HeartWare Ventricular Assist Device Implantation Research Articles

Surgical Outcomes of Centrifugal Continuous-Flow Implantable Left Ventricular Assist Devices: Heartmate 3 versus Heartware Ventricular Assist Device.

Left ventricular assist devices (LVADs) are widely employed as a therapeutic option for end-stage heart failure. We evaluated the outcomes associated with centrifugal-flow LVAD implantation, comparing 2 device models: the Heartmate 3 (HM3) and the Heartware Ventricular Assist Device (HVAD). Data were collected from patients who underwent LVAD implantation between June 1, 2015 and December 31, 2022. We analyzed overall survival, first rehospitalization, and early, late, and LVAD-related complications. In total, 74 patients underwent LVAD implantation, with 42 receiving the HM3 and 32 the HVAD. A mild Interagency Registry for Mechanically Assisted Circulatory Support score was more common among HM3 than HVAD recipients (p=0.006), and patients receiving the HM3 exhibited lower rates of preoperative ventilator use (p=0.010) and extracorporeal membrane oxygenation (p=0.039). The overall early mortality rate was 5.4% (4 of 74 patients), with no significant difference between groups. Regarding early right ventricular (RV) failure, HM3 implantation was associated with a lower rate (13 of 42 [31.0%]) than HVAD implantation (18 of 32 [56.2%], p=0.051). The median rehospitalization-free period was longer for HM3 recipients (16.9 months) than HVAD recipients (5.3 months, p=0.013). Furthermore, HM3 recipients displayed a lower incidence of late hemorrhagic stroke (p=0.016). In the multivariable analysis, preoperative use of continuous renal replacement therapy (odds ratio, 22.31; p=0.002) was the only significant predictor of postoperative RV failure. The LVAD models (HM3 and HVAD) demonstrated comparable overall survival rates. However, the HM3 was associated with a lower risk of late hemorrhagic stroke.

The Impact of Adverse Events on Functional Capacity and Quality of Life After HeartWare Ventricular Assist Device Implantation.

Left ventricular assist devices (LVADs) improve quality of life (QoL) and functional capacity (FC) for patients with advanced heart failure. The association between adverse events (AEs) and changes in QoL and FC are unknown. Patients treated with the HeartWare ventricular assist device (HVAD) with paired 6-minute walk distance (6MWD, n = 263) and Kansas City Cardiomyopathy Questionnaires (KCCQ, n = 272) at baseline and 24 months in the ENDURANCE and ENDURANCE Supplemental Trial databases were included. Patients were stratified based upon occurrence of clinically significant AEs during the first 24 months of support and analyzed for the mean change in 6MWD and KCCQ. The impact of AE frequency on change in 6MWD and KCCQ from baseline to 24 months was evaluated. Of the AEs examined, only sepsis was associated with an improvement in 6MWD (109 m vs. 16 m, p = 0.002). Patients without improvement in 6MWD test from baseline to 24 months had significantly more AEs than those with FC improvement (p = 0.0002). Adverse events did not affect the KCCQ overall summary score. In this analysis, patients with fewer AEs had greater improvement in FC during the 24-month follow up. The frequency of AEs did not have a significant impact on QoL after LVAD implantation.

Comprehensive Analysis of Differential Expressed Genes Related with Myocardial Reverse Remodeling Following HeartWare Ventricular Assist Device Implantation

Purpose Clinical and experimental studies have suggested that the powerful mechanical unloading effects caused by left ventricular assist device (LVAD) may induce reverse remodeling of the failing heart. However, the detailed mechanism and process have not been fully elucidated. Recent advances in next generation sequencing has enhanced transcriptomic analysis to quantify gene expression extensively. We aimed to characterize gene expression profiling related with left ventricle (LV) reverse remodeling in failing human heart, before and after HeartWare LVAD (HVAD) implant. Methods Sequencing-based comprehensive analysis of gene expression profiling was performed through next generation sequencing in paired human failing LV samples (n=5; median age, 54 years; 4 men) collected pre- and post- HVAD, as well as non-failing human LV collected from donors (n=8, median age, 41 years; 3 men). Results Overall, mapping of sequencing reads corresponded to 48,162 genes in these human LV samples. Among them, 9,094 differentially expressed genes were found in pre- HVAD compared with non-failing LV, while 6,788 differentially expressed genes were detected in post- HVAD compared with non-failing LV (Figure). The discrepancy in the number of differentially expressed genes between pre- and post- HVAD is associated with the effect caused by HVAD. Furthermore, paired analysis performed between pre- and post- HVAD suggest serum amyloid A1 may contribute a major mechanism of LV reverse remodeling. Conclusion Our proposed analysis identified that the gene expression profiling was markedly influenced in response to HVAD. These results suggest that the altered genes expression during HVAD implantation may play important role in the pathogenesis of heart failure and reverse remodeling.

Quality Over Quantity: Standardization of Pediatric HeartWare Ventricular Assist Device Dressing Changes.

