Publications (63)280.41 Total impact
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Article: Sustained safety and effectiveness of paclitaxel-eluting stents for femoropopliteal lesions: two-year follow-up from the Zilver PTX randomized and single-arm clinical studies.
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ABSTRACT: OBJECTIVE: A prospective, multinational randomized controlled trial (RCT) and a complementary single-arm study evaluated the 2-year safety and effectiveness of a paclitaxel-coated drug-eluting stent (DES) in patients with superficial femoral artery (SFA) lesions. The RCT compared the DES to percutaneous transluminal angioplasty (PTA) and provisional bare metal stent (BMS) placement. BACKGROUND: Local drug delivery for SFA lesions has been investigated with the intent of limiting restenosis similarly to DES for the coronary arteries. One-year outcomes of DES in the SFA are promising but longer-term benefits have not been established. METHODS: In the RCT, patients were randomly assigned to primary DES (n=236) or PTA (n=238). Acute PTA failure occurred in 120 patients, who underwent secondary randomization to DES (n=61) or BMS (n=59). The single-arm study enrolled 787 patients with DES treatment. RESULTS: Compared with the control group, the primary DES group demonstrated significantly superior 2-year event-free survival (86.6% versus 77.9%; p=0.02) and primary patency (74.8% versus 26.5%; p<0.01). In addition, the provisional DES group exhibited superior 2-year primary patency compared with the provisional BMS group (83.4% versus 64.1%; p<0.01) and achieved higher sustained clinical benefit (83.9% versus 68.4%; p=0.05). The 2-year freedom from target lesion revascularization with primary DES was 80.5% in the single-arm study and 86.6% in the RCT. CONCLUSIONS: The 2-year outcomes with the paclitaxel-eluting stent support its sustained safety and effectiveness in patients with femoropopliteal arterial disease, including the long-term superiority of the DES to PTA and to provisional BMS.Journal of the American College of Cardiology 04/2013; · 14.16 Impact Factor -
Article: Reply:.
Journal of Endovascular Therapy 04/2013; 20(2):252-3. · 2.86 Impact Factor -
Article: Rotational and aspiration atherectomy for infrainguinal in-stent restenosis.
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ABSTRACT: Background: To report feasibility and safety of the Pathway PV™ Atherectomy System during percutaneous peripheral vascular interventions of in-stent restenosis. Patients and methods: 33 patients (66.7 % men; mean age 68.7 years; 39.4 % diabetics) with symptomatic infrainguinal in-stent restenosis were enrolled at 5 study sites. Primary study endpoint was the 30-day serious adverse event (SAE) rate. At one study site a subgroup of 13 patients was scheduled for additional follow-up examinations with duplex Results: Forty lesions with a mean lesion length of 85.7 mm (range 6 - 370 mm) were treated including total occlusions (20 %) and infrapopliteal lesions (5 %). In sixteen target lesions (40 %) procedural success was reached with atherectomy alone, 23 lesions (57.5 %) received adjunctive percutaneous transluminal angioplasty to obtain a sufficient angiographic result. Freedom from device-related SAEs was 100 %. Overall there were 11 unexpected adverse events in 11 patients, two of which were serious (retroperitoneal bleeding and access site infection). The ankle-brachial index increased significantly from 0.65 ± 0.13 at baseline to 0.82 ± 0.15 at 30 days. Mean Rutherford category improved from 2.8 ± 0.7 at baseline to 1.0 ± 1.2. In the subgroup with longer follow- up primary patency was 33 % after 12 months and 25 % after 24 months. Secondary patency was 92 % after 12 and 24 months. Conclusions: The use of the Pathway PV™ System during percutaneous peripheral vascular interventions of in-stent restenosis appears to be feasible and safe but does not seem to offer a sustainable solution regarding long term patency. A combination with drug eluting balloon angioplasty could be an interesting option and should be evaluated in further clinical trials.VASA.: Zeitschrift für Gefässkrankheiten. Journal for vascular diseases 03/2013; 42(2):127-33. · 1.31 Impact Factor -
Article: Bifurcation stenting after failed angioplasty of infrapopliteal arteries in critical limb ischemia: Techniques and short-term follow-up.
