Hypothermic oxygenated perfusion of the donor heart in heart transplantation: the short-term outcome from a randomised, controlled, open-label, multicentre clinical trial.

BACKGROUND: Static cold storage (SCS) remains the gold standard for preserving donor hearts before transplantation but is associated with ischaemia, anaerobic metabolism, and organ injuries, leading to patient morbidity and mortality. We aimed to evaluate whether continuous, hypothermic oxygenated machine perfusion (HOPE) of the donor heart is safe and superior compared with SCS. METHODS: We performed a multinational, multicentre, randomised, controlled, open-label clinical trial with a superiority design at 15 transplant centres across eight European countries. Adult candidates for heart transplantation were eligible and randomly assigned in a 1:1 ratio. Donor inclusion criteria were age 18-70 years with no previous sternotomy and donation after brain death. In the treatment group, the preservation protocol involved the use of a portable machine perfusion system ensuring HOPE of the resting donor heart. The donor hearts in the control group underwent ischaemic SCS according to standard practices. The primary outcome was time to first event of a composite of either cardiac-related death, moderate or severe primary graft dysfunction (PGD) of the left ventricle, PGD of the right ventricle, acute cellular rejection at least grade 2R, or graft failure (with use of mechanical circulatory support or re-transplantation) within 30 days after transplantation. We included all patients who were randomly assigned, fulfilled inclusion and exclusion criteria, and received a transplant in the primary analysis and all patients who were randomly assigned and received a transplant in the safety analyses. This trial was registered with ClicalTrials.gov (NCT03991923) and is ongoing. FINDINGS: A total of 229 patients were enrolled between Nov 25, 2020, and May 19, 2023. The primary analysis population included 204 patients who received a transplant. There were no patients who received a transplant lost to follow-up. All 100 donor hearts preserved with HOPE were transplantable after perfusion. The primary endpoint was registered in 19 (19%) of 101 patients in the HOPE group and 31 (30%) of 103 patients in the SCS group, corresponding to a risk reduction of 44% (hazard ratio 0·56; 95% CI 0·32-0·99; log-rank test p=0·059). PGD was the primary outcome event in 11 (11%) patients in the HOPE group and 29 (28%) in the SCS group (risk ratio 0·39; 95% CI 0·20-0·73). In the HOPE group, 63 (65%) patients had a reported serious adverse event (158 events) versus 87 (70%; 222 events) in the SCS group. Major adverse cardiac transplant events were reported in 18 (18%) and 33 (32%) patients in the HOPE and SCS group (risk ratio 0·56; 95% CI 0·34-0·92). INTERPRETATION: Although there was not a significant difference in the primary endpoint, the 44% risk reduction associated with HOPE was suggested to be a clinically meaningful benefit. Post-transplant complications, measured as major adverse cardiac transplant events, were reduced. Analysis of secondary outcomes suggested that HOPE was beneficial in reducing primary graft dysfunction. HOPE in donor heart preservation addresses the existing challenges associated with graft preservation and the increasing complexity of donors and heart transplantation recipients. Future investigation will help to further elucidate the benefit of HOPE. FUNDING: XVIVO Perfusion.

Bilateral Femoral Cannulation Is Associated With Reduced Severe Limb Ischemia-Related Complications Compared With Unilateral Femoral Cannulation in Adult Peripheral Venoarterial Extracorporeal Membrane Oxygenation: Results From the Extracorporeal Life Support Registry.

