Characteristics and Outcomes of Prolonged Venoarterial Extracorporeal Membrane Oxygenation After Cardiac Surgery: The Post-Cardiotomy Extracorporeal Life Support (PELS-1) Cohort Study.

OBJECTIVES: Most post-cardiotomy (PC) extracorporeal membrane oxygenation (ECMO) runs last less than 7 days. Studies on the outcomes of longer runs have provided conflicting results. This study investigates patient characteristics and short- and long-term outcomes in relation to PC ECMO duration, with a focus on prolonged (> 7 d) ECMO. DESIGN: Retrospective observational cohort study. SETTING: Thirty-four centers from 16 countries between January 2000 and December 2020. PATIENTS: Adults requiring post PC ECMO between 2000 and 2020. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Characteristics, in-hospital, and post-discharge outcomes were compared among patients categorized by ECMO duration. Survivors and nonsurvivors were compared in the subgroup of patients with ECMO duration greater than 7 days. The primary outcome was in-hospital mortality. Two thousand twenty-one patients were included who required PC ECMO for 0-3 days (n = 649 [32.1%]), 4-7 days (n = 776 [38.3%]), 8-10 days (n = 263 [13.0%]), and greater than 10 days (n = 333 [16.5%]). There were no major differences in the investigated preoperative and procedural characteristics among ECMO duration groups. However, the longer ECMO duration category was associated with multiple complications including bleeding, acute kidney injury, arrhythmias, and sepsis. Hospital mortality followed a U-shape curve, with lowest mortality in patients with ECMO duration of 4-7 days (n = 394, 50.8%) and highest in patients with greater than 10 days ECMO support (n = 242, 72.7%). There was no significant difference in post-discharge survival between ECMO duration groups. In patients with ECMO duration greater than 7 days, age, comorbidities, valvular diseases, and complex procedures were associated with nonsurvival. CONCLUSIONS: Nearly 30% of PC ECMO patients were supported for greater than 7 days. In-hospital mortality increased after 7 days of support, especially in patients undergoing valvular and complex surgery, or who had complications, although the long-term post-discharge prognosis was comparable to PC ECMO patients with shorter support duration.

Features and Outcomes of Females and Males Requiring Postcardiotomy Extracorporeal Life Support.

BACKGROUND: Although cardiogenic shock requiring extracorporeal life support (ECLS) after cardiac surgery is associated with high mortality, the impact of sex on outcomes of post-cardiotomy ECLS remains unclear with conflicting results in literature. We compare patient characteristics, in-hospital outcomes, and overall survival between females and males requiring post-cardiotomy ECLS. METHODS: This retrospective, multicentre (34 centres), observational study included adults requiring post-cardiotomy ECLS between 2000 and 2020. Pre-operative, procedural, and ECLS characteristics, complications, and survival were compared between females and males. Association between sex and in-hospital survival was investigated through mixed-Cox proportional hazards models. RESULTS: This analysis included 1823 patients [females:40.8%; median age:66.0 (interquartile range:56.2-73.0 years)]. Females underwent more mitral (females:38.4%, males:33.1%, p=0.019) and tricuspid (females:18%, males:12.4%, p<0.001) valve surgery, while males had more coronary artery surgery (females:45.9%, males:52.4%, p=0.007). ECLS implantation was more common intra-operatively in females (females:64.1%, males:59.1%) and post-operatively in males (females:35.9%, males:40.9%, p=0.036). Ventricular unloading (females:25.1%, males:36.2%, p<0.001) and intra-aortic balloon pump (females: 25.8%, males:36.8%, p<0.001) were most frequently used in males. Females suffered more post-operative right ventricular failure (females:24.1%, males:19.1%, p=0.016) and limb ischemia (females:12.3%, males:8.8%, p=0.23). In-hospital mortality was 64.9% in females and 61.9% in males (p=0.199) with no differences in 5-year survival (females:20%, 95%CI:17-23; males:24%, 95%CI:21-28;p=0.069). Crude hazard ratio for in-hospital mortality in females was 1.12 (95%CI: 0.99-1.27,p=0.069) and did not change after adjustments. CONCLUSIONS: This study demonstrates that females and males requiring post-cardiotomy ECLS have different pre-operative and ECLS characteristics, as well as complications, without a statistical difference in in-hospital and 5-year survival.

End-stage heart failure: The future of heart transplant and artificial heart.

