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Franz-josef Neumann - One of the best experts on this subject based on the ideXlab platform.
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lCLINICAL INVESTIGATION l Percutaneous Peripheral Atherectomy of Femoropopliteal Stenoses Using a New-Generation Device: Six-Month Results From a Single-Center Experience
2016Co-Authors: Franz-josef NeumannAbstract:l l Purpose: To report the early and 6-month results after Atherectomy of femoropopliteal lesions using a new Atherectomy Device compatible with a 7-F sheath. Methods: Fifty-two patients (36 men; mean age 6767 years) with stable, chronic lower limb occlusive disease were enrolled prospectively in a study of percutaneous directional atherec-tomy using the SilverHawk Atherectomy Catheter. The 71 femoropopliteal stenoses were grouped for analysis according to pathology: 30 (42%) primary stenoses, 27 (38%) native vessel restenoses, and 14 (20%) in-stent restenoses. The overall average stenosis length was 48664 mm (range 10±300). There were more diabetics in the primary lesion cohort, whereas the lesion length of the in-stent restenoses was nearly twice as long as the other groups. Results: After Atherectomy alone, residual stenosis was #50 % in 68 (96%) lesions and #30 % in 54 (76%). Additional balloon angioplasty was used in 41 (58%) lesions, primarily to smooth the arterial contour; stents were implanted in 4 (6%) arteries. Acute results after Atherectomy and additional therapy were identical for the 3 groups (mean residual stenosis 15 % in primary lesions, 8 % in restenoses, and 14 % in in-stent lesions). At the beginnin
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lCLINICAL INVESTIGATION l Initial Clinical Experience With Percutaneous Atherectomy in the Infragenicular Arteries
2016Co-Authors: Endovasc J Ther, Thomas Zeller, Md Ulrich Frank, Md Karlheinz Buè Rgelin, Franz-josef NeumannAbstract:l l Purpose: To evaluate the ef®cacy and safety of a new Atherectomy Device for the treatment of infragenicular lesions in arteries with a reference diameter of at least 2.5 mm. Methods: Twenty-seven below-the-knee lesions in 17 patients (12 men; mean age 69612 years) with chronic peripheral arterial occlusive disease were treated with directional ath-erectomy. The target lesion was in the popliteal artery (segment 3) in 2 (7%) cases, the tibioperoneal trunk in 12 (44%), the peroneal artery in 8 (30%), the anterior tibial artery in 2 (7%), and the posterior tibial artery in 3 (11%). Six (22%) of the lesions were in-stent stenoses. The mean diameter stenosis was 87%69%, and the mean lesion length was 34624 mm. Results: All but 2 (7%) of the lesions could be treated successfully (residual stenosis,30%) with the Atherectomy catheter (93 % technical success) using an average of 562 (range 1± 10) passes of the Device. Six lesions (22%) were treated after predilation and 21 (78%) with primary Atherectomy. In 8 (30%) lesions, additional balloon angioplasty was performed. The 2 failures were in heavily calci®ed lesions through which the Device could not pass despite predilation. The mean diameter stenosis after Atherectomy was 14%622 % (range 0%±90%); after additional balloon angioplasty, the mean residual stenoses reduced to 12%621 % (range 0%±100%). One (6%) of the 2 patients who failed Atherectomy sustained a thrombotic occlusion of the target vessel. This complication was treated successfully with local lysis, but the vessel reoccluded 3 days later; a stent was implanted. The mean ankle-brachial index increased from 0.5060.27 to 0.8660.40 before discharge. Conclusions: Below-the-knee native vessel lesions and in-stent restenoses with a diameter of at least 2.5 mm can be treated successfully and safely with this new Atherectomy cath-eter. Additional balloon angioplasty was necessary in only a few cases
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percutaneous peripheral Atherectomy of femoropopliteal stenoses using a new generation Device six month results from a single center experience
Journal of Endovascular Therapy, 2004Co-Authors: Thomas Zeller, U Frank, Karlheinz Burgelin, Uwe Schwarzwalder, Aljoscha Rastan, Pietro Amantea, Christian Muller, Peterchristian Flugel, Franz-josef NeumannAbstract:Purpose:To report the early and 6-month results after Atherectomy of femoropopliteal lesions using a new Atherectomy Device compatible with a 7-F sheath.Methods:Fifty-two patients (36 men; mean age...
