Durable LVAD Research Articles

Impact of mechanical circulatory support on in-hospital outcomes among patients with ventricular tachycardia requiring ablation.

Ventricular tachycardia (VT) ablation is a high-risk procedure, particularly due to the potential for hemodynamic instability. Mechanical circulatory support (MCS) is increasingly utilized to manage these risks. This study investigated the in-hospital outcomes of VT ablation with MCS use, emphasizing its impact on mortality and procedural complications. We retrospectively analyzed patients undergoing VT ablation from 2019 to 2020, using the National Inpatient Sample data. Patients aged 18 years and over were included. MCS includes a percutaneous left ventricular assist device (pLVAD), extracorporeal membrane oxygenation (ECMO), and intraaortic balloon pump (IABP). We also conducted a subgroup analysis for patients experiencing cardiogenic shock (CS). The primary outcome was in-hospital mortality; secondary outcomes included acute kidney injury (AKI), AKI-requiring dialysis, any bleeding events, gastrointestinal bleeding, ischemic stroke, heart transplant, and durable LVAD (dLVAD) utilization. We included 14 450 patients, of whom 6.5% utilized MCS. The MCS group showed a higher in-hospital mortality rate than the non-MCS group (24% vs. 2%, p < 0.01). Secondary outcomes showed statistically higher rates in the MCS group compared to the non-MCS groups. Stratification by MCS modality did not affect outcomes except that pLVAD was associated with lower rates of AKI. In the CS subgroup, the MCS group exhibited significantly higher mortality compared to the non-MCS group (32% vs. 8.4%, p < 0.01). The use of MCS during VT ablation is associated with increased in-hospital mortality, underscoring the severity of cases requiring such support. These findings show the need for careful assessment and optimal usage of MCS to enhance patient outcomes.

Mechanical circulatory support for cardiogenic shock during the peripartum period.

Cardiomyopathies account for more than half of the cardiovascular disease during the peripartum period. In the extreme, patients may present with cardiogenic shock (CS) requiring mechanical circulatory support (MCS). The aim of this study was to report our experience with CS requiring MCS in the peripartum period. We present a single-center retrospective analysis of all CS cases involving MCS during the peripartum period that occurred between 2012 and 2023. Eleven cases were included. Median age was 33, median BMI was 30.4, and 73% underwent a caesarian-section for delivery. CS presentation occurred in 36.4% during pregnancy and in 63.6% after delivery. Most patients were in Society for Cardiovascular Angiography & Interventions (SCAI) Stage C shock and in 37% the suspected etiology was peripartum cardiomyopathy. MCS usage included intra-aortic balloon pump (4), Impella microaxial blood pump (2), veno-arterial extracorporeal membrane oxygenation (6), and temporary right ventricle assist devices (2), with some patients having multiple MCS devices. The rate of major complications was 36.4%. During a median follow-up of 4.5 years, 7 patients had sustained cardiac recovery (63.6%), 1 patient (9.1%) underwent cardiac transplantation, 2 patients (18.2%) received a durable LVAD, and 2 (18.2%) have died. MCS in severe CS cases during the peripartum period is rare and associated with favorable outcomes. High recovery rates suggest favoring first MCS/LVAD over transplant.

Influence of implantation strategy in the transition from temporary left ventricular assist device to durable mechanical circulatory support.

