Short- and long-term outcomes in isolated vs. hybrid thoracoscopic ablation in patients with atrial fibrillation: a systematic review and reconstructed individual patient data meta-analysis.

AIMS: Both isolated thoracoscopic and hybrid thoracoscopic atrial fibrillation (AF) ablation techniques have demonstrated favourable outcomes in the management of patients with (long-standing) persistent AF, as compared with catheter ablation. However, it is currently unknown whether there is a difference in short- and long-term outcomes when comparing these two minimally invasive surgical AF ablation procedures. Therefore, a systematic review and meta-analysis were performed to investigate these two techniques, with a specific emphasis on long-term freedom from atrial tachyarrhythmias (ATAs). METHODS AND RESULTS: A systematic search through PubMed, EMBASE, and the Cochrane Library databases was performed. All studies reporting on short-term outcomes were included in the meta-analysis. A pooled analysis of long-term freedom from ATA was performed based on Kaplan-Meier (KM) curve-derived individual patient data. Reconstructed individual time-to-event data were analysed in a multivariable Cox frailty model with adjustments for age, sex, type of AF, duration of AF history, and study variable (frailty term in the frailty Cox model). In total, 53 studies were included in the meta-analysis, encompassing 4950 patients. There were no differences in major short-term outcomes (mortality or stroke) between isolated thoracoscopic and hybrid thoracoscopic ablation. A total of 18 studies reported KM curves for long-term freedom from ATA, comprising 2038 patients. Adjusted analysis revealed that hybrid ablation was significantly associated with greater freedom from ATA [adjusted hazard ratio (aHR) = 0.59, 95% confidence interval (CI): 0.43-0.83, P < 0.001] compared with isolated thoracoscopic ablation. Additionally, older age (aHR = 1.07, 95% CI: 1.03-1.12, P = 0.002) and a higher percentage of male patients (aHR = 1.02, 95% CI: 1.01-1.03, P < 0.001) were significantly associated with lower long-term freedom from ATA recurrence. CONCLUSION: Hybrid thoracoscopic AF ablation is associated with a greater long-term freedom from ATA when compared with isolated thoracoscopic ablation, without differences in complications.

Totally endoscopic coronary artery bypass grafting: experience in 1500 patients.

OBJECTIVES: Totally endoscopic coronary artery bypass grafting (TECAB) is a minimally invasive approach to achieve surgical revascularization through a minimally invasive approach. Still, data regarding non-robotic TECAB are limited. This report presents the results of a TECAB technique using long-shafted instruments, defined as Endo-CABG, from a single-centre experience in 1500 consecutive patients. METHODS: One thousand and five hundred patients underwent Endo-CABG between January 2016 and February 2023. Data were collected retrospectively, and patients were followed up for 1 year. The primary outcome of this study was major adverse cardiac and cerebrovascular events (MACCE)-free survival. Secondary efficacy outcomes were graft failure and mortality. Furthermore, we analysed factors influencing long-term freedom from MACCE and all-cause mortality. RESULTS: The mean age was 68 [61-75] years, of which 193 (12.87%) were octogenarians. Multivessel disease was present in 1409 (93.93%) patients, and the mean EuroSCORE II was 1.64 [1.09-2.92] %. All patients underwent full arterial revascularization with bilateral internal mammary grafting in 88.47%. Graft failure occurred in 1.80% of cases after 1 year (n = 27). Thirty-day mortality was 1.73% (n = 26), 1-year survival was 94.7% (95% CI: 93.5-95.9%; n = 26) and 1-year MACCE-free survival was 91.7% (95% CI: 90.2-93.2%). Age, left ventricular ejection fraction, arterial hypertension and urgency were significantly associated with 1-year MACCE-free survival. CONCLUSIONS: Endo-CABG appears to be a safe procedure, achieves surgical revascularization and provides good outcomes regarding graft failure and MACCE at 1 year, while age, left ventricular ejection fraction, arterial hypertension and urgency were associated with 1-year outcomes.

Permanent pacemaker implantation after combined mitral- and tricuspid valve surgery-a nationwide multicentre study.

