Günes Dogan

First experiences with HeartMate 3 follow-up and adverse events

Background: The novel HeartMate 3 (HM3) left ventricular assist device (LVAD) received its CE mark in October 2015. It is a new compact LVAD featuring fully magnetically levitated pump, artificial pulse, large pump gaps, and a modular driveline. Here, we present outcomes and adverse events of a single‐center cohort 6 months after HM3 implantation. Methods: We retrospectively studied a patient cohort of 27 patients who were supported with the HM3 at a single institution. We excluded patients with biventricular assist devices and other types of assist devices as well as LVAD exchange and re‐operative procedures. Results: Twenty‐seven patients were enrolled into the study. Within 1 year after HM3 implantation, 1 patient received a heart transplant and 3 patients died. Thirty‐day survival was 88.9% and 6 months 85.2%. No pump thrombosis and no strokes were observed within 6 months. Right heart failure was diagnosed in 1 patient after HM3 implantation (3.7%). No technical complications of the pump were documented. No pump exchanges were necessary. Conclusions: The novel LVAD HM3 has already shown good CE mark trial results. Within this first report after the CE mark trial, the 6‐month survival after HM3 implantation was 85.2%. The HM3 showed excellent midterm results with 0% stroke and 0% pump thrombosis rates 6 months after implantation.

First series of left ventricular assist device exchanges to HeartMate 3

OBJECTIVES Left ventricular assist device (LVAD) exchange is becoming a standard surgical procedure. The exchange procedure is an opportunity to upgrade patients to a new generation pump that offers advanced reduction of adverse events or longer battery hours. METHODS We performed an analysis of 6 consecutive patients who underwent LVAD exchange to HeartMate 3 either from a HeartWare or HeartMate (HM) II device. Minimally invasive operations were performed through a lateral thoracotomy. Follow-up time was 6 months after LVAD exchange. RESULTS We present 4 patients with the HM II and 2 patients with the HeartWare ventricular assist device (HVAD) who underwent LVAD exchange to HM III. The average age was 57.5 years. At the time of the LVAD exchange, all patients were classified as Interagency Registry for Mechanically Assisted Circulatory Support level 3. In 5 cases, LVAD infection led to LVAD exchange (83%, 5/6). The remaining patient underwent LVAD exchange due to pump thrombosis (16%, 1/6). The 6-month survival rate after LVAD exchange was 100% (6/6). None of the patients was postoperatively supported by extracorporeal membrane oxygenation. No patient experienced postoperative relevant bleeding. One patient suffered minor cerebral bleeding (16.6%, 1/6). At the 6-month follow-up examination, 1 patient reported a single syncope and several low-flow alarms (1/6). The remaining 5 patients showed no adverse events or technical malfunctions of the VAD (5/6). CONCLUSIONS LVAD exchanges from HM II as well from HVAD to HM 3 are proven to be technically feasible. Due to the advantages and technical improvements of the new-generation pumps, this procedure is an excellent opportunity to give patients access to a superior generation of assist device.

One year outcomes with the HeartMate 3 left ventricular assist device

Background The HeartMate 3 (HM3; Abbott Laboratories, Lake Forest, Ill) left ventricular assist device (LVAD) received its Conformité Européenne mark for Europe in October 2015 and is currently under investigation of the Food and Drug Administration to gain approval in the United States. Within this study, we present the first real‐world experiences, 1‐year outcomes, and adverse events of a single‐center cohort treated with the HM3. Methods We prospectively studied midterm results of 27 consecutive patients receiving the HM3 at a single institution. After HM 3 implantation, survival, causes of death, and complications were recorded for all patients. Follow up was 100% complete. Results Twenty‐seven patients were enrolled into the study. Within 1 year after HM3 implantation, 3 patients underwent heart transplantation and 3 patients died. Thirty‐day survival was 88.9%, 6‐month 85.2%, and 1‐year survival 85.2%. No pump thrombosis and no strokes were observed within the study group. One incident of gastrointestinal bleeding was observed (3.7%). Right heart failure was diagnosed in 1 patient after HM3 implantation (3.7%). No technical complications of the pump were documented. No pump exchanges were necessary. The main complication was LVAD‐related infection (22.2%). Conclusions The novel LVAD HM3 has already shown excellent Conformité Européenne mark trial results. Within this cohort, 1‐year survival after HM3 implantation was 85%. The HM3 showed excellent midterm results with 0% stroke and 0% pump thrombosis rates 1 year after implantation.

Five-year results of patients supported by HeartMate II: outcomes and adverse events

OBJECTIVES Improved outcomes over the past decade have increased confidence of physicians and patients in extended duration of left ventricular assist device (LVAD) support. This single-centre cohort study reports 5-year outcomes with the HeartMate II (HMII) LVAD. METHODS We describe a cohort of 89 patients who received a HMII LVAD between February 2004 and December 2010. The causes of death and adverse events were assessed by examination of medical records. A total of 202.74 patient-years were analysed. RESULTS After 5 years, of the 89 patients, 15 patients remained on device therapy, 39 patients died, 28 patients underwent heart transplantation and 7 patients underwent explantation of the HMII for recovery. One year after the HMII implantation, there was a survival of 71% in the study cohort. In the following years, the survival rate was 65% in the 2nd year, 63% in the 3rd year, 56% in the 4th year and 54% after 5 years of LVAD support. Ten LVAD exchanges were performed in 8 (11%) patients. Currently (March 2017), 12 patients still remain on their original device. The longest ongoing patient on the HMII has been supported for over 11 years (4097 days). The most common adverse events were bleeding (68%; 1.5837 events per patient-year) and LVAD infection [49%; 1.0666 events per patient-year]. Seven cases of pump thrombosis were described (8%; 0.1131 events per patient-year). CONCLUSIONS This is the first single-cohort study to describe a 5-year survival of HMII patients on extended duration of support. A 5-year survival of 54% was observed in this single-centre cohort.

