Key issues in trial design for ventricular assist devices

A position statement of the Heart Failure Society of America

Marvin A. Konstam, Joann Lindenfeld, Ileana L. Pina, Milton Packer, Ronald M. Lazar, Lynne Warner Stevenson

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

A wide array of novel medical devices on the horizon offers promise of substantial clinical benefit to patients with heart failure, including those presently considered to be "end-stage." VADs are an established tool for allowing critically ill patients to undergo cardiac transplant. We have witnessed the first definitive demonstration of survival benefit from VADs as destination devices. Novel advances in VAD design hold the potential for expanding the indication to broader populations and offering improved survival, H-QOL, and device reliability, and/or reduced device-related morbidity. The challenge will be to design clinical trials that will expedite advances in the field, while assuring the safety and efficacy of new devices. Such designs will facilitate the application of new devices as bridges to transplant, as destination therapy, and as instruments for improvement in underlying cardiac pathology.

Original languageEnglish (US)
Pages (from-to)91-100
Number of pages10
JournalJournal of Cardiac Failure
Volume10
Issue number2
DOIs
StatePublished - Apr 2004
Externally publishedYes

Fingerprint

Heart-Assist Devices
Equipment and Supplies
Transplants
Survival
Critical Illness
Heart Failure
Clinical Trials
Pathology
Morbidity
Safety
Population

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Key issues in trial design for ventricular assist devices : A position statement of the Heart Failure Society of America. / Konstam, Marvin A.; Lindenfeld, Joann; Pina, Ileana L.; Packer, Milton; Lazar, Ronald M.; Warner Stevenson, Lynne.

In: Journal of Cardiac Failure, Vol. 10, No. 2, 04.2004, p. 91-100.

Research output: Contribution to journalArticle

Konstam, Marvin A. ; Lindenfeld, Joann ; Pina, Ileana L. ; Packer, Milton ; Lazar, Ronald M. ; Warner Stevenson, Lynne. / Key issues in trial design for ventricular assist devices : A position statement of the Heart Failure Society of America. In: Journal of Cardiac Failure. 2004 ; Vol. 10, No. 2. pp. 91-100.
@article{29d9e8c04d0c43a7a0c639d73aafc903,
title = "Key issues in trial design for ventricular assist devices: A position statement of the Heart Failure Society of America",
abstract = "A wide array of novel medical devices on the horizon offers promise of substantial clinical benefit to patients with heart failure, including those presently considered to be {"}end-stage.{"} VADs are an established tool for allowing critically ill patients to undergo cardiac transplant. We have witnessed the first definitive demonstration of survival benefit from VADs as destination devices. Novel advances in VAD design hold the potential for expanding the indication to broader populations and offering improved survival, H-QOL, and device reliability, and/or reduced device-related morbidity. The challenge will be to design clinical trials that will expedite advances in the field, while assuring the safety and efficacy of new devices. Such designs will facilitate the application of new devices as bridges to transplant, as destination therapy, and as instruments for improvement in underlying cardiac pathology.",
author = "Konstam, {Marvin A.} and Joann Lindenfeld and Pina, {Ileana L.} and Milton Packer and Lazar, {Ronald M.} and {Warner Stevenson}, Lynne",
year = "2004",
month = "4",
doi = "10.1016/j.cardfail.2004.02.009",
language = "English (US)",
volume = "10",
pages = "91--100",
journal = "Journal of Cardiac Failure",
issn = "1071-9164",
publisher = "Churchill Livingstone",
number = "2",

}

TY - JOUR

T1 - Key issues in trial design for ventricular assist devices

T2 - A position statement of the Heart Failure Society of America

AU - Konstam, Marvin A.

AU - Lindenfeld, Joann

AU - Pina, Ileana L.

AU - Packer, Milton

AU - Lazar, Ronald M.

AU - Warner Stevenson, Lynne

PY - 2004/4

Y1 - 2004/4

N2 - A wide array of novel medical devices on the horizon offers promise of substantial clinical benefit to patients with heart failure, including those presently considered to be "end-stage." VADs are an established tool for allowing critically ill patients to undergo cardiac transplant. We have witnessed the first definitive demonstration of survival benefit from VADs as destination devices. Novel advances in VAD design hold the potential for expanding the indication to broader populations and offering improved survival, H-QOL, and device reliability, and/or reduced device-related morbidity. The challenge will be to design clinical trials that will expedite advances in the field, while assuring the safety and efficacy of new devices. Such designs will facilitate the application of new devices as bridges to transplant, as destination therapy, and as instruments for improvement in underlying cardiac pathology.

AB - A wide array of novel medical devices on the horizon offers promise of substantial clinical benefit to patients with heart failure, including those presently considered to be "end-stage." VADs are an established tool for allowing critically ill patients to undergo cardiac transplant. We have witnessed the first definitive demonstration of survival benefit from VADs as destination devices. Novel advances in VAD design hold the potential for expanding the indication to broader populations and offering improved survival, H-QOL, and device reliability, and/or reduced device-related morbidity. The challenge will be to design clinical trials that will expedite advances in the field, while assuring the safety and efficacy of new devices. Such designs will facilitate the application of new devices as bridges to transplant, as destination therapy, and as instruments for improvement in underlying cardiac pathology.

UR - http://www.scopus.com/inward/record.url?scp=3042747124&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=3042747124&partnerID=8YFLogxK

U2 - 10.1016/j.cardfail.2004.02.009

DO - 10.1016/j.cardfail.2004.02.009

M3 - Article

VL - 10

SP - 91

EP - 100

JO - Journal of Cardiac Failure

JF - Journal of Cardiac Failure

SN - 1071-9164

IS - 2

ER -