Underwent Ventricular Assist Devices Placement Research Articles

Abstract 12339: Erythropoietin Use in Pediatric Ventricular Assist Device Patients

Background: Anemia is common in pediatric ventricular assist device (VAD) patients. Erythropoietin (EPO) has been used to reduce blood transfusions in children after VAD placement. A study in adults showed EPO use after left VAD implantation was associated with higher rates of suspected pump thrombosis. No studies have evaluated the use of EPO in pediatric patients receiving VAD support. Objectives: We aim to assess EPO use in all pediatric patients who underwent placement of a VAD and to assess outcomes for children who received EPO compared to those who did not. Methods: We identified patients from the Pediatric Health Information System who underwent VAD placement from 2010-2020. Use of EPO was described across all sites. Cohorts were compared to assess differences in blood transfusions received post-VAD, incidence of stroke and pump-exchange. Multivariable Cox proportional hazard and logistic regression models were constructed to adjust for confounding factors for outcomes of VAD exchange and stroke, respectively. Results: A total of 1260 patients were included, of which 336 (27%) received EPO. Patients who received EPO were younger (median 3.5y vs. 9y, p<0.001) and more likely to have congenital heart disease (55% vs. 45%, p=0.002). Patients on EPO received fewer blood transfusions compared to those not on EPO [median 0/month (IQR 0-0.9) vs. 0/month (IQR 0-2.3), p<0.001]. VAD exchange and stroke were more common in patients on EPO (10.1% vs. 5.5%, p=0.004 and 37.8% vs. 25%, p<0.001, respectively). After adjusting for confounding factors, the use of EPO was not independently associated with the need for VAD exchange (adjusted hazard ratio 1.2, 95% confidence 0.78 - 1.9, p=0.378). However, EPO remained independently associated with stroke during the hospitalization (adjusted hazard ratio 1.6, 95% confidence 1.2 - 2.1, p=0.002). Conclusion: EPO was used in approximately 1 out of 4 pediatric VAD patients. Those who received EPO were younger and more likely to have congenital heart disease. The use of EPO is associated with fewer post-VAD blood transfusions. EPO was not independently associated with VAD exchange but remained independently associated with stroke during the VAD hospitalization.

Perioperative Morbidity and Outcomes in Pediatric Patients Transitioned From Extracorporeal Membrane Oxygenation to Ventricular Assist Device Support: A Study of the Society of Thoracic Surgeons Congenital Heart Surgery Database.

As a bridge to transplant strategy, children transitioned from extracorporeal membrane oxygenation (ECMO) to ventricular assist device (VAD) have higher waitlist mortality compared with those who receive de novo VAD. However, the contribution of the immediate perioperative period and differences in the two groups are not well studied. We performed a nested case-control study between children receiving de novo VAD (group 1) and those transitioned from ECMO to VAD (group 2) between 2014 and 2019 using The Society of Thoracic Surgeons (STS) database. A total of 735 children underwent VAD placement with 498 in group 1 and 237 in group 2. Patients in group 2 were significantly younger, smaller, and significantly sicker, were twice as likely to transition to biventricular VAD and need unplanned reoperations. Overall mortality was 16% for group 1 and 34% for group 2 ( p < 0.01). Regression analysis showed that ECMO use (odds ratio [OR], 2.17 [1.3-3.4]), ventilator need (OR, 2.2 [1.3-3.9]), and cardiogenic shock (OR, 1.8 [1.2-2.8]) were all independent preoperative predictors of VAD mortality while dialysis need (OR, 25.5 [8.6-75.3]), stroke (OR, 6.2 [3.1-12.6]), and bleeding (OR, 1.9 [1.1-3.4]) were independent postoperative predictors of VAD mortality within 30 days (all p < 0.05). The study demonstrated significant baseline differences between the two cohorts, warranting avoidance of comparison. Early elective VAD placement in this cohort of patients should be sought to avoid interim ECMO and high post-VAD mortality.

