To manage myocardial recovery in patients with the HeartWare left ventricular assist device (HVAD), we describe a minimally invasive approach (decommissioning) that involves disconnecting the driveline and occluding the outflow tract through a small left thoracotomy incision, leaving the device in situ, in conjunction with optimal medical therapies and comprehensive assessment of left ventricular recovery. Nine patients (all male, 37 ± 12 years, all nonischemic dilated cardiomyopathy) had an HVAD implanted for 766 ± 343 days. When left ventricular function improved to mild impairment by echocardiography, patients underwent assessment at reduced flow (2578 ± 148 to 1822 ± 67 rpm) with documentation of compensated right heart hemodynamics and ejection fraction 52 ± 8%. Eight of nine patients underwent decommissioning, and 1 patient had a hybrid procedure of percutaneous occlusion of outflow graft and surgical division of driveline. Two patients died postoperatively at 413 days (sepsis) and 810 days (heart failure). In conclusion, in selected patients with nonischemic dilated cardiomyopathy, a prolonged period of HVAD support in conjunction with heart failure medications can lead to recovery of left ventricular function. Surgical decommissioning is then an option to remove these patients from support. These patients are, however, not cured and remain at risk for future deterioration in ventricular function and infections.

Advances in left ventricular assist device (LVAD) therapy have resulted in increasing numbers of adult LVAD recipients in the community. However, device failure, stroke, bleeding, LVAD thrombosis and systemic infection can be life-threatening emergencies. Currently, four LVAD systems are implanted in six UK transplant centres, each of which provides device-specific information to local emergency services. This has resulted in inconsistent availability and content of information with the risks of delayed or inappropriate decision-making. In order to improve patient safety, a consortium of UK healthcare professionals with expertise in LVADs developed universally applicable prehospital emergency algorithms. Guidance was framed as closely as possible on the standard ABCDE approach to the assessment of critically ill patients.

A review of warfarin management within our institute was undertaken to assess compliance over a period of time within target INR range of patients supported on Heartware HVADS. Warfarin management within our institute is performed by our VAD team. Patients are provided with a Roche coagucheck XS INR tester which enables INR testing at home. Patients are instructed when to check their INR reading by our nurse specialist. Patients will either have to contact the nurse specialist or will be contacted by the nurse specialist as part of our telephone surveillance program. If they are to contact the nurse specialist they are asked to contact with their INR readings during a specific time. Within our institute we target an INR range of 2.6-3.5. Over a four week period we recorded the patients INR readings and compliance. We looked at the range the INR reading fell within and assessed how often the patients INR readings were within our target range. We recorded information related to compliance by reviewing how many patients took the instructed dose, and when they contacted the nurse. At the point of review we had a cohort of 46 patients. 5 of those were on Tinzaparin, 4 due to GI bleeding and 1 due to erratic INR. Over the 4 weeks 376 INR readings were scheduled. Out of those 376 readings 89% of patients gave INR readings and of those, 93% took the instructed dose. Of those INR readings that were obtained we found that 62.5% were within our target range of 2.6-3.5. Heartware recommend a target INR of 2-3 for the HVAD device, 75.8% were within this range. Of our cohort 4.1% of the readings were less than 2 requiring tinzaparin. From reviewing the data we found that home testing allows us to keep our patients within our target range designated for the LVAD for a sufficient period of time. The home testing prevents the patient having to spend time in warfarin clinics and allows our VAD team to maintain greater control over the patients anti-coagulation. We have compared our data to the main warfarin clinic ran at our institute and found that our time spent within range was similar. In the warfarin clinic 67.9% of patients spent time within the target range of 2.5-3.5 and for the Heartware target range of 2-3 their time spent within range was 80%. On comparing this data you can see that home management of INR readings in this cohort of patients is comparable to that of a well-established warfarin clinic.

