Project description:BackgroundRecent trials showed that TAVI is neither inferior nor superior to surgical aortic valve replacement. The aim of this study was to evaluate the outcomes of Sutureless and Rapid Deployment Valves (SuRD-AVR) when compared to TAVI in low surgical risk patients with isolated aortic stenosis.MethodsData from five European Centers were retrospectively collected. We included 1306 consecutive patients at low surgical risk (EUROSCORE II < 4) who underwent aortic valve replacement by means of SuRD-AVR (n = 636) or TAVI (n = 670) from 2014 to 2019. A 1:1 nearest-neighbor propensity-score was performed, and two balanced groups of 346 patients each were obtained. The primary endpoints of the study were: 30-day mortality and 5-year overall survival. The secondary endpoint was 5-year survival freedom from major adverse cardiovascular and cerebrovascular events (MACCEs).ResultsThirty-day mortality was similar between the two groups (SuRD-AVR:1.7%, TAVI:2.0%, p = 0.779), while the TAVI group showed a significantly lower 5-year overall survival and survival freedom from MACCEs (5-year matched overall survival: SuRD-AVR: 78.5%, TAVI: 62.9%, p = 0.039; 5-year matched freedom from MACCEs: SuRD-AVR: 64.6%, TAVI: 48.7%, p = 0.004). The incidence of postoperative permanent pacemaker implantation (PPI) and paravalvular leak grade ≥ 2 (PVL) were higher in the TAVI group. Multivariate Cox Regression analysis identified PPI as an independent predictor for mortality.ConclusionsTAVI patients had a significantly lower five-year survival and survival freedom from MACCEs with a higher rate of PPI and PVL ≥ 2 when compared to SuRD-AVR.
Project description:Underexpansion of transcatheter heart valves and the surgically implanted Perceval sutureless aortic valve bioprosthesis has been suggested as an underlying mechanism for hypo-attenuated leaflet thickening (HALT). This was a single-center prospective observational study that included 47 patients who underwent surgical aortic valve replacement with the Perceval sutureless bioprosthesis (LivaNova, London, United Kingdom) from 2012 to 2016 and were studied by four-dimensional cardiac computed tomography (CT). The association between overall and regional expansion and the prevalence of HALT was analyzed. In total 46 patients were included in the analysis. HALT was found in 39.1% of patients and the mean overall prosthesis expansion was 75.5?±?5.2% (range 64.6-84.8%). Overall expansion did not differ between patients with HALT compared with patients without HALT (mean overall expansion 74.0?±?5.2% vs. 76.5?±?5.0%, P?=?0.11). The prevalence of HALT was lower in patients with overall expansion?>?80% compared to patients with expansion?<?80% expansion though not significantly (20% vs. 44.4%, P?=?0.16). None or trivial regional underexpansion was found in 94.7% of coronary cusps. There was no significant association between regional underexpansion and the prevalence of HALT (mean coronary cusp angle 120?±?8° vs. 119?±?10°, P?=?0.53). The prevalence of HALT and overall underexpansion was high in the Perceval sutureless bioprosthetic valve. Overall underexpansion was not associated with HALT. Whether severe overall underexpansion increases the risk for HALT requires further study. Regional underexpansion was uncommon in the Perceval sutureless bioprosthetic valve and not associated with HALT.Clinical trial registration Unique identifier: NCT03753126 (http://www.clinicaltrials.gov).
Project description:ObjectiveTo examine the source of observed lower risk-adjusted mortality for blacks than whites within the Veterans Affairs (VA) system by accounting for hospital site where treated, potential under-reporting of black deaths, discretion on hospital admission, quality improvement efforts, and interactions by age group.Data sourcesData are from the VA Patient Treatment File on 406,550 hospitalizations of veterans admitted with a principal diagnosis of acute myocardial infarction, stroke, hip fracture, gastrointestinal bleeding, congestive heart failure, or pneumonia between 1996 and 2002. Information on deaths was obtained from the VA Beneficiary Identification Record Locator System and the National Death Index.Study designThis was a retrospective observational study of hospitalizations throughout the VA system nationally. The primary outcome studied was all-location mortality within 30 days of hospital admission. The key study variable was whether a patient was black or white.Principal findingsFor each of the six study conditions, unadjusted 30-day mortality rates were significantly lower for blacks than for whites (p<.01). These results did not vary after adjusting for hospital site where treated, more complete ascertainment of deaths, and in comparing results for conditions for which hospital admission is discretionary versus non-discretionary. There were also no significant changes in the degree of difference by race in mortality by race following quality improvement efforts within VA. Risk-adjusted mortality was consistently lower for blacks than for whites only within the population of veterans over age 65.ConclusionsBlack veterans have significantly lower 30-day mortality than white veterans for six common, high severity conditions, but this is generally limited to veterans over age 65. This differential by age suggests that it is unlikely that lower 30-day mortality rates among blacks within VA are driven by treatment differences by race.
