Trend in morbidity and mortality in surgical aortic valve replacement: a retrospective, observational, single-centre study.
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ABSTRACT: Objectives
Continuous improvement in the management of patients undergoing surgical aortic valve replacement (SAVR) may have considerably enhanced surgical outcomes including in-hospital mortality and perioperative complications. We aimed to analyse in-hospital mortality and morbidity trends in patients undergoing SAVR in a single centre to provide insights for future benchmarking for transcatheter aortic valve implantation indications.Methods
This was a retrospective study of prospectively collected data from patients undergoing either isolated SAVR or combined with coronary artery bypass grafting (CABG) at the Bristol Heart Institute, UK, from January 2000 to December 2017. Baseline characteristics were extracted and analysed across 3 different eras (2000-2005, 2006-2011 and 2012-2017). Risk-adjusted time trend was obtained from univariate and multivariate logistic regression including all baseline characteristics.Results
A total of 2719 patients (63.2%) underwent isolated SAVR, and 1581 (36.8%) underwent combined CABG and SAVR during the study period. For patients undergoing SAVR, in-hospital mortality decreased from 2.9% in 2000-2005 to 0.7% in 2012-2017 (risk-adjusted time trend 0.0001). Hospital mortality in patients aged 75-79 and ≥80 years decreased from 5.6% and 5.3% to 0.4% and 2.2%, respectively. Mortality after combined SAVR and CABG did not significantly decrease (from 3.9% in 2000-2005 to 3.5% in 2012-2017; risk-adjusted time trend = 0.62). However, in patients aged ≥80 years, index hospitalization mortality showed a decreasing non-significant trend from 9.8% to 4.8%.Conclusions
Our findings support the hypothesis that mortality and morbidity rates following SAVR have significantly improved over the years, including for patients at high risk.
SUBMITTER: Dimagli A
PROVIDER: S-EPMC7723024 | biostudies-literature |
REPOSITORIES: biostudies-literature
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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.
| S-EPMC5471875 | biostudies-literature
Project description:ObjectiveThis study aimed to compare the outcomes of minimally invasive aortic valve replacement (MICS-AVR) versus transfemoral transcatheter aortic valve replacement (TF-TAVR) in Asian patients.MethodsWe conducted a retrospective, observational, single-center study in Japan, including cases of MICS-AVR (n = 202) and TF-TAVR (n = 248) between 2014 and 2021. In a total of 450 cases, propensity score matching was performed at a ratio of 1:1, resulting in 96 pairs. Furthermore, we performed competing-risk regression and mediation analyses to determine the treatment effect on outcomes of interests, considering death as a competing risk, and to evaluate the mediation effect of paravalvular leak (PVL) severity.ResultsThere were similar incidences of all-cause death, cardiac death, stroke and cerebral hemorrhage, and aortic valve reintervention between the 2 groups. However, the TF-TAVR cohort had a longer hospital length of stay and higher rates of significant PVL compared with the MICS-AVR cohort. Multivariable-adjusted Cox regression analyses revealed that heart failure hospitalization (hazard ratio [HR] = 0.129, 95% confidence interval [CI]: 0.038 to 0.445, p = 0.001) and permanent pacemaker implantation (HR = 0.050, 95% CI: 0.006 to 0.409, p = 0.005) favored MICS-AVR. Competing-risk regression analyses confirmed similar findings. All outcomes were unrelated to PVL severity.ConclusionsTo our knowledge, this is the first comparative study of clinical outcomes in Asian patients undergoing MICS-AVR versus TF-TAVR, revealing that MICS-AVR could be a feasible and efficient alternative to TF-TAVR. Future larger-scale randomized controlled trials are needed to validate the present results.
