Among patients with out-of-hospital cardiac arrest (OHCA) and ventricular fibrillation, more than half present with refractory ventricular fibrillation unresponsive to initial standard advanced ...cardiac life support (ACLS) treatment. We did the first randomised clinical trial in the USA of extracorporeal membrane oxygenation (ECMO)-facilitated resuscitation versus standard ACLS treatment in patients with OHCA and refractory ventricular fibrillation.
For this phase 2, single centre, open-label, adaptive, safety and efficacy randomised clinical trial, we included adults aged 18–75 years presenting to the University of Minnesota Medical Center (MN, USA) with OHCA and refractory ventricular fibrillation, no return of spontaneous circulation after three shocks, automated cardiopulmonary resuscitation with a Lund University Cardiac Arrest System, and estimated transfer time shorter than 30 min. Patients were randomly assigned to early ECMO-facilitated resuscitation or standard ACLS treatment on hospital arrival by use of a secure schedule generated with permuted blocks of randomly varying block sizes. Allocation concealment was achieved by use of a randomisation schedule that required scratching off an opaque layer to reveal assignment. The primary outcome was survival to hospital discharge. Secondary outcomes were safety, survival, and functional assessment at hospital discharge and at 3 months and 6 months after discharge. All analyses were done on an intention-to-treat basis. The study qualified for exception from informed consent (21 Code of Federal Regulations 50.24). The ARREST trial is registered with ClinicalTrials.gov, NCT03880565.
Between Aug 8, 2019, and June 14, 2020, 36 patients were assessed for inclusion. After exclusion of six patients, 30 were randomly assigned to standard ACLS treatment (n=15) or to early ECMO-facilitated resuscitation (n=15). One patient in the ECMO-facilitated resuscitation group withdrew from the study before discharge. The mean age was 59 years (range 36–73), and 25 (83%) of 30 patients were men. Survival to hospital discharge was observed in one (7%) of 15 patients (95% credible interval 1·6–30·2) in the standard ACLS treatment group versus six (43%) of 14 patients (21·3–67·7) in the early ECMO-facilitated resuscitation group (risk difference 36·2%, 3·7–59·2; posterior probability of ECMO superiority 0·9861). The study was terminated at the first preplanned interim analysis by the National Heart, Lung, and Blood Institute after unanimous recommendation from the Data Safety Monitoring Board after enrolling 30 patients because the posterior probability of ECMO superiority exceeded the prespecified monitoring boundary. Cumulative 6-month survival was significantly better in the early ECMO group than in the standard ACLS group. No unanticipated serious adverse events were observed.
Early ECMO-facilitated resuscitation for patients with OHCA and refractory ventricular fibrillation significantly improved survival to hospital discharge compared with standard ACLS treatment.
National Heart, Lung, and Blood Institute.
The prevalence of coronary artery disease (CAD) among patients with refractory out-of-hospital (OH) ventricular fibrillation (VF)/ventricular tachycardia (VT) cardiac arrest is unknown.
The goal of ...this study was to describe the prevalence and complexity of CAD and report survival to hospital discharge in patients experiencing refractory VF/VT cardiac arrest treated with a novel protocol of early transport to a cardiac catheterization laboratory (CCL) for extracorporeal life support (ECLS) and revascularization.
Between December 1, 2015, and December 1, 2016, consecutive adult patients with refractory OH VF/VT cardiac arrest requiring ongoing cardiopulmonary resuscitation were transported by emergency medical services to the CCL. ECLS, coronary angiography, and percutaneous coronary intervention were performed, as appropriate. Functionally favorable survival to hospital discharge (Cerebral Performance Category 1 or 2) was determined. Outcomes in a historical comparison group were also evaluated.
Sixty-two (86%) of 72 transported patients met emergency medical services transport criteria. Fifty-five (89%) of the 62 patients met criteria for continuing resuscitation on CCL arrival; 5 had return of spontaneous circulation, 50 received ECLS, and all 55 received coronary angiography. Forty-six (84%) of 55 patients had significant CAD, 35 (64%) of 55 had acute thrombotic lesions, and 46 (84%) of 55 had percutaneous coronary intervention with 2.7 ± 2.0 stents deployed per patient. The mean SYNTAX score was 29.4 ± 13.9. Twenty-six (42%) of 62 patients were discharged alive with Cerebral Performance Category 1 or 2 versus 26 (15.3%) of 170 in the historical comparison group (odds ratio: 4.0; 95% confidence interval: 2.08 to 7.7; p < 0.0001).
Complex but treatable CAD was prevalent in patients with refractory OH VF/VT cardiac arrest who also met criteria for continuing resuscitation in the CCL. A systems approach using ECLS and reperfusion seemed to improve functionally favorable survival.
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Resuscitation of refractory out-of-hospital ventricular fibrillation/ventricular tachycardia (VF/VT) cardiac arrest using extracorporeal membrane oxygenation (ECMO) establishes a complex patient ...population. We aimed to describe the critical care strategies and outcomes in this population.