Background. Mechanical circulatory support in the pediatric population is currently limited to pulsatile ventricular assist devices (VAD). In recent years, the use of durable, newer generation, continuous flow devices have increased substantially among adults with end-stage heart failure. We examined the extended role of this device in the pediatric population (aged less than 18 years).Methods. Between 2010 and 2015, 12 patients (median age 7.1 years; range, 3.7 to 17.0; one third of patients were aged 5 years or less) received a HeartWare ventricular assist device (HVAD; HeartWare, Framingham, MA), 11 for cardiomyopathy and 1 for posttransplant rejection. Right VAD support (n = 5; 42%) was provided by a short-term device (Levitronix, Zurich, Switzerland).Results. Overall, 1 patient died (day 638), 8 patients (67%) underwent transplantation, 1 patient (8.3%) recovered, and 2 patients (17%) remain on HVAD. The mean length of support was 150 days (range, 16 to 638). Four patients (33.3%) were discharged home (all left VAD). In the left VAD group (n = 7), 3 patients subsequently received transplants (days 185, 201, and 234, respectively), 1 recovered (day 149), 1 died (day 638), 1 remained on HVAD (day 198), and 1 needed conversion to biventricular assist device (BIVAD [day 73]). In the BIVAD group (n = 5), right VAD was weaned in 3 (60%), all subsequently received transplants, and 2 remained on BIVAD support until transplant (days 16 and 17, respectively). One BIVAD patient required conversion to central cannulation for longer-term support. Four BIVAD patients (80%) were in Interagency Registry for Mechanically Assisted Circulatory Support level 1 before VAD compared with 2 (29%) in the left VAD group (p = not significant). The actuarial survival rate was 100% at 1 year with no neurologic events.Conclusions. The third-generation, continuous flow device can provide durable support in the pediatric population. The selection strategy for patients who benefit most from the device continues to evolve. It is anticipated that a smaller design in the future will benefit an even wider pediatric population with heart failure. (C) 2016 by The Society of Thoracic Surgeons

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.

It is not known whether aortic valve opening (AVO) is beneficial or detrimental in patients with continuous flow ventricular assist devices (VAD). Retrospective analysis of 147 patients that received a HeartWare HVAD® as bridge to transplant or bridge to candidacy between July 2009 and August 2015, of whom 126 had at least 30 days follow-up before first event. Aortic valve opening (AVO) included complete opening, partial in every cardiac cycle, or in only a proportion of cycles but on a regular basis. The aortic valve was considered closed when it was completely closed, when opening was very occasional and not regular, or the leaflets moved slightly without demonstrable flow through the valve. Outcomes included survival, pump thrombosis (PT), and ischemic stroke (IS), or combined thrombotic event (PT + IS = CTE). Median time on HVAD support was 495 days (IQR 228-1045). Mean device speed was 2584±185 rpm. Of the 126 patients with at least 30 days of follow-up until first event, 29% had an episode of first PT, and 19% IS. Aortic valve did not open in 37% of patients. AVO was associated with better survival on device (1180 vs 617 days; p=0.01) in the whole cohort of 147 patients. In the 126 patients with at least 30 days of follow-up before events, AV was more frequently closed in patients with worse ejection fraction on support (14±6% vs 18±9%; p=0.009), more dilated pre-adverse event echocardiogram (LV end-diastolic diameter (LVEDD): 66±12 mm vs 62±10 mm; p=0.04) and pre-implant LVEDD (70±10 mm vs 66±9 mm; p=0.06). CTE-free survival on the device was significantly lower in patients with a closed aortic valve (median 791 vs 1426 days; p=0.008) as well as PT-free survival on the device (median 1063 vs 1689 days; p=0.05). Aortic valve closure was associated with worse post-implant LV function, greater LV dilatation, and increased likelihood of serious thrombotic adverse events. This reflects the higher risk profile of those subjects with very poor post-operative LV function and dilated ventricles. Prospective studies are required to determine whether ensuring aortic valve opening reduces thrombotic risk and overall survival.