Perioperative Morbidity and Outcomes of Transitioning from ECMO to VAD Support in Pediatric Patients: A STS Study

<h3>Purpose</h3> As a bridge to transplant strategy, children transitioned from ECMO to VAD (ventricular assist device) have higher waitlist mortality compared to those who receive de novo VAD. However, the reasons and timing for such additive morbidity and mortality are unclear. We therefore studied the acute perioperative morbidity and mortality in de novo VAD (group 1) to those transitioned from ECMO to VAD (group 2) using the comprehensive data from The Society of Thoracic Surgeons (STS) database. <h3>Methods</h3> Pediatric patients receiving VAD between 2014-19 reported to STS database were identified and selected based on surgical codes and device specifications. Patients were then divided into group 1 and 2 and perioperative data analyzed using appropriate statistical tests. <h3>Results</h3> A total of 735 children underwent VAD placement with 498 in group 1 and 237 in group 2. Patients in group 2 were significantly younger, smaller, were in cardiogenic shock or have CPR. Patients in group 2 also were significantly likely to have hepatic, renal and neurologic dysfunction at baseline and be three times as likely to be on ventilator (all p <0.001, Table 1). Group 2 patients were twice as likely to transition to biVAD compared to group 1. Post-operative course was significant for unplanned reoperations in 8% group 1 versus 34% in group 2 (p<0.001). VAD related complications were similar after VAD implantation in both groups except intracranial bleeding in 4% for group 1 while 13% for group 2 (p<0.01). Overall mortality was 16% for group 1 and 34% for group 2 (p<0.01). Regression analysis showed that ECMO use (OR 2.17), ventilator (OR 2.2), cardiogenic shock (OR1.8) were all independent preoperative predictors of VAD mortality while renal failure, stroke and bleeding were independent post-operative predictors of VAD mortality within 30 days. <h3>Conclusion</h3> There are significant baseline differences in the cohorts undergoing de novo VAD compared to those transitioned from ECMO, however the need for such ECMO is an important predictor of early post VAD mortality. Therefore, early and elective VAD placement in this cohort of patients should be sought to avoid high post-VAD mortality. Comparison of these two strategies should be avoided without accounting for baseline differences while optimal type and timing of support is researched.

Safety and Feasibility of Exercise Rehabilitation in Children with Ventricular Assist Devices.

Children with advanced heart failure may require ventricular assist devices (VAD) while awaiting heart transplantation. Currently, no data exist regarding the safety of exercise rehabilitation (ER) in children on VAD support. The purpose of this study was to determine the safety and feasibility of ER in children on VAD support awaiting heart transplantation. Eligible patients underwent VAD placement between 1998 and 2019; both inpatient and outpatient participants were included. After VAD implantation and when ambulatory, patients were enrolled in ER. Exercise sessions were scheduled three times a week and consisted of aerobic and musculoskeletal conditioning. A total of 29 patients (59% male, mean age 14 ± 3.2years) were included with a median VAD duration of 120 ± 109days. Cardiac diagnoses included cardiomyopathy (81%) and congenital heart disease (19%). VAD type included pulsatile (59%) and continuous-flow devices (41%). Eight hundred and sixty-four (85%) ER sessions were successfully completed and began at a mean of 49days (range 19-108) after VAD implant. No adverse events, including episodes of hypotension, significant complex arrhythmia, or VAD malfunction occurred during exercise testing or ER, and no sessions were discontinued prematurely. Pediatric patients on VAD support can safely participate in ER with relatively high compliance, and sessions can be implemented early after VAD implantation. Given the safety profile, ER in pediatric VAD recipients, which is a modifiable pre-transplant risk factor that may improve functional capacity, warrants further study as a potential modality to improve post-transplant outcomes.

Outcomes of Ventricular Assist Device Use in Children for Bridge to Heart Retransplantation

<h3>Purpose</h3> As the use of pediatric ventricular assist devices (VAD) has increased, more children are being supported with VADs for transplant graft failure as a bridge to heart re-transplant (HT). Little is known about VAD outcomes for graft failure where left ventricular (LV) function is preserved, and LV chamber dilation is uncommon. We sought to examine VAD outcomes as a bridge to HT for this important subset of HF patients. <h3>Methods</h3> Organ Procurement and Transplant Network (OPTN) data were used to identify all children ≤21 years who underwent VAD placement between 2004 and 2020 as a bridge to heart re-transplant. Cox proportional hazard modeling was used to identify risk factors for mortality. <h3>Results</h3> Of 723 children listed for heart re-transplant, 144 were supported with MCS (87 with a VAD and 57 with ECMO alone). Of 87 VAD recipients, 41 (68%) received an LVAD alone, 29 (33%) received BIVADs, 9 (10%) received an TAH, and 7 (8%) an isolated RVAD. The most common isolated LVAD used was the Berlin Heart (N=16, 39%), a percutaneous LVAD (Impella or Tandem, N=11, 26%), and Heartware HVAD (N=6, 15%). The most common BIVAD configuration was bilateral Berlin Hearts (N=15, 52%) and bilateral CentriMag (10%). Since 2011 (when complete VAD survival data become available), overall survival to HT was 72%, with 61% reaching transplant while 11% remained on the waitlist. Survival was significantly worse compared to pediatric VAD patients supported for DCM and comparable to children with CHD (P=0.31) (Figure). For children supported with the Berlin Heart, outcomes for LVAD and BIVAD patients were similar (P=0.69) in contrast to other diagnoses where BIVAD outcomes are typically inferior to LVAD outcomes. <h3>Conclusion</h3> VAD outcomes for bridge to re-transplant are significantly worse than DCM patients and comparable to outcomes for CHD. While BIVAD outcomes are typically worse than LVAD outcomes for most cardiac diagnoses, outcomes appear similar for children supported for graft failure.

