical impediment to stents and antirestenotic therapies such as drug-coated balloons (DCBs), as evidenced by worse patency outcomes in this group. ...
Purpose:
To report midterm results of the "pave-and-crack" technique to facilitate safe and effective scaffolding of heavily calcified femoropopliteal lesions in preparation for delivery of a Supera interwoven stent.
Methods:
Data were collected retrospectively on 67 consecutive patients (mean age 71±8 years; 54 men) treated with this technique between November 2011 and February 2017 at a single center. A third (22/64, 34%) of the patients had critical limb ischemia (CLI). Most lesions were TASC D (52/67, 78%), and the majority were occlusions (61/66, 92%). The mean lesion length was 26.9±11.2 cm. Nearly two-thirds (40/64, 62%) had grade 4 calcification (Peripheral Arterial Calcium Scoring System). To prepare for Supera stenting, the most heavily calcified segments of the lesion were predilated aggressively to obliterate recoil. A Viabahn stent-graft was then implanted to "pave" the lesion and protect from vessel rupture as aggressive predilation continued until the calcified plaque was "cracked" before lining the entire lesion with a Supera stent. Patency and target lesion revascularization (TLR) rates were estimated using the Kaplan-Meier method.
Results:
Procedural success was achieved in 100% and technical success (residual stenosis <30%) in 98% (66/67). The mean cumulative stent lengths were 16±9 cm for the Viabahn and 23±12 cm for the Supera. Only 2 complications occurred (distal embolization and access-site pseudoaneurysm). Two CLI patients died within 30 days, and 3 patients (all claudicants) underwent a TLR. Patients were followed for a mean 19±18 months, during which another 2 CLI patients died and 1 patient had a major amputation. One-year primary and secondary patency estimates were 79% and 91%, respectively; freedom from TLR was 85%.
Conclusion:
Despite severe lesion calcification, patients experienced high technical success and a safe and durable therapy at midterm follow-up with the femoropopliteal "pave-and-crack" technique.
... A study evaluated the use of this laser for 411 consecutive procedures in 318 patients with long SFA occlusions and found that the technical success rate was 91%, and the 1-year secondary patency rate was 71%. 40) In the Laser Angioplasty for Critical Limb Ischemia (LACI) trial, 423 lesions were treated in 145 patients who were poor candidates for surgical revascularization; the reported 6-month limb salvage rate was 93%. 41) The EXCITE (Excimer Laser Atherectomy) trial enrolled patients from 40 United States centers and included patients with a Rutherford class 1-4 target lesion length ≥4 cm and a vessel diameter of 5-7 mm. ...
Several meta-analyses and multicenter trials have shown that chronic limb ischemia did not occur for up to 5 years in 50%–70% of patients who underwent saphenous vein grafts, with limb salvage and perioperative mortality rates of >80% and 3%, respectively. However, open surgical bypass can have limitations, including postoperative morbidity/wound complications of 10%–20% and prolonged length of hospital stay and outpatient care. Several studies have analyzed clinical outcomes for patients with critical limb ischemia treated with endovascular therapies, but they have been mainly retrospective with significant heterogeneity or were single center. Only few randomized trials have compared surgical vs. endovascular therapy. These included the Bypass vs. Angioplasty in Severe Ischemia of the Leg (BASIL) trial, with no differences found in amputation-free or overall survival rates at 1 year; however, late outcomes favored the surgical group. The Bypass or Angioplasty in Severe Intermittent Claudication (BASIC) trial concluded that the 1-year patency rates were 82% and 43% for bypass and angioplasty, respectively. The BEST Endovascular vs. Best Surgical Therapy in Patients with Critical Limb Ischemia (BEST-CLI) trial is currently enrolling patients. This review analyzed studies comparing open vs. endovascular therapy in patients with femoropopliteal disease. (This is a review article based on the invited lecture of the 45th Annual Meeting of Japanese Society for Vascular Surgery.)
... Recanalization with the Excimer Laser-assisted technique, designed to provide an option for the recanalization of CTOs, showed 1-year assisted-primary and secondary patency rates of 65.1% and 75.9%, respectively. 25 However, our experience shows that we were able to extend the endovascular indication also in difficult lesions and a primary patency rate of 54.2% after 36 months is an indicator of a lasting result, probably related more closely to the use of a stent. The high technical success rate, despite the unchanged midterm patency of the lesion, means it can be considered as offering a significant opportunity for those patients with distal ulcers, requiring an improved distal perfusion only for the time needed for the healing of the trophic lesion. ...
Aims:
The crossing of chronic total occlusions (CTOs) is the key step for an endovascular treatment. The Ocelot system is a novel device that combines a steerable drilling tip with optical coherence tomography (OCT) technology. It provides intraluminal imaging to help the crossing of CTOs in the femoropopliteal segment. Aim of the study was to determine early and midterm results after recanalization with this device.
