Project description:Background: Traditionally, the only effective treatment for aortic stenosis was surgical aortic valve replacement (SAVR). Transcatheter aortic valve replacement (TAVR) was approved in the United States in late 2011 and provided a critical alternative therapy. Our aims were to investigate the trends in the utilization of SAVR in the early vs. late TAVR era and to assess SAVR and TAVR outcomes. Methods: Using the 2011-2017 National Inpatient Sample database, we identified hospitalizations for patients with a most responsible diagnosis of aortic stenosis during which an aortic valve replacement (AVR) was performed, either SAVR or TAVR. Patients' sociodemographic and clinical characteristics, procedure complications, length of stay, and mortality were analyzed. Multivariable analyses were performed to identify predictors of in-hospital mortality. Piecewise regression analyses were performed to assess temporal trends in SAVR and TAVR utilization. Results: A total of 542,734 AVR procedures were analyzed. The utilization of SAVR was steady until 2014 with a significant downward trend in the following years 2015-2017 (P = 0.026). In contrast, a steady upward trend was observed in the TAVR procedure with a significant increase during the years 2015-2017 (P = 0.006). Higher in-hospital mortality was observed in SAVR patients. The mortality rate declined from 2011 to 2017 in a significantly higher proportion in the TAVR compared with the SAVR group. Conclusion: Utilization of SAVR showed a downward trend during the late TAVR era (2015-2017), and TAVR utilization demonstrated a steady upward trend during the years 2011-2017. Higher in-hospital mortality was recorded in patients who underwent SAVR.
Project description:BackgroundCOVID-19 has caused the deferral of millions of elective procedures, likely resulting in a backlog of cases. We estimate the number of postponed surgical aortic valve replacement (sAVR) and transcatheter aortic valve replacement (TAVR) procedures during the first two waves of the COVID-19 pandemic in Germany.MethodsUsing German national records, all isolated TAVR and sAVR procedures between 2007 and 2020 were identified. Using weekly TAVR and sAVR procedures between 2017 and 2019, we created a forecast for 2020 and compared it with the observed number of procedures in 2020.ResultsIn Germany, a total of 225,398 isolated sAVR and 159,638 isolated TAVR procedures were conducted between 2007 and 2020 that were included in our analysis. The reduction in all AVR procedures (sAVR and TAVR) for the entire year 2020 was 19.07% (95%CI: 15.19-22.95%). During the first wave of the pandemic (week 12-21), the mean weekly reduction was 32.06% (23.44-40.68%) and during the second wave of the pandemic (week 41-52), the mean weekly reduction was 25.58% (14.19-36.97%). The number of sAVR procedures decreased more than the number of TAVR procedures (24.63% vs. 16.42% for the entire year 2020).ConclusionThe first year of the COVID-19 pandemic saw a substantial postponing of AVR procedures in Germany. Postponing was higher for sAVR than for TAVR procedures and less pronounced during the second wave of the COVID-19 pandemic.
Project description:AbstractTranscatheter aortic valve replacement (TAVR) is a standard treatment indicated for severe aortic stenosis in high-risk patients. The objective of this study was to evaluate the incidence of pacemaker dependency after permanent pacemaker implantation (PPI) following TAVR or surgical aortic valve replacement (SAVR) and the risk of mortality at a tertiary center in Korea.In this retrospective study conducted at a single tertiary center, clinical outcomes related to pacemaker dependency were evaluated for patients implanted with pacemakers after TAVR from January 2012 to November 2018 and post-SAVR from January 2005 to May 2015. Investigators reviewed patients' electrocardiograms and baseline rhythms as well as conduction abnormalities. Pacemaker dependency was defined as a ventricular pacing rate > 90% with an intrinsic rate of <40 bpm during interrogation.Of 511 patients who underwent TAVR for severe AS, 37(7.3%) underwent PPI after a median duration of 6 (3-7) days, whereas pacemakers were implanted after a median interval of 13 (8-28) days post-SAVR in 10 of 663 patients (P < .001). Pacemaker dependency was observed in 36 (97.3%) patients during 7 days immediately post-TAVR and in 25 (64.9%) patients between 8 and 180 days post-TAVR. Pacemaker dependency occurred after 180 days in 17 (50%) patients with TAVR and in 4 (44.4%) patients with SAVR. Twelve (41.4%) patients were pacemaker-dependent after 365 days post-TAVR.Pacemaker dependency did not differ at 6 months after TAVR vs SAVR. In patients undergoing post-TAVR PPI, 58.6% were not pacemaker-dependent at 1 year after the TAVR procedure.
