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Eberhard Grube - One of the best experts on this subject based on the ideXlab platform.
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progress and current status of Percutaneous Aortic Valve replacement results of three device generations of the coreValve revalving system
Circulation-cardiovascular Interventions, 2008Co-Authors: Eberhard Grube, Lutz Buellesfeld, Ralf Mueller, Barthel Sauren, Bernfried Zickmann, Dinesh Nair, Harald Beucher, Thomas Felderhoff, Stein Iversen, Ulrich GerckensAbstract:Background— Percutaneous Aortic Valve replacement is a new emerging technology for interventional treatment of severe Aortic Valve stenosis in surgical high-risk patients. This study was intended to provide a summary of the development and current safety and efficacy status of the self-expanding CoreValve Revalving prosthesis. Method and Results— Between 2005 and 2008, we have enrolled 136 consecutive patients with Percutaneous Aortic Valve replacement using the CoreValve prosthesis. In this prospective nonrandomized, single-center trial, we analyzed procedural outcome, complications and clinical status up to 1 year. First, second, and third generation of the CoreValve prosthesis were implanted in 10, 24, and 102 consecutive high-risk patients (logistic EuroScore: 23.1�15.0%) with severe symptomatic Aortic Valve stenosis. Mean transvalvular pressure gradient was 41.5�16.7 mm Hg. The procedural success rate increased from generation 1/2 to 3 from 70.0%/70.8% to 91.2% (P=0.003). The 30-day combined rate of ...
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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 Aortic Valve replacement for severe Aortic regurgitation in degenerated bioprosthesis the first Valve in Valve procedure using the coreValve revalving system
Catheterization and Cardiovascular Interventions, 2007Co-Authors: Peter Wenaweser, Lutz Buellesfeld, Ulrich Gerckens, Eberhard GrubeAbstract:Percutaneous Valve replacement for severe Aortic stenosis has shown to be an alternative treatment option for non-surgical candidates. We report on the first successful Valve in Valve procedure in an 80-year-old patient with a severe regurgitation of a degenerated Aortic bioprosthesis using the CoreValve Revalving system.
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Percutaneous Aortic Valve replacement for severe Aortic stenosis in high risk patients using the second and current third generation self expanding coreValve prosthesis device success and 30 day clinical outcome
Journal of the American College of Cardiology, 2007Co-Authors: Eberhard Grube, Ulrich Gerckens, Lutz Buellesfeld, Peter Wenaweser, Barthel Sauren, Gerhard Schuler, Axel Linke, F W Mohr, Thomas Walther, Bernfried ZickmannAbstract:Objectives We sought to determine both the procedural performance and safety of Percutaneous implantation of the second (21-French [F])- and third (18-F)-generation CoreValve Aortic Valve prosthesis (CoreValve Inc., Irvine, California). Background Percutaneous Aortic Valve replacement represents an emerging alternative therapy for high-risk and inoperable patients with severe symptomatic Aortic Valve stenosis. Methods Patients with: 1) symptomatic, severe Aortic Valve stenosis (area 2 ); 2) age ≥80 years with a logistic EuroSCORE ≥20% (21-F group) or age ≥75 years with a logistic EuroSCORE ≥15% (18-F group); or 3) age ≥65 years plus additional prespecified risk factors were included. Introduction of the 18-F device enabled the transition from a multidisciplinary approach involving general anesthesia, surgical cut-down, and cardiopulmonary bypass to a truly Percutaneous approach under local anesthesia without hemodynamic support. Results A total of 86 patients (21-F, n = 50; 18-F, n = 36) with a mean Valve area of 0.66 ± 0.19 cm 2 (21-F) and 0.54 ± 0.15 cm 2 (18-F), a mean age of 81.3 ± 5.2 years (21-F) and 83.4 ± 6.7 years (18-F), and a mean logistic EuroSCORE of 23.4 ± 13.5% (21-F) and 19.1 ± 11.1% (18-F) were recruited. Acute device success was 88%. Successful device implantation resulted in a marked reduction of Aortic transvalvular gradients (mean pre 43.7 mm Hg vs. post 9.0 mm Hg, p Conclusions Treatment of severe Aortic Valve stenosis in high-risk patients with Percutaneous implantation of the CoreValve prosthesis is feasible and associated with a lower mortality rate than predicted by risk algorithms.