Bridging from temporary microaxial left ventricular assist device (tLVAD) to durable left ventricular assist device (dLVAD) is playing an increasing role in the treatment of terminally ill heart failure patients. Scant data exits about the best implantation strategy. The aim of this study is to analyze differences in dLVAD implantation technique and effects on patient outcomes. Data from 341 patients (19 European centers), between 01/2017 and 10/2022, who underwent bridge to bridge implantation from tLVAD to dLVAD were retrospectively analyzed. The outcomes of the different implantation techniques on cardiopulmonary bypass (CPB), extracorporeal life support (ECLS) or tLVAD were compared. Durable LVAD implantation was performed employing CPB in 70% of cases (n = 238, group 1), ECLS in 11% (n = 38, group 2) and tLVAD in 19% (n = 65, group 3).Baseline characteristics showed no significant differences in age (p = 0.140), BMI (p = 0.388), creatinine (p = 0.659), Meld score (p = 0.190) and rate of dialysis (p = 0.110). Group 3 had significantly less patients with preoperatively invasive ventilation and cardiopulmonary resuscitation before tLVAD implantation (p = 0.009 and p < 0.001 respectively). Concomitant procedures were performed more often in group 1 and 2 compared to group 3 (24%, 37% and 5%, respectively, p < 0.001).The 30-day mortality showed a significant better survival after inverse probability of treatment weighting in group 3, but the 1-year mortality showed no significant differences between groups (p = 0.012 and 0.581, respectively).Post-operative complications like rate of RVAD implantation or re-thoracotomy due to bleeding, post-operative respiratory failure and renal replacement therapy showed no significant differences between groups.Freedom from first adverse event like stroke, driveline infection or pump thrombosis during follow-up was not significantly different between groups.Post-operative blood transfusion within 24-hours were significantly higher in groups 1 and 2 compared to surgery on tLVAD support (p < 0.001 and p = 0.003, respectively). In our analysis, the transition from tLVAD to dLVAD without further circulatory support did not show a difference in post-operative long-term survival, but a better 30-day survival was reported. The implantation by using only tLVAD showed a reduction in post-operative transfusion rates, right heart failure and the re-thoracotomy rate without increasing the risk of postoperative stroke or pump thrombosis. In this small cohort study, our data supports the hypothesis that we could demonstrate dLVAD implantation on tLVAD is a safe and feasible technique in selected patients.

Late Follow-up for a Randomized Trial of Surgical Treatment of Tricuspid Valve Regurgitation in Patients Undergoing Left Ventricular Assist Device Implantation

ObjectivesWe previously reported that concurrent tricuspid valve surgery (TVS) was not associated with a lower incidence of early RHF among patients undergoing durable LVAD implantation. This is a follow-up analysis to further define the clinical impact of concurrent TVS within 12-months of follow-up. MethodsPatients with moderate or severe TR on pre-operative echocardiography (n=71) were randomized to either LVAD implantation alone (No TVS, n=34) or with concurrent TVS (TVS, n=37). Randomization was stratified by pre-operative right ventricular dysfunction. Patients were followed for at least 12-months after surgery. The incidence of RHF was determined using INTERMACS criteria by an adjudication committee. Functional studies and repeat echocardiography were performed at 12-months. ResultsDemographics were similar between the two arms. At 12-months, the rate of moderate or severe RHF was 50.0% (No TVS) versus 51.4% (TVS). No patients developed RHF between 6- and 12-months following the procedure. Death from RHF was 5.4% (TVS) versus 8.8% (No TVS). At 12-months, there was no significant difference in TR severity between the two arms due to improvement in TR severity in the No TVS arm. On cardiopulmonary exercise testing at 12+ months, there was no significant difference in peak oxygen consumption. ConclusionsIn patients with significant pre-implant TR, the severity of TR improved over time in the LVAD implantation alone arm. By 12-months, there is no significant difference in TR severity between the two arms. This may account for the lack of difference in late clinical or functional parameters.

Heartmate 3 Left Ventricular Assist Device Bend Relief Disconnection Causing Laceration of the Outflow Graft.

As technology in mechanical circulatory support continues to advance, so does the utilization of durable left ventricular assist devices (LVADs). We present the first reported case of HeartMate 3 (HM3) LVAD bend relief disconnection causing laceration of the outflow graft. Our patient is a 34 year old male with end-stage heart failure status post-HM3 implantation with recent debridement of a driveline infection who presented with weakness and sanguineous drainage 5 days after an episode of heavy lifting associated with a palpable substernal pop. During the initial evaluation, he experienced sudden massive decompression of a left chest hematoma through a thoracotomy incision with exsanguinating hemorrhage and an abrupt drop in LVAD flow. An emergent anterolateral thoracotomy was performed where it was discovered that the bend relief was disconnected and had lacerated the outflow graft. The graft was repaired and the ring was removed using a diamond blade rotary saw. He was discharged home and made a full recovery. Mechanical device malfunction has been documented in several prior versions of durable LVADS. Although there have been reported cases in the Heartmate 2, this is the first reported case of a HM3 bend relief disconnection and resultant laceration of the outflow graft.