In the last decades, outcomes significantly improved for both heart transplantation and LVAD. Heart transplantation remains the gold standard for the treatment of end stage heart failure and will remain for many years to come. The most relevant limitations are the lack of grafts and the effects of long-term immunosuppressive therapy that involve infectious, cancerous and metabolic complications despite advances in immunosuppression management. Mechanical circulatory support has an irreplaceable role in the treatment of end-staged heart failure, as bridge to transplant or as definitive implantation in non-transplant candidates. Although clinical results do not overcome those of HTx, improvement in the new generation of devices may help to reach the equipoise between the two therapies. This review will go through the evolution, current status and perspectives of both therapeutics.

Patient and Management Variables Associated With Survival After Postcardiotomy Extracorporeal Membrane Oxygenation in Adults: The PELS-1 Multicenter Cohort Study.

Background Extracorporeal membrane oxygenation (ECMO) has been increasingly used for postcardiotomy cardiogenic shock, but without a concomitant reduction in observed in-hospital mortality. Long-term outcomes are unknown. This study describes patients' characteristics, in-hospital outcome, and 10-year survival after postcardiotomy ECMO. Variables associated with in-hospital and postdischarge mortality are investigated and reported. Methods and Results The retrospective international multicenter observational PELS-1 (Postcardiotomy Extracorporeal Life Support) study includes data on adults requiring ECMO for postcardiotomy cardiogenic shock between 2000 and 2020 from 34 centers. Variables associated with mortality were estimated preoperatively, intraoperatively, during ECMO, and after the occurrence of any complications, and then analyzed at different time points during a patient's clinical course, through mixed Cox proportional hazards models containing fixed and random effects. Follow-up was established by institutional chart review or contacting patients. This analysis included 2058 patients (59% were men; median [interquartile range] age, 65.0 [55.0-72.0] years). In-hospital mortality was 60.5%. Independent variables associated with in-hospital mortality were age (hazard ratio [HR], 1.02 [95% CI, 1.01-1.02]) and preoperative cardiac arrest (HR, 1.41 [95% CI, 1.15-1.73]). In the subgroup of hospital survivors, the overall 1-, 2-, 5-, and 10-year survival rates were 89.5% (95% CI, 87.0%-92.0%), 85.4% (95% CI, 82.5%-88.3%), 76.4% (95% CI, 72.5%-80.5%), and 65.9% (95% CI, 60.3%-72.0%), respectively. Variables associated with postdischarge mortality included older age, atrial fibrillation, emergency surgery, type of surgery, postoperative acute kidney injury, and postoperative septic shock. Conclusions In adults, in-hospital mortality after postcardiotomy ECMO remains high; however, two-thirds of those who are discharged from hospital survive up to 10 years. Patient selection, intraoperative decisions, and ECMO management remain key variables associated with survival in this cohort. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT03857217.

On-Support and Postweaning Mortality in Postcardiotomy Extracorporeal Membrane Oxygenation.

BACKGROUND: Postcardiotomy venoarterial extracorporeal membrane oxygenation (VA ECMO) is characterized by discrepancies between weaning and survival-to-discharge rates. This study analyzes the differences between postcardiotomy VA ECMO patients who survived, died on ECMO, or died after ECMO weaning. Causes of death and variables associated with mortality at different time points are investigated. METHODS: The retrospective, multicenter, observational Postcardiotomy Extracorporeal Life Support Study (PELS) includes adults requiring postcardiotomy VA ECMO between 2000 and 2020. Variables associated with on-ECMO mortality and postweaning mortality were modeled using mixed Cox proportional hazards, including random effects for center and year. RESULTS: In 2058 patients (men, 59%; median age, 65 years; interquartile range [IQR], 55-72 years), weaning rate was 62.7%, and survival to discharge was 39.6%. Patients who died (n = 1244) included 754 on-ECMO deaths (36.6%; median support time, 79 hours; IQR, 24-192 hours), and 476 postweaning deaths (23.1%; median support time, 146 hours; IQR, 96-235.5 hours). Multiorgan (n = 431 of 1158 [37.2%]) and persistent heart failure (n = 423 of 1158 [36.5%]) were the main causes of death, followed by bleeding (n = 56 of 754 [7.4%]) for on-ECMO mortality and sepsis (n = 61 of 401 [15.4%]) for postweaning mortality. On-ECMO death was associated with emergency surgery, preoperative cardiac arrest, cardiogenic shock, right ventricular failure, cardiopulmonary bypass time, and ECMO implantation timing. Diabetes, postoperative bleeding, cardiac arrest, bowel ischemia, acute kidney injury, and septic shock were associated with postweaning mortality. CONCLUSIONS: A discrepancy exists between weaning and discharge rate in postcardiotomy ECMO. Deaths occurred during ECMO support in 36.6% of patients, mostly associated with unstable preoperative hemodynamics. Another 23.1% of patients died after weaning in association with severe complications. This underscores the importance of postweaning care for postcardiotomy VA ECMO patients.

