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CARDIOVASCULAR
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Clinical Evidence

Read journal articles, abstracts and other clinical evidence related to the CentriMag™ Acute Circulatory Support System with Full MagLev™ Flow Technology:

General Publications

Experience with the Levitronix CentriMag circulatory support system as a bridge to decision in patients with refractory acute cardiogenic shock and multisystem organ failure
John et al., 2007
A single-center retrospective analysis of 12 patients who underwent CentriMag System™ biventricular placement for refractory acute cardiogenic shock. 8 patients were bridged to long-term LVAD, 2 patients were explanted successfully, and 2 patients died on support. Long-term survival at 30-days was 75% and at 1-year was 62.5%.

Initial experience with CentriMag extracorporeal membrane oxygenation for support of critically ill patients with refractory cardiogenic shock
Aziz et al., 2010
A single-center retrospective analysis of 10 consecutive patients who received CentriMag ECMO support for cardiogenic shock refractory to conventional therapy. The average duration of ECMO was 5.8 days with 60% survival to discharge. There were no major device-related complications. CentriMag ECMO was easy to insert, functioned without error, and significantly reduced expected mortality.

Clinical experience using the Levitronix CentriMag System for temporary right ventricular mechanical circulatory support
Bhama et al., 2006
A single-center retrospective analysis of 29 patients who received CentriMag System for right ventricular (RV) support for cardiogenic shock post-cardiotomy (24%), post-cardiac transplant (35%), and post-LVAD placement (41%). The mean support time was 8 days with 52% survival to discharge. Complications included infection (45%), arrhythmia (45%), reoperation for bleeding (35%), stroke (10%), and air embolism (3%). There were no device failures. The CentriMag System provides effective temporary support for RV failure with ease of implantation and a high rate of successful device weaning.

Computational and experimental evaluation of the fluid dynamics and hemocompatibility of the CentriMag Blood Pump
Zhang et al., 2006
A computation and experimental study to analyze the hemodynamic and hemocompatibility performance of the CentriMag System using computational fluid dynamics (CFD)-based modeling. The results indicated no significant high shear stress in the pump. The 1.5mm gap passages between the outer rotor walls and the lower housing cavity provide very good surface washing and reduced shear stresses resulting in a low hemolysis rate of NIH=0.0029 without a decrease in the pump’s performance (pressure head: 352 mmHg at a flow rate of 5.0 L/min and a rotational speed of 4000 rpm).

CentriMag VAD PMA

Use of mechanical circulatory support devices in end-stage heart failure patients
Loforte et al., 2014
A double-center retrospective analysis of the use of mechanical circulatory support devices in 116 acute or chronic end-stage heart failure patients. CentriMag was used as a temporary VAD in right-, left-, or biventricular configuration in 50 patients (43%) labeled as Group A. CentriMag was the only device used as an isolated RVAD in 24 patients (21%). Group B consisted of 66 patients (57%) implanted with long-term support devices including HeartMate I and II, Novacor, HVAD, Jarvik, InCor, and SynCardia. Kaplan-Meier method was used to calculate survival curves and determine survival outcomes for VAD patients and transplanted patients receiving no prior VAD support. Success was defined as recovery, heart transplantation, and hospital discharge.

Group A had an overall success rate of 54% with a mean support time of 10.2 ± 6.6 days. 15 patients died on support. Adverse events included reoperation due to bleeding (36%), major cerebral events (10%), and pulmonary hemorrhage (2%). No device failures were noted.

Group B had an overall success rate of 73% for LVAD and 47% for BiVAD. 73% of LVAD patients were discharged home and 18% died after discharging due to driveline infection (8%), cerebral hemorrhage (8%), and unknown cause in 1 patient.

Overall, the rate of heart transplant was 26%. The overall 1- and 5-year survival rates after transplant were 73% and 60% respectively. When a decision to treat with VAD or TAH is made early, either modality can be used as an alternative to heart transplant, affording comparable early to mid-term outcomes.

