Transcatheter vs Surgical Aortic Valve Replacement in Pure Native Aortic Regurgitation.

BACKGROUND: Patients with pure native aortic regurgitation (AR) have been excluded from transcatheter aortic valve replacement (TAVR) trials. We sought to examine midterm outcomes with TAVR in AR compared with surgical AVR (SAVR) in a contemporary cohort. METHODS: Medicare beneficiaries who underwent elective TAVR or SAVR for pure AR from 2016 to 2019 were identified. Patients with concomitant aortic stenosis and who underwent a valve-in-valve intervention or concomitant mitral valve or ascending aorta operation were excluded. The primary outcome was all-cause mortality in the longest follow-up. Secondary outcomes included stroke, endocarditis, and redo AVR. Overlap propensity score weighting was used to adjust for confounders. RESULTS: During the study period, 11,027 patients with pure AR underwent elective AVR (TAVR, n = 1147; SAVR, n = 9880). SAVR patients were younger, with fewer comorbidities and less frailty compared with TAVR patients. TAVR was associated with adjusted 30-day mortality comparable to SAVR. After a median follow-up of 31 months (interquartile range, 18-44 months), TAVR was associated with higher adjusted risk of death (hazard ratio [HR], 1.41; 95% CI, 1.03-1.93; P = .02) and need for redo-AVR (HR, 2.13; 95% CI, 1.05-4.34; P = .03) compared with SAVR. The risk of stroke (HR, 1.65; 95% CI, 0.95-2.87; P = .07) and endocarditis (HR, 2.60; 95% CI, 0.92-7.36; P = .07) was numerically higher with TAVR. CONCLUSIONS: In Medicare patients with pure native AR, TAVR with the current commercially available transcatheter valves has comparable short-term outcomes. Although long-term outcomes were inferior to SAVR, the possibility of residual confounding, biasing long-term outcomes, given older and frailer TAVR patients, cannot be excluded.

Automated Titanium Fasteners Versus Hand-Tied Knots: A Randomized Controlled Trial.

BACKGROUND: The relative benefits of automated titanium fasteners (LSI Solutions, Victor, NY) have not been examined in patients undergoing sternotomy. The aim of this study was to assess the time and cost required for suture fixation with the automated device versus conventional hand tying in sternotomy for mitral or tricuspid ring annuloplasty. METHODS: Fifty patients scheduled to undergo primary mitral or tricuspid, or both, ring annuloplasty-based valve repair operation by a single surgeon were randomly assigned to receive either conventional hand-tied knots or automated titanium fasteners, with 25 patients in each group. The primary outcome variable was the time required to affix the annuloplasty device to the valve annulus. RESULTS: The times taken to affix a mitral annuloplasty band or ring were 6.1 ± 0.9 min for manual tying versus 3.1 ± 0.4 min for automated fasteners (p < 0.0001); when calculated per annuloplasty stitch, the values were 22 ± 2 s versus 12 ± 1.1 s, respectively (p < 0.0001). The corresponding values for tricuspid annuloplasty were 4.2 ± 1.2 min (hand tying) versus 2.2 ± 0.3 min (automated fasteners) (p = 0.0005), and the times for each suture were 20 ± 2.1 s versus 13 ± 2 s, respectively (p = 0.0004). The use of the automated fastener had no significant impact on aortic cross-clamp time or cardiopulmonary bypass duration. Total cost associated with annuloplasty fixation with automated titanium fasteners (device cost in addition to operating room time cost) was significantly higher than with hand tying ($1,190 ± 374 vs $164 ± 60; p < 0.0001). CONCLUSIONS: Using the automated fastener to facilitate annuloplasty fixation through a sternotomy resulted in a small procedural time savings (average of 10 s/stitch) that had no overall impact on cardiopulmonary bypass or cross-clamp times but added an average cost of $1,026 to the operation.