HeartWare HVAD Research Articles

TriVAD: Successful use of Impella 5.5 and Protek Duo CentriMag RVAD following Heartware HVAD thrombosis as a bridge to heart transplant.

Pump thrombosis remains a feared complication following placement of durable left ventricular assist devices (LVAD) and can be particularly detrimental to individuals being bridged to heart transplantation. Complications associated with this malfunction not only increase morbidity related to right heart failure, hemolysis, and other organ failure, but may ultimately jeopardize a patient's heart transplant candidacy. Additionally, reoperation for durable ventricular device replacement not only poses additional surgical risks to patients but can potentially complicate or even prohibit transplantation in the future. This case report describes a novel configuration of temporary, groin-free, percutaneously-deployed biventricular mechanical circulatory devices to support a patient with biventricular failure due to partial LVAD thrombosis. The use of less invasive mechanical support measures, such as the approach described here, may help patients achieve adequate hemodynamic support while allowing them to remain ambulatory and facilitate successful bridging to heart transplantation.

Feasibility Testing of the Bionet Sonar Ultrasound Transcutaneous Energy Transmission (UTET) System for Wireless Power and Communication of a LVAD.

To address the clinical need for totally implantable mechanical circulatory support devices, Bionet Sonar is developing a novel Ultrasonic Transcutaneous Energy Transmission (UTET) system that is designed to eliminate external power and/or data communication drivelines. UTET systems were designed, fabricated, and pre-clinically tested using a non-clinical HeartWare HVAD in static and dynamic mock flow loop and acute animal models over a range of pump speeds (1800, 2400, 3000 RPM) and tissue analogue thicknesses (5, 10, 15mm). The prototypes demonstrated feasibility as evidenced by meeting/exceeding function, operation, and performance metrics with no system failures, including achieving receiver (harvested) power exceeding HVAD power requirements and data communication rates of 10kB/s and pump speed control (> 95% sensitivity and specificity) for all experimental test conditions, and within healthy tissue temperature range with no acute tissue damage. During early-stage development and testing, engineering challenges for UTET size reduction and stable and safe operation were identified, with solutions and plans to address the limitations in future design iterations also presented.

Durable left ventricular assist devices following temporary circulatory support on a microaxial flow pump with and without extracorporeal life support

BackgroundCirculatory support with a catheter-based microaxial flow pump (mAFP) plays a major role in the treatment of severe cardiogenic shock. In most patients who fail to recover while on temporary mechanical circulatory support (tMCS) and who are not eligible for heart transplantation, durable left ventricular assist device (dLVAD) implantation is usually considered a reliable option. This study aimed to describe the outcome of dLVAD therapy following mAFP support and to identify predictors of mortality. MethodsThis was a retrospective analysis of data from a multicenter registry on patients who underwent dLVAD implantation following tMCS with a mAFP between January 2017 and October 2022 (n = 332) from 19 European centers. ResultsPatients were supported with an Impella 5.5 (n = 92), 5.0 (n = 153) or CP (n = 87) and were transitioned to a HeartWare HVAD (n = 128) or Heartmate 3 (n = 204) during the same period. One hundred and twenty-five patients (39.2%) also required extracorporeal life support before and/or during mAFP therapy. The 30-day and 1-year survival were 87.8% and 71.1%, respectively. The following risk factors for 1-year mortality were identified: age (odds ratio [OR], 1.02), specifically age over 55 years (OR, 1.09), body mass index >30 kg/m2 (OR, 2.2), female sex (OR for male sex, 0.43), elevated total bilirubin (OR, 1.12), and low platelet count (OR, 0.996). ConclusionsBased on the identified risk factors, a risk score for estimating 1-year mortality was calculated to optimize patient selection for dLVAD implantation.

Backwash Maneuver for HeartMate3 Inflow Thrombosis: Experience From Two Cases.

The ingested pump inflow thrombus, although rare, is a potentially life-threatening complication of left ventricular assist devices. During the last years, the backwash maneuver is considered an alternative method to pump replacement for the treatment of inflow thrombosis, showing high success rate in selected patients with HeartWare HVAD devices. However, that was not the case in our present report, in which we detail the application of this method in two HeartMate3 patients with ingested pump inflow thrombus. Washing out the thrombus was not feasible in either case, possibly due to mechanical aspects of the inflow part of the HeartMate3 pump. As a result, we remain skeptical regarding the use of the method in HeartMate3 patients with inflow thrombosis.