Pediatric patients are unique both in their diagnosis and clinical presentation before implantation of a ventricular assist device (VAD) and in their driveline site characteristics post-implant. There is limited evidence in scholarly literature that describes complications of pediatric VAD driveline sites or approaches by which to manage them. The Cardiac Center at The Children's Hospital of Philadelphia (CHOP) follows a standard of care for HeartWare VAD (HVAD) dressing changes in the inpatient setting with the goal of transitioning patients to weekly dressing changes by the time they are discharged to home. As a patient with an HVAD nears discharge, members of an interprofessional team collaborate with insurance providers and home care agencies to procure the appropriate supplies needed at home. Individualized plans of care are necessary for patients who are unable to transition to weekly dressings; however, customized products (such as silicone foam border dressings and antimicrobial agents) may be challenging to supply as single items from home care agencies. Between March 2014 and June 2017, 15 patients underwent HVAD implantation, and eight (53%) were discharged home. Ten patients (67%) were able to transition to weekly dressing changes. Individualized plans of care for driveline site management were required for six (40%) patients with persistent drainage. Three patients (20%) experienced a driveline site infection. This article describes how a quality improvement (QI) initiative using rapid-cycle improvement methodology was executed to standardize HVAD dressing changes in our pediatric population.

Mid-Term Outcomes after Limited Incision HeartWare Ventricular Assist Device Implantation

Objectives: Limited incision left ventricular assist device (LVAD) implantation has evolved as an alternative to standard median sternotomy. We present our mid-term outcomes with this innovative approach regarding survival and perioperative adverse events.

Can an Alternative Outflow Strategy be Utilized for High-Risk Bridged Patients with Previous Cardiac Surgery?

The HeartWare ventricular assist device (HVAD) is an implantable continuous-flow centrifugal pump that has allowed the development of sternal-sparing techniques, with the use of alternative outflow strategies. We compared early outcomes for patients bridged with the conventional versus alternative outflow graft strategy. From January 2013 to October 2014, 89 patients with HVAD implantation were identified. Survival was analyzed with Kaplan-Meier methods, and a log-rank test was used to compare outcomes between groups. Thirty patients (34%) had ≥1 previous sternotomy before HVAD implantation. Eight patients (27%) were approached using an alternative outflow graft technique with outflow graft connection to the descending aorta (n = 4, 50%) or left subclavian artery (n = 4, 50%), whereas 22 (73%) were implanted via a conventional sternotomy approach with the outflow graft to the ascending aorta. Preoperative characteristics (age, Interagency Registry for Mechanically Assisted Circulatory Support [INTERMACS], and Lietz-Miller score) were comparable between groups (all p > 0.05). Median follow-up was 4.7 (2.8-9.3) months of support. Outcomes were comparable between conventional and alternative outflow groups; survival at 6 months was 74% for the conventional group and 83% in the alternative outflow group. An alternative outflow graft strategy can be utilized to support bridged patients with a history of prior sternotomy.

In-hospital outcomes of a minimally invasive off-pump left thoracotomy approach using a centrifugal continuous-flow left ventricular assist device

Minimally invasive left thoracotomy (MILT) and off-pump implantation strategies have been anecdotally reported for implantation of the HeartWare ventricular assist device (HVAD). We analyzed our experience with off-pump MILT implantation techniques and compared early in-hospital outcomes with conventional on-pump sternotomy (CS) implantation strategy. Between January 2013 and February 2014, 51 patients underwent HVAD implantation and were included in this study. Thirty-three patients had CS, whereas 18 patients underwent off-pump MILT. To compare outcomes of these techniques, a multivariate analysis using propensity score modeling was performed after adjusting for age, INTERMACS, Kormos and Leitz-Miller (LM) scores. Mean age at implant was 57 (range 18 to 69) years, and overall in-hospital mortality was 8%. Univariate analysis revealed a statistically significant reduction in days on inotropes (p = 0.04), and a trend toward reduced intra-operative blood product administration (p = 0.08) in the MILT group. There was no difference in intensive-care-unit length of stay (p = 0.5), total length of stay (p = 0.76), post-operative blood product administration (p = 0.34) and total time on mechanical ventilation (p = 0.32). After adjusting for age, INTERMACS profile and Kormos and LM scores, no statistically significant differences were observed between the MILT and CS groups. An off-pump MILT implantation strategy can be utilized as a safe surgical approach for patients undergoing HVAD implantation. Further large collaborative studies are needed to identify advantages of the MILT approach.

Clinical outcomes after implantation of a centrifugal flow left ventricular assist device and concurrent cardiac valve procedures.