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midterm results after Atherectomy assisted angioplasty of below knee arteries with use of the silverhawk Device
Journal of Vascular and Interventional Radiology, 2004Co-Authors: Thomas Zeller, U Frank, Karlheinz Burgelin, Uwe Schwarzwalder, Aljoscha Rastan, Pietro Amantea, Christian Muller, Peterchristian Flugel, Hans Krankenberg, Franz-josef NeumannAbstract:PURPOSE Prospective evaluation of the 3-and 6-month results after Atherectomy of below-knee arterial lesions with a reference diameter of at least 2.0 mm with use of the Silverhawk Device MATERIALS AND METHODS Fifty-two below-knee lesions in 33 patients (61% men; mean age, 70 years ± 11) with chronic peripheral occlusive disease of the lower limbs were treated with directional Atherectomy. Target lesions were the popliteal artery (segment 3), n = 4 (8%); tibioperoneal trunk, n = 22 (42%); peroneal artery, n = 18 (34%); anterior tibial artery, n = 5 (10%); posterior tibial artery, n = 3 (6%); and in-stent lesions, n = 8 (16%). All interventions were performed via a 6-F sheath. The average degree of diameter stenosis was 89% ± 10% (range, 70%–100%; n = 12 [23%] occlusions) and the mean lesion length was 48 mm ± 28 RESULTS All but one lesion (2%) could be treated with the Atherectomy catheter. After additional balloon angioplasty, all but one lesion was treated, with a residual stenosis no greater than 30% (98%), with 7.2 passes per lesion ± 2.8 (range, 1–12) performed with the Device. Fifteen lesions (29%) were treated after predilation and 37 (71%) were treated with primary Atherectomy. In 15 lesions (29%), additional balloon angioplasty was performed, and two lesions required stent implantation as a result of dissection. The mean stenosis diameter after Atherectomy was 12% ± 18% (range, 0–100%). After additional therapy, the mean stenosis diameter was 6% ± 9% (range, 0%–30%). A residual stenosis no greater than 30% was achieved in 50 lesions (96%). The mean ankle-brachial index significantly increased from 0.46 ± 0.27 to 0.80 ± 0.34 before discharge and remained improved during follow-up. One procedural complication (3%) was observed in which an intermittent occlusion of the target vessel occurred after an unsuccessful attempt to cross the lesion with the Atherectomy Device; this was then treated successfully with local lysis. One patient with one treated lesion died during follow-up. The rates of restenosis of at least 70% (diagnosed by duplex ultrasonography) were 14% (seven of 51 lesions) after 3 months and 22% (11 of 51) after 6 months. The 3-month and 6-month cumulative event-free survival were 91% ± 4.1% and 76.9% ± 5.8% and the 3-month and 6-month cumulative patency rates were 98% ± 1.9% and 94.1% ± 3.3%, respectively CONCLUSION Below-knee native vessel lesions with a diameter of at least 2.0 mm can be treated with the Silverhawk catheter with a high success rate and a low complication rate. Midterm technical and clinical results are encouraging. Additional balloon angioplasty might be necessary in selected cases
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initial clinical experience with a new percutaneous peripheral Atherectomy Device for the treatment of femoro popliteal stenoses
Rofo-fortschritte Auf Dem Gebiet Der Rontgenstrahlen Und Der Bildgebenden Verfahren, 2004Co-Authors: Thomas Zeller, B. Reimers, H Krankenberg, U Frank, Karlheinz Burgelin, Uwe Schwarzwalder, Franz-josef NeumannAbstract:BACKGROUND Evaluation of the efficacy and safety of a new 7F-Atherectomy Device (30-day endpoint) for the treatment of short and mid-length arterial lesions with a reference diameter of 2.5-7 mm. MATERIAL AND METHODS Fifty-eight femoto-popliteal stenoses in 46 patients (67% male, mean age 66 +/- 9 years) with chronic peripheral occlusive disease of the lower limbs [Rutherford stage 2: n = 13 (28%); stage 3: n = 29 (63%), stage 4: 2 (4%), stage 5: n = 2 (4%)], were treated with directional Atherectomy. Target lesion characteristics: Common femoral artery: n = 1 (2%), superficial femoral artery: n = 47 (81%); popliteal artery, n = 10 (17%); in stent n = 3 (5 %). Thirty (65 %) of the interventions were performed using an antegrade approach, 16 (35%) interventions in cross-over technique. Mean degree of stenosis was 83 +/- 11 mm, mean length of lesion was 37 +/- 37 mm. RESULTS 6.5 +/- 2 (4-10) passes of the lesion were performed with the catheter. Three lesions were treated after predilatation, 55 (95%) interventions as primary Atherectomy. In 31/58 lesions (53%) additional balloon angioplasty was performed, in 1 lesion (2%) additional stent placement was needed. The mean degree of stenosis after Atherectomy was reduced to 29 +/- 20% (0-60%) after additional balloon angioplasty, it was 11 +/- 10% (0-30 %). A residual stenosis of < 50% after plain Atherectomy was achieved in 55 (95%) lesions, of < 30% in 49 (84%). COMPLICATIONS 3 (6.5%) cases of embolism of debris were detected and treated successfully by aspiration. The mean ankle-brachial index increased from 0.62 +/- 0.12 to 0.92 +/- 0.36 before discharge, and to 0.86 +/- 0.17 after 30 days. Rutherford stage after 30 days: stage 0: n = 038 (83%); Stage 1: n = 4 (8%); Stage 2: n = 3 (6%); Stage 5: n = 1 (2%). CONCLUSION Lesions up to 8 cm in length of the femoropopliteal arteries can be treated successfully in most cases with the new Atherectomy catheter. Embolism, the only complication that occurred, can be avoided by cleaning the nose cone after at least 4 passes of the lesion.
Nicolas W. Shammas - One of the best experts on this subject based on the ideXlab platform.