Outcomes of Ventricular Assist Device Use for Bridge to Heart Transplant in Children with Single-Ventricle Heart Disease

<h3>Purpose</h3> As the use of pediatric ventricular assist devices (VAD) has increased, more children are being supported with VADs for single-ventricle heart disease (SVD). Little is known about outcomes for this rapidly growing population of advanced HF patients. We sought to examine trends in VAD use for SVD and to assess outcomes. <h3>Methods</h3> Organ Procurement and Transplant Network (OPTN) data were used to identify all children ≤21 years who underwent VAD placement between 2004 and 2020 for SVD. Cox proportional hazard modeling was used to identify risk factors for mortality defined as death or clinical deterioration. <h3>Results</h3> Of 1955 children with SVD, 315 were supported with an MCS device (145 SVADs and 170 ECMO only). Of the SVADs, 142 (97%) received an SVAD alone as the primary device, 2 (1%) received BIVADs and 1 (1%) a TAH. The most common VAD brands were the Berlin Heart EXCOR (N=44, 30%), the CentriMag/PediMag (N=40, 28%), Heartware HVAD (N=35, 24%), and the CentriMag/PediMag (ZZ%) and the Heartmate III (N=8, 6%). Since 2011 (when complete VAD survival data become available), overall survival to HT was 62% of whom 58% reached transplant; 38% died or deteriorated, and 2% recovered. Survival was significantly worse compared to pediatric VAD patients supported for DCM and comparable to patients supported for 2-ventricle CHD (P=0.79) (Find). Survival to transplant was highest for adult continuous flow devices (77%) and lower for the CentriMag/PediMag system (63%) and the Berlin Heart EXCOR (63%). <h3>Conclusion</h3> VAD outcomes for bridge to transplant for single-ventricle heart disease patients are similar to other forms of 2-ventricle CHD but inferior to DCM. The highest survival appears to be in patients receiving adult CF devices with room for improvement in smaller patients receiving non-dischargeable devices.

US Trends in Pediatric VAD Utilization - Where are We Now?

Pediatric ventricular assist device (VAD) therapy is a rapidly changing field where devices and applications are rapidly evolving. We sought to describe some of the most recent trends in pediatric VAD use and contemporary outcomes since UNOS began collecting VAD data on all listed patients regardless of whether they survived. All children ≤21 years of age listed for isolated HT between Jan 2004 and 2019 and underwent VAD placement were identified using OPTN data. Descriptive statistics were used to characterize recent trends in VAD utilization. Waitlist survival in children with cardiomyopathy, CHD and single-ventricle heart disease were estimated using the Kaplan-Meier method. Overall, 2059 children met the study inclusion criteria of whom the median age was 11 (IQR 1, 17), median weight 38 (11,66) kg, 26% were black; 18.3 had congenital heart disease (CHD) including 5.1% with single-ventricle (SV) HD. Forty-nine percent were supported with a VAD at listing, 72% at transplant and 13% received a VAD but was not supported at listing or transplant. Overall, 64% received LVADs, 31% BIVADs, 2.5% RVADs 1.7% total artificial hearts (TAH). Implants of the Berlin Heart fell dipped sharply to 34 in 2015 after a peak of 63 but have rebounded since in the era of bivalirudin. As of 2018, the Heartware HVAD was the most commonly implanted VAD in children (N=61) followed by the Berlin Heart (N=48), CentriMag/PediMag (N=18) and Heartmate III (N=11). The fastest growing segment of VAD patients are single-ventricle patients (Figure). The total number of pediatric VADs continues to grow at a brisk pace. The most recent era has seen growth of the Heartmate III and resurgence of the Berlin Heart EXCOR, after a brief decline in 2015. Single-ventricle and Heartmate III patients represent the fastest growing segment of the VAD population.

