Early detection of oliguric events in critically ill patients in the ICU with a novel continuous urine flow measurement device: results of an initial validation study.

OBJECTIVES: Urine output is used to evaluate fluid status and is an important marker for acute kidney injury (AKI). Our primary aim was to validate a new automatic urine output monitoring device by comparison to the current practice - the standard urometer. METHODS: We conducted a prospective observational study in three ICUs. Urine flow measurements by Serenno Medical Automatic urine output measuring device (Serenno Medical, Yokneam, Israel) were compared to standard urometer readings taken automatically at 5-minutes intervals by a camera, and to hourly urometer readings by the nurses, both over 1 to 7 days. Our primary outcome was the difference between urine flow assessed by the Serenno device and reference camera-derived measurements (Camera). Our secondary outcome was the difference between urine flow assessed by the Serenno device and hourly nursing assessments (Nurse), and detection of oliguria. RESULTS: Thirty-seven patients completed the study, with 1,306 h of recording and a median of 25 measurement hours per patient. Bland and Altman analysis comparing the study device to camera measurements demonstrated good agreement, with a bias of -0.4 ml/h and 95% confidence intervals ranging from - 28 to 27ml/h. Concordance was 92%. The correlation between Camera and hourly nursing assessment of urine output was distinctly worse with a bias of 7.2 ml and limits of agreement extending from - 75 to + 107 ml. Severe oliguria (urine output < 0.3 ml/kg/h) lasting 2 h or more was common and observed in 8 (21%) of patients. Among the severe oliguric events lasting more than 3 consecutive hours, 6 (41%) were not detected or documented by the nursing staff. There were no device-related complications. CONCLUSION: The Serenno Medical Automatic urine output measuring device required minimal supervision, little ICU nursing staff attention, and is sufficiently accurate and precise. In addition to providing continuous assessments of urine output, it was considerably more accurate than hourly nursing assessments.

Weight gain post-heart transplantation is associated with an increased risk for allograft vasculopathy and rejection.

OBJECTIVE: Obesity and overweight are associated with an increased risk for cardiovascular disease. Since fat mass (FM) and fat-free mass (FFM) both contribute to total body weight (TBW), we characterized the post-heart transplantation (HT) change in TBW and its implications for outcomes. METHODS: Post-HT changes in TBW, FM, and FFM were reviewed for 211 HT patients assessed during 1997-2017. Endpoints included cardiac allograft vasculopathy (CAV) and rejection. RESULTS: Median TBW increased by 7.3% at 1 year, with a significant rise in the obese category (28% vs. 13%, p < 0.001) and with FM versus FFM making the main contribution (23% vs. 3%, p < 0.001). When patients were divided according to median TBW change ("high" vs. "low"), Kaplan-Meier analysis showed that 10-year freedom from CAV (log-rank p < 0.005) and rejection (log-rank p < 0.01) was significantly higher for the "low" TBW change group. Consistently, multivariable analyses showed that the "high" group was independently associated with significant 3.5-fold and 4.2-fold increased risks for CAV (95% CI 1.4-8.7, p = 0.01) and rejection (95% CI 1.2-15.4, p = 0.03), respectively. CONCLUSIONS: Weight gain, contributed mostly by FM, is independently associated with an increased risk for CAV and rejection. Follow-up emphasis should be placed on weight gain and preventative measures.

The Impact of Initiation of an Intensivist-Led Patient Management Protocol on Outcomes After Cardiac Surgery.

OBJECTIVES: Prolonged intensive care unit stay after cardiac surgery is associated with high mortality. The aim of this study was to evaluate the impact of the introduction of a quality improvement program under the supervision of an intensivist on the long-term mortality of high-risk patients with prolonged intensive care unit (ICU) stay after cardiac surgery. DESIGN: Retrospective study of prospectively collected data. SETTING: Cardiac surgery ICU. PARTICIPANTS: A total of 7,549 patients after cardiac surgery. INTERVENTIONS: Patients were divided into two periods: 2004 to 2007, before introducing the quality improvement program (3,315 patients), and 2009 to 2014, after introduction of the program (4,234 patients). In the period from 2004 to 2007, patients were divided into group I (ICU stay ≥ seven days), which included 242 patients, and group III (ICU stay < seven days), which included 3,073 patients. Also, in the period from 2009 to 2014 patients, were divided into group II (ICU stay ≥seven days), which included 326 patients, and group IV (ICU stay < seven days), which included 3,908 patients. Patient outcomes were compared. Follow-up was five years for each group. MEASUREMENTS AND MAIN RESULTS: The European System for Cardiac Operative Risk Evaluation did not differ significantly among the groups. When comparing between group I and group II, 30-day mortality decreased significantly from 24.8% to 16.6%, six-month mortality from 27.3% to 19.3%, one-year mortality from 42.1% to 32.2%, 3-year mortality from 54.5% to 43.3%, and 5-year mortality from 61.2% to 51.8%. In comparing between group III and group IV, the authors did not observe a statistically significant decrease of mortality. CONCLUSIONS: Intensivist-led patient management protocol is associated with decreased long-term mortality in high-risk patients with a prolonged ICU stay.

