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      Patient Activity and Survival Following Implantable Cardioverter-Defibrillator Implantation: The ALTITUDE Activity Study

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          Abstract

          Background

          Physical activity data are collected automatically by implantable cardioverter-defibrillators (ICDs). Though these data potentially provide a quantifiable and easily accessible measure of functional status, its relationship with survival has not been well studied.

          Methods and Results

          Patients enrolled in the Boston Scientific LATITUDE remote monitoring system from 2008 to 2012 with ICDs were eligible. Remote monitoring data were used to calculate mean daily activity at baseline (30 to 60 days after implantation), and longitudinally. Cox regression was used to examine the association between survival and increments of 30 minutes/day in both (1) mean baseline activity and (2) time-varying activity, with both adjusted for demographic and device characteristics. A total of 98 437 patients were followed for a median of 2.2 years (mean age of 67.7±13.1 years; 71.7% male). Mean baseline daily activity was 107.5±66.2 minutes/day. The proportion of patients surviving after 4 years was significantly higher among those in the most versus least active quintile of mean baseline activity (90.5% vs. 50.0%; log-rank P value, <0.001). Lower mean baseline activity (i.e., incremental difference of 30-minutes/day) was independently associated with a higher risk of death (adjusted hazard ratio [AHR], 1.44; 95% confidence interval [CI], 1.427 to 1.462). Time-varying activity was similarly associated with a higher risk of death (AHR, 1.48; 95% CI, 1.451 to 1.508), indicating that a patient having 30 minutes per day less activity in a given month has a 48% increased hazard for death when compared to a similar patient in the same month.

          Conclusions

          Patient activity measured by ICDs strongly correlates with survival following ICD implantation.

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          Most cited references16

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          Long-term outcome after ICD and CRT implantation and influence of remote device follow-up: the ALTITUDE survival study.

          Outcome data for patients receiving implantable cardioverter-defibrillator (ICD) and cardiac resynchronization therapy-defibrillator (CRT-D) devices treated outside of clinical trials are lacking. No clinical trial has evaluated mortality after device implantation or after shock therapy in large numbers of patients with implanted devices that regularly transmit device data over a network. Survival status in patients implanted with ICD and CRT devices across the United States from a single manufacturer was assessed. Outcomes were compared between patients followed in device clinic settings and those who regularly transmit remote data collected from the device an average of 4 times monthly. Shock delivery and electrogram analysis could be ascertained from patients followed on the network, enabling survival after ICD shock to be evaluated. One- and 5-year survival rates in 185,778 patients after ICD implantation were 92% and 68% and were 88% and 54% for CRT-D device recipients. In 8228 patients implanted with CRT-only devices, survival was 82% and 48% at 1 and 5 years, respectively. For the 69,556 ICD and CRT-D patients receiving remote follow-up on the network, 1- and 5-year survival rates were higher compared with those in the 116,222 patients who received device follow-up in device clinics only (50% reduction; P<0.0001). There were no differences between patients followed on or off the remote network for the characteristics of age, gender, implanted device year or type, and economic or educational status. Shock therapy was associated with subsequent mortality risk for both ICD and CRT-D recipients. Survival after ICD and CRT-D implantation in patients treated in naturalistic practice compares favorably with survival rates observed in clinical trials. Remote follow-up of device data is associated with excellent survival, but arrhythmias that result in device therapy in this population are associated with a higher mortality risk compared with patients who do not require shock therapy.
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            Combined heart failure device diagnostics identify patients at higher risk of subsequent heart failure hospitalizations: results from PARTNERS HF (Program to Access and Review Trending Information and Evaluate Correlation to Symptoms in Patients With Heart Failure) study.