Between December 1, 2015 and January 1, 2018, 100 consecutive adult patients with refractory VF/VT out-of-hospital cardiac arrest and ongoing CPR were transported to the cardiac catheterization laboratory. ECMO, coronary angiography, and percutaneous coronary intervention were performed. Patients achieving an organized cardiac rhythm were admitted to the cardiac intensive care unit (CICU). All patients were considered eligible for necessary intervention/surgery until declaration of death.
Of 100 appropriately transported patients, 83 achieved CICU admission. 40/83 (48%) discharged functionally intact. Multi-system organ failure occurred in all patients. Cardiac, pulmonary, renal, and liver injury improved within 3–4 days. Neurologic injury caused death in 26/37 (70%) patients. Poor neurologic outcomes were associated with anoxic injury or cerebral edema on admission head CT, decline in cerebral oximetry over the first 48 h, and elevated neuron specific enolase on CICU admission. For survivors, mean time to ECMO decannulation was 3.5 ± 0.2 days, following commands at 5.7 ± 0.8 days, and hospital discharge at 21 ± 3.2 days. 41/83 (49%) patients developed infections. CPR caused traumatic injury requiring procedural/surgical intervention in 22/83 (27%) patients.
Multi-system organ failure is ubiquitous but treatable with adequate hemodynamic support. Neurologic recovery was prolonged requiring delayed prognostication. Immediate 24/7 availability of surgical and medical specialty expertise was required to achieve 48% functionally intact survival.
Objectives This study sought to assess the impact of continuous flow left ventricular assist devices (LVADs) on functional capacity and heart failure-related quality of life. Background Newer ...continuous-flow LVAD are smaller and quieter than pulsatile-flow LVADs. Methods Data from advanced heart failure patients enrolled in the HeartMate II LVAD (Thoratec Corporation, Pleasanton, California) bridge to transplantation (BTT) (n = 281) and destination therapy (DT) (n = 374) trials were analyzed. Functional status (New York Heart Association NYHA functional class, 6-min walk distance, patient activity scores), and quality of life (Minnesota Living With Heart Failure MLWHF and Kansas City Cardiomyopathy Questionnaires KCCQ) were collected before and after LVAD implantation. Results Compared with baseline, LVAD patients demonstrated early and sustained improvements in functional status and quality of life. Most patients had NYHA functional class IV symptoms at baseline. Following implant, 82% (BTT) and 80% (DT) of patients at 6 months and 79% (DT) at 24 months improved to NYHA functional class I or II. Mean 6-min walk distance in DT patients was 204 m in patients able to ambulate at baseline, which improved to 350 and 360 m at 6 and 24 months. There were also significant and sustained improvements from baseline in both BTT and DT patients in median MLWHF scores (by 40 and 42 U in DT patients, or 52% and 55%, at 6 and 24 months, respectively), and KCCQ overall summary scores (by 39 and 41 U, or 170% and 178%). Conclusions Use of a continuous flow LVAD in advanced heart failure patients results in clinically relevant improvements in functional capacity and heart failure-related quality of life.
Left ventricular assist devices (LVADs) are increasingly used in patients with heart failure. To study the impact of stroke on clinical outcomes after continuous-flow (CF-) LVAD implantation, we ...evaluated our single-center experience.
From 2006 to 2013, we implanted the HeartMate II CF-LVAD in 230 patients. We used standard statistical methods to evaluate our results.
Of our study group, 185 patients (80.4%) received the CF-LVAD as a bridge to transplantation. Strokes occurred in a total of 39 patients (17%), an incidence rate of 0.064 strokes per person-year: 19 (48.7%) were embolic, and 20 (51.3%) were hemorrhagic. The stroke-free rate at 6 months after HeartMate II implantation was 92.6%, at 12 months, 89.6%, and at 24 months, 86.1%. Baseline demographic characteristics did not differ significantly, except that stroke patients had a lower incidence of coronary artery disease (p = 0.004) and prior cardiac surgery (p = 0.001). We noted a trend toward an increased risk of stroke in patients with CF-LVAD-related infections (p = 0.053). The survival rate in stroke (versus stroke-free) patients at 6 months was 84.6% (versus 84.2%); at 12 months, 71.8% (versus 81.6%); and at 24 months, 53.9% (versus 74.7%; p = 0.0019). During a median follow-up time of 761 days, mortality risk in stroke patients was 2.01 times that of stroke-free patients (hazard ratio = 2.01; p = 0.004).
Stroke while on CF-LVAD support was associated with significant mortality. To reduce the risk of stroke, it is essential to further elucidate risk factors, to optimize anticoagulation, and to further understand the impact of LVAD-related infections.
