Transcatheter Aortic Valve Replacement in Low-risk Patients With Bicuspid Aortic Valve Stenosis

Abstract

IMPORTANCEThe outcomes of transcatheter aortic valve replacement (TAVR) in low-risk patients with bicuspid aortic valve stenosis have not been studied in a large scale, multicentered, prospective fashion.OBJECTIVE To evaluate the procedural safety, efficacy, and 30-day outcomes of TAVR in patients with bicuspid aortic stenosis at low surgical risk. DESIGN, SETTING, AND PARTICIPANTS The Low Risk Bicuspid Study is a prospective, single-arm trial study with inclusion/exclusion criteria developed from the Evolut Low Risk Randomized Trial. Follow-up is planned for 10 years. Patients underwent TAVR at 25 centers in the United States who were also participating in the Evolut Low Risk Randomized Trial from December 2018 to October 2019. Eligible patients had severe bicuspid aortic valve stenosis and met American Heart Association/American College of Cardiology guideline indications for aortic valve replacement. INTERVENTIONS Patients underwent attempted implant of an Evolut or Evolut PRO transcatheter aortic valve, with valve size based on annular measurements. MAIN OUTCOMES AND MEASURESThe prespecified primary end point was the incidence of all-cause mortality or disabling stroke at 30 days. The prespecified primary efficacy end point was device success defined as the absence of procedural mortality, the correct position of 1 bioprosthetic heart valve in the proper anatomical location, and the absence of more than mild aortic regurgitation postprocedure.RESULTS A total of 150 patients underwent an attempted implant. Baseline characteristics include mean age of 70.3 (5.5) years, 48.0% female (n = 72), and a mean Society of Thoracic Surgeons score of 1.4 (0.6%). Most patients (136; 90.7%) had Sievers type I valve morphology. The incidence of all-cause mortality or disabling stroke was 1.3% (95% CI, 0.3%-5.3%) at 30 days. The device success rate was 95.3% (95% CI, 90.5%-98.1%). At 30 days, the mean (SD) AV gradient was 7.6 (3.7) mm Hg and effective orifice area was 2.3 (0.7) cm 2 . A new permanent pacemaker was implanted in 22 patients (15.1%). No patients had greater than mild paravalvular leak. CONCLUSIONS AND RELEVANCETranscatheter aortic valve replacement in low-surgical risk patients with bicuspid aortic valve stenosis achieved favorable 30-day results, with low rates of death and stroke and high device success rate.

Transcatheter Aortic Valve Implantation in Sievers Type 0 vs. Type 1 Bicuspid Aortic Valve Morphology: Systematic Review and Meta-Analysis

“…Conversely, no significant differences in procedural or 30-day mortality were detected between the Sievers type 0 vs. type 1 BAV in the other five enrolled studies (8,(19)(20)(21)(22). Notably, three of them reported no procedural death or 30-day death for the patients with Sievers type 0 BAV (20)(21)(22). Consistently, a similar mortality up to 5 years was demonstrated between the two BAV subsets in the patients receiving SAVR after adjusting for age, diabetes, and left ventricular ejection fraction (26).…”

“…However, these mortality differences were driven by just several cases from the above early small-scale studies. Conversely, no significant differences in procedural or 30-day mortality were detected between the Sievers type 0 vs. type 1 BAV in the other five enrolled studies (8,(19)(20)(21)(22). Notably, three of them reported no procedural death or 30-day death for the patients with Sievers type 0 BAV (20)(21)(22).…”

“…The inclusion flow chart of the current study is shown in Figure 1. Six studies (1,239 patients) were enrolled to compare the procedural and clinical outcomes of TAVI between the Sievers type 0 and type 1 BAV (8,13,(19)(20)(21)(22). The bias risk of the enrolled studies was generally low based on the Newcastle-Ottawa scale criteria (…”

Bicuspid Aortic Valve Is Associated with Less Coronary Calcium and Coronary Artery Disease Burden

“…TAVR has recently emerged for treatment of BAV stenosis with promising initial results, despite technical challenges related to the distinct BAV geometry and coronary sinus asymmetry have resulted in higher complication rates [ 7 ]. Notably, in patients with BAV, CTA succeeded in the majority of patients (67.2%) to rule out coronary stenosis >50%.…”

“…The coronary artery calcium score (CACS) allows for quantification of total calcium burden. CTA is routinely performed in patients with severe aortic stenosis before transcatheter aortic valve replacement (TAVR) for procedure planning [ 7 ] for both TAV and BAV [ 8 ]. However, in more than 50% of patients with TAV stenosis, coronary CTA fails to exclude obstructive CAD due to high CACS [ 9 ].…”