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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, Ulrich Gerckens, Lutz Buellesfeld, Barthel Sauren, Bernfried Zickmann, Thomas Felderhoff, Jean C Laborde, 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.
Hermann Reichenspurner - One of the best experts on this subject based on the ideXlab platform.
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midterm stability and hemodynamic performance of a transfemorally implantable nonmetallic retrievable and repositionable Aortic Valve in patients with severe Aortic stenosis up to 2 year follow up of the direct flow medical Valve a pilot study
Circulation-cardiovascular Interventions, 2011Co-Authors: Klaudija Bijuklic, Hendrik Treede, Reginald I Low, Hermann Reichenspurner, Thilo Tuebler, Andreas Wandler, John H Harreld, Joachim SchoferAbstract:Background—Misplacement during Percutaneous Aortic Valve implantation can be associated with severe complications. The direct flow medical (DFM) Valve is repositionable and retrievable; however, the nonmetallic inflatable and conformable design of the Valve results in less radial force, which may have an impact on stability and Valve function over time. We, therefore, analyzed the midterm stability of the position, shape, and hemodynamic performance of the DFM Percutaneous Aortic Valve. Methods and Results—Sixteen symptomatic high-risk for surgery patients with Aortic stenosis and a logistic EuroSCORE >20 underwent implantation and were the subject of this analysis. Clinical, echocardiographic, and dual-source multislice computed tomography data were obtained during 2-year follow-up. The 1- and 2-year survival rates were 81% and 69%, respectively. The dual-source multislice computed tomography follow-up indicated no changes in position, diameter, and orifice area of the DFM Valve over time. Echocardiograp...
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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.
John G Webb - One of the best experts on this subject based on the ideXlab platform.
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Percutaneous Aortic Valve Implantation Retrograde From the Femoral Artery
2014Co-Authors: John G Webb, Ron Carere, Christopher E Buller, Md Brad, I. Munt, Sanjeevan Pasupati Md Samuel LichtensteinAbstract:Background—Percutaneous Aortic Valve implantation by an antegrade transvenous approach has been described but is problematic. Retrograde prosthetic Aortic Valve implantation via the femoral artery has potential advantages. Percutaneous prosthetic Aortic Valve implantation via the femoral arterial approach is described and the initial experience reported. Methods and Results—The Valve prosthesis is constructed from a stainless steel stent with an attached trileaflet equine pericardial Valve and a fabric cuff. After routine Aortic balloon valvuloplasty, a 22F or 24F sheath is advanced from the femoral artery to the aorta. A steerable, deflectable catheter facilitates manipulation of the prosthesis around the Aortic arch and through the stenotic Valve. Rapid ventricular pacing is used to reduce cardiac output while the delivery balloon is inflated to deploy the prosthesis within the annulus. Percutaneous Aortic prosthetic Valve implantation was attempted in 18 patients (aged 816 years) in whom surgical risk was deemed excessive because of comorbidities. Iliac arterial injury, seen in the first 2 patients, did not recur after improvement in screening and access site management. Implantation was successful in 14 patients. After successful implantation, the Aortic Valve area increased from 0.60.2 to 1.60.4 cm2. There were no intraprocedural deaths. At follow-up of 7555 days, 16 patients (89%) remained alive. Conclusions—This initial experience suggests that Percutaneous transarterial Aortic Valve implantation is feasible in selected high-risk patients with satisfactory short-term outcomes. (Circulation. 2006;113:842-850.) Key Words: aorta stenosis catheters stents valvuloplasty Symptomatic Aortic stenosis is an accepted indication forsurgery, in which Valve replacement can both reduce symptoms and extend life.1 Despite this, many patients with severe Aortic stenosis do not undergo surgery because of excessive risk, advanced age, or preference. Prognosis with medical management is poor,1 and Percutaneous alternatives to surgery have been limited to balloon valvuloplasty with palliation that is modest and short-lived.2,
