Effectiveness and Safety of the Impella 5.0 as a Bridge to Cardiac Transplantation or Durable Left Ventricular Assist Device

doi:10.1016/j.amjcard.2016.02.038

The American Journal of Cardiology

Volume 117, Issue 10, 15 May 2016, Pages 1622-1628

https://doi.org/10.1016/j.amjcard.2016.02.038 Get rights and content

Many patients with end-stage heart failure require mechanical circulatory support as a temporizing measure to enable multidisciplinary assessment for the most suitable therapeutic strategy. Impella 5.0 can be used as a bridge to decision to evaluate patients for potential recovery or bridge to next therapy (bridge to heart transplantation [BTHT] or bridge to durable left ventricular assist device or VAD [BLVAD]. Our goal was to examine single-center outcomes with the Impella 5.0 device as a bridge to next therapy (BTHT or BTLVAD). Forty patients underwent Impella 5.0 support from December 2009 to December 2015 with the intent of BTHT (n = 20) or BTLVAD (n = 20). The primary end point was survival to next therapy. Secondary end points included hemodynamic assessments and in-hospital/30-day complications. All patients were inotrope-dependent, with severely depressed left ventricular ejection fraction (12%) and renal insufficiency (creatinine 2.0 mg/dl). Most were Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) 2 (66%) with biventricular failure (65%). Thirty patients (75%) survived to next therapy, including transplant (n = 13), durable LVAD (n = 15), and recovery of native heart function (n = 2). No strokes or major bleeding events requiring surgery were observed. Acute renal dysfunction, bleeding requiring transfusion, hemolysis, device malfunction, limb ischemia occurred in 13 (33%), 11 (28%), 3 (8%), 4 (10%), and 1 (3%) patients, respectively. Survival rate to discharge and/or 30 days was 68% (27 of 40). Temporary support with the Impella 5.0 allows for an effective bridge to decision strategy for hemodynamic stabilization and multidisciplinary heart team assessment of critically ill patients with heart failure. In conclusion, many of these patients can be subsequently bridged to the next therapy with favorable outcomes.

Section snippets

Methods

Ninety consecutive patients who were supported with Impella technology (Abiomed) from March 2009 to December 2015 at a single center. Of these, 50 patients were excluded from the final analysis for the following reasons: 31 patients were supported with Impella 2.5, 6 patients were supported with Impella CP (cardiac power), 3 patients were supported with Impella RP (right peripheral), and 9 patients were supported with Impella 5.0 but with the intent to bridge the patient to recovery and failure

Results

All 40 patients were supported with Impella 5.0 with the intent to bridge the patient to heart transplant or long-term LVAD. Twenty patients (50%) received the device as a BTHT decision and 20 patients received the device as a BTLVAD strategy to a durable LVAD (Figure 1). Overall, the patients were predominantly INTERMACS score 1 (32%) or 2 (66%; Table 1). At presentation, all patients were inotrope dependent (100%), requiring an average of 2 inotropic agents for hemodynamic support. Other

Discussion

The present analysis represents the largest published series to date of patients bridged with short-term Impella 5.0 support to durable LVAD or transplantation. Lower levels of support with Impella 2.5 and CP were excluded because they do not necessarily provide durable support after prolonged states of cardiogenic shock in patients with end-stage heart failure and thus are not used in our institution for the purpose of bridging to heart transplant or durable LVAD. The most common reasons for

Disclosures

Dr. Hall is a consultant for AbioMed. The other authors have no conflicts of interest to disclose.

References (18)

A. Lemaire et al.
The Impella device for acute mechanical circulatory support in patients in cardiogenic shock
Ann Thorac Surg
(2014)
L.W. Miller et al.
Patient selection for ventricular assist devices: a moving target
J Am Coll Cardiol
(2013)
J.K. Kirklin et al.
Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) analysis of pump thrombosis in the HeartMate II left ventricular assist device
J Heart Lung Transplant
(2014)
A.J. Boyle et al.
Clinical outcomes for continuous-flow left ventricular assist device patients stratified by pre-operative INTERMACS classification
J Heart Lung Transplant
(2011)
F.D. Pagani et al.
The use of extracorporeal life support in adult patients with primary cardiac failure as a bridge to implantable left ventricular assist device
Ann Thorac Surg
(2001)
D. Hoefer et al.
Outcome evaluation of the bridge-to-bridge concept in patients with cardiogenic shock
Ann Thorac Surg
(2006)
T. Chamogeorgakis et al.
Outcomes of axillary artery side graft cannulation for extracorporeal membrane oxygenation
J Thorac Cardiovasc Surg
(2013)
M.A. Castillo-Sang et al.
Thirty-five day Impella 5.0 support via right axillary side graft cannulation for acute cardiogenic shock
Innovations (Phila)
(2013)
T. Chamogeorgakis et al.
Which is better: a miniaturized percutaneous ventricular assist device or extracorporeal membrane oxygenation for patients with cardiogenic shock?
ASAIO J
(2013)