The double barrel Impella exchange: A reliable method for uninterrupted mechanical circulatory support

Classic Impella exchange interrupts flow when the old device is pulled into the aorta before advancing the new device across the aortic valve, threatening circulatory collapse and loss of left ventricular access. In “double barrel,” uninterrupted Impella exchange, the new device is placed into the ventricle alongside the old, where flow is first transitioned completely. Of thirty-one consecutive patients undergoing this procedure, none experienced intraoperative cardiac arrest and 96.8% (30/31) had no new aortic insufficiency. One vascular complication ensued following known preoperative iliac injury. One patient suffered nonembolic stroke; another had subarachnoid hemorrhage. Fifty-five percent (17/31) of patients survived, with 22.6% (7/31) recovering, 25.8% (8/31) undergoing transplant, and 6.5% (2/31) transitioning to durable LVAD. Impella-only survival (83.3%, 10/12) was significantly higher than Impella-ECMO survival (36.8%, 7/19) (OR 14.46, 95% CI 1.74-119.93, p=0.01). We conclude “double barrel” technique is reliable in device-dependent cardiogenic shock patients, offering significant advantage and minimal risk.

Impact of intra-aortic balloon pump diastolic augmentation on survival in patients with cardiogenic shock

Abstract Funding Acknowledgements Type of funding sources: Other. Main funding source(s): PI funded - Jason Katz, MD Background Temporary MCS devices are routinely used in pts with CS. The most commonly used temporary MCS device worldwide is the IABP, which increases DBP, enhances coronary perfusion, and improves cardiac output. No randomized controlled trial has demonstrated its superiority over standard care practices and observational data suggest heterogeneity in its hemodynamic effect. IABP response likely depends on optimizing several pt- and device-related factors, most notably the ability to augment DBP. Unfortunately, a notable gap exists in defining the association of augmented DBP (aDBP) with mortality, and none of the contemporary clinical trials have systematically assessed this concept. Purpose In a cohort of pts with CS, the goal was to investigate the association between aDBP and survival in those supported with an IABP. Methods In a retrospective analysis of prospectively collected data from pts with CS who underwent IABP placement at Duke from 1/2010-6/2021 we describe baseline characteristics and discharge outcomes stratified by aDBP. Pre-insertion DBP was measured immediately prior to IABP, while post-insertion aDBP was collected 2 hrs following device placement. Success was defined as survival to hospital discharge. Death prior to discharge, hospice care, or escalation to ECMO, Impella, durable LVAD, or heart transplant were all considered a non-successful result. A multivariate logistic regression model was created to assess the association of aDBP on outcome, adjusting for pre-IABP DBP, age, sex, race, history of MI and HF. Results 514 CS pts were identified, of which 470 (91%) had available pre-insertion DBP and post-insertion aDBP. The modal age was 65-74 yrs, 75% were male, 54% were white, 85% had prior HF, and 34% had prior MI. Figure 1A shows the distribution of pre-insertion DBP (median 67 mmHg) and post-insertion aDBP (median 106 mmHg). Overall, 49% of pts had a successful outcome. There was a u-shaped relationship between aDBP and the likelihood of success; as an example, for a modeled pt (65-75yo male, pre-insertion DBP of 66 mmHg, no HF or MI), the predicted probability of a successful outcome increased from 10% to 65% as aDBP rose to 120 mmHg, followed by a subsequent decline (Figure 1B). The relationship between either absolute or relative change in aDBP over baseline, on the other hand, was no longer u-shaped, but rather linear. After multivariate adjustment, only aDBP was associated with success such that every 10mmHg increase in aDBP over baseline was associated with improved survival to hospital discharge (OR 1.12, p=0.03). Conclusions In a cohort of pts with CS managed with an IABP, we report for the first time that aDBP is associated with improved survival to hospital discharge. Future prospective and randomized analyses should aim to capture degree of augmentation when studying counterpulsation devices, and this may help to clarify the currently controversial role of the IABP in contemporary CS care.

