Safety and Performance of the Aortix Device in Acute Decompensated Heart Failure and Cardiorenal Syndrome.

BACKGROUND: Cardiorenal syndrome (CRS) complicates 33% of acute decompensated heart failure (ADHF) admissions, and patients with persistent congestion at discharge have high 30-day event rates. OBJECTIVES: The purpose of this study was to evaluate a novel catheter-deployed intra-aortic entrainment pump (IAEP) in patients with ADHF with CRS and persistent congestion. METHODS: A multicenter (n = 14), nonrandomized, single-arm, safety and feasibility study of IAEP therapy was conducted. Within patient changes (post-pre IAEP therapy) in fluid loss, hemodynamics, patient-reported dyspnea, and serum biomarkers were assessed using Wilcoxon signed-rank testing. RESULTS: Of 21 enrolled patients, 18 received Aortix therapy. Mean ± SD patient age was 60.3 ± 7.9 years. The median left ventricular ejection fraction was 22.5% (25th-75th percentile: 10.0%-53.5%); 27.8% had a left ventricular ejection fraction ≥50%. Pre-therapy, patients received 8.7 ± 4.1 days of loop diuretic agents and 44% were on inotropes. Pump therapy averaged 4.6 ± 1.6 days, yielding net fluid losses of 10.7 ± 6.5 L (P < 0.001) and significant (P < 0.01) reductions in central venous pressure (change from baseline: -8.5 mm Hg [25th-75th percentile: -3.5 to -10.0 mm Hg]), pulmonary capillary wedge pressure (-11.0 mm Hg [25th-75th percentile: -5.0 to -14.0 mm Hg]), and serum creatinine (-0.2 mg/dL [25th-75th percentile: -0.1 to -0.5 mg/dL]) with improved estimated glomerular filtration rate (+5.0 mL/min/1.73 m2 [25th-75th percentile: 2.0-9.0 mL/min/1.73 m2]) and patient-reported dyspnea score (+16 [25th-75th percentile: 3-37]). Dyspnea scores, natriuretic peptides, and renal function improvements persisted through 30 days. CONCLUSIONS: This pilot study of patients with ADHF, persistent congestion, and worsening renal function due to CRS supports the potential for safely achieving decongestion using IAEP therapy. These initial promising results provide the basis for future randomized clinical trials of this novel pump. (An Evaluation of the Safety and Performance of the Aortix System for Intra-Aortic Mechanical Circulatory Support in Patients with Cardiorenal Syndrome [The Aortix CRS Pilot Study]; NCT04145635).

Implantable cardioverter defibrillators in patients with orthotopic heart transplant: A multicenter case series.

BACKGROUND: Sudden cardiac death (SCD) is common after orthotopic heart transplant (OHT). No clear guidelines for implantable cardioverter defibrillator (ICD) implantation in OHT patients at high risk for SCD currently exist. OBJECTIVES: To assess the safety, efficacy, and benefit of ICDs and resynchronization therapy post-OHT. We also provide a systematic review of previous reports. METHODS: A retrospective multicenter cohort study within the United States. Patients with ICD post-OHT between 2000 and 2020 were identified. RESULTS: We analyzed 16 patients from 4 centers. The mean standard-deviation (SD) age was 43 (18) years at OHT and 51 (20) years at ICD implantation. The mean (SD) duration from OHT to ICD implantation was 9 (5) years. The mean (SD) left ventricular ejection fraction (LVEF) was 35% (17%). There were 2 (13%) postprocedural complications: 1 hematoma and 1 death. Mean (SD) follow-up was 24 (23) months. Survival rate was 63% (10/16) at 1 year and 56% (9/16) at 2 years, with 6/7 of those who died having LVEF < 35% at the time of the ICD implantation. Patients were more likely to receive appropriate therapy if their ICD was implanted for secondary (5/8) rather than primary (0/8) prevention (p = .007). Of those who did, 4 patients survived to 30 days post-ICD therapy. Severe CAV was not associated with the rate of appropriate therapy. CONCLUSIONS: Beneficial outcomes were observed when ICDs were implanted for secondary prevention only, and in patients with higher baseline LVEF. We also observed benefits with resynchronization therapy.

National Landscape of Hospitalizations in Patients with Left Ventricular Assist Device. Insights from the National Readmission Database 2010-2015.

