Ventricular Assist Device Therapy Research Articles

P80: Adding Intra-Aortic Balloon Pump Counter-Pulsation To Vasodilator Therapy Results In Better Organ Perfusion In Patients With Biventricular Heart Failure Awaiting A Heart Transplant

Background: Significant right ventricular dysfunction with elevated central venous pressure is associated with poor survival in heart failure patients with reduced ejection fraction (HFrEF). Heart transplant is often the only option for this group of patients, as they are not candidates for left ventricular assist device therapy. Medical management of HFrEF involves lowering the systemic afterload with vasodilators. While this therapy is very effective in isolated left ventricular dysfunction, in patients with biventricular dysfunction and high venous pressure, vasodilation can lead to low organ perfusion pressure, resulting in organ dysfunction. Organ perfusion pressure is calculated as the difference between mean arterial pressure and central venous pressure. We hypothesized that combining intra-aortic balloon pump (IABP) counter-pulsation with vasodilator therapy might be a good clinical option for stabilizing these patients while awaiting a heart transplant. Methods: To understand the hemodynamics of vasodilator and IABP therapy in biventricular heart failure, we used a closed-loop multiscale model of the entire cardiovascular system, including a one-dimensional model of the arterial tree coupled with a lumped model of the heart and IABP counter-pulsation. In addition, a baroreceptor model was also used to capture the physiological changes secondary to ventricular dysfunction realistically. Results: Our mathematical model accurately captures the features of the aortic pressure waveform with IABP support (Figure 1) and the hemodynamic consequences of the onset of right ventricular dysfunction (Table 1). Biventricular dysfunction leads to lower cardiac output and organ perfusion pressure when compared with isolated left ventricular dysfunction. Vasodilation during biventricular dysfunction increases the cardiac output but reduces the organ perfusion pressure further. IABP counter-pulsation increases cardiac output along with higher mean arterial pressure and hence higher organ perfusion pressure. The best results are seen when vasodilators are used in conjunction with IABP, where a “sweet spot” of maximal increase in cardiac output with the best possible organ perfusion pressure is obtained, and this combined additive effect of IABP counter-pulsation and vasodilation is also reflected across the renal vasculature (Table 1). Conclusion: Vasodilation with high venous pressure can lead to low organ perfusion pressure and consequent organ dysfunction. Fine-tuning IABP counter-pulsation and vasodilator seems to confer a substantial hemodynamic benefit in this setting.Figure 1. Simulated aortic pressure waveform with IABP support

Predictors and clinical implications of residual mitral regurgitation following left ventricular assist device therapy

BackgroundCorrection of mitral regurgitation (MR) at the time of left ventricular assist device (LVAD) implantation remains controversial. There is conflicting evidence regarding the clinical impact of residual MR, and studies...

Value of implant-based telemonitoring in the high-risk population of ventricular assist device patients

Abstract Funding Acknowledgements Type of funding sources: None. Background Telemonitoring of heart failure (HF) patients is an evolving field. Prior studies presented promising results. However, the relevance of telemonitoring in the specific cohort of end-stage HF patients on ventricular assist device (VAD) therapy has not been analysed yet. Purpose This study aimed to evaluate the benefit of daily implant-based multiparameter-telemonitoring in high-risk HF-patients on VAD therapy with an implantable cardioverter-defibrillator (ICD) or a cardiac resynchronization defibrillator (CRT-D) including telemonitoring function. Beyond that, patients’ outcome and complication rates were evaluated. Methods A total of 30 end-stage HF-patients (65 ± 10 years, 89 % male) with a VAD and an ICD or a CRT-D with telemonitoring function were included in this observational single center study. Long-term follow-up data (4.28 ± 2.62 years) were assessed. Results All patients (n=30, 100%) received daily ICD or CRT-D telemonitoring. In the majority of patients (73%, n=22) the telemedical center had to take actions a mean of 3 times. Most events (84%, n=45) were identified within 24 hours. An acute alert due to sustained ventricular arrhythmias (VAs) occurred in 13 patients (65%) with 46% of them (n=6) requiring a shock delivery. Eight patients (62%) were hospitalized due to symptomatic VAs. Inadequate shocks were recognized in 3 patients (23%). In 12 patients (92%) immediate medication adjustments were recommended. Relevant lead problems were revealed in 13 patients (43%) with 6 patients (46%) undergoing consecutive lead revisions. Device-reprogramming was recommended in 50% of all VAD-patients (n=15). Compared to HF-patients without remote monitoring, daily telemonitoring significantly reduced the number of in-hospital device controls by 44% (p<0.01). Conclusions Daily implant-based-telemonitoring increased patient safety as it allowed for pre-emptive interventions and an immediate detection of cardiac arrhythmias and device/lead problems. Even in this high-risk HF-patient population, telemonitoring significantly reduced the number of in-hospital device-controls. Further studies are warranted to confirm these initial observations.

