Center for Heart Transplant and Assist Devices

Oak Lawn, IL, United States

Center for Heart Transplant and Assist Devices

Oak Lawn, IL, United States
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Najjar S.S.,MedStar Heart Institute | Slaughter M.S.,University of Louisville | Pagani F.D.,University of Michigan | Starling R.C.,Cleveland Clinic | And 10 more authors.
Journal of Heart and Lung Transplantation | Year: 2014

Background The HeartWare left ventricular assist device (HVAD, HeartWare Inc, Framingham, MA) is the first implantable centrifugal continuous-flow pump approved for use as a bridge to transplantation. An infrequent but serious adverse event of LVAD support is thrombus ingestion or formation in the pump. In this study, we analyze the incidence of pump thrombus, evaluate the comparative effectiveness of various treatment strategies, and examine factors pre-disposing to the development of pump thrombus. Methods The analysis included 382 patients who underwent implantation of the HVAD as part of the HeartWare Bridge to Transplant (BTT) and subsequent Continued Access Protocol (CAP) trial. Descriptive statistics and group comparisons were generated to analyze baseline characteristics, incidence of pump thrombus, and treatment outcomes. A multivariate analysis was performed to assess significant risk factors for developing pump thrombus. Results There were 34 pump thrombus events observed in 31 patients (8.1% of the cohort) for a rate of 0.08 events per patient-year. The incidence of pump thrombus did not differ between BTT and CAP. Medical management of pump thrombus was attempted in 30 cases, and was successful in 15 (50%). A total of 16 patients underwent pump exchange, and 2 underwent urgent transplantation. Five patients with a pump thrombus died after medical therapy failed, 4 of whom also underwent a pump exchange. Survival at 1 year in patients with and without a pump thrombus was 69.4% and 85.5%, respectively (p = 0.21). A multivariable analysis revealed that significant risk factors for pump thrombus included a mean arterial pressure > 90 mm Hg, aspirin dose ≤ 81 mg, international normalized ratio ≤ 2, and Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) profile level of ≥ 3 at implant. Conclusions Pump thrombus is a clinically important adverse event in patients receiving an HVAD, occurring at a rate of 0.08 events per patient-year. Significant risk factors for pump thrombosis include elevated blood pressure and sub-optimal anti-coagulation and anti-platelet therapies. This suggests that pump thrombus event rates could be reduced through careful adherence to patient management guidelines. © 2014 International Society for Heart and Lung Transplantation.


Guglielmi A.A.,Center for Heart Transplant and Assist Devices | Guglielmi K.E.,Center for Heart Transplant and Assist Devices | Bhat G.,Center for Heart Transplant and Assist Devices | Siemeck R.,Center for Heart Transplant and Assist Devices | Tatooles A.J.,Center for Heart Transplant and Assist Devices
ASAIO Journal | Year: 2014

Patients with refractory congestive heart failure may be considered for implantation of a left ventricular assist device (LVAD). Renal failure after LVAD placement can occur to varying degrees from cardiorenal syndrome (CRS) or due to intrinsic renal disease. Patients with severely impaired renal function after LVAD may require renal replacement therapy (RRT) as a temporary or permanent means of support. We present a unique case of a patient who initiated peritoneal dialysis (PD) 1 year after placement of an LVAD for destination therapy (DT). One year later, PD continues to be successfully utilized by this patient for RRT. There are several proven and theoretical benefits to PD in LVAD patients. Peritoneal dialysis can provide sustained daily ultrafiltration offering greater hemodynamic stability, preservation of residual renal function, and a lower risk of systemic infection. Conversely, limitations to PD include nutritional risks due to peritoneal albumin losses, hyperglycemia, and potential limitations to successful catheter placement. Considering our patient's successful outcome and the potential benefits associated with PD, despite the limitations, we conclude that PD should strongly be considered in patients with LVADs that require RRT. Copyright © 2013 by the American Society for Artificial Internal Organs.


