Outcomes of surgical ablation for atrial fibrillation in on- versus off-pump coronary artery bypass grafting.

OBJECTIVES: A considerable number of patients undergoing coronary artery bypass grafting surgery suffer from atrial fibrillation and should be treated concomitantly. This manuscript evaluates the impact of on-pump versus off-pump bypass grafting on the applied lesion set and rhythm outcome. METHODS: Between January 2017 and April 2020, patients who underwent combined bypass grafting and surgical ablation for atrial fibrillation were consecutively enrolled in the German CArdioSurgEry Atrial Fibrillation registry (CASE-AF, 17 centres). Data were prospectively collected. Follow-up was planned after one year. RESULTS: A total of 224 patients were enrolled. No differences in baseline characteristics were seen between on- and off-pump bypass grafting, especially not in type of atrial fibrillation and left atrial size. In the on-pump group (n = 171, 76%), pulmonary vein isolation and an extended left atrial lesion set were performed more often compared to off-pump bypass grafting (58% vs 26%, 33 vs 9%, respectively, P < 0.001). In off-pump bypass grafting a box isolating the atrial posterior wall was the dominant lesion (72% off-pump vs 42% on-pump, P < 0.001). Left atrial appendage management was comparable in on-pump versus off-pump bypass grafting (94% vs 91%, P = 0.37). Sinus rhythm at follow-up was confirmed in 61% in the on-pump group and in 65% in the off-pump group (P = 0.66). No differences were seen in in-hospital or follow-up complication-rates between the two groups. CONCLUSIONS: In coronary artery bypass grafting patients undergoing concomitant atrial fibrillation ablation, our data suggests that the technique applied for myocardial revascularization (off-pump vs on-pump) leads to differences in the ablation lesion set, but not in safety and effectiveness.

Reliability of EuroSCORE II on Prediction of Thirty-Day Mortality and Long-Term Results in Patients Treated with Sutureless Valves.

Background: EuroSCORE II (ES2) is a reliable tool for preoperative cardiac surgery mortality risk prediction; however, a patient's age, a surgical procedure's weight and the new devices available may cause its accuracy to drift. We sought to investigate ES2 performance related to the surgical risk and late mortality estimation in patients who underwent aortic valve replacement (AVR) with sutureless valves. Methods: Between 2012 and 2021, a total of 1126 patients with isolated aortic stenosis who underwent surgical AVR by means of sutureless valves were retrospectively collected from six European centers. Patients were stratified into three groups according to the EuroSCORE II risk classes (ES2 < 4%, ES2 4-8% and ES2 > 8%). The accuracy of ES2 in estimating mortality risk was assessed using the standardized mortality ratio (O/E ratio), ROC curves (AUC) and Hosmer-Lemeshow (HL) test for goodness-of-fit. Results: The overall observed mortality was 3.0% (predicted mortality ES2: 5.39%) with an observed/expected (O/E) ratio of 0.64 (confidential interval (CI): 0.49-0.89). In our population, ES2 showed a moderate discriminating power (AUC 0.65, 95%CI 0.56-0.72, p < 0.001; HL p = 0.798). Good accuracy was found in patients with ES2 < 4% (O/E ratio 0.54, 95%CI 0.23-1.20, AUC 0.75, p < 0.001, HL p = 0.999) and for patients with an age < 75 years (O/E ratio 0.98, 95%CI 0.45-1.96, AUC 0.76, p = 0.004, HL p = 0.762). Moderate discrimination was observed for ES2 in the estimation of long-term risk of mortality (AUC 0.64, 95%CI: 0.60-0.68, p < 0.001). Conclusions: EuroSCORE II showed good accuracy in patients with an age < 75 years and patients with ES2 < 4%, while overestimating risk in the other subgroups. A recalibration of the model should be taken into account based on the complexity of actual patients and impact of new technologies.

Sutureless Aortic Valve Replacement vs. Transcatheter Aortic Valve Implantation in Patients with Small Aortic Annulus: Clinical and Hemodynamic Outcomes from a Multi-Institutional Study.

