The Experts below are selected from a list of 360 Experts worldwide ranked by ideXlab platform

Johannes Lammer - One of the best experts on this subject based on the ideXlab platform.

  • heparin bonded covered Stents versus bare metal Stents for complex femoropopliteal artery lesions the randomized viastar trial viabahn endoprosthesis with propaten bioactive surface via versus bare Nitinol Stent in the treatment of long lesions in su
    Journal of the American College of Cardiology, 2013
    Co-Authors: Johannes Lammer, Philipp J Schaefer, Stefan Muellerhuelsbeck, T Rand, Klaus A. Hausegger, Manfred Gschwendtner, Martin Funovics, Florian Wolf, Thomas Zeller, Aljoscha Rastan
    Abstract:

    Objectives The hypothesis that endovascular treatment with covered Stents has equal risks but higher efficacy than bare-metal Stents (BMS) in long femoropopliteal artery disease was tested. Background Although endovascular treatment of short superficial femoral artery lesions revealed excellent results, efficacy in long lesions remains unsatisfactory. Methods In a prospective, randomized, single-blind, multicenter study, 141 patients with symptomatic peripheral arterial disease were assigned to treatment with heparin-bonded, covered Stents (Viabahn 72 patients) or BMS (69 patients). Clinical outcomes and patency rates were assessed at 1, 6, and 12 months. Results Mean ± SD lesion length was 19.0 ± 6.3 cm in the Viabahn group and 17.3 ± 6.6 cm in the BMS group. Major complications within 30 days were observed in 1.4%. The 12-month primary patency rates in the Viabahn and BMS groups were: intention-to-treat (ITT) 70.9% (95% confidence interval [CI]: 0.58 to 0.80) and 55.1% (95% CI: 0.41 to 0.67) (log-rank test p = 0.11); treatment per-protocol (TPP) 78.1% (95% CI: 0.65 to 0.86) and 53.5% (95% CI: 0.39 to 0.65) (hazard ratio: 2.23 [95% CI: 1.14 to 4.34) (log-rank test p = 0.009). In lesions ≥20 cm, (TransAtlantic Inter-Society Consensus class D), the 12-month patency rate was significantly longer in VIA patients in the ITT analysis (VIA 71.3% vs. BMS 36.8%; p = 0.01) and the TPP analysis (VIA 73.3% vs. BMS 33.3%; p = 0.004). Freedom from target lesion revascularization was 84.6% for Viabahn (95% CI: 0.72 to 0.91) versus 77.0% for BMS (95% CI: 0.63 to 0.85; p = 0.37). The ankle-brachial index in the Viabahn group significantly increased to 0.94 ± 0.23 compared with the BMS group (0.85 ± 0.23; p  Conclusions This randomized trial in symptomatic patients with peripheral arterial disease who underwent endovascular treatment for long femoropopliteal lesions demonstrated significant clinical and patency benefits for heparin-bonded covered Stents compared with BMS in lesions ≥20 cm and for all lesions in the TPP analysis. In the ITT analysis for all lesions, which was flawed by major protocol deviations in 8.5% of the patients, the difference was not significant. (GORE VIABAHN® endoprosthesis with bioactive propaten surface versus bare Nitinol Stent in the treatment of TASC B, C and D lesions in superficial femoral artery occlusive disease; ISRCTN48164244 )

  • Nitinol Stent implantation versus balloon angioplasty for lesions in the superficial femoral artery and proximal popliteal arteryclinical perspective
    Circulation-cardiovascular Interventions, 2010
    Co-Authors: John R Laird, Johannes Lammer, Gary M Ansel, Dierk Scheinert, Barry T Katzen, Maurice Buchbinder, Rajesh Dave, Alexandra J Lansky, Jeffrey P Carpenter, Ecaterina Cristea
    Abstract:

    Background— Controversy still exists regarding the best endovascular treatment strategy for patients with symptomatic disease of the superficial femoral artery. There are conflicting data regarding the benefits of superficial femoral artery Stenting and the role of primary Stenting compared with balloon angioplasty with provisional Stent implantation. Methods and Results— A total of 206 patients from 24 centers in the United States and Europe with obstructive lesions of the superficial femoral artery and proximal popliteal artery and intermittent claudication were randomized to implantation of Nitinol Stents or percutaneous transluminal angioplasty. The mean total lesion length was 71 mm for the Stent group and 64 mm for the angioplasty group. Acute lesion success (<30%residual stenosis) was superior for the Stent group compared with the angioplasty group (95.8% versus 83.9%; P <0.01). Twenty-nine (40.3%) patients in the angioplasty group underwent bailout Stenting because of a suboptimal angiographic result or flow-limiting dissection. Bailout Stenting was treated as a target lesion revascularization and loss of primary patency in the final analysis. At 12 months, freedom from target lesion revascularization was 87.3% for the Stent group compared with 45.1% for the angioplasty group ( P <0.0001). Duplex ultrasound-derived primary patency at 12 months was better for the Stent group (81.3% versus 36.7%; P <0.0001). Through 12 months, fractures occurred in 3.1% of Stents implanted. No Stent fractures resulted in loss of patency or target lesion revascularization. Conclusions— In this multicenter trial, primary implantation of a self-expanding Nitinol Stent for moderate-length lesions in the superficial femoral artery and proximal popliteal artery was associated with better acute angiographic results and improved patency compared with balloon angioplasty alone. Clinical Trial Registration— URL: . Unique identifier: [NCT00673985][1]. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT00673985&atom=%2Fcirccvint%2F3%2F3%2F267.atom