OBJECTIVES: Peripheral venoarterial extracorporeal membrane oxygenation (ECMO) with femoral access is obtained through unilateral or bilateral groin cannulation. Whether one cannulation strategy is associated with a lower risk for limb ischemia remains unknown. We aim to assess if one strategy is preferable. DESIGN: A retrospective cohort study based on the Extracorporeal Life Support Organization registry. SETTING: ECMO centers worldwide included in the Extracorporeal Life Support Organization registry. PATIENTS: All adult patients (≥ 18 yr) who received peripheral venoarterial ECMO with femoral access and were included from 2014 to 2020. INTERVENTIONS: Unilateral or bilateral femoral cannulation. MEASUREMENTS AND MAIN RESULTS: The primary outcome was the occurrence of limb ischemia defined as a composite endpoint including the need for a distal perfusion cannula (DPC) after 6 hours from implantation, compartment syndrome/fasciotomy, amputation, revascularization, and thrombectomy. Secondary endpoints included bleeding at the peripheral cannulation site, need for vessel repair, vessel repair after decannulation, and in-hospital death. Propensity score matching was performed to account for confounders. Overall, 19,093 patients underwent peripheral venoarterial ECMO through unilateral ( n = 11,965) or bilateral ( n = 7,128) femoral cannulation. Limb ischemia requiring any intervention was not different between both groups (bilateral vs unilateral: odds ratio [OR], 0.92; 95% CI, 0.82-1.02). However, there was a lower rate of compartment syndrome/fasciotomy in the bilateral group (bilateral vs unilateral: OR, 0.80; 95% CI, 0.66-0.97). Bilateral cannulation was also associated with lower odds of cannulation site bleeding (bilateral vs unilateral: OR, 0.87; 95% CI, 0.76-0.99), vessel repair (bilateral vs unilateral: OR, 0.55; 95% CI, 0.38-0.79), and in-hospital mortality (bilateral vs unilateral: OR, 0.85; 95% CI, 0.81-0.91) compared with unilateral cannulation. These findings were unchanged after propensity matching. CONCLUSIONS: This study showed no risk reduction for overall limb ischemia-related events requiring DPC after 6 hours when comparing bilateral to unilateral femoral cannulation in peripheral venoarterial ECMO. However, bilateral cannulation was associated with a reduced risk for compartment syndrome/fasciotomy, lower rates of bleeding and vessel repair during ECMO, and lower in-hospital mortality.

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.

Neurologic complications in patients receiving aortic versus subclavian versus femoral arterial cannulation for post-cardiotomy extracorporeal life support: results of the PELS observational multicenter study.

BACKGROUND: Cerebral perfusion may change depending on arterial cannulation site and may affect the incidence of neurologic adverse events in post-cardiotomy extracorporeal life support (ECLS). The current study compares patients' neurologic outcomes with three commonly used arterial cannulation strategies (aortic vs. subclavian/axillary vs. femoral artery) to evaluate if each ECLS configuration is associated with different rates of neurologic complications. METHODS: This retrospective, multicenter (34 centers), observational study included adults requiring post-cardiotomy ECLS between January 2000 and December 2020 present in the Post-Cardiotomy Extracorporeal Life Support (PELS) Study database. Patients with Aortic, Subclavian/Axillary and Femoral cannulation were compared on the incidence of a composite neurological end-point (ischemic stroke, cerebral hemorrhage, brain edema). Secondary outcomes were overall in-hospital mortality, neurologic complications as cause of in-hospital death, and post-operative minor neurologic complications (seizures). Association between cannulation and neurological outcomes were investigated through linear mixed-effects models. RESULTS: This study included 1897 patients comprising 26.5% Aortic (n = 503), 20.9% Subclavian/Axillary (n = 397) and 52.6% Femoral (n = 997) cannulations. The Subclavian/Axillary group featured a more frequent history of hypertension, smoking, diabetes, previous myocardial infarction, dialysis, peripheral artery disease and previous stroke. Neuro-monitoring was used infrequently in all groups. Major neurologic complications were more frequent in Subclavian/Axillary (Aortic: n = 79, 15.8%; Subclavian/Axillary: n = 78, 19.6%; Femoral: n = 118, 11.9%; p < 0.001) also after mixed-effects model adjustment (OR 1.53 [95% CI 1.02-2.31], p = 0.041). Seizures were more common in Subclavian/Axillary (n = 13, 3.4%) than Aortic (n = 9, 1.8%) and Femoral cannulation (n = 12, 1.3%, p = 0.036). In-hospital mortality was higher after Aortic cannulation (Aortic: n = 344, 68.4%, Subclavian/Axillary: n = 223, 56.2%, Femoral: n = 587, 58.9%, p < 0.001), as shown by Kaplan-Meier curves. Anyhow, neurologic cause of death (Aortic: n = 12, 3.9%, Subclavian/Axillary: n = 14, 6.6%, Femoral: n = 28, 5.0%, p = 0.433) was similar. CONCLUSIONS: In this analysis of the PELS Study, Subclavian/Axillary cannulation was associated with higher rates of major neurologic complications and seizures. In-hospital mortality was higher after Aortic cannulation, despite no significant differences in incidence of neurological cause of death in these patients. These results encourage vigilance for neurologic complications and neuromonitoring use in patients on ECLS, especially with Subclavian/Axillary cannulation.

