Medical Management of Patients with the HeartMate II Left Ventricular Assist Devices. A Single Center Experience

Medical Management of Patients with the HeartMate II Left Ventricular Assist Devices. A Single Center Experience

S122 Journal of Cardiac Failure Vol. 21 No. 8S August 2015 elevated HR compared to those without an elevated HR (cost ratio 2.62, 95% CI 2.07, 3.31, P...

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S122 Journal of Cardiac Failure Vol. 21 No. 8S August 2015 elevated HR compared to those without an elevated HR (cost ratio 2.62, 95% CI 2.07, 3.31, P!0.001). This association remained significant after adjustment for baseline characteristics (adjusted cost ratio 1.61, 95% CI 1.26, 2.05, P!0.001). Patients with an elevated HR had higher 1-year mortality compared to those without an elevated HR (Figure 1). This association also remained significant after adjustment for other baseline characteristics including beta-blocker use (adjusted hazard ratio 1.80, 95% CI 1.14, 2.83, P50.011). Conclusions: At a large tertiary care center, despite high use of beta-blockers, elevated HR was observed in 73% of HFrEF patients. Elevated HR was associated with increased 1-year mortality and increased direct medical costs per day alive.

Figure 1. Kaplan-Meier Mortality Rates for Patients With and Without an Elevated Heart Rate ($ 70bpm) at the Time of Echocardiogram.

298 OptiVol Impedance Threshold Crossing Predicts Patients with Higher Mortality or Hospitalization Risk Among Medicare Recipients Jason Brown1,2, Kenneth Bilchick3, Alvaro Alonso2, Eduardo Warman1; 1Medtronic PLC, Minneapolis, MN; 2University of Minnesota, Minneapolis, MN; 3University of Virginia, Charlottesville, VA Introduction: Intrathoracic impedance threshold crossing has been associated with clinically relevant heart failure events and death in patients with chronic systolic heart failure; however, the impact of impedance threshold measurements on longterm clinical events and mortality in a real-world cohort of older patients with Medicare coverage is unknown. Furthermore, previous studies have not considered important covariates also potentially associated with heart failure mortality, such as NHYA class, hypertension, diabetes mellitus, and smoking status, which are available in the Medicare database. The hypothesis of the present study was that OptiVolÒ impedance threshold crossings would have an important impact on predicting both patient mortality and heart failure-related hospitalizations in Medicare patients after adjustments for key covariates. Methods: A cohort combining the Medicare Implantable Cardioverter-Defibrillator Registry data (implanted in 2005 and 2006), Medicare claims data, and data from Medtronic’s CareLinkÒ Network were analyzed via an extended Cox Proportional Hazards model to assess the associations of impedance threshold crossing with both patient mortality and heart failure-related hospitalization. OptiVolÒ threshold crossing was treated as a time-dependent variable in this analysis. Results: A total of 1,819 CRT patients were matched between the Medicare registry data and Medtronic’s CareLinkÒ network based on the basis of implant date, patient gender, device model, patient age at implant, and de-identified (3-digit) ZIP code information. Only OptiVolÒ-enabled CRT devices were included in this analysis. The median follow-up was 3.5 years. An impedance threshold crossing at any point in the device follow-up period was associated with a 74% increased risk of patient death (HR 1.74, 95% CI: 1.20-2.61) after adjustment for LVEF, ischemic heart disease, smoking status, age at implant, systolic blood pressure, diabetes status, and the prescription of beta-blockers, digoxin, and amiodarone. Furthermore, after adjusting for these same covariates, an impedance threshold crossing at any point in the device follow-up period was associated with an 86% increased risk of a heart failure related hospitalization (HR 1.86, 95%CI: 1.24-2.82). Conclusion: In an early Medicare cohort of CRT patients, an OptiVolÒ impedance threshold crossing indicated an increased risk of both patient mortality as well as heart failure related hospitalization. This is the first study in which device measured data was combined with Medicare outcomes data to validate the long-term importance of this thoracic impedance measurement in this cohort.