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acute and 30 day safety and effectiveness evaluation of eximo medical s b laser a novel Atherectomy Device in subjects affected with infrainguinal peripheral arterial disease results of the ex pad 03 trial
Cardiovascular Revascularization Medicine, 2020Co-Authors: Nicolas W. Shammas, Pradeep Chandra, Marianne Brodmann, Barry Weinstock, Gino Sedillo, Ian Cawich, Antonio Micari, Arthur Lee, Chris Metzger, Luis Mariano PalenaAbstract:Abstract Background B-Laser™ is a novel Atherectomy Device that uses a solid-state third harmonic pulsed Nd:YAG laser with an output of 355 nm. Early data showed that the B-Laser™ is safe in treating a broad range of infrainguinal arterial lesions . We present the results of the EX-PAD-03 U.S. pivotal trial of the EXIMO B-Laser™. Methods EX-PAD-03 is a prospective, single-arm, multi-center, international, open-label, clinical study. The study enrolled patients in the United States and Europe. The primary efficacy endpoint was the average reduction in residual diameter stenosis of >20% from baseline prior to any adjunctive therapy achieved by the B-Laser™ catheter alone. The primary safety endpoint was freedom from major adverse events (MAEs) defined as: unplanned target limb amputation above the ankle, clinically driven target lesion revascularization (CD-TLR) and cardiovascular related death. Results A total of 97 subjects (107 lesions) were enrolled. Mean age was 70.5 years and 51% were males. Diabetes mellitus was present in 42.3%. Mean lesion length was 53.96 ± 43.18 mm and 26.2% had severe calcification. Lesions were de novo (79.4%), followed by in-stent restenosis (ISR) (15.9%) and non in-stent restenosis (4.7%). The mean percent stenosis at the target lesion as assessed by the Core lab was 85.7% ± 12.2 (femoro-popliteal 85.6 ± 12.8%; tibials 86.0 ± 9.6%). Post B-Laser™ and prior to adjunctive therapy, the mean percent stenosis at the target lesion was 52.1%. This resulted in a mean reduction from baseline to post B-Laser™ of 33.6% ± 14.2% meeting the primary efficacy endpoint goal. The freedom from MAE through the 30-day follow-up period after intervention was 98.9%. Per Core lab, there was no Device-related distal embolization , dissections that required additional therapy, perforation, or pseudoaneurysm . Bailout stenting was 0.9%. A significant improvement from baseline in ABI (0.24 ± 0.18), Rutherford category (−1.79 ± 1.22) and WIQ (0.26 ± 0.28) were noted at 1 month. There was no target lesion revascularization and the patency was 96.8% by duplex ultrasound criteria at 30-day follow up. Conclusion The Eximo B-Laser™ is effective and safe in ablating atherosclerotic and restenotic tissue for both above and below the knee obstructive arterial disease . The Device has a high safety profile including a low risk of distal embolization.
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crt 200 06 acute and 30 day safety and effectiveness evaluation of eximo medical s b laser a novel Atherectomy Device in subjects affected with infrainguinal peripheral arterial disease results of the ex pad 03 trial
Jacc-cardiovascular Interventions, 2019Co-Authors: Nicolas W. Shammas, Pradeep Chandra, Marianne Brodmann, Barry Weinstock, Gino Sedillo, Ian Cawich, Antonio Micari, Arthur Lee, Chris Metzger, Luis Mariano PalenaAbstract:B-Laser™ is a novel Atherectomy Device that uses a solid-state third harmonic pulsed Nd:YAG laser with an output of 355 nm. Early data showed that the B-Laser™ is safe in treating a broad range of infrainguinal arterial lesions. We present the results of the EX-PAD-03 U.S. pivotal trial of the
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two blades up runs using the jetstream navitus Atherectomy Device achieve optimal tissue debulking of nonocclusive in stent restenosis observations from a porcine stent balloon injury model
Journal of Endovascular Therapy, 2015Co-Authors: Nicolas W. Shammas, Nicole Aasen, Lynn Bailey, Jay Budrewicz, Trent Farago, Gary JarvisAbstract:Purpose: To determine the number of runs with blades up (BU) using the JetStream Navitus to achieving optimal debulking in a porcine model of femoropopliteal artery in-stent restenosis (ISR). Methods: In this porcine model, 8 limbs were implanted with overlapping nitinol self-expanding stents. ISR was treated initially with 2 blades-down (BD) runs followed by 4 BU runs (BU1 to BU4). Quantitative vascular angiography (QVA) was performed at baseline, after 2 BD runs, and after each BU run. Plaque surface area and percent stenosis within the treated stented segment were measured. Intravascular ultrasound (IVUS) was used to measure minimum lumen area (MLA) and determine IVUS-derived plaque surface area. Results: QVA showed that plaque surface area was significantly reduced between baseline (83.9%±14.8%) and 2 BD (67.7%±17.0%, p=0.005) and BU1 (55.4%±9.0%, p=0.005) runs, and between BU1 and BU2 runs (50.7%±9.7%, p<0.05). Percent stenosis behaved similarly with no further reduction after BU2. There were no furt...
