February 21, 2024
In this episode, Jon Marinaro and Zack Shinar go through the hot off the press Inception trial.  The trial was touted as a negative ECPR study though many reasons make this trial different then the ARREST trial.  They go through several important take home points for practitioners starting or running an ECPR/ECMO program.

In this episode, Jon Marinaro and Zack Shinar go through the hot off the press Inception trial.  The trial was touted as a negative ECPR study though many reasons make this trial different then the ARREST trial.  They go through several important take home points for practitioners starting or running an ECPR/ECMO program.

 

Inception Trial

https://www.nejm.org/doi/full/10.1056/NEJMoa2204511

5 thoughts on “82: Inception Trial with Jon Marinaro

  1. If you look at the supplementary data, it is distressing to see that 9 of the 14 survivors in the ECLS group did not actually receive ECMO, and of the 46 with successful ECMO only 5 had survival until hospital discharge.

    If you look at this data in the context of the Oslo study, it may be a word of caution NOT to compromise the quality of ACLS and other standards of care just to get the cannulation done and circuit running.

  2. Interesting analysis. Have looked at the supplemental data, and there is a lot of interesting data there. Keep in mind, many of these hospitals started enrolling patients way later into the study, with multiple centers only enrolling for less than a year between the covid waves or after. Getting very high volumes of over 100 patients (what they are achieving in Minneapolis) will be difficult at these centers, you will be looking at 15 to 50 ECPR cases per year at these centers. That is the cost of trying to implement ECPR as widely as possible and trying to provide nationwide access. Also, the Dutch system has a very high-performing EMS system and citizen alert system leading to very high OHCA survival, which means fewer and possibly less futile potential ECPR candidates. For a recent study looking at OHCA (all causes) survival in a Dutch EMS region (EMS is heavily standardized in The Netherlands and all work according to a national protocol), search for “Improved ROSC rates in out-of-hospital cardiac arrest patients after introduction of a text message alert system for trained volunteers”.

    Many of the centers participating in the trial had no ECPR experience, and many only had ECMO experience in their role as heart centers (cardiothoracic surgery). There are 15 such centers in The Netherlands that focus on all complex cardiac problems, and the only ones allowed to do adult cardiothoracic surgery. The hospitals were a mix of academic and non-academic hospitals, but each participating center was a heart center. Multiple of them are ECMO centers of excellence (ranging from silver to platinum). The center that set up the trial and did most of the ECPR cases is a center with over a decade of ECPR experience and research.

    One of the centers I am familiar with, a regional non-academic hospital in a medium-sized city (~500k), only started their ECPR program in 2019 (so after the trial started). It is one of the smaller/smallest participating centers. Their reason was that the nearest 2 hospitals providing ECPR were too far away (both 20 kilometers/12 miles from the hospital) for large parts of the population in that city. Both these hospitals were in a neighboring city and are large academic hospitals that had been running their ECPR program for years at that moment. One center is a platinum center of excellence for ECMO, the other is the largest hospital in the country. The period before that they went to these hospitals to learn about their ECPR program and how to set it up. These centers assisted that hospital in setting up its ECPR program. Then they decided to just try it for real before officially setting up their ECPR program.

    Their ECPR team consists of an interventional cardiologist, intensivist, cardiothoracic surgeon, perfusionist, physician, and ICU nurse, with the procedure being done in the heart catheterization room (right in the ED). When they started their program in 2019, they also reported that they were happy with their first cases, with around a third surviving in good neurologic condition. Patients that would have otherwise very likely not achieved survival. They thought they would eventually have about 15 ECPR cases per year for their center. Their EMS agency has the protocol to recognize potential ECPR patients (VF/VT/PEA, not asystole as primary rhythm, age <70, start arrest to arrival ED <45 min, start arrest to BLS <5 min). They need to start considering ECPR during the 3rd block of resuscitations, and if the decision is made for ECPR alert the ECPR center right after the 3rd block and initiate transport. Then the ECPR team is alerted (or gets the team ready by the predicted arrival team) so that the OHCA patient could immediately be brought to the heart catheterization room and be met by the ECPR team.