The importance of timing in postcardiotomy venoarterial extracorporeal membrane oxygenation: A descriptive multicenter observational study.

OBJECTIVES: Postcardiotomy extracorporeal membrane oxygenation (ECMO) can be initiated intraoperatively or postoperatively based on indications, settings, patient profile, and conditions. The topic of implantation timing only recently gained attention from the clinical community. We compare patient characteristics as well as in-hospital and long-term survival between intraoperative and postoperative ECMO. METHODS: The retrospective, multicenter, observational Postcardiotomy Extracorporeal Life Support (PELS-1) study includes adults who required ECMO due to postcardiotomy shock between 2000 and 2020. We compared patients who received ECMO in the operating theater (intraoperative) with those in the intensive care unit (postoperative) on in-hospital and postdischarge outcomes. RESULTS: We studied 2003 patients (women: 41.1%; median age: 65 years; interquartile range [IQR], 55.0-72.0). Intraoperative ECMO patients (n = 1287) compared with postoperative ECMO patients (n = 716) had worse preoperative risk profiles. Cardiogenic shock (45.3%), right ventricular failure (15.9%), and cardiac arrest (14.3%) were the main indications for postoperative ECMO initiation, with cannulation occurring after (median) 1 day (IQR, 1-3 days). Compared with intraoperative application, patients who received postoperative ECMO showed more complications, cardiac reoperations (intraoperative: 19.7%; postoperative: 24.8%, P = .011), percutaneous coronary interventions (intraoperative: 1.8%; postoperative: 3.6%, P = .026), and had greater in-hospital mortality (intraoperative: 57.5%; postoperative: 64.5%, P = .002). Among hospital survivors, ECMO duration was shorter after intraoperative ECMO (median, 104; IQR, 67.8-164.2 hours) compared with postoperative ECMO (median, 139.7; IQR, 95.8-192 hours, P < .001), whereas postdischarge long-term survival was similar between the 2 groups (P = .86). CONCLUSIONS: Intraoperative and postoperative ECMO implantations are associated with different patient characteristics and outcomes, with greater complications and in-hospital mortality after postoperative ECMO. Strategies to identify the optimal location and timing of postcardiotomy ECMO in relation to specific patient characteristics are warranted to optimize in-hospital outcomes.

The Relation Between Obesity and Mortality in Postcardiotomy Venoarterial Membrane Oxygenation.

BACKGROUND: Obesity is an important health problem in cardiac surgery and among patients requiring postcardiotomy venoarterial extracorporeal membrane oxygenation (V-A ECMO). Still, whether these patients are at risk for unfavorable outcomes after postcardiotomy V-A ECMO remains unclear. The current study evaluated the association between body mass index (BMI) and in-hospital outcomes in this setting. METHODS: The Post-cardiotomy Extracorporeal Life Support (PELS-1) study is an international, multicenter study. Patients requiring postcardiotomy V-A ECMO in 36 centers from 16 countries between 2000 and 2020 were included. Patients were divided in 6 BMI categories (underweight, normal weight, overweight, class I, class II, and class III obesity) according to international recommendations. Primary outcome was in-hospital mortality, and secondary outcomes included major adverse events. Mixed logistic regression models were applied to evaluate associations between BMI and mortality. RESULTS: The study cohort included 2046 patients (median age, 65 years; 838 women [41.0%]). In-hospital mortality was 60.3%, without statistically significant differences among BMI classes for in-hospital mortality (P = .225) or major adverse events (P = .126). The crude association between BMI and in-hospital mortality was not statistically significant after adjustment for comorbidities and intraoperative variables (class I: odds ratio [OR], 1.21; 95% CI, 0.88-1.65; class II: OR, 1.45; 95% CI, 0.86-2.45; class III: OR, 1.43; 95% CI, 0.62-3.33), which was confirmed in multiple sensitivity analyses. CONCLUSIONS: BMI is not associated to in-hospital outcomes after adjustment for confounders in patients undergoing postcardiotomy V-A ECMO. Therefore, BMI itself should not be incorporated in the risk stratification for postcardiotomy V-A ECMO.

Impact of Surgeon Experience and Centre Volume on Outcome After Off-Pump Coronary Artery Bypass Surgery: Results From the European Multicenter Study on Coronary Artery Bypass Grafting (E-CABG) Registry.

