Transcatheter aortic valve replacement (TAVR) is a feasible option among selected patients with bicuspid aortic valve (BAV) anatomy, but increased risk of complications warrants “caution and further evidence,” according to meta-analysis of trial data.
Published online Monday and in the Oct. 11 issue of JACC: Cardiovascular Interventions, the study noted that there are currently limited observational data to support the use of TAVR in the context of bicuspid anatomy.
Led by Claudio Montalto, MD, from the University of Pavia, Italy, and Oxford University Hospital NHS Trust, England, the team pooled data from more than 180,000 patients in 17 clinical studies to compare the feasibility, safety, and clinical outcomes of TAVR in BAV versus tricuspid aortic valve (TAV) stenosis.
The team found that TAVR in BAV was associated with similar 1-year survival rates and device success as TAV but revealed higher rates of moderate to severe paravalvular leak (PVL), annular rupture, and cerebral ischemic events in the BAV group – noting that these warrant caution and further evidence.
“Our findings suggest that randomized clinical trials are required to ascertain if a percutaneous strategy is preferrable over surgery to treat patients with bicuspid anatomy,” they said.
Montalto and colleagues compared outcomes of TAVR in BAV versus TAV in a meta-analysis of 17 studies and 181,433 patients. Primary endpoints were 1-year survival and device success, while secondary endpoints included moderate to severe PVL and a composite endpoint of periprocedural complications; incidence rates of individual procedural endpoints were also explored individually.
A secondary analysis of 7,071 matched subjects with similar baseline characteristics was also performed, said the authors.
They reported that device success and 1-year survival rates were similar between subjects with BAV and TAV (97% vs 94% [P = 0.55] and 91.3% vs 90.8% [P = 0.22], respectively).
“In patients with BAV, a trend toward a higher risk for periprocedural complications was observed in our main analysis (risk ratio [RR]: 1.12; 95% CI: 0.99-1.27; P = 0.07) but not in the matched population secondary analysis (RR: 1.00; 95% CI: 0.81-1.24; P = 0.99),” they noted.
Furthermore, the risk for moderate to severe PVL was higher in subjects with BAV (RR: 1.42; 95% CI: 1.29-1.58; P < 0.0001) as well as the incidence of cerebral ischemic events (2.4% vs 1.6%; P = 0.015) and of annular rupture (0.3% vs 0.02%; P = 0.014) in matched subjects.
The authors concluded that although “selected subjects” with BAV can undergo TAVR with similar outcomes and success rates as those with TAV, the higher rates of periprocedural complications “warrant expert operators who can manage them promptly.”
They added that adequately powered randomized trials are needed to help determine whether the findings from the study are generalizable and noted that device technology improvements dedicated to bicuspid anatomy might also improve the outcomes of TAVR in these patient groups.
Patient selection is critical
Writing in an accompanying editorial, Didier Tchetche, MD, and Saifullah Siddiqui, MD, from the Clinique Pasteur, Toulouse, France said the meta-analysis provides “very clear” conclusions regarding BAVs – adding that the authors “perfectly outline the limitations of each study and perform a propensity-matched analysis.”
The editorialists noted that while there are multiple devices that are currently used and demonstrate similar outcomes in TAV aortic stenosis (AS) patients, for BAV, the majority of the experience in larger studies is with the balloon-expandable SAPIEN and self-expanding Evolut platforms.
Therefore, they noted that the findings of the analysis cannot be extrapolated to TAVR devices other than these two.
“As expected, patient selection is crucial,” the experts added. “Experience has shown that not all BAV AS is suitable for TAVR.”
“We must ask ourselves who should not undergo TAVR in the context of BAV? This is a critical and expansive question for which we can only provide personal insights and hope that our scientific societies will soon offer specific recommendations,”
They noted that a group of experts recently proposed a consensus on BAV management based on the balloon expandable SAPIEN 3 platform, outlining an age below 65 to 70 years, aortopathy with excessive dilation of the ascending aorta, malignancy of the calcification pattern, and concomitant severe coronary disease or multivalvular disease are reasons not to consider TAVR in a bicuspid patient.
“While the techniques and technology continue to improve, we know that there is still room for growth in TAVR in BAV AS. What does the future hold for these patients and for those of us that treat them?” they questioned.
“Ultimately, we would hope to see critical technological refinements such as dedicated TAVR devices that achieve minimal regurgitation rates, appropriate circularity, and optimal hemodynamics and avoid the need for oversizing and post-dilatation.”
Montalto C, Sticchi A, Crimi G, et al. Outcomes After Transcatheter Aortic Valve Replacement in Bicuspid Versus Tricuspid Anatomy: A Systematic Review and Meta-Analysis. JACC Cardiovasc Interv 2021;14:2144-2155.
Tchetche D, Siddiqui S. Patient Selection Makes the Difference for TAVR in Bicuspid Aortic Stenosis. JACC Cardiovasc Interv 2021;14:2166-2156-2157.
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