OBJECTIVE: This study aimed to compare hemodynamic performances and clinical outcomes of patients with small aortic annulus (SAA) who underwent aortic valve replacement by means of sutureless aortic valve replacement (SUAVR) or transcatheter aortic valve implantation (TAVI). METHODS: From 2015 to 2020, 622 consecutive patients with SAA underwent either SUAVR or TAVI. Through a 1:1 propensity score matching analysis, two homogeneous groups of 146 patients were formed. Primary endpoint: all cause-death at 36 months. Secondary endpoints: incidence of moderate to severe patient-prosthesis mismatch (PPM) and incidence of major adverse cardiovascular and cerebrovascular events (MACCEs). RESULTS: All-cause death at three years was higher in the TAVI group (SUAVR 12.2% vs. TAVI 21.0%, P=0.058). Perioperatively, comparable hemodynamic performances were recorded in terms of indexed effective orifice area (SUAVR 1.12 ± 0.23 cm2/m2 vs. TAVI 1.17 ± 0.28 cm2/m2, P=0.265), mean transvalvular gradients (SUAVR 12.9 ± 5.3 mmHg vs. TAVI 12.2 ± 6.2 mmHg, P=0.332), and moderate-to-severe PPM (SUAVR 4.1% vs. TAVI 8.9%, P=0.096). TAVI group showed a higher cumulative incidence of MACCEs at 36 months (SUAVR 18.1% vs. TAVI 32.6%, P<0.001). Pacemaker implantation (PMI) and perivalvular leak ≥ 2 were significantly higher in TAVI group and identified as independent predictors of mortality (PMI: hazard ratio [HR] 3.05, 95% confidence interval [CI] 1.34-6.94, P=0.008; PPM: HR 2.72, 95% CI 1.25-5.94, P=0.012). CONCLUSION: In patients with SAA, SUAVR and TAVI showed comparable hemodynamic performances. Moreover, all-cause death and incidence of MACCEs at follow-up were significantly higher in TAVI group.

Epicardial and endocardial surgical ablation of atrial fibrillation: outcomes from CASE-AF Registry.

OBJECTIVES: The German CArdioSurgEry Atrial Fibrillation Registry is a prospective, multicentric registry analysing outcomes of patients undergoing surgical ablation for atrial fibrillation as concomitant or stand-alone procedures. This data sub-analysis of the German CArdioSurgEry Atrial Fibrillation Registry aims to describe the in-hospital and 1-year outcomes after concomitant surgical ablation, based on 2 different ablation approaches, epicardial and endocardial surgical ablation. METHODS: Between January 2017 and April 2020, 17 German cardiosurgical units enrolled 763 consecutive patients after concomitant surgical ablation. In the epicardial group, 413 patients (54.1%), 95.6% underwent radiofrequency ablation. In the endocardial group, 350 patients (45.9%), 97.7% underwent cryoablation. 61.5% of patients in the epicardial group and 49.4% of patients in the endocardial group presenting with paroxysmal atrial fibrillation. Pre-, intra- and post-operative data were gathered. RESULTS: Upon discharge, 32.3% (n = 109) of patients after epicardial surgical ablation and 24.0% (n = 72) of patients after endocardial surgical ablation showed recurrence of atrial fibrillation. The in-hospital mortality rate was low, 2.2% (n = 9) in the epicardial and 2.9% (n = 10) in the endocardial group. The overall 1-year procedural success rate was 58.4% in the epicardial and 62.2% in the endocardial group, with significant symptom improvement in both groups. The 1-year mortality rate was 7.7% (n = 30) in epicardial and 5.0% (n = 17) in the endocardial group. CONCLUSIONS: Concomitant surgical ablation is safe and effective with significant improvement in patient symptoms and freedom from atrial fibrillation. Adequate cardiac rhythm monitoring should be prioritized for higher quality data acquisition.

Partial versus Complete Sternotomy for Aortic Valve Replacement-Multicenter Study.