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ABSTRACT: OBJECTIVES: To report on the efficacy of drug eluting stents (DES) in below the knee lesions involving arterial bifurcations after failed angioplasty. BACKGROUND: DES have become a mainstay in the treatment of below the knee lesions. However, little is known about the efficacy of DES in infapopliteal lesions involving the arterial bifurcations. This is the first report on the endovascular treatment of below-the knee bifurcations. METHODS: 11 patients with critical lower limb ischemia (CLI) and complex infrapopliteal atherosclerotic disease underwent provisional DES placement in infrapopliteal bifurcation lesions. Clinical and angiographic follow-up data were prospectively collected in all patients. RESULTS: Technical success was achieved in all cases. After 6 months, the two vessel primary patency (2VPP) rate was 54.5% and the one vessel primary patency (1VPP) rate was 81.8%. Between baseline and the follow-up, mean ABI increased from 0.31±0.10 to 0.68±0.16, and mean Rutherford-Becker class (RBC) decreased from 4.73±0.20 to 3.00±1.41 (p<0.001 for both comparisons). CONCLUSIONS: Bifurcation stenting techniques, that are described for the coronary arteries can be also performed in the infrapopliteal arteries. However, early reocclusion was frequent in this case series, when stenting was performed in a bail-out setting. If balloon angioplasty alone leads to no sufficient results in bifurcation lesions, a single stent strategy could also be considered. © 2013 Wiley Periodicals, Inc.Catheterization and Cardiovascular Interventions 02/2013; · 2.29 Impact Factor -
Article: First clinical experience with the GARDEX EPD: a novel embolic protection device for carotid artery stenting.
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ABSTRACT: Aims: Carotid artery stenting (CAS) has become an alternative to carotid endarterectomy in the treatment of carotid artery disease. The use of an embolic protection device (EPD) can reduce the frequency of embolic events during CAS. Difficult vascular anatomy may complicate current generation EPD placement. This problem is addressed by a new EPD, the GARDEX System. The aim of this study was to assess the safety and performance of the GARDEX EPD during CAS. Methods and results: Thirty-eight patients underwent CAS with the GARDEX EPD in two medical centres. All patients were prospectively followed up for 30 days. Device performance and procedural details were collected and analysed prospectively. Vessel anatomy and lesion morphology were evaluated and stratified into a scoring system for anatomic difficulty. More than a third of the patients were considered to have difficult vascular anatomy for CAS. All enrolled patients were successfully treated. There was one (2.6%) minor periprocedural stroke and there were two (5.3%) periprocedural TIAs which resolved within 24 hours. No additional complications were noted during the 30-day follow-up period. Conclusions: In this first experience, CAS under cerebral protection with the GARDEX EPD was safe and feasible. Our data suggest that the use of the GARDEX EPD is simple and shows high success rates even in challenging anatomies. The role of this new device in CAS needs to be further confirmed in a larger patient population.EuroIntervention: journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology 01/2013; 8(9):1026-32. · 3.29 Impact Factor -
Article: 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.
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ABSTRACT: 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. The optimal endovascular treatment strategy for atherosclerotic popliteal artery disease is not known. 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). 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. Over a 12-month observation period, the patency rate and durability of SUPERA stents implanted for severe popliteal artery disease were high.01/2013; 6(1):65-71. · 1.07 Impact Factor -
Article: A Prospective Randomized Multicenter Comparison of Balloon Angioplasty and Infrapopliteal Stenting With the Sirolimus-Eluting Stent in Patients With Ischemic Peripheral Arterial Disease: 1-Year Results From the ACHILLES Trial.
