Feb 12, 2021
In this podcast Dr. Demetri Yannopoulos, a interventional cardiologist with M Health Fairview and Interventional Cardiology Researcher Director with the University of Minnesota-Twin Cities, discusses ECPR (ECMO Cardiopulmonary Resuscitation), the recent Arrest Trial and the Mobile ECMO program.
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CPR was introduced in the 1960s. At the time, research at John Hopkins was being conducted on pigs in ventricular fibrillation and ventricular tachycardia who required defibrillation. It was noted that when pushing defibrillation paddles against the chest wall, the arterial pressure of the subjects increased. It was concluded that with compression, pulsatile flow was generated. This was essentially the first iteration of closed chest CPR. Over the next 50 years or so, clinicians have been looking for better ways to improve survival outcomes. Key factors include early identification, early CPR, along with obtaining resources and assistance to improve ventilation, perfusion, and defibrillation. Poor predictors of survival for cardiac arrest include CPR for greater than 30 minutes and individuals with coronary artery blockage. With the integration of ECMO, it was found that by bypassing the heart and lungs and essentially taking on their functions, outcomes improved.
Dr. Yannopoulos reiterates that CPR for greater than 30 minutes results in poor outcomes, thereby creating a goal to both normalize pressures during this time while also fixing the offending cause, such as a coronary artery occlusion. Around 2015, in the Minnesota metro area, visionary EMS directors implemented an alternative option: If a patient fails three shocks, with ongoing CPR, the patient was transferred to a tertiary care facility with ECMO cannulation capabilities. Once on ECMO, these patients were transferred to the University of MN where they underwent PCI to evaluate for reversible causes such as occluded coronary vessels, PE, etc. Outcomes of this therapy showed 30-40% patient survival, which is a game changing result, thus the need for a randomized control trial, the ARREST Trial.
The ARREST Trial studied a group of patients with out-of-hospital cardiac arrest (OHCA) in ventricular fibrillation, refractory to defibrillation and initial ACLS treatment. This was a randomized control trial where one group was randomized to an ECMO intervention arm, versus a standard ACLS therapy arm. It was a phase 2, single center, open-label, adaptive, safety and efficacy randomized clinical trial. Specific subject criteria included adults aged 18-75 with OHCA, refractory ventricular fibrillation, with no return of spontaneous circulation (ROSC) after three shocks, with an automated cardiopulmonary resuscitation device or LUCAS device and estimated transfer time shorter than 30 minutes. The primary outcome of the trial was survival to hospital discharge. Secondary outcomes included safety, survival and functional assessment at hospital discharge, at 3 months and 6 months after discharge. Results of the ACLS arm showed a 7% survivability, and zero at both three and six months, while the ECMO arm fared better with a 43% survivability.
After enrolling 30 patients, the study was terminated at the first pre-planned interim analysis by the National Heart, Lung and Blood Institute after a unanimous recommendation from the Data Safety Monitoring Board, because the posterior probability of ECMO superiority exceeded the prespecified monitoring boundary. Cumulative 6-month survival was significantly better in the early ECMO group compared to the standard ACLS group. No unanticipated serious adverse events were observed. Conclusion: early ECMO-facilitated resuscitation for patients with OHCA and refractory ventricular fibrillation, significantly improved survival to hospital discharge compared with standard ACLS treatment.
The Minnesota Mobile Resuscitation Consortium or MMRC, which was the first program to serve an entire metropolitan area in order to rapidly deliver extracorporeal membrane oxygenation (ECMO)-facilitated resuscitation to patients with refractory ventricular fibrillation/ventricular tachycardia (VF/VT) out-of-hospital cardiac arrest (OHCA).
This was an observational cohort study that analyzed consecutive patients prospectively enrolled in the MMRC's ECMO-facilitated resuscitation program. Entry criteria were identical to the ARREST Trial, adults 18-75 with an out-of-hospital cardiac arrest in VF or CT with no return of spontaneous circulation post 3 shocks, use of a LUCAS or automated cardiopulmonary resuscitation device, and an estimated transfer time of less 30 minutes. The primary endpoint was functionally favorable survival to hospital discharge with Cerebral Performance Category (CPC) 1 or 2. CPC 1 results in good cerebral performance: conscious, alert, able to work, that might have some mild neuro or psych deficits. CPC 2 results in moderate cerebral disability; conscious, sufficient cerebral function for independent activities of daily living (ADLS). Secondary endpoints included 3-month functionally favorable survival.
Between the period of December 1, 2019 and April 1, 2020, 63 consecutive patients were transported, and of these 58 were treated by the mobile ECMO service. Post EMCO treatment 25 of the 58 or 43% were both discharged from the hospital and alive at 3 months with CPC 1 or 2.
This first, community-wide ECMO-facilitated resuscitation program in the US demonstrated 100% successful cannulation, 43% functionally favorable survival rates at hospital discharge and 3 months.
As the research continues, reaching 25-30% positive outcomes would be adequate to start a viable program. Dr. Yannopoulos speculates that with overall system improvement and refined protocols, that number can be as high as 70-80%, which is an incredible number. The future of ECPR will require a combined effort of the healthcare systems, policy makers, administrators, and communities. With a successful program in the urban and suburban areas, future research can hopefully expand access to more rural populations. Dr. Yannopoulos emphasizes that this is not a hospitalized based program, it relies on the EMS system, and those providers, especially medics, are key to the success of the program.
At the time of this interview, the mobile ECMO program was on hold due to COVID, but currently the mobile ECMO program has a pending restart date of March 1st.
Thanks for listening.