Matthias Ulrich

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.

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.

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.

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.

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.

Outback catheter for femoropopliteal occlusions: immediate and long-term results.

Purpose: 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. Methods: 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. Results: 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. Conclusion: 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.

Treatment of complex atherosclerotic femoropopliteal artery disease with a self-expanding interwoven nitinol stent: midterm results from the Leipzig SUPERA 500 registry

AIMS To examine the efficacy and durability of an interwoven self-expanding nitinol stent in the treatment of complex femoropopliteal artery lesions in unselected patients. METHODS AND RESULTS Five hundred and twenty-seven limbs in 470 patients with femoropopliteal arterial disease were treated with SUPERA stents. Follow-up data were prospectively collected in a single-centre registry and were available for 439 patients (492 limbs). The patients were followed by Doppler ultrasound, stent roentgenograms, estimation of Rutherford-Becker class (RBC) and ankle-brachial index (ABI). Total occlusions were present in 277 limbs (52.6%) and 52.4% had either moderate or severe calcification. The mean lesion length was 126.4 mm. The primary patency (PP) rates were 83.3% after 12 months and 72.8% at two years. The secondary patency rates were 98.1% after 12 months and 92.0% at two years. Patency rates did not differ between superficial femoral artery (SFA) and popliteal lesions. Between baseline and a mean of 21 months of follow-up, mean ABI increased from 0.53 to 0.91, and mean RBC decreased from 3.0 to 1.9 (p<0.001 for both comparisons). Radiographs performed on 229 patients at a mean of 16.6 months confirmed the absence of stent fractures in all patients. CONCLUSIONS Over a two-year surveillance period, the patency rate and fracture resistance of SUPERA stents implanted for complex femoropopliteal artery disease were high.

Drug-Eluting Stents for the Treatment of Vertebral Artery Origin Stenosis

Purpose: To present our experience with the use of drug-eluting stents (DES) in patients with symptomatic vertebral artery ostium stenosis (VAOS). Methods: Between 2003 and 2008, 28 consecutive patients (17 men; mean age 66 years) with symptomatic extracranial vertebral artery stenosis were treated with a paclitaxel-eluting stent. All patients were prospectively scheduled for serial clinical, duplex, and angiographic follow-up to identify restenosis. Results: After stent implantation, the mean stenosis was reduced from 68% to 9%. There were no periprocedural neurological complications. After a mean follow-up of 16 months (range 5–41), no strokes, worsening of symptoms, or deaths occurred. Angiographic restenosis >50% was seen in 6 (21.4%) patients. Restenosis occurred significantly more often in patients with an ipsilateral subclavian artery stenosis (p=0.01). Radiography during follow-up angiography revealed stent fracture in 1 patient and stent compression/kinking in 11 (39%) of the patients. Stent compression and recoil, not intimal hyperplasia, were the major contributing factors to restenosis. Conclusion: Compared to the restenosis rate of bare metal stents reported in the literature, DES seems to be superior for the treatment of VAOS. However, stent compression and recoil are relevant problems contributing to restenosis. Further improvement of the materials for the interventional treatment of VAOS seems necessary.

Anatomic variables contributing to a higher periprocedural incidence of stroke and TIA in carotid artery stenting: single center experience of 833 consecutive cases.

This study was conducted to identify patient‐related variables that are associated with a higher rate of neurological adverse events during carotid artery stenting (CAS).