Primary Left Ventricular Assist Device Research Articles

Escalating Surgical Treatment for Left Ventricular Assist Device Infection and Expected Mortality: Clinical Risk Prediction Score.

Left ventricular assist devices (LVAD) improve survival for patients with cardiac failure, but LVAD specific infections (VSI) remain a challenge with poorly understood predictive risk factors. Furthermore, the indications and utility of escalating medical treatment to surgical debridement and potential flap reconstruction are not well-characterized. A retrospective review of consecutive patients undergoing primary LVAD implantation at a tertiary academic center was performed. The primary outcomes measures were 90-day and overall mortality after VSI. Cox proportional hazards regression was used to generate a risk-prediction score for mortality. Of the 760 patients undergoing primary LVAD implantation, 255 (34%) developed VSI; of these 91 (36%) were managed medically, 134 (52%) with surgical debridement, and 30 (12%) with surgical debridement and flap reconstruction. One-year survival after infection was 85% with median survival of 2.40 years. Factors independently associated with increased mortality were diabetes (hazard ratio (HR) 1.44, p=0.04), methicillin-resistant Staphylococcus aureus infection (HR 1.64, p=0.03), deep space (pump pocket/outflow cannula) involvement (HR 2.26, p<0.001) and extra-corporeal membrane oxygenation after LVAD (HR 2.52, p<0.01. Factors independently associated with decreased mortality were flap reconstruction (HR 0.49, p=0.02) and methicillin-sensitive Staphylococcus aureus infection (HR 0.63, p=0.03). A clinical risk prediction score was developed using these factors and showed significant differences in median survival, which was 5.67 years for low-risk (score 0-1), 3.62 years for intermediate-risk (score 2), and 1.48 years for high-risk (score >3) (p<0.001) patients. We developed a clinical risk prediction score to stratify VSI patients. In selected cases, escalating surgical treatment was associated with increased survival. Future work is needed to determine if early surgical debridement and flap reconstruction can alter outcomes in select cases of VSI.

Preoperative pulmonary function is associated with left ventricular assist device outcomes

IntroductionAlthough left ventricular assist device (LVAD) implantation is associated with improved survival in patients with end-stage heart failure, the impact of preoperative pulmonary function on short-term outcomes is unclear. MethodsWe conducted a retrospective review of all primary LVAD implants at a single institution. Common measures of preoperative pulmonary function were evaluated. Survival was estimated using the Kaplan-Meier method. ResultsFrom 2017–2022, 107 patients underwent primary LVAD implantation. Prior to implantation, 68 (63.6 %) were on room air, 28 (26.4 %) were on nasal cannula, 2 (1.9 %) were on noninvasive positive pressure ventilation, and 9 (8.5 %) were on the ventilator. The average preoperative fraction of inspired oxygen (FiO2) was 25.3 ± 8.2 % while the mean percentage predicted forced expiratory volume in 1 second (FEV1) was 71.4 ± 20.9 %. Overall, 1-year survival was 86.8 %, the median postoperative ventilator time was 20.4 [4.2-77.7] h, and 18 (16.8 %) patients required postoperative tracheostomy. When stratified by pulmonary function, lower FEV1 and increased preoperative FiO2 were associated with decreased 1-year survival ConclusionsIn conclusion, preoperative pulmonary function is associated with short-term LVAD survival, postoperative ventilatory time, and need for tracheostomy. Therefore, rigorous pulmonary function evaluation may help in appropriate preoperative risk stratification.

Kidney Function Trajectories and Right Heart Failure Following LVAD Implantation.