Donor thyroid hormone therapy is associated with an increased risk of graft dysfunction after heart transplantation.

OBJECTIVE: Heart transplantation (HT) is uniquely associated with the potential impact of thyroid hormone therapy at three intersecting levels-donor, operation, and recipient. We aimed to study the effect of thyroid hormone therapy of the donor on primary graft dysfunction (PGD). METHODS: A retrospective cohort study was conducted on 209 HT recipients assessed from 1997 to 2018; for 33 of the recipients, the donors had received T4 (DT4 group), and for 176, the donors had not (NoDT4 group). The primary endpoint was PGD defined according to the International Society for Heart and Lung consensus statement. RESULTS: Both the incidence (58% vs 35%, P = .022) and the severity of PGD (42% vs 25% moderate/severe, P = .007) were significantly higher in the DT4 recipients. Multivariable analysis showed donor T4 therapy to be independently associated with a ~3.5-fold increased risk for PGD (OR = 3.44, 95% CI 1.26-9.86). These results remained consistent after propensity score analysis. CONCLUSIONS: Donor thyroid hormone therapy is independently associated with an increased risk of PGD. Hypothesizing a "withdrawal effect" as the cause, we suggest that administration of thyroid hormone to the recipient at time of reperfusion could counter this negative effect. Prospective studies are needed to validate this hypothesis-generating study.

Surgical Pericardiectomy for Constrictive Pericarditis: A Single Tertiary Center Experience.

BACKGROUND: Although surgery is the sole therapeutic option for patients with constrictive pericarditis (CP), reports on high postoperative mortality rates have led to hesitant surgery referral. The aim of this study was to report the short- and long-term outcomes of surgical pericardiectomy (SP) from a large tertiary center. METHODS: Between January 2005 and January 2017, 55 consecutive patients underwent SP after comprehensive echocardiography, computed tomography, and hemodynamic studies. Detailed clinical, imaging, surgical techniques and follow-up outcomes were recorded. RESULTS: The most common etiology was idiopathic (n = 27, 49%) and 33 patients (60%) were in functional class 3/4. Sixteen patients (29%) underwent concomitant interventions during SP, and cardiopulmonary bypass (CPB) was used in these, as well as in four additional cases. Complete resection, independent of CPB, was achieved in 96%. One patient died during the index hospitalization, and four (7%) needed re-explorations due to bleeding. While 12 patients (22%) died during a mean follow-up of 52 ± 39 months, only 1 death was due to right heart failure. Functional class significantly improved (with a p-value < 0.001), diuretics were discontinued in all, and significant reductions of right atrial pressures were recorded. None of these outcomes differed as a result of concomitant interventions at the time of SP. CONCLUSION: Short- and long-term outcomes of SP, performed either alone or concomitantly with other procedures, indicate high safety and favorable clinical and hemodynamic efficacy for the treatment of CP.

Does duration of donor brain injury impact heart transplantation outcomes?

AIM: We aimed to study the implications of pre-transplantation time intervals on HT outcomes. METHODS: Brain injury time (BIT) was defined as the period from the donor brain injury to brain death declaration. Brain death interval (BDI) was defined as the period from brain death to application of an aortic cross-clamp during donor heart procurement. Allograft ischemia was defined as the time from donor aortic cross-clamp to aortic unclamping. End points included mortality and rejections. RESULTS: Between 1997 and 2017, we assessed 173 patients. Kaplan-Meier analyses showed that prolonged donor BIT, BDI, allograft ischemia, and total injury time had no significant effect on mortality and rejections. Patients were subdivided into short BIT (<97 hours, n = 87) and long BIT (≥97 hours, n = 86) groups. No differences in rejection scores nor in time to first rejection were noted. Kaplan-Meier analysis showed a similar long-term survival in the two groups. Sub-analysis of both groups according to their median BDI (12 hours) revealed no differences in mortality or time to rejection. CONCLUSIONS: Pre-transplantation time intervals do not affect mortality or rejection. Our findings have important clinical implications regarding HT allocation and organ availability.

