Impact of gender on long-term prognosis after transcatheter edge-to-edge repair for mitral regurgitation

Background A symptomatic and prognostic benefit by Transcatheter edge-to-edge repair (TEER) for mitral regurgitation (MR) has been proven. A variety of individual factors including female sex has been suggested to be associated with adverse outcome in cardio-surgical procedures. Purpose While gender is factored in common risk factor models for adverse outcome, evidence on sex-specific differences in long-term outcome after TEER for MR is limited. We aimed to investigate the impact of gender on prognosis in a large monocentric cohort with long-term follow-up. Methods We analyzed survival stratified for gender after successful isolated edge-to-edge repair of MR in the period between 06/2010 and 03/2018 (exclusion of combined forms of TMVR) in a monocentric retrospective cohort by performing survival analyses and cox regression analyses. Results Consecutively, 627 patients (47.0% females, 57.4% functional MR; survival status was available in 96.7%) entered the study and were followed for a median follow-up period of 462 days [IQR 142–945 days]. Survival rates were 97.6% at discharge, 75.7% after 1, 54.5% after 3, 37.6% after 5 and 21.7% after 7 years. Risk score as calculated by the Logistic Euroscore I did not differ significantly between females and males (at baseline: 25.0 [IQR 18.0/34.8] vs. 27.0 [18.4/40.1]%, p=0.093) and no relevant differences were found for in-hospital (2.0 vs. 2.7%, p=0.613), 30 days (4.8 vs. 6.5%, p=0.473) and 1-year mortality (27.0 vs. 25.3%, p=0.675). At the time of procedure, women were older (79.9 [IQR 75.6/84.4] vs. 78.3 [72.9/83.4] years, p<0.001), were less often affected by coronary artery disease (53.1% vs. 75.0% p<0.001), diabetes mellitus (23.7% vs. 31.3%, p=0.040) and impaired left ventricular function (44.5±12.9% vs. 38.9±13.4%, p<0.001). Regarding long-term survival, women had a better prognosis after MR-therapy, especially in functional etiology: e.g., 4-year survival in FMR 65.7 vs. 35.7%, p=0.006 (Figure 1). Remarkably, female sex was associated with a lower risk for long-term mortality in the Cox-regression models, especially in the FMR subgroup (total cohort: univariate HR 0.81 [0.62–1.04], p=0.101; FMR: univariate HR 0.68 [0.49–0.96], p=0.028). Conclusion In our cohort of patients undergoing TEER for MR, we found no evidence for an impaired short- and mid-term prognosis for female patients. In contrary and not as indicated by Logistic Euroscore, female sex was associated with better long-term survival in comparison to men despite higher median age, which might be partly explained by a slightly more favorable cardiovascular risk profile. FUNDunding Acknowledgement Type of funding sources: None. Figure 1

Low Incidence of Structural Valve Degeneration With the Trifecta Aortic Valve Bioprosthesis.

Objectives: An ideal bioprosthetic heart valve would have excellent haemodynamic performance and a low rate of Structural Valve Degeneration (SVD). The objective of this study was to investigate the haemodynamic performance and incidence of reintervention due to SVD of the Trifecta aortic valve.Methods:Between 2012 to 2019, 2934 valve surgeries were performed in which 2185 were biological valves. Out of 2185 patients, only 399 patients had undergone Trifecta biological Aortic Valve Replacement (AVR). Three surgeons performed all aortic Trifecta valve surgeries. Operative mortality, incidence of reintervention and overall survival figures was calculated. Results: A total of 399 patients were included of which 260 (65.2%) were male. The mean (± SD) age was 73.4 ± 8.0 with 41 patients (10.3%) aged under 65 with 222 patients (55.6%) had isolated AVR and 176 (44.1%) had AVR combined with coronary artery bypass grafting and a single patient underwent aortic and mitral valve replacement. The mean (±SD) logistic EuroSCORE was 7.4 (±2.7). The median valve size used was 23mm. A total of 21 patients (5.3%) required a permanent pacemaker to be implanted. The 30-day mortality rate was 2.8% (n=11). The rate of structural valve degeneration was 0.3% and median follow-up was 782 days. Neither peak nor mean valve gradients were significantly different between year 1 vs. year 3 (peak gradient: 18.3±8.0 vs. 17.1±8.5, p=0.34; mean gradient: 9.8±4.6 vs. 8.7±4.6, p=0.16). Conclusions: Mid-term echocardiographic data showed a low rate of significant regurgitation and excellent gradients. Larger multicentre studies are required to validate these findings.