There are more references available in the full text version of this article.

Cited by (106)

Impella – Current issues and future expectations for the percutaneous, microaxial flow left ventricular assist device
2024, Journal of Cardiology
The importance of temporary mechanical circulatory support for treating acute heart failure with cardiogenic shock is increasingly recognized, and Impella (Abiomed, Danvers, MA, USA) has received particular attention in this regard. Impella is an axial flow left ventricular assist device (LVAD) built into the tip of a catheter. It is inserted via a peripheral artery and implanted into the left ventricle. Although the morphology of Impella is different from a typical LVAD, it has similar actions and effects as an LVAD in terms of left ventricular drainage and aortic blood delivery. Impella increases mean arterial pressure (MAP) and systemic blood flow, thereby improving peripheral organ perfusion and promoting recovery from multiple organ failure. In addition, left ventricular unloading with increased MAP increases coronary perfusion and decreases myocardial oxygen demand, thereby promoting myocardial recovery. Impella is also useful as a mechanical vent of the left ventricle in patients supported with veno-arterial extracorporeal membrane oxygenation. Indications for Impella include emergency use for cardiogenic shock and non-emergent use during high-risk percutaneous coronary intervention and ventricular tachycardia ablation. Its intended uses for cardiogenic shock include bridge to recovery, durable device, heart transplantation, and heart surgery. Prophylactic use of Impella in high-risk patients undergoing open heart surgery to prevent postcardiotomy cardiogenic shock is also gaining attention. While there have been many case reports and retrospective studies on the benefits of Impella, there is little evidence based on sufficiently large randomized controlled trials (RCTs). Currently, several RCTs are now ongoing, which are critical to determine when, for whom, and how these devices should be used. In this review, we summarize the principles, physiology, indications, and complications of the Impella support and discuss current issues and future expectations for the device.
The International Society for Heart and Lung Transplantation/Heart Failure Society of America Guideline on Acute Mechanical Circulatory Support
2023, Journal of Heart and Lung Transplantation
In spite of medical advances, cardiogenic and pulmonary shock are associated with high mortality and morbidity. The availability and use of acute or temporary mechanical support devices has grown over the years, with the goal of improving patient outcomes by temporarily providing support to allow time for organ recovery or for longer-term decisions including transition to durable therapies. A collaborative effort commissioned by the International Society of Heart and Lung Transplantation and the Heart Failure Society of America has developed this critically-needed guideline for the management of patients requiring acute mechanical circulatory support (MCS). The document covers definitions of cardiogenic and pulmonary shock, medical treatment and surgical interventions, management of patients supported with temporary devices, complications, special populations, and social and ethical dilemmas. The writing groups include multidisciplinary members from both societies with a focus on diversity in gender, geography, area of expertise and level of seniority. The target audience includes cardiologists, especially interventional and advanced heart failure, pulmonarycritical care specialists, intensivists, cardiothoracic surgeons, as well as referring providers.
The International Society for Heart and Lung Transplantation/Heart Failure Society of America Guideline on Acute Mechanical Circulatory Support
2023, Journal of Cardiac Failure
Aortic Root Thrombosis in patients with HeartMate 3 left ventricular assist device support
2023, Journal of Heart and Lung Transplantation
Aortic root thrombosis(ART) is a complication of continuous-flow left ventricular assist device therapy. However, the incidence and related complications of ART in HeartMate 3 (HM3) patients remain unknown.
Patients who underwent HM3 implantation from November 2014 to August 2020 at a quaternary academic medical center were included. Demographics and outcomes were abstracted from the medical record. Echocardiograms and contrast-enhanced computed tomography studies were reviewed to identify patients who developed ART and/or moderate or greater aortic insufficiency (AI) on HM3 support.