Does donor-recipient age difference matter in outcome of heart transplantation?

OBJECTIVE: Potential interactions between donor-recipient age difference and outcomes after heart transplantation are not well known. We thus aimed to study the impact of donor-recipient age difference on heart transplantation outcomes. METHODS: Between 1995 and 2017, we assessed 234 heart transplantation patients. Based on donor-recipient age difference histogram, we stratified these patients into three groups: older donors (donor-recipient difference > 0; n = 48), younger donors (donor-recipient difference 0 to -20 years; n = 82), and much younger donors (donor-recipient difference <-20 years; n = 104). RESULTS: The baseline metabolic risk profile of the recipients was significantly higher for the much younger donor group compared with the younger and older groups, including hypertension (52% vs 33% vs 25%, P = 0.002), dyslipidemia (51% vs 51% vs 29%, P = 0.027), diabetes (30% vs 16% vs 17%, P = 0.044), and smoking history (53% vs 46% vs 29%, P = 0.024), respectively. There were no significant differences between the groups in long-term survival, cardiac allograft vasculopathy, or rejection-free survival in unadjusted and adjusted analyses. In the much younger donor group, gender matching was associated with a lower incidence of primary graft dysfunction (37% vs 58% P = 0.05). CONCLUSIONS: Donor-recipient age difference does not significantly impact long-term heart transplantation outcomes.

Donor-recipient ethnic mismatching impacts short- and long-term results of heart transplantation.

BACKGROUND: The impact of donor-recipient ethnic matching on heart transplantation (HT) has been poorly studied with inconclusive results. We aimed to investigate the impact of ethnic matching on HT outcomes in Israeli multiethnic patients. METHODS: The study comprised 168 patients who underwent HT from 1990-2017. Patients and their donors were ethnically categorized to Jews and Arabs. Primary end points were all-cause in-hospital and late mortality; secondary end points included primary graft dysfunction (PGD), rejections, and vasculopathy. RESULTS: Donor-recipient ethnic matching was found in 111 patients, while 57 were ethnically mismatched. Baseline characteristics were similar in both groups. Ethnic mismatching was associated with >7-fold (P = 0.018) increased risk for in-hospital mortality and >8-fold (P < 0.001) increased risk for PGD. Kaplan-Meier survival analysis showed that overall survival at 10 years was significantly higher among matched patients (73% vs 43%, log-rank P < 0.001). Multivariate analysis showed that ethnic mismatching was associated with an approximately fourfold higher risk for death (P < 0.01). These findings were validated by propensity score analysis. The ethnic mismatched group experienced significantly higher rejection rates compared with the matched group with lower survival free of rejections (log-rank P = 0.029). No differences in vasculopathy were found. CONCLUSIONS: Donor-recipient ethnic mismatch is an important independent predictor of early- and long-term outcomes following HT, and is associated with increased risk for PGD, rejections, and mortality. These findings will help to design tailored treatment protocols leading to improved outcomes after HT.

Trends and Outcomes in Heart Transplantation over the Past Three Decades: A Single Tertiary Center Experience in Israel.

BACKGROUND: Heart transplantation (HT) is the treatment of choice for patients with end-stage heart failure. The HT unit at the Sheba Medical Center is the largest of its kind in Israel. OBJECTIVES: To evaluate the experience of HT at a single center, assess trends over 3 decades, and correlate with worldwide data. METHODS: Between 1990 and 2017, we reviewed all 285  adult HT patients. Patients were grouped by year of HT: 1990-1999 (decade 1), 2000-2009 (decade 2), and 2010-2017 (decade 3). RESULTS: The percentage of women undergoing HT has increased and etiology has shifted from ischemic to non-ischemic cardiomyopathy (10% vs. 25%, P = 0.033; 70% vs. 40% ischemic, for decades 1 vs. 3, respectively). Implantation of left ventricular assist device as a bridge to HT has increased. Metabolic profile has improved over the years with lower low-density lipoprotein, diabetes, and hypertension after HT (101 mg/dl, 27%, and 41% at decade 3, respectively). There has been a prominent change in immunosuppressive treatments, currently more than 90% are treated with tacrolimus, compared with 2.7% and 30.9% in decades 1 and 2, respectively (P < 0.001). Cardiac allograft vasculopathy (CAV) rates have declined significantly (47% vs. 17.5% for decades 1 and 2, P < 0.001) as have the combined endpoint of CAV/death. Similarly, the current incidence of acute rejections is significantly lower. CONCLUSIONS: Our analysis of over 25 years of a single-center experience with HT shows encouraging improved results, which are in line with worldwide standards and experience.

