The European Registry for Patients with Mechanical Circulatory Support of the European Association for Cardio-Thoracic Surgery: third report.

OBJECTIVES: In the third report of the European Registry for Patients with Mechanical Circulatory Support of the European Association for Cardio-Thoracic Surgery, outcomes of patients receiving mechanical circulatory support are reviewed in relation to implant era. METHODS: Procedures in adult patients (January 2011-June 2020) were included. Patients from centres with <60% follow-ups completed were excluded. Outcomes were stratified into 3 eras (2011-2013, 2014-2017 and 2018-2020). Adverse event rates (AERs) were calculated and stratified into early phase (<3 months) and late phase (>3 months). Risk factors for death were explored using univariable Cox regression with a stepwise time-varying hazard ratio (<3 vs >3 months). RESULTS: In total, 4834 procedures in 4486 individual patients (72 hospitals) were included, with a median follow-up of 1.1 (interquartile range: 0.3-2.6) years. The annual number of implants (range: 346-600) did not significantly change (P = 0.41). Both Interagency Registry for Mechanically Assisted Circulatory Support class (classes 4-7: 23, 25 and 33%; P < 0.001) and in-hospital deaths (18.5, 17.2 and 11.2; P < 0.001) decreased significantly between eras. Overall, mortality, transplants and the probability of weaning were 55, 25 and 2% at 5 years after the implant, respectively. Major infections were mainly noted early after the implant occurred (AER<3 months: 1.44 vs AER>3 months: 0.45). Bilirubin and creatinine levels were significant risk factors in the early phase but not in the late phase after the implant. CONCLUSIONS: In its 10 years of existence, EUROMACS has become a point of reference enabling benchmarking and outcome monitoring. Patient characteristics and outcomes changed between implant eras. In addition, both occurrence of outcomes and risk factor weights are time dependent.

Propensity score-based analysis of long-term follow-up in patients supported with durable centrifugal left ventricular assist devices: the EUROMACS analysis.

OBJECTIVES: The HeartWare HVAD (HW) and the HeartMate3 (HM3) are presently the most commonly used continuous-flow left ventricular assist devices worldwide. We compared the outcomes of patients supported with either of these 2 devices based on data from the EUROMACS (European Registry for Patients with Mechanical Circulatory Support). METHODS: A retrospective analysis of the survival and complications profile in propensity score-matched adult patients enrolled in the EUROMACS between 01 January 2016 and 01 September 2020 and supported with either an HW or HM3. Matching included demographic parameters, severity of cardiogenic shock and risk-modifying end-organ parameters that impact long-term survival. Survival on device and major postoperative adverse events were analysed. RESULTS: Following 1:1 propensity score matching, each group consisted of 361 patients. Patients were well balanced (<0.1 standardized mean difference). The median follow-up was similar in both groups [396 (interquartile range (IQR) 112-771) days for HW and 376 (IQR 100-816) days for HM3]. The 2-year survival was similar in both groups [HW: 61% 95% confidence interval (CI) (56-67%) vs HM3: 68% 95% CI (63-73%) (stratified hazard ratio for mortality: 1.13 95% CI (0.83-1.54), P = 0.435].The cumulative incidence for combined major adverse events and unexpected readmissions was similar in both groups [subdistribution hazard ratio (SHR) 1.0 (0.84-1.21), P = 0.96]. Patients in the HW group demonstrated a higher risk of device malfunction [SHR 2.44 (1.45-3.71), P < 0.001], neurological dysfunction [SHR 1.29 (1.02-1.61), P = 0.032] and intracranial bleeding [SHR 1.76 (1.13-2.70), P = 0.012]. CONCLUSIONS: Mid-term survival in both groups was similar in a propensity-matched analysis. The risk of device malfunction, neurological dysfunction and intracranial bleeding was significantly higher in HW patients.

Combined epicardial and endocardial ablation for atrial fibrillation: Best practices and guide to hybrid convergent procedures.

