Underwent Left Ventricular Assist Device Implantation Research Articles

Sex-related differences in left ventricular assist device utilization and outcomes: results from the PCHF-VAD registry.

Data on sex and left ventricular assist device (LVAD) utilization and outcomes have been conflicting and mostly confined to US studies incorporating older devices. This study aimed to investigate sex-related differences in LVAD utilization and outcomes in a contemporary European LVAD cohort. This analysis is part of the multicentre PCHF-VAD registry studying continuous-flow LVAD patients. The primary outcome was all-cause mortality. Secondary outcomes included ventricular arrhythmias, right ventricular failure, bleeding, thromboembolism, and the haemocompatibility score. Multivariable Cox regression models were used to assess associations between sex and outcomes. Overall, 457 men (81%) and 105 women (19%) were analysed. At LVAD implant, women were more often in Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) profile 1 or 2 (55% vs. 41%, P=0.009) and more often required temporary mechanical circulatory support (39% vs. 23%, P=0.001). Mean age was comparable (52.1 vs. 53.4years, P=0.33), and median follow-up duration was 344 [range 147-823] days for women and 435 [range 190-816] days for men (P=0.40). No significant sex-related differences were found in all-cause mortality (hazard ratio [HR] 0.79 for female vs. male sex, 95% confidence interval [CI] [0.50-1.27]). Female LVAD patients had a lower risk of ventricular arrhythmias (HR 0.56, 95% CI [0.33-0.95]) but more often experienced right ventricular failure. No significant sex-related differences were found in other outcomes. In this contemporary European cohort of LVAD patients, far fewer women than men underwent LVAD implantation despite similar clinical outcomes. This is important as the proportion of female LVAD patients (19%) was lower than the proportion of females with advanced HF as reported in previous studies, suggesting underutilization. Also, female patients were remarkably more often in INTERMACS profile 1 or 2, suggesting later referral for LVAD therapy. Additional research in female patients is warranted.

Outcomes of concomitant aortic valve procedures and left ventricular assist device implantation: A systematic review and meta-analysis.

Left ventricular assist device (LVAD) implantation is frequently employed in patients with end-stage heart failure. The outcomes of addressing the repair of all substantial aortic valvular disease at the time of LVAD implantation remain unclear. We sought to assess the clinical outcomes in patients undergoing LVAD implantation concomitant with aortic valve procedures (AVPs) compared with isolated LVAD implantation. A literature search was performed using PubMed, Embase, and Cochrane library from inception till June 2022. Primary outcomes included short-term mortality and long-term survival. Random effects models were used to compute mean differences and odds ratios with 95% confidence intervals (CIs). A total of 14 observational studies (N=52 693) met our inclusion criteria. Concomitant LVAD implantation and AVPs were associated with higher short-term mortality (OR=1.61 [95% CI, 1.06-2.42]; p=0.02) and mean CPBt (MD=43.25 [95% CI, 22.95-63.56]; p < 0.0001), and reduced long-term survival (OR=0.70 [95% CI, 0.55-0.88]; p=0.003) compared with isolated LVAD implantation. No difference in the odds of cerebrovascular accident (OR=1.05 [95% CI, 0.79-1.39]; p=0.74) and mean length of hospital stay (MD=2.89 [95% CI, -4.04 to 9.82]; p=0.41) was observed between the two groups. On adjusted analysis, short-term mortality was significantly higher in the LVAD group with concurrent AVPs when compared with the isolated LVAD group (aHR=1.50 [95% CI, 1.20-1.87]; p=0.0004). Concurrent AVPs were associated with higher short-term mortality and reduced long-term survival in patients undergoing LVAD implantation compared with isolated LVAD implantation.

