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Mechanical Bridge to Long-Term Device Implant: The Necessary Step for Better Outcomes

Maltais, Simon*; Stulak, John M.†‡; Zalawadiya, Sandip K.†‡

doi: 10.1097/MAT.0000000000000235
Invited Commentary

From the *Department of Cardiac Surgery, Department of Medicine, Vanderbilt Heart and Vascular Institute, Nashville, Tennessee; and Division of Cardiothoracic Surgery, Mayo Clinic College of Medicine, Rochester, Minnesota.

Submitted for consideration March 2015; accepted for publication in revised form March 2015.

Disclosure: The authors have no conflicts of interest to report.

Correspondence: Simon Maltais, 1215 21st Avenue South, Medical Center East, Suite 5025, Nashville, TN 37232-8802. Email: simon.maltais@vanderbilt.edu.

Cardiogenic shock (CS) has profound impact on short- and long-term mortality and morbidities.1–3 However, recent advancements in revascularization strategies and availability of newer generation short- and long-term mechanical circulatory support devices (MCSD) have significantly improved outcomes in patients with CS.2,3 The significance lies in particular with the short-term MCSD as they not only provide successful hemodynamic support but also serve as a “bridge to decision” (BTD) for heart transplantation and durable MCSD or “bridge to bridge” (BTB) for durable MCSD. Among myriads of temporary short-term devices available in the market today, particular emphasis should be placed upon certain technical, clinical, and economic characteristics of these VADs when choosing one (Table 1).

Impella 5.0 (Abiomed, Danvers, MA) is one of the short-term MCSD, which is approved in the United States since 2009 for circulatory support up to 6 hours and have CE mark approval in Europe for up to 10 days duration. It is a microaxial, catheter-based MCSD which is inserted in a retrograde fashion via peripheral surgical vascular access. Technical ease of utilization and profile of hemodynamic support makes it an attractive short-term MCSD option.4 With its ability to be inserted in axillary artery, it raises the field of short-term MCSD to a higher level. Besides providing adequate hemodynamic support and thereby supporting the end-organ function and allowing adequate time to assess the candidacy for heart transplant or durable MCSD implantation, it also allows for early ambulation and rehabilitation; thereby, helping to optimize clinical condition of CS patients before a major cardiac surgery.

At present, the clinical experience with Impella 5.0 implantation via axillary approach is limited and, therefore, study by Doersch et al.5 certainly adds to the growing body of literature.6–10 In their report of 15 patients supported via axillary Impella 5.0 (~94% of the patients being in Interagency Registry of Mechanically Assisted Circulatory Support class I), they were successful in reducing their 30 day and discharge mortality to 27% and 33%, respectively. In addition, Impella 5.0 use was successful as BTB for durable MCSD implantation in 20% of the patients (three out of 15 HeartMate II implantation) and bridging to recovery for the remaining patients (40%, six out of 15) at the time of discharge. These findings are comparable, if not better than that of published reports on other temporary MCSDs.11–14

Adverse short- and long-term association of prolonged bed-rest among hospitalized patients, especially those in intensive care units (ICU), have been well demonstrated.15 Physical therapy and early progressive ambulation among ICU patients is not only feasible,16,17 but also considered a standard of care now, especially after cardiac surgery.18 From the commercially available temporary MCSDs, intraaortic balloon pump (IABP; axillary approach), Centrimag and Impella (axillary approach) are the only devices having potential to allow for early ambulation. Prior reports with both axillary IABP19 and Centrimag11,20 support have shown that they can be successfully used as bridge to recovery, transplantation or durable MCSD implantation and can allow early ambulation. However, suboptimal hemodynamic support offered by IABP4,21 and the need for sternotomy approach with Centrimag implantation20 can potentially be the limitation of these two devices. On the contrary, axillary Impella 5.0 provides better hemodynamic support and does not need a sternotomy for implantation; thereby, making it an attractive option for temporary MCSD support. Doersch et al.5 were able to demonstrate high success rate with axillary Impella 5.0 for early ambulation in majority of the patients along improved hemodynamics and stabilization of the end-organ function. In addition, they observed minimal device-related complications; notably none had access site bleeding, hematoma or infection and thromboembolism, and only one patient had mild aortic regurgitation and another had device failure.

Hemolysis related to the device use requiring blood transfusions are common with Impella use.22 Although no information was available for blood transfusions requirement in the study by Doersch et al.,5 a nonsignificant drop in hemoglobin and hematocrit levels was observed. Hemolysis requiring blood transfusions can be an important limitation of Impella use, especially for those to be considered for heart transplantation as number of blood transfusions can potentially increase the risk of sensitization and graft dysfunction/loss.23 Although the successful experience of Impella 5.05 is encouraging, an important limitation of sample size needs to be taken into account while reviewing their findings.

In aggregate, study done by Doersch et al.5 is an encouraging step toward emphasizing the importance of early ambulation in the management of CS patients. It further opens up the field for questions; especially, the direct comparison between temporary MCSDs capable of providing adequate hemodynamic support along with allowing for early ambulation in patients with CS before their cardiac surgery as BTD or BTB.

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