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Effective endovascular treatment of calcified femoropopliteal disease with directional Atherectomy and distal embolic protection: Final results of the DEFINITIVE Ca++ trial
Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions, 2014Co-Authors: David H. Roberts, Prakash Krishnan, Khusrow Niazi, William Miller, Roger Gammon, Theodore Schreiber, Nicolas W. Shammas, Daniel G. ClairAbstract:Objectives The purpose of the DEFINITIVE Ca++ study was to evaluate the safety and effectiveness of directional Atherectomy and distal embolic protection, used together to treat moderate to severely calcified femoropopliteal lesions. Background Despite advances in endovascular treatment modalities, treatment of calcified lesions remains a challenge. Methods A total of 133 subjects with 168 moderate to severely calcified lesions were enrolled. Lesions were treated with directional Atherectomy Devices, coupled with distal embolic protection. Results The 30-day freedom from MAE rate was 93.1%. Per angiographic core laboratory assessment, the primary effectiveness endpoint (≤50% residual diameter stenosis) was achieved in 92.0% (lower confidence bound of 87.6%) of lesions. By core lab analysis, these results did not achieve the success criteria (90%) for the primary effectiveness objective. Per site assessment, the objective was met with the endpoint being achieved in 97.0% (lower confidence bound 93.8%). A mean residual diameter stenosis of 33.3% was achieved with the directional Atherectomy Device. This was further decreased to 24.1% with the use of adjunctive therapy. The proportion of asymptomatic subjects [Rutherford Clinical Category (RCC) = 0] increased from 0% at baseline to 52.3% at the 30-day follow-up visit. In total, 88.5% of subjects experienced an improvement of one or more Rutherford categories. Conclusions The results of the DEFINITIVE Ca++ study demonstrate that the SilverHawk™ and TurboHawk™ Atherectomy Devices are safe and effective in the endovascular treatment of moderate to severely calcified lesions in the superficial femoral and/or popliteal arteries when used with the SpiderFX™ distal embolic protection Device. © 2014 Wiley Periodicals, Inc.
Thomas Zeller - One of the best experts on this subject based on the ideXlab platform.
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lCLINICAL INVESTIGATION l Initial Clinical Experience With Percutaneous Atherectomy in the Infragenicular Arteries
2016Co-Authors: Endovasc J Ther, Thomas Zeller, Md Ulrich Frank, Md Karlheinz Buè Rgelin, Franz-josef NeumannAbstract:l l Purpose: To evaluate the ef®cacy and safety of a new Atherectomy Device for the treatment of infragenicular lesions in arteries with a reference diameter of at least 2.5 mm. Methods: Twenty-seven below-the-knee lesions in 17 patients (12 men; mean age 69612 years) with chronic peripheral arterial occlusive disease were treated with directional ath-erectomy. The target lesion was in the popliteal artery (segment 3) in 2 (7%) cases, the tibioperoneal trunk in 12 (44%), the peroneal artery in 8 (30%), the anterior tibial artery in 2 (7%), and the posterior tibial artery in 3 (11%). Six (22%) of the lesions were in-stent stenoses. The mean diameter stenosis was 87%69%, and the mean lesion length was 34624 mm. Results: All but 2 (7%) of the lesions could be treated successfully (residual stenosis,30%) with the Atherectomy catheter (93 % technical success) using an average of 562 (range 1± 10) passes of the Device. Six lesions (22%) were treated after predilation and 21 (78%) with primary Atherectomy. In 8 (30%) lesions, additional balloon angioplasty was performed. The 2 failures were in heavily calci®ed lesions through which the Device could not pass despite predilation. The mean diameter stenosis after Atherectomy was 14%622 % (range 0%±90%); after additional balloon angioplasty, the mean residual stenoses reduced to 12%621 % (range 0%±100%). One (6%) of the 2 patients who failed Atherectomy sustained a thrombotic occlusion of the target vessel. This complication was treated successfully with local lysis, but the vessel reoccluded 3 days later; a stent was implanted. The mean ankle-brachial index increased from 0.5060.27 to 0.8660.40 before discharge. Conclusions: Below-the-knee native vessel lesions and in-stent restenoses with a diameter of at least 2.5 mm can be treated successfully and safely with this new Atherectomy cath-eter. Additional balloon angioplasty was necessary in only a few cases
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percutaneous rotational and aspiration Atherectomy in infrainguinal peripheral arterial occlusive disease a multicenter pilot study
Journal of Endovascular Therapy, 2007Co-Authors: Thomas Zeller, U Frank, Karlheinz Burgelin, Aljoscha Rastan, Hans Krankenberg, Sebastian Sixt, Andrej Schmidt, Thilo Tubler, Thomas Schwarz, Uwe SchwarzwalderAbstract:PURPOSE To report a safety and efficacy study of the first rotational aspiration Atherectomy system (Pathway PV) for the treatment of arterial lesions below the femoral bifurcation. METHODS From December 2005 to February 2006, 15 patients (9 men; mean age 71+/-9 years) with Rutherford stage 2 to 5 lower limb ischemia were enrolled at 3 study sites. Target lesions were in the superficial femoral (n = 7, 47%), popliteal (n = 7, 47%), and posterior tibial (n = 1, 6%) arteries. Mean diameter stenosis was 97%+/-10%; mean lesion length was 61+/-62 mm (range 5-250). The primary study endpoint was the 30-day serious adverse event (SAE) rate. RESULTS Interventional success (residual stenosis <30%) was achieved in all lesions (100%). Stand alone Atherectomy was performed in 6 (40%) patients, adjunctive balloon angioplasty in 7 (47%), and stenting/endografting in 2 (13%). The SAE rate at 30 days was 20% (3/15), including 1 perforation due to an unrecognized displacement of the guidewire (sealed with an endograft), 1 false aneurysm at the puncture site (successful duplex-guided compression therapy), and 1 dissection in conjunction with a distal embolism (stent implantation and aspiration thrombectomy). Primary patency rates measured by duplex ultrasound at 1 and 6 months were 100% and 73%, respectively; the TLR rate was 0% after 6 months. The ankle-brachial index increased significantly from 0.54+/-0.3 at baseline to 0.89+/-0.16, 0.88+/-0.19, and 0.81+/-0.20 (p<0.05) at discharge, 1 month, and 6 months, respectively. Mean Rutherford categories were 2.92+/-1.19 (range 1-5), 0.64+/-1.12 (range 0-1), and 0.83+/-1.33 (range 0-3) at the same time points (p<0.05). CONCLUSION The application of this new Atherectomy Device was feasible in all cases. The serious adverse event rate was moderate; however, all events were solved during the index procedure. The 0% 6-month TLR rate is promising.