The number of patients with left ventricular assist devices (LVAD) has increased over the years and it is important to identify the etiologies for hospital admission, as well as the costs, length of stay and in-hospital complications in this patient group. Using the National Readmission Database from 2010 to 2015, we identified patients with a history of LVAD placement using International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) code V43.21. We aimed to identify the etiologies for hospital admission, patient characteristics, and in-hospital outcomes. We identified a total of 15,996 patients with an LVAD, the mean age was 58 years and 76% were males. The most common cause of hospital readmission after LVAD was heart failure (HF, 13%), followed by gastrointestinal (GI) bleed (11.8%), device complication (11.5%), and ventricular tachycardia/fibrillation (4.2%). The median length of stay was 6 days (3-11 days) and the median hospital costs was $12,723 USD. The in-hospital mortality was 3.9%, blood transfusion was required in 26.8% of patients, 20.5% had acute kidney injury, 2.8% required hemodialysis, and 6.2% of patients underwent heart transplantation. Interestingly, the most common cause of readmission was the same as the diagnosis for the preceding admission. One in every four LVAD patients experiences a readmission within 30 days of a prior admission, most commonly due to HF and GI bleeding. Interventions to reduce HF readmissions, such as speed optimization, may be one means of improving LVAD outcomes and resource utilization.

Heart transplant recipients with confirmed 2019 novel coronavirus infection: The Detroit experience.

A chronic immunosuppressed state as in solid organ transplant recipients is a reported risk factor for the novel 2019 coronavirus infection. Patients with a history of orthotopic heart transplant (OHT) at a tertiary care transplant center in Detroit, Michigan were retrospectively reviewed from March until May 2020. Clinical parameters and outcomes of 5 OHT recipients and one combined heart-lung recipient with confirmed SARS-CoV-2 were obtained. The cohort was predominately African American males with median age of 59 years (interquartile range, 48.25-73.25). All patients were classified as having mild-moderate disease; none required intubation or ICU admission with no deaths. The most common presenting symptoms were fever and shortness of breath 83% (n = 5), followed by cough and chills 67% (n = 4). All admitted patients (n = 5) received hydroxychloroquine and 3 received high-dose steroids. Antimetabolites were held for 2 patients (33.3%). The calcineurin inhibitor trough goal was decreased in only 1 patient; 3 other patients, without change in goal, required calcineurin inhibitor dosage reduction. Two patients requiring readmission presented 7 and 23 days after initial symptoms onset. In conclusion, our experience with OHT patients infected by the SARS-CoV-2 virus did not have an elevated risk of severe infection. Impact of modifying immunosuppression remains unclear.

Pulmonary Function Testing and Outcomes after Left Ventricular Assist Device Implantation.

BACKGROUND: Pulmonary function testing (PFT) is often done during workup prior to left ventricular assist devices (LVAD), but its utility for predicting outcomes and changes in pulmonary function post-LVAD is not well established. We assessed the association of baseline PFT metrics with outcomes after LVAD, and quantified the changes in PFTs post-LVAD. METHODS AND RESULTS: A retrospective study of 178 patients receiving continuous flow LVADs was conducted. A total of 129 subjects had baseline PFT data and 54 of these had repeat tests after LVAD. We collected PFT data (FEV1, FVC, FEV1/FVC ratios, and DLCO) at baseline and post-LVAD, and tested the association with survival, right heart failure, quality of life (Kansas City Cardiomyopathy Questionnaire [KCCQ]) and functional capacity (six-minute walking distance [6MWD]). Proportional hazards and linear regressions determined relationships between baseline PFT data and survival time and functional outcomes, respectively. Paired t-tests compared pre- and post- LVAD PFT variables. There was no association of baseline PFT parameters with survival time post-LVAD (all P > .2), nor the incidence of perioperative RV failure (all P > .15). There were no significant associations of the baseline PFT metrics with the change in KCCQ or 6MWD.  There were statistically significant declines in FEV1, FEV1/FVC ratio, and DLCO after LVAD (P < .05). CONCLUSION: In this single center study, there was no relationship between baseline PFTs and post-LVAD outcomes, and PFT parameters often worsened after LVAD. Further studies are needed to determine whether PFTs are useful in this setting, and what, if any, impact LVAD therapy has on pulmonary function.