Yost G.,Center for Heart Transplant and Assist Devices | Gregory M.,Center for Heart Transplant and Assist Devices | Bhat G.,Center for Heart Transplant and Assist Devices
Nutrition in Clinical Practice | Year: 2015

Background: Malnutrition is known to negatively impact the clinical course of advanced heart failure and is associated with increased mortality following left ventricular assist device (LVAD) implantation. Appropriate assessment of nutrition requirements in these patients is critical in their clinical care, yet there has been little discussion on how to best determine resting energy expenditure (REE) in the hospital setting. We investigated the use of indirect calorimetry in a group of patients with advanced heart failure. Materials and Methods: Results from preoperative indirect calorimetry testing in 98 patients undergoing evaluation for LVAD candidacy were collected. REE was compared with 10 predictive equations that estimated caloric need based on a range of patient-specific demographic and clinical variables. Results: This study enrolled 22 female and 76 male patients with a mean age of 59.4 ± 12.5 years, body mass index of 29.6 ± 6.0 kg/m2, and ejection fraction of 19.4 ± 6.6%. The average REE by indirect calorimetry in this group was 1610.0 ± 612.7 kcal/d. All predictive equations significantly overestimated REE. However, those equations intended for use in the critically ill demonstrated the greatest accuracy, with the Brandi equation achieving both the highest correlation (r = 0.605, P <.001) and the lowest standard error of the estimate (504.8 kcal/d). Conclusions: Indirect calorimetry may be reliably and safely used to determine caloric requirements in patients with advanced heart failure. The use of predictive equations based on demographic and clinical parameters appears to generate inaccurate estimations of REE in these patients. However, equations designed for use in critically ill patients better estimate nutrition requirements than those designed for healthy individuals. © 2015 American Society for Parenteral and Enteral Nutrition.


Bhat G.,Center for Heart Transplant and Assist Devices | Yost G.,Center for Heart Transplant and Assist Devices | Mahoney E.,Center for Heart Transplant and Assist Devices
Journal of Heart and Lung Transplantation | Year: 2015

Background Cognitive impairment is frequent in patients with heart failure (HF) and can lead to poor quality of life and increased risk of mortality. The Montreal Cognitive Assessment (MoCA) is a simple screening tool that is sensitive to mild cognitive impairment (MCI) and that has been validated in the settings of neurologic and cardiovascular disease. This study determined the extent of cognitive impairment in patients with HF undergoing evaluation for advanced surgical therapy and evaluated changes in MoCA score with follow-up cognitive assessment at 8 months after left ventricular assist device (LVAD) implantation. Methods As part of routine assessment for LVAD candidacy, 176 patients with advanced HF were administered the MoCA; 56 patients were reevaluated 8 months after LVAD implantation. Results Patients with MCI, indicated by MoCA score <26 out of 30, made up 67% of the study cohort. MCI was associated with significantly older age, higher CHADS2 (congestive HF, hypertension, age >75 years, diabetes mellitus, prior stroke or transient ischemic attack) risk score, statin use, history of stroke and hypertension, and reduced serum cholesterol levels. In 56 patients who underwent follow-up evaluation after LVAD implantation, total MoCA score and visuospatial, executive, and delayed recall cognitive domains were significantly improved. Conclusions This study assessed the use of the MoCA in patients with end-stage HF being evaluated for advanced surgical therapy. We found the MoCA to be a rapid, simple, and powerful tool for detecting cognitive impairment in these patients. MCI was highly prevalent in the cohort. Significant improvement in overall MoCA score was noted after LVAD implantation. © 2015 International Society for Heart and Lung Transplantation.


Abbasi S.A.,Harvard University | Abbasi S.A.,University of Illinois at Chicago | Ertel A.,University of Illinois at Chicago | Shah R.V.,Harvard University | And 7 more authors.
Journal of Cardiovascular Magnetic Resonance | Year: 2013

Background: Cardiovascular magnetic resonance (CMR) can provide important diagnostic and prognostic information in patients with heart failure. However, in the current health care environment, use of a new imaging modality like CMR requires evidence for direct additive impact on clinical management. We sought to evaluate the impact of CMR on clinical management and diagnosis in patients with heart failure. Methods. We prospectively studied 150 consecutive patients with heart failure and an ejection fraction ≤50% referred for CMR. Definitions for "significant clinical impact" of CMR were pre-defined and collected directly from medical records and/or from patients. Categories of significant clinical impact included: new diagnosis, medication change, hospital admission/discharge, as well as performance or avoidance of invasive procedures (angiography, revascularization, device therapy or biopsy). Results: Overall, CMR had a significant clinical impact in 65% of patients. This included an entirely new diagnosis in 30% of cases and a change in management in 52%. CMR results directly led to angiography in 9% and to the performance of percutaneous coronary intervention in 7%. In a multivariable model that included clinical and imaging parameters, presence of late gadolinium enhancement (LGE) was the only independent predictor of "significant clinical impact" (OR 6.72, 95% CI 2.56-17.60, p=0.0001). Conclusions: CMR made a significant additive clinical impact on management, decision-making and diagnosis in 65% of heart failure patients. This additive impact was seen despite universal use of prior echocardiography in this patient group. The presence of LGE was the best independent predictor of significant clinical impact following CMR. © 2013 Abbasi et al.; licensee BioMed Central Ltd.