Preoperative kidney dysfunction is a risk factor for right heart failure (RHF) after implantation of a left ventricular assist device (LVAD). However, characteristic kidney function trajectories before and after post-LVAD RHF are uncertain, so we investigated this. We identified individuals who received primary continuous-flow LVAD implantation from July 1, 2014 to December 31, 2017 in the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) data set. Incident RHF was ascertained using the INTERMACS definition at 1 and 3 months and classified as transient or persistent. Kidney function trajectories before and after RHF onset, and relationships of baseline kidney function with RHF risk at the different time points, were assessed. We identified 8076 LVAD recipients who met inclusion criteria. Incident RHF was present at 1 month in 26.4%. There were 4850 individuals with follow-up at 3 months, with incident RHF in 4.2%. Kidney function trajectories differed from pre-LVAD implantation to 1-month follow-up by RHF category, with those developing persistent RHF having no improvement in baseline kidney function. For trajectories before the 3-month RHF ascertainment time, the shape was similar for those with and without RHF, with lower estimated glomerular filtration rate levels among those who developed RHF. Baseline estimated glomerular filtration rate levels below the normal range were associated with higher risk of RHF at 1 and 3 months. In LVAD recipients, preimplantation kidney function and subsequent kidney function trajectories differed substantially by RHF at 1 and 3 months postimplantation, even after adjustment for several confounders. This may demonstrate bidirectional associations between kidney function and right ventricular function in LVAD recipients.

Gastrointestinal bleeding following Heartmate 3 left ventricular assist device implantation: The Michigan Bleeding Risk Model

BackgroundGastrointestinal bleeding (GIB) results in frequent hospitalizations and impairs quality of life in durable left ventricular assist device (LVAD) recipients. Anticipation of these events before implantation could have important implications for patient selection and management. MethodsThe study population included all adult HeartMate 3 (HM3) primary LVAD recipients enrolled in the STS-Intermacs registry from January 2017-December 2020. Using multivariable modeling methodologies, we investigated the relationships between preimplantation characteristics and postimplant bleeding, bleeding and death, and additional bleeding episodes on subsequent bleeding episodes, and created a risk score to predict the likelihood of post-LVAD GIB based solely on pre-implantation factors. ResultsOf 6425 patients who received a HM3 LVAD, 1010 (15.7%) patients experienced GIB. Thirteen pre-implantation factors were independent predictors of post-LVAD GIB. A risk score was created from these factors and calculated for each patient. By 3-years postimplant, GIB occurred in 11%, 26%,and 43% of low-, medium- and high-risk patients. Experiencing one post-LVAD GIB event was associated with an increased risk for further GIB events, with 33.9% of patients experiencing at least one recurrence. While post-LVAD GIB was associated with mortality, there was no relationship between number of GIB events and death. ConclusionThe Michigan Bleeding Risk Model is a simple tool which facilitates the prediction of post-LVAD GIB in HM3 recipients, by using 13 pre-implant variables. The implementation of this tool may help in the risk stratification process and may have therapeutic and clinical implications in HM3 LVAD recipients.

The Society of Thoracic Surgeons Intermacs 2023 Annual Report: Focus on Magnetically Levitated Devices

The 14th Annual Report from The Society of Thoracic Surgeons (STS) Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) describes outcomes of 27,493 patients with a continuous-flow left ventricular assist device (LVAD) from the past decade (2013-2022). In 2022, 2517 primary LVADs were implanted, of which 2512 (99.8%) were fully magnetically levitated (Mag-Lev) devices. This shift to nearly exclusive use of a Mag-Lev device led us to examine its outcomes compared with contemporary (2018-2022) and historical (2013-2017) non-Mag-Lev cohorts. Patients supported by a Mag-Lev device (n= 10,920) had a higher 1- and 5-year survival of 86% (vs 79% and 81%, P < .0001) and 64% (vs 44% and 44%, P < .0001), respectively, than those receiving non-Mag-Lev devices during the contemporary and historical eras. Over 5 years, freedom from gastrointestinal bleeding (72% vs 60%, P < .0001), stroke (87% vs 67%, P < .0001), and device malfunction/pump thrombus (83% vs 54%, P < .0001), but not device-related infection (61% vs 64%, P= .93), was higher with Mag-Lev devices compared with non-Mag-Lev support during the contemporary era. In this large primacy cohort of real-world patients with advanced heart failure, this report underscores markedimprovements in short- and intermediate-term survival and reduction of adverse events with a contemporary Mag-Lev LVAD.