BACKGROUND: The benefits of minimally invasive techniques in cardiac surgery remain poorly defined. We evaluated the short- and mid-term outcomes after surgical aortic valve replacement through partial upper versus complete median sternotomy (MS) in a large, German multicenter cohort. METHODS: A total of 2,929 patients underwent isolated surgical aortic valve replacement via partial upper sternotomy (PUS, n = 1,764) or MS (n = 1,165) at nine participating heart centers between 2016 and 2020. After propensity-score matching, 1,990 patients were eligible for analysis. The primary end point was major adverse cardiac and cerebrovascular events (MACCE), a composite of death, myocardial infarction, and stroke at 30 days and in follow-up, up to 5 years. Secondary end points were acute kidney injury, length of hospital stay, transfusions, deep sternal wound infection, Dressler's syndrome, rehospitalization, and conversion to sternotomy. RESULTS: Unadjusted MACCE rates were significantly lower in the PUS group both at 30 days (p = 0.02) and in 5-year follow-up (p = 0.01). However, after propensity-score matching, differences between the groups were no more statistically significant: MACCE rates were 3.9% (PUS) versus 5.4% (MS, p = 0.14) at 30 days, and 9.9 versus 11.3% in 5-year follow-up (p = 0.36). In the minimally invasive group, length of intensive care unit (ICU) stay was shorter (p = 0.03), Dressler's syndrome occurred less frequently (p = 0.006), and the rate of rehospitalization was reduced significantly (p < 0.001). There were 3.8% conversions to full sternotomy. CONCLUSION: In a large, German multicenter cohort, MACCE rates were comparable in surgical aortic valve replacement through partial upper and complete sternotomies. Shorter ICU stay and lower rates of Dressler's syndrome and rehospitalization were in favor of the partial sternotomy group.

Isolated or Combined Ascending Aortic Replacement through a Partial Sternotomy: Early and Midterm Outcomes.

BACKGROUND: We aimed to investigate the in-hospital and midterm outcomes of patients undergoing ascending aortic replacement (AAR) through a partial or a full sternotomy approach through a propensity matching analysis. METHODS: We retrospectively included all patients (n = 167) who underwent elective AAR in our institution between 2013 and 2020. The study population was divided into two groups according to the surgical access (40 patient in the partial sternotomy or "PS" group and 127 in the full sternotomy or "FS" group). Due to the significant differences between the groups, a propensity matching of 1:3 was applied. In-hospital complications, survival, and reoperation at follow-up were investigated. RESULTS: The PS group showed higher cross-clamp and cardiopulmonary bypass times than the FS group (94.2 vs. 83 minutes and 164.2 vs. 126.8 minutes, respectively). Moreover, the postoperative ventilation time was significantly higher in the PS group, but it did not affect the length of stay in the intensive care unit (ICU). The incidences of bleeding, stroke, and mortality were comparable between the two groups (11 vs. 3%, 3 vs. 6%, and 5 vs. 3%, respectively). After a median follow-up of 2 ± 1.98 years, the Kaplan-Meier analysis showed no significant differences between the two groups (log-rank, p = 0.17) in terms of survival. CONCLUSION: The surgical ascending aorta replacement through a partial sternotomy is associated with longer operative times, but this does not affect the early as well as the long-term follow-up.

Platelet Reduction after Transcatheter Aortic Valve Implantation: Results from the PORTRAIT Study.

Background: An unexplained condition that follows transcatheter aortic valve implantation (TAVI) is platelet count reduction (PR). According to published research, patients with balloon-expandable valves (BEVs) had a greater PR than those with self-expandable valves (SEVs). Objectives: The purpose of this study was to investigate the incidence and clinical effects of PR following TAVI. Methods: In total, 1.122 adult TAVI patients were enrolled. Propensity score matching was carried out in a 1:1 ratio between patients with BEVs and those with SEVs. The analysis included changes in platelet count, in-hospital mortality, and early postoperative adverse events. Results: Notably, 632 patients were matched (BEV:316; SEV:316). All patients' post-procedural platelet counts changed according to a parabolic curve, using a mixed regression model for repeated analyses (estimate = -0.931; standard error = 0.421; p = 0.027). The platelet count varied comparably in patients with BEVs and SEVs (estimate = -4.276, standard error = 4.760, p = 0.369). The average time for obtaining the nadir platelet count value was three days after implantation (BEV: 146 (108-181) vs. SEV: 149 (120-186); p = 0.142). Overall, 14.6% of patients (92/632) had post-procedural platelet count <100,000/µL. There was no difference between the two prosthesis types (BEV:51/316; SEV:41/316; p = 0.266). Thrombocytopenia was found to be significantly linked to blood product transfusions, lengthier stays in the intensive care unit and hospital, and in-hospital mortality. Conclusions: TAVI, irrespective of the type of implanted valve, is linked to a significant but temporary PR. Thrombocytopenia increases the risk of serious complications and in-hospital death in TAVI patients. To explore and clarify the causes and associated effects, further prospective research is necessary.

