Use Of Left Ventricular Assist Devices Research Articles

Outcomes of implantable cardioverter-defibrillators in patients with a left ventricular assist device: a systematic review and meta-analysis

Abstract Introduction Implantable Cardioverter-Defibrillators (ICDs) improve survival in advanced heart failure with reduced ejection fraction (HFrEF) and prevent sudden cardiac death. However, the prognostic benefits of ICDs among patients with a Left Ventricular Assist Device (LVAD) remain uncertain and controversial. Therefore, we conducted a systematic review and meta-analysis to assess the effectiveness and safety of ICD implantation among LVAD recipients. Methods We performed a systematic review and meta-analysis following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. We searched PubMed and EMBASE for the peer-reviewed articles published in English assessing the impact of ICD implantation among LVAD recipients, till 10/01/2024. ICD implantation was defined as implantation before LVAD, simultaneous implantation with LVAD, or within 30 days of LVAD insertion. Two independent review authors assessed the quality and risk of bias of the included studies. A random-effect model was used to combine data in forest plots. The primary outcome was all-cause mortality associated with ICD implantation compared to no ICD implantation, and the secondary outcomes included ventricular arrhythmia (VT), and hemorrhagic stroke. Heterogeneity was assessed using Q test and I2, with I2 > 50% indicating marked heterogeneity. Results A total of 13 observational studies comprising 54571 recipients of LVAD were included in the analysis of the primary outcome. All-cause mortality was similar among patients with ICD versus no ICD (Odds Ratio [OR]= 0.77; 95% CI, 0.57-1.04, I2= 89%, P=0.09), as shown in Figure 1. Likewise, ICD implantation was associated with similar rates of VT and hemorrhagic stroke (VT: OR= 1.81, 95% Cl, 0.82-4.01, I2= 90%, P=0.14; hemorrhagic stroke: OR= 1.01, 95% Cl, 0.81-1.25, I2= 0%, P= 0.95). Conclusion Among patients with HFrEF and LVAD as advanced heart failure therapy, ICD implantation didn’t provide additional prognostic survival benefit, suggesting possible use of LVAD without ICD implantation.Figure 1.Forest plot of mortality

Reversibility of precapillary pulmonary hypertension and outcomes after heart transplantation bridged with left ventricular assist devices: insight from the UNOS

Abstract Background In light of the updated lowered threshold for diagnosing pulmonary hypertension (PH), the reversibility of precapillary PH with left ventricular assist device (LVAD) and the associated post heart transplantation (HT) outcomes remain unclear. Purpose and methods Using data from the United Network for Organ Sharing database, we aimed to investigate predictors of persistent precapillary PH in HT recipients bridged with LVAD, and examine the interrelated post-HT survival, using the updated pulmonary vascular resistance (PVR) cutoff of >2 WU for precapillary PH. Results Among 2169 HT recipients bridged with LVAD, 1299 had PVR>2 at baseline; 551 (42.4%) of whom normalized their PVR≤2 and 748 (57.6%) remained with elevated PVR>2 after LVAD implantation. Female sex (adjusted odds ratio [aOR] 2.22, 95% confidence interval [CI]:1.61-3.07, p<0.001) and inotropes-treatment at-listing (aOR 1.31, 95% CI: 1.03-1.66, p=0.028) were associated with persistently elevated PVR post LVAD. Conversely, longer duration of LVAD support (aOR 0.74, 95% CI: 0.65-.84, p<0.001) and use of HeartMate 2 (aOR 0.74, CI: 0.59-0. 93, p=0.011) were protective against persistently elevated PVR post-LVAD. Persistently elevated PVR >2 post-LVAD was associated with increased risk of death compared to those who normalized their PVR (adjusted hazard ratio [aHR] 1.26, 95% CI: 1.01-1.57, p=0.037). However, normalized PVR post-LVAD group had comparable survival to those with PVR≤2 at baseline (aHR 0.76, 95% CI: 0.57-1.02, p=0.07). Conclusions Many HT recipients bridged with LVAD remain with PVR>2 post-LVAD implantation, which is associated with increased risk of death post-HT compared to patients with normalized PVR post-LVAD.