  • Nitinol Stent implantation versus balloon angioplasty for lesions in the superficial femoral artery and proximal popliteal artery twelve month results from the resilient randomized trial
    Circulation-cardiovascular Interventions, 2010
    Co-Authors: John R Laird, Johannes Lammer, Gary M Ansel, Dierk Scheinert, Barry T Katzen, Jeffrey S Carpenter, Maurice Buchbinder, Rajesh Dave, Alexandra J Lansky, Ecaterina Cristea
    Abstract:

    Background Controversy still exists regarding the best endovascular treatment strategy for patients with symptomatic disease of the superficial femoral artery. There are conflicting data regarding the benefits of superficial femoral artery Stenting and the role of primary Stenting compared with balloon angioplasty with provisional Stent implantation. Methods and results A total of 206 patients from 24 centers in the United States and Europe with obstructive lesions of the superficial femoral artery and proximal popliteal artery and intermittent claudication were randomized to implantation of Nitinol Stents or percutaneous transluminal angioplasty. The mean total lesion length was 71 mm for the Stent group and 64 mm for the angioplasty group. Acute lesion success ( Conclusions In this multicenter trial, primary implantation of a self-expanding Nitinol Stent for moderate-length lesions in the superficial femoral artery and proximal popliteal artery was associated with better acute angiographic results and improved patency compared with balloon angioplasty alone. Clinical trial registration URL: http://www.clinicaltrials.gov. Unique identifier: NCT00673985.

  • Nitinol Stent implantation versus balloon angioplasty for lesions in the superficial femoral artery and proximal popliteal artery twelve month results from the resilient randomized trial
    Circulation-cardiovascular Interventions, 2010
    Co-Authors: John R Laird, Johannes Lammer, Gary M Ansel, Dierk Scheinert, Barry T Katzen, Jeffrey S Carpenter, Maurice Buchbinder, Rajesh Dave, Alexandra J Lansky, Ecaterina Cristea
    Abstract:

    BACKGROUND: Controversy still exists regarding the best endovascular treatment strategy for patients with symptomatic disease of the superficial femoral artery. There are conflicting data regarding the benefits of superficial femoral artery Stenting and the role of primary Stenting compared with balloon angioplasty with provisional Stent implantation. METHODS AND RESULTS: A total of 206 patients from 24 centers in the United States and Europe with obstructive lesions of the superficial femoral artery and proximal popliteal artery and intermittent claudication were randomized to implantation of Nitinol Stents or percutaneous transluminal angioplasty. The mean total lesion length was 71 mm for the Stent group and 64 mm for the angioplasty group. Acute lesion success (<30%residual stenosis) was superior for the Stent group compared with the angioplasty group (95.8% versus 83.9%; P<0.01). Twenty-nine (40.3%) patients in the angioplasty group underwent bailout Stenting because of a suboptimal angiographic result or flow-limiting dissection. Bailout Stenting was treated as a target lesion revascularization and loss of primary patency in the final analysis. At 12 months, freedom from target lesion revascularization was 87.3% for the Stent group compared with 45.1% for the angioplasty group (P<0.0001). Duplex ultrasound-derived primary patency at 12 months was better for the Stent group (81.3% versus 36.7%; P<0.0001). Through 12 months, fractures occurred in 3.1% of Stents implanted. No Stent fractures resulted in loss of patency or target lesion revascularization. CONCLUSIONS: In this multicenter trial, primary implantation of a self-expanding Nitinol Stent for moderate-length lesions in the superficial femoral artery and proximal popliteal artery was associated with better acute angiographic results and improved patency compared with balloon angioplasty alone. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00673985.

  • mr angiography vs ct angiography in the follow up of Nitinol Stent grafts in endoluminally treated aortic aneurysms
    European Radiology, 2002
    Co-Authors: Manfred Cejna, Johannes Lammer, Christian Loewe, Maria Schoder, Albert Dirisamer, Thomas Holzenbein, G Kretschmer, Siegfried Thurnher
    Abstract:

    Our objective was to evaluate the accuracy of contrast-enhanced 3D MR angiography (MRA) in the follow-up of patients with endoluminally treated aortic aneurysms and correlate these findings with uni- or biphasic CT angiography (CTA). Forty MR angiograms in 32 patients with implanted aortic Nitinol Stent grafts were compared to CTA. Twenty-two MR examinations were correlated with arterial-phase CTA (uniphasic), and 18 MR examinations were correlated with biphasic CTA. Uniphasic CTA demonstrated three type-1/type-3 endoleaks and four reperfusion (type-2) endoleaks. In addition, MRA depicted two type-2 reperfusion endoleaks that were missed by CTA. Using biphasic CTA, two type-1/type-3 endoleaks and three reperfusion (type-2) endoleaks were detected; of those, delayed scanning detected three reperfusion (type-2) endoleaks missed during arterial-phase CTA. In addition to the findings by CTA, MRA depicted another type-2 reperfusion endoleak. Magnetic resonance angiography is at least as sensitive as uni- or biphasic CTA for detecting endoleaks and may consequently offer advantages in patients with contraindications to iodinated contrast agents.

Gary M Ansel - One of the best experts on this subject based on the ideXlab platform.