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percutaneous peripheral Atherectomy of femoropopliteal stenoses using a new generation Device six month results from a single center experience
Journal of Endovascular Therapy, 2004Co-Authors: Thomas Zeller, U Frank, Karlheinz Burgelin, Uwe Schwarzwalder, Aljoscha Rastan, Pietro Amantea, Christian Muller, Peterchristian Flugel, Franz-josef NeumannAbstract:Purpose:To report the early and 6-month results after Atherectomy of femoropopliteal lesions using a new Atherectomy Device compatible with a 7-F sheath.Methods:Fifty-two patients (36 men; mean age...
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midterm results after Atherectomy assisted angioplasty of below knee arteries with use of the silverhawk Device
Journal of Vascular and Interventional Radiology, 2004Co-Authors: Thomas Zeller, U Frank, Karlheinz Burgelin, Uwe Schwarzwalder, Aljoscha Rastan, Pietro Amantea, Christian Muller, Peterchristian Flugel, Hans Krankenberg, Franz-josef NeumannAbstract:PURPOSE Prospective evaluation of the 3-and 6-month results after Atherectomy of below-knee arterial lesions with a reference diameter of at least 2.0 mm with use of the Silverhawk Device MATERIALS AND METHODS Fifty-two below-knee lesions in 33 patients (61% men; mean age, 70 years ± 11) with chronic peripheral occlusive disease of the lower limbs were treated with directional Atherectomy. Target lesions were the popliteal artery (segment 3), n = 4 (8%); tibioperoneal trunk, n = 22 (42%); peroneal artery, n = 18 (34%); anterior tibial artery, n = 5 (10%); posterior tibial artery, n = 3 (6%); and in-stent lesions, n = 8 (16%). All interventions were performed via a 6-F sheath. The average degree of diameter stenosis was 89% ± 10% (range, 70%–100%; n = 12 [23%] occlusions) and the mean lesion length was 48 mm ± 28 RESULTS All but one lesion (2%) could be treated with the Atherectomy catheter. After additional balloon angioplasty, all but one lesion was treated, with a residual stenosis no greater than 30% (98%), with 7.2 passes per lesion ± 2.8 (range, 1–12) performed with the Device. Fifteen lesions (29%) were treated after predilation and 37 (71%) were treated with primary Atherectomy. In 15 lesions (29%), additional balloon angioplasty was performed, and two lesions required stent implantation as a result of dissection. The mean stenosis diameter after Atherectomy was 12% ± 18% (range, 0–100%). After additional therapy, the mean stenosis diameter was 6% ± 9% (range, 0%–30%). A residual stenosis no greater than 30% was achieved in 50 lesions (96%). The mean ankle-brachial index significantly increased from 0.46 ± 0.27 to 0.80 ± 0.34 before discharge and remained improved during follow-up. One procedural complication (3%) was observed in which an intermittent occlusion of the target vessel occurred after an unsuccessful attempt to cross the lesion with the Atherectomy Device; this was then treated successfully with local lysis. One patient with one treated lesion died during follow-up. The rates of restenosis of at least 70% (diagnosed by duplex ultrasonography) were 14% (seven of 51 lesions) after 3 months and 22% (11 of 51) after 6 months. The 3-month and 6-month cumulative event-free survival were 91% ± 4.1% and 76.9% ± 5.8% and the 3-month and 6-month cumulative patency rates were 98% ± 1.9% and 94.1% ± 3.3%, respectively CONCLUSION Below-knee native vessel lesions with a diameter of at least 2.0 mm can be treated with the Silverhawk catheter with a high success rate and a low complication rate. Midterm technical and clinical results are encouraging. Additional balloon angioplasty might be necessary in selected cases
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initial clinical experience with a new percutaneous peripheral Atherectomy Device for the treatment of femoro popliteal stenoses
Rofo-fortschritte Auf Dem Gebiet Der Rontgenstrahlen Und Der Bildgebenden Verfahren, 2004Co-Authors: Thomas Zeller, B. Reimers, H Krankenberg, U Frank, Karlheinz Burgelin, Uwe Schwarzwalder, Franz-josef NeumannAbstract:BACKGROUND Evaluation of the efficacy and safety of a new 7F-Atherectomy Device (30-day endpoint) for the treatment of short and mid-length arterial lesions with a reference diameter of 2.5-7 mm. MATERIAL AND METHODS Fifty-eight femoto-popliteal stenoses in 46 patients (67% male, mean age 66 +/- 9 years) with chronic peripheral occlusive disease of the lower limbs [Rutherford stage 2: n = 13 (28%); stage 3: n = 29 (63%), stage 4: 2 (4%), stage 5: n = 2 (4%)], were treated with directional Atherectomy. Target lesion characteristics: Common femoral artery: n = 1 (2%), superficial femoral artery: n = 47 (81%); popliteal artery, n = 10 (17%); in stent n = 3 (5 %). Thirty (65 %) of the interventions were performed using an antegrade approach, 16 (35%) interventions in cross-over technique. Mean degree of stenosis was 83 +/- 11 mm, mean length of lesion was 37 +/- 37 mm. RESULTS 6.5 +/- 2 (4-10) passes of the lesion were performed with the catheter. Three lesions were treated after predilatation, 55 (95%) interventions as primary Atherectomy. In 31/58 lesions (53%) additional balloon angioplasty was performed, in 1 lesion (2%) additional stent placement was needed. The mean degree of stenosis after Atherectomy was reduced to 29 +/- 20% (0-60%) after additional balloon angioplasty, it was 11 +/- 10% (0-30 %). A residual stenosis of < 50% after plain Atherectomy was achieved in 55 (95%) lesions, of < 30% in 49 (84%). COMPLICATIONS 3 (6.5%) cases of embolism of debris were detected and treated successfully by aspiration. The mean ankle-brachial index increased from 0.62 +/- 0.12 to 0.92 +/- 0.36 before discharge, and to 0.86 +/- 0.17 after 30 days. Rutherford stage after 30 days: stage 0: n = 038 (83%); Stage 1: n = 4 (8%); Stage 2: n = 3 (6%); Stage 5: n = 1 (2%). CONCLUSION Lesions up to 8 cm in length of the femoropopliteal arteries can be treated successfully in most cases with the new Atherectomy catheter. Embolism, the only complication that occurred, can be avoided by cleaning the nose cone after at least 4 passes of the lesion.
Martin B Leon - One of the best experts on this subject based on the ideXlab platform.
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optimal directional coronary Atherectomy final results of the optimal Atherectomy restenosis study oars
Circulation, 1998Co-Authors: Charles A Simonton, Donald S Baim, Peter J. Fitzgerald, Martin B Leon, Tomoaki Hinohara, K M Kent, Robert M Bersin, B H Wilson, G S Mintz, Paul G. YockAbstract:Background—Previous clinical trials of directional coronary Atherectomy (DCA) have failed to show significant improvement in early or late outcomes compared with balloon angioplasty (PTCA). The present study tested the hypothesis that more aggressive “optimal” Atherectomy could be performed safely to produce larger initial lumen diameters and a lower late restenosis rate. Methods and Results—The present study was a prospective multicenter registry of consecutive patients undergoing optimal DCA of de novo or restenotic lesions in 3.0- to 4.5-mm native coronary arteries. Optimal DCA was defined as using a 7F Atherectomy Device and adjunctive PTCA if necessary to achieve a <15% residual stenosis. Six-month angiographic and 1-year clinical follow-up was planned in all patients. A total of 199 patients with 213 lesions met eligibility criteria for enrollment. Short-term procedural success was achieved in 97.5%, with a major complication rate (death, emergency bypass surgery, or Q-wave myocardial infarction [MI...
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Preliminary experience with adjunct directional coronary Atherectomy after high-speed rotational Atherectomy in the treatment of calcific coronary artery disease
The American journal of cardiology, 1993Co-Authors: Gary S. Mintz, Jeffrey J Popma, Augusto D. Richard, Kenneth M. Kent, Lowell F. Satler, Martin B LeonAbstract:A high-speed rotational Atherectomy was performed followed by adjunct directional Atherectomy in 10 patients with symptomatic coronary artery disease and calcified target lesions and the results were evaluated using quantitative coronary arteriography and intravascular ultrasound. Target lesion calcium is common in obstructive coronary artery disease. High-speed rotational coronary Atherectomy preferentially abrades noncompliant atherosclerotic plaque material, especially calcium, but often requires adjunct balloon angioplasty to achieve optimal lumen dimensions. Directional coronary Atherectomy has limited efficacy in heavily calcified plaque; usually, it is a definitive primary procedure in large arteries with noncalcified target lesions. Neither of these Devices alone is effective in treating calcified target lesions in large coronary arteries. Before intervention, after rotational and adjunct directional Atherectomy, these measurements were obtained: quantitative coronary arteriographic measurements of minimal lumen diameter and percent diameter stenosis and intravascular ultrasound measurements of external elastic membrane, lumen, and plaque + media crosssectional areas; percent cross-sectional narrowing; minimal lumen diameter; and target-lesion arc of calcium. With use of quantitative coronary arteriography, the preintervention minimal lumen diameter measured 0.7 ± 0.4 mm, increased to 1.5 ± 0.5 mm after rotational Atherectomy (p = 0.0013) and to 2.5 ± 0.3 