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Recanalization of Chronic Occlusions of the Superficial Femoral Artery Using the Outback (TM) Re-Entry Catheter: A Single Centre Experience
Abstract
To report our experience with a catheter system (The Outback catheter) designed to allow fluoroscopically controlled re-entry after subintimal guide wire passage during recanalization of chronically occluded femoro-popliteal arteries.
Between March 2007 and August 2008, 65 legs in 61 patients (60% male, mean age 73 (49-98 years) with chronic occlusion of the SFA and proximal popliteal artery were treated. Clinical presentation was severe intermittent claudication (Rutherford category 3, 59%), rest pain (Rutherford category 4, 16%), and minor ulcerations (Rutherford category 5, 25%). In all cases, the true lumen could not be entered by using standard antegrade catheter and guide wire techniques.
Median lesion length was 200 +/- 102 mm. Recanalization of the arterial occlusion was successful in 57 of 65 treated lesions (88%). One patient died of myocardial infarction after delayed femoral bleeding possibly due to extensive recanalization attempts. There were no further procedure-related complications.
Use of the Outback re-entry catheter system is a valuable option for interventional therapy of chronically occluded femoro-popliteal arteries following failed standard antegrade recanalization attempt.
... 1 Adjunct Professor of Vascular Surgery at the University Federal Fluminense RJ, Brazil 2 Nurse Coordinator of the Vascular Clinic Ocke Reis, Brazil prevent this series of events has been increasingly used. Not only in patients with critical limb ischemia, but also those with claudication [8][9][10][13][14][15][16][17][18][19][20]. ...
... The femoropopliteal occlusion is the classic indication for reentry catheter use in patients with intermittent claudication or critical ischemia member [8,10,[13][14][15][16][17][18][19][20]. There are also reports of successfully use of the device in the aortoiliac and popliteal segments. ...
... A study in diabetic population where the primary method of treatment was angioplasty, the technical impossibility to use the traditional endovascular procedure was observed in 25% (144/564) of them [27]. The reentry catheters rate to cross the critical atherosclerotic plaques ranges from 65% to 96%, possible explanations for the different rates of successes includes: surgeon's learning curve, occlusion length, severity of calcification and location of the lesion (aortic, iliac, superficial femoral or popliteal artery) [13][14][15][16][17][18][28][29][30][31]. ...
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 outcomes of crossing tools' usage are promising, but importantly they may increase the procedure cost. These tools are not widely available, require additional training and are not cost-effective [10][11][12]. ...
... Occurrence of perioperative complications associated with access site was 4.8% for perforation of the target vessel and 5.0% for hematoma and pseudoaneurysm. There was one reported case of a severe bleeding complication (fatal myocardial infarction associated with bleeding) [10,11]. ...
Introduction
Fifty percent of cases of peripheral artery disease are caused by chronic total occlusion (CTO) of the superficial femoral artery (SFA). Ten–fifteen percent of percutaneous SFA recanalization procedures are unsuccessful. In those cases the retrograde technique can increase the success rate of the procedure, but the long-term follow-up of such procedures is still unknown.
Aim
To assess the efficacy and clinical outcomes during long-term follow-up after retrograde recanalization of the SFA.
Material and methods
We included patients after at least one unsuccessful percutaneous antegrade recanalization of the SFA. Patients were evaluated for the procedural and clinical follow-up of mean time 13.9 months.
Results
The study included 17 patients (7 females, 10 males) who underwent percutaneous retrograde recanalization of the SFA from June 2011 to June 2015. The mean age of patients was 63 ±7 years. Retrograde puncture of the distal SFA was successful in all cases. A retrograde procedure was performed immediately after antegrade failure in 4 (23.5%) patients and after a previously failed attempt in 13 (76.5%) patients. The procedure was successful in 15 (88.2%) patients, and unsuccessful in 2 (11.8%) patients. Periprocedural complications included 1 peripheral distal embolization (successfully treated with aspiration thrombectomy), 1 bleeding event from the puncture site and 7 puncture site hematomas. During follow-up the all-cause mortality rate was 5.8% (1 patient, non-cardiac death). The primary patency rate at 12 months was 88.2% and secondary patency 100%.
Conclusions
The retrograde SFA puncture seems to be a safe and successful technique for CTO recanalization and is associated with a low rate of perioperative and long-term follow-up complications.
... Finally, 11 observational studies were included for further analysis. [4][5][6][7][13][14][15][16][17][18] Outcome measures included technical success of true lumen re-entry, any metrics of device re-entry accuracy (if reported), and periprocedure complications according to international reporting standards. 10 Pooled proportional outcomes were calculated with a random effects model to account for clinical and conceptual heterogeneity as described elsewhere in detail. ...
... The Outback re-entry catheter has been tested in several studies. [4][5][6][7][13][14][15][16][17][18] To our knowledge, this is one of the largest retrospective analyses of Outback-assisted subintimal recanalization including CTOs in both the aortoiliac and infrainguinal regions. In the present report, the Outback re-entry catheter performed very well, with an overall 93% success rate and an associated 17% rate of minor complications without any major events. ...
To report a single-center experience with the Outback re-entry device for targeted distal true lumen re-entry during subintimal recanalization of chronic total occlusions (CTOs) and compare the results with a systematic review of the literature.
Between February 2011 and July 2013, 104 Outback devices were employed in 91 patients (mean age 64±9 years; 57 men) for subintimal recanalization of 100 vessels with CTOs after initial failure of spontaneous reentry. Fifty-two cases involved a retrograde approach to aortoiliac occlusions and 48 were re-entry attempts in infrainguinal CTOs. Outcome measures included complications and technical success, defined as successful targeted re-entry at the preplanned site of the distal true lumen. To evaluate device accuracy, the re-entry distance (between the point of true vessel reconstitution and the eventual re-entry point) was measured.
Outback success was 93% (93/100); only 7 cases failed owing to heavy calcification (5/52 aortoiliac vs 2/48 infrainguinal, p=0.44). Re-entry was highly accurate, with a re-entry distance of ~1 cm in both subgroups (1.2±0.1 cm in aortoiliac vs 1.3±0.1 cm in infrainguinal, p=0.40). There were no major and 17 minor complications (9/52 aortoiliac vs 8/48 infrainguinal, p=0.93). Results are in line with the systematic review that identified 11 studies (only 1 randomized trial) involving mostly the femoropopliteal segment (119 aortoiliac and 464 infrainguinal segments). The pooled Outback success rate was 90% (95% confidence interval 85% to 94%) and the pooled complication rate was 4.3% (95% confidence interval 1.6% to 8.3%).
The Outback device is safe and has a very high rate of achieving targeted true lumen re-entry, which minimizes the sacrifice of healthy vessel in the aortoiliac and infrainguinal arteries.
© The Author(s) 2015.
... f Final angiography of the peroneal access site exhibiting vessel patency and no evidence of vessel injury entry, as first described by Bolia et al., is an appealing alternative strategy for treatment of CTOs, but it is not uncommon to fail true lumen access using a wire alone (Bolia et al. 1990). The Outback re-entry device is one of several support devices that has shown to be successful in transfemoral access, and more recently via transpedal access, when wire escalation techniques fail (Beschorner et al. 2009;Gandini et al. 2013;Patrone and Stehno 2019;Hayakawa et al. 2020). At our own practice, while the majority of femoral-popliteal CTOs can be crossed using standard techniques (mainly wire escalation therapies via transepdal or even dual access), < 5% of cases require the use of a support device. ...
Background
Transpedal access is increasingly utilized for the treatment of peripheral artery disease (PAD). Femoral-popliteal artery chronic total occlusions (CTOs) are some of the most difficult lesion subsets that sometimes require the use of re-entry support devices during percutaneous intervention. Limited data is available on the use of re-entry devices when treating femoral-popliteal CTOs via transpedal access. The aim of this study was to demonstrate the feasibility of using the Outback® Elite re-entry device for the treatment of femoral-popliteal CTOs via the transpedal approach in an outpatient based lab setting.
Methods
Seventeen patients presented with femoral-popliteal CTOs in which treatment required the use of the Outback® Elite re-entry device. All procedures were performed in a single outpatient based lab. Patients were followed at 1 week and 1 month post-procedure, with lower extremity arterial duplex ultrasound assessment during the 1 month follow-up.
Results
The average patient age was 78 years-old, with 71% being males. Most patients presented with Rutherford class IV symptoms. Procedural success was achieved in all patients with no requirement to convert to femoral artery access in any of the cases. No immediate post-procedural complications nor at any time during follow-up were observed. Ultrasonography at 1 month follow-up showed patent intervention sites and access site vessels in all patients.
Conclusion
The use of the Outback® Elite re-entry device for the treatment of femoral-popliteal CTOs via transpedal access is a feasible option and may have potential benefits by avoiding risks associated with traditional femoral artery access.
... The initial step of the endovascular process is to cross the lesion using a guidewire, and although passing through the true lumen is the principle, subintimal angioplasty [59,60] is an alternative option. Re-entry devices such as OUT-BACK (Cardinal Health Japan G.K., Tokyo) ( Figure 5) are used for navigating guidewire tips through subintimal spaces to distal true lumina [61][62][63][64][65][66][67][68][69]. ...