Impact of Different Therapeutic Strategies With Left Ventricular Assist Devices on Health-Related Quality of Life During Prolonged Device-Based Support.

Background: Left ventricular assist device (LVAD) implantation improves survival and health-related quality of life (HRQoL) of patients with heart failure. However, the impact of LVADs or different LVAD-based therapeutic strategies on long-term HRQoL has not been investigated. We evaluated the long-term HRQoL of Japanese patients who were treated with different LVAD-based therapeutic strategies. Methods and Results: Patients whose data were recorded in the Japanese Registry for Mechanical Assisted Circulatory Support between January 2010 and December 2018 were divided into 3 groups: primary implantable LVAD (G-iLVAD; n=483), primary paracorporeal LVAD (n=33), and bridge-to-bridge from paracorporeal to implantable LVAD (n=65). HRQoL was evaluated using the EuroQoL 5-dimension 3-level (EQ-5D-3L) before and 3 and 12 months after LVAD implantation; the mean EQ-5D-3L visual analog scale (VAS) score in the G-iLVAD group at these time points was 47.4, 71.1, and 72.9, respectively (where scores of 0 and 100 indicate worst and best imaginable health state, respectively). Changes in the least squares means of the VAS scores at 3 and 12 months after implantation differed significantly among the 3 groups. Social function, disability, and physical and mental problems were significantly lower in the G-iLVAD than other groups. Conclusions: HRQoL improved significantly at 3 and 12 months after LVAD implantation in all groups. Physical function showed a stronger improvement than did social function, disability, and mental function.

Cardiac Cachexia in Left Ventricular Assist Device Recipients and the Implications of Weight Gain Early After Implantation.

Background Severe cardiac cachexia or malnutrition are commonly considered relative contraindications to left ventricular assist device (LVAD) implantation, but post-LVAD prognosis for patients with cachexia is uncertain. Methods and Results Intermacs (Interagency Registry for Mechanically Assisted Circulatory Support) 2006 to 2017 was queried for the preimplantation variable cachexia/malnutrition. Cox proportional hazards modeling examined the relationship between cachexia and LVAD outcomes. Of 20 332 primary LVAD recipients with available data, 516 (2.54%) were reported to have baseline cachexia and had higher risk baseline characteristics. Cachexia was associated with higher mortality during LVAD support (unadjusted hazard ratio [HR], 1.36 [95% CI, 1.18-1.56]; P<0.0001), persisting after adjustment for baseline characteristics (adjusted HR, 1.23 [95% CI, 1.0-1.42]; P=0.005). Mean weight change at 12 months was +3.9±9.4 kg. Across the cohort, weight gain ≥5% during the first 3 months of LVAD support was associated with lower mortality (unadjusted HR, 0.90 [95% CI, 0.84-0.98]; P=0.012; adjusted HR, 0.89 [95% CI, 0.82-0.97]; P=0.006). Conclusions The proportion of LVAD recipients recognized to have cachexia preimplantation was low at 2.5%. Recognized cachexia was independently associated with higher mortality during LVAD support. Early weight gain ≥5% was independently associated with lower mortality during subsequent LVAD support.

Adverse events after left ventricular assist device implantation linked to psychosocial risk in women and men