  • patient level meta analysis of 999 claudicants undergoing primary femoropopliteal Nitinol Stent implantation
    Catheterization and Cardiovascular Interventions, 2017
    Co-Authors: Krishna J Rochasingh, Gary M Ansel, Michael D Dake, Peter Schneider, Joshua A Beckman, Sean P Lyden, Manish Mehta, Christopher M Mullin, Michael R. Jaff
    Abstract:

    Condensed Abstract The factors that impact the clinical effectiveness of bare Nitinol Stents in claudicants with symptomatic femoropopliteal atherosclerosis are incompletely known. The authors analyzed variables that may influence Stent durability and provide a benchmark for their effectiveness. Data analyzed from six studies (999 patients) included baseline noninvasive hemodynamic tests, angiographic characteristics, ultrasound defined Stent patency and target lesion revascularization through 12-months. Baseline ankle-brachial index and lesion length predicted Stent patency and target lesion revascularization and when combined interacted significantly to better predict outcomes. This meta-analysis provides an important comparator against which emerging therapies that treat claudicants with femoropopliteal atherosclerosis can be assessed. Subject Code Peripheral Artery Disease Background The performance of bare metal Nitinol Stents in patients with symptomatic femoropopliteal peripheral artery disease (PAD) is not well defined. Methods Patient-level data from six large prospective trials sponsored by medical device manufacturers was abstracted and analyzed to identify a cohort of patients with claudication and femoropopliteal artery occlusive disease. Twelve-month binary patency and target lesion revascularization (TLR) rates were primary outcomes. Stent patency was assessed by duplex ultrasonography (DUS) and TLR was a clinically driven intervention. To characterize the effects of patient characteristics on the outcomes, meta-regression was performed via mixed effects logistic regression models with patient-level covariates. Results About 999 patients were analyzed; the mean ABI was 0.68 ± 0.18, the mean lesion length was 84 ± 53 mm, the mean lesion stenosis was 78%, and nearly two thirds of patients had mild to severe calcification. The mean Rutherford clinical category was 2.7 ± 0.6 and ranged from 2.6 to 2.8 in all studies. The 12-month patency across all studies was 69.8% and TLR rates ranged from 9.2% to 19.7%. Multivariable analysis demonstrated that baseline ABI and baseline target lesion length predicted both primary patency and TLR. Further, these two variables interacted significantly to better predict TLR outcomes when used in combination. Conclusion The 12-month clinical effectiveness of bare Nitinol Stents to treat patients with symptomatic femoropopliteal PAD is acceptable and is impacted by clinical and lesion-specific characteristics. These data provide an important and useful benchmark to compare the clinical benefit of emerging endovascular PAD therapies. © 2017 Wiley Periodicals, Inc.

  • three year results of the vibrant trial of viabahn endoprosthesis versus bare Nitinol Stent implantation for complex superficial femoral artery occlusive disease
    Journal of Vascular Surgery, 2013
    Co-Authors: Patrick J Geraghty, Mark W. Mewissen, Michael R. Jaff, Gary M Ansel
    Abstract:

    Objective The predominant mode of bare Nitinol Stent failure is diffuse in-Stent restenosis, and failure rates correlate to the length and complexity of the treated lesion. Addition of an expanded polytetrafluoroethylene lining to a Nitinol Stent frame, as found in the VIABAHN endoprosthesis, mitigates the ingrowth of intimal hyperplasia. We compared the long-term outcomes of complex superficial femoral artery disease intervention using the VIABAHN endoprosthesis to those obtained with bare Nitinol Stent implantation. Methods One hundred forty-eight patients with symptomatic complex superficial femoral artery disease (TransAtlantic Inter-Society Consensus I class C and D lesions, accompanied by intermittent claudication or ischemic rest pain) were randomized to endovascular intervention using either bare Nitinol Stent implantation (76 patients) or nonheparin-bonded VIABAHN endoprosthesis deployment (72 patients). Patency, limb hemodynamics, and quality of life were evaluated at 1, 6, 12, 24, and 36 months following intervention. Results The average treated lesion measured 18 ± 8 cm in length, and 58.8% of lesions displayed segmental or complete occlusion. At 3 years, primary patency rates (defined by peak systolic velocity ratio ≤2.0 and no target lesion revascularization) did not significantly differ between patients treated with the VIABAHN Stent graft and those who received a bare Nitinol Stent (24.2% vs 25.9%; P  = .392). Stent fractures were significantly more common in bare Nitinol Stents (50.0%) than in the VIABAHN endoprostheses (2.6%). Primary-assisted patency rates were higher in those receiving bare Nitinol Stents than the VIABAHN Stent graft (88.8% vs 69.8%; P  = .04), although secondary patency rates did not differ between bare Nitinol Stent and Stent graft recipients (89.3% vs 79.5%; P  = .304). There were no instances of procedure-related mortality or amputation. The hemodynamic improvement and quality measures improved equally in both groups. Conclusions The long-term outcomes of complex superficial femoral artery disease intervention using the VIABAHN endograft and bare Nitinol Stents are similar. Although primary patency rates are low in both study arms, excellent primary-assisted and secondary patency rates were achieved, with sustained augmentation of limb perfusion and quality-of-life measures. Patency rates diminish most rapidly in the first year after device implantation.

