Use of a percutaneous temporary circulatory support device as a bridge to decision during acute decompensation of advanced heart failure

Author’s Accepted Manuscript Use of a percutaneous temporary circulatory support device as a bridge to decision during acute decompensation of advanced heart failureTemporary MCS as Bridge to Decision Shelley A. Hall, Nir Uriel, Sandra A. Carey, Michelle Edens, Geoffrey Gong, Michele Esposito, Ryan O’Kelly, Shiva Annamalai, Nima Aghili, S. Adatya, Navin K. Kapur

PII: DOI: Reference:

http://www.jhltonline.org

S1053-2498(17)32035-1 http://dx.doi.org/10.1016/j.healun.2017.09.020 HEALUN6610

To appear in: Journal of Heart and Lung Transplantation Cite this article as: Shelley A. Hall, Nir Uriel, Sandra A. Carey, Michelle Edens, Geoffrey Gong, Michele Esposito, Ryan O’Kelly, Shiva Annamalai, Nima Aghili, S. Adatya and Navin K. Kapur, Use of a percutaneous temporary circulatory support device as a bridge to decision during acute decompensation of advanced heart failureTemporary MCS as Bridge to Decision, Journal of Heart and Lung Transplantation, http://dx.doi.org/10.1016/j.healun.2017.09.020 This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting galley proof before it is published in its final citable form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.

USE OF A PERCUTANEOUS TEMPORARY CIRCULATORY SUPPORT DEVICE AS A BRIDGE TO DECISION DURING ACUTE DECOMPENSATION OF ADVANCED HEART FAILURE

Shelley A. Hall MD,1 Nir Uriel MD,2 Sandra A. Carey PhD,3 Michelle Edens BS,3 Geoffrey Gong,4 Michele Esposito MD,5 Ryan O’Kelly BS,5 Shiva Annamalai MD,5 Nima Aghili,5 S. Adatya,2 Navin K. Kapur MD5

1

Division of Cardiology, Department of Internal Medicine, Baylor University Medical Center, Dallas, TX

2

Department of Medicine, Cardiology Division, University of Chicago Medical Center, Chicago, IL

3

Annette C. and Harold C. Simmons Transplant Institute, Baylor Scott & White Research Institute, Dallas, TX

4

Baylor Heart and Vascular Hospital, Baylor Scott & White Research Institute, Dallas, TX

5

The Acute Mechanical Support Working Group at The Cardiovascular Center, Tufts Medical Center, Boston, MA

Short title: Temporary MCS as Bridge to Decision Word Count (Abstract + main text): 3,010 Grant support: None Disclosures: Dr. Kapur receives research funding from Abiomed Inc, Maquet Inc, and Cardiac Assist Inc. Dr. Hall is a consultant for Abiomed, Inc. The other authors have no conflicts of interest to disclose. Address for correspondence: Shelley A. Hall, M.D., Center for Advanced Heart and Lung Disease, Baylor University Medical Center, 3410 Worth St., Suite 545, Dallas, TX 75246 Tel 214-820-6856; FAX 214-820-1474; E-mail [email protected]

1

ABSTRACT Background: Prognosis is poor for patients with decompensated advanced heart failure (HF) refractory to medical therapy. Evaluating candidacy for durable mechanical circulatory support (MCS), cardiac transplantation, or palliative care is complex and time is often needed to stabilize the patient hemodynamically. The Impella 5.0 is a minimally invasive axial-flow catheter capable of providing full temporary hemodynamic support. We report a multicenter series on the use of this device for bridge to decision (BTD) in decompensated advanced HF patients. Methods: In a retrospective evaluation at 3 centers of patients with advanced HF who acutely decompensated and received the Impella 5.0 for BTD, we analyzed demographics, procedural characteristics, in-hospital and intermediate-term outcomes, and in-hospital complications. Results: Fifty-eight patients met inclusion criteria from 2010-2015. All were inotrope-dependent; mean ejection fraction was 13%, median age was 59 years (IQR 48-64). Mean duration of support was 7 days (range 0-22). Thirty-nine patients survived to next therapy (67%), with most receiving durable MCS (N=20) or heart transplantation (N=15). In-hospital complications included bleeding (N=9) and hemolysis (N=4). Of patients who survived to next therapy, 1-year survival was 65% for those who received durable MCS, 87% for those transplanted, and 75% for those stabilized and weaned. Conclusions: The Impella 5.0 may provide a BTD strategy for patients with advanced HF and acute hemodynamic instability. Prospective studies are needed to evaluate safety and effectiveness of this device in this patient population.

