Long-term outcomes of truncus arteriosus repair: A modulated renewal competing risks analysis.

OBJECTIVE: In this study, we sought to identify independent risk factors for mortality and reintervention after early surgical correction of truncus arteriosus using a novel statistical method. METHODS: Patients undergoing neonatal/infant truncus arteriosus repair between January 1984 and December 2018 were reviewed retrospectively. An innovative statistical strategy was applied integrating competing risks analysis with modulated renewal for time-to-event modeling. RESULTS: A total of 204 patients were included in the study. Mortality occurred in 32 patients (15%). Smaller right ventricle to pulmonary artery conduit size and truncal valve insufficiency at birth were significantly associated with overall mortality (right ventricle to pulmonary artery conduit size: hazard ratio, 1.34; 95% confidence interval, 1.08-1.66, P = .008; truncal valve insufficiency: hazard ratio, 2.5; 95% confidence interval, 1.13-5.53, P = .024). truncal valve insufficiency at birth, truncal valve intervention at index repair, and number of cusps (4 vs 3) were associated with truncal valve reoperations (truncal valve insufficiency: hazard ratio, 2.38; 95%, confidence interval, 1.13-5.01, P = .02; cusp number: hazard ratio, 6.62; 95% confidence interval, 2.54-17.3, P < .001). Right ventricle to pulmonary artery conduit size 11 mm or less was associated with a higher risk of early catheter-based reintervention (hazard ratio, 1.54; 95% confidence interval, 1.04-2.28, P = .03) and reoperation (hazard ratio, 1.96; 95% confidence interval, 1.33-2.89, P = .001) on the right ventricle to pulmonary artery conduit. CONCLUSIONS: Smaller right ventricle to pulmonary artery conduit size and truncal valve insufficiency at birth were associated with overall mortality after truncus arteriosus repair. Quadricuspid truncal valve, the presence of truncal valve insufficiency at the time of diagnosis, and truncal valve intervention at index repair were associated with an increased risk of reoperation. The size of the right ventricle to pulmonary artery conduit at index surgery is the single most important factor for early reoperation and catheter-based reintervention on the conduit.

Low left ventricular ejection fraction, complication rescue, and long-term survival after coronary artery bypass grafting.

OBJECTIVES: To evaluate the association between low left ventricular ejection fraction (LVEF), complication rescue, and long-term survival after isolated coronary artery bypass grafting. METHODS: National cohort study of patients who underwent isolated coronary artery bypass grafting (2000-2016) using Veterans Affairs Surgical Quality Improvement Program data. Left ventricular ejection fraction was categorized as ≥35% (n = 55,877), 25%-34% (n = 3893), or <25% (n = 1707). Patients were also categorized as having had no complications, 1 complication, or more than 1 complication. The association between LVEF, complication rescue, and risk of death was evaluated with multivariable Cox regression. RESULTS: Among 61,477 patients, 6586 (10.7%) had a perioperative complication and 2056 (3.3%) had multiple complications. Relative to LVEF ≥35%, decreasing ejection fraction was associated with greater odds of complications (25%-34%, odds ratio, 1.30 [1.18-1.42]; <25%, odds ratio, 1.65 [1.43-1.92]). There was a dose-response relationship between decreasing LVEF and overall risk of death (≥35% [ref]; 25%-35%, hazard ratio, 1.46 [1.37-1.55]; <25%, hazard ratio, 1.68 [1.58-1.79]). Among patients who were rescued from complications, there were decreases in 10-year survival, regardless of LVEF. Among those rescued after multiple complications, LVEF was no longer associated with risk of death. CONCLUSIONS: While decreasing LVEF is associated with post-coronary artery bypass grafting complications, patients rescued from complications have worse long-term survival, regardless of left ventricular function. Prevention and timely treatment of complications should remain a focus of quality improvement initiatives, and future work is needed to mitigate their long-term detrimental impact on survival.

Correlation between perioperative outcomes and long-term survival for non-small lung cancer treated at major centers.