Early aspirin initiation following heart transplantation is associated with reduced risk of allograft vasculopathy during long-term follow-up.

AIM: Cardiac allograft vasculopathy (CAV) is a major cause of morbidity and mortality after heart transplantation (HT). Enhanced platelet reactivity is a contributing factor. We aimed to investigate the association between early initiation of aspirin therapy post-HT and the 15-year risk of the development of CAV. METHODS: We studied 206 patients who underwent HT between 1991 and 2016. Multivariate Cox proportional hazards regression modeling was employed to evaluate the association between early aspirin initiation and the long-term risk of CAV. RESULTS: Ninety-seven patients (47%) received aspirin therapy. At 15 years of follow-up, the rate of CAV was lowered by sixfold in patients treated with aspirin compared with the non-treated patients: 7% vs 37% (log-rank P-value<.001). The corresponding rates of the combined end-point of CAV or death were also lower in patients treated with aspirin, compared with the non-treated patients: 42% vs 78% (log-rank P < .001). Consistently, multivariate analysis showed that early aspirin therapy was associated with a significant 84% (P < .001) reduction in CAV risk, and with a corresponding 68% (P < .0001) reduction in the risk of the combined end-point of CAV or death. We further validated these results using a propensity score-adjusted Cox model. CONCLUSIONS: Early aspirin initiation is independently associated with a significant reduction in the risk of CAV.

Risk of early, intermediate, and late rejection following heart transplantation: Trends over the past 25 years and relation to changes in medical management. Tertiary center experience: The Sheba Heart Transplantation Registry.

AIM: To explore the trends in the risk for rejection following heart transplantation (HT) over the past 25 years, and their relation to changes in medical management. METHODS: The study population comprised 216 HT patients. Rejection periods were defined as follows: 0-3 months (early), 3-12 months (intermediate), and 12+ months (late). HT era was dichotomized as follows: 1991-1999 (remote era) and 2000-2016 (recent era). Medication combination was categorized as newer (TAC, MMF, and everolimus) vs older therapies (AZA, CSA). RESULTS: Multivariate analysis showed that patients who underwent HT during the recent era experienced a significant reduction in the risk for major rejection. These findings were consistent for early (OR = 0.44 [95% CI 0.22-0.88]), intermediate (OR = 0.02 [95% CI 0.003-0.11]), and late rejections (OR = 0.18 [95% CI 0.05-0.52]). Using the year of HT as a continuous measure showed that each 1-year increment was independently associated with a significant reduction in the risk for early, intermediate, and late rejections (5%, 21%, 18%, respectively). In contrast, the risk reduction associated with newer types of immunosuppressive therapies was not statistically significant after adjustment for the treatment period. CONCLUSIONS: Major rejection rates following HT have significantly declined over the past 2 decades even after adjustment for changes in immunosuppressive therapies, suggesting that other factors may also play a role in the improved outcomes of HT recipients.

Evaluation of the impact of a quality improvement program and intensivist-directed ICU team on mortality after cardiac surgery.

OBJECTIVE: Quality improvement is an important pursuit for critical care teams. DESIGN: The authors performed an observational cohort study with historic control. SETTING: Eight-bed cardiac surgery ICU in a tertiary university hospital. PARTICIPANTS: A total of 4,866 patients undergoing cardiac surgery over a 6-year period between January 2005 and December 2010. INTERVENTIONS: In this study, the influence of the introduction of a quality improvement program under the supervision of a newly appointed intensivist on patient outcomes after cardiac surgery was evaluated. Patients were further divided into three 2-year periods: Period I, 2005-2006, before appointment of an intensivist; Period II, 2007-2008, after appointment of an intensivist and initial introduction of a quality improvement program; and Period III, 2009-2010, after implementation of the program and introduction of Critical Care Information Systems. MEASUREMENTS AND MAIN RESULTS: There were 1,633, 1,690, and 1,543 patients in each period, respectively. There was no significant difference in the severity of patient illness between the groups. Unadjusted in-hospital mortality decreased from 6.37% (104 patients) in Period I to 4.32% (73 patients) and 3.3% (51 patients) in Periods II and III, respectively (p< 0.01). CONCLUSIONS: Appointment of an intensivist-directed team model and introduction of quality improvement interventions were associated with decreased mortality after cardiac surgery.