  • major adverse limb events and wound healing following infrapopliteal artery Stent implantation in patients with critical limb ischemia the xcell trial
    Catheterization and Cardiovascular Interventions, 2012
    Co-Authors: Krishna J Rochasingh, Gary M Ansel, Michael R. Jaff, John R Laird, James Joye, Peter Schneider
    Abstract:

    Background Percutaneous transluminal angioplasty (PTA) with Stent deployment of infrapopliteal arteries is an accepted but unproven therapy for patients with critical limb ischemia (CLI). We evaluated the safety and effectiveness of the Xpert™ self-expanding Nitinol Stent (Abbott Vascular, Redwood City, CA) in Rutherford Class 4–6 subjects with infrapopliteal lesions of 4–15 cm in length. Methods and Results 120 patients (140 limbs, 212 implanted devices) underwent primary infrapopliteal Nitinol Stent deployment as part of this multicenter registry. The primary endpoint was 12-month amputation-free survival (AFS); secondary endpoints included limb salvage, target lesion revascularization (TLR), 6- month angiographic patency, and 6- and 12-month outcomes of wound healing and pain relief. Despite a 6-month binary Stent restenosis rate of 68.5%, the 12-month AFS rate was 78.3%. Stratified according to baseline Rutherford classes 4, 5 and 6, the 12-month AFS rates were 100%, 77.3%, and 55.2%, respectively, and freedom from major amputation rates were 100%, 90.9%, and 70.1%, respectively. The 12-month freedom from major amputation rate and clinically driven TLR were 89.6% and 70.1%, respectively. The 6- and 12-month complete wound-healing rates were 49.0% and 54.4%, respectively. Rutherford class 4 patients had significant pain relief through 12-months (P<0.05). Conclusions Primary infrapopliteal Nitinol Stenting to treat CLI is safe and effective in improving 6-and 12-month clinical outcomes. © 2012 Wiley Periodicals, Inc.

  • Nitinol Stent implantation versus balloon angioplasty for lesions in the superficial femoral artery and proximal popliteal arteryclinical perspective
    Circulation-cardiovascular Interventions, 2010
    Co-Authors: John R Laird, Johannes Lammer, Gary M Ansel, Dierk Scheinert, Barry T Katzen, Maurice Buchbinder, Rajesh Dave, Alexandra J Lansky, Jeffrey P Carpenter, Ecaterina Cristea
    Abstract:

    Background— Controversy still exists regarding the best endovascular treatment strategy for patients with symptomatic disease of the superficial femoral artery. There are conflicting data regarding the benefits of superficial femoral artery Stenting and the role of primary Stenting compared with balloon angioplasty with provisional Stent implantation. Methods and Results— A total of 206 patients from 24 centers in the United States and Europe with obstructive lesions of the superficial femoral artery and proximal popliteal artery and intermittent claudication were randomized to implantation of Nitinol Stents or percutaneous transluminal angioplasty. The mean total lesion length was 71 mm for the Stent group and 64 mm for the angioplasty group. Acute lesion success (<30%residual stenosis) was superior for the Stent group compared with the angioplasty group (95.8% versus 83.9%; P <0.01). Twenty-nine (40.3%) patients in the angioplasty group underwent bailout Stenting because of a suboptimal angiographic result or flow-limiting dissection. Bailout Stenting was treated as a target lesion revascularization and loss of primary patency in the final analysis. At 12 months, freedom from target lesion revascularization was 87.3% for the Stent group compared with 45.1% for the angioplasty group ( P <0.0001). Duplex ultrasound-derived primary patency at 12 months was better for the Stent group (81.3% versus 36.7%; P <0.0001). Through 12 months, fractures occurred in 3.1% of Stents implanted. No Stent fractures resulted in loss of patency or target lesion revascularization. Conclusions— In this multicenter trial, primary implantation of a self-expanding Nitinol Stent for moderate-length lesions in the superficial femoral artery and proximal popliteal artery was associated with better acute angiographic results and improved patency compared with balloon angioplasty alone. Clinical Trial Registration— URL: . Unique identifier: [NCT00673985][1]. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT00673985&atom=%2Fcirccvint%2F3%2F3%2F267.atom

  • Nitinol Stent implantation versus balloon angioplasty for lesions in the superficial femoral artery and proximal popliteal artery twelve month results from the resilient randomized trial
    Circulation-cardiovascular Interventions, 2010
    Co-Authors: John R Laird, Johannes Lammer, Gary M Ansel, Dierk Scheinert, Barry T Katzen, Jeffrey S Carpenter, Maurice Buchbinder, Rajesh Dave, Alexandra J Lansky, Ecaterina Cristea
    Abstract:

    Background Controversy still exists regarding the best endovascular treatment strategy for patients with symptomatic disease of the superficial femoral artery. There are conflicting data regarding the benefits of superficial femoral artery Stenting and the role of primary Stenting compared with balloon angioplasty with provisional Stent implantation. Methods and results A total of 206 patients from 24 centers in the United States and Europe with obstructive lesions of the superficial femoral artery and proximal popliteal artery and intermittent claudication were randomized to implantation of Nitinol Stents or percutaneous transluminal angioplasty. The mean total lesion length was 71 mm for the Stent group and 64 mm for the angioplasty group. Acute lesion success ( Conclusions In this multicenter trial, primary implantation of a self-expanding Nitinol Stent for moderate-length lesions in the superficial femoral artery and proximal popliteal artery was associated with better acute angiographic results and improved patency compared with balloon angioplasty alone. Clinical trial registration URL: http://www.clinicaltrials.gov. Unique identifier: NCT00673985.

Ho Young Song - One of the best experts on this subject based on the ideXlab platform.