OBJECTIVES: The threshold to perform concomitant TV repair (TVr) during primary mitral valve (MV) surgery has decreased, based on recent randomized evidence. Based on these developments, the indication for TVr during MV surgery is expected to increase further. However, concerns have been raised regarding the risk of permanent pacemaker implantation (PPI) during a concomitant procedure. Therefore, we aim to assess the incidence of PPI in combined MV and TV surgery in a nationwide registry. METHODS: The current study uniquely cross-linked the Cardiothoracic and Pacemaker/ICD registry of the Netherlands Heart Registration. Patients undergoing primary MV and TV surgery (± ASD closure, rhythm surgery, CABG) between January 1st-December 31st 2021 were included. The primary outcome was PPI within 30 days after surgery. Subgroup analyses were performed for isolated MV and TV surgery and MV repair. The association between concomitant TV surgery and PPI was assessed using multivariable binary logistic regression analyses. RESULTS: A total of 1060 patients (n = 833 MV, n = 227 MV+TV) were included. The overall incidence of PPI was 4.3%. No significant difference in PPI between MV and MV+TV surgery were found (3.7% vs 6.6%, P = 0.06). Concomitant TV surgery was not an independent risk factor for PPI after surgery after adjustment for covariates. These results were robust across subgroup and sensitivity analyses. CONCLUSIONS: The current study was not able to find a statistical difference between the PPI rate in MV surgery patients and MV + TV surgery patients. Extension of the waiting period prior to PPI, may result in decreased PPI rates.

Outcomes of Mitral Valve Regurgitation Management after Expert Multidisciplinary Valve Team Evaluation.

Background/Objectives: Mitral regurgitation (MR) affects millions worldwide, necessitating timely intervention. There are significant clinical challenges in the conservative management of MR, leaving a knowledge gap regarding the impact of multidisciplinary decision-making on treatment outcomes. This study aimed to provide insights into the impact of multidisciplinary decision-making on the survival outcomes of MR patients, focusing on conservative approaches. Methods: This study retrospectively analyzes 1365 patients evaluated by an expert multidisciplinary heart team (MDT) in a single center from 2015 to 2022. Treatments included surgery, catheter-based interventions, and conservative management. Propensity matching was utilized to compare surgery and conservative approaches. Results: Surgical intervention was associated with superior long-term survival outcomes compared to conservative and catheter-based treatments, particularly for degenerative MR (DMR). Survival rates of patients deemed by the MDT to have non-severe DMR were comparable to surgical patients (HR 1.07, 95% CI: 0.37-3.12, p = 0.90). However, non-severe functional MR (FMR) patients trended towards elevated mortality risk (HR 1.77, 95% CI: 0.94-3.31, p = 0.07). Pharmacological treatment for DMR was associated with significantly higher mortality compared to surgery (HR 8.0, 95% CI: 1.78-36.03, p = 0.001). Functional MR patients treated pharmacologically exhibited a non-significantly higher mortality risk compared to surgical intervention (HR 1.93, 95% CI: 0.77-4.77, p = 0.20). Conclusions: Survival analysis revealed significant benefits for surgical intervention, contrasting with elevated mortality risks associated with conservative management. "Watchful waiting" may be appropriate for non-severe DMR, while FMR may require closer monitoring. Further research is needed to assess the impact of regular follow-up or delayed surgery on survival rates, as pharmacological therapy has limited long-term efficacy for DMR.

Routine Protamine Administration for Bleeding in Transcatheter Aortic Valve Implantation: The ACE-PROTAVI Randomized Clinical Trial.