Reasons for women's increased probability to experience adverse events (AEs) after left ventricular assist device (LVAD) implantation compared with men's remain uncertain. We explored the role of psychosocial risk in the experience of AEs in women and men. INTERMACS patients receiving a primary continuous-flow LVAD between July2006 and December 2017, median follow-up 13.6 months, were included (n=20,123, 21.3% women). Time-to-event was calculated with cumulative incidence functions for 10 types of AEs separately (e.g., infection, device malfunction), each time accounting for the competing outcomes death, heart transplant, and device explant due to recovery. Event-specific Cox proportional hazard models were run with a binary psychosocial risk variable (including substance abuse, psychiatric diagnosis, limited social support, limited cognition, repeated noncompliance), controlled for covariates. Psychosocial risk was more prevalent in men than in women (21.4% vs 17.5%, p<0.001). Seven out of 10 AEs were more likely in women than in men (e.g., infection 44.5% vs 39.2%, p<0.001). The association of psychosocial risk with each AE was either stronger in women than in men (e.g., device malfunction HRadj 1.29, 95% confidence interval (CI) (1.06-1.56) vs HRadj 1.10, 95% CI (0.97-1.25); rehospitalization HRadj 1.15, 95% CI (1.02-1.29) vs HRadj 1.03, 95% CI (0.97-1.10) or similar between sexes. Independent of clinical parameters, the presence of psychosocial risk is associated with increases in AEs. This suggests that early modification of psychosocial risk factors may have the potential to lower the risk for AEs in this patient population.

Managing Right Ventricular Failure After Left Ventricular Assist Device Implant at a Destination Therapy Center

Although left ventricular assist device (LVAD) implant is associated with an increased survival in patients with end-stage heart failure, severe right ventricular failure requiring a right ventricular assist device (RVAD) placement is associated with increased short-term morbidity and mortality. Patients not eligible for transplant have limited options, which may impact decision-making and outcomes at nontransplant centers. We conducted a retrospective review of all LVAD implants at our nontransplant center. Primary stratification was by the need for a postoperative RVAD implant. The primary outcome was survival. The Cox proportional hazards regression modeling was used to further evaluate mortality. From 2017 to 2022, 128 patients underwent a primary LVAD implant and 24 (18.75%) required a perioperative RVAD placement. RVAD implant was associated with increased operative mortality (1.92% vs 33.33%, p <0.01) and decreased 1-year (91.29% vs 60.60%, p <0.01) and 2-year survival (84.05% vs 36.36%, p <0.01). However, in patients who survived their index hospitalization, 1-year (93.00% vs 91.67%, p=0.78) and 2-year (86.16% vs 55.00%, p=0.10) mortality were similar. On multivariable analysis, the need for a RVAD was associated with an increased hazard of 1-year (5.60 [1.96 to 16.01], p <0.01) and 2-year (5.17 [2.01 to 13.28], p <0.01) mortality. In conclusion, our series from a nontransplant center suggests that patients who survive the implant have acceptable short-term survival, even if they do not have a transplant option; thus, carefully selected patients with biventricular failure may benefit from an LVAD implant, even if an RVAD is needed.

Mechanical circulatory support for adults in Japan: A 10-year perspective.

Globalization in Asia and consequent strengthening of healthcare economic factors in tandem with an increasing heart failure (HF) population have enhanced potential for development and progress in the fields of HF medicine and mechanical circulatory support (MCS). In Japan, there are unique opportunities to investigate the outcome of acute and chronic MCS and a national registry for percutaneous and implantable left ventricular assist device (LVAD) including Impella pumps has been established. A Peripheral extracorporeal membrane oxygenation (ECMO) for acute MCS has been used in more than 7000 patients annually and Impella usage in more than 4000 patients over the past 4 years was noted. Recently, a novel centrifugal pump with hydrodynamically levitated impeller was developed and approved for mid-term extracorporeal circulatory support. In terms of chronic MCS more than 1200 continuous flow LVADs have been implanted during the past decade, and 2-year survival rate after primary LVAD implantation is 91%. Because of donor organ shortage, more than 70% of heart transplant recipients required LVAD support for more than 3 years and prevention and treatment of complications during long-term LVAD support have become important. Five important topics including hemocompatibility-related complications, LVAD infections, aortic valve insufficiency, right ventricular failure and cardiac recovery during LVAD support are discussed in this review for improving clinical outcomes. Findings from Japan will continue to provide useful information regarding MCS for the Asia-Pacific region and beyond.