Comparison of long-term outcomes after trans-catheter aortic valve implantation between patients primarily diagnosed by cardiac murmur and those diagnosed by other reasons

Careful auscultation is the first step to diagnose aortic stenosis (AS). The aim of this study was to compare clinical outcomes following transcatheter aortic valve implantation (TAVI) between the patients primarily diagnosed by heart murmur and those diagnosed by other reasons. We retrospectively included 258 patients who underwent TAVI in our medical center, and divided those into the murmur group (n = 81) and the other-reason group (n = 177) according to the primary reason for AS diagnosis. The primary endpoint was the major adverse cardiovascular and cerebrovascular events (MACCE), which was defined as the composite of cardiovascular death, hospitalization due to acute decompensated heart failure, and disabling stroke. The murmur group included younger patients than the other-reason group (82.8 year-old vs. 84.0 year-old, P = 0.02). History of AF was more frequently observed in the other-reason group than in the murmur group (21.5% vs. 7.4%, P <0.01). STS score and logistic EuroSCORE were lower in the murmur group than in the other-reason group (STS: 4.7% vs. 7.2%, P <0.01, logistic EuroSCORE: 8.3% vs. 11.2%, P <0.01). The median follow-up period was 562 days. MACCE was more frequently observed in the other-reason group than in the murmur group (27.7% vs. 9.9%, Log Rank P <0.01). The multivariate COX hazard analysis revealed that the AS patients primarily diagnosed by heart murmur was inversely associated with MACCE (HR 0.38, 95%CI 0.17–0.86, P = 0.020). Among AS patients who underwent TAVI, the patients primarily diagnosed by heart murmur were significantly associated with favorable long-term clinical outcomes.

Inferior outcomes following cardiac surgery in patients with a functioning renal allograft

OBJECTIVES Renal transplantation is an effective treatment for end-stage renal failure. The aim of this study was to evaluate outcomes for these patients undergoing cardiac surgery. METHODS A retrospective analysis identified patients with a functioning renal allograft at the time of surgery. A 2:1 propensity matching was performed. Patients were matched on: age, sex, left ventricle function, body mass index, preoperative creatinine, operation priority, operation category and logistic EuroSCORE. RESULTS Thirty-eight patients undergoing surgery with a functioning renal allograft were identified. The mean age was 62.4 years and 66% were male. A total of 44.7% underwent coronary artery bypass grafting and 26.3% underwent a single valve procedure. The mean logistic EuroSCORE was 10.65. The control population of 76 patients was well matched. Patients undergoing surgery following renal transplantation had a prolonged length of intensive care unit (3.19 vs 1.02 days, P &lt; 0.001) and hospital stay (10.3 vs 7.17 days, P = 0.05). There was a higher in-hospital mortality (15.8% vs 1.3%, P = 0.0027). Longer-term survival on Kaplan–Meier analysis was also inferior (P &lt; 0.001). One-year survival was 78.9% vs 96.1% and 5-year survival was 63.2% vs 90.8%. A further subpopulation of 11 patients with a failed renal allograft was identified and excluded from the main analysis; we report demographic and outcome data for them. CONCLUSIONS Patients with a functioning renal allograft are at higher risk of perioperative mortality and inferior long-term survival following cardiac surgery. Patients in this population should be appropriately informed at the time of consent and should be managed cautiously in the perioperative period with the aim of reducing morbidity and mortality.

Anticoagulation and outcomes after surgical aortic valve replacement with a biological prosthesis

Background No strong recommendation exists regarding the use of short-term anticoagulation after surgical aortic valve replacement (SAVR) with a biological prosthesis. Purpose Our aim was to analyze outcomes of patients receiving warfarin versus low-molecular weight heparin (LMWH) after isolated SAVR. Methods We retrospectively analyzed all adult patients who underwent surgery between 2009 and 2017 at our department (n=598). Exclusion criteria included pre-operative anticoagulation, atrial fibrillation, dialysis, previous aortic valve replacement, or active endocarditis. Patients who were discharged alive were stratified according to the type of anticoagulation (warfarin, n=332, 55.5%; LMWH, n=266, 44.5%). Long-term survival during the follow-up period was analyzed (median follow-up, 5.6 years). Results Patients who received warfarin had significantly lower logistic EuroSCORE and were younger (Table 1). Warfarin was more frequently utilized between 2009 and 2014, whereas LMWH was more commonly used between 2015 and 2017. Kaplan-Meier curves in Figure 1 show that patients who received warfarin had significantly superior long-term survival (log-rank test: p=0.002). Multivariable Cox proportional hazards regression analysis confirmed that the use of warfarin was associated with significantly lower risk of long-term mortality when compared with LMWH (hazard ratio [HR] 0.50, 95% confidence interval [CI] 0.34–0.74, p=0.001). Covariables in this model included logistic EuroSCORE, era, and duration of cardiopulmonary bypass. Conclusions The present analysis suggests that the use of warfarin is associated with significantly superior survival after SAVR with a biological prosthesis. Our findings require validation in a prospective randomized controlled trial. Figure 1. Kaplan-Meier survival curves Funding Acknowledgement Type of funding source: None

