Study Compares Early Outcomes of TAVI Versus SAVR in Real-World Patients With Bicuspid Aortic Valve Stenosis

June 13, 2022—In a nationwide, multicenter, propensity score–matched cohort study using real-world data comparing transcatheter aortic valve implantation (TAVI) and surgical aortic valve replacement (SAVR) in bicuspid aortic valve (BAV) stenosis, Majmundar et al found a reduced risk of in-hospital mortality in the TAVI group and similar rates of 30-day and 6-month major adverse cardiovascular events (MACE) between groups. The study was published online in EuroIntervention.

Investigators used ICD-10 codes in the Nationwide Readmission Database to identify patients who underwent TAVI or SAVR for BAV between 2016 and 2018.

The primary outcome measure was in-hospital mortality. The secondary outcome measures were 30-day and 6-month MACE, defined as a composite of all-cause mortality during readmission, stroke readmission, and cardiovascular hospitalization.

Propensity score–matched cohorts were generated for the TAVI and SAVR for in-hospital, short-term outcomes, and for medium-term outcomes to have 30-day and 6-month follow-ups for all patients. Univariate logistic and Cox-proportional regression were used to calculate the odds ratio (OR), hazard ratio (HR), and 95% CI. Sensitivity and unmeasured bias analyses were conducted to assess the robustness of the findings.

A search of the Nationwide Readmission Database yielded 17,068 total patients who underwent SAVR or TAVI for BAV stenosis during the study period. Of these, 15,539 (90.5%) underwent SAVR and 1,629 (9.5%) underwent TAVI. Matching yielded 1,393 pairs with 30-day follow-up and 848 pairs with 6-month follow-up.

Patients who underwent TAVI were older, more were female, and there was a higher prevalence of all comorbidities except obesity, which was higher in the SAVR group. TAVI was more often performed at high-volume, large hospitals and as a nonelective procedure as compared with SAVR.

TAVI was associated with reduced in-hospital mortality as compared with SAVR (0.7% vs 1.8%; OR, 0.35; 95% CI, 0.13-0.93; P = .0035). Patients who underwent TAVI had a lower risk of major bleeding, vascular complications, acute kidney injury, cardiorespiratory complications, and need for cardiothoracic reintervention. Rates of MACE were similar between the two groups, both at 30 days (1% for TAVI vs 1.5% for SAVR; OR, 0.65; 95% CI, 0.27-1.58; P = .343) and 6 months (4.2% for TAVI vs 4.9% for SAVR; HR, 0.86; 95% CI, 0.44-1.69; P = .674). TAVI was associated with a higher risk of pacemaker implantation at 30 days (2.2% for TAVI vs 0.2% for SAVR; P = .006).

Limitations, as reported by the study investigators, included the use of an administrative database and procedural codes to identify the patient cohort and the lack of information on prosthetic valve characteristics and BAV morphology or echocardiographic parameters.

Based on study results, the investigators concluded that TAVI might be a suitable alternative to SAVR if long-term outcomes with TAVI valves are acceptable.