Sayer G.,Center for Heart Transplant and Assist Devices | Sayer G.,University of Illinois at Chicago | Bhat G.,Center for Heart Transplant and Assist Devices | Bhat G.,University of Illinois at Chicago
Cardiology Clinics | Year: 2014

The renin-angiotensin-aldosterone system (RAAS) plays a critical role in the pathophysiology of heart failure with reduced ejection fraction (HFrEF). Targeting components of the RAAS has produced significant improvements in morbidity and mortality. Angiotensin-converting enzyme (ACE) inhibitors remain first-line therapy for all patients with a reduced ejection fraction. Angiotensin-receptor blockers may be used instead of ACE inhibitors in patients with intolerance, or in conjunction with ACE inhibitors to further reduce symptoms. Recent data support broader indications for aldosterone antagonists in heart failure, and the combination of an ACE-inhibitor and aldosterone antagonist has become the preferred strategy for dual blockade of the RAAS. © 2014 Elsevier Inc.


Aggarwal A.,Center for Heart Transplant and Assist Devices | Raghuvir R.,Center for Heart Transplant and Assist Devices | Eryazici P.,Center for Heart Transplant and Assist Devices | MacAluso G.,Center for Heart Transplant and Assist Devices | And 5 more authors.
Annals of Thoracic Surgery | Year: 2013

Background: Significant aortic insufficiency (AI) after left ventricular assist device (LVAD) placement affects device performance and end-organ perfusion. This study examined the development and progression of AI after implantation of continuous-flow LVAD. Methods: Seventy-nine patients undergoing Heart Mate II (Thoratec Corp, Pleasanton, CA) LVAD implantation for predominantly destination therapy (n = 69 [87%]) were examined. Preoperative and postoperative echocardiograms for all patients were reviewed at the intervals of 0 to 3, 3 to 6, 6 to 12, 12 to 18, and 18 to 24 months. AI was graded on an interval scale of 0, none; 0.5, trivial; 1, mild; 1.5, mild to moderate; 2, moderate; 2.5, moderate to severe; and 3, severe. Development and progression of AI were analyzed. Results: The incidence of significant AI (mild or greater) was 52% (n = 41). Median time to AI development was 187 days. The median duration of VAD support was 761 days. Mild AI developed in 41 patients (52%). No severe AI developed. In the Cox regression model (hazard ratio [95% confidence interval]), aortic valve closure (2.51 [1.06 to 5.89]; p = 0.03), and age (1.04 [1.008 to 1.08]; p = 0.01) were independent predictors of AI development. There was no difference in mortality rates in the two groups (p = 0.40 by log-rank test). A mixed-model linear regression analysis showed a significant overall progression of AI over time (β ± standard error, 0.06 ± 0.02; p = 0.006). Conclusions: AI develops over time in a significant number of Heart Mate II LVAD patients. AI is more common in patients with closed aortic valves and in the older age group. As more patients require long-term VAD support, the development of AI will need careful attention and monitoring. © 2013 The Society of Thoracic Surgeons.


Aggarwal A.,Center for Heart Transplant and Assist Devices | Kumar A.,Center for Heart Transplant and Assist Devices | Gregory M.P.,Advocate Christ Medical Center | Blair C.,Center for Heart Transplant and Assist Devices | And 4 more authors.
Nutrition in Clinical Practice | Year: 2013