(1092) - Comparison of Hemodynamics in Patients Bridged to Transplant with Temporary vs Durable LVAD

(1092) - Comparison of Hemodynamics in Patients Bridged to Transplant with Temporary vs Durable LVAD

(156) - Myocardial Functional Improvement is Associated with Improved HF-Related Outcomes in Patients While on Durable LVAD: An STS INTERMACS Analysis

(156) - Myocardial Functional Improvement is Associated with Improved HF-Related Outcomes in Patients While on Durable LVAD: An STS INTERMACS Analysis

(244) - Impact of Hemolysis During Micro-Axial Flow Pump Support on Early Outcomes After Durable LVAD Implantation: Insights from an International Registry

(244) - Impact of Hemolysis During Micro-Axial Flow Pump Support on Early Outcomes After Durable LVAD Implantation: Insights from an International Registry

(833) - The Impact of Body Surface Area and Left Ventricular Size on Outcomes Following Durable LVAD Implantation

(833) - The Impact of Body Surface Area and Left Ventricular Size on Outcomes Following Durable LVAD Implantation

(772) - Incidence of Moderate and Severe Primary Graft Dysfunction in DBD vs. DCD Heart Transplantation in Patients with Pre-Existing Durable LVAD Support

(772) - Incidence of Moderate and Severe Primary Graft Dysfunction in DBD vs. DCD Heart Transplantation in Patients with Pre-Existing Durable LVAD Support

(580) - Impact of Stroke After Durable LVAD Implantation in Patients Bridged with Micro-Axial Flow Pump: Insights from an International Registry

(580) - Impact of Stroke After Durable LVAD Implantation in Patients Bridged with Micro-Axial Flow Pump: Insights from an International Registry

(1291) - Complex Management of a Young Cardiomyopathy Patient Leading to Durable LVAD

(1291) - Complex Management of a Young Cardiomyopathy Patient Leading to Durable LVAD

(471) - Pre-Operative INTERMACS Profile as a Predictor of Outcomes in Durable LVAD Patients in the Modern Era

(471) - Pre-Operative INTERMACS Profile as a Predictor of Outcomes in Durable LVAD Patients in the Modern Era

Left ventricular assist devices: yesterday, today, and tomorrow.

The shortcomings of expense, power requirements, infection, durability, size, and blood trauma of current durable LVADs have been recognized for many years. The LVADs of tomorrow aspire to be fully implantable, durable, mitigate infectious risk, mimic the pulsatile nature of the native cardiac cycle, as well as minimize bleeding and thrombosis. Power draw, battery cycle lifespan and trans-cutaneous energy transmission remain barriers to completely implantable systems. Potential solutions include decreases in pump electrical draw, improving battery lifecycle technology and better trans-cutaneous energy transmission, potentially from Free-range Resonant Electrical Energy Delivery. In this review, we briefly discuss the history of LVADs and summarize the LVAD devices in the development pipeline seeking to address these issues.

Access to durable LVAD therapy for patients with limited social support: Surveying program-specific approaches

Racial and ethnic disparities in provision of LVAD therapy have been identified. These disparities may be at least partially related to socioeconomic factors, including social support networks and financial constraints. This study aimed to identify specific barriers, and variations in institutional approaches, to the provision of equitable care to underserved populations. A survey was administered to 237 LVAD program personnel, including physicians, LVAD coordinators and social workers, at more than 100 LVAD centers across 7 countries. Three-fourths of respondents reported that their program required a support person to live with the LVAD patient for some period of time following implantation. In addition, 31% of respondents reported that patients with the inability to pay for medications are turned down at their program. The most significant barriers to successful LVAD implantation were lack of social support, lack of insurance and lack of timely referral. The most consistently identified supports needed from the hospital system for success in underserved populations were the provision of a solution for patient transportation to and from hospital visits and the provision of financial support. This survey highlights the challenges facing LVAD programs that care for underserved patient populations, and sets the stage for specific interventions aimed at reducing disparities in access to care.