Purpose While the HeartWare® Ventricular Assist System (HVAS) is a successful therapy for end-stage heart failure, outpatient management methods can vary significantly and require further investigation. Methods A survey to assess the long-term HVAS patient management and monitoring strategies was completed by 36 international heart centers that currently have over 1,450 patients on VAD support either at home or in the hospital. Multiple choice questions examined VAD program characteristics, anticoagulation management, driveline exit-site dressing and showering recommendations, blood pressure and pump parameter monitoring, and patient discharge protocols. Results Outpatient international normalized ratio (INR) was most frequently measured every 3–4 days (28.6%), and the most frequent schedule for changing driveline exit site dressings was 3 times per week (30.6%). Only 25.7% of centers required their patients to measure blood pressure at home. A subgroup analysis was performed to assess the influence of center experience and larger centers generally had more frequent monitoring compared to smaller centers. Conclusions This survey showed specific differences in outpatient management strategies that were previously unreported. However, further studies with correlations to patient outcomes are necessary to determine optimal patient management recommendations.

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. (C) 2016 by The Society of Thoracic Surgeons

PurposeWe investigated the serial changes in left ventricular (LV) dimensions and aortic root size in our adult patient cohort supported by the HeartWare® ventricular assist device (HVAD). We hypothesised that in those who develop mild or more de-novo aortic incompetence (AI) the aortic root dilates whilst LV dimensions remain unchanged.MethodsA retrospective analysis of echocardiograms was performed on those who had HVAD implanted over a 3.5 yr period. 101 HVAD's were implanted in 96 patients.Echocardiograms performed pre and at 1 and 2 years post were analysed. Only those with native aortic valves and an HVAD for 6 months were included, and grouped into those with none or trace AI or mild or more AI.Results84.5% were male, mean age 47+/– 12.6 yrs.Dilated cardiomyopathy was etiology in 53.5%. Mean duration of HVAD support was 624 +/– 359 days. Aortic annulus dimensions significantly increased in both groups at 1 and 2 years (Tables 1,2). At 2 years in those with AI the Sinuses of Valsalva were also larger, p=0.002. LVEDD significantly reduced in those with no or trace AI at 1 and 2 years but remained unchanged in those with AI at both points.ConclusionLong term HVAD support leads to dilatation of the aortic annulus, and additional root dilatation in those with mild or more AI overtime. The proximity of the outflow graft insertion to the aortic root with the constant strain of flow may explain these findings. Further studies should focus on alternate insertion sites of the outflow graft, more distant to the aortic root.Table 1Change in serial aortic root and LV dimensions in those supported out to 1 yearImplants = 53Echo = 48None or trace AI (n=35)Mean +/- SDMedian (IQR)P valueMild or more AI (n=13)Mean +/- SDMedian (IQR)P valuePre Implant1 YearPre Implant1 YearAortic annulus (mm)20 (20,22)22 (21,24)0.00620.0 +/- 2.822.6 +/- 3.00.05Sinus of Valsalva (mm)29.1 +/- 3.028.9 +/- 3.00.81429.1 +/- 2.330.1 +/- 3.90.5LV end diastolic dimension (LVEDD, mm)67.7 +/- 9.660.2 +/- 13.40.01267.5 +/- 10.564.1 +/- 10.80.42LV end systolic dimension (LVESD, mm)60.0 +/- 10.652.6 +/- 14.30.02460.3 +/- 11.858.8 +/- 13.00.79 Open table in a new tab Table 2Change in serial aortic root and LV dimensions in those supported out to 2 yearsImplants = 31Echo = 27None or trace AI (n=19)Mean +/– SDMedian (IQR)Mild or more AI* (n=8)Mean +/– SDMedian (IQR)Pre Implant1 year2 YearPre Implant1 Year2 YearAortic Annulus (mm)20.7 +/– 2.922.7 +/– 2.223.1 +/– 3.020.3 +/– 3.221.8 +/– 3.123.1 +/– 2.6Sinus of Valsalva (mm)29.9 +/– 3.630.5 +/– 2.931.3 +/– 3.729 +/– 2.328.8 +/– 5.531.9 +/– 7LVEDD (mm)67.8 +/– 9.061.4 +/– 12.861.7 +/– 12.765 (57.5, 73)59 (56, 64)57.5 (55, 62)LVESD (mm)61 (51,65)55 (39.5, 65.5)61 (44, 67.5)57 +/– 9.957.8 +/– 8.557.3 +/– 8.5 Open table in a new tab PurposeWe investigated the serial changes in left ventricular (LV) dimensions and aortic root size in our adult patient cohort supported by the HeartWare® ventricular assist device (HVAD). We hypothesised that in those who develop mild or more de-novo aortic incompetence (AI) the aortic root dilates whilst LV dimensions remain unchanged. We investigated the serial changes in left ventricular (LV) dimensions and aortic root size in our adult patient cohort supported by the HeartWare® ventricular assist device (HVAD). We hypothesised that in those who develop mild or more de-novo aortic incompetence (AI) the aortic root dilates whilst LV dimensions remain unchanged. MethodsA retrospective analysis of echocardiograms was performed on those who had HVAD implanted over a 3.5 yr period. 101 HVAD's were implanted in 96 patients.Echocardiograms performed pre and at 1 and 2 years post were analysed. Only those with native aortic valves and an HVAD for 6 months were included, and grouped into those with none or trace AI or mild or more AI. A retrospective analysis of echocardiograms was performed on those who had HVAD implanted over a 3.5 yr period. 101 HVAD's were implanted in 96 patients.Echocardiograms performed pre and at 1 and 2 years post were analysed. Only those with native aortic valves and an HVAD for 6 months were included, and grouped into those with none or trace AI or mild or more AI. Results84.5% were male, mean age 47+/– 12.6 yrs.Dilated cardiomyopathy was etiology in 53.5%. Mean duration of HVAD support was 624 +/– 359 days. Aortic annulus dimensions significantly increased in both groups at 1 and 2 years (Tables 1,2). At 2 years in those with AI the Sinuses of Valsalva were also larger, p=0.002. LVEDD significantly reduced in those with no or trace AI at 1 and 2 years but remained unchanged in those with AI at both points. 84.5% were male, mean age 47+/– 12.6 yrs.Dilated cardiomyopathy was etiology in 53.5%. Mean duration of HVAD support was 624 +/– 359 days. Aortic annulus dimensions significantly increased in both groups at 1 and 2 years (Tables 1,2). At 2 years in those with AI the Sinuses of Valsalva were also larger, p=0.002. LVEDD significantly reduced in those with no or trace AI at 1 and 2 years but remained unchanged in those with AI at both points. ConclusionLong term HVAD support leads to dilatation of the aortic annulus, and additional root dilatation in those with mild or more AI overtime. The proximity of the outflow graft insertion to the aortic root with the constant strain of flow may explain these findings. Further studies should focus on alternate insertion sites of the outflow graft, more distant to the aortic root.Table 1Change in serial aortic root and LV dimensions in those supported out to 1 yearImplants = 53Echo = 48None or trace AI (n=35)Mean +/- SDMedian (IQR)P valueMild or more AI (n=13)Mean +/- SDMedian (IQR)P valuePre Implant1 YearPre Implant1 YearAortic annulus (mm)20 (20,22)22 (21,24)0.00620.0 +/- 2.822.6 +/- 3.00.05Sinus of Valsalva (mm)29.1 +/- 3.028.9 +/- 3.00.81429.1 +/- 2.330.1 +/- 3.90.5LV end diastolic dimension (LVEDD, mm)67.7 +/- 9.660.2 +/- 13.40.01267.5 +/- 10.564.1 +/- 10.80.42LV end systolic dimension (LVESD, mm)60.0 +/- 10.652.6 +/- 14.30.02460.3 +/- 11.858.8 +/- 13.00.79 Open table in a new tab Long term HVAD support leads to dilatation of the aortic annulus, and additional root dilatation in those with mild or more AI overtime. The proximity of the outflow graft insertion to the aortic root with the constant strain of flow may explain these findings. Further studies should focus on alternate insertion sites of the outflow graft, more distant to the aortic root.

