Dissemination of Transcatheter Aortic Valve Replacement in the United States

Valle, Javier A.; Li, Zhuokai; Kosinski, Andrzej S.; Nelson, Adam; Vemulapalli, Sreekanth; Cleveland, Joseph C.; Fullerton, David A.; Messenger, John C.; Rove, Jessica Y.; Bricker, Rory S.; Bradley, Steven M; Yeh, Robert W.; Armstrong, Ehrin J.; Waldo, Stephen W.; Carroll, John D.

doi:10.1016/j.jacc.2021.06.028

Cited by 25 publications

(10 citation statements)

References 17 publications

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“…A large body of literature suggests that patients who live further away are less likely to access care, even after adjustment for need (so called distance decay) and that travel times of more than 22 minutes or 10 miles may negatively associate with health outcomes . This analysis confirms that the rural population, already experiencing uneven dissemination of TAVI manifesting as longer driving times and worse outcomes, would be disproportionately affected by efforts to strictly enforce volume- or outcome-based standards for offering TAVI services. Of note, HRRs are defined by the Dartmouth Atlas based on natural referral patterns for centralized cardiovascular and neurosurgical care.…”

Section: Discussionmentioning

confidence: 73%

Modeling the Association of Volume vs Composite Outcome Thresholds With Outcomes and Access to Transcatheter Aortic Valve Implantation in the US

et al. 2023

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ImportanceProfessional societies and the Centers for Medicare &amp; Medicaid Services suggest volume thresholds to ensure quality in transcatheter aortic valve implantation (TAVI).ObjectiveTo model the association of volume thresholds vs spoke-and-hub implementation of outcome thresholds with TAVI outcomes and geographic access.Design, Setting, and ParticipantsThis cohort study included patients who enrolled in the US Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy registry. Site volume and outcomes were determined from a baseline cohort of adults undergoing TAVI between July 1, 2017, and June 30, 2020.ExposuresWithin each hospital referral region, TAVI sites were categorized by volume (&lt;50 or ≥50 TAVIs per year) and separately by risk-adjusted outcome on the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy 30-day TAVI composite during the baseline period (July 2017 to June 2020). Outcomes of patients undergoing TAVIs from July 1, 2020, to March 31, 2022, were then modeled as though the patients had been treated at (1) the nearest higher volume (≥50 TAVIs per year) or (2) the best outcome site within the hospital referral region.Main Outcomes and MeasuresThe primary outcome was the absolute difference in events between the adjusted observed and modeled 30-day composite of death, stroke, major bleeding, stage III acute kidney injury, and paravalvular leak. Data are presented as the number of events reduced under the above scenarios with 95% bayesian credible intervals (CrIs) and median (IQR) driving distance.ResultsThe overall cohort included 166 248 patients with a mean (SD) age of 79.5 (8.6) years; 74 699 (47.3%) were female and 6657 (4.2%) were Black; 158 025 (95%) were treated in higher-volume sites (≥50 TAVIs) and 75 088 (45%) were treated in best-outcome sites. Modeling a volume threshold, there was no significant reduction in estimated adverse events (−34; 95% CrI, −75 to 8), while the median (IQR) driving time from the existing site to the alternate site was 22 (15-66) minutes. Transitioning care to the best outcome site in a hospital referral region resulted in an estimated 1261 fewer adverse outcomes (95% CrI, 1013-1500), while the median (IQR) driving time from the original site to the best site was 23 (15-41) minutes. Directionally similar findings were observed for Black individuals, Hispanic individuals, and individuals from rural areas.Conclusions and RelevanceIn this study, compared with the current system of care, a modeled outcome-based spoke-and-hub paradigm of TAVI care improved national outcomes to a greater extent than a simulated volume threshold, at the cost of increased driving time. To improve quality while maintaining geographic access, efforts should focus on reducing site variation in outcomes.

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Section: Discussionmentioning

confidence: 73%

Modeling the Association of Volume vs Composite Outcome Thresholds With Outcomes and Access to Transcatheter Aortic Valve Implantation in the US

et al. 2023

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“…44 Finally, it was demonstrated that the extension of TAVI procedures to new centres with regional condensation results in decreased quality of care. 45 While it is argued that many of the trials used devices that have been improved, it is important to note that classic surgery has also developed during this time. This became prominently evident in the FAME 3 trial, where enrolled patients were practically identical to the SYNTAX trial, but they only experienced half of the adverse events than in SYNTAX in both treatment arms.…”

Section: Aortic Valvementioning

confidence: 99%

“…44 Finally, it was demonstrated that the extension of TAVI procedures to new centres with regional condensation results in decreased quality of care. 45…”

Section: Surgical Treatment Of Valve Diseasementioning

confidence: 99%

Cardiac Surgery 2021 Reviewed

Doenst

Schneider

Can

et al. 2022

Thorac Cardiovasc Surg

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PubMed displayed more than 35,000 hits for the search term “cardiac surgery AND 2021.” We used the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-analyses) approach and selected relevant publications for a results-oriented summary. As in recent years, we reviewed the fields of coronary and conventional valve surgery and their overlap with their interventional alternatives. COVID reduced cardiac surgical activity around the world. In the coronary field, the FAME 3 trial dominated publications by practically repeating SYNTAX, but with modern stents and fractional flow reserve (FFR)-guided percutaneous coronary interventions (PCIs). PCI was again unable to achieve non-inferiority compared with coronary artery bypass graft surgery (CABG) in patients with triple-vessel disease. Survival advantages of CABG over PCI could be linked to a reduction in myocardial infarctions and current terminology was criticized because the term “myocardial revascularization” is not precise and does not reflect the infarct-preventing collateralization effect of CABG. In structural heart disease, new guidelines were published, providing upgrades of interventional treatments of both aortic and mitral valve disease. While for aortic stenosis, transcatheter aortic valve implantation (TAVI) received a primary recommendation in older and high-risk patients; recommendations for transcatheter mitral edge-to-edge treatment were upgraded for patients considered inappropriate for surgery. For heart team discussions it is important to know that classic aortic valve replacement currently provides strong signals (from registry and randomized evidence) for a survival advantage over TAVI after 5 years. This article summarizes publications perceived as important by us. It can neither be complete nor free of individual interpretation, but provides up-to-date information for decision-making and patient information.

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“…The outcomes of interventions, be it surgical or THV, are in direct relationship with the team and operator's experience. Indeed, a recent analysis of the US availability of centers that perform TAVI interventions has shown worrisome results with an unacceptable increment of mortality after the opening of new THV centers that treat lower risk patients [6]. On the other hand, it appears obvious, and has been demonstrated several times, that outcome is a byproduct of experience, and although monitoring of outcome is historically common practice among cardiac surgeons, this seems to be a "new requisite" in the interventionalists world.…”

Section: Where To Treat Patients With Severe Aortic Stenosismentioning

confidence: 99%