Driveline Infection in Patients With Left Ventricular Assist Devices Implanted as Destination Therapy

Donor organ shortages cause increasing demand for mechanical circulatory support in patients with end-stage heart failure not only as a bridge to heart transplantation but mainly as a destination therapy. Improved results and increased applicability and durability of left ventricular assist devices (LVADs) have established this treatment option as an alternative to heart transplantation in selected patients. One of the most common complications after LVAD implantation is driveline infections (DLIs). This study aimed to expand the understanding of DLI epidemiology and potential changes in implantation techniques regarding optimizing DLI prevention and treatment among all patients undergoing LVAD (Medtronic's Heartware HVAD and HeartMate 3 Abbott LVAD system) implantation with at least 12 months of follow-up time between 2015 and 2022. There were 120 individuals with LVAD implantation, of whom 90 had 12 months of follow-up (85 men [94%], 5 women [6%]) with a median age of 58 years (50.25-63.75). The median body mass index was 27.12 kg/m2 (25.27-29.68). Of the 90 patients, 43 had ischemic heart failure (48%), 43 had dilated cardiomyopathy (48%), and the remaining 3 had other etiologies (3%), such as postinflammatory, and the remaining 1 had congenital heart defect (1%). Preoperative echocardiography revealed a mean left ventricle ejection fraction of 13.8% and a median left ventricle dimension of 7.55 cm (6.92-8.2). Imaging confirmed pulmonary hypertension in 61 patients (68%). Thirty-four of the 90 patients had diabetes (38%), and 16 were active smokers (18%). Median follow-up was 30 months (17.25-42), with the longest period being 82 months. More than half of the patients (n = 52; 57%) experienced a DLI. The median time to the first episode of DLI was 13 months (6-25). The most common pathogen revealed in wound swab culture was methicillin-sensitive Staphylococcus aureus (n = 23; 44%), Pseudomonas aeruginosa (n = 9; 17%), Proteus mirabilis (n = 4; 7%), and others. We observed that deeper driveline implantation below the left rectus muscle and just above the posterior rectus sheath resulted in fewer DLIs and longer free-from-DLI follow-up time. There was no statistically significant difference in DLI frequency between patients with or without diabetes mellitus. Appropriate selection of candidates and timing of LVAD implantation are critical for improved outcomes of destination therapy. DLI is the most common complication after LVAD implantation. Optimal surgical techniques and early implementation of targeted antibiotics are crucial. Significant challenges remain in optimizing DLI prevention and treatment.

(829) - The Forgotten Pump - Waitlist & Post-Transplant Outcomes of Heart Transplant Recipients Supported by Heartware HVAD Before & After Device Recall

(829) - The Forgotten Pump - Waitlist & Post-Transplant Outcomes of Heart Transplant Recipients Supported by Heartware HVAD Before & After Device Recall

Multicenter evaluation of left ventricular assist device implantation with or without ECMO bridge in cardiogenic shock.

The efficacy of extracorporeal membrane oxygenation (ECMO) as a bridge to left ventricular assist device (LVAD) remains unclear, and recipients of the more contemporary HeartMate 3 (HM3) LVAD are not well represented in previous studies. We therefore undertook a multicenter, retrospective study of this population. INTERMACS 1 LVAD recipients from five U.S. centers were included. In-hospital and one-year outcomes were recorded. The primary outcome was the overall mortality hazard comparing ECMO versus non-ECMO patients by propensity-weighted survival analysis. Secondary outcomes included survival by LVAD type, as well as postoperative and one-year outcomes. One hundred and twenty-seven patients were included; 24 received ECMO as a bridge to LVAD. Mortality was higher in patients bridged with ECMO in the primary analysis (HR 3.22 [95%CI 1.06-9.77], p = 0.039). Right ventricular assist device was more common in the ECMO group (ECMO: 54.2% vs non-ECMO: 11.7%, p < 0.001). Ischemic stroke was higher at one year in the ECMO group (ECMO: 25.0% vs non-ECMO: 4.9%, p = 0.006). Among the study cohort, one-year mortality was lower in HM3 than in HeartMate II (HMII) or HeartWare HVAD (10.5% vs 46.9% vs 31.6%, respectively; p < 0.001) recipients. Pump thrombosis at one year was lower in HM3 than in HMII or HVAD (1.8% vs 16.1% vs 16.2%, respectively; p = 0.026) recipients. Higher mortality was observed with ECMO as a bridge to LVAD, likely due to higher acuity illness, yet acceptable one-year survival was seen compared with historical rates. The receipt of the HM3 was associated with improved survival compared with older generation devices.