Post-cardiotomy extracorporeal life support: A cohort of cannulation in the general ward.

OBJECTIVES: Post-cardiotomy extracorporeal life support (ECLS) cannulation might occur in a general post-operative ward due to emergent conditions. Its characteristics have been poorly reported and investigated This study investigates the characteristics and outcomes of adult patients receiving ECLS cannulation in a general post-operative cardiac ward. METHODS: The Post-cardiotomy Extracorporeal Life Support (PELS) is a retrospective (2000-2020), multicenter (34 centers), observational study including adult patients who required ECLS for post-cardiotomy shock. This PELS sub-analysis analyzed patients´ characteristics, in-hospital outcomes, and long-term survival in patients cannulated for veno-arterial ECLS in the general ward, and further compared in-hospital survivors and non-survivors. RESULTS: The PELS study included 2058 patients of whom 39 (1.9%) were cannulated in the general ward. Most patients underwent isolated coronary bypass grafting (CABG, n = 15, 38.5%) or isolated non-CABG operations (n = 20, 51.3%). The main indications to initiate ECLS included cardiac arrest (n = 17, 44.7%) and cardiogenic shock (n = 14, 35.9%). ECLS cannulation occurred after a median time of 4 (2-7) days post-operatively. Most patients' courses were complicated by acute kidney injury (n = 23, 59%), arrhythmias (n = 19, 48.7%), and postoperative bleeding (n = 20, 51.3%). In-hospital mortality was 84.6% (n = 33) with persistent heart failure (n = 11, 28.2%) as the most common cause of death. No peculiar differences were observed between in-hospital survivors and nonsurvivors. CONCLUSIONS: This study demonstrates that ECLS cannulation due to post-cardiotomy emergent adverse events in the general ward is rare, mainly occurring in preoperative low-risk patients and after a postoperative cardiac arrest. High complication rates and low in-hospital survival require further investigations to identify patients at risk for such a complication, optimize resources, enhance intervention, and improve outcomes.

Multicenter exploration of specialist palliative care in patients with left ventricular assist devices - a retrospective study.

BACKGROUND: The number of advanced heart failure patients with left ventricular assist devices (LVAD) is increasing. Despite guideline-recommendations, little is known about specialist palliative care involvement in LVAD-patients, especially in Europe. This study aims to investigate timing and setting of specialist palliative care in LVAD-patients. METHODS: We conducted a retrospective multicenter study in 2022. Specialist palliative care services in German LVAD-centers were identified and invited to participate. Forty adult LVAD-patients (mean age 65 years (SD 7.9), 90% male) from seven centers that received a specialist palliative care consultation during hospitalization were included. RESULTS: In 37 (67.3%) of the 55 LVAD-centers, specialist palliative care was available. The median duration between LVAD-implantation and first specialist palliative care contact was 17 months (IQR 6.3-50.3 months). Median duration between consultation and death was seven days (IQR 3-28 days). 65% of consults took place in an intensive/intermediate care unit with half of the patients having a Do-Not-Resuscitate order. Care planning significantly increased during involvement (advance directives before: n = 15, after: n = 19, p < 0.001; DNR before: n = 20, after: n = 28, p < 0.001). Symptom burden as assessed at first specialist palliative care contact was higher compared to the consultation requests (request: median 3 symptoms (IQR 3-6); first contact: median 9 (IQR 6-10); p < 0.001) with a focus on weakness, anxiety, overburdening of next-of-kin and dyspnea. More than 70% of patients died during index hospitalization, one third of these in a palliative care unit. CONCLUSIONS: This largest European multicenter investigation of LVAD-patients receiving specialist palliative care shows a late integration and high physical and psychosocial symptom burden. This study highlights the urgent need for earlier integration to identify and address poorly controlled symptoms. Further studies and educational efforts are needed to close the gap between guideline-recommendations and the current status quo.

Heart transplantation in the era of corona virus disease 2019: Impact of the pandemic on donors, recipients and outcome.