BACKGROUND: The public is placing increased emphasis on specialty specific rankings, thereby affecting patients' choices of clinical care programs. In the spirit of transparency, public reporting initiatives are underway or being considered by various surgical specialties whose databases rank programs based on short-term outcomes. Of concern, short-term risk avoidance excludes important comparative cases from surgical database participation and may adversely affect overall long-term oncologic treatment team results. To assess the validity of comparing short-term perioperative and long-term survival outcomes of all patients treated at major centers, we studied the correlations between these variables. METHODS: The National Cancer Database was queried for patients diagnosed with non-small cell lung carcinoma (NSCLC) between 2008 and 2012, yielding 5-year follow-up data for all patients at centers treating at least 100 patients annually. Mortality (30- and 90-day), unplanned 30-day readmissions, and hospital length of stay were modeled using logistic regression with sex, race, age, Charlson-Deyo combined comorbidity, extent of surgery, income, insurance status, histology, grade, and analytic stage as predictors, all with 2-way interaction terms. The differences between the predicted rates and observed rates were calculated for each short-term outcome, and the average of these was used to create a short-term metric (STM). A similar approach was used to create a long-term metric (LTM) that used overall survival as a single dependent variable. Centers were ranked into deciles based on these metrics. Visual plotting as well as correlation coefficients were used to judge correlation between STM and LTM. RESULTS: A total of 298,175 patients from 541 centers were included in this analysis, of whom 102,860 underwent surgical resection for NSCLC. The correlation between STM and LTM was negative using parametric estimates (Pearson correlation coefficient = -0.09 [P = .03] and -0.22 [P < .01]) and nonparametric estimates (Spearman rank correlation coefficient = -0.09 [P = .02] and -0.22 [P < .01]) for squamous cell carcinoma and adenocarcinoma, respectively. CONCLUSIONS: Short-term perioperative outcome rankings correlate poorly with long-term survival outcome rankings when cancer treatment centers are compared. Factors explaining this discrepancy merit further study. Rankings based on short-term outcomes alone may be incomplete for public reporting.

Mechanical vs Bioprosthetic Aortic Valve Replacement in Patients Younger Than 70 Years of Age: A Hazard Ratio Meta-analysis.

BACKGROUND: The choice between mechanical valves (MVs) and bioprosthetic valves (BVs) in patients undergoing aortic valve surgery is complex, requiring a balance between the inferior durability of BV and the indicated long-term anticoagulation therapy with MV. This is especially challenging in the middle age group (< 70 years), which has seen an increased use of BV over recent years. METHODS: A meta-analysis of randomised controlled trials (RCTs), observational studies using propensity score matching (PSM) and inverse probability weighting (IPW) was conducted to examine the clinical outcomes of patients < 70 years of age undergoing aortic valve replacement. The primary outcome was overall long-term mortality. Secondary outcomes included bleeding events, reoperation, systemic thromboembolism, and cerebrovascular accident. RESULTS: Fifteen studies (1 RCT, 12 PSM studies, and 2 IPW studies; aggregated sample size 16,876 patients) were included. Median follow-up was 7.8 years. Mortality was higher with BVs vs MVs (hazard ratio [HR] 1.22, 95% confidence interval [CI] 1.00-1.49), as was reoperation (HR 3.05, 95% CI 2.22-4.19). Bleeding risk was lower with BVs (HR 0.58, 95% CI 0.48-0.69), and the risk of stroke was similar in both valve types (HR 0.96, 95% CI 0.83-1.11) CONCLUSIONS: This broadest meta-analysis comparing BV and MV suggests a survival benefit for MVs in patients < 70 years of age. This should lead to reassessment of current patterns used in the choice of valves for patients < 70 among the cardiothoracic surgery community.

2-Year Outcomes of Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation.

