Andrej Schmidt

First Experience With Drug-Eluting Balloons in Infrapopliteal Arteries: Restenosis Rate and Clinical Outcome

OBJECTIVES The purpose of this study was to investigate the efficacy of drug-eluting balloons (DEBs) in the treatment of long infrapopliteal lesions with regard to the short-term restenosis rate and midterm clinical result. BACKGROUND Restenosis rates of long-segment tibial artery disease are very high. Recently, a restenosis rate of 69% at 3 months after standard balloon angioplasty was demonstrated. METHODS Infrapopliteal angioplasty was performed with a paclitaxel-eluting balloon (In.Pact Amphirion, Medtronic, Minneapolis, Minnesota). Clinical and angiographic follow-up was performed at 3 months to detect binary restenosis, and further clinical assessment was performed over a 12-month period thereafter. RESULTS In 104 patients, 109 limbs were treated for critical limb ischemia (82.6%) or severe claudication (17.4%). Mean lesion length of the arteries treated was 176 ± 88 mm. Angiography studied in 84 treated arteries at 3 months showed a restenosis in 27.4% (19.1% had restenosis of more than 50%, and 8.3% were totally occluded) and usually occurred focally. Only in 9.5% of all angiographically followed up arteries was the entire treated segment restenosed or reoccluded. During a follow-up period of 378 ± 65 days, 1 patient was lost and 17 died. Of the 91 limbs remaining in the analysis, clinical improvement was present in 83 (91.2%). Complete wound healing occurred in 74.2%, whereas major amputation occurred in 4 patients, resulting in limb salvage of 95.6% for patients with critical limb ischemia. CONCLUSIONS The early restenosis rate of long-segment infrapopliteal disease is significantly lower after treatment with DEBs compared with historical data using uncoated balloons. Randomized trials are required to show whether this difference will lead to improvement in clinical outcomes.

Randomized comparison of everolimus-eluting versus bare-metal stents in patients with critical limb ischemia and infrapopliteal arterial occlusive disease.

OBJECTIVE Critical limb ischemia, the most severe form of peripheral arterial disease, results in extremity amputation if left untreated. Endovascular recanalization of stenotic or occluded infrapopliteal arteries has recently emerged as an effective form of therapy, although the duration of patency is typically limited by restenosis. Recently, it has been suggested that drug-eluting stents originally developed for the coronary arteries might also be effective in preventing restenosis in the infrapopliteal arteries. This prospective, randomized, controlled clinical trial tested the hypothesis that treatment of infrapopliteal arterial occlusive lesions with an everolimus-eluting stent (Xience V) would provide superior patency to treatment with a bare-metal stent (Multi-Link Vision). METHODS A sample size of 140 patients was planned to be enrolled at five European investigative sites. The primary end point was arterial patency at 12 months, defined as the absence of ≥50% restenosis based on quantitative analysis of contrast angiography. RESULTS Between March of 2008 and September of 2009, 74 patients were treated with Xience V and 66 patients were treated with Vision. After 12 months, the primary patency rate after treatment with Xience V was 85% compared with 54% after treatment with Vision (P = .0001). Treatment with Xience V significantly reduced mean in-stent diameter stenosis (21% ± 21% vs 47% ± 27%; P < .0001) and mean in-stent late lumen loss (0.78 ± 0.63 vs 1.41 ± 0.89 mm; P = .001). There were no differences in the percentage of patients receiving a designation of Rutherford class 0 or 1 at the 12-month follow-up visit (56% for Vision, vs 60% for Xience V; P = .68). Major extremity amputations were rare in both groups (two for Vision and one for Xience V). The use of the Xience V stent significantly reduced the need for repeat intervention: freedom from target lesion revascularization was 91% for Xience V vs 66% for Vision (P = .001). CONCLUSIONS Treatment of the infrapopliteal occlusive lesions of critical limb ischemia with everolimus-eluting stents reduces restenosis and the need for reintervention compared with bare metal stents.