INTRODUCTION: Since March 2020, the COVID-19 pandemic has tremendously impacted health care all around the globe. We analyzed the impact of the pandemic on donors, recipients, and outcome of heart transplantation (HTx). METHODS: Between 2010 and early 2022, a total of n = 235 patients underwent HTx in our department. Patients were assigned to the study groups regarding the date of the performed HTx. Group 1 (09/2010 to 02/2020): n = 160, Group 2 (03/2020 to 02/2022): n = 75. RESULTS: Since the pandemic, the etiology of heart failure in the recipients has shifted from dilated (Group 1: 53.8%, Group 2: 32.0%) to ischemic cardiomyopathy (Group 1: 39.4%, Group 2: 50.7%, p < .01). The percentage of high urgency status of the recipients dropped from 50.0% to 36.0% (p = .05), and the use of left ventricular assist (LVAD) support from 56.9% to just 37.3% (p < .01). Meanwhile, the waiting time for the recipients also decreased by about 40% (p = .05). Since the pandemic, donors were 2- times more likely to have been previously resuscitated (Group 1: 21.3%, Group 2: 45.3% (p < .01), and drug abuse increased by more than 3-times (p < .01), indicating acceptance of more marginal donors. Surprisingly, the incidence of postoperative severe primary graft dysfunction requiring extracorporeal life support decreased from 33.1% to 19.4% (p = .04) since the pandemic. CONCLUSION: The COVID-19 pandemic affected both donors and recipients of HTX but not the postoperative outcome. Donors nowadays are more likely to suffer from ischemic heart disease and are less likely to be on the high-urgency waitlist and on LVAD support. Simultaneously, an increasing number of marginal donors are accepted, leading to shorter waiting times.

Impact of circadian rhythm and daytime variation on outcome after heart transplantation.

INTRO: Recently, the impact of circadian rhythm and daytime variation on surgical outcomes has attracted interest. Although studies for coronary artery and aortic valve surgery report contrary results, effects on heart transplantation have not been studied. METHODS: Between 2010 and February 2022, 235 patients underwent HTx in our department. The recipients were reviewed and categorized according to the start of the HTx procedure - between 04:00 am and 11:59 am (morning, n = 79), 12:00 pm and 07:59 pm (afternoon, n = 68) or 08:00 pm and 03:59 am (night, n = 88). RESULTS: The incidence of high urgency status was slightly but not significantly increased (p = .08) in the morning (55.7%), compared to the afternoon (41.2%) or night (39.8%). The most important donor and recipient characteristics were comparable among the three groups. The incidence of severe primary graft dysfunction (PGD) requiring extracorporeal life support (morning: 36.7%, afternoon: 27.3%, night: 23.0%, p = .15) was also similarly distributed. In addition, there were no significant differences for kidney failure, infections, and acute graft rejection. However, the incidence of bleeding that required rethoracotomy showed an increased trend in the afternoon (morning: 29.1%, afternoon: 40.9%, night: 23.0%, p = .06). 30-day survival (morning: 88.6%, afternoon: 90.8%, night: 92.0%, p = .82) and 1-year survival (morning: 77.5%, afternoon: 76.0%, night: 84.4%, p = .41) were comparable between all groups. CONCLUSION: Circadian rhythm and daytime variation did not affect the outcome after HTx. Postoperative adverse events as well as survival were comparable throughout day- and night-time. As the timing of the HTx procedure is rarely possible and depends on the timing of organ recovery, these results are encouraging, as they allow for the continuation of the prevalent practice.

Clinical outcomes of hundred large Impella implantations in cardiogenic shock patients based on individual clinical scenarios.

BACKGROUND: Large Impella systems (5.0 or 5.5; i.e., Impella 5+) (Abiomed Inc., Danvers, MA, USA) help achieve better clinical outcomes through relevant left ventricular unloading in acute cardiogenic shock (CS). Here, we report our experience with Impella 5+, while focusing on the clinical outcomes depending on individual case scenarios in patients with acute CS. METHODS: This single-center retrospective observational study included 100 Impella 5+ implantations conducted on patients with acute CS from November 2018 to October 2021. After excluding 10 reimplantation cases, 90 cases were enrolled for further analysis. RESULTS: In-hospital and 30-day mortality rates were 56.7% (n = 51) and 48.9% (n = 44), respectively. In-hospital mortality was lower in patients with acute myocardial infarction (AMI) than in non-AMI patients (p = 0.07). Young age and low lactate levels were the independent predictors of successful transition and survival after permanent mechanical circulatory support/heart transplantation (pMCS/HTX) (age, p = 0.03; lactate level, p = 0.04; survived after pMCS/HTX, n = 11; died on Impella, n = 41). During simultaneous utilization of venoarterial extracorporeal membrane oxygenation therapy and Impella 5+, termed ECMELLA therapy, high dose of noradrenaline was a predictive factor for in-hospital mortality by multivariate analysis (n = 0.02). CONCLUSIONS: Our results suggest that enhanced Impella support might have better clinical outcomes among acute CS patients supported with large Impella, those with AMI than those with no AMI. Young age and low lactate levels were predictors of successful bridging to pMCS/HTX and favorable clinical outcomes thereafter. The clinical outcomes of ECMELLA therapy might depend on noradrenaline dose at the time of Impella 5+ implantation.

