ABSTRACT
BACKGROUND: Among patients with advanced heart failure (HF), treatment with a left ventricular assist device (LVAD) improves health-related quality of life (HRQOL). We investigated the association between psychosocial risk factors, HRQOL and outcomes after LVAD implantation. METHODS: A retrospective cohort (nâ¯=â¯9832) of adults aged ≥ 19 years who received durable LVADs between 2008 and 2017 was identified by using the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS). Patients were considered to have psychosocial risk factors if ≥ 1 of the following were present: (1) substance abuse; (2) limited social support; (3) limited cognitive understanding; (4) repeated nonadherence; and (5) major psychiatric disease. Multivariable logistic and linear regression models were used to evaluate the association between psychosocial risk factors and change in Kansas City Cardiomyopathy Questionnaire (KCCQ)-12 scores from baseline to 1 year, persistently poor HRQOL (KCCQ-12 score < 45 at baseline and 1 year), and 1-year rehospitalization. RESULTS: Among the final analytic cohort, 2024 (20.6%) patients had ≥ 1 psychosocial risk factors. Psychosocial risk factors were associated with a smaller improvement in KCCQ-12 scores from baseline to 1 year (mean ± SD, 29.1 ± 25.9 vs 32.6 ± 26.1; Pâ¯=â¯0.015) for a difference of -3.51 (95% confidence interval [CI]: -5.88 to -1.13). Psychosocial risk factors were associated with persistently poor HRQOL (adjusted odds ratio [aOR] 1.35, 95% confidence interval [CI] 1.04-1.74), and 1-year all-cause readmission (adjusted hazard ratio [aHR] 1.11, 95% CI 1.05-1.18). Limited social support, major psychiatric disorder and repeated nonadherence were associated with persistently poor HRQOL, while major psychiatric disorder was associated with 1-year rehospitalization. CONCLUSION: The presence of psychosocial risk factors is associated with lower KCCQ-12 scores and higher risk for readmission at 1 year after LVAD implantation. These associations are statistically significant, but further research is needed to determine whether these differences are clinically meaningful.
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OBJECTIVE: Smaller body surface area (BSA) frequently precludes patients from left ventricular assist device (LVAD) therapy. We sought to investigate the clinical outcomes in patients with small BSA undergoing less invasive LVAD implantation. METHODS: We conducted a retrospective review of 216 patients implanted with HeartMate 3 LVAD (Abbott, Chicago, IL) via less invasive surgery at our institution. Patients were dichotomized based on their preimplant BSA for comparison between small BSA (≤1.8 m2) and normal/large BSA (>1.8 m2). We analyzed patient perioperative characteristics and outcomes. RESULTS: In our study, small BSA was found in 32 patients (14.8%), while 184 patients (85.2%) had normal/large BSA. Women were more prevalent in the small BSA group (50.0% vs 13.0%, P < 0.001). Preoperative and intraoperative data showed comparable results. Major complications and hospital length of stay did not differ by BSA group. Patients with smaller BSA had significantly decreased pump parameters at discharge, including LVAD flow (4.11 ± 0.49 vs 4.60 ± 0.54 L/min, P < 0.001) and pump speed (5,200 vs 5,400 rpm, P < 0.001). Survival to discharge and within 6 months after implantation were similar between the groups. CONCLUSIONS: Our study results suggest that less invasive HeartMate 3 implantation can be safely performed and demonstrates equivalent outcomes in patients with smaller body habitus. Randomized trials are required to confirm our data.
