Cardiol Res

Cardiology Research, ISSN 1923-2829 print, 1923-2837 online, Open Access

Article copyright, the authors; Journal compilation copyright, Cardiol Res and Elmer Press Inc

Journal website https://www.cardiologyres.org

Original Article

Volume 3, Number 2, April 2012, pages 54-66

Treating Refractory Cardiogenic Shock With the TandemHeart and Impella Devices: A Single Center Experience

Figure 1. Change in ejection fraction before and after percutaneous left ventricular assist device support for cardiogenic shock. Mean ejection fraction for all patients with measurements before and after PLVAD support for cardiogenic shock. Dotted bar: before PLVAD insertion; Solid bar: after PLVAD removal; IABP: intra-aortic balloon pump.

**Table 1.** Patient Demographics and Medical History
	Total	IABP	IMP	TH
IABP: Intra-Aortic Balloon Pump; IMP: Impella L.P. 2.5; TH: TandemHeart; PLVAD: Impella or TandemHeart
PCI: Percutaneous Coronary Intervention; MI: Myocardial Infarction; CABG: Coronary Artery Bypass Graft; CHF: Congestive Heart Failure
Number of Patients	76	66% (50/76)	9% (7/76)	25% (19/76)
IABP Prior to PLVAD			71% (5/7)	53% (10/19)
IABP During PLVAD			57% (4/7)	21% (4/19)
IABP After PLVAD			14% (1/7)	5% (1/19)
Age (years)	67.9 ± 11.9	67.4 ± 11.4	69.7 ± 10.5	68.5 ± 14.1
Male Gender	65% (49/76)	58% (29/50)	86% (6/7)	74% (14/19)
Race, Caucasian	13% (10/76)	12% (6/50)	14% (1/7)	16% (3/19)
Asian	26% (20/76)	24% (12/50)	14% (1/7)	37% (7/19)
Hispanic	41% (31/76)	42% (21/50)	43% (3/7)	37% (7/19)
Black	11% (8/76)	12% (6/50)	0% (0/7)	11% (2/19)
Unknown/Other	9% (7/76)	10% (5/50)	29% (2/7)	0% (0/19)
Hypertension	68% (52/76)	68% (34/50)	57% (4/7)	74% (14/19)
Diabetes Mellitus	55% (42/76)	64% (32/50)	57% (4/7)	32% (6/19)
Insulin-Dependent	17% (13/76)	24% (12/50)	0% (0/7)	5% (1/19)
Hyperlipidemia	51% (39/76)	56% (28/50)	71% (5/7)	32% (6/19)
Atrial Fibrillation	7% (5/76)	8% (4/50)	0% (0/7)	5% (1/19)
Current Smoker	22% (17/76)	18% (9/50)	29% (2/7)	32% (6/19)
Remote Smoker	21% (16/76)	18% (9/50)	14% (1/7)	32% (6/19)
Remote PCI	20% (15/76)	22% (11/50)	57% (4/7)	0% (0/19)
Remote MI	13% (10/76)	12% (6/50)	43% (3/7)	5% (1/19)
Remote CABG	11% (8/76)	14% (7/50)	14% (1/7)	0% (0/19)
Creatinine (mg/dl)	1.9 ± 1.9 (75)	2.1 ± 2.2 (49)	1.5 ± 0.9 (7)	1.8 ± 1.2 (19)
% (n) ≥ 1.4	50% (38/75)	52% (26/50)	43% (3/7)	47% (9/19)
Hemodialysis	8% (6/76)	10% (5/50)	0% (0/7)	5% (1/19)
History Of Prior CHF	29% (22/76)	24% (12/50)	43% (3/7)	37% (7/19)
Ejection Fraction	30 ± 17 (62)	33 ± 16 (39)	22 ± 10 (6)	27 ± 18 (17)
% (n) ≤ 35%	55% (42/62)	56% (22/39)	100% (6/6)	82% (14/17)
% (n) ≤ 25%	41% (31/62)	39% (15/39)	57% (4/6)	71% (12/17)
Aortic Stenosis	9% (7/76)	8% (4/50)	0% (0/7)	16% (3/19)
Aortic Regurgitation	4% (3/76)	2% (1/50)	0% (0/7)	11% (2/19)
Mitral Regurgitation	12% (9/76)	14% (7/50)	14% (1/7)	5% (1/19)