Machine learning for risk prediction of in-hospital mortality in adult cardiac surgery

Background Risk prediction plays a central role in clinical decision-making for patients undergoing cardiac surgery. The logistic EuroSCORE has demonstrated a dangerous calibration drift with the changing patient case-mix, resulting in a significant overestimation of mortality and risk-averse practice. Despite these limitations, it continues being used in the United Kingdom due to a lack of alternative validated models. It is urgent to find a replacement for EuroSCORE with a better calibrated prediction model. Machine learning models are increasingly used for risk prediction in medicine due to their potential of overcoming limitations of regression models. Precisely quantifying the risk of in-hospital mortality may better inform patient-centred decision-making and direct targeted quality improvement interventions. Methods This is a retrospective monocentric cohort study using prospectively collected fully anonymised data from the National Adult Cardiac Surgery Audit database, restricted to patients undergoing adult cardiac surgery at our institute from 1996 to 2017 (n=28,761). The aim was to develop a predictive model with improved discriminatory power and calibration using machine learning methods. Model calibration was assessed using the calibration belt method. Discrimination power of each model (area under the receiver operating characteristic curve [AUC]) was compared with the logistic EuroSCORE using the De Long's test. Results A time series of the observed:expected (O:E) ratio for the logistic EuroSCORE showed a linear decrease with a slope of −7.4x10–3. The calibration belt showed a significant risk overestimation across all risk categories (p&lt;0.001). Model discrimination was excellent over time, with a marginal but significant linear trend in reducing the AUC (p=0.03). Although miscalibration was detected for all models (p&lt;0.05), neural network achieved the best calibration with a test statistic of 13.3, followed by logistic regression (18.0), and EuroSCORE (228.7). The neural network achieved the highest AUC (0.82, 95% CI 0.78–0.85) of all models and was marginally non-significantly higher than that of the logistic EuroSCORE (0.79, 95% CI 0.75–0.83, p=0.056). Conclusion Our neural network model of cardiac surgery in-hospital mortality achieves slightly improved discriminatory power and significantly better calibration compared to that of EuroSCORE, making it more appropriate for dealing with the changing patient case-mix. Further model training on larger datasets with larger demographics is necessary. Clinical implementation of such models may reduce risk of overestimation of mortality. Funding Acknowledgement Type of funding source: None

Incidence, predictors and outcomes of Valve-in-valve (ViV) Transcatheter aortic valve replacement (TAVR): a systematic review and meta-analysis

Background Surgical aortic valve replacement has been the treatment of choice for patients with aortic valve disease before the arrival of transcatheter aortic valve replacement (TAVI), although limited by degeneration of the bioprosthesis. “Redo” intervention itself is burdened by high risk of complications and valve-in-valve (ViV) TAVI could be a valid strategy of redo for patients with comorbidities. The aim of this meta-analysis is to give an overview of the state of the art of ViV TAVI in high-risk patients, analyzing efficacy, safety, intra-hospital outcomes and 1-year outcomes and assess predictors of survival at short and mid-term follow up. Methods Two independent reviewers screened all studies investigating patients undergoing ViV TAVI. PubMed database was searched for reports published in English according to the following highly sensitive strategy: (Transcatheter[All Fields] AND “aortic”[All Fields]) AND valve-in-valve[All Fields] AND “implantation”[All Fields] NOT (review[pt] OR editorial[pt] OR letter[pt])AND “humans”[MeSH Terms]). Mortality at 30 days and at 1 year were the primary end point, while procedural and short-term outcomes and echocardiographic parameters at hospital discharge were the secondary end points. Results Of 286 studies identified, 26 articles were included, with a total of 1448 patients. Median age was 78.8 years, 57.7% of the patients were male. Median STS-predicted risk of mortality was 9.4% while median Logistic EuroSCORE was 31.3%. Median age of bioprosthesis was 10 years with 84.6% of stented valves. Stenosis (45%), followed by regurgitation (31%) and mixed defects (21%) were the causes of prosthesis failure. Diameter of the degenerated valve was ≤21 mm in 25.4%, 22–25 mm in 55% and &gt;25mm in 11.7% of the patients. Transfemoral approach was preferred (76%), with a prevalence of balloon expandable valve (73.3%). Mean post procedural gradient was 16.7±0.8 mmHg. Mean follow up was 376 days. Overall and cardiovascular mortality at 30 days was 6.5% and 5.5% respectively, while at 1 year it was 14.5% and 8.9% respectively. Regarding short-term outcomes, overall bleeding (10.4%), pacemaker implantation (9.4%) and vascular complications (8.3%) were the most common peri-procedural complications, while stroke (2.3%), myocardial infarction (2.7%) and coronary obstruction (2.8%) were less frequent. At meta-regression analysis study year (p&lt;0.001), Logistic Euroscore (p&lt;0.01) and valve diameter ≤21 mm (p&lt;0.05) at 30 days, and stenosis as reason for failure (p=0.05) at 1 year were identified as possible predictors of survival. Conclusions Percutaneous valve-in-valve aortic valve implantation offers a valid strategy to treat high risk patients with a degenerative bioprosthesis. Short and mid-term outcomes are substantially superimposable to those of TAVI, except for coronary obstruction which appears more frequent. Future studies are needed to find predictors of long- term survival and outcomes in lower risk patients. Outcome of VIV TAVI Funding Acknowledgement Type of funding source: None

