Conventional versus minimally invasive extra-corporeal circulation in patients undergoing cardiac surgery: A randomized controlled trial (COMICS).

INTRODUCTION: The trial hypothesized that minimally invasive extra-corporeal circulation (MiECC) reduces the risk of serious adverse events (SAEs) after cardiac surgery operations requiring extra-corporeal circulation without circulatory arrest. METHODS: This is a multicentre, international randomized controlled trial across fourteen cardiac surgery centres including patients aged ≥18 and <85 years undergoing elective or urgent isolated coronary artery bypass grafting (CABG), isolated aortic valve replacement (AVR) surgery, or CABG + AVR surgery. Participants were randomized to MiECC or conventional extra-corporeal circulation (CECC), stratified by centre and operation. The primary outcome was a composite of 12 post-operative SAEs up to 30 days after surgery, the risk of which MiECC was hypothesized to reduce. Secondary outcomes comprised: other SAEs; all-cause mortality; transfusion of blood products; time to discharge from intensive care and hospital; health-related quality-of-life. Analyses were performed on a modified intention-to-treat basis. RESULTS: The trial terminated early due to the COVID-19 pandemic; 1071 participants (896 isolated CABG, 97 isolated AVR, 69 CABG + AVR) with median age 66 years and median EuroSCORE II 1.24 were randomized (535 to MiECC, 536 to CECC). Twenty-six participants withdrew after randomization, 22 before and four after intervention. Fifty of 517 (9.7%) randomized to MiECC and 69/522 (13.2%) randomized to CECC group experienced the primary outcome (risk ratio = 0.732, 95% confidence interval (95% CI) = 0.556 to 0.962, p = 0.025). The risk of any SAE not contributing to the primary outcome was similarly reduced (risk ratio = 0.791, 95% CI 0.530 to 1.179, p = 0.250). CONCLUSIONS: MiECC reduces the relative risk of primary outcome events by about 25%. The risk of other SAEs was similarly reduced. Because the trial terminated early without achieving the target sample size, these potential benefits of MiECC are uncertain.

Individualized heparin monitoring and management reduces protamine requirements in cardiac surgery on minimal invasive extracorporeal circulation; A prospective randomized study.

INTRODUCTION: Individualized heparin and protamine management is increasingly used as a strategy to reduce coagulation activation and bleeding complications. While it is associated with increased heparin requirements during Cardiopulmonary Bypass (CPB), the impact on protamine administration remains controversial. We aim to investigate the effect of heparin level-guided monitoring on protamine dosing during cardiac surgery where low-anticoagulation protocols are implemented. METHODS: This is a prospective, randomized, controlled trial. A total of 132 patients undergoing elective full-spectrum cardiac surgery with Minimal Invasive Extracorporeal Circulation (MiECC) were recruited. All patients were managed by the same anaesthetic, surgical and perfusion team. Patients were randomly allocated in two groups; the individualized heparin-protamine titration (IHPT) group and the conventional heparinization and reversal group by using ACT (cACT) with a 0.75:1, protamine: heparin ratio. Titration was accomplished with the Hepcon HMS Plus (Medtronic, Minneapolis, MN) system. The primary outcome of the study was the total protamine dose used. Secondary outcomes comprised of the total heparin dose, the percentage of patients achieving target ACT, 24-h transfusion requirements, postoperative bleeding, duration of mechanical ventilation, major morbidity and length of hospital stay. Patients in each group were divided in two subgroups according to the target ACT; those operated for coronary artery bypass grafting (CABG) using a target ACT >300 s and the rest (non-CABG) patients operated with a target ACT >400 s, respectively. RESULTS: Protamine requirements were significantly reduced when IHPT was implemented; CABG (118 ± 24 mg vs 163 ± 61 mg; p < 0.001) and non-CABG cases (151 ± 46 mg vs 197 ± 45 mg; p < 0.001). Moreover, heparin requirements were significantly higher in the non-CABG subgroup managed with IHPT (34,539 ± 7658 IU vs 29,893 ± 9037 IU; p = 0.02). In overall, no significant differences were detected with respect to postoperative bleeding, transfusion of RBC or other blood products. CONCLUSIONS: Individualized heparin monitoring and management reduces protamine requirements in cardiac surgery with MiECC implementing reduced anticoagulation strategy. TRIAL REGISTRATION: clinicaltrials.gov; NCT04215588.