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Percutaneous Aortic Valve replacement vascular outcomes with a fully Percutaneous procedure
Journal of the American College of Cardiology, 2012Co-Authors: Stefan Toggweiler, Ronen Gurvitch, Jonathon Leipsic, David A Wood, Alexander B Willson, Ronald K Binder, Anson Cheung, John G WebbAbstract:Objectives The aim of this study was to evaluate vascular complications in a consecutive patient population undergoing transfemoral Percutaneous Aortic Valve replacement (PAVR) applying current Valve Academic Research Consortium definitions. Background Vascular complications have been the major cause of mortality and morbidity associated with PAVR. Both open surgical and fully Percutaneous access site strategies have been advocated. Methods All patients undergoing transfemoral PAVR during fiscal years 2009 and 2010 were prospectively evaluated at baseline, after the procedure, and at 30 days. Results PAVR was performed in 137 consecutive patients. All but 1 patient underwent planned arteriotomy closure using a Percutaneous pre-closure technique. Smaller sheaths, rigorous angiographic and computed tomographic screening and patient selection, and Percutaneous vascular repair techniques were increasingly used over this period. From 2009 to 2010, major vascular complications decreased from 8% to 1% (p = 0.06), minor vascular complications decreased from 24% to 8% (p Conclusions Vascular complications occur more often if the minimal artery diameter is smaller than the external sheath diameter, in the presence of moderate or severe calcification, and in patients with peripheral vascular disease. With careful patient selection, advanced interventional techniques, and a fully Percutaneous procedure, marked reductions in vascular and bleeding complications can be achieved.
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ct of the ilio femoral arteries using direct Aortic contrast injection proof of feasibility in patients screened towards Percutaneous Aortic Valve replacement
Swiss Medical Weekly, 2009Co-Authors: Fabian Nietlispach, Jeanbernard Masson, Jonathon Leipsic, Ron Carere, Saad Albugami, John G WebbAbstract:Principles Transfemoral Aortic Valve implantation (TAVI) is a promising treatment modality for selected patients with severe symptomatic Aortic stenosis. Peripheral access via the femoral and iliac artery is an important issue, limiting this technique's applicability in patients suffering from peripheral arterial disease. Multislice computed tomography (MSCT) reliably identifies patients with suitable peripheral access. However, MSCT involves an additional contrast dye burden in patients often suffering from renal failure. In this study, the feasibility of direct-Aortic-contrast-injection for MSCT was investigated, aiming to reduce total contrast load. Methods Patients undergoing evaluation for TAVI underwent an aortogram including iliac and femoral arteries. In 7 selected patients with questionable peripheral access, MSCT was performed by advancing a pigtail catheter to the level of L2, followed by direct injection of 15-20 ml of contrast mixed with an equal volume of saline. This injection was followed by an injection of 40 ml of saline. Scanning was initiated 4 seconds after starting the contrast injection. All MSCT scans were obtained using a 64 slice scanner. Results In all 7 patients, except one, the distal aorta, iliac and femoral arteries where adequately imaged to allow reliable assessment of peripheral access for TAVI. Of the 7 patients evaluated, 2 were rejected for TAVI based on the information of the MSCT using direct-Aortic-contrast-injection. Limitations of the technique may be an underestimation of the arterial diameter due to spasms at the puncture site. Conclusion MSCT using direct-Aortic-contrast-injection for assessment of peripheral access for TAVI is feasible and may provide good diagnostic images with a reduced volume of contrast.