Relationships between sex and in-hospital outcomes of patients with acute cardiogenic shock receiving mechanical circulatory support

BackgroundCardiovascular disease is the leading cause of mortality in women. Despite this there is a paucity of data on the impact of sex on utilization and outcomes of temporary mechanical circulatory support (tMCS) in patients hospitalized with Acute Myocardial Infarction (AMI) Cardiogenic Shock (CS). MethodsWe examined the 2016–2019 National Inpatient Sample database to identify cases of AMI-CS. Men were used as our control group, while women comprised our cohort. The primary outcome was in-hospital mortality. Secondary outcomes included the use of tMCS including; left ventricular assist device (LVAD) use, Impella use, and Intra-Aortic Balloon Pump (IABP) use, length of stay (LOS) and total hospitalization cost (THC). Multivariate linear and logistic regression models were used to adjust for confounders. ResultsAmong patients hospitalized for AMI (N = 2,622,939), 37.7 % were Female. A Female sex was associated with a higher inpatient mortality (adjusted OR [aOR] 1.06, p < 0.001), a lower likelihood of LVAD use (2.3 % vs. 2.9 % and p < 0.001), IABP use (3.0 % vs. 4.4 % and p < 0.001), Impella use (1.0 % vs. 1.5 % and p < 0.001), a longer mean LOS (4.4 vs 4.3 days and p < 0.001) and lower THC ($88,097 vs. $104,101, p < 0.001) compared to male patients for AMI-CS. ConclusionFemale patients admitted for AMI-CS were less likely to receive tMCS despite a higher mortality rate and a slightly longer LOS compared to male patients. Further studies are necessary to confirm these findings and elucidate clearer causality for such disparities.

Left ventricular assist device in the presence of subcutaneous implantable cardioverter defibrillator: data from a multicenter experience

Abstract Background Left ventricular assist devices (LVADs) are an increasingly used strategy for the management of patients with advanced heart failure (HF).Subcutaneous implantable cardioverter defibrillator (S-ICD) might be a viable alternative to conventional ICDs, with a lower risk of short- and long-term of device-related complications and infections. Purpose:The aim of this multicenter study was to evaluate the outcomes and management of S-ICD recipients who underwent LVAD implantation. Methods:The study population included patients with an S-ICD who underwent LVAD implantation for advanced HF despite optimal medical therapy. Results:The study population included 30 patients (25 male;median age 45 [38-52] years).The HeartMate III was the most common LVAD type. Median follow-up in the setting of concomitant use of S-ICDs and LVADs was 7 months (1-20).There were no reports of inability to interrogate S-ICD systems in this population.Electromagnetic interference (EMI) occurred in 21 (70%) patients.The primary sensing vector was the one most significantly involved in determining EMI.Twenty-seven patients (90%) remained eligible for S-ICD implantation with at least one optimal sensing vector.The remaining 3 patients (10%) were ineligible for S-ICD after attempts of reprogramming of sensing vectors. Six patients (20%) experienced inappropriate shocks due to EMI. Six patients (20%) experienced appropriate shocks.No S-ICD extraction because of need for antitachycardia pacing,ineffective therapy or infection was reported. Conclusions: Concomitant use of LVAD and S-ICD is feasible in most patients. However, the potential risk of EMI oversensing, IS,and undersensing in the post-operative period following LVAD implantation should be considered.Careful screening for EMI should be performed in all sensing vectors after LVAD implantation.

LVAD as a Bridge to Transplantation-Current Status and Future Perspectives.

Heart failure (HF) is a common disease associated with high morbidity and mortality rates despite advanced pharmacological therapies. Heart transplantation remains the gold standard therapy for end-stage heart failure; however, its application is curtailed by the persistent shortage of donor organs. Over the past two decades, mechanical circulatory support, notably Left Ventricular Assist Devices (LVADs), have been established as an option for patients waiting for a donor organ. This comprehensive review focuses on elucidating the benefits and barriers associated with this application. We provide an overview of landmark clinical trials that have evaluated the use of LVADs as a bridge to transplantation therapy, with a particular focus on post-transplant outcomes. We discuss the benefits of stabilizing patients with these systems, weighing associated complications and limitations. Further technical advancements and research on optimal implantation timing are critical to ultimately improve outcomes and securing quality of life. In a world where the availability of donor organs remains constrained, LVADs are an increasingly important piece of patient care, bridging the critical gap to transplantation in advanced heart failure management.