Keywords: Advanced heart failure; Cardiogenic shock; Temporary circulatory support; Impella

2

INTRODUCTION Prognosis is poor for patients with acutely decompensated advanced heart failure (HF) refractory to medical therapy.1 Evaluating candidacy for durable mechanical circulatory support, orthotopic heart transplantation (OHTx), or palliative care is complex and may take a meaningful amount of time. This complexity is compounded by hemodynamic instability. Additionally, outcomes are worse for patients who undergo durable left ventricular assist device (LVAD) implantation while in cardiogenic shock (INTERMACS level 1) compared to outcomes for hemodynamically stable patients,2 and rarely can these patients be listed for transplant. Temporary circulatory support (TCS) devices may offer a bridge-todecision (BTD) option in this population, providing hemodynamic stabilization and potentially slowing, stopping or reversing the downward spiral of cardiogenic shock until transition to durable therapy is appropriate.3

The Impella 5.0 is one of several TCS devices currently available. It offers full systemic circulatory support (up to 5 L/min), direct left ventricular (LV) unloading, and minimally invasive implantation avoiding a sternotomy.4 Several reports have described its use for hemodynamic support in cardiogenic shock,5,6 and a recent single-center study reported 30-day outcomes for advanced HF patients who received Impella 5.0 support as a bridge to OHTx or durable LVAD.7 The support device is a 21 French microaxial blood pump mounted on a 9 French catheter.5 It is implanted through the femoral or axillary artery via surgical cutdown and advanced across the aortic valve until the pump inlet resides in the mid left ventricle (LV). Blood is pumped from the LV and ejected through the outlet into the ascending aorta. The Impella 5.0 supports systemic perfusion.4 Implantation via the axillary artery facilitates ambulation while on pump for patients who experience sufficient recovery.8,9

We report both acute and intermediate-term outcomes from a multicenter observational study of patients with advanced chronic HF who received the Impella 5.0 as a BTD while being considered for OHTx or durable LVAD. 3

METHODS This was a 3-center, retrospective, observational study conducted at Baylor University Medical Center, Tufts Medical Center, and the University of Chicago Medical Center. Data were collected retrospectively via chart review. The study was approved by the institutional review board at each center.

Patient population All patients who received the Impella 5.0 for hemodynamic support due to acute decompensation of advanced HF from 2010-2015 were included. This cohort included all 40 patients described in an earlier report.7 The need for temporary circulatory support to hemodynamically stabilize the patients prior to transition to OHTx, durable LVAD, or palliative care was based on the clinical judgement of the treating physicians. Patients who received the device due to hemodynamic instability in the absence of preexisting advanced HF were excluded (myocarditis, cardiogenic shock secondary to acute myocardial infarction, and post-cardiotomy cardiogenic shock). Patients for whom Impella 5.0 support was considered but implantation of the device was not possible were also excluded.

The lead author, as an investigator in the Impella Registry (currently named cVAD Registry), utilized a tabulation of all data submitted to the registry by her site (Baylor University Medical Center) provided by Abiomed. All Impella Registry sites enter their data into the registry electronically. Abiomed provided the data in a format allowing analysis. Authors NU and NKK provided patient data from their internal VAD registries.

Definitions of outcomes and complications Survival to next therapy was defined as removal from Impella support at the time of durable LVAD implant or OHTx, or weaning from Impella support after hemodynamic stabilization.