Importance: Vascular complications after transfemoral transcatheter aortic valve implantation (TAVI) remain an important cause of procedure-related morbidity. Routine reversal of anticoagulation with protamine at the conclusion of transfemoral TAVI could reduce complications, but data remain scarce. Objective: To evaluate the efficacy and safety of routine protamine administration after transfemoral TAVI. Design, Setting, and Participants: The ACE-PROTAVI trial was an investigator-initiated, double-blind, placebo-controlled randomized clinical trial performed at 3 Australian hospitals between December 2021 and June 2023 with a 1-year follow-up period. All patients accepted for transfemoral TAVI by a multidisciplinary heart team were eligible for enrollment. Interventions: Eligible patients were randomized 1:1 between routine protamine administration and placebo. Main Outcomes and Measures: The coprimary outcomes were the rate of hemostasis success and time to hemostasis (TTH), presented as categorical variables and compared with a χ2 test or as continuous variables as mean (SD) or median (IQR), depending on distribution. The major secondary outcome was a composite of all-cause death, major and minor bleeding complications, and major and minor vascular complications after 30 days, reported in odds ratios (ORs) with 95% CIs and P values. Results: The study population consisted of 410 patients: 199 patients in the protamine group and 211 in the placebo group. The median (IQR) patient age in the protamine group was 82 (77-85) years, and 68 of 199 patients receiving protamine (34.2%) were female. The median (IQR) patient age in the placebo group was 80 (75-85) years, and 89 of 211 patients receiving the placebo (42.2%) were female. Patients receiving up-front protamine administration had a higher rate of hemostasis success (188 of 192 patients [97.9%]) than patients in the placebo group (186 of 203 patients [91.6%]; absolute risk difference, 6.3%; 95% CI, 2.0%-10.6%; P = .006); in addition, patients receiving up-front protamine had a shorter median (IQR) TTH (181 [120-420] seconds vs 279 [122-600] seconds; P = .002). Routine protamine administration resulted in a reduced risk of the composite outcome in the protamine group (10 of 192 [5.2%]) vs the placebo group (26 of 203 [12.8%]; OR, 0.37; 95% CI, 0.1-0.8; P = .01). This difference was predominantly driven by the difference in the prevalence of minor vascular complications. There were no adverse events associated with protamine use. Conclusions and Relevance: In the ACE-PROTAVI randomized clinical trial, routine administration of protamine increased the rate of hemostasis success and decreased TTH. The beneficial effect of protamine was reflected in a reduction in minor vascular complications, procedural time, and postprocedural hospital stay duration in patients receiving routine protamine compared with patients receiving placebo. Trial Registration: anzctr.org.au Identifier: ACTRN12621001261808.

Percutaneous coronary intervention with drug-eluting stents versus coronary bypass surgery for coronary artery disease: A Bayesian perspective.

OBJECTIVES: Coronary revascularization is frequently performed for coronary artery disease (CAD). This study aims to assess the totality of randomized evidence comparing percutaneous coronary intervention with drug-eluting stents (DES-PCI) with coronary artery bypass grafting (CABG) for CAD. METHODS: A systematic search was applied to 3 electronic databases, including randomized trials comparing DES-PCI with CABG for CAD with 5-year follow-up. A Bayesian hierarchical meta-analytic model was applied. The primary outcome was all-cause mortality at 5 years; secondary outcomes were stroke, myocardial infarction, and repeat revascularization. End points were reported in median relative risks (RRs) and absolute risk differences, with 95% credible intervals (CrIs). Kaplan-Meier curves were used to reconstruct individual patient data. RESULTS: Six studies comprising 8269 patients (DES-PCI, n = 4134; CABG, n = 4135) were included. All-cause mortality at 5 years was increased with DES-PCI (median RR, 1.23; 95% CrI, 1.01-1.45), with a median absolute risk difference of +2.3% (95% CrI, 0.1%-4.5%). For stroke, myocardial infarction, and repeat revascularization, the median RRs were 0.79 (95% CrI, 0.54-1.25), 1.84 (95% CrI, 1.23-2.75), and 1.80 (95% CrI, 1.51-2.16) for DES-PCI, respectively. In a sample of 1000 patients undergoing DES-PCI instead of CABG for CAD, a median of 23 additional deaths, 46 myocardial infarctions, and 85 repeat revascularizations occurred at 5 years, whereas 10 strokes were prevented. CONCLUSIONS: The current data suggest a clinically relevant benefit of CABG over DES-PCI at 5 years in terms of mortality, myocardial infarction, and repeat revascularization, despite an increased risk of stroke. These findings may guide the heart-team and the shared decision-making process.

The prognostic impact of unplanned invasive coronary angiography following coronary artery bypass grafting.