Subject(s)
Heart Failure , Heart-Assist Devices , Thoracic Surgical Procedures , Humans , Female , Heart-Assist Devices/adverse effects , Body Surface Area , Retrospective StudiesSubject(s)
Cardiomyopathies , Heart Failure , Humans , Male , Female , Sex Characteristics , Heart Failure/pathology , Cardiomyopathies/genetics , Myocardium/pathology , Gene ExpressionABSTRACT
BACKGROUND: There are limited data regarding racial disparities in outcomes after left ventricular assist device (LVAD) implantation. The purpose of this study was to compare clinical characteristics and the burden of readmissions by race among patients with LVAD. METHODS: The study population included 461 patients implanted with LVADs at the University of Rochester Medical Center, NY from May 2008 to March 2020. Patients were stratified by race as White patients (N = 396 [86%]) and Black patients (N = 65 [14%]). The Anderson-Gill recurrent regression analysis was used to assess the independent association between race and the total number of admissions after LVAD implant during an average follow-up of 2.45 ± 2.30 years. RESULTS: Black patients displayed significant differences in baseline clinical characteristics compared to White patients, including a younger age, a lower frequency of ischemic etiology, and a higher baseline serum creatinine. Black patients had a significantly higher burden of readmissions after LVAD implantation as compared with White patients 10 versus 7 (average number of hospitalizations per patient at 5 years of follow-up, respectively) translated into a significant 39% increased risk of recurrent readmissions after multivariate adjustment (Hazard ratio 1.39, 95% CI; 1.07-1.82, p 0.013). CONCLUSION: Black LVAD patients experience an increased burden of readmissions compared with White patients, after adjustment for baseline differences in demographics and clinical characteristics. Future studies should assess the underlying mechanisms for this increased risk including the effect of social determinants of health on the risk of readmissions in LVAD recipients.
Subject(s)
Heart Failure , Heart-Assist Devices , Patient Readmission , Race Factors , Humans , White , Black or African American , Male , Female , Adult , Middle Aged , Aged , Heart Failure/epidemiology , Retrospective StudiesABSTRACT
BACKGROUND: Patients with heart failure (HF) represent a large population of patients who are at high risk for complications related to undiagnosed atrial fibrillation (AF). However, currently there are limited modalities available for early AF detection in this high-risk population. An implantable cardiac monitor (ICM) is inserted subcutaneously and can provide long-term arrhythmia information via remote monitoring. METHODS AND RESULTS: Confirm-AF is a prospective randomized, nonblinded, two arm, multicenter clinical trial to be performed in the United States, enrolling 477 patients with a history of HF hospitalization and left ventricular ejection fraction >35% from 30 medical sites. Patients will be randomized in a 2:1 fashion to undergo ICM implant with remote monitoring and symptom-triggered mobile app transmissions versus (vs.) Non-ICM management and follow-up. The primary objective of this trial is to compare the time to first detection of AF lasting > 5 min using an Abbott ICM compared to non-ICM monitoring in symptomatic HF patients. This article describes the design and analytic plan for the Confirm-AF trial. CONCLUSIONS: The Confirm-AF trial seeks to accurately define the burden of AF in high-risk HF patients with LVEF > 35% using an Abbott ICM. A finding showing significantly higher incidence of AF along with improved clinical outcomes with ICM monitoring is expected to have substantial clinical implications and may change the method of monitoring high-risk HF patients.
Subject(s)
Atrial Fibrillation , Heart Failure , Humans , United States , Atrial Fibrillation/complications , Atrial Fibrillation/diagnosis , Atrial Fibrillation/epidemiology , Prospective Studies , Stroke Volume , Electrocardiography , Electrocardiography, Ambulatory/methods , Ventricular Function, Left , Heart Failure/complications , Heart Failure/diagnosisABSTRACT
OBJECTIVES: The objective of this single-center, pilot, prospective, and historical control study is to evaluate safety and feasibility outcomes associated with left atrial appendage exclusion (LAAE) concomitant with left ventricular assist device (LVAD) implantation via less invasive surgery (LIS) as a stroke prevention strategy. METHODS: A predefined number of 30 eligible subjects scheduled for LIS LVAD with LAAE were enrolled in the prospective arm between January 2020 and February 2021. Eligible retrospective LIS LVAD patients without LAAE were propensity-matched in a 1:1 ratio with the prospective arm subjects. The primary study objectives were to evaluate the safety, feasibility, and efficacy of the LAAE concomitant with LIS LVAD. RESULTS: Preoperative characteristics of patients in the Non-LAAE and LAAE groups were similar. LAAE was successfully excluded in all prospective patients (100%). Primary safety endpoints of chest tube output within the first 24 postoperative hours, Reoperation for bleeding within 48 h, and index hospitalization mortality demonstrated comparable safety of LAAE versus Non-LAAE with LIS LVAD. Cox proportional hazard regression demonstrated that LAAE with LIS LVAD was associated with 37% and 49% reduction in the risk of stroke and disabling stroke, respectively (p > .05). CONCLUSION: Results from our pilot study demonstrated the safety and feasibility of LAAE concomitant with LIS LVAD as a stroke prevention strategy. This is the first prospective study describing LAAE performed concomitantly to less invasive LVAD implantation. The efficacy of LAAE in long-term stroke prevention needs to be confirmed in future prospective randomized clinical trials.