A Phase 2a dose-escalation study of the safety, tolerability, pharmacokinetics and haemodynamic effects of BMS-986231 in hospitalized patients with heart failure with reduced ejection fraction.

AIMS: This study was designed to evaluate the safety, tolerability and haemodynamic effects of BMS-986231, a novel second-generation nitroxyl donor with potential inotropic, lusitropic and vasodilatory effects in patients hospitalized with decompensated heart failure and reduced ejection fraction (HFrEF). METHODS AND RESULTS: Forty-six patients hospitalized with decompensated HFrEF were enrolled into four sequential dose-escalation cohorts in this double-blind, randomized, placebo-controlled Phase 2a study. Patients with baseline pulmonary capillary wedge pressure (PCWP) of ≥20 mmHg and a cardiac index of ≤2.5 L/min/m2 received one 6-h i.v. infusion of BMS-986231 (at 3, 5, 7 or 12 µg/kg/min) or placebo. BMS-986231 produced rapid and sustained reductions in PCWP, as well as consistent reductions in time-averaged pulmonary arterial systolic pressure, pulmonary arterial diastolic pressure and right atrial pressure. BMS-986231 increased non-invasively measured time-averaged stroke volume index, cardiac index and cardiac power index values, and decreased total peripheral vascular resistance. There was no evidence of increased heart rate, drug-related arrhythmia or symptomatic hypotension with BMS-986231. Analyses of adverse events throughout the 30-day follow-up did not identify any toxicities specific to BMS-986231, with the potential exception of infrequent mild-to-moderate headaches during infusion. There were no treatment-related serious adverse events. CONCLUSIONS: BMS-986231 demonstrated a favourable safety and haemodynamic profile in patients hospitalized with advanced heart failure. Based on preclinical data and these study's findings, it is possible that the haemodynamic benefits may be mediated by inotropic and/or lusitropic as well as vasodilatory effects. The therapeutic potential of BMS-986231 should be further assessed in patients with heart failure.

Comprehensive analysis of cardiopulmonary exercise testing and mortality in patients with systolic heart failure: the Henry Ford Hospital cardiopulmonary exercise testing (FIT-CPX) project.

BACKGROUND: Many studies have shown a strong association between numerous variables from a cardiopulmonary exercise (CPX) test and prognosis in patients with heart failure with reduced ejection fraction (HFrEF). However, few studies have compared the prognostic value of a majority of these variables simultaneously, so controversy remains regarding optimal interpretation. METHODS AND RESULTS: This was a retrospective analysis of patients with HFrEF (n = 1,201; age = 55 ± 13 y; 33% female) and a CPX test from 1997 to 2010. Thirty variables from a CPX test were considered in separate adjusted Cox regression analyses to describe the strength of the relation of each to a composite end point of all-cause mortality, left ventricular assist device implantation, or heart transplantation. During a median follow-up of 3.8 years, there were 577 (48.0%) events. The majority of variables were highly significant (P < .001). Among these, percentage of predicted maximum V˙O2 (ppMV˙O2; Wald = 203; P < .001; C-index = 0.73) was similar to VE-VCO2 slope (Wald = 201; P < .001; C = 0.72) and peak V˙O2 (Wald = 161; P < .001; C = 0.72). In addition, there was no significant interaction observed for peak respiratory exchange ratio <1 vs ≥1. CONCLUSIONS: Consistent with prior studies, many CPX test variables were strongly associated with prognosis in patients with HFrEF. The choice of which variable to use is up to the clinician. Renewed attention should be given to ppMV˙O2, which appears to be highly predictive of survival in these patients.

Cardiac rehabilitation improves functional capacity and patient-reported health status in patients with continuous-flow left ventricular assist devices: the Rehab-VAD randomized controlled trial.