Project description:BackgroundBiological valve prostheses in rapid-deployment aortic valve replacement (RD AVR) procedures have demonstrated excellent outcomes. However, previous studies indicate a lack of specific surgical outcomes for the bicuspid aortic valve (BAV) or recommend RD AVR implementation. The existing literature comparing the clinical and hemodynamic outcomes of patients with BAV and those with tricuspid aortic valves (TAVs) after RD AVR is limited. Therefore, this study evaluated the safety and feasibility of RD AVR in BAV, including Sievers type 0, and compared the early clinical and hemodynamic outcomes of patients who underwent RD AVR at a single center based on aortic valve type.MethodsOur institution officially commenced performing RD AVR using Intuity valves in September 2022. The medical records of 80 patients who underwent aortic valve replacement (AVR) between September 1, 2022, and July 31, 2023 were retrospectively analyzed. In this set, 30 patients underwent RD AVR for aortic stenosis. Among the 30 RD AVR cases, groups A and B comprised 16 (53.3%) patients with TAV and 14 (46.7%) with BAV, respectively. The preoperative characteristics and postoperative echocardiographic data were compared between the two groups.ResultsNo statistically significant differences in preoperative characteristics, including mean age and sex distribution, were found between groups A and B. Notably, no patient in both groups exhibited mild- or higher-grade aortic regurgitation. The postoperative transvalvular mean pressure gradients showed significantly lower values in group B than in group A (12.20±4.64 vs. 16.26±5.49 mmHg, P=0.03). The necessity to insert a permanent pacemaker was not found in any of the patients (0%) in group A but was found in one (7.1%) patient in group B (P=0.46). Among the BAV cases, six (20%) were categorized as Sievers type 0. Of the 14 patients in group B, six with Sievers type 0 and the remaining eight with other bicuspid valve types were designated as groups B0 and B1, respectively. Similarly, no significant difference in postoperative transvalvular mean pressure gradient was observed between the two groups (11.33±4.49 vs. 12.86±4.94 mmHg, P=0.56). No in-hospital mortality was observed among all 30 patients.ConclusionsIn this study, RD AVR was considered feasible in a small, carefully selected cohort of patients with aortic stenosis, even in BAV, including Sievers type 0, as observed from the standpoint of postoperative hemodynamic outcomes and the incidence of aortic regurgitation.
Project description:Background In the absence of randomized controlled trials, reports from nonrandomized studies comparing valve-in-valve implantation (ViV) to redo surgical aortic valve replacement (rAVR) have shown inconsistent results. Methods and Results PubMed/MEDLINE, Google Scholar, and CENTRAL (Cochrane Central Register of Controlled Trials) were searched through December 2021. Meta-Analysis of Observational Studies in Epidemiology guidelines were followed. The protocol was registered at the International Prospective Register of Systematic Reviews. Random effects models were applied. The primary outcomes of interest were short-term and midterm mortality. Secondary outcomes included stroke, myocardial infarction, acute renal failure, and permanent pacemaker implantation, as well as prosthetic aortic valve regurgitation, mean transvalvular gradient, and severe prosthesis-patient mismatch. Of 8881 patients included in 15 studies, 4458 (50.2%) underwent ViV and 4423 (49.8%) rAVR. Short-term mortality was 2.8% in patients undergoing ViV compared with 5.0% in patients undergoing rAVR (risk ratio [RR] 0.55 [95% CI, 0.34-0.91], P=0.02). Midterm mortality did not differ in patients undergoing ViV compared with patients undergoing rAVR (hazard ratio, 1.27 [95% CI, 0.72-2.25]). The rate of acute kidney failure was lower following ViV, (RR, 0.54 [95% CI, 0.33-0.88], P=0.02), whereas prosthetic aortic valve regurgitation (RR, 4.18 [95% CI, 1.88-9.3], P=0.003) as well as severe patient-prothesis mismatch (RR, 3.12 [95% CI, 2.35-4.1], P<0.001) occurred more frequently. The mean transvalvular gradient was higher following ViV (standard mean difference, 0.44 [95% CI, 0.15-0.72], P=0.008). There were no significant differences between groups with respect to stroke (P=0.26), myocardial infarction (P=0.93), or pacemaker implantation (P=0.21). Conclusions Results of this meta-analysis demonstrate better short-term mortality after ViV compared with rAVR. Midterm mortality was similar between groups. Given the likely selection bias in these individual reports, an adequately powered multicenter randomized clinical trial with sufficiently long follow-up in patients with low-to-intermediate surgical risk is warranted. Registration URL: crd.york.ac.uk/prospero/. Unique identifier: CRD42021228752.