Methods and results:
During a period of 16 months, 84 CTOs were treated using the Ocelot system and prospectively registered. The primary end points were technical success and the primary and secondary patency of the lesion. Risk factors associated with early and midterm results were also analyzed. In all, 58 (69.0%) lesions were treated for intermittent claudication, 26 (31.0%) for critical limb ischemia, 34 (40.5%) were classified as Trans-Atlantic Inter-Society Consensus II D lesions, and 22 (26.2%) showed severe calcifications. The technical success rate was 72.6%. During 36 months of follow-up (mean 25.9), there were 10 reinterventions. The primary and secondary patency at 36 months were 54.2% and 68.1%, respectively.
Conclusions:
In our experience, the Ocelot system would appear to be a safe and effective tool for increasing the applicability of endovascular techniques. However, the midterm results did not show drastic improvement.
... Scheinert and colleagues 45 reported data on excimer laser in CTOs of the superficial femoral artery. In 318 consecutive patients (411 superficial femoral artery, SFAs), the occlusion length was 19.4 AE 6.0 cm in length. ...
Atherectomy improves the acute procedural success of a procedure whether treating de novo or restenotic (including in-stent) disease. Intermediate follow-up results seem to be in favor of atherectomy in delaying and reducing the need for repeat revascularization in patients with femoropopliteal in-stent restenosis. Recent data suggest that avoiding cutting into the external elastic lamina is an important factor in reducing restenosis. The interplay between directional atherectomy and drug-coated balloons is unclear.
... In another study by Scheinert et al., 411 SFA long-segment occlusions were recanalized with laser-assisted angioplasty with an average lesion length of 19.4 cm achieving technical success of 90.5%. Complications included acute re-occlusion (1%), perforation (2.2%) and distal embolization (3.9%), while the 1-year assisted primary and secondary patency rates were 65.1 and 75.9%, respectively [29]. Interestingly, in contrary to excisional atherectomy options, the risk of distal embolization with laser use in the lower extremity was found to be comparable to the risk after angioplasty and stenting [30]. ...
Traditional percutaneous balloon angioplasty and stent placement is based on mechanical plaque disruption and displacement within the arterial wall. On the contrary, transcatheter atherectomy achieves atherosclerotic plaque clearance by means of directional plaque excision or rotational plaque removal or laser plaque ablation. Debulking atherectomy may allow for a more uniform angioplasty result at lower pressures with consequently less vessel barotrauma and improved luminal gain, thereby decreasing the risk of plaque recoil and dissection that may require permanent metal stenting. It has been also argued that atherectomy may disrupt the calcium barrier and optimize drug transfer and delivery in case of drug-coated balloon applications. The authors discuss the various types of atherectomy devices available in clinical practice to date and critically appraise their mode of action as well as relevant published data in each case. Overall, amassed randomized and observational evidence indicates that percutaneous atherectomy of the femoropopliteal and infrapopliteal arteries may achieve high technical success rates and seems to lessen the frequency of bailout stenting, however, at the expense of increased risk of peri-procedural distal embolization. Long-term clinical outcomes reported to date do not support the superiority of percutaneous atherectomy over traditional balloon angioplasty and stent placement in terms of vessel patency or limb salvage. The combination of debulking atherectomy and drug-coated balloons has shown promise in early studies, especially in the treatment of more complex lesions. Unanswered questions and future perspectives of this continuously evolving endovascular technology as part of a broader treatment algorithm are discussed.
... Chronic arterial total occlusions (CTOs) with a strong calcium component and extensive lesions (>15 cm) are still today, a factor limiting for endovascular treatment because of the difficulty in transposing these lesions with guide wires and catheters commonly used [7][8][9][10][11][12][13]. We can use specialized devices to cross lesions such as Frontrunner -Cordis (Figure 1, 2). ...
The current treatment of lower limb ischemia involves aggressive interventions in order to save the compromised limb and the patient’s life. The risk factors for peripheral arterial occlusive disease are essentially the same as those for atherosclerosis. Ischemic limb has a negative impact on the cardiovascular system and has been associated with increased mortality in patients with arterial occlusive disease. Atherosclerotic lesions with chronic total occlusion in the peripheral arteries are a difficult subset to treat by open or endovascular approaches. Improvements in revascularization techniques have produced more efficient results, in this situation, a minimally invasive endovascular intervention is a more attractive option compared to conventional open procedures, because it is associated with reduced surgical trauma. Now a days we`ve had new endovascular techniques, tactics and surgical materials to contribute to the technical development and improvement of our results for treatment of peripheral arterial disease. Total atherosclerotic arterial occlusions may be a limiting factor for endovascular treatment because of the difficulty in crossing the lesions with conventional guide wires and catheters. Achieving true lumen after subintimal crossing can be challenging and specialized catheters can be used to re-enter the true lumen. In this article, we provide a review of specific devices frontrunner and outback that may increase the procedural success of treating peripheral arterial total occlusions.
