Percutaneous assist devices in acute myocardial infarction with cardiogenic shock: Review, meta-analysis

Table 1 Main characteristics of the selected studies

Ref.	Setting	Study design	Etiology of CS	Cardiac arrest	Treatment	Period	No. of pts
IABP vs medical therapy
Anderson et al[32], 1997 (GUSTO-I)	United States, Europe	Obs.; multicenter	STEMI	No	PCI	1990-1993	37
Sanborn et al[33], 2000 (SHOCK Registry)	United States, Canada, Europe, New Zealand	Obs.; multicenter registry	AMI	No	PCI or CABG	1993-1997	383
Barron et al[34], 2001 (NRMI-2)	United States	Obs.; multicenter registry	AMI	No	PCI	1994- < 2000	2990
French et al[31], 2003 (SHOCK Trial 12-mo survival)	United States, Canada, Europe, New Zealand	RCT; multicenter	AMI	No	PCI or CABG	1993-1998	152
Vis et al[35,36], 2007 (AMC CS)	Europe	Obs.; single-center	STEMI	No	PCI	1997-2005	292
Gu et al[37], 2010	Asia	Obs.; single-center	STEMI	No	PCI	2003-2008	91
Prondzinsky et al[27], 2010 (IABP-SHOCK)	Europe	RCT; single-center	AMI	No	PCI	2003-2004	40
Stub et al[38], 2011	Europe	Obs.; multicenter registry	ACS	No	PCI	2004-2010	410
Zeymer et al[39], 2011 (Euro Heart Survey PCI)	Europe	Obs.; multicenter registry	STEMI or NSTEMI	No	PCI	2005-2008	653
Thiele et al[4], 2012 (IABP-SCHOCK II)	Europe	RCT; multicenter	AMI	No	PCI (95.8%), CABG (3.5%), PCI and CABG (0.7%)	2009-2012	598
Zeymer et al[40], 2013 (ALKK-PCI)	Europe	Obs.; multicenter registry	STEMI or NSTEMI	No	PCI	2006-2011	1913
Dziewierz et al[41], 2014 (EUROTRANSFER registry)	Europe	Obs.; multicenter registry	STEMI	No	PCI (49 pts), CABG (2 pts)	2005-2007	51
Kunadian et al[44], 2015 (BCIS registry)	Europe	Obs.; multicenter registry	ACS	No	PCI	2005-2011	6120
Kim et al[42], 2015 (KAMIR)	Asia	Obs.; multicenter registry	AMI	Yes	PCI	2005-2014	1214
Suzuki et al[43], 2015 (Tokyo CCU Network Scientific Council)	Asia	Obs.; multicenter registry	STEMI	No	PCI	2009-2011	119
PLVADs (TandemHeart, Impella® 2.5) vs IABP
Thiele et al[29], 20051	Europe	RCT; single center	AMI	No	PCI (49 pts), CABG (2 pts)	2000-2003	41
Burkoff et al[28], 20061	United States, Europe	RCT; multicenter	AMI (70%)	No	PCI (22 pts), CABG (3 pts)	2002-2004	33
Seyfarth et al[30], 20082 (ISAR-SHOCK)	Europe	RCT; two-center	AMI	No	PCI (22 pts)	2004-2007	26
Schwartz et al[46], 20121,2	United States	Obs.; single center	68% STEMI, 11% OHCA	Yes	PCI (63 pts), CABG (5 pts)	2008-2010	76
Shah et al[47], 20121,2	United States	Obs.; single center	STEMI or UA/NSTEMI	No	PCI	2007-2009	17
Manzo-Silberman et al[45], 20132	Europe	Obs.; single center registry	ACS (mainly), OHCA	Yes	PCI (54 pts)	2007-2010	78
ECMO plus IABP vs IABP
Sheu et al[18], 2010	Asia	Obs.; single center	STEMI	No	PCI	1993-2009	71
Tsao et al[21], 2012	Asia	Obs.; single center	AMI	No	PCI	2004-2009	58
Perazzolo Marra et al[48], 2013	Europe	Obs.; single center	AMI	No	PCI	2010-2012	35
ECMO plus IABP vs ECMO
Yamauchi et al[49], 2009	Asia	Obs.; single center	AMI	No	PCI	2000-2007	16
Chung et al[50], 2011	Asia	Obs.; multicenter	AMI, INCA (14 pts)	Yes	PCI (7 pts), CABG (13 pts)	2206-2009	20
Kagawa et al[51], 2012	Asia	Obs.; multicenter	ACS, INCA, OHCA	Yes	PCI	2004-2011	73
Aoyama et al[52], 2014	Asia	Obs.; single center	AMI, INCA (2 pts, OHCA 7 pts)	Yes	PCI (34 pts), CABG (4 pts)	1993-2000	38
Park et al[53], 2014	Asia	Obs.; single center	AMI	No	PCI (78 pts), PCI e/o CABG (10 pts), medical treatment (8 pts)	2004-2011	96
Kim et al[54], 2014	Asia	Obs.; multicenter	ACS	No	PCI (53 pts), CABG (5 pts)	2010-2013	58