Impact of post-transplant stroke and subsequent functional independence on outcomes following heart transplantation under the 2018 United States heart allocation system

This study evaluates the clinical trends, risk factors, and effects of post-transplant stroke and subsequent functional independence on outcomes following orthotopic heart transplantation under the 2018 heart allocation system. The United Network for Organ Sharing registry was queried to identify adult recipients from October 18, 2018 to December 31, 2021. The cohort was stratified into 2 groups with and without post-transplant stroke. The incidence of post-transplant stroke was compared before and after the allocation policy change. Outcomes included post-transplant survival and complications. Multivariable logistic regression was performed to identify risk factors for post-transplant stroke. Sub-analysis was performed to evaluate the impact of functional independence among recipients with post-transplant stroke. A total of 9,039 recipients were analyzed in this study. The incidence of post-transplant stroke was higher following the policy change (3.8% vs 3.1%, p=0.017). Thirty-day (81.4% vs 97.7%) and 1-year (66.4% vs 92.5%) survival rates were substantially lower in the stroke cohort (p<0.001). The stroke cohort had a higher rate of post-transplant renal failure, longer hospital length of stay, and worse functional status. Multivariable analysis identified extracorporeal membrane oxygenation, durable left ventricular assist device, blood type O, and redo heart transplantation as strong predictors of post-transplant stroke. Preserved functional independence considerably improved 30-day (99.2% vs 61.2%) and 1-year (97.7% vs 47.4%) survival rates among the recipients with post-transplant stroke (p<0.001). There is a higher incidence of post-transplant stroke under the 2018 allocation system, and it is associated with significantly worse post-transplant outcomes. However, post-transplant stroke recipients with preserved functional independence have improved survival, similar to those without post-transplant stroke.

Test Bench for Right Ventricular Failure Reversibility: The Hybrid BiVAD Concept.

When heart transplantation and myocardial recovery are unlikely, patients presenting with biventricular cardiogenic shock initially treated with extracorporeal membrane oxygenation (ECMO) may benefit from a mechanical support upgrade. In this scenario, a micro-invasive approach is proposed: the combination of the double-lumen ProtekDuo cannula (Livanova, London, UK) and the Impella 5.5 (Abiomed, Danvers, MA) trans-aortic pump that translates into a hybrid BiVAD. All consecutive ECMO patients presenting with biventricular cardiogenic shock and ineligibility to heart transplantation from August 2022 were prospectively enrolled. The clinical course, procedural details, and in-hospital events were collected via electronic medical records. A total of three patients, who were temporarily not eligible for heart transplantation or durable LVAD due to severe acute pneumonia and right ventricular (RV) dysfunction, were implanted with a hybrid BiVAD. This strategy provided high-flow biventricular support while pulmonary function ameliorated. Moreover, by differentially sustaining the systemic and pulmonary circulation, it allowed for a more adequate reassessment of RV function. All the patients were considered eligible for isolated durable LVAD and underwent less invasive LVAD implantation paired with a planned postoperative RVAD. In all cases, RV function gradually recovered and the RVAD was successfully removed. The Hybrid BiVAD represents an up-to-date micro-invasive mechanical treatment of acute biventricular failure beyond ECMO. Its rationale relies on more physiological circulation across the lungs, the complete biventricular unloading, and the possibility of including an oxygenator in the circuit. Finally, the independent and differential control of pulmonary and systemic flows allows for more accurate RV function evaluation for isolated durable LVAD eligibility reassessment.