Endovascular treatment is effective for symptomatic peripheral arterial disease (PAD). Following recent device improvements, favorable long-term outcomes have been achieved in iliac arteries as well as small arteries such as the femoral and popliteal arteries.
This paper outlines the history and recent advances in endovascular treatment of peripheral vascular diseases as well as the characteristics and usage of devices. The history and the advances in endovascular treatment of peripheral vascular disease have been parallel, with the development of devices such as catheters and stents. Accordingly, endovascular treatment is now recommended in guidelines as the first-line for PAD.
... "Technik der subintimalen Rekanalisation von Gefäßläsionen in der AFS"; . Abb. 2; [7,9,[14][15][16]). Kitrou et al. [9] publizierten kürzlich eines der bisher größten Patientenkollektive auf dem Gebiet der aortoiliakalen CTOs (n = 52) mit einem hohen technischen Erfolg des OUTBACK ® von 93,4 % (9,6 % technisches Versagen ausschließlich bei schweren Verkalkungen). ...
Clinical/methodical issue:
This article gives an overview of the current importance of so-called subintimal recanalization in the lower extremities.
Standard radiological methods:
The primary technical goal of endovascular interventions in the lower extremities is the endoluminal restoration of blood circulation from the iliac arteries into the feet.
Methodical innovations:
If endoluminal recanalization of e.g. high-grade flow-relevant stenoses or chronic total occlusion (CTO) is technically not possible, subintimal recanalization is a promising option and the only remaining minimally invasive alternative. During subintimal recanalization a channel is intentionally generated in the vessel wall (dissection) in order to bypass e. g. a chronic vascular occlusion over as short a distance as possible.
Performance:
The technical success rate for subintimal recanalization of CTO of the lower extremities is 65-100 %. Technical failure occurs in approximately 25 % using the catheter and wire technique and is caused in most cases by difficulties in reaching the true lumen after the subintimal passage (the so-called re-entry).
Achievements:
Compared to conventional subintimal recanalization, in recent years so-called re-entry devices have expanded the technical possibilities and depending on the medical experience and training level of the physician, provide an improvement in the technical success rate, a lower complication rate, a reduction of fluoroscopy time and the amount of necessary contrast medium but also result in higher costs.
Practical recommendations:
Subintimal recanalization, whether carried out conventionally with a catheter and wire or using re-entry devices, of high-grade stenoses or CTO in the lower extremities provides a high technical success rate but requires an experienced and trained physician who is capable of operating the elaborate materials and mastering any possible complications.
... 7,8 Recently, drug-coated balloons have shown almost equivalent results to bare metal stents in TransAtlantic Inter-Society Consensus (TASC) II A and B lesions, [9][10][11][12] whereas drug-eluting stents were superior to bare metal stents in the same indication. 13 With advancing technologies, endovascular recanalization of long lesions (TASC II C and D 4 ) has become technically feasible in a large percentage of patients, 14 but the durability of PTA in long SFA lesions remains poor. 15 Primary stent placement has shown promising results in a single-arm study, 16 and the subgroup analysis of lesions longer than 15 cm in the Zilver PTX single-arm trial using a paclitaxel-eluting stent suggested even better results. ...
Purpose: To confirm the performance and safety of the 25-cm Viabahn endoprosthesis with Propaten bioactive surface when used in the treatment of de novo and/or restenotic TransAtlantic Inter-Society Consensus II C and D lesions of the superficial femoral artery and proximal popliteal artery.
Methods: The 25-cm Gore Viabahn Endoprosthesis study (ClinicalTrials.gov identifier NCT01263665) is a prospective, multicenter, single-arm study that enrolled 71 patients (50 men; mean age 66.7 +/- 8.34 years) with lifestyle-limiting claudication (Rutherford class 2 to 4) and lesions longer than 20 cm (mean length 26.5 +/- 5.31 cm, range 20-40). The majority of lesions (92.9%) were total occlusions. The primary performance outcome was post-deployment stent length within 610% of the pre-deployment stent length determined angiographically by quantitative vascular analysis. The primary safety outcome was device- and procedure-related serious adverse events occurring within 30 days of the procedure. The patients underwent follow-up examinations at 1 month and 1 year.
Results: The median follow-up was 12.3 months (mean 12.3 +/- 0.6). Nine (12.7%) patients discontinued the study due to different reasons including 2 bypass surgeries. Angiography was available in 60 patients to determine the primary performance outcome, which was met in all cases. Two (2.8%) patients experienced a procedure-/ device-related adverse event (dissection) during the 30-day follow-up. Kaplan-Meier estimates for 1-year primary and secondary patency were 67.0% [95% confidence interval (CI) 53.5% to 77.3%] and 96.9% (95% CI 88.0% to 99.2%), respectively. Changes in ankle-brachial index and Rutherford category at 1 and 12 months each showed sustained improvement.
Conclusion: This study confirms that the 25-cm Viabahn endoprosthesis acutely performs as intended and is safe when used as indicated in complex femoropopliteal lesions. Oneyear primary and secondary patency rates are satisfying and comparable to historical prosthetic bypass graft outcomes.
... In all patients, revascularization was attempted using the subintimal technique but while in group 2, the conventional manual reentry technique was performed to regain access to the true lumen ( Fig. 2) [6,7], in group 1, the OUTBACK V R LTD reentry catheter was used ( Fig. 1) [4,8]. The proximal end of the OUTBACK Re-Entry Catheter consists of a handle with a rotating hemostasis valve (RHV), a flush port for internal device flushing and a proximal braided shaft. ...
Purpose:
To assess the efficacy and safety of the Outback device in patients with a chronic total occlusion (CTO) of the superficial femoral artery and evaluate its impact on fluoroscopy and procedural times.
Materials and methods:
From October 2006 to March 2007, 52 patients affected by TASC II-D superficial femoral artery CTO were treated with subintimal recanalization. Clinical indications for endovascular recanalization were: claudication, tissue loss, and at rest leg pain with critical limb ischemia. In 26 patients the manual reentry technique was used and in 26 the OUTBACK(®) LTD Re-Entry Catheter was used. Total procedure time, fluoroscopy time and precision in targeting the expected reentry site have been compared.
Results:
Technical success was achieved in all cases (100%). In group 2, the planned in-target re-entry was achieved in 11/26 cases (42.3%). The procedure was performed with a traditional antegrade approach in 23/26 (88.4%) cases and in three cases (11.6%) a combined antegrade/retrograde approach was necessary. In group 1, the in-target re-entry was achieved in 26/26 cases (100%). In group 2, the mean procedural time was 55.4 ± 14.2 min with a mean fluoroscopy time 39.6 ± 13.9 min compared to 36.0 ± 9.4 min and 29.8 ± 8.9 min, respectively, of group 1 (P < 0.0001).
Conclusions:
In our experience, the use of this device is very useful for the revascularization of chronic femoral occlusions, even calcific, in which an accurate re-entry cannot be achieved with the conventional subintimal technique. In these cases, the Outback device grants high technical success rates and a significant reduction of procedural and fluoroscopy times.
INTRODUCTION: In their daily practice, vascular specialists face the challenge of treating peripheral artery disease (PAD) of the lower limbs. During the last decade, there has been an increasing adoption of endovascular techniques worldwide and a simultaneous expansion of the endovascular instrument portfolio to improve technical results during PAD treatment. The proper use of dedicated endovascular devices is essential to achieve technical success.
EVIDENCE ACQUISITION: To know indication, mechanism of action, and possible complications of different devices is of paramount importance to achieve immediate procedural success in the shortest time possible and long-term patency of the treated vessels.
EVIDENCE SYNTHESIS: All the re-entry catheters on the market are presented with their own unique characteristics. The pros and cons of the use of these devices is also discussed and compared to other possible recanalization strategies.
CONCLUSIONS: The re-entry devices have been demonstrated to be effective in increasing the procedural success rate, in limiting the dissection of distal healthy vessel segments and shortening the procedural time. They should therefore be considered part of essential tools in the treatment of lower limb chronic total occlusions especially for clinicians who don’t feel comfortable in performing retrograde access.
KEY WORDS: Peripheral arterial disease; Chronic limb-threatening ischemia; Endovascular procedures; Angioplasty
Background
Endovascular treatment (EVT) of superficial femoral artery (SFA) lesions that can be reached through transradial access (TRA) has often been performed due to its low invasiveness. For complex lesions such as chronic total occlusion (CTO) treated via TRA, EVT is still challenging due to poor device backup and guidewire operability. However, TRA might be preferred in patients with a high risk of bleeding or restricted access sites.
Case series
Both patients were diagnosed with peripheral artery disease and had an occlusion in one of their SFAs. They were treated using the balloon backed-up microcatheter technique (BBQ), a novel technique devised by us to treat patients with CTO through TRA. No complications were observed in either patient; therefore, we consider that both the procedures using this technique were successful.
