Primary Left Ventricular Assist Device Implantation Research Articles

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.

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.

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.

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.

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.

Predictors of Failure to Rescue After Left Ventricular Assist Device Implantation

<h3>Purpose</h3> Failure to rescue (FTR), defined as death after a complication, is an established hospital quality metric for coronary and valve surgery. While prior work has documented interhospital variability in FTR after durable left ventricular assist device (LVAD), less is known about patient and complication-specific predictors of FTR in this setting. <h3>Methods</h3> Patients undergoing primary LVAD implantation from 2012-2017 were selected from the INTERMACS database. The cohort was divided into two groups and compared based on patient survival following complications and FTR. FTR was defined as patient in-hospital mortality after experiencing at least one of the following major complications: severe right heart failure, respiratory failure, renal failure requiring dialysis, major infection, device malfunction, and bleeding requiring reoperation. Multivariable logistic regression was used to evaluate both pre-operative patient and complication specific predictors of FTR. Stepwise selection was used to arrive at the final model. <h3>Results</h3> Of the 13,617 patients in the sample, 4,839 (35.5%) experienced a major complication of which 854 (17.6%) died (i.e., FTR). Patients in the FTR group were more likely to be older (61.3 +/- 11.5 vs 56.9 +/-12.9, p<0.001), INTERMACS Profile 1 (30.9% vs 20.9%, p<0.0001), and Destination Therapy (55.6% vs 48.3%, p=0.0003). Significant predictors of FTR included: a history of prior CABG (OR = 1.54, CI95%: 1.31-1.82), valve surgery (OR = 1.50, CI95%: 1.07-2.11), preoperative dialysis (OR = 2.29, CI95%: 1.70-3.08) and preoperative ECMO (OR=4.27, CI95%: 3.01-6.04). Patients developing right heart failure had the highest complication-specific FTR rate (75.3%) followed by reintubation (45.1%), Table 1. <h3>Conclusion</h3> This study identified four significant preoperative predictors of FTR after durable LVAD placement. Future work should focus on identifying patients at highest risk of FTR, as well as early recognition and management of complications.

Abstract 12609: Contemporary Trends of Outcomes in Left Ventricular Assist Device: Insight From Nationwide Readmission Database

Hypothesis: We aimed to analyze trends of 30-day readmission and find high-risk patients associated with increased risk of mortality, resource utilization, and readmission after primary left ventricular assist device (LVAD) implantation. Introduction: Limited data exist on the contemporary trends of readmission rates and patients at a higher risk of worse outcomes post-LVAD. Methods: This is a retrospective study of adults from the NRD who received primary durable LVAD implantation from 2010-2018. The main outcomes were 30-day readmission rates and their trends in patients with primary durable LVAD implantation from 2010-2018. This study also sought to identify the patients at the highest risk for readmission, in-hospital mortality, and resource utilization. Results: A total of 31,002 adults with primary durable LVAD implantation were included in the present analysis. Overall, 3808 (12.3%) died, and 27168 (87.6%) were discharged alive. Of those discharged alive, 8303 (30.6%) patients were readmitted within 30 days. The trend of 30-day all-cause readmission among LVAD implantation patients remained similar from 2010-2018 (p=0.809). The in-hospital mortality during index hospitalization significantly decreased (p=0.014), and the mean cost of index hospitalization increased (p=0.031) during the study period. The patients with post-LVAD in-hospital cardiac, vascular, and thromboembolic complications (i.e., high-risk patients) had the highest mortality, resource utilization, and readmission rates as compared with patients without major complications. Conclusions: This study found that the readmission rates associated with LVAD implantation did not change from 2010-2018 and identified high-risk patients who may benefit from closer monitoring after primary LVAD implantation.

