Seyfarth 2008.

Study characteristics
Methods	Study design: prospective RCT Study grouping: parallel group Date of the study: September 2004 to January 2007. Number of study centres and location: 2 study centres in Germany Total duration of the study: approximately 3 years Study setting: tertiary referral centre
Participants	Baseline characteristics IABP Age (median): 67 (IQR 55–80) years Male gender, n (%): 11 (85%) Smoking, n (%): 7 (54%) pH: N/A Lactate: N/A Baseline lung function: N/A Cause of CS: post‐AMI MAD Age (median): 65 (IQR 55–80) years Male gender, n (%): 8 (62%) Smoking, n (%): 8 (62%) pH: N/A Lactate: N/A Baseline lung function: N/A Cause of CS: post‐AMI Inclusion criteria: AMI < 48 hours, confirmed by ischaemic symptoms for ≥ 30 minutes with elevated cardiac markers or ST‐segment elevation or left bundle branch block. AMI suspected when participants were resuscitated and cardiac markers or electrocardiographic changes (or both) met criteria for AMI/acute coronary syndrome; CS defined using both clinical and haemodynamic criteria as previously described in the SHOCK trial. Clinical criteria were hypotension (systolic blood pressure < 90 mmHg) and heart rate > 90 beats/minute or need for positive inotropic drugs to maintain systolic blood pressure > 90 mmHg and end‐organ hypoperfusion (cool extremities or urine output < 30 mL/hour) or pulmonary oedema. Haemodynamic criteria were either Cardiac Index ≤ 2.2 L/minute/m² of body surface area and PCWP > 15 mmHg or an angiographically measured left ventricular ejection fraction < 30% and left ventricular end diastolic pressure > 20 mmHg. Onset of shock had to be within 24 hours. Exclusion criteria: aged < 18 years; prolonged resuscitation (> 30 minutes); hypertrophic obstructive cardiomyopathy; definite thrombus in left ventricle; treatment with IABP; severe valvular disease or mechanical heart valve; CS caused by mechanical complications of AMI such as ventricular septal defect, acute mitral regurgitation greater than second degree or rupture of ventricle; predominant right ventricular failure or need for a right VAD; sepsis; known cerebral disease; bleeding with a need for surgical intervention pulmonary embolism; allergy to heparin or any known coagulopathy; aortic regurgitation greater than second degree; pregnancy and inclusion in another study or trial. Pretreatment: no statistically significant differences between the study groups with respect to clinical characteristics and baseline haemodynamics. Number of participants randomised: 26 Number of participants lost to follow‐up: 0 Number of participants analysed: 26
Interventions	Intervention characteristics MAD Type of MCS: Impella LP2.5 Duration from diagnosis to intervention (median): 4.5 (IQR 3.8–13.2) hours Duration of treatment (median): 25 (IQR 6.0–41.0) hours Concomitant medications: 84% inotropic support IABP Duration from diagnosis to intervention (median): 5.0 (IQR 3.3–13.0) hours Duration of treatment (median): 23 (IQR 14.1–34.1) hours Concomitant medications: 92% inotropic support
Outcomes	Haemodynamic effect Change in Cardiac Index, which was greater in the MAD group (MAD: 0.49 (SD 0.46) L/minute/m²); IABP: 0.11 (SD 0.31) L/minute/m²; P = 0.02). MAP increased in the MAD group by 9.0 (SD 14) mmHg vs –1.2 (SD 16.2) mmHg in the IABP group. Overall outcome Overall survival similar in both groups with 6 participants who died in each group (54% survived to 30 days in both groups). Survival 30‐day survival: MCS: 7/13 (54%); IABP: 7/13 (54%) 1‐year survival: N/A Survival measured to: transplant: unsupported cardiac function Not described Quality of life Not described Major adverse cardiovascular events Limb ischaemia: MCS: 1; IABP: 0 Other complications: not described Dialysis‐dependent Not reported Length of hospital stay Not reported Length of ICU stay Not reported Major adverse events Not reported
Identification	Sponsorship source: Abiomed Europe Gmb Country: Germany Setting: 2 centres Comments: Authors name: Melchior Seyfarth Institution: Deutsches Herzzentrum München Email: seyfarth@dhm.mhn.de Address: Deutsches Herzzentrum München, Lazarettstrasse 36, 80636 Munich, Germany Year: 2008
Notes	Interventions The assigned device was implanted after revascularisation therapy and following the measurement of baseline haemodynamic parameters.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Stated the participants were randomly allocated to either device, but the method of allocation not described.
Allocation concealment (selection bias)	Unclear risk	Allocation concealment not described.
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Unable to blind participants and personnel.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	No description of whether the outcome assessment was blinded or not.
Incomplete outcome data (attrition bias) All outcomes	Low risk	No loss of follow‐up.
Selective reporting (reporting bias)	Low risk	Complete description of outcome data.
Other bias	Unclear risk	Unclear throughout the paper how they dealt with the risk of bias.