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ABSTRACT: The study investigated the efficacy and safety of a balloon expandable, sirolimus-eluting stent (SES) in patients with symptomatic infrapopliteal arterial disease. Results of infrapopliteal interventions using balloon angioplasty and/or bare stents are limited by a relatively high restenosis rate, which could be potentially improved by stabilizing the lesion with a SES. Two hundred patients (total lesion length 27 ± 21 mm) were randomized to infrapopliteal SES stenting or percutaneous transluminal balloon angioplasty (PTA). The primary endpoint was 1-year in-segment binary restenosis by quantitative angiography. Ninety-nine and 101 patients (mean age 73.4 years; 64% diabetics) were randomized to SES and PTA, respectively (8 crossover bailout cases to SES). At 1 year, there were lower angiographic restenosis rates (22.4% vs. 41.9%, p = 0.019), greater vessel patency (75.0% vs. 57.1%, p =0.025), and similar death, repeat revascularization, index-limb amputation rates, and proportions of patients with improved Rutherford class for SES versus PTA. SES implantation may offer a promising therapeutic alternative to PTA for treatment of infrapopliteal peripheral arterial disease.Journal of the American College of Cardiology 12/2012; 60(22):2290-5. · 14.16 Impact Factor -
Article: Initial Experience With the 5×300-mm Proteus Embolic Capture Angioplasty Balloon in the Treatment of Peripheral Vascular Disease.
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ABSTRACT: Purpose: To describe the use of the 5×300-mm Proteus embolic capture angioplasty (ECA) balloon catheter to reduce embolic burden in complex TASC II (TransAtlantic Inter-Society Consensus) C and D femoropopliteal interventions. Methods: A non-randomized safety and feasibility study was conducted at 2 centers enrolling 15 subjects (9 women; mean age 72.5±9.5 years, range 53-85) suffering from Rutherford-Becker category 2 to 4 occlusive disease. Of the 20 lesions in 15 limbs, 16 were TASC II D and 4 were TASC II C. Average baseline stenosis was 95%±12%; 16 lesions were totally occluded. Half of the lesions were de novo, 5 were restenotic, and 5 were in-stent stenoses. Average lesion length was 284±50 mm. In addition to using the ECA device, 18 of the target lesions were treated with stents and 4 with rotational thrombectomy devices. Distal angiography was performed before and after use of the ECA device to locate any periprocedural embolic events. Results: Procedural success was achieved in 100% lesions. The ECA balloon was used for predilation in 11 lesions and for postdilation in 9. No distal embolization or flow-limiting vessel dissections were observed despite the complex nature of the cases. Three non-device-related complications were reported (pseudoaneurysm, myocardial infarction, acute renal failure) and resolved without sequelae within 30 days. Analysis of the particles recovered from 5 ECA balloons demonstrated a mean 257±185 particles, with a mean major axial dimension of 0.54±0.04 mm (range 0.11-7.54). There were a mean 7.67±6.03 particles >2 mm in diameter, and all samples contained 1 to 3 particles >4 mm in diameter. Conclusion: In this small series, the 5×300-mm ECA embolic capture balloon catheter was an effective tool for avoiding embolic events in long peripheral lesions, with a good safety profile. The device might be considered as part of routine clinical practice for complex TASC II C/D femoropopliteal lesions.Journal of Endovascular Therapy 12/2012; 19(6):826-33. · 2.86 Impact Factor -
Article: Endovascular brachytherapy using liquid Beta-emitting rhenium-188 for the treatment of long-segment femoropopliteal in-stent stenosis.
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ABSTRACT: 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. 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. 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. EVBT with liquid beta-emitting Re-188 was safe and effective in preventing restenosis in long-segment femoropopliteal ISS.Journal of Endovascular Therapy 08/2012; 19(4):467-75. · 2.86 Impact Factor -
Article: Anatomic variables contributing to a higher periprocedural incidence of stroke and TIA in carotid artery stenting: single center experience of 833 consecutive cases.