Primary heart dysfunction is greater with combined heart and lung compared with isolated heart procurement.

OBJECTIVE: Combined heart and lungs (CHL) procurement differs from isolated heart (IH) procurement in several aspects, including lung recruitment, cannulation, and preservation requirements. We aimed to investigate whether CHL versus IH procurement contributes to the development of primary graft dysfunction (PGD) after heart transplantation (HT). METHODS: Between 1999 and 2019, we assessed 175 patients undergoing HT at a single center. Patients were divided into IH (n = 61) or CHL (n = 114) procurement groups. End points included PGD (defined according to the International Society for Heart and Lung Transplantation consensus statement) and long-term survival. RESULTS: The incidence of PGD was significantly greater in CHL recipients compared with IH recipients (53.5% vs 16.4%, P < .001). Multivariable analysis showed that CHL procurement was independently associated with a significant 4.6-fold increased risk for PGD (95% confidence interval, 2.1-11, P < .001). Univariable and multivariable analyses showed that the overall survival was not significantly affected by the procurement group (log-rank P = .150, hazard ratio, 1.13; 95% confidence interval, 0.68-1.88, P = .646). The simultaneous procurement of abdominal organs was not associated with an increased risk of PGD in HT recipients. These results remained consistent in a propensity-matched analysis. CONCLUSIONS: Combined procurement of heart and lungs is independently associated with an increased risk of PGD. Further prospective studies are needed to validate this hypothesis-generating study.

Anatomical and clinical risk stratification tool for mortality risk assessment following revascularization for multivessel coronary artery disease.

OBJECTIVE: This study aimed to assess the prognostic ability of SYNTAX score II in left main and/or 3-vessel disease patients undergoing revascularization either by coronary artery bypass grafting or percutaneous coronary intervention in a national registry. METHODS: This prospective registry included consecutive patients with multivessel disease enrolled between January and April 2013 from all 22 hospitals in Israel that perform coronary angiography. Of the 1112 study patients, 368 patients (33%) had a low (<25), 372 (33%) had an intermediate (25-35) and 372 patients (33%) a high (≥35) SYNTAX score II. RESULTS: Patients with a high SYNTAX score II had higher 30-day mortality compared with those with an intermediate or low SYNTAX score II (2.8% vs 0.6% vs 0% respectively, P = .001). Each 1-unit increment in SYNTAX score II increased the odds for death at 30 days by 11% (95% CI, 1.02-1.22; P = .026). Six-year mortality was higher among patients with a high compared with an intermediate or low SYNTAX score II (34.9% vs 11% vs 3.8%; log-rank P < .001). By adding a SYNTAX score II to standard prognostic factors, we showed a significant improvement of 40.1% (P < .001) for predicting 6-year mortality. The area under the curve of the SYNTAX score II (continuous) yielded 0.79 (95% CI, 0.75-0.82) in predicting 6-year mortality. CONCLUSIONS: Our findings show that the admission SYNTAX score II is a powerful marker of short- and long-term mortality, and therefore may be used as a risk stratification tool in patients with multivessel coronary artery disease who are candidates for revascularization.

Subclinical postoperative atrial fibrillation: a randomized trial.

Background: Postoperative atrial fibrillation (POAF) is the most common complication of cardiac surgery, requiring interventions and prolonging hospital stay. POAF is associated with increased mortality and a higher rate of systemic thrombo-embolism. The rates of recurrent AF, optimal follow-up and management remain unclear. We aimed to evaluate the incidence of recurrent atrial fibrillation (AF) events, during long term follow-up in patients with POAF following cardiac surgery. Methods: Patients with POAF and a CHA2DS2-VASc score of ≥2 were randomized in a 2:1 ratio to either implantation of a loop recorder (ILR) or ECG monitoring using periodic Holters. Participants were followed prospectively for 2 years. The primary end point was the occurrence of AF longer than 5 min. Results: The final cohort comprised of 22 patients, of whom 14 received an ILR. Over a median follow up of 25.7 (IQR of 24.7-44.4) months, 8 patients developed AF, representing a cumulative annualized risk of AF recurrence of 35.7%. There was no difference between ILR (6 participants, 40%) and ECG/Holter (2 participants, 25% p = 0.917). All 8 patients with AF recurrence were treated with oral anticoagulation. There were no cases of mortality, stroke or major bleeding. Two patients underwent ILR explantation due to pain at the implantation site. Conclusions: The rate of recurrent AF in patients with POAF after cardiac surgery and a CHA2DS2-VASc score of ≥2 is approximately 1 in 3 when followed systematically. Further research is need to assess the role of ILRs in this population.