BACKGROUND: Transcatheter mitral valve replacement (TMVR) is feasible for selected patients with severe mitral regurgitation (MR) who are poor candidates for valve surgery. Intermediate-term to long-term TMVR outcomes have not been reported. OBJECTIVES: This study sought to evaluate the safety and effectiveness through 2-year follow-up of TMVR in high-surgical-risk patients with severe MR. METHODS: The first 100 patients enrolled in the Expanded Clinical Study of the Tendyne Mitral Valve System, an open-label, nonrandomized, prospective study of transapical TMVR, were followed for 2 years. RESULTS: The patients (aged 74.7 ± 8.0 years, 69.0% male) had symptomatic (66.0% New York Heart Association [NYHA] functional class III or IV) grade 3+ or 4+ MR that was secondary or mixed in 89 (89.0%). Prostheses were successfully implanted in 97 (97.0%) patients. At 2 years, all-cause mortality was 39.0%; 17 (43.6%) of 39 deaths occurred during the first 90 days. Heart failure hospitalization (HFH) fell from 1.30 events per year preprocedure to 0.51 per year in the 2 years post-TMVR (P < 0.0001). At 2 years, 93.2% of surviving patients had no MR. No patient had >1+ MR. The improvement in symptoms at 1 year (88.5% NYHA functional class I or II) was sustained to 2 years (81.6% NYHA functional class I or II). Among survivors, the left ventricular ejection fraction was 45.6 ± 9.4% at baseline and 39.8 ± 9.5% at 2 years (P = 0.0012). Estimated right ventricular systolic pressure decreased from 47.6 ± 8.6 mm Hg to 32.5 ± 10.4 mm Hg (P < 0.005). CONCLUSIONS: In this study, the impact of TMVR on severity of MR, reduction in HFH rate, and improvement in symptoms was sustained through 2 years. All-cause mortality and the need for HFH was highest in the first 3 months postprocedure. (Expanded Clinical Study of the Tendyne Mitral Valve System; NCT02321514).

Fractional Flow Reserve to Guide Treatment of Patients With Multivessel Coronary Artery Disease.

BACKGROUND: There is limited evidence that fractional flow reserve (FFR) is effective in guiding therapeutic strategy in multivessel coronary artery disease (CAD) beyond prespecified percutaneous coronary intervention or coronary graft surgery candidates. OBJECTIVES: The FUTURE (FUnctional Testing Underlying coronary REvascularization) trial aimed to evaluate whether a treatment strategy based on FFR was superior to a traditional strategy without FFR in the treatment of multivessel CAD. METHODS: The FUTURE trial is a prospective, randomized, open-label superiority trial. Multivessel CAD candidates were randomly assigned (1:1) to treatment strategy based on FFR in all stenotic (≥50%) coronary arteries or to a traditional strategy without FFR. In the FFR group, revascularization (percutaneous coronary intervention or surgery) was indicated for FFR ≤0.80 lesions. The primary endpoint was a composite of major adverse cardiac or cerebrovascular events at 1 year. RESULTS: The trial was stopped prematurely by the data safety and monitoring board after a safety analysis and 927 patients were enrolled. At 1-year follow-up, by intention to treat, there were no significant differences in major adverse cardiac or cerebrovascular events rates between groups (14.6% in the FFR group vs 14.4% in the control group; hazard ratio: 0.97; 95% confidence interval: 0.69-1.36; P = 0.85). The difference in all-cause mortality was nonsignificant, 3.7% in the FFR group versus 1.5% in the control group (hazard ratio: 2.34; 95% confidence interval: 0.97-5.18; P = 0.06), and this was confirmed with a 24 months' extended follow-up. FFR significantly reduced the proportion of revascularized patients, with more patients referred to exclusively medical treatment (P = 0.02). CONCLUSIONS: In patients with multivessel CAD, we did not find evidence that an FFR-guided treatment strategy reduced the risk of ischemic cardiovascular events or death at 1-year follow-up. (Functional Testing Underlying Coronary Revascularisation; NCT01881555).

Surveillance Imaging Following Acute Type A Aortic Dissection.

