Original Investigation
Bicuspid Aortic Valve Morphology and Outcomes After Transcatheter Aortic Valve Replacement

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Abstract

Background

Bicuspid aortic stenosis accounts for almost 50% of patients undergoing surgical aortic valve replacement in the younger patients. Expanding the indication of transcatheter aortic valve replacement (TAVR) toward lower-risk and younger populations will lead to increased use of TAVR for patients with bicuspid aortic valve (BAV) stenosis despite the exclusion of bicuspid anatomy in all pivotal clinical trials.

Objectives

This study sought to evaluate the association of BAV morphology and outcomes of TAVR with the new-generation devices.

Methods

Patients with BAV confirmed by central core laboratory computed tomography (CT) analysis were included from the international multicenter BAV TAVR registry. BAV morphology including the number of raphe, calcification grade in raphe, and leaflet calcium volume were assessed with CT analysis in a masked fashion. Primary outcomes were all-cause mortality at 1 and 2 years, and secondary outcomes included 30-day major endpoints and procedural complications.

Results

A total of 1,034 CT-confirmed BAV patients with a mean age of 74.7 years and Society of Thoracic Surgeons score of 3.7% underwent TAVR with contemporary devices (n = 740 with Sapien 3; n = 188 with Evolut R/Pro; n = 106 with others). All-cause 30-day, 1-year, and 2-year mortality was 2.0%, 6.7%, and 12.5%, respectively. Multivariable analysis identified calcified raphe and excess leaflet calcification (defined as more than median calcium volume) as independent predictors of 2-year all-cause mortality. Both calcified raphe plus excess leaflet calcification were found in 269 patients (26.0%), and they had significantly higher 2-year all-cause mortality than those with 1 or none of these morphological features (25.7% vs. 9.5% vs. 5.9%; log-rank p < 0.001). Patients with both morphological features had higher rates of aortic root injury (p < 0.001), moderate-to-severe paravalvular regurgitation (p = 0.002), and 30-day mortality (p = 0.016).

Conclusions

Outcomes of TAVR in bicuspid aortic stenosis depend on valve morphology. Calcified raphe and excess leaflet calcification were associated with increased risk of procedural complications and midterm mortality. (Bicuspid Aortic Valve Stenosis Transcatheter Aortic Valve Replacement Registry; NCT03836521)

Key Words

aortic stenosis
bicuspid aortic valve
transcatheter aortic valve implantation

Abbreviations and Acronyms

BAV
bicuspid aortic valve
CI
confidence interval
CT
computed tomography
STS
Society of Thoracic Surgeons
TAVR
transcatheter aortic valve replacement

Cited by (0)

Dr. Kim has received proctor or speaker fees from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic. Dr. Victoria has received speaker fees from Abbott Vascular, Medtronic, Edwards Lifesciences, GE Healthcare, and Merck Sharp & Dohme. Dr. Dhoble has served as a proctor and consultant for Abbott Vascular, Edwards Lifesciences, and Keystone Heart; and has served on the physician review committee for the Keystone Heart REFLECT trial. Dr. Babaliaros has received consulting fees from Edwards Lifesciences and Abbott Vascular; and has equity in Transmural Systems. Dr. Jilaihawi has served as a consultant for Boston Scientific and Medtronic; and has received research grants from Abbott Vascular, Edwards Lifesciences, Medtronic, and Bracco. Dr. Pilgrim has received research grants to the institution and speaker fees from Boston Scientific and Biotronik; and has received consultant fees from HighLife SAS. Dr. Backer has served as a consultant for Abbott and Boston Scientific. Dr. Renker has received speaker fees from Abbott. Dr. Pershad has received speaking fees and honoraria from Boston Scientific, Medtronic, Asahi Intecc, Edwards Lifesciences, and Abiomed; and has received consultancy fees from Abiomed and Boston Scientific. Dr. Chakravarty has received support from Edwards Lifesciences, Medtronic, and Abbott. Dr. Whisenant has served as a consultant for Edwards Lifesciences and Boston Scientific. Dr. Windecker has received research and educational grants to the institution from Abbott, Amgen, Bristol-Myers Squibb, Bayer, Boston Scientific, Biotronik, Cardinal Health, CardioValve, CSL Behring, Daiichi-Sankyo, Edwards Lifesciences, Johnson & Johnson, Medtronic, Querbet, Polares, Sanofi, Terumo, and Sinomed; serves as an unpaid member of the steering/executive group of trials funded by Abbott, Abiomed, Amgen, Bristol-Myers Squibb, Boston Scientific, Biotronik, Cardiovalve, Edwards Lifesciences, MedAlliance, Medtronic, Polares, Sinomed, V-Wave, and Xeltis, but has not received personal payments by any pharmaceutical company or device manufacturer; and has been member of the steering/executive committee group of several investigator-initiated trials that receive funding from industry without impact on his personal remuneration. Dr. Sondergaard has served as a proctor for and received institutional grants from Edwards Lifesciences. Dr. Chevalier has served as a consultant for Medtronic. Dr. Mack has received nonfinancial support from Edwards Lifesciences, Abbott, and Medtronic outside of the submitted work. Dr. Leon has received grants and other support from Edwards Lifesciences, Medtronic, and Boston Scientific outside of the submitted work. Dr. Makkar has received research grants and consulting and speaker fees from Edwards Lifesciences, Abbott, Medtronic, and Boston Scientific. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

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