ACS: Acute coronary syndrome; AMI: Acute myocardial infarction; CABG: Coronary artery bypass grafting; CS: Cardiogenic shock; ECMO: Extracorporeal membrane oxygenation; IABP: Intra-aortic balloon pump; INCA: In-of-hospital cardiac arrest; NSTEMI: Non-ST-elevation myocardial infarction; PCI: Percutaneous coronary intervention; PLVADs: Percutaneous left ventricular assist devices with (¹TandemHeart, or

²Impella^® 2.5); pts: Patients; Obs.: Observational study; OHCA: Out-of-hospital cardiac arrest; RCT: Randomized controlled trial; STEMI: ST-elevation myocardial infarction; UA: Unstable angina.

Table 2 Meta-analysis before and after sensitivity analysis

Comparison/subgroup	RR
	Before				After
	n	I2(%)	Estimate (95%CI)	P	n	I2(%)	Estimate (95%CI)	P
Inhospital mortality
IABP vs medical therapy
Observational studies	11	63	1.21 (1.08, 1.36)	0.0008	9	19	1.17 (1.09, 1.26)	< 0.0001
RCTs	2	0	0.97 (0.81, 1.18)	0.78	2	0	0.97 (0.81, 1.18)	0.78
Overall effect	13	62	1.18 (1.06, 1.32)	0.002	11	24	1.15 (1.07, 1.24)	0.0002
Test for subgroup differences1	χ2 = 3.83, df = 1 (P = 0.05), I2 = 73.9%				χ2 = 3.14, df = 1 (P = 0.08), I2 = 68.2%
ECMO plus IABP vs ECMO
Observational studies	6	12	0.78 (0.65, 0.94)	0.008	5	0	0.80 (0.68, 0.94)	0.006
Late mortality
IABP vs medical therapy
Observational studies	3	90	0.92 (0.51, 1.67)	0.78	2	60	1.16 (0.69, 1.95)	0.57
RCTs	3	32	1.16 (0.86, 1.58)	0.34	2	0	1.56 (0.97, 2.52)	0.07
Overall effect	6	85	1.08 (0.82, 1.41)	0.60	4	0	1.38 (1.30, 1.46)	< 0.00001
Test for subgroup differences1	χ2 = 0.48, df = 1 (P = 0.49), I2 = 0%				χ2 = 0.68, df = 1 (P = 0.41), I2 = 0%

¹Between observational studies and RCTs. IABP: Intra-aortic balloon pump; RCT: Randomized controlled trial; ECMO: Extracorporeal membrane oxygenation.

Table 3 Benefit - harm observed in the experimental group and result of Trial Sequential Analysis

Groups			Mortality rate (%)		RRR	Effect of experimental support				Trial Sequential Analysis
Experimental	Control	Experimental	Control	NNT	NNH	Harm1	Benefit1	Required information size	Results
Inhospital mortality
IABP2	vs	Medical therapy2	45.99	40.62	-13.22		18	5.37		2174	Conclusive
PLVADs	vs	IABP	55.93	47.71	-17.23		12	8.22		1161	Inconclusive
ECMO + IABP	vs	IABP	36.36	60.53	39.92	5			24.16	150	Conclusive
ECMO + IABP2	vs	ECMO2	61.29	66.67	8.06	19			5.38	Not calculable	Inconclusive
Late mortality
IABP	vs	Medical therapy	52.02	39.32	-32.28		7	12.70		5984	Futility
IABP2	vs	Medical therapy2	52.08	37.68	-38.22		6	14.40		168	Conclusive

¹Number of patients out of 100;

²Comparison after sensitivity analysis.