The absence of strategies to consistently and effectively address nonparoxysmal atrial fibrillation by nonpharmacological interventions has represented a long-standing treatment gap. A combined epicardial/endocardial ablation strategy, the hybrid Convergent procedure, was developed in response to this clinical need. A subxiphoid incision is used to access the pericardial space facilitating an epicardial ablation directed at isolation of the posterior wall of the left atrium. This is followed by an endocardial ablation to complete isolation of the pulmonary veins and for additional ablation as needed. Experience gained with the hybrid Convergent procedure during the last decade has led to the development and adoption of strategies to optimize the technique and mitigate risks. Additionally, a surgical and electrophysiology "team" approach including comprehensive training is believed critical to successfully develop the hybrid Convergent program. A recently completed randomized clinical trial indicated that this ablation strategy is superior to an endocardial-only approach for patients with persistent atrial fibrillation. In this review, we propose and describe best practice guidelines for hybrid Convergent ablation on the basis of a combination of published data, author consensus, and expert opinion. A summary of clinical outcomes, emerging evidence, and future perspectives is also given.

Simplified, less-invasive left ventricular assist device implantation in patients with post-coronary artery bypass grafting.

Less-invasive left ventricular assist device implantation is becoming the technique of choice for implementation of new-generation heart pumps. The less-invasive technique is particularly useful for patients with a history of cardiac surgical procedures, such as coronary artery bypass grafting. Yet, in redo cases, severe pericardial adhesions may force experienced operators to opt for alternative outflow graft placement, such as in the descending aorta. We propose a surgical technique in which the left ventricular device is implanted through a limited thoracic incision, with the outflow graft anastomosed to the ascending aorta, avoiding collision with coronary bypass grafts. The key element of the proposed technique is a tunnel connecting 2 pleural cavities, in which the outflow graft is placed, entirely bypassing the pericardium.

The SAVI-TF Registry: 1-Year Outcomes of the European Post-Market Registry Using the ACURATE neo Transcatheter Heart Valve Under Real-World Conditions in 1,000 Patients.

OBJECTIVES: The SAVI-TF (Symetis ACURATE neo Valve Implantation Using Transfemoral Access) registry was initiated to study the ACURATE neo transcatheter heart valve in a large patient population treated under real-world conditions. BACKGROUND: The self-expanding, supra-annular ACURATE neo prosthesis is a transcatheter heart valve that gained the Conformité Européene mark in 2014, but only limited clinical data are available so far. METHODS: This prospective, multicenter registry enrolled 1,000 patients at 25 European centers who were followed for 1 year post-procedure. RESULTS: Mean patient age was 81.1 ± 5.2 years; mean logistic European System for Cardiac Operative Risk Evaluation I score, European System for Cardiac Operative Risk Evaluation II score, and Society of Thoracic Surgeons score were 18.1 ± 12.5%, 6.6 ± 7.5%, and 6.0 ± 5.6%, respectively. At 1 year, 8.0% (95% confidence interval [CI]: 6.3% to 9.7%) of patients had died, 2.3% (95% CI: 1.3% to 3.2%) had disabling strokes, and 9.9% (95% CI: 8.1% to 11.8%) had permanent pacemaker implantations. Through 1 year, 5 reinterventions (0.5%; 95% CI: 0.1% to 1.0%) were performed: 3 valve-in-valve and 2 surgical aortic valve replacements. Mean effective orifice area was 1.84 ± 0.43 cm2, mean gradient was 7.3 ± 3.7 mm Hg, and greater than mild paravalvular leakage was observed in 3.6% of patients. CONCLUSIONS: Transfemoral implantation of the ACURATE neo prosthesis resulted in favorable 1-year clinical and echocardiographic outcomes with very low mortality and new pacemaker rates.

Hybrid Coronary Revascularization in Selected Patients With Multivessel Disease: 5-Year Clinical Outcomes of the Prospective Randomized Pilot Study.