... The indications for this last option have been extended, because of its lower invasiveness and morbidity. In fact, in the past, it was used only for short stenosis and occlusions, while, nowadays, also longer lesions are eligible for this treatment [5]. ...
Rotational atherectomy for the treatment of isolated femoral artery traumatic lesion: a case report. G. Esposito, L. Di Serafino, G. Gargiulo, A. Sannino, G.G. Schiattarella, A. Franzone, C. Perrino, M. Chiariello. We describe the case of a 50-year-old man with an isolated plaque of the left distal superficial femoral artery (SFA), probably not related to atherosclerosis, but rather to a traumatic event. He was admitted to our hospital because of intermittent claudication. The critical distal SFA stenosis was documented by angiography and the lesion was treated by rotational atherectomy without stent implantation. At 1-year follow up, Doppler Ultrasound scan demonstrated a normal flow pattern of the left SFA and downstream districts in the absence of any complication. Therefore, rotational atherectomy is a safe and effective technique particularly in cases of peripheral arterial disease wherein stent implantation is dangerous.
The current laser atherectomy technologies to treat patients with challenging (to‐cross) total chronic occlusions with a step‐by‐step (SBS) approach (without leading guide wire ), are lacking real‐time signal monitoring of the ablated tissues, and carry the risk for vessel perforation. We present first time post‐classification of ablated tissues using acoustic signals recorded by a microphone placed nearby during five atherectomy procedures using 355 nm solid‐state Auryon™ laser device performed with an SBS approach, some with highly severe calcification. Using our machine learning algorithm, the classification results of these ablation signals recordings from five patients showed 93.7% classification accuracy with arterial vs. non‐arterial wall material. While still very preliminary and requiring a larger study and thereafter as commercial device, the results of these first acoustic post‐classification in SBS cases are very promising. This study implies, as a general statement, that on‐line recording of the acoustic signals using a non‐contact microphone, may potentially serve for an on‐line classification of the ablated tissue in SBS cases. This technology could be used to confirm correct positioning in the vasculature, and by this, to potentially further reduce the risk of perforation using 355 nm laser atherectomy in such procedures.
This article is protected by copyright. All rights reserved.
More than 200 million people worldwide have peripheral artery disease (PAD) or its most severe manifestation, critical limb ischemia (CLI). While endovascular treatment has become first line therapy in most cases, a number of challenges remain for optimal treatment of femoropopliteal (FP) or infrapopliteal (IP) disease, especially when these lesions are severely calcified, chronic total occlusions (CTOs) or in-stent restenosis (ISR). Continued evolution of technologies has significantly improved the outcomes for endovascular treatment. A number of new devices are in the pipeline right now, including new paclitaxel eluting stents and balloons, intravascular lithotripsy to treat severely calcified lesions, adventitial delivery of anti-restenotic agents to limit restenosis rates, and percutaneous femoro-popliteal bypass.
Endovascular intervention devices for femoral-popliteal arterial disease have evolved in the last decade to more effectively treat patients with symptoms of claudication, improve tissue healing, and prevent amputation in patients with critical limb ischemia. Drug-eluting stents and drug-coated balloon therapies have demonstrated significant improvements in short- and mid-term patency and decreases in future target vessel interventions over uncoated balloon angioplasty. Adjunctive lesion preparation options including atherectomy devices are available to treat more complex and calcified lesions, but comparative data are still required.
The laser has become an integral part of modern medicine, procedures based on this technique have found their way into a multitude of medical disciplines. There is, however, no data available on the detailed quantitative development of laser use in the medical sector. This fact gave rise to the idea of the present study, which analysed the raw data of the quality report of German hospitals with respect to this subject. Over the nine years of report, a steady increase in the cumulative number of cases was evident, although not all body regions in which the medical laser is used followed this trend. The CO2 laser was found to be the most commonly applied laser, even though a large spectrum of different laser types is used. Based on the present study the importance of the laser for medical purposes can be confirmed. This article is protected by copyright. All rights reserved.
