Neil Wrightson

A multicenter study of the HeartWare ventricular assist device in small children

A multicenter study of the HeartWare ventricular assist device in small children Oliver Miera, MD, Richard Kirk, MD, Holger Buchholz, MD, Katharina R.L. Schmitt, MD, Christina VanderPluym, MD, Ivan M. Rebeyka, MD, Neil Wrightson, MD, Felix Berger, MD, Massimo Griselli, MD, and Jennifer Conway, MD From the Department of Congenital Heart Disease/Pediatric Cardiology, Deutsches Herzzentrum Berlin, Berlin, Germany; Department of Pediatric Cardiology, Freeman Hospital, Newcastle Upon Tyne, UK; Stollery Children’s Hospital, University of Alberta, Edmonton, Alberta, Canada; and the Department of Cardiology, Boston Children’s Hospital, Boston, Massachusetts, USA

An alternative approach to explantation and exchange of the HeartWare left ventricular assist device

OBJECTIVES Left ventricular assist device (LVAD) explantation and exchange is a relatively infrequent but potentially complex procedure. Patients requiring such procedures have multisystem suboptimal physiological reserve due to end-stage heart failure and are prone to complications. Less-invasive procedures are believed to facilitate postoperative recovery and early mobilization. We describe an alternative approach to explantation and exchange of the HeartWare LVAD through left thoracotomy. METHODS Six patients (M = 4, F = 2, mean age = 49.16 years) underwent device explant/exchange or initial implant (explant = 2, exchange = 3, initial implant = 1) through left thoracotomy utilizing cardiopulmonary bypass and induced ventricular fibrillation (VF). The mean bypass time and mean VF arrest time were 82 and 3 min, respectively. A new outflow graft was anastomosed to the previous outflow graft in 3 cases of device exchange and to the descending aorta in 1 case of initial implant. RESULTS One patient died in the intensive care unit due to unrelated causes (gram-negative sepsis) after device exchange. All others were discharged alive and currently remain on follow-up. The mean length of hospital stay was 40.66 days. CONCLUSIONS On-pump approach through single thoracotomy incision is safe and equally suitable for device explant, exchange and initial implant. However, structural heart defects requiring surgical correction and the requirement of simultaneous right ventricular assist device are the limitations of this approach.

Four-year outcomes with third-generation centrifugal left ventricular assist devices in an era of restricted transplantation

OBJECTIVES Third-generation ventricular assist devices (VADs) are associated with improved outcomes, though in recent clinical trials bridge-to-transplant (BTT) rates are ∼30% at 6 months, so that transplantation can be used as a ‘bail out’ for serious complications. In the UK, there was a significant reduction in heart transplantation rates over the last decade, so that transplantation from VADs is much less frequent. The objective of this study was to determine outcomes and their predictors in this situation of low BTT rates, and as patients were exposed to long-term support, the incidence and outcomes of VAD thrombosis. METHODS We analysed outcomes for 102 consecutive patients between 2009 and 2013 (mean age 47 ± 13; VentrAssist n = 6 and HeartWare n = 96). The median duration of support was 462 ± 426 days. RESULTS Survival rates on the device were 75 and 66% at 1 and 2 years, respectively. Older age and more acute INTERMACS groups were significantly related to reduced survival within the first 90 days (P = 0.030 and 0.010, respectively). Poor preoperative right ventricular (RV) function had a negative effect on survival after 1 year (P = 0.009), though not earlier. VAD thrombosis (n = 24 HeartWare and n = 1 VentrAssist) occurred at 0.18 events per patient-year for HeartWare and 0.07 for VentrAssist devices at a median time of onset at 404 ± 281 days. There was no significant effect of VAD thrombosis on survival. Only 14 of 102 patients were transplanted at a median of 334 ± 347 days, and only 3 were transplanted within the first 6 months. CONCLUSIONS Third-generation left ventricular assist device implants with a low rate of transplantation have similar survival to destination therapy, and are susceptible to long-term complications of VAD thrombosis and right heart failure.

Outcomes following more than two decades of paediatric cardiac transplantation

OBJECTIVE There have been significant changes in the field of paediatric cardiac transplantation over the last two decades. We report experience of over 22 years from a single UK transplant centre. METHODS A total of 189 orthotopic cardiac transplants were performed in 182 children aged <18 years between March 1987 and March 2009 in our institution. Patients were identified and outcomes reviewed using the cardiopulmonary transplant database and hospital medical records. RESULTS 182 patients underwent cardiac transplantation, mean age 8.3 years (0.1-17.9 years), 91 (50%) male. Mean follow-up time was 9.0 years (0.3-22.3 years). 117 patients (64%) had a diagnosis of cardiomyopathy, 65 (36%) had congenital heart disease. There was no significant difference in age at transplant between the group with cardiomyopathy and the group with congenital heart disease. 32 patients (17.6%) were on mechanical support prior to transplant. Three (1.6%) patients have required long-term renal replacement therapy post transplant, and 16 (8.8%) developed post-transplant lymphoproliferative disease. Survival was 93% at 30 days, 89% at 1 year, 85% at 5 years, 70% at 10 years and 67% at 15 years with a decrease in mortality over time. Seven patients (3.8%) were re-transplanted. CONCLUSIONS Outcomes following cardiac transplantation in childhood are improving with increased experience. There has been a reduction in 30-day mortality over time.

