Transcatheter aortic valve replacement in patients with severe aortic stenosis who are at high risk for surgical complications: Summary assessment of the California Technology Assessment Forum

Jeffrey A. Tice, Frank W. Sellke, Hartzell V Schaff

Research output: Contribution to journalArticle

6 Citations (Scopus)

Abstract

Background The California Technology Assessment Forum is dedicated to assessment and public reporting of syntheses of available data on medical technologies. In this assessment, transcatheter aortic valve replacement (TAVR) was evaluated for patients with severe aortic stenosis (AS) who are at high risk for complications. Methods and Results In this assessment, 5 criteria were used: Regulatory approval, sufficient scientific evidence to allow conclusions on effectiveness, evidence that the technology improves net health outcomes, evidence that the technology is as beneficial as established methods, and availability of the technology outside investigational settings. In this assessment, all 5 criteria were judged to have been met. The primary benefit of TAVR is the ability to treat AS in patients who would otherwise be ineligible for surgical aortic valve replacement. It may also be useful for patients at high surgical risk by potentially reducing periprocedural complications and avoiding the morbidity and recovery from undergoing heart surgery. Potential harms include the need for conversion to an open procedure, perioperative death, myocardial infarction, stroke, bleeding, valve embolization, aortic regurgitation, heart block that requires a permanent pacemaker, renal failure, pulmonary failure, and major vascular complications such as cardiac perforation or arterial dissection. Potential long-term harms include death, stroke, valve failure or clotting, and endocarditis. As highlighted at the February 2012 California Technology Assessment Forum meeting, the dispersion of this technology to new centers across the United States must proceed with careful thought given to training and proctoring multidisciplinary teams to become new centers of excellence. Conclusions TAVR is a potentially lifesaving procedure that may improve quality of life for patients at high risk for surgical AVR. However, attention needs to be paid to appropriate patient selection, their preoperative evaluation, surgical techniques, and postoperative care to preserve and improve on the results attained in the Placement of Aortic Transcatheter Valve trial. Specialty societies are collaborating to ensure that this happens in a rational and comprehensive manner.

Original languageEnglish (US)
JournalJournal of Thoracic and Cardiovascular Surgery
Volume148
Issue number2
DOIs
StatePublished - 2014

Fingerprint

Biomedical Technology Assessment
Aortic Valve Stenosis
Technology
Aortic Valve
Stroke
Conversion to Open Surgery
Heart Block
Aortic Valve Insufficiency
Postoperative Care
Endocarditis
Surgical Instruments
Patient Selection
Thoracic Surgery
Renal Insufficiency
Blood Vessels
Dissection
Myocardial Infarction
Quality of Life
Transcatheter Aortic Valve Replacement
Hemorrhage

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Surgery
  • Pulmonary and Respiratory Medicine

Cite this

@article{5c581a6aa9894072a88fe9b231f3f2ce,
title = "Transcatheter aortic valve replacement in patients with severe aortic stenosis who are at high risk for surgical complications: Summary assessment of the California Technology Assessment Forum",
abstract = "Background The California Technology Assessment Forum is dedicated to assessment and public reporting of syntheses of available data on medical technologies. In this assessment, transcatheter aortic valve replacement (TAVR) was evaluated for patients with severe aortic stenosis (AS) who are at high risk for complications. Methods and Results In this assessment, 5 criteria were used: Regulatory approval, sufficient scientific evidence to allow conclusions on effectiveness, evidence that the technology improves net health outcomes, evidence that the technology is as beneficial as established methods, and availability of the technology outside investigational settings. In this assessment, all 5 criteria were judged to have been met. The primary benefit of TAVR is the ability to treat AS in patients who would otherwise be ineligible for surgical aortic valve replacement. It may also be useful for patients at high surgical risk by potentially reducing periprocedural complications and avoiding the morbidity and recovery from undergoing heart surgery. Potential harms include the need for conversion to an open procedure, perioperative death, myocardial infarction, stroke, bleeding, valve embolization, aortic regurgitation, heart block that requires a permanent pacemaker, renal failure, pulmonary failure, and major vascular complications such as cardiac perforation or arterial dissection. Potential long-term harms include death, stroke, valve failure or clotting, and endocarditis. As highlighted at the February 2012 California Technology Assessment Forum meeting, the dispersion of this technology to new centers across the United States must proceed with careful thought given to training and proctoring multidisciplinary teams to become new centers of excellence. Conclusions TAVR is a potentially lifesaving procedure that may improve quality of life for patients at high risk for surgical AVR. However, attention needs to be paid to appropriate patient selection, their preoperative evaluation, surgical techniques, and postoperative care to preserve and improve on the results attained in the Placement of Aortic Transcatheter Valve trial. Specialty societies are collaborating to ensure that this happens in a rational and comprehensive manner.",
author = "Tice, {Jeffrey A.} and Sellke, {Frank W.} and Schaff, {Hartzell V}",
year = "2014",
doi = "10.1016/j.jtcvs.2013.09.056",
language = "English (US)",
volume = "148",
journal = "Journal of Thoracic and Cardiovascular Surgery",
issn = "0022-5223",
publisher = "Mosby Inc.",
number = "2",

}

TY - JOUR

T1 - Transcatheter aortic valve replacement in patients with severe aortic stenosis who are at high risk for surgical complications

T2 - Summary assessment of the California Technology Assessment Forum

AU - Tice, Jeffrey A.