OBJECTIVES: This study examined the effects of a cardiac rehabilitation (CR) program on functional capacity and health status (HS) in patients with newly implanted left ventricular assist devices (LVADs). BACKGROUND: Reduced functional capacity and HS are independent predictors of mortality in patients with heart failure. CR improves both, and is related to improved outcomes in patients with heart failure; however, there is a paucity of data that describe the effects of CR in patients with LVADs. METHODS: Enrolled subjects (n = 26; 7 women; age 55 ± 13 years; ejection fraction 21 ± 8%) completed a symptom-limited cardiopulmonary exercise test, the Kansas City Cardiomyopathy Questionnaire (KCCQ), a 6-min walk test (6MW), and single-leg isokinetic strength test before 2:1 randomization to CR versus usual care. Subjects in the CR group underwent 18 visits of aerobic exercise at 60% to 80% of heart rate reserve. Within-group changes from baseline to follow-up were analyzed with a paired t-test, whereas an independent t-test was used to determine differences in the change between groups. RESULTS: Within-group improvements were observed in the CR group for peak oxygen uptake (10%), treadmill time (3.1 min), KCCQ score (14.4 points), 6MW distance (52.3 m), and leg strength (17%). Significant differences among groups were observed for KCCQ, leg strength, and total treadmill time. CONCLUSIONS: Indicators of functional capacity and HS are improved in patients with continuous-flow LVADs who attend CR. Future trials should examine the mechanisms responsible for these improvements, and if such improvements translate into improved clinical outcomes. (Cardiac Rehabilitation in Patients With Continuous Flow Left Ventricular Assist Devices:Rehab VAD Trial [RehabVAD]; NCT01584895).

Relationship of tricuspid repair at the time of left ventricular assist device implantation and survival.

PURPOSE: Tricuspid regurgitation contributes to right ventricular failure (RVF) and is associated with worse clinical outcomes in patients undergoing left ventricular assist device (LVAD) treatment. However, whether tricuspid valve repair (TVR) at the time of LVAD implantation improves outcomes is not clear. METHODS: We identified all patients undergoing initial implantation of a long-term continuous-flow LVAD at our institution from March 2006 to August 2011. We assessed the impact of TVR on survival and incidence of RVF using Kaplan-Meier curves and proportional hazards regression adjusted for age, gender, baseline tricuspid regurgitation, RV function, MELD score, albumin, and indication (bridge vs. destination). RESULTS: A total of 101 patients were included in the analysis, of which 14 patients underwent TVR concomitant LVAD. All TVR patients had moderate or severe baseline regurgitation. Crude survival was not different between groups. In multivariable models adjusted for confounding factors, TVR showed a significant association with improved survival (HR = 0.1, p = 0.049). Adjusted models showed no difference in RVF. CONCLUSIONS: In this cohort of patients, TVR at the time of LVAD implantation appears associated with better survival. Additional larger studies are needed to verify the effect of TVR at the time of LVAD implantation, and whether it should be utilized more frequently.

Assessing the potential of e-mail for communicating drug therapy recommendations to physicians in patients with heart failure and ventricular-assist devices.

PURPOSE: This project explores electronic mail (e-mail) as a potential medium for pharmacists to communicate pharmacotherapy interventions to prescribers. METHODS: This retrospective descriptive analysis was conducted at an urban, academic teaching hospital. The pharmacist attempted a drug therapy intervention via e-mail when unable to make face-to-face contact with the attending physician. Eligible patients for this project were admitted to the advanced heart failure (HF) team between December 1, 2010, and July 31, 2011, and had at least 1 attempted e-mail intervention. The primary outcome was the number of accepted interventions, while the secondary end point was the time until a physician e-mail response. RESULTS: A total of 51 e-mail interventions were attempted on 29 patients (mean age = 53, 24% caucasian, 59% male, 69% left ventricular-assist device [VAD]). Overall, of the total 51 interventions,44 (86.3%) were accepted. The average time to a physician e-mail response was 41 minutes. Initiation of drug therapy and changing dose and route or frequency accounted for the most frequent intervention (33%). The most common drug classes involved in the e-mail interventions were angiotensin-converting enzyme inhibitors (15.7%), loop diuretics (9.8%), and antiplatelet agents (7.8%). CONCLUSION: Clinical pharmacists with well-established physician relationships can effectively implement timely drug therapy recommendations using e-mail communications in patients with advanced HF or VADs.

High rates of false-positive hepatitis C antibody tests can occur after left ventricular assist device implantation.

Hepatitis C virus (HCV) screening is routine before cardiac transplantation, and virus presence is an exclusion at most centers. Left ventricular assist devices (LVADs) are often used as a bridge to transplantation and cause immune activation. We collected data on 32 consecutive patients undergoing LVAD placement between January 2006 and February 2008 at a single center. Of the 23 potential bridge-to-transplant patients with HCV testing before and after LVAD, seven (30%) turned positive for HCV antibody but did not have true HCV infection on confirmatory testing. Cardiac transplant care providers should be aware of possible false-positive HCV antibody tests in this setting.