2021 MiECTiS focused update on the 2016 position paper for the use of minimal invasive extracorporeal circulation in cardiac surgery.

The landmark 2016 Minimal Invasive Extracorporeal Technologies International Society (MiECTiS) position paper promoted the creation of a common language between cardiac surgeons, anesthesiologists and perfusionists which led to the development of a stable framework that paved the way for the advancement of minimal invasive perfusion and related technologies. The current expert consensus document offers an update in areas for which new evidence has emerged. In the light of published literature, modular minimal invasive extracorporeal circulation (MiECC) has been established as a safe and effective perfusion technique that increases biocompatibility and ultimately ensures perfusion safety in all adult cardiac surgical procedures, including re-operations, aortic arch and emergency surgery. Moreover, it was recognized that incorporation of MiECC strategies advances minimal invasive cardiac surgery (MICS) by combining reduced surgical trauma with minimal physiologic derangements. Minimal Invasive Extracorporeal Technologies International Society considers MiECC as a physiologically-based multidisciplinary strategy for performing cardiac surgery that is associated with significant evidence-based clinical benefit that has accrued over the years. Widespread adoption of this technology is thus strongly advocated to obtain additional healthcare benefit while advancing patient care.

Modular minimally invasive extracorporeal circulation ensures perfusion safety and technical feasibility in cardiac surgery; a systematic review of the literature.

INTRODUCTION: Despite extensive evidence that shows clinical of superiority of MiECC, worldwide penetration remains low due to concerns regarding air handling and volume management in the context of a closed system. The purpose of this study is to thoroughly investigate perfusion safety and technical feasibility of performing all cardiac surgical procedures with modular (hybrid) MiECC, as experienced from the perfusionist's perspective. METHODS: We retrospectively reviewed perfusion charts of consecutive adult patients undergoing all types of elective, urgent, and emergency cardiac surgery under modular MiECC. The primary outcome measure was perfusion safety and technical feasibility, as evidenced in the need for conversion from a closed to an open circuit. A systematic review of the literature was conducted aiming to ultimately clarify whether there are any safety issues regarding MiECC technology. RESULTS: We challenged modular MiECC use in a series of 403 consecutive patients of whom a significant proportion (111/403; 28%) underwent complex surgery including reoperations (4%), emergency repair of acute type A aortic dissection and composite aortic surgery (1.7%). Technical success rate was 100%. Conversion to an open circuit was required in 18/396 patients (4.5%), excluding procedures performed under circulatory arrest. Open configuration accounted for 40% ± 21% of total procedural perfusion time and was related to significant hemodilution and increase in peak lactate levels. Systematic review revealed that safety of the procedure challenged originated from a single report, while no clinical adverse event related to MiECC was identified. CONCLUSIONS: Use of modular MiECC secures safety and ensures technical feasibility in all cardiac surgical procedures. It represents a type III active closed system, while its stand-by component is reserved for a small (<5%) proportion of procedures and for a partial procedural time. Thus, it eliminates any safety concern regarding air handling and volume management, while it overcomes any unexpected intraoperative scenario.

Minimal invasive extracorporeal circulation preserves coagulation integrity.

INTRODUCTION: Coagulopathy after cardiac surgery is a serious multifactorial complication that results in postoperative bleeding requiring transfusion of red blood cells and procoagulant products. Use of cardiopulmonary bypass represents the major contributing factor affecting coagulation. We sought to prospectively investigate the effect of contemporary minimal invasive extracorporeal circulation (MiECC) on coagulation parameters using point-of-care (POC) rotational thromboelastometry and the relation to postoperative bleeding. METHODS: Patients undergoing elective cardiac surgery on MiECC were prospectively recruited. Anticoagulation strategy was based on individualized heparin management and heparin level-guided protamine titration. Rotational thromboelastometry testing was performed before induction of anesthesia and after aortic cross-clamp release. A strict POC-guided transfusion protocol was implemented. The primary endpoint was the assessment of viscoelastic properties of the coagulating blood at the end of surgery compared to preoperative values and the relation to postoperative bleeding and 24-hour transfusion requirements. RESULTS: Fifty patients were included in the study with a significant proportion having complex surgery. Thirteen patients (26%) required blood transfusion (mean rate: 0.5 ± 1 units per patient), 5/50 (10%) received coagulation factors while no patient received fresh frozen plasma, platelets or fibrinogen. Thromboelastometry analysis showed that the major derangement was CT EXTEM > 100 seconds in 28/50 (56%) and A10 EXTEM < 40 mm in one (2%) patient without clinical significance. Platelet function was preserved throughout surgery. A10-FIBTEM was found predictive of postoperative bleeding at 12 hours. CONCLUSIONS: MiECC preserves clot quality throughout surgery acting in both key determinants of clot strength; fibrinogen and platelets. This is clinically translated into minimal postoperative bleeding and restricted use of blood products and coagulation factors.

