Anamika Chatterjee

Left Ventricular Assist Devices – A State of the Art Review

Cardiovascular diseases are the leading cause of mortality rates throughout the world. Next to an insufficient number of healthy donors, this has led to increasing numbers of patients on heart transplant waiting lists with prolonged waiting times. Innovative technological advancements have led to the production of ventricular assist devices that play an increasingly important role in end stage heart failure therapy. This review is intended to provide an overview of current implantable left ventricular assist devices, different design concepts and implantation techniques. Challenges such as infections and thromboembolic events that may occur during LVAD implantations have also been discussed.

The momentum of HeartMate 3: a novel active magnetically levitated centrifugal left ventricular assist device (LVAD)

Left ventricular assist devices (LVADs) are emerging as the treatment of choice for advanced heart failure due to the dearth of healthy donor hearts for cardiac transplantation. The HeartMate 3 LVAD is a novel centrifugal pump which was developed to provide hemodynamic support in heart failure patients, either as a bridge to transplant (BTT), myocardial recovery, or as destination therapy (DT). Technological and clinical advancements have led to optimized hemocompatibility and development of less invasive surgical procedures for the implantation of this pump. The worldwide first implantation of the HeartMate 3 was performed by Prof. Schmitto and his team at Hannover Medical School, Germany in 2014, paving the way for subsequent surgical developments. This article summarizes the advanced technological and clinical aspects of the HeartMate 3 and outlines future technical developments for safe and effective treatment of advanced heart failure.

Successful HeartMate 3 implantation in isolated right heart failure—first in man experience of right heart configuration

In this article, we present the case of a 72-year-old male patient suffering from a severe form of singular isolated end-stage right heart failure based on arrhythmogenic right ventricular cardiomyopathy (ARVC), who was admitted to our clinic for acute cardiac decompensation.

Clinical overview of the HVAD: a centrifugal continuous-flow ventricular assist device with magnetic and hydrodynamic bearings including lateral implantation strategies

Growing worldwide incidences of end-stage heart failure and declining rates of cardiac transplants have given rise to the need for alternative treatment options, based on mechanical circulatory support (MCS) devices such as left ventricular assist devices (LVADs). Technologically advanced LVADs such as the HVAD® (HeartWare®, Medtronic) facilitate safe and efficient treatment of heart failure patients with reduced post-operative complications, which is attributed to their considerably miniaturized size. This also facilitates the development and implementation of novel, minimally-invasive surgical techniques. The HVAD is a centrifugal pump, manufactured by HeartWare Inc., (Framingham, MA, USA) and subsequently by Medtronic Inc., (Minnesota, MN, USA), and has been approved for clinical application after receiving the CE Mark approval in 2008 and the FDA approval in 2012. Current research efforts are focused on further miniaturization alongside optimization of electronic and software controllers as well as implementation of the transcutaneous energy transfer (TET) technology. Salient features of the HVAD pump technology, clinical applications and future optimization strategies have been discussed in this article.

The evolution of mechanical circulatory support (MCS): a new wave of developments in MCS and heart failure treatment

Cardiovascular diseases and heart failure (HF) remain one of the major causes of worldwide mortality. According to the American Heart Association, 85.6 million adults in the US suffer from cardiovascular diseases, out of which 5.7 million are living with HF (1). Decades of dedicated efforts on clinical as well as technological aspects of mechanical circulatory support (MCS) devices have led to their widespread success and acceptance for the treatment of advanced HF.

Left ventricular assist device exchange for the treatment of HeartMate II pump thrombosis