BACKGROUND: Survivors of acute type A aortic dissection (ATAAD) repair remain at risk for long-term complications. Guidelines recommend postoperative imaging surveillance, but adherence is uncertain. OBJECTIVES: The aim of this study was to define the real-world frequency of postoperative imaging and characterize long-term outcomes of ATAAD. METHODS: Population-based administrative health databases for Ontario, Canada, were linked to identify patients who underwent ATAAD repair and survived at least 90 days. Guideline-directed imaging surveillance (GDIS) was defined as undergoing a computed tomographic or magnetic resonance imaging scan at 6 and 12 months postoperatively and then annually thereafter. Multivariable time-to-event analysis explored the associations between GDIS and all-cause mortality and reintervention. RESULTS: A total of 888 patients who survived urgent ATAAD repair between April 1, 2005, and March 31, 2018, were included. Median follow-up after ATAAD repair was 5.2 years (interquartile range: 2.4-7.9 years). A total of 14% patients received GDIS throughout follow-up. At 6 years, 3.9% of patients had received GDIS. The mortality rate was 4% at 1 year, 14% at 5 years, and 29% at 10 years. Incidence of aortic reintervention was 3% at 1 year, 9% at 5 years, and 17% at 10 years; the majority of these were urgent (68%), and they carried a 9% 30-day mortality rate. Greater adherence to GDIS was associated with mortality (hazard ratio: 1.08; 95% confidence interval: 1.05-1.11) and reintervention (hazard ratio: 1.04; 95% confidence interval: 1.01-1.07). CONCLUSIONS: Adherence to GDIS following ATAAD repair is poor, while long-term mortality and reinterventions remain substantial. Further research is needed to determine if guidelines should be modified.

Preoperative versus Post-operative Radiotherapy for Extremity Soft tissue Sarcoma: a Systematic Review and Meta-analysis of Long-term Survival.

BACKGROUND: The role of perioperative radiotherapy in the management of resectable extremity soft tissue sarcoma (ESTS) is widely recognised for local tumour control, wound complications (WC) and long-term function. However, debate continues regarding its implications on long-term survival. This study aimed to determine whether the timing of perioperative radiotherapy affects long-term survival outcomes in adults with ESTS. METHODS: A systematic literature search of MEDLINE, EMBASE, Web of Science and Cochrane was performed. The primary outcome measure was the pooled hazard ratio (HR) at 95% confidence intervals. Secondary outcomes and subgroup analyses were presented as cumulative odds ratios (OR). A random-effects, generic inverse variance method and sensitivity analysis were performed to minimise heterogeneity. RESULTS: Six studies (n = 4192 patients) were identified. Time-to-event analysis demonstrated a statistically significant advantage in post-operative radiotherapy for overall survival (HR 1.15 and p = 0.05). Combined HRs for disease-free (1.25 and p = 0.22) and disease-specific (1.06 and p = 0.43) survival also favoured post-operative radiotherapy but did not achieve statistical significance. Post-operative radiotherapy was shown to confer an overall (OR 1.19 and p = 0.01), disease-free (OR 1.19 and p = 0.01) and disease-specific (OR 1.19 and p = 0.01) survival advantage on subgroup analysis. This survival benefit was best observed at three years in the disease-free survival comparison (OR 1.55 and p = 0.003). Preoperative radiotherapy was associated with more WC (OR 2.74 and p<0.00001). CONCLUSIONS: Pooled analysis of published literature suggests that post-operative radiotherapy confers a significant long-term survival advantage with fewer WC. Further large multicentre randomised controlled trials with long-term follow-up are required to determine the optimal perioperative radiotherapy regime in adult ESTS.

Effect of Heart Failure on Long-Term Clinical Outcomes After Percutaneous Coronary Intervention Versus Coronary Artery Bypass Grafting in Patients With Severe Coronary Artery Disease.

Background Heart failure might be an important determinant in choosing coronary revascularization modalities. There was no previous study evaluating the effect of heart failure on long-term clinical outcomes after percutaneous coronary intervention (PCI) relative to coronary artery bypass grafting (CABG). Methods and Results Among 14 867 consecutive patients undergoing first coronary revascularization with PCI or isolated CABG between January 2011 and December 2013 in the CREDO-Kyoto PCI/CABG registry Cohort-3, we identified the current study population of 3380 patients with three-vessel or left main coronary artery disease, and compared clinical outcomes between PCI and CABG stratified by the subgroup based on the status of heart failure. There were 827 patients with heart failure (PCI: N=511, and CABG: N=316), and 2553 patients without heart failure (PCI: N=1619, and CABG: N=934). In patients with heart failure, the PCI group compared with the CABG group more often had advanced age, severe frailty, acute and severe heart failure, and elevated inflammatory markers. During a median 5.9 years of follow-up, there was a significant interaction between heart failure and the mortality risk of PCI relative to CABG (interaction P=0.009), with excess mortality risk of PCI relative to CABG in patients with heart failure (HR, 1.75; 95% CI, 1.28-2.42; P<0.001) and no excess mortality risk in patients without heart failure (HR, 1.04; 95% CI, 0.80-1.34; P=0.77). Conclusions There was a significant interaction between heart failure and the mortality risk of PCI relative to CABG with excess risk in patients with heart failure and neutral risk in patients without heart failure.