Fever and inflammatory markers do not predict infection in pediatric ventricular assist device recipient

ObjectiveWe sought to assess the relationship between serious infections and fever, white blood cell count (WBC), and C-reactive protein (CRP) levels in children on ventricular assist device (VAD). MethodsWe retrospectively reviewed all children who underwent VAD placement from 2006 to 2014 at Children's Hospital of Pittsburgh. Daily maximum temperature, maximum WBC, CRP levels, microbiologic data and antibiotic use were abstracted from the electronic health record. Serious infection was defined as bacteremia, mediastinitis and/or driveline infection. ResultsThirty-six consecutive patients underwent VAD placement with mean age of 7.1 years ±6.3 years (range 9 days −18.1 years). The median duration of VAD support was 24 days (1–102 days). Patients were on antibiotics for 58% of total VAD days. We found no drive line infections or mediastinitis and only 5 episodes of blood stream infections in 4 patients (11%) during 1167 total days. Fever was present on 23% of total VAD days and nearly all (35/36) patients had at least one day of fever. CRP was elevated in 298 of 318 (94%) of all samples tested. 53% (448/851) of the total WBC assessments were elevated. On detailed analysis of confirmed bloodstream infection, only 2 of the 5 episodes were associated with fever within 24 h of the positive culture. WBC and CRP levels (drawn within 24 h of positive culture) were normal in 2/5 (40%). ConclusionsDespite a low prevalence of serious infection in our pediatric VAD cohort, we found that fever, elevated WBC and CRP were common. This suggests that traditional markers of infection are unreliable. Fever, elevated WBC count and elevated CRP were poorly predictive of serious bacterial infection in our pediatric VAD cohort. Their presence alone should not be an indication for long-term antibiotics.

Epidemiology of Left Ventricular Assist Device Infections: Findings From a Large Nonregistry Cohort.

Infection is a major complication during circulatory support with a left ventricular assist device (VAD). Changes in device characteristics and treatment practices in the last decade can affect the epidemiology of infection. The International Society for Heart and Lung Transplantation (ISHLT) has published recommendations on the prevention and management of VAD infections, but data to support these recommendations remain sparse. We performed a retrospective review of 455 patients who underwent VAD placement from 2009 to 2015. Infection episodes were defined using ISHLT criteria and were also grouped as endovascular or local. Analysis included descriptive statistics. There were 174 patients (38.6%) with a VAD infection. Infection incidence was 36.9 cases per 100 person-years of VAD support. The driveline was the most common infection site (67.2%). Systemic inflammatory response syndrome (SIRS) criteria were not satisfied in 29.2% of patients with endovascular infections, and computed tomography (CT) examinations were normal in 37.7% of cases. Gram-positive bacteria caused 65.6% of infections in patients with an available culture. Antimicrobial suppression was used in 72.3% of patients who survived treatment. Median survival after infection was 35 months for patients with VAD-related infections versus 14 months for patients with VAD-specific infections. VAD infections continue to be a major complication after implantation. Clinical criteria alone were not predictive of serious infections, and many patients with confirmed infection had normal CTs. Patients with VAD-specific infections had lower median survival than patients with VAD-related infections.

Stroke Risk and Mortality in Patients With Ventricular Assist Devices.

Ventricular assist devices (VADs) have advanced the management of end-stage heart failure. However, these devices are associated with hemorrhagic and thrombotic complications, including stroke. We assessed the incidence, risk factors, and outcomes of ischemic and hemorrhagic stroke after VAD placement. Using administrative claims data from acute care hospitals in California, Florida, and New York from 2005 to 2013, we identified patients who underwent VAD placement, defined by the International Classification of Diseases, Ninth Revision, Clinical Modification code 37.66. Ischemic and hemorrhagic strokes were identified by previously validated coding algorithms. We used survival statistics to determine the incidence rates and Cox proportional hazard analyses to examine the associations. Among 1813 patients, we identified 201 ischemic strokes and 116 hemorrhagic strokes during 3.4 (±2.0) years of follow-up after implantation of a VAD. The incidence of stroke was 8.7% per year (95% confidence interval [CI], 7.7-9.7). The annual incidence of ischemic stroke (5.5%; 95% CI, 4.8-6.4) was nearly double that of hemorrhagic stroke (3.1%; 95% CI, 2.6-3.8). Women faced a higher hazard of stroke than men (hazard ratio, 1.6; 95% CI, 1.2-2.1), particularly hemorrhagic stroke (hazard ratio, 2.2; 95% CI, 1.4-3.4). Stroke was strongly associated with subsequent in-hospital mortality (hazard ratio, 6.1; 95% CI, 4.6-7.9). The incidence of stroke after VAD implantation was 8.7% per year, and incident stroke was strongly associated with subsequent in-hospital mortality. Notably, ischemic stroke occurred at nearly twice the rate of hemorrhagic stroke. Women seemed to face a higher risk for hemorrhagic stroke than men.