1801. LVAD antimicrobial prophylaxis and infections, a 12-year experience

Abstract Background The incidence of end-stage heart failure necessitating advanced cardiac therapy continues to increase in the United states. Implantable left ventricular assist devices (LVADs) represent an important modality that is utilized both as a bridge to heart transplant or as destination therapy. LVAD-associated infections, ranging from driveline exit site or pocket infections to endovascular infections, are a major complication with high mortality. Antibiotic prophylaxis at time of LVAD implantation is therefore an important strategy to mitigate infections. However, a clear surgical infection prophylaxis regimen and associated outcomes have not been reported. Methods We performed a single center, retrospective cohort study evaluating the impact of antimicrobial prophylaxis on risk of infection in patients who underwent LVAD implantation between February 2007 and June 2019 at Mayo Clinic. LVAD-specific and related infections were defined according to the International Society of Heart Lung Transplantation criteria. Single drug prophylaxis (SDP) included cefazolin only, vancomycin only, or cefazolin and vancomycin; multidrug (MDP) regimen includes either of the SDP regimens plus another antibiotic. We compared incidence of infection within 90-day and within one-year of implantation, as well as risk of C. difficile infections between the SDP and MDP cohorts. Results We reviewed 403 patients who received LVAD implantation (Table 1), 402 of had information on surgical prophylaxis. 307 (76%) patients received SDP and 95 patients (24%) received MDP. 14 patients developed an infection within 1 year of implantation (Table 2). There was no difference in the incidence of infections between SDP and MDP arms both at 90 days and 1-year post-implantation (p=0.11). The median time of infection since LVAD implantation was similar between SDP and MDP (p=0.37) arms. Incidence of C. difficile infection was not different between groups (p=0.10) (Table 3). Conclusion There was no significant difference in incidence or time to first infection, within 90-day and 1-year of implantation, between single- and multidrug antibiotic surgical prophylaxis regimens administered at the time of LVAD implantation. Future prospective trials are needed to develop a clear LVAD antibiotic prophylaxis protocol. Disclosures John C. O'Horo, Sr., MD, MPH, Bates college: Advisor/Consultant|MITRE corporation: Grant/Research Support|nferenec, Inc: Grant/Research Support.

677 PREDICTION OF RIGHT VENTRICULAR FAILURE AFTER LEFT VENTRICULAR ASSIST DEVICE IMPLANTATION: ROLE OF VASODILATOR CHALLENGE

Abstract Pulmonary artery pulsatility index (PAPi) is an indicator of right ventricular (RV) function and an independent predictor of right ventricular failure (RVF) following left ventricular assist device (LVAD) implantation. Administration of vasodilator challenge during right heart catheterization (RHC) could reduce RV workload allowing a better assessment of its functional reserve. Patients undergoing LVAD implantation at our Institution between May 2013 and August 2021 were enrolled. Only patients who had undergone RHC and vasodilator challenge with sodium nitroprusside were analyzed. We collected all available clinical, instrumental, and haemodynamic parameters, at baseline and after nitroprusside infusion and evaluated potential associations with post-LVAD RVF. Of the 54 patients analyzed, 19 (35%) developed RVF after LVAD implantation. Fractional area change (FAC) (OR: 0.647, CI: 0.481–0.871; P = 0.004), pulmonary artery systolic pressure (PASP)(OR: 0.856, CI: 0.761–0.964; P=0.010), and post-sodium nitroprusside (NTP) PAPi (OR: 0.218, CI: 0.073–0.653; P = 0.006) were independent predictors of post-LVAD RVF. The model combining FAC, PASP, and post-NTP PAPi demonstrated a predictive accuracy of 90.7%. Addition of post-NTP PAPi significantly increased the predictive accuracy of the European Registry for Patients with Mechanical Circulatory Support right-sided heart failure risk score [79.4 vs. 70.4%; area under the curve (AUC): 0.841 vs. 0.724, P = 0.022] and the CRITT score (79.6% vs. 74%; AUC: 0.861 vs. 0.767 P = 0.033). Post-NTP PAPi has observed to be an independent predictor of RVF following LVAD implantation. Dynamic assessment of PAPi using a vasodilator challenge may represent a method of testing RV functional reserve in candidates for LVAD implantation. Larger and prospective studies are needed to confirm this hypothesis.