    These days, the hospital has handled around 30 ECPR resuscitations as part of its program from the start of its program (2019) until 2022. That also includes the time period the program was stopped (April 2020 – March 2022). Of course, over time an inexperienced center like this gained experience for ECPR over the years and nailed down what does work and doesn't work. And now they even have a NEJM-published multi-center RCT they took part in to put that in writing for the rest of the world to learn from as well. The program has not been stopped due to this trial not showing a significant benefit. The anecdotal experience is positive, but more importantly, there are still many lessons to be learned and experience to be gained for these centers. Although the anecdotal experience is happy, and other Dutch hospitals as well saying that they are achieving higher survival, the cold hard figures from a multicenter RCT show a significantly less positive image. This might also just be an effect that could only be measured by a properly set up study, like a multicenter RCT. To my knowledge, none of the centers stopped their program, and more hospitals are now providing ECPR in The Netherlands. So 13 instead of 10 taking part in INCEPTION (all heart centers, so 13/15).

    In regard to the prehospital program, the second HEMS team joined the ECPR arm of the trial later in 2022. During the first year of the study (2022) they had around 30 ECPR inclusions (mostly done by one HEMS team). The flow times afor the first 14 cases are indeed significantly lower, going as low as 30 minutes, with the median sitting around 40 minutes.

    1. Also wanted to add some background information, which could help put things into perspective.

      The population is roughly around 18 million these days. That is in a land area of 33 500km2 (12 900 sq mi), meaning it has a population density of nearly 537 people per km2 (1400 people per sq mi). Within that area, there are 25 regional EMS authorities and 4 HEMS MMT (mobile medical teams). There are also 2 ground-based only MMTs and there are plans for an additional HEMS MMT. And there is one Belgian and 3 German HEMS teams that frequently respond in The Netherlands.

      In regard to hospitals around 80 EDs with more and more closing (centering emergency care). With 14 being level 1 trauma centers, 42 level 2, and the rest all being level 3s. These 14 level 1s are part of 11 trauma regions, and to my knowledge, there are plans to bring that back to 10 level 1s. 30 can provide PCI, where your STEMI and OHCA patient will be transported, and of those 15 are cardiothoracic surgical centers. 13 of those provide ED-ECMO (of which 10 participated in INCEPTION). And 13 neurosurgical centers, 17 provide mechanical thrombectomy (clot retrieval, most took part in MR CLEAN trial).

      The hospital I was talking about was HAGA hospital in The Hague. It is one of the 2 main hospitals in The Hague (city proper), and there are 3 more hospitals within the urban area. The city has a population of 500k, an urban area with a population of 1.1 million, and a metropolitan area of 2.7 million people (together with the city of Rotterdam). HAGA is a non-academic teaching hospital operating from a single hospital site. It existed since 1823, has around 5000 employees, and has over 600 hospital beds. It is also a level 1 trauma center (together with other hospital in the city), heart center (other hospital only PCI), and mechanical thrombectomy center (together with other hospital in the city). It is also the designated ECMO and ECPR center of the region. They are quite new in ECPR, in the past 1.5 years to 2 years they treated around 65 patients with ECMO and treated around 30 patients with ECPR.

      In regard to the nearest ECPR capable centers, both are large academic centers that are both 20 kilometers or 12 miles (in different directions) from HAGA in neighboring cities. That is roughly a 20-minute trip with an ambulance, too large of a time loss for such a time-sensitive procedure as ECPR. These are Leiden University Medical Center and Erasmus Medical Center, and as academic hospitals provide all facets of specialized medical care. Both are ECLS-registered centers, of which one is a platinum-level center of excellence. Both have had a lot more ECPR experience, both doing it for years already. Erasmus started their ECPR program in 2016. LUMC is a hospital whose roots date back to 1575 and has around 9000 employees and 900 beds. EMC is a hospital whose roots date back to 1840, has over 16000 employees (excluding students), and has 1350 beds. This is all one large densely populated region and is serviced by a HEMS team that provides prehospital ECMO in the entire region these hospitals serve since the start of 2022.

      Due to a high-performance citizen alert, EMS, and hospital system survival of OHCA is on the higher side. In a 2022 study using data from 2018 in the Hollands-Midden EMS region (only ECPR/heart/PCI center in the region is LUMC). Using data on OHCA (all causes, including unwitnessed and non-shockable initial rhythms), 82% were transported to the hospital (56.4% of the total to LUMC). 18% were terminated at the scene. ROSC at ED was achieved in 61% of cases, 29% survived at 3 months, and 26% at 6 months. Of patients transported to LUMC, 77% achieved ROSC, 43% survived at 3 months, and 37% survived at 1 year. Patients brought to LUMC had neurologic outcome data. Of patients that survived 66% had a CPC score of 1 and 31% a CPC score of 2 (together 97%), and the last 3% had a CPC score of 3.

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