No difference by hospital volume in events after TAVR for bicuspid aortic valves
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Low- and high-volume hospitals that performed transcatheter aortic valve replacement for bicuspid aortic valves had similar rates of in-hospital and 30-day outcomes, according to data presented at the virtual Society for Cardiovascular Angiography and Interventions Scientific Sessions.
These similarities were observed despite high-volume centers performing the procedure on patients with greater comorbid risk, according to the data, which were simultaneously published in JACC: Cardiovascular Interventions.
Nicholas Kassis, MD, resident physician at Cleveland Clinic Foundation, and colleagues analyzed data from 1,626 patients from the Nationwide Readmissions Database who underwent TAVR of bicuspid aortic valves between 2012 and 2017. Low-volume hospitals were defined as those that performed up to 100 total annual TAVR procedures, whereas high-volume hospitals were defined as those who performed more than 100 TAVR procedures per year.
Among the cohort, 53.1% underwent TAVR at high-volume hospitals. Bicuspid aortic valves accounted for 0.9% of all TAVR procedures at low-volume hospitals and 1% of procedures at high-volume hospitals.
Compared with low-volume hospitals, patients who underwent TAVR at high-volume hospitals were older (mean age, 68 years vs. 64 years), more likely to smoke tobacco (45.8% vs. 36.6%) and more likely to have renal failure (30.9% vs. 28.7%), HF (73% vs. 54.5%), prior MI (12.7% vs. 5.6%) and diabetes (29.2% vs. 23.3%; P < .001 for all).
The rate of in-hospital stroke was 3.6% at high-volume hospitals and 1.8% at low-volume hospitals (P = .034). In-hospital mortality occurred at a rate of 2.3% in high-volume hospitals compared with 3.8% at low-volume hospitals (P = .109). The risk for hospital discharge with disability after TAVR was lower at high-volume hospitals compared with low-volume hospitals after adjusting for sex, age, CHA2DS2-VASc score and comorbidities (OR = 0.655; 95% CI, 0.523-0.82). Hospital volume was not linked to different rates of mortality (OR = 0.689; 95% CI, 0.368-1.29) or in-hospital stroke (OR = 1.519; 95% CI, 0.775-2.976).
“Our study must be interpreted as strictly observational and inherently limited by its reliance on administrative reporting and inability to account for potential confounders including device type, operator experience, patient selection and, notably, the varied use of embolic protection devices across hospitals,” Kassis and colleagues wrote in JACC: Cardiovascular Interventions. “Nonetheless, our data reflect current practice and suggest that aggressive stroke prevention strategies should be pursued in patients with bicuspid aortic valves who are to undergo TAVR.” – by Darlene Dobkowski
References:
Kassis N, et al. Abstract III-52. Presented at: Society for Cardiovascular Angiography and Interventions Scientific Sessions; May 14-16, 2020 (virtual meeting).
Kassis N, et al. JACC Cardiovasc Interv. 2020;doi:10.1016/j.jcin.2020.04.007.
Disclosures: Kassis reports no relevant financial disclosures. Please see the study for all other authors’ relevant financial disclosures.
Perspective
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Ashish Pershad, MD
The first message that we need to clearly send out is that this study was performed on an administrative database, the Nationwide Readmissions Database. These data are observational and subject to all the limitations of an observational administrative dataset.
In Circulation this past February (Halim SA, et al. Circulation. 2020;doi:10.1161/CIRCULATIONAHA.119.040333.), outcomes in bicuspid aortic valves were compared with tricuspid aortic valves for patients with severe aortic stenosis in the Transcatheter Valve Therapy registry. They showed that there was no difference in outcomes for hard endpoints of stroke and mortality but with higher rates of stroke and paravalvular leak in the bicuspid group.
The first take-home message is that you can treat bicuspid aortic valves with current-generation transcatheter valve technology with similar outcomes as tricuspid valves. The myth that needs to be dispelled is that bicuspid valves are off-limits for TAVR.
The second takeaway is that stroke and mortality did not seem to be different between low-volume and high-volume centers. They defined low-volume centers as centers doing less than 100 procedures and high-volume centers as centers doing greater than 100 procedures. However, the percentage of bicuspid cases treated at both low- and high-volume centers was 1% of their total volume.
The third takeaway was that we need to do more and try to figure out how we can reduce the risk for stroke, a devastating event which is unpredictable. Further research needs to be put into how we can try to reduce our periprocedural stroke risk in both bicuspid and tricuspid valves. Numerically, the risk of stroke appears to be higher in bicuspid patients, and whether that is statistically significant is dependent on what study you look at.
I don’t think these findings will change a lot in clinical practice. Bicuspid valves are being treated currently with TAVR. If adverse findings are noted on CTA or if they have concomitant root pathology, valve disease or complex CAD, these patients are not optimal candidates for TAVR and should be offered surgery.
We still need randomized controlled studies, comparing surgery with TAVR in bicuspid valves. Even though observational data are helpful, it does not definitively answer the question of if outcomes with bicuspid aortic valves are similar to that with tricuspid aortic valve stenosis.
Collapse
Kassis N, et al. Abstract III-52. Presented at: Society for Cardiovascular Angiography and Interventions Scientific Sessions; May 14-16, 2020 (virtual meeting).
Kassis N, et al. JACC Cardiovasc Interv. 2020;doi:10.1016/j.jcin.2020.04.007.
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