Table 1. Patient Demographics and Medical History

Total

IABP

IMP

IABP: Intra-Aortic Balloon Pump; IMP: Impella L.P. 2.5; TH: TandemHeart; PLVAD: Impella or TandemHeart

PCI: Percutaneous Coronary Intervention; MI: Myocardial Infarction; CABG: Coronary Artery Bypass Graft; CHF: Congestive Heart Failure

Number of Patients

66% (50/76)

9% (7/76)

25% (19/76)

IABP Prior to PLVAD

71% (5/7)

53% (10/19)

IABP During PLVAD

57% (4/7)

21% (4/19)

IABP After PLVAD

14% (1/7)

5% (1/19)

Age (years)

67.9 ± 11.9

67.4 ± 11.4

69.7 ± 10.5

68.5 ± 14.1

Male Gender

65% (49/76)

58% (29/50)

86% (6/7)

74% (14/19)

Race, Caucasian

13% (10/76)

12% (6/50)

14% (1/7)

16% (3/19)

Asian

26% (20/76)

24% (12/50)

14% (1/7)

37% (7/19)

Hispanic

41% (31/76)

42% (21/50)

43% (3/7)

37% (7/19)

Black

11% (8/76)

12% (6/50)

0% (0/7)

11% (2/19)

Unknown/Other

9% (7/76)

10% (5/50)

29% (2/7)

0% (0/19)

Hypertension

68% (52/76)

68% (34/50)

57% (4/7)

74% (14/19)

Diabetes Mellitus

55% (42/76)

64% (32/50)

57% (4/7)

32% (6/19)

Insulin-Dependent

17% (13/76)

24% (12/50)

0% (0/7)

5% (1/19)

Hyperlipidemia

51% (39/76)

56% (28/50)

71% (5/7)

32% (6/19)

Atrial Fibrillation

7% (5/76)

8% (4/50)

0% (0/7)

5% (1/19)

Current Smoker

22% (17/76)

18% (9/50)

29% (2/7)

32% (6/19)

Remote Smoker

21% (16/76)

18% (9/50)

14% (1/7)

32% (6/19)

Remote PCI

20% (15/76)

22% (11/50)

57% (4/7)

0% (0/19)

Remote MI

13% (10/76)

12% (6/50)

43% (3/7)

5% (1/19)

Remote CABG

11% (8/76)

14% (7/50)

14% (1/7)

0% (0/19)

Creatinine (mg/dl)

1.9 ± 1.9 (75)

2.1 ± 2.2 (49)

1.5 ± 0.9 (7)

1.8 ± 1.2 (19)

% (n) ≥ 1.4

50% (38/75)

52% (26/50)

43% (3/7)

47% (9/19)

Hemodialysis

8% (6/76)

10% (5/50)

0% (0/7)

5% (1/19)

History Of Prior CHF

29% (22/76)

24% (12/50)

43% (3/7)

37% (7/19)

Ejection Fraction

30 ± 17 (62)

33 ± 16 (39)

22 ± 10 (6)

27 ± 18 (17)

% (n) ≤ 35%

55% (42/62)

56% (22/39)

100% (6/6)

82% (14/17)

% (n) ≤ 25%

41% (31/62)

39% (15/39)

57% (4/6)

71% (12/17)

Aortic Stenosis

9% (7/76)

8% (4/50)

0% (0/7)

16% (3/19)

Aortic Regurgitation

4% (3/76)

2% (1/50)

0% (0/7)

11% (2/19)

Mitral Regurgitation

12% (9/76)

14% (7/50)

14% (1/7)

5% (1/19)