Impact of continuous-flow left ventricular assist device support on right ventricular function.

BACKGROUND: Continuous-flow (CF) pumps have yielded improvements in short- and long-term survival and quality of life, and have reduced the number of left ventricular assist device (LVAD)-related complications. However, their ability to unload the right ventricle (RV) and improve RV function has not been as clearly defined. We evaluated the short- and mid-term effects of CF-LVADs on central venous pressure (CVP), pulmonary artery pressures (PAP), pulmonary capillary wedge pressure (PCWP), cardiac index (CI), RV ejection fraction (RVEF), RV end-diastolic dimension (RVEDD), RV stroke work index (RVSWI), tricuspid annular plane systolic excursion (TAPSE) and severity of tricuspid regurgitation (TR). METHODS: From March 2006 through June 2012, 130 patients with chronic heart failure underwent implantation of a CF-LVAD (122 HeartMate II and 8 HeartWare devices) as a bridge to transplant (n = 76) or as destination therapy (n = 54). Patients with pre-operative long-term LVADs (n = 4) and patients who underwent concomitant tricuspid valve repairs during their LVAD implant (n = 21) were excluded from the analysis. Echocardiograms and right heart catheterizations of the remaining 105 patients were reviewed pre-operatively and at 1 and 6 months post-LVAD implantation. RESULTS: At 1 month post-LVAD implantation, CVP decreased from 12.4 ± 5.9 mm Hg to 8.7 ± 4.5 mm Hg (p < 0.001), systolic PAP decreased from 52.3 ± 14.1 mm Hg to 36.8 ± 11.3 mm Hg (p < 0.001), PCWP decreased from 23.0 ± 9.4 mm Hg to 12.9 ± 8.0 mm Hg (p < 0.001), CI index increased from 1.8 ± 0.5 liters/min m2 to 2.4 ± 0.5 liters/min m2 (p < 0.001), RVEF increased from 33.1 ± 4.9% to 40.4 ± 6.2% (p < 0.001), RVEDD decreased from 36 mm to 31 mm (p = 0.020), RVSWI improved from 408.6 ± 144.6 mm Hg ml m2 to 614.4 ± 196.2 mm Hg ml m2 (p < 0.001), and mean TAPSE increased from 1.1 ± 0.4 cm to 1.9 ± 0.4 cm (p = 0.004). Similarly, qualitative RV function on echocardiography improved from 57.1% moderately or severely reduced pre-operatively to 38.1% at 1 month (p = 0.008). Severity of TR decreased from 11.4% moderate or severe pre-operatively to 4.8% at 1 month (p < 0.001). These improvements were maintained at 6 months post-LVAD. CONCLUSIONS: CF-LVAD support significantly decreased CVP and RVEDD, with concomitant improvement in RV function, as measured by increases in RVEF, RVSWI and TAPSE, as well as improvements in the qualitative echocardiographic appearance of RV contractility and a reduction in TR.

Management of aortic valve insufficiency in patients supported by long-term continuous flow left ventricular assist devices.

Continuous flow (CF) left ventricular assist devices (LVADs) have yielded improved outcomes in patient survival and quality of life compared with first-generation pulsatile pumps; however, they have been associated with an increased incidence of postimplant aortic valve insufficiency (AI), which can have can have serious clinical consequences if not diagnosed and treated expeditiously. We reviewed our experience with AI after LVAD since the start of our CF LVAD program. From March 2006 through July 2011, 94 patients with chronic heart failure underwent implantation of a HeartMate II (HM II) LVAD. Severe AI developed in three patients after CF LVAD implantation. The clinical records of these patients were reviewed to analyze the presenting signs and symptoms of AI, identify the duration of LVAD support when the AI occurred, how the AI was treated, and the outcomes.

Left ventricular reverse remodeling with a continuous flow left ventricular assist device measured by left ventricular end-diastolic dimensions and severity of mitral regurgitation.