Evaluation of NT-proBNP to predict outcomes in advanced heart failure.

Aims:  To determine which factors predict outcomes in a group of patients with advanced heart failure, and in particular if NT‐proBNP provides additional clinical and prognostic information to other haemodynamic and biochemical data.

Development of de novo aortic valve incompetence in patients with the continuous-flow HeartWare ventricular assist device.

BACKGROUND In this study we investigated the development of aortic incompetence (AI) and change in aortic root and left ventricular dimensions after implantation of the continuous-flow HeartWare ventricular assist device (HVAD) in our adult patient cohort. METHODS A retrospective analysis of serial echocardiograms was performed on patients implanted with an HVAD between July 2009 and July 2013. Data from echocardiograms performed before and at 1 and 2 years (±3 months) were analyzed. Patients with native aortic valves (AoVs) with no previous intervention and HVAD in situ for ≥6 months were included. RESULTS A total of 73 HVADs in 71 patients with a mean duration of support of 624 ± 359 days were included in our study. One patient developed moderate AI at 1 year (1.9%). Mild or greater AI was more likely in those with a closed or intermittently opening AoV at 1 year (p = 0.005). Aortic annulus dimensions increased significantly at 1 and 2 years, regardless of extent of AI. At 2 years, in those with mild or worse AI, the sinuses of Valsalva were also larger (p = 0.002). Left ventricular end-diastolic dimension (LVEDD) was significantly reduced in those with no or trace AI at 1 and 2 years (p = 0.012 and p = 0.008, respectively), but remained unchanged in those with AI at both time-points. CONCLUSIONS The development of more than mild AI is rare in HVAD patients at our center. When encountered, it is more common with a closed AoV. Dilation of the aortic annulus, and root dilation in those with mild or more AI, is seen with HVAD support over time.

Successful HeartWare Bridge to Recovery in a 3-Year Old: A Game Changer?

We report a 3-year-old boy weighing 13.5 kg who presented with intractable cardiac failure resulting from myocarditis and was treated by implantation of a HeartWare (HVAD) device. He was discharged home with the device. His cardiac function subsequently recovered, and the device was decommissioned. We believe this to be the youngest HVAD recipient and the only child to have recovered and had the device decommissioned.

Impact of aortic valve closure on adverse events and outcomes with the HeartWare ventricular assist device

BACKGROUND This study examined whether aortic valve opening (AVO) and other echocardiographic parameters influence outcomes in patients on left ventricular (LV) assist device (LVAD) support. Pump thrombosis (PT) and ischemic stroke (IS) are known complications of LVAD, but mechanisms that could influence them are not completely understood. METHODS This was a retrospective analysis of 147 patients who received a HeartWare Ventricular Assist Device ( HeartWare International) as a bridge to transplant or to candidacy between July 2009 and August 2015, of whom 126 had at least 30 days of follow-up before the first event (30-days-out cohort). Outcomes included survival, PT, IS, and PT+IS (combined thrombotic event; CTE). RESULTS Median time on support was 518 days. Of the 30-days-out cohort, 29% had a first PT and 19% a first IS. AVO was associated with longer survival on device (1,081 vs 723 days; p = 0.01) in the entire cohort. In the 30-days-out cohort, the aortic valve was more frequently closed in patients with lower ejection fractions on support (14% ± 6% vs 18% ± 9%; p = 0.009), more dilated pre-event echocardiogram (LV end-diastolic diameter, 66 ± 12 mm vs 62 ± 10 mm; p = 0.04), and pre-implant LV end-diastolic diameter (70 ± 10 mm vs 66 ± 9 mm; p = 0.06). CTE-free survival on the device was lower with a closed aortic valve (897 vs 1,314 days; p = 0.003) as was PT-free survival on the device (1,070 vs 1,457 days; p = 0.02). Cox regression analysis showed that AVO was an independent predictor of CTE (p = 0.03) CONCLUSIONS: Thrombotic events are relatively frequent in patients on long-term LVAD support. A closed aortic valve was associated with decreased overall survival, thrombosis-free survival, and poorer LV function on support. These are high-risk patients, so whether they require more intense anti-coagulation or prioritizing for transplantation requires further research.

An ISHLT consensus document for prevention and management strategies for mechanical circulatory support infection

1053-2498/

Life-sustaining medical devices at the end of life

see fron rights reserved. http://dx.doi.org/10.10 Authors’ Disclosure The authors have m Heart and Lung Transp S.A., P.G., M.H., S.M Pediatric Thoracic T Schubert) Nursing, Health Sci Heart Failure and T F.G., A.L., S.P., S.Sch Pharmacy and Phar Mechanical Circulat F.G., A.L., S.P., S.S., The following auth Circulatory Assist Clin Reprint requests: S Arizona, 5777 East M +480 342 0115. Fax: E-mail address: ku CONSENSUS STATEMENT