            We sought to determine the utility of combined heart failure (HF) device diagnostic information to predict clinical deterioration of HF in patients with systolic left ventricular dysfunction. Some implantable devices continuously monitor HF device diagnostic information, but data are limited on the ability of combined HF device diagnostics to predict HF events. The PARTNERS HF (Program to Access and Review Trending Information and Evaluate Correlation to Symptoms in Patients With Heart Failure) was a prospective, multicenter observational study in patients receiving cardiac resynchronization therapy (CRT) implantable cardioverter-defibrillators. HF events were independently adjudicated. A combined HF device diagnostic algorithm was developed on an independent dataset. The algorithm was considered positive if a patient had 2 of the following abnormal criteria during a 1-month period: long atrial fibrillation duration, rapid ventricular rate during atrial fibrillation, high (> or =60) fluid index, low patient activity, abnormal autonomics (high night heart rate or low heart rate variability), or notable device therapy (low CRT pacing or implantable cardioverter-defibrillator shocks), or if they only had a very high (> or =100) fluid index. We used univariate and multivariable analyses to determine predictors of subsequent HF events within a month. We analyzed data from 694 CRT defibrillator patients who were followed for 11.7 +/- 2 months. Ninety patients had 141 adjudicated HF hospitalizations with pulmonary congestion at least 60 days after implantation. Patients with a positive combined HF device diagnostics had a 5.5-fold increased risk of HF hospitalization with pulmonary signs or symptoms within the next month (hazard ratio: 5.5, 95% confidence interval: 3.4 to 8.8, p < 0.0001), and the risk remained high after adjusting for clinical variables (hazard ratio: 4.8, 95% confidence interval: 2.9 to 8.1, p < 0.0001). Monthly review of HF device diagnostic data identifies patients at a higher risk of HF hospitalizations within the subsequent month. (PARTNERS HF: Program to Access and Review Trending Information and Evaluate Correlation to Symptoms in Patients With Heart Failure; NCT00279955). Copyright (c) 2010 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
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              Development and validation of an integrated diagnostic algorithm derived from parameters monitored in implantable devices for identifying patients at risk for heart failure hospitalization in an ambulatory setting

              Background We developed and validated a heart failure (HF) risk score combining daily measurements of multiple device-derived parameters. Methods Heart failure patients from clinical studies with implantable devices were used to form two separate data sets. Daily HF scores were estimated by combining changes in intra-thoracic impedance, atrial fibrillation (AF) burden, rapid rate during AF, %CRT pacing, ventricular tachycardia, night heart rate, heart rate variability, and activity using a Bayesian model. Simulated monthly follow-ups consisted of looking back at the maximum daily HF risk score in the preceding 30 days, categorizing the evaluation as high, medium, or low risk, and evaluating the occurrence of HF hospitalizations in the next 30 days. We used an Anderson–Gill model to compare survival free from HF events in the next 30 days based on risk groups. Results The development data set consisted of 921 patients with 9790 patient-months of data and 91 months with HF hospitalizations. The validation data set consisted of 1310 patients with 10 655 patient-months of data and 163 months with HF hospitalizations. In the validation data set, 10% of monthly evaluations in 34% of the patients were in the high-risk group. Monthly diagnostic evaluations in the high-risk group were 10 times (adjusted HR: 10.0; 95% CI: 6.4–15.7, P < 0.001) more likely to have an HF hospitalization (event rate of 6.8%) in the next 30 days compared with monthly evaluations in the low-risk group (event rate of 0.6%). Conclusion An HF score based on implantable device diagnostics can identify increased risk for HF hospitalization in the next 30 days.
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                Author and article information

                Journal
                J Am Heart Assoc
                J Am Heart Assoc
                jah3
                Journal of the American Heart Association: Cardiovascular and Cerebrovascular Disease
                John Wiley & Sons, Ltd (Chichester, UK )
                2047-9980
                2047-9980
                May 2015
                15 May 2015
                : 4
                : 5
                : e001775
                Affiliations
                Beth Israel Deaconess Medical Center Boston, MA (D.B.K., S.L.M.)
                Harvard Medical School Boston, MA (D.B.K., S.L.M., S.-L.N.
                Hebrew SeniorLife Institute for Aging Research Boston, MA (D.B.K., S.L.M.)
                North American Science Associates, Inc Minneapolis, MN (J.M.)
                Boston Scientific St Paul, MN (P.W.J.)
                Harvard School of Public Health Boston, MA (S.-L.N.)
                Mayo Clinic Rochester, MN (D.L.H.)
                Lahey Clinic Burlington, MA (M.R.R.)
                Harvard Clinical Research Institute Boston, MA (M.R.R.)
                Author notes
                Correspondence to: Daniel B. Kramer, MD, MPH, Beth Israel Deaconess Medical Center, 185 Pilgrim Rd, Boston, MA 02215. E-mail: dkramer@ 123456bidmc.harvard.edu

                This data was presented as an Oral Presentation at the Heart Rhythm Society’s 36th Annual Scientific Sessions, May 15, 2015 in Boston, MA.

                Article
                10.1161/JAHA.115.001775
                4599410
                25979902
                a7ac59c9-62e6-4bea-8912-c8925d78d756
                © 2015 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.

                This is an open access article under the terms of the Creative Commons Attribution-NonCommercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.

                History
                : 06 January 2015
                : 06 March 2015
                Categories
                Original Research

                Cardiovascular Medicine
                death,implantable cardioverter-defibrillators,sudden
                Cardiovascular Medicine
                death, implantable cardioverter-defibrillators, sudden

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