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J S Sachweh - One of the best experts on this subject based on the ideXlab platform.
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introduction of a flexible polymeric heart Valve Prosthesis with special design for aortic position
European Journal of Cardio-Thoracic Surgery, 2004Co-Authors: Sabine Daebritz, Benita Hermanns, Bernd Fausten, J Groetzner, B J Messmer, Joerg Schroeder, R Autschbach, J S SachwehAbstract:Objective: Current prosthetic heart Valves necessitate permanent anticoagulation or have limited durability and impaired hemodynamic performance compared to natural Valves. Recently a polymeric Valve prostheses with special design for mitral position demonstrated excellent in vitro and in vivo results with improved durability and no need for permanent anticoagulation. In this study, a respective flexible polymeric aortic Valve is presented and in vitro and in vivo results are reported. Methods: The aortic Prosthesis (ADIAM® lifescience AG, Erkelenz, Germany) is entirely made of polycarbonaturethane. The tri-leaflet flexible Prosthesis mimicks the natural aortic Valve and has a diminished pressure loss and reduced stress and strain peaks at the commissures. The Valve underwent long-term in vitro testing and in vivo-testing in a growing calve animal model (20 weeks, 7 aortic Valves) and was compared to two different commercial bioprostheses. Results: The polymeric aortic heart Valve substitute demonstrated excellent in vitro and in vivo hemodynamics. Five/seven animals with aortic PCU-prostheses had an excellent clinical long-term course. The explanted Valves showed a variable degree of calcification. Two of the seven animals died at 27 and 77 days due to pannus overgrowth causing severe LVOTO without degeneration of the Valve itself. Both animals with commercial bioprostheses had to be sacrificed because of congestive heart failure related to structural degeneration of the bioProsthesis after 10 and 30 days of implantation. There was no increased thrombogenity of the PCU Valves compared to bioprostheses. Conclusion: The new flexible polymeric aortic Valve Prosthesis is superior to current bioprostheses in animal testing.
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introduction of a flexible polymeric heart Valve Prosthesis with special design for mitral position
Circulation, 2003Co-Authors: Sabine Daebritz, J S Sachweh, Benita Hermanns, Bernd Fausten, Andreas Franke, J Groetzner, B Klosterhalfen, B J MessmerAbstract:Background— Current heart Valve prostheses are constructed mimicking the native aortic Valve. Special hemodynamic characteristics of the mitral Valve such as a nonaxial central inflow with creation of a left ventricular vortex have so far not been taken into account. A new polycarbonaturethane (PCU) bileaflet heart Valve Prosthesis with special design for the mitral position is introduced, and results of animal testing are presented. Methods and Results— After in vitro testing, 7 PCU-prostheses and 7 commercial bioprostheses (Perimount, n=4; Mosaic, n=3) were implanted in mitral position into growing Jersey calves (age 3–5 months, weight 60–97 kg) for 20 weeks. 2-Dimensional echocardiography was performed after implantation and before sacrification. Autopsy included histologic, radiographic, and electron microscopic examination of the Valves. In vitro durability was proven for >15 years. After implantation 2-dimensional-echocardiography showed no relevant gradient or regurgitation of any Prosthesis. Clini...
B J Messmer - One of the best experts on this subject based on the ideXlab platform.
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introduction of a flexible polymeric heart Valve Prosthesis with special design for aortic position
European Journal of Cardio-Thoracic Surgery, 2004Co-Authors: Sabine Daebritz, Benita Hermanns, Bernd Fausten, J Groetzner, B J Messmer, Joerg Schroeder, R Autschbach, J S SachwehAbstract:Objective: Current prosthetic heart Valves necessitate permanent anticoagulation or have limited durability and impaired hemodynamic performance compared to natural Valves. Recently a polymeric Valve prostheses with special design for mitral position demonstrated excellent in vitro and in vivo results with improved durability and no need for permanent anticoagulation. In this study, a respective flexible polymeric aortic Valve is presented and in vitro and in vivo results are reported. Methods: The aortic Prosthesis (ADIAM® lifescience AG, Erkelenz, Germany) is entirely made of polycarbonaturethane. The tri-leaflet flexible Prosthesis mimicks the natural aortic Valve and has a diminished pressure loss and reduced stress and strain peaks at the commissures. The Valve underwent long-term in vitro testing and in vivo-testing in a growing calve animal model (20 weeks, 7 aortic Valves) and was compared to two different commercial bioprostheses. Results: The polymeric aortic heart Valve substitute demonstrated excellent in vitro and in vivo hemodynamics. Five/seven animals with aortic PCU-prostheses had an excellent clinical long-term course. The explanted Valves showed a variable degree of calcification. Two of the seven animals died at 27 and 77 days due to pannus overgrowth causing severe LVOTO without degeneration of the Valve itself. Both animals with commercial bioprostheses had to be sacrificed because of congestive heart failure related to structural degeneration of the bioProsthesis after 10 and 30 days of implantation. There was no increased thrombogenity of the PCU Valves compared to bioprostheses. Conclusion: The new flexible polymeric aortic Valve Prosthesis is superior to current bioprostheses in animal testing.