Changes in Therapy and Outcome of Patients Requiring Veno-Venous Extracorporeal Membrane Oxygenation for COVID-19.

BACKGROUND: Coronavirus disease 2019 (COVID-19)-related acute respiratory distress syndrome requiring veno-venous extracorporeal membrane oxygenation (vv-ECMO) is related with poor outcome, especially in Germany. We aimed to analyze whether changes in vv-ECMO therapy during the pandemic were observed and lead to changes in the outcome of vv-ECMO patients. METHODS: All patients undergoing vv-ECMO support for COVID-19 between 2020 and 2021 in a single center (n = 75) were retrospectively analyzed. Weaning from vv-ECMO and in-hospital mortality were defined as primary and peri-interventional adverse events as secondary endpoints of the study. RESULTS: During the study period, four infective waves were observed in Germany. Patients were assigned correspondingly to four study groups: ECMO implantation between March 2020 and September 2020: first wave (n = 11); October 2020 to February 2021: second wave (n = 23); March 2021 to July 2021: third wave (n = 25); and August 2021 to December 2021: fourth wave (n = 20). Preferred cannulation technique changed within the second wave from femoro-femoral to femoro-jugular access (p < 0.01) and awake ECMO was implemented. Mean ECMO run time increased by more than 300% from 10.9 ± 9.6 (first wave) to 44.9 ± 47.0 days (fourth wave). Weaning of patients was achieved in less than 20% in the first wave but increased to approximately 40% since the second one. Furthermore, we observed a continuous numerically decrease of in-hospital mortality from 81.8 to 57.9% (p = 0.61). CONCLUSION: Preference for femoro-jugular cannulation and awake ECMO combined with preexisting expertise and patient selection are considered to be associated with increased duration of ECMO support and numerically improved ECMO weaning and in-hospital mortality.

[Recommendations of the S3 Guideline "Use of Extracorporeal Circulation (ECLS/ ECMO) for Cardiac and Circulatory Failure" of the Association of Scientific Medical Societies in Germany]. / Empfehlungen der S3-Leitlinie (AWMF) "Einsatz der extrakorporalen Zirkulation (ECLS/ECMO) bei Herz- und Kreislaufversagen".

In recent years, the use of mechanical support for patients with cardiac or circulatory failure has continuously increased, leading to 3,000 ECLS/ECMO (extracorporeal life support/extracorporeal membrane oxygenation) implantations annually in Germany. Due to the lack of guidelines, there is an urgent need for evidence-based recommendations addressing the central aspects of ECLS/ECMO therapy. In July 2015, the generation of a guideline level S3 according to the standards of the Association of the Scientific Medical Societies in Germany (AWMF) was announced by the German Society for Thoracic and Cardiovascular Surgery (GSTCVS). In a well-structured consensus process, involving experts from Germany, Austria and Switzerland, delegated by 16 scientific societies and the patients' representation, the guideline "Use of extracorporeal circulation (ECLS/ECMO) for cardiac and circulatory failure" was created under guidance of the GSTCVS, and published in February 2021. The guideline focuses on clinical aspects of initiation, continuation, weaning and aftercare, herein also addressing structural and economic issues. This article presents an overview on the methodology as well as the final recommendations.

Donor hypernatremia is associated with increased mortality after heart transplantation: A retrospective study.