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comparison of the hemodynamic performance of Percutaneous and surgical bioprostheses for the treatment of severe Aortic stenosis
Journal of the American College of Cardiology, 2009Co-Authors: Marie-annick Clavel, John G Webb, Jeanbernard Masson, Eric Dumont, Philippe Pibarot, Daniel Doyle, Lukas Altwegg, Christopher R Thompson, Robert De Larochelliere, Sebastien BergeronAbstract:Objectives This study was undertaken to compare the hemodynamic performance of a Percutaneous bioprosthesis to that of surgically implanted (stented and stentless) bioprostheses for the treatment of severe Aortic stenosis. Methods Fifty patients who underwent Percutaneous Aortic Valve implantation (PAVI) with the Cribier-Edwards or Edwards SAPIEN bioprosthetic Valve (Edwards Lifesciences, Inc., Irvine, California) were matched 1:1 for sex, Aortic annulus diameter, left ventricular ejection fraction, body surface area, and body mass index, with 2 groups of 50 patients who underwent surgical Aortic Valve replacement (SAVR) with a stented Valve (Edwards Perimount Magna [SAVR-ST group]), or a stentless Valve (Medtronic Freestyle, Medtronic, Minneapolis, Minnesota [SAVR-SL group]). Doppler echocardiographic data were prospectively obtained before the intervention, at discharge, and at 6- to 12-month follow-up. Results Mean transprosthetic gradient at discharge was lower (p Conclusions PAVI provided superior hemodynamic performance compared with the surgical bioprostheses in terms of transprosthetic gradient and prevention of severe prosthesis-patient mismatch, but was associated with a higher incidence of AR.
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Percutaneous Aortic Valve replacement will become a common treatment for Aortic Valve disease.
JACC. Cardiovascular interventions, 2008Co-Authors: John G WebbAbstract:Percutaneous Valve replacement is developing into an effective and reproducible therapy for Aortic Valve stenosis. Initial experience suggests that outcomes compare favorably with conventional Valve surgery in selected patients with comorbidities, such as advanced age. Caution is prudent, however, in the future a more mature procedure might represent a viable alternative for a much broader range of patients.
Joachim Schofer - One of the best experts on this subject based on the ideXlab platform.
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midterm stability and hemodynamic performance of a transfemorally implantable nonmetallic retrievable and repositionable Aortic Valve in patients with severe Aortic stenosis up to 2 year follow up of the direct flow medical Valve a pilot study
Circulation-cardiovascular Interventions, 2011Co-Authors: Klaudija Bijuklic, Hendrik Treede, Reginald I Low, Hermann Reichenspurner, Thilo Tuebler, Andreas Wandler, John H Harreld, Joachim SchoferAbstract:Background—Misplacement during Percutaneous Aortic Valve implantation can be associated with severe complications. The direct flow medical (DFM) Valve is repositionable and retrievable; however, the nonmetallic inflatable and conformable design of the Valve results in less radial force, which may have an impact on stability and Valve function over time. We, therefore, analyzed the midterm stability of the position, shape, and hemodynamic performance of the DFM Percutaneous Aortic Valve. Methods and Results—Sixteen symptomatic high-risk for surgery patients with Aortic stenosis and a logistic EuroSCORE >20 underwent implantation and were the subject of this analysis. Clinical, echocardiographic, and dual-source multislice computed tomography data were obtained during 2-year follow-up. The 1- and 2-year survival rates were 81% and 69%, respectively. The dual-source multislice computed tomography follow-up indicated no changes in position, diameter, and orifice area of the DFM Valve over time. Echocardiograp...
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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.
Jeanclaude Laborde - One of the best experts on this subject based on the ideXlab platform.
