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not predict clinical outcome in stable patients with CAD after a follow up of two years. Nevertheless, patients with RPR on aspirin might benefit from clopidogrel.

Clinical Science: Special Reports III

Author Disclosures: A. Pettersen: None. I. Seljeflot: None. M.H. Abdelnoor: None. H. Arnesen: None.

Room S100c Abstracts 21829–21835

2010 Late-Breaking Clinical Trial Abstracts and Clinical Science: Special Reports Abstracts


21829 Telemonitoring to Improve Outcomes after Heart Failure Hospitalization: A Randomized Clinical Trial

21785 Health-Related Quality of Life After Transcatheter Aortic Valve Implantation vs. Non-Surgical Therapy Among Inoperable Patients With Severe Aortic Stenosis: Results From the Randomized PARTNER Trial (Cohort B)

David J Cohen, Saint Luke’s Mid America Heart Institute, Kansas City, MO; Matthew R Reynolds, Harvard Clinical Rsch Institute, Boston, MA; Yang Lei, Elizabeth M Mahoney, Saint Luke’s Mid America Heart Institute, Kansas City, MO; Lars G Svensson, E M Tuzcu, Cleveland Clinic, Cleveland, OH; Jeffrey W Moses, Columbia Univ Med Cntr, New York, NY; John G Webb, St. Paul’s Hosp, Vancouver, Canada; Michael Mack, Baylor Health System, Dallas, TX; D C Miller, Stanford Univ Med Cntr, Palo Alto, CA; Augusto Pichard, Washington Hosp Cntr, Washington, DC; Raj Makkar, Cedars Sinai Med Cntr, Los Angeles, CA; Howard C Herrmann, Hosp of the Univ of Pennsylvania, Philadelphi, PA; Peter Block, Emory Univ Hosp, Atlanta, GA; Craig R Smith, Martin B Leon; Columbia Univ Med Cntr, New York, NY

Background: Recently, transcatheter aortic valve implantation (TAVI) has been developed as a less-invasive alternative to aortic valve replacement (AVR) for patients with severe aortic stenosis (AS). However, the impact of TAVI on patients’ functional status and health-related quality of life (HRQOL)– particularly in comparison to non-surgical therapies– is unknown. We therefore performed a prospective HRQOL study in conjunction with the Placement of Aortic Transcatheter Valves (PARTNER) Trial. Methods: Between 5/07 and 3/09, 358 patients with severe, symptomatic AS who were determined to be “inoperable” for surgical AVR by a multidisciplinary committee were randomized to either TAVI using the Edwards-SAPIEN valve (n179) or continued standard therapies (including balloon aortic valvuloplasty as required) (n179). HRQOL was assessed for all patients at baseline, 1, 6, and 12 months after randomization using validated instruments including the Kansas City Cardiomyopathy Ques- tionnaire (KCCQ), SF-12 Health Status Survey, and the EuroQOL (EQ-5D). Results: Baseline characteristics were well-matched between the 2 treatment groups. The mean age was 83 years, 54% were female, 37% had undergone previous CABG, 23% had severe COPD, 15% had porcelain aortas, and 13% had either chest wall radiation or severe deformities. Predicted 30-day mortality was 11.7% according to the STS risk score. Baseline HRQOL demonstrated substantial impairment for both generic and disease-specific measures (see Table). Follow-up HRQOL comparisons both within-group and between the TAVI and standard therapy groups will be presented. Conclusions: HRQOL is markedly reduced among patients with severe AS who are not candidates for surgical AVR. Direct comparison of the HRQOL benefits of TAVI vs. standard non-surgical therapies should provide important insight into both the magnitude and durability of benefit among this highly complex patient population.

Sarwat I Chaudhry, Yale Univ Sch Medicine, New Haven, CT; Jennifer A Mattera, Yale-New Haven Hosp, New Haven, CT; Jeptha P Curtis, Beth Hodshon, Jeph Herrin, Yale Univ Sch Medicine, New Haven, CT; Zhenqiu Lin, Yale-New Haven Hosp, New Haven, CT; John A Spertus, Mid America Heart Institute of St. Luke’s Hosp, St. Louis, MO; Christopher O Phillips, Morehouse Sch of Medicine, Atlanta, GA; Harlan M Krumholz; Yale Univ Sch Medicine, New Haven, CT