BACKGROUND AND AIMS: Donor hypernatremia has been associated with primary graft dysfunction in heart transplantation (HTx) and is correlated with impaired outcome following liver and renal transplantation. However, controversial data exist regarding the impact of sodium dysregulation on survival. This study aims to investigate the impact of donor sodium levels on early morbidity and short- and midterm survival following HTx. METHODS: Between September 2010 and June 2021, a total of n = 218 patients underwent HTx in our center. From those, 214 could be included retrospectively in our study. For each donor, sodium levels were collected and different cut-off levels from 145 to 159 mmol/L were investigated by Kaplan-Meier-analysis. Then, recipients were divided in three groups regarding donor sodium: Normonatremia (133-145 mmol/L, n = 73), mild hypernatremia (146-156 mmol/L, n = 105) and severe hypernatremia (>156 mmol/L, n = 35). Recipient and donor variables were reviewed and compared, including peri- and postoperative characteristics and recipient survival after up to 5 years after transplantation. RESULTS: All patients were comparable regarding baseline characteristics and perioperative parameters. Regarding early mortality, 90-day survival was significantly reduced only in patients with severe donor hypernatremia in comparison to normonatremia (90% vs. 71%, p = .02), but not in mild hypernatremia (89%, p = .89). One-year survival was comparable in all groups (p > .28). CONCLUSION: Severe donor hypernatremia was associated with reduced short-term survival, while the correlation weakens > 1 year after HTx. As our study is limited due to the nature of its retrospective, single-center approach, future prospective studies are needed to evaluate the importance of donor management with regard to hypernatremia.

COVID-19 pandemic deteriorates aftercare attendance in heart transplant recipients independently of perceived impact on social life.

BACKGROUND: Heart transplant (HTx) recipients are at an increased risk of developing infections or malignancies due to immunosuppressive medication. Thus, regular aftercare in those patients is of utmost importance. The extent of collateral damage due to the COVID-19 pandemic (delayed or canceled clinical visits and diagnostics) on high-risk patients is yet unknown. We believe that, especially for HTx-patients, data acquisition on potential pandemic-related nonattendance is crucial to improve clinical care in the future. Therefore, we aim to decipher possible COVID-19-related alterations in attendance to clinical care after HTx using a survey-based approach. METHODS: HTx recipients, 2 years beyond transplantation were selected (n = 75). We filed a paper-based questionnaire or an online survey containing nine items about COVID-19-related exceptional circumstances. Fifty-two patients (69%) returned fully answered questionnaires. RESULTS: A perceived impact on daily life was evident with 79% of all patients, reporting a moderate-to-severe negative influence of the COVID-19 pandemic on daily routine. We detected increased nonattendance of clinical care during the COVID-19 pandemic compared to prepandemic time (38 vs. 6%, p < .0001). The various diagnostic modalities of aftercare were heterogeneously affected, ranging from 2% nonattendance for influence vaccination and 18% for colonoscopy. Off note, nonattendance to clinical care within the pandemic was independent of perceived impact of the pandemia on daily life (p > .68). CONCLUSIONS: For the first time, we objectively demonstrate a significant decrease in attendance to clinical care in HTx recipients during the COVID-19 pandemic. Efforts are needed to increase attendance in this highly vulnerable patient cohort.

Cytomegalovirus in the transplant setting: Where are we now and what happens next? A report from the International CMV Symposium 2021.

The CMV Symposium in September 2021 was an international conference dedicated to cytomegalovirus (CMV) infection after solid organ or hematopoietic stem cell transplantation. This review provides an overview of the presentations given by the expert faculty, supplemented with educational clinical cases. Topics discussed include CMV epidemiology and diagnosis, the burden of CMV infection and disease, CMV-specific immunity and management of CMV in transplant settings. Major advances in the prevention and treatment of CMV in the past decade and increased understanding of CMV immunity have led to improved patient outcomes. In the future, management algorithms may be individualized based on the transplant recipient's immune profile, which will mark the start of a new era for patients with CMV.

Predictive Value of Body Mass Index in Minimally Invasive Mitral Valve Surgery.

BACKGROUND: With this study we aimed to analyze if the separate consideration of body mass index (BMI) could provide any superior predictive values compared with the established risk scores in isolated minimally invasive mitral valve surgery (MIMVS). This might facilitate future therapeutic decision-making, e.g., regarding the question surgery versus transcatheter mitral valve repair (TMVr). METHODS: We assessed the relevance of BMI in non-underweight patients who underwent isolated MIMVS. The risk predictive potential of BMI for mortality and several postoperative adverse events was assessed in 429 consecutive patients. This predictive potential was compared with that of European System for Cardiac Outcome Risk Evaluation II (EuroSCORE II) and the Society of Thoracic Surgeons score (STS score) using a comparative receiver operating characteristic curve analysis. RESULTS: BMI was a significant numeric predictor of wound healing disorders (p = 0.001) and proved to be significantly superior in case of this postoperative adverse event compared with the EuroSCORE II (p = 0.040) and STS score (p = 0.015). Except for this, the predictive potential of BMI was significantly inferior compared with that of the EuroSCORE II and STS score for several end points, including 30-day (p = 0.029 and p = 0.006) and 1-year (p = 0.012 and p = 0.001) mortality. CONCLUSION: Therefore, we suggest that, in the course of decision-making regarding the right treatment modality for non-underweight patients with isolated mitral valve regurgitation, the sole factor of BMI should not be given a predominant weight.