  • benign tracheobronchial strictures long term results and factors affecting airway patency after temporary Stent placement
    American Journal of Roentgenology, 2007
    Co-Authors: Ji Hoon Shin, Chang Jin Yoon, Tae Sun Shim, Ho Young Song, Giyoung Ko
    Abstract:

    OBJECTIVE. The purpose of our study was to evaluate long-term results and identify factors affecting airway patency after temporary placement of a covered, retrievable Nitinol Stent for benign tracheobronchial strictures.MATERIALS AND METHODS. Polyurethaneor polytetrafluoroethylene (PTFE)-covered retrievable expandable Nitinol Stents were placed fluoroscopically in 24 patients with benign tracheobronchial strictures. Improvement in respiratory status and complications were evaluated. Maintained patency of airway after temporary Stenting was calculated and compared between the 2- and 6-month Stenting groups. Factors for maintained patency after temporary Stenting were evaluated.RESULTS. A total of 30 Stents were successfully placed and well tolerated in 24 patients. Tissue hyperplasia, Stent migration, and bronchial obstruction of the left upper lobe occurred in 36.7%, 13.3%, and 3.3% of patients, respectively. All Stents were successfully removed electively either 2 (n = 12) or 6 (n = 12) months after pla...

  • treatment of tracheobronchial obstruction with a polytetrafluoroethylene covered retrievable expandable Nitinol Stent
    Journal of Vascular and Interventional Radiology, 2006
    Co-Authors: Ji Hoon Shin, Giyoung Ko, Hyunki Yoon, Tae Sun Shim, Ho Young Song, Heung Kyu Ko, Kyubo Sung
    Abstract:

    PURPOSE To evaluate the clinical effectiveness of polytetrafluoroethylene (PTFE)–covered retrievable expandable Nitinol Stents in tracheobronchial strictures. MATERIALS AND METHODS With fluoroscopic guidance, PTFE-covered retrievable expandable Nitinol Stents were placed in 15 symptomatic patients with benign ( n = 6) or malignant ( n = 9) tracheobronchial strictures. Complications and improvement in respiratory status were evaluated. Stents were removed electively 6 months after placement in benign strictures or if complications occurred. Membrane degradation or separation from the wire mesh was evaluated in removed Stents. RESULTS A total of 17 Stents were successfully placed and were well tolerated in all patients. Sputum retention, Stent migration, and tissue hyperplasia occurred in 23.5% ( n = 4), 17.6% ( n = 3), and 17.6% ( n = 3) of Stents, respectively. A total of 11 Stents were successfully removed electively 6 months after placement ( n = 4) or when complications occurred ( n = 7). All 11 such Stents were removed without difficulty with use of standard techniques, antecedent balloon dilation being necessary in two cases as a result of tissue hyperplasia. No removed Stent showed signs of membrane degradation, and two removed Stents showed signs of membrane separation from the mesh. CONCLUSIONS PTFE-covered retrievable expandable Nitinol Stents were effective in the treatment of tracheobronchial strictures. Stent removal was easy with use of standard techniques, and no removed Stent showed evidence of membrane degradation.

  • A Dual Expandable Nitinol Stent: Experience in 102 Patients with Malignant Gastroduodenal Strictures
    Journal of Vascular and Interventional Radiology, 2004
    Co-Authors: Ho Young Song, Ji Hoon Shin, Chang Jin Yoon, Yook Jh
    Abstract:

    PURPOSE To investigate the technical feasibility and clinical effectiveness of a dual expandable Nitinol Stent in the palliative treatment of malignant gastroduodenal strictures MATERIALS AND METHODS The dual Stent consisted of two Stents, an outer partially covered Stent and an inner bare Nitinol Stent. The outer diameter of the Stent delivery system was 3.8 mm. With fluoroscopic guidance, the outer Stent was placed into the stricture, followed by coaxial placement of the inner Stent. The Stent placement was attempted in 102 consecutive patients with malignant gastroduodenal strictures. The underlying causes of malignant strictures were gastric cancer ( n = 55), pancreatic cancer ( n = 24), gallbladder cancer ( n = 7), cholangiocarcinoma ( n = 5), duodenal cancer ( n = 5), and metastatic cancer ( n = 6). All patients presented with symptoms of gastric outlet obstruction RESULTS Stent placement was technically successful and well tolerated in 101 of 102 patients (99%). After Stent placement, 85 of the 101 patients (84%) with technical success experienced improvement of their symptoms. Tumor overgrowth occurred in five patients, Stent migration in two, mucosal hyperplasia in one, bleeding in one, and jaundice in two. Seventy one of the 101 patients died 5 to 340 days (mean, 71 days) after Stent placement from progression of their disease, myocardial infarction, bleeding, or sepsis. The remaining 30 patients are still alive 6 to 227 days (mean, 39 days) after Stent placement. The 30-day, 60-day, 90-day, and 180-day survival rates were 78%, 58%, 39%, and 8%, respectively CONCLUSION The dual Stent with a 3.8-mm Stent delivery system is easy to insert, safe, and reasonably effective for the palliative treatment of malignant gastroduodenal strictures

  • malignant tracheobronchial strictures palliation with covered retrievable expandable Nitinol Stent
    Journal of Vascular and Interventional Radiology, 2003
    Co-Authors: Ji Hoon Shin, Gyoosik Jung, Giyoung Ko, Tae Sun Shim, Ho Young Song
    Abstract:

