Michael Piorkowski

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.

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.

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-Coated Balloons for Complex Femoropopliteal Lesions: 2-Year Results of a Real-World Registry

OBJECTIVES The authors sought to investigate the efficacy of a drug-coated balloon (DCB) for treatment of complex femoropopliteal lesions. BACKGROUND Superiority of DCBs compared with uncoated balloon angioplasty for femoropopliteal interventions has been demonstrated in randomized trials for short lesions. Their performance in complex lesions with higher restenosis rates is unclear. METHODS Patency, target lesion revascularization (TLR) rate, clinical improvement, and safety endpoints of femoropopliteal lesions in 288 limbs (n = 260) treated with the In.Pact Pacific or Admiral DCB (Medtronic, Minneapolis, Minnesota) were retrospectively analyzed for up to 2 years of follow-up. Predictors of restenosis were identified by logistic regression. RESULTS Lesions were de novo in 51.7%, restenosis in 11.1%, and in-stent restenosis in 37.2%. Mean lesion length was 24.0 ± 10.2 cm, and 65.3% were occluded. Stent implantation was performed in 23.3%. Kaplan Meier estimates of primary patency were 79.2% and 53.7% for all lesions at 1 and 2 years, respectively, whereas freedom from TLR was 85.4% and 68.6%. Primary patency for in-stent restenosis treatment was 76.6% and 48.6%, and freedom from TLR was 83.0% and 58.7% at 1 and 2 years, respectively. Rutherford category improved from a median 3.3 to 1.2 at 1 year, and to 1.1 at 2 years. Major amputation rate was 2.1% at 2 years. No adverse events were thought to be attributable to the coating of the balloon. CONCLUSIONS These results suggest that DCB are safe and effective in delaying rather than preventing restenosis in long, complex lesions and restenosis of the femoropopliteal tract. Further studies are recommended to confirm these results.

ADP induced platelet degranulation in healthy individuals is reduced by clopidogrel after pretreatment with atorvastatin

Statins inhibit platelet reactivity and reduce blood thrombogenicity. The effectiveness of clopidogrel in inhibiting platelet reactivity was suggested to be reduced in the presence of atorvastatin due to shared enzymes in metabolism. Healthy individuals, 17 pretreated with atorvastatin (20 mg/d for 3 days) and 17 without pretreatment, as well as 15 patients with stable coronary artery disease (CAD) and concurrent atorvastatin therapy were started on clopidogrel (loading dose 300 mg, then 75 mg/d). P-selectin on platelet surface after stimulation with ADP or Thrombin Receptor Activating Peptide (TRAP) was flow cytometrically measured before and during clopidogrel administration. Whole blood platelet agglutination was tested by a platelet function assay.TRAP and - in trend - ADP induced p-selectin exposure was reduced by the atorvastatin pretreatment before clopidogrel was added. Combining clopidogrel with atorvastatin in the healthy individuals led to a further reduction in ADP-induced platelet p-selectin exposure. Clopidogrel also reduced platelet reactivity in CAD patients with concurrent atorvastatin medication. We conclude that pretreatment with atorvastatin reduces platelet reactivity before administration of clopidgrel. No drug interaction was seen, however, platelet inhibitory effects were observed during the treatment with clopidogrel and atorvastatin.

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).

Endovascular Brachytherapy Using Liquid Beta-Emitting Rhenium-188 for the Treatment of Long-Segment Femoropopliteal In-Stent Stenosis