Special Considerations for Advanced Heart Failure Surgeries: Durable Left Ventricular Devices and Heart Transplantation.

Heart transplantation and durable left ventricular assist devices (LVADs) represent two definitive therapies for end-stage heart failure in the modern era. Despite technological advances, both treatment modalities continue to experience unique risks that impact surgical and perioperative decision-making. Here, we review special populations and factors that impact risk in LVAD and heart transplant surgery and examine critical decisions in the management of these patients. As both heart transplantation and the use of durable LVADs as destination therapy continue to increase, these considerations will be of increasing relevance in managing advanced heart failure and improving outcomes.

Reversibility of precapillary pulmonary hypertension and outcomes after heart transplantation bridged with left ventricular assist devices: Insight from the United Network for Organ Sharing

BackgroundIn light of the updated lowered threshold for diagnosing pulmonary hypertension (PH), the reversibility of precapillary PH with left ventricular assist device (LVAD) and the associated post-heart transplantation (HT) outcomes remain unclear. MethodsUsing data from the United Network for Organ Sharing database, we aimed to investigate predictors of persistent precapillary PH in HT recipients bridged with LVAD and examine the interrelated post-HT survival using the updated pulmonary vascular resistance (PVR) cutoff of >2 Wood units for precapillary PH. ResultsAmong 2169 HT recipients bridged with LVAD, 1299 had PVR >2 at baseline; 551 (42.4%) of whom normalized their PVR ≤2 and 748 (57.6%) remained with elevated PVR >2 after LVAD implantation. Female sex (adjusted odds ratio [aOR]; 2.22, 95% confidence interval [CI], 1.61-3.07; P < .001) and inotrope treatment at listing (aOR, 1.31; 95% CI, 1.03-1.66; P = .028) were associated with persistently elevated PVR after LVAD. Conversely, longer duration of LVAD support (aOR, 0.74; 95% CI, 0.65-0.84; P < .001) and use of HeartMate II (aOR, 0.74; CI, 0.59-0.93; P = .011) were found to be protective against persistently elevated PVR after LVAD. Persistently elevated PVR >2 after LVAD was associated with increased risk of death compared with those who normalized their PVR (adjusted hazard ratio [aHR], 1.26; 95% CI, 1.01-1.57; P = .037). However, the normalized PVR post-LVAD group had comparable survival with those with PVR ≤2 at baseline (aHR, 0.76; 95% CI, 0.57-1.02; P = .07). ConclusionsMany recipients of HT bridged with LVAD remain with PVR >2 after LVAD implantation, which is associated with increased risk of death after HT compared with patients with normalized PVR after LVAD.

Left ventricular assist device and transcatheter edge-to-edge mitral valve repair in advanced heart failure: allies or enemies?

The implantation of left ventricular assist devices (LVADs) has been increasing, with good long-term results, in parallel with a growing population with advanced heart failure (HF). However, in some European countries, LVADs are still underused, with one of the main issues being the patient's late referral. On the contrary, the use of transcatheter edge-to-edge mitral valve repair (TEER) has exponentially increased over the past decade, expanding its potential use even in patients on the heart transplantation waiting list. Even though the study populations of the main trials that investigated the prognostic impact of LVAD and TEER are different, in clinical practice a clear distinction might not be so clear. Therefore, patients with refractory HF symptoms and significant mitral regurgitation should be thoroughly evaluated through a multidisciplinary Heart Team meeting with both an advanced HF specialist and interventional cardiologist, to avoid futile procedures and to define the optimal timing for advanced HF therapies, when they are indicated. We analyzed the main available studies and registries on both TEERs and LVADs and we compared their populations and outcomes, to provide the current evidence on the use of LVAD and TEER in the HF population, especially in the light of the recently released 5-year follow-up results, giving some insights on the Italian situation, and finally to stress the importance of a solid HF network between hospitals, aiming for advanced HF patients' timely referral for LVAD or heart transplants.