The Freeman Hospital in Newcastle is one of the leading centres for cardiac transplantation and implantation of ventricular assist devices in the UK, receiving referrals to the Advanced Heart Failure Service predominantly from the North of England, but also Northern Ireland and complex cases from other regions. We were keen to establish whether referring clinicians felt they had sufficient knowledge about the service, its role and which patients may benefit from referral. We designed an online survey and sent a link via email to 127 potential referrers (predominantly colleagues who had referred to the service in the past). 56 of the 127 clinicians responded, giving a response rate of 44% (Table 1). Although 76% of those responding to the survey had previously referred at least one patient, only 70% reported being fully aware of the role of the Advanced Heart Failure Service, 62% felt they had a clear understanding of which patients to refer and 60% were confident in how to refer. Only 21% felt they had sufficient information about the service and guidelines for referral. The uncertainty amongst clinicians about who to refer influences whether patients are referred for advanced heart failure therapies, and therefore impacts on patient care as patients who may benefit from therapies such as transplantation or ventricular assist devices may not be referred for assessment. Factors prompting clinicians to refer patients with heart failure and relatively few co-morbidites, or which deter them from referring, are detailed in Figures 1 and 2. Only 51% would consider referring a patient with more than 1 heart failure hospitalisation in the last year and fewer than 50% would consider referring patients with multiple ICD shocks, new renal impairment, or hypotension requiring reduction or discontinuation of ACE inhibitors/beta blockers, despite all of these being recognised adverse prognostic signs in patients with heart failure. The most common factor deterring clinicians from referring was the presence of multiple co-morbidities (74%). Disappointingly, other reasons for not referring included being unsure of who to refer (14%) or how to refer (10%). 84% of clinicians would be more likely to refer in the future if NICE approved VADs as ‘destination therapy’ rather than only as a ‘bridge to transplant’. Other advances in heart failure management that may increase the likelihood of clinicians referring in the future are summarised in Table 2. There is a clear demand for increased access to information about the Freeman Hospital Advanced Heart Failure Service and guidelines on who to refer, with 84% being “extremely interested” and the remaining 16% “quite interested” in receiving more information. With better education amongst referring clinicians, and NICE approval of destination therapy, referrals will likely increase significantly.

PurposeThe HeartWare® left ventricular assist device (HVAD) is successfully being used as a bridge-to-transplant and destination therapy in end-stage heart failure patients. To enhance patient functional status and outcomes optimal patient management is required. The aim of this study was to assess the different long-term HVAD patient management and monitoring strategies in various international heart centers.MethodsA survey containing 24 questions (multiple answer choices) about what, when and how to monitor in HVAD patients was sent out to 86 international (excluding the United States) VAD coordinators representing different centers. Questions covered topics related to site organization, anticoagulation, driveline exit site dressing and showering, blood pressure and pump parameter monitoring, and patient discharge.ResultsResponses were received by 42% (N=36) of the invited participants. Respondents were VAD coordinators representative of small, medium and large VAD implant centers. Following initial discharge, 20% of patients go immediately to rehabilitation center and 46% directly to home. Most centers (28%) measure outpatient INRs every 3-4 days, and the most frequent schedule for driveline exit site dressing changes is 3 times per week (31%). Interestingly, 14% of the centers do not allow their patients to shower, despite the availability of shower bags. It was also interesting to find that only 25% of centers are requiring their patients to measure blood pressure at home, although recent data suggesting strong correlations of elevated blood pressure (>90mmHg) with strokes and VAD thrombus.ConclusionPatient management varies significantly among different heart centers. Careful adherence to patient management guidelines will optimize outcomes and improve patient quality of life. PurposeThe HeartWare® left ventricular assist device (HVAD) is successfully being used as a bridge-to-transplant and destination therapy in end-stage heart failure patients. To enhance patient functional status and outcomes optimal patient management is required. The aim of this study was to assess the different long-term HVAD patient management and monitoring strategies in various international heart centers. The HeartWare® left ventricular assist device (HVAD) is successfully being used as a bridge-to-transplant and destination therapy in end-stage heart failure patients. To enhance patient functional status and outcomes optimal patient management is