| S-EPMC10714700 | biostudies-literature
Project description:Background Prior studies showed that life expectancy in patients who underwent surgical aortic valve replacement (AVR) was lower than in the general population. Explanations for this shorter life expectancy are unknown. The aim of this nationwide, observational cohort study was to investigate the cause-specific death following surgical AVR. Methods and Results We included 33 018 patients who underwent primary surgical AVR in Sweden between 1997 and 2018, with or without coronary artery bypass grafting. The SWEDEHEART (Swedish Web-System for Enhancement and Development of Evidence-Based Care in Heart Disease Evaluated According to Recommended Therapies) register and other national health-data registers were used to obtain and characterize the study cohort and to identify causes of death, categorized as cardiovascular mortality, cancer mortality, or other causes of death. The relative risks for cause-specific mortality in patients who underwent AVR compared with the general population are presented as standardized mortality ratios. During a mean follow-up period of 7.3 years (maximum 22.0 years), 14 237 (43%) patients died. The cumulative incidence of death from cardiovascular, cancer-related, or other causes was 23.5%, 8.3%, and 11.6%, respectively, at 10 years, and 42.8%, 12.8%, and 23.8%, respectively, at 20 years. Standardized mortality ratios for cardiovascular, cancer-related, and other causes of death were 1.79 (95% CI, 1.75-1.83), 1.00 (95% CI, 0.97-1.04), and 1.08 (95% CI, 1.05-1.12), respectively. Conclusions We found that life expectancy following AVR was lower than in the general population. Lower survival after AVR was explained by an increased relative risk of cardiovascular death. Future studies should focus on the role of earlier surgery in patients with asymptomatic aortic stenosis and on optimizing treatment and follow-up after AVR. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT02276950.
| S-EPMC8751948 | biostudies-literature
Project description:ImportanceHospital outcomes for transcatheter aortic valve replacement (TAVR) may be dependent on the quality of evaluation, personnel, and procedural and postprocedural care common to patients undergoing cardiac surgery.ObjectivesWe sought to assess whether those hospitals with better patient outcomes for surgical aortic valve replacement (SAVR) subsequently achieved better TAVR outcomes after launching TAVR programs.Design, setting, and participantsThis national cohort included US patients 65 years and older. The analysis used the Centers for Medicare and Medicaid Services' Medicare Provider and Review data collected between January 1, 2010, and September 29, 2015. Only hospitals performing at least 1 SAVR prior to September 1, 2011, and performing at least 1 TAVR after this date were included in the analysis. Data analysis was completed from June 2018 to August 2018.InterventionsIsolated aortic valve replacements.Main outcomes and measuresHospital risk-adjusted 30-day mortality for SAVR in the pre-TAVR period was used as a surrogate for SAVR quality. Thirty-day and 1-year TAVR mortality rates were examined after stratification by quartile of baseline hospital risk-adjusted SAVR mortality.ResultsA total of 51 924 TAVR procedures were performed in 519 hospitals, of which 19 798 were performed at hospitals in quartile 1 (the lowest risk-adjusted SAVR mortality rate), 7663 were performed in quartile 2, 10 180 were performed in quartile 3, and 14 283 were performed in quartile 4 (the highest risk-adjusted SAVR mortality rate). Observed mortality rates at 30 days consistently increased with increasing baseline hospital SAVR risk-adjusted mortality (quartile 1, 917 patients [4.6%]; quartile 2, 381 [5.0%]; quartile 3, 521 [5.1%]; quartile 4, 800 [5.6%]; P < .001). The same pattern was observed in 1-year mortality (quartile 1, 3359 [17.0%]; quartile 2, 1337 [17.5%]; quartile 3, 1852 [18.2%]; quartile 4, 2652 [18.6%]; P < .001). After multivariable analysis, compared with the lowest quartile of SAVR mortality, undergoing TAVR at a hospital with higher baseline SAVR mortality continued to be associated with higher 30-day mortality (odds ratios: quartile 2, 1.02 [95% CI, 0.87-1.21]; quartile 3, 1.13 [95% CI, 1.02-1.26]; quartile 4, 1.23 [95% CI, 1.07-1.40]; P = .02) and 1-year mortality (hazard ratios: quartile 2, 1.04 [95% CI, 0.92-1.17]; quartile 3, 1.14 [95% CI, 1.02-1.28]; quartile 4, 1.16 [95% CI, 1.05-1.28]; P = .02).Conclusions and relevanceHospitals with higher SAVR mortality rates also had higher short-term and long-term TAVR mortality after initiating TAVR programs. Quality of cardiac surgical care may be associated with a hospital's performance with new structural heart disease programs.