Subject(s)
Atrial Appendage , Heart Failure , Heart-Assist Devices , Stroke , Humans , Retrospective Studies , Prospective Studies , Atrial Appendage/surgery , Pilot Projects , Treatment Outcome , Stroke/etiology , Stroke/prevention & control , Heart Failure/surgeryABSTRACT
BACKGROUND: Chronic cerebral hypoperfusion is a potential mechanism that causes cognitive impairment in patients with heart failure. Cognitive impairment in this population is associated with an increased mortality and poorer quality of life. Understanding the etiopathogenesis of cognitive impairment is crucial to developing effective treatment. A left ventricular assist device (LVAD) is a durable mechanical circulatory support device that restores systemic perfusion in patients with heart failure, potentially reversing cerebral hypoperfusion and cognitive impairment. OBJECTIVE: This case series and systematic review examines the effect of LVAD implantation on cognition in patients with heart failure. METHODS: We report a case series of 4 LVAD recipients at a tertiary academic center who underwent preimplant and postimplant cognitive testing. We also conducted a systematic review of studies with adult recipients of a continuous-flow LVAD whose cognition was measured before and after implantation. We searched Medline, EMBASE, SCOPUS, and the Cochrane library (start of database to July 16, 2021) for longitudinal, peer-reviewed studies written in English. RESULTS: Cognitive improvement after LVAD implantation was observed in the case series, with improvement on phonemic fluency and digit symbol coding assessments. Two out of 4 cases in the case series improved on Clinical Dementia Rating: one from moderate dementia to mild cognitive impairment and another from mild cognitive impairment to unimpaired. Seven studies were included in the systematic review and were heterogeneous regarding cognitive tests employed, follow-up period, and measured outcomes. Montreal Cognitive Assessment and Trail-Making Test Part B were used most commonly. Cognitive improvement was reported in all 7 studies with at least 1 study reporting statistically significant improvements in each the following cognitive domains: delayed and immediate recall, executive function, visuospatial function, verbal function, attention, and processing speed. Most studies had small sample sizes and lacked a control group. CONCLUSIONS: LVAD implantation appears to be associated with improved cognition. Adequately powered, prospective studies are needed to examine the effect of LVAD on cognitive function in patients with heart failure. Additionally, studies that directly examine cerebral blood flow in conjunction with cognitive assessment are needed to establish the relationship between the reversal of cerebral hypoperfusion and improved cognition.