Outcomes of Extracorporeal Membrane Oxygenation (ECMO) for COVID-19 Patients: A Multi-Institutional Analysis.

BACKGROUND: In March 2020, COVID-19 was announced as a global pandemic. The first COVID-19 patient was connected to an ECMO device in Israel during that time. Since then, over 200 patients have required ECMO support due to COVID-19 infection. The present study is a multi-institutional analysis of all COVID-19 patients requiring veno-venous (VV) ECMO in Israel. The aim was to characterize and compare the survivors and deceased patients as well as establish risk factors for mortality. METHODS: This retrospective multi-institutional study was conducted from March 2020 to March 2021 in eleven of twelve ECMO centers operating in Israel. All COVID-19 patients on VV ECMO support were included in the cohort. The patients were analyzed based on their comorbidities, procedural data, adverse event on ECMO, and outcomes. Univariate and multivariate analyses were used to compare the deceased and the surviving patients. RESULTS: The study included 197 patients, of which 150 (76%) were males, and the mean age was 50.7 ± 12 years. Overall mortality was 106 (54%). Compared with the deceased subjects, survivors were significantly younger (48 ± 11 vs. 53 ± 12 years), suffered less from ischemic heart disease (IHD) (3% vs. 12%), and were ventilated for a significantly shorter period (≤4 days) prior to cannulation (77% vs. 63%). Patients in the deceased group experienced more kidney failure and sepsis. Rates of other complications were comparable between groups. CONCLUSIONS: Based on this study, we conclude that early cannulation (≤4 days) of younger patients (≤55 years) may improve overall survival and that a history of IHD might indicate a reduced prognosis.

Timing of Lung Transplant Referral in Patients with Severe COVID-19 Lung Injury Supported by ECMO.

Severe respiratory failure caused by COVID-19 often requires mechanical ventilation, including extracorporeal membrane oxygenation (ECMO). In rare cases, lung transplantation (LTx) may be considered as a last resort. However, uncertainties remain about patient selection and optimal timing for referral and listing. This retrospective study analyzed patients with severe COVID-19 who were supported by veno-venous ECMO and listed for LTx between July 2020 and June 2022. Out of the 20 patients in the study population, four who underwent LTx were excluded. The clinical characteristics of the remaining 16 patients were compared, including nine who recovered and seven who died while awaiting LTx. The median duration from hospitalization to listing was 85.5 days, and the median duration on the waitlist was 25.5 days. Younger age was significantly associated with a higher likelihood of recovery without LTx after a median of 59 days on ECMO, compared to those who died at a median of 99 days. In patients with severe COVID-19-induced lung damage supported by ECMO, referral to LTx should be delayed for 8-10 weeks after ECMO initiation, particularly for younger patients who have a higher probability of spontaneous recovery and may not require LTx.

In-hospital and 6-month outcomes in patients with COVID-19 supported with extracorporeal membrane oxygenation (EuroECMO-COVID): a multicentre, prospective observational study.