Versatility and patient outcomes with the levitronix centrimag temporary ventricular assist device
McCormick et al., 2010
A retrospective review from the Utah Artificial Heart Program database of 83 patients implanted with CentriMag temporary VAD in a right- (n=30), left- (n=8), biventricular (n=25), or cardiopulmonary support (CPS) (n=30) configuration. Outcomes included survival to discharge along with 30-day, 6-month, and 1-year survival rates for each configuration. The longest mean support duration was 11 days for RVAD configuration, while the shortest was 4 days for cardiopulmonary support. Survival to discharge was 60% for RVAD, 63% for LVAD, 40% for BiVAD, and 30% for CPS.

Incidence and outcome of Levitronix CentriMag support as rescue therapy for early cardiac allograft failure: a United Kingdom national study
Thomas et al., 2011
A retrospective review from the comprehensive UK Cardiothoracic Transplant Audit of 572 patients receiving a heart transplant in the UK between 2003 and 2008. 34 patients required CentriMag support for graft failure with 22 BiVADs, 10 RVADs, and 2 LVADs. There were no significant differences in transplant characteristics between cohorts.

35% of patients were explanted with 9 patients surviving past 1-year with 3 dying post-explant on day 5, 20, and 71. 30-day survival was 50% (95% CI, 32-65) and 1-year survival was 32% (95% CI, 18-48). Patients who received a VAD for bridging prior to transplant had significantly better survival after CentriMag for graft failure (p=0.029). CentriMag support led to the salvage of 32% of patients with severe allograft failure.

Outcomes of a multicenter trial of the Levitronix CentriMag ventricular assist system for short-term circulatory support
John et al., 2011
Two nonrandomized, multicenter pilot studies to evaluate the use of the CentriMag System. The first trial used CentriMag as an LVAD or BiVAD to treat patients in cardiogenic shock. The second utilized CentriMag as an RVAD after implantation of a commercially available LVAD. Success was defined as survival to 30 days after weaning, to transplant, or to long-term VAD.

38 patients were supported at 7 centers (12 after cardiotomy, 14 after myocardial infarction, and 12 with RV failure after LVAD implant). Left- (n=8), right- (n=12), and biventricular (n=18) configurations were utilized. Mean support was 13 days with 47% surviving to to 30 days after weaning. Complications included bleeding (21%), infection (5%), respiratory failure (3%), hemolysis (5%), and neurologic dysfunction (11%). There were no device failures.

Bridge-to-decision therapy with a continuous-flow external ventricular assist device in refractory cardiogenic shock of various cases
Takayama et al., 2014
A single center retrospective analysis of 158 device runs in 143 patients receiving mechanical circulatory support as a bridge-to-decision in the setting of refractory cardiogenic shock. 71% of the patients were INTERMACS Registry profile 1 with several different device configurations (67% BiVAD, 26% RVAD, 8% LVAD). The median duration of support was 14 days with a 30-day survival of 69% and 1-year survival of 49%. 30% had myocardial recovery, 15% received implantable VAD, and 18% received heart transplantation. Complications included major bleeding (33%) and cerebrovascular accidents (14%). There were no pump failures or thrombosis.

Post-heart transplantation outcome of HeartMate II-bridged recipients requiring unplanned concomitant temporary right ventricular mechanical support
Urban et al., 2015
A single center retrospective analysis of 64 patients transplanted from a HeartMate II device. The patients were divided into two groups. Group 1 received an isolated LVAD (n=56) and Group 2 required RV mechanical support after LVAD placement (n=8). Early graft loss was 10.7% with an isolated LVAD and 25% with additional RVAD support (p=0.26). There were no differences in the rates of primary graft dysfunction, renal failure, and stroke between the two groups. The 3-year graft survival rate was 86 ± 5% in isolated LVAD and 75 ± 15% in LVAD + RVAD (p=0.326).

Heart transplant recipients who require unplanned RV support after LVAD placement achieved comparable rates of early graft loss, renal failure, and stroke in comparison with an isolated LVAD. The small sample size suggests the need for further studies.