required. The aim of this study was to assess the different long-term HVAD patient management and monitoring strategies in various international heart centers. MethodsA survey containing 24 questions (multiple answer choices) about what, when and how to monitor in HVAD patients was sent out to 86 international (excluding the United States) VAD coordinators representing different centers. Questions covered topics related to site organization, anticoagulation, driveline exit site dressing and showering, blood pressure and pump parameter monitoring, and patient discharge. A survey containing 24 questions (multiple answer choices) about what, when and how to monitor in HVAD patients was sent out to 86 international (excluding the United States) VAD coordinators representing different centers. Questions covered topics related to site organization, anticoagulation, driveline exit site dressing and showering, blood pressure and pump parameter monitoring, and patient discharge. ResultsResponses were received by 42% (N=36) of the invited participants. Respondents were VAD coordinators representative of small, medium and large VAD implant centers. Following initial discharge, 20% of patients go immediately to rehabilitation center and 46% directly to home. Most centers (28%) measure outpatient INRs every 3-4 days, and the most frequent schedule for driveline exit site dressing changes is 3 times per week (31%). Interestingly, 14% of the centers do not allow their patients to shower, despite the availability of shower bags. It was also interesting to find that only 25% of centers are requiring their patients to measure blood pressure at home, although recent data suggesting strong correlations of elevated blood pressure (>90mmHg) with strokes and VAD thrombus. Responses were received by 42% (N=36) of the invited participants. Respondents were VAD coordinators representative of small, medium and large VAD implant centers. Following initial discharge, 20% of patients go immediately to rehabilitation center and 46% directly to home. Most centers (28%) measure outpatient INRs every 3-4 days, and the most frequent schedule for driveline exit site dressing changes is 3 times per week (31%). Interestingly, 14% of the centers do not allow their patients to shower, despite the availability of shower bags. It was also interesting to find that only 25% of centers are requiring their patients to measure blood pressure at home, although recent data suggesting strong correlations of elevated blood pressure (>90mmHg) with strokes and VAD thrombus. ConclusionPatient management varies significantly among different heart centers. Careful adherence to patient management guidelines will optimize outcomes and improve patient quality of life. Patient management varies significantly among different heart centers. Careful adherence to patient management guidelines will optimize outcomes and improve patient quality of life.

Heart failure is affecting an increasing number of people in the UK. Some patients who have severe heart failure only have heart transplant as an option, and with prolonged waiting times on the transplant list, many may die waiting. To bridge these patients until a suitable organ is available, patients are being fitted with left ventricular assist devices (LVAD). These devices are mechanical pumps that assist weakened hearts in circulating blood around the body. An LVAD pump requires close monitoring of the pump's readings, exit site and anticoagulation while in hospital and once the patient has been discharged home. By creating a specialist nurse post to introduce a weekly telephone call to this caseload of patients, the authors' institute was able to reduce the amount of patients admitted by 15.5% and the amount of days spent in hospital was reduced by 20.9% over the same period.

PurposeOutcome and quality of life in adults on ventricular assist devices (VAD) has been substantially improved with the introduction of implantable third generation devices. In small children only paracorporeal VAD are available for long term support. The purpose of this study was to analyze if mechanical support with the HeartWare® VAD (HVAD), which is approved for patients with a body surface area (BSA) over 1 m², is safe and effective in smaller children.MethodsThis was a retrospective international multicenter review of the HVAD® in children with a BSA under 1 m². Three centers (Germany, United Kingdom, Canada) participated in this study.ResultsTen children (5 female, 5 male), median age 8.3 years (range 3.7-10), who underwent HVAD implantation between 2010 and 2014, were enrolled. Diagnosis was congenital heart disease in three, and dilated cardiomyopathy in seven children. Median body weight was 19.9 kg (range 13.5 - 23), mean height 121 cm (range 102 - 150), and mean BSA 0.8 m² (range 0.6 - 0.9). Left ventricular diameter was 4.9 cm (range 3.5 - 6.2). The HVAD was implanted in the left ventricular apex in all patients, in two the outflow graft was narrowed to increase afterload of the pump. At day one after implantation median pump speed was 2200 rpm (1900 - 2500) resulting in a flow of 2.1 L/min (1.6 - 2.9). After implantation inotropic support with epinephrine was needed for 2 days (range 0 - 15) and milrinone for 16.5 days (range 6 - 41). Two children were on temporarily right