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ABSTRACT: 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). CAS is considered as an alternative treatment for patients with carotid artery stenosis. Despite technical advancements and increase of operator experience, periprocedural neurologic complications cannot completely be prevented. Case selection based on anatomical criteria and other patient characteristics could improve the outcome after CAS. Between 2006 and 2009, 833 CAS procedures were performed in 751 consecutive patients under cerebral protection. The influence of patient characteristics, procedural details, and the anatomy of the supraaortic vessels on the incidence of major in-hospital adverse events was assessed. Successful CAS was performed in 99.2% of the procedures. The in-hospital death and stroke rate was 2.0% (1 major stroke, 10 minor strokes, and 7 deaths). Octogenarians had a fourfold higher death and stroke rate than patients younger than 80 years old. There was an increased risk of stroke and death in patients with critical aortic stenosis. Presence of a bovine arch, tortous common carotid artery (CCA) and angulated distal internal carotid artery were associated with a higher risk of stroke and transient ischemic attack. A recently developed scoring system for anatomic suitability correlates well with the periprocedural neurological outcome in this case series. Anatomical conditions and octogenarian age were associated with an increased rate of neurologic adverse events during CAS. Our findings support a newly proposed scoring system for anatomic suitability to identify patients at high risk for CAS.Catheterization and Cardiovascular Interventions 03/2012; 80(2):321-8. · 2.29 Impact Factor -
Article: Nitinol stent implantation vs. balloon angioplasty for lesions in the superficial femoral and proximal popliteal arteries of patients with claudication: three-year follow-up from the RESILIENT randomized trial.
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ABSTRACT: To evaluate longer outcomes of primary nitinol stenting for the treatment of femoropopliteal lesions up to 15 cm long after these stents were found to have superior short-term patency vs. balloon angioplasty. Two hundred and six patients (143 men; mean age 67 years) with intermittent claudication due to superficial femoral and proximal popliteal artery lesions were randomized (2:1) to treatment with nitinol stents or balloon angioplasty at 24 US and European centers and followed for 3 years. In that time, 15 patients died, 20 withdrew consent, and 10 were lost to follow-up, leaving 161 (78.2%) patients for 36-month assessment. The 12-month freedom from target lesion revascularization (TLR) was 87.3% for the stent group vs. 45.2% for the angioplasty group (p<0.0001). At 3 years, there was no difference in survival (90.0% vs. 91.7%, p=0.71) or major adverse events (75.2% vs. 75.2%, p=0.98) between the stent and angioplasty groups. Duplex ultrasound was not mandated after the first year, so stent patency could not be ascertained beyond 1 year, but freedom from TLR at 3 years was significantly better in the stent group (75.5% vs. 41.8%, p<0.0001), as was clinical success (63.2% vs. 17.9%, p<0.0001). At 18 months, a 4.1% (12/291) stent fracture rate was documented. In this multicenter trial, primary implantation of a nitinol stent for moderate-length lesions in the femoropopliteal segment of patients with claudication was associated with better long-term results vs. balloon angioplasty alone.Journal of Endovascular Therapy 02/2012; 19(1):1-9. · 2.86 Impact Factor -
Article: Retrograde recanalization technique for use after failed antegrade angioplasty in chronic femoral artery occlusions.
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ABSTRACT: 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. 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. 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. 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.Journal of Endovascular Therapy 02/2012; 19(1):23-9. · 2.86 Impact Factor -
Article: Sirolimus-eluting stents for the treatment of infrapopliteal arteries in chronic limb ischemia: long-term clinical and angiographic follow-up.
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ABSTRACT: To present the 5-year angiographic and clinical results of a retrospective registry assessing the performance of sirolimus-eluting stents (SES) in the treatment of infrapopliteal atherosclerotic disease. From 2004 to 2009, 158 patients (95 men; mean age 71.9 years) with chronic lower limb ischemia (Rutherford categories 3-6) underwent primary SES placement in focal infrapopliteal lesions. The angiographic endpoint was patency, defined as freedom from in-stent stenosis (ISS) >50%. Clinical endpoints were death, amputation, and bypass surgery. Results were correlated with patient and lesion characteristics and cumulative outcomes were assessed with Kaplan-Meier analysis. Technical success was achieved in all cases. The primary patency rates were 97.0% after 6 months, 87.0% after 12 months, and 83.8% at 60 months. In-stent stenosis was predominantly observed in the first year after stent placement. Female gender was associated with a higher rate of ISS. During clinical follow-up of 144 (91%) patients over a mean 31.1±20.3 months, there were 27 (18.8%) deaths, 4 (2.8%) amputations, and no bypass surgery. Clinical status improved in 92% of the patients with critical limb ischemia (CLI) and 77% of the patients suffering from claudication (p=0.022). Treatment of focal infrapopliteal lesions with SES showed encouraging long-term angiographic results in this registry. Clinical improvement was evident, but more pronounced in CLI patients than in patients suffering from claudication. Further studies are needed to evaluate the potential clinical benefit of SES as compared to balloon angioplasty or bare metal stents in the treatment of infrapopliteal lesions.Journal of Endovascular Therapy 02/2012; 19(1):12-9. · 2.86 Impact Factor -
Article: Randomized comparison of everolimus-eluting versus bare-metal stents in patients with critical limb ischemia and infrapopliteal arterial occlusive disease.