**Table 2.** Presentation
	Total	IABP	IMP	TH
^aIncludes 1 patient each with stable angina (IABP), post-ablation ventricular tachycardia (IABP), myocarditis (TH), severe mitral regurgitation (TH).
^bincludes patients with myocarditis, severe mitral regurgitation, pending CABG, pending transplant, early death. IABP: Intra-Aortic Balloon Pump; IMP: Impella L.P. 2.5; TH: TandemHeart; OSH: Out-Side Hospital; MI: Myocardial Infarction; CHF: Congestive Heart Failure; CS: Cardiogenic Shock; PCI: Percutaneous Coronary Intervention; CABG: Coronary Artery Bypass Graft; EF: Ejection Fraction; PTCA: Percutaneous Transluminal Coronary Angioplasty; DES: Drug Eluting Stent; RA: Rotational Atherectomy; BMS: Bare Metal Stent.
Transferred From OSH	40% (30/76)	34% (17/50)	57% (4/7)	47% (9/19)
Emergent	84% (64/76)	98% (49/50)	57% (4/7)	58% (11/19)
Elective	16% (12/76)	2% (1/50)	43% (3/7)	42% (8/19)
STEMI	59% (45/76)	70% (35/50)	43% (3/7)	37% (7/19)
Peri-operative STEMI	3% (2/76)	4% (2/50)	0% (0/7)	0% (0/19)
Cardiac Arrest	11% (8/76)	16% (8/50)	0% (0/7)	0% (0/19)
Non-STEMI	9% (7/76)	4% (2/50)	43% (3/7)	11% (2/19)
CHF	16% (12/76)	6% (3/50)	14% (1/7)	42% (8/19)
Othera	5% (4/76)	4% (2/50)	0% (0/7)	11% (2/19)
CS Began in Cath Lab	21% (16/76)	20% (10/50)	29% (2/7)	21% (4/19)
Received CPR	49% (37/76)	54% (27/50)	43% (3/7)	37% (7/19)
On Vasopressors	99% (75/76)	100% (50/50)	86% (6/7)	100% (19/19)
Mean Number of Vasopressors	1.6 ± 0.6	1.6 ± 0.6	1.3 ± 0.8	1.7 ± 0.7
Dopamine	83% (63/76)	82% (41/50)	71% (5/7)	90% (17/19)
Norepinephrine	50% (38/76)	54% (27/50)	43% (3/7)	42% (8/19)
Dobutamine	15% (11/76)	14% (7/50)	0% (0/7)	21% (4/19)
Epinephrine	5% (4/76)	2% (1/50)	0% (0/7)	16% (3/19)
Neosynephrine	7% (5/76)	6% (3/50)	14% (1/7)	5% (1/19)
Revascularization
PCI	83% (63/76)	84% (42/50)	100% (7/7)	74% (14/19)
Failed Lytics (Rescue PCI)	11% (8/76)	8% (4/50)	29% (2/7)	11% (2/19)
Aortic Valvuloplasty	7% (5/76)	6% (3/50)	0% (0/7)	11% (2/19)
PCI and CABG	5% (4/76)	6% (3/50)	0% (0/7)	5% (1/19)
CABG Alone	4% (3/76)	4% (2/50)	0% (0/7)	5% (1/19)
Noneb	13% (10/76)	12% (6/50)	0% (0/7)	21% (4/19)
Type of Intervention
PTCA	74% (56/76)	74% (37/50)	100% (7/7)	63%(12/19)
Thrombectomy	40% (30/76)	44% (22/50)	29% (2/7)	32%(6/19)
DES	40% (30/76)	34% (17/50)	71% (5/7)	42%(8/19)
BMS	21% (16/76)	22% (11/50)	14% (1/7)	21%(4/19)
RA	7% (5/76)	4% (2/50)	0% (0/7)	16%(3/19)
Aortic Valvuloplasty	7% (5/76)	6% (3/50)	0% (0/7)	11%(2/19)

Table 2. Presentation

Total

IABP

IMP

^aIncludes 1 patient each with stable angina (IABP), post-ablation ventricular tachycardia (IABP), myocarditis (TH), severe mitral regurgitation (TH).

^bincludes patients with myocarditis, severe mitral regurgitation, pending CABG, pending transplant, early death. IABP: Intra-Aortic Balloon Pump; IMP: Impella L.P. 2.5; TH: TandemHeart; OSH: Out-Side Hospital; MI: Myocardial Infarction; CHF: Congestive Heart Failure; CS: Cardiogenic Shock; PCI: Percutaneous Coronary Intervention; CABG: Coronary Artery Bypass Graft; EF: Ejection Fraction; PTCA: Percutaneous Transluminal Coronary Angioplasty; DES: Drug Eluting Stent; RA: Rotational Atherectomy; BMS: Bare Metal Stent.