P474 A PIVOTAL ROLE OF THE MULTIDISCIPLINARY TEAM IN THE BRIDGING THE PATIENT TO HEART TRANSPLANTATION

Abstract The complexity of care of the patients affected by advanced heart failure (AHF) requires a dedicated team led by cardiologists and consists of nurses, physical therapists, patient care coordinator, nurse educator, dietician, anesthesiologists, and perfusionists. Multidisciplinary team “ has been shown to reduce the risk of hospitalization, death, and health care costs in randomized controlled trials”1. AHF is characterized by the progressive worsening of the clinical conditions of the patient unresponsive to the optimal medical therapy. Therefore, the short–term mechanical circulatory supports as Intraaortic Balloon Pump (IABP) may represent a valid strategy for optimizing and bridging the patient affected by AHF to the heart transplant2. A 52 years old lady with the diagnosis of the AHF and associated cachexia and sarcopenia has admitted in emergency. Despite of the high dose of inotrope severe hypotension required a IABP support to provide an adequate organs perfusion. Left ventricular assist device therapy has been rule out: the patient originated from the other country lives alone so no caregiver may be designed and trained to provide a support during the period following the LVAD’s implantation. For over than 130 days the patient well tolerates a treatment with inotrope at low dosage under continuously IABP support without a complications. Dedicated nurse in collaboration with the physical therapist provide a self mobilization of the patient with ambulatory IABP that is favorable to strengthen the level of her autonomy during the pre–transplant period. The out of bed position was performed by patient every day maintaining an acceptable level of muscle trophism to make the cardiac transplant program attainable. The patient was ambulating during almost every day sessions of the physical therapy covering the distance about 260 meters. A comfort environment, a quality of sleeping and an unchanged sleep–wake cycle are factors that enhance the patient’s experience. After more than five months of hospitalization, the patient receives her new heart. Heart–failure associated cachexia and sarcopenia, one of the most critical issues in the patients with AHF were regressed as a result of intensive physical activity and regular mobility of the patient. Synergic effort and expertise of each member of the multidisciplinary team has been a significant impact to successfully bridges critically ill lady to her complete recovery after the heart transplantation.

Blood flow kinetic energy is a novel marker for right ventricular global systolic function in patients with left ventricular assist device therapy.

Right ventricular (RV) failure remains a major concern in heart failure (HF) patients undergoing left ventricular assist device (LVAD) implantation. We aimed to measure the kinetic energy of blood in the RV outflow tract (KE-RVOT) - a new marker of RV global systolic function. We also aimed to assess the relationship of KE-RVOT to other echocardiographic parameters in all subjects and assess the relationship of KE-RVOT to hemodynamic parameters of RV performance in HF patients. Fifty-one subjects were prospectively enrolled into 4 groups (healthy controls, NYHA Class II, NYHA Class IV, LVAD patients) as follows: 11 healthy controls, 32 HF patients (8 NYHA Class II and 24 Class IV), and 8 patients with preexisting LVADs. The 24 Class IV HF patients included 21 pre-LVAD and 3 pre-transplant patients. Echocardiographic parameters of RV function (TAPSE, St', Et', IVA, MPI) and RV outflow color-Doppler images were recorded in all patients. Invasive hemodynamic parameters of RV function were collected in all Class IV HF patients. KE-RVOT was derived from color-Doppler imaging using a vector flow mapping proprietary software. Kruskal-Wallis test was performed for comparison of KE-RVOT in each group. Correlation between KE-RVOT and echocardiographic/hemodynamic parameters was assessed by linear regression analysis. Receiver operating characteristic curves for the ability of KE-RVOT to predict early phase RV failure were generated. KE-RVOT (median ± IQR) was higher in healthy controls (55.10 [39.70 to 76.43] mW/m) than in the Class II HF group (22.23 [15.41 to 35.58] mW/m, p < 0.005). KE-RVOT was further reduced in the Class IV HF group (9.02 [5.33 to 11.94] mW/m, p < 0.05). KE-RVOT was lower in the LVAD group (25.03 [9.88 to 38.98] mW/m) than the healthy controls group (p < 0.005). KE-RVOT had significant correlation with all echocardiographic parameters and no correlation with invasive hemodynamic parameters. RV failure occurred in 12 patients who underwent LVAD implantation in the Class IV HF group (1 patient was not eligible due to death immediately after the LVAD implantation). KE-RVOT cut-off value for prediction of RV failure was 9.15 mW/m (sensitivity: 0.67, specificity: 0.75, AUC: 0.66). KE-RVOT, a novel noninvasive measure of RV function, strongly correlates with well-established echocardiographic markers of RV performance. KE-RVOT is the energy generated by RV wall contraction. Therefore, KE-RVOT may reflect global RV function. The utility of KE-RVOT in prediction of RV failure post LVAD implantation requires further study.