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ABSTRACT: 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). 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. 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). 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.Journal of vascular surgery: official publication, the Society for Vascular Surgery [and] International Society for Cardiovascular Surgery, North American Chapter 12/2011; 55(2):390-8. · 3.52 Impact Factor -
Article: A novel self-expanding interwoven nitinol stent for complex femoropopliteal lesions: 24-month results of the SUPERA SFA registry.
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ABSTRACT: 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. 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). 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. 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.Journal of Endovascular Therapy 12/2011; 18(6):745-52. · 2.86 Impact Factor -
Article: Percutaneous transluminal angioplasty versus turbostatic carbon-coated stents in infrapopliteal arteries: InPeria II trial.
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ABSTRACT: To determine the clinical outcome and the success of stent application for high-grade lesions of the infrapopliteal arteries compared with treatment with percutaneous transluminal angioplasty (PTA) in critical limb ischemia (CLI). In this ethics board-approved randomized prospective study, PTA or stent application was performed on 131 lesions in 88 patients with CLI. The primary end points were clinical improvement after endovascular treatment and limb salvage rate. Secondary end points were defined by the minimal lumen diameter (MLD) before and after the revascularization procedure, percentage of residual diameter stenosis (DS), binary restenosis rate (>50% DS and >70% DS), and incidence of target lesion revascularization at 9-month follow-up. At 3 months, the clinical status in the PTA group was less improved than that in the stent group (P = .008). At 9 months, there had been five minor and two major amputations in the PTA group and five major and five minor amputations in the stent group. MLD was significantly larger and the percentage of DS was significantly less in the stent group at completion angiography. At 9 months, the angiographic control showed better trends for the stent group in comparison to the PTA group despite that no significant differences were detected (MLD, 1.19 mm ± 0.92 vs 1.02 mm ± 1.02; DS, 38.68% ± 25.47 vs 43.31% ± 28.37). Infrapopliteal stent application is an effective treatment modality in CLI. The PTA and stent groups were essentially equal at 3 and 9 months except for the difference in clinical improvement in the stent group at 3 months.Radiology 11/2011; 261(2):634-42. · 5.73 Impact Factor -
Article: Pharmacokinetic analysis after implantation of everolimus-eluting self-expanding stents in the peripheral vasculature.
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ABSTRACT: A novel self-expanding drug-eluting stent was designed to release everolimus 225 μg/cm(2) to prevent restenosis following peripheral arterial intervention. The purpose of this study was to measure the pharmacokinetic profile of everolimus following stent implantation. One hundred four patients with symptomatic peripheral arterial disease underwent implantation of everolimus-eluting stents in the femoropopliteal arteries. In a prespecified subset of 26 patients, blood samples for assay of everolimus content were collected prior to stent implantation, at 1, 4, and 8 hours postprocedure, prior to discharge, and at 1 month postprocedure. A total of 39 stents, ranging from 28 mm to 100 mm in length, were implanted in 26 patients, resulting in a total delivered everolimus dose range of 3.0 to 7.6 mg. Following the procedure, the maximum observed everolimus blood concentrations (C(max)) varied from 1.83 ± 0.05 ng/mL after implantation of a single 80-mm stent to 4.66 ± 1.78 ng/mL after implantation of two 100-mm stents. The mean time to peak concentration (T(max)) varied from 6.8 hours to 35 hours. The pharmacokinetics of everolimus were dose-proportional in that dose-normalized C(max) and area under the curve values were constant over the studied dose range. After implantation of everolimus-eluting self-expanding stents in the femoropopliteal arteries, systemic blood concentrations of everolimus are predictable and considerably lower than blood concentrations observed following safe oral administration of everolimus.Journal of vascular surgery: official publication, the Society for Vascular Surgery [and] International Society for Cardiovascular Surgery, North American Chapter 11/2011; 55(2):400-5. · 3.52 Impact Factor -
Article: Nitinol stents with polymer-free paclitaxel coating for lesions in the superficial femoral and popliteal arteries above the knee: twelve-month safety and effectiveness results from the Zilver PTX single-arm clinical study.