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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.
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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.
| S-EPMC6583695 | biostudies-literature
Project description:Aortic stenosis (AS) is the second most common valvular heart disease in the United States. Although the prevalence of AS does not significantly differ between the sexes, there is some controversy on whether sex differences affect the long-term mortality of patients with severe AS undergoing surgical aortic valve replacement (SAVR). Therefore, we retrospectively analyzed the medical records of 917 patients (female, n = 424 [46.2%]) with severe AS who had undergone isolated SAVR at a tertiary care center between January 2005 and December 2018. During a median follow-up of 5.2 years, 74 (15.0%) male patients and 41 (9.7%) female patients died. The Kaplan-Meier analysis revealed that the 10-year mortality rate was significantly higher in male than female patients (24.7% vs. 17.9%, log-rank p = 0.005). In the sequential Cox proportional hazard regression model for assessing long-term mortality up to 10 years post-surgery, the adjusted hazard ratio of male sex for mortality was 1.93 (95% confidence interval, 1.28-2.91; p = 0.002). The association between male sex and postoperative long-term mortality was not significantly diminished by any demographic or clinical factor in subgroup analyses. In conclusion, female sex was significantly associated with better long-term survival in patients with severe AS undergoing SAVR.
| S-EPMC9331870 | biostudies-literature
Project description:BackgroundThere is scarce knowledge about the association between socioeconomic status and mortality in patients undergoing surgical aortic valve replacement. This study explores the associations between income, education and marital status, and long-term mortality risk.MethodsIn this national registry-based observational cohort study we included all 14,537 patients aged >18 years who underwent isolated surgical aortic valve replacement for aortic stenosis in Sweden 1997-2020. Socioeconomic status and comorbidities were collected from three mandatory national registries. Cox regression models adjusted for patient characteristics and comorbidities were used to estimate the mortality risk.ResultsMortality risk was higher for patients in the lowest versus the highest income quintile (adjusted hazard ratio [aHR] 1.36, 95 % confidence interval [CI]: 1.11-1.65), for patients with <10 years education versus >12 years (aHR 1.20, 95 % CI:1.08-1.33), and for patients who were not married/cohabiting versus those who were (aHR 1.24, 95 % CI:1.04-1.48). Patients with the most unfavorable socioeconomic status (lowest income, shortest education, never married/cohabiting) had an adjusted median survival of 2.9 years less than patients with the most favorable socioeconomic status (14.6 years, 95 % CI: 13.2-17.4 years vs. 11.7 years, 95 % CI: 9.8-14.4).ConclusionsLow socioeconomic status in patients undergoing surgical aortic valve replacement is associated with shorter survival and an increased long-term adjusted mortality risk. These results emphasize the importance of identifying surgical aortic valve replacement patients with unfavorable socioeconomic situation and ensure sufficient post-discharge surveillance.