Disparities by Sex, Race, and Ethnicity in Use of Left Ventricular Assist Devices and Heart Transplants Among Patients With Heart Failure With Reduced Ejection Fraction.

The extent to which sex, racial, and ethnic groups receive advanced heart therapies equitably is unclear. We estimated the population rate of left ventricular assist device (LVAD) and heart transplant (HT) use among (non-Hispanic) White, Hispanic, and (non-Hispanic) Black men and women who have heart failure with reduced ejection fraction (HFrEF). We used a retrospective cohort design combining counts of LVAD and HT procedures from 19 state inpatient discharge databases from 2010 to 2018 with counts of adults with HFrEF. Our primary outcome measures were the number of LVAD and HT procedures per 1000 adults with HFrEF. The main exposures were sex, race, ethnicity, and age. We used Poisson regression models to estimate procedure rates adjusted for differences in age, sex, race, and ethnicity. In 2018, the estimated population of adults aged 35 to 84 years with HFrEF was 69 736, of whom 44% were women. Among men, the LVAD rate was 45.6, and the HT rate was 26.9. Relative to men, LVAD and HT rates were 72% and 62% lower among women (P<0.001). Relative to White men, LVAD and HT rates were 25% and 46% lower (P<0.001) among Black men. Among Hispanic men and women and Black women, LVAD and HT rates were similar (P>0.05) or higher (P<0.01) than among their White counterparts. Among adults with HFrEF, the use of LVAD and HT is lower among women and Black men. Health systems and policymakers should identify and ameliorate sources of sex and racial inequities.

Abstract 18632: Mechanical Circulatory Support in Patients Without Cardiogenic Shock Undergoing Percutaneous Coronary Intervention

Background: The use of mechanical circulatory support (MCS) devices for high-risk percutaneous coronary intervention (PCI) has increased over the last decade. However, data on outcomes between MCS device type have been mixed and long-term outcomes are limited. Our aim was to examine the association between intravascular microaxial left ventricular assist device (LVAD) or intra-aortic balloon pump (IABP) use in patients without cardiogenic shock undergoing PCI. Methods: This retrospective study analyzed administrative claims data from a large, insured population across the United States. Patients who underwent PCI without cardiogenic shock from 4/1/2016 to 7/31/2022 were included. Using inverse probability treatment weighting (IPTW), we assessed for the association between device type and all-cause mortality during the index admission, 30-days, and up to 1-year. Secondary outcomes included stroke, bleeding, incident dialysis, repeat revascularization, and total healthcare costs. Results: We identified 2,879 patients undergoing PCI without cardiogenic shock, the mean (SD) age was 68.2 (12.5) years, 27% (n=764) were women, and 61% (n=1,757) had a primary diagnosis of acute myocardial infarction (AMI). After IPTW, intravascular LVAD use was not associated with a statistically significant difference in in-hospital (Odds ratio [OR] 1.30; 95% Confidence interval [CI]: 0.88-1.91, P =0.19) or 30-day (OR 1.19; 95% CI:0.84-1.69, P =0.33) mortality compared to IABP use. At 1-year, intravascular LVAD use was associated with a significant increase in mortality (Hazard ratio 1.23; 95% CI:1.04-1.46, P =0.01). Compared to those receiving an IABP, index admission mean total costs ($81,970 vs. $65,298; P &lt;0.001) and mean monthly costs ($11,030 vs. $14,133; P &lt;0.001) up to 1-year were significantly higher in those receiving an intravascular LVAD. There was no significant association between device type and stroke, bleeding, incident dialysis, and repeat revascularization at any timepoint (all, P &gt;0.05). Conclusions: In patients without cardiogenic shock undergoing PCI, intravascular LVAD use was associated with higher costs but not associated with lower mortality. Randomized data is needed to improve device selection for these patients.