Contemporary Trends of Clinical Outcomes in Primary Left Ventricular Assist Device Implantation and Postprocedure High-Risk Categories

ObjectiveWe aimed to analyze trends of 30-day readmission and find high-risk patients associated with increased risk of mortality, resource use, and readmission after primary left ventricular assist device (LVAD) implantation. Limited data exist on the contemporary trends of readmission rates and patients at a higher risk of worse outcomes after LVAD implantation. Methods and ResultsThis is a retrospective study of adults from the Nationwide Readmission Database who underwent primary durable LVAD implantation from 2010 to 2018. The main outcomes were 30-day readmission rates and their trends in patients with primary durable LVAD implantation from 2010 to 2018. This study also sought to identify patients at the highest risk for readmission, in-hospital mortality, and resource use. A total of 31,002 adults with primary durable LVAD implantation were included in the present analysis. Overall, 3808 patients (12.3%) died and 27,168 (87.6%) were discharged alive. Of those discharged alive, 8303 patients (30.6%) were readmitted within 30 days. The trend of 30-day all-cause readmission among LVAD implantation patients remained similar from 2010 to 2018 (P = .809). The in-hospital mortality rate during the index hospitalization decreased significantly (P = .014), and the mean cost of an index hospitalization increased (P = .031) during the study period. The patients with post-LVAD in-hospital cardiac, vascular, and thromboembolic complications (ie, high-risk patients) had the highest mortality, resource use, and readmission rates compared with patients without major complications. ConclusionsThis study found that the readmission rates associated with LVAD implantation did not change from 2010 to 2018 and identified high-risk patients who may benefit from closer monitoring after primary LVAD implantation.

Bridge-to-Bridge Left Ventricular Assist Device Implantation Strategy vs. Primary Left Ventricular Assist Device Implantation Strategy.

The bridge-to-bridge (BTB) strategy, a conversion to durable left ventricular assist device (LVAD) after stabilization using surgical temporary mechanical circulatory supports for a couple of months, is not uncommon in Japan. However, its effect on clinical outcomes in comparison with a primary durable LVAD implantation strategy remains unknown.Methods and Results:Data of 837 consecutive patients (median age 45, 73% males) who underwent durable LVAD implantation as BTB (n=168) or primary implant (n=669) between April 2011 and April 2019 were retrospectively reviewed from the prospective multicenter Japanese mechanically assisted circulatory support registry. The BTB group was younger and had comparable end-organ function, better hemodynamic profile, and longer operative time compared with the primary implant group at baseline. The 3-year survival was 80% vs. 87% (P=0.007) for the BTB and primary implant groups respectively, with greater observed rates of stroke and infection as the predominant causes of death. The BTB strategy was independently associated with increased 3-year mortality (hazard ratio 2.69 [1.43-5.07], P=0.002) in addition to other significant risk factors. The BTB cohort had comparable baseline characteristics to the primary implant cohort at the time of durable LVAD conversion, but had lower 3-year survival. Detailed analysis clarifying the causality of this finding should improve outcomes with the BTB strategy.

Treatment With Impella Increases the Risk of De Novo Aortic Insufficiency Post Left Ventricular Assist Device Implant

BackgroundImpella (Abiomed Inc, Danvers, MA) is a temporary mechanical support device positioned across the aortic valve, and can be used to support patient before LVAD implantation. There are no data on the incidence of aortic insufficiency (AI) in patients supported with Impella as a bridge to durable LVAD implantation. We sought to assess the incidence of AI in patients with Impella support as a bridge to durable left ventricular assist device (LVAD) implantation. MethodsWe reviewed all patients undergoing primary LVAD implantation at the University of Pennsylvania from January 2015 onward, comparing those supported with Impella as temporary mechanical support with those supported by either venoarterial extracorporeal life support or an intra-aortic balloon pump. We reviewed transthoracic echocardiography preoperatively, as well as at 1 week, 1, 3, 6, 9, and 12 months after LVAD implantation. ResultsA total of 215 echocardiograms were analyzed in 41 patients. Eleven patients were supported with Impella before LVAD implant—6 patients with Impella alone (5 with Impella CP, 1 with Impella 5.0) and 5 with Impella in conjunction with venoarterial extracorporeal life support (2 with Impella 2.5, 2 with Impella CP, and 1 with Impella 5.0). After LVAD implant, mild or moderate AI developed in 82% of patients supported with Impella (9 of 11) compared with 43% of those without Impella (13 of 30) (P = .038). ConclusionsPatients supported by Impella as a bridge to durable LVAD have a higher risk of developing AI. Further studies are needed to assess this risk as the use of the Impella increases.