Subject(s)
Heart Failure , Heart-Assist Devices , Adult , Humans , Heart-Assist Devices/adverse effects , Quality of Life , Heart Failure/therapy , Treatment Outcome , Cognition/physiologyABSTRACT
BACKGROUND: Right ventricular failure (RVF) remains one of the major causes of morbidity and mortality after left ventricular assist device (LVAD) implantation. We sought to compare immediate postoperative invasive hemodynamics and the risk of RVF following two different surgical approaches: less invasive surgery (LIS) versus full sternotomy (FS). METHODS: The study population comprised all 231 patients who underwent implantation of a HeartMate 3 (Abbott) LVAD at our institution from 2015 to 2020, utilizing an LIS (n = 161; 70%) versus FS (n = 70; 30%) surgical approach. Outcomes included postoperative invasive hemodynamic parameters, vasoactive-inotropic score (VIS), RVF during index hospitalization, and 6-month mortality. RESULTS: Baseline clinical characteristics of the two groups were similar. Multivariate analysis showed that LIS, compared with FS, was associated with the improved cardiac index (CI) at the sixth postoperative hour (p = .036) and similar CI at 24 h, maintained by lower VIS at both timepoints (p = .002). The LIS versus FS approach was also associated with a three-fold lower incidence of in-hospital severe RVF (8.7% vs. 28.6%, p < .001) and need for RVAD support (5.0% vs. 17.1%, p = .003), and with 68% reduction in the risk of 6-month mortality after LVAD implantation (Hazard ratio, 0.32; CI, 0.13-0.78; p = .012). CONCLUSION: Our findings suggest that LIS, compared with FS, is associated with a more favorable hemodynamic profile, as indicated by similar hemodynamic parameters maintained by lower vasoactive-inotropic support during the acute postoperative period. These findings were followed by a reduction in the risk of severe RVF and 6-month mortality in the LIS group.
Subject(s)
Heart Failure , Heart-Assist Devices , Ventricular Dysfunction, Right , Heart-Assist Devices/adverse effects , Hemodynamics , Humans , Postoperative Period , Retrospective Studies , Ventricular Dysfunction, Right/etiologyABSTRACT
It has been suggested that maintaining low mean arterial pressure (MAP) in left ventricular assist device (LVAD) recipients is associated with a reduced risk of stroke/death. However, the lower limit of the optimal MAP range has not been established. We aimed to identify this lower limit in a contemporary cohort of LVAD recipients with frequent longitudinal MAP measurements. We analyzed 86,651 MAP measurements in 309 patients with an LVAD (32% LVADs with full magnetic levitation of the impeller) at a tertiary medical center during a mean follow-up of 1.7 ± 1.1 years. Cox proportional hazards regression modeling was used to study the association of serial MAP measurements with stroke/death within 3 years after index discharge. Multivariate analysis identified MAP ≤75 mm Hg, compared with MAP >75 mm Hg, as the low MAP threshold associated with increased risk of death (hazard ratio [HR] 4.74, 95% confidence interval [CI] 2.85 to 7.87, p <0.001), stroke (HR 2.72;, 95% CI 1.39 to 5.33, p = 0.01), and stroke/death (HR 4.45, 95% CI 2.83 to 6.99, p <0.001). The risk associated with MAP ≤75 mm Hg was consistent in subgroups categorized by age, gender, race, device type, renal function, right-sided heart failure, and blood pressure medications. In conclusion, our findings suggest that maintaining MAP ≤75 mm Hg during long-term follow-up in LVAD recipients is associated with increased risk of stroke/death regardless of risk factors or medical management.
Subject(s)
Heart Failure , Heart-Assist Devices , Hypotension , Stroke , Blood Pressure , Heart Failure/complications , Heart Failure/epidemiology , Heart Failure/therapy , Heart-Assist Devices/adverse effects , Humans , Hypotension/etiology , Retrospective Studies , Stroke/etiology , Treatment OutcomeABSTRACT
BACKGROUND: Historically, obesity was considered a relative contraindication to left ventricular assist device (LVAD) implantation with less invasive surgery (LIS). The present study aimed to compare the outcomes of obese patients who underwent LVAD implantation through LIS with those who received full sternotomy (FS) implantation. METHODS: We retrospectively reviewed all patients implanted with HeartMate 3 LVAD in our institution between September 2015 and June 2020. Obese patients (BMI ≥ 30 kg/m2) were included and dichotomized based on surgical approach into the FS or LIS cohort. RESULTS: Of 231 implanted patients, 107 (46%) were obese and included in the study. FS was performed in 26 (24%) patients and LIS approach in 81 (76%) patients. Preoperative patient characteristics were similar between the cohorts. Postoperatively, patients in LIS cohort had less bleeding (p = 0.029), fewer transfusions (p = 0.042), shorter duration of inotropic support (p = 0.049), and decreased incidence of severe RV failure (11.1% vs 30.8%, p = 0.028). Survival to discharge for the obese population was 87.5% overall and did not differ based on an approach (91.4% LIS vs 76.9% FS, p = 0.079). More LIS patients were discharged home (60.0% vs 82.4%, p = 0.041) rather than to rehabilitation center. CONCLUSION: Our results showed that the LIS approach in obese patients is associated with fewer postoperative complications and a trend towards better short-term survival. These results suggest that less invasive LVAD implantation is a safe and effective approach for obese patients. Future prospective randomized trials are required to substantiate these results.