AIM: The aim of this study was to assess the impact of surgeon experience and centre volume on early operative outcomes in patients undergoing off-pump coronary artery bypass (OPCAB) surgery. METHOD: Of 7,352 patients in the European Multicenter Study on Coronary Artery Bypass Grafting (E-CABG) registry, 1,549 underwent OPCAB and were included in the present analysis. Using adjusted regression analysis, we compared major early adverse events after procedures performed by experienced OPCAB surgeons (i.e., ≥20 cases per year; n=1,201) to those performed by non-OPCAB surgeons (n=348). Furthermore, the same end points were compared between procedures performed by OPCAB surgeons in high OPCAB volume centres (off-pump technique used in >50% of cases; n=894) and low OPCAB volume centres (n=307). RESULTS: In the experienced OPCAB surgeon group, we observed shorter procedure times (ß -43.858, 95% confidence interval [CI] -53.322 to -34.393; p<0.001), a lower rate of conversion to cardiopulmonary bypass (odds ratio [OR] 0.284, 95% CI 0.147-0.551; p<0.001), a lower rate of prolonged inotrope or vasoconstrictor use (OR 0.492, 95% CI 0.371-0.653; p<0.001), a lower rate of early postprocedural percutaneous coronary interventions (OR 0.335, 95% CI 0.169-0.663; p=0.002), and lower 30-day mortality (OR 0.423, 95% CI 0.194-0.924; p=0.031). In high OPCAB volume centres, we found a lower rate of prolonged inotrope use (OR 0.584, 95% CI 0.419-0.814; p=0.002), a lower rate of postprocedural acute kidney injury (OR 0.382, 95% CI 0.198-0.738; p=0.004), shorter duration of intensive care unit (ß -1.752, 95% CI -2.240 to -1.264; p<0.001) and hospital (ß -1.967; 95% CI -2.717 to -1.216; p<0.001) stays, and lower 30-day mortality (OR 0.316, 95% CI 0.114-0.881; p=0.028). CONCLUSIONS: Surgeon experience and centre volume may play an important role on the early outcomes after OPCAB surgery.

Is there a sex gap in outcomes of comparable patients supported with left ventricular assist devices?

OBJECTIVES: Historically, females were described as suffering from worse outcomes after left ventricular assist device (LVAD) implantation. However, females' preoperative conditions are unique, making direct comparisons with males challenging. This study aimed to select through propensity score (PS) matching two preoperatively comparable populations of females and males and test if any real sex-related difference exists regarding survival and adverse events after LVAD implantation. METHODS: This retrospective single-center observational study investigated patients who received LVAD implantation between 2010 and 2018. PS matching was applied to balance preoperative heterogeneity between males and females. Primary endpoint was survival at follow-up. Secondary endpoints included perioperative outcomes and LVAD-related adverse events. RESULTS: 92 fully comparable females(n = 46) and males(n = 46) were selected after PS matching (median age:57 years, min-max:18-75). 26.1% of patients required preoperative mechanical circulatory support. Females needed more intraoperative fresh frozen plasma (p < 0.001) and platelets transfusions (p = 0.008) compared to males, but postoperative outcomes were comparable between groups. In-hospital, 1 and 2-year survival were 78.3%, 69.6% and 65.2%, respectively, with no differences between groups. Survival probability remained comparable up to 8 years of follow-up (p = 0.35). Overall, females showed a higher rate of strokes (p = 0.039) compared to males in the follow-up time. CONCLUSIONS: After reducing preoperative heterogeneity between females and males, survival after LVAD implantation does not differ based on sex. However, differences might exist in terms of higher transfusions and strokes in females. Reducing preoperative sex disparities and developing intraoperative and anticoagulation strategies which acknowledge sex-related variations might help abolishing differences in LVAD outcomes.

Postcardiotomy Venoarterial Extracorporeal Membrane Oxygenation With and Without Intra-Aortic Balloon Pump.

OBJECTIVES: To compare the outcomes of patients with postcardiotomy shock treated with venoarterial extracorporeal membrane oxygenation (VA-ECMO) only compared with VA-ECMO and intra-aortic balloon pump (IABP). DESIGN: A retrospective multicenter registry study. SETTING: At 19 cardiac surgery units. PARTICIPANTS: A total of 615 adult patients who required VA-ECMO from 2010 to 2018. The patients were divided into 2 groups depending on whether they received VA-ECMO only (ECMO only group) or VA-ECMO plus IABP (ECMO-IABP group). MEASUREMENTS AND MAIN RESULTS: The overall series mean age was 63 ± 13 years, and 33% were female. The ECMO-only group included 499 patients, and 116 patients were in the ECMO-IABP group. Urgent and/or emergent procedures were more common in the ECMO-only group. Central cannulation was performed in 47% (n = 54) in the ECMO-IABP group compared to 27% (n = 132) in the ECMO-only group. In the ECMO-IABP group, 58% (n = 67) were successfully weaned from ECMO, compared to 46% (n = 231) in the ECMO-only group (p = 0.026). However, in-hospital mortality was 63% in the ECMO-IABP group compared to 65% in the ECMO-only group (p = 0.66). Among 114 propensity score-matched pairs, ECMO-IABP group had comparable weaning rates (57% v 53%, p = 0.51) and in-hospital mortality (64% v 58%, p = 0.78). CONCLUSIONS: This multicenter study showed that adjunctive IABP did not translate into better outcomes in patients treated with VA-ECMO for postcardiotomy shock.