Infections in Patients With Left Ventricular Assist Devices: Current State and Future Perspectives.

Mechanical circulatory support is increasingly being used as bridge-to-transplant and destination therapy in patients with advanced heart failure. Technologic improvements have led to increased patient survival and quality of life, but infection remains one of the leading adverse events following ventricular assist device (VAD) implantation. Infections can be classified as VAD-specific, VAD-related, and non-VAD infections. Risk of VAD-specific infections, such as driveline, pump pocket, and pump infections, remains for the duration of implantation. While adverse events are typically most common early (within 90 days of implantation), device-specific infection (primarily driveline) is a notable exception. No diminishment over time is seen, with event rates of 0.16 events per patient-year in both the early and late periods postimplantation. Management of VAD-specific infections requires aggressive treatment and chronic suppressive antimicrobial therapy is indicated when there is concern for seeding of the device. While surgical intervention/hardware removal is often necessary in prosthesis-related infections, this is not so easily accomplished with VADs. This review outlines the current state of infections in patients supported with VAD therapy and discusses future directions, including possibilities with fully implantable devices and novel approaches to treatment.

A Systematic Review and Physiology of Pulmonary Artery Pulsatility Index in Left Ventricular Assist Device Therapy.

Right heart failure is a major complication following left ventricular assist device (LVAD) implantation. Pulmonary artery pulsatility index (PAPi) has been evaluated as a haemodynamic marker for right heart failure, but PAPi is dependent on pulmonary vascular resistance. We conducted a systematic review to assess the relationship between PAPi and right heart failure and death in patients undergoing LVAD implantation; and examined the relationship between PAPi cut-off and pulmonary vascular resistance. We searched PubMed, EMBASE, CENTRAL and manually screened retrieved references to identify all clinical studies reporting PAPi in adult patients with a durable LVAD. Eligibility criteria were prespecified and two reviewers independently screened and extracted data; the Newcastle-Ottawa Scale was used to assess quality of non-randomized studies. This study was prospectively registered on PROSPERO (CRD42021259009). From 283 unique records, we identified 16 studies reporting haemodynamic assessment in 20,634 adult patients with an implanted durable LVAD. Only 2 studies reported on mortality and in both, a lower PAPi was significantly associated with death. Fifteen studies reported right heart failure data and in ten studies a lower PAPi was significantly associated with right heart failure. Six studies reported on PAPi cut-offs ranging from 0.88 to 3.3; and the cut-offs were directly related to pulmonary vascular resistance (r = 0.6613, p = 0.019). Lower PAPi was associated with right heart failure and death following LVAD implantation, but a single PAPi cut-off cannot be defined, as it is dependent on pulmonary vascular resistance.

Clinical outcomes of ventricular assist device support by HIV infection status: An STS-INTERMACS analysis

Cardiovascular disease remains the leading cause of mortality in human immunodeficiency virus-infected (HIV-positive) patients. Ventricular assist device therapy is rarely offered to these patients and data on outcomes are sparse. We investigated outcomes following ventricular assist device implants for HIV-positive as compared to non-HIV-infected (HIV-negative) patients. We analyzed 22,065 patients from the Interagency Registry for Mechanically Assisted Circulatory Support registry for outcomes by HIV status. A propensity-matched analysis adjusting for 21 preimplant risk factors was also conducted. Compared with 21,980 HIV-negative device recipients, the 85 HIV-positive recipients were younger (median age 58 years vs 59 years, p=0.02), had lower body mass index (26kg/m2 vs 29kg/m2, p=0.001), and had higher rates of prior stroke (8% vs 4%, p=0.02). In the matched HIV-positive and HIV-negative cohorts, there was significantly higher mortality in HIV-positive patients in earlier implant years, however, this association was not seen in later implant years (2018-2020). In both unmatched and matched cohorts, no significant differences in postimplantation stroke, major bleeding, or major infection were noted. With recent advancements in mechanical circulatory support and HIV treatment, ventricular assist device therapy is a viable therapeutic option for HIV-positive patients with end-stage heart failure.