Conclusions
We devised a technique that improved the backup of devices and maintained the torque response of the guidewire. This is because the 0.035-in. balloon catheter was anchored in the blood vessel and the microcatheter was trapped inside the monorail lumen of a 0.035-in. balloon catheter without crushing the lumen of the microcatheter. We introduce this technique in our report.
Purpose:
To describe a parallel wiring using a single intravascular ultrasound catheter with double rapid exchange lumens (PASSABLE) technique for peripheral CTOs.
Technique:
The technique is demonstrated in a 73-year-old patient with CTOs of the superficial femoral and popliteal artery. Intravascular ultrasound (IVUS) examination revealed the first guidewire was advanced to the intramedial space of the popliteal artery. Following insertion of the first guidewire into only the distal rapid exchange lumen of the IVUS catheter and a second guidewire into the proximal rapid exchange lumen, a guidewire torquer was passed over it and tightened close to an exit port of the proximal rapid exchange lumen to prevent it from exiting an entry port while advancing the IVUS catheter. The IVUS catheter was advanced to the intraplaque region using only the distal rapid exchange lumen and the second guidewire was then advanced to the intraplaque region under IVUS guidance. The IVUS-guided wiring using the second guidewire on both the distal and proximal rapid exchange lumen was continued and resulted in a successful guidewire crossing into the distal true lumen.
Conclusion:
This novel technique may prove beneficial in enabling operators to perform IVUS-guided parallel wiring more easily and efficiently.
Background
Drug-coated balloons (DCB) have demonstrated satisfactory clinical results in the treatment of femoropopliteal artery diseases.
Objective
To evaluate the efficacy and safety of the Reewarm™ PTX DCB in the treatment of femoropopliteal artery lesions compared with plain balloon.
Methods
This was a multi-center, parallel-group, randomized controlled trial in patients with femoropopliteal artery lesions in China,. The participants were randomized 1:1 to percutaneous transluminal angioplasty with Reewarm™ PTX DCB or with standard plain balloon (PTA group) after pre-dilatation with a residual stenosis less than 70%. The primary endpoint was late lumen loss (LLL) at 6 months in the intent-to-treat set. The secondary endpoints included the target lesion revascularization (TLR) and major advance events(MAE)rate at 12 months.
Results
Between July 2014 and April 2017, a total of 200 patients were enrolled. The mean age of the subjects was 67.8 ± 9.2 years in the DCB group (n = 100) and 69.4 ± 10.3 years in the PTA group (n = 100). The LLL at 6 months in the DCB group was significantly lower than in the PTA group (0.5 ± 0.8 mm vs. 1.5 ± 1.2 mm, P < 0.001). The TLR rate in the DCB group was lower than in the PTA group at 12 months (15.0% vs. 29.0%, P < 0.05). The occurrence of MAE⁴ in the DCB group by 12 months was lower than in the PTA group (23.0% vs. 38.0%, P < 0.05).
Conclusion
Reewarm-PTX drug-coated balloon is associated with better efficacy and safety than the plain balloon for femoropopliteal lesion.
Aims
A distal approach in endovascular procedures for revascularization of lowers limbs can be considered in case of no re-entry in subintimal recanalization. The aim of this study is to evaluate the feasibility of a medial approach to the infrageniculate popliteal artery (IPA) using existing CT scan simulation and punctures performed on cadavers.
Methods and results
CT angiographies of lower extremities were used to simulate IPA puncture and puncture trajectory. Tissues damaged during the trajectory between the puncture site and the access related injuries were analyzed.
Anatomical punctures on cadaverous model were also performed. Corpses were placed in supine position, the hip in slight flexion (40°) and abduction (external rotation of 60°). A 16G needle was used for the IPA puncture.
Twelve CT angiography simulations were made. Out of these 12 simulations, 9 revealed an isolated lesion of the popliteal vein, 2 isolated lesions of the tibial nerve. A lesion of the tibial nerve and the popliteal vein on the same simulation was once observed. Damage to the medial gastrocnemius muscle could not be avoided in each case.
Ten punctures were performed on cadavers with technical success. There were 6 popliteal vein lesions, 3 tibial nerve lesions and 1 case without lesion. In all cases, damage to the medial gastrocnemius muscle was seen.
Conclusion
This medial approach was feasible and is accompanied by trauma of elements of the popliteal pedicle. Preoperative CT angiography could anticipate best site of puncture and potential access related injury.
Background:
Subintimal angioplasty (SIA) is often utilized to cross femoropopliteal (FP) artery chronic total occlusions (CTOs). Re-entry devices (RED) can further assist with true lumen re-entry.
Objective:
To systematically review the literature for studies reporting on the use of SIA, with or without RED.
Methods:
A systematic review according to the PRISMA guidelines was performed. Quantitative synthesis was applied when possible.
Results:
87 studies and 4665 patients (5161 lesions) were included (63.9% male). 46.7% of patients had critical limb ischemia at the time of the intervention. Two RED types were used (Pioneer and Outback). Sixty-eight studies included lesions treated with SIA without RED, 17 studies included lesions treated with RED only, and two studies included a comparison between the two treatment methods. In total, 3898 (83.6%) patients were treated with SIA without RED and 754 (12.2%) with RED. Procedural success rate ranged from 64.5%-100% (92.5% for SIA without RED, 88.3% for RED cases). The complication rate ranged from 1.6% - 28% among different studies (cumulative rates: SIA: 9.1%, RED 9.3%). Perforations occurred in 1.6% of the total population (n = 46). Primary patency at one year ranged from 22% to 94.1%. Newer studies had a higher patency rate, ranging from 70% to 94.1%.
Conclusion:
SIA with or without RED is a valuable alternative to intraluminal crossing for endovascular treatment of FP CTOs. Procedural success was excellent for both techniques, while the cumulative complication rate was numerically lower in the RED group. Short- and long-term outcomes were acceptable for both techniques.
Background
Heparin-bonded covered stent grafts (Viabahn) are used to treat femoropopliteal long-segment arteriosclerotic lesions. The aim of this study was to evaluate the long-term outcome of Viabahn grafts with a covered stent length of minimum 25 cm.
Methods
We conducted a retrospective analysis of patients receiving a heparin-bonded stent graft in our clinic who met the length criteria between July 2010 and March 2018. Primary endpoints were patency rates, limb salvage and survival after five years. Secondary endpoint was the 30-day outcome including early complications.
Results
A total of 62 patients (45 male, median age 70.5 years) were included. The median arteriosclerotic lesion length was 25 cm (22.0–41.3 cm), the minimum covered stent length was 25 cm (25–46 cm). All lesions were TASC C and D lesions. The 30-day mortality was 0%, an early stent graft occlusion occurred in 8.1%. A major amputation was performed in 1.6%. Primary patency, primary assisted patency, secondary patency, limb salvage and survival were 38.5%, 45.7%, 52.4%, 92.8% and 68.9% after five years. Distal stent graft end below the femoral condyles and critical limb ischemia was associated with a significant decreased survival. The diameter of the stent had no influence on the outcome.
Conclusion
The Viabahn stent graft for long segment arteriosclerotic lesions is a feasible treatment with adequate long-term results.
Chronic total occlusions (CTOs) are widely prevalent in peripheral arterial interventions. It is estimated that CTOs are encountered in 25–50% of all lesions treated [1]. Multiple predictors of failure to cross CTO have been reported including lesion length, the presence of side branches at the proximal or distal cap, heavily calcified vessels, and operator’s experience. A failure rate of up to 50% has been reported when intraluminal crossing of a CTO was attempted with conventional guidewires [2, 3] but significantly improved with specialized crossing devices into the 70% range [3]. A subintimal approach is likely to have a higher initial success rate in the 80% range, but this is dependent on operator’s familiarity with reentry devices and lack of severe calcification at the reentry site. Also a higher loss of patency is seen with an initial subintimal approach on intermediate-term follow-up [4–6]. In all comers, the overall technical failure rate remains high at approximately 20% with conventional guidewires and balloons [2, 7]. In this chapter we review published data on CTO devices in peripheral interventions. Randomized comparisons of the effectiveness and safety of these devices in treating CTO are lacking. We therefore present observational studies and non-randomized comparisons between these devices while acknowledging the significant limitations of the data.
Background:
In recent years subintimal angioplasty (SIA) has become an established percutaneous procedure for the treatment of symptomatic lower limb arterial chronic total occlusions. However, the clinical benefits of this practice remain unclear. The aim of the review was to determine the effectiveness of SIA on clinical outcomes. This is an update of a review first published in 2013.
Objectives:
To assess the effectiveness of SIA versus other treatment for people with lower limb arterial chronic total occlusions, determined by the effects on clinical improvement, technical success rate, patency rate, limb salvage rate, and morbidity rates.
Search methods:
The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register (last searched January 2016) and Cochrane Central Register of Controlled Trials (CENTRAL) (2015, Issue 12). We also searched clinical trials registries.