Long-term survival after surgical treatment for post-infarction mechanical complications: results from the Caution study.

BACKGROUND AND AIMS: Mechanical complications (MCs) are rare but potentially fatal sequelae of acute myocardial infarction (AMI). Surgery, though challenging, is considered the treatment of choice. The authors sought to study early and long-term results of patients undergoing surgical treatment for post-AMI MCs. METHODS: Patients undergone surgical treatment for post-infarction MCs between 2001 through 2019 in 27 centers worldwide were retrieved from the database of CAUTION study. In-hospital and long-term mortality were the primary outcomes. Cox proportional hazards regression models were used to determine independent factors associated with overall mortality. RESULTS: The study included 720 patients. The median age was 70.0 [62.0-77.0] years, with a male predominance (64.6%). The most common MC encountered was ventricular septal rupture (VSR) (59.4%). Cardiogenic shock was seen on presentation in 56.1% of patients. In-hospital mortality rate was 37.4%; in more than 50% of cases, the cause of death was low cardiac output syndrome (LCOS). Late mortality occurred in 133 patients, with a median follow-up of 4.4 [1.0-8.6] years. Overall survival at 1, 5 and 10 years was 54.0%, 48.1% and 41.0%, respectively. Older age (p < 0.001) and postoperative LCOS (p < 0.001) were independent predictors of overall mortality. For hospital survivors, 10-year survival was 65.7% and was significant higher for patients with VSR than those with papillary muscle rupture (long-rank P = 0.022). CONCLUSIONS: Contemporary data from a multicenter cohort study show that surgical treatment for post-AMI MCs continues to be associated with high in-hospital mortality rates. However, long-term survival in patients surviving the immediate postoperative period is encouraging.Trial registration number: NCT03848429.

Comparison of 4 mortality scores for surgical repair of type A aortic dissection: a multicentre external validation.

OBJECTIVES: In the last decades, 4 different scores for the prediction of mortality following surgery for type A acute aortic dissection (TAAD) were proposed. We aimed to validate these scores in a large external multicentre cohort. METHODS: We retrospectively analysed patients who underwent surgery for TAAD between 2000 and 2020. Patients were enrolled from 10 centres from 2 European countries. Outcomes were the early (30-day and/or in-hospital) and 1-year mortality. Discrimination, calibration and observed/expected (O/E) ratio were evaluated. RESULTS: A total of 1895 patients (31.7% females, mean age 63.72 ± 12.8 years) were included in the study. Thirty-day mortality and in-hospital mortality were 21.7% (n = 412) and 22.5% (n = 427) respectively. The German Registry of Acute Aortic Dissection Type A (GERAADA) score shows to have the best discrimination [area under the curve (AUC) 0.671 and 0.672] in predicting as well the early and the 1-year mortality, followed by the International Registry of Acute Aortic Dissection (IRAD) model 1 (AUC 0.658 and 0.672), the Centofanti (AUC 0.645 and 0.66) and the UK aortic score (AUC 0.549 and 0.563). According to Hosmer-Lemeshow and Brier tests, the IRAD model I and GERAADA, respectively, were well calibrated for the early mortality, while the GERAADA and Centofanti for the 1-year mortality. The O/E analysis showed a marked underestimation for patients labelled as low-risk for UK aortic score and IRAD model I for both outcomes. CONCLUSIONS: The GERAADA score showed the best performance in comparison with other scores. However, none of them achieved together a fair discrimination and a good calibration for predicting either the early or the 1-year mortality.