To compare antegrade versus retrograde recanalization, in terms of procedural time, radiation and contrast agent exposure, number and total length of implanted stents and procedural complications, in long and calcified, de novo femoropopliteal occlusions. We performed retrospective matching of prospectively acquired data by lesion length, occlusion length and lesion calcification by the peripheral arterial calcium scoring system (PACSS) score in patients who were referred for endovascular treatment due to symptomatic peripheral artery disease (PAD). Forty-two consecutive patients with antegrade and 23 patients with retrograde after failed antegrade recanalization were identified (mean lesion length = 32.1 ± 6.9 cm; mean occlusion length = 24.6 ± 7.7 cm; PACSS score = 3.25 ± 0.91). 23% of the patients had intermittent claudication, whereas 77% exhibited critical limb ischemia (CLI). Patients who underwent retrograde versus antegrade recanalization required a significantly lower number of stents (0.9 ± 1.0 versus 1.8 ± 1.4, p = 0.01) and a lower total stent length (6.8 ± 8.5 cm versus 11.7 ± 9.9 cm, p < 0.05) in the interest of more extensive coverage of the lesions using drug coated balloons (DCB) (28.5 ± 12.0 cm versus 18.2 ± 16.0 cm, p = 0.01). No re-entry device was required with the retrograde versus 9 of 42 (21%) with the antegrade recanalization group (p = 0.02). The rate of complications due to retrograde puncture was low (one patient with hematoma and one with distal pseudoaneurysm, both managed conservatively). In long and calcified femoropopliteal occlusions, the retrograde approach is associated with a lower number of re-entry devices and stents and with more extensive lesion coverage with DCB, in the interest of costs and possibly long-term patency.
Background:
Currently, there exists limited data on patient outcome following the use of drug-coated balloons to treat complex femoropopliteal arterial occlusive lesions. The aim of the present study was to investigate the outcomes of patient treated with drug-coated balloons (DCB) and to identify predictors of restenosis.
Methods:
We retrospectively investigated medical records from 120 patients (137 limbs) treated with DCBs for femoropopliteal lesions at a single center between 2013 and 2016. Primary patency, target lesion revascularization (TLR), and risk factors of restenosis were analyzed.
Results:
There were 80 de novo and 57 in-stent restenosis lesions. Mean lesion length was 22.2 ± 11.6 cm. The clinical primary patency was 85.2% at 1 year, and 65.3% after 2 years. The TLR-free survival rate was 93.0% at 1 year, and 87.1% after 2 years. Critical limb ischemia (CLI; hazard ratio [HR] 5.80, 95% confidence interval [CI], 1.26-26.68, p=0.024) and hypercholesterolemia (HR 4.66, 95% CI 1.30-16.76, p=0.018) were identified as independent predictors of restenosis. In addition, non-use of cilostazol, and popliteal artery involvement showed trends toward an increased risk of restenosis.
Conclusions:
Treatment with DCBs showed excellent primary patency and TLR-free survival at one year after the procedure. However, the primary patency continuously deteriorated beyond one year, suggesting a late catch-up phenomenon. The risk of restenosis after treatment with DCBs was significantly associated with CLI and hypercholesterolemia.
Dr. Armstrong is a consultant or advisory board member to Abbott Vascular, Boston Scientific, Cardiovascular Systems Incorporated, Medtronic, Merck, and Spectranetics. Dr. Waldo receives investigator-initiated research grants from Abiomed Incorporated, Cardiovascular Systems Incorporated, and Merck Pharmaceuticals.
Acute limb ischemia is a vascular emergency, threatening the viability of the affected limb and requiring immediate recognition and treatment. Even with revascularization of the affected extremity, acute limb ischemia is associated with significant morbidity and mortality resulting in up to a 15% risk of amputation during the initial hospitalization and a 1 in 5 risk of mortality within 1 year of the index event. This review summarizes the current management of acute limb ischemia. Understanding the diagnosis and therapeutic options will aid clinicians in treating these critically ill patients.
Lower extremity peripheral arterial occlusive disease poses a unique challenge to traditional angioplasty-based endovascular therapies. Factors that negatively affect the long-term results of percutaneous intervention include the length of the diseased segment, the presence of total occlusion, diabetes mellitus, poor distal runoff, and critical limb ischemia as the clinical presentation. Chronic total occlusion may be present in up to 40 % of patients undergoing treatment for symptomatic peripheral arterial disease, and procedural success rates have historically been lower in the setting of chronic total occlusion. These challenges have spawned the development of a host of new technologies in an attempt to improve the safety and effectiveness of percutaneous revascularization for lower extremity peripheral arterial disease.
Endovascular interventions for symptomatic peripheral artery disease (PAD) have undergone significant progress in recent years. Trials, however, remain limited for evaluating the efficacy and safety of these technologies in critical limb ischemia (CLI). This chapter attempts to review the mechanism of restenosis which has provided the impetus for the development of multiple endovascular options for PAD interventions. Following it is a review of available evidence for the use of percutaneous transluminal angioplasty (PTA), stent technologies including bare-metal (BMS), bare-nitinol, and drug-eluting stents (DES); cryoplasty; cutting and scoring balloons; and drug-eluting balloon (DEB) technologies. Finally, adjunctive technologies designed for intervention in special circumstances are reviewed including atherectomy technologies, technologies for intervening on chronic total occlusions (CTOs), and embolic protection devices.
