Clinical outcomes of the Lotus Valve in patients with bicuspid aortic valve stenosis: An analysis from the RESPOND study

There is no author summary for this article yet. Authors can add summaries to their articles on ScienceOpen to make them more accessible to a non-specialist audience.

Abstract

Aims

Patients with bicuspid valves represent a challenging anatomical subgroup for transcatheter aortic valve implantation (TAVI). This analysis evaluated the clinical outcomes of the fully repositionable and retrievable Lotus Valve System in patients with bicuspid aortic valves enrolled in the RESPOND post‐market registry.

Methods and Results

The prospective, open‐label RESPOND study enrolled 1,014 patients at 41 centers in Europe, New Zealand, and Latin America, 31 (3.1%) of whom had bicuspid aortic valves. The mean age in the bicuspid patient cohort was 76.4 years, 64.5% were male, and the baseline STS score was 6.0 ± 10.2. Procedural success was 100%, with no cases of malpositioning, valve migration, embolization, or valve‐in‐valve. Repositioning was attempted in 10 cases (32.3%). There was one death (3.2%) and one stroke (3.2%) at 30‐day follow‐up. Mean AV gradient was reduced from 48.7 ± 17.0 mmHg at baseline to 11.8 ± 5.1 mmHg at hospital discharge ( P < 0.001); mean effective orifice area (EOA) was increased from 0.6 ± 0.2 cm ² to 1.7 ± 0.4 cm ² ( P < 0.001). There were no cases of moderate or severe paravalvular leak (PVL) adjudicated by the core laboratory; four subjects (13.8%) had mild PVL, 5 (17.2%) had trace PVL. The rate of pacemaker (PM) implantation for PM‐naïve patients was 22.2% (6/27).

Conclusions

Data from the RESPOND registry demonstrate good clinical and echocardiographic outcomes up to 1 year postimplantation in patients with bicuspid aortic valves using the repositionable Lotus Valve.

Related collections

Most cited references 22

Record: found
Abstract: found
Article: not found

Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document.

A Pieter Kappetein, Stuart Head, Philippe Genereux … (2012)

The aim of the current Valve Academic Research Consortium (VARC)-2 initiative was to revisit the selection and definitions of transcatheter aortic valve implantation (TAVI) clinical endpoints to make them more suitable to the present and future needs of clinical trials. In addition, this document is intended to expand the understanding of patient risk stratification and case selection. A recent study confirmed that VARC definitions have already been incorporated into clinical and research practice and represent a new standard for consistency in reporting clinical outcomes of patients with symptomatic severe aortic stenosis (AS) undergoing TAVI. However, as the clinical experience with this technology has matured and expanded, certain definitions have become unsuitable or ambiguous. Two in-person meetings (held in September 2011 in Washington, DC, USA, and in February 2012 in Rotterdam, the Netherlands) involving VARC study group members, independent experts (including surgeons, interventional and non-interventional cardiologists, imaging specialists, neurologists, geriatric specialists, and clinical trialists), the US Food and Drug Administration (FDA), and industry representatives, provided much of the substantive discussion from which this VARC-2 consensus manuscript was derived. This document provides an overview of risk assessment and patient stratification that need to be considered for accurate patient inclusion in studies. Working groups were assigned to define the following clinical endpoints: mortality, stroke, myocardial infarction, bleeding complications, acute kidney injury, vascular complications, conduction disturbances and arrhythmias, and a miscellaneous category including relevant complications not previously categorized. Furthermore, comprehensive echocardiography recommendations are provided for the evaluation of prosthetic valve (dys)function. Definitions for the quality of life assessments are also reported. These endpoints formed the basis for several recommended composite endpoints. This VARC-2 document has provided further standardization of endpoint definitions for studies evaluating the use of TAVI, which will lead to improved comparability and interpretability of the study results, supplying an increasingly growing body of evidence with respect to TAVI and/or surgical aortic valve replacement. This initiative and document can furthermore be used as a model during current endeavors of applying definitions to other transcatheter valve therapies (for example, mitral valve repair). Copyright © 2012 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

0 comments Cited 399 times – based on 0 reviews      Review now

Bookmark

Record: found
Abstract: found
Article: not found

A classification system for the bicuspid aortic valve from 304 surgical specimens.

Hans-H. Sievers, Claudia Schmidtke (2007)

In general, classification of a disease has proven to be advantageous for disease management. This may also be valid for the bicuspid aortic valve, because the term "bicuspid aortic valve" stands for a common congenital aortic valve malformation with heterogeneous morphologic phenotypes and function resulting in different treatment strategies. We attempted to establish a classification system based on a 5-year data collection of surgical specimens. Between 1999 and 2003 a precise description of valve pathology was obtained from operative reports of 304 patients with a diseased bicuspid aortic valve. Several different characteristics of bicuspid aortic valves were tested to generate a pithy and easily applicable classification system. Three characteristics for a systematic classification were found appropriate: (1) number of raphes, (2) spatial position of cusps or raphes, and (3) functional status of the valve. The first characteristic was found to be the most significant and therefore termed "type." Three major types were identified: type 0 (no raphe), type 1 (one raphe), and type 2 (two raphes), followed by two supplementary characteristics, spatial position and function. These characteristics served to classify and codify the bicuspid aortic valves into three categories. Most frequently, a bicuspid aortic valve with one raphe was identified (type 1, n = 269). This raphe was positioned between the left (L) and right (R) coronary sinuses in 216 (type 1, L/R) with a hemodynamic predominant stenosis (S) in 119 (type 1, L/R, S). Only 21 patients had a "purely" bicuspid aortic valve with no raphe (type 0). A classification system for the bicuspid aortic valve with one major category ("type") and two supplementary categories is presented. This classification, even if used in the major category (type) alone, might be advantageous to better define bicuspid aortic valve disease, facilitate scientific communication, and improve treatment.