Surgical revascularization for acute coronary syndromes: a report from the North Rhine-Westphalia surgical myocardial infarction registry

OBJECTIVES The aim of this was to analyse current outcomes in patients referred to coronary artery bypass grafting (CABG) for acute coronary syndromes (ACSs), including ST-elevation or non-ST-elevation ACS (non-ST-segment elevation myocardial infarction) or unstable angina. METHODS Patients (n = 2432) undergoing CABG for ACS between January 2010 and December 2017 were prospectively entered into a surgical myocardial infarction registry in North Rhine-Westphalia, Germany. Key end points were in-hospital all-cause mortality (IHM) and major adverse cardio-cerebral events (MACCE). Predictors for IHM and MACCE were analysed by multivariable logistic regression. RESULTS Patients (78% males) were referred for CABG for unstable angina (25%), non-ST-segment elevation myocardial infarction (50%), and ST-segment elevation myocardial infarction (25%). The mean patient age was 68 ± 11 years, logistic EuroSCORE was 19 ± 18% and three-vessel and left main stem diseases were diagnosed in 81% and 45% of patients, respectively. On-pump CABG with cardiac arrest or beating heart was performed in 92% and 2%, respectively, with only 6% off-pump surgery and 6% multiple arterial revascularization (3.1 ± 1.0 grafts, 93% left internal thoracic artery). Emergency CABG was performed in 23% of patients (42% in ST-segment elevation myocardial infarction; P &lt; 0.001). The total IHM and MACCE rates were 8.1% and 17.5% and were highest in ST-segment elevation myocardial infarction patients with 12.6% and 28.5%, respectively (P &lt; 0.001). Key predictors for IHM and MACCE were female gender, elevated troponin, left ventricular ejection fraction, inotropic support, logistic EuroSCORE, cardiopulmonary bypass and aortic clamp time and the need for emergency CABG. CONCLUSIONS Surgical myocardial revascularization in patients with ACS is still linked to substantial in-hospital mortality. Emergency CABG for patients with ACS was associated with poorer outcomes.

Validation of Cardiac Surgery Score (CASUS) in Postoperative Cardiac Patients

Introduction. Cardiac Surgery Score (CASUS) was introduced in 2005 as the first postoperative scoring system specific for patients who had cardiac surgery. Prior to this, European System for Cardiac Operative Risk Evaluation (EuroSCORE) has been used preoperatively, while Intensive Care National Audit and Research Centre Score (ICNARC) and Acute Physiology and Chronic Health Evaluation II (APACHE II) scores, which are widely used in general intensive care unit population, have been used to score cardiac patients postoperatively. The development of CASUS by Hekmat and colleagues for use in postoperative cardiac patients aims to change this. We wanted to validate CASUS against the well-established preoperative Logistic EuroSCORE, and postoperative APACHE II and ICNARC scores. Method. Institutional approval for this study was granted by the Audit and Clinical Governance Committee. We analyzed prospectively collected data of patients who had cardiac surgery in Castle Hill Hospital between January 2016 and September 2018. All patients who underwent surgery in the unit would have had Logistic EuroSCORE, APACHE, and ICNARC scores calculated as standard. CASUS was then calculated for these patients based on their day 1 postoperative variables. The scoring systems were compared and data presented as area under the receiver operating characteristic curve. Result. Our study shows that CASUS is the best predictor of mortality followed by ICNARC, Logistic EuroSCORE, and APACHE II. ICNARC score remains the most accurate predictor of renal and pulmonary complication followed by CASUS. Conclusion. CASUS is a useful scoring system in post-cardiac surgery patients. The accuracy of CASUS and ICNARC scores in predicting mortality, pulmonary, and renal complications are comparable.