Background: Malnutrition has been shown to affect clinical outcomes in patients with heart failure. The aim of this study was to analyze the incidence of malnutrition and to assess its prognostic significance in patients with advanced heart failure (AHF) (being evaluated for left ventricular assist device [LVAD] or cardiac transplant) based on nutrition status as assessed by the Mini Nutritional Assessment (MNA). Methods: A retrospective analysis was conducted on 154 patients. During evaluation, a complete nutrition assessment was performed, and diagnosis of malnutrition and risk of malnutrition was done with the MNA. Its possible independent association with mortality was assessed. Results: The mean (SD) age of the patients was 59.3 (14.1) years, with 76% men. Twenty-two percent were classified as malnourished, 68% at risk of malnutrition, and 10% well nourished. The mortality in the 3 groups was 26.5%, 42.0%, and 6.7%, respectively (P =.02). In the multivariate logistic regression analysis, the undernutrition state (malnourished + at risk) was an independent predictor of mortality (odds ratio, 7.9; confidence interval, 1.01-62.30; P =.04). Conclusions: The state of undernutrition is an independent predictor of mortality in patients with AHF. Early recognition of undernutrition through use of the MNA may affect the long-term prognosis of these patients by enabling early intervention. © 2012 American Society for Parenteral and Enteral Nutrition.


Yost G.,Center for Heart Transplant and Assist Devices | Gregory M.,Advocate Christ Medical Center | Bhat G.,Center for Heart Transplant and Assist Devices
Nutrition in Clinical Practice | Year: 2014

Background: It has been shown that malnutrition affects clinical outcomes in patients with advanced heart failure and that nutrition status, as determined by the Mini Nutritional Assessment (MNA), can be used as an independent predictor of mortality. The aim of this study was to evaluate the prognostic utility of the short-form MNA (MNA-SF) as a surrogate to the MNA in patients with advanced heart failure. Methods: Data retrospectively gathered from nutrition assessments of 162 patients were analyzed. Results: As defined by the MNA, the cohort included 40 (24.7%) patients classified as malnourished, 106 (65.4%) classified as at risk, and 16 (9.9%) classified as well nourished. The mortality for the groups was 37.3%, 47.4%, and 40.5%, respectively. A linear regression showed strong correlation between the MNA and MNA-SF (r = 0.778, P <.0001). A significant difference was observed in survival between the undernourished state (at risk + malnourished) and the well-nourished state, as determined by the MNA-SF (P <.001). Conclusions: The MNA-SF is a rapid nutrition assessment that correlates strongly with the full-form MNA and is an independent predictor of mortality. © 2014 American Society for Parenteral and Enteral Nutrition.


Aggarwal A.,Center for Heart Transplant and Assist Devices | Pant R.,Center for Heart Transplant and Assist Devices | Kumar S.,Center for Heart Transplant and Assist Devices | Sharma P.,Center for Heart Transplant and Assist Devices | And 4 more authors.
Annals of Thoracic Surgery | Year: 2012

Background: Continuous flow left ventricular assist devices (CF-LVADs) have emerged as the standard of care for patients in advanced heart failure (HF) requiring long-term mechanical circulatory support. Gastrointestinal (GI) bleeding has been frequently reported within this population. Methods: A retrospective analysis of 101 patients implanted with the Heart Mate II from January 2005 to August 2011 was performed to identify incidence, etiology, and management of GI bleeding. Univariate and multivariate regression analysis was conducted to identify related risk factors. Results: A significant incidence of GI bleeding (22.8%) occurred in our predominantly destination therapy (DT) (93%) population. Fifty-seven percent of the patients with bleeding episodes bled from the upper GI (UGI) tract (with 54% bleeding from gastric erosions and 37% from ulcers/angiodysplasias), whereas 35% of patients bled from the lower GI (LGI) tract. Previous history of GI bleeding (odds ratio [OR], 22.7; 95% CI, 2.2-228.6; p = 0.008), elevated international normalized ratio (INR) (OR, 3.9; CI, 1.2-12.9; p = 0.02), and low platelet count (OR, -0.98; CI, 0.98 -0.99; p = 0.001) were independent predictors of GI hemorrhage. Recurrent bleeding was more common in older patients (mean, 70 years; p = 0.01). The majority of bleeders (60%) rebled from the same site. Management strategies included temporarily withholding anticoagulation, decreasing the speed of LVADs, and using octreotide. Octreotide did not impact the amount of packed red blood cells used, rebleeding rates, length of hospital stay, or all-cause mortality. Only 1 patient died as a direct consequence of GI bleeding. Conclusions: Multiple factors account for GI bleeding in patients on CF-VADs. A previous history of bleeding increases risk significantly and warrants careful monitoring. © 2012 The Society of Thoracic Surgeons.

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