OBJECTIVES: This study aimed to investigate the 5-year clinical follow-up of the HYBRID (Hybrid Revascularization for Multivessel Coronary Artery Disease) trial. BACKGROUND: The HYBRID trial, the only randomized study involving thorough analysis of outcome after the 2 procedures, suggested that hybrid coronary revascularization (HCR) is feasible in selected patients with multivessel coronary disease referred for conventional coronary artery bypass grafting (CABG). There are currently no long-term outcome data from randomized trials in this setting. METHODS: A total of 200 patients with multivessel coronary disease referred for conventional surgical revascularization were randomly assigned to undergo HCR or CABG. The primary endpoint was the occurrence of all-cause mortality at 5 years. RESULTS: Nine patients (4 in HCR and 5 in CABG group) were lost to the 5-year follow-up. Finally, 191 patients (94 in HCR and 97 in CABG group) formed the basis of this study. The groups were well balanced in terms of pre-procedural characteristics. All-cause mortality at 5-year follow-up was similar in the 2 groups (6.4% for HCR vs. 9.2% for CABG; p = 0.69). The rates of myocardial infarction (4.3% vs. 7.2%; p = 0.30), repeat revascularization (37.2% vs. 45.4%; p = 0.38), stroke (2.1% vs. 4.1%; p = 0.35), and major adverse cardiac and cerebrovascular events (45.2% vs. 53.4%; p = 0.39) were also similar in the 2 groups. CONCLUSIONS: HCR has similar 5-year all-cause mortality when compared with conventional coronary bypass grafting (Safety and Efficacy Study of Hybrid Revascularization in Multivessel Coronary Artery Disease; NCT01035567).

Real-world experience using the ACURATE neo prosthesis: 30-day outcomes of 1,000 patients enrolled in the SAVI TF registry.

AIMS: The aim of the SAVI TF registry was to assess the safety and performance of the self-expanding ACURATE neo transfemoral transcatheter heart valve in a large patient population with severe aortic stenosis and to investigate whether the outcomes obtained in the CE-mark cohort can be replicated in an unselected all-comers population. METHODS AND RESULTS: From October 2014 until April 2016, 1,000 patients were enrolled in this prospective, European multicentre registry. Patients were 81.1±5.2 years and had a logistic EuroSCORE II and STS score of 6.6±7.5% and 6.0±5.6%, respectively. Predilatation was performed in 96.1% of patients and postdilatation in 44.8%. Procedural and device success were both obtained in 98.7%; failure comprised nine valve-in-valve procedures, three conversions to surgery, and one aborted procedure. The primary endpoint was 30-day mortality, which was observed in 14 patients (1.4% [95% CI: 0.7-2.1]). Disabling stroke was seen in 1.2% (95% CI: 0.5-1.9) and new pacemaker implantation in 8.3% (95% CI: 6.6-10.0). At discharge, mean effective orifice area was 1.77±0.46 cm² and mean gradient 8.4±4.0 mmHg; 4.1% of patients had a more than mild paravalvular leak. CONCLUSIONS: In this initial experience, treatment with the ACURATE neo prosthesis resulted in good clinical outcomes with very low complication rates.

Hybrid revascularization for multivessel coronary artery disease.