4

Right ventricular (RV) failure was defined by echocardiography interpretation, often supported by right heart catheter hemodynamics. Bleeding was defined as blood loss requiring transfusion or surgical repair for resolution. Hemolysis was defined as two plasma-free hemoglobin values >40 mg/dL within a single 48-hour period, or the combination of clinical signs (e.g. hematuria) and laboratory testing including reduced hemoglobin, elevated lactate dehydrogenase, and elevated indirect bilirubin. Cerebrovascular accident/stroke was defined as any new, temporary or permanent, focal or global neurological deficit ascertained by standard neurological examination, persisting beyond 24 hours or <24 hours with evidence of infarction or hemorrhage on an imaging study. Vascular complication requiring surgery was defined as pseudoaneurysm; arteriovenous fistula; vessel thrombosis; vessel dissection, perforation or rupture; or vessel stenosis, requiring surgical intervention. Infection was defined as a clinical infection accompanied by pain, fever, drainage and/or leukocytosis that was treated by anti-microbial agents. Hematoma was defined as any hematoma (swelling ≥5 cm in maximum diameter at vascular access site) diagnosed by ultrasound, computed tomography or palpation at the skin. Valve injury was defined as injury of any valve (aortic, mitral, tricuspid or pulmonic) regardless of cause by Doppler echocardiography, compared to baseline or noted at autopsy. Device malfunction was defined as an unexpected change in Impella 5.0 device performance that was contradictory to the labeling and/or negatively impacted the treatment of the patient, when the device was used in compliance with the instructions for use.

Statistical analysis Continuous data are presented as means with standard deviation and compared using the independent samples t-test. Categorical data are presented as percentages and compared using the Fisher’s exact test. Kaplan-Meier methods were used to estimate intermediate-term survival. A two-tailed p-value <0.05 was considered statistically significant. All analyses were performed using JMP 11.1.1 (SAS Institute Inc., Cary, NC).

5

RESULTS Seventy-seven subjects received the Impella 5.0 device for hemodynamic support at our three centers between January 2010 and December 2015 (Figure 1). Nineteen subjects were excluded from the analysis due to the absence of preexisting advanced HF [myocarditis (N=7), cardiogenic shock secondary to acute myocardial infarction (N=5), and post-cardiotomy cardiogenic shock (N=5)], or due to inability to implant the device (N=2). The remaining 58 subjects received Impella 5.0 support for acutely decompensated advanced HF and were included in the analysis. The majority of implants (74%) were via the axillary artery, usually right, using an insertion technique as outlined in prior publications.9, 10 The remaining implants were via the femoral artery.

Prior to Impella 5.0 implant, all patients displayed severe LV dysfunction despite inotropic support, with a mean LV ejection fraction of 13% (Table 1). Nearly 75% of patients also exhibited moderate or severe RV dysfunction by echo imaging, hemodynamics or clinical assessment. Systemic hemodynamics were severely compromised, with a mean systolic blood pressure <90 mmHg, mean cardiac index of 1.8 L/min/m2, and mean pulmonary capillary wedge pressure of 28 mmHg (Table 2). Evidence of end-organ hypoperfusion was present, with mean creatinine at 2.0 mg/dL, mean mixed venous oxygen saturation of 54%, and associated values for central venous pressure, total bilirubin, and albumin.

Outcomes of acute circulatory support In this cohort, TCS improved hemodynamics, producing statistically significant increases in cardiac index and systolic blood pressure and a statistically significant reduction in pulmonary capillary wedge pressure (Figure 2). Cardiac power output [(mean arterial pressure x cardiac output [CO])/451],11 calculated using right heart catheterization data for the 32 patients who had such data available, increased to a mean of 1.1 W, compared to 0.6 W before Impella activation (p=0.0001).

6

Thirty-nine patients (67%) survived to next therapy, and 19 (33%) expired on acute support (Figure 3A). The mean duration of Impella support was 7±5 days, and was significantly shorter for patients who expired on acute support compared to those who survived to next therapy (5±5 days vs. 9±5 days, p=0.01). Of the 39 patients who survived to next therapy, 51% (N=20) received durable LVADs, 39% (N=15 of 39) underwent OHTx, and 10% (N=4) were hemodynamically stabilized and weaned from Impella support (Figure 3B). The durations of support for the patients transitioned to LVAD, transplant, or weaning were 9±6 days, 9±5 days, and 7±4 days, respectively. Of the 19 patients who expired on acute Impella support, 68% (N=13) expired due to multi-organ system failure (MOSF), 21% (N=4) expired following withdrawal of Impella support (due to futility and patients' family decision), and 11% (N=2) expired due to sepsis.