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post implantation repositioning of the coreValve Percutaneous Aortic Valve
Jacc-cardiovascular Interventions, 2010Co-Authors: Azeem Latib, Jeanclaude Laborde, Iassen Michev, Matteo Montorfano, Antonio ColomboAbstract:A 76-year-old man presented with congestive heart failure on the basis of severe Aortic stenosis (AS). Echocardiography confirmed severe calcific AS (mean gradient = 45 mm Hg, peak gradient = 78 mm Hg, Aortic Valve area = 0.5 cm2, annulus diameter = 25 mm) and globally depressed left ventricular (LV
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Percutaneous Aortic Valve implants under sedation our initial experience
Catheterization and Cardiovascular Interventions, 2008Co-Authors: Miles Behan, Peter Haworth, Nevil Hutchinson, Uday Trivedi, Jeanclaude Laborde, David HildicksmithAbstract:Objectives: We have developed an approach where Percutaneous Aortic Valve (PAVI) procedures are done under remifentanil-based sedation administered by an anesthetist. We report here our initial experience. Background: Percutaneous Aortic Valve implantation is proving to be an effective treatment for Aortic stenosis in patients with significant comorbidity precluding surgical Aortic Valve replacement. Most PAVIs have been done under general anesthetic with transoesophageal echocardiography (TOE). General anesthesia in this patient group is hazardous and associated with significant complications. Methods and Results: CoreValve implantation was performed via the retrograde approach in 12 patients at our cardiothoracic center between December 2007 and May 2008. Three had the procedure under general anesthetic and nine under sedation. There were no differences between the groups in terms of comorbidities and clinical characteristics. The procedure was visualized using fluoroscopic Aortic calcification coupled with multiple small volume aortograms. One patient converted from sedation to general anesthetic during the procedure. One patient in the general anesthetic group died from respiratory complications. There were no significant differences in procedural success, procedure time, or hospital stay between the two groups. Conclusion: Percutaneous Aortic Valve implantation can, in the majority of cases, be performed under remifentanil-based sedation. Our initial experience suggests that this should result in a shorter implant procedure time, reduced stay in high dependency areas, and shorter time to hospital discharge. © 2008 Wiley-Liss, Inc.
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Percutaneous Aortic Valve replacement pavr with the coreValve self expanding bioprosthesis in severe calcific Aortic stenosis results in improvement of symptoms of heart failure and early regression of left ventricular wall thickness
Heart Lung and Circulation, 2008Co-Authors: Hasan Jilaihawi, Jeanclaude Laborde, Derek Chin, Elaine Logtens, Tomasz J Spyt, Jan KovacAbstract:Background: The early effects on left ventricular wall thickness and symptoms of heart failure in patients with severe degenerative Aortic stenosis following Percutaneous Aortic Valve replacementwith theCoreValve stented bioprosthesis were studied. Methods: Patients undergoing pAVR with the CoreValve stented bioprosthesis for severe calcific Aortic stenosis with symptoms of heart failure of NYHA 2 or more were studied. Transthoracic echocardiograms were performed prior to the procedure and at 1 month follow up. Aortic Valve area by continuity equation and biplane ejection fraction was calculated. To assess hypertrophy, interventricular septal dimension in end diastole (IVSd) from the parasternal long axis view was recorded. NYHA status was recorded baseline and at 1 month. Differences were assessed using a paired samples T-test for normally distributed data or Wilcoxon two related samples analyses Methods of study: Twenty eightpatients aged from40 to 60 with coronary heart disease (CHD) with II–III functional class (FC) of CHF (NYHA) developed after myocardial infarction were examined. 