Association Between Radial Versus Femoral Access for Percutaneous Coronary Intervention and Long-Term Mortality.

Background Percutaneous coronary intervention with radial arterial access has been associated with fewer occurrences of major bleeding. However, published data on the long-term mortality and major adverse cardiac events after percutaneous coronary intervention with radial or femoral arterial access are inconclusive. Method and Results This was a territory-wide retrospective cohort study including 26 022 patients who underwent first-ever percutaneous coronary intervention between January 1, 2010 and December 31, 2017 in Hong Kong. Among the 14 614 patients matched by propensity score (7307 patients in each group), 558 (7.6%) and 787 (10.8%) patients died during the observation period in the radial group and femoral group, respectively, resulting in annualized all-cause mortality rates of 2.69% and 3.87%, respectively. The radial group had a lower risk of all-cause mortality compared with the femoral group up to 3 years after percutaneous coronary intervention (hazard ratio [HR], 0.70; 95% CI, 0.63-0.78; P<0.001). Radial access was associated with a lower risk of major adverse cardiac events (HR, 0.78; 95% CI, 0.73-0.83, P<0.001), myocardial infarction after hospital discharge (HR, 0.78; 95% CI, 0.70-0.87, P<0.001), and unplanned revascularization (HR, 0.76; 95% CI, 0.68-0.85, P<0.001). The risks of stroke were similar across the 2 groups (HR, 0.96; 95% CI, 0.82-1.13, P=0.655). Conclusions Radial access was associated with a significant reduction in all-cause mortality at 3 years compared with femoral access. Radial access was associated with reduced risks of myocardial infarction and unplanned revascularization, but not stroke. The benefits were sustained beyond the early postoperative period.

Early and long-term results of hypothermic circulatory arrest in aortic surgery: a 20-year single-centre experience.

AIMS: The aim of this study was to document the postoperative outcomes of patients who underwent hypothermic circulatory arrest (HCA), the evolution of HCA management over time and to identify the risks factor for early mortality and postoperative stroke. METHODS: Four hundred and twenty-four patients who underwent aortic surgery with HCA at our institution between January 1995 and June 2016 were consecutively included. RESULTS: The main indications were degenerative aneurysm (254; 59.9%) and acute type A aortic dissection (146; 34.4%). Interventions were performed under deep (18.4 ±â€Š0.9°C; n = 350; 82.5%) or moderate (23.9 ±â€Š1.9°C; n = 74; 17.5%) hypothermia. Antegrade cerebral perfusion (ACP) was employed in 86 (20.3%) cases. The use of moderate hypothermia significantly increased from 2011, to become the preferred strategy in 2016. The in-hospital mortality was 12.5% and the postoperative stroke rate was 7.1%. Kaplan--Meier 5-year survival was 65.7%. Nonelective timing [odds ratio (OR) 4.05; P < 0.001], stroke (OR 3.77' P = 0.032), renal failure (OR 2.49; P = 0.023), redo surgery (2.42; P = 0.049) and CPB time (OR 1.05; P = 0.03) were independent risk factors for in-hospital mortality in multivariate analysis. Femoral cannulation was the only independent risk factor for stroke (OR 3.97; P = 0.002). The level of hypothermia and the use of ACP were not associated with either in-hospital mortality or postoperative stroke. CONCLUSION: HCA might be widely considered to achieve a radical treatment of the aortic disease, provided that hypothermia is maintained below the 24°C safety threshold and ACP is used for HCA exceeding 30 min, to ensure optimal brain, spinal cord and visceral organs protection.