Background Pump thrombosis is the most severe and acute complication of left ventricular assist device (LVAD) therapy and treatment remains challenging. Whilst lysis therapy is often not successful, the exchange of the occluded LVAD is currently the most applied therapeutic treatment for this event. With this study we examine the effects of minimal-invasive LVAD exchange on the rate re-thrombosis and outcomes as well as adverse events in the study group. Methods Between February 2004 and December 2015 more than 600 LVADs were implanted at our institution. We retrospectively studied a patient cohort of 41 patients who underwent LVAD exchange because of pump thrombosis at a single institution. Outcomes, rates of re-thrombosis and adverse events were analyzed. Results Between February 2004 and December 2015, 87 exchanges of LVADs were performed at a single center. In 41 cases pump thrombosis was the reason for LVAD exchange. A total of 28 patient years (10,276 days) were analyzed. Average ICU stay was 15.8±20.4 days and average in-hospital stay 38.1±37.3 days after LVAD exchange. After thirty days the survival rate was 80.5%, 75.6% after 6 months and 70.7% one year after LVAD exchange. Out of the study cohort, three patients have successfully undergone heart transplantation. Twelve patients suffered a stroke postoperatively (29%). Twelve patients needed postoperative dialysis (29%). No technical complications of the VAD were recorded in the study group. Two patients underwent successful LVAD explantation due to myocardial recovery. One year after LVAD exchange, 14 patients underwent re-exchange due to pump thrombosis (34%). Eight patients suffered from a LVAD related infection out of which two patients were treated by pump exchange. A total of 12 patients died during the complete one year follow up of this study (29%). Four patients died in the second, two in the third and one in the fourth year after LVAD exchange. The remaining 17 patients are still ongoing on the device.Conclusions: It is generally feasible to treat pump thrombosis via LVAD exchange. Yet, the exchange procedure is not without risk and the risk of re-thrombosis (34%), stroke (29%), postoperative dialysis (29%) and perioperative complications remains high.

Argatroban administration as therapy for thrombosis in patients with continuous-flow ventricular assist devices

Background Device thrombosis is one of the main complications in left ventricular assist devices (LVAD) therapy and remains a challenging issue. Data on device thrombosis management, especially on the application of direct thrombin inhibitors such as argatroban, is limited and a consensus on thrombosis management has not yet been established. Methods In this study we analysed retrospective clinical data obtained from 26 patients on VAD therapy who received argatroban for suspected VAD thrombosis, between April, 2012 and February, 2017. Results Thirteen patients (50%) showed resolution of thrombus after argatroban therapy. Eight of 26 patients (30.8%) were free of thrombotic events 90 days after discharge. Argatroban therapy was unsuccessful in 13 patients of the study cohort, leading to subsequent VAD-exchange. Six of 13 patients with first VAD-exchange had no thrombotic events 90 days after discharge. Six patients (23.1%) suffered from bleeding, especially gastrointestinal bleeding. No hemorrhagic strokes were observed. Three patients (11.5%) did not survive the follow-up period. Conclusions Argatroban appears to be an alternative to other pharmacological treatment options in VAD thrombosis. Efficacy and safety characteristics are acceptable, but further investigation on larger populations is necessary.

In vitro study for the evaluation of transluminal aspiration as a novel treatment option for thrombosis in the HeartWare HVAD

Introduction: Pump thrombosis of left ventricular assist devices remains a devastating complication with high morbidity and mortality. Despite the improvements made, the matter affects many patients and the treatment options are limited to thrombolysis and surgical replacement. An alternative approach using the aspiration Indigo catheter was tested. Methods: An Indigo thrombectomy catheter was used within an in vitro model to assess the direct aspiration of prefabricated clots from three different positions within the HeartWare HVAD (inlet, outlet, and housing). The experiments were conducted with a straight and an angled catheter. The aspiration pressure was constant. The flow, power consumption, and pressure head of the left ventricular assist devices were measured at pre-defined measuring points. Results: The device was more effective (success rate 71%) at inlet and outlet of the left ventricular assist device. In addition, the duration of aspiration and the aspiration volume were shorter in comparison to the aspiration in the housing (inlet M = 19.75 s, outlet M = 60.50 s, and housing M = 38.75 s). Moreover, the aspiration volume was associated with the aspiration duration and the weight of thrombi but not with their volume. Noteworthy, the angled catheter showed an improved performance compared to the straight one (67%–33%). The recorded parameters showed no major changes during the use of the catheter. After application of the Indigo catheter, flow and pressure head of the pump could be restored. Conclusions: The aspiration system showed promising results under specific conditions for the treatment of pump thrombosis in an in vitro model. However, further examination, including in vivo experiments, will justify its effectiveness.

Novel centrifugal pump for heart failure patients: initial success and future challenges

In June 2014 the worldwide first implantation of a new and promising Left Ventricular Assist System (LVAS) for end-stage heart failure therapy was performed by Dr. Schmitto and his team at Hannover Medical School, Hannover, Germany (1).