Of the 39 patients who survived to next therapy, 87% (N=34) survived to 30 days or discharge (whichever was longer) post-Impella explant/transition to next therapy. Survival to 30 days or discharge was 85% (N=17) for the patients who received LVADs, 93% (N=14) for those who underwent OHTx, and 75% (N=3) for those who were stabilized and weaned from support. Causes of death prior to 30 days or discharge were: LVAD patients, MOSF (N=2, at 2 days and 5 months post-LVAD) and sepsis (N=1, at 24 days post-LVAD); transplant patient, acute rejection (29 days post-transplant); and weaned patient, end-stage cardiomyopathy following discharge to hospice (13 days post-wean).

Compared to patients who survived to next therapy, patients who expired on acute support were more likely to have received mechanical ventilation prior to Impella support (47 vs. 12%, p=0.01), had a higher mean creatinine level (2.4±0.9 vs. 1.8±0.7 mg/dL, p=0.03), and had a lower mean platelet count (157±59 vs. 212±118 103/µL) (Tables 1 and 2). Patients who expired on Impella support showed trends toward requiring higher levels of inotropic support, being more likely to exhibit moderate/severe RV dysfunction, and presenting with a lower mean arterial pressure than patients who survived to next therapy.

7

Intermediate outcomes for acute support survivors Of the 39 patients who survived to next therapy, estimated 1-year survival post-Impella explant/transition to next therapy was 65% for the patients who received LVADs, 87% for those who underwent OHTx, and 75% for those who were stabilized and weaned from support (Figure 4). Of the 20 LVAD patients, 12 survived to 1 year post-implant, 7 died within 1 year, and 1 was lost to follow-up at 9 months post-LVAD implant. Of the 15 transplant patients, 13 survived to 1 year post-transplant and 2 died within 1 year. Of the 4 weaned patients, 2 survived to 1 year post-weaning, 1 died within 1 year, and 1 was lost to follow up at 9 months post-weaning.

In-hospital complications Infection and bleeding requiring transfusion were the most common in-hospital complications, affecting 19% (N=11) and 16% (N=9) of patients, respectively (Table 3). None of the patients required surgical exploration or repair for bleeding. Less than 10% of the patients experienced hemolysis (N=4), hematoma (N=3), valve injury (N=1), or vascular complication requiring surgery (N=1). No patients experienced a stroke. Four patients (7%) experienced Impella 5.0 device malfunction, all of whom survived to the next therapy. For one patient, the pressure sensor failed but the device operated adequately until explant. For one patient, the device fractured during explant. The device was successfully removed with no clinical sequalae. The remaining two patients experienced pump stoppage prior to transition to next therapy, and in both cases the Impella 5.0 was successfully replaced with a second Impella 5.0.

DISCUSSION In this largest series reported to date on patients with advanced HF and acute hemodynamic instability, the Impella 5.0 stabilized these patients so that candidacy for advanced therapies such as OHTx, durable LVAD, or palliative care could be evaluated in a timely manner. This study expands an earlier report to a multicenter setting, including follow-up of all patients to 1 year post explant of the Impella device, and provides an analysis of predictors of survival to next therapy. Specifically, we identified statistically 8

significant improvements in cardiac index, systolic blood pressure, cardiac output, and pulmonary wedge pressure. Two-thirds of patients survived to the next therapy after 9±5 days on Impella 5.0 support, with infection (in 19% of cases) and bleeding requiring transfusion (16%) the most common in-hospital complications. In 2 of the 77 patients originally screened, the device could not be implanted. These results suggest that the Impella 5.0 is a feasible tool for critically ill patients, whose expected survival is less than 50% by historical literature.12,13 The 1-year survival after LVAD was 65%, which is better than the general historical 50% for INTERMACS 1. However, our cohort was preselected to be eligible for the BTD approach. Nonetheless, given the 0% survival that the patient was facing prior to Impella implant (because at that time the patient was considered too high risk for durable LVAD implant), we believe that the Impella BTD approach yielded encouraging results.