OBJECTIVES: Myocardial ischaemia following coronary artery bypass grafting (CABG) is a potentially devastating complication. Nevertheless, the incidence, aetiology and prognostic relevance of unplanned coronary angiography (uCAG) remain understudied. We aimed to investigate the prevalence and outcome of patients undergoing urgent, uCAG in the postoperative period following CABG. METHODS: We screened all patients undergoing isolated elective CABG in an academic referral centre between 2016 and 2021 and identified patients undergoing uCAG within 30 days of surgery. For uCAG patients, a distinction was made between patients undergoing re-revascularization (REV) and patients receiving conservative management (CON). The primary outcomes were 30-day mortality and unadjusted and adjusted long-term survival. Secondary outcomes were the indication for and prevalence of uCAG and urgent revascularization. RESULTS: Of the 1918 patients undergoing isolated CABG, 78 individuals needed uCAG (4.1%), of whom 45 underwent immediate revascularization (REV group; 2.3% overall, 57% within the uCAG group, median age 69.9 years) and 33 were treated conservatively (CONS group; 1.7% overall, 42% within the uCAG group, median age 69.1 years). Patients undergoing uCAG (n = 78) had a higher 30-day mortality than patients not undergoing uCAG (n = 1840, 30-day mortality: 9.0% vs 0.4%, P < 0.001). Long-term survival was significantly decreased in patients undergoing uCAG in both unadjusted (hazard ratio 2.20, 95% confidence interval 1.30-3.73) and EuroSCORE-, age- and sex-adjusted models (hazard ratio uCAG 2.03, 95% confidence interval 1.16-3.56). CONCLUSIONS: Unplanned postoperative coronary angiography is performed in 4.1% of isolated CABG procedures, and patients in need of such urgent invasive evaluation are subjected to decreased short- and long-term survival.

Benefit of isolated surgical valve repair or replacement for functional tricuspid regurgitation and long-term outcomes stratified by the TRI-SCORE.

BACKGROUND AND AIMS: Severe tricuspid regurgitation (TR) is associated with increased mortality rates, but benefit of its correction and ideal timing are not clearly determined. This study aimed to identify patient subsets who might benefit from surgery. METHODS: In TRIGISTRY, an international cohort study of consecutive patients with severe isolated functional TR (33 centers, 10 countries), survival rates up to 10 years were compared between patients who underwent isolated tricuspid valve (TV) surgery (repair or replacement) and those conservatively managed, overall and according to TRI-SCORE category (low: ≤3, intermediate: 4-5, high: ≥6). RESULTS: 1,217 were managed conservatively, and 551 underwent isolated TV surgery (200 repairs, 351 replacements). TRI-SCORE distribution was 33% low, 32% intermediate, and 35% high. At 10 years, survival rates were similar between surgical and conservative management (41% vs. 36%; hazard ratio [HR] 0.97; 95% confidence interval [CI] 0.88-1.08, P=0.57). Surgery improved survival compared to conservative management in the low TRI-SCORE category (72% vs. 44%; HR 0.27; 95% CI 0.20-0.37, P<0.0001), but not in the intermediate (36% vs. 37%, HR 1.17; 95%CI 0.98-1.40, P=0.09) or high categories (20% vs. 24%; HR 1.06; 95% CI 0.91-1.25, P=0.45). Both repair and replacement improved survival in the low TRI-SCORE category (84% and 61% vs. 44%; HR 0.11; 95% CI 0.06-0.19, P<0.0001, and HR 0.65; 95% CI 0.47-0.90, P=0.009). Repair showed benefit in the intermediate category (59% vs. 37%; HR 0.49; 95% CI 0.35-0.68, P<0.0001) while replacement was possibly harmful (25% vs. 37%; HR 1.43; 95% CI 1.18-1.72, P=0.0002). CONCLUSIONS: Higher survival rates were observed with repair than replacement and benefit of intervention declined as TRI-SCORE increased with no benefit of any type of surgery in the high TRI-SCORE category. These results emphasize the importance of timely intervention and patient selection to achieve the best outcomes and the need for randomized controlled trials. TRIAL REGISTRATION: TRIGISTRY: ClinicalTrials.gov, NCT05825898.

Modeling creatine-kinase MB concentrations following coronary artery bypass grafting.