Subject(s)
Heart Failure/surgery , Heart-Assist Devices , Minimally Invasive Surgical Procedures/methods , Obesity/complications , Postoperative Complications/epidemiology , Prosthesis Implantation/adverse effects , Adult , Female , Follow-Up Studies , Heart Failure/complications , Humans , Incidence , Male , Middle Aged , Retrospective Studies , Time Factors , United States/epidemiologyABSTRACT
INTRODUCTION: We sought to develop and implement a comprehensive enhanced recovery after surgery (ERAS) protocol for patients implanted with a left ventricular assist device (LVAD). METHODS AND RESULTS: In this article, we describe our approach to the development and phased implementation of the protocol. Additionally, we reviewed prospectively collected data for patients who underwent LVAD implantation at our institution from February 2019 to August 2020. To compare early outcomes in our patients before and after protocol implementation, we dichotomized patients into two 6-month cohorts (the pre-ERAS and ERAS cohorts) separated from each other by 6 months to allow for staff adoption of the protocol. Of the 115 LVAD implants, 38 patients were implanted in the pre-ERAS period and 46 patients in the ERAS period. Preoperatively, the patients` characteristics were similar between the cohorts. Postoperatively, we observed a decrease in bleeding (chest tube output of 1006 vs 647.5 mL, P < .001) and blood transfusions (fresh frozen plasma 31.6% vs 6.7%, Pâ¯=â¯.04; platelets 42.1% vs 8.7%, Pâ¯=â¯.001). Opioid prescription at discharge were 5-fold lower with the ERAS approach (P < .01). Furthermore, the number of patients discharged to a rehabilitation facility decreased significantly (20.0% vs 2.4%, Pâ¯=â¯.02). The index hospitalization length of stay and survival were similar between the groups. CONCLUSIONS: ERAS for patients undergoing LVAD implantation is a novel, evidence-based, interdisciplinary approach to care with multiple potential benefits. In this article, we describe the details of the protocol and early positive changes in clinical outcomes. Further studies are needed to evaluate benefits of an ERAS protocol in an LVAD population.Lay Summary: Enhanced recovery after surgery (ERAS) is the implementation of standardized clinical pathways that ensures the use of best practices and decreased variation in perioperative care. Multidisciplinary teams work together on ERAS, thereby enhancing communication among health care silos. ERAS has been used for more than 30 years by other surgical services and has been shown to lead to a decreased length of stay, fewer complications, lower mortality, fewer readmissions, greater job satisfaction, and lower costs. Our goal was to translate these benefits to the perioperative care of complex patients with a left ventricular assist device. Early results suggest that this goal is possible; we have observed a decrease in transfusions, discharge on opioids, and discharge to a rehabilitation facility.