ventricular mechanical support for 6 and 8 days. After a median support time of 130 days (range 17 - 351) eight children were transplanted successfully, one was weaned from the system, one is still on support. Mortality was 0%. Four children were discharged home on support, two of them attended school. Complications included driveline infections (n=2), transient ischemic attack (n=1), stroke (n=1) and bleeding requiring transfusion (n=2). Thrombosis of the pump occurred in three; - one pump was left in situ (VAD decommissioned), one thrombolysed and one exchanged.ConclusionMechanical support with HeartWare® VAD in small children is feasible and can be achieved with a low mortality and morbidity. This device has the added benefit that some children can be discharged home. PurposeOutcome and quality of life in adults on ventricular assist devices (VAD) has been substantially improved with the introduction of implantable third generation devices. In small children only paracorporeal VAD are available for long term support. The purpose of this study was to analyze if mechanical support with the HeartWare® VAD (HVAD), which is approved for patients with a body surface area (BSA) over 1 m², is safe and effective in smaller children. Outcome and quality of life in adults on ventricular assist devices (VAD) has been substantially improved with the introduction of implantable third generation devices. In small children only paracorporeal VAD are available for long term support. The purpose of this study was to analyze if mechanical support with the HeartWare® VAD (HVAD), which is approved for patients with a body surface area (BSA) over 1 m², is safe and effective in smaller children. MethodsThis was a retrospective international multicenter review of the HVAD® in children with a BSA under 1 m². Three centers (Germany, United Kingdom, Canada) participated in this study. This was a retrospective international multicenter review of the HVAD® in children with a BSA under 1 m². Three centers (Germany, United Kingdom, Canada) participated in this study. ResultsTen children (5 female, 5 male), median age 8.3 years (range 3.7-10), who underwent HVAD implantation between 2010 and 2014, were enrolled. Diagnosis was congenital heart disease in three, and dilated cardiomyopathy in seven children. Median body weight was 19.9 kg (range 13.5 - 23), mean height 121 cm (range 102 - 150), and mean BSA 0.8 m² (range 0.6 - 0.9). Left ventricular diameter was 4.9 cm (range 3.5 - 6.2). The HVAD was implanted in the left ventricular apex in all patients, in two the outflow graft was narrowed to increase afterload of the pump. At day one after implantation median pump speed was 2200 rpm (1900 - 2500) resulting in a flow of 2.1 L/min (1.6 - 2.9). After implantation inotropic support with epinephrine was needed for 2 days (range 0 - 15) and milrinone for 16.5 days (range 6 - 41). Two children were on temporarily right ventricular mechanical support for 6 and 8 days. After a median support time of 130 days (range 17 - 351) eight children were transplanted successfully, one was weaned from the system, one is still on support. Mortality was 0%. Four children were discharged home on support, two of them attended school. Complications included driveline infections (n=2), transient ischemic attack (n=1), stroke (n=1) and bleeding requiring transfusion (n=2). Thrombosis of the pump occurred in three; - one pump was left in situ (VAD decommissioned), one thrombolysed and one exchanged. Ten children (5 female, 5 male), median age 8.3 years (range 3.7-10), who underwent HVAD implantation between 2010 and 2014, were enrolled. Diagnosis was congenital heart disease in three, and dilated cardiomyopathy in seven children. Median body weight was 19.9 kg (range 13.5 - 23), mean height 121 cm (range 102 - 150), and mean BSA 0.8 m² (range 0.6 - 0.9). Left ventricular diameter was 4.9 cm (range 3.5 - 6.2). The HVAD was implanted in the left ventricular apex in all patients, in two the outflow graft was narrowed to increase afterload of the pump. At day one after implantation median pump speed was 2200 rpm (1900 - 2500) resulting in a flow of 2.1 L/min (1.6 - 2.9). After implantation inotropic support with epinephrine was needed for 2 days (range 0 - 15) and milrinone for 16.5 days (range 6 - 41). Two children were on temporarily right ventricular mechanical support for 6 and 8 days. After a median support time of 130 days (range 17 - 351) eight children were transplanted successfully, one was weaned from the system, one is still on support. Mortality was 0%. Four children were discharged home on support, two of them attended school. Complications included driveline infections (n=2), transient ischemic attack (n=1), stroke (n=1) and bleeding requiring transfusion (n=2). Thrombosis of the pump occurred in three; - one pump was left in situ (VAD decommissioned), one thrombolysed and one exchanged. ConclusionMechanical support with HeartWare® VAD in small children is feasible and can be achieved with a low mortality and morbidity. This device has the added benefit that some children can be discharged home. Mechanical support with HeartWare® VAD in small children is feasible and can be achieved with a low mortality and morbidity. This device has the added benefit that some children can be discharged home.