BACKGROUND: An increase in cardiac biomarkers is a prerequisite for diagnosing periprocedural myocardial infarction (PMI) after coronary artery bypass grafting (CABG). Early-phase risk detection may be aided by modeling time-dependent serum creatine kinase-MB (CK-MB) concentrations. This study aimed to model the kinetics of CK-MB while identifying its influencing factors. METHODS: Patients who underwent elective CABG and had CK-MB measurements within 72 hours postoperatively were included. The primary outcome was the modeled post hoc kinetics of CK-MB in patients without potential PMI. These patients were defined as having no potential PMI based on the absence of ischemic electrocardiographic abnormalities, imaging abnormalities, in-hospital cardiac arrest, mortality, or postoperative unplanned catheterization. A web-based application was created using mixed-effect modeling to provide an interactive and individualized result. RESULTS: A total of 1589 CK-MB measurements from 635 patients who underwent elective isolated CABG were available for analysis. Of these, 609 patients (96%) had no potential PMI and 26 (4%) had potential PMI. Male sex, aortic cross-clamp time, and cardioplegia type significantly impacted CK-MB concentrations. The diagnostic accuracy of the model had an area under the receiver operating characteristic curve of 82.8% (95% confidence interval, 72.6%-90.2%). A threshold of 7 µg/L yielded a sensitivity of 94% and a specificity of 80% (positive predictive value, 17%; negative predictive value, 99%) for excluding potential PMI in our study population. CONCLUSIONS: CK-MB release after CABG depends on the timing of measurement, patient sex, aortic cross-clamp time, and cardioplegia type. The model (available at https://www.cardiomarker.com/ckmb) can be validated, reproduced, refined, and applied to other biomarkers.

Extracorporeal cardiopulmonary resuscitation versus standard treatment for refractory out-of-hospital cardiac arrest: a Bayesian meta-analysis.

BACKGROUND: The outcomes of several randomized trials on extracorporeal cardiopulmonary resuscitation (ECPR) in patients with refractory out-of-hospital cardiac arrest were examined using frequentist methods, resulting in a dichotomous interpretation of results based on p-values rather than in the probability of clinically relevant treatment effects. To determine such a probability of a clinically relevant ECPR-based treatment effect on neurological outcomes, the authors of these trials performed a Bayesian meta-analysis of the totality of randomized ECPR evidence. METHODS: A systematic search was applied to three electronic databases. Randomized trials that compared ECPR-based treatment with conventional CPR for refractory out-of-hospital cardiac arrest were included. The study was preregistered in INPLASY (INPLASY2023120060). The primary Bayesian hierarchical meta-analysis estimated the difference in 6-month neurologically favorable survival in patients with all rhythms, and a secondary analysis assessed this difference in patients with shockable rhythms (Bayesian hierarchical random-effects model). Primary Bayesian analyses were performed under vague priors. Outcomes were formulated as estimated median relative risks, mean absolute risk differences, and numbers needed to treat with corresponding 95% credible intervals (CrIs). The posterior probabilities of various clinically relevant absolute risk difference thresholds were estimated. RESULTS: Three randomized trials were included in the analysis (ECPR, n = 209 patients; conventional CPR, n = 211 patients). The estimated median relative risk of ECPR for 6-month neurologically favorable survival was 1.47 (95%CrI 0.73-3.32) with a mean absolute risk difference of 8.7% (- 5.0; 42.7%) in patients with all rhythms, and the median relative risk was 1.54 (95%CrI 0.79-3.71) with a mean absolute risk difference of 10.8% (95%CrI - 4.2; 73.9%) in patients with shockable rhythms. The posterior probabilities of an absolute risk difference > 0% and > 5% were 91.0% and 71.1% in patients with all rhythms and 92.4% and 75.8% in patients with shockable rhythms, respectively. CONCLUSION: The current Bayesian meta-analysis found a 71.1% and 75.8% posterior probability of a clinically relevant ECPR-based treatment effect on 6-month neurologically favorable survival in patients with all rhythms and shockable rhythms. These results must be interpreted within the context of the reported credible intervals and varying designs of the randomized trials. REGISTRATION: INPLASY (INPLASY2023120060, December 14th, 2023, https://doi.org/10.37766/inplasy2023.12.0060 ).

Sex-Specific Troponin and Creatine Kinase Thresholds After Coronary Bypass Surgery.