Elderly Patients With Higher Acuity Have Similar Left Ventricular Assist Device Outcomes as Younger Patients at a Nontransplant Center

Although left ventricular assist device (LVAD) implantation is associated with acceptable survival, previous reports have demonstrated that advanced age is associated with increased short-term mortality. Because age is a relative contraindication to transplantation, nontransplant centers tend to implant a disproportionate number of elderly patients. We undertook this study to evaluate the impact of advanced age on LVAD outcomes at a nontransplant center. We conducted a retrospective review of all LVAD implants at our center from 2017 to 2022. Primary stratification was by age >70 years. The primary outcome was survival as assessed by the Kaplan-Meier method. The risk of 1-year mortality was further evaluated using multivariable Cox proportional hazards regression modeling. From 2017 to 2022, 93 patients underwent LVAD implantation. The mean age was 65.03 ± 11.28 years, with a median age of 68 (60 to 73) years. Most patients were INTERMACS 1 or 2 (71 patients; 76.34%). When stratified by age, 41 patients (44.09%) were aged ≥70 years. Patients aged ≥70 years had similar 30-day (96.15% vs 100.00%, p=0.213), 1-year (90.05% vs 84.00%, p=0.444), and 2-year survival (82.03% vs 84.00%, p=0.870). When only the INTERMACS 1 and 2 patients with higher acuity were included, there was still no difference in 30-day, 1-year, or 2-year survival. On multivariable analysis, age >70 years was not associated with an increased hazard of 1-year mortality (0.90 [0.22 to 3.67], p=0.878). In conclusion, in carefully selected patients, age >70 years is not associated with increased short-term mortality. Age alone should not be a contraindication to LVAD therapy.

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.

Distinct Transcriptomic and Proteomic Profile Specifies Patients Who Have Heart Failure With Potential of Myocardial Recovery on Mechanical Unloading and Circulatory Support.

Extensive evidence from single-center studies indicates that a subset of patients with chronic advanced heart failure (HF) undergoing left ventricular assist device (LVAD) support show significantly improved heart function and reverse structural remodeling (ie, termed "responders"). Furthermore, we recently published a multicenter prospective study, RESTAGE-HF (Remission from Stage D Heart Failure), demonstrating that LVAD support combined with standard HF medications induced remarkable cardiac structural and functional improvement, leading to high rates of LVAD weaning and excellent long-term outcomes. This intriguing phenomenon provides great translational and clinical promise, although the underlying molecular mechanisms driving this recovery are largely unknown. To identify changes in signaling pathways operative in the normal and failing human heart and to molecularly characterize patients who respond favorably to LVAD unloading, we performed global RNA sequencing and phosphopeptide profiling of left ventricular tissue from 93 patients with HF undergoing LVAD implantation (25 responders and 68 nonresponders) and 12 nonfailing donor hearts. Patients were prospectively monitored through echocardiography to characterize their myocardial structure and function and identify responders and nonresponders. These analyses identified 1341 transcripts and 288 phosphopeptides that are differentially regulated in cardiac tissue from nonfailing control samples and patients with HF. In addition, these unbiased molecular profiles identified a unique signature of 29 transcripts and 93 phosphopeptides in patients with HF that distinguished responders after LVAD unloading. Further analyses of these macromolecules highlighted differential regulation in 2 key pathways: cell cycle regulation and extracellular matrix/focal adhesions. This is the first study to characterize changes in the nonfailing and failing human heart by integrating multiple -omics platforms to identify molecular indices defining patients capable of myocardial recovery. These findings may guide patient selection for advanced HF therapies and identify new HF therapeutic targets.

Hyponatremia Is a Powerful Predictor of Poor Prognosis in Left Ventricular Assist Device Patients.

Serum sodium is an established prognostic marker in heart failure (HF) patients and is associated with an increased risk of morbidity and mortality. We sought to study the prognostic value of serum sodium in left ventricular assist device (LVAD) patients and whether hyponatremia reflects worsening HF or an alternative mechanism. We identified HF patients that underwent LVAD implantation between 2008 and 2019. Hyponatremia was defined as Na ≤134 mEq/L at 3 months after implantation. We assessed for differences in hyponatremia before and after LVAD implantation. We also evaluated the association of hyponatremia with all-cause mortality and recurrent HF hospitalizations. There were 342 eligible LVAD patients with a sodium value at 3 months. Among them, there was a significant improvement in serum sodium after LVAD implantation compared to preoperatively (137.2 vs. 134.7 mEq/L, P < 0.0001). Patients with and without hyponatremia had no significant differences in echocardiographic and hemodynamic measurements. In a multivariate analysis, hyponatremia was associated with a markedly increased risk of all-cause mortality (HR 3.69, 95% CI, 1.93-7.05, P < 0.001) when accounting for age, gender, co-morbidities, use of loop diuretics, and B-type natriuretic peptide levels. Hyponatremia was also significantly associated with recurrent HF hospitalizations (HR 2.11, 95% CI, 1.02-4.37, P = 0.04). Hyponatremia in LVAD patients is associated with significantly higher risk of all-cause mortality and recurrent HF hospitalizations. Hyponatremia may be a marker of ongoing neurohormonal activation that is more sensitive than other lab values, echocardiography parameters, and hemodynamic measurements.