Sutureless Aortic Valve Replacement vs. Transcatheter Aortic Valve Implantation in Patients with Small Aortic Annulus: Clinical and Hemodynamic Outcomes from a Multi-Institutional Study

ABSTRACT Objective: This study aimed to compare hemodynamic performances and clinical outcomes of patients with small aortic annulus (SAA) who underwent aortic valve replacement by means of sutureless aortic valve replacement (SUAVR) or transcatheter aortic valve implantation (TAVI). Methods: From 2015 to 2020, 622 consecutive patients with SAA underwent either SUAVR or TAVI. Through a 1:1 propensity score matching analysis, two homogeneous groups of 146 patients were formed. Primary endpoint: all cause-death at 36 months. Secondary endpoints: incidence of moderate to severe patient-prosthesis mismatch (PPM) and incidence of major adverse cardiovascular and cerebrovascular events (MACCEs) Results: All-cause death at three years was higher in the TAVI group (SUAVR 12.2% vs. TAVI 21.0%, P=0.058). Perioperatively, comparable hemodynamic performances were recorded in terms of indexed effective orifice area (SUAVR 1.12 ± 0.23 cm2/m2 vs. TAVI 1.17 ± 0.28 cm2/m2, P=0.265), mean transvalvular gradients (SUAVR 12.9 ± 5.3 mmHg vs. TAVI 12.2 ± 6.2 mmHg, P=0.332), and moderate-to-severe PPM (SUAVR 4.1% vs. TAVI 8.9%, P=0.096). TAVI group showed a higher cumulative incidence of MACCEs at 36 months (SUAVR 18.1% vs. TAVI 32.6%, P<0.001). Pacemaker implantation (PMI) and perivalvular leak ≥ 2 were significantly higher in TAVI group and identified as independent predictors of mortality (PMI: hazard ratio [HR] 3.05, 95% confidence interval [CI] 1.34-6.94, P=0.008; PPM: HR 2.72, 95% CI 1.25-5.94, P=0.012). Conclusion: In patients with SAA, SUAVR and TAVI showed comparable hemodynamic performances. Moreover, all-cause death and incidence of MACCEs at follow-up were significantly higher in TAVI group.

Platelet Reduction after Aortic Bioprosthesis Implantation: Results from the PORTRAIT Study.

Background: Platelet count reduction (PR) is a common but unclear phenomenon that occurs after aortic bioprosthesis valve implantation (bio-AVR). This study aimed to investigate the occurrence and clinical impact of PR in patients receiving stented, rapid deployment (RDV), or stentless bioprostheses. Methods: 1233 adult bio-AVR patients were enrolled. Platelet count variation, early post-operative adverse events, and in-hospital mortality were analysed. Results: 944 patients received a stented valve, an RDV was implanted in 218 patients, and 71 patients had a stentless bioprosthesis. In all groups, the platelet count at discharge was lower than the baseline values (p < 0.001). The percentage of PR was 27% in the stented group, 56% in the RDV group, and 55% in the stentless group. A higher platelet reduction, reaching the minimum platelet value, was observed in the RDV (mean: -30.84, standard error (SE): 5.91, p < 0.001) and stentless (mean: 22.54, SE: 9.10, p = 0.03) groups compared to the stented group. A greater PR occurred as the size of the bioprosthesis increased in RDV (p = 0.01), while platelet count variation was not directly proportional to the stented bioprosthesis size (p < 0.001). PR was not affected by cardiopulmonary bypass (mean: -0.00, SE: 0.001, p = 0.635) or cross-clamp (mean: -0.00, SE: 0.002, p = 0.051) times in any of the groups. RDV subjects experienced more in-hospital adverse events. PR was found to be associated with ischemic strokes in the overall population. Conclusions: Bio-AVR is associated with significant but transient PR. RDV patients more likely experience significant PR and related adverse clinical events. PR is associated with ischemic strokes, regardless of the bioprosthesis type.