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introduction of a flexible polymeric heart Valve Prosthesis with special design for mitral position
Circulation, 2003Co-Authors: Sabine Daebritz, J S Sachweh, Benita Hermanns, Bernd Fausten, Andreas Franke, J Groetzner, B Klosterhalfen, B J MessmerAbstract:Background— Current heart Valve prostheses are constructed mimicking the native aortic Valve. Special hemodynamic characteristics of the mitral Valve such as a nonaxial central inflow with creation of a left ventricular vortex have so far not been taken into account. A new polycarbonaturethane (PCU) bileaflet heart Valve Prosthesis with special design for the mitral position is introduced, and results of animal testing are presented. Methods and Results— After in vitro testing, 7 PCU-prostheses and 7 commercial bioprostheses (Perimount, n=4; Mosaic, n=3) were implanted in mitral position into growing Jersey calves (age 3–5 months, weight 60–97 kg) for 20 weeks. 2-Dimensional echocardiography was performed after implantation and before sacrification. Autopsy included histologic, radiographic, and electron microscopic examination of the Valves. In vitro durability was proven for >15 years. After implantation 2-dimensional-echocardiography showed no relevant gradient or regurgitation of any Prosthesis. Clini...
Sabine Daebritz - One of the best experts on this subject based on the ideXlab platform.
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introduction of a flexible polymeric heart Valve Prosthesis with special design for aortic position
European Journal of Cardio-Thoracic Surgery, 2004Co-Authors: Sabine Daebritz, Benita Hermanns, Bernd Fausten, J Groetzner, B J Messmer, Joerg Schroeder, R Autschbach, J S SachwehAbstract:Objective: Current prosthetic heart Valves necessitate permanent anticoagulation or have limited durability and impaired hemodynamic performance compared to natural Valves. Recently a polymeric Valve prostheses with special design for mitral position demonstrated excellent in vitro and in vivo results with improved durability and no need for permanent anticoagulation. In this study, a respective flexible polymeric aortic Valve is presented and in vitro and in vivo results are reported. Methods: The aortic Prosthesis (ADIAM® lifescience AG, Erkelenz, Germany) is entirely made of polycarbonaturethane. The tri-leaflet flexible Prosthesis mimicks the natural aortic Valve and has a diminished pressure loss and reduced stress and strain peaks at the commissures. The Valve underwent long-term in vitro testing and in vivo-testing in a growing calve animal model (20 weeks, 7 aortic Valves) and was compared to two different commercial bioprostheses. Results: The polymeric aortic heart Valve substitute demonstrated excellent in vitro and in vivo hemodynamics. Five/seven animals with aortic PCU-prostheses had an excellent clinical long-term course. The explanted Valves showed a variable degree of calcification. Two of the seven animals died at 27 and 77 days due to pannus overgrowth causing severe LVOTO without degeneration of the Valve itself. Both animals with commercial bioprostheses had to be sacrificed because of congestive heart failure related to structural degeneration of the bioProsthesis after 10 and 30 days of implantation. There was no increased thrombogenity of the PCU Valves compared to bioprostheses. Conclusion: The new flexible polymeric aortic Valve Prosthesis is superior to current bioprostheses in animal testing.
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introduction of a flexible polymeric heart Valve Prosthesis with special design for mitral position
Circulation, 2003Co-Authors: Sabine Daebritz, J S Sachweh, Benita Hermanns, Bernd Fausten, Andreas Franke, J Groetzner, B Klosterhalfen, B J MessmerAbstract:Background— Current heart Valve prostheses are constructed mimicking the native aortic Valve. Special hemodynamic characteristics of the mitral Valve such as a nonaxial central inflow with creation of a left ventricular vortex have so far not been taken into account. A new polycarbonaturethane (PCU) bileaflet heart Valve Prosthesis with special design for the mitral position is introduced, and results of animal testing are presented. Methods and Results— After in vitro testing, 7 PCU-prostheses and 7 commercial bioprostheses (Perimount, n=4; Mosaic, n=3) were implanted in mitral position into growing Jersey calves (age 3–5 months, weight 60–97 kg) for 20 weeks. 2-Dimensional echocardiography was performed after implantation and before sacrification. Autopsy included histologic, radiographic, and electron microscopic examination of the Valves. In vitro durability was proven for >15 years. After implantation 2-dimensional-echocardiography showed no relevant gradient or regurgitation of any Prosthesis. Clini...
