Functional Status and Quality of Life 6 Months After Extracorporeal Membrane Oxygenation Therapy for COVID-19-Related Pulmonary Failure.

Extracorporeal membrane oxygenation (ECMO) is increasingly used in COVID-19-related pulmonary failure and the number of patients recovering from COVID-19 is growing. Here, we assess survival and recovery 6 months after ECMO for COVID-19. From April 2020 to September 2021, n = 60 (60.5 [51.0-65.0] years, 23.3% female) were treated with venovenous/venoarterial ECMO for COVID-19. 41.7% were weaned off ECMO, survival-to-discharge was 40.0% (n = 24). Age (63.0 [60.0-66.8] vs. 55.0 [43.8-60.0] years, p < 0.001), vasoactive support (97.2% vs . 75.0%, p = 0.013), and pre-ECMO SOFA scores (13.0 [12.0-14.8] vs. 12.0 [10.0-13.8] p = 0.036) correlated with nonsurvival. All patients aged >65 years, with histories of neoplasia, immunocompromise, chronic renal failure, or frailty died. After 6 months, 20 were alive (6-month survival 33.3%, survival conditioned on survival-to-discharge 83.3%), with follow-up in 19. 57.9% showed no relevant, 26.3% moderate, 15.8% severe deficits. Cardiopulmonary status was satisfactory (mMRC level: 84.2% ≤2). 73.7% were independent in daily life. Cognitive impairments were frequent (52.6%). 26.3% showed moderate depression, 15.8% posttraumatic stress disorder. Social and work life were considerably affected. Extracorporeal membrane oxygenation thus can serve as salvage therapy in COVID-19, but advanced age, immunocompromise, histories of neoplasia, and frailty must be considered as relative contraindications. Age, vasoactive support, and SOFA scores assist discriminating in daily practice. Deficits after 6 months are substantial, and efforts need to focus on long-term recovery.

Identifying patients at risk: multi-centre comparison of HeartMate 3 and HeartWare left ventricular assist devices.

AIMS: Since the withdrawal of HeartWare (HVAD) from the global market, there is an ongoing discussion if and which patients require prophylactically exchange for a HeartMate 3 (HM3). Therefore, it is important to study outcome differences between HVAD and HM3 patients. Because centres differ in patient selection and standard of care, we performed a propensity score (PS)-based study including centres that implanted both devices and aimed to identify which HVAD patients are at highest risk. METHODS AND RESULTS: We performed an international multi-centre study (n = 1021) including centres that implanted HVAD and HM3. PS-matching was performed using clinical variables and the implanting centre. Survival and complications were compared. As a sensitivity analysis, PS-adjusted Cox regression was performed. Landmark analysis with conditional survival >2 years was conducted to evaluate long-term survival differences. To identify which HVAD patients may benefit from a HM3 upgrade, Cox regression using pre-operative variables and their interaction with device type was performed. Survival was significantly better for HM3 patients (P < 0.01) in 458 matched patients, with a median follow-up of 23 months. Within the matched cohort, HM3 patients had a median age of 58 years, and 83% were male, 80% of the HVAD patients were male, with a median age of 59 years. PS-adjusted Cox regression confirmed a significantly better survival for HM3 patients when compared with HVAD, with a HR of 1.46 (95% confidence interval 1.14-1.85, P < 0.01). Pump thrombosis (P < 0.01) and ischaemic stroke (P < 0.01) occurred less in HM3 patients. No difference was found for haemorrhagic stroke, right heart failure, driveline infection, and major bleeding. Landmark-analysis confirmed a significant difference in conditional survival >2 years after implantation (P = 0.03). None of the pre-operative variable interactions in the Cox regression were significant. CONCLUSIONS: HM3 patients have a significantly better survival and a lower incidence of ischaemic strokes and pump thrombosis than HVAD patients. This survival difference persisted after 2 years of implantation. Additional research using post-operative variables is warranted to identify which HVAD patients need an upgrade to HM3 or expedited transplantation.

Extracorporeal life support in therapy-refractory cardiocirculatory failure: looking beyond 30 days.