Pulsatile flow left ventricular assist devices (LVADs) maximally unload the left ventricle (LV), leading to reverse remodeling of the myopathic LV that manifests as decreased LV end-diastolic dimension (LVEDD) and decreased severity of mitral regurgitation (MR). There is a paucity of data, however, regarding the ability of continuous flow (CF) pumps to adequately decompress the LV to induce similar reverse remodeling. We sought to evaluate the effects of CF-LVADs on LV reverse remodeling. From March 2006 through July 2011, one hundred patients with chronic heart failure underwent implantation of CF-LVAD (93 HeartMate II LVADs and seven HeartWare LVADs) as bridge-to-transplant (n = 68) and destination therapies (n = 32). Echocardiograms and right heart catheterizations were reviewed preoperatively and at 1 and 6 months post-LVAD implantation. Mean age was 52.1 ± 12.1 years; etiology of heart failure was ischemic cardiomyopathy in 34 patients and nonischemic dilated cardiomyopathy in 66 patients. Median LVAD support time was 378.3 days; 371.5 days for patients who received bridge-to-transplant therapy and 422.2 days for patients who underwent destination therapy. Left ventricular end-diastolic dimension significantly decreased at 1 month post-LVAD implantation from 71.6 ± 12.4 to 58.3 ± 13.8 mm (p < 0.001). Severity of MR also significantly decreased from 76.0% of patients having moderate or severe MR preoperatively to 8.0% with moderate or severe MR at 1 month post-LVAD (p < 0.001). These reductions were maintained at 6 months. These data demonstrate the ability of a CF-LVAD to significantly decompress the LV, leading to significant reductions in LVEDD and severity of MR. This reverse remodeling was apparent in the early postoperative period and was sustained at 6 months. Further studies are warranted to investigate whether this correlates with clinical LV recovery.

Successful treatment of a continuous flow left ventricular assist device thrombosis with eptifibatide.

Left ventricular assist device thrombosis is a rare but potentially lethal complication of mechanical circulatory support. Here, we present a case of successful treatment of a suspected HeartMate II thrombosis with the glycoprotein IIb/IIIa inhibitor, eptifibatide. The patient presented with signs and symptoms of heart failure, along with acute kidney injury and hemolytic anemia that did not respond to diuresis, inotrope support, or anticoagulation. Treatment with eptifibatide resulted in marked clinical and hemodynamic improvement within 24 hrs. The patient was transitioned to clopidogrel and discharged without further incident. Eptifibatide may represent a potential therapeutic option for patients with device thrombosis.

Gastrointestinal bleeding with the HeartMate II left ventricular assist device.

BACKGROUND: Continuous flow left ventricular assist devices (CF-LVADs) have yielded improved outcomes compared with pulsatile flow devices for patients on long-term support. However, significant rates of gastrointestinal bleeding (GIB) have been observed during CF-LVAD support. METHODS: From March 2006 through March 2011, 86 patients with chronic heart failure underwent implantation of a CF-LVAD (HeartMate II; Thoratec Corp., Pleasanton, CA). Records were reviewed to determine the prevalence of post-implant GIB, location of the bleeding site and associated morbidity and mortality. Uni- and multivariate analyses were conducted to identify independent predictors of GIB. RESULTS: GIB occurred in 19 patients (22.1%) with a duration of support that ranged from 5 to 456 days. Sources of GIB included small bowel and rectum in 6 patients each, large bowel in 2 patients and stomach in 1 patient. No definite source was identified in 4 patients. There were no deaths referable to GIB. Recurrent GIB occurred in 4 patients. History of a GIB prior to LVAD implant was the only variable significantly different between patients with and without post-implant GIB (21.1% vs 10.4%, p = 0.016), and was the only independent predictor of GIB (OR = 2.24, 95% CI 2.121 to 2.435, p = 0.004). CONCLUSIONS: Gastrointestinal bleeding is a frequent source of morbidity for patients on HeartMate II LVAD support but does not significantly impact survival. As implantation of CF-LVADs with non-pulsatile flow gains popularity for both bridge-to-transplant and destination therapy, a better understanding of the pathophysiology of GIB in these patients will be needed for minimizing this complication.

Non-cardiac surgery in patients on long-term left ventricular assist device support.