Impact of Gastrointestinal Bleeding Burden with Subsequent Outcomes after Left Ventricular Assist Device Implant

Gastrointestinal bleeding (GIB) is a frequent post left ventricular assist device (LVAD) co-morbidity, and many patients require multiple endoscopic interventions. While GI bleeding events have been shown to impact subsequent outcomes, the association of the burden of GI bleeding interventions with subsequent outcomes has not been specifically analyzed. Between February 2007 and June 2019, 389 patients underwent primary LVAD implantation at our Clinic. Median age at implant was 62 years (range, 18-82 years) and 306 (79%) were male. Etiology of heart failure was ischemic in 182 patients (47%) and indication for implant was destination therapy in 266 (69%). Axial flow pump was utilized in 282 (73%) and centrifugal flow in 105 (27%). Median preoperative duration of heart failure was 8.9 years. Early mortality occurred in 27/387 patients (7%). Follow-up was available in all 350 early survivors for a median of 1.8 years (920 years of patient support). There were 462 GI bleeding events in the 350 early survivors during the follow up time period. During these 462 bleeding events, endoscopic procedures were performed in 341/462 instances (74%) and intervention was performed in 96/341 (28%). Figure 1 shows the relative hazard of outcomes as related to burden of GI interventions for bleeding; late survival (p=0.95) and thrombotic complications (p=0.69) were not significantly impacted by increasing number of required GI interventions. However, risk of subsequent stroke (p=0.04) was significantly increased with higher number of procedures required. GI bleeding events are common after LVAD implant and endoscopic interventions are often required. Anticoagulation cessation is often required during these instances, and subsequent risk of stroke may be increased as the number of these procedures required is increased. Careful attention to peri-procedural anticoagulation and management may be critical to reduce subsequent unintended adverse events.

The Effect of Left Thoracotomy LVAD Implantation to LVAD Surgery and Followed Heart Transplantation Surgery

Left ventricular assist device (LVAD) implantations have traditionally been approached via full median sternotomy (FS). Recently, minimally invasive left thoracotomy (LT) approach has been popularized with improved surgical technique and emergence of smaller centrifugal LVAD devices. However, the surgical outcomes from minimal surgical approach remains to be unclear. The primary objective was to compare outcomes among patients who received an LVAD via FS compared to LT as well as their subsequent outcomes following heart transplantation. This is a single center retrospective study. 126 patients who underwent primary LVAD implantation from Jan 2014 to June 2018 are included (FS group n=83, LT group n=43). 49 patients had following HT (FS group n=27, LT group n=22). Preoperative patient demographics, intraoperative variables, hospital stay, postoperative survival and complications from LVAD implantation and heart transplantation were analyzed. Preoperatively, FS group had higher right atrial pressure (p<0.05). Intraoperative data showed LT group had 24% longer LVAD implant surgical time (p<0.05). Kaplan Meier curve showed better survival in LT group after LVAD implantation (p=0.04). The 1 year survival rate after heart transplantation was 100% for both groups. For post LVAD complications, FS group had more gastrointestinal bleeding events (p<0.05). There were no significant differences in post heart transplantation complications. Lastly, average length of hospital stay after LVAD implantation and heart transplantation showed no significance, respectively (25.0±24.9 vs 19.3±12.0, p=0.18),(28.2±41.9 vs 21.1± 13.7, p=0.46). Our study showed LT group was associated with improved survival after LVAD implantation. However, our study has limitation of containing bias from retrospective, non-randomized study design. Further, larger studies are warranted to prove the effects of minimally invasive LVAD implantation surgery.