Expanding Our Methodological Toolbox to Improve Quality: The Role of Mixed-Methods Evaluations.

The care delivered to patients with cardiovascular disease involves coordination among a multitude of clinical team members spanning diverse inpatient and outpatient settings. The majority of quality improvement interventions in cardiovascular care have been developed based on quantitative evidence, which neither fully accounts for multilevel determinants (eg, patient, clinician, and institution) nor contextualization from key informants. The rigor and effectiveness of these interventions would be enhanced by mixed-methods studies whose strengths include (1) the use of qualitative research methodologies (eg, eliciting patient or clinician perspectives on barriers and facilitators of best practices) and (2) integrating qualitative and quantitative data and analyses to understand more fully effective strategies for achieving optimal care and outcomes for these patients across diverse settings. This article illustrates the application of a complex mixed-methods design to advance an evidence-based, customizable infection prevention toolkit for durable left ventricular assist device therapy. The study (1) uses quantitative clinical data merged with Medicare claims to evaluate interhospital variability in the incidence of infection; (2) uses qualitative methods to understand local practice patterns across low- and high-performing centers; and (3) integrates both data sources to gain a comprehensive understanding of the overall findings.

Long-term outcome of EVAHEART I implantable ventricular assist device for the treatment of end stage heart failure: clinical 3-year follow-up results of 15 cases

Objective: To evaluate the long-term efficacy and safety of the implantable ventricular assist system EVAHEART I in clinical use. Methods: Fifteen consecutive patients with end-stage heart failure who received left ventricular assist device therapy in Fuwai Hospital from January 2018 to December 2021 were enrolled in this study, their clinical data were retrospectively analyzed. Cardiac function, liver and kidney function, New York Heart Association (NYHA) classification, 6-minute walk distance and quality of life were evaluated before implantation and at 1, 6, 12, 24 and 36 months after device implantation. Drive cable infection, hemolysis, cerebrovascular events, mechanical failure, abnormally high-power consumption and abnormal pump flow were recorded during follow up. Results: All 15 patients were male, mean average age was (43.0±7.5) years, including 11 cases of dilated cardiomyopathy, 2 cases of ischemic cardiomyopathy, and 2 cases of valvular heart disease. All patients were hemodynamically stable on more than one intravenous vasoactive drugs, and 3 patients were supported by preoperative intra aortic balloon pump (IABP). Compared with before device implantation, left ventricular end-diastolic dimension (LVEDD) was significantly decreased ((80.93±6.69) mm vs. (63.73±6.31) mm, P<0.05), brain natriuretic peptide (BNP), total bilirubin and creatinine were also significantly decreased ((3 544.85±1 723.77) ng/L vs. (770.80±406.39) ng/L; (21.28±10.51) μmol/L vs. (17.39±7.68) μmol/L; (95.82±34.88) μmol/L vs. (77.32±43.81) μmol/L; P<0.05) at 1 week after device implantation. All patients in this group were in NYHA class Ⅳ before implantation, and 9 patients could recover to NYHA class Ⅲ, 3 to class Ⅱ, and 3 to class Ⅰ at 1 month after operation. All patients recovered to class Ⅰ-Ⅱ at 6 months after operation. The 6-minute walk distance, total quality of life and visual analogue scale were significantly increased and improved at 1 month after implantation compared with those before operation (P<0.05). All patients were implanted with EVAHEART I at speeds between 1 700-1 950 rpm, flow rates between 3.2-4.5 L/min, power consumption of 3-9 W. The 1-year, 2-year, and 3-year survival rates were 100%, 87%, and 80%, respectively. Three patients died of multiple organ failure at 412, 610, and 872 d after surgery, respectively. During long-term device carrying, 3 patients developed drive cable infection on 170, 220, and 475 d after surgery, respectively, and were cured by dressing change. One patient underwent heart transplantation at 155 d after surgery due to bacteremia. Three patients developed transient ischemic attack and 1 patient developed hemorrhagic stroke events, all cured without sequelae. Conclusion: EVAHEART I implantable left heart assist system can effectively treat critically ill patients with end-stage heart failure, can be carried for long-term life and significantly improve the survival rate, with clear clinical efficacy.