Selection criteria:
We included data from randomized controlled trials comparing the effectiveness of SIA and any other management method in the treatment of lower limb arterial chronic total occlusions. The primary intervention of interest was SIA, with or without a stent, for the restoration of vessel patency in people with occlusions of a lower limb artery. We compared SIA against alternative modalities used to restore vessel patency, including conventional percutaneous transluminal angioplasty, surgical bypass, or any other treatments. We compared different SIA devices and techniques against each other.
Data collection and analysis:
Two review authors independently selected trials, assessed trials for eligibility and methodological quality, and extracted data. The third review author resolved disagreements.
Main results:
Two studies, involving a total of 147 participants with TransAtlantic Inter-Society Consensus (TASC)-II D femoropopliteal lesions, met our inclusion criteria and were included in the review. Both studies were small but otherwise of high methodological quality. However, the treatment techniques and control groups of the two studies differed, precluding the combining of study results and resulting in the evidence being less applicable. We therefore considered the quality of the evidence to be low.In one study, participants with TASC-II D lesions were randomized to receive either SIA with stenting of the superficial femoral artery or remote endarterectomy (RE) with stenting of the superficial femoral artery. Three-year follow-up results showed a Rutherford classification improvement of 64% in the SIA group compared to 80% in the RE group (risk ratio (RR) 0.79, 95% confidence interval (CI) 0.61 to 1.03; 95 participants; P = 0.079). Postexercise ankle brachial index improvements (defined as an increased value of 0.2) were reported in 70% of participants in the SIA group compared to 82% in the RE group (RR 0.86, 95% CI 0.68 to 1.08; 95 participants; P = 0.18). The study reported the technical success rate was 93% for the SIA group and 96% for the RE group (RR 0.97, 95% CI 0.88 to 1.07; 95 participants; P = 0.91). Primary patency at 12 months was 59.1% in the SIA group compared to 78.4% in the RE group (RR 0.75, 95% CI 0.57 to 1.00; 95 participants; P = 0.05). Primary patency at 24 months was 56.8% in the SIA group compared to 76.5% in the RE group (RR 0.74, 95% CI 0.55 to 1.00; 95 participants; P = 0.05) and 47.7% in the SIA group and 62.7% in the RE group at 36 months (RR 0.76, 95% CI 0.52 to 1.11; 95 participants; P = 0.15). Assisted primary patency was 52.3% in the SIA group compared to 70.6% in the RE group (P = 0.01) at 36 months. Secondary patency was better for the RE group (P = 0.03) at 36 months. Limb salvage at three years' follow-up was 95% in the SIA group and 98% in the RE group (RR 0.97, 95% CI 0.90 to 1.05; 95 participants; P = 0.4). There were no perioperative deaths, but complications occurred in two SIA participants (femoral pseudoaneurysm and pulmonary edema) and in three RE participants (seroma, femoral pseudoaneurysm, superficial femoral artery acute occlusion).In the second study, the effects of the SIA OUTBACK re-entry catheter device in people affected by TASC-II D superficial femoral artery chronic total occlusion were compared with the SIA manual re-entry technique. This study did not report clinical improvement and limb salvage. Technical success was achieved in all cases in both the OUTBACK device and manual groups. The primary 6-month patency rate was 100% in the OUTBACK group (26 of 26 participants) compared to 96.2% in the manual group (25 of 26 participants) (RR 1.04, 95% CI 0.94 to 1.15). The primary 12-month patency rate was 92.3% in the OUTBACK group (24 of 26 participants) compared to 84.6% in the manual group (22 of 26 participants) (RR 1.09, 95% CI 0.90 to 1.33). Patency rates at 24 and 36 months were not reported. The study reported that there were no complications.
Authors' conclusions:
Using the GRADE approach, we classified the quality of the evidence presented by both studies in this review as low due to small study size and the small number of studies. In addition, the two included trials differed from each other in the techniques and control used, and we were therefore unable to combine the data. Consequently there is currently insufficient evidence to support SIA over other techniques. Evidence from more randomized controlled trials is needed to assess the role of SIA in people with chronic lower limb arterial total occlusions.
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.
Introducing anti-restenotic drug-based treatment modalities in femoropopliteal interventions is the potential revolutionizing reperfusion treatment of peripheral artery disease. Durability of recanalization procedures using drug-coated balloons (DCB) and drug-eluting stents (DES) yields in excellent mid-term and long-term technical and clinical outcomes and may be cost saving on the long term as compared to traditional treatment modalities such as plain old balloon angioplasty (POBA) and bare metal nitinol stent implantation. Drug-eluting bioresorbable scaffolds are another drug-based promising treatment option but are still investigational. In particular, DCB provide a novel method to locally deliver paclitaxel into the arterial wall without the need of a chronically implanted delivery system or even if those devices will be indicated, they can be delivered focally. Following the first positive pilot studies, two large pivotal trials have confirmed superiority of DCB over plain old balloon angioplasty (POBA) in the treatment of TASC II A and B femoropopliteal lesions. Even for more complex femoropopliteal lesions such as long lesions and instent restenosis, single center studies and small randomized studies have shown promising mid-term technical and clinical results. For DES, follow-up data for the only commercially available device are now presented up to 5 years with excellent clinical outcome regarding freedom from target lesion revascularization and improvement of walking capacity. This review article summarizes the current knowledge and perspectives of drug-based endovascular treatment modalities in femoropopliteal interventions and discusses still unresolved needs.
Critical limb ischemia (CLI) as defined by the TransAtlantic Inter-Society Consensus (TASC) is persistent recurring ischemic rest pain necessitating opiate analgesics for more than 2 weeks, ulceration or gangrene of the foot or toes, ankle-brachial index (ABI)
Opinion statement:
Drug-coated balloons (DCBs) provide a novel method to locally deliver paclitaxel into the arterial wall without the need of a chronically implanted delivery system. Following the first positive pilot studies, two large pivotal trials have confirmed superiority of DCBs over plain old balloon angioplasty (POBA) in the treatment of TASC II A and B femoro-popliteal lesions. Even for more complex femoro-popliteal lesions such as long lesions and in-stent restenosis, single-center studies and small randomized studies have shown promising mid-term technical and clinical results. This review article summarizes the current knowledge about DCBs in femoro-popliteal interventions, supplements published guidelines with evidence-based recommendations, and discusses still unresolved needs.
The hypothesis that covered stents are superior to bare-metal stents (BMS) in long femoropopliteal artery disease was tested. The one-year results of the VIASTAR trial revealed a patency benefit of covered stents in the treatment-per-protocol (TPP) analysis only.
A prospective, randomized, single-blind, multicenter study evaluated 141 patients with symptomatic peripheral arterial disease (PAD) after treatment with heparin-bonded covered stents (VIABAHN(®) Endoprosthesis) or BMS. Clinical outcomes and patency rates were assessed at 1, 6, 12, and 24 months. Mean lesion length was 19.0 ± 6.3 cm in the VIABAHN(®) versus 17.3 ± 6.6 cm in the BMS group.
The 24-month primary patency rates in the VIABAHN(®) and BMS group were: intention-to-treat 63.1 (95 % CI 0.52-0.76) versus 41.2 % (95 % CI 0.29-0.57; log rank p = 0.04) and TPP 69.4 (95 % CI 0.58-0.83) versus 40.0 % (95 % CI 0.28-0.56; log rank p = 0.004). Freedom from target-lesion-revascularization (TLR) was 79.4 (95 % CI 0.70-0.90) versus 73.0 % (95 % CI 0.63-0.85) for VIABAHN(®) versus BMS (log rank p = 0.37). For the TPP group in lesions ≥20 cm, the 24-month patency rates were 65.2 (95 % CI 0.50-0.85) versus 26.7 % (95 % CI 0.12-0.59; log rank p = 0.004) for VIABAHN(®) versus BMS, and freedom from TLR was 80.0 (95 % CI 0.68-0.94) versus 61.9 % (95 % CI 0.44-0.87; log rank p = 0.13). The ankle brachial index was 0.89 ± 0.18 versus 0.91 ± 0.17 (p = 0.76) at 24-month in the VIABAHN(®) versus the BMS group, respectively.
At 24-month, this trial in PAD patients with long femoropopliteal lesions demonstrated a significantly improved primary patency rate for heparin-bonded covered stents compared to BMS, however, without a significant impact on clinical outcomes and TLR rate (Reg. Nr. ISRCTN48164244).
Endovascular treatment has become first--line approach for revascularization of long and complex femoropopliteal lesions in many centers. This development urges the need for endovascular approaches with a sustainable success in terms of patency. In several recently published trials the VIABAHN endoprosthesis has shown promising patency rates comparable or even better than traditional surgical bypass procedures with prosthetic material.
Aim:
Aim of the study was to provide additional clinical data regarding the safety and technical success of the OffRoad Re-Entry Catheter System (Boston Scientific, Natick, MA, USA) for subintimal recanalization of chronic total occlusions (CTO) in the femoropopliteal arteries.