Transferred From OSH

40% (30/76)

34% (17/50)

57% (4/7)

47% (9/19)

Emergent

84% (64/76)

98% (49/50)

57% (4/7)

58% (11/19)

Elective

16% (12/76)

2% (1/50)

43% (3/7)

42% (8/19)

STEMI

59% (45/76)

70% (35/50)

43% (3/7)

37% (7/19)

Peri-operative STEMI

3% (2/76)

4% (2/50)

0% (0/7)

0% (0/19)

Cardiac Arrest

11% (8/76)

16% (8/50)

0% (0/7)

0% (0/19)

Non-STEMI

9% (7/76)

4% (2/50)

43% (3/7)

11% (2/19)

CHF

16% (12/76)

6% (3/50)

14% (1/7)

42% (8/19)

Othera

5% (4/76)

4% (2/50)

0% (0/7)

11% (2/19)

CS Began in Cath Lab

21% (16/76)

20% (10/50)

29% (2/7)

21% (4/19)

Received CPR

49% (37/76)

54% (27/50)

43% (3/7)

37% (7/19)

On Vasopressors

99% (75/76)

100% (50/50)

86% (6/7)

100% (19/19)

Mean Number of Vasopressors

1.6 ± 0.6

1.3 ± 0.8

1.7 ± 0.7

Dopamine

83% (63/76)

82% (41/50)

71% (5/7)

90% (17/19)

Norepinephrine

50% (38/76)

54% (27/50)

43% (3/7)

42% (8/19)

Dobutamine

15% (11/76)

14% (7/50)

0% (0/7)

21% (4/19)

Epinephrine

5% (4/76)

2% (1/50)

0% (0/7)

16% (3/19)

Neosynephrine

7% (5/76)

6% (3/50)

14% (1/7)

5% (1/19)

Revascularization

PCI

83% (63/76)

84% (42/50)

100% (7/7)

74% (14/19)

Failed Lytics (Rescue PCI)

11% (8/76)

8% (4/50)

29% (2/7)

11% (2/19)

Aortic Valvuloplasty

7% (5/76)

6% (3/50)

0% (0/7)

11% (2/19)

PCI and CABG

5% (4/76)

6% (3/50)

0% (0/7)

5% (1/19)

CABG Alone

4% (3/76)

4% (2/50)

0% (0/7)

5% (1/19)

Noneb

13% (10/76)

12% (6/50)

0% (0/7)

21% (4/19)

Type of Intervention

PTCA

74% (56/76)

74% (37/50)

100% (7/7)

63%(12/19)

Thrombectomy

40% (30/76)

44% (22/50)

29% (2/7)

32%(6/19)

DES

40% (30/76)

34% (17/50)

71% (5/7)

42%(8/19)

BMS

21% (16/76)

22% (11/50)

14% (1/7)

21%(4/19)

7% (5/76)

4% (2/50)

0% (0/7)

16%(3/19)

Aortic Valvuloplasty

7% (5/76)

6% (3/50)

0% (0/7)

11%(2/19)