299 How do Patients with Ventricular Assist Devices Die? A Look at End of Life Outcomes Esther S. Pak, Eva Laverty-Wilson, Christyna Zalewski, Wald Joyce, Pavan Atluri, Eduardo Rame, James N. Kirkpatrick; Hospital of the University of Pennsylvania, Philadelphia, PA Background: Though ventricular assist devices (VADs) improve survival for patients with advanced heart failure, VADs are associated with complications that can result in poor end of life outcomes and death. The purpose of this study was to describe the end of life outcomes and palliative care involvement in the care of VAD patients. Methods: At the Hospital of the University of Pennsylvania, 66 patients who underwent VAD implantation died during the years 2009 to 2013. Retrospective chart and INTERMACS database reviews were conducted. Logistic regression analyses were performed to examine the association between demographic and clinical factors and end of life outcomes. Results: The sample was comprised of patients 80% male, 84% Caucasian, 75% with education above high school, and with an average age of 62 +13. 57% of these patients received VAD as destination therapy. Out of the total who died on VAD support, the percentage of patients per year who did not survive past implant hospitalization were: 2008_0%; 2009_15%; 2010_17%; 2011_14%; 2012_5%; and 2013_22%. Those who survived past implant hospitalization but died later were hospitalized an average of 24+34 days with a range of 2 to 143 days. The average time spent on VAD support prior to death was 384+323 days. Two thirds died in the inpatient setting. The most frequent causes of death were stroke/intracranial hemorrhage (31.8%), infection (19%) and multiorgan failure (16%). VAD thrombosis was associated with cause of death in 10% of patients prior to 2011 and 12% of patients after 2011. Thirty five percent of patients had palliative care involvement, on an average of 9 days with a range of 2 to 180 days prior to death. Of patients who died due to CNS complications, 43% had documented palliative care involvement. Though all VAD patients are required to complete advance directives, sixty percent of patients had advance directives physically available in their medical records at time of death. Logistic regression analysis showed that of all predictors including demographics number of comorbid conditions, history of ionotrope support prior to implantation, and greater number of days hospitalized were associated with death in the hospital (p50.03). More days hospitalized was also associated with more palliative care involvement (p50.039). There was a trend toward an association between education level and death in the hospital (p50.063). Conclusion: Though VADs improve quality of life after implantation in most patients, there are opportunities to improve quality of death. Our study demonstrated high rates of hospitalizations/time hospitalized and death in the hospital setting, and low rates of palliative care involvement. Further research is needed to help improve end of life outcomes in VAD patients.

300 Medical Management of Patients with the HeartMate II Left Ventricular Assist Devices. A Single Center Experience Adam F. Burdorf, John Um, Eugenia Raichlin, Eric Rome, Jason Darrah, Sara Varnado, Brian Lowes; University of Nebraska Medical Center, Omaha, NE Background: The efficacy of optimal medical therapy (OMT) with systolic heart failure is well established. Recent data has demonstrated myocardial recovery in patients with end-stage cardiomyopathy via the use of mechanical as well as pharmacological support. Despite having evidence that a similar regimen (beta-blockade, ACEi/ARBs, diuretics and aldosterone antagonist) may benefit myocardial recovery, their use in this population varies. This study evaluates the proportion of patients with LVADs in our institution that received what is considered OMT as it pertains to systolic heart failure. Methods: We performed a retrospective analysis of 146 patients following implantation of the HeartMate II Left Ventricular Assist Device between 2009 and 2014 at our institution. Their medication regimen was evaluated at 3 months post implant. Patients included were over the age of 18 and we excluded patients who failed to have their device for 3 months following implant due to device explant, transplant or death as well as those with missing information. Bridge to transplant as well as destination LVAD patients were included. We then evaluated the percentage of patients on beta-blockers, ACEi or ARBs, aldosterone antagonists Table 1.

Medical Therapy in LVAD Patients Beta-Blocker ACEi ARB Aldosterone Antagonist Diuretic

23(20.9%) 63 (57.2%) 11 (10%) 55 (50%) 78 (70.9%)

LVEF in Patients Receiving OMT vs. Non-OMT at Three Months

OMT Non-OMT

Pre-LVAD

3 Months Post Implant

12.6% 12.8%

29.4% 18.1%

The 19th Annual Scientific Meeting and diuretics. We also compared LVEF at 3 months post implant. Results: Of the 146 patients evaluated, 110 patients met inclusion criteria. Of those 110 patients, 49.1% were DT LVAD patients and 78.2% were male. With regard to medical therapy, 20.9% were on Beta-Blockade, 57.2% ACEi, 10% ARB, 50% aldosterone antagonists and 70.9% on diuretic therapy. In our patient population only 9 (8%) were on what is considered OMT (Beta-blocker, ACEi/ARB and Aldosterone antagonists). The average change in left ventricular ejection fraction over the 3 month period was 6.97%. The change in LVEF for patients on OMT compared to those not on OMT was 16.88% versus 5.29%. Conclusions: In this single center, retrospective analysis, 92% of patients were not maintained on OMT with regard to systolic heart failure. Furthermore, there was a more significant increase in LVEF in patients on OMT compared to those not receiving OMT.