Outcome of Temporary Circulatory Support As a Bridge-to-Left Ventricular Assist Device Strategy in Cardiogenic Shock Patients.

OBJECTIVES: Temporary circulatory support (TCS) as a bridge-to-left ventricular assist device (BTL) in cardiogenic shock patients has been increasing, but limited data exists on this BTL strategy. We aimed at analyzing the outcome of BTL patients in a population of cardiogenic shock patients compared with those without TCS at the time of the left ventricular assist device (LVAD) surgery and identify predictors of postoperative mortality in this specific population. DESIGN: A multicenter retrospective observational study conducted in 19 centers from 2006 to 2016. SETTING: Nineteen French centers. PATIENTS: A total of 329 cardiogenic shock patients at the time of LVAD implantation were analyzed. Patients were divided in three groups: those under TCS at the time of LVAD implantation (n = 173), those with TCS removal before LVAD surgery (n = 24), and those who did not undergo a bridging strategy (n = 152). Primary endpoint was 30-day mortality. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Among the BTL group, 68 (39.3%), 18 (10.4%), and 15 (8.7%) patients were under venoarterial extracorporeal membrane oxygenation, Impella, and IABP support alone, and 72 patients (20.6%) were under multiple TCS support. BTL patients presented similar 30 days survival compared with the TCS removal and non-BTL groups. However, BTL group had a significantly longer ICU duration stay, with two-fold duration of mechanical ventilation time, but the three groups experienced similar postoperative complications. Multivariate analysis identified three independent predictors of mortality in the BTL group: combined surgery with LVAD, body mass index (BMI), and heart failure (HF) duration. BTL strategy was not an independent predictor of mortality in cardiogenic shock patients who underwent LVAD. CONCLUSIONS: BTL strategy is not associated with a lower survival among cardiogenic shock patients with LVAD implantation. Predictors of mortality are combined surgery with LVAD, higher BMI, and HF duration.

Gender and the Outcome of Postcardiotomy Veno-arterial Extracorporeal Membrane Oxygenation.

OBJECTIVE: There is a paucity of sex-specific data on patients' postcardiotomy venoarterial extracorporeal membrane oxygenation (VA-ECMO). The present study sought to assess this issue in a multicenter study. DESIGN: Retrospective, propensity score-matched analysis of an international registry. SETTING: Multicenter study, tertiary university hospitals. PARTICIPANTS: Data on adult patients undergoing postcardiotomy VA-ECMO. MEASUREMENTS AND MAIN RESULTS: Between January 2010 and March 2018, patients treated with postcardiotomy VA-ECMO at 17 cardiac surgery centers were analyzed. Index procedures considered were coronary artery bypass graft surgery, isolated valve surgery, their combination, and proximal aortic root surgery. Hospital and five-year mortality constituted the endpoints of interest. Propensity score matching was adopted with logistic regression. A total of 358 patients (mean age: 63.3 ± 12.3 years; 29.6% female) were identified. Among 94 propensity score-matched pairs, women had a higher hospital mortality (70.5% v 56.4%, p = 0.049) compared with men. Logistic regression analysis showed that women (odds ratio [OR], 1.87; 95% confidence interval [CI] 1.10-3.16), age (OR, 1.06; 95%CI 1.04-1.08) and pre-ECMO arterial lactate (OR, 1.09; 95%CI 1.04-1.16) were independent predictors of hospital mortality. No differences between female and male patients were observed for other outcomes. Among propensity score-matched pairs, one-, three-, and five-year mortality were 60.6%, 65.0%, and 65.0% among men, and 71.3%, 71.3%, and 74.0% among women, respectively (p = 0.110, adjusted hazard ratio, 1.27; 95%CI 0.96-1.66). CONCLUSIONS: In postcardiotomy VA-ECMO, female patients demonstrated higher hospital mortality than men. Morbidity and late mortality were similar between the two groups.

Coronary Artery Bypass Grafting in Patients With High Risk of Bleeding.