Impact of adverse events on health-related quality of life after left ventricular assist device implantation: An STS INTERMACS analysis

We sought to quantify the impact of pre- and postoperative variables on health-related quality of life (HRQOL) after left ventricular assist device (LVAD) implantation. Primary durable LVAD implants between 2012 and 2019 in the Interagency Registry for Mechanically Assisted Circulatory Support were identified. Multivariable modeling using general linear models assessed the impact of baseline characteristics and postimplant adverse events (AEs) on HRQOL as assessed by the EQ-5D visual analog scale (VAS) and the Kansas City Cardiomyopathy Questionnaire-12 (KCCQ) at 6 months and 3 years. Of 22,230 patients, 9,888 had VAS and 10,552 had KCCQ reported at 6 months, and 2,170 patients had VAS and 2,355 had KCCQ reported at 3 years postimplant. VAS improved from a mean of 38.2 ± 28.3 to 70.7 ± 22.9 at 6 months and from 40.1 ± 27.8 to 70.3 ± 23.1 at 3 years. KCCQ improved from 28.2 ± 23.9 to 64.3 ± 23.2 at 6 months and from 29.8 ± 23.7 to 63.0 ± 23.7 at 3 years. Preimplant variables, including baseline VAS, had small effect sizes on HRQOL while postimplant AEs had large negative effect sizes. Recent stroke, respiratory failure, and renal dysfunction had the largest negative effect on HRQOL at 6 months, while recent renal dysfunction, respiratory failure, and infection had the largest negative effect at 3 years. AEs following LVAD implantation have large negative effects on HRQOL in early and late follow-up. Understanding the impact of AEs on HRQOL may assist shared decision-making regarding LVAD eligibility. Continued efforts to reduce post-LVAD AEs are warranted to improve HRQOL in addition to survival.

The Impact of MOMENTUM 3 Trial Eligibility on Left Ventricular Assist Device Outcomes: A Real-World Experience

IntroductionAlthough the landmark MOMENTUM 3 trial was associated with excellent short-term left ventricular assist device (LVAD) outcomes, many end-stage heart failure patients would not have met the trial eligibility criteria. Moreover, the outcomes of trial ineligible patients are poorly characterized. Therefore, we undertook this study to compare MOMENTUM 3 eligible and ineligible patients. MethodsWe conducted a retrospective review of all primary LVAD implants from 2017 to 2022. Primary stratification was according to MOMENTUM 3 inclusion and exclusion criteria. Primary outcome was survival. Secondary outcomes included complications and length of stay. Multivariable Cox proportional hazards regression models were constructed to further characterize outcomes. ResultsFrom 2017 to 2022, 96 patients underwent primary LVAD implantation. Thirty-seven (38.54%) patients were trial eligible while 59 (61.46%) were ineligible. When stratified by trial eligibility, patients who were trial eligible had higher 1-year (80.15% versus 94.52%, P = 0.04) and 2-year survival (70.17% versus 94.52%, P = 0.02). Multivariable analysis showed that trial eligibility was protective of mortality at both 1 y (HR: 0.19 [0.04-0.99], P = 0.049) and 2 y (HR: 0.17 [0.03-0.81], P = 0.03). Although the groups had similar rates of bleeding, stroke, and right ventricular failure, trial ineligibility was associated with a longer periprocedural length of stay. ConclusionsIn conclusion, the majority of contemporary LVAD patients would not have been eligible for the MOMENTUM 3 trial. Ineligible patients have decreased but acceptable short-term survival. Our findings suggest that a simply reductionist approach to short-term mortality may improve outcomes but fail to capture the majority of patients who could benefit from therapy.