mm after adjunct directional Atherectomy (p < 0.001). The preintervention percent diameter stenosis measured 78 ± 15%, decreased to 50 ± 17% after rotational Atherectomy (p = 0.0011), and to 17 ± 11% (p < 0.001) after adjunct directional coronary Atherectomy. The 9 patients studied by intravascular ultrasound had arcs of target lesion calcification that measured 271 ± 92 ° before intervention, decreased to 210 ± 120 ° after rotational Atherectomy (p = 0.046) and to 163 ± 122 ° after adjunct directional Atherectomy (p = 0.0015), with distinct directional Atherectomy cuts into calcium. Before intervention, target lesion external elastic membrane area measured 20.4 ± 2.3 mm2, lumen area measured 1.5 ± 0.6 mm2, plaque + media area measured 18.9 ± 2.3 mm2, and percent cross-sectional narrowing measured 93 ± 3. After rotational Atherectomy, target lesion external elastic membrane area measured 21.2 ± 2.3 mm2 (p = NS), lumen area increased to 4.4 ± 1.0 mm2 (p < 0.001), plaque + media area decreased to 16.8 ± 2.8 mm2 (p = 0.072), and percent cross-sectional narrowing decreased to 79 ± 7 (p = 0.0024). After adjunct directional Atherectomy, target lesion external elastic membrane area measured 23.5 ± 2.9 mm2 (p = NS), lumen area increased further to 7.7 ± 1.2 mm2 (p < 0.001), plaque + media area decreased further to 15.8 ± 3.0 mm2 (p = 0.063), and percent cross-sectional narrowing decreased even more, to 67 ± 6 (p < 0.001). Rotational Atherectomy appears to alter the calcified plaque to render it susceptible to the directional Atherectomy Device. Thus, there seems to be a synergistic relation between high-speed rotational and adjunct directional Atherectomy in treating calcified coronary artery target lesions.
Uwe Schwarzwalder - One of the best experts on this subject based on the ideXlab platform.
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percutaneous rotational and aspiration Atherectomy in infrainguinal peripheral arterial occlusive disease a multicenter pilot study
Journal of Endovascular Therapy, 2007Co-Authors: Thomas Zeller, U Frank, Karlheinz Burgelin, Aljoscha Rastan, Hans Krankenberg, Sebastian Sixt, Andrej Schmidt, Thilo Tubler, Thomas Schwarz, Uwe SchwarzwalderAbstract:PURPOSE To report a safety and efficacy study of the first rotational aspiration Atherectomy system (Pathway PV) for the treatment of arterial lesions below the femoral bifurcation. METHODS From December 2005 to February 2006, 15 patients (9 men; mean age 71+/-9 years) with Rutherford stage 2 to 5 lower limb ischemia were enrolled at 3 study sites. Target lesions were in the superficial femoral (n = 7, 47%), popliteal (n = 7, 47%), and posterior tibial (n = 1, 6%) arteries. Mean diameter stenosis was 97%+/-10%; mean lesion length was 61+/-62 mm (range 5-250). The primary study endpoint was the 30-day serious adverse event (SAE) rate. RESULTS Interventional success (residual stenosis <30%) was achieved in all lesions (100%). Stand alone Atherectomy was performed in 6 (40%) patients, adjunctive balloon angioplasty in 7 (47%), and stenting/endografting in 2 (13%). The SAE rate at 30 days was 20% (3/15), including 1 perforation due to an unrecognized displacement of the guidewire (sealed with an endograft), 1 false aneurysm at the puncture site (successful duplex-guided compression therapy), and 1 dissection in conjunction with a distal embolism (stent implantation and aspiration thrombectomy). Primary patency rates measured by duplex ultrasound at 1 and 6 months were 100% and 73%, respectively; the TLR rate was 0% after 6 months. The ankle-brachial index increased significantly from 0.54+/-0.3 at baseline to 0.89+/-0.16, 0.88+/-0.19, and 0.81+/-0.20 (p<0.05) at discharge, 1 month, and 6 months, respectively. Mean Rutherford categories were 2.92+/-1.19 (range 1-5), 0.64+/-1.12 (range 0-1), and 0.83+/-1.33 (range 0-3) at the same time points (p<0.05). CONCLUSION The application of this new Atherectomy Device was feasible in all cases. The serious adverse event rate was moderate; however, all events were solved during the index procedure. The 0% 6-month TLR rate is promising.
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percutaneous peripheral Atherectomy of femoropopliteal stenoses using a new generation Device six month results from a single center experience
Journal of Endovascular Therapy, 2004Co-Authors: Thomas Zeller, U Frank, Karlheinz Burgelin, Uwe Schwarzwalder, Aljoscha Rastan, Pietro Amantea, Christian Muller, Peterchristian Flugel, Franz-josef NeumannAbstract:Purpose:To report the early and 6-month results after Atherectomy of femoropopliteal lesions using a new Atherectomy Device compatible with a 7-F sheath.Methods:Fifty-two patients (36 men; mean age...