Role of Genetic Polymorphisms in the Development of Complications in Patients with Implanted Left Ventricular Assist Devices: HeartWare, HeartMate II, and HeartMate 3

Left ventricular assist device (LVAD) implantation is one of the mechanical circulatory support (MCS) treatments for advanced heart failure (HF) patients. MCS has emerged as a lifesaving therapy that improves patients’ quality of life. However, MCS remains limited by a paradoxical coagulopathy accompanied by thrombosis and bleeding. The mechanisms of MCS thrombosis are increasingly being defined, but MCS-related bleeding, which is related to shear-mediated alteration of platelet function, remains poorly understood. Complications might develop due to the high non-physiological shear stress in the device and as a consequence of individual variability in response to the antithrombotic therapy. Thromboelastography (TEG) and genotyping of gene polymorphisms that are involved in the coagulation cascade and in the metabolism of the antithrombotic therapy might be valuable sources of information for the reduction of complication development. The aim of the study was to identify genetic factors related to the development of device complications according to the implanted LVAD type. We compared the clinical and genetic data of HF patients (n = 98) with/without complications with three types of implanted devices: HeartWare HVAD (HW), HeartMate II (HMII), and HeartMate 3 (HM3). rs9923231 in VKORC1 (95%CI −6.28–0.22, p = 0.04) and rs5918 in ITGB3 genes (95%CI 0.003–4.36, p = 0.05) showed significant association with the TEG coagulation index parameter, which identified hyper- and hypo-coagulation states. The wild genotype of rs5918 in the ITGB3 gene prevailed in patients implanted with HM3 devices, which developed fewer complications than with HMII (p = 0.04). Individual genetic information could be useful in the management of patients with HF and the implantation of MCS to reduce the development of complications.

Transition from temporary microaxial left ventricular assist devices to durable mechanical circulatory support systems

Abstract Background Circulatory support with a catheter-based microaxial temporary left ventricular assist device (tLVAD) plays a major role in the treatment of severe cardiogenic shock. In most patients who fail to recover while on temporary mechanical circulatory support (tMCS), durable left ventricular assist device (dLVAD) therapy is usually considered a reliable option. The aim of this study was to identify outcome predictors after the transition from a catheter-based microaxial tLVAD to dLVAD. Methods This is a retrospective analysis of data from a multicentre registry on patients who were transitioned from a catheter-based microaxial tLVAD to a dLVAD between 01/2017 and 10/2022 (n=341) from 19 European high-volume centres with regard to survival and outcome up to one year after dLVAD implantation. Results Patients were supported with an Impella 5.5 (92), 5.0 (155), CP (92), or 2.5 (2) and transitioned to Heartmate 3 (205), a HeartWare HVAD (129) or EXCOR VAD (7) during the same period. The Impella was implanted via the axillary artery in 245 (71.8%), the femoral artery in 93 (27.3%), and via direct access to the aorta in three (0.9%) patients. One hundred and thirty-three (40.5%) patients additionally required extracorporeal life support before and/or during Impella therapy. The aetiology of cardiogenic shock necessitating tMCS was most commonly acute myocardial infarction (31.7%), followed by acute decompensation of ischaemic (28.4%) or dilated cardiomyopathy (27.0%). The 30-day and 1-year survival were 87% and 70%, respectively. The uni- and multivariable analysis included 312 patients with an at least 1-year follow-up or death within the first year after dLVAD implantation. The following risk factors for 1-year mortality were identified: age (OR 1.02), specifically age over 55 years (OR 1.09), BMI &amp;gt;30 kg/m² (OR 2.2), female sex (OR for male sex 0.4), as well as elevated total bilirubin (OR 1.13) and low platelet counts (OR 0.996). Conclusions During preoperative conditioning, efforts should be undertaken towards normalising platelet counts and liver function. Using the identified risk factors as a basis, we created a risk score to estimate 1-year mortality to optimise patient selection for dLVAD implantation, with the aim of improving the outcome in this critical patient population.Normogram 1y-mortality prediction scoreCIF death grouped by quartiles of score