Impact of Left Ventricular Assist Devices on Days Alive and Out of Hospital in Hemodynamically Stable Patients with End-Stage Heart Failure: A Propensity Score Matched Study.

The two main surgical options to treat end-stage heart failure are heart transplantation (HTx) or left ventricular assist device (LVAD) implantation. In hemodynamically stable patients, the decision for HTx listing with or without LVADs is challenging. We analyzed the impact of both options on days alive and out of hospital (DAOH) and survival. This retrospective study screened all patients with HTx or LVAD implantation between 2010 and 2020. The main inclusion criterion was hemodynamic stability defined as independence of intravenous inotropic/vasoactive support at decision. Propensity score matching (PSM) was performed. The primary endpoint was DAOH within one year after the decision. Secondary endpoints included survival, duration until HTx, and hospitalizations. In total, 187 patients received HTx and 227 patients underwent LVAD implantation. There were 21 bridge-to-transplant (BTT)-LVAD patients (implantation less than a month after HTx listing or listing after implantation) and 44 HTx-waiting patients included. PSM identified 17 matched pairs. Median DAOH at one year was not significantly different between the groups (BTT-LVAD: median 281, IQR 89; HTx waiting: median 329, IQR 74; p = 0.448). Secondary endpoints did not differ significantly. Our data suggest that BTT-LVAD implantation may not be favorable in terms of DAOH within one year for hemodynamically stable patients compared to waiting for HTx. Further investigations on quality of life and long-term outcomes are warranted.

Novel Estimates of Renal Function are Associated with Short-Term Left Ventricular Assist Device Outcomes

IntroductionAlthough preoperative kidney function has been associated with left ventricular assist device (LVAD) outcomes, most previous estimates of glomerular filtration rates (eGFRs) have utilized race in the calculation. Recently, novel eGFR equations independent of race have been suggested and validated. Therefore, we undertook this study to evaluate the predictive value of a novel, non–race-based eGFR calculation on short-term LVAD outcomes. MethodsWe conducted a retrospective review of all primary LVAD implants from 2017 to 2022 at our institution. eGFR was calculated using the novel Chronic Kidney Disease Epidemiology Collaboration 2021 formula (CKD-EPI 2021). eGFR was also calculated according to the Modification of Diet in Renal Disease equation for historical reference. Primary stratification was by eGFR: ≥60, 30-60, and <30. The primary outcome was 1-y survival. Multivariable Cox proportional hazards regression modeling was used to further evaluate the impact of kidney function on 1-y mortality. ResultsFrom 2017 to 2022, 91 patients underwent LVAD implantation with a HeartMate 3 device. The average age was 65.20 ± 11.08, 77 (84.62%) were male, and 14 (15.38%) were Black. The mean CKD-EPI 2021 eGFR was 56.07 ± 23.55 compared with 54.72 ± 26.37 as calculated by Modification of Diet in Renal Disease (P = 0.719). Overall, 30-d and 1-y survival was 96.7% and 85.0%, respectively. When stratified by eGFR, there was a significant difference in 1-y survival (≥60, 93.46%; 30-60, 87.36%; <30, 62.75%; P = 0.016). On multivariable analysis, a preoperative eGFR <30 was associated with an increased hazard of 1-y mortality (5.58 [1.06-29.17], P = 0.043). ConclusionsIn conclusion, non–race-based estimates of renal function are predictive of short-term LVAD outcomes. Further investigation of this phenomenon is warranted.

The prognostic value of clinical frailty scale and outcomes in older patients undergoing left ventricular assist device implantation.