Ventricular Assist Device in Acute Myocardial Infarction

BackgroundPatients with acute myocardial infarction (AMI) complicated by acute heart failure or cardiogenic shock have high mortality with conventional management. ObjectivesThis study evaluated outcomes of patients with AMI who received durable ventricular assist devices (VAD). MethodsPatients in the INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) registry who underwent VAD placement in the setting of AMI were included and compared with patients who received VAD for non-AMI indications. ResultsVAD were implanted in 502 patients with AMI: 443 left ventricular assist devices; 33 biventricular assist devices; and 26 total artificial hearts. Median age was 58.3 years, and 77.1% were male. At implantation, 66% were INTERMACS profile 1. A higher proportion of AMI than non-AMI patients had pre-operative intra-aortic balloon pumps (57.6% vs. 25.3%; p < 0.01), intubation (58% vs. 8.3%; p < 0.01), extracorporeal membrane oxygenation (17.9% vs. 1.7%, p < 0.01), cardiac arrest (33.5% vs. 3.3%, p < 0.01), and higher-acuity INTERMACS profiles. At 1 month post-VAD, 91.8% of AMI patients were alive with ongoing device support, 7.2% had died on device, and 1% had been transplanted. At 1-year post-VAD, 52% of AMI patients were alive with ongoing device support, 25.7% had been transplanted, 1.6% had left VAD explanted for recovery, and 20.7% had died on device. The AMI group had higher unadjusted early phase hazard (hazard ratio [HR]: 1.24; p = 0.04) and reduced late-phase hazard of death (HR: 0.57; p = 0.04) than the non-AMI group did. After accounting for established risk factors, the AMI group no longer had higher early mortality hazard (HR: 0.89; p = 0.30), but it had lower late mortality hazard (HR: 0.55; p = 0.02). ConclusionsPatients with AMI who receive VAD have outcomes similar to other VAD populations, despite being more critically ill pre-implantation. VAD therapy is an effective strategy for patients with AMI and acute heart failure or shock in whom medical therapy is failing.

Abstract WP194: Stroke Risk and Mortality in Patients with Ventricular Assist Devices

Background: Ventricular assist devices (VADs) have revolutionized the management of end-stage heart failure. However, these devices are associated with many complications, including stroke. Hypothesis: We sought to determine the risk and risk factors for stroke after VAD placement and to assess the hypothesis that stroke is associated with increased mortality after VAD placement. Methods: From administrative claims data on all discharges from nonfederal acute care hospitals in California, Florida, and New York from 2005-2012, we used International Classification of Diseases, 9 th Revision, Clinical Modification ( ICD-9-CM ) code 37.66 to identify patients who underwent VAD placement. Patients were included regardless of whether they underwent VAD placement as destination therapy or as bridge to transplant. Ischemic and hemorrhagic strokes were identified by validated coding algorithms. Kaplan-Meier statistics were used to calculate cumulative rates. Cox proportional hazard analyses were used to identify risk factors for stroke in patients with VADs and to evaluate the association between stroke (modeled as a time-varying covariate) and mortality. Results: We had 3.0 (±1.7) years of follow-up data on 1,398 patients after implantation of a VAD. The mean age of the patients was 55.4 years (±13.2), and patients were predominantly male. A total of 227 strokes were identified: 147 ischemic and 79 hemorrhagic. The cumulative stroke rate was 24.3% (95% confidence interval [CI], 21.3-27.7%). After adjustment for age, race, insurance status, and comorbidities, women had a higher hazard of stroke than men (hazard ratio [HR], 1.7; 95% CI, 1.2-2.3), particularly hemorrhagic stroke (HR, 2.6; 95% CI, 1.5-4.3). Stroke was strongly associated with subsequent mortality (HR, 4.1; 95% CI, 3.3-5.1). Conclusion: Stroke is common in patients after VAD placement and is strongly associated with mortality in this vulnerable population. Women appear to be at higher stroke risk than men, particularly for hemorrhagic stroke.