Lower limb arterial recanalization is a term that encom- passes various therapeutic manoeuvres with the goal of re-opening or dilating occluded and stenotic arteries. This chapter deals primarily with the treatment of chronic infra-inguinal occlusive disease. Percutaneous transluminal angioplasty (PTA) and stents are,at present, accepted as effective treatment in a substantial portion of iliac artery lesions [52]. The role of endovascular repair in the femoro-popliteo-crural system is still the subject of debate [37,55]. Percutaneous revascularization of femo- ro-popliteal arteries has shown high restenosis rates and stents should be confined to flow-limiting dissections or where there have been inadequate results from balloon angioplasty alone [27].
The treatment of peripheral arterial disease (PAD) has witnessed a remarkable evolution in the past two decades. While endovascular therapy has become well established as a primary treatment modality in aortoiliac occlusive disease, transcatheter treatment of infrainguinal occlusive disease remains controversial. The availability of a wide range of therapeutic options and devices applicable to infrainguinal interventions has resulted in a dramatic increase in the number of peripheral endovascular procedures over the past decade, with a staggering reported 979 % growth in peripheral vascular interventions reported since 1995. Despite this remarkable growth and increasing acceptance, many questions remain unanswered regarding the indications, choice of device/technique, clinical efficacy, long-term outcome, and cost-effectiveness of the available competing modalities. These decisions are also compounded by intense and often conflicting marketing efforts by the industry in the current competitive market. With the scarcity of randomized controlled trials, much of the published reports for newer endovascular technologies rely primarily on immediate angiographic outcomes and target limb revascularization (TLR) data. The following text is meant to provide an overview over current treatment options, technologies, and devices based on available evidence and the experience and opinions of the authors. The endovascular surgeon must be familiar with all the available treatments for PAD in order to continue to manage these patients amidst the increasingly complex health-care environment.
In den letzen Jahren haben sich vermehrt (Interventions-)Kardiologen den extrakardialen Gefäßen gewidmet. Schwerpunkte sind hier die katheterinterventionelle Behandlung von Karotis- und Nierenarterienstenosen, da sich diese Stenosen besonders gut mit aus der Koronarintervention bekannten Kathetertechniken diagnostizieren und behandeln lassen. Um den interessierten Kardiologen einen Einblick in die angiologischen Grundlagen zu ermöglichen, wurde dieses im Umfang begrenzte Kapitel neu aufgenommen. Im Gegensatz zur Kardiologie gibt es in der Angiologie nur eine sehr begrenzte Anzahl guter randomisierter Studien, die „evidence based“ Empfehlungen erlauben.
Objectives:
The authors sought to investigate the efficacy of a drug-coated balloon (DCB) for treatment of complex femoropopliteal lesions.
Background:
Superiority of DCBs compared with uncoated balloon angioplasty for femoropopliteal interventions has been demonstrated in randomized trials for short lesions. Their performance in complex lesions with higher restenosis rates is unclear.
Methods:
Patency, target lesion revascularization (TLR) rate, clinical improvement, and safety endpoints of femoropopliteal lesions in 288 limbs (n = 260) treated with the In.Pact Pacific or Admiral DCB (Medtronic, Minneapolis, Minnesota) were retrospectively analyzed for up to 2 years of follow-up. Predictors of restenosis were identified by logistic regression.
Results:
Lesions were de novo in 51.7%, restenosis in 11.1%, and in-stent restenosis in 37.2%. Mean lesion length was 24.0 ± 10.2 cm, and 65.3% were occluded. Stent implantation was performed in 23.3%. Kaplan Meier estimates of primary patency were 79.2% and 53.7% for all lesions at 1 and 2 years, respectively, whereas freedom from TLR was 85.4% and 68.6%. Primary patency for in-stent restenosis treatment was 76.6% and 48.6%, and freedom from TLR was 83.0% and 58.7% at 1 and 2 years, respectively. Rutherford category improved from a median 3.3 to 1.2 at 1 year, and to 1.1 at 2 years. Major amputation rate was 2.1% at 2 years. No adverse events were thought to be attributable to the coating of the balloon.
Conclusions:
These results suggest that DCB are safe and effective in delaying rather than preventing restenosis in long, complex lesions and restenosis of the femoropopliteal tract. Further studies are recommended to confirm these results.
Laser atherectomy has been used to treat peripheral arterial disease for the past 20 years but has yet to he widely accepted. Some of the skepticism arises from earlier versions of the laser that caused significant thermal injury to the vessel resulting in very high complication rates. Lasers, catheter technology and our understanding of the interactions between light, blood and tissues has advanced significantly over the past 20 years. The current excimer laser uses a pulsed beam that causes little thermal damage and has the ability to cross complex calcified lesions. Unfortunately, technical success has not been associated with good long term patency. Most vessels are not treatable with laser alone and require concomitant angioplasty and stenting. Multiple reinterventions are often needed to obtain the desired clinical outcome. Balloon angioplasty has been shown to have similar patency rates despite the improved technical success with the laser. This makes support of laser therapy difficult as a first line treatment in all patients. The question then becomes what is the role for laser atherectomy? Is the remarkable science and potential applications of lasers in peripheral arterial disease underappreciated or do we need to limit its use to a small subset of patients?