**Table 3.** Procedural Complications and 30-Day Outcomes
	Total	IABP	IMP	TH
^a3 resolved upon device removal, 1 resolved upon device adjustment, and none required surgery. ^bIncludes 1 each of acute arterial embolization of subclavian artery (IABP), clot seen on catheter in setting of apical aneurysm (Impella), and decrease in blood pressure to 60/40 during first attempt at transeptal puncture (TandemHeart, second attempt successful) IABP: Intra-Aortic Balloon Pump; IMP: Impella L.P. 2.5; TH: TandemHeart; CPR: cardiopulmonary resuscitation.
Successful Device Initiation	100% (76/76)	100% (50/50)	100% (7/7)	100% (19/19)
Angiographic Success	90% (57/63)	86% (36/42)	100% (7/7)	100% (14/14)
Procedural Success	89% (56/63)	86% (36/42)	100% (7/7)	93% (13/14)
Final Follow Up (Days)	12.5 ± 12.1	12.5 ± 11.9	18.4 ± 13.8	10.5 ± 11.7
30 Days	24% (18/76)	34% (17/50)	43% (3/7)	16% (3/19)
Death	40% (30/76)	34% (17/50)	14% (1/7)	63% (12/19)
Emergent Device Placement	41% (26/64)	35% (17/49)	25% (1/4)	73% (8/11)
Elective Device Placement	33% (4/12)	0% (0/1)	0% (0/3)	50% (4/8)
Did Not Receive CPR	28% (11/39)	17% (4/23)	0% (0/4)	58% (7/12)
Received CPR	51% (19/37)	48% (13/27)	33% (1/3)	71% (5/7)
Stroke	4% (3/76)	4% (2/50)	0% (0/7)	5% (1/19)
Limb Ischemia^a	7% (5/76)	6% (3/50)	0% (0/7)	11% (2/19)
Other^b	4% (3/76)	2% (1/50)	14% (1/7)	5% (1/19)

Table 3. Procedural Complications and 30-Day Outcomes

Total

IABP

IMP

^a3 resolved upon device removal, 1 resolved upon device adjustment, and none required surgery. ^bIncludes 1 each of acute arterial embolization of subclavian artery (IABP), clot seen on catheter in setting of apical aneurysm (Impella), and decrease in blood pressure to 60/40 during first attempt at transeptal puncture (TandemHeart, second attempt successful) IABP: Intra-Aortic Balloon Pump; IMP: Impella L.P. 2.5; TH: TandemHeart; CPR: cardiopulmonary resuscitation.

Successful Device Initiation

100% (76/76)

100% (50/50)

100% (7/7)

100% (19/19)

Angiographic Success

90% (57/63)

86% (36/42)

100% (7/7)

100% (14/14)

Procedural Success

89% (56/63)

86% (36/42)

100% (7/7)

93% (13/14)

Final Follow Up (Days)

12.5 ± 12.1

12.5 ± 11.9

18.4 ± 13.8

10.5 ± 11.7

30 Days

24% (18/76)

34% (17/50)

43% (3/7)

16% (3/19)

Death

40% (30/76)

34% (17/50)

14% (1/7)

63% (12/19)

Emergent Device Placement

41% (26/64)

35% (17/49)

25% (1/4)

73% (8/11)

Elective Device Placement

33% (4/12)

0% (0/1)

0% (0/3)

50% (4/8)

Did Not Receive CPR

28% (11/39)

17% (4/23)

0% (0/4)

58% (7/12)

Received CPR

51% (19/37)

48% (13/27)

33% (1/3)

71% (5/7)

Stroke

4% (3/76)

4% (2/50)

0% (0/7)

5% (1/19)

Limb Ischemia^a

7% (5/76)

6% (3/50)

0% (0/7)

11% (2/19)

Other^b

4% (3/76)

2% (1/50)

14% (1/7)

5% (1/19)