OBJECTIVES: The aim of this study was to assess the feasibility of hybrid coronary revascularization (HCR) in patients with multivessel coronary artery disease (MVCAD) referred for standard coronary artery bypass grafting (CABG). BACKGROUND: Conventional CABG is still the treatment of choice in patients with MVCAD. However, the limitations of standard CABG and the unsatisfactory long-term patency of saphenous grafts are commonly known. METHODS: A total of 200 patients with MVCAD involving the left anterior descending artery (LAD) and a critical (>70%) lesion in at least 1 major epicardial vessel (except the LAD) amenable to both PCI and CABG and referred for conventional surgical revascularization were randomly assigned to undergo HCR or CABG (in a 1:1 ratio). The primary endpoint was the evaluation of the safety of HCR. The feasibility was defined by the percent of patients with a complete HCR procedure and the percent of patients with conversions to standard CABG. The occurrence of major adverse cardiac events such as death, myocardial infarction, stroke, repeated revascularization, and major bleeding within the 12-month period after randomization was also assessed. RESULTS: Most of the pre-procedural characteristics were similar in the 2 groups. Of the patients in the hybrid group, 93.9% had complete HCR and 6.1% patients were converted to standard CABG. At 12 months, the rates of death (2.0% vs. 2.9 %, p = NS), myocardial infarction (6.1% vs. 3.9%, p = NS), major bleeding (2% vs. 2%, p = NS), and repeat revascularization (2% vs. 0%, p = NS) were similar in the 2 groups. In both groups, no cerebrovascular incidents were observed. CONCLUSIONS: HCR is feasible in select patients with MVCAD referred for conventional CABG. (Safety and Efficacy Study of Hybrid Revascularization in Multivessel Coronary Artery Disease [POL-MIDES]; NCT01035567).

European experience of the convergent atrial fibrillation procedure: multicenter outcomes in consecutive patients.

BACKGROUND: The objective of this collaborative, multicenter, European effort was to evaluate the outcomes of the convergent procedure for the treatment of persistent and long-standing persistent atrial fibrillation (AF) in consecutive patients at 4 European centers. METHODS: Outcomes of consecutive patients, undergoing the convergent procedure at 4 European centers, were evaluated in this study. Epicardial ablation was performed before endocardial ablation. Convergent procedure outcomes were recorded by interrogation of implanted loop recorders or Holter monitors. Rhythm status and required interventions (antiarrhythmic drugs, cardioversions, and repeat ablations) were quantified 6 and 12 months after the procedure. Outcomes, monitoring type, and patient baseline characteristics were analyzed and reported. RESULTS: Seventy-three consecutive patients presenting with persistent AF (30.1%) or long-standing persistent AF (69.9%) underwent the convergent procedure between January 2010 and December 2011. At 6 months, 82% (56/68) were in sinus rhythm. At 12 months, 80% (53/66) were in sinus rhythm; single-procedure maintenance of sinus rhythm without postblanking period interventions was 76% (50/66); 52% (34/66) were in sinus rhythm and not receiving antiarrhythmic drugs. CONCLUSIONS: This multicenter European collaborative effort demonstrated that the convergent procedure is a safe and efficacious treatment option for persistent and long-standing persistent AF.

Minimally invasive surgery for atrial fibrillation.

Atrial fibrillation (AF) remains the most common cardiac arrhythmia, affecting nearly 2% of the general population worldwide. Minimally invasive surgical ablation remains one of the most dynamically evolving fields of modern cardiac surgery. While there are more than a dozen issues driving this development, two seem to play the most important role: first, there is lack of evidence supporting percutaneous catheter based approach to treat patients with persistent and long-standing persistent AF. Paucity of this data offers surgical community unparalleled opportunity to challenge guidelines and change indications for surgical intervention. Large, multicenter prospective clinical studies are therefore of utmost importance, as well as honest, clear data reporting. Second, a collaborative methodology started a long-awaited debate on a Heart Team approach to AF, similar to the debate on coronary artery disease and transcatheter valves. Appropriate patient selection and tailored treatment options will most certainly result in better outcomes and patient satisfaction, coupled with appropriate use of always-limited institutional resources. The aim of this review, unlike other reviews of minimally invasive surgical ablation, is to present medical professionals with two distinctly different, approaches. The first one is purely surgical, Standalone surgical isolation of the pulmonary veins using bipolar energy source with concomitant amputation of the left atrial appendage-a method of choice in one of the most important clinical trials on AF-The Atrial Fibrillation Catheter Ablation Versus Surgical Ablation Treatment (FAST) Trial. The second one represents the most complex approach to this problem: a multidisciplinary, combined effort of a cardiac surgeon and electrophysiologist. The Convergent Procedure, which includes both endocardial and epicardial unipolar ablation bonds together minimally invasive endoscopic surgery with electroanatomical mapping, to deliver best of the two worlds. One goal remains: to help those in urgent need for everlasting relief.