The aim of this prospective study was to evaluate the impact of the excimer laser technology as the first line endovascular treatment of critical limb ischemia (CLI) in diabetic patients. The protocol allowed the use of laser ablation of obstructive lesions when conventional endoluminal guidewire crossing of the plaque was unsuccessful. To extrapolate the data of patients with completed six month follow-up we restricted the observation to an extent of 15 months. In this time course, 67 diabetic patients with CUI were brought in to have "operative angiography" with the intention to treat with endovascular techniques: among the 67 cases, laser was used in 35 patients to treat 49 lesions. All lesions are type D in the TACS classification. Immediate clinical success, defined as restored direct arterial flow to the foot was 90%. Patency rates were assessed using the Kaplan-Meier survival curves. The patency rates (freedom from target lesion revascularization) were 94.7% at three months, 91.8% at six months, 85.0% at nine months, 85.0% at 12 months and 72.8% at 15 months. Limb salvage rate at 6 and 12 months were 100% and 94% (33 out of the 35 patients) respectively. Our study showed that the excimer laser assisted angioplasty is effective in limb salvage in CLI patients with diabetes, and that endoluminal driven atherectomy allows long-term success reducing the need of stents application in the lower limb arteries.
In this chapter, the ENABLER-P balloon catheter system, is presented as an ideal tool for crossing of chronic total occlusions (CTOs) in the femoropopliteal arteries. The ENABLER-P balloon catheter system is designed to facilitate intraluminal advancement of standard guidewires through and beyond CTOs in the peripheral vasculature. The chapter also presents some tips and tricks for using the ENABLER-P balloon catheter system. Early clinical use of this device suggests that the ENABLER-P balloon catheter system could be a safe and effective tool for recanalization of CTOs. More extensive clinical application of this system may show it to be a simple, safe, and more reliable method to cross CTOs. Future directions for the ENABLER-P balloon catheter system will likely include additional balloon sizes including those for occlusions below the knee.
General principles of vascular stents Biologic response to intravascular stent placement Indications for stent placement Relative contraindications to stent placement Complications Stents in iliac arteries Stents in femoropopliteal arteries Infrapopliteal stents Stents in peripheral veins Future stents Summary References
IntroductionRecanalization of pelvic arteriesRecanalization of the femoropopliteal tractInfrapopliteal angioplastyReferences
Complex arterial occlusive disease in the aging, medically unfit population has become a common clinical problem for the modern clinical vascular practice. Multiple treatment strategies have evolved with the introduction of endovascular therapy. The management of these patients has become increasingly challenging, especially without robust clinical trial results. We review the current literature and describe our results and approach to these difficult patients.
The burden of critical limb ischemia (CLI) is progressively rising, because of an increasing prevalence of diabetes mellitus and greater life expectancy in developed countries. There is no doubt, that distal bypass grafting is a standardized and well-accepted treatment option with good long-term results. However, patients with CLI have severe comorbidities which can influence the outcome of arterial revascularization. Additionally, the introduction of dedicated minimal invasive techniques has made percutaneous arterial revascularization an attractive alternative and therefore is being used increasingly for the treatment of patients with CLI and tibioperoneal lesions. The primary goal of any endoluminal approach is aimed to restore straight in-line blood flow to the foot in at least one vessel in order to limb salvage. It offers the advantages of local anaesthesia, shorter hospital stay and the option of re-intervention in case of a new clinical impairment. However, only patients in Rutherford classes 4-6 should be candidates for infragenicular revascularization. The clinical success of an infrapopliteal intervention depends on patient optimization with medical control of life-threatening co-morbidities and good inflow into the infragenicular region which must be secured by either endovascular or surgical approach.
Objective:
Endovascular treatment (EVT) using a popliteal approach is effective for superficial femoral artery (SFA) chronic total occlusion (CTO); however, its effectiveness, safety, and consequent complications are unclear.
Materials and methods:
We studied 324 consecutive EVTs (in 187 patients) performed at three centers between April 2008 and March 2013, and selected all EVTs that included SFA CTO regions. A total of 91 EVTs (in 65 patients) were included and divided into two groups; "with popliteal approach" (WPA) and "without popliteal approach" (WOPA).
Results:
Despite higher rates of hypertension (WPA, 88.9% vs. WOPA, 69.1%; p = 0.04) and CTO length >200 mm (55.6% vs. 28.3%, respectively; p <0.01), the primary success rate was better in the WPA group (97.2% vs. 78.2%, respectively; p <0.01); however, both total complication rate and major complication rate were not significantly different. We compared popliteal puncture using a sheath and using a microcatheter alone. There were no significant differences between sheath and microcatheter use in terms of primary success rates (95.5% vs. 100%, respectively; p = 0.61) and puncture site complications (22.7% vs. 14.2%, respectively; p = 0.53).