0 comments Cited 251 times – based on 0 reviews      Review now

Bookmark

Record: found
Abstract: found
Article: not found

Outcomes in Transcatheter Aortic Valve Replacement for Bicuspid Versus Tricuspid Aortic Valve Stenosis.

Sung-Han Yoon, Sabine Bleiziffer, Ole De Backer … (2017)

Transcatheter aortic valve replacement (TAVR) is being increasingly performed in patients with bicuspid aortic valve stenosis (AS).

0 comments Cited 116 times – based on 0 reviews      Review now

Bookmark

All references

Author and article information

Contributors

Daniel J. Blackman:

ORCID: https://orcid.org/0000-0001-9039-6130

daniel.blackman1@nhs.net

Journal

Journal ID (nlm-ta): Catheter Cardiovasc Interv

Journal ID (iso-abbrev): Catheter Cardiovasc Interv

Journal ID (doi): 10.1002/(ISSN)1522-726X

Journal ID (publisher-id): CCD

Title: Catheterization and Cardiovascular Interventions

Publisher: John Wiley & Sons, Inc. (Hoboken, USA )

ISSN (Print): 1522-1946

ISSN (Electronic): 1522-726X

Publication date (Electronic): 17 February 2019

Publication date (Print): 01 May 2019

Volume: 93

Issue: 6 ( doiID: 10.1002/ccd.v93.6 )

Pages: 1116-1123

Affiliations

[ ¹ ] Department of Cardiology Leeds General Infirmary Leeds United Kingdom

[ ² ] Interventional Cardiology Thoraxcenter, Erasmus Medical Center CE Rotterdam The Netherlands

[ ³ ] Clinic for Thoracic and Cardiovascular Surgery, Herz‐ und Diabeteszentrum NRW Ruhr‐University Bochum Bad Oeynhausen Germany

[ ⁴ ] Department of Cardiology University of Rostock Rostock Germany

[ ⁵ ] Cardiothoracic and Vascular Department Azienda Ospedaliero Universitaria Pisana Pisa Italy

[ ⁶ ] Cardiology Department Heart Center Leipzig at the University of Leipzig Leipzig Germany

[ ⁷ ] Interventional Cardiology, Heart Center University Hospital Bonn Bonn Germany

[ ⁸ ] The Heart and Lung Centre New Cross Hospital Wolverhampton United Kingdom

[ ⁹ ] Swiss Cardiovascular Center Bern University Hospital Bern Bern Switzerland

[ ¹⁰ ] Department of Internal Medicine II University of Ulm Germany

[ ¹¹ ] Department of Cardiology and Cardiothoracic Surgery St. George's Hospital London United Kingdom

[ ¹² ] Interventional Cardiology Boston Scientific Corporation Marlborough Massachusetts

[ ¹³ ] Deutsches Herzzentrum Berlin Klinik für Herz‐Thorax‐Gefässchirurgie Berlin Germany

Author notes

[*] [* ] Correspondence

Daniel J Blackman, MD, Leeds General Infirmary, Great George Street, Leeds, United Kingdom

Email: daniel.blackman1@ 123456nhs.net

Author information

Daniel J. Blackman https://orcid.org/0000-0001-9039-6130

Lennart Van Gils https://orcid.org/0000-0003-2877-4350

Article

Publisher ID: CCD28120

DOI: 10.1002/ccd.28120

PMC ID: 6593645

PubMed ID: 30773838

SO-VID: b079beb0-1854-49eb-b038-29e9c2e2d888

License:

This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.

History

Date received : 22 March 2018

Date revision received : 04 January 2019

Date accepted : 20 January 2019

Page count

Figures: 5, Tables: 3, Pages: 7, Words: 4894

Funding

Funded by: Boston Scientific Corporation

Custom metadata

source-schema-version-number 2.0

component-id ccd28120

cover-date May 1, 2019

details-of-publishers-convertor Converter:WILEY_ML3GV2_TO_NLMPMC version:5.6.5 mode:remove_FC converted:26.06.2019

Keywords: aortic regurgitation,aortic valve stenosis,bicuspid,transcatheter aortic valve implantation,transfemoral

Data availability:

Keywords: aortic regurgitation, aortic valve stenosis, bicuspid, transcatheter aortic valve implantation, transfemoral

Clinical outcomes of the Lotus Valve in patients with bicuspid aortic valve stenosis: An analysis from the RESPOND study

Read this article at

Abstract

Aims

Methods and Results

Conclusions

Related collections

Software for SAXS correction and analysis

Most cited references 22

Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document.

A classification system for the bicuspid aortic valve from 304 surgical specimens.

Outcomes in Transcatheter Aortic Valve Replacement for Bicuspid Versus Tricuspid Aortic Valve Stenosis.

Author and article information

Contributors

Journal

Affiliations

Author notes

Author information

Article

History

Page count

Funding

Categories

Custom metadata

Comments

Comment on this article

Similar content 1,114

Cited by 7

Most referenced authors 755