BACKGROUND: Postoperative bleeding after cardiac surgery is associated with increased morbidity and mortality. We tested the hypothesis that patients with a preoperatively estimated high risk of severe perioperative bleeding may have impaired early outcome after on-pump versus off-pump coronary artery bypass grafting (CABG). METHOD: Data from 7,352 consecutive patients who underwent isolated CABG from January 2015 to May 2017 were included in the multicentre European Coronary Artery Bypass Grafting registry. The postoperative bleeding risk was estimated using the WILL-BLEED risk score. Of all included patients, 3,548 had an increased risk of severe perioperative bleeding (defined as a WILL-BLEED score ≥4) and were the subjects of this analysis. We compared the early outcomes between patients who underwent on-pump or off-pump CABG using a multivariate mixed model for risk-adjusted analysis. RESULTS: Off-pump surgery was performed in 721 patients (20.3%). On-pump patients received more packed red blood cell units (on-pump: 1.41 [95% confidence interval {CI} 0.99-1.86]; off-pump: 0.86 [95% CI 0.64-1.08]; p<0.001), had a longer stay in the intensive care unit (on-pump: 4.4 [95% CI 3.6-8.1] days; off-pump: 3.2 [95% CI 2.0-4.4] days; p=0.049), and a higher rate of postoperative atrial fibrillation (on-pump: 46.5% [95% CI 34.9-58.1]; off-pump: 31.3% [95% CI 21.7-40.9]; p=0.025). Furthermore, on-pump patients showed a trend towards a higher rate of postoperative stroke (on-pump: 2.4% [95% CI 0.9-4.1]; off-pump: 1.1 [95% CI 0.2-2.7]; p=0.094). CONCLUSION: Our data suggest that in patients with an increased risk of bleeding, the use of cardiopulmonary bypass is associated with higher morbidity. These patients may benefit from off-pump surgery if complete revascularisation can be ensured.

Neurological Complications in High-Risk Patients Undergoing Coronary Artery Bypass Surgery.

BACKGROUND: Coronary artery bypass grafting (CABG) without cardiopulmonary bypass and minimal or no aortic manipulation may be associated with a lower risk of neurological complications. We investigated this issue in patients with a high risk of perioperative stroke. METHODS: Data on 7352 patients who underwent isolated CABG from January 2015 to May 2017 were included in the multicenter study E-CABG (European Coronary Artery Bypass Grafting) registry. Of these, 684 patients had an increased risk of neurological complications, ie, previous stroke or transient ischemic attack, severe carotid artery stenosis or occlusion, or previous carotid artery intervention. In this subgroup, we analyzed the rates of the combined primary endpoint comprising any postoperative stroke or transient ischemic attack. A comparative analysis between CABG with and without aortic cross-clamping was performed. RESULTS: The primary endpoint was more often reached when aortic cross-clamping was used (propensity score matching, without vs with aortic cross-clamp: 0.9% vs 7.2%; P = .016). In comparison with all other revascularization techniques, off-pump CABG with avoidance of aortic manipulation was associated with the lowest rate of neurological complications (0.7%). CONCLUSIONS: In patients with increased risk of perioperative stroke, aortic manipulation including the use of cardiopulmonary bypass or partial clamping for central anastomoses is associated with higher rates of postoperative neurological complications. These patients may benefit from off-pump surgery without aortic manipulation if complete revascularization can be ensured.

Biocompatibility of an apical ring plug for left ventricular assist device explantation: Results of a feasibility pre-clinical study.

BACKGROUND: Patients receiving left ventricle assist devices (LVADs) as bridge to recovery remain a minority with 1%-5% of LVADs explanted after improvement of myocardial function. Nevertheless, considering the growing population of patients supported with LVADs, an increasing demand of new explantation strategies is expected in the near future. A novel plug for LVAD explantation has been developed and its biocompatibility profile needs to be proved. This study tested the biocompatibility of this novel plug in an in vivo ovine model. METHODS: Six adult Blackhead Persian female sheep received plug implantation on the cardiac apex via minimally invasive approach and were clinically observed up to 90 days. Echocardiography was performed to detect thrombus formation or further plug-related complications. After the observation period, euthanasia was performed and samples including the plug and the surrounding tissues were obtained to be analyzed with correlative light and electron microscopy. Organ necrosis, ischemia and peripheral embolism were investigated. RESULTS: Three animals survived surgery and completed the follow-up time without experiencing clinical complications. Echocardiographic controls excluded the presence of an intracavitary thrombus in the left ventricle (LV). Autopsy confirmed no signs of local infection, LV thrombus or peripheral embolism. Light and electron microscopy revealed an intact epithelium covering a layer of connective tissue on the plug surface facing the heart lumen. CONCLUSIONS: This novel apical plug for LVAD explantation allows for endothelial and connective tissue growth on its ventricular side within 90 days from surgery. Further studies are required to fully demonstrate the biocompatibility of this apical plug and investigate the optimal anticoagulation regimen to be applied after implantation.