Conclusion:
A popliteal approach improved the primary success rate of EVT for SFA CTO.
Chronic total occlusion (CTO) of peripheral arteries can cause claudication or even critical limb ischemia. CTOs consist of various degrees of fibro-atheromatous plaque and thrombus depending on the mechanism of occlusion and its duration. Because of often complex and long occlusions, more than 80% of patients usually need a more specialized crossing technique over the standard technique. Several devices are now available that may enable treatment of these difficult lesions. These devices cross the calcified plaque using different physical principles, such as blunt microdissection, optical coherence reflectometry, laser, or mechanical vibration. All these new technologies are unable to see the true lumen of the vessel. Optical Coherent Reflectometry with radio frequency ablative energy is a forward-looking system that has been utilized to treat CTOs.
This paper presents the results of a prospective study of percutaneous transluminal angioplasty (PTA) for the treatment of patients with peripheral arterial occlusive disease and identifies the variables that are predictive of long-term success. The variables believed to be important prognostically were recorded for 984 consecutive PTAs performed between July 1978 and July 1986. Success or failure was defined using a combination of clinical and objective vascular laboratory criteria. The overall long-term success was estimated by the Kaplan-Meier method and differences between curves of success rate versus time for each variable were determined by the Wilcoxon and log-rank statistics. The combination of variables associated with success were determined by the Cox proportional hazards regression model. For all cases, the initial success rate was 88.6 +/- 1.0% and at 5 years was 48.2 +/- 2.3%. The following variables, when considered individually, were associated with success (p less than 0.05): indication for PTA, site of PTA, severity of lesion, runoff, number of sites dilated, diabetes, and the occurrence of a complication. From the Cox model, by using a stepwise multiple regression procedure, the following combination of variables were found to be predictive of success (p less than 0.05): (1) indication (claudication vs. salvage), (2) site (common iliac vs. other), (3) severity of lesion (stenosis vs. occlusion), and (4) runoff (good vs. poor). For all combinations of these four significant variables, curves of the success rate versus time were calculated. In conclusion, this study has identified the combination of four variables that together predict if PTA is likely to be successful in the management of a patient with peripheral arterial occlusive disease.
Purpose:
In this prospective study we investigated the site, occurrence, and development of stenoses and occlusions following recanalization of superficial femoral artery occlusions.
Methods:
Recanalization of an occluded femoropopliteal artery was attempted in 62 patients. Follow-up examinations included clinical examination and color-flow duplex scanning at regular intervals. Arteriography was used to determine the localization of the recurrent disease relative to the initially occluded segment.
Results:
During a mean follow-up of 23 months (range 0-69 months) 14 high-grade restenoses, indicated by a peak systolic velocity ratio > 3.0, were detected by color-flow duplex scanning. Occlusion of the treated segment occurred in 11 patients. The cumulative 3-year primary patency rate for high-grade restenoses and occlusions combined was 44% (SE 9%). By arteriographic examination the site of restenosis was localized in the distal half of the treated vessel segment in 16 of 21 cases.
Conclusion:
Most restenoses and occlusions occurred during the first year and most disease developed at the previous intervention site. The site of restenosis is more frequently in the distal part of the initially treated segment, a finding that may have therapeutic implications.
Excimer lasers are pulsed gas lasers that use a mixture of a rare gas and halogen as the active medium to generate pulses of short wavelength, high energy ultraviolet light. A krypton-fluoride gas mixture was used to achieve an excimer emission at a wavelength of 248 nm.A total of 30 atherosclerotic coronary artery segments were irradiated over a range of pulse energies (250 to 750 mJ), repetition rates (2 to 25 Hz), average powers (1.9 to 18.8 watts) and cumulative exposures (3 to 12 seconds). In no case was there gross, light microscopic or ultrastructural evidence of the pathologic injury typically associated with continuous wave laser irradiation of coronary artery segments. Similar results were achieved after excimer laser irradiation of 30 samples of myocardium. Excimer irradiation of calcified aortic valve leaflets accomplished focal debridement without pathologic tissue injury; when total debridement was attempted, however, gross charring was observed.The paucity of pathologic alterations observed after excimer irradiation of cardiovascular tissue may prove beneficial in precisely controlling laser ablation of pathologic tissue without injury to the surrounding normal tissue. Clinical application of excimer laser irradiation requires resolution of several issues, including the development of suitable fiberoptics and laser coupling, evaluation of potential ultraviolet toxicity, and demonstration that ultraviolet light can be transmitted through a blood-filled system.