Project description:ObjectivesThe aim of this study was to examine whether hospital surgical aortic valve replacement (SAVR) volume was associated with corresponding transcatheter aortic valve replacement (TAVR) outcomes.BackgroundRecent studies have demonstrated a volume-outcome relationship for TAVR.MethodsIn total, 208,400 fee-for-service Medicare beneficiaries were analyzed for all aortic valve replacement procedures from 2012 to 2015. Claims for patients <65 years of age, concomitant coronary artery bypass grafting surgery, other heart valve procedures, or other major open heart procedures were excluded, as were secondary admissions for aortic valve replacement. Hospital SAVR volumes were stratified on the basis of mean annual SAVR procedures during the study period. The primary outcomes were 30-day and 1-year post-operative TAVR survival. Adjusted survival following TAVR was assessed using multivariate Cox regression.ResultsA total of 65,757 SAVR and 42,967 TAVR admissions were evaluated. Among TAVR procedures, 21.7% (n = 9,324) were performed at hospitals with <100 (group 1), 35.6% (n = 15,298) at centers with 100 to 199 (group 2), 22.9% (n = 9,828) at centers with 200 to 299 (group 3), and 19.8% (n = 8,517) at hospitals with ≥300 SAVR cases/year (group 4). Compared with group 4, 30-day TAVR mortality risk-adjusted odds ratios were 1.32 (95% confidence interval: 1.18 to 1.47) for group 1, 1.25 (95% confidence interval: 1.12 to 1.39) for group 2, and 1.08 (95% confidence interval: 0.82 to 1.25) for group 3. These adjusted survival differences in TAVR outcomes persisted at 1 year post-procedure.ConclusionsTotal hospital SAVR volume appears to be correlated with TAVR outcomes, with higher 30-day and 1-year mortality observed at low-volume centers. These data support the importance of a viable surgical program within the heart team, and the use of minimum SAVR hospital thresholds may be considered as an additional metric for TAVR performance.
Project description:ImportanceThe Centers for Medicare & Medicaid Services national coverage determination for transcatheter aortic valve replacement (TAVR) includes volume requirements for surgical aortic valve replacement (SAVR) for hospitals seeking to initiate or continue TAVR programs. Evidence regarding the association between SAVR volume and TAVR outcomes is limited.ObjectiveTo examine the association of hospital SAVR and combined SAVR and TAVR volumes with patient outcomes of TAVR procedures performed within 1 year, 2 years, and for the entire period after initiation of TAVR programs.Design, setting, and participantsThis observational cohort study included 60 538 TAVR procedures performed in 438 hospitals between October 1, 2011, and December 31, 2015, among Medicare beneficiaries.Main outcomes and measuresThe associations between SAVR volume, SAVR and TAVR volumes, and risks of death, death or stroke, and readmissions within 30 days were determined using a hierarchical logistic regression model adjusting for patient and hospital characteristics. The association between SAVR and SAVR and TAVR volumes and 1-year and 2-year mortality after TAVR procedures was determined using a multivariable proportional hazard model with a robust variance estimator. The associations for procedures performed within 1 year, 2 years, and for the entire period after initiation of TAVR programs were examined.ResultsAmong the 60 538 patients, 29 173 were women and 31 365 were men, with a mean (SD) age of 82.3 (8.0) years. Hospitals with high SAVR volume (mean annual volume, ≥97 per year) were more likely to adopt TAVR early and had a higher growth in TAVR volumes over time (median TAVR volume by hospitals with high SAVR volume and low SAVR volume: year 1, 32 vs 19; year 2, 48 vs 28; year 3, 82 vs 38; year 4, 118 vs 54; P < .001). In adjusted analysis, high hospital SAVR volume alone was not associated with better patient outcomes after TAVR. When hospital TAVR and SAVR volumes were jointly analyzed, patients treated in hospitals with high TAVR volume had lower 30-day mortality after TAVR (high TAVR and low SAVR vs low TAVR and low SAVR: odds ratio, 0.85; 95% CI, 0.72-0.99; high TAVR and high SAVR vs low TAVR and high SAVR: odds ratio, 0.81; 95% CI, 0.69-0.95), the effect of which was more pronounced when hospitals also had high SAVR volume. Patients treated in hospitals with high SAVR volume and high TAVR volume had the lowest 30-day mortality (vs hospitals with low SAVR volume and TAVR volume: odds ratio, 0.77; 95% CI, 0.66-0.89).Conclusions and relevanceHospitals with high SAVR volume are most likely to be fast adopters of TAVR. Hospital SAVR volume alone is not associated with better TAVR outcomes. Accumulating high volumes of TAVR is associated with lower mortality after TAVR, particularly when hospitals have high SAVR volumes. Hospitals with high caseloads of both SAVR and TAVR are likely to achieve the best outcomes.