AU - Sellke, Frank W.

AU - Schaff, Hartzell V

PY - 2014

Y1 - 2014

N2 - Background The California Technology Assessment Forum is dedicated to assessment and public reporting of syntheses of available data on medical technologies. In this assessment, transcatheter aortic valve replacement (TAVR) was evaluated for patients with severe aortic stenosis (AS) who are at high risk for complications. Methods and Results In this assessment, 5 criteria were used: Regulatory approval, sufficient scientific evidence to allow conclusions on effectiveness, evidence that the technology improves net health outcomes, evidence that the technology is as beneficial as established methods, and availability of the technology outside investigational settings. In this assessment, all 5 criteria were judged to have been met. The primary benefit of TAVR is the ability to treat AS in patients who would otherwise be ineligible for surgical aortic valve replacement. It may also be useful for patients at high surgical risk by potentially reducing periprocedural complications and avoiding the morbidity and recovery from undergoing heart surgery. Potential harms include the need for conversion to an open procedure, perioperative death, myocardial infarction, stroke, bleeding, valve embolization, aortic regurgitation, heart block that requires a permanent pacemaker, renal failure, pulmonary failure, and major vascular complications such as cardiac perforation or arterial dissection. Potential long-term harms include death, stroke, valve failure or clotting, and endocarditis. As highlighted at the February 2012 California Technology Assessment Forum meeting, the dispersion of this technology to new centers across the United States must proceed with careful thought given to training and proctoring multidisciplinary teams to become new centers of excellence. Conclusions TAVR is a potentially lifesaving procedure that may improve quality of life for patients at high risk for surgical AVR. However, attention needs to be paid to appropriate patient selection, their preoperative evaluation, surgical techniques, and postoperative care to preserve and improve on the results attained in the Placement of Aortic Transcatheter Valve trial. Specialty societies are collaborating to ensure that this happens in a rational and comprehensive manner.

AB - Background The California Technology Assessment Forum is dedicated to assessment and public reporting of syntheses of available data on medical technologies. In this assessment, transcatheter aortic valve replacement (TAVR) was evaluated for patients with severe aortic stenosis (AS) who are at high risk for complications. Methods and Results In this assessment, 5 criteria were used: Regulatory approval, sufficient scientific evidence to allow conclusions on effectiveness, evidence that the technology improves net health outcomes, evidence that the technology is as beneficial as established methods, and availability of the technology outside investigational settings. In this assessment, all 5 criteria were judged to have been met. The primary benefit of TAVR is the ability to treat AS in patients who would otherwise be ineligible for surgical aortic valve replacement. It may also be useful for patients at high surgical risk by potentially reducing periprocedural complications and avoiding the morbidity and recovery from undergoing heart surgery. Potential harms include the need for conversion to an open procedure, perioperative death, myocardial infarction, stroke, bleeding, valve embolization, aortic regurgitation, heart block that requires a permanent pacemaker, renal failure, pulmonary failure, and major vascular complications such as cardiac perforation or arterial dissection. Potential long-term harms include death, stroke, valve failure or clotting, and endocarditis. As highlighted at the February 2012 California Technology Assessment Forum meeting, the dispersion of this technology to new centers across the United States must proceed with careful thought given to training and proctoring multidisciplinary teams to become new centers of excellence. Conclusions TAVR is a potentially lifesaving procedure that may improve quality of life for patients at high risk for surgical AVR. However, attention needs to be paid to appropriate patient selection, their preoperative evaluation, surgical techniques, and postoperative care to preserve and improve on the results attained in the Placement of Aortic Transcatheter Valve trial. Specialty societies are collaborating to ensure that this happens in a rational and comprehensive manner.

UR - http://www.scopus.com/inward/record.url?scp=84904621861&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84904621861&partnerID=8YFLogxK

U2 - 10.1016/j.jtcvs.2013.09.056

DO - 10.1016/j.jtcvs.2013.09.056

M3 - Article

C2 - 24252939

AN - SCOPUS:84904621861

VL - 148

JO - Journal of Thoracic and Cardiovascular Surgery

JF - Journal of Thoracic and Cardiovascular Surgery

SN - 0022-5223

IS - 2

ER -