Relative survival after aortic valve surgery in patients with bicuspid aortic valves.

OBJECTIVES: The objective of this cohort study was to analyse long-term relative survival in patients with bicuspid aortic valve (BAV) who underwent aortic valve surgery. METHODS: We studied 865 patients with BAVs who participated in three prospective cohort studies of elective, open-heart, aortic valve surgery at the Karolinska University Hospital, Stockholm, Sweden, between 2007 and 2020. The expected survival for the age, sex and calendar year-matched general Swedish population was obtained from the Human Mortality Database. The Ederer II method was used to calculate relative survival, which was used as an estimate of cause-specific survival. RESULTS: No differences were found in the observed versus expected survival at 1, 5, 10 or 12 years: 99%, 94%, 83% and 76% vs 99%, 93%, 84% and 80%, respectively. The relative survival at 1, 5, 10 and 12 years was 100% (95% CI 99% to 100%), 101% (95% CI 99% to 103%), 99% (95% CI 95% to 103%) and 95% (95% CI 87% to 102%), respectively. The relative survival at the end of follow-up tended to be lower for women than men (86% vs 95%). The mean follow-up was 6.3 years (maximum 13.3 years). CONCLUSIONS: The survival of patients with BAV following aortic valve surgery was excellent and similar to that of the general population. Our results suggest that the timing of surgery according to current guidelines is correct and provide robust long-term survival rates, as well as important information about the natural history of BAV in patients following aortic valve surgery.

Management and Outcome of Patients Admitted With Tricuspid Regurgitation in France.

BACKGROUND: Growing evidence shows a major outcome impact and undertreatment of tricuspid regurgitation (TR), but large and comprehensive contemporary reports of management and outcome at the nationwide level are lacking. METHODS: We gathered all consecutive patients admitted with a diagnosis of likely functional TR in 2014-2015 in France from the Programme de Médicalisation des Systèmes d'Information national database and collected rate of surgery, in-hospital mortality, 1-year mortality, or heart failure (HF) readmission rates. RESULTS: In 2014-2015, 17,676 consecutive patients (75 ± 14 years of age, 51% female) were admitted with a TR diagnosis. Charlson index was ≥ 2 in 56% of the population and 46% presented with HF. TR was associated with prior cardiac surgery, ischemic/dilated cardiomyopathy, or mitral regurgitation in 73% of patients. Only 10% of TR patients overall and 67% of those undergoing mitral valve surgery received a tricuspid valve intervention. Among the 13,654 (77%) conservatively managed patients, in-hospital mortality, 1-year mortality, and 1-year mortality or HF readmission rates were 5.1%, 17.8%, and 41%, respectively, overall, and 5.3%,17.2%, and 37%, respectively, among those with no underlying medical conditions (8-fold higher than predicted for age and gender). CONCLUSIONS: This nationwide cohort of patients admitted with TR included elderly patients with frequent comorbidities/underlying cardiac diseases. In patients conservatively managed, mortality and morbidity were considerably high over a short time span. Despite this poor prognosis, only 10% of patients underwent a tricuspid valve intervention. These nationwide data showing a considerable risk and potential underuse of treatment highlight the critical need to develop strategies to improve the management and outcomes of TR patients.

Root abscess in the setting of infectious endocarditis: Short- and long-term outcomes.