OBJECTIVES: Venoarterial extracorporeal life support (ECLS) has emerged as a potentially life-saving treatment option in therapy-refractory cardiocirculatory failure, but longer-term outcome is poorly defined. Here, we present a comprehensive follow-up analysis covering all major organ systems. METHODS: From February 2012 to December 2016, 180 patients were treated with ECLS for therapy-refractory cardiogenic shock or cardiac arrest. The 30-day survival was 43.9%, and 30-day survivors (n = 79) underwent follow-up analysis with the assessment of medium-term survival, quality of life, neuropsychological, cardiopulmonary and end-organ status. RESULTS: After a median of 1.9 (1.1-3.6) years (182.4 patient years), 45 of the 79 patients (57.0%) were alive, 35.4% had died and 7.6% were lost to follow-up. Follow-up survival estimates were 78.0% at 1, 61.2% at 3 and 55.1% at 5 years. NYHA class at follow-up was ≤II for 83.3%. The median creatinine was 1.1 (1.0-1.4) mg/dl, and the median bilirubin was 0.8 (0.5-1.0) mg/dl. No patient required dialysis. Overall, 94.4% were free from moderate or severe disability, although 11.1% needed care. Full re-integration into social life was reported by 58.3%, and 39.4% were working. Quality of life was favourable for mental components, but a subset showed deficits in physical aspects. While age was the only peri-implantation parameter significantly predicting medium-term survival, adverse events and functional status at discharge or 30 days were strong predictors. CONCLUSIONS: This study demonstrates positive medium-term outcome with high rates of independence in daily life and self-care but a subset of 10-20% suffered from sustained impairments. Our results indicate that peri-implantation parameters lack predictive power but downstream morbidity and functional status at discharge or 30 days can help identify patients at risk for poor recovery.

Outcome of patients treated with extracorporeal life support in cardiogenic shock complicating acute myocardial infarction: 1-year result from the ECLS-Shock study.

BACKGROUND: Treatment with extracorporeal life support (ECLS) in acute myocardial infarction (AMI) complicated by cardiogenic shock (CS) fell short of improving myocardial recovery measured by 30 day ejection fraction in the ECLS-SHOCK trial. However, to date, no data regarding impact of ECLS on long-term outcomes exist. METHODS: In this randomized, controlled, prospective, open-label trial, 42 patients with CS complicating AMI were randomly assigned to ECLS (ECLS group, n = 21) or no ECLS (control group, n = 21). The primary endpoint was left ventricular ejection fraction (LVEF) after 30 days. Secondary endpoints included mortality and neurological outcome after 12 months. Evaluation of neurological outcome used the modified Rankin Scale. RESULTS: The 12-month all-cause mortality was 19% in the ECLS group versus 38% in the control group (p = 0.31). Only one patient (control group) died after the initial 30 days. Three patients underwent elective percutaneous coronary intervention (PCI) during follow-up (one in the control and two in the ECLS group). Favorable neurological outcome (modified Rankin Score ≤ 2) was seen in 61.9% of patients in the ECLS group versus 57.1% in the control group (p = 1). CONCLUSION: This pilot study showed that randomized studies with ECLS in CS patients are feasible and safe. Small numbers of included patients impede meaningful conclusions about mortality and neurological outcome. Our findings of numerical differences in mortality and survival with severe neurological impairment give an urgent call for larger multi-centric randomized trials assessing the endpoint of all-cause mortality but also considering the effects on neurological outcome measures.

Remote ECLS-Implantation and Transport for Retrieval of Cardiogenic Shock Patients.

OBJECTIVE: Extracorporeal life support (ECLS) emerges as a salvage option in therapy refractory cardiogenic shock but is limited to highly specialized tertiary care centers. Critically ill patients are often too unstable for conventional transport. Mobile ECLS programs for remote implantation and subsequent air or ground-based transport for patient retrieval could solve this dilemma and make full-spectrum advanced cardiac care available to patients in remote hospitals in whom shock otherwise might be fatal. METHODS: From December 2012 to March 2016, 40 patients underwent venoarterial ECLS implantation in remote hospitals with subsequent transport to our center and were retrospectively analyzed. The mobile ECLS team was available 24/7, implantation was performed percutaneously bedside, and compact support systems designed for transport were used. RESULTS: Twenty percent of the patients were female; the mean age was 55 ± 10 years, and the mean Interagency Registry for Mechanically Assisted Circulatory Support score was 1.3 ± 0.5. Patient retrieval was accomplished via ground-based (n = 29, 72.5%, mean distance = 27.9 ± 29.7 km [range, 5.6-107.1 km]) or air (n = 11, mean distance = 62.4 ± 27.2 km [range, 38.9-116.4 km]) transport. No ECLS-related complications occurred during transport. The ECLS system could be explanted in 65.0% (n = 26) of patients, and the 30-day survival rate was 52.5% (n = 21). CONCLUSION: Remote ECLS implantation and interfacility transport on ECLS are feasible and effective. Interdisciplinary teams and full-spectrum cardiac care are essential to achieve optimal outcomes. Rapid-response ECLS networks have the potential to substantially increase the survival of cardiogenic shock patients.