Abstract 16939: Pediatric Quality of Life While Supported With a Ventricular Assist Device

Introduction: The Ventricular Assist Device (VAD) has emerged as an important treatment option for bridging pediatric patients with heart failure to transplant. VADs have been shown to improve survival; however, quality of life (QoL) while supported with a pediatric VAD is unknown. Methods: In this prospective study, pediatric patients, and their parents, who underwent VAD placement completed a generic PedsQL 4.0 biweekly until heart transplant or death. Data are reported at last follow-up with a VAD and compared to three previously reported groups: age-matched healthy controls, outpatients with severe heart disease and children after heart transplant. Results: From December 2007 to August 2013, 13 patients received VAD support for at least two weeks and completed a PedsQL. The mean age at implant was 10.0 ± 4.2 years with a median duration of support of 1.6 months (Table 1). Pre-implant INTERMACS profile was 1 for 3/13 (23%) and 2 for 10/13 (77%). Patients self-reported significantly (p&lt;0.05) reduced total and physical QoL scores when compared to each of the three comparison groups. Self-reported psychosocial QoL scores were significantly lower than healthy controls only. Parent proxy-reported scores were significantly lower than all three comparison groups for all three categories (Figure 1). Conclusion: A large deficit exists in the QoL of pediatric patients supported by a VAD compared to outpatient management of severe heart disease or post-heart transplant patients; however, VAD patients do represent a sicker group. Improvements in QoL must be made, as time spent with a VAD is expected to increase. Though a small sample, these data can serve as a baseline for future comparison.

An Old Problem with a New Therapy

Conventional algorithms for diagnosis and treatment of gastrointestinal bleeding (GIB) in patients with nonpulsatile ventricular assist devices (VADs) may take days to perform while patients require transfusions. We developed a new algorithm based on deep overtube-assisted enteroscopy (DOAE) to facilitate a rapid diagnosis and treatment. From 2004 to 2012, 84 patients who underwent VAD placement in our institution, were evaluated for episodes of GIB. Our new algorithm for the management of GIB using DOAE was evaluated by dividing the episodes into three groups: group A (traditional management without enteroscopy), group B (traditional management with enteroscopy performed >24 hours after presentation), and group C (new management algorithm with enteroscopy performed <24 hours after presentation). Gastrointestinal bleeding was observed in 14 (17%) of our study patients for a total of 45 individual episodes of which 28 met our criteria for subanalysis. Forty-one (84%) lesions were confined to the upper gastrointestinal tract with more than 91% of these lesions being arteriovenous malformations. Average number of transfusions in groups A, B, and C were 4.1, 6.3, and 1.3, respectively (p = 0.001). The number of days to treatment was significantly shorter in group C than group B (0.4 vs. 5.3 days, p = 0.0002). Our new algorithm for the management of GIB using DOAE targets the most common locations of bleeding found in this patient population. When performed early, DOAE has the potential to decrease the need for transfusions and allow for an early diagnosis of GIB in VAD recipients.

Echocardiographic Evaluation of Ventricular Assist Devices in Pediatric Patients

The use of ventricular assist devices (VADs) in children is challenging because of small patient size, frequent structural heart disease, and the need for biventricular assist devices. This report describes the role of echocardiography in the management of children supported by VADs. A retrospective review of the records of all pediatric patients who underwent VAD placement between May 2005 and May 2011 was performed to collect demographics, cardiac diagnoses, details of VADs, and transthoracic and transesophageal echocardiographic findings from the time of initial diagnosis until VAD explantation. The study included 32 patients (median age, 3 years; age range, 20 days to 16 years; median weight, 12.3 kg; weight range, 3.5-60 kg), 20 with left ventricular assist devices and 12 with biventricular assist devices. Diagnoses included dilated cardiomyopathy or myocarditis (n = 27) and congenital heart disease (n = 5). The median duration of support was 12 days (range, 1-141 days). Patients with decreased right ventricular function were 8 times more likely to undergo biventricular assist device placement compared with those with normal right ventricular function (P = .026). Pre-VAD intracardiac shunts were identified in 11 patients and intracardiac thrombus in one patient. Cardiac chamber dimensions and mitral insufficiency were significantly reduced after VAD implantation. Postimplantation pericardial effusions were recognized in 16 patients and pericardial hematomas in 12 patients. Echocardiography is invaluable in the management of pediatric patients receiving VADs. It is helpful in pre-VAD assessment, guiding intraoperative device placement, recognizing VAD dysfunction, and identifying postimplantation complications.