Hermann Reichenspurner - One of the best experts on this subject based on the ideXlab platform.
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retrograde transarterial implantation of a nonmetallic aortic Valve Prosthesis in high surgical risk patients with severe aortic stenosis
Circulation-cardiovascular Interventions, 2008Co-Authors: Joachim Schofer, Olaf Franzen, Hendrik Treede, Michael Schluter, Thilo Tubler, Andrea Pascotto, Reginald I Low, Steven F Bolling, Thomas Meinertz, Hermann ReichenspurnerAbstract:Background— To assess the feasibility and safety of retrograde transarterial implantation of a novel nonmetallic aortic Valve Prosthesis (Direct Flow Medical Inc, Santa Rosa, Calif), a prospective single-center study was performed in patients with severe aortic stenosis at high risk for open-heart surgery. Methods and Results— Fifteen patients (intention-to-treat cohort) with an aortic Valve area ≤0.8 cm2, a ≥35-mm Hg mean transvalvular pressure gradient, and a logistic EuroSCORE ≥20% were enrolled. Percutaneous aortic Valve replacement was performed with the patient under general anesthesia. Hemodynamic parameters were assessed before and after implantation by transesophageal echocardiography. Clinical follow-up and transthoracic echocardiographic assessment were obtained at 30 days. Procedural success was achieved in 12 patients (80%). Surgical conversion became necessary at day 2 in 1 patient; 11 patients (73%) were discharged with a permanent implant. In these patients, implantation resulted acutely i...
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retrograde transarterial implantation of a nonmetallic aortic Valve Prosthesis in high surgical risk patients with severe aortic stenosis a first in man feasibility and safety study
Circulation-cardiovascular Interventions, 2008Co-Authors: Joachim Schofer, Olaf Franzen, Hendrik Treede, Michael Schluter, Thilo Tubler, Andrea Pascotto, Reginald I Low, Steven F Bolling, Thomas Meinertz, Hermann ReichenspurnerAbstract:Background —To assess the feasibility and safety of retrograde transarterial implantation of a novel nonmetallic aortic Valve Prosthesis (Direct Flow Medical, Inc.), a prospective single-center study was performed in patients with severe aortic stenosis at high risk for open-heart surgery. Methods and Results —Fifteen patients (intention-to-treat cohort) with an aortic Valve area ≤0.8 cm2, a ≥35 mmHg mean transvalvular pressure gradient, and a logistic EuroSCORE ≥20% were enrolled. Percutaneous aortic Valve replacement was performed with the patient in general anesthesia. Hemodynamic parameters were assessed pre and post implantation by transesophageal echocardiography. Clinical follow-up and transthoracic echocardiographic assessment were obtained at 30 days. Procedural success was achieved in 12 patients (80%). Surgical conversion became necessary at day 2 in 1 patient, thus 11 patients (73%) were discharged with a permanent implant. In these patients, implantation resulted acutely in a significant increase in aortic Valve area (median 1.64 [IQR, 1.27 - 1.74] vs. 0.60 [0.46 - 0.69] cm2; P = 0.0033) and a concomitant reduction in the mean pressure gradient (14.0 [13.2 - 16.5] vs. 54.0 [43.2 - 59.8] mmHg; P = 0.0033). At 30 days, 1 cardiac death (6.7%; 95% CI, 0.2%-32.0%) and 1 major stroke were observed. The 10 surviving patients with a permanent implant showed marked hemodynamic and clinical improvement at this time point. Conclusions —In this small series of patients, percutaneous implantation of the Direct Flow Medical aortic Valve Prosthesis in high-surgical-risk patients was feasible and associated with a reasonably low safety profile.
Eberhard Grube - One of the best experts on this subject based on the ideXlab platform.
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percutaneous implantation of the first repositionable aortic Valve Prosthesis in a patient with severe aortic stenosis
Catheterization and Cardiovascular Interventions, 2008Co-Authors: Lutz Buellesfeld, Ulrich Gerckens, Eberhard GrubeAbstract:Objectives and Background: Percutaneous aortic Valve replacement is a new less-invasive alternative for high-risk surgical candidates with aortic stenosis. However, the clinical experience is still limited, and the currently available ‘first-generation devices’ revealed technical shortcomings, such as lack of repositionability and presence of paravalvular leakages. We report the first-in-man experience with the new self-expanding Lotus™ Valve Prosthesis composed of a nitinol frame with implemented bovine pericardial leaflets which is designed to address these issues, being repositionable and covered by a flexible membrane to seal paravalvular gaps. We implanted this Prosthesis in a 93-year old patient presenting with severe symptomatic aortic stenosis (Valve area: 0.6 cm2). Surgical Valve replacement had been declined due to comorbidities. Methods and Results: We used a retrograde approach for insertion of the 21-French Lotus catheter loaded with the Valve Prosthesis via surgical cut-down to the external iliac artery. Positioning of the Valve was guided by transesophageal echo and supra-aortic angiograms. The Prosthesis was successfully inserted and deployed within the calcified native Valve. Echocardiography immediately after device deployment showed a significant reduction of the transaortic mean pressure gradient (32 to 9 mmHg; final Valve area 1.7 cm2) without evidence of residual aortic regurgitation. The postprocedural clinical status improved from NYHA-IV to NYHA-II. These results remained unchanged up to the 3 month follow-up. Conclusions: Successful percutaneous aortic Valve replacement can be performed using the new self-expanding and repositionable Lotus Valve for treatment of high-risk patients with aortic Valve stenosis. Further studies are mandatory to assess device safety and efficacy in larger patient populations. © 2008 Wiley-Liss, Inc.