BACKGROUND: The impact of sex-differences on the release of cardiac biomarkers after coronary artery bypass grafting (CABG) remains unknown. The aim of our study was to (1) investigate the impact of sex-differences in cardiac biomarker release after CABG and (2) determine sex-specific thresholds for high-sensitivity cardiac troponin (hs-cTn) and creatine kinase-myocardial band (CK-MB) associated with 30-day major adverse cardiovascular events (MACE) and mortality. METHODS: A consecutive cohort of 3687 patients, comprising 643 women (17.4%) and 3044 men (82.6%), undergoing CABG from 2008 to 2021 in 2 tertiary university centers with serial postoperative cTn and CK-MB measurement was analyzed. The composite primary outcome was MACE at 30 days. Secondary end points were 30-day mortality and 5-year mortality and MACE. Sex-specific thresholds for cTn and CK-MB were determined. RESULTS: Lower levels of cTn were found in women after CABG (69.18 vs 77.57 times the upper reference limit [URL]; P < .001). The optimal threshold value for cTn was calculated at 94.36 times the URL for female patients and 206.07 times the URL for male patients to predict 30-day MACE. Female patients missed by a general threshold had increased risk for MACE or death within 30 days (cTn: MACE: odds ratio [OR], 3.78; 95% CI, 1.03-13.08; P = .035; death: OR, 4.98; 95% CI, 1.20-20.61; P = .027; CK-MB: MACE: OR, 10.04; 95% CI, 2.07-48.75; P < .001; death: OR 13.59; 95% CI, 2.66-69.47; P = .002). CONCLUSIONS: We provide evidence for sex-specific differences in the outcome and biomarker release after CABG. Sex-specific cutoffs are necessary for the diagnosis of perioperative myocardial injury to improve outcomes of women after CABG.

Favorable resuscitation characteristics in patients undergoing extracorporeal cardiopulmonary resuscitation: A secondary analysis of the INCEPTION-trial.

Introduction: Extracorporeal cardiopulmonary resuscitation (ECPR) is increasingly used as a supportive treatment for refractory out-of-hospital cardiac arrest (OHCA). Still, there is a paucity of data evaluating favorable and unfavorable prognostic characteristics in patients considered for ECPR. Methods: We performed a previously unplanned post-hoc analysis of the multicenter randomized controlled INCEPTION-trial. The study group consisted of patients receiving ECPR, irrespective of initial group randomization. The patients were divided into favorable survivors (cerebral performance category [CPC] 1-2) and unfavorable or non-survivors (CPC 3-5). Results: In the initial INCEPTION-trial, 134 patients were randomized. ECPR treatment was started in 46 (66%) of 70 patients in the ECPR treatment arm and 3 (4%) of 74 patients in the conventional treatment arm. No statistically significant differences in baseline characteristics, medical history, or causes of arrest were observed between survivors (n = 5) and non-survivors (n = 44). More patients in the surviving group had a shockable rhythm at the time of cannulation (60% vs. 14%, p = 0.037), underwent more defibrillation attempts (13 vs. 6, p = 0.002), and received higher dosages of amiodarone (450 mg vs 375 mg, p = 0.047) despite similar durations of resuscitation maneuvers. Furthermore, non-survivors more frequently had post-ECPR implantation adverse events. Conclusion: The persistence of ventricular arrhythmia is a favorable prognostic factor in patients with refractory OHCA undergoing an ECPR-based treatment. Future studies are warranted to confirm this finding and to establish additional prognostic factors.Clinical trial Registration:clinicaltrials.gov registration number NCT03101787.

One-year postprocedural quality of life following mitral valve surgery: data from The Netherlands heart registration.

OBJECTIVES: The aim of surgical treatment of mitral valve disease is to reverse heart failure and to restore life expectancy and quality of life (QoL). In mitral valve surgery, QoL has not been studied extensively, especially regarding the surgical approach. The current study aimed to evaluate QoL after mitral valve surgery through full sternotomy and a minimally invasive approach (MIMVS). METHODS: All patients undergoing mitral valve surgery between 2013-2018 through sternotomy or a MIMVS approach (right anterolateral mini-thoracotomy, sternal-sparing), with or without concomitant tricuspid valve surgery, surgical ablation, or atrial septal defect closure were eligible for inclusion in this multicentre nationwide registry in the Netherlands. Quality of life was measured using the 12- and 36-item short form surveys, before surgery and postoperatively at 1 year. Independent predictors for loss of QoL were evaluated. RESULTS: 485 patients were included (full sternotomy: n = 276, and MIMVS: n = 209). Overall, patients experienced a significant increase in physical component score (56 [42-75] vs 74 [57-88], p < 0.001) and mental component score at 1-year (63 [52-74] vs 70 [59-86], p < 0.001). Baseline QoL scores and new onset of atrial arrhythmia were independently associated with a clinically relevant reduction in physical and mental QoL. CONCLUSIONS: Mitral valve surgery is associated with significant improvement in physical and mental QoL. Baseline QoL scores and new onset of atrial arrhythmia are associated with a clinically relevant reduction in postoperative QoL.