HFSA

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mortality was comparable. (Group I 0.6% vs. Group II 1.0%; p 5 .52). Comparing the time periods March 2013-March 2014 vs. March 2014-March 2015: PC involvement with pts on the HF unit increased from 3.0 % to 16.9 % ( p ! 0.0001) and overall hospice referral rates increased 58% from 4.5 % to 7.1% (p 5 0.013). Conclusions: HF pts at higher risk of mortality based on a validated risk model were older, had a higher case mix index and LOS. Readmission rates were comparable at 7 and 30 days as was inpatient mortality. Successful integration of SC into a HF Care Pathway resulted in: Increased and earlier documentation of goals of care, increased hospice and SNF referrals, increased patient satisfaction and greater overall involvement of PC with a large cohort of HF pts. Incorporation of PC services using this “Supportive Care” approach into a HF Care Pathway has great potential to improve outcomes and improve overall patient satisfaction in this complex group of patients.

301 The Relationship Between Glucose Variability and In-Hospital Mortality in Patients With Acute Heart Failure Syndrome: Data From the Korean Acute Heart Failure (KorAHF) Registry Jaewon Oh1, Seok-Min Kang1, Eun-Seok Jeon2, Jae-Joong Kim3, Sang Hong Baek4, Myeong-Chan Cho5, Shung Chull Chae6, Dong-Ju Choi7, Byung-Su Yoo8, ByungHee Oh9; 1Yonsei University College of Medicine, Seoul, Republic of Korea; 2 Sungkyunkwan University College of Medicine, Seoul, Republic of Korea; 3 University of Ulsan College of Medicine, Seoul, Republic of Korea; 4Catholic University of Korea College of Medicine, Seoul, Republic of Korea; 5Chungbuk National University College of Medicine, Cheongju, Republic of Korea; 6 Kyungpook National University College of Medicine, Daegu, Republic of Korea; 7 Seoul National University Bundang Hospital, Seongnam, Republic of Korea; 8 Yonsei University Wonju College of Medicine, Wonju, Republic of Korea; 9Seoul National University Hospital, Seoul, Republic of Korea Background: Hyperglycemia during hospitalization is a risk predictor in acute heart failure syndrome (AHFS). Increased glycemic variability has been linked to a worse prognosis in critically ill patients (pts). However, the relationship between glucose variability (GV) and clinical outcomes in AHFS remains largely unknown. Methods and Results: We analyzed 5,660 AHFS pts (3,019 males, 68 6 14 years old, 37.4% ischemic origin, left ventricular ejection fraction 38.5 6 16.1%) from Korean Acute Heart Failure (KorAHF) Registry. We defined GV as standard deviation of serum glucose at admission, maximum, minimum and discharge. There were 270 cases of all-cause in-hospital mortality (4.8%). Mean glucose at admission and discharge were 156 6 77 and 126 6 57 mg/dL, respectively and mean GV was 36.6 6 44.3 (n55,547). The AHFS group with lower GV (!22.52, below median GV) had significantly higher heart rate and lower body mass index compared to those with higher GV ($22.52, above median GV). However, there were not significant differences in left ventricular ejection fraction and blood pressure between two groups. In correlation analysis, GV was significantly associated with B-type Natriuretic Peptide (BNP, r50.114, p!0.001), N-terminal pro-BNP (r50.150, p!0.001) and high sensitive c-reactive protein (r50.206, p!0.001). In multivariate logistic regression analysis for in-hospital mortality, higher GV was an independent prognostic marker after adjusting other risk factors including diabetes mellitus on the treatment (hazard ratio 4.024, 95% confidence interval 2.696-6.005, p!0.001). Conclusion: Our study found the first evidence that higher GV was related to higher in-hospital mortality in large cohort of AHFS. Therefore, the further prospective research regarding the prognostic value of GV during hospitalization should be warranted and it may provide a new information in the risk stratification of AHFS. This research was supported by a fund (2013-E63003-01) by the Korea National Institute of Health.