The use of durable LVADs is growing exponentially. Over the past decade, LVAD implantation for INTERMACS-1 patients has declined due to a high risk of early mortality after LVAD surgery. Thus, more physicians are looking for alternative approaches such as TCS devices. However, these devices differ from LVADs in several important ways, and not all TCS devices are made the same. Possible advantages of the Impella 5.0 over other TCS options (i.e. intra-aortic balloon pump (IABP) or venoarterial extracorporeal membrane oxygenation (ECMO)) include the magnitude of LV unloading (contrasted to increased afterload on ECMO) and the marked increase in cardiac output (unlike IABP, which is a diastolic pressure augmentation device requiring native cardiac contractility for its function14). Axillary approach in carefully selected patients demonstrated profound device stability and allows more patient movement, even to the point of ambulation. Second, in contrast to durable LVADs, withdrawal of temporary support if a patient is identified as a poor candidate for OHTx or LVAD is often considered a successful outcome for use of the device. This ability to “buy time” to sort through the myriad other clinical issues that go into candidacy for durable support treatments (such as determination of adequate social support or investigation of other comorbidities) so that appropriate decisions can be made is a critical objective of the BTD strategy. 9

The earlier report on the Impella 5.0 device as a means of TCS showed 75% survival to next therapy and similarly improved hemodynamics.7 The current study confirms these earlier results in a multicenter setting and provides additional information on in-hospital complications and intermediate survival. Another study, by Lemaire et al,6 showed similar short-term survival and low complication rates, but their study population differed in that approximately two-thirds had post-cardiotomy cardiac shock. A recent study of TCS devices utilized prior to durable VAD implantation demonstrated that, while hemodynamics recovered and end-organ dysfunction reversed, postoperative mortality and morbidity were still comparable to INTERMACS profile 1.15

Of the 19 patients who did not survive on Impella 5.0 support, two-thirds expired as a result of multiorgan system failure and this manifested itself early in the course of support as demonstrated by a much shorter support duration of 5±5 days. Earlier implantation with the Impella device, before severe organ failure occurs, would be warranted in patients who are in cardiogenic shock, if feasible, in order to further increase survival rates on TCS. Most notably, non-survivors demonstrated higher incidence of end organ insufficiency, represented by higher creatinine and more mechanical ventilation at time of Impella insertion. In addition, these patients also trended more commonly to moderate or severe RV dysfunction. This is not a surprise, as refractory RV dysfunction is a negative prognostic indicator for successful VAD implantation and the Impella 5.0 may allow “pre-screening” for the ability of the RV to adequately perform. Other devices, specifically designed for RV failure, exist.16

TCS enables the care team to provide adequate hemodynamic support during a critical clinical situation and thus accomplish multiple tasks. The first goal is stabilization of patients in cardiogenic shock and hopefully, implantation is early enough to allow reversal of end organ dysfunction. This study suggests that earlier implantation, prior to end organ failure, is the key to successful outcomes.

Our findings

indicate that this type of TCS is a feasible option for BTD in patients with preexisting advanced HF and 10

acute decompensation being evaluated for advanced therapies. Providing a means to allow stabilization and reversal of cardiogenic shock before a final decision on next therapy is made will ultimately improve these patients’ chances of survival from the acute incident and the ability to successfully undergo a more durable solution via OHTx or LVAD.

LIMITATIONS This study was limited by its retrospective design and the lack of a matched comparison group. Although this cohort constitutes the largest reported series of Impella 5.0 implantations to date, the number of patients is small for statistical analysis. Additionally, the decision to use TCS was at the discretion of the treating physician and did not depend on objective inclusion or exclusion criteria, limiting our ability to compare outcomes in this study to those in other published studies. However, even though our data lack the granularity to determine exactly how individual patients arrived at the point where acute TCS was being considered, none of the participating centers used the Impella device beyond the scope of what is described in the Methods section. Geographical differences in waiting times for cardiac transplant make widespread application of the Impella 5.0 as a BTT modality impractical and bridge to LVAD more realistic. A multicenter prospective trial is needed to formally assess safety, short-, and long-term efficacy of the Impella 5.0 in this high-mortality patient population.

ACKNOWLEDGEMENTS Grant support: None Disclosures: Dr. Kapur receives research funding from Abiomed Inc, Maquet Inc, and Cardiac Assist Inc. Dr. Hall is a consultant for Abiomed, Inc. The other authors have no conflicts of interest to disclose.

11

REFERENCES

1.