The Society of Thoracic Surgeons Intermacs 2022 Annual Report: Focus on the 2018 Heart Transplant Allocation System

The 13th annual report from The Society of Thoracic Surgeons (STS) Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) highlights outcomes for 27,314 patients receiving continuous-flow durable left ventricular assist devices (LVAD) during the last decade (2012-2021). In 2021, 2464 primary LVADs were implanted, representing a 23.5% reduction in the annual volume compared with peak implantation in 2019 and an ongoing trend from the prior year. This decline is likely a reflection of the untoward effects of the coronavirus disease 2019 pandemic and the change in the United States heart transplant allocation system in 2018. The last several years have been characterized by a shift in device indication and type, with 81.1% of patients now implanted as destination therapy and 92.7% receiving an LVAD with full magnetic levitation in 2021. However, despite an older, more ill population being increasingly supported preimplant with temporary circulatory devices in the recent (2017-2021) vs prior (2012-2016) eras, the 1- and 5-year survival continues to improve, at 83.0% and 51.9%, respectively. The adverse events profile has also improved, with a significant reduction in stroke, gastrointestinal bleeding, and hospital readmissions. Finally, we examined the impact of the change in the heart transplant allocation system in 2018 on LVAD candidacy, implant strategy, and outcomes. In the competing-outcomes analysis, the proportion of transplant-eligible patients receiving a transplant has declined from 56.5% to 46.0% at 3 years, whereas the proportion remaining alive with ongoing support has improved from 24.1% to 38.1% at 3 years, underscoring the durability of the currently available technology.

Hyperpolypharmacy is a predictor of mortality after left ventricular assist device (LVAD) implantation

BackgroundThe prevalence of (hyper)polypharmacy in patients on left ventricular assist device (LVAD) support and its effect on clinical outcomeis unknown. Therefore, we aimed to determine the prevalence of (hyper)polypharmacy in LVAD patients and evaluate its association with mortality and complications. Materials and methods210 patients aged ≥40 years who received a primary LVAD implantation between 2011 and 2019 were included for analysis. Polypharmacy and hyperpolypharmacy were defined as the concomitant use of 5–9 and ≥10 medications at discharge after LVAD implantation, respectively. Cause specific cox regression was used to assess the association of ≥10 medications with mortality, cardiac arrhythmia, driveline infection and major bleeding. ResultsThe median age of the patients was 57.5 years, and 35.7 % were female. The average number of discharge medications was 8.8 ± 2.3 per patient. The prevalence of patients with 5–9 medications and ≥10 medications was 62.9 % and 34.8 %, respectively. The median follow-up duration was 948 days (interquartile range 874 days). The prescription of ≥10 medications was significantly associated with a higher risk of mortality (HR 2.03; 95 % CI 1.15–3.6, p-value 0.02) adjusted for sex, age, comorbidity and stratified for device type. The prescription of ≥10 medications was not associated with a higher risk of major bleeding, cardiac arrhythmia or driveline infection. Conclusions(Hyper)polypharmacy is highly prevalent in LVAD patients and is independently associated with a higher risk of mortality. Future research is needed to assess the efficacy of individual risk-benefit profiling of (cardiovascular) medication to ensure appropriate polypharmacy and to decrease negative health outcomes.

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.

Incompleteness of health-related quality of life assessments before left ventricular assist device implant: A novel quality metric.