Influence of age on resistance to distraction after tracheal anastomoses in dogs: An ex vivo study.

OBJECTIVE: To determine the influence of age on the ability of tracheal anastomoses to sustain distraction in dogs. STUDY DESIGN: Ex vivo study. SAMPLE POPULATION: Cadaveric canine tracheae (n = 16). METHODS: Tracheae were harvested from the cadavers of 8 immature and 8 adult dogs. Each trachea underwent end-to-end annular ligament anastomosis with a simple continuous pattern with 2-0 polypropylene on a taper cut needle. The constructs were tested to failure in distraction, with a tensiometer set at a drop head speed of 50 mm/min, as determined by preliminary testing. Failure was defined by tissue pullthrough or suture material failure. The force and elongation at failure were compared between age groups. RESULTS: The median age was 5.5 months (4-7.5 months) in immature dogs and 8.25 years in adult dogs (2-18 years) Tracheal anastomoses failed at lower forces (44.91 ± 59.03 N) but sustained more elongation (39.75 ± 5.45%) in immature dogs than in adult dogs (149.31 ± 45.36 N, P = .007 and 30.57 ± 7.19%, P = .0012, respectively). Tissue apposition was not achieved in 4 specimens each in immature and adult dogs, respectively. CONCLUSIONS: The technique used for tracheal anastomoses in this study failed at lower loads but sustained more elongation when performed in immature dogs. CLINICAL SIGNIFICANCE: Immature dogs may be able to withstand longer tracheal resection than adult dogs but reinforcement techniques seem mandatory to improve resistance to tension. Alternative anastomosis techniques should be considered to improve tissue apposition.

Minimal invasive extracorporeal circulation preserves platelet function after cardiac surgery: a prospective observational study.

INTRODUCTION: Cardiac surgery on conventional cardiopulmonary bypass induces a combination of thrombocytopenia and platelet dysfunction which is strongly related to postoperative bleeding. Minimal invasive extracorporeal circulation has been shown to preserve coagulation integrity, though effect on platelet function remains unclear. We aimed to prospectively investigate perioperative platelet function in a series of patients undergoing cardiac surgery on minimal invasive extracorporeal circulation using point-of-care testing. METHODS: A total of 57 patients undergoing elective cardiac surgery on minimal invasive extracorporeal circulation were prospectively recruited. Anticoagulation strategy was based on individualized heparin management and heparin level-guided protamine titration performed in all patients with a specialized point-of-care device (Hemostasis Management System - HMS Plus; Medtronic, Minneapolis, MN, USA). Platelet function was evaluated with impedance aggregometry using the ROTEM platelet (TEM International GmbH, Munich, Germany). ADPtest and TRAPtest values were assessed before surgery and after cardiopulmonary bypass. RESULTS: ADPtest value was preserved during surgery on minimal invasive extracorporeal circulation (58.2 ± 20 U vs. 53.6 ± 21 U; p = 0.1), while TRAPtest was found significantly increased (90 ± 27 U vs. 103 ± 38 U; p = 0.03). Postoperative ADPtest and TRAPtest values were inversely related to postoperative bleeding (correlation coefficient: -0.29; p = 0.03 for ADPtest and correlation coefficient: -0.28; p = 0.04 for TRAPtest). The preoperative use of P2Y12 inhibitors was identified as the only independent predictor of a low postoperative ADPtest value (OR = 15.3; p = 0.02). CONCLUSION: Cardiac surgery on minimal invasive extracorporeal circulation is a platelet preservation strategy, which contributes to the beneficial effect of minimal invasive extracorporeal circulation in coagulation integrity.