Potential impact of oxygenators with venous air trap on air embolism in veno-arterial Extracorporeal Life Support.

BACKGROUND: Air embolism is a potentially fatal but underrecognized complication in Extracorporeal Life Support (ECLS). Oxygenators containing venous air traps have been developed to minimize the risk of air embolism in daily care. OBJECTIVE: We reproduced air embolism as occurring via a central venous catheter in an experimental setting to test the potential of oxygenators with and without venous bubble trap (VBT) to withhold air. METHODS: An in vitro ECLS circuit was created and a central venous catheter with a 3-way stopcock and a perforated male luer cap was inserted into the inflow line. Three different oxygenators with and without VBT and their capability to withhold air were examined. After 60 seconds of stable ECLS flow, the stopcock was opened towards the atmosphere for 3 minutes. Afterwards, air accumulation within the oxygenator was determined. RESULTS: Comparison of the total air entrapment showed a significant superiority of the oxygenators with VBT (p < 0.001). All oxygenators were able to partly withhold macro air boli, however, the capacity of oxygenators with VBT was higher. Passing through the oxygenator resulted in a reduction of microbubbles in all cases. CONCLUSIONS: Macro air emboli can be substantially reduced by usage of oxygenators that contain a VBT, whereas the capability to withhold microbubbles to a vast extent seems to depend on the intrinsic oxygenator's membrane.

When all else fails: extracorporeal life support in therapy-refractory cardiogenic shock.

OBJECTIVES: No guidelines for mechanical circulatory support in patients with therapy-refractory cardiogenic shock and multiorgan failure including ongoing cardiopulmonary resuscitation (CPR) exist. To achieve immediate cardiopulmonary stabilization, we established an interdisciplinary concept with on-site percutaneous extracorporeal life support (ECLS) implantation. METHODS: From February 2012 to November 2014, 96 patients were deemed eligible for ECLS implantation. Establishing ECLS was successful in 87 patients (mean age 54 ± 13 years, 16% female, initial flow 4.4 ± 0.9 l/min). Aetiologies included acute coronary syndromes (n = 52, 60%), cardiomyopathies (n = 25, 29%) and other pathologies. Fifty-nine patients (68%) had been resuscitated, and in 27 (31%), implantation was performed during CPR; 11 patients (13%) were awake at implantation and 20 (23%) underwent implantation in the referring hospital. RESULTS: Metabolic parameters differed in non-survivors versus survivors before ECLS implantation (pH 7.15 ± 0.23 vs. 7.27 ± 0.18, P = 0.007; lactate levels 10.90 ± 6.00 mmol/l vs. 8.79 ± 5.78 mmol/l, P = 0.091) and 6 h postimplantation (pH 7.27 ± 0.11 vs. 7.37 ± 0.11, P < 0.001; lactate levels 10.19 ± 5.52 mmol/l vs. 5.52 ± 4.17 mmol/l, P < 0.001). Altogether 44 patients could be weaned, and 9 were bridged to assist device implantation and 1 to heart transplantation. The mean time of support was 6 days, and the 30-day survival rate was 47% (n = 41). CONCLUSIONS: ECLS serves as a bridge-to-decision and bridge-to-treatment device. Our interdisciplinary ECLS programme achieved acceptable survival of critically ill patients despite a substantial percentage of patients having been resuscitated and no absolute exclusion criteria. Further studies defining inclusion- and exclusion criteria might additionally improve outcome.