Improved health-related quality of life (HRQOL) is an important outcome following durable left ventricular assist device (LVAD) implant. However, half of pre-implant HRQOL data are incomplete in The Society of Thoracic Surgeons' Intermacs registry. Pre-implant HRQOL incompleteness may reflect patient status or hospital resources to capture HRQOL data. We hypothesized that pre-implant HRQOL incompleteness predicts 90 day outcomes and serves as a novel quality metric. Risk factors for pre-implant HRQOL (EQ-5D-5L visual analog scale; 12-item Kansas City Cardiomyopathy Questionnaire "KCCQ") incompleteness were examined by stepwise logistic modeling. Direct standardization method was used to calculate adjusted incompleteness rates using a mixed effects logistic model. Hospitals were dichotomized as low or high based on median adjusted incompleteness rates. Andersen-Gill models were used to associate pre-implant HRQOL adjusted incompleteness rate with adverse events within 90 day post-implant. The study cohort included 14,063 patients receiving a primary LVAD (4/2012-8/2017). HRQOL incompleteness at high-rate hospitals was more often due to administrative reasons (risk difference, EQ-5D: 10.1%; KCCQ-12: 11.6%) and less likely due to patient reasons (risk difference, EQ-5D: -8.9%; KCCQ-12: -11.4%). A 10% increase in the adjusted pre-implant EQ-5D incompleteness rate was significantly associated with higher risk of infection-related mortality (HR: 1.09), infection (HR: 1.05), and renal dysfunction (HR: 1.03). A 10% increase in the adjusted pre-implant KCCQ-12 incompleteness rate was significantly associated with higher risk of infection (HR: 1.04). Hospital adjusted pre-implant HRQOL incompleteness was predictive of 90-day post-implant outcomes and may serve as a novel quality metric.

Impact of Preoperative Liver Function on Short-Term HeartMate 3 Outcomes

Although left ventricular assist device (LVAD) therapy is associated with improved survival, the impact of preoperative liver function on short-term outcomes is unclear. We conducted a retrospective review of all primary HeartMate 3 LVAD implants at a single center. Composite metrics of hepatic function including the model for end-stage liver disease (MELD), the MELD with sodium, and the MELD excluding international normalized ratio (MELD-XI) were evaluated. Receiver operator characteristic curves were compared to determine which equation was most predictive of 1-year survival. Primary stratification was based on MELD-XI tertiles. Secondary stratification was based on hypoalbuminemia (<3.0 mg/100 ml). A total of 94 patients underwent primary LVAD implantation from 2017 to 2022. MELD-XI and hypoalbuminemia were most associated with 1-year outcomes. When stratified by MELD tertiles, higher MELD was strongly associated with decreased 30 days (100.00% vs 100.00% vs 90.32%, p=0.04), 1-year (93.00% vs 93.32% vs 69.79%, p=0.01), and 2-year survival (93.00% vs 83.21% vs 69.79%, p=0.04). In addition, while hypoalbuminemia was associated with similar 30 days (97.87% vs 95.74%, p=0.56) survival, it was associated with a significant decrease in 1-year (92.93% vs 77.92%, p=0.03) and 2-year survival (92.93% vs 68.89%, p <0.01). These results persisted on multivariable analysis for both MELD-XI score (p=0.04) and hypoalbuminemia (p=0.04). In conclusion, this is the first study to demonstrate that preoperative MELD-XI score and serum albumin levels are associated with short-term HeartMate 3 outcomes.

Development of a non‐transplant left ventricular assist device program

Although the established long-term benefit of left ventricular assist device (LVAD) therapy has led to its proliferation as destination therapy (DT), few studies have evaluated LVAD outcomes at nontransplant centers. We undertook this study to better evaluate our experience in building a nontransplant, DT LVAD program. We conducted a retrospective review of all LVADs implanted from 2010 to 2021. Patient, operative, and outcome data were extracted from the electronic medical record. Secular trends were evaluated by organizing the data into eras of implant. Survival was assessed using the Kaplan-Meier method. Multivariable Cox proportional hazards regression models further evaluated outcomes. From 2010 to 2021, 100 primary LVAD implants were performed. Annual volume grew from 1 to 30 implants per year. The average age of our cohort was 65.7 years, most patients (80%) were male, 51% had an ischemic etiology, and 65 (65%) were INTERMACS profile 1 or 2. Our 1- and 2-year survival were 82% and 79%, respectively. Multivariable analysis of 1-year mortality demonstrated that decreasing renal function and increased cardiopulmonary bypass (CPB) time were associated with increased mortality while preoperative hemoglobin was protective. When stratified by era of implant, our most recent patients were more likely to be INTERMACS profile 1 or 2; had shorter CPB and aortic cross clamp times; required fewer reoperations for bleeding; and suffered less right ventricular failure requiring mechanical support. A single, nontransplant LVAD center can experience significant growth in volume in a high-acuity cohort while maintaining acceptable outcomes and quality of care.