Impact of Frailty on Left Ventricular Assist Device Clinical Outcomes

Frailty is a clinical syndrome prevalent in older adults and carries poor outcomes in patients with heart failure.We investigated the impact of frailty on left ventricular assist device (LVAD) clinical outcomes. The Nationwide Readmission Database was used to retrospectively identify patients with a primary diagnosis of heart failure who underwent LVAD implantation during their hospitalization from 2014 to 2020. Patients were categorized into frail and nonfrail groups using the Hospital Frailty Risk Score. Cox and logistic regression were used to predict the impact of frailty on inpatient mortality, 30-day readmissions, length of stay, and discharge to a skilled nursing facility.LVADs were implanted in 11,465 patients who met the inclusion criteria. There was more LVAD use in patients who were identified as frail (81.6% vs 18.4%, p <0.001). The Cox regression analyses revealed that LVAD insertion was not associated with increased inpatient mortality in frail patients (hazard ratio 1.15, 95% confidence interval 0.81 to 1.65, p=0.427). Frail patients also did not experience a higher likelihood of readmissions within 30days (hazard ratio 1.15, 95% confidence interval 0.91 to 1.44, p=0.239).LVAD implantation did not result in a significant increase in inpatient mortality or readmission rates in frail patients compared with nonfrail patients. These data support continued LVAD use in this high-risk patient population.

Care and Monitoring of Pregnant Patients With Left Ventricular Assist Devices.

Cardiovascular disease is one of the leading causes of maternal mortality in the United States. Although still rare, pregnancy in patients with left ventricular assist devices (LVADs) is becoming more common. Typical indications for the use of LVADs in reproductive-aged females include ischemic cardiomyopathy, nonischemic (familial) dilated cardiomyopathy, peripartum cardiomyopathy, and some forms of myocarditis. An LVAD drains blood through a cannula placed into the apex of the left ventricle and then returns it to the proximal aorta bypassing the aortic valve allowing hemodynamic support in parallel with the native circulation. The physiologic changes associated with pregnancy, mainly increased blood volume and hypercoagulability, may adversely affect patients with LVADs, leading to many experts recommending against pregnancy. Maternal-fetal medicine specialists should have a central role within a multidisciplinary team required to provide optimal care for this high-risk group of patients.

The Association of the UNOS Heart Allocation Policy Change With Transplant and Left Ventricular Assist Device Access and Outcomes

In October 2018, the allocation policy for adult orthotopic heart transplant (OHTx) in the United States was changed, with the goal of reducing waitlist mortality and providing broader sharing of donor organs within the United States. This study aimed to assess the association of this policy change with changes in access to OHTx versus left ventricular assist devices (LVADs), overall and in key sociodemographic subgroups, in the United States from 2016 to 2019. We identified all patients receiving OHTx or LVAD between 2016 and 2019 using the National Inpatient Sample. Controlling for medical co-morbidities, prepolicy trends, and within-hospital-year effects, we fit a dynamic logistic regression model to evaluate patient and hospital factors associated with receiving OHTx versus LVAD before versus after policy change. We also examined the frequency of temporary mechanical circulatory support in the same fashion. We identified 2,264 patients who received OHTx and 3,157 who received LVADs during the study period. In its first year of implementation, the United Network for Organ Sharing policy change of 2018 was associated with no overall change utilization of OHTx versus LVAD. In OHTx recipients, the frequency of use of temporary mechanical circulatory support changed from 15.6% in the before period to 42.6% in the after period (p<0.001). Although the policy change was associated with differences in the odds of receiving an OHTx versus LVAD between different regions of the country, there were no significant changes based on age, gender, race/ethnicity, insurance status, or rurality. In conclusion, the United Network for Organ Sharing policy change on access to OHTx was associated with no overall change in OHTx versus LVAD use in its first year of implementation although we observed small changes in relative odds of transplant based on rurality. Shifts in regional allocation were not significant overall, although certain regions appeared to have a relative increase in their use of OHTx.

Clinical Outcomes of Left Ventricular Assist Device Pump Infection.