**Table 4.** Bleeding Complications
	Total	IABP	IMP	TH
^aPerclose device (Abbott Vascular, Redwood City, CA) using the "preclose" technique; ^bother reasons include coagulopathy, ventricular wall rupture, anemia at presentation, and pulmonary hemorrhage. IABP: Intra-Aortic Balloon Pump; IMP: Impella L.P. 2.5; TH: TandemHeart; CABG: Coronary Artery By-pass graphing; TIMI: Thrombolysis in Myocardial Infarction.
TIMI Minor Bleed	22% (17/76)	24% (12/50)	14% (1/7)	21% (4/19)
TIMI Major Bleed	33% (25/76)	24% (12/50)	43% (3/7)	53% (10/19)
Bleeding Requiring Surgery	0% (0/76)	0% (0/50)	0% (0/7)	0% (0/19)
Retroperitoneal Bleed	0% (0/76)	0% (0/50)	0% (0/7)	0% (0/19)
Vascular Closure Device^a	20% (15/76)	0% (0/50)	57% (4/7)	58% (11/19)
Other Reason for Bleeding^b	22% (17/76)	20% (10/50)	14% (1/7)	32% (6/19)
Platelets (k/ul)
Before	216 ± 85 (75)	231 ± 87 (49)	234 ± 51 (7)	171 ± 77 (19)
After	128 ± 65 (71)	137 ± 62 (47)	156 ± 73 (7)	91 ± 57 (17)
Before-After Change	-90 ± 71 (71)	-95 ± 65 (47)	-78 ± 90 (7)	-80 ± 83 (17)
Hemoglobin (g/dL)
Before	12.4 ± 2.2 (74)	12.4 ± 2.1 (48)	11.9 ± 1.8 (7)	12.5 ± 2.7 (19)
After	9.7 ± 2.0 (71)	10.2 ± 1.5 (46)	8.5 ± 2.6 (7)	8.8 ± 2.4 (18)
Before-After Change	-2.7 ± 2.2 (71)	-2.3 ± 1.9 (46)	-3.4 ± 2.4 (7)	-3.7 ± 2.4 (18)
Transfusion
Fresh Frozen Plasma	7% (5/76)	4% (2/50)	0% (0/7)	16% (3/19)
Platelets	9% (7/76)	6% (3/50)	0% (0/7)	21% (4/19)
Packed Red Blood Cells	47% (36/76)	34% (17/50)	57% (4/7)	79% (15/19)
Mean Number	4.1 ± 4.2	2.6 ± 1.2	4.5 ± 3.7	5.5 ± 5.9

Table 4. Bleeding Complications

Total

IABP

IMP

^aPerclose device (Abbott Vascular, Redwood City, CA) using the "preclose" technique; ^bother reasons include coagulopathy, ventricular wall rupture, anemia at presentation, and pulmonary hemorrhage. IABP: Intra-Aortic Balloon Pump; IMP: Impella L.P. 2.5; TH: TandemHeart; CABG: Coronary Artery By-pass graphing; TIMI: Thrombolysis in Myocardial Infarction.

TIMI Minor Bleed

22% (17/76)

24% (12/50)

14% (1/7)

21% (4/19)

TIMI Major Bleed

33% (25/76)

24% (12/50)

43% (3/7)

53% (10/19)

Bleeding Requiring Surgery

0% (0/76)

0% (0/50)

0% (0/7)

0% (0/19)

Retroperitoneal Bleed

0% (0/76)

0% (0/50)

0% (0/7)

0% (0/19)

Vascular Closure Device^a

20% (15/76)

0% (0/50)

57% (4/7)

58% (11/19)

Other Reason for Bleeding^b

22% (17/76)

20% (10/50)

14% (1/7)

32% (6/19)

Platelets (k/ul)

Before

216 ± 85 (75)

231 ± 87 (49)

234 ± 51 (7)

171 ± 77 (19)

After

128 ± 65 (71)

137 ± 62 (47)

156 ± 73 (7)

91 ± 57 (17)

Before-After Change

-90 ± 71 (71)

-95 ± 65 (47)

-78 ± 90 (7)

-80 ± 83 (17)

Hemoglobin (g/dL)

Before

12.4 ± 2.2 (74)

12.4 ± 2.1 (48)

11.9 ± 1.8 (7)

12.5 ± 2.7 (19)

After

9.7 ± 2.0 (71)

10.2 ± 1.5 (46)

8.5 ± 2.6 (7)

8.8 ± 2.4 (18)

Before-After Change

-2.7 ± 2.2 (71)

-2.3 ± 1.9 (46)

-3.4 ± 2.4 (7)

-3.7 ± 2.4 (18)

Transfusion

Fresh Frozen Plasma

7% (5/76)

4% (2/50)

0% (0/7)

16% (3/19)

Platelets

9% (7/76)

6% (3/50)

0% (0/7)

21% (4/19)

Packed Red Blood Cells

47% (36/76)

34% (17/50)

57% (4/7)

79% (15/19)

