Percutaneous Transcatheter Implantation of an Aortic Valve Prosthesis for Calcific Aortic Stenosis First Human Case Description
Alain Cribier,Hélène Eltchaninoff,Assaf Bash,Nicolas Borenstein,Christophe Tron,Fabrice Bauer,Geneviève Derumeaux,Frédéric Anselme,François Laborde,Martin B. Leon +9 more
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TLDR
A percutaneous implantable prosthetic heart valve (PHV) composed of 3 bovine pericardial leaflets mounted within a balloon-expandable stent was developed in this article.Abstract:
Background— The design of a percutaneous implantable prosthetic heart valve has become an important area for investigation. A percutaneously implanted heart valve (PHV) composed of 3 bovine pericardial leaflets mounted within a balloon-expandable stent was developed. After ex vivo testing and animal implantation studies, the first human implantation was performed in a 57-year-old man with calcific aortic stenosis, cardiogenic shock, subacute leg ischemia, and other associated noncardiac diseases. Valve replacement had been declined for this patient, and balloon valvuloplasty had been performed with nonsustained results. Methods and Results— With the use of an antegrade transseptal approach, the PHV was successfully implanted within the diseased native aortic valve, with accurate and stable PHV positioning, no impairment of the coronary artery blood flow or of the mitral valve function, and a mild paravalvular aortic regurgitation. Immediately and at 48 hours after implantation, valve function was excellent, resulting in marked hemodynamic improvement. Over a follow-up period of 4 months, the valvular function remained satisfactory as assessed by sequential transesophageal echocardiography, and there was no recurrence of heart failure. However, severe noncardiac complications occurred, including a progressive worsening of the leg ischemia, leading to leg amputation with lack of healing, infection, and death 17 weeks after PHV implantation. Conclusions— Nonsurgical implantation of a prosthetic heart valve can be successfully achieved with immediate and midterm hemodynamic and clinical improvement. After further device modifications, additional durability tests, and confirmatory clinical implantations, PHV might become an important therapeutic alternative for the treatment of selected patients with nonsurgical aortic stenosis.read more
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Journal ArticleDOI
Transcatheter Aortic-Valve Implantation for Aortic Stenosis in Patients Who Cannot Undergo Surgery
Martin B. Leon,Craig R. Smith,Michael J. Mack,D. Craig Miller,Jeffrey W. Moses,Lars G. Svensson,E. Murat Tuzcu,John G. Webb,Gregory P. Fontana,Raj Makkar,David L. Brown,Peter C. Block,Robert A. Guyton,Augusto D. Pichard,Joseph E. Bavaria,Howard C. Herrmann,Pamela S. Douglas,John L. Petersen,Jodi J. Akin,William N. Anderson,Duolao Wang,Stuart J. Pocock +21 more
TL;DR: In patients with severe aortic stenosis who were not suitable candidates for surgery, TAVI, as compared with standard therapy, significantly reduced the rates of death from any cause, the composite end point of deathFrom any cause or repeat hospitalization, and cardiac symptoms, despite the higher incidence of major strokes and major vascular events.
Journal ArticleDOI
Transcatheter versus Surgical Aortic-Valve Replacement in High-Risk Patients
Craig R. Smith,Martin B. Leon,Michael J. Mack,D. Craig Miller,Jeffrey W. Moses,Lars G. Svensson,E. Murat Tuzcu,John G. Webb,Gregory P. Fontana,Raj Makkar,Mathew R. Williams,Todd M. Dewey,Samir R. Kapadia,Vasilis Babaliaros,Vinod H. Thourani,Paul J. Corso,Augusto D. Pichard,Joseph E. Bavaria,Howard C. Herrmann,Jodi J. Akin,William N. Anderson,Duolao Wang,Stuart J. Pocock +22 more
TL;DR: In high-risk patients with severe aortic stenosis, transcatheter and surgical procedures for aorti-valve replacement were associated with similar rates of survival at 1 year, although there were important differences in periprocedural risks.
Journal ArticleDOI
Two-Year Outcomes after Transcatheter or Surgical Aortic-Valve Replacement
Susheel Kodali,Mathew R. Williams,Craig R. Smith,Lars G. Svensson,John G. Webb,Raj Makkar,Gregory P. Fontana,Todd M. Dewey,Vinod H. Thourani,Augusto D. Pichard,Michael P. Fischbein,Wilson Y. Szeto,Scott Lim,Kevin L. Greason,Paul S. Teirstein,S. Chris Malaisrie,Pamela S. Douglas,Rebecca T. Hahn,Brian Whisenant,Alan Zajarias,Duolao Wang,Jodi J. Akin,William N. Anderson,Martin B. Leon,Trial Investigators +24 more
TL;DR: A 2-year follow-up of patients in the PARTNER trial supports TAVR as an alternative to surgery in high-risk patients, but paravalvular regurgitation was more frequent after T AVR and was associated with increased late mortality.
Journal ArticleDOI
Standardized Endpoint Definitions for Transcatheter Aortic Valve Implantation Clinical Trials : A Consensus Report From the Valve Academic Research Consortium
Martin B. Leon,Nicolo Piazza,Eugenia Nikolsky,Eugene H. Blackstone,Donald E. Cutlip,Arie Pieter Kappetein,Mitchell W. Krucoff,Michael J. Mack,Roxana Mehran,Craig Miller,Marie-Angèle Morel,John L. Petersen,Jeffrey J. Popma,Johanna J.M. Takkenberg,Alec Vahanian,Gerrit-Anne van Es,Pascal Vranckx,John G. Webb,Stephan Windecker,Patrick W. Serruys +19 more
TL;DR: Although consensus criteria will invariably include certain arbitrary features, an organized multidisciplinary process to develop specific definitions for TAVI clinical research should provide consistency across studies that can facilitate the evaluation of this new important catheter-based therapy.
Journal ArticleDOI
Registry of Transcatheter Aortic-Valve Implantation in High-Risk Patients
TL;DR: This prospective registry study reflected real-life TAVI experience in high-risk elderly patients with aortic stenosis, in whom T AVI appeared to be a reasonable option.
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