(335) Left Ventricular Assist Device Therapy in “Cold and Dry” Patients

(335) Left Ventricular Assist Device Therapy in “Cold and Dry” Patients

(334) Outcomes and Quality of Life in Patients Receiving Durable Ventricular Assist Device Therapy with Bivad Support

(334) Outcomes and Quality of Life in Patients Receiving Durable Ventricular Assist Device Therapy with Bivad Support

Successful support of biventricular heart failure in an adult patient by the Berlin Heart EXCOR system as a bridge to transplant: literature review.

Right heart failure is ahuge challenge in left ventricular assist device therapy and its occurrence is associated with increased mortality and morbidity. Other options include the use od temporary right ventricular assist device, use of two continous flow biventricular assist devices, use of total artificial heart and the use of paracorporeal biventricular assist devices.In this report we described the successful use of the paracorporeal pulsatile Berlin Heart EXCOR system as abridge to transplant in a62 years old patient with end-stage biventricular heart failure (Tab. 1, Fig. 3, Ref. 22). Keywords: biventricular heart failure, mechanical circulatory support, biventricular assist device, Berlin Heart EXCOR system, heart transplantation.

Surgical Interventions for Late Aortic Valve Regurgitation Associated with Continuous Flow-Left Ventricular Assist Device Therapy: Experience Gained and Lessons Learned.

This study aimed to investigate the outcomes of surgical interventions for symptomatic moderate-to-severe aortic regurgitation (AR), including aortic valve replacement (AVR) and repair (AVP), in 184 patients who underwent continuous flow-left ventricular assist device (Cf-LVAD) implantation as a bridge-to-transplant (BTT) between November 2007 and April 2020. Ten patients (median age, 34 (25-41) years; 60% men) underwent surgical interventions (AVR, n = 6; AVP, n = 4) late after cf-LVAD implantation. The median duration after the device implantation was 34 (24-44) months. Three patients required additional tricuspid valve repair. Aortic valve suturing resulted in severe recurrent AR 6 months postoperatively, due to leaflet cutting in one patient. Seven patients with AVR survived without regurgitation during the study period, except for one non-survivor complicated by liver failure due to postoperative right heart failure. Therefore, six patients after AVP (n = 4) and AVR (n = 2) underwent successful heart transplantation 7 (4-13) months after aortic intervention. Kaplan-Meier analysis showed no significant difference in overall survival through 5 years after cf-LVAD implantation, regardless of the surgical AV intervention chosen (log-rank test, p = 0.86). In conclusion, surgical interventions (AVR or AVP) for patients with an ongoing cf-LVAD are safe, effective, and viable options.

188: PHARMACOKINETIC ANALYSIS OF ANTIMICROBIAL THERAPY IN VENTRICULAR ASSIST DEVICE-SUPPORTED PATIENTS

Introduction: As a result of underlying heart failure, the utilization of left ventricular assist devices (VAD) has increased as a means of offloading the failing ventricle to improve cardiac output. Importantly, after device implantation and once end-organ perfusion has been enhanced, new pharmacokinetic alterations may acutely develop which may require pre-emptive dose adjustments for several pharmacotherapies. Currently, there are limited data in patients with VADs to determine patient and population-specific antimicrobial disposition. The purpose of this study is to assess perioperative pharmacokinetic changes in patients during VAD implantation receiving prophylactic antibiotics. Methods: Patients will be prospectively enrolled to collect blood samples peri-operatively and post-operatively. Blood samples will be used to analyze the antimicrobial concentrations using a validated high-performance liquid chromatography (HPLC-UV) assay. Results: To date, 11 patients have been enrolled in this study. Enrollees are on average 63 years of age, predominately male (82%), with nonischemic cardiomyopathy (64%). LVAD implantation consisted of HeartMate3 (n=9), and HVAD devices (n=2). Standard prophylactic regimens for LVAD implantation include ceftazidime and vancomycin. Intra-operatively, all patients received one prophylactic dose of ceftazidime 2 grams from which samples were collected thereafter. The median samples collected intra-operatively was 4 (IQR 3,6). Post-operatively, ceftazidime prophylaxis was continued for 36 hours, and samples were typically collected after the third ceftazidime dose. The median samples collected post-operatively was 4 (IQR 4,5). Antimicrobial plasma concentrations are currently pending processing and analysis. The drug concentration in the serum will be analyzed to determine the maximum concentration, area under the concentration-time profile for the dosing interval, half-life, clearance, and volume of distribution. Conclusions: In this medically complex heart failure patient population, use of narrow therapeutic index drugs can have detrimental consequences if they are not dosed appropriately. This study will provide practitioners more insight in perioperative dosing regimens for VAD patients by understanding how serum drug levels may be altered with VAD therapy.