Retrograde Approach for Complex Popliteal and Tibioperoneal Occlusions

Purpose: To describe the technical aspects of the retrograde approach for endovascular treatment of complex popliteal and/or tibioperoneal occlusions and determine its efficacy in minimizing failure rates. Methods: An observational registry of retrograde revascularizations was maintained at our institution over 14 months (September 2006 to December 2007). During this time frame, antegrade revascularization failed in 62 (17.8%) of 343 limbs with complex total occlusions of the popliteal and/or infrapopliteal vascular territory. Of these antegrade failures, 51 (82.2%) limbs in 51 patients (32 men; mean age 72±8 years) were suitable for a retrograde attempt. From this subgroup, 45 (88.2%) were treated via a percutaneous transpedal access site and 6 (11.8%) via a transcollateral intra-arterial technique. Results: The overall success rate was 86.3% (44/51); adjunctive stenting was needed in 21 (41.1%) to optimize results. Only 1 (1.9%) major complication (a pedal access site occlusion) and 4 (7.8%) minor sequelae (arterial perforation in 3 and a pedal hematoma without consequence) were documented. Conclusion: In complex popliteal to infrapopliteal occlusions, an antegrade recanalization attempt can fail in up to 20% of the cases. The additional use of a retrograde approach seems feasible and safe and can favorably modify this failure rate. This technique could be valuable for patients with critical limb ischemia due to popliteal and infrapopliteal occlusions once larger studies with follow-up confirm safety, efficacy, and clinical benefit.

Angiographic patency and clinical outcome after balloon‐angioplasty for extensive infrapopliteal arterial disease

Background and objective: Restenosis‐rate after balloon‐angioplasty of long segment tibial arterial disease is largely unknown. We investigated the restenosis‐rates angiographically in patients with critical limb ischemia (CLI) due to extensive infrapopliteal lesions. Methods: Angioplasty for infrapopliteal lesions exclusively ≥80 mm in length was performed using dedicated 80–120 mm long low‐profile balloons. Follow‐up included angiography at 3 months and clinical assessment at 3 and 15 months. Results: Angioplasty was performed in 77 infrapopliteal arteries of 62 limbs of 58 CLI patients with a Rutherford class 4 in 16 (25.8%) limbs and Rutherford class 5 in 46 limbs (74.2%). Average lesion length was 18.4 cm. Treated arteries were stenosed in 35.1% and occluded in 64.9%. After 3 months, a clinical improvement (marked reduction of ulcer‐size or restpain) was seen in 47 (75.8%) limbs, 14 (22.6%) limbs were clinically unchanged and 1 (1.6%) limb showed a clinical deterioration. Angiography at 3 months showed no significant restenosis in 24 of 77 (31.2%) treated arteries, a restenosis ≥50% in 24 (31.2%) arteries and a reocclusion in 29 of 77 (37.6%). At 15 months death rate was 10.5%. After repeat angioplasty in case of restenosis cumulative clinical results at 15 months were minor amputations in 8.1%, no major amputations resulting in a limb‐salvage rate of 100% with no patient requiring bypass surgery. Conclusions: Restenosis‐rate after angioplasty of extensive infrapopliteal arterial disease is high and occurs early after treatment. Despite this the clinical results are excellent, especially given the length of the arterial segments diseased.

Proximal endovascular flow blockage for cerebral protection during carotid artery stenting: results from a prospective multicenter registry.

Purpose: To evaluate the feasibility of cerebral protection during carotid artery stenting (CAS) using the Mo.Ma device, which prevents cerebral embolization by proximal endovascular blockage of blood flow in the internal and external carotid arteries. Methods: In 14 European centers, 157 patients (121 men; mean age 68.0±8.3 years) were enrolled in a prospective registry between March 2002 and March 2003. Eligible patients had a symptomatic (>50%) or asymptomatic (>70%) stenosis of the internal carotid artery suitable for carotid stenting. Protected carotid stenting was performed with the Mo.Ma system, which occludes both the common and external carotid arteries via 2 independently inflatable compliant low-pressure balloons before any device is advanced across the lesion. Blood is aspirated through the catheter intermittently or at the end of the procedure. Results: The device was successfully positioned and stents were implanted in all cases. Diameter stenosis was reduced from 84.1%±7.8% to 6.7%±5.1%. The mean duration of flow blockage was 7.6±5.9 minutes. In 12 (7.6%) patients, transient intolerance to flow blockade was observed, but the procedures were completed successfully. In 124 (79.6%) cases, there was macroscopic evidence of debris after filtering the aspirated blood. In-hospital complications included 4 (2.5%) minor strokes, 8 (5.1%) transient ischemic attacks, no deaths, and no major strokes, resulting in a 2.5% death/stroke rate at discharge. At 30-day follow-up, there was 1 cardiac death, 1 major stroke, and 3 minor strokes, for an overall 5.7% 30-day death/stroke rate and a 30-day major stroke and death rate of 1.3%. Conclusions: Cerebral protection with proximal endovascular blood flow blockage during CAS is feasible, with a high procedural success rate.