Introduction: Telemonitoring, the use of communication technology to monitor clinical status, may improve the care of patients with heart failure. A system of daily symptom and weight monitoring could provide the opportunity for intervention before patients become severely ill and require hospitalization. Patients’ participation in the program could favorably affect their health behaviors. Hypothesis: Daily telemonitoring of heart failure symptoms and self-reported body weight will reduce the combined outcome of all-cause readmission or death by at least 25% within 6 months of hospital discharge. Methods: 1653 patients hospitalized for heart failure across the U.S. were enrolled in the trial within 30 days of discharge. Patients randomized to the intervention group were instructed to make a daily, toll-free call to an interactive voice response system (Pharos Innovations, Northfield, IL). On each call, patients were asked to respond to pre-recorded questions about heart failure symptoms and body weight using the telephone key pad. The information was transferred to a secure Internet site for review by clinicians. Patients assigned to usual care received heart failure educational materials and guideline-based care. The intervention was implemented, and all outcomes were assessed, during the 180 days following study enrollment. The study was designed to have 90% power to detect a 25% relative risk reduction in the primary endpoint of either all-cause rehospitalization or death within 180 days. The study is funded by the National Heart, Lung, and Blood Institute. Results: Enrollment is complete and assessment of all outcomes will be finalized by July 31, 2010. The study results will be finalized for presentation at the AHA Scientific Sessions. Conclusions: We will present the results of the largest randomized controlled telemonitoring study of an interactive voice response system for patients recently hospitalized with heart failure. With growing interest in reducing readmissions for heart failure, data on the effectiveness of a simple, non-invasive, hardware-free remote monitoring system can inform practice and policy decisions regarding the use and reimbursement for this strategy.

Author Disclosures: S.I. Chaudhry: None. J.A. Mattera: None. J.P. Curtis: None. B. Hodshon: None. J. Herrin: None. Z. Lin: None. J.A. Spertus: None. C.O. Phillips: None. H.M. Krumholz: None.

21855 State-Wide Care is Improved in the Reperfusion of Acute MI in Carolina Emergency Department Emergency Response (RACE-ER) Systems Improvement Program

Christopher B Granger MD, Duke Clinical Rsch Inst, Durham, NC; Lisa M Monk RN, MSN, Novant Health, Winston-Salem, NC; Mayme L Roettig RN, MSN, Hussein R Al-Khalidi PhD, Duke Clinical Rsch Inst, Durham, NC; Robert J Applegate MD, Wake Forst Univ, Winston-Salem, NC; Claire C Corbett MMS, NREMT-P, New Hanover Regional Med Cntr, Wilmington, NC; J L Garvey MD, Carolina’s Med Cntr, Charlotte, NC; William R Hathawy MD, Mission Memorial Hosp, Asheville, NC; B H Wilson MD, Carolina’s Med Cntr, Charlotte, NC; James G Jollis MD; Duke Clinical Rsch Inst, Durham, NC

Author Disclosures: D.J. Cohen: Research Grant; Significant; Edwards Lifesciences. Consul- tant/Advisory Board; Modest; Medtronic, Inc. M.R. Reynolds: Research Grant; Significant; Edwards Lifesciences. Y. Lei: None. E.M. Mahoney: None. L.G. Svensson: None. E.M. Tuzcu: None. J.W. Moses: None. J.G. Webb: Consultant/Advisory Board; Significant; Edwards Lifesciences. M. Mack: None. D.C. Miller: Consultant/Advisory Board; Modest; Medtronic, Inc. A. Pichard: Speakers Bureau; Modest; St. Jude Medical. Consultant/Advisory Board; Modest; Edwards Lifesciences. R. Makkar: None. H.C. Herrmann: None. P. Block: None. C.R. Smith: None. M.B. Leon: None.

Background/Objective: ACC/AHA Guidelines now recommend development of systems of STEMI care, including a focus on reducing first medical contact to reperfusion. Our objective was to extend the prior RACE project to integrate care in all hospitals and EMS systems in North Carolina to increase speed and rate of reperfusion. Methods: We measured delays of coronary reperfusion using ACTION Registry/Get With The Guidelines in STEMI patients from July 2008 through December 2009, including before (July to September 2008) and 3 months after (September to December 2009) a year-long implementation in the 21 percutaneous coronary interventions (PCI) hospitals and 98 without PCI (non-PCI hospitals, of which 52 routinely transferred patients for primary PCI), and over 500 associated EMS systems. The intervention focused on early diagnosis, early reperfusion activation, and optimizing performance at each point of care: EMS, emergency department, catheterization laboratory, and transfer. Results: Preliminary results show that of 6822 STEMI patients treated at PCI hospitals over the course of the study, 1066 were pre-intervention and 1179 post-intervention. Of these, 57% presented directly to PCI centers and 43% were transferred from non-PCI centers. Of direct presenters, patients presented via EMS 69% of the time pre and 76% post-intervention. Median reperfusion times significantly improved according to first door-to-device (p0.0001; presenting to PCI hospital 67 to 60 minutes; transferred to PCI hospital among transfer-designated centers 119 to 108 minutes, p0.01), and first medical contact to device (p0.0001; presenting to PCI hospital via EMS 103 to 91 minutes). While both significantly improved, the post-intervention proportion of patients with transfer first door to device was only 32% 90 minutes and 64%

  • 120 minutes. Eligible but not treated with reperfusion dropped from 5.5% to 4.0%. In

contrast to RACE data from 2006 when in-hospital mortality was 7.5%, mortality was 5.8% pre and 5.6% post intervention. Conclusions: A comprehensive state-wide program focused on regional systems for reperfusion for STEMI can significantly improve quality of care, and ongoing improvements as guided by Mission: Lifeline are needed.

Author Disclosures: C.B. Granger MD: Research Grant; Significant; Sanofi-Aventis, Genentech, Boehringer Ingelheim, BMS. Consultant/Advisory Board; Modest; Novartis, Roche,. Consultant/

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