Long-term implantable ventricular assist device support in children

BackgroundIn pediatrics, implantable continuous-flow ventricular assist devices (IC-VAD) are often used as a “temporary” support, bridging children to cardiac transplantation during the same hospital admission. MethodsWe conducted a retrospective review of our consecutive patients undergoing IC-VAD support at a tertiary pediatric heart center between 2008 and 2022. ResultsWe identified 100 IC-VAD implant encounters: HeartWare HVAD (67; 67%), HeartMate II (17; 17%), and HeartMate 3 (16; 16%). The median (range) age, weight, and body surface area at implantation were 14.1 (3.0-56.5) years, 54.8 (13.3-140) kg, and 1.6 (0.6-2.6) m2, respectively. Cardiomyopathy (58; 58%) was the most common etiology, followed by congenital heart disease (37; 37%, including 13 single ventricle). At 6 months of IC-VAD support, 94 (94%) encounters achieved positive outcomes: ongoing support (59; 59%), transplant (33; 33%), and cardiac recovery (2; 2%). Eighty-two encounters (82%) resulted in home discharge with ongoing VAD support, including 38 (46%, out of 82) requiring readmission and 7 (9%, out of 82) resulting in death. There was a clinically significant decrease in morbidity rates before versus after home discharge: bleeding (1.55 vs 0.06), infection (0.84 vs 0.37), and stroke (0.84 vs 0.15 event per patient-year). Overall, 86 encounters (86%) reached positive end points at the latest follow-up (64 transplant, 15 ongoing support, and 7 recovery). Infection (29%; 4 of 14) was the most common cause of negative outcomes, followed by cerebrovascular accident (21%; 3), and unresolved frailty (21%; 3). The estimated overall survival at 1, 2, and 5 years was 90%, 86%, and 77%, respectively. ConclusionsThis study suggests the feasibility of outpatient management of pediatric IC-VAD support. The ability to offer true long-term support maximizes the potential of IC-VAD support, not limited to a temporary bridging tool for heart transplantation.

Outcome of patients supported with the HeartMate 3 after extracorporeal life support: On behalf of the Durable Mechanical Circulatory Support After Extracorporeal Life Support Study Group

ObjectivesThe Durable Mechanical Circulatory Support System After Extracorporeal Life Support registry is a multicenter registry of patients who were bridged from extracorporeal life support to a durable mechanical circulatory support system. Although numerous studies have highlighted the favorable outcomes after implantation of the HeartMate 3 (Abbott), the objective of our study is to examine the outcomes of patients who received HeartMate 3 support after extracorporeal life support. MethodsData of patients undergoing HeartMate 3 implantation from January 2016 to April 2022 at 14 centers were collected and evaluated. Inclusion criteria were patients with extracorporeal life support before HeartMate 3 implantation. The outcome was reported and compared with patients receiving other types of pumps. ResultsA total of 337 patients were bridged to durable mechanical circulatory support system after extracorporeal life support in the study period. Of those patients, 140 were supported with the HeartMate 3. The other types of pumps included 170 HeartWare HVADs (Medtronic) (86%), 14 HeartMate II devices (7%), and 13 (7%) other pumps (7%). Major postoperative complications included right heart failure requiring temporary right ventricular assist device in 60 patients (47%). Significantly lower postoperative stroke (16% vs 28%, P = .01) and pump thrombosis (3% vs 8%, P = .02) rates were observed in the patients receiving the HeartMate 3. The 30-day, 1-year, and 3-year survivals in patients receiving the HeartMate 3 were 87%, 73%, and 65%, respectively. ConclusionsIn this critically ill patient population, the survivals of patients who were transitioned to the HeartMate 3 are deemed acceptable and superior to those observed when extracorporeal life support was bridged to other types of durable mechanical circulatory support systems.

Left ventricular assist devices for treatment of refractory advanced heart failure: the Western Australian experience.