Heart failure impacts patients' functional capabilities, ultimately leading to frailty. The use of a left ventricular assist device(LVAD) is acceptable as both destination therapy and bridge to transplant in heart failure management. We aim to evaluate the prognostic value of the Clinical Frailty Scale (CFS) on outcomes in older patients undergoing implantation of LVAD. We conducted a retrospective chart review of patients ≥ 60 years old that underwent LVAD implantation at our medical center from May 1, 2018, to October 30, 2020. CFS was retrospectively assigned before LVAD placement and CFS scores > 4 was considered frail. Kaplan-Meier curves and Cox regression were used to analyze 1-year survival estimates. Forty percent of the cohort was classified as frail according to CFS. Thirty-day re-admission rateswere comparable between frail and non-frail patients (46% vs 35%; P=0.419). 1-year survival was lower in the frail vs non-frail group (log rank, P=0.017). On Cox analysis, only frailty was associated with 1-year post-intervention mortality (hazard ratio [HR]=5.64, 95% confidence interval [CI]=1.131-28.212; P=0.035). CFS-defined frailty was associated with increased risk of 1-year mortality after LVAD implantation. CFS may be a valuable tool in the frailty assessment for risk stratification of patients undergoing LVAD implantation. Multicenter studies are required to validate these findings.

Abstract 13706: Late Presentation Right Ventricular Failure in Patients With Left Ventricular Assist Device

Introduction: Right Ventricular Failure (RVF) is an incompletely characterized complication seen in patients following durable left ventricular assist device (LVAD) implantation. Previous research focused on early post-implantation RVF, and its definitions are inconsistent. This study aims to characterize the incidence and clinical features of late presentation RVF in LVAD patients. Methods: This retrospective cohort study included all subjects who underwent LVAD implantation at the University of Washington between 2005 and 2021 and were on support for at least 90 days. Late RVF was defined as meeting Mechanical Circulatory Support Academic Research Consortium criteria and late RVF onset &gt;30 days post-implantation. The outcomes of interest were late RVF incidence and mortality while on LVAD support. Using Cox regression models, baseline factors were assessed as potential predictors for late RFV, with the time-varying exposure of developing late RVF after LVAD implantation as a risk factor for death. Results: The cohort included 430 LVAD recipients, median age 56 years (IQR 43-64), 17% women and 75% Caucasian. A total of 115 subjects met criteria for late RVF with a median time to RVF of 48 months (95% CI 43-63) and an incidence rate of 18.3 events per 100 person-years. Multivariable analysis showed that albumin, destination therapy (DT) LVAD, use of inotropes longer than 2 weeks post LVAD implantation, and device type were associated with development of late RVF. DT as treatment intention was the predictor with the highest hazard ratio (HR= 2.82, 95% CI 1.75-4.55, p&lt;0.001). After controlling for several covariates, RVF was associated with an increased hazard of death (HR 1.87, 95% CI 1.22 - 2.86, p = 0.004) (Figure). Conclusions: Late RVF while on LVAD support was a relatively common complication in this cohort and was associated with significantly higher mortality. LVAD implantation as DT was the predictor most strongly associated with late RVF.

Abstract 15045: Impact of Left Ventricular Assist Device (LVAD) Type on Arrhythmic Outcomes in Patients With Continuous Flow LVADs

Introduction: Cardiac arrhythmias are common in continuous flow left ventricular assist device (LVAD) recipients. The impact of axial vs. intrapericardial centrifugal LVAD pumps on arrhythmia incidence and associated clinical outcomes is unclear. Hypothesis: This multicenter study evaluated the impact of LVAD type (axial vs. centrifugal) on incidence of atrial and ventricular arrhythmias, ICD shocks and mortality in LVAD patients. Methods: Analysis was done on 536 patients who underwent LVAD implantation at 5 US centers from 2008 to 2016. The groups were divided based on their LVAD type (axial - HeartMate II [HMII, n=433] vs. centrifugal - HeartWare (HW, n=103). Baseline characteristics as well as incidence of post-LVAD atrial arrhythmias (PL-AA), ventricular arrhythmias (PL-VA) and ICD shocks were analyzed in these groups. Multivariable Cox Regression analysis was used to identify predictors of survival. Results: Of 536 patients, 433 had HMII axial LVAD and 103 had HW centrifugal VAD implant. At baseline, HMII group had more males, higher proportion of CRT-D and higher prevalence of AA (Table 1A). Left ventricular dimensions were similar between groups. During a median follow-up of 537 days of LVAD support, incidence of PL-VA and ICD shocks were significantly higher in the HM2 group compared to HW group whereas incidence of PL-AA was not significantly different (Table 1A). In multivariable Cox Regression analysis, LVAD indication was the only variable that predicted survival (Table 1B). Type of LVAD (axial vs. centrifugal) was not associated with survival (HMII vs. HW - HR 1.04, P=0.48). Conclusions: In this multi-center continuous flow LVAD cohort, axial HM2 VAD patients had a higher incidence of PL-VA and ICD shocks. Type of LVAD (axial vs. centrifugal) was not associated with survival.