Background. The systemic morphologic right ventricle (RV) in congenitally corrected transposition of the great arteries or after atrial switch for transposition of the great arteries is associated with late ventricular failure. Although the role of the left ventricular assist device (LVAD) in supporting the failing LV is established, the indications and outcomes of using LVAD in a systemic RV remain unclear. We assessed the role of a third-generation LVAD for systemic RV support.Methods. Seven patients (mean age, 36 years) received the HeartWare (HeartWare International Inc, Framingham, MA) VAD for systemic RV failure (congenitally corrected transposition of the great arteries in 1 and after atrial switch in 6). Four patients (57%) had severe subpulmonic LV failure, and aggressive perioperative diuresis with or without hemofiltration was used to off-load the subpulmonic LV. The indications of VAD were (1) bridge to transplant in 3 and (2) bridge to decision for a high transpulmonary gradient in 4. Transplantation outcome was compared with systemic RV failure without VAD bridge in 19 patients (years 1989 to 2013).Results. Systemic RV support alone was achieved in all patients, with no early deaths (<= 30 days). Overall, 6 (86%) returned home, 3 (44%) received a transplant, 2 (28%) died of noncardiac causes, and 2 (28%) continue on VAD support (median support, 232 days). Repeat catheterization (n = 4) showed an improved median transpulmonary gradient in 3 patients (median 18.5 mm Hg pre-VAD vs 8.0 mm Hg post-VAD). Two bridge-to-decision patients received transplants at 640 and 685 days. The stroke rate on VAD support was 43% (2 thromboembolic and 1 hemorrhagic; 3 with satisfactory recovery). De novo aortic regurgitation was 29% (n = 2; 1 valve replacement). All patients (n = 3) survived transplantation (vs 10.5% early mortality without VAD bridge; p = 1.00) and were well at follow-up (range, 53 to 700 days).Conclusions. The third-generation VAD provides durable support for systemic RV failure as a bridge to transplant and as a strategy to reduce pulmonary vascular resistance. Although concomitant subpulmonic LV failure is common, systemic RV support alone was achieved in all patients. (C) 2014 by The Society of Thoracic Surgeons

Long term home based LVAD therapy provides new challenges in outpatient care. In 2009 we discharged our first patient for long term home based care. At this time we relied upon the patient contacting our team if there was a deterioration in condition. Sometimes this meant we were already behind in treatment process for the patient. In 2013 in order to provide our patients with a better standard of care we implemented a simple telephone clinic system in order to identify any change in their medical condition or device parameters. Earlier detection would allow for appropriate therapy to be given before irreversible damage occurred. Our strategy was to improve patient care and in turn reduce our re-admissions and length of stay. Long term recipients were monitored over a 10 month period using a weekly telephone clinic algorithm. The algorithm used dictated that each patient got at least one weekly phone call unless they were in clinic. Although the patients compliance or condition sometimes warranted more frequent follow up. There were also parameters set for what information would be gathered during these phone calls and they were: general well being, temperature, body weight, VAD flow, power, drive line observation and INR reading. This was stored centrally on a database that allowed every member of the LVAD team to have up to date information on each patients condition. Over a 10 month period all re-admission data was collected. Elective admissions were removed from the data as they were not as a response to unexpected deterioration in a patients health. The number of patients re-admitted fell by 5.8%. The number days spent in hospital fell by 13.6%. The new measures of remote follow up and data collection have reduced our re-admission rate, length of stay and also improved communication with our patients. We have been able to identify issues with deterioration in health earlier and deal with it more effectively. With these simple measures we have improved our patients home base care and quality of life.