Iatrogenic Lutembacher Syndrome after Percutaneous Mitral Commissurotomy.

Atrial septal defects (ASDs) are common immediately after percutaneous mitral commissurotomy (PMC). They are usually small, hemodynamically insignificant, and tend to decrease or disappear within 6 to 12 months. Herein, a case is described of persistent ASD in a patient with mitral valve stenosis who had undergone successful PMC three years previously. The patient had signs and symptoms of right heart failure and severe tricuspid regurgitation (TR) with borderline right ventricular systolic function on echocardiography, in addition to the ASD. Cardiac magnetic resonance (CMR) imaging played a significant role in decision-making by clarifying the anatomy of the ASD and severity of the shunt, measuring right ventricular systolic function, and providing absolute quantification for TR. The right ventricular systolic function was normal on CMR, rendering the patient suitable for surgical treatment. Persistent iatrogenic ASDs have become an increasingly common finding after invasive procedures requiring trans-septal puncture and the manipulation of catheters. Multimodality imaging can provide significant aid in the management of patients with valvular heart disease complicated by iatrogenic shunts.

Quantification of Operational Learning in Minimal Invasive Extracorporeal Circulation.

Minimal invasive extracorporeal circulation (MiECC) has initiated important new efforts within science and technology towards a more physiologic perfusion. In this study, we aim to investigate the learning curve of our center regarding MiECC. We studied a series of 150 consecutive patients who underwent elective coronary artery bypass grafting by the same surgical team during the initial phase of MiECC application. Patients were randomly assigned into two groups. Group A (n = 75) included patients operated on MiECC, while group B (n = 75) included patients operated with conventional cardiopulmonary bypass (cCPB). The primary end-point of the study was to identify whether there is a learning curve when operating on MiECC. The following parameters were unrelated with increasing experience, even though the results favored MiECC use: reduced CPB duration (102.9 ± 25 vs. 122.2 ± 33 min, P <0.001), peak troponin release (0.07 ± 0.02 vs. 0.1 ± 0.04 ng/mL, P < 0.01), peak creatinine levels (0.97 ± 0.24 vs. 1.2 ± 0.3 mg/dL, P < 0.001), duration of mechanical ventilation (14.1 ± 7.2 vs. 36.9 ± 59.8 h, P < 0.01) and ICU stay (2.1 ± 0.7 vs. 4.4 ± 6.4 days, P < 0.01). However, need for intraoperative blood transfusion showed a trend towards a gradual decrease as experience with MiECC system was accumulating (R2 = 0.094, P = 0.007). Subsequently, operational learning applied to postoperative hematocrit and hemoglobin levels (R2 = 0.098, P = 0.006). We identified that advantages of MiECC technology in terms of reduced hemodilution and improved end-organ protection and clinical outcome are evident from the first patient. Optimal results are obtained with 50 cases; this refers mainly to significant reduction in the need for intraoperative blood transfusion. Teamwork from surgeons, anesthesiologists, and perfusionists is of paramount importance in order to maximize the clinical benefits from this technology.

A multidisciplinary perioperative strategy for attaining "more physiologic" cardiac surgery.

BACKGROUND: Cardiac surgery is, by definition, a "non-physiologic" intervention associated with systemic adverse effects. Despite advances in surgical technique, cardiopulmonary bypass (CPB) technology as well as anaesthesia management and patient care, there is still significant morbidity and subsequent mortality. AIM: We consider that the contemporary demand for further improving patient outcome mandates the upgrade from optimal perfusion during the procedure as the gold standard to the concept of a "more physiologic" cardiac surgery. Our policy is a multidisciplinary perioperative strategy based on goal-directed perfusion throughout surgery incorporating in-line monitoring. This translates to "prevent rather than correct" malperfusion through real-time adjustment rather than correction of derangement detected late by incremental evaluation. METHOD: The strategy is based on continuous monitoring of cardiac index, SvO2, DO2i, DO2i/VCO2i and rSO2. Data acquisition is followed by action when needed; this includes stepwise: transfusion, increase of cardiac output and initiation of inotropic/vasoactive support. Moreover, implementation of minimally invasive extracorporeal circulation (MiECC) is considered as a fundamental component of physiologic perfusion when on-CPB, providing improved circulatory support and end-organ protection. CONCLUSION: We consider that, with this strategy which establishes optimal perfusion perioperatively, we attain the goal of a "more physiologic" cardiac surgery.