Right heart failure after left ventricular assist device: From mechanisms to treatments.

Left ventricular assist device (LVAD) therapy is a lifesaving option for patients with medical therapy-refractory advanced heart failure. Depending on the definition, 5-44% of people supported with an LVAD develop right heart failure (RHF), which is associated with worse outcomes. The mechanisms related to RHF include patient, surgical, and hemodynamic factors. Despite significant progress in understanding the roles of these factors and improvements in surgical techniques and LVAD technology, this complication is still a substantial cause of morbidity and mortality among LVAD patients. Additionally, specific medical therapies for this complication still are lacking, leaving cardiac transplantation or supportive management as the only options for LVAD patients who develop RHF. While significant effort has been made to create algorithms aimed at stratifying risk for RHF in patients undergoing LVAD implantation, the predictive value of these algorithms has been limited, especially when attempts at external validation have been undertaken. Perhaps one of the reasons for poor performance in external validation is related to differing definitions of RHF in external cohorts. Additionally, most research in this field has focused on RHF occurring in the early phase (i.e., ≤1 month) post LVAD implantation. However, there is emerging recognition of late-onset RHF (i.e., > 1 month post-surgery) as a significant cause of morbidity and mortality. Late-onset RHF, which likely has a unique physiology and pathogenic mechanisms, remains poorly characterized. In this review of the literature, we will describe the unique right ventricular physiology and changes elicited by LVADs that might cause both early- and late-onset RHF. Finally, we will analyze the currently available treatments for RHF, including mechanical circulatory support options and medical therapies.

Defining early right ventricular failure during left ventricular assist device implantation: Retrospective analysis of intraoperative management

Objectives: In this study, we aimed to share the intraoperative anesthesia management of left ventricular assist device (LVAD) implantation and our approach to right ventricular failure (RVF) that developed in this process, and our results. Patients and methods: A total of 82 patients (71 males, 11 females; mean age: 49.4±9.4 years; range, 18 to 71 years) who underwent LVAD implantation between February 2013 and June 2020 were included in the retrospective study. Preoperative echocardiography, cardiac catheterization findings, and intraoperative records were reviewed. In light of the preoperative hemodynamic, echocardiographic, and preoperative echocardiographic findings of the patients, RVF levels were preoperatively determined, and a medical and mechanical support therapy algorithm for RVF was created. The postoperative outcomes were evaluated within the framework of this algorithm. Results: The mean preoperative left ventricular ejection fraction was 19.6%, and the mean right ventricular ejection fraction was 37.4%. According to our algorithm, eight (9.7%) patients developed severe, 12 (14.6%) moderate, and 48 (58.5%) mild RVF. No RVF was present in 14 (17.2%) patients. The vasoactive inotrope score was 25.7±1.3 in the advanced RVF group and compatible with the severity of RVF. Extracorporeal membrane oxygenation use was required in three (37.5%) patients who had severe RVF. Right ventricular assist device was implanted in one of the three patients with extracorporeal membrane oxygenation due to advanced RVF in the postoperative period. Mortality was observed in two (25%) patients in the advanced group, one (8.3%) in the moderate, three (6.25%) in the mild, and two (14%) in the normal RVF group. Conclusion: A standardized method for defining the RVF severity and a well-defined treatment protocol according to its degree of severity is lacking. Considering hemodynamic and echocardiographic data, grading of RVF in patients is vital for determining the treatment protocol. Treatment for RVF should be converted into standard universal algorithms.