Setoguchi S, Stevenson LW, Schneeweiss S. Repeated hospitalizations predict mortality in the community population with heart failure. Am Heart J 2007;154:260-6.

2.

Boyle AJ, Ascheim DD, Russo MJ et al. Clinical outcomes for continuous-flow left ventricular assist device patients stratified by pre-operative INTERMACS classification. J Heart Lung Transplant 2011;30:402-7.

3.

Rihal CS, Naidu SS, Givertz MM et al. 2015 SCAI/ACC/HFSA/STS Clinical Expert Consensus Statement on the Use of Percutaneous Mechanical Circulatory Support Devices in Cardiovascular Care: Endorsed by the American Heart Assocation, the Cardiological Society of India, and Sociedad Latino Americana de Cardiologia Intervencion; Affirmation of Value by the Canadian Association of Interventional Cardiology-Association Canadienne de Cardiologie d'intervention. J Am Coll Cardiol 2015;65:e7-e26.

4.

Burkhoff D, Naidu SS. The science behind percutaneous hemodynamic support: a review and comparison of support strategies. Catheter Cardiovasc Interv 2012;80:816-29.

5.

Griffith BP, Anderson MB, Samuels LE, Pae WE, Jr., Naka Y, Frazier OH. The RECOVER I: a multicenter prospective study of Impella 5.0/LD for postcardiotomy circulatory support. J Thorac Cardiovasc Surg 2013;145:548-54.

6.

Lemaire A, Anderson MB, Lee LY et al. The Impella device for acute mechanical circulatory support in patients in cardiogenic shock. Ann Thorac Surg 2014;97:133-8.

12

7.

Lima B, Kale P, Gonzalez-Stawinski GV, Kuiper JJ, Carey S, Hall SA. Effectiveness and Safety of the Impella 5.0 as a Bridge to Cardiac Transplantation or Durable Left Ventricular Assist Device. Am J Cardiol 2016;117:1622-8.

8.

Pozzi M, Quessard A, Nguyen A et al. Using the Impella 5.0 with a right axillary artery approach as bridge to long-term mechanical circulatory assistance. Int J Artif Organs 2013;36:605-11.

9.

Schibilsky D, Lausberg H, Haller C et al. Impella 5.0 Support in INTERMACS II Cardiogenic Shock Patients Using Right and Left Axillary Artery Access. Artif Organs 2015;39:660-3.

10.

Sassard T, Scalabre A, Bonnefoy E, Sanchez I, Farhat F, Jegaden O. The right axillary artery approach for the Impella Recover LP 5.0 microaxial pump. Ann Thorac Surg 2008;85:1468-70.

11.

Mendoza DD, Cooper HA, Panza JA. Cardiac power output predicts mortality across a broad spectrum of patients with acute cardiac disease. Am Heart J 2007;153:366-70.

12.

Carroll BJ, Shah RV, Murthy V et al. Clinical Features and outcomes in adults with cardiogenic shock supported by extracorporeal membrane oxygenation. Am J Cardiol 2015;116:1624-30.

13.

Spinar J, Parenica J, Vitovec J et al. Baseline characteristics and hospital mortality in the Acute Heart Failure Database (AHEAD) Main registry. Crit Care 2011;15:R291.

14.

Annamalai SK, Buiten L, Esposito ML et al. Acute Hemodynamic Effects of Intra-Aortic Balloon Counterpulsation Pumps in Advanced Heart Failure. J Card Fail 2017.

13

15.

Shah P, Pagani FD, Desai SS et al. Outcomes of Patients Receiving Temporary Circulatory Support Before Durable Ventricular Assist Device. Ann Thorac Surg 2016.

16.

Anderson MB, Goldstein J, Milano C et al. Benefits of a novel percutaneous ventricular assist device for right heart failure: The prospective RECOVER RIGHT study of the Impella RP device. J Heart Lung Transplant 2015;34:1549-60.

FIGURE LEGENDS Figure 1. Patient flow chart, with outcome of acute support. Figure 2. Hemodynamic improvement on acute support. Figure 3. Outcomes of acute support, competing outcomes depiction. A: acute support outcomes for all patients. B: Next therapies for patients who survived the acute support phase. Figure 4. Intermediate outcomes, acute support survivors.

