Left Ventricular Dyssynchrony Does Not Deteriorate Acutely on Cessation of Cardiac Resynchronization Therapy in Long Term Responders

S76 Journal of Cardiac Failure Vol. 12 No. 6 Suppl. 2006 Conclusion: In AA patients with NYHA class III and IV HF, cardiac mortality was the most common cause of death, principally due to SCD and PF. ISDN/HYD principally decreases cardiac mortality by decreasing PF deaths in this moderately severe HF population. This finding is consistent with the marked reduction in HF hospitalizations previously reported with ISDN/HYD in A-HeFT. BiDil (N 5 518) Placebo (N 5 532) Event rate n (%) Total no. of deaths Cardiac deaths Sudden cardiac death (SCD) Pump failure death (PF) Myocardial infarction-related death Non-heart failure (vascular death) Cerebrovascular accident death Vascular-related death Non-cardiovascular death Non-cardiovascular cause death Unknown cause death

32 21 17 4 0 5 4 1 6 3 3

(6.2) (4.1) (3.3) (0.8) (0.0) (1.0) (0.8) (0.2) (1.2) (0.6) (0.6)

Event rate n (%) 54 42 24 16 2 3 3 0 9 5 4

(10.2) (7.9) (4.5) (3.0) (0.4) (0.6) (0.6) (0.0) (1.7) (0.9) (0.8)

p-value 0.024 0.009 0.343 0.012 0.501

0.605

244 Multidisciplinary Congestive Heart Failure Clinic for Older Women: A Randomized Controlled Trial Nahid A. Azad, Frank Molnar, Anna M. Byszewski; Medicine, University of Ottawa, Ottawa, ON, Canada; Medicine, The Ottawa Hospital, Ottawa, ON, Canada; Medicine, The Ottawa Hospital, Ottawa, ON, Canada Objectives: To determine whether a multidisciplinary clinical pathway, a blueprint of the patient care processes for female patients over age 65, will improve patients’ quality of life and functional capacities in comparison to usual care for CHF. Design: A randomized controlled trial. The intervention consisted of a series of 12 visits over 6 weeks to optimize medical care, and to engage in an exercise program with strong educational, counseling and dietary management, involving physician, nursing, dietary, physiotherapy, pharmacy, occupational therapy and social work. Setting: Patients were referred from the Ottawa Hospital and the community with a diagnosis of CHF and were screened to ensure they met the eligibility criteria. Participants: Ninety-one community dwelling women aged 63 to 89 with the diagnosis of CHF were enrolled in this study. Measurements: The primary outcome measure was the Minnesota Living with Heart Failure Questionnaire (MLHFQ). The secondary outcome measures included the MOS 36-Item Short-Form Health Survey (SF-36), the Folstein Mini-mental State Examination (MMSE), the 15 item Geriatric Depression Scale (GDS), the Physical Self-Maintenance Scale (PSMS), and survival and health service utilization over 6 months. Results: There was no difference between the two groups in MMSE or GDS scores by the end of six weeks cycle. Comparison of change from baseline MLHFQ score, including physical and emotional components, did not show a difference (P ! 0.470). There was also no difference between the two groups in functional outcome as measured by change from baseline PSMS score (P ! 0.321). The treatment group had a tendency to more ER visits (for all reasons and for CHF) and hospitalizations. The treatment group had significantly more cardiologist visits during the study period (P ! 0.0001). Conclusion: It is feasible to conduct a randomized study in a frail community-based older female population and to test a complex multidisciplinary pathway. Future studies should provide further insight into the optimal intensity and duration of heart failure management programs, and which patients derive the greatest benefit.

245 What Risks Are Associated with Cardiopulmonary Exercise Testing in Cardiac Resynchronization Therapy Studies? John Boehmer1, Michael Higginbotham2, Steve Higgins3, David De Lurgio4, Jill Schafer5, Elizabeth Galle5, Patrick Yong5; 1Medicine, Milton S Hershey Medical Center, Hershey, PA; 2Medicine, Duke University School of Medicine, Durham, NC; 3Cardiology, Scripps Memorial Hospital, La Jolla, CA; 4Medicine, Emory University School of Medicine, Atlanta, GA; 5CRM, Guidant Corporation, Saint Paul, MN Introduction: Symptom-limited maximal cardiopulmonary exercise tests (CPX) are commonly used to measure functional capacity in heart failure patients (HF pts) participating in cardiac resynchronization therapy (CRT) studies. Although the general risks associated with exercise testing are well known, specific adverse events (AE) and AE rates have not been systematically evaluated in a large cohort of pts with advanced HF participating in clinical research trials. Methods: The AE databases from three large CRT studies (CONTAK CD, COMPANION exercise substudy, and DECREASE-HF) were pooled and reviewed for events associated with CPX as adjudicated by the investigator. All three studies mandated monitoring during testing per