Few studies have focused on the clinical outcomes and risk factors of left ventricular assist device (LVAD) pump infection, and no standard treatment for LVAD pump infection has been established. Therefore, we used a therapeutic flowchart to manage LVAD pump infections. We retrospectively evaluated 220 patients who underwent continuous-flow LVAD implantation between January 2005 and March 2021 at Osaka University, Japan. First, we performed wound debridement, negative-pressure wound therapy, antibiotic treatment, and omental flap transposition. Subsequently, we administered conservative treatment, scheduled implantable LVAD exchange, or emergent removal of the implantable LVAD and exchange for extracorporeal LVAD or percutaneous LVAD (IMPELLA). Pump infections occurred in 32 patients. The survival rates of patients with pump infections during LVAD support were 93%, 74%, and 61% at 180 days, 1 year, and 2 years after LVAD pump infection, respectively. Fifteen patients underwent successful heart transplantation. Bridge-to-bridge surgery, preoperative use of venoarterial extracorporeal membrane oxygenation or percutaneous LVAD, high lactate dehydrogenase levels, and driveline infection were significantly associated with pump infection. Our study reveals that poor preoperative condition and driveline infection were significant risk factors for LVAD pump infection.

Comparative Effectiveness of Percutaneous Microaxial Left Ventricular Assist Device vs Intra-Aortic Balloon Pump or No Mechanical Circulatory Support in Patients With Cardiogenic Shock

Recent studies have produced inconsistent findings regarding the outcomes of the percutaneous microaxial left ventricular assist device (LVAD) during acute myocardial infarction with cardiogenic shock (AMICS). To compare the percutaneous microaxial LVAD vs alternative treatments among patients presenting with AMICS using observational analyses of administrative data. This comparative effectiveness research study used Medicare fee-for-service claims of patients admitted with AMICS undergoing percutaneous coronary intervention from October 1, 2015, through December 31, 2019. Treatment strategies were compared using (1) inverse probability of treatment weighting to estimate the effect of different baseline treatments in the overall population; (2) instrumental variable analysis to determine the effectiveness of the percutaneous microaxial LVAD among patients whose treatment was influenced by cross-sectional institutional practice patterns; (3) an instrumented difference-in-differences analysis to determine the effectiveness of treatment among patients whose treatment was influenced by longitudinal changes in institutional practice patterns; and (4) a grace period approach to determine the effectiveness of initiating the percutaneous microaxial LVAD within 2 days of percutaneous coronary intervention. Analysis took place between March 2021 and December 2022. Percutaneous microaxial LVAD vs alternative treatments (including medical therapy and intra-aortic balloon pump). Thirty-day all-cause mortality and readmissions. Of 23 478 patients, 14 264 (60.8%) were male and the mean (SD) age was 73.9 (9.8) years. In the inverse probability of treatment weighting analysis and grace period approaches, treatment with percutaneous microaxial LVAD was associated with a higher risk-adjusted 30-day mortality (risk difference, 14.9%; 95% CI, 12.9%-17.0%). However, patients receiving the percutaneous microaxial LVAD had a higher frequency of factors associated with severe illness, suggesting possible confounding by measures of illness severity not available in the data. In the instrumental variable analysis, 30-day mortality was also higher with percutaneous microaxial LVAD, but patient and hospital characteristics differed across levels of the instrumental variable, suggesting possible confounding by unmeasured variables (risk difference, 13.5%; 95% CI, 3.9%-23.2%). In the instrumented difference-in-differences analysis, the association between the percutaneous microaxial LVAD and mortality was imprecise, and differences in trends in characteristics between hospitals with different percutaneous microaxial LVAD use suggested potential assumption violations. In observational analyses comparing the percutaneous microaxial LVAD to alternative treatments among patients with AMICS, the percutaneous microaxial LVAD was associated with worse outcomes in some analyses, while in other analyses, the association was too imprecise to draw meaningful conclusions. However, the distribution of patient and institutional characteristics between treatment groups or groups defined by institutional differences in treatment use, including changes in use over time, combined with clinical knowledge of illness severity factors not captured in the data, suggested violations of key assumptions that are needed for valid causal inference with different observational analyses. Randomized clinical trials of mechanical support devices will allow valid comparisons across candidate treatment strategies and help resolve ongoing controversies.

TOP5: Heart Transplant versus LVADs: Is destination therapy the new goal?