Impact of COVID-19 on incidence and outcomes of post-infarction mechanical complications in Europe.

OBJECTIVES: Post-acute myocardial infarction mechanical complications (post-AMI MCs) represent rare but life-threatening conditions, including free-wall rupture, ventricular septal rupture and papillary muscle rupture. During the coronavirus disease-19 (COVID-19) pandemic, an overwhelming pressure on healthcare systems led to delayed and potentially suboptimal treatments for time-dependent conditions. As AMI-related hospitalizations decreased, limited information is available whether higher rates of post-AMI MCs and related deaths occurred in this setting. This study was aimed to assess how COVID-19 in Europe has impacted the incidence, treatment and outcome of MCs. METHODS: The CAUTION-COVID19 study is a multicentre retrospective study collecting 175 patients with post-AMI MCs in 18 centres from 6 European countries, aimed to compare the incidence of such events, related patients' characteristics, and outcomes, between the first year of pandemic and the 2 previous years. RESULTS: A non-significant increase in MCs was observed [odds ratio (OR) = 1.15, 95% confidence interval (CI) 0.85-1.57; P = 0.364], with stronger growth in ventricular septal rupture diagnoses (OR = 1.43, 95% CI 0.95-2.18; P = 0.090). No significant differences in treatment types and mortality were found between the 2 periods. In-hospital mortality was 50.9% and was higher for conservatively managed cases (90.9%) and lower for surgical patients (44.0%). Patients admitted during COVID-19 more frequently had late-presenting infarction (OR = 2.47, 95% CI 1.24-4.92; P = 0.010), more stable conditions (OR = 2.61, 95% CI 1.27-5.35; P = 0.009) and higher EuroSCORE II (OR = 1.04, 95% CI 1.01-1.06; P = 0.006). CONCLUSIONS: A non-significant increase in MCs incidence occurred during the first year of COVID-19, characterized by a significantly higher rate of late-presenting infarction, stable conditions and EuroSCORE-II if compared to pre-pandemic data, without affecting treatment and mortality.

The current clinical practice for management of post-infarction ventricular septal rupture: a European survey.

Aims: Many historical and recent reports showed that post-infarction ventricular septal rupture (VSR) represents a life-threatening condition and the strategy to optimally manage it remains undefined. Therefore, disparate treatment policies among different centres with variable results are often described. We analysed data from European centres to capture the current clinical practice in VSR management. Methods and results: Thirty-nine centres belonging to eight European countries participated in a survey, filling a digital form of 38 questions from April to October 2022, to collect information about all the aspects of VSR treatment. Most centres encounter 1-5 VSR cases/year. Surgery remains the treatment of choice over percutaneous closure (71.8% vs. 28.2%). A delayed repair represents the preferred approach (87.2%). Haemodynamic conditions influence the management in almost all centres, although some try to achieve patients stabilization and delayed surgery even in cardiogenic shock. Although 33.3% of centres do not perform coronarography in unstable patients, revascularization approaches are widely variable. Most centres adopt mechanical circulatory support (MCS), mostly extracorporeal membrane oxygenation, especially pre-operatively to stabilize patients and achieve delayed repair. Post-operatively, such MCS are more often adopted in patients with ventricular dysfunction. Conclusion: In real-life, delayed surgery, regardless of the haemodynamic conditions, is the preferred strategy for VSR management in Europe. Extracorporeal membrane oxygenation is becoming the most frequently adopted MCS as bridge-to-operation. This survey provides a useful background to develop dedicated, prospective studies to strengthen the current evidence on VSR treatment and to help improving its currently unsatisfactory outcomes.

A Machine Learning Model for the Accurate Prediction of 1-Year Survival in TAVI Patients: A Retrospective Observational Cohort Study.