Purpose To evaluate the efficacy and safety of endovascular brachytherapy with liquid beta-emitting rhenium-188 (Re-188) in patients with long-segment in-stent stenosis in the femoropopliteal segment. Methods From July 2009 to April 2011, 90 consecutive patients (59 men; mean age 68.3±10.3 years, range 43–86) with symptomatic in-stent stenosis/occlusion (24.6-cm mean lesion length) of the femoropopliteal segment underwent angioplasty and subsequent endovascular brachytherapy. The liquid beta-emitting Re-188 was applied to the target lesion within an angioplasty balloon using a dose of 13 Gy at a depth of 2 mm into the vessel wall. Clinical and angiographic follow-up data were collected up to 2 years. The main study endpoints were the 6- and 12-month primary patency rates defined as <50% in-stent stenosis as detected by duplex ultrasound. Clinical endpoints were the cumulative rates of death, amputation, and bypass surgery, as well as improvement in the Rutherford category and the ankle-brachial index. Results were correlated with patient and lesion characteristics. Results Primary technical success was achieved in all patients, with 1 early stent thrombosis, but no other complications related to the irradiation. Eighty-eight patients reached the 6-month and 82 the 12-month examinations; the primary patency was 95.2% and 79.8%, respectively. In-stent stenosis occurred in 9 patients, while 10 patients had reocclusion of the treated segment. During follow-up, there were 2 late acute thrombotic occlusions, both after discontinuation of clopidogrel. The clinical status improved in 67.0% and 62.2% of the patients after 6 and 12 months, respectively. No patient, lesion, or procedure variables were predictive of restenosis after EVBT. Conclusion EVBT with liquid beta-emitting Re-188 was safe and effective in preventing restenosis in long-segment femoropopliteal ISS.

SUMMIT registry: one-year outcomes after implantation of the EPIC self-expanding nitinol stent in the femoropopliteal segment.

Purpose: To evaluate the efficacy and safety of the EPIC self-expanding nitinol stent in patients with femoropopliteal occlusive disease. Methods: The prospective, multicenter, nonrandomized SUMMIT study ( ClinicalTrials.gov identifier NCT01336101) enrolled 100 patients (76 men; mean age 67.6 years) with symptomatic de novo femoropopliteal disease undergoing angioplasty and subsequent implantation of EPIC stents from April 2011 to October 2011. The mean lesion length was 69.5±40.5 mm; 29 of the lesions were total occlusions. Clinical examination and duplex sonography were prospectively performed after 6 and 12 months. The primary endpoint was in-stent restenosis as assessed by duplex ultrasound (peak systolic velocity ratio ≥2.5). Further outcome measures were patency rates, improvement in the Rutherford category and ankle-brachial index (ABI), as well as stent integrity based on plain radiography. Results: A residual stenosis <30% was achieved in all procedures. The primary patency rates were 96.8% after 6 months and 85.1% at 1 year. The secondary patency rates were 97.9% and 91.2% at the same intervals. The 1-year binary >50% restenosis rate was 15.7%. Freedom from target lesion revascularization at 1 year was 92.3%. Between baseline and the 12-month follow-up, the mean ABI increased from 0.73 to 0.96, and the mean Rutherford category decreased from 2.9 to 1.0 (p<0.001 for both comparisons). Plain radiographs from 86 patients at the 12-month examination confirmed the absence of stent fractures. Conclusion: The outcome of the SUMMIT registry demonstrates that the EPIC self-expanding nitinol vascular stent is a safe and effective device for treating peripheral artery disease in the femoropopliteal segment.

Late open conversion after endovascular aneurysm repair

OBJECTIVES Endovascular treatment of the infrarenal abdominal aorta (endovascular repair, EVAR) has emerged as an alternative to open surgery. However, a small subset of patients exists who undergo conversion either in the first 30 postoperative days or later during the course of postoperative surveillance. In the present study, we review our experience with late conversion operations. METHODS Between December 2004 and August 2012, 411 EVARs were performed. During the same time interval, nine patients (males) with a mean age of 71 years (range, 59-79 years) required late open conversion. The median interval between EVAR and the conversion operation was 34 months (range 14-60 months). RESULTS The indications for late conversion included persistent proximal type I endoleak (n = 2), type II endoleak with sac enlargement (n = 1), aneurysm rupture (n = 1), endotension (n = 2), stent-graft thrombosis (n = 1) and stent-graft infection (n = 2). Complete stent-graft explantation was performed in five patients. Eight patients underwent elective conversion. One patient presenting with rupture had an emergency operation. The 30-day mortality rate was 0%. CONCLUSIONS Late open conversion after EVAR can be performed safely and successfully. Complete stent-graft explantation may be our preferred treatment option, but it is not always necessary, except in cases presenting with graft infection.