A Novel Self-Expanding Interwoven Nitinol Stent for Complex Femoropopliteal Lesions: 24-Month Results of the SUPERA SFA Registry:

Purpose To examine the efficacy and integrity of a novel interwoven self-expanding nitinol stent system for the treatment of complex femoropopliteal lesions in a “real world” medical practice. Methods This retrospective analysis included 107 consecutive patients (77 men; mean age 68.9 years) with atherosclerotic femoropopliteal lesions (occlusions in 31%) who underwent implantation of 137 SUPERA stents. The patients were followed for up to 24 months by Doppler ultrasound examinations, radiography of the stent, and assessments of Rutherford-Becker class and ankle-brachial index (ABI). Results The mean implanted stent length was 111±50 mm (range 40–270). Procedure success (residual stenosis <30%) was achieved in 99% of procedures. The 6-, 12-, and 24-month cumulative primary patency rates (± standard error) were 93.1%±2.5%, 84.7%±3.6%, and 76.1%±4.5%, respectively, and the secondary patency rates were 99.0%±0.1%, 94.8%±0.2% and 91.9%±0.3%, respectively. Between baseline and 24 months, mean ABI increased from 0.68±0.14 to 0.87±0.10 and the mean Rutherford-Becker class decreased from 3.3±0.7 to 2.0±1.0 (p=0.0001 for both). Radiographs performed in 91 patients at a mean of 16.8±7.0 months found no stent fractures. Conclusion Over a 2-year surveillance period, excellent durability without stent fractures was documented after implantation of the SUPERA stent in complex femoropopliteal lesions. In addition, significant improvements were observed in symptom classification and hemodynamics.

One-Year Outcome of Percutaneous Rotational Atherectomy with Aspiration in Infrainguinal Peripheral Arterial Occlusive Disease: The Multicenter Pathway PVD Trial

Purpose: To report a safety and efficacy study of a novel rotational atherectomy system with aspiration capabilities for the treatment of infrainguinal arterial lesions. Methods: From February 2006 to January 2007, 172 patients (88 women; mean age 72 years, range 51–93; 47% diabetics) with Rutherford class 1–5 lower limb ischemia were enrolled at 9 study sites. Inclusion criteria were atherosclerotic stenoses >70% and up to 10 cm long in the femoropopliteal segment or up to 3 cm long in the infrapopliteal vessels (reference vessel diameter 3.0–5.0 mm). In the study, 210 lesions (mean length 2.7 cm) were treated with the Pathway PV System, including total occlusions (31%), lesions with a moderate to high calcium score (51%), and post-angioplasty (non-stent) restenotic lesions (15%). The primary study endpoint was the 30-day major adverse event (MAE) rate. Results: Device success was 99% (208/210 lesions). MAE at 30 days was 1% (2 preplanned amputations). Clinically driven target lesion revascularization rates at 6 and 12 months were 15% (25/172) and 26% (42/162), respectively. The 1-year restenosis rate was 38.2% based on duplex imaging. The ankle-brachial index increased significantly from 0.59±0.21 at baseline to 0.82±0.27 (p<0.05) at 12 months. Mean Rutherford class improved from 3.0±0.9 at baseline to 1.5±1.3 at 1 year (p<0.05). Conclusion: The use of the Pathway PV System in atherosclerotic lesions appears to be safe and effective in improving stenosis severity, even in the presence of challenging lesion conditions. Vessel patency following intervention appears to be good up to 12 months, and these results translate into clinical benefit.

Treatment of Complex Atherosclerotic Popliteal Artery Disease With a New Self-Expanding Interwoven Nitinol Stent : 12-Month Results of the Leipzig SUPERA Popliteal Artery Stent Registry