BACKGROUND: predicting the 1-year survival of patients undergoing transcatheter aortic valve implantation (TAVI) is indispensable for managing safe early discharge strategies and resource optimization. METHODS: Routinely acquired data (134 variables) were used from 629 patients, who underwent transfemoral TAVI from 2012 up to 2018. Support vector machines, neuronal networks, random forests, nearest neighbour and Bayes models were used with new, previously unseen patients to predict 1-year mortality in TAVI patients. A genetic variable selection algorithm identified a set of predictor variables with high predictive power. RESULTS: Univariate analyses revealed 19 variables (clinical, laboratory, echocardiographic, computed tomographic and ECG) that significantly influence 1-year survival. Before applying the reject option, the model performances in terms of negative predictive value (NPV) and positive predictive value (PPV) were similar between all models. After applying the reject option, the random forest model identified a subcohort showing a negative predictive value of 96% (positive predictive value = 92%, accuracy = 96%). CONCLUSIONS: Our model can predict the 1-year survival with very high negative and sufficiently high positive predictive value, with very high accuracy. The "reject option" allows a high performance and harmonic integration of machine learning in the clinical decision process.

Sutureless versus transcatheter valves in patients with aortic stenosis at intermediate risk: A multi-institutional European study.

BACKGROUND: Recent randomized controlled trials showed comparable short-term outcomes of transcatheter aortic valve implantation versus surgical aortic valve replacement in intermediate and low-risk patients. However, independent studies comparing transcatheter aortic valve implantation results versus surgical aortic valve replacement at 5 years showed worsening outcomes in patients treated with transcatheter aortic valve implantation. The aim of this study was to analyze mid- to long-term outcomes of patients with isolated aortic stenosis and an intermediate-risk profile who underwent aortic valve replacement using a sutureless valve versus transcatheter aortic valve implantation. METHODS: This retrospective multi-institutional European study investigated 2,123 consecutive patients with isolated aortic stenosis at intermediate risk profile treated with sutureless aortic valve replacement (824 patients) or transcatheter aortic valve implantation (1,299 patients) from 2013 to 2020. After 1:1 propensity score matching, 2 balanced groups of 517 patients were obtained. Primary endpoints were as follows: 30 days, late all-cause, and cardiac-related mortality. Secondary endpoints included major adverse cardiocerebrovascular events (all-cause death, stroke/transient ischemic attack, endocarditis, reoperation, permanent pacemaker implantation, and paravalvular leak grade ≥2). RESULTS: Median follow-up was 4.3 years (interquartile range 1.1-7.4 years). Primary endpoints were as follows-30-day mortality sutureless aortic valve replacement: 2.13% versus transcatheter aortic valve implantation: 4.64% (P = .026), all-cause mortality sutureless aortic valve replacement: 36.7% ± 7.8% vs transcatheter aortic valve implantation: 41.8% ± 8.2% (P = .023), and cardiac-related mortality sutureless aortic valve replacement: 10.2% ± 2.8% vs transcatheter aortic valve implantation: 19.2% ± 3.5%;(P = .00043) at follow-up. Secondary endpoints were as follows-major adverse cardiocerebrovascular events in the sutureless aortic valve replacement group: 47.2% ± 9.0% versus transcatheter aortic valve implantation: 57.3% ± 7.5% (P < .001). In particular, the incidence of permanent pacemaker implantation (sutureless aortic valve replacement: 6.38% versus transcatheter aortic valve implantation: 11.8% [P = .002]) and paravalvular leak ≥2 (sutureless aortic valve replacement: 0.97% versus transcatheter aortic valve implantation: 4.84% [P = .001]) was significantly higher in transcatheter aortic valve implantation group. At Multivariable Cox regression analysis, paravalvular leak ≥2 (hazard ratio: 1.63%; 95% confidence interval: 1.06-2.53, P = .042) and permanent pacemaker implantation (hazard ratio: 1.49%; 95% confidence interval: 1.02-2.20, P = .039) were identified as predictors of mortality. CONCLUSION: Sutureless aortic valve replacement showed a significantly lower incidence of all-cause mortality, cardiac-related death, permanent pacemaker implantation, and paravalvular leak than transcatheter aortic valve implantation. Moreover, permanent pacemaker implantation and paravalvular leak negatively affected survival in patients treated for isolated aortic stenosis.

