Table 3.
Main Clinical Studies of Percutaneous MCS devices in AMI with Cardiogenic Shock.
| First Author/Study (Ref. #) | N | Study Type | Study Arms | Definition | Primary Endpoint | Salient Findings |
|---|---|---|---|---|---|---|
| IABP | ||||||
| IABP-SHOCK-II [5,65,66] | 600 | RCT | IABP versus no IABP | AMI with cardiogenic shock (SBP < 90 mmHg for >30 min or need for vasoactive agents, pulmonary congestion, impaired organ perfusion) | 30-day, 1-year, 6-year all-cause mortality | No difference in survival at 30 days [5], 1 year [65], and 6 years [66]. No differences recurrent MI, stroke, ischemic comp, severe bleeding, or sepsis. |
| TACTICs [106] | 57 | RCT | Fibrinolytic therapy with IABP versus without IABP | AMI with sustained hypotension and heart failure with signs of hypoperfusion | 6-month all-cause Mortality | No survival benefit except for patients with Killip III/IV supported with IABP. |
| Waksman et al. [107] | 45 | Prospective, nonrandomized | Fibrinolytic therapy with IABP versus without IABP | AMI complicated by cardiogenic shock | In-hospital and 1-year all-cause mortality | In-hospital and 1-year survival improved with IABP after early revascularization with fibrinolytic therapy. |
| NRMI [108] | 23,180 | Observational | Fibrinolytic or PCI with IABP versus no IABP | AMI with cardiogenic shock at initial presentation or during hospitalization | In-hospital all-cause mortality | IABP was associated with decreased in-hospital mortality in patients received fibrinolysis but not PCI. |
| Hariss et al. [62] | 48 | Observational | IABP prior to PCI versus late IABP | AMI complicated by cardiogenic shock | In-hospital all-cause mortality | Early IABP was associated with decreased in-hospital mortality compared with late IABP. |
| Sjauw et al. [63] | 1009 (RCTs) 10,529 (cohort studies) | Meta-analysis (7 RCTs, 9 cohort studies) | IABP versus no IABP | AMI complicated by cardiogenic shock | 30-day all-cause mortality | No survival benefit or improvement in LV ejection fraction with IABP. |
| Impella | ||||||
| ISAR-SHOCK [72] | 25 | RCT | Impella 2.5 versus IABP | AMI complicated by cardiogenic shock | Change in the CI at 30 min post implantation | Superior hemodynamics with Impella. Mortality was similar between the two groups. |
| EUROSHOCK [39] | 120 | Observational | Impella 2.5 | AMI complicated by cardiogenic shock | 30-day all-cause mortality | 30-day mortality was high at 64% despite improvement in hemodynamic and metabolic parameters with Impella. |
| IMPRESS in Severe Shock [6] | 48 | RCT | Impella CP versus IABP | AMI with severe shock (SBP < 90 mmHg or the need for vasoactive agents, and all required mechanical ventilation) | 30-day all-cause mortality | Mortality occurred in 50% of patients with no significant survival benefit with Impella. |
| Karatolios et al. [74] | 90 | Observational | Impella versus medical therapy | AMI with post-cardiac arrest cardiogenic shock | In-hospital all-cause mortality | Impella group had better survival at discharge and after 6 months despite being a sicker group. |
| Schrage et al. [75] | 237 | Observational | Impella 2.5 (~30%), Impella CP (~70%) versus IABP (matched from IABP-SHOCK trial) | AMI with cardiogenic shock (SBP < 90 mmHg for >30 min or need for vasoactive agents, pulmonary congestion, impaired organ perfusion) | 30-day all-cause mortality | Impella was not associated with lower 30-day mortality. Severe bleedings and peripheral vascular complications were more common with Impella use. |
