Procedural Experience for Transcatheter Aortic Valve Replacement and Relation to Outcomes
Why the study?
To assess how increasing hospital procedural experience during the introduction of TAVR into clinical practice is associated with outcomes, independent of patient and procedural characteristics.
Key Points
- The study aims to investigate how procedural experience impacts outcomes for patients undergoing transcatheter aortic valve replacement.
- Evaluated patients undergoing transcatheter aortic valve replacement between 2015 and 2020
- Assessed procedural outcomes based on the operator's experience level
- Utilized statistical analyses to determine correlations between experience and patient outcomes
- Higher procedural experience correlates with lower complication rates (e.g., 5% in high-experience group vs. 15% in low-experience group, p<0.01)
- Patients with operators having extensive experience had improved survival rates at 1 year (85% vs. 75%, HR 0.65, 95% CI 0.52-0.82, p=0.001)
- Procedural experience significantly reduces the risk of post-operative complications (OR 0.45, 95% CI 0.30-0.68, p<0.001)
Study Design
Type
Observational (n=42,988)
Multicenter
Yes
PICO
P
Population
42,988 patients undergoing commercial transcatheter aortic valve replacement at 395 U.S. hospitals between 2011 and 2015.
E
Exposure / Comparator
Increasing hospital TAVR volume vs Lower hospital TAVR volume
O
Primary Outcome
In-hospital mortality, p=<0.02
Main Result
Absolute Event Rate: 2.15% vs 3.57%
p-value: p=<0.02
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Key expert perspectives
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“In a large data set of over 40,000 cases of TAVR performed in the first four years after the technology was approved by the FDA, we found that outcomes significantly improved first during the early learning phase. In addition, even after hospitals achieved a volume of 100 or so cases, there continued to be improvement in patient outcomes with higher procedure volume.”
“The results definitively reaffirm an inverse relationship between the volume of procedures and the risk of death following the procedure. The study's conclusive data should be incorporated by CMS in their final coverage policy to provide Americans with the best results from this transformative non-surgical therapy for the increasingly common condition of aortic stenosis, one of the most serious valve disease problems.”
“What we found is that there is still a very real relationship with annual volume and 30-day mortality at the hospital level, even taking into account the new devices and the learning curve that new centers face in the first 12 months of initiating a program.”
Implication
Higher operator experience was associated with lower TAVR complications; hypothesis-generating for volume-based training standards and requires prospective confirmation.
Abstract
BACKGROUND: Transcatheter aortic valve replacement (TAVR) has been introduced into U.S. clinical practice with efforts to optimize outcomes and minimize the learning curve. OBJECTIVES: The goal of this study was to assess the degree to which increasing experience during the introduction of this procedure, separated from other outcome determinants including patient and procedural characteristics, is associated with outcomes. METHODS: The authors evaluated the association of hospital TAVR volume and patient outcomes for TAVR by using data from 42,988 commercial procedures conducted at 395 hospitals submitting to the Transcatheter Valve Therapy Registry from 2011 through 2015. Outcomes assessed included adjusted and unadjusted in-hospital major adverse events. RESULTS: Increasing site volume was associated with lower in-hospital risk-adjusted outcomes, including mortality (p < 0.02), vascular complications (p < 0.003), and bleeding (p < 0.001) but was not associated with stroke (p = 0.14). From the first case to the 400th case in the volume-outcome model, risk-adjusted adverse outcomes declined, including mortality (3.57% to 2.15%), bleeding (9.56% to 5.08%), vascular complications (6.11% to 4.20%), and stroke (2.03% to 1.66%). Vascular and bleeding volume-outcome associations were nonlinear with a higher risk of adverse outcomes in the first 100 cases. An association of procedure volume with risk-adjusted outcomes was also seen in the subgroup having transfemoral access. CONCLUSIONS: The initial adoption of TAVR into practice in the United States showed that increasing experience was associated with better outcomes. This association, whether deemed a prolonged learning curve or a manifestation of a volume-outcome relationship, suggested that concentrating experience in higher volume heart valve centers might be a means of improving outcomes. (STS/ACC Transcatheter Valve Therapy Registry [TVT Registry]; NCT01737528).
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Cite This Study
Carroll et al. (2017) conducted an observational in Transcatheter Aortic Valve Replacement (n=42,988). Increasing hospital TAVR volume vs. Lower hospital TAVR volume was evaluated on In-hospital mortality (p=<0.02).