Cardiac valve procedures are commonly performed concurrently during implantation of left ventricular assist devices, but the added procedural risk has not been studied in detail. Data from patients receiving the HeartWare Ventricular Assist Device in the ADVANCE bridge to transplant (BTT) trial and continued access protocol were reviewed. Of 382 consecutive patients who completed follow-up between August 2008 and June 2013 (mean time on support 389 days, median 271 days), 262 (68.6%) underwent isolated HeartWare Ventricular Assist Device implantation, 75 (19.6%) a concurrent valve procedure, and 45 (11.8%) concurrent nonvalvular procedures. Of the concurrent valve procedures, 56 were tricuspid, 13 aortic, and 6 mitral. Survival was similar between groups (79% for concurrent valve procedures and 85% for HeartWare Ventricular Assist Device only at 1 year; P=0.33). Concurrent valve procedures were also associated with increased unadjusted early right heart failure (RHF). A multivariable analysis for death and RHF (121 total events) identified female sex (odds ratio=2.0 [95% confidence interval, 1.2-3.3; P=0.0053]) and preimplant tricuspid regurgitation severity (odds ratio=2.9 [95% confidence interval, 1.8-4.8, P<0.0001]) as independent predictors while concurrent tricuspid valve procedures (TVP) were not predictors. Furthermore, patients with significant preimplant tricuspid regurgitation who did not receive a TVP experienced an increased rate of late RHF compared with those who received TVP (0.19 versus 0.05 events per patient-year, respectively; P=0.024). Compared with HeartWare Ventricular Assist Device alone, survival was equivalent for the concurrent valve procedure group. Tricuspid regurgitation severity was the most important predictor of increased postoperative RHF, and concurrent TVP was not an independent predictor of RHF overall. Concurrent TVP may reduce the rate of late RHF for patients with significant preimplant tricuspid insufficiency. http://www.clinicaltrials.gov. Unique identifier: NCT00751972.

Off-Pump HeartWare Ventricular Assist Device Implantation With Outflow Graft Anastomosis to the Left Subclavian Artery

A novel, off-pump implantation technique for the HeartWare ventricular assist device with outflow graft anastomosis to the left subclavican artery is described. Cannulation of the left ventricular apex is performed through an incision in the left fourth or fifth intercostal space. The outflow graft is anastomosed to the left subclavian artery after tunneling through the left thoracic cavity and the first intercostal space. This technique is especially appealing in redo cases as well as in patients with significant calcifications of the ascending aorta or in destination-therapy patients.

(83) - HeartWare Ventricular Assist Device Implantation: Are In-Hospital Outcomes Using a Minimally Invasive Thoracotomy Approach Comparable to Conventional Sternotomy?

(83) - HeartWare Ventricular Assist Device Implantation: Are In-Hospital Outcomes Using a Minimally Invasive Thoracotomy Approach Comparable to Conventional Sternotomy?

(142) - Can a Minimally Invasive OFF-pump Implantation Strategy be Considered Safe for Selected Patients Undergoing HeartWare Ventricular Assist Device Implantation?

(142) - Can a Minimally Invasive OFF-pump Implantation Strategy be Considered Safe for Selected Patients Undergoing HeartWare Ventricular Assist Device Implantation?

Do Not Touch the Sternum—Thoracotomy Incisions for HVAD Implantation

Median sternotomy is associated with specific complications, and sternal wound infections carry a high risk for left ventricular assist device patients. Techniques using thoracotomy incisions and sparing the sternum are therefore being developed to reduce complications and increase patient safety. The HeartWare ventricular assist device (HVAD) continuous flow pump is a miniaturized full support device that lends itself especially well for lateral implantation. We here present our techniques for HVAD implantation with outflow to either the ascending or the descending aorta.

Initial Clinical Experience With the HeartWare Left Ventricular Assist System: A Single-Center Report

The HeartWare ventricular assist device (HVAD) system (HeartWare International Inc, Framingham, MA) is a new centrifugal continuous-flow ventricular assist device. The aim of the present study is to review our institutional experience with this novel device. We reviewed the files of 50 patients (39 men, 11 women) with a mean age of 50.6 ± 11.8 years (range, 19 to 70 years) who underwent HVAD implantation between July 2009 and November 2011. Two patients underwent HeartWare BIVAD implantation. The underlying heart diseases were end-stage ischemic heart disease (n = 12), acute myocardial infarction (n = 9), dilated cardiomyopathy (n = 27) and acute myocarditis (n = 2). Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) profiles were level 1 (n = 11), 2 (n = 5), 3 (n = 10), and 4 (n = 24). After a cumulative support duration of 11,086 days, Kaplan-Meier analysis revealed a survival of 82.0%, 77.9%, 75.5%, at 1, 12, and 24 months, respectively. Causes of early death were right heart failure (n = 4), multiorgan failure (n = 2), septic shock (n = 2), and major neurologic complications (n = 4). One late death occurred due to a right heart failure. Comparison between patients operated on in cardiogenic shock (INTERMACS 1 and 2) and patients who underwent elective HVAD implantation (INTERMACS 3 and 4) revealed a survival of 61.5% and 44.1% for the INTERMACS 1 and 2 group and 90.3% and 87.1% for the INTERMACS 3 and 4 group at 1 and 12 months, respectively (odds ratio, 4.67; p = 0.003). One patient was weaned from the system after 2 years. Eleven patients (22%) were successfully bridged to transplantation. Mean time to transplantation was 209 days (range, 72 to 427 days). Posttransplant survival at the 1-year follow-up was 90.9% (11 patients). Our experience with HVAD shows satisfying results with an excellent posttransplantation survival. Moreover, the stratified survival based on the level of preoperative stability shows better outcomes in patients undergoing elective HVAD implantation.