Removal of Electrophysiological Devices in the Context of Heart Transplantation: Comparison of Combined and Staged Extraction Procedures.

BACKGROUND: During heart transplantation (HTx), tip of the leads of cardiac implantable electrophysiological devices (CIEPD) has to be cut when resecting the heart. Timing of the removal of the remaining device and leads is still discussed controversially. METHODS: Between 2010 and 2021, n = 201 patients underwent HTx, of those n = 124 (61.7%) carried a present CIEPD. These patients were divided on the basis of the time of complete device removal (combined procedure with HTx, n = 40 or staged procedure, n = 84). RESULTS: CIEPD was removed 11.4 ± 6.7 days after the initial HTx in staged patients. Dwelling time, number of leads as well as incidence of retained components (combined: 8.1%, staged: 7.7%, p = 1.00) were comparable between both groups. While postoperative incidence of infections (p = 0.52), neurological events (p = 0.47), and acute kidney injury (p = 0.44) did not differ, staged patients suffered more often from primary graft dysfunction with temporary mechanical assistance (combined: 20.0%, staged: 40.5%, p = 0.03). Consecutively, stay on intensive care unit (p = 0.02) was prolonged and transfusions of red blood cells (p = 0.15) and plasma (p = 0.06) as well as re-thoracotomy for thoracic bleeding complications (p = 0.10) were numerically increased in this group. However, we did not observe any differences in postoperative survival. CONCLUSION: Presence of CIEPD is common in HTx patients. However, the extraction strategy of CIEPD most likely did not affect postoperative morbidity and mortality except primary graft dysfunction. Especially, retained components, blood transfusions, and infective complications are not correlated to the timing of CIEPD removal.

Coronary artery bypass grafting under sole Impella 5.0 support for patients with severely depressed left ventricular function.

Selection of the ideal surgical procedure for coronary revascularization in patients with severe cardiac dysfunction at times may represent a challenge. In recent years, with the advent of surgical large microaxial pumps, e.g., Impella 5.0 (Abiomed Inc., Boston, USA), specific support and effective unloading of the left ventricle has become available. In the interventional field, good results have been achieved with smaller microaxial pumps in the setting of so-called protected percutaneous coronary intervention. In this study, we would like to share our early experience with surgical coronary revascularization under the sole support of Impella 5.0, omitting the use of heart-lung machine in three cases of severe cardiac dysfunction due to complex ischemic heart disease. Effective circulatory support intraoperatively and postoperatively speaks in favor of this technique in selected patients.

Effect of preoperative erector spinae muscles mass on postoperative outcomes in patients with left ventricular assist devices.

BACKGROUND: Frailty influences the postoperative outcomes in patients undergoing left ventricular assist device (LVAD) implantation. Recently, erector spinae muscle (ESM) mass has been proposed as a parameter to assess frailty accurately. Thus, the purpose of the present study was to evaluate whether preoperative ESM mass is associated with short- and long-term clinical outcomes in patients with LVAD. METHODS: A total of 119 consecutive patients with LVAD were enrolled between January 2010 and October 2017 at a single heart center. The ESM area, ESM index, and Hounsfield units (HU) of the ESM were calculated by computed tomography for preoperative ESM mass evaluation. We then statistically evaluated the in-hospital mortality, major adverse cardiovascular events (MACE), duration of hospital stay, and long-term survival. RESULTS: In a multivariate Cox regression analysis, ESM mass indicated no effect on all clinical outcomes. In addition, the ESM area presented a weak but significant negative linear correlation only with the duration of hospital stay (r = -0.21, p < .05). In contrast, the Model For End-stage Liver Disease (MELD) score and preoperative venous-arterial extracorporeal membrane oxygenation (va-ECMO) were significant predictive factors for in-hospital mortality (MELD score: p < .001, hazard ratio [HR] 1.1; preoperative va-ECMO: p < .01, HR 2.72) and MACE (MELD score: p < .001, HR 1.07; preoperative va-ECMO: p < .005, HR 2.62). CONCLUSION: Preoperative ESM mass might predict the length of hospital stay in patients undergoing LVAD implantation. In contrast, it had no effect on MACE, in-hospital mortality, or long-term survival in this study.