OBJECTIVES: To evaluate the influence of an aortic root abscess on perioperative outcomes and long-term survival in patients with active infectious endocarditis that was treated surgically. METHODS: From 1996 to 2017, 336 consecutive patients were treated with aortic valve or root replacement for infective endocarditis, including patients with (n = 179) or without (n = 157) a root abscess. Data were obtained from the Society of Thoracic Surgeons data warehouse, through chart review, patient surveys, and National Death Index data. RESULTS: Demographic characteristics were similar between groups except the root abscess group had a significantly lower prevalence of congestive heart failure and higher rates of prosthetic valve endocarditis. The abscess group had significantly more aortic root replacements as well as longer cardiopulmonary bypass and crossclamp times. Operative mortality was 8.4% and 3.8% (P = .11) for the abscess and no abscess groups, respectively. Nevertheless, the root-abscess group had prolonged ventilation and longer intensive care unit stays. Kaplan-Meier survival was similar between root abscess and no abscess groups (10-year survival 41% vs 43%; P = .35). Significant risk factors for all-time mortality included age greater than 70 (hazard ratio [HR], 2.85; 95% confidence interval [CI], 1.55, 5.24), the presence of a root abscess (HR, 1.42; 95% CI, 1.02, 1.96), intravenous drug use (HR, 1.81; 95% CI, 1.13, 2.89), congestive heart failure (HR, 1.72; 95% CI, 1.22, 2.42), renal failure requiring dialysis (HR, 3.26; 95% CI, 2.30, 4.64), liver disease (HR, 3.04; 95% CI, 1.65, 5.60), and postoperative sepsis (HR, 3.00; 95% CI, 1.30, 6.93). The 10-year rate of reoperation was also similar between groups (5.9% vs 7.9%). CONCLUSIONS: Thorough and extensive debridement is critical for successful treatment of active endocarditis with root abscess. Bioprosthetic stented and stentless valves are valid conduits to treat endocarditis with root abscess.

Sex Differences in All-Cause Mortality in the Decade Following Complex Coronary Revascularization.

BACKGROUND: The poorer prognosis of coronary artery disease in females compared with males is related mainly to differences in baseline characteristics. In the SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) trial, the effect of treatment with percutaneous coronary intervention (PCI) versus coronary artery bypass grafting surgery (CABG) on mortality at 5 years differed significantly between females and males; however, the optimal revascularization beyond 5 years according to sex has not been evaluated. OBJECTIVES: The aim of this study was to investigate the impact of sex on mortality and sex-treatment interaction at 10 years. METHODS: The SYNTAXES (SYNTAX Extended Survival) study evaluated vital status up to 10 years in 1,800 patients with de novo 3-vessel and/or left main coronary artery disease randomized to treatment with PCI or CABG in the SYNTAX trial. All-cause death at 10 years was separately evaluated in female and male patients with complex coronary artery disease. RESULTS: Of 1,800 patients, 402 (22.3%) were female and 1,398 (77.7%) were males. Females had a higher 10-year mortality rate compared with males (32.8% vs. 24.7%; log-rank p = 0.002), but female sex was not an independent predictor of mortality (adjusted hazard ratio: 1.02; 95% confidence interval: 0.76 to 1.36). Mortality at 10 years tended to be lower after CABG than after PCI, with a similar treatment effect for female and male patients (adjusted hazard ratio for females: 0.90 [95% confidence interval: 0.54 to 1.51]; adjusted hazard ratio for males: 0.76 [95% confidence interval: 0.56 to 1.02]; p for interaction = 0.952). CONCLUSIONS: Female sex was not an independent predictor of mortality at 10 years in patients with complex coronary artery disease. The interaction between sex and treatment with PCI or CABG that was observed at 5 years was no longer present at 10 years. (Synergy Between PCI With TAXUS and Cardiac Surgery: SYNTAX Extended Survival [SYNTAXES], NCT03417050; SYNTAX Study: TAXUS Drug-Eluting Stent Versus Coronary Artery Bypass Surgery for the Treatment of Narrowed Arteries [SYNTAX], NCT00114972).

Long-Term Clinical Outcomes for Non-ST Elevation Acute Coronary Syndrome Patients with High-Risk Angiographic Findings Undergoing Percutaneous Coronary Intervention.

