Acute myocardial infarction complicated by cardiogenic shock (AMI-CS) is a severe condition with high mortality. Early revascularization and Impella device (Abiomed) support improve outcomes. Observational studies like the National Cardiogenic Shock Initiative (NCSI), Inova-Shock registry, and J-PVAD (Japan registry for percutaneous ventricular assist device) registry emphasize the importance of structured care systems when using mechanical circulatory support (MCS). Following the release of the Danger Shock trial, MCS use is expected to rise. Hospitals will need to monitor practices and work with payers to ensure coverage. Using regional real-world data can assist this process, making the collection and analysis of MCS outcomes essential. The NCSI (NCT03677180) aimed to evaluate outcomes with a protocolized approach prioritizing rapid diagnosis, timely MCS delivery, and invasive hemodynamic monitoring via pulmonary artery (PA) catheters. The study involved 406 patients from 2016 to 2020, with an average age of 64 years. Most (67%) had shock, with 85% on vasoactive drugs. Witnessed outof-hospital cardiac arrest occurred in 17%, and in-hospital arrest in 30%. During MCS implantation, 9% were actively resuscitating. Patients mostly in SCAI stage C/D (73%) and stage E (27%) presented with low blood pressure, high lactate, and reduced cardiac power output. About 70% received MCS before PCI, with 90% using PA catheters. Most had STEMI, with median door-to-support and door-to-balloon times of about 78 and 81 minutes. Survival rates were high: 99% procedural, 79% to discharge, 77% at 30 days, and 62% at one year for stage C/D shock. Patients with stage E shock had lower survival. Early use of MCS improved hemodynamics and survival. Further research, like the CERAMICS (Can Escalation Reduce Acute Myocardial Infarction in Cardiogenic Shock) study, aims to refine escalation strategies. The Danger Shock trial highlighted the importance of minimizing complications such as bleeding, limb ischemia, haemolysis, and kidney injury. Currently in Hong Kong, prevalence of CS among AMI patients is 5-10%, in-line with global statistics. Among which, 30-day and 1-year mortality of AMI-CS patients in Hong Kong was reported at 29% and 39.5% respectively. Although the use of MCS has been shown in the above overseas studies to improved survival rates of AMI-CS patients, the utilisation rate of MCS among AMI-CS patients in Hong Kong was reported at 36.5% in a previous single-centre study, limited by an array of factors including limited device availability, allocations of resources and patient selection strategy, lack of region-specific evidence and device affordability. Global Cardiogenic Shock Initiative (GCSI) is an ongoing international multicenter registry involving centers from USA, Germany, and Hong Kong, and focus on the outcomes of AMI-CS patients received Impella support. The GCSI is expanding to many other regions. In the Hong Kong Cardiogenic Shock Initiative (HK-CGSI) study we aim to include sites with experience in MCS, all of whom have the capability of MCS escalation and evaluate outcomes across these centers. The goal is not only to capture the effects of previously established best practices but gain insights into regional best practices, and together with data from the global cardiogenic shock initiative (GCSI), to better establish the adoption of novel best practices and their effect on complication rates. In parallel to GCSI-eligible cohort, i.e. Impella used as the first supporting device for patients with AMI-CS, given the significant portion of patients who could not receive MCS under current limitations in Hong Kong, in the HK-CSI, we will include also the GCSI-ineligible cohort, i.e. AMI-CSI without using Impella or not as the first MCS used, to understand the full picture of clinical outcomes of AMI-CS patients of Hong Kong. The HK-CSI study is an observational registry solely and not a treatment study. This single-arm registry captures data generated during procedures which are considered standard of care. Participation in this registry will be performed with waiver of consent of the patient and will have no influence on the type and extent of treatment.
Study Type
OBSERVATIONAL
Enrollment
320
Prince of Wales Hospital
Hong Kong, Shatin, Hong Kong
MCS escalation rate during index hospitalisation
MCS escalation rate of AMI-CS patient with use of MCS
Time frame: Perioperative
1-year mortality
1-year mortality of AMI-CS patient with use of MCS
Time frame: 1-year
1-year mortality
1-year mortality of AMI-CS patient without use of MCS
Time frame: 1-year
30-day mortality
30-day mortality of AMI-CS patient without use of MCS
Time frame: 30-day
30-day mortality
30-day mortality of AMI-CS patient with use of MCS
Time frame: 30-day
180-day Mortality rate
180-day mortality rate of AMI-CS patient with use of MCS
Time frame: 180-day
180-day Mortality rate
180-day mortality rate of AMI-CS patient without use of MCS
Time frame: 180-day
30-day MCS escalation rate
MCS escalation rate of AMI-CS patient with use of MCS at 30-day
Time frame: 30-day
180-day MCS escalation rate
MCS escalation rate of AMI-CS patient with use of MCS at 30-day
Time frame: 180-day
360-day MCS escalation rate
MCS escalation rate of AMI-CS patient with use of MCS at 30-day
Time frame: 360-day
Rate of In-Hospital Access Site Bleeding
Rate of In-Hospital Access Site Bleeding rated by BARC Bleeding Events during index hospitalization
Time frame: Perioperative
Rate of acute kidney injury
Acute kidney injury (AKI) per KIDIGO (modified AKIN level \>=2) during index hospitalization
Time frame: Perioperative
Rate of Acute Limb Ischemia
Acute Limb Ischemia requiring fasciotomy and/or amputation during index hospitalization
Time frame: Perioperative
Lactate level
Lactate Clearance during index hospitalization
Time frame: Perioperative
Blood Transfusion rate
Rate of Blood Transfusion due to Consumption during index hospitalization
Time frame: Perioperative
Blood Transfusion rate
Rate of Blood Transfusion due to Hemolysis during index hospitalization
Time frame: Perioperative
MCS escalation rate
MCS escalation rate of AMI-CS patient with use of MCS During index hospitalisation
Time frame: Perioperative
MCS escalation rate
MCS escalation rate of AMI-CS patient with use of MCS During index hospitalisation within 12 hours of hemodynamic findings
Time frame: First 12 hours during index hospitalisation
Rate of MCS re-introduction after removal
Rate of MCS re-introduction after removal in AMI-CS patient with use of MCS
Time frame: Perioperative until discharge
Access Site Complication rate
Rate of MCS Access Site Complications within 48 hours of MCS removal
Time frame: within 48 hours of MCS removal
Access Site bleeding rate
Rate of MCS Access Site bleeding within 48 hours of MCS removal
Time frame: within 48 hours of MCS removal
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