Minimally invasive approach to thoracic effusions in patients with ventricular assist devices

The aim of this study was to compare our experience between open and video-assisted thoracic surgery (VATS) approaches to the management of thoracic effusions in ventricular assist device (VAD) patients. This was a retrospective review of a prospectively collected database of VAD patients at a single institution. Patients who were operated on for pericardial and/or pleural effusions were included. Primary outcomes included operative mortality and morbidity as well as effusion recurrence. From 1993 to 2009, 360 adult patients underwent VAD placement. Twenty-three patients (11.9%) required operative management of pleural (n = 24), pericardial (n = 13) or both pleural and pericardial (n = 6) effusions [open = 20 (47%); VATS = 23 (53%)]. Drainage with decortication was performed in five patients, with the remaining undergoing drainage alone. Open and VATS patients were similar in age, gender and indication for VAD support. Conversion from VATS to open was necessary in four patients (17%). There was no operative mortality and no difference in perioperative complications between approaches. The open and VATS approaches had similar rates of pleural (open = 63%; VATS = 41%; P = 0.42) and pericardial (open = 31%; VATS = 17%; P = 1) effusion recurrences. In spite of apparent challenges, the VATS approach may be as safe and effective as open surgery for the management of pleural and pericardial effusions in VAD patients in centres with significant minimally invasive thoracic experience.

Improved survival among ventricular assist device recipients with a concomitant implantable cardioverter-defibrillator

Ventricular tachyarrhythmia events (VTE) are common among refractory heart failure patients requiring ventricular assist device (VAD) support. It is unknown whether implantable cardioverter-defibrillator (ICD) detection and therapy can extend survival in the VAD population. The purpose of this study was to evaluate the survival experience of refractory heart failure patients requiring VAD support with and without a concomitant ICD. Multivariable analysis of the Cleveland Clinic registry of consecutive patients with and without an ICD who underwent VAD placement between 1991 and 2008 using traditional and propensity-matched methods. The primary endpoint was all-cause mortality. Among 478 VAD recipients (age 53.5 +/- 12.0 years, 80% male), 90 patients (18.8%) had an ICD at the time of VAD placement. VTE occurred in 26 patients (28.9%) at a mean of 32.4 +/- 47.1 days, with appropriate treatment in 24 patients (75% initial shock, 25% successful antitachycardia pacing). A concomitant ICD during VAD support was associated with a significant reduction in mortality (hazard ratio [HR] 0.55 [confidence interval 0.32-0.94]; P = .028) after adjustment for age, gender, left ventricular ejection fraction, VAD type, year placed, diagnosis and duration, complications, dialysis-dependent renal failure, and extended survival (median survival 295 vs. 226 days; P = .024). A propensity-matched analysis of 134 patients with and without ICD also demonstrated that a concomitant ICD was associated with lower all-cause mortality (odds ratio 0.42 [confidence interval 0.19-0.95]; P = .04). A concomitant ICD among VAD recipients is associated with extended survival.

Body Mass Index and Outcome After Ventricular Assist Device Placement

The implantation of ventricular assist devices (VAD) is an established treatment for end-stage congestive heart failure. Extremes of body mass index (BMI) are associated with decreased survival after cardiac surgery. Many patients with congestive heart failure develop cardiac cachexia. In this study the association between BMI and outcomes after VAD implantation was investigated. Consecutive patients (n = 590) who underwent VAD placement between 1996 and 2006 were divided into five groups based on BMI (kg/m2) quintiles (<20; 20-24; 25-29; 30-35; and >35). In a multivariate analysis adjusted for age, sex, diagnosis, emergency level, and type of device (left ventricular or biventricular assist device), procedural success (recovery, transplantation, or 30-day survival) and complications were analyzed. The best group was set as reference category for calculation of odds ratios. The groups with both extremes of BMI had the worst outcomes. The best procedural success was in the group with BMI 25 to 29 kg/m2. Underweight patients had similar survival rates to patients with normal weight. Overweight and obese patients did not have decreased survival. Extreme obesity at the time of VAD implantation showed elevated risk for postoperative death. There was no significant difference for BMI groups in the type of complications and cause of death. Cumulative survival curves for BMI category and overall VAD patient survival showed no significant differences. Cardiac cachexia need not be an exclusion criterion for VAD placement. Underweight patients appear to have benefit from mechanical support. Severely obese patients should be carefully selected before VAD placement.

