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Editor's Note
July 2017

The Balance Between Access and Quality in Transcatheter Valve Therapies

Author Affiliations
  • 1Cardiovascular Division, Brigham and Women’s Hospital, Boston, Massachusetts
  • 2Associate Editor, JAMA Cardiology
JAMA Cardiol. 2017;2(7):741. doi:10.1001/jamacardio.2017.1651

Transcatheter aortic valve replacement (TAVR) is a transformative technology that has revolutionized the care of patients with symptomatic severe aortic stenosis. Procedural TAVR volumes are now comparable with those for isolated surgical AVR and continued growth is expected with expanding numbers of patients meeting eligibility requirements. Randomized clinical trials of TAVR vs surgical AVR in low surgical risk patients are under way; planning for a trial of TAVR vs active surveillance in asymptomatic patients is in its late stages. Currently, there are more than 500 US TAVR hospitals, a more than 3-fold increase since 2012.

The rational dispersion of this technology has been a consistent concern since it was first approved for commercial use. How should patient access to this life-changing procedure be balanced against the need to promote the highest-quality care and insure optimal outcomes? Strategies used to address this challenge have included linkage of site selection criteria to Centers for Medicare & Medicaid Services reimbursement, US Food and Drug Administration indications for use labeling, institutional and operator requirements recommended by professional societies, and medical device company support. Participation in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry (NCT01737528) is a requisite. The cumulative experience with TAVR is now robust enough to carefully examine not only survival and functional outcomes, but also the processes of care and measures of efficiency and quality that define best practices. It is inevitable that the conversation will turn to questions such as whether there are too many, too few, or just the right number of individual hospitals and whether alternative models of integrated care across hospitals should be considered, especially as the field of transcatheter therapies continues to evolve.

There is an inverse association between TAVR hospital volume and in-hospital death, vascular complications, and bleeding.1 In this issue of JAMA Cardiology, Khera and colleagues2 describe an inverse association between TAVR hospital volumes and 30-day readmission rates. Despite the controversies surrounding the readmission rate metric, scrutiny of processes designed to optimize transitions of care should be promoted.

Reports of this nature can inform policy discussions regarding dissemination of high-impact expensive technologies. Prior efforts to limit high-risk surgical procedures to higher-volume hospitals/operators were met with vigorous pushback.3 Nevertheless, there is widespread acknowledgment that a prospective, multistakeholder conversation regarding a health systems approach to treating patients with valve disease, much like that espoused by the Brain Attack Coalition for acute stroke,4 is necessary.

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Article Information

Corresponding Author: Patrick T. O’Gara, MD, Cardiovascular Division, Brigham and Women’s Hospital, 75 Francis St, Boston, MA 2115 (pogara@bwh.harvard.edu).

Conflict of Interest Disclosures: The author has completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported.

References
1.
Carroll  JD, Vemulapalli  S, Dai  D,  et al.  The association between procedural experience for transcatheter aortic valve replacement and outcomes: insights from the STS/ACC TVT Registry.  J Am Coll Cardiol. In press.Google Scholar
2.
Khera  S, Kolte  D, Gupta  T,  et al.  Association between hospital volume and 30-day readmissions following transcatheter aortic valve replacement [published online May 11, 2017].  JAMA Cardiol. doi:10.1001/jamacardio.2017.1630Google Scholar
3.
Urbach  DR.  Pledging to eliminate low-volume surgery.  N Engl J Med. 2015;373(15):1388-1390.PubMedGoogle ScholarCrossref
4.
Alberts  MJ, Wechsler  LR, Jensen  ME,  et al.  Formation and function of acute stroke-ready hospitals within a stroke system of care recommendations from the brain attack coalition.  Stroke. 2013;44(12):3382-3393.PubMedGoogle ScholarCrossref
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