Project description:Dystrophic calcifications of the aortic valve may cause symptomatic aortic stenosis and account for a significant portion of patients who undergo elective valve replacement. Calcifications appearing grossly as a cloudy fluid surrounding the aortic valve leaflets are an uncommon finding. Normally, calcified aortic valves are characterised by large, nodular masses within the aortic cusps. We report a case of dystrophic calcifications on a stenotic aortic valve encountered intraoperatively, which was suggestive of infective endocarditis and abscess formation. Aortic valve leaflets and necrotic-appearing thymic lymph node tissue were submitted for histology and special stains. Cultures were negative and histology did not show evidence of infection. Tissue histology demonstrated extensive dystrophic calcifications, which were polarised to reveal abundant calcium oxalate crystals. The benign nature of this unique pathological finding ruled out any suspicion of infection, avoiding a prolonged course of intravenous antibiotics in this patient.
Project description:Although the results of the early TAVI experience are promising, longer-term follow-up is necessary before the procedure can be extended to lowerrisk patients. Many issues are not yet resolved, including the long-term effects of paravalvular leaks (which occur in most TAVI patients), the true stroke rate in TAVI patients (which is probably in the range of 5% to 6%), and the need for permanent pacemaker implantation (which ranges from 5% to 40% in TAVI patients, depending upon the device used). As the procedure is extended into the lower-risk population, these issues will assume greater import than they have in the population currently in treatment—very elderly, high-risk patients with limited life expectancy. As in the coronary-revascularization paradigm of percutaneous coronary intervention versus coronary artery bypass grafting, there will be increasing adoption of the transcatheter approach. Just as the rumors of the demise of surgical bypass were premature, conventional AVR will continue to be the predominant technique for the treatment of aortic stenosis during at least the next decade. Although the percentage of patients treated by a transcatheter approach will continue to increase, regulatory and reimbursement factors are likely to be the primary determinants of the rate of adoption.
Project description:ObjectiveIn patients with mild to moderate operative risk, surgical aortic valve replacement (SAVR) is still the preferred treatment for patients with severe symptomatic aortic stenosis (AS). Aiming to broaden the knowledge of postsurgical outcomes, this study reports a broad set of morbidity outcomes following surgical intervention.MethodsOur cohort comprised 442 patients referred for severe AS; 351 had undergone SAVR, with the remainder (91) not operated on. All patients were evaluated using the 6-minute walk test (6MWT), were assigned a New York Heart Association class (NYHA) and Canadian Cardiovascular Society class (CCS), with additional scores for health-related quality of life (HRQoL), cognitive function (Mini-Mental State Examination (MMSE)) and myocardial remodelling (at inclusion and at 1-year follow-up). Adverse events and mortality were recorded.ResultsThree-year survival after SAVR was 90.0%. SAVR was associated with an improved NYHA class, CCS score and HRQoL, and provoked reverse ventricular remodelling. The 6MWT decreased, while the risks of major adverse cardiovascular events (death, non-fatal stroke/transient ischaemic attack or myocardial infarction) and all-cause hospitalisation (incidence rate per 100 patient-years) were 13.5 and 62.4, respectively. The proportion of cognitive disability measured by MMSE increased after SAVR from 3.2% to 8.8% (p=0.005). Proportion of patients living independently at home, having attained NYHA class I, was met by 49.1% at 1 year. Unoperated individuals had a poor prognosis in terms of any outcome.ConclusionThis study provides knowledge of outcomes beyond what is known about the mortality benefit after SAVR to provide insight into the morbidity burden of modern-day SAVR.