Background: With improving survival of patients following acute coronary syndromes and chronic heart failure, more patients are reaching the end stage of illness requiring heart transplantation (HT) as a finalgoal therapy. Mechanical circulatory support (MCS) devices like the left ventricular assist device (LVAD) play a major role as destination therapy or bridging therapy for this patient demographic. The improvement of modern LVADs paired with the increase of life expectancy, and the underwhelming engagement of HT donation in the US, ponders on the suggestibility of redirecting efforts for destination or bridging therapy for a growing population. This study assesses the tendencies of LVAD use in comparison to those of HT performance, and analyses the direct correlation with one another as predictive values for future directives in the AHF population. Methods: National data from the Organ Procurement & Transplantation Network (OPTN) was retrieved for the use of LVADs, the performance of primary HT and re-do HT over the last 30 years. Upon data retrieval, descriptive statistics were identified for 6 different groups (ages 18-34, 35-49, 50-64, above 65 years, and the collective adult cohort) including annual growth rate, and comparison within the group means. A regression analysis was performed to determine the variable relationship between LVAD placement and performance of HT. Results: Since 1992, a total of 75098 HT, and 21041 LVAD placements have been performed in the US. There is a significant difference in the number of HT and LVAD placements performed (LVAD vs PT: p=0.0001; LVAD vs re-do HT: p=0.0001). However, upon regression analysis, 64% of LVAD placement determines the subsequent bridging to HT, and the annual growth rate of LVAD placement has a positive significant correlation with the relatively sustained number of HT performed yearly (Coefficient of 0.87; Confidence interval 95%, p=0.000). When comparing LVAD placement to primary HT performance and re-do HT, a significant increase will continue to occur based on the thus-far determined growth rate across all age groups (p= 0.0001). Thus, suggestive that within the upcoming years, the number of LVADs placed will equal the amount of HT performed. Conclusions: With the continuance in evolution and improvement of LVADs in the AHF population and the uneven number of HT performed, this study outlines that the growing tendencies of MCS should be prioritized in lieu of HT availability or strategies to increase donation culture. The prioritization of MCS should aim for a better and comprehensive understanding of the role of these devices and adequate management in a long-term basis.Figure 1. LVAD, primary transplant and transplant repeat annual growth rate

Reciprocal interferences of the left ventricular assist device and the aortic valve competence.

Patients suffering from end-stage heart failure tend to have high mortality rates. With growing numbers of patients progressing into severe heart failure, the shortage of available donors is a growing concern, with less than 10% of patients undergoing cardiac transplantation (CTx). Fortunately, the use of left ventricular assist devices (LVADs), a variant of mechanical circulatory support has been on the rise in recent years. The expansion of LVADs has led them to be incorporated into a variety of clinical settings, based on the goals of therapy for patients ailing from heart failure. However, with an increase in the use of LVADs, there are a host of complications that arise with it. One such complication is the development and progression of aortic regurgitation (AR) which is noted to adversely influence patient outcomes and compromise pump benefits leading to increased morbidity and mortality. The underlying mechanisms are likely multifactorial and involve the aortic root-aortic valve (AV) complex, as well as the LVAD device, patient, and other factors, all of them alter the physiological mechanics of the heart resulting in AV dysfunction. Thus, it is imperative to screen patients before LVAD implantation for AR, as moderate or greater AR requires a concurrent intervention at the time of LVADs implantation. No current strict guidelines were identified in the literature search on how to actively manage and limit the development and/or progression of AR, due to the limited information. However, some recommendations include medical management by targeting fluid overload and arterial blood pressure, along with adjusting the settings of the LVADs device itself. Surgical interventions are to be considered depending on patient factors, goals of care, and the underlying pathology. These interventions include the closure of the AV, replacement of the valve, and percutaneous approach via percutaneous occluding device or transcatheter aortic valve implantation. In the present review, we describe the interaction between AV and LVAD placement, in terms of patient management and prognosis. Also it is provided a comprehensive echocardiographic strategy for the precise assessment of AV regurgitation severity.

Biventricular assist devices and total artificial heart: Strategies and outcomes.