The study cohort included 197 HM3 patients with a median postimplant follow-up of 17.5 months. Nineteen patients (9.6%) developed ART during HM3 support, and 15 patients (7.6%) developed moderate or greater AI. Baseline age, gender, race, implantation strategy, and INTERMACS classification were similar between the ART and no-ART groups. ART was associated with an increased risk of death, stroke, or aortic valve (AV) intervention (subhazard ratio [SHR] 3.60 [95% confidence interval (CI) 1.71-7.56]; p = 0.001) and moderate or greater AI (SHR 11.1 [CI 3.60-34.1]; p < 0.001) but was not associated with a statistically significantly increased risk of death or stroke on HM3 support (2.12 [0.86-5.22]; p = 0.10). Of the 19 patients with ART, 6 (31.6%) developed moderate or greater AI, necessitating more frequent AV interventions (ART: 5 AV interventions [3 surgical repairs, 1 surgical replacement, 1 transcatheter replacement; 26.3%]; no-ART: 0).
Nearly 10% of HM3 patients developed ART during device support. ART was associated with increased risk of a composite end-point of death, stroke, or AV intervention as well as moderate or greater AI.
Transinnominate Impella 5.5 insertion as a bridge to transplantation in a pediatric patient in refractory cardiogenic shock
2022, JTCVS Techniques
Citation Excerpt :
Finally, the innominate graft was ligated, oversewn, and buried in the subcutaneous tissue. The Impella microaxial LVAD has emerged as a feasible alternative to ECMO in stabilizing patients with hemodynamic collapse.3,4 The Impella 5.5 provides >6 L/min of peak flow and can be inserted via a transaxillary or transaortic approach.5
Using Base Excess, Albumin, Lactate, and Renal Function to Predict 30-Day Mortality in Patients Requiring Impella Monotherapy for Left-Sided Mechanical Circulatory Support: The BALLAR Score
2022, Cardiovascular Revascularization Medicine
To create a simple scoring system that can estimate 30-day mortality in patients requiring left-sided Impella implantation as standalone mechanical circulatory support (MCS).
We retrospectively analysed 79 consecutive patients who required left-sided Impella MCS monotherapy. Regression analysis was used to elucidate significant associations between biochemical markers before Impella implantation and all-cause mortality at 30 days. Using these factors, a simple additive scoring system was created using a previously validated approach.
The BALLAR scoring system was created. Patients are assigned points based upon biochemical markers. These are summed and the final points tally provides an estimate of 30-day mortality. The points are assigned as follows:
Lactate (mmol/l): ≤1.9: 0 points, 2–4.9: 1 Point, ≥5: 4 Points
Creatinine Clearance (ml/min): ≤29.9: 6 points, 30–59.9: 4 points, 60–89.9: 1 point, ≥90: 0 points
Serum Albumin (mmol/l): <25: 6 points, 25–34.9: 3 points, ≥35: 0 points
Base Excess (mmol/L): < −2: 2 points, ≥−2: 0 points
The total score can be used to estimate the probability of death at 30 days. A score less than 6 predicts a 30-day mortality of under 5%, whereas a score over 11 predicts a greater than 95% chance of death within 30 days.
Using this simple heuristic predicted 89% of 30-day deaths in our cohort. All the misclassifications were in the intermediate probability range (scores 5–11). This simple scoring system gives an effective estimate of the probability of death at 30 days in our cohort of patients.

View all citing articles on Scopus

: See page 1627 for disclosure information.

View full text

Heart FailureEffectiveness and Safety of the Impella 5.0 as a Bridge to Cardiac Transplantation or Durable Left Ventricular Assist Device

Section snippets

Methods

Results

Discussion

Disclosures

Ann Thorac Surg

J Am Coll Cardiol

J Heart Lung Transplant

J Heart Lung Transplant

Ann Thorac Surg

Ann Thorac Surg

J Thorac Cardiovasc Surg

Thirty-five day Impella 5.0 support via right axillary side graft cannulation for acute cardiogenic shock

Innovations (Phila)

Which is better: a miniaturized percutaneous ventricular assist device or extracorporeal membrane oxygenation for patients with cardiogenic shock?

ASAIO J

Heart Failure
Effectiveness and Safety of the Impella 5.0 as a Bridge to Cardiac Transplantation or Durable Left Ventricular Assist Device