Sutureless and Rapid Deployment vs. Transcatheter Valves for Aortic Stenosis in Low-Risk Patients: Mid-Term Results.

BACKGROUND: Recent 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. METHODS: Data 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). RESULTS: Thirty-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. CONCLUSIONS: TAVI 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.

Impact of prophylactic intra-aortic balloon pump on early outcomes in patients with severe left ventricular dysfunction undergoing elective coronary artery bypass grafting with cardiopulmonary bypass.

OBJECTIVE: Our aim was to analyse whether prophylactic preoperative intraaortic balloon pump (IABP) improves outcomes in hemodynamically stable patients with low left ventricular ejection fraction (LVEF ≤30%) undergoing elective myocardial revascularization (CABG) using cardiopulmonary bypass (CPB). Secondary aim was to identify the predictors for low cardiac output syndrome (LCOS). METHODS: Prospectively collected data of 207 consecutive patients with LVEF ≤30% undergoing elective isolated CABG with CPB from 01/2009 to 12/2019, 136 with and 71 patients without IABP, were retrieved retrospectively. Patients with prophylactic IABP were matched 1:1 with patients without IABP by a propensity score matching. Stepwise logistic regression was conducted to identify predictors of postoperative LCOS in the propensity-matched cohort. P value ≤0.05 was considered significant. RESULTS: Reduced postoperative LCOS (9.9% vs. 26.8%, P = 0.017) was observed in patients receiving prophylactic IABP. Stepwise logistic regression identified preoperative IABP as preventive factor for postoperative LCOS [Odds Ratio (OR) 0.19,95% Confidence Interval (CI), 0.06-0.55, P = 0.004]. The need of vasoactive and inotropic support was lower in patients with prophylactic IABP at 24, 48 and 72 h after surgery (12.3 [8.2-18.6] vs. 22.2 [14.4-28.8], P < 0.001, 7.7 [3.3-12.3] vs.16.3 [8.9-27.8], P < 0.001 and 2.4 [0-7] vs. 11.5 [3.1-26], P < 0.001, respectively). The patients in both groups did not differ in terms of in-hospital mortality (7.0% vs. 9.9%, P = 0.763). There were no major IABP-related complications. CONCLUSIONS: Elective patients with left ventricular ejection fraction ≤30% undergoing CABG with CPB and prophylactic IABP insertion had less low cardiac output syndrome and similar in-hospital mortality.

Extracorporeal life support in mitral papillary muscle rupture: Outcome of multicenter study.

BACKGROUND: Post-acute myocardial infarction papillary muscle rupture (post-AMI PMR) may present variable clinical scenarios and degree of emergency due to result of cardiogenic shock. Veno-arterial extracorporeal life support (V-A ECLS) has been proposed to improve extremely poor pre- or postoperative conditions. Information in this respect is scarce. METHODS: From the CAUTION (meChanical complicAtion of acUte myocardial infarcTion: an InternatiOnal multiceNter cohort study) database (16 different Centers, data from 2001 to 2018), we extracted adult patients who were surgically treated for post-AMI PMR and underwent pre- or/and postoperative V-A ECLS support. The end-points of this study were in-hospital survival and ECLS complications. RESULTS: From a total of 214 post-AMI PMR patients submitted to surgery, V-A ECLS was instituted in 23 (11%) patients. The median age was 61.7 years (range 46-81 years). Preoperatively, ECLS was commenced in 10 patients (43.5%), whereas intra/postoperative in the remaining 13. The most common V-A ECLS indication was post-cardiotomy shock, followed by preoperative cardiogenic shock and cardiac arrest. The median duration of V-A ECLS was 4 days. V-A ECLS complications occurred in more than half of the patients. Overall, in-hospital mortality was 39.2% (9/23), compared to 22% (42/219) for the non-ECLS group. CONCLUSIONS: In post-AMI PMR patients, V-A ECLS was used in almost 10% of the patients either to promote bridge to surgery or as postoperative support. Further investigations are required to better evaluate a potential for increased use and its effects of V-A ECLS in such a context based on the still high perioperative mortality.