Surgical treatment of left main disease and severe carotid stenosis: does the off-pump technique provide a better outcome?

OBJECTIVES: Left main disease (LMD), combined with carotid artery stenosis (CAS), constitutes a high-risk patient population. Priority is often given to coronary revascularization, due to the severity of the angina. However, the choice of revascularization strategy [off-pump coronary artery bypass (OPCAB) vs coronary artery bypass grafting (CABG)] remains elusive. METHODS: A total of 1340 patients with LMD were non-randomly assigned to either on-pump (CABG group, n = 680) or off-pump (OPCAB group, n = 634) revascularization between 1 January 2006 and 21 September 2010. Multivariable regression was used to determine the risk-adjusted impact of a revascularization strategy on a composite in-hospital outcome (MACCE), and proportional hazards regression was used to define the variables affecting long-term survival. RESULTS: Significant CAS was found in 130 patients: 84 (13.1%) patients underwent OPCAB, while 46 patients (6.8%) underwent CABG (P < 0.05). Patients with a history of stroke/transient ischaemic attack were also more likely to receive OPCAB (7.1 vs 4.7%; P = 0.08). OPCAB patients were older, in a higher New York Heart Association (NYHA) class, with a lower LVEF and higher EuroSCORE. A calcified aorta was found in 79 patients [OPCAB-CABG: 49 (7.73%) vs 30 (4.41%); P = 0.016] and resulted in a less complex revascularization (OPCAB-CABG: 2.3 ± 0.71 vs 3.19 ± 0.82; P < 0.05), and 30-day mortality was insignificantly higher in the CABG (2.7 vs 2.8%) as well as MACCE (11.2 vs 12.2%; P = NS). This trend reversed when late mortality was evaluated; however, it did not reach significance at 60 months. Preoperative renal impairment requiring dialysis was found to be a technique-independent predictor of MACCE. The number of arterial conduits also influenced MACCE. CONCLUSIONS: Off-pump coronary revascularization may offer risk reduction of neurological complications in patients with a significant carotid artery disease and a history of previous stroke, but a larger study population is needed to support this thesis. The growing discrepancy in long-term survival should draw attention to a more complete revascularization in OPCAB patients.

Progenitor cells from the explanted heart generate immunocompatible myocardium within the transplanted donor heart.

RATIONALE: Chronic rejection, accelerated coronary atherosclerosis, myocardial infarction, and ischemic heart failure determine the unfavorable evolution of the transplanted heart in humans. OBJECTIVE: Here we tested whether the pathological manifestations of the transplanted heart can be corrected partly by a strategy that implements the use of cardiac progenitor cells from the recipient to repopulate the donor heart with immunocompatible cardiomyocytes and coronary vessels. METHODS AND RESULTS: A large number of cardiomyocytes and coronary vessels were created in a rather short period of time from the delivery, engraftment, and differentiation of cardiac progenitor cells from the recipient. A proportion of newly formed cardiomyocytes acquired adult characteristics and was integrated structurally and functionally within the transplant. Similarly, the regenerated arteries, arterioles, and capillaries were operative and contributed to the oxygenation of the chimeric myocardium. Attenuation in the extent of acute damage by repopulating cardiomyocytes and vessels decreased significantly the magnitude of myocardial scarring preserving partly the integrity of the donor heart. CONCLUSIONS: Our data suggest that tissue regeneration by differentiation of recipient cardiac progenitor cells restored a significant portion of the rejected donor myocardium. Ultimately, immunosuppressive therapy may be only partially required improving quality of life and lifespan of patients with cardiac transplantation.