Left ventricular (LV) assist devices (LVADs) can prolong survival and improve quality of life in end-stage heart failure. Review outcomes of the Western Australian LVAD programme. Retrospective database and medical record review. One hundred forty-seven LVADs have been implanted in 23 years, of which 95 were newer-generation devices (HeartWare HVAD [HW], HeartMate II and HeartMate 3). Presented data refer to these devices only. Most patients (94%) were classed as bridge-to-transplant or -candidacy/decision, with the remainder classed as 'destination therapy' (DT). Mean LV ejection fraction was 20%, and 36% had severe right ventricular dysfunction. Sixty-two percent of patients had a nonischaemic cardiomyopathy. Following LVAD implant, the median length of stay in intensive care was 2 days, and in the hospital overall was 23 days. Ninety-six percent of patients survived to hospital discharge, and, following discharge, 98% of days with LVAD were spent as an outpatient. The median number of hospital readmissions was 1.5 per patient per year. LVAD-associated infection requiring admission or intravenous antibiotics at any time after implant occurred in 36%, significant gastrointestinal bleeding in 19% and stroke in 11%. The percentage of patients alive with LVAD still in situ at 1, 2 and 5 years was 94%, 88% and 62% respectively, which exceeds current international registry outcomes. All DT patients survived at least 4 years, spending 97% of days with LVAD as an outpatient. The two longest-surviving HW DT patients worldwide (11.3 and 10.5 years) are among this cohort. Excellent outcomes can be achieved with LVADs in appropriately selected patients.

TOP3: Over 100 Fontan Patients on Ventricular Assist Device Support: An ACTION Update

Background: Many Fontan patients will require end-stage heart failure therapy, and an increasing number are requiring systemic ventricular assist device (VAD) support. This report describes the pre-implant characteristics and clinical outcomes of the largest cohort of Fontan VAD patients. Methods: Fontan patients with systemic VAD support were identified from the Advanced Cardiac Therapies Improving Outcomes Network (ACTION) registry. Patient characteristics and outcomes are described (median, interquartile range). Results: Between 1/2012-12/2022, 107 Fontan patients had VAD implanted (age 10, IQR 5-16 years; 27% female), with 69% as bridge to transplant. Implantable continuous devices (IC-VADs) were most common, with Medtronic Heartware HVAD (31%) and Abbott Heartmate 3 (20%), followed by Berlin EXCOR (22%) and paracorporeal continuous devices (20%). At implant, 58% were on >≥2 inotropes, 26% on extracorporeal membrane oxygenation, 41% were intubated, 48% on total parenteral nutrition, and 8% on dialysis; 28% were INTERMACS Profile 1. Over a median 113 (IQR 43-266) days of support, 75% experienced >≥1 adverse event, with infection most common (10.5 per 100 patient-months) followed by bleeding (8.7 per 100 patient-months) and neurologic dysfunction (5.5 per 100 patient-months). Of patients on IC-VADs, 49% were discharged. At 1 year post-VAD implant, 54% were transplanted, 18% died, and 26% were still on support. Conclusion: Despite requiring high level of support (ECMO, intubation, multiple inotropes) at time of implant, an increasing number of Fontan patients are being successfully supported with VADs, with almost half of patients with IC-VADs discharged on support. Though the majority are alive at 1-year post-implant, adverse events remain common.

Bridging to transplant with HeartMate 3 left ventricular assist devices in the new heart organ allocation system: An individualized approach.

Following the MOMENTUM 3 trial and the discontinuation of the HeartWare HVAD, the HeartMate 3 LVAD (HM 3) has become the main durable device for bridging to transplantation; however, outcome of this strategy in the new heart allocation system is not well understood. The United Network for Organ Sharing (UNOS) registry was queried to include adult patients (≥18 years old) listed for heart transplantation between 2010 and 2020. Trends in durable LVAD utilization and outcomes of patients with HM 3 LVAD were examined in the pre- vs post-heart allocation system. From 2017 to 2020, there was a 28.3% decline in the number of patients waitlisted with an FDA-approved durable LVAD. Overall, 449 patients were waitlisted with HM 3 in the pre-allocation era compared to 1094 patients in the post-allocation. Cumulative incidence of heart transplantation (53.4% vs 50.7%, p=0.76) and death or delisting for worsening status (5.0%, vs 4.2%, p=0.43) at 1-year after listing with HM 3 LVAD was comparable in the pre- vs post-allocation era. Old age (>50), ischemic HF, poor functional status, elevated creatinine (>1.3 mg/dL), pulmonary hypertension (>3 WU), and obesity (body mass index > 33 kg/m2) were predictors of post-transplant graft mortality after bridging with HM 3. While the utilization of durable devices as BTT have declined under the new heart allocation system, bridging with HM 3 LVAD remains a safe strategy in carefully selected patients. Bridging decision should be individualized based on patient risk factors.

