Summary of main clinical studies relating to MCS devices used in CGS
| Study (year) | Study type | Main findings | Survival benefit |
| Device: IABP | |||
| IABP-SHOCK II (2013)25 29 30 | RCT (n=598). | In STEMI patients with CGS, treated with PCI or coronary artery bypass graft surgery, 30-day and 12-month mortality were similar in the IABP group compared to the control group (RR: 0.96, 95% CI 0.79 to 1.17, p=0.69 and RR: 1.01, 95% CI 0.86 to 1.18, p=0.91, respectively). With long-term follow-up (6.2 years), mortality was not different between the IABP and the control group (66.3% vs 67.0%, RR: 0.99, 95% CI 0.88 to 1.11, p=0.98). | No |
| British Columbia Cardiac Registry (2016)27 | Registry (n=700). | In STEMI patients with CGS treated with PCI IABP use was not associated with mortality (up to 3 years), in propensity-matched analysis (HR: 1.23, 95% CI 0.84 to 1.80, p=0.288). | No |
| Zeymer et al (2011)26 | Registry (n=653). | In STEMI patients with CGS, treated with PCI, in-hospital mortality with and without IABP was 56.9% and 36.1%, respectively, but in the multivariate analysis, IABP was not associated with improved survival (OR: 1.47, 95% CI 0.97 to 2.21, p=0.07). | No |
| Sanborn et al. (2000)28 | Registry (n=856). | In STEMI patients with CGS treated with thrombolytic therapy, IABP use was associated with a lower in-hospital mortality compared with no IABP use (50% vs 72%, p<0.0001). | Yes |
| Device: TandemHeart percutaneous ventricular assist device | |||
| Thiele et al (2005)38 | RCT (n=41). | In patients with CGS after AMI, 30-day mortality was similar between patients in the IABP group versus the TandemHeart group (45% vs 43%, log-rank p=0.86). | No |
| Burkhoff et al (2006)37 | RCT (n=42). | In patients with CGS (62% due to AMI), 30-day survival was similar between patients in the IABP group and the TandemHeart group. | No |
| Device: Impella percutaneous ventricular assist device | |||
| Thiele et al (2017)34 | Meta-analysis (n=148). | In patients with CGS, who received either Impella (CP or 2.5) or TandemHeart compared to IABP therapy, there was no difference in 30-day mortality (RR: 1.01, 95% CI 0.70 to 1.44, p=0.98, I2=0%), but there was higher bleeding with Impella/ TandemHeart compared to IABP (RR: 2.50, 95% CI 1.55 to 4.04, p<0.001, I2=0%). | No |
| IMPRESS in Severe SHOCK (2017)35 | RCT (n=48). | STEMI patients with CGS, randomised to Impella CP versus IABP had similar 30-day mortality (46% vs 50%, HR: 0.96, 95% CI 0.42 to 2.18, p=0.92). Six-month mortality was also similar in the Impella CP group versus IABP group (50% vs 50%, HR: 1.04, 95% CI 0.47 to 2.32, p=0.92). | No |
| Seyfarth et al (2008)36 | RCT (n=26). | AMI patients with CGS, randomised to Impella 2.5 versus IABP had similar 30-day mortality (46% in both groups). | No |
| Pappalardo et al (2017)39 | Retrospective cohort study (n=157). | Patients with refractory CGS (85% STEMI) treated with Impella (CP or 2.5) and VA-ECMO versus VA-ECMO without Impella had lower hospital mortality (47% vs 80%, p<0.001). | Yes |
| Device: peripheral VA-ECMO | |||
| Ouweneel et al (2016)47 | Meta-analysis (n=235). | VA-ECMO use in CGS patients was associated with a 33% higher 30-day survival compared with IABP therapy (95% CI 14% to 52%, p=0.70) but no significant difference when compared with with TandemHeart or Impella (−3%; 95% CI −21% to 14%; p=0.70). | Yes |
| Sheu et al (2010)46 | Cohort study with historical controls (n=334). | In patients with STEMI complicated by CGS, VA-ECMO was associated with lower 30-day mortality than standard care without ECMO (p<0.04). | Yes |
CGS, cardiogenic shock; VA-ECMO, veno-arterial extracorporeal membrane oxygenation; IABP, intra-aortic balloon pump counterpulsation; MCS, mechanical circulatory support; PCI, percutaneous coronary intervention; RCT, randomised clinical trial.