PRospective REgistry of PAtients in REfractory cardiogenic shock—The PREPARE CardShock registry

Abstract

Aim Cardiogenic shock (CS) is a hemodynamically complex multisystem syndrome associated with persistently high morbidity and mortality. As CS is characterized by progressive failure to provide adequate systemic perfusion, supporting end‐organ perfusion using mechanical circulatory support (MCS) seems intriguing. Since most patients with CS present in the catheterization laboratory, percutaneously implantable systems have the widest adoption in the field. We evaluated feasibility, outcomes, and complications after the introduction of a full‐percutaneous program for both the Impella CP device and venoarterial extracorporeal membrane oxygenator (VA‐ECMO). Methods PREPARE CardShock (PRospective REgistry of PAtients in REfractory cardiogenic shock) is a prospective single‐center registry, including 248 consecutive patients between May 2019 and April 2021, who underwent cardiac catheterization and displayed advanced cardiogenic shock. The median age was 70 (58–77) years and 28% were female. Sixty‐five percent of the cases had cardiac arrest, of which 66% were out‐of‐hospital cardiac arrest. A local standard operating procedure (SOP) indicating indications as well as relative and absolute contraindications for different means of MCS (Impella CP or VA‐ECMO) was used to guide MCS use. The primary endpoint was in‐hospital death and secondary endpoints were spontaneous myocardial infarction and major bleedings during the hospital stay. Results Overall mortality was 50.4% with a median survival of 2 (0–6) days. Significant independent predictors of mortality were cardiac arrest during the index event (odds ratio [OR] with 95% confidence interval [CI]: 2.53 [1.43–4.51]; p = 0.001), age > 65 years (OR: 2.05 [1.03–4.09]; p = 0.036]), pH < 7.30 (OR: 2.69 [1.56–4.66]; p < 0.001), and lactate levels > 2 mmol/L (OR: 4.51 [2.37–8.65]; p < 0.001). Conclusions Conclusive SOPs assist target‐orientated MCS use in CS. This study provides guidance on the implementation, validation, and modification of newly established MCS programs to aid centers that are establishing such programs.

Finding the best protocol for shock

“…The authors report on the use of various MCS, however, they do not compare the different strategies head to head, thus it is difficult to draw conclusions regarding selection of MCS strategies based on this algorithm. Although only a small cohort of patients is reported here, mortality remained around 50% despite receiving MCS, results that are similar to historically reported survival rates for patients with AMI and CS without the use of Impella and extracorporeal membrane oxygenation, thus it is unclear whether this protocol would provide a positive impact on survival 1,2 …”

“…In this issue, von Lewinski et al reported on the use of a standard operating procedure (SOP) to guide decision‐making in the use of mechanical circulatory support (MCS) in CS. In this report, an SOP using patient characteristics including the need for cardiopulmonary resuscitatoin, age, lactate levels, pH, and predicted response to percutaneous cornary intervention was used to help determine patient appropriateness for MCS and determine the type of support 2 …”

Outcomes of ECLS-SHOCK Eligibility Criteria Applied to a Real-World Cohort

“…While various decision algorithms have been published to facilitate the selection of patients who might benefit from VA-ECMO [9], hardly any data of adequately powered, prospective, and randomized trials was available [10][11][12].…”

“…Moreover, baseline characteristics and outcomes may differ between patients that do or do not fulfil ECLS-SHOCK eligibility criteria. [9] is a prospective single center registry, including all patients who underwent cardiac catheterization due to CS at the University Heart Center Graz, Austria, within a consecutive 4-year period from May 2019 to May 2023. At this center, approximately 1200 acute-coronary-syndrome patients are treated per year.…”

“…At this center, approximately 1200 acute-coronary-syndrome patients are treated per year. In this study, CS was defined as a hemodynamically compromised condition requiring vasopressor support, matching the Society for Cardiovascular Angiography and Interventions (SCAI) classifications C to E [9]. During the observation period, 557 patients were included in the registry.…”