Subject(s)
Enhanced Recovery After Surgery , Heart Failure , Heart-Assist Devices , Heart Failure/surgery , Hospitalization , Humans , Patient DischargeABSTRACT
There are limited data on the association of smoking with the risk of stroke following left ventricular assist device (LVAD) implantation. We designed this study to analyze the impact of smoking status at the time of LVAD implantation on stroke. We hypothesized that current smokers are at increased risk of stroke when compared with patients who were former or never smokers. The study population comprised of 369 patients in the University of Rochester Medical Center LVAD database, implanted with an LVAD between 2008 and 2018. Patients were stratified as current smoker (smoking within 30 days before LVAD implantation), former smoker, and never smoker. Stroke was defined as a transient ischemic attack or cerebrovascular accident (hemorrhagic or ischemic). There were 45 current smokers, 198 former smokers, and 125 never smokers. Current smokers were younger (mean age 50 ± 11 years), as compared with former (58 ± 12 years) and never smokers (56 ± 13 years) p < 0.001. At 2 years following LVAD implantation, the cumulative incidence of stroke was significantly higher among current smokers (39%) as compared with former and never smokers (16% and 15%, respectively; p = 0.022 for the overall difference during follow-up). In a multivariate model adjusted for significant clinical variables, current smoking was associated with a significant 88% (p = 0.018) higher risk of stroke when compared with all noncurrent smokers. In conclusion, our data suggest that LVAD candidates who are current smokers experience a significantly higher risk of stroke following device implantation.
Subject(s)
Heart Failure , Heart-Assist Devices , Stroke , Adult , Heart Failure/epidemiology , Heart Failure/etiology , Heart-Assist Devices/adverse effects , Humans , Incidence , Middle Aged , Retrospective Studies , Risk Factors , Smoking/adverse effects , Stroke/epidemiology , Stroke/etiologyABSTRACT
BACKGROUND: Peripartum cardiomyopathy (PPCM) occurs in ≈1:2000 deliveries in the United States and worldwide. The genetic underpinnings of PPCM remain poorly defined. Approximately 10% of women with PPCM harbor truncating variants in TTN (TTNtvs). Whether mutations in other genes can predispose to PPCM is not known. It is also not known if the presence of TTNtvs predicts clinical presentation or outcomes. Nor is it known if the prevalence of TTNtvs differs in women with PPCM and preeclampsia, the strongest risk factor for PPCM. METHODS: Women with PPCM were retrospectively identified from several US and international academic centers, and clinical information and DNA samples were acquired. Next-generation sequencing was performed on 67 genes, including TTN, and evaluated for burden of truncating and missense variants. The impact of TTNtvs on the severity of clinical presentation, and on clinical outcomes, was evaluated. RESULTS: Four hundred sixty-nine women met inclusion criteria. Of the women with PPCM, 10.4% bore TTNtvs (odds ratio=9.4 compared with 1.2% in the reference population; Bonferroni-corrected P [P*]=1.2×10-46). We additionally identified overrepresentation of truncating variants in FLNC (odds ratio=24.8, P*=7.0×10-8), DSP (odds ratio=14.9, P*=1.0×10-8), and BAG3 (odds ratio=53.1, P*=0.02), genes not previously associated with PPCM. This profile is highly similar to that found in nonischemic dilated cardiomyopathy. Women with TTNtvs had lower left ventricular ejection fraction on presentation than did women without TTNtvs (23.5% versus 29%, P=2.5×10-4), but did not differ significantly in timing of presentation after delivery, in prevalence of preeclampsia, or in rates of clinical recovery. CONCLUSIONS: This study provides the first extensive genetic and phenotypic landscape of PPCM and demonstrates that predisposition to heart failure is an important risk factor for PPCM. The work reveals a degree of genetic similarity between PPCM and dilated cardiomyopathy, suggesting that gene-specific therapeutic approaches being developed for dilated cardiomyopathy may also apply to PPCM, and that approaches to genetic testing in PPCM should mirror those taken in dilated cardiomyopathy. Last, the clarification of genotype/phenotype associations has important implications for genetic counseling.
Subject(s)
Cardiomyopathies/genetics , Peripartum Period/genetics , Adult , Cardiomyopathies/physiopathology , Female , Humans , Phenotype , Pregnancy , Retrospective StudiesABSTRACT
[Figure: see text].