The association between ventricular arrhythmias (VAs) and mortality in patients supported by continuous flow left ventricular assist devices (LVAD) remains controversial. To evaluate the association ...between pre-implantation, early (≤ 30 day) post-implantation VAs and mortality in bridge to transplant (BTT) and destination therapy (DT) LVAD patients, separately. The risk factors for post LVAD VAs were also investigated. In this observational cohort study, we included 341 patients who received a first time, continuous flow LVAD between January 1st 2010 and July 30th 2018. We used Kaplan-Meier curves and multivariable cox regression analyses to study the association between VAs and mortality in the BTT and DT populations. The mean age of the cohort was 58 ± 14 years, with 82% males, 53% had ischemic cardiomyopathy, and 45% were DT. The mean follow-up was 2.2 ± 2.1 years. In both BTT and DT cohorts, pre LVAD VAs were not associated with mortality after LVAD implantation (log-rank p = 0.95 and p = 0.089, respectively). In the BTT population, early post-LVAD VAs were not statistically associated with increased mortality (log rank p = 0.072). In the DT patients, early post LVAD VAs were associated with a 67% increase in the hazards rate of mortality on LVAD support (HR 1.67 1.05-2.65, p = 0.029). The final model was adjusted for type of cardiomyopathy, INTERMACS profile, glomerular filtration rate, post LVAD atrial fibrillation, age and cerebrovascular events. Early post-LVAD VA is common after LVAD implantation and is an independent predictor of mortality in the DT LVAD population.
The HeartWare Ventricular Assist System (HeartWare Inc, Framingmam, MA) is a miniaturized implantable, centrifugal design, continuous-flow blood pump. The pivotal bridge to transplant and continued ...access protocols trials have enrolled patients with advanced heart failure in a bridge-to-transplant indication.
The primary outcome, success, was defined as survival on the originally implanted device, transplant, or explant for ventricular recovery at 180 days. Secondary outcomes included an evaluation of survival, functional and quality of life outcomes, and adverse events.
A total of 332 patients in the pivotal bridge to transplant and continued access protocols trial have completed their 180-day primary end-point assessment. Survival in patients receiving the HeartWare pump was 91% at 180 days and 84% at 360 days. Quality of life scores improved significantly, and adverse event rates remain low.
The use of the HeartWare pump as a bridge to transplant continues to demonstrate a high 180-day survival rate despite a low rate of transplant. Adverse event rates are similar or better than those observed in historical bridge-to-transplant trials, despite longer exposure times due to longer survival and lower transplant rates.
Abstract
The EUROMACS Right-Sided Heart Failure Risk Score was developed to predict right ventricular failure (RVF) after left ventricular assist device (LVAD) placement. The predictive ability of ...the EUROMACS score has not been tested in other cohorts. We performed a single center analysis of a continuous-flow (CF) LVAD cohort (n = 254) where we calculated EUROMACS risk scores and assessed for right ventricular heart failure after LVAD implantation. Thirty-nine percent of patients (100/254) had post-operative RVF, of which 9% (23/254) required prolonged inotropic support and 5% (12/254) required RVAD placement. For patients who developed RVF after LVAD implantation, there was a 45% increase in the hazards of death on LVAD support (HR 1.45, 95% CI 0.98–2.2,
p
= 0.066). Two variables in the EUROMACS score (Hemoglobin and Right Atrial Pressure to Pulmonary Capillary Wedge Pressure ratio) were not predictive of RVF in our cohort. Overall, the EUROMACS score had poor external discrimination in our cohort with area under the curve of 58% (95% CI 52–66%). Further work is necessary to enhance our ability to predict RVF after LVAD implantation.
Pump thrombosis is a dreaded complication of long-term implantable ventricular assist devices. No guidance exists regarding the diagnosis and management of this entity despite its significant ...morbidity. After considerable thought and deliberation, a group of leading investigators in the field of mechanical support propose an algorithm for the diagnosis and management of this vexing entity based on clinical symptoms and serologic and imaging studies.
The increased applicability and excellent results with left ventricular assist devices (LVADs) have revolutionized the treatment options available for patients with end-stage heart failure. Until ...recently, most patients who have undergone LVAD implantation have been supported by pulsatile devices. Unfortunately, the use of the latter devices is associated with significant comorbidity, primarily as a result of their large size and limited durability. The HeartMate II and the Jarvik 2000 pumps, both of which incorporate axial-flow and rotary pump technology represent the next generation of devices. The clinical use of these newer axial-flow pumps have resulted in superior outcomes, including significantly reduced complication rates with improved durability. However, as with all new technology, axial-flow LVADs have also introduced a different set of management issues, as well as certain complications, into the mechanical circulatory support arena—issues and complications that were previously absent or unimportant with pulsatile LVADs. Concerns include the effects of continuous-flow on the systemic circulation and end-organ function, risk of thromboembolism and pump thrombosis, increased incidence of gastrointestinal bleeding and ventricular arrhythmias, as well as the effects of partial unloading on pulmonary hemodynamics. Different strategies are required to optimize outcomes with these newer devices.
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