BACKGROUND: An increasing number of patients on left ventricular assist device (LVAD) support are requiring non-cardiac surgical (NCS) procedures. We reviewed our experience with the management of patients on continuous flow (CF) LVAD support undergoing NCS. METHODS: From March 2006 through March 2011, 86 patients with chronic heart failure underwent implantation of a HeartMate II (Thoratec Corp, Pleasanton, CA) LVAD. Clinical records of these patients were reviewed to identify patients who underwent NCS while on LVAD support, with a focus on peri-operative death, bleeding, thrombosis, and device malfunction, as well as management of pre-operative anti-coagulation. RESULTS: While on CF-LVAD support, 20 patients underwent 25 NCSs, comprising 13 major and 12 minor procedures. Operations were performed electively in 22 and as emergencies in 3. No peri-operative deaths, thromboembolic complications, or device malfunctions occurred. The incidence of bleeding requiring transfusion of packed red blood cells was 36.0%, including 25% of patients undergoing minor NCSs and 46.2% undergoing major NCSs (p = 0.004). All bleeding complications occurred in patients on both warfarin and aspirin pre-operatively. The only significant differences between patients who did and did not require transfusion were pre-operative warfarin use and significantly higher pre-operative international normalized ratio in the transfused group (1.9 ± 0.4 vs 1.4 ± 0.3; p = 0.008). CONCLUSIONS: Non-cardiac operations can be performed safely in patients with CF-LVADs. It may possible to reduce peri-operative bleeding by lowering pre-operative anti-coagulation goals, especially before major surgery. However, additional analysis is required to determine if this can be performed safely.

Short term effects of milrinone on biomarkers of necrosis, apoptosis, and inflammation in patients with severe heart failure.

INTRODUCTION: Inotropes are associated with adverse outcomes in heart failure (HF), raising concern they may accelerate myocardial injury. Whether biomarkers of myocardial necrosis, inflammation and apoptosis change in response to acute milrinone administration is not well established. METHODS: Ten patients with severe HF and reduced cardiac output who were to receive milrinone were studied. Blood samples were taken just before initiation of milrinone and after 24 hours of infusion. Dosing was at the discretion of the patient's attending physician (range 0.25-0.5 mcg/kg/min). Plasma measurements of troponin, myoglobin, N-terminal-pro-BNP, interleukin-6, tumor necrosis factor-alpha, soluble Fas, and soluble Fas-ligand were performed at both time points. RESULTS: Troponin was elevated at baseline in all patients (mean 0.1259 +/- 0.17 ng/ml), but there was no significant change after 24 hours of milrinone (mean 0.1345 +/- 0.16 ng/ml, p = 0.44). There were significant improvements in interleukin-6, tumor necrosis factor-alpha, soluble Fas, and soluble Fas-ligand (all p < 0.05) indicative of reduced inflammatory and apoptotic signaling compared to baseline. CONCLUSION: In conclusion, among patients with severe HF and low cardiac output, ongoing myocardial injury is common, and initiation of milrinone did not result in exacerbation of myocardial injury but instead was associated with salutary effects on other biomarkers.

Stress echocardiography for risk stratification in patients with end-stage renal disease undergoing renal transplantation.

BACKGROUND: The predictive accuracy of stress echocardiography (SE) for adverse cardiac events has been variable in the population with end-stage renal disease undergoing renal transplantation (RT). METHODS: We performed a retrospective study of 149 patients who had pretransplant SE before RT between 1997 and 2003. Patients were followed up for a mean of 2.85 years for major adverse cardiovascular events (MACE). RESULTS: Of 149 patients studied, 139 had a negative SE, 65% were African American; 12 underwent cardiac catheterization. Only 1 patient required pre-RT revascularization. Sixteen MACE occurred over the follow-up period. SE had 37.5% sensitivity, 95.3% specificity, 33.3% positive predictive value, and 96.1% negative predictive value for MACE in the first year post-RT. First-year posttransplant event rates were 4.0% versus 30% (P < .001) for patients with a negative SE and positive SE, respectively. Multivariate predictors of MACE were positive SE (hazard ratio [HR] 7.64), hemoglobin less than 11 g/dL post-RT (HR 4.44), and calcium channel blocker use posttransplant (HR 2.90). CONCLUSIONS: A negative SE has low incidence of MACE in this intermediate- to high-risk patient subset. A positive SE predicts a sevenfold higher risk of cardiovascular events regardless of the need for revascularization before the transplant.