Methods:
A total of 92 patients (mean age 70.3±10.6 years; 70% male) were enrolled in this prospective, single-arm, post-market study conducted at 12 European centers. Patients were required to have claudication or critical limb ischemia and a CTO lesion in a native femoropopliteal artery. The primary safety endpoint was the composite rate of device-related major adverse events (MAEs; i.e., death, perforation requiring intervention, clinically significant peripheral embolism, and major amputation of the treated lower limb) at 30 days. Effectiveness was based on device technical success, defined as placement of a guidewire in the true lumen distal to a CTO.
Results:
Ninety patients were evaluable for the primary safety endpoint. The 30-day device-related MAE rate was 3.3% (3/90), with an upper confidence bound of 6.5%, which was lower than the prespecified performance goal of 15%. All 3 events were clinically significant peripheral emboli. Technical success was 84.8% (78/92) with a lower confidence bound of 78.6%, which exceeded the prespecified performance goal of 76%. A decrease of ≥1 Rutherford category was observed in 75% (65/87) of patients at the 30 day visit.
Conclusion:
The Re-ROUTE trial results demonstrate acceptable performance of the OffRoad system in terms of safety and technical success for the recanalization of femoropopliteal CTOs.
We performed several techniques for chronic total occlusion (CTO) lesions in peripheral arterial disease (PAD). We evaluated the cases using the metal tip catheter (MT). We performed peripheral endovascular therapy (EVT) using MT in 31 cases 32 lesions of PAD from March 2007 to March 2011. Twenty-nine cases were CTO lesions using MT for back up of guidewire or MT alone in order to penetrate like a bougie with the blunt tip of MT. Two cases were acute arterial thrombosis for thrombectomy. Seven cases were CTO of the iliac artery (IA) and 25 cases were of the femoral artery (FA). Seven cases were in-stent restenosis. All 7 cases of IA were successfully treated with the initial techniques. We were unable to penetrate by MT(MT-) in 7 cases of FA, and in 2 cases out of the 7, we were even unable to cross the guidewire. Mean lesion length was 80 ± 42 mm in IA and 188 ± 88 mm in SFA. Among them, MT- was 164 ± 67 mm with no significant differences. Procedure time of EVT for CTO using MT was significantly shorter than other strategies. We had no complications such as perforation by using MT. MT provides high initial success rate by spectacular penetration performance and pushability. MT is a safe and effective device for CTO in PAD.
A 75-year-old hemodialysis patient with right critical limb ischemia received endovascular therapy for a chronic total occlusion (CTO) in a diffusely calcified superficial femoral artery (SFA). During a retrograde approach, a Brockenbrough needle (BN) was able to penetrate the calcified hard plaque formed in the middle segment of the CTO. Moreover, bougie dilatation with the BN allowed balloon crossing and stent deployment, even after failure to pass a 2.0-mm monorail balloon across the plaque. These results suggest that the BN offers a new therapeutic option in the penetration and modification of severely calcified CTO in SFA.
Peripheral arterial disease of the lower limb is a manifestation of atherosclerosis, with a prevalence ranging from 4 to 12% in the adult population and increasing up to 20% in elderly individuals (i.e. > 70 years old). Peripheral arterial disease is a marker of systemic atherosclerosis and is associated with increased cardiovascular morbidity and mortality. Therapeutic strategies are firstly aimed at reducing systemic cardiovascular risk burden. Therefore, intensive risk factor modification, and antiplatelet therapy should be implemented in all patients with peripheral arterial disease. Endovascular and surgical treatment are often highly valuable to improve rest pain and ulcer healing. The initial work-up includes non-invasive measurement of the ankle–brachial index, as well as measurement of the toe pressure. In case of a severe ischemia–ankle pressure inferior or equal to 50 mmHg and/or toe pressure inferior or equal to 30 mmHg – a revascularisation attempt should be proposed. We discuss here some recent advances in the endovascular field. Technical aspects of sub-intimal vs intraluminal recanalisation will be discussed, focusing on the different kinds of devices (e.g. crossing, reentry, debulking devices) actually at the interventionist's disposal. As endovascular techniques are constantly evolving, a multidisciplinary approach, including all cardiovascular specialists, is often needed.
The hypothesis that endovascular treatment with covered stents has equal risks but higher efficacy than BMS in long femoro-popliteal artery disease was tested.
While endovascular treatment of short SFA lesions revealed excellent results, efficacy in long lesions remains unsatisfactory.
In a prospective, randomized, single-blind, multicenter study 141 patients with symptomatic PAD were assigned to treatment with heparin-bonded, covered stents (VIABAHN®, 72 patients) or BMS (69 patients). Clinical outcomes and patency rates were assessed at 1, 6, and 12-months.
Mean lesion length was 19.0±6.3cm versus 17.3±6.6cm in the VIABAHN® versus BMS group. Major complications within 30-days were observed in 1.4%. The 12-months primary patency rates in the VIABAHN® and BMS group were: ITT 70.9% (95%CI, 0.58-0.80) and 55.1% (95%CI, 0.41-0.67; log rank p=0.11), TPP 78.1% (95%CI, 0.65-0.86) and 53.5% (95%CI, 0.39-0.65) (HR 2.23, 95%CI, 1.14-4.34; log rank p=0.009). In lesions ≥20cm (TASC D) the 12-months patency rate was significantly longer in VIA patients in the ITT-analysis (VIA 71.3% versus BMS 36.8%; p=0.01) and the TPP-analysis (VIA 73.3% versus BMS 33.3%; p=0.004). Freedom from target lesion revascularization was 84.6% for VIABAHN® (95%CI, 0.72-0.91) versus BMS 77.0% (95%CI, 0.63-0.85; p=0.37). The ankle-brachial index in the VIABAHN® group significantly increased to 0.94±0.23 (versus BMS 0.85±0.23; p<0.05) at 12-months.
This randomized trial in symptomatic PAD patients who underwent endovascular treatment for long femoro-popliteal lesions demonstrated significant clinical and patency benefits for heparin-bonded covered stents compared to BMS in lesions ≥20cm and for all lesions in the TPP analysis. In the ITT analysis for all lesions, which however was diluted by 8.5% major protocol violations, the difference was not significant (Reg.Nr. ISRCTN48164244). Clinical trial ID: VIASTAR; http://www.controlled-trials.com/ISRCTN48164244; ISRCTN48164244.
Subintimal angioplasty (SIA) has become an established percutaneous procedure for the treatment of symptomatic lower limb arterial occlusions in recent years. However, the clinical benefits of this practice remain unclear. The aim of the review was to determine the effectiveness of SIA on clinical outcomes.
To assess the effectiveness of SIA versus any other treatment for patients with chronic lower limb artery occlusion. This will be determined by the effects on clinical improvement, technical success rate, patency rate, limb salvage rate, and morbidity rates.
The Cochrane Peripheral Vascular Diseases Group Trials Search Co-ordinator (TSC) searched the Specialised Register (last searched January 2013) and CENTRAL (2012, Issue 12). Clinical trials databases were also searched.
We planned to include data from randomized controlled trials comparing the effectiveness of SIA and any other management method in the treatment of chronic lower limb arterial occlusion.
Two authors evaluated the trials identified from the searches for appropriateness of inclusion.
There were no randomized controlled trials in which SIA was compared with any other treatment.
Randomized controlled trial evidence for the effectiveness of SIA is lacking. There is a need for high-quality randomized controlled trials comparing SIA with any other treatment.
We demonstrate feasibility of implantation of a self-expanding interwoven nitinol stent in a claudicant, where recanalization attempt of a heavily calcified, occluded superficial femoral artery (TASC D lesion) was complicated by a previously implanted, fractured standard stent. Wire passage through the occlusion and beyond the fractured stent could only be achieved through the subintimal space. A dedicated reentry device was used to allow distal wire entry into the true lumen at the level of the popliteal artery. Despite crushing of the fractured stent with a series of increasingly sized standard balloons, a significant recoil remainded in the area of the crushed stent. To secure patency of the femoro-popliteal artery we therefore decided to implant the novel self-expanding interwoven nitinol stent (Supera Veritas (TM), IDEV), whose unique feature is an exceptional high radial strength. Patient presented asymptomatic without any impairment of his walking capacity at three month follow up and duplex ultrasound confirmed patency of the stent. Subintimal recanalizations can be complicated by previously implanted stents, in particular in the presence of stent fracture, where intraluminal wire passage often can not be achieved. Considering the high radial strength and fracture resistance, interwoven nitinol stents represent a good treatment option in those challenging cases and they can be used to crush standard nitinol and ballonexpandable stents.
Complex, long segment lesions of the superficial femoral artery (SFA) are common, occurring in 40% of patients with peripheral vascular disease. In particular, chronic total occlusions (CTOs) continue to pose a challenge in the endovascular management of SFA disease. Several conventional wire and catheter based techniques have been described including subintimal recanalization and retrograde techniques. In addition, advances in endovascular technology have led to the development of a series of new devices aimed specifically at facilitating the crossing of long segment SFA occlusions or establishing re-entry of the true lumen. Here we present an overview of the minimally invasive techniques used to recanalize CTOs of the SFA and the latest specialized devices available for both recanalization and re-entry, as well as a summary of the literature supporting their application.