| Wernly et al. [76] | 588 | Meta-analysis (4 studies) | Impella versus IABP or medical therapy alone | AMI with cardiogenic shock | 30-day all-cause mortality | No improvement in short-term survival with Impella. Higher risk of major bleeding and peripheral ischemic events with Impella. |
| Cheng et al. [109] | 100 | Meta-analysis (3 RCTs; 1 for Impella versus IABP and 2 for TandemHeart versus IABP)) | Impella or TandemHeart versus IABP | AMI with cardiogenic shock | 30-day all-cause mortality | No significant differences in 30-day mortality. Improved hemodynamics with Impella and TandemHeart. Higher rates of bleeding with TandemHeart and of hemolysis with Impella. |
| Alushi et al. [110] | 116 | Observational | Impella 2.5 (~30%), Impella CP (~70%) versus IABP | AMI with cardiogenic shock | 30-day all-cause mortality | No significant differences in 30-day mortality. Impella significantly reduced the inotropic score, lactate levels, and improved LVEF compared with IABP. Higher rates of bleeding with Impella. |
| TandemHeart | ||||||
| Kar et al. [43] | 117 | Observational | TandemHeart | Severe cardiogenic shock despite vasopressor and IABP support | 30-day all-cause mortality | 30-day mortality: 40%. Improvement in hemodynamics refractory to vasopressors and IABP. |
| Thiele et al. [80] | 41 | RCT | TandemHeart versus IABP | AMI with cardiogenic shock (CI < 2.1 L/min/m2, lactate > 2) | Change in cardiac index | Hemodynamic and metabolic parameters were reversed more effectively by TandemHeart. 30-day mortality was similar. Bleeding and ischemic events were more common with TandemHeart. |
| Burkhoff et al. [81] | 42 | RCT | TandemHeart versus IABP | Severe cardiogenic shock (most had AMI and failed IABP) | 30-day all-cause mortality | Similar mortality rates and adverse events at 30 days. Superior hemodynamics with TandemHeart. |
| VA-ECMO | ||||||
| Esper et al. [84] | 18 | Observational | VA-ECMO | Severe cardiogenic shock due to ACS | Survival to hospital discharge | Survival rates at discharge: 67%. High bleeding rates (94% required blood transfusion). |
| Negi et al. [85] | 15 | Observational | VA-ECMO | AMI with severe cardiogenic shock (60% had STEMI and IABP support) | Survival to hospital discharge | Survival rates at discharge: 47%. Vascular complications: 53%. |
| Nichol et al. [111] | 1494 (84 studies) | Systematic review | VA-ECMO | Cardiogenic shock or cardiac arrest | Survival to hospital discharge | Survival to hospital discharge: 50%. |
| Sheu et al. [112] | Group 1: 115 Group 2: 219 | Observational | Group 1: profound shock without ECMO versus group 2: profound shock with ECMO | AMI and profound cardiogenic shock (SBP < 75 mmHg despite IABP and vasopressor support) | 30-day survival | ECMO group had higher survival rates: 60.9% versus 28% in non-ECMO group. |
| Takayama et al. [113] | 90 | Observational | VA-ECMO | Refractory cardiac shock (AMI in 49%) | Survival to hospital discharge | Survival to hospital discharge: 49%. Bleeding and stroke rates: 26%; and LV distension and pulmonary edema: 18%. |
Abbreviations: ACS, acute coronary syndrome; AMI, acute myocardial infarction; CI, cardiac index; IABP, intraaortic balloon pump; IMPRESS in Severe SHOCK, IMPella versus IABP Reduces mortality in STEMI patients treated with primary PCI in Severe cardiogenic SHOCK; ISAR-SHOCK, Impella LP 2.5 versus IABP in Cardiogenic SHOCK; LVEF, left ventricular ejection fraction; MCS, mechanical circulatory support; NRMI, National Registry of Myocardial Infarction; PCI, percutaneous coronary intervention; RCT, randomized controlled study; SBP, systolic blood pressure; STEMI, ST-elevation myocardial infarction; VA-ECMO, venoarterial extracorporeal membrane oxygenation.