In contrast to the advanced development of the left ventricular assist device (LVAD) therapy for advanced heart failure, the mechanical circulatory support (MCS) with biventricular assist device (BVAD) and total artificial heart (TAH) options remain challenging. The treatment strategy of BVAD and TAH therapy largely depends on the support duration. For example, an extracorporeal centrifugal pump, typically referred to as a temporary surgical extracorporeal right ventricular assist device, is implanted for the short term with acute right ventricular failure following LVAD implantation. Meanwhile, off-label use of a durable implantable LVAD is a strategy for long-term right ventricular support. Hence, this review focuses on the current treatment strategies and clinical outcomes based on each ventricle support duration. In addition, the issue of heart failure post-heart transplantation (post-HT) is explored. We will discuss MCS therapy options for post-HT recipients.

Sex disparities in left ventricular assist device implantation outcomes: A systematic review and meta-analysis of over 50 000 patients.

Left ventricular assist devices (LVAD) represent an important therapeutic option for patients progressing to end-stage heart failure. Women have been historically underrepresented in LVAD studies, and have been reported to have worse outcomes despite technological optimisation. We aimed to systematically explore the evidence on sex disparities in the use and outcomes of LVAD implantation. A systematic database search with meta-analysis was conducted of comparative original articles of men versus women undergoing LVAD implantation, in EMBASE, MEDLINE, Cochrane database and Google Scholar, from inception to July 2022. Primary outcomes were stroke (haemorrhagic and ischaemic) and early/overall mortality. Secondary outcomes were LVAD thrombosis, right VAD implantation, major bleeding, kidney dysfunction, and device/driveline infection. Our search yielded 137 relevant studies, including 22 meeting the inclusion criteria with a total of 53 227 patients (24.2% women). Overall mortality was higher in women (odds ratio [OR] 1.35, 95% confidence interval [CI] 1.05-1.62, p= 0.02), as was overall stroke (OR 1.32, 95%CI 1.06-1.66, p= 0.01), including ischemic (OR 1.80, 95%CI 1.22-2.64, p= 0.003) and haemorrhagic (OR 1.72, 95%CI 1.09-2.70, p= 0.02). Women had more frequent right VAD implantation (OR 2.11, 95%CI 1.24-3.57, p= 0.006) and major bleeding (OR 1.40, 95%CI 1.06-1.85, p= 0.02). Kidney dysfunction, LVAD thrombosis, and device/driveline infections were comparable between sexes. Our analysis suggests that women face a greater risk of adverse events and mortality post-LVAD implantation. Although the mechanisms remain unclear, the difference in outcomes is thought to be multifactorial. Further research, that includes comprehensive pre-operative characteristics and post-operative outcomes, is encouraged.

Microaxial Left Ventricular Assist Device in Cardiogenic Shock: A Systematic Review and Meta-Analysis.

Microaxial left ventricular assist devices (LVAD) are increasingly used to support patients with cardiogenic shock; however, outcome results are limited to single-center studies, registry data and select reviews. We conducted a systematic review and meta-analysis, searching three databases for relevant studies reporting on microaxial LVAD use in adults with cardiogenic shock. We conducted a random-effects meta-analysis (DerSimonian and Laird) based on short-term mortality (primary outcome), long-term mortality and device complications (secondary outcomes). We assessed the risk of bias and certainty of evidence using the Joanna Briggs Institute and the GRADE approaches, respectively. A total of 63 observational studies (3896 patients), 6 propensity-score matched (PSM) studies and 2 randomized controlled trials (RCTs) were included (384 patients). The pooled short-term mortality from observational studies was 46.5% (95%-CI: 42.7–50.3%); this was 48.9% (95%-CI: 43.8–54.1%) amongst PSM studies and RCTs. The pooled mortality at 90 days, 6 months and 1 year was 41.8%, 51.1% and 54.3%, respectively. Hemolysis and access-site bleeding were the most common complications, each with a pooled incidence of around 20%. The reported mortality rate of microaxial LVADs was not significantly lower than extracorporeal membrane oxygenation (ECMO) or intra-aortic balloon pumps (IABP). Current evidence does not suggest any mortality benefit when compared to ECMO or IABP.