OBJECTIVE: We aim to evaluate the long-term prognosis of non-ST elevation acute coronary syndrome (NSTE-ACS) patients with high-risk coronary anatomy (HRCA). BACKGROUND: Coronary disease severity is important for therapeutic decision-making and prognostication among patients presenting with NSTE-ACS. However, long-term outcome in patients undergoing percutaneous coronary intervention (PCI) with HRCA is still unknown. METHOD: NSTE-ACS patients undergoing PCI in Fuwai Hospital in 2013 were prospectively enrolled and subsequently divided into HRCA and low-risk coronary anatomy (LRCA) groups according to whether angiography complies with the HRCA definition. HRCA was defined as left main disease >50%, proximal LAD lesion >70%, or 2- to 3- vessel disease involving the LAD. Prognosis impact on 2-year and 5-year major adverse cardiovascular and cerebrovascular events (MACCE) is analyzed. RESULTS: Out of 4,984 enrolled patients with NSTE-ACS, 3,752 patients belonged to the HRCA group, while 1,232 patients belonged to the LRCA group. Compared with the LRCA group, patients in the HRCA group had worse baseline characteristics including higher age, more comorbidities, and worse angiographic findings. Patients in the HRCA group had higher incidence of unplanned revascularization (2 years: 9.7% vs. 5.1%, p < 0.001; 5 years: 15.4% vs. 10.3%, p < 0.001), 2-year MACCE (13.1% vs. 8.8%, p < 0.001), and 5-year death/MI/revascularization/stroke (23.0% vs. 18.4%, p = 0.001). Kaplan-Meier survival analysis showed similar results. After adjusting for confounding factors, HRCA is independently associated with higher risk of revascularization (2 years: HR = 1.636, 95% CI: 1.225-2.186; 5 years: HR = 1.460, 95% CI: 1.186-1.798), 2-year MACCE (HR = 1.275, 95% CI = 1.019-1.596) and 5-year death/MI/revascularization/stroke (HR = 1.183, 95% CI: 1.010-1.385). CONCLUSION: In our large cohort of Chinese patients, HRCA is an independent risk factor for long-term unplanned revascularization and MACCE.

The Market Reacts Quickly: Changes in Paclitaxel Vascular Device Purchasing Within the Ascension Healthcare System.

BACKGROUND: A meta-analysis of trials in endovascular therapy suggested an increased mortality associated with treatment exposure to paclitaxel. Multiple publications and corrections of prior data were performed, and the United States Food and Drug Administration has issued multiple advisories regarding paclitaxel use. We analyzed how this controversy impacted device purchasing and related utilization patterns in the period immediately following publication of the meta-analysis. METHODS AND RESULTS: Ascension Healthcare System purchase data over a 14-month period were synthesized across centers for both paclitaxel and non-paclitaxel devices. A fixed-effects regression model and a binary regression model with facility-level controls were used to compare purchasing patterns before and after the meta-analysis. Purchase volumes of each paclitaxel device fell. Pooled purchase volumes of all paclitaxel devices decreased from a 14-month peak of 631 devices in October 2018 to a 14-month nadir of 359 devices in February 2019. An F-test comparing the pooled-month specific fixed effects for the months before vs after the publication of the meta-analysis has an F-statistic of 11.64, suggesting that average purchasing levels in the two periods are statistically different (P<.001). Utilization of non-paclitaxel devices did not decline. CONCLUSIONS: Purchase volumes of paclitaxel devices decreased immediately during the months following publication of the related meta-analysis. Total Ascension-wide paclitaxel device purchase volume in February 2019 demonstrated a 43.1% reduction from peak monthly purchase volume during the assessed period and a 32.5% reduction compared with November 2019, the last month preceding publication of the meta-analysis.

Long-term mortality rate for cardiovascular disease in 656 chronic myeloid leukaemia patients treated with second- and third-generation tyrosine kinase inhibitors.

BACKGROUND: Limited information is available regarding the rate of long-term cardiovascular (CV) mortality in chronic myeloid leukaemia (CML) patients treated with second- and third-generation tyrosine kinase inhibitors (2ndG/3rdG TKIs) in the real-life practice. METHODS: We identified 656 consecutive CML patients treated with nilotinib, dasatinib, bosutinib and ponatinib. RESULTS: The 15-year CV-mortality free survival was 93 ±â€¯2.8%. Age ≥65 years (p = 0.005) and a positive history of CV disease (p = 0.04) were significantly associated with a lower CV-mortality free survival. CV disease accounted for 16.5% and 5% of potential years of life lost (PYLL) in male and female patients, respectively. The standard mortality ratio (SMR) following ischemic heart disease (IHD) was 3.9 in males and 3.8 in female patients, meaning an excess of IHD deaths observed, in comparison with the population of control. CONCLUSION: Prevention strategies based on CV risk factors, in particular in those patients with a previous history of CV disease, should be considered.