Heart Failure Duration Association with Gastrointestinal Bleeding Post Left Ventricular Assist Device

Gastrointestinal bleeding (GIB) is a frequent post left ventricular assist device (LVAD) co-morbidity with gastrointestinal angiodysplasia (GIAD) commonly implicated. Timing of LVAD therapy is variable, but no study has specifically analyzed duration of pre-LVAD heart failure on GI bleeding outcomes after VAD implantation. Between February 2007 and June 2019, 389 patients underwent primary LVAD implantation at our clinic. Median age at implant was 62 years (range, 18-82 years) and 306 (79%) were male. Etiology of heart failure was ischemic in 182 patients (47%) and indication for implant was destination therapy in 266 (69%). Axial flow pump was utilized in 282 (73%) and centrifugal flow in 105 (27%). Median preoperative duration of heart failure was 8.9 years. Early mortality occurred in 27/387 patients (7%). Follow-up was available in all 350 early survivors for a median of 1.8 years (920 years of patient support). There were 462 GI bleeding events in the 350 early survivors during the follow up time period. Figure 1 shows the relative hazard of GIB as time from heart failure diagnosis to LVAD implant increases and suggests a possible nonlinear trend for time from heart failure diagnosis to LVAD implant between 1000 and 6000 days and lowest relative hazard of GIB. There are wider confidence bands below 3000 days and above 6000 days so it cannot be concluded that hazard of GIB decreases in these ranges. This approached statistical significance (P=0.06) supporting a possible trend. GI bleeding events are common after LVAD implant and a longer preoperative duration of heart failure prior to LVAD implant may increase burden of this adverse event. This would be a powerful factor in considering someone for LVAD implant earlier rather than protracted heart failure management if clinically indicated.

Aortic Insufficiency After Left Ventricular Assist Device Implantation: Predictors and Outcomes

The aim of this study was to evaluate the incidence, risk factors, and clinical impact of progression of aortic insufficiency (AI) after left ventricular assist device (LVAD) implantation. Patients undergoing primary durable LVAD implantation between 2004 and 2018 were included. Significant AI was defined as more than mild AI. Clinical and echocardiographic data were collected. Patients were stratified by degree of pre-LVAD AI into 3 groups: no AI, group I; trace AI, group II; and mild AI, group III. Three hundred sixteen eligible patients underwent LVAD implant, 229 patients (72.5%) in group I, 54 (17.1%) in group II, and 33 (10.4%) in group III. Median follow-up was 469 days. Forty-two patients (13.3%) progressed to significant AI during follow-up. Group III patients had the highest rate of developing significant AI (I, 10.0%; II, 13.0%; III, 36.4%; P= .002). Freedom from significant AI at 1 year after LVAD implant was 94.5% in group I, 86.1% in group II, and 62.4% in group III (P < .001). Predictors of developing significant AI included mild preoperative AI, ischemic cardiomyopathy, and shorter duration of LVAD support. Patients with significant AI after LVAD implantation had higher mortality compared with those without (59.5% vs 37.2%; P= .006). Although some patients supported with an LVAD develop significant AI, this risk is increased in those with mild AI preoperatively. This finding, in conjunction with the increased mortality risk once significant AI develops, suggests that closer follow-up and management of LVAD patients with mild preoperative AI may be prudent.