Venoarterial Extracorporeal Membrane Oxygenation for Postcardiotomy Shock-Analysis of the Extracorporeal Life Support Organization Registry.

OBJECTIVES: Refractory postcardiotomy cardiogenic shock complicating cardiac surgery yields nearly 100% mortality when untreated. Use of venoarterial extracorporeal membrane oxygenation for postcardiotomy cardiogenic shock has increased worldwide recently. The aim of the current analysis was to outline the trends in use, changing patient profiles, and in-hospital outcomes including complications in patients undergoing venoarterial extracorporeal membrane oxygenation for postcardiotomy cardiogenic shock. DESIGN: Analysis of extracorporeal life support organization registry from January 2010 to December 2018. SETTING: Multicenter worldwide registry. PATIENTS: Seven-thousand one-hundred eighty-five patients supported with venoarterial extracorporeal membrane oxygenation for postcardiotomy cardiogenic shock. INTERVENTIONS: Venoarterial extracorporeal membrane oxygenation. MEASUREMENTS AND MAIN RESULTS: Hospital death, weaning from extracorporeal membrane oxygenation, hospital complications. Mortality predictors were assessed by multivariable logistic regression. Propensity score matching was performed for comparison of peripheral and central cannulation for extracorporeal membrane oxygenation. A significant trend toward more extracorporeal membrane oxygenation use in recent years (coefficient, 0.009; p < 0.001) was found. Mean age was 56.3 ± 14.9 years and significantly increased over time (coefficient, 0.513; p < 0.001). Most commonly, venoarterial extracorporeal membrane oxygenation was instituted after coronary artery bypass surgery (26.8%) and valvular surgery (25.6%), followed by heart transplantation (20.7%). Overall, successful extracorporeal membrane oxygenation weaning was possible in 4,520 cases (56.4%), and survival to hospital discharge was achieved in 41.7% of cases. In-hospital mortality rates remained constant over time (coefficient, -8.775; p = 0.682), whereas complication rates were significantly reduced (coefficient, -0.009; p = 0.003). Higher mortality was observed after coronary artery bypass surgery (65.4%), combined coronary artery bypass surgery with valve (68.4%), and aortic (69.6%) procedures than other indications. Lower mortality rates were observed in heart transplantation recipients (46.0%). Age (p < 0.001), central cannulation (p < 0.001), and occurrence of complications while on extracorporeal membrane oxygenation were independently associated with poorer prognosis. CONCLUSIONS: The analysis confirmed increased use of venoarterial extracorporeal membrane oxygenation for postcardiotomy cardiogenic shock. Mortality rates remained relatively constant over time despite a decrease in complications, in the setting of supporting older patients.

Moderate acceptance of COVID-19 vaccination in patients pre- and post-heart transplantation: Experiences from a German Transplant Centre.

INTRODUCTION AND OBJECTIVES: Patients awaiting heart transplantation (HTx) are at increased risk developing severe coronavirus disease 2019 (COVID-19). Patients supported by a left ventricular assist device (LVAD) face additional risks due to coagulopathies during COVID-19. Following HTx, elevated risk factors for severe COVID-19 persist due to chronic immunosuppression and frequent comorbidities. Taken together, COVID-19 vaccination is of critical importance in all three patient cohorts. Here, we report our experience to deliver COVID-19 vaccination in a German transplant center. METHODS AND RESULTS: We screened 211 patients for contraindications and offered the remaining 186 eligible patients COVID-19 vaccination. Of those, 133 patients (71%) accepted the offer and were vaccinated. Acceptance of vaccination differed between HTx recipients (84 of 113, 74%), patients on the waiting list (34 of 47, 72%), and patients with LVAD support (28 of 50, 56%). The LVAD cohort demonstrated lower acceptance levels for vaccination compared to HTx recipients and patients awaiting HTx (74% vs. 56%; p = 0.028). CONCLUSION: We demonstrate for the first time only moderate acceptance levels of COVID-19 vaccination in HTx recipients and candidates on the waiting list compared to general population, despite perceived high-risk for severe disease. Additionally, those supported by LVAD have even lower adherence. Efforts may need to be made to increase acceptance in this vulnerable as well as cost-intensive patient cohort.