Revisiting Pulmonary Hypertension in the Era of Temporary Mechanical Circulatory Support – Literature Review and Case-Based Discussion

Pulmonary arterial hypertension (PAH) is characterized by persistently increased pressure in the pulmonary arteries. New defining criteria for the different hemodynamic types of pulmonary hypertension (PH) that occur with left heart disease have been proposed by the task force on PH. After consideration of the changes in the general definition of PH in left heart disease, the proposed hemodynamic definition was: (1) isolated postcapillary PH: pulmonary artery wedge pressure >15 mm Hg and mean pulmonary arterial pressure (mPAP) >20 mm Hg and pulmonary vascular resistance (PVR) <3 Woods units (WU); and (2) combined post- and precapillary PH: pulmonary artery wedge pressure >15 mm Hg, mPAP >20 mm Hg, and PVR ≥3 WU. Secondary PH is initially reversible, but eventually, it can become fixed because of the remodeling process of the pulmonary vascular system. Limitations in defining both the time for and amount of reversibility lack clarity. We discuss a case of PH as a framework to better understand these key principles in addressing patients' candidacy for heart or heart-lung transplantation. We performed a literature search for all available contemporary data with the following terms: "pulmonary hypertension," "reversal," "Impella 5.5," "temporary mechanical support," and "LVAD" using the National Library of Medicine - PubMed and PubMed Central between 2019 and 2023. A total of 14 published papers were found with these search. From these, 3 addressed the issue of PH and reversibility in the setting of LHD after durable LVAD placement. No papers were found using Impella 5.5 and PH during this timeframe. Given the paucity of data in the field regarding temporary mechanical circulatory support and pulmonary hypertension, we present a case-based discussion to guide the reader in understanding the potential impact of this method in patients with WHO Class 2 Pulmonary hypertension. A 49-year-old woman with a medical history of acute on chronic biventricular systolic and diastolic heart failure, American College of Cardiology stage D, Stevenson profile C, New York Heart Association class IV (ejection fraction 18%) secondary to nonischemic cardiomyopathy after cardiac resynchronization therapy, pulmonary hypertension, bilateral deep vein thrombosis, and segmental pulmonary embolism presented for heart transplant evaluation. Her cardiac output and central hemodynamics were measured, and she was found to have a pulmonary artery (PA) pressure of 78/38 with a mean PA pressure of 51, pulmonary capillary wedge pressure (PCWP) 30, transpulmonary pressure gradient (TPG) 21, thermodilution cardiac output (CO) 3.35 L/min, and cardiac input (CI) 1.75 L/min/m2. Her PVR was 6.2 WU. Provocative pharmacologic testing for reversibility of PH was performed using sodium nitroprusside, which resulted in a blood pressure of 83/57 (92), heart rate 92/min, and PA pressure of 71/31, with a mean PA pressure of 44 PCWP 22, TPG 22, CO 4.8 L/min, and CI of 2.48 L/min/m2 with a PVR of 4.5 WU. Following this, the patient underwent Impella 5.5 placement through the right axillary artery to optimize afterload reduction and improve end-organ perfusion. Post-Impella hemodynamics on milrinone 0.5 mcg/kg/min demonstrated the following: blood pressure 90/66 (74), heart rate 53/min, and PA pressure of 56/29, with a mean PA pressure of 38, PCWP 24, TPG 14, CO 6 L/min, and CI of 2.9 L/min/m2 with a PVR of 2.3 WU. Left ventricular assist device support with Impella 5.5 is associated with a reduction in mPAP and PVR over weeks to months and thus plays a crucial role as a bridge to transplant. Our case and this review highlights the characteristics of PH resulting from heart failure with reduced ejection fraction and discusses the important clinical issues related to the treatment of these patients. We have shown that left ventricular assist device therapy with Impella 5.5 can effectively reduce left-sided filling pressures and lead to PH improvement. We demonstrate the potential benefits of Impella 5.5 in the management of patients with WHO 2 PH and cardiogenic shock with impaired hemodynamics.