Preliminary Experience of Extracorporeal Cytokine Hemoadsorption during Left Ventricular Assist Device Implantation in Cardiogenic Shock Patients.

Systemic inflammation due to cardiogenic shock is associated with vasoplegia leading to organ hypoperfusion, right heart failure, and poor clinical outcome. Extracorporeal cytokine hemoadsorption emerged to attenuate excessive levels of inflammatory cytokines, potentially improving patient outcomes. Nevertheless, its prognostic impact during high-risk left ventricular assist device (LVAD) implantation remains unknown. In total, 40 consecutive patients with advanced heart failure underwent continuous-flow LVAD implantation at our institution between 2018 and 2020. Out of 25 high-risk patients in cardiogenic shock (Interagency Registry for Mechanically Assisted Circulatory Support profile 1 and 2), 9 patients (CytoSorb group) underwent LVAD implantation with and 16 patients (control group) without simultaneous cytokine hemoadsorption during cardiopulmonary bypass. Besides preoperative patient characteristics, postoperative lactate clearance, vasopressor administration and mean arterial pressure, perioperative complication, and 30-day mortality rates were retrospectively analyzed. Apart from an increased rate of reoperations within the CytoSorb group, baseline characteristics including the severity of ventricular dysfunction and consecutive signs of end-organ failure were similar in both groups. Preoperative short-term mechanical circulatory support bridging was comparable (66.7 vs. 75%; p = 0.66) prior to LVAD implantation. Procedural characteristics including intraoperative volume management and postoperative vasopressor administration were similar in both groups. There was no difference regarding postoperative lactate clearance, although postoperative mean arterial pressure was significantly higher in the control group (71.3 vs. 57.4 mm Hg; p < 0.01). Furthermore, the 30-day mortality rate was significantly higher in the CytoSorb group (33.3 vs. 0.0%; p = 0.01). Extracorporeal cytokine hemoadsorption during high-risk LVAD implantation was not associated with a decrease of postoperative vasopressor support, improved hemodynamics, or an accelerated lactate clearance.

Impact of time off anticoagulation in patients with continuous-flow left ventricular assist devices.

Patients with left ventricular assist devices (LVADs) receive anticoagulation to decrease the risk of thrombosis. Various circumstances require discontinuing anticoagulation in LVAD patients, but the risks entailed are not well defined. In a retrospective review of LVAD implantation procedures, we examined the effect of time off anticoagulation on thrombosis and mortality rates after implantation. An international normalized ratio ≤ 1.5 was used to screen for patients taken off anticoagulation. Patients were divided into three groups by the cumulative number of days off anticoagulation: no discontinuation, short-term discontinuation (< 30days), and long-term discontinuation (≥ 30days). Rates of ischemic stroke, pump thrombosis, and mortality were compared among groups. Of 245 patients who underwent LVAD implantation during the study, 70 (28.6%) were off anticoagulation during follow-up: 37 (15.1%) had short-term discontinuation (median, 11days), and 33 (13.5%) had long-term discontinuation (median, 124days). Patients with long-term discontinuation had a higher rate of ischemic stroke (adjusted hazard ratio 8.5, p = 0.001) and death (adjusted hazard ratio 3.9, p = 0.001). The three groups did not differ in pump thrombosis rate. We conclude that after LVAD implantation, discontinuing anticoagulation for ≥ 30days is independently associated with an increased risk of ischemic stroke and death.

Artificial intelligence-based body composition predicts postoperative complications and mortality in advanced heart failure patients receiving long-term mechanical circulatory support