BACKGROUND: Extracorporeal membrane oxygenation (ECMO) has been widely used in patients with COVID-19, but uncertainty remains about the determinants of in-hospital mortality and data on post-discharge outcomes are scarce. The aims of this study were to investigate the variables associated with in-hospital outcomes in patients who received ECMO during the first wave of COVID-19 and to describe the status of patients 6 months after ECMO initiation. METHODS: EuroECMO-COVID is a prospective, multicentre, observational study developed by the European Extracorporeal Life Support Organization. This study was based on data from patients aged 16 years or older who received ECMO support for refractory COVID-19 during the first wave of the pandemic-from March 1 to Sept 13, 2020-at 133 centres in 21 countries. In-hospital mortality and mortality 6 months after ECMO initiation were the primary outcomes. Mixed-Cox proportional hazards models were used to investigate associations between patient and management-related variables (eg, patient demographics, comorbidities, pre-ECMO status, and ECMO characteristics and complications) and in-hospital deaths. Survival status at 6 months was established through patient contact or institutional charts review. This study is registered with ClinicalTrials.gov, NCT04366921, and is ongoing. FINDINGS: Between March 1 and Sept 13, 2020, 1215 patients (942 [78%] men and 267 [22%] women; median age 53 years [IQR 46-60]) were included in the study. Median ECMO duration was 15 days (IQR 8-27). 602 (50%) of 1215 patients died in hospital, and 852 (74%) patients had at least one complication. Multiorgan failure was the leading cause of death (192 [36%] of 528 patients who died with available data). In mixed-Cox analyses, age of 60 years or older, use of inotropes and vasopressors before ECMO initiation, chronic renal failure, and time from intubation to ECMO initiation of 4 days or more were associated with higher in-hospital mortality. 613 patients did not die in hospital, and 547 (95%) of 577 patients for whom data were available were alive at 6 months. 102 (24%) of 431 patients had returned to full-time work at 6 months, and 57 (13%) of 428 patients had returned to part-time work. At 6 months, respiratory rehabilitation was required in 88 (17%) of 522 patients with available data, and the most common residual symptoms included dyspnoea (185 [35%] of 523 patients) and cardiac (52 [10%] of 514 patients) or neurocognitive (66 [13%] of 512 patients) symptoms. INTERPRETATION: Patient's age, timing of cannulation (<4 days vs ≥4 days from intubation), and use of inotropes and vasopressors are essential factors to consider when analysing the outcomes of patients receiving ECMO for COVID-19. Despite post-discharge survival being favourable, persisting long-term symptoms suggest that dedicated post-ECMO follow-up programmes are required. FUNDING: None.

Effect of levosimendan infusion prior to left ventricular assist device implantation on right ventricular failure.

OBJECTIVE: Investigate the safety and efficacy of preoperative levosimendan in patients undergoing left ventricular assist device (LVAD) implantation. METHODS: Consecutive patients who received LVADs (HeartMate-2, 3, HVAD) in a single tertiary medical center (2012-2018). INTERMACS profile 1 patients were excluded. The primary outcome was post-LVAD right ventricular failure (RVF) and inhospital mortality rates. The secondary outcomes included other clinical, echocardiographic and hemodynamic parameters at follow-up. RESULTS: Final cohort consisted of 62 patients (40[65%] in the levosimendan group and 22[35%] in the no-levosimendan group). Post-operative RVF rate and inotrope or ventilation support time were similar in the levosimendan and no-levosimendan groups (7.5% vs. 13.6%; P = 0.43, median of 51 vs. 72 h; P = 0.41 and 24 vs. 27 h; P = 0.19, respectively). Length of hospitalization, both total and in the intensive care unit, was not statistically significant (median days of 13 vs. 16; P = 0.34, and 3 vs. 4; P = 0.44, respectively). Post-operative laboratory and echocardiographic parameters and in-hospital complication rate did not differ between the groups, despite worse baseline clinical parameters in the Levosimendan group. There was no significant difference in the in-hospital and long term mortality rate (2.5% vs. 4.5%; P > 0.999 and 10% vs. 27.3% respectively; P = 0.64). CONCLUSIONS: Levosimendan infusion prior to LVAD implantation was safe and associated with comparable results without significant improved post-operative outcomes, including RVF.

Unusual complications following left ventricular assisted device implantation: case series.

BACKGROUND: While left ventricular assisted devices (LVAD) have revolutionized the treatment of advanced heart failure, they are associated with a wide range of complications, including bleeding and infection which are the most common complications reported in the literature. Our case series report four unusual complications not related to gastrointestinal bleeding and infections and their management. CASE PRESENTATION: A 61 year old female after LVAD implantation with late onset of severe symptomatic aortic regurgitation treated by transfemoral transcatheter valve implantation (TAVI) with good long term results. A 75 year old male patient with acute pump failure secondary to cable damage, who underwent urgent pump replacement. A 49 year old female patient with a history of myoma who developed massive uterine bleeding which was treated with emergent open hysterectomy after failed gonadotropin-releasing hormone therapy replacement. A 57 year old male patient with device display failure 1 month after LVAD implantation without the ability to monitor speed, power consumption and blood flow. CONCLUSIONS: LVAD patients can be presented with a great variety of complications. Physicians should be aware of their manifestations and the management options.