Hybrid atrial fibrillation ablation.

In this state-of-the art review on hybrid atrial fibrillation (AF) ablation, we briefly focus on the pathophysiology of AF, the rationale for the hybrid approach, its technical aspects and the efficacy and safety outcomes after hybrid AF ablation, both from meta-analyses and randomized control trial data. Also, we performed a systematic search to provide a provisional overview of real-world hybrid AF ablation efficacy and safety outcomes. Furthermore, we give an insight into the 'Maastricht approach', an approach that allows us to tailor the ablation procedure to the individual patient. Finally, we reflect on future perspectives with the objective to continue improving our thoracoscopic hybrid AF ablation approach. Based on the review of the available literature, we believe it is fair to state that thoracoscopic hybrid AF ablation is a valid alternative to catheter ablation for the treatment of patients with more persistent forms of AF.

The impact of high versus standard enteral protein provision on functional recovery following intensive care admission: Protocol for a pre-planned secondary Bayesian analysis of the PRECISe trial.

BACKGROUND: The PRECISe trial is a pragmatic, multicenter randomized controlled trial that evaluates the effect of high versus standard enteral protein provision on functional recovery in adult, mechanically ventilated critically ill patients. The current protocol presents the rationale and analysis plan for an evaluation of the primary and secondary outcomes under the Bayesian framework, with an emphasis on clinically important effect sizes. METHODS: This protocol was drafted in agreement with the ROBUST-statement, and is submitted for publication before database lock and primary data analysis. The primary outcome is health-related quality of life as measured by the EQ-5D-5L health utility score and is longitudinally assessed. Secondary outcomes comprise the 6-min walking test and handgrip strength over the entire follow-up period (longitudinal analyses), and 60-day mortality, duration of mechanical ventilation, and EQ-5D-5L health utility scores at 30, 90 and 180 days (cross-sectional). All analyses will primarily be performed under weakly informative priors. When available, informative priors elicited from contemporary literature will also be incorporated under alternative scenarios. In all other cases, objectively formulated skeptical and enthusiastic priors will be defined to assess the robustness of our results. Relevant identified subgroups were: patients with acute kidney injury, severe multi-organ failure and patients with or without sepsis. Results will be presented as absolute risk differences, mean differences, and odds ratios, with accompanying 95% credible intervals. Posterior probabilities will be estimated for clinically important benefit and harm. DISCUSSION: The proposed secondary, pre-planned Bayesian analysis of the PRECISe trial will provide additional information on the effects of high protein on functional and clinical outcomes in critically ill patients, such as probabilistic interpretation, probabilities of clinically important effect sizes, and the integration of prior evidence. As such, it will complement the interpretation of the primary outcome as well as several secondary and subgroup analyses.

Early extracorporeal CPR for refractory out-of-hospital cardiac arrest - A pre-planned per-protocol analysis of the INCEPTION-trial.

BACKGROUND: Evidence for extracorporeal cardiopulmonary resuscitation (CPR) in refractory out-of-hospital cardiac arrest (OHCA) remains inconclusive. Recently, the INCEPTION-trial, comparing extracorporeal with conventional CPR, found no statistically significant difference in neurologically favorable survival. Since protocol deviations were anticipated, a pre-specified per-protocol analysis was foreseen. METHODS: The per-protocol analysis of the INCEPTION trial excluded patients not meeting inclusion or exclusion criteria, amongst which time-to-cannulation of >60 minutes, and achieving a return of spontaneous circulation before hospital arrival. Crossovers were excluded as well. The primary outcome (30-day survival in a neurologically favorable condition; cerebral performance category [CPC] 1-2) was primarily analyzed under a frequentist statistical framework. In addition, Bayesian analysis under a minimally informative prior was performed. RESULTS: Eighty-one patients were included in the per-protocol analysis (extracorporeal CPR n = 33, conventional CPR n = 48). Thirty-day survival with CPC1-2 was 15% in the extracorporeal CPR group versus 9% in the conventional CPR group (adjusted OR 1.9; 95% CI 0.4-9.3; p-value 0.393). Bayesian analysis showed an 84% posterior probability of any ECPR benefit and a 61% posterior probability of a 5% absolute risk reduction for the primary outcome. CONCLUSION: A pre-planned, pre-specified per-protocol analysis of the INCEPTION-trial, found a higher survival with favorable neurological in patients undergoing ECPR versus CCPR for refractory shockable OHCA. This difference did not reach statistical significance, but results should be interpreted with care, in the light of the small remaining sample size.