302 Heart Failure Supportive Care: Integrating Mortality Risk Modeling Into Heart Failure Care to Impact Outcomes Mitchell T. Saltzberg, Roshni Guerry, Kelly A. Whitmarsh, Carolyn Moffa, Lisa Keichline; ChristianaCare Health System, Newark, DE Background: Heart Failure (HF) patients (pts) at high risk for mortality are often readmitted prior to engaging palliative care (PC). Risk modeling and earlier engagement of PC may help reduce this risk. Methods: The ChristianaCare HF Program partnered with the PC team to screen all CHF pts admitted to the HF unit with a previously validated mortality risk tool according to our Supportive Care Pathway (Figure 1). If the score was O 6 points (High Risk), a member of the PC team provided a “Supportive Care” (SC) consult. Goals of care were discussed and documented, a CHF checklist was completed to identify missed opportunities and where appropriate, pts were offered end of life care. Results: 634 pts were screened in total from March 2014 - March 2015. Group 1 (Low risk: n5 527; Age 70.6 +/- 1.0; LOS 6.32 days; risk score 5 3.63; Case Mix Index 5 1.57) and Group 2 (High risk; n5 107; Age 76.4 +/- 2.4 yrs; LOS 8.48 days; risk score 5 6.98; Case Mix Index 5 1.80) were compared. Goals of care documentation increased with SC (6%vs.45%; p 5 0.001) and occurred much earlier in the admission (2.7 days vs. 3.8 days). 105 SC consults were generated (98 % of pts with Risk Score O/5 6). The % Hospice referrals were higher in Group II (42 vs 8.7; p ! 0.0001). More Group II pts were discharged to a Skilled Nursing facility (SNF) (44.2% vs 14.8%; p 5 0.001). 7 and 30 day readmission rates were similar between Group I and Group II (7 Day: 4.6%vs. 6.7% ; p5 0.33) and (30 day: 17.4% vs. 22.1%; p 5 .27). Patient satisfaction scores were higher with SC (Top Box Score 77.3% vs. 92.3 % : Group I vs. Group II). Inpatient

Figure 1.

303 Inverse Changes in Quality of Life for Patients and Caregivers After Implantation of a Ventricular Assist Device Julie T. Bidwell, Christopher S. Lee; Oregon Health & Science University, Portland, OR Introduction: Ventricular Assist Device (VAD) implantation is emerging as a main therapeutic option for patients with advanced heart failure (HF). In order to be eligible for VAD therapy, most centers require that patients designate a primary informal caregiver to assist with post-operative recovery, device management, and HF self-care. Although implantation typically results in improvements in quality of life (QOL) for the patient, little is known quantitatively about post-implantation changes in QOL for the caregiver. Hypothesis: We hypothesized that patient QOL would significantly increase post-implantation, while caregiver QOL would significantly decrease. Methods: This was a prospective longitudinal study of patients receiving VAD therapy for advanced HF and their informal caregivers (n527 patient-caregiver dyads). QOL was measured immediately before VAD implantation and again 30 days post-implantation in both patients and caregivers. For patients, QOL was measured using the symptom subscale of the Kansas City Cardiomyopathy Questionnaire (KCCQ). For caregivers, QOL was measured using the Physical Component Summary of the Short Form-36 (SF-36 PCS). Both measures have a possible range of 0-100, with higher scores indicating better QOL. Changes in QOL from baseline to 30 days post-implant were examined using paired t-tests. Effect size was quantified in the metric of Cohen’s d. Results: On average, caregivers and patients were 54.9610.3 years of age and 54.3614.6 years of age, respectively. The majority of patients were male (n524, 88.9%), while the majority of caregivers were female (n523, 85.2%), and most dyads were spousal (n521, 77.8%). One third of patients (n59) had NYHA Class IV HF prior to implantation, and most were receiving a VAD as a bridge to transplant (n517, 63.0%). While patient QOL significantly increased from baseline to 30 days post-implant (pre-implant mean556.0625.0; post-implant mean569.4623.0; t(26)5-2.4, p50.03), caregiver QOL significantly decreased (pre-implant mean555.267.1; post-implant mean551.9610.3; t(26)52.4, p50.03). Both the increase in patient QOL and the simultaneous decrease in caregiver QOL were moderate-sized effects (d50.45 and d50.46, respectively). Conclusions: In this study of VAD patients and their caregivers, QOL for patients significantly improved from preimplant to 30 days post-implant, while QOL for caregivers significantly declined. Although VAD therapy is associated with positive QOL outcomes for patients, clinicians and researchers should recognize that caregivers may be at particular risk for decreases in QOL after implantation.