| S-EPMC10661603 | biostudies-literature
Project description:ObjectiveBioprosthetic aortic valves with an extended subannular component, such as transcatheter valves, exert increased compression on the cardiac conduction system and increase the risk for permanent pacemaker implantation. It is unknown if the On-X mechanical prosthetic valve, which has an elongated subannular valve housing, increases the risk of permanent pacemaker implantation following aortic valve replacement.DesignObservational nationwide cohort study.SettingSwedish population-based study.ParticipantsAll patients aged 18-65 years who underwent primary mechanical aortic valve replacement in Sweden between 2005 and 2018. We used the Swedish Web system for Enhancement and Development of Evidence-based care in Heart disease Evaluated According to Recommended Therapies register and other Swedish national health-data registers.ExposurePatients implanted with an On-X valve versus patients implanted with other bileaflet mechanical valves.Primary and secondary outcome measuresPrimary outcome measure was permanent pacemaker implantation within 30 days of surgery.ResultsA total of 2602 patients were included, and 581 patients received an On-X valve and 2021 patients received a St Jude Masters/Regent (n=945) or Carbomedics Reduced valve (n=1076). In the total study population, 115 (4.4%) permanent pacemaker implantations were performed within 30 days after aortic valve replacement. In the propensity score matched population, there was no significant difference in the rate of permanent pacemaker implantation in the On-X group compared with the control group: 3.6% (95% CI: 2.4% to 5.5%) vs 4.0% (95% CI: 2.7% to 5.9%), p=0.877.ConclusionsThe On-X prosthetic heart valve was associated with a similarly low risk for permanent pacemaker implantation after aortic valve replacement compared with other conventional bileaflet mechanical valves. The On-X elongated subannular valve housing does not interfere with the cardiac conduction system.
| S-EPMC8603281 | biostudies-literature
Project description:Background The treatment of aortic stenosis is evolving rapidly. Pace of change in the care of patients undergoing transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) differs. We sought to determine differences in temporal changes in 30-day mortality, 30-day readmission, and length of stay after TAVR and SAVR. Methods and Results We conducted a retrospective cohort study of patients treated in the United States between 2012 and 2019 using data from the Medicare Data Set Analytic File 100% Fee for Service database. We included consecutive patients enrolled in Medicare Parts A and B and aged ≥65 years who had SAVR or transfemoral TAVR. We defined 3 study cohorts, including all SAVR, isolated SAVR (without concomitant procedures), and elective isolated SAVR and TAVR. The primary end point was 30-day mortality; secondary end points were 30-day readmission and length of stay. Statistical models controlled for patient demographics, frailty measured by the Hospital Frailty Risk Score, and comorbidities measured by the Elixhauser Comorbidity Index (ECI). Cox proportional hazard models were developed with TAVR versus SAVR as the main covariates with a 2-way interaction term with index year. We repeated these analyses restricted to full aortic valve replacement hospitals offering both SAVR and TAVR. The main study cohort included 245 269 patients with SAVR and 188 580 patients with TAVR, with mean±SD ages 74.3±6.0 years and 80.7±6.9 years, respectively, and 36.5% and 46.2% female patients, respectively. Patients with TAVR had higher ECI scores (6.4±3.6 versus 4.4±3) and were more frail (55.4% versus 33.5%). Total aortic valve replacement volumes increased 61% during the 7-year span; TAVR volumes surpassed SAVR in 2017. The magnitude of mortality benefit associated with TAVR increased until 2016 in the main cohort (2012: hazard ratio [HR], 0.76 [95% CI, 0.67-0.86]; 2016: HR, 0.39 [95% CI, 0.36-0.43]); although TAVR continued to have lower mortality rates from 2017 to 2019, the magnitude of benefit over SAVR was attenuated. A similar pattern was seen with readmission, with a lower risk of readmission from 2012 to 2016 for patients with TAVR (2012: HR, 0.68 [95% CI, 0.63-0.73]; 2016: HR, 0.43 [95% CI, 0.41-0.45]) followed by a lesser difference from 2017 to 2019. Year over year, TAVR was associated with increasingly shorter lengths of stay compared with SAVR (2012: HR, 1.91 [95% CI, 1.84-1.98]; 2019: HR, 5.34 [95% CI, 5.22-5.45]). These results were consistent in full aortic valve replacement hospitals. Conclusions The rate of improvement in TAVR outpaced SAVR until 2016, with the recent presence of U-shaped phenomena suggesting a narrowing gap between outcomes. Future longitudinal research is needed to determine the long-term implications of lowering risk profiles across treatment options to guide case selection and clinical care.
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