Telemonitoring and Care Program for Left Ventricular Assist Device Patients During COVID-19 Outbreak: A European Experience.

Coronavirus disease 2019 (COVID-19) radically modified the organization of healthcare systems with shutdown of routine activities and outpatient clinics. Herein, we report our institutional experience with a Telemonitoring and Care Program (TC-Program) to monitor and support left ventricular assist device (LVAD) patients during COVID-19 outbreak. This single-arm cohort study analyzed 156 patients who entered the TC-Program at our institution between April and August 2020. The TC-Program was based on routine phone calls to patients and a 24/7 emergency line. In November 2020, patients were asked for feedback on the TC-Program and checked for survival, transplant, or explant. The primary endpoint was the rate of TC-Program-driven interventions. Patients (males: 82.8%) were 61 years old (interquartile range [IQR]: 53.0-67.5) and on LVAD support for 1,266 days (IQR: 475-2,211). Patients were included in the TC-Program for a median time of 99 days (min:15, max:120) and received a median number of six phone calls (min:1, max:14). Twenty-three patients (14.7%) were referred for clinical evaluation after phone contact. Two patients (1.27%) were diagnosed with COVID-19: one of them died after intensive care, and one remained paucisymptomatic and recovered. Three patients asked to exit the program considering it not useful while the others gave high rates in terms of usefulness (median: 9, IQR: 8-10), information (median: 9, IQR: 8-10), good medical care (median: 9, IQR: 8-10), and psychologic support (median: 8, IQR: 7-10). A TC-Program based on the four ICSA principles (Inform, Care, Support, and Adapt) is feasible in LVAD patients and can be rapidly implemented during the COVID-19 pandemic.

Three-year follow-up after less-invasive left ventricular assist device exchange to HeartMate 3™.

BACKGROUND: Device exchange to a newer generation left ventricular assist device (LVAD) offers the opportunity to benefit from improved adverse events profiles. We present the three-year results of a patient cohort undergoing VAD upgrades to a new generation device focusing on outcomes and adverse events. METHODS: We present the first series of patients who underwent LVAD upgrade to HeartMate 3™ (Abbott Laboratories; Abbott Park, IL, USA). All operations were performed less invasively. Follow-up time was three years after LVAD exchange. RESULTS: Overall four HeartMate II™ (Abbott Laboratories; Abbott Park, IL, USA) and two HVAD patients underwent LVAD upgrade. In five cases severe infection of the VAD led to device exchange (83%, 5/6). Three-year survival after LVAD exchange was 100% (6/6). In the follow-up examinations one patient showed a single syncope and several low flow alarms (1/6). The remaining five patients showed no technical malfunctions of the LVAD or hemodynamic adverse events (5/6). Four out of five patients whose devices had to be changed due to an infection suffered a local re-infection (4/5), which did not require any further surgical intervention. Four patients were successfully transplanted, and two patients were still on device support at three years after LVAD exchange. CONCLUSIONS: Three-year outcomes and adverse events after LVAD exchange to HeartMate 3™ (Abbott Laboratories). show excellent results. The superior hemocompatibility in terms of pump thrombosis makes the HM3 a favored choice in case of LVAD exchange due previous pump thrombosis. However, in cases of exchange due to device infection the risk of re-infection remains high.

Sex differences in outcomes following less-invasive left ventricular assist device implantation.

BACKGROUND: Worse outcomes in women compared to men undergoing left ventricular assist device (LVAD) implantation remain an underestimated problem in heart failure (HF) patients. With device miniaturization, less-invasive LVAD implantation techniques have gained relevance, but their impact on outcomes in women is unknown. This study investigates sex-related differences in patients undergoing LVAD implantation through less-invasive procedures. METHODS: This retrospective single-center cohort study included patients who underwent isolated LVAD implantation between 2011 and 2018 through less-invasive techniques. Propensity score matching (PSM) was utilized to balance preoperative heterogeneity. Primary endpoint was two-year survival, and secondary endpoints included long-term survival, surgical outcomes and postoperative adverse events. RESULTS: Baseline analysis of 191 patients (females 18.3%) showed differences in terms of age [female (median, 52; IQR, 47-61); male (median, 58.5; IQR, 49-66); P=0.005], underlying diagnosis (P<0.001), INTERMACS profile (P=0.009), history of previous cardiac surgery (P=0.049) and preoperative creatinine values [female (median, 110; IQR, 71-146); male (median, 126; IQR, 9-168); P=0.049]. Over a follow-up of 460.68 patient-years, Kaplan-Meyer analysis showed better survival in females (P=0.027) and a similar probability of cardiac transplantation (P=0.288). After PSM, females showed higher needs for intraoperative fresh frozen plasma (P=0.044) and platelets (P=0.001) but comparable postoperative outcomes. No sex-related differences were noticed regarding two-year outcomes, long-term survival and adverse events. LVAD-related infections remained the most common complication with males experiencing more pump infections than women (P=0.050). CONCLUSIONS: Patients receiving less-invasive LVAD implantation do not show significant sex-related differences in short and long-term outcomes and survival. Prospective studies are needed to evaluate the role of less-invasive techniques in reducing sex-based disparities after LVAD implantation.