    PURPOSE To evaluate the safety and clinical effectiveness of a covered retrievable expandable Nitinol Stent for the treatment of malignant tracheobronchial stricture and/or esophagorespiratory fistula (ERF). MATERIALS AND METHODS With fluoroscopic guidance, Stents were placed in 35 symptomatic patients with malignant tracheobronchial stricture and/or ERF in most cases caused by lung or esophageal cancer. The site of stricture was most commonly at the trachea or left main bronchus. If there were complications, the Stent was removed with a retrieval set. Nine patients had combined symptomatic ERF. RESULTS A total of 47 tracheobronchial Stents were placed and were technically successful and well-tolerated in all patients. Improvement of dyspnea was achieved in 92% of the patients (24 of 26 patients). Associated ERF in nine patients was effectively treated with tracheobronchial Stent placement with or without esophageal Stent placement. Stent migration, tumor overgrowth, symptomatic sputum retention, and hemoptysis occurred in 17% (6/35), 6% (2/35), 20% (7/35), and 17% (6/35) of patients, respectively. There were no documented cases of tumor ingrowth. Stent removal was performed easily in five patients when Stent migration ( n = 2), severe pain ( n = 1), tumor overgrowth ( n = 1), or persiStent gastrobronchial fistula ( n = 1) developed. All patients died 2 days to 26 weeks (mean, 9.62 weeks) after Stent placement because of disease progression ( n = 18), pneumonia ( n = 9), hemoptysis ( n = 5), or unknown cause ( n = 3). CONCLUSION Use of a covered retrievable expandable Nitinol Stent is a safe and effective method for relieving dyspnea. This procedure contributed to improved quality of life for patients with malignant tracheobronchial stricture and/or ERF. Stent retrievability was useful in resolving Stent-related complications.

  • obstruction of the lacrimal system treatment with a covered retrievable expandable Nitinol Stent versus a lacrimal polyurethane Stent
    Radiology, 2003
    Co-Authors: Giyoung Ko, Kyubo Sung, Ho Young Song, Hyunki Yoon
    Abstract:

    PURPOSE: To compare the clinical effectiveness of a covered Nitinol Stent with that of a polyurethane Stent for treatment of lacrimal system obstructions. MATERIALS AND METHODS: A Nitinol Stent was knit from a single thread of 0.1-mm Nitinol wire in a tubular configuration and was covered by dipping the Stent into a polyurethane solution. The Stent was 4 mm in diameter and 30 or 35 mm long. With fluoroscopic guidance, a covered Nitinol Stent (n = 33, group A) or a polyurethane Stent (n = 35, group B) was placed in 68 patients. The following items were evaluated retrospectively: technical success, procedure time, cumulative patency rate, and complications. An unpaired Student t test was used to analyze the difference between the procedure times. Kaplan-Meier survival curves and a log-rank test were used to compare the cumulative patency rates. RESULTS: Stent placement was technically successful in 31 (94%) of 33 patients in group A and in all 35 (100%) patients in group B. After Stent placement, all patien...

Dierk Scheinert - One of the best experts on this subject based on the ideXlab platform.

  • treatment of complex atherosclerotic femoropopliteal artery disease with a self expanding interwoven Nitinol Stent midterm results from the leipzig supera 500 registry
    Eurointervention, 2014
    Co-Authors: Martin Werner, Michael Piorkowski, Susanne Scheinert, Matthias Ulrich, Yvonne Bausback, Sven Braunlich, Andrej Schmidt, Anett Paetzold, Ursula Banningeichenseer, Dierk Scheinert
    Abstract:

    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.

  • Nitinol Stent implantation in the superficial femoral artery and proximal popliteal artery twelve month results from the complete se multicenter trial
    Journal of Endovascular Therapy, 2014
    Co-Authors: John R Laird, Thomas Zeller, Dierk Scheinert, Ash Jain, Robert L Feldman, Jeffrey J Popma, Ehrin J Armstrong, Michael R. Jaff
    Abstract:

    PurposeTo determine the safety and efficacy of a new-generation Nitinol Stent with enhanced flexibility in arterial lesions in the superficial femoral artery (SFA) and proximal popliteal artery (PP...

  • the united states study for evaluating endovascular treatments of lesions in the superficial femoral artery and proximal popliteal by using the protege everflex Nitinol Stent system ii durability ii
    Journal of Vascular Surgery, 2013
    Co-Authors: Jon S Matsumura, Dierk Scheinert, Marc Bosiers, Dai Yamanouchi, Jeffrey Goldstein, Christopher W Pollock, Greg A Schultz, Krishna J Rochasingh
    Abstract:

    Objective Angioplasty and Stenting are options for revascularization of symptomatic femoral popliteal disease. Although angioplasty alone is effective in short lesions, longer lesions are often treated with Stents. Multiple overlapping Stents are expensive and may be associated with Stent fracture. This trial evaluated the safety and efficacy of a single self-expanding Stent up to 20 cm in length in patients with atherosclerotic disease of the superficial femoral artery (SFA) and proximal popliteal artery. Methods Patients with lesions >4 cm and  Results The study enrolled 287 patients (66% male; mean age, 68 years) with stenotic, restenotic, or occluded lesions of the SFA at 44 investigational sites in the United States and Europe. Systemic comorbidities included hypertension (88%), hyperlipidemia (86%), diabetes (43%), and prior SFA intervention (41%). The mean lesion length measured by the core laboratory was 89 mm. The mean normal-to-normal lesion length measured by sites was 110 mm. A total of 303 Stents were implanted, and 95% of patients received a single Stent. No major adverse events occurred at 30 days. At 1 year, primary outcome of duplex ultrasound Stent patency was 67.7% in evaluable patients, and among 1-year secondary outcomes, the mean ankle-brachial index increased by 0.25. Walking Improvement Questionnaire scores improved in pain by 33.7, distance by 37.1, speed by 18.6, and stair climbing by 24.7. The Kaplan-Meier estimate of primary patency was 77.2%, primary assisted patency was 86.9%, and secondary patency was 87.3%. Rutherford clinical category improved in 83.5% of patients. Stent fracture rate was 0.4%. Matched absolute claudication distance was 412 feet greater and was not statistically different in this subgroup of 29 individuals. Conclusions The results of DURABILITY II (StuDy for EvalUating EndovasculaR TreAtments of Lesions in the Superficial Femoral Artery and Proximal Popliteal By usIng the Protege EverfLex Nitinol Stent SYstem II) suggest that a new single Stent strategy is safe and effective for the treatment of long lesions of the SFA and proximal popliteal arteries at 1 year.