In a large‐volume multidisciplinary setting individual surgeon volume does not impact LVAD outcomes

BackgroundIn complex operations surgeon volume may impact outcomes. We sought to understand if individual surgeon volume affects left ventricular assist device (LVAD) outcomes.MethodsWe reviewed primary LVAD implants at an experienced ventricular assist devices (VAD)/transplant center between 2013 and 2019. Cases were dichotomized into a high‐volume group (surgeons averaging 11 or more LVAD cases per year), and a low‐volume group (10 or less per year). Propensity score matching was performed. Survival to discharge, 1‐year survival, and incidence of major adverse events were compared between the low‐ and high‐volume groups. Predictors of survival were identified with multivariate analysis.ResultsThere were 315 patients who met inclusion criteria‐45 in the low‐volume group, 270 in the high‐volume group. There was no difference in survival to hospital discharge between the low (91.9%) and high (83.3%) volume matched groups (p = .22). Survival at 1‐year was also similar (85.4% vs. 80.6%, p = .55). There was no difference in the incidence of major adverse events between the groups. Predictors of mortality in the first year included: age (hazards ratio [HR]: 1.061, p < .001), prior sternotomy (HR: 1.991, p = .01), increasing international normalized ratio (HR: 4.748, p < .001), increasing AST (HR: 1.001, p < .001), increasing bilirubin (HR: 1.081, p = .01), and preoperative mechanical ventilation (HR: 2.662, p = .005). Individual surgeon volume was not an independent predictor of discharge or 1‐year survival.ConclusionThere was no difference in survival or adverse events between high and low volume surgeons suggesting that, in an experienced multidisciplinary setting, low‐volume VAD surgeons can achieve similar outcomes to their high‐volume colleagues.

Impact of Adverse Events on Health-Related Quality of Life After Left Ventricular Assist Device Implantation - An STS INTERMACS Analysis

<h3>Purpose</h3> Our aim was to quantify the impact of pre- and post-operative variables on health-related quality of life (HRQOL) after left ventricular assist device (LVAD) implantation. <h3>Methods</h3> Primary continuous flow durable LVAD implants, with or without concomitant valve surgery, between 2012-2019 in the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) were identified. Multivariable modeling using general linear models assessed the impact of baseline patient characteristics, operative factors including device type, and post-implant adverse events (AEs) on HRQOL as assessed by the EQ-5D Visual Analog Scale [(VAS, 0 (worst) to 100 (best health state)] at 6 months and 3 years post-LVAD. Recent AEs were defined as occurring within 60 days prior to follow-up. <h3>Results</h3> Of 22,230 primary LVAD implants, 9,888 patients were alive with complete VAS data at 6 months, and 2,170 were alive with complete VAS data at 3 years follow-up. Median VAS improved from 40 [IQR 10-60] pre-implant to 75 [IQR 60-85] at 6 months and 75 [IQR 60-85] at 3 years (p<0.001). Pre-implant variables, including baseline VAS, were weakly associated with HRQOL, while post-implant AEs had a large negative association. Lower NYHA class at follow-up had a large positive association with HRQOL both at 6 months and 3 years. Recent stroke, recent respiratory failure, and recent renal dysfunction were most strongly associated with impaired HRQOL at 6 months, while recent renal dysfunction, recent respiratory failure, and recent infection were most strongly associated at 3 years (<b>Figure</b>). <h3>Conclusion</h3> AEs following LVAD implantation are most strongly associated with impaired HRQOL in both the early and late follow-up periods. Understanding the impact of AEs on HRQOL may assist clinicians and patients in shared decision making regarding LVAD therapy eligibility and timing of implant. Continued efforts to reduce post-LVAD AE burden are warranted to not only improve survival but also HRQOL.