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ABSTRACT: To report a prospective, single-arm, multicenter clinical study evaluating the Zilver PTX drug-eluting stent for treating the above-the-knee femoropopliteal segment (NCT01094678; http://www.clinicaltrials.gov ). The Zilver PTX drug-eluting stent is a self-expanding nitinol stent with a polymer-free paclitaxel coating. Patients with symptomatic (Rutherford category 2-6) de novo or restenotic lesions (including in-stent stenosis) of the above-the-knee femoropopliteal segment were eligible for enrollment. Between April 2006 and June 2008, 787 patients (578 men; mean age 66.6±9.5 years) were enrolled at 30 international sites. Nine hundred lesions (24.3% restenotic lesions of which 59.4% were in-stent stenoses) were treated with 1722 Zilver PTX stents; the mean lesion length was 99.5±82.1 mm. The 12-month Kaplan-Meier estimates included an 89.0% event-free survival rate, an 86.2% primary patency rate, and a 90.5% rate of freedom from target lesion revascularization. There were no paclitaxel-related adverse events reported. The 12-month stent fracture rate was 1.5%. The ankle-brachial index, Rutherford score, and walking distance/speed scores significantly improved (p<0.001) from baseline to 12 months. These results indicate that the Zilver PTX drug-eluting stent is safe for treatment of patients with de novo and restenotic lesions of the above-the-knee femoropopliteal segment. At 1 year, the overall anatomical and clinical effectiveness results suggest that this stent is a promising endovascular therapy.Journal of Endovascular Therapy 10/2011; 18(5):613-23. · 2.86 Impact Factor -
Article: First experience with drug-eluting balloons in infrapopliteal arteries: restenosis rate and clinical outcome.
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ABSTRACT: 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. 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. 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. 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. 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.Journal of the American College of Cardiology 09/2011; 58(11):1105-9. · 14.16 Impact Factor -
Article: Effect of carotid artery stenting on the release of S-100B and neurone-specific enolase.
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ABSTRACT: Serum levels of S-100B and neurone-specific enolase (NSE) reflect cerebral injury in a variety of neurological conditions such as stroke, traumatic brain injury, and cardiac arrest. There are limited data on the release of S-100B and NSE following carotid artery stenting (CAS). In 22 patients undergoing CAS, serial blood samples for S-100B and NSE were collected before and 2, 4, and 6 to 8 hours after the procedure. A group of 20 patients with significant CAS undergoing purely diagnostic angiography served as controls. A significant increase in S-100B levels was observed 2 hours after the procedure in patients with CAS (P = .001) with a gradual decline over the next hours. In contrast, patients who underwent purely diagnostic angiography did not show significant changes in S-100B levels up to 8 hours after the procedure. Neither patients with CAS nor those undergoing diagnostic angiography displayed any significant changes in serial NSE levels.Angiology 07/2011; 62(5):376-80. · 1.51 Impact Factor
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Top Journals
Institutions
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2012–2013
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Universitäts-Herzzentrum Freiburg - Bad Krozingen
Bad Krozingen, Baden-Wuerttemberg, Germany
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2011–2013
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Stanford Medicine
Stanford, CA, USA
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2010–2012
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University of California, Davis
- School of Medicine
Davis, CA, USA
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2004–2008
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University of Leipzig
- Institut für Sozialmedizin, Arbeitsmedizin und Public Health
Leipzig, Saxony, Germany
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2005
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Azienda ULSS numero 13 Mirano
Mirano, Veneto, Italy
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2001
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Friedrich-Alexander Universität Erlangen-Nürnberg
Erlangen, Bavaria, Germany
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