Mean Number

4.1 ± 4.2

2.6 ± 1.2

4.5 ± 3.7

5.5 ± 5.9

**Table 5.** Hemodynamics
	Total	IABP	IMP	TH
IABP: Intra-Aortic Balloon Pump; IMP: Impella L.P. 2.5; TH: TandemHeart; RPM: Rotations Per Minute; EF: Ejection Fraction; SBP: Systolic Blood Pressure in mmHg; MBP: Mean Blood Pressure in mmHg; HR: Heart Rate; ^a99% of the documented SBPs and MBPs were supported by vasopressors; ^bin addition, 2 patients each with an IABP and TandemHeart had no detectable SBP.
EF
Before	30.4 ± 16.5% (62)	33 ± 16% (39)	22 ± 10% (6)	27 ± 18% (17)
After	38.8 ± 16.9% (60)	38 ± 14% (40)	34 ± 15% (6)	39 ± 21% (13)
Before-after change	+6.6 ± 11.4% (50)	+5.8 ± 11.3% (32)	+12.5 ± 15.1% (6)	+5.8 ± 9.7% (12)
Before-after P value	0.00015	0.0065	0.098	0.062
SBP^a
Before^b	97 ± 23 (71)	97 ± 24 (48)	105 ± 25 (7)	93 ± 20 (16)
During	111 ± 21 (70)	115 ± 20 (48)	111 ± 26 (7)	101 ± 21 (15)
After	111 ± 16 (54)	114 ± 15 (36)	113 ± 16 (6)	98 ± 14 (12)
Before-during change	+14 ± 20 (70)	+18 ± 19 (48)	+6 ± 9 (7)	+6 ± 21 (15)
Before-after change	+12 ± 26 (54)	+17 ± 29 (36)	+4 ± 19 (6)	+4 ± 14 (12)
Before-after P value	0.00076	0.0015	0.621	0.307
MBP^a
Before	75 ± 18 (71)	76 ± 18 (48)	76 ± 18 (7)	73 ± 16 (16)
During	88 ± 18 (70)	89 ± 18 (48)	84 ± 21 (7)	87 ± 17 (15)
After	77 ± 11 (54)	77 ± 11 (36)	79 ± 11 (6)	78 ± 13 (12)
Before-during change	+13 ± 15 (70)	+14 ± 15 (48)	+8 ± 15 (7)	+13 ± 16 (15)
Before-after change	+1 ± 18 (54)	+1 ± 19 (36)	0 ± 22 (6)	+3 ± 14 (12)
HR
Before	93 ± 23 (71)	95 ± 23 (48)	77 ± 17 (7)	93 ± 25 (16)
During	95 ± 21 (70)	95 ± 23 (48)	88 ± 15 (7)	98 ± 20 (15)
After	87 ± 16 (54)	86 ± 14 (36)	88 ± 22 (6)	90 ± 19 (12)
Before-during change	+3 ± 27 (70)	1 ± 28 (48)	+11 ± 28 (7)	+7 ± 25 (15)
Before-after change	-4 ± 25 (54)	-6 ± 25 (36)	+7 ± 24 (6)	-1 ± 25 (12)

Table 5. Hemodynamics

Total

IABP

IMP

IABP: Intra-Aortic Balloon Pump; IMP: Impella L.P. 2.5; TH: TandemHeart; RPM: Rotations Per Minute; EF: Ejection Fraction; SBP: Systolic Blood Pressure in mmHg; MBP: Mean Blood Pressure in mmHg; HR: Heart Rate; ^a99% of the documented SBPs and MBPs were supported by vasopressors; ^bin addition, 2 patients each with an IABP and TandemHeart had no detectable SBP.

Before

30.4 ± 16.5% (62)

33 ± 16% (39)

22 ± 10% (6)

27 ± 18% (17)

After

38.8 ± 16.9% (60)

38 ± 14% (40)

34 ± 15% (6)

39 ± 21% (13)

Before-after change

+6.6 ± 11.4% (50)

+5.8 ± 11.3% (32)

+12.5 ± 15.1% (6)

+5.8 ± 9.7% (12)

Before-after P value

0.00015

0.0065

0.098

0.062

SBP^a

Before^b

97 ± 23 (71)

97 ± 24 (48)

105 ± 25 (7)

93 ± 20 (16)

During

111 ± 21 (70)

115 ± 20 (48)