Outcome of Repeat Venoarterial Extracorporeal Membrane Oxygenation in Postcardiotomy Cardiogenic Shock.

OBJECTIVE: Data on patients requiring a second run of venoarterial extracorporeal membrane oxygenation (VA-ECMO) support in patients affected by postcardiotomy cardiogenic shock (PCS) are very limited. The authors aimed to investigate the effect of a second run of VA-ECMO on PCS patient survival. DESIGN: Retrospective analysis of an international registry. SETTING: Multicenter study, tertiary university hospitals. PARTICIPANTS: Data on adult PCS patients receiving a second run of VA-ECMO. MEASUREMENTS AND MAIN RESULTS: A total of 674 patients with a mean age of 62.9 ± 12.7 years were analyzed, and 21 (3.1%) patients had a second run of VA-ECMO. None of them required more than two VA-ECMO runs. The median duration of VA-ECMO therapy was 135 hours (interquartile range [IQR] 61-226) in patients who did not require a VA-ECMO rerun. In the rerun VA-ECMO group the median overall duration of VA-ECMO therapy was 183 hours (IQR 107-344), and the median duration of the first run was 114 hours (IQR 66-169). Nine (42.9%) of the patients who required a second run of VA-ECMO died during VA-ECMO therapy, whereas five (23.8%) survived to hospital discharge. No differences between patients treated with single or second VA-ECMO runs were observed in terms of hospital mortality and late survival. In patients requiring a second VA-ECMO run, the actuarial survival estimates at three and 12 months after VA-ECMO weaning were 23.8% ± 9.3% and 19.6% ± 6.4%, respectively. CONCLUSIONS: Repeat VA-ECMO therapy is a valid treatment strategy for PCS patients. Early and late survivals are similar between patients who have undergone a single or second run of VA-ECMO.

Lateral Thoracotomy for Ventricular Assist Device Implantation: A Meta-Analysis of Literature.

The use of lateral thoracotomy (LT) for implanting left ventricular assist devices (LVADs) is worldwide increasing, although the available evidence for its positive effects compared with conventional sternotomy (CS) is limited. This systematic review and meta-analysis analyzes the outcomes of LT compared with CS in patients undergoing implantation of a centrifugal continuous-flow LVAD. Four databases and 1,053 publications were screened until December 2019. Articles including patients undergoing implantation of a centrifugal continuous-flow LVAD through LT were included. A meta-analysis to compare LT and CS was performed to summarize evidences from studies including both LT and CS patients extracted from the same population. Primary outcome measure was in-hospital or 30-day mortality. Eight studies reporting on 730 patients undergoing LVAD implantation through LT (n = 242) or CS (n = 488) were included in the meta-analysis. Left thoracotomy showed lower in-hospital/30-day mortality (odds ratio [OR]: 0.520, 95% confidence interval [CI]: 0.27-0.99, p = 0.050), shorter intensive care unit (ICU) stay (mean difference [MD]: 3.29, CI: 1.76-4.82, p < 0.001), lower incidence of severe right heart failure (OR: 0.41; CI: 0.19-0.87, p = 0.020) and postoperative right ventricular assist device (RVAD) implantation (OR: 0.27, CI: 0.10-0.76, p = 0.010), fewer perioperative transfusions (MD: 0.75, CI: 0.36-1.14, p < 0.001), and lower incidence of renal failure (OR: 0.45, CI: 0.20-1.01, p = 0.050) and device-related infections (OR: 0.45, CI: 0.20-1.01, p = 0.050), respectively. This meta-analysis demonstrates that implantation of a centrifugal continuous-flow LVAD system via LT benefits from higher short-term survival, less right heart failure, lower postoperative RVAD need, shorter ICU stay, less transfusions, lower risk of device-related infections and kidney failure. Prospective studies are needed for further proof.