Treatment of infected thoracic aortic prosthetic grafts with the in situ preservation strategy: a review of its history, surgical technique, and results.

For cardiothoracic surgeons prosthetic graft infection still represents a difficult diagnostic and treatment problem to manage. An aggressive surgical strategy involving removal and in situ replacement of all the prosthetic material combined with extensive removal of the surrounding mediastinal tissue remains technically challenging in any case. Mortality and morbidity rates following such a major and risky surgical procedure are high due to the nature of the aggressive surgical approach and multi-organ failure typically caused by sepsis. However, removal of the infected prosthetic graft in patients who had an operation to reconstruct the ascending aorta and/or the aortic arch is not always possible or necessary for selected patients according to current alternative treatment options. Rather than following the traditional surgical concept of aggressive graft replacement nowadays a more conservative surgical approach with in situ preservation and coverage of the prosthetic graft by vascular tissue flaps can result in a good outcome. In this article, we review the relevant literature on this specific topic, particularly in terms of graft-sparing surgery for infected ascending/arch prosthetic grafts with special emphasis on staged treatment and the use of omentum transposition.

Enhanced recovery after elective coronary revascularization surgery with minimal versus conventional extracorporeal circulation: a prospective randomized study.

OBJECTIVE: A minimal extracorporeal circulation (MECC) circuit integrates the advances in cardiopulmonary bypass (CPB) technology into a single circuit and is associated with improved short-term outcome. The aim of this study was to prospectively evaluate MECC compared with conventional CPB in facilitating fast-track recovery after elective coronary revascularization procedures. DESIGN: Prospective randomized study. SETTING: All patients scheduled for elective coronary artery surgery were evaluated, excluding those considered particularly high risk for fast-track failure. The fast-track protocol included careful preoperative patient selection, a fast-track anesthetic technique based on minimal administration of fentanyl, surgery at normothermia, early postoperative extubation in the cardiac recovery unit, and admission to the cardiothoracic ward within the first 24 hours postoperatively. PARTICIPANTS: One hundred twenty patients were assigned randomly into 2 groups (60 in each group). INTERVENTIONS: Group A included patients who were operated on using the MECC circuit, whereas patients in Group B underwent surgery on conventional CPB. MEASUREMENTS AND MAIN RESULTS: Incidence of fast-track recovery was significantly higher in patients undergoing MECC (25% v 6.7%, p = 0.006). MECC also was recognized as a strong independent predictor of early recovery, with an odds ratio of 3.8 (p = 0.011). Duration of mechanical ventilation and cardiac recovery unit stay were significantly lower in patients undergoing MECC together with the need for blood transfusion, duration of inotropic support, need for an intra-aortic balloon pump, and development of postoperative atrial fibrillation and renal failure. CONCLUSIONS: MECC promotes successful early recovery after elective coronary revascularization procedures, even in a nondedicated cardiac intensive care unit setting.

Successful high-risk percutaneous coronary intervention with the use of minimal extracorporeal circulation system.

Minimal extracorporeal circulation (MECC) represents a contemporary system which integrates several advances in cardiopulmonary bypass technology in a single circuit. We challenged the efficacy of the MECC system to support the circulation in elective high-risk percutaneous coronary intervention (PCI). A 78-year-old patient with complex coronary disease who would have been otherwise rejected for interventional therapy underwent PCI with rotablation on MECC support. The MECC system provided hemodynamic support at a flow of 1.8 L min(-1) m(-2) while perfusion pressure was kept at a minimum of 70 mm Hg. This allowed for successful angioplasty of the left main stem and a chronically occluded right coronary artery, which otherwise produced significant hemodynamic compromise. This case illustrates that mechanical circulatory support with the MECC system could provide a stable environment and a "safety net" for carrying out complex percutaneous coronary intervention in high-risk patients.

A modified two-port thoracoscopic technique versus axillary minithoracotomy for the treatment of recurrent spontaneous pneumothorax: a prospective randomized study.