Paclitaxel-coated balloon (PCB) angioplasty reduces neointimal proliferation, restenosis, and clinical need for target lesion revascularization (TLR). PCB was superior for coronary restenosis in bare-metal and drug-eluting stents compared with uncoated balloon angioplasty and was noninferior compared with paclitaxel-eluting stents. PCB angioplasty should be considered for treatment of coronary in-stent restenosis. For de novo lesions, PCB plus endothelial progenitor cell capturing stents reduced restenosis and TLR in early reports. Among patients with de novo lesions and diabetes, the combination of PCB plus bare-metal stent revealed similar results in lesions compared with paclitaxel-eluting stents. The early results for PCB in small vessels are also very encouraging. Dual antiplatelet therapy duration may be shorter with PCB angioplasty compared with drug-eluting stents. Nevertheless, the risk for thrombotic vessel occlusion is minimized. Considering peripheral arterial disease, PCB angioplasty for femoropopliteal lesions was superior to uncoated balloon angioplasty. Registries indicate PCB to also be effective in lesions below the knee. Since there is no certain class effect, efficacy and safety have to be demonstrated for different types of PCB for coronary and peripheral interventions.
To evaluate the safety and effectiveness of a new system to facilitate intraluminal advancement of conventional guidewires through chronic total occlusions (CTO) of the superficial femoral artery (SFA) and popliteal artery.
The ENABLER-P Balloon Catheter System uses a unique balloon-anchoring mechanism and an automated balloon inflation device for steady, controlled advancement of a standard non-hydrophilic guidewire. The system was evaluated in 37 patients (22 men; mean age 67 years (range 41-87) with femoropopliteal CTOs averaging 86 mm in length (range 10-340). The device was used in a variety of occlusions, including heavily calcified, long, and fibrotic lesions. After successful guidewire recanalization facilitated by the system, occluded arterial segments were treated conventionally with balloon angioplasty, atherectomy, and stents as appropriate.
The primary endpoint of successful crossing was achieved in 86% (32/37) of the overall study population. The average activation time for successful crossing was 5.3 minutes (range 0.4-22). Of the 32 cases successfully crossed with the ENABLER-P System, all but 1 was successfully recanalized. One (3%) device-related complication occurred when the wire was advanced into a side branch when treating a 300-mm-long flush ostial SFA occlusion; the resulting perforation was managed with a covered stent without further sequelae.
This novel system, which provides enhanced force to a standard guidewire tip for controlled intraluminal advancement, is a promising device for the treatment of peripheral CTOs.
Currently, recanalization of chronic total occlusions (CTOs) in peripheral arteries remains a challenging obstacle encountered by clinical practitioners. Percutaneous CTO interventions are associated with low rates of procedural success using standard guidewires and catheters. When guidewires cannot cross the occluded segment or fail to reenter the true lumen after subintimal crossing of the occlusion, successful recanalization may be unachievable. In the last few years, the emergence of novel devices and new techniques has dramatically improved the success rates of the revascularization for CTOs. This paper reviews the published data of current devices and specialized techniques of percutaneous intervention to relieve CTOs.
Tremendous advances have been made in the endovascular treatment of lower-extremity arterial occlusive disease. New technology has enabled operators to successfully revascularize patients with complex arterial occlusive disease. This article summarizes the latest advances in endovascular therapy of aortoiliac and femoral arteries and reviews the clinical outcomes and costs associated with the use of these treatments.
Endovascular therapy (EVT) utilizing percutaneous transluminal angioplasty has become a standard technique to re-establish sufficient blood flow in ischemic limbs of patients with peripheral arterial disease (PAD). Long chronic total occlusion (CTO) of the superficial femoral artery (SFA) remains one of the challenging lesions in the field of EVT for PAD patients, despite the recent introduction of many dedicated interventional devices such as high-performance guidewires. In this article, we report a novel interventional technique, trans-collateral angioplasty (TCA), to improve the initial success rate of EVT for long SFA-CTO lesions. We present one representative case, and describe the technical tips and appropriate device selection criteria for the TCA procedure. The outcomes of TCA for long SFA-CTO performed last year at our institution are also summarized and discussed.
Even if recently the first positive results were presented for a paclitaxel releasing drug eluting stent there are still concerns about stent implantation in the femoro-popliteal artery. This makes any stentless technology attractive that achieves at least as good acute and longer term results in this vessel area. Three randomized studies investigating the value of short time paclitaxel release using a drug coated balloon gave promising results with significantly improved patency rates compared to plain balloon angioplasty in femoro-popliteal lesions and at least as good patency results as for the majority of bare metal nitinol stents (THUNDER, FEMPAC, LEVANT 1). Below-the-knee this promising concept is still under evaluation (PICCOLO study) whereas the first positive results for drug eluting stents in shorter lesions had been recently presented (YUKON BTK, DESTINY). This article gives an overview upon already published and presented data and still ongoing trials on drug releasing balloons in the peripheral arteries.
To report a retrospective, single-center study that evaluates technical and clinical outcomes from subintimal recanalization of femoropopliteal chronic total occlusions (CTO) facilitated by the Outback re-entry catheter.
The Outback catheter was required to complete recanalization of femoropopliteal CTOs (mean lesion length 195 ± 91 mm) in 118 limbs of 113 patients (77 men; mean age 70 ± 10 years). In 80/118 (67.8%) limbs, treatment was performed for claudication and in the remaining 38 (32.2%) for critical limb ischemia (CLI). Technical and procedural success, clinical outcome, and cumulative patency rates in follow-up were evaluated.
Re-entry was accomplished in 108/118 limbs (91.5%) with recanalization completed in 107/118 (90.7%). Of these, only 61/107 (57%) arteries were left with a residual stenosis <30%. Complications included minor bleeding of the target vessel (5/118, 4.2%) and minor hematoma/pseudoaneurysm at the access site (6/118, 5.1%). Acute reocclusion developed in 2/118 cases (1.7%) without major complication. After 12 months, primary patency was 56.7%, assisted primary patency 83.1%, and secondary patency 89.1%. Primary patency was significantly reduced in limbs with residual stenosis. Over a median 15-month follow-up (range 2-32), 4 major and 2 minor amputations were performed in patients with CLI.
The Outback catheter is a reliable tool to recanalize challenging chronic femoropopliteal occlusions after failed guidewire re-entry. Restenosis rates are high, which may be due to the severity and extent of disease in these patients, who are particularly challenging.
Objective
To report the efficacy and safety of the Outback((R)) LTD (R) Re-Entry Catheter in reentering the distal true lumen during percutaneous intentional extraluminal revascularization (PIER). Background
Reentry catheters are used to treat chronic, total arterial occlusions of the lower extremities when standard methods of recanalization have failed. Success and complication rates of these catheters in the real world are uncertain and variable. MethodsA retrospective review of our peripheral catheterization database from January 2004 to September 2009 was undertaken to identify consecutive cases of peripheral chronic total occlusions (CTOs) requiring the use of the Outback reentry catheter. Patient demographics, indication for the procedure, location and extent of occlusion, procedural success, and complications were studied. ResultsA total of 51 patients were identified. Of the 51, 28 (54.9%) patients presented with nonhealing ulcer and 22 (43.1%) had lifestyle-limiting claudication. One patient presented with acute limb ischemia. There were 6 (11.8%) patients with common iliac artery occlusion, 2 (3.9%) with external iliac artery occlusion, 1 (1.9%) with common femoral artery occlusion, 35 (68.6%) with superficial femoral artery occlusion, 6 (11.8%) with popliteal artery occlusion, and 1 (1.9%) with tibioperoneal artery occlusion. Median lesion length was 230 mm. Procedural success was achieved in 49 patients (96.1%). There was 1 (1.9%) periprocedural complication. Conclusion
Use of Outback((R)) LTD (R) Re-Entry Catheter is a safe and valuable option for PIER/subintimal angioplasty and recanalization in patients with symptomatic lower-extremity CTOs. However, long-term patency remains unknown. (c) 2012 Wiley Periodicals, Inc.
The technique of subintimal angioplasty has been attempted on 200 consecutive femoropopliteal artery occlusions of median (range) length 11 (2-37) cm. The principle of the technique is to traverse the occlusion in the subintimal plane and recanalise by inflating the angioplasty balloon within the subintimal space. The technical success rate was 159/200 (80%) and was not significantly different for occlusions < 10 cm (81%, n = 73), 11-20 cm (83%, n = 63) or > 20 cm (68%, n = 23), p = 0.20. There were no deaths nor limb loss resulting from the procedure. The median (range) ankle-brachial pressure index increased from 0.61 (0.21-1.0) preangioplasty to 0.90 (0.26-1.50) postangioplasty. The actuarial haemodynamic patencies of technically successful procedures at 12 and 36 months were 71% and 58% respectively, the symptomatic patencies were 73% and 61%. A multiple regression analysis showed that smoking multiplied the risk of reocclusion by 2.70 (p < 0.001), each additional run-off vessel reduced the risk by 0.54 (p < 0.001) and the risk increased by 1.73 (p = 0.020) for every 10 cm of occlusion length. In conclusion, the technical success rate (80%) of subintimal angioplasty for femoropopliteal occlusions is unrelated to occlusion length and for all procedures, including technical failures, cumulative symptomatic and haemodynamic patencies of 46 and 48% can be achieved at 3 years. The factors influencing long-term patency were smoking, the number of calf run-off vessels and occlusion length.