Increasing the primary success rate in recanalization of peripheral vascular occlusions is one aim of using laser techniques in the treatment of peripheral vascular disease. Although reports of lasers enabling recanalization after failure of guide wires have been numerous, direct comparisons of the success of the two techniques in a randomized trial have been few. The results of a randomized trial showed no statistical difference in recanalization of femoropopliteal occlusions between the conventional guide wire and hybrid laser probe. The number of patients with iliac occlusions was small and comparisons are difficult to make, but the findings suggest that the hybrid laser probe has little to offer. Immediate crossover to the alternative method allowed investigation of the relationship between the two methods in practice. Combining the two methods improved the primary success rate from 82% to 91% for femoropopliteal occlusions randomized to laser thermal recanalization and from 74% to 91% for those randomized to conventional recanalization.
One hundred and thirty-seven consecutive percutaneous transluminal angioplasties (PTA) were performed for femoropopliteal vascular disease including 58 stenoses and 79 total occlusions. Nine occlusions could not be crossed with the guidewire, but in the remaining 128 the haemodynamic and clinical success as well as vascular patency were evaluated. The results were grouped into the following subsets: the indication for PTA, the severity of the vascular lesion, the crural run-off and the length of lesion. The results were in every respect poor with total occlusions when compared with stenoses. This was explained by a high incidence (41%) of rethrombosis within hours of dilatation. Early rethrombosis was seen with all lengths of occlusion (1-27 cm) with no statistically significant difference from other subsets. This study concludes that conventional PTA in femoropopliteal occlusions should be reserved for cases of limb salvage, preferably in patients who are technically inoperable. We suggest a new technique of segmentally enclosed thrombolysis to prevent early rethrombosis after PTA in femoropopliteal occlusions.
A metal-tipped laser fibre was used during percutaneous angioplasty of femoral/popliteal or iliac artery occlusions in 56 patients. Primary success was achieved in 50 (89%) of these total occlusions, providing a channel for subsequent balloon dilatation. Before the procedure, 18 lesions had been judged untreatable by conventional angioplasty and four of the six failures were in these. Complications directly attributable to the laser probe were one case of vessel perforation and two cases of entry into vessel walls; these had no sequelae. Other acute complications were a distal thrombosis in a non-heparinised patient, requiring local streptokinase treatment, and two reocclusions and one transient peripheral embolic episode in the first 24 hours. The laser probe technique has potential for increasing the proportion of patients suitable for angioplasty.
Endoscopic laser ablation of atheroma using continuous wave lasers is limited by imprecise control of thermal ablation, resulting in a crater that expands in width and depth, with thermal damage to adjacent normal tissue. We compared the gross and histologic effects of pulsed 308 mm excimer irradiation to continuous-wave Nd:YAG and Argon Ion laser irradiation, and pulsed 1,060 nm, 532 nm, 355 nm, and 266 nm laser irradiation in 205 atherosclerotic aortic segments. In contrast to the continuous-wave Nd: YAG, Argon Ion, and pulsed 1,060 nm, 532 nm, and 355 nm laser irradiation, which produced gross and histologic evidence of uncontrolled ablation, the 308 nm and 266 nm pulsed lasers induced incisions that conformed precisely to the beam configuration without gross evidence of thermal injury. The incision edges from these two lasers were histologically smooth and comparable to a scalpel incision. Our histologic findings suggest that rapid, precise endoscopic ablation of vascular and nonvascular tissue can be performed at these shorter pulsed wavelengths with very high precision with relatively little damage or risk to adjacent tissue.
Continuous-wave (CW) laser irradiation of cardiovascular tissues is characterized by 2 distinctive histologic findings: a superficial zone of coagulation necrosis and a subjacent zone of polymorphous lacunae. The present investigation was designed to determine whether such injury could be eliminated by altering the temporal profile of laser energy delivery. One hundred forty-five myocardial slices were irradiated with an air-tissue interface using CW laser irradiation at wavelengths of 488 to 515 nm (argon), 1,064 nm (Nd-YAG) and 10,600 nm (CO2). Pulsed laser irradiation included 248 nm (excimer); 355, 532 and 1,064 nm (Nd-YAG); and 515 nm (mode-locked argon). Energy profiles in the pulsed mode included a range of repetition rates (1 Hz to 256 MHz), pulse duration (0.2 to 358 ns) and pulse energies (2 nJ to 370 mJ). Resultant average powers were 0.1 to 38 W. Grossly visible charring of myocardial tissue was observed at all laser wavelengths when the laser energy profile was CW or pulsed at high repetition rates (more than 2 KHz) and low pulse energies (less than 3 mJ) independent of the wavelengths used. In contrast, when laser energy was pulsed at low repetition rates (less than 200 Hz) and large pulse energies (more than 10 mJ), neither gross nor histologic signs of thermal injury were observed. Pathologic injury associated with laser-induced tissue ablation may thus be substantially reduced by use of pulsed energy delivery at low repetition rates. Potential advantages of pulsed laser energy include a more benign healing process, a less thrombogenic surface, and improved preservation of structural tissue integrity.