Results of non-elective withdrawal of continuous-flow left ventricular assist devices in selected patients

Protocols have been developed to identify patients for elective withdrawal of continuous-flow left ventricular device (cfLVAD) support. However, little is known about non-elective explantation or decommissioning of cfLVADs. A retrospective analysis of all patients who underwent left ventricular assist device (LVAD) explantation or decommissioning at a single center between 2002 and 2021 was performed. Sixty-one patients underwent withdrawal of a cfLVAD (HeartMate II [Abbott] n=17, HeartMate 3 [Abbott] n=2, HeartWare HVAD [Medtronic] n=36, INCOR [Berlin Heart] n=6). The median follow-up after withdrawal was 1,039 days. The survival at 5 years was 76.1% (95% CI: 64.2%-95.2%). Predictors of worse outcomes in univariate regressive analysis were the duration of heart failure and the age at LVAD implantation. Of the 61 patients, 40 underwent elective withdrawal following a specific protocol. The other twenty-one patients underwent non-elective withdrawal of the cfLVAD because of device infection (n=12), device thrombosis (n=6), device malfunction (n=2) or due to acute intracerebral bleeding (n=1), also with an excellent survival at 5 years of 81.3%. (95% CI: 63.8-1). The withdrawal was performed in these patients even though they did not fulfill established criteria for successful explantation or decommissioning like clinical stability (n=21), left ventricular end-diastolic diameter ≤ 55 mm (n=3), performance of right heart catheterization (n=6), or pulmonary artery wedge pressure ≤ 15 mm Hg (n=3). Non-elective withdrawal is possible in selected patients after discussion in a team of experienced cardiac surgeons, cardiologists, technicians, and VAD coordinators. The appropriate preoperative assessment before decommissioning or explantation of a cfLVAD warrants further investigation.

Abstract 15585: Myocardial Reserve After Milrinone to Predict Right Ventricular Failure After LVAD Implantation

Introduction: Right ventricular failure (RVF) after left ventricular assist device (LVAD) implantation is a common complication associated with increased morbidity and mortality. Identifying patients at risk for RVF remains challenging. We sought to assess pre-operative right ventricular myocardial reserve after milrinone loading as a risk predictor for post-LVAD RVF. Methods: Adult patients implanted with LVADs from 2013-2019 at a single center who had right heart catherization with milrinone drug study within 30-days preoperatively were included. In addition to standard hemodynamic variables, pulmonary artery pulsatility index (PAPI), right atrial to pulmonary capillary wedge pressure ratio (RA/PCWP), right ventricular stroke work index (RVSWI), pulmonary vascular resistance index (PVRi), and stroke volume index (SVI) were recorded before and after milrinone bolus (50 mcg/kg over ten minutes). Incidence of RVF defined by MCS-ARC criteria within one-year post LVAD were recorded. Student’s unpaired t-tests were used to compare mean of hemodynamic markers to RVF outcome. Results: A total 34 patients were included; 38% women, 50% African American, 68% had non-ischemic cardiomyopathy, 47% implanted with HeartMate 3 LVAD, 20.5% with HeartMate 2, and 32% with HeartWare HVAD. Final right atrial pressure (RAP) after milrinone was higher in those with post-LVAD RVF (15.5 + 7.8mmHg vs 9.2 + 3.9mmHg, p=0.005), as was final diastolic PA pressure (34.3 + 9.2mmHg vs 25.6 + 7.7mmHg, p=0.006). SVI post-milrinone was numerically higher in those without post-LVAD RVF (32.3 + 9.2 vs 26.0 + 7.9mL/m 2 , p=0.06). Percent change in PAPI (p=0.26), RA/PCWP (p=0.35), RVSWI (p=0.10), or PVRi (p=0.92) after milrinone were not associated with RVF. Conclusions: Persistently elevated RAP and diastolic PA pressure, despite milrinone infusion, are associated with RVF after LVAD implantation. Continued reduction in SVI post milrinone may also identify patients at risk for post-LVAD RVF.