To report our experience using a commercially available catheter-based system equipped with an intravascular ultrasound (IVUS) transducer to achieve controlled true lumen re-entry in patients undergoing subintimal angioplasty for chronic total occlusions (CTO) or aortic dissections.
During an 8-month period, 10 patients (6 men; mean age 73.4 years) with lower extremity (LE) ischemia from CTOs (n=7) or true lumen collapse from aortic dissections (n=3) were treated. Subintimal access and controlled re-entry of the CTOs were performed with a commercially available 6.2-F dual-lumen catheter, which contained an integrated 64-element phased-array IVUS transducer and a deployable 24-G needle through which a guidewire was passed once the target lumen was reached. The occluded segments were balloon dilated; self-expanding nitinol stents were deployed. In the aortic dissections, fenestrations were performed using the same device, with the IVUS unit acting as the guide. The fenestrations were balloon dilated and stented to support the true lumen.
Time to effective re-entry ranged from 6 to 10 minutes (mean 7) in the CTOs; antegrade flow was restored in all 7 CTOs, and the patients were free of ischemic symptoms at up to 8-month follow-up. In the aortic dissection cases, the fenestrations equalized pressures between the lumens and restored flow into the compromised vessels. There were no complications related to the use of this device in any of the 10 patients.
Our preliminary results demonstrate the feasibility of using this catheter-based system for subintimal recanalization with controlled re-entry in CTOs and for aortic flap fenestrations in aortic dissections. This approach can improve the technical success rate, reduce the time of the procedure, and minimize potential complications.
To review clinical outcomes of patients with chronic limb ischemia and TASC type C lesions treated with sirolimus-eluting versus bare SMART nitinol self-expanding stents.
Data were obtained from a randomized, multicenter, double-blinded study conducted in 2 phases. All 93 patients had chronic limb ischemia and superficial femoral artery (SFA) occlusions or stenoses (average lesion length 8.3 cm). In total, 47 patients (31 men; mean age 66.3+/-9.1 years, range 50-84) received the sirolimus-eluting SMART stent and 46 patients (36 men; mean age 65.9 +/-10.8 years, range 38-83) received a bare SMART nitinol stent. Both groups were followed for a mean 24 months.
Both the sirolimus-eluting and the bare SMART stents were effective in revascularizing the diseased SFA and in sustaining freedom from restenosis. For both types of stents, improvements in ankle-brachial indices (ABI) and symptoms of claudication were maintained over 24 months (median 24-month ABI 0.96 for the sirolimus group versus 0.87 for the bare stent group, p>0.05). At 24 months, the restenosis rate in the sirolimus group was 22.9% versus 21.1% in the bare stent group (p>0.05). The cumulative in-stent restenosis rates according to duplex ultrasound were 4.7%, 9.0%, 15.6%, and 21.9%, respectively, at 6, 9, 18, and 24 months; the rates did not differ significantly between the treatment groups. The TLR rate for the sirolimus group was 6% and for the bare stent group 13%; the TVR rates were somewhat higher: 13% and 22%, respectively. Mortality rates did not differ significantly between the groups.
These data demonstrate that the sirolimus-eluting and the bare SMART stent are effective, safe, and free from restenosis in a majority of patients for up to 24 months. Because the restenosis rate in the bare stent group is unexpectedly low, no significant difference could be found between the sirolimus-eluting and the bare SMART stents.
Drug-eluting stents reduce restenosis in coronary arteries, but clinical trials have failed to prove their efficacy in peripheral arteries. We investigated the use of paclitaxel-coated angioplasty balloons and paclitaxel dissolved in the angiographic contrast medium during angioplasty of the leg.
In a small, multicenter trial, we randomly assigned 154 patients with stenosis or occlusion of a femoropopliteal artery to treatment with standard balloon catheters coated with paclitaxel, uncoated balloons with paclitaxel dissolved in the contrast medium, or uncoated balloons without paclitaxel (control). The primary end point was late lumen loss at 6 months.
The mean (+/-SD) age of the patients was 68+/-8 years, 24% were smokers, and 49% had diabetes. Twenty-seven percent of the lesions were total occlusions, and 36% were restenotic lesions. The mean lesion length was 7.4+/-6.5 cm. There were no significant differences in baseline characteristics between the groups. There were no adverse events attributable to the paclitaxel-coated balloons. At 6 months, the mean late lumen loss was 1.7+/-1.8 mm in the control group, as compared with 0.4+/-1.2 mm (P<0.001) in the group treated with paclitaxel-coated balloons and 2.2+/-1.6 mm (P=0.11) in the group treated with paclitaxel in the contrast medium. The rate of revascularization of target lesions at 6 months was 20 of 54 (37%) in the control group, 2 of 48 (4%) in the group treated with paclitaxel-coated balloons (P<0.001 vs. control), and 15 of 52 (29%) in the group treated with paclitaxel in the contrast medium (P=0.41 vs. control); at 24 months, the rates increased to 28 of 54 (52%), 7 of 48 (15%), and 21 of 52 (40%), respectively.
Use of paclitaxel-coated angioplasty balloons during percutaneous treatment of femoropopliteal disease is associated with significant reductions in late lumen loss and target-lesion revascularization. No significant benefit is seen with the use of a paclitaxel-containing contrast medium. (ClinicalTrials.gov number, NCT00156624 [ClinicalTrials.gov].).
A b s t r ac t BACKGROUND Drug-eluting stents reduce restenosis in coronary arteries, but clinical trials have failed to prove their efficacy in peripheral arteries. We investigated the use of paclitaxel-coated angioplasty balloons and paclitaxel dissolved in the angiographic contrast medium during angioplasty of the leg. METHODS In a small, multicenter trial, we randomly assigned 154 patients with stenosis or occlusion of a femoropopliteal artery to treatment with standard balloon catheters coated with paclitaxel, uncoated balloons with paclitaxel dissolved in the contrast medium, or uncoated balloons without paclitaxel (control). The primary end point was late lumen loss at 6 months. RESULTS The mean (±SD) age of the patients was 68±8 years, 24% were smokers, and 49% had diabetes. Twenty-seven percent of the lesions were total occlusions, and 36% were restenotic lesions. The mean lesion length was 7.4±6.5 cm. There were no significant differences in baseline characteristics between the groups. There were no adverse events attributable to the paclitaxel-coated balloons. At 6 months, the mean late lumen loss was 1.7±1.8 mm in the control group, as compared with 0.4±1.2 mm (P<0.001) in the group treated with paclitaxel-coated balloons and 2.2±1.6 mm (P = 0.11) in the group treated with paclitaxel in the contrast medium. The rate of revascularization of target lesions at 6 months was 20 of 54 (37%) in the control group, 2 of 48 (4%) in the group treated with paclitaxel-coated balloons (P<0.001 vs. control), and 15 of 52 (29%) in the group treated with paclitaxel in the contrast medium (P = 0.41 vs. control); at 24 months, the rates increased to 28 of 54 (52%), 7 of 48 (15%), and 21 of 52 (40%), respectively. CONCLUSIONS Use of paclitaxel-coated angioplasty balloons during percutaneous treatment of femoropopliteal disease is associated with significant reductions in late lumen loss and target-lesion revascularization. No significant benefit is seen with the use of a paclitaxel-containing contrast medium. (ClinicalTrials.gov number, NCT00156624.)
A technique for recanalization of femoral and popliteal arterial occlusions by intentional subintimal dissection is described. Recanalization with this technique was attempted in 71 occlusions of the femoro-popliteal segment with a mean length of 11.4 cm. Primary technical success was achieved in 54 (76%) cases, with complications occurring in 4 (5.6%). Of 44 successful cases reviewed at a mean follow up of 6 months, 37 (84%) were either asymptomatic or improved. The technique has proved to be an effective method of treating occlusions of the femoral and popliteal arteries with an acceptable complication rate. It may allow successful angioplasty where the standard intraluminal method fails, particularly when reconstructive surgery is the only option.
We report the results of 50 angioplasty procedures via the popliteal artery. A 3-year follow-up including control of blood pressures at ankle and toe levels show results comparable to reports in the literature. This new approach for angioplasty of the superficial femoral artery and eventually of coexisting iliac lesions enables treatment of previously inaccessible lesions. The technique is especially suited for lesions close to the takeoff of the superficial femoral artery.