American College of Sports Medicine guidelines. Results: The total population studied included 1201 pts, characterized as 74% male, mean age 65 years, NYHA Class II/III/IV (13%/80%/7%), mean LVEF 22%, and 63% ischemic etiology. Of 3006 CPX tests conducted, a test-related AE was observed in 31 (1.0%) as described in the table below. None of the AEs resulted in death or permanent injury. Of eight pts with angina/ST segment changes, two underwent diagnostic cardiac catheterization and four received nitroglycerin. Sustained ventricular tachyarrhythmias were successfully terminated by the implanted defibrillator. Otherwise, no intervention was required beyond rest and observation. AE Description

n (%)

Angina Ventricular tachyarrhythmia Atrial tachyarrhythmia Hypertension Inappropriate shock Hypotension Bradycardia ST segment changes Syncope Muscle spasms

7 7 5 3 2 2 2 1 1 1

(0.23%) (0.23%) (0.17%) (0.10%) (0.07%) (0.07%) (0.07%) (0.03%) (0.03%) (0.03%)

Conclusions: The AE rate of CPX testing in CRT trials of HF pts was 1.0% and were of the type typically associated with CPX. All AEs were successfully resolved and none were life threatening. Thus, CPX tests were performed with relatively little incremental risk. Proper supervision by study investigators and medical discretion in avoiding tests in high-risk patients may likely have contributed to this outcome.

246 Left Ventricular Dyssynchrony Does Not Deteriorate Acutely on Cessation of Cardiac Resynchronization Therapy in Long Term Responders Suman Kuppahally1, Michael Fowler1, Paul Wang1, Randall Vagelos1, Amin AlAhmad1, Allan Paloma1, David Liang1; 1Cardiovascular Medicine, Stanford University, Stanford, CA Introduction: The benefits of cardiac resynchronization therapy (CRT) are attributed to reverse remodeling of left ventricle (LV) but not all patients respond to it. Although responders have greater LV dyssynchrony than non-responders prior to CRT it remains unclear whether long term responders have a greater acute change on withholding CRT. Hypothesis: On turning off CRT, responders should show more acute deterioration in LV dyssynchrony as compared to non-responders. Methods: Patients who received CRT as per standard criteria for 26.2 6 8.7 months were screened to identify 18 responders (nonischemic-16) and 10 nonresponders (nonischemic-5). A true responder was defined as a patient with a lowering of NYHA functional class by one point and an increase in LV ejection fraction (LVEF) by $10% after CRT. We assessed the acute change in LVEF, LV volumes, mitral regurgitation (MR) and LV dyssynchrony with septal-to-posterior wall motion delay (SPWMD) and 12-segment tissue Doppler imaging (TDI) with CRT on and off modes. Results: On turning off CRT, responders showed a trend towards deterioration of LV dyssynchrony with SPWMD (CRT on- 63.33 6 50.52; CRT off- 85.0 6 43.96, p value 5 NS) and TDI (CRT on- 32.38 6 18.04; CRT off- 37.88 6 16.72, p value 5 NS) that did not reach statistical significance. MR worsened in CRT off mode in responders only (p ! 0.01). LV EF or volumes did not change significantly in the CRT on or off modes in both responders and nonresponders. Conclusion: Although there is a trend towards recurrence of LV dyssynchrony in long term responders after cessation of CRT, a difference between responders and nonresponders was only observed in evaluation of MR in CRT on and off modes. Comparison between long term responders and nonresponders to CRT with CRT on and off modes Responder (n 5 18) CRT on

CRT off

Non responder (n 5 10) CRT on

LV EDV (ml) 119.94 6 36.24 120 6 48.26 211.0 6 LV ESV (ml) 61.64 6 27.92 60.94 6 26.15 151.5 6 EF % 50.52 6 7.36 48.82 6 8.30 29.10 6 SPWMD (ms) 63.33 6 50.52 85.0 6 43.96 85 6 2 SD TDI index 32.38 6 18.04 37.88 6 16.72 31.44 6 * MR (grade 1-4) 0.83 6 0.51 1.22 6 0.42 1.5 6

CRT off

85.76 206.33 6 93.30 72.22 138.88 6 72.97 7.20 30.7 6 9.80 41.76 80 6 45.66 19.70 34.07 6 24.47 0.97 1.4 6 1.07

*p value ! 0.01, EDV-end-diastolic volume, ESV-end-systolic volume, EF-Ejection fraction, MR-Mitral regurgitation.