The relevance of 18F-fluorodeoxyglucose positron emission tomography/computed tomography imaging in diagnosing prosthetic graft infections post cardiac and proximal thoracic aortic surgery.

OBJECTIVES: Diagnosis of prosthetic graft infection after cardiac and proximal aortic surgery is a challenge. Besides technical considerations, redo surgery is associated with substantial morbidity and mortality. Therefore, an accurate diagnosis is mandatory. We report on our experience with hybrid 18-fluorodeoxyglucose positron emission tomography ((18)F-FDG PET)/computed tomography (CT) imaging, which is increasingly used to diagnose infections in the detection of graft infection after cardiac surgery. METHODS: Twenty-six patients who underwent (18)F-FDG PET/CT imaging after cardiac surgery between February 2010 and September 2014 for suspected graft infection were retrospectively analysed (81% male, age 54.3 ± 13.7 years). PET/CT imaging was performed 36.5 ± 70.5 (0.5-300) months after surgery. 2 patients (8%) had undergone aortic valve replacement (concomitant ascending and proximal arch replacement in 1), 1 (4%) aortic root reconstruction, 9 (35%) aortic root replacement (concomitant partial arch in 4, arch replacement and postoperative TEVAR in 1), 2 (8%) ascending aortic and partial arch replacement and 2 (8%) ascending aortic replacement along with frozen elephant trunk. In 10 (38%), more than one previous cardiac surgical procedure had been performed. Maximum standardized uptake values (SUVmax) were obtained for all patients. If the patients were reoperated on, the final diagnosis was derived from intraoperative findings and/or microbiological results. Otherwise, the longest clinical follow-up available served as a reference. RESULTS: Conventional CT was positive for infection in 13 cases (50%). In 22 (85%), PET was indicative of infection (SUVmax 10.5 ± 4.1). PET did not only confirm true-positive CT results in all but 1 case; in almost 30%, it provided substantial additional diagnostic information in comparison with CT alone. Receiver operating characteristic analysis identified an SUVmax of 7.25 to achieve maximum sensitivity (89%) and specificity (100%) in prediction of infection. Twelve patients (46%) required redo surgery for graft infection; in 1 additional patient (4%), sternal re-fixation was necessary. Furthermore, 2 patients had to be reoperated on for torn-out anastomosis and paraprosthetic perfusion (8%). CONCLUSIONS: PET provides functional data, confirms a CT diagnosis and may even increase diagnostic sensitivity in comparison with CT alone in selected cases. Specificity can be compromised by postoperative changes or chronic inflammatory reactions induced by the graft. CT and/or echocardiography should remain the first diagnostic step in case of a suspected infection because of their broad and fast availability. If confirmation is needed or diagnosis is not achievable using conventional methods, PET might be chosen as the next modality to gain additional information in experienced centres.

Diagnosis of coronary affection in patients with AADA and treatment of postcardiotomy myocardial failure using extracorporeal life support (ECLS).

BACKGROUND: Myocardial ischemia due to concomitant coronary artery disease (CAD) or coronary dissection in patients with acute aortic dissection type Stanford A (AADA) is associated with myocardial failure and poor outcomes. Preoperative coronary angiography in this group of patients is still debated. The use of CT scan to diagnose coronary affection along with the establishment of high-pitched dual-spiral CT protocols are essential for improving outcomes. METHODS: We retrospectively analyzed six AADA patients with heart failure who were treated using extracorporeal life support (ECLS). Options for diagnosing coronary affection and different therapeutic strategies for postcardiotomy cardiogenic shock in this patient cohort are discussed. RESULTS: Retrospective review of CT images showed coronary abnormalities in 83% (n=5). Four patients (67%) underwent unplanned coronary artery bypass grafting (CABG). ECLS was instituted in 67% (n=4) due to left heart failure and in 33% (n=2) due to right heart failure. Thirty day mortality was 67% (n=4). The two patients that received ECLS for right ventricular support survived and both had undergone CABG. CONCLUSION: Besides preoperative evaluation of the extent of the dissection, focus on coronary affection in CT-scans helps to triage the operative procedure. Hybrid operating rooms allow for immediate interventional and/or surgical treatment and enable for immediate control of revascularization results. The use of ECLS over other types of ventricular support systems may allow for myocardial recovery in selected cases.