Heparin-Induced Thrombocytopenia in Left Ventricular Assist Device Bridge-to-Transplant Patients

The presence of heparin-induced thrombocytopenia (HIT) increases the risk for thromboembolic events in ventricular assist device (VAD) patients undergoing transplantation. However, cardiopulmonary bypass with alternative anticoagulants is often complicated by bleeding. Owing to this concern, we compared outcomes of HIT-positive versus control bridge-to-transplantation VAD patients; both groups were reexposed to heparin for cardiopulmonary bypass during transplant. From February 2000 to January 2006, data were reviewed on 92 consecutive adult patients who underwent VAD placement as a bridge to transplantation. Patients in whom thrombocytopenia developed after heparin exposure were tested for HIT with an enzyme-linked immunosorbent assay for antiheparin/platelet factor-4 (HPF4) antibody (GTI Diagnostics, Waukesha, Wisconsin). During VAD support, heparin was avoided in HIT-positive patients, but all patients were reexposed to heparin during transplantation. Comparisons between HIT-positive and control patients for survival and freedom from thromboembolic events were determined using the Kaplan-Meier method and log-rank test. Continuous and categorical variables were compared using the Wilcoxon rank-sum and Student t test. Twenty-four of the 92 patients (26.1%) were determined to be HIT positive by enzyme-linked immunosorbent assay. Survival to transplant was not different between the two groups. When compared with control patients, HIT-positive patients who were reexposed to heparin had a greater decrease in platelet counts immediately after transplant (postoperative days 1 to 4, p < 0.05). Despite this transient thrombocytopenia, there was no difference in posttransplant mortality or thromboembolism. Heparin-induced thrombocytopenia-positive VAD patients did not experience increased thromboembolism or mortality after heparin reexposure. In light of the risks of using heparin alternatives, heparin reexposure is a safe management strategy for HIT-positive VAD patients.

High Incidence of Thromboembolic Complications and PF4 Positivity in Patients with Ventricular Assist Devices.

Patients with ventricular assist devices (VAD) are at high risk for thromboembolic complications (TEC) probably due to platelet activation and excessive thrombin generation once the device is implanted. This warrants prophylactic use of full dose anticoagulation, usually with unfractionated heparin (UFH), which increases the risk for development of heparin-induced thrombocytopenia (HIT). We retrospectively evaluated the incidence of TEC and PF4 positivity in 50 sequential patients who underwent VAD placement for severe ventricular dysfunction between November 2002 and April 2005. Median age at VAD placement was 52 years (range 18–72), 68% were men, and all patients were on full dose UFH post-VAD insertion. TEC were observed in 22/50 patients (44%), with 8 patients experiencing >1 event. CNS embolic phenomena occurred in 11/22 (50% of TEC), with watershed/non-embolic CNS infarcts being identified in 2 additional patients. Splenic infarcts were identified in 6/22 (27%). Two patients had lower extremity deep vein thromboses (DVT), and two patients had pulmonary emboli. One patient died from complications of multiple infarcts involving his spleen and gut that were attributed to HIT. All patients became thrombocytopenic (<150K) at some point during VAD/UFH use. 44 patients (88%) dropped the platelet count below 100K with an average nadir of 56K. Antibodies to the PF4/heparin complex were checked using a standard enzyme immunoassay (EIA) in 38 (76%) patients, and found to be positive in 17 (44.7%). PF4 antibodies were detected using the EIA in 50% of patients with TEC and in 25% of patients with no documented TEC. A functional antibody assay was checked in a total of 17 patients, the serotonin release assay (SRA) in 13 and heparin-induced agglutination (HIA) in 4 cases. The SRA was only positive in 2/13 cases, and concordant with the PF4 result both times. The HIA was positive once, and concordant with the PF4 result. These results highlight the high incidence of TEC in patients with a VAD, despite anticoagulation therapy. There is a particularly high rate of embolic stroke in this patient population, and better ways of preventing this complication need to be explored. Thrombocytopenia is also extremely common post-VAD placement, prompting evaluation of HIT in over ¾ of the patients, often necessitating use of direct thrombin inhibitors. The frequent detection of PF4 antibodies in this patient group and lack of correlation with functional assays illustrates the need for more specific laboratory means to quickly confirm those patients with HIT.