Project description:ObjectiveTo assess hospital and geographic variability in 30-day mortality after surgery for CRC and examine the extent to which sociodemographic, area-level, clinical, tumor, treatment, and hospital characteristics were associated with increased likelihood of 30-day mortality in a population-based sample of older CRC patients.Data sources/study settingLinked Surveillance Epidemiology End Results (SEER) and Medicare data from 47,459 CRC patients aged 66 years or older who underwent surgical resection between 2000 and 2005, resided in 13,182 census tracts, and were treated in 1,447 hospitals.Study designAn observational study using multilevel logistic regression to identify hospital- and patient-level predictors of and variability in 30-day mortality.Data collection/extraction methodsWe extracted sociodemographic, clinical, tumor, treatment, hospital, and geographic characteristics from Medicare claims, SEER, and census data.Principal findingsOf 47,459 CRC patients, 6.6 percent died within 30 days following surgery. Adjusted variability in 30-day mortality existed across residential census tracts (predicted mortality range: 2.7-12.3 percent) and hospitals (predicted mortality range: 2.5-10.5 percent). Higher risk of death within 30 days was observed for CRC patients age 85+ (12.7 percent), census-tract poverty rate >20 percent (8.0 percent), two or more comorbid conditions (8.8 percent), stage IV at diagnosis (15.1 percent), undifferentiated tumors (11.6 percent), and emergency surgery (12.8 percent).ConclusionsSubstantial, but similar variability was observed across census tracts and hospitals in 30-day mortality following surgery for CRC in patients 66 years and older. Risk of 30-day mortality is driven not only by patient and hospital characteristics but also by larger social and economic factors that characterize geographic areas.
Project description:ObjectiveTo assess the hypothesis that postoperative survival exhibits heterogeneity associated with the timing of quality metrics.Data sourcesRetrospective observational study using the Nationwide Inpatient Sample from 2005 through 2009.Study designSurvival analysis was performed on all admission records with a procedure code for major cardiac surgery (n = 595,089). The day-by-day hazard function for all-cause in-hospital mortality at 1-day intervals was analyzed using joinpoint regression (a data-driven method of testing for changes in hazard).Data extraction methodsA comprehensive analysis of a publicly available national administrative database was performed.Principal findingsStatistically significant shifts in the pattern of postoperative mortality occurred at day 6 (95 percent CI = day 5-8) and day 30 (95 percent CI = day 20-35).ConclusionsWhile the shift at day 6 plausibly can be attributed to the separation between routine recovery and a complicated postoperative course, the abrupt increase in mortality at day 30 has no clear organic etiology. This analysis raises the possibility that this observed shift may be related to clinician behavior because of the use of 30-day mortality as a quality metric, but further studies will be required to establish causality.
Project description:BackgroundReadmission within 30 d of an acute hospital stay is frequent, costly, and increasingly subject to penalties. Early readmission is most common after vascular surgery; these patients are often discharged to skilled nursing facilities (SNFs), making postacute care an essential partner in reducing readmissions. We characterize 30-day readmissions among vascular surgery patients discharged to SNF to provide evidence for this understudied segment of readmission after specialty surgery.MethodsWe utilize the Centers for Medicare & Medicaid Services Chronic Conditions Warehouse, a longitudinal 5% national random sample of Medicare beneficiaries to study 30-day readmission or death after discharge to SNF following abdominal aortic aneurysm repair or lower extremity revascularization from 2005-2009. Descriptive statistics and logistic regression with Least Adaptive Shrinkage and Selection Operator were used for analysis.ResultsTwo thousand one hundred ninety-seven patients underwent an abdominal aortic aneurysm procedure or lower extremity revascularization at 686 hospitals and discharged to 1714 SNFs. Eight hundred (36%) were readmitted or had died at 30 d. In adjusted analysis, predictors of readmission or death at 30 d included SNF for-profit status (OR [odds ratio] = 1.2; P = 0.032), number of hospitalizations in the previous year (OR = 1.06; P = 0.011), number of comorbidities (OR = 1.06; P = 0.004), emergent procedure (OR = 1.69; P < 0.001), renal complication (OR = 1.38; P = 0.003), respiratory complication (OR = 1.45; P < 0.001), thromboembolic complication (OR = 1.57; P = 0.019), and wound complication (OR = 0.70; P = 0.017).ConclusionsPatients discharged to SNF following vascular surgery have exceptionally high rates of readmission or death at 30 d. Many factors predicting readmission or death potentially modify decision-making around discharge, making early detection, discharge planning, and matching patient needs to SNF capabilities essential to improving outcomes.
Project description:The prevalence of hypo-attenuated leaflet thickening (HALT) and reduced leaflet motion (RLM) is unknown in surgically implanted bioprostheses because systematic investigation of HALT and/or RLM is limited to a few catheter-based valves. The aim of this study was to investigate the prevalence of HALT and RLM by cardiac computed tomography in patients who underwent surgical aortic valve replacement and received a Perceval sutureless aortic valve bioprosthesis. This was a single-center prospective observational study that included 47 patients (83.5% of the total number of implantations) who underwent surgical aortic valve replacement with implantation of the Perceval sutureless bioprosthesis (LivaNova PLC, London, UK) at Karolinska University Hospital in Stockholm, Sweden from 2012 to 2016 and were studied by cardiac computed tomography. Cardiac computed tomography was performed at a median of 491 days (range 36-1247 days) postoperatively. HALT was found in 18 (38%) patients and RLM in 13 (28%) patients. All patients with RLM had HALT. Among patients with HALT, 5 out of 18 patients (28%) were treated with anticoagulation (warfarin or any novel oral anticoagulant) at the time of cardiac computed tomography. Among patients with RLM, 3 out of 13 patients (23%) were treated with anticoagulation. HALT and RLM were prevalent in the surgically implanted Perceval sutureless aortic valve bioprosthesis. Both HALT and RLM were found in patients with ongoing anticoagulation treatment. Whether these findings are associated with adverse events needs further study. URL: http://www.clinicaltrials.gov. Unique identifier: NCT02671474.