The Effect of Postoperative Vasoplegia to the Survival of LVAD Recipients

Purpose Vasoplegia syndrome (VS) is characterized by decreased systemic vascular resistance, refractory hypotension, and metabolic acidosis. VS can develop during and after left ventricular assist device (LVAD) implantation, which significantly complicates postoperative management. However, because of the limited prior studies, the causes, risk factors, and the effect of VS on outcomes are not well known. The aim of the study is to analyze the effect of VS in our cohort. Methods From January 2015 through February 2018, 134 patients with chronic end-stage heart failure underwent primary LVAD implantation in our single center. We defined vasoplegia as patients with normal cardiac index requiring >24-hour use of intravenous vasopressors within 48 hours following primary LVAD implantation to maintain a mean arterial pressure >70 mmHg, as previously reported. Patients were grouped as VS group and non-VS group. Pre- and intraoperative demographics, short- and long-term survival were analyzed between the groups. Correlation between VS and mortality, as well as independent risk factors for VS, were analyzed using Cox regression models. Results 134 patients were stratified into 2 groups: VS group (n=91) and non-VS group (n=43). Cox univariate analysis demonstrated VS was not an independent predictor for mortality (Hazard Ratio (HR) 0.74, p=0.41, 95% Confidence interval (CI) 0.36-0.74). Cox multivariate analysis revealed preoperative elevated Alanine Aminotransferase (ALT) was an independent predictor for VS occurrence (HR 1.001, p=0.003, 95% CI 1.000-1.002). Kaplan Meier curve showed no statistical difference in survival on LVAD between 2 groups. (p=0.20) Conclusion In our cohort, VS was not associated with higher mortality on LVAD support. Patients with preoperative elevated ALT may benefit from optimization prior to implantation to prevent VS. Additional researches are required to further explore VS mechanism and understand the effect on LVAD population outcomes.

Serial Assessment of Pulmonary Artery Pulsatility Index Provides Incremental Risk Assessment for Early Right Ventricular Failure after Left Ventricular Assist Device Implantation

Purpose PAPi (pulmonary artery pulsatility index) is a predictor of early right ventricular failure (RVF) post left ventricular assist device (LVAD) implantation and has been studied using hemodynamics from single, isolated time points. Since multiple clinical factors and therapies are known to impact RV function in pre-LVAD patients, we hypothesized that serial PAPi measurements would provide incremental risk stratification for early post-LVAD RVF. Methods A total of 394 consecutive patients undergoing primary durable LVAD implantation at our center from 2004 to 2017 were retrospectively enrolled. Serial invasive hemodynamics obtained during inpatient swan guided therapy (77%) or consecutive outpatient right heart catheterizations were recorded. The lowest, highest (“Best”), change (“Delta”) and most proximal PAPi to LVAD implant were calculated. RVF was defined as need for RVAD or prolonged inotrope use > 14 days post-operatively. Multivariate logistic regression determining independent associates of early RVF was performed. Results RVF occurred in 82 of the 394 patients (21%). Those who developed early RVF had significantly lower mean Delta PAPi (2.0 vs 5.3, p Conclusion The best PAPi achieved during medical optimization prior to LVAD implantation provides independent and incremental risk stratification for early RVF, likely identifying RV reserve.

Beyond Mortality - Significant Morbidity and Function Decline Follows Left Ventricular Assist Device Exchange