14

15

16

Table 1. Baseline Patient Characteristics

All (N=58)

Expired on acute support (N=19)

Survived to next therapy (N=39)

P value

Age (years)

55 +/- 14

52 +/- 17

56 +/- 12

0.34

Male sex (%)

79

79

79

1.00

Transfer admission (%)

50

58

46

0.57

Number of inotropes

1.8 +/- 0.9

2.2 +/- 1.1

1.7 +/- 0.8

0.10

Mechanical ventilation (%)

24

47

12

0.01

Intra-aortic balloon pump (%)

23

21

24

1.00

Cardiomyopathy: Ischemic (%)

43

37

46

0.58

57

63

54

Hypertension (%)

41

26

49

0.16

Renal insufficiency (%)

57

58

57

1.00

Diabetes (%)

39

37

39

1.00

Peripheral vascular disease (%)

5

5

6

1.00

Chronic obstructive pulmonary disease (%)

12

5

16

0.40

Cerebrovascular disease (%)

5

5

6

1.00

Valvular disease (%)

27

22

29

0.75

Prior coronary artery bypass graft surgery (%)

24

16

28

0.35

LVEF (%)

13 +/- 7

13 +/- 9

12 +/- 6

0.69

Mitral valve regurgitation

2 +/- 1

2 +/- 1

2 +/- 1

0.83

Moderate to severe RV

73

92

66

0.13

Non-ischemic (%)

Echocardiogram

17

dysfunction (%) Data are expressed as mean +/- standard deviation for continuous variables and percentage for categorical variables. LVEF: left ventricular ejection fraction.

18

Table 2. Baseline Hemodynamics and Laboratory Values All (N=58)

Expired on acute support (N=19)

Survived to next therapy (N=39)

P value

Systolic blood pressure (mmHg)

89 +/- 16

87 +/- 16

90 +/- 15

0.50

Diastolic blood pressure (mmHg)

60 +/- 11

58 +/- 11

62 +/- 11

0.18

Mean blood pressure (mmHg)

70 +/- 11

66 +/- 10

83 +/- 19

0.11

Pulmonary artery systolic blood pressure (mmHg)

56 +/- 15

56 +/- 14

56 +/- 16

0.91

Pulmonary artery diastolic blood pressure (mmHg)

32 +/- 8

33 +/- 6

31 +/- 9

0.39

Pulmonary capillary wedge pressure (mmHg)

28 +/- 9

30 +/- 9

27 +/- 10

0.52

Central venous pressure (mmHg)

17 +/- 8

19 +/- 7

16 +/- 9

0.28

Cardiac output (L/min)

3.7 +/- 1.9

3.8 +/- 2.5

3.7 +/- 1.5

0.99

Cardiac index (L/min/m2)

1.8 +/- 0.6

1.8 +/- 0.7

1.8 +/- 0.6

0.97

Cardiac power output (W)

0.6 +/- 0.3

0.6 +/- 0.5

0.6 +/- 0.2

0.85

Sodium (mmol/L)

134 +/- 7

137 +/- 8

133 +/- 6

0.14

Creatinine (mg/dL)

2.0 +/- 0.8

2.4 +/- 0.9

1.8 +/- 0.7

0.03

Total bilirubin (mg/dL)

2.4 +/- 3.6

3.4 +/- 5.5

1.9 +/- 1.6

0.26

Hemoglobin (g/dL)

10.9 +/- 2.0

11.2 +/- 2.2

10.7 +/- 1.9

0.40

Platelet count (103/l)

193 +/- 104

157 +/- 59

212 +/- 118

0.03

Albumin

3.0 +/- 0.6

2.9 +/- 0.8

3.1 +/- 0.5

0.29

SvO2 (%)

54 +/- 13

57 +/- 12

53 +/- 13

0.26

Hemodynamics

Laboratory values

Data are expressed as mean +/- standard deviation.

19

Table 3. In-Hospital Complications Bleeding requiring transfusion (%)

16

Bleeding requiring surgery (%)

0

Hemolysis (%)

7

Cerebrovascular accident/stroke (%)

0

Vascular complication requiring surgery (%)

2

Infection (%)

19

Hematoma (%)

5

Valve injury (%)

2

Device malfunction (%)

7

Data are expressed as percentage of patients.

20