111 ± 26 (7)

101 ± 21 (15)

After

111 ± 16 (54)

114 ± 15 (36)

113 ± 16 (6)

98 ± 14 (12)

Before-during change

+14 ± 20 (70)

+18 ± 19 (48)

+6 ± 9 (7)

+6 ± 21 (15)

Before-after change

+12 ± 26 (54)

+17 ± 29 (36)

+4 ± 19 (6)

+4 ± 14 (12)

Before-after P value

0.00076

0.0015

0.621

0.307

MBP^a

Before

75 ± 18 (71)

76 ± 18 (48)

76 ± 18 (7)

73 ± 16 (16)

During

88 ± 18 (70)

89 ± 18 (48)

84 ± 21 (7)

87 ± 17 (15)

After

77 ± 11 (54)

77 ± 11 (36)

79 ± 11 (6)

78 ± 13 (12)

Before-during change

+13 ± 15 (70)

+14 ± 15 (48)

+8 ± 15 (7)

+13 ± 16 (15)

Before-after change

+1 ± 18 (54)

+1 ± 19 (36)

0 ± 22 (6)

+3 ± 14 (12)

Before

93 ± 23 (71)

95 ± 23 (48)

77 ± 17 (7)

93 ± 25 (16)

During

95 ± 21 (70)

95 ± 23 (48)

88 ± 15 (7)

98 ± 20 (15)

After

87 ± 16 (54)

86 ± 14 (36)

88 ± 22 (6)

90 ± 19 (12)

Before-during change

+3 ± 27 (70)

1 ± 28 (48)

+11 ± 28 (7)

+7 ± 25 (15)

Before-after change

-4 ± 25 (54)

-6 ± 25 (36)

+7 ± 24 (6)

-1 ± 25 (12)

**Table 6.** In-Hospital Mortality Rates for Patients with Cardiogenic Shock
Report	N	Cohort	In-hospital Mortality
^aMortality in the SHOCK trial was 47% in patients randomized to early revascularization and standard medical therapy and 56% in patients randomized to standard medical therapy (the difference was not significant at 30 days but reached significance at 6 months). ^bMortality in the SHOCK registry was 47% in patients treated with an IABP and thrombolytics, but baseline characteristics and revascularization rates favored this group.STEMI: ST-segment elevation myocardial infarction; Imp: Impella; TH: TandemHeart.
SHOCK trial [1]	302	STEMI with cardiogenic shock due predominantly to left ventricular dysfunction; excluded mechanical cause of shock, severe systemic illness, not suitable for revascularization	51%^a
SHOCK registry [2]	1190	Patients excluded from SHOCK trial	60%^b
Meta-analysis [7] of 3 randomized trials of IABP vs. Imp/TH	100	Excluded age >75, sepsis, right heart failure, aortic regurgitation, mechanical complications, severe peripheral vascular disease, other	42% IABP 45% Imp / TH
This study	76	All patients with percutaneous left ventricular assist devices; Excluded none	40%

Table 6. In-Hospital Mortality Rates for Patients with Cardiogenic Shock

Report

Cohort

In-hospital Mortality

^aMortality in the SHOCK trial was 47% in patients randomized to early revascularization and standard medical therapy and 56% in patients randomized to standard medical therapy (the difference was not significant at 30 days but reached significance at 6 months). ^bMortality in the SHOCK registry was 47% in patients treated with an IABP and thrombolytics, but baseline characteristics and revascularization rates favored this group.STEMI: ST-segment elevation myocardial infarction; Imp: Impella; TH: TandemHeart.

SHOCK trial [1]

302

STEMI with cardiogenic shock due predominantly to left ventricular dysfunction; excluded mechanical cause of shock, severe systemic illness, not suitable for revascularization

51%^a

SHOCK registry [2]

1190

Patients excluded from SHOCK trial

60%^b

Meta-analysis [7] of 3 randomized trials of IABP vs. Imp/TH

100

Excluded age >75, sepsis, right heart failure, aortic regurgitation, mechanical complications, severe peripheral vascular disease, other

42% IABP
45% Imp / TH

This study

All patients with percutaneous left ventricular assist devices; Excluded none

40%