  • 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
    Jacc-cardiovascular Interventions, 2013
    Co-Authors: Dierk Scheinert, Michael Piorkowski, Susanne Scheinert, Matthias Ulrich, Martin Werner, Yvonne Bausback, Sven Braunlich, Anett Paetzold, Ursula Banningeichenseer, Andrej Schmidt
    Abstract:

    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 Conclusions Over a 12-month observation period, the patency rate and durability of SUPERA Stents implanted for severe popliteal artery disease were high.

  • a novel self expanding interwoven Nitinol Stent for complex femoropopliteal lesions 24 month results of the supera sfa registry
    Journal of Endovascular Therapy, 2011
    Co-Authors: Dierk Scheinert, Lars Grummt, Michael Piorkowski, Susanne Scheinert, Matthias Ulrich, Martin Werner, Yvonne Bausback, Sven Braunlich, Andrej Schmidt
    Abstract:

    PurposeTo 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.Method...

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  • incidence predictors and prognosis of in Stent occlusion after endovascular treatment with Nitinol Stents for femoropopliteal lesions
    Journal of Vascular Surgery, 2014
    Co-Authors: Tomoharu Dohi, Osamu Iida, Masaaki Uematsu, Keisuke Hirano, Yoshimitsu Soga, Kenji Suzuki, Mitsuyoshi Takahara, Shinsuke Nanto
    Abstract:

    Objective Widespread use of self-expanding Nitinol Stent-based endovascular treatment (EVT) for femoropopliteal (FP) lesions has been fueled by its less-invasive nature and modest durability; however, prevalence, predictors and prognosis of in-Stent occlusion are undefined and were investigated here. Methods This study entailed a multicenter, retrospective analysis of a prospectively maintained database. Between January 2004 and December 2011, 2447 de novo FP lesions (mean length, 143 ± 87 mm; 52% chronic total occlusions) from 2008 patients (mean age, 73.0 ± 9.2 years; 71% male; 61% diabetics; 32% critical limb ischemia; and 24% on hemodialysis) were treated with Nitinol Stent-based EVT. Study outcome was in-Stent occlusion: rates (1, 3, and 5 years), predictors and association with limb prognosis. Results In-Stent occlusion rate was 5.2%, 11.2%, and 16.4% at 1, 3, and 5 years, respectively (mean follow-up, 2.3 ± 1.7 years). Female sex, critical limb ischemia, and Transatlantic Inter-Society Consensus II class C/D (multivariate Cox proportional hazard ratio [HR], 1.75, 1.49, and 3.34, respectively) were independent predictors of in-Stent occlusion after FP Stenting, which was associated with poor limb prognosis (major amputation, HR 6.35; major adverse limb event, major adverse limb event, HR, 21.1). Conclusions Moderate in-Stent occlusion rates were observed after Nitinol Stent-based EVT. Closer attention is warranted with high-risk cases because of poorer limb prognosis.

  • five year outcomes of self expanding Nitinol Stent implantation for chronic total occlusion of the superficial femoral and proximal popliteal artery
    Catheterization and Cardiovascular Interventions, 2013
    Co-Authors: Yasunari Sakamoto, Osamu Iida, Keisuke Hirano, Yoshimitsu Soga, Kenji Suzuki, Toshiya Muramatsu, Reiko Tsukahara
    Abstract:

    Objective To investigate the 5-year patency rates and predictors of restenosis after self-expanding Nitinol Stent implantation for chronic total occlusion (CTO) in superficial femoral and proximal popliteal artery (SFPA) lesions. Background Outcomes and long-term patency rates after self-expanding Nitinol Stent for CTO in the SFPA lesions have not been clarified. Methods From January 2004 to December 2009, 861 serial arteriosclerosis obliterans patients, 1,017 limbs, underwent endovascular therapy with implantation of a self-expanding Nitinol Stent for SFPA lesions at four institutions in Japan. Of the cohort, 352 patients, 383 limbs, had self-expanding Nitinol Stents implanted for CTOs in the SFPA and were followed for 5 years. We retrospectively investigated patency rate and multivariate predictors associated with restenosis. Results Mean age was 72 ± 9 years and 31% were female patients. In total, 58% of the patients had diabetes mellitus and 25% were patients with critical limb ischemia. Occluded length was 194 ± 89 mm, mean total Stent length was 198 ± 7 mm, and mean Stent diameter was 7.1 ± 0.9 mm. Five-year primary and secondary patency rates were 51.8 and 79.5%, respectively, and the rates of freedom from bypass surgery, major or minor amputation, and all-cause death were 96.1, 96.2, and 78.4%, respectively. Female gender (odds ratio, 1.95; P = 0.0051) and mean Stent diameter (odds ratio, 0.77; P = 0.0324) were factors strongly associated with restenosis. Conclusions Women and patients requiring small Stents failed to maintain primary patency when treated with self-expanding Nitinol Stents for CTO lesions in the SFPA. Although primary patency was low, the secondary patency rate was acceptable. © 2013 Wiley Periodicals, Inc.