Utilization of COVID-19 positive donors for heart transplantation and associated short-term outcomes

The safety and efficacy of using COVID-19 positive donors in heart transplantation (HT) are increasingly relevant, but not well established. The present study evaluated the characteristics and utilization of such donors and associated post-HT outcomes. All adult (≥18 years old) potential donors and HT recipients in the United States from April 21, 2020 to March 31, 2022 were included. Donor COVID-19 status was defined by the presence (or absence) of any positive test within 21 days of organ recovery. Donor and recipient characteristics and post-HT outcomes, including a primary composite of death, graft failure, and re-transplantation, were compared by donor COVID-19 status. Of 967 COVID-19(+) potential donors, 19.3% (n=187) were used for HT compared to 26.7% (n=6277) of COVID-19(-) donors (p < 0.001). Transplanted COVID-19(+) vs COVID-19(-) donors were younger, but otherwise were similar. Recipients of hearts from COVID-19+ vs COVID-19(-) donors less frequently received pre-HT inotropes (24.1% vs 31.7%, p=0.023) and ventricular assist device therapy (29.7% vs 36.8%, p=0.040). There were no significant differences in any post-HT outcome by donor COVID-19 status, including the primary composite outcome at 90 days (5.4% vs 5.6%, p=0.91). Among COVID-19(+) donors, the presence of a subsequent negative test prior to transplant was not associated with posttransplant outcomes. Our results suggest that carefully selected COVID-19 positive donors may be used for HT with no difference in short-term post-transplant outcomes. Additional data regarding donor and recipient treatments and impact of vaccination should be collected to better inform our use of organs from COVID(+) donors.

End-of-Life in Pediatric Patients Supported by Ventricular Assist Devices: A Network Database Cohort Study.

Most pediatric patients on ventricular assist device (VAD) survive to transplantation. Approximately 15% will die on VAD support, and the circumstances at the end-of-life are not well understood. We, therefore, sought to characterize patient location and invasive interventions used at the time of death. Retrospective database study of a cohort meeting inclusion criteria. Thirty-six centers participating in the Advanced Cardiac Therapies Improving Outcomes Network (ACTION) Registry. Children who died on VAD therapy in the period March 2012 to September 2021. None. Of the 117 of 721 patients (16%) who died on VAD, the median (interquartile range) age was 5 years (1-16 yr) at 43 days (17-91 d) postimplant. Initial goals of therapy were bridge to consideration for candidacy for transplantation in 60 of 117 (51%), bridge to transplantation in 44 of 117 (38%), bridge to recovery 11 of 117 (9%), or destination therapy (i.e., VAD as the endpoint) in two of 117 (2%). The most common cause of death was multiple organ failure in 35 of 117 (30%), followed by infection in 12 of 117 (10%). Eighty-five of 92 (92%) died with a functioning device in place. Most patients were receiving invasive interventions (mechanical ventilation, vasoactive infusions, etc.) at the end of life. Twelve patients (10%) died at home. One-in-six pediatric VAD patients die while receiving device support, with death occurring soon after implant and usually from noncardiac causes. Aggressive interventions are common at the end-of-life. The ACTION Registry data should inform future practices to promote informed patient/family and clinician decision-making to hopefully reduce suffering at the end-of-life.

Clinical outcomes of continuous flow left ventricular assist device therapy as bridge to transplant strategy in muscular dystrophy: a single-center study.