Subject(s)
Antifibrotic Agents/pharmacology , Cardiomegaly/prevention & control , Extracellular Matrix , Myocardium/pathology , Myofibroblasts/drug effects , Pyrans/pharmacology , Angiotensin II/pharmacology , Animals , Cell Survival/drug effects , Disease Models, Animal , Fibrosis , Gene Expression , Heart Failure/drug therapy , Heart Failure/pathology , Humans , Male , Mice , Mice, Inbred C57BL , Myocardial Infarction/pathology , NIH 3T3 Cells , Pyrans/isolation & purification , Ventricular Remodeling/drug effects , p38 Mitogen-Activated Protein Kinases/drug effects , p38 Mitogen-Activated Protein Kinases/metabolism , rho-Associated Kinases/drug effects , rho-Associated Kinases/metabolismABSTRACT
BACKGROUND: Studies of long-term inotrope use in advanced HF have previously provided limited and conflicting results. This study aimed to evaluate the safety and efficacy of long-term milrinone use and identify predictors of failure to bridge to orthotropic heart transplant (OHT) in a cohort of end-stage heart failure (HF) patients listed for heart transplantation and receiving inotrope therapy. METHODS: The study included 150 adults listed for OHT at a single center from 2001 to 2017 who received milrinone therapy for ≥30 days. Multivariate Cox proportional hazards models were used to identify factors associated with "failure" (left ventricular assist device, intra-aortic balloon pump, status downgrade due to instability, death) vs. "success" (OHT, recovery) during bridging to OHT. RESULTS: "Failure" occurred in 33 (22%) patients. Factors independently associated with failure included male sex (HR = 7.6; p = 0.004), no implantable cardioverter-defibrillator (HR = 3.8; p = 0.009), and lack of guideline-directed medical therapy (GDMT) with a beta-blocker (HR = 7.8; p = 0.002) or angiotensin-converting enzyme inhibitor/angiotensin receptor blocker (HR = 6.3; p < 0.001). Patients who received fewer guideline-directed medications had a higher cumulative probability of failure. Adverse events included central line-associated bloodstream infection (2.55 per 1000 line-days) and arrhythmia (1.59 per 1000 treatment-days). CONCLUSIONS: Our findings suggest that long-term milrinone therapy in selected patients is associated with a high rate of successful bridging to OHT and a low rate of adverse events. Patients intolerant of GDMT are more likely to fail to bridge to OHT without mechanical support. Sex differences in outcomes associated with milrinone therapy should be explored.
Subject(s)
Heart Failure , Heart Transplantation , Heart-Assist Devices , Adult , Female , Heart Failure/diagnosis , Heart Failure/drug therapy , Humans , Male , Milrinone/adverse effects , Retrospective Studies , Treatment OutcomeABSTRACT
Background and study aims Left ventricular assist device (LVAD) placement is a therapeutic modality for patients with end-stage heart failure. Gastrointestinal bleeding is a common complication following LVADâimplantation. The aim of this study was to report our experience in management and outcomes of gastrointestinal bleeding in a large cohort of patients with LVADs. Patients and methods We performed a retrospective review of all patients who underwent LVAD implantation at the University of Rochester Medical Center from January 2008 to June 2017. Data were collected on patient characteristics, clinical aspects of gastrointestinal bleeding events, and procedural interventions. A Cox proportional hazard model was utilized to identify potential risk factors for a gastrointestinal bleeding event. Results During the study period, 345 patients underwent LVAD implantation. Of these, 125 patients (36.2â%) experienced 297 gastrointestinal bleeding events resulting in 533 endoscopic procedures. The diagnostic yield of endoscopy in determining a bleeding source was 49.5â%. If required, therapeutic interventions were successful in achieving homeostasis in 96.2â% of procedures. Our 30-day overall post-procedure adverse event (AE) rate was 6.6â%. Procedure-related (bleeding, infection, and perforation) AEs were very minimal (2.8â%). A Cox proportional hazard model indicated that older age at implant, female sex, African-American race, diabetes mellitus, and pulmonary hypertension were statistically significant predictors of a gastrointestinal bleeding event following LVADâimplantation. Conclusions LVADâpatients have a high risk of gastrointestinal bleeding. Endoscopy was able to safely locate a bleeding lesion in approximately half of our patients and was successful in treating bleeding lesions in a majority of the cases.