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percutaneous implantation of the coreValve self expanding Valve Prosthesis in high risk patients with aortic Valve disease the siegburg first in man study
Circulation, 2006Co-Authors: Eberhard Grube, Jean Claude Laborde, Ulrich Gerckens, Thomas Felderhoff, Barthel Sauren, Lutz Buellesfeld, Ralf Mueller, Maurizio Menichelli, Thomas M Schmidt, Bernfried ZickmannAbstract:Background— The morbidity and mortality of surgical aortic Valve replacement are increased in elderly patients with multiple high-risk comorbid conditions. Therefore, a prospective, single-center, nonrandomized study was performed in high-risk patients with aortic Valve disease to evaluate the feasibility and safety of percutaneous implantation of a novel self-expanding aortic Valve bioProsthesis (CoreValve). Methods and Results— Symptomatic high-risk patients with an aortic Valve area 2 were considered for enrollment. CoreValve implantation was performed under general anesthesia with extracorporeal support using the retrograde approach. Clinical follow-up and transthoracic echocardiography were performed after the procedure and at days 15 and 30 after device implantation to evaluate short-term patient and device outcomes. A total of 25 patients with symptomatic aortic Valve stenosis (mean gradient before implantation, 44.2±10.8 mm Hg) and multiple comorbidities (median logistic EuroScore, 11.0%) were enrolled. Device success and procedural success were achieved in 22 (88%) and 21 (84%) patients, respectively. Successful device implantation resulted in a marked reduction in the aortic Valve gradients (mean gradient after implantation, 12.4±3.0 mm Hg; P Conclusions— Percutaneous implantation of the self-expanding CoreValve aortic Valve Prosthesis in high-risk patients with aortic stenosis with or without aortic regurgitation is feasible and, when successful, results in marked hemodynamic and clinical improvement.
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first report on a human percutaneous transluminal implantation of a self expanding Valve Prosthesis for interventional treatment of aortic Valve stenosis
Catheterization and Cardiovascular Interventions, 2005Co-Authors: Eberhard Grube, Jean Claude Laborde, Ulrich Gerckens, Thomas Felderhoff, Barthel Sauren, Lutz Buellesfeld, Bernfried Zickmann, Andreas Bootsveld, Stein IversenAbstract:Background: Percutaneous aortic Valve replacement is a new technology for the treatment of patients with significant aortic Valve stenosis. We present the first report on a human implantation of a self-expanding aortic Valve Prosthesis, which is composed of three bovine pericardial leaflets inserted within a self-expanding nitinol stent. The 73-year-old woman presented with severe symptomatic aortic Valve stenosis (mean transvalvular gradient of 45 mmHg; Valve area of 0.7 cm2). Surgical Valve replacement had been declined for the patient because of comorbidities, including previous bypass surgery. Method and Results: A retrograde approach via the common iliac artery was used for Valve deployment. The contralateral femoral vessels were used for a temporary extracorporal circulation, unloading the left ventricle during the actual stent expansion. Clinical, hemodynamic, and echocardiographic outcomes were assessed serially during the procedure. Clinical and echocardiographic follow-up at day 1, 2, and 14 post procedure was performed to evaluate the short-term outcome. The Prosthesis was successfully deployed within the native aortic Valve, with accurate and stable positioning and with no impairment of the coronary artery or vein graft blood flow. 2D and doppler echo immediately after device deployment showed a significant reduction in transaortic mean pressure gradient (from 45 to 8 mmHg) without evidence of aortic or mitral Valve insufficiency. The clinical status has then significantly improved. These results remained unchanged up to the day 14 follow-up. Conclusion: This case report demonstrates a successful percutaneous implantation of a self-expanding aortic Valve Prosthesis with remarkable functional and clinical improvements in the acute and short-term outcome. © 2005 Wiley-Liss, Inc.