OBJECTIVES We examined the efficacy and durability of a new interwoven self-expanding nitinol stent system in the treatment of complex popliteal artery lesions in unselected patients. BACKGROUND The optimal endovascular treatment strategy for atherosclerotic popliteal artery disease is not known. METHODS We retrospectively analyzed the data gathered in 101 consecutive patients presenting with atherosclerotic, popliteal arterial disease, who underwent implantation of 125 stents. The patients were followed for 12 months by Doppler ultrasound examinations, stent roentgenograms, and estimation of Rutherford-Becker class (RBC) and ankle-brachial index (ABI). RESULTS The mean age of the patients was 73.1 years, and 52.5% were men. Total occlusions were present in 48 patients (47.5%). The mean stent length was 84.3 ± 45.1 mm (range 40 to 240 mm). A <30% residual stenosis was achieved in 98.0% of procedures. The 6- and 12-month primary patency rates were 94.6 ± 2.3% and 87.7 ± 3.7%, respectively, and the secondary patency rates 97.9 ± 1.5% and 96.5 ± 2.0%, respectively. Between baseline and 12 months of follow-up, mean ABI increased from 0.58 ± 0.15 to 0.97 ± 0.18, and mean RBC decreased from 3.1 ± 0.9 to 1.4 ± 0.8 (p < 0.001 for both comparisons). Radiographs performed on 51 patients, at a mean of 15.2 months, confirmed the absence of stent fractures in 100% of examinations. CONCLUSIONS Over a 12-month observation period, the patency rate and durability of SUPERA stents implanted for severe popliteal artery disease were high.

Secondary surgical procedures after endovascular stent grafting of the thoracic aorta: successful approaches to a challenging clinical problem.

OBJECTIVE To evaluate the results of open surgical repair for complications after endovascular thoracic aorta stenting. METHODS A total of 14 patients (8 male, mean age 59.8 +/- 14.8 years) underwent conventional surgical therapy at our institution over a 5-year period after previous thoracic aortic stent implantation. The indications for surgery, intraoperative strategy, and perioperative and follow-up results were analyzed. RESULTS The indication for stent implantation was type B aortic dissection in 10 patients, expanding degenerative thoracic aneurysm in 3 patients, and pseudoaneurysm in 1 patient. The median interval to conventional surgery after stent implantation was 4.5 months (range 0.1-49 months). The indication for surgery was persistent type I endoleak with progressive aneurysm enlargement in 7 patients, aortoesophageal fistula in 2 patients, retrograde type A dissection in 2 patients, infection of the endoprosthesis in 2 patients, and aortic valve insufficiency caused by perforation of noncoronary and right coronary cusps in 1 patient. The endograft had to be removed in 9 (64%) patients, and 5 (36%) patients required replacement of the thoracoabdominal aorta. In-hospital mortality was 7% (1 patient). No patients had a postoperative stroke or paraparesis. Eleven (79%) patients are alive after a mean follow-up of 13.5 +/- 10.1 months (range 1-36 months). CONCLUSIONS Secondary surgical procedures after stenting of the thoracic aorta can be performed with very good results, despite the challenging clinical scenarios. Identification of successful surgical strategies for this difficult clinical problem is important in the era of increasing endovascular therapy.

Retrograde recanalization technique for use after failed antegrade angioplasty in chronic femoral artery occlusions.

Purpose To describe a technique to approach chronic total occlusions (CTOs) of the superficial femoral artery (SFA) after failed antegrade recanalization as an alternative to a conventional transpopliteal approach. Methods A retrospective analysis was undertaken of 50 patients (37 men; mean age 71 years) who underwent retrograde recanalization via a distal SFA access after failed antegrade recanalization of SFA CTOs that were not beyond the adductor canal. Antegrade recanalization failed due to flush SFA occlusion, occluded stents, wire perforation, and re-entry failure. Retrograde SFA access required introduction of a 7- to 15-cm, 21-G needle distal to the occlusion. A 0.018-inch guidewire was inserted through the needle followed by a 4- or 6-F, 10-cm sheath or dedicated support catheter only. All retrograde SFA punctures were performed with the patient in the supine position. Once retrograde passage of the occlusion was successful, oftentimes requiring a “double-balloon” technique to disrupt the dissection membrane with abutting balloons delivered from both access sites, balloon angioplasty and/or stenting could be performed from either direction. Results Retrograde puncture of the distal SFA was successful in all cases. Retrograde recanalization involved insertion of a 6-F sheath in 3 (6%) cases, a 4-F sheath in 32 (64%), and a sheathless approach in 15 (30%). The “double-balloon” technique was necessary to achieve guidewire passage in 12 cases. Recanalization was successful in 48 (96%) cases. Hemostasis time at the distal puncture site was 9.2 minutes (range 3–30). Perioperative complications included 4 pseudoaneurysms (2 groins, 2 distal), 1 peripheral embolization, and 1 small arteriovenous fistula at the distal puncture site. Conclusion For failure of antegrade recanalization of SFA occlusions, the retrograde SFA puncture distal to the adductor canal with the patient remaining supine is a safe and successful technique that represents a convenient alternative to the conventional transpopliteal approach.