Percutaneous intentional extraluminal recanalisation (PIER) of the femoropopliteal artery is a new catheter technique to overcome long chronic occlusions. This technique was applied to 40 long chronic occlusions of the femoropopliteal segment. The mean length of the superficial femoral artery (SEA) occlusions was 16.9 cm, the mean length of the popliteal occlusions was 11.8 cm and the mean length of the femoropopliteal occlusions was 27.6 cm. Primary recanalisation success was 85%. Patency showed a significant correlation with poor initial angiographic result (p < 0.05). Life-time table analysis of the successful group demonstrated a primary clinical patency of 59% at 1 and 2 years and a secondary clinical patency of 71% at 1 year and 65% at 2 years. There were no serious complications related to this technique. PIER technique is simple and cost-effective, and shows a good initial success-rate with a promising 2 years clinical patency. This technique might be of importance for patients with a critical lower leg ischaemia, when there are contraindications for primary bypass surgery either from a technical or a general point of view.
Patients with critical limb ischaemia (CLI) often have occlusive disease of the crural arteries. Therefore attempts at treating CLI by minimally invasive means has to be directed towards recanalization of occluded crural arteries. Subintimal angioplasty of long occlusions of the crural arteries is safe and effective and is therefore an excellent alternative to reconstructive surgery in patients who are frequently elderly and frail. It is also relatively cheap when compared to bypass surgery.
A new and simple technique to treat long superficial femoral artery occlusions is explained step by step. Both authors have extensive experience with this technique of percutaneous intentional extraluminal (subintimal) recanalization and this paper is based on their personal experience. Technical considerations, indications, pitfalls, possible complications and results are discussed.
Subintimal angioplasty (SIA) has been advocated to treat long segment lower extremity arterial occlusions, but many question its value. We evaluated the role of SIA in a group of patients with severe lower extremity arterial occlusive disease.
During a 2.5-year period, 39 patients with arterial occlusions (median length, 8 cm; range, 2 to 31 cm) were treated on an intention-to-treat basis with SIA. Twenty-five patients had gangrene, five had rest pain, and nine had disabling (<one block) claudication. There were 24 superficial femoral, two superficial-femoral-popliteal, four popliteal, two popliteal-tibial, five tibial, and two external iliac artery lesions. With fluoroscopic guidance, via a prograde common femoral artery puncture (n = 29) or a contralateral common femoral artery puncture (n = 9), a subintimal dissection plane was created across the occlusion with a standard guidewire and catheter. The arterial lumen was reentered distal to the occlusion, and the recanalized segment balloon was dilated. All patients were followed prospectively with arterial duplex scan.
SIA was technically successful in 34 of 39 patients (87%). All five failures were from an inability to reenter the patent lumen distally. These five patients underwent successful bypasses that in no case were more distal than would have been required before SIA. In the 34 technically successful SIAs, pain completely resolved (14/14) and areas of gangrene (21/25) healed. The cumulative patency rate in patients who underwent successful SIA was 74% +/- 10% at 12 months. The mean increase in ankle-brachial index after SIA was 0.34 (range, 0.1 to 0.69). There were two distal embolic events, successfully treated surgically (n = 1) or with catheter-directed techniques (n = 1). Three patients underwent subsequent bypass, and the remaining five patients remain asymptomatic.
SIA is feasible and can be effective in some patients with lower extremity arterial occlusions and threatened limbs. These results, plus SIA's many advantages, support an increasing role for it in the treatment of lower extremity arterial occlusive disease.
To report the initial experience with a new catheter system (The Outback catheter) designed to allow fluoroscopically controlled re-entry of the true arterial lumen after subintimal guidewire passage during recanalization procedures of arterial occlusions.
The catheter was used in 10 patients with intermittent claudication caused by chronic segmental occlusions of the superficial femoral or popliteal arteries. In all patients, conventional guidewire recanalization had failed.
In 8 patients, successful true lumen re-entry was achieved with the Outback catheter. Percutaneous transluminal angioplasty was successfully performed in these patients without complications. Two technical failures occurred in heavily calcified arteries.
The Outback catheter was safe and effective when used in complicated recanalization procedures in the superficial femoral and popliteal artery and the tibial trunk.
To evaluate the fate of collateral vessels adjacent to and within the target lesion following subintimal angioplasty (SIA).
Pre and postprocedural angiograms were reviewed for 29 patients undergoing SIA of the lower extremity arteries over a 3-year period. The number of patent collateral vessels </=5 cm proximal to the occlusion (proximal segment) and </=5 cm distal to the occlusion (distal segment) were recorded pre and postprocedurally and compared. In addition, the number of collateral vessels that were re-opened within the recanalized segment following SIA was counted.
The mean number of patent collaterals in the proximal segment was 1.9 (range 0-4) preprocedurally and 1.4 (range 0-4) postprocedurally (p<0.002). The mean number of patent collaterals in the distal segment was 1.9 (range 0-4) pre-procedurally and 1.0 (range 0-4) postprocedurally (p<0.0001). Previously absent collaterals within the recanalized segment were observed in 4 (14%) of 29 patients post-SIA. The mean number of collateral vessels within all 3 segments (proximal, treated, and distal) was 3.9 collaterals preprocedurally and 2.9 collaterals postprocedurally.
Some collateral vessels are sacrificed during SIA, but the majority are preserved. In addition, SIA has the potential to open new collaterals within the occluded segment. These collaterals may play an important role should restenosis develop within the target segment.
Objective:
The acute technical failure of endovascular treatment of chronic total occlusions (CTOs) is most often due to the inability to re-enter the true lumen after occlusion is crossed in a subintimal plane. This study reports our initial experience with true lumen re-entry devices in the treatment of CTOs.
Methods:
Patients with treatment of CTOs were identified from our vascular registry. All patients in whom the Pioneer catheter or the Outback catheter were used were also identified from a prospectively maintained separate database of cases in which true lumen re-entry devices were used. We used procedural data from the prospective database and reviewed the medical records. Lesion character and location, access type, location of true lumen re-entry, stent usage, procedural times, and complications, were tabulated.
Results:
From August 2003 to December 2004, endovascular techniques were used to treat 87 CTOs in 58 iliac and 29 superficial femoral arteries. In 24 (26%), the true lumen could not be re-entered by using standard catheter and wire techniques. The true lumen was not initially re-entered in 20 (34%) of 58 of treated iliac CTOs and four (13%) of 29 of treated superficial femoral artery CTOs (73% TASC C and D lesions). Intravascular ultrasound-guided true lumen re-entry using the Pioneer catheter (21 CTOs), or fluoroscopic-guided true lumen re-entry using the Outback catheter (3 CTOs) was successful in achieving true lumen re-entry in all cases at the location desired. Total time of re-entry catheter manipulation required to achieve re-entry was <10 minutes and was routinely accomplished in <3 minutes. All occlusions were stented. No cases were converted to open repair. Bleeding from the recanalization and angioplasty site occurred in four patients (15%). It was controlled with use of covered stents in two cases, and resolved after placement of uncovered stents in the other two. No significant bleeding occurred at the sites of true lumen re-entry needle deployment. All occlusions treated with true lumen re-entry devices remain clinically patent at a mean follow-up of 5.8 months.
Conclusions:
Endovascular treatment of chronic total occlusions is often limited by the inability to re-enter the true lumen after subintimal crossing of the occluded segment. This occurs more commonly with treatment of iliac occlusions than in superficial femoral artery occlusions. True lumen re-entry catheters are very effective at gaining wire passage back to the true lumen and facilitating successful endovascular treatment of chronic total occlusions that would otherwise require open bypass.
Endovascular treatment of iliac artery occlusions can be unsuccessful due to a failure to break back into the true lumen, and lesions without a proximal stump can be particularly problematic. True lumen re-entry catheters have not been previously used for this type of lesion. The authors report eight patients, five males and three females, with lifestyle-limiting intermittent claudication referred for endovascular treatment. Imaging demonstrated unilateral chronic total occlusion of the common iliac artery in six patients and two patients with short patent stumps at the origin of the occluded common iliac artery. Endovascular therapy was initially unsuccessful due to an inability to re-enter the true lumen after crossing the occlusion in the subintimal plane. With the assistance of the Outback LTD catheter it was possible to achieve continuity of the dissecting tract with the true lumen, thus facilitating successful primary stenting in all eight patients. To our knowledge this is the first report of the use of the Outback LTD catheter in this type of lesion.
To report the safety and efficacy of a clip device to close retrograde popliteal artery puncture sites used in recanalization of the superficial femoral artery (SFA).
From January 2005 to March 2007, 28 patients (20 men; mean age 66+/-10 years) with stable chronic peripheral artery disease were treated for chronic total SFA occlusion. All patients received aspirin and clopidogrel and were heparinized during the procedure. After failed antegrade recanalization, the SFA was revascularized via a retrograde transpopliteal access. The StarClose Vascular System was used to seal the popliteal artery puncture site.
All (100%) interventions were finished successfully, and hemostasis was secured with the StarClose device in all cases. There was 1 (3.6%) major complication with the StarClose system: a transient popliteal artery occlusion induced by plaque shift during sheath removal, which was corrected with balloon angioplasty via the femoral access. Three (10.8%) small hematomas (<5 cm) occurred at the puncture site without causing significant patient discomfort.
In this small experience, the StarClose Vascular Closure System appeared to be an effective and safe sealing device after percutaneous transpopliteal interventions. Plaque shifting leading to stenosis or occlusion at the puncture site can occur.