In muscular dystrophies (MD) patients with end-stage heart failure (HF), continuous flow left ventricular assist device (cf-LVAD) therapy is still controversial due to a progressive nature of MD-associated muscle weakness. All the MD patients who had cf- VAD implants between March 2013 and August 2019 in our hospital were retrospectively studied. Study end points were death, major LVAD-associated complications or respiratory dysfunction caused by muscular weakness. A total of 11 MD patients (Becker type: n = 6; Emery-Dreifuss Myodystrophy: n = 2; Fukuyama subtype: n = 1; Limb-girdle 1B: n = 2) were enrolled. median age 41years (IQR; 29-47); median Japanese Registry for Mechanically Assisted Circulatory Support: level 3 (2-3); a median interval between MD diagnosis and LVAD implantation 9years (6-18). The pulmonary function test at LVAD implantation showed a median of %VC; 62% (45-82), FEV1%, 82% (81-88). Survival to discharge was 100% without pulmonary complication and early VAD-related complications. During a median follow-up of 38months (27-53), re-admissions were needed due to device infection (n = 2), cerebrovascular accidents (disabling, n = 2 and non-disabling, n = 2), ventricular tachycardia (n = 4), and right HF (n = 3), respectively. 7 patients received successful heart transplant after a median waiting time of 44months (34-61); 3 patients are still on the waiting list (waiting time: 21, 38, and 39months). One patient died of right HF 15months after VAD implantation. No one had overt pulmonary dysfunction during LVAD support. In selected MD patients with end-stage HF, cf-LVAD therapy is a viable therapeutic option as bridge to heart transplant.

Interventricular-Septal Output While Supported on Left Ventricular Assist Device Therapy.

The effects of left ventricular unloading on septal function in patients with left ventricular assist devices (LVADs) have not been well characterized in vivo. The purpose of this study was to evaluate the relationship between markers of septal function with echocardiography in relationship to RV dysfunction and late RV failure after LVAD implantation. A retrospective study was conducted of patients supported on centrifugal-flow LVADs implanted over a 10-year period. Echocardiographic data were collected pre-operatively and up to 2 years after implantation. Interventricular septum (IVS) measurements were taken at end-systole and end-diastole. Interventricular-septal output (ISO) was calculated using the formula: (IVSs-IVSd)×heart rate. A total of 110 patients were included. An immediate and sustained reduction in both lateral annulus systolic velocity (RVS') and TAPSE were observed after implant ( p < 0.0001). However, ISO gradually decreased over time ( p < 0.0001). While ISO was not predictive of late RV failure, a decrease in ISO by 25% or greater from pre-implant to hospital discharge was associated with late RV failure (OR 4.8; 95% CI, 1.4-16.5; p = 0.012) even after adjusting for relevant clinical variables ( p ≤ 0.01 for each model). RV function is known to be influenced by mechanical ventricular interdependence and we demonstrate that measurement of ISO may be a useful marker in assessing RV dysfunction and predicting RV failure in patients following LVAD implantation.

Surgical Treatment of Tricuspid Valve Regurgitation in Patients Undergoing Left Ventricular Assist Device Implantation: Interim analysis of the TVVAD trial

ObjectivesRight heart failure remains a serious complication of left ventricular assist device therapy. Many patients presenting for left ventricular assist device implantation have significant tricuspid regurgitation. It remains unknown whether concurrent tricuspid valve surgery reduces postoperative right heart failure. The primary aim was to identify whether concurrent tricuspid valve surgery reduced the incidence of moderate or severe right heart failure within the first 6 months after left ventricular assist device implantation. MethodsPatients with moderate or severe tricuspid regurgitation on preoperative echocardiography were randomized to left ventricular assist device implantation alone (no tricuspid valve surgery) or with concurrent tricuspid valve surgery. Randomization was stratified by preoperative right ventricular dysfunction. The primary end point was the frequency of moderate or severe right heart failure within 6 months after surgery. ResultsThis report describes a planned interim analysis of the first 60 randomized patients. The tricuspid valve surgery group (n = 32) had mild or no tricuspid regurgitation more frequently on follow-up echocardiography studies compared with the no tricuspid valve surgery group (n = 28). However, at 6 months, the incidence of moderate and severe right heart failure was similar in each group (tricuspid valve surgery: 46.9% vs no tricuspid valve surgery: 50%, P = .81). There was no significant difference in postoperative mortality or requirement for right ventricular assist device between the groups. There were also no significant differences in secondary end points of functional status and adverse events. ConclusionsThe presence of significant tricuspid regurgitation before left ventricular assist device is associated with a high incidence of right heart failure within the first 6 months after surgery. Tricuspid valve surgery was successful in reducing postimplant tricuspid regurgitation compared with no tricuspid valve surgery but was not associated with a lower incidence of right heart failure.