Less Invasive Surgical Approaches for Left Ventricular Assist Device Implantation

For several years, the standard implantation strategy of ventricular assist devices has involved a full sternotomy approach. However, less invasive implantation techniques are now becoming increasingly popular as they are associated with reduction of trauma, blood loss, and arrhythmogenic complications, as well as a decreased duration of intensive care unit and in-hospital stay. Thus, due to miniaturization and increasing technical improvement of ventricular assist devices, less invasive strategies for implantation, explantation, exchange, and concomitant cardiac procedures are on the rise. In this review article, we report on the state of the art of less invasive techniques for implantation, explantation, exchange, and combined cardiac procedures of ventricular assist devices.

Prognostic Value of the Nutritional Risk Index in Candidates for Continuous Flow Left Ventricular Assist Device Therapy

INTRODUCTION AND OBJECTIVES Malnutrition has been shown to affect clinical outcomes in patients with heart failure. The aim of this study was to analyze the impact of preoperative nutritional status assessed by the nutritional risk index (NRI) on the prognosis of patients with a continuous-flow left ventricular assist device (cf-LVAD). METHODS We performed a retrospective study of 279 patients who underwent cf-LVAD implantation between 2009 and 2015 in our center. Preoperative NRI was calculated and the patients were followed-up for 1 year. The association between preoperative NRI and postoperative clinical events was analyzed using multivariable logistic regression. RESULTS The prevalence of severe (NRI <83.5), moderate (83.5 ≤ NRI <97.5) and mild (97.5 ≤ NRI <100) nutritional risk was 5.4%, 21.5%, and 9.3%. Mortality rates 1 year after cf-LVAD implantation in these 3 categories were 53.3%, 31.7%, 23.1% vs 18.0% (P <.001) in patients with a normal IRN. A normal preoperative NRI value was an independent predictor of lower risk of death from any cause during follow-up (aHR per 1 unit, 0.961; 95%CI, 0.941-0.981; P <.001) was and a predictor for a lower risk of postoperative infections (aOR, 0.968; 95%CI, 0.946-0.991; P=.007), respiratory failure (aOR, 0,961; 95%CI, 0.936-0.987; P=.004), and right heart failure (aOR, 0.963; 95%CI, 0.934-0.992; P=.014). CONCLUSIONS Malnourished patients are at increased risk for postoperative complications and death after cf-LVAD implantation. Assessment of nutritional risk could improve patient selection and the early initiation of nutritional support.

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.

Hemoadsorption in cardiac shock with biventricular failure and giant-cell myocarditis: A case report:

Purpose: Giant-cell myocarditis represents a rare and often fatal autoimmune disorder. Despite extracorporeal life support being a valid treatment option, alternatives to control the underlying inflammatory response remain sparse. A new hemoadsorption device (CytoSorb) has recently been introduced to treat patients with an excessive inflammatory response. Methods: A 57-year-old patient developed fulminant right heart failure, respiratory insufficiency, hemodynamic instability, and oliguric–anuric renal failure. An extracorporeal life support together with an Impella was implanted for circulatory support. Due to non-pulsatility, acontractility of the left ventricle and a heavily reduced right ventricular function, a left ventricular assist device implantation and change from extracorporeal life support to veno-pulmonary arterial extracorporeal membrane oxygenation was performed. Since adequate hemodynamic stabilization could not be achieved and due to increasing inflammatory mediators and bilirubin levels, the decision was made to additionally integrate a CytoSorb hemoadsorber into the system. Results: The combined treatment resulted in a clear and steady improvement in hemodynamics and the inflammatory condition with marked reductions in all measured parameters throughout the treatment period. Metabolic acidosis resolved and liver function improved. Conclusion: Extracorporeal life support therapy represents a bridging approach to heart transplantation or to cardiac recovery and can be complemented by CytoSorb as an independent therapeutic option. The patient described herein with giant-cell myocarditis and fulminant cardiac failure who received substantial extracorporeal support in combination with CytoSorb hemoadsorption therapy benefited in terms of an improvement of organ function and his inflammatory situation.

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.

Treatment of an Intercostal Left Ventricular Assist Device Prolapse by Upgrading From HeartMate II to HeartMate 3: LETTER TO THE EDITOR

To the Editor, The HeartMate II (HMII, St. Jude Medical, Saint Paul, MN, USA) is the most commonly used left ventricular assist device (LVAD) worldwide. Despite many technical and surgical improvements within the field of mechanical circulatory support, infection and thrombosis are still major complications of LVAD therapy (1,2). When conservative treatments of infection or thrombosis fail, pump exchange can be considered. In many cases, surgeons can avoid performing a full sternotomy and instead perform an anterolateral thoracotomy for the exchange procedure (3–6). This technique lowers the risk of bleeding, sternal instabilities, formation of adhesions, and right heart failure. However, due to the size of the pump corpus, resection of ribs may be necessary in some cases. We present the first case of a HMII LVAD pump prolapse which was successfully treated by upgrading the device to a HeartMate 3 (HM3, Thoratec Corporation, Pleasanton, CA, USA).