BACKGROUND: Currently, most thoracic surgeons perform surgical pleurodesis for recurrent spontaneous pneumothorax (RSP) by video-assisted thoracic surgery (VATS). However, the superiority of VATS over axillary minithoracotomy is not been established in prospective studies to date. A modified two-port VATS technique and axillary minithoracotomy were prospectively evaluated for possible differences in the short- and long-term outcome for patients. METHODS: In this study, 66 consecutive patients underwent surgical pleurodesis for RSP through either a modified two-port VATS procedure (group A, 33 patients) or axillary minithoracotomy (group B, 33 patients). According to the study design (NCT01192217), the patients were randomly assigned to the two groups, which were similar in terms of age and body mass index. One-lung ventilation time, histology of the available lung parenchyma specimens, early postoperative complications, length of chest tube drainage and hospital stay, recurrence rate, and a score for patient satisfaction with treatment based on the sum of postoperative pain, dependent-arm mobilization, and return to full activity subscores were evaluated. The follow-up period varied from 3 to 53 months (median, 30 months). RESULTS: The one-lung ventilation and operating times were significantly longer (p < 0.001) in group A than in group B. The overall detection of blebs, bulla, or both was 51.5% in group A and 63.8% in group B. The recurrence rate, complication rate, postoperative chest tube drainage duration, postoperative hospital stay, and incidence of chronic pain did not differ between the two groups. The score for patient satisfaction with treatment was significantly higher in group A than in group B (p < 0.001) according the subscores for better dependent-arm mobilization and return to full activity. CONCLUSIONS: Axillary minithoracotomy and VATS are equally effective for the treatment of RSP, although the rate for resection of blebs, bulla, or both is higher with the axillary minithoracotomy procedure. Although VATS is more time consuming, it offers to the patient more satisfaction with treatment.

Prognostic value of combined preoperative phase angle and handgrip strength in cardiac surgery.

OBJECTIVES: Phase angle (PA) constitutes a bioelectrical impedance measurement, indicating cell membrane health and integrity, hydration, and nutritional status. Handgrip strength (HS) has been also associated with body composition, nutritional status, inflammation, and functional ability in several chronic diseases. Although their prognostic significance as independent biomarkers has been already investigated regarding the outcomes of a cardiac surgery, our study is the first one to assess the combined predictive value of preoperative PA and HS. DESIGN AND METHODS: HS and PA measurements were performed preoperativelyin 195 patients undergoing cardiac surgery. The association ofthe combination of HS and PAwith all-cause mortality rates was the primary study outcome, while its association with the intensive care unit (ICU) length of stay (LOS) was the secondary one. RESULTS: PA was positively correlated with HS (r = 0.446, p < 0.005) and negatively with EuroSCORE II (r = - 0.306 p < 0.005). The combination of PA < 5.15 and HS < 25.5 was associated with higher one-year all-cause mortality (OR = 9.28; 95% CI 2.50-34.45; p = 0.001) compared to patients with PA > 5.15 and HS > 25.5, respectively. Patients with combined lower values of PA and HS (PA < 5.15 and HS < 30.7) were at higher risk of prolonged ICU LOS (OR = 4.02; 95% CI 1.53-10.56; p = 0.005) compared to those with higher PA-HS (PA > 5.15-HS > 30.7). The combination of PA-HS was also significantly linked with EuroSCORE II. CONCLUSION: The combination of low preoperative PA and HS values was significantly associated with higher risk of all-cause mortality at 12 months and prolonged ICU LOS; thereby it might serve as a clinically useful prognostic biomarker after cardiac surgery procedures.

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.

Hybrid approach of ventricular assist device and autologous bone marrow stem cells implantation in end-stage ischemic heart failure enhances myocardial reperfusion.

We challenge the hypothesis of enhanced myocardial reperfusion after implanting a left ventricular assist device together with bone marrow mononuclear stem cells in patients with end-stage ischemic cardiomyopathy. Irreversible myocardial loss observed in ischemic cardiomyopathy leads to progressive cardiac remodelling and dysfunction through a complex neurohormonal cascade. New generation assist devices promote myocardial recovery only in patients with dilated or peripartum cardiomyopathy. In the setting of diffuse myocardial ischemia not amenable to revascularization, native myocardial recovery has not been observed after implantation of an assist device as destination therapy. The hybrid approach of implanting autologous bone marrow stem cells during assist device implantation may eventually improve native cardiac function, which may be associated with a better prognosis eventually ameliorating the need for subsequent heart transplantation. The aforementioned hypothesis has to be tested with well-designed prospective multicentre studies.