CentriMag Extracorporeal Membrane Oxygenation (ECMO)

Thoratec CentriMag for temporary treatment of refractory cardiogenic shock or severe cardiopulmonary insufficiency: a systematic literature review and meta-analysis of observational studies
Borisenko et al., 2014
A systematic literature review of 53 publications including 999 patients to evaluate the effect of CentriMag Pump™ as a temporary VAD and part of ECMO on the outcomes in patients with cardiac and cardiac-respiratory failure. CentriMag was used as a VAD in 72% and as a part of ECMO in 25%. Mean run duration was 25 days in precardiotomy, 10.9 days in post-cardiac surgery, 8.8 days in post-transplant graft failure, and 16 days in post-LVAD placement for RV failure. Overall, 74% of patients were recovered or bridged with a 1-year survival of 54%. CentriMag is effective for temporary support of patients with cardiac and cardiorespiratory failure.

Short-term mechanical circulatory support as a bridge to durable left ventricular assist device implantation in refractory cardiogenic shock: a systematic review and meta-analysis
Den Uil et al., 2017
A systematic literature review of patients with cardiogenic shock from acute myocardial infection, end-stage cardiomyopathy, or acute myocarditis, receiving short-term mechanical circulatory support (MCS). 39 studies were reviewed including 4,151 patients who received a mix of circulatory support devices. Central access ECMO with a CentriMag Pump was utilized in 128 patients with a mean support duration of 20 ± 20 days. ECMO was used as bridge to transplant in 19%, bridge to durable MCS in 25%, bridge to recovery in 27%, and bridge to palliation in 27%. Survival to hospital discharge was 66%.

CentriMag venoarterial extracorporeal membrane oxygenation support as treatment for patients with refractory postcardiotomy cardiogenic shock
Mikus et al., 2013
A single center retrospective analysis of experience with CentriMag in the setting of venoarterial ECMO support as treatment for postcardiotomy cardiogenic shock. 14 patients received support after cardiac surgery with 8 central cannulations and 6 peripheral cannulations. Mean duration of support was 5 days with a range of 1-55 days. 50% were weaned from ECMO, 50% died on support due to multiple organ failure and 43% were successfully discharged home. CentriMag in ECMO configuration was easy to install and manage while proving to be effective in the management of postcardiotomy cardiogenic shock.

A systematic review of effectiveness and economic evaluation of Cardiohelp and portable devices for extracorporeal membrane oxygenation
Mahboub-Ahari et al., 2018
A systematic literature review of 7 studies to compare safety, effectiveness, and economic impact of CentriMag and Cardiohelp. Cardiohelp had more technological safety features but was more complex to use than CentriMag. There was no statistically significant difference between the devices when considering effectiveness. Both devices were below willingness-to-pay threshold and considered cost-effective with proper patient selection.

Minimally invasive CentriMag ventricular assist device support integrated with extracorporeal membrane oxygenation in cardiogenic shock patients: a comparison with conventional centrimag biventricular configuration
Takeda et al., 2017
A single center retrospective analysis of 112 patients requiring ECMO for treatment of cardiogenic shock. 22 patients were implanted via a novel minimally invasive surgical approach (EcVAD). 90 patients were implanted via the conventional method of sternotomy (BiVAD). The EcVAD group required less transfusions and had a significantly lower incidence of major bleeding of 32% vs 72% in BiVAD group (p<0.01). 30-day survival was 86% in EcVAD vs 76% in BiVAD (p=0.39). One-year survival was 61% in EcVAD and 55% in BiVAD (p=0.7).

Survival on biventricular mechanical support with the CentriMag as a bridge to decision: a single-center risk stratification
Mohamedali et al., 2015
A single-center retrospective analysis of 48 patients receiving support with CentriMag through central cannulation. 19 patients were treated with VA-ECMO configuration. The overall median duration of support was 14 days. 30-day survival was 56%. 9 patients were bridged to recovery while 14 were converted to durable LVAD therapy. The cohort was placed into two groups for risk stratification. Group 1 (n=23) consisted of patients who recovered or received a durable LVAD while Group 2 (n=25) consisted of those who died on support or were explanted for withdrawal of care. There were no clinically significant different between the two groups in terms of age, sex, etiology, hemodynamic co-morbidities, or laboratory parameters. CentriMag can be used as a bridge to decision in patients with a 30-day survival > 50%.

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