Abstract Background Obesity is an independent cardiovascular risk factor and is associated with higher postoperative infection rates in patients after cardiac surgery. However, in heart failure, obesity has been described as beneficial in terms of survival (“obesity paradox”); whereas sarcopenia is associated with poor prognosis. An increasing number of advanced heart failure patients requires surgical treatment in terms of left ventricular assist device (LVAD) implantation. The postoperative in-hospital survival has improved in recent years but is still relatively high (11.1%). The impact of body composition on outcome in this population remains unclear. Purpose The aim of this investigation was to examine the preoperative computed tomography (CT) body composition based on artificial intelligence (AI) analysis as a predictor of the postoperative outcome in advanced heart failure patients, who underwent LVAD implantation. Methods Preoperative CT scans of 137 patients who received LVAD implantations between 2015 and 2020 were retrospectively analyzed using an AI-powered automated software tool based on a convolutional neural network, U-net, developed for image segmentation (Visage version 7.1., Visage Imaging GmbH, Berlin, Germany; Figure 1). Assessment of body composition included visceral and subcutaneous adipose tissue areas (VAT, SAT), psoas and total abdominal muscle areas (PMA, TAMA) and sarcopenia (defined as lumbal skeletal muscle index ≤38.5 cm2/m2 in women and ≤54.4 cm2/m2 in men). The body composition parameters were correlated with postoperative major complication rates and survival. Results The mean age of patients was 58.21±11.9 years; 122 (89.1%) were male. Most patients had severe heart failure requiring inotropes (INTERMACS profile I-III, 71.9%) secondary to coronary artery diseases or dilated cardiomyopathy (96.4%). 44 (32.1%) patients were obese (BMI ≥30 kg/m2), 96 (70.1%) were sarcopene and 19 (13.9%) were sarcopene obese. Adipose tissue was associated with a significantly higher risk of overall postoperative complications (SAT 158.22 cm2 [63.09, 256.78 cm2] vs. 124.04 cm2 [42.86, 187.68 cm2], p=0.049) and in-hospital mortality (VAT 168.11 cm2 [134.19, 285.27 cm2] vs. 135.42 cm2 [49.44, 227.91 cm2], p=0.033; SAT 227.28 cm2 [139.38, 304.35 cm2] vs. 173.81 cm2 [97.65, 254.16 cm2], p=0.009). Sarcopenia did not influence the postoperative outcome and survival within 1 year post LVAD implantation. Conclusions Preoperative AI-based CT body composition identifies patients with poor prognosis after LVAD implantation. Adipose tissue areas predict in-hospital mortality, thus, obesity as a perioperative risk factor outweighs the protective effect known in heart failure patients when undergoing LVAD implantation. Funding Acknowledgement Type of funding sources: None.

TEMPORAL TRENDS OF ISCHEMIC AND HEMORRHAGIC STROKE AFTER LEFT VENTRICULAR ASSIST DEVICE IMPLANTATION IN THE UNITED STATES (2017-2019)

TEMPORAL TRENDS OF ISCHEMIC AND HEMORRHAGIC STROKE AFTER LEFT VENTRICULAR ASSIST DEVICE IMPLANTATION IN THE UNITED STATES (2017-2019)

Impact of narrowing perioperative antibiotic prophylaxis for left ventricular assist device implantation.

Although infections are a significant potential complication among patients undergoing left ventricular assist device (LVAD) implantation, standardized surgical infection prophylaxis (SIP) regimens are not well defined. At Montefiore Medical Center, a 4-drug SIP regimen containing fluconazole, ciprofloxacin, rifampin, and vancomycin was previously utilized. In January 2020, the antimicrobial stewardship program implemented a 2-drug SIP regimen of vancomycin and cefazolin to limit exposure to broad-spectrum antibiotics. This study evaluated LVAD-associated infection rates prior to and following the SIP revision. A retrospective review of patients who underwent LVAD implantation from 1/2018 to 4/2021 was performed. Infections were classified using the International Society for Heart and Lung Transplantation definitions. Infection rates at 2weeks, 30 days, and 90 days post-implantation in the 4-drug SIP regimen (1/2018-12/2019) and the 2-drug SIP regimen (1/2020 to 4/2021) were compared. A total of 71 patients were included. The number of patients with LVAD-associated infections (including surgical site infections) was not significantly different in either SIP group at 2weeks (9%vs. 4%, p=.64), 30 days (9%vs. 11%, p=.99), or 90 days (19%vs. 14%, p=.75). There was no statistically significant difference in 30 or 90-day mortality. LVAD-associated gram-negative (7%vs. 7%; p>.99) and fungal (5%vs. 0%; p=.51) infections were uncommon. The most common organism isolated was Staphylococcus aureus, and the most common type of infection was pneumonia in both SIP groups. No significant difference in LVAD-associated infections or infection-related mortality was observed with de-escalation of perioperative antibiotics. Additional studies with larger sample sizes are needed to endorse the findings of this study.