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midterm results after Atherectomy assisted angioplasty of below knee arteries with use of the silverhawk Device
Journal of Vascular and Interventional Radiology, 2004Co-Authors: Thomas Zeller, U Frank, Karlheinz Burgelin, Uwe Schwarzwalder, Aljoscha Rastan, Pietro Amantea, Christian Muller, Peterchristian Flugel, Hans Krankenberg, Franz-josef NeumannAbstract:PURPOSE Prospective evaluation of the 3-and 6-month results after Atherectomy of below-knee arterial lesions with a reference diameter of at least 2.0 mm with use of the Silverhawk Device MATERIALS AND METHODS Fifty-two below-knee lesions in 33 patients (61% men; mean age, 70 years ± 11) with chronic peripheral occlusive disease of the lower limbs were treated with directional Atherectomy. Target lesions were the popliteal artery (segment 3), n = 4 (8%); tibioperoneal trunk, n = 22 (42%); peroneal artery, n = 18 (34%); anterior tibial artery, n = 5 (10%); posterior tibial artery, n = 3 (6%); and in-stent lesions, n = 8 (16%). All interventions were performed via a 6-F sheath. The average degree of diameter stenosis was 89% ± 10% (range, 70%–100%; n = 12 [23%] occlusions) and the mean lesion length was 48 mm ± 28 RESULTS All but one lesion (2%) could be treated with the Atherectomy catheter. After additional balloon angioplasty, all but one lesion was treated, with a residual stenosis no greater than 30% (98%), with 7.2 passes per lesion ± 2.8 (range, 1–12) performed with the Device. Fifteen lesions (29%) were treated after predilation and 37 (71%) were treated with primary Atherectomy. In 15 lesions (29%), additional balloon angioplasty was performed, and two lesions required stent implantation as a result of dissection. The mean stenosis diameter after Atherectomy was 12% ± 18% (range, 0–100%). After additional therapy, the mean stenosis diameter was 6% ± 9% (range, 0%–30%). A residual stenosis no greater than 30% was achieved in 50 lesions (96%). The mean ankle-brachial index significantly increased from 0.46 ± 0.27 to 0.80 ± 0.34 before discharge and remained improved during follow-up. One procedural complication (3%) was observed in which an intermittent occlusion of the target vessel occurred after an unsuccessful attempt to cross the lesion with the Atherectomy Device; this was then treated successfully with local lysis. One patient with one treated lesion died during follow-up. The rates of restenosis of at least 70% (diagnosed by duplex ultrasonography) were 14% (seven of 51 lesions) after 3 months and 22% (11 of 51) after 6 months. The 3-month and 6-month cumulative event-free survival were 91% ± 4.1% and 76.9% ± 5.8% and the 3-month and 6-month cumulative patency rates were 98% ± 1.9% and 94.1% ± 3.3%, respectively CONCLUSION Below-knee native vessel lesions with a diameter of at least 2.0 mm can be treated with the Silverhawk catheter with a high success rate and a low complication rate. Midterm technical and clinical results are encouraging. Additional balloon angioplasty might be necessary in selected cases
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initial clinical experience with a new percutaneous peripheral Atherectomy Device for the treatment of femoro popliteal stenoses
Rofo-fortschritte Auf Dem Gebiet Der Rontgenstrahlen Und Der Bildgebenden Verfahren, 2004Co-Authors: Thomas Zeller, B. Reimers, H Krankenberg, U Frank, Karlheinz Burgelin, Uwe Schwarzwalder, Franz-josef NeumannAbstract:BACKGROUND Evaluation of the efficacy and safety of a new 7F-Atherectomy Device (30-day endpoint) for the treatment of short and mid-length arterial lesions with a reference diameter of 2.5-7 mm. MATERIAL AND METHODS Fifty-eight femoto-popliteal stenoses in 46 patients (67% male, mean age 66 +/- 9 years) with chronic peripheral occlusive disease of the lower limbs [Rutherford stage 2: n = 13 (28%); stage 3: n = 29 (63%), stage 4: 2 (4%), stage 5: n = 2 (4%)], were treated with directional Atherectomy. Target lesion characteristics: Common femoral artery: n = 1 (2%), superficial femoral artery: n = 47 (81%); popliteal artery, n = 10 (17%); in stent n = 3 (5 %). Thirty (65 %) of the interventions were performed using an antegrade approach, 16 (35%) interventions in cross-over technique. Mean degree of stenosis was 83 +/- 11 mm, mean length of lesion was 37 +/- 37 mm. RESULTS 6.5 +/- 2 (4-10) passes of the lesion were performed with the catheter. Three lesions were treated after predilatation, 55 (95%) interventions as primary Atherectomy. In 31/58 lesions (53%) additional balloon angioplasty was performed, in 1 lesion (2%) additional stent placement was needed. The mean degree of stenosis after Atherectomy was reduced to 29 +/- 20% (0-60%) after additional balloon angioplasty, it was 11 +/- 10% (0-30 %). A residual stenosis of < 50% after plain Atherectomy was achieved in 55 (95%) lesions, of < 30% in 49 (84%). COMPLICATIONS 3 (6.5%) cases of embolism of debris were detected and treated successfully by aspiration. The mean ankle-brachial index increased from 0.62 +/- 0.12 to 0.92 +/- 0.36 before discharge, and to 0.86 +/- 0.17 after 30 days. Rutherford stage after 30 days: stage 0: n = 038 (83%); Stage 1: n = 4 (8%); Stage 2: n = 3 (6%); Stage 5: n = 1 (2%). CONCLUSION Lesions up to 8 cm in length of the femoropopliteal arteries can be treated successfully in most cases with the new Atherectomy catheter. Embolism, the only complication that occurred, can be avoided by cleaning the nose cone after at least 4 passes of the lesion.