1st group was formed from 13 patients with II FC and 2nd group was formed from 15 patients with III FC of CHF. All the patients obtained carvedilol at a dose 25–30mg per day. All the patients were examined initially and in 6 months by SPECT with radiopharmpreparation 99MTc Sestamibi at rest and with nitroglycerin test (NGT). Results of study: Analysis of the initial data of myocardial SPECT in patients of the IIIrd FC of CHFhas revealed substantial injuries in myocardial perfusion with a presence of stable zones of aperfusion and hypoperfusion. A reliable perfection of regional perfusion and EF noted to be after SPECT with NGT in patients of the IInd and IIIrd FC of CHF that evidenced an availability of vital myocardium of the left ventricle (LV). EF at rest was increased by 23% in 6 months in patients with the IInd FC CHF, after NGT by 24.2%. Data of patients with the IIIrd FC of CHF in dynamic of 6 months treatment with carvedilol, indices of local perfusion of myocardial LV were increased with a reliable reduction of an index of myocardial disordered perfusion of rest and after NGT by 23.4% (p< 0.05) and 45.2% (p< 0.02) respectively, and index of aperfusion by 35.1% (p< 0.05) at rest as compared with an initial one. Conclusions: Thus, 6 months therapy with carvedilol
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surgical aspects of endovascular retrograde implantation of the Aortic coreValve bioprosthesis in high risk older patients with severe symptomatic Aortic stenosis
The Journal of Thoracic and Cardiovascular Surgery, 2007Co-Authors: Bertrand Marcheix, Jeanclaude Laborde, Colin Berry, Yoan Lamarche, Anique Ducharme, Raoul Bonan, Anita W Asgar, Arsene Basmadjian, Andre Y Denault, Raymond CartierAbstract:Objectives Aortic stenosis is one of the most common forms of acquired valvular heart disease in adults, and the proportion of patients unsuitable for conventional surgery is increasing. Consequently, the development of new less-invasive techniques to treat severe Aortic stenosis is crucially important. Current experience in Percutaneous Aortic Valve replacement is limited to a few groups, and the search for an optimal technique continues. We report our experience with retrograde endovascular bioprosthesis implantation with brief cardiopulmonary bypass support in high-risk older patients. Methods The CoreValve pericardial bioprosthesis (CoreValve, Inc, Paris, France) is sutured on a nitinol frame and delivered in a 21F catheter. All procedures were performed under femoro–femoral cardiopulmonary bypass support consisting of an Aortic balloon valvuloplasty followed by prosthesis deployment within the Aortic annulus under fluoroscopy. Ten high-risk surgical patients underwent Percutaneous Valve replacement. Results Immediate improvement in Aortic Valve function was observed in all patients. The Aortic Valve area increased from 0.57 ± 0.19 to 1.2 ± 0.35 cm 2 ( P = .00001), the mean transAortic Valve gradient decreased from 51 ± 19 to 11 ± 3 mm Hg ( P P = .01). Conclusions Aortic Valve replacement with the CoreValve bioprosthesis can be performed with favorable early technical results in high-risk patients. However, the morbidity and short-term mortality of such procedures remain significant.
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novel therapeutic aspects of Percutaneous Aortic Valve replacement with the 21f coreValve revalving system
Catheterization and Cardiovascular Interventions, 2007Co-Authors: Colin Berry, Jeanclaude Laborde, Yoan Lamarche, Anique Ducharme, Raymond Cartier, Anita W Asgar, Bertrand Marcheix, Pierre Couture, Arsene Basmadjian, Raoul BonanAbstract:Aims: Percutaneous Aortic Valve replacement (PAVR) is an emerging therapy for nonsurgical patients with severe Aortic stenosis (AS). We investigated whether novel therapeutic approaches may facilitate AVR outcomes for high-risk patients. Methods and Results: Eleven patients [n = 6 (54%) men] aged 82 ± 10 years underwent PAVR after being refused for open surgery. The mean±SD AV area and left ventricular ejection fraction (LVEF) of these patients was 0.56 ± 0.19 cm2 and 49 ± 17%, respectively, with severe functional limitation (NYHA class III (n = 8) and IV (n = 3)). One patient underwent PAVR combined with simultaneous Percutaneous coronary intervention (PCI). Two male patients needed left iliac artery angioplasty. A Percutaneous ventricular assist device (PVAD) was used in the most recent case. Compared with pre-PAVR, mean AV area (1.3 ± 0.4 cm2; P < 0.001) and LVEF (56 ± 11%; P < 0.001) increased. One man had a peri-procedural stroke and died 5 days post-PAVR. Four other patients died within 4 months of hospital discharge. The median duration of survival of the survivors was 305 (range 249–431) days. Conclusions: Novel Percutaneous techniques facilitate CoreValve PAVR (21 Fr.). Future lower profile devices (e.g. 18 Fr. Generation III CoreValve) should permit inclusion of a broader spectrum of high-risk patients. PAVR may evolve toward a full Percutaneous approach. © 2007 Wiley-Liss, Inc.