ABSTRACT
As median survival for left ventricular assist device (LVAD) patients increases, the incidence of adverse events requiring device exchange is likely to increase as well. Less invasive surgical approaches for device exchange of older generation pumps have demonstrated multiple potential benefits compared with median sternotomy. However, there remains a paucity of data in regard to less invasive surgical techniques for the exchange of the newest generation intrapericardial devices. In this report we describe a complete sternal-sparing technique for the LVAD exchange of a HeartMate 3 via bilateral minithoracotomies.
Subject(s)
Device Removal/methods , Heart-Assist Devices , Minimally Invasive Surgical Procedures/methods , Organ Sparing Treatments/methods , Prosthesis Implantation/methods , Sternum , Thoracotomy/methods , Aged , Heart-Assist Devices/adverse effects , Humans , Male , Reoperation , Sternotomy/methods , Survival RateABSTRACT
BACKGROUND: Left ventricular assist devices (LVADs) have improved outcomes for selected patients with advanced heart failure, but alternative optimal surgical techniques remain to be defined. We aim to describe our initial experience in using a sternal-sparing (SS) technique for implantation of a magnetically levitated LVAD, the HeartMate 3 (HM3) pump. METHODS: This retrospective, single-center study included consecutive patients implanted with the HM3 LVAD between September 2015 and September 2018. Patients were compared based on surgical approach: SS or traditional sternotomy (TS). The primary outcome was overall survival at 6 months. Secondary outcomes included peri-operative complications, blood product utilization, and hospital readmissions. RESULTS: Of 105 patients implanted with the HM3 LVAD, 41 (39%) were implanted via SS and 64 (61%) via TS approach. There were no intraoperative conversions. The SS patients were younger; otherwise, all other characteristics were similar between cohorts. The SS cohort demonstrated a significantly lower incidence of severe right ventricular failure (7% vs 28%, pâ¯=â¯0.012), fewer blood-product transfusions (41% vs 86%, p < 0.001), and shorter index hospital length of stay (15.5 vs 21 days, pâ¯=â¯0.018). Six-month survival was 93% for the SS cohort. CONCLUSIONS: In this single-center observational study, we have demonstrated that the SS approach may be a safe and effective surgical technique for implantation of the HM3 LVAD in well-selected patients. The potential benefits compared with TS require further inquiry.
Subject(s)
Heart Failure/surgery , Heart-Assist Devices , Sternotomy/methods , Ventricular Function, Left/physiology , Adult , Aged , Female , Heart Failure/physiopathology , Humans , Male , Middle Aged , Retrospective Studies , Time Factors , Treatment OutcomeABSTRACT
Data on the clinical significance of early hospital readmission within 90 days following left ventricular assist device (LVAD) implantation in patients with continuous-flow LVAD are limited. We aimed to assess the incidence, predictors, and outcomes of 90-day readmission in LVAD patients. Hospital readmission or death was assessed within 90 days after hospital discharge in 177 patients with HeartMate II LVADs implanted between May 2008 and June 2014. Predictors of early readmission and risk of death were evaluated using multivariable Cox models following adjustment for clinical covariates. Hospital readmission or death rate was 37% within 90 days. Age at implantation (hazard ratio [HR] = 1.03 per 1 year increase, p = 0.016), diabetes (HR = 2.19, p = 0.031) and smoking at baseline (HR = 2.06, p = 0.034) predicted early hospital readmission, while a higher baseline body mass index was found to be protective (HR = 0.92 per each unit increase in body mass index, p = 0.003). One-year all-cause mortality was 19% in patients with early hospital readmission as compared to 1% with no early hospital readmission (HR 15.50, p = 0.01). One-year mortality was 35% in patients with 2 or more readmissions compared to 10% mortality in patients with one readmission and 1% mortality in patients with no readmissions (p < 0.001). In LVAD patients, there is a high incidence of hospital readmission within 90 days, which is associated with an increased mortality. Targeted interventions, such as closer follow-up to prevent early and recurrent hospital readmissions in LVAD recipients, are warranted to improve outcomes.