  • Successful outside-the-Stent Stenting for in-Stent chronic total occlusion in the common iliac artery
    Cardiovascular intervention and therapeutics, 2012
    Co-Authors: Takayuki Ishihara, Osamu Iida, Masaki Awata, Shin Okamoto, Tomoharu Dohi, Masashi Fujita, Kei Sato, Kiyonori Nanto, Tetsuya Watanabe, Fusako Sera
    Abstract:

    Several studies showed durable long-term clinical benefit of endovascular therapy with Stenting in aorto-iliac occlusive disease. Although in-Stent restenosis is easily treated in routine practice, we experienced an uncommon case of failed reconstitution of in-Stent total occlusion at the common iliac artery (CIA). The case was treated with Nitinol Stent implantation outside of the in-Stent occlusion site, and good vessel patency was observed at 14 months after the procedure. Nitinol Stent implantation outside of an in-Stent occlusion in the CIA is a novel reconstitution strategy when the guide wire cannot pass the occlusion site within a previously implanted Stent.

  • utility of new classification based on clinical and lesional factors after self expandable Nitinol Stenting in the superficial femoral artery
    Journal of Vascular Surgery, 2011
    Co-Authors: Yoshimitsu Soga, Osamu Iida, Keisuke Hirano, Kenji Suzuki, Hiroyoshi Yokoi, Atsushi Tosaka, Masakiyo Nobuyoshi
    Abstract:

    Background The aim of this study was to investigate the predictive value of clinical classification schemes that assess primary patency after self-expandable Nitinol Stent in the superficial femoral artery (SFA). Methods This study was a multicenter retrospective study of prospective databases. From April 2004 to December 2009, 1001 limbs (807 patients) that underwent successful Nitinol Stent implantation for de novo SFA lesions were identified and analyzed. Primary patency was defined as treated vessel without restenosis (defined as >2.4 of peak systolic velocity ratio by duplex) and repeat revascularization. Six items were included in the classification: female, diabetes, dialysis, critical limb ischemia (CLI), lesion length > 150 mm, and poor runoff; the FeDCLIP score. A lesion length >150 mm was scored as 2 points. The others were assigned 1 point each. The scores of 0 to 2, 3 to 4, and ≥5 points were classified as low-, moderate-, and high-risk patients, respectively. Outcome measures were primary and secondary patency and all-cause mortality up to 6 years in each risk group. Results The mean follow-up interval was 26.8 ± 14.6 months. Primary patencies were 85.7%, 77.3%, and 74.2% in the low-risk group; 71.5%, 54.7%, and 51.9% in the moderate-risk group; and 53.0%, 24.3%, and 20.8% in the high-risk group at 1, 3, and 5 years, respectively. The secondary patencies were 94.6%, 92.3%, and 90.8% in the low-risk group; 89.5%, 83.1%, and 83.1% in the moderate-risk group; and 82.7%, 73.1%, and 73.1% in the high-risk group at 1, 3, and 5 years, respectively. There were significant differences in primary and secondary patency among the three risk groups (P Conclusions New classification schemes based on FeDCLIP score were useful for risk stratification in vessel patency and mortality after self-expandable Nitinol Stenting for SFA disease.

  • retrospective multicentre analysis of s m a r t vs luminexx Nitinol Stent implantation for superficial femoral artery lesions real sl registry 5 years experience
    Japanese Circulation Journal-english Edition, 2011
    Co-Authors: Osamu Iida, Masaaki Uematsu, Keisuke Hirano, Yoshimitsu Soga, Toshiya Muramatsu, Shin Okamoto, Tomoharu Dohi, Masakiyo Nobuyoshi, Hiroyoshi Yokoi, Masashi Fujita
    Abstract:

    Background: The Nitinol Stent has proven superior primary patency than balloon angioplasty in superficial femoral artery (SFA) lesions, but a systematic comparison of the patency of 2 different Nitinol Stents (S.M.A.R.T. and Luminexx) in patients with SFA lesions has not been done. Methods and Results: A multicenter, prospective database that included 511 consecutive patients who had undergone endovascular therapy with Nitinol Stenting for 638 limbs (S.M.A.R.T.: n=503; Luminexx: n=135) was retrospectively analyzed. Patency was assessed by duplex ultrasound. Outcomes were compared between the groups by the Kaplan-Meier and log-rank methods. To minimize the differences between each group, propensity-matched analysis was also performed. Stent fracture occurred in 11% (57/503) of the S.M.A.R.T. and 23% (31/135) of the Luminexx Stents (P=0.0005). Despite a higher prevalence of chronic total occlusion (55% vs. 40%, P=0.002) and longer lesions (154±93mm vs. 135±71mm, P=0.03) in the S.M.A.R.T. group, there was no significant difference in patency for up to 5 years (P=0.50). When 119 lesions per group were assessed after propensity-matched analysis, the 5-year patency rate was 74% for the S.M.A.R.T. and 65% for the Luninexx Stent (P=0.10). Conclusions: Despite a different Stent fracture rate, there was no significant difference in terms of patency between the S.M.A.R.T. and Luninexx Stents for up to 5 years. (Circ J 2011; 75: 421-427)