Abstract Objectives The study aimed to compare long-term outcomes of the David and Yacoub valve-sparing aortic root replacement (VSARR) procedures in a nationwide, low-volume setting. Methods All patients undergoing elective VSARR in Denmark between January 2010 and April 2022 were identified using the Danish registries. The primary end-point was all-cause death. Secondary end-points included stroke, reoperation, a composite of death or reoperation, and long-term echocardiographic outcomes. Analyses were performed in both crude and propensity score-matched (PSM) populations and compared with outcomes from a control group comprised of all elective composite root replacement procedures performed at the contributing centres in the study period. Results A total of 160 patients underwent VSARR (median age; David vs Yacoub; 49.7 [SD 14.1] years vs 51.5 [SD 14.3] years; P = .42) with the David (n = 92, 57.5%; median follow-up 8.2 [SD 3.6] years) or Yacoub (n = 68, 42.5%; median follow-up 7.1 [SD 2.4] years) procedure. Ten-year all-cause death was similar (David 9.3% [95% CI: 2.3-15.2] vs Yacoub 8.8% [95% CI: 3.6-20.6]; log-rank P = .54). Reoperation rates (log-rank P = .12), stroke incidence (P = .41), and the composite end-point of death or reoperation (log-rank P = .63) were comparable, with consistent findings in the PSM cohort. Long-term echocardiographic follow-up demonstrated no difference in recurrent regurgitation, stenosis, or valve-related complications. Compared to elective composite root replacement (CRR) (n = 486), VSARR demonstrated lower rate of all-cause death (P = .027) and stroke (P = .026), while reoperation rate was higher (13.8% vs 4.3%; P < .001). However, the risk of reoperation was comparable between procedures when accounting for competing risk of death (log-rank P = .17). Conclusions Long-term outcomes following elective VSARR using the David and Yacoub procedure were comparable. VSARR was associated with lower risk of all-cause death and stroke compared to elective CRR, supporting the two VSARR procedures as durable options when performed in experienced centres with careful patient selection, even in low-volume settings.
Aortic valve-sparing root replacement and composite root replacement: a Danish multicentre nationwide study
Abstract Aims Aortic valve-sparing root replacement is recommended over composite root replacement for aortic root aneurysms, especially in younger patients, but long-term outcomes in low-volume nationwide settings remain unclear. The objectives are to compare long-term survival, stroke, and reoperation rates between the two procedures in a low-volume national setting. Methods and results Patients were identified from the Western Danish Heart Registry and the Danish Heart Registry. Cases were validated by review of operative descriptions. The primary outcome was long-term survival from all-cause mortality; secondary outcomes included stroke, reoperation, recurrent aortic regurgitation, and aortic stenosis. Groups were balanced using propensity score matching. Echocardiographic data were provided for the matched cohort. We identified 760 patients treated with composite root replacement and 179 patients with aortic valve-sparing root replacement between January 2010 and April 2022. Mean follow-up was 6.5 years. Composite root replacement patients were younger [50.7 years (SD 14.1) vs. 55.2 (SD 13.5), P < 0.001], but more comorbid with a median EuroSCOREII of 5.5 [interquartile range (IQR): 3.3–11.7] vs. 3.4 (IQR: 2.6–5.0) (P < 0.001). After matching 157 patients per group, aortic valve-sparing root replacement showed improved 10-year survival [91.2%, 95% confidence interval (CI) 82.3–95.8 vs. 80.4%, 95% CI 70.0–87.5, log-rank P = 0.026], with lower 10-year stroke risk (4.9%, 95% CI 1.8–13.0 vs. 18.9%, 95% CI 11.7–29.9, log-rank P = 0.007). Risk of reoperation was nonsignificant (log-rank P = 0.12), which was consistent in the crude population when accounting for competing risk of death (log-rank P = 0.09). Conclusion In this nationwide study, aortic valve-sparing root replacement was associated with better long-term survival and lower stroke risk, supporting its role as a durable surgical option for selected patients.
Self-expanding Transcatheter vs Surgical Aortic Valve Replacement in Intermediate-Risk Patients
Importance In patients with severe aortic valve stenosis at intermediate surgical risk, transcatheter aortic valve replacement (TAVR) with a self-expanding supra-annular valve was noninferior to surgery for all-cause mortality or disabling stroke at 2 years. Comparisons of longer-term clinical and hemodynamic outcomes in these patients are limited. Objective To report prespecified secondary 5-year outcomes from the Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement (SURTAVI) randomized clinical trial. Design, Setting, and Participants SURTAVI is a prospective randomized, unblinded clinical trial. Randomization was stratified by investigational site and need for revascularization determined by the local heart teams. Patients with severe aortic valve stenosis deemed to be at intermediate risk of 30-day surgical mortality were enrolled at 87 centers from June 19, 2012, to June 30, 2016, in Europe and North America. Analysis took place between August and October 2021. Intervention Patients were randomized to TAVR with a self-expanding, supra-annular transcatheter or a surgical bioprosthesis. Main Outcomes and Measures The prespecified secondary end points of death or disabling stroke and other adverse events and hemodynamic findings at 5 years. An independent clinical event committee adjudicated all serious adverse events and an independent echocardiographic core laboratory evaluated all echocardiograms at 5 years. Results A total of 1660 individuals underwent an attempted TAVR (n = 864) or surgical (n = 796) procedure. The mean (SD) age was 79.8 (6.2) years, 724 (43.6%) were female, and the mean (SD) Society of Thoracic Surgery Predicted Risk of Mortality score was 4.5% (1.6%). At 5 years, the rates of death or disabling stroke were similar (TAVR, 31.3% vs surgery, 30.8%; hazard ratio, 1.02 [95% CI, 0.85-1.22]; P = .85). Transprosthetic gradients remained lower (mean [SD], 8.6 [5.5] mm Hg vs 11.2 [6.0] mm Hg; P &lt; .001) and aortic valve areas were higher (mean [SD], 2.2 [0.7] cm 2 vs 1.8 [0.6] cm 2 ; P &lt; .001) with TAVR vs surgery. More patients had moderate/severe paravalvular leak with TAVR than surgery (11 [3.0%] vs 2 [0.7%]; risk difference, 2.37% [95% CI, 0.17%- 4.85%]; P = .05). New pacemaker implantation rates were higher for TAVR than surgery at 5 years (289 [39.1%] vs 94 [15.1%]; hazard ratio, 3.30 [95% CI, 2.61-4.17]; log-rank P &lt; .001), as were valve reintervention rates (27 [3.5%] vs 11 [1.9%]; hazard ratio, 2.21 [95% CI, 1.10-4.45]; log-rank P = .02), although between 2 and 5 years only 6 patients who underwent TAVR and 7 who underwent surgery required a reintervention. Conclusions and Relevance Among intermediate-risk patients with symptomatic severe aortic stenosis, major clinical outcomes at 5 years were similar for TAVR and surgery. TAVR was associated with superior hemodynamic valve performance but also with more paravalvular leak and valve reinterventions.