HeartWare HVAD Exchange to HeartMate3: Principles, Techniques, and Pitfalls

Since the recall of the HeartWare HVAD device in 2021, the management of the remaining implants range from medical management, transplant, to exchange. This article describes 2 feasible approaches to exchange the HVAD to the HeartMate3 device through a combination of a left lateral thoracotomy with a superior hemi-sternotomy. These approaches minimize dissection and complications of a redo-sternotomy and minimizes bypass time. Pitfalls and solutions are also herein described. Since the recall of the HeartWare HVAD device in 2021, the management of the remaining implants range from medical management, transplant, to exchange. This article describes 2 feasible approaches to exchange the HVAD to the HeartMate3 device through a combination of a left lateral thoracotomy with a superior hemi-sternotomy. These approaches minimize dissection and complications of a redo-sternotomy and minimizes bypass time. Pitfalls and solutions are also herein described. Commentary: HeartWare HVAD to HeartMate 3 Device Exchange: Assessing the Technical ChallengesOperative Techniques in Thoracic and Cardiovascular SurgeryPreviewA HeartWare HVAD-to-HeartMate 3 left ventricular device exchange. Full-Text PDF

Feasibility and role of echocontrast evaluation of patients with LVAD

Abstract Background Advanced heart failure is a clinical syndrome characterized by persistent or progressive symptoms of heart failure despite optimal medical therapy. Left ventricular assist device (LVAD) brings survival benefits and improvement in quality of life, compared with conventional medical treatments. Development of Right ventricle failure in patients with LVAD has a direct effect on mortality and hospitalization. Purpose Evaluation of clinical safety and feasibility of echocontrast in patients implanted with 3 different types of LVAD; improvement in the visualization of heart structures; intra and inter-operator agreement of RV assesement with and without contrast. Methods 43 patients were implanted with LVAD, 7 patients (16%) with Jarvik 2000, 31 (72%) with HeartMAte 3, 5 (12%) with (HeartWAre HVAD). Nine patients (21%) had contraindication or refused contrast. In 3 (7%) patients was technically challenging to obtain apical images at all levels. Two (5%) patients lost their follow-up. Our final population was of 29 (67%) patients (mean age 65±7 y; 100% Male). We assessed the reproducibility of these measurements between two different expert blind operators. Results Total 329 (64%) of 516 RV wall segments were available for qualitative analysis without contrast vs 451 (87%) with contrast (p&amp;lt;0.001) with a significant improvement of the evaluability of regional contractility (especially due to the better evaluation of medial and apical segments of lateral and anterior walls) and FAC (41% vs 90%, p&amp;lt;0.001). Evaluation of TAPSE, TR and sPAP was similar with and without contrast (p=NS). All the RV parameters showed little inter-operator variability when measured with contrast. TAPSE, FAC, and RWMA showed an excellent reproducibility (ICC &amp;gt;0.86) while it was good for 2D-baseline derived parameters (ICC = 0.74) showing improvement of inter operator reproducibility in the evaluation of regional contractility in the contrast echocardiography modality. Conclusion EC is safe with all the types of LVAD examined. Accurate and reproducible visualization of RV is imperative for reliability of information, a routine use of EC could play a pivotal role in interpreting RV features. EC improves RV morphologic and functional judgment allowing greater accuracy and precision in the assessment of both global and regional RV functions. This finding may have important clinical improvement, especially in the future for analysis focused in RV prognostic role in LVAD patients. Funding Acknowledgement Type of funding sources: None.