Introduction The operative exchange of a durable left ventricular assist device (LVAD) has become more commonplace. While most of the literature has focused on survival and surgical technique, little is known about the impact of LVAD exchange on patient morbidity and functional status. Hypothesis Morbidity and re-hospitalization will be common following LVAD exchange, while functional status will decline. Using each patient as their own control, there will be increased post-operative complication, morbidity, and 90-day readmission in comparison to the initial implant. Methods The medical record of all patients receiving a durable LVAD at our institution between January 2007 and December 2017 were reviewed. Those patients requiring LVAD exchange were included in this analysis. Patients were following for 1 year or until death or transplantation. Results Between January 2007 and December 2017, 341 patients underwent primary LVAD implantation. A total of 17 patients (5%) required device exchange, with indications including: pump thrombosis/hemolysis (47%), driveline injury or malfunction (29.4%), infection (11.8%), LVAD failure/stoppage (5.9%), and cannula malposition (5.9%). One-year mortality after LVAD exchange was 29.4% with a 50% mortality in those who had pump thrombosis as the indication for exchange, and 100% mortality in those with an ischemic etiology to their heart failure. Eight patients (47%) required a total of 12 hospital readmissions within 90 days of discharge following LVAD exchange. Indications for re-hospitalization included infection, post-operative wound management, and organ failure. Nine patients (53%) had at least one significant event within 90 days of device exchange, including cardiogenic shock, right ventricular failure, recurrent thrombosis, prolonged renal impairment requiring dialysis, gastrointestinal bleeding, stroke, and infection. Of the patients with a documented NYHA class pre- and post-device exchange (12 of 17), the majority had either no improvement or had a decline in functional status. Analysis is being performed to use each patient as their own control and compare post-operative complications, morbidity, and 90-day readmission in the initial implant versus LVAD exchange. Conclusions Not only does LVAD exchange lead to increased mortality, it is also associated with increased morbidity and re-hospitalization. Additionally, functional status may fail to improve after operative intervention. For a group of patients who routinely rank quality of life over survival, the unintended consequences of LVAD pump exchange mandate further exploration.

Caregiver status and outcomes after durable left ventricular assist device implantation

ObjectivesTo determine the relationship between caregiver status and outcomes after durable left ventricular assist device (LVAD) implantation. BackgroundThe absence of a caregiver is a relative contraindication to durable LVAD support. MethodsForty-three patients that underwent primary LVAD implantation were divided into three groups: those with caregivers that retained their roles for the duration of LVAD support (CG group), those with caregivers that resigned their roles (CG-QUIT group), and those implanted without an assigned caregiver (No-CG group). Group-specific characteristics and post-implant outcomes were compared. ResultsIn the CG-QUIT group, caregivers did not live in the same home (0.0% vs. 80.6% of CG group) and none were spouses (0.0% vs. 64.5% for CG group). Thirty-day readmission rate was highest in the CG-QUIT group (83.3% vs. 25.8% in CG group and 16.7% in No-CG group). ConclusionsCaregiver relationships were more likely to be maintained for the duration of LVAD support when the caregiver was a spouse and resided in the same home as the patient. Carefully selected patients implanted without a designated caregiver had comparable outcomes to those who retained their original caregiver.

A multi-institutional outcome analysis of patients undergoing left ventricular assist device implantation stratified by sex and race

Earlier studies have demonstrated disparities in patients undergoing left ventricular assist device (LVAD) implantation when stratified according to sex and race. Because very few data exist from large investigations, we reviewed data from the registry of the Mechanical Circulatory Support Research Network. Between May 2004 and September 2014, 734 patients underwent primary LVAD implantation at our institutions. Median age at implant was 57 (range 18 to 82) years and there were 577 males (80%). Race included Caucasian (C) in 586 patients (82%), African-American (AA) in 112 (16%), and other (O) in 21 (3%). Between sexes, significant pre-operative differences most commonly included median age at implant (males 60 years, females 57 years), ischemic etiology (53% vs 35%) and mean INTERMACS profile (2.9 vs 2.5). Between races, significant pre-operative differences most commonly included median age at implant (C = 61 vs AA = 51 vs O = 51), New York Heart Association functional class (85% vs 100% vs 92%) and ischemic etiology (55% vs 24% vs 40%). There were no significant differences in survival at 1, 3 or 5 years by sex or race. Similarly, there were no differences in time-related freedom from stroke, drive-line infection, gastrointestinal bleeding or pump thrombus by sex or race. After controlling for differences, neither sex nor race was associated with survival (p = 0.09 and p = 0.18, respectively), stroke (p = 0.28 and p = 0.21), drive-line infection (p = 0.9 and p = 0.92), gastrointestinal bleed (p = 0.48 and p = 0.45) or pump thrombus (p = 0.99 and p = 0.8). In this large, multi-institutional analysis, although some pre-operative clinical characteristics varied, they did not translate into any significant differences in late survival or complications while on LVAD support.