Extracorporeal life support in cardiac arrest: a post hoc Bayesian re-analysis of the INCEPTION trial.

AIMS: Previously, we performed the multicentre INCEPTION trial, randomizing patients with refractory out-of-hospital cardiac arrest (OHCA) to extracorporeal cardiopulmonary resuscitation (ECPR) or conventional cardiopulmonary resuscitation (CCPR). Frequentist analysis showed no statistically significant treatment effect for the primary outcome; 30-day survival with a favourable neurologic outcome (cerebral performance category score of 1-2). To facilitate a probabilistic interpretation of the results, we present a Bayesian re-analysis of the INCEPTION trial. METHODS AND RESULTS: We analysed survival with a favourable neurologic outcome at 30 days and 6 months under a minimally informative prior in the intention-to-treat population. Effect sizes are presented as absolute risk differences (ARDs) and relative risks (RRs), with 95% credible intervals (CrIs). We estimated posterior probabilities at various thresholds, including the minimal clinically important difference (MCID) (5% ARD), based on expert consensus, and performed sensitivity analyses under sceptical and literature-based priors. The mean ARD for 30-day survival with a favourable neurologic outcome was 3.6% (95% CrI -9.5-16.7%), favouring ECPR, with a median RR of 1.22 (95% CrI 0.59-2.51). The posterior probability of an MCID was 42% at 30 days and 42% at 6 months, in favour of ECPR. CONCLUSION: Bayesian re-analysis of the INCEPTION trial estimated a 42% probability of an MCID between ECPR and CCPR in refractory OHCA in terms of 30-day survival with a favourable neurologic outcome. TRIAL REGISTRATION: Clinicaltrials.gov (NCT03101787, registered 5 April 2017).

Stroke reduction by cerebral embolic protection devices in transcatheter aortic valve implantation: a systematic review and Bayesian meta-analysis.

OBJECTIVES: The use of cerebral embolic protection (CEP) during transcatheter aortic valve implantation (TAVI) has been studied in several randomised trials. We aimed to perform a systematic review and Bayesian meta-analysis of randomised CEP trials, focusing on a clinically relevant reduction in disabling stroke. METHODS: A systematic search was applied to three electronic databases, including trials that randomised TAVI patients to CEP versus standard treatment. The primary outcome was the risk of disabling stroke. Outcomes were presented as relative risk (RR), absolute risk differences (ARDs), numbers needed to treat (NNTs) and the 95% credible intervals (CrIs). The minimal clinically important difference was determined at 1.1% ARD, per expert consensus (NNT 91). The principal Bayesian meta-analysis was performed under a vague prior, and secondary analyses were performed under two informed literature-based priors. RESULTS: Seven randomised studies were included for meta-analysis (n=3996: CEP n=2126, control n=1870). Under a vague prior, the estimated median RR of CEP use for disabling stroke was 0.56 (95% CrI 0.28 to 1.19, derived ARD 0.56% and NNT 179, I2=0%). Although the estimated posterior probability of any benefit was 94.4%, the probability of a clinically relevant effect was 0-0.1% under the vague and informed literature-based priors. Results were robust across multiple sensitivity analyses. CONCLUSION: There is a high probability of a beneficial CEP treatment effect, but this is unlikely to be clinically relevant. These findings suggest that future trials should focus on identifying TAVI patients with an increased baseline risk of stroke, and on the development of new generation devices. PROSPERO REGISTRATION NUMBER: CRD42023407006.