Concomitant left atrial appendage closure with left ventricular assist device surgery can reduce ischemic cerebrovascular accidents

Abstract Background It remains unknown if concomitant left atrial appendage closure (LAAC) at the time of left ventricular assist device (LVAD) surgery can reduce ischemic cerebrovascular accidents. Purpose The purpose of this study is to assess the impact of LAAC at LVAD surgery on the incidence of ischemic cerebrovascular accidents. Methods Between January 2012 and November 2021, 310 patients underwent LVAD surgery with HeartMate II or III. Out of 310 patients, 98 patients (31.6%) underwent concomitant LAAC. The cohort was divided into two groups: patients with LAAC (Group A, n=98) and without LAAC (Group B, n=212). To minimize device bias, LVAD surgery with HeartWare HVAD device was excluded. The ischemic cerebrovascular accident was defined as ischemic stroke, hemorrhagic stroke or transient ischemic attack. We reviewed early and long-term clinical outcomes. The incidence of ischemic cerebrovascular accidents was compared between two groups using the Kaplan-Meier method. We also investigated if LAAC was associated with ischemic cerebrovascular accidents by Cox proportional hazards analysis. Results There were no significant differences in baseline characteristics between two groups including age (Group A: 55.0±12.3 years old, Group B: 56.9±14.1 years old, p=0.26), preoperative CHADS2 score (Group A: 2.40±1.1, Group B: 2.58±1.1, p=0.19) and history of atrial fibrillation (Group A: 42.9%, Group B: 42.5%, p=0.95). In-hospital mortality was not significantly different between the two groups (Group A: 7.1%, Group B: 12.3%, p=0.16). In terms of postoperative complications, there were no significant differences between two groups in requiring extracorporeal membrane oxygenation, re-exploration for bleeding and newly required hemodialysis. Median follow up period was 474 days. Thirty-five patients (11.2%) developed ischemic cerebrovascular accidents (5 patients in Group A and 30 patients in Group B). The rate of freedom from ischemic cerebrovascular accidents in Group A (94.1% at 500 days and 94.1% at 1500 days) was significantly higher than that in Group B (88.2% at 500 days and 77.4% at 1500 days; log rank=0.024). In a Cox proportional hazards regression analysis including LAAC, age, history of atrial fibrillation, diabetes mellitus and Heartmate 3 device implantation, LAAC was associated with reducing the incidence of ischemic cerebrovascular accidents (hazard ratio 0.37, 95% CI 0.13–0.89, p=0.02). Conclusion Concomitant LAAC at the time of LVAD surgery can reduce ischemic cerebrovascular accidents without increasing perioperative mortality and complications. Funding Acknowledgement Type of funding sources: None.

Bivalirudin or Unfractionated Heparin for Anticoagulation in Pediatric Patients on Continuous Flow Ventricular Assist Device Support: Single-Center Retrospective Cohort Study

Bivalirudin is a direct thrombin inhibitor that is being increasingly used for anticoagulation in children after ventricular assist device (VAD) implantation. While the data on bivalirudin use in pulsatile flow VADs are growing, reports on its use in patients on continuous flow (CF) VAD as well as comparisons of associated outcomes with unfractionated heparin (UFH) remain limited. Retrospective cohort study. Single tertiary-quaternary referral center. All patients less than 21 years old on CF-VAD support who received bivalirudin or UFH for anticoagulation between the years 2016 and 2020. Not applicable. Clinical characteristics compared between the cohorts included time to target range of anticoagulation, markers of hemolysis, and prevalence of hemocompatibility-related adverse events such as major hemorrhagic complications, ischemic stroke, and pump thrombosis. In 42 unique patients (41 HeartWare HVAD [Medtronic, Minneapolis, MN], one HeartMate 3 LVAD [Abbott Laboratories, Abbott Park, IL]) during the study period, a total of 67 encounters of IV anticoagulation infusions (29 UFH and 38 bivalirudin) were retrospectively reviewed. In comparison with use of UFH, bivalirudin was associated with lesser odds of major bleeding complications (odds ratio [OR], 0.29; 95% CI, 0.09-0.97; p = 0.038). We failed to identify any difference in odds of major thrombotic complications (OR, 2.53; 95% CI, 0.47-13.59; p = 0.450). Eight of the patients (28%) on UFH were switched to bivalirudin due to hemorrhagic or thrombotic complications or inability to achieve therapeutic anticoagulation, while two of the patients (5%) on bivalirudin were switched to UFH due to hemorrhagic complications. Bivalirudin was used for a "washout" in eight cases with concern for pump thrombosis-six had resolution of the pump thrombosis, while two needed pump exchange. Use of bivalirudin for anticoagulation in patients on CF-VAD support was associated with lesser odds of hemorrhagic complications compared with use of UFH. Bivalirudin "washout" was successful in medical management of six of eight cases of possible pump thrombosis.