Timecourse of Weight and Intrathoracic Impedance Changes during Volume Overload

The 14th Annual Scientific Meeting Vigo, Vigo, Spain; 5Sorin Group GmbH, Munchen, Germany; 6SANA-Klinikum Remscheid, Remscheid, Germany Introduction: While atrial pacing (Ap) has been found to alleviate atrial arrhythmia (AA) burden, unnecessary ventricular pacing (Vp) was shown to be potentially detrimental. This study aimed to determine the correlation between Ap/Vp and AA burden through a 6 months (M) follow up (FU) in Sinus Node Disease (SND) patients (pts). Methods: After dual chamber pacemaker’s implantation, a 3M run-in period was performed in order to monitor AA burden and AV conduction. Pts presenting paroxysmal AA and less than 3% Vp were then followed up to 6M FU. AA burden was ascertained from device memories as the time spent in mode switch in days per month of FU. The impact of Ap and Vp on AA burden was assessed based on a linear regression and Receiver Operating Characteristic (ROC) analysis. Results: 105 pts (74.8 6 8.8 yrs, 44% male, 35% SND, 35% brady-tachy syndrome (BTS), 25% SND/BTS and 5% other) were followed up to 5.6 6 0.7M. Mean (median) Ap and Vp were 71.6 + / 26.8% (78%) and 24.1 + / 36.4% (1%), respectively. A linear correlation could be observed between Ap and AA burden (p ! 0.0001). No linear correlation could be retrieved between Vp and AA burden (p 5 0.6). The Ap cutoff value determined with the ROC analysis was 95%. A significant impact of Ap on AA burden was observed. Impact of Ap on AA burden Impact of Ap Nb of pts Ap (%) mean + / SD AA burden (days/month) Mean + / 2 sided Wilcoxon test

SD

!78% O 5 78% 53 52 49.4 + / 19.9 94.3 + / 5.6 4.03 6 6.4 0.54 6 0.95 P 5 0.0006

Conclusions: These results showed that Ap is inversely correlated with AA burden (p ! 0.0001) through a 6M FU. No correlation could be observed between Vp and AA burden, most probably due to an insufficient number of pts and a limited FU. Enhanced atrial pacing may reduce the frequency of AA.

221 Role of Superoxide Dismutase in Exercise Tolerance in Patients with Hypertension Comparing to Ischemic Heart Disease Milica Dekleva1, Jelena Suzic2, Sanja Mazic2, Mirko Colic3, Milena Kleut2, Angelina Stevanovic4; 1University Clinical Centar Zvezdara, Belgrade, Serbia; 2 University Clinical Centar Dr Dragisa Misovic, Belgrade, Serbia; 3Institute for Cardiovascular Disease Dedinje, Belgrade, Serbia; 4Railway Health Care Institute, Belgrade, Serbia Increased reactive oxidative species production (termed oxidative stress) has been implicated in patients with hypertension or with myocardial infarction. Influence of oxidative stress on cardiopulmonary capacity level of those two groups of patients is not well known. The aim of the study was to assess value of cardiopulmonary exercise testing (CPET) for detection of functional capacity profiles in two groups of patients with different origin of heart disease, but with same level of LV diastolic dysfunction (LVDD). Herein, we estimated contribution of antioxidative defense by superoxide dismutase (SOD) on exercise tolerance in both study groups. Methods: Forty patients aged 50.76 6 8.9 years with history of hypertension and 31 patients after myocardial infarction (AMI) aged 49.84 6 6.9 years were enrolled. All patients with mild LVDD, i.e., early filling/late filling velocity !1 with deceleration time of early filling O220ms and preserved systolic function (ejection fraction O50%), underwent Doppler echocardiography and graded maximal CPET on bicycle.The activity of SOD (U/g Hb) was measured by testing the inhibition degree of a tetrazolium salt oxidation reaction with commercially available kit (Randox Laboratories) Results: Clinical, Doppler-Echocardiographic and cardiopulmonary characteristics at rest were similar among two groups. However, significantly lower values of reached peak VO2 (1715 vs. 2083 ml/min, p !0.001), oxygen pulse (12 vs. 14.6 ml/beat, p !0.001), and percentage of peak VO2 at anaerobic threshold (55 vs. 64, p 5 0.007) were found in hypertensive group. There was significant difference between SOD level in hypertensive and in ischemic group (934 vs. 1051 U/g, p 5 0.001) with close correlations between SOD level and peak VO2 (r 5 0.432, p 5 0.002) in hypertensive group. Logistic regression revealed that SOD was the strongest predictor for exercise capacity (F 5 11.54, p 5 0.001) in hypertensive patients. Conclusion: In patients with mild LVDD, CPET profiles can be various, respective to etiology of heart disease. Patients after AMI had better antioxidative protection than patients with long standing hypertension. Lower activity of SOD significantly contributed to decreased cardiopulmonary capacity in hypertensive patients.

222 Implantable Cardioverter Defibrillator Electrogram Adjudication for Large National Device Registries: Methodology and Initial Observations from the ALTITUDE Study Brian D. Powell1, Yongmei Cha1, Samuel J. Asirvatham1, Michael K. Cao2, David A. Cesario2, Paul W. Jones3, Milan Seth3, David L. Hayes1, Leslie A. Saxon2, F.



HFSA

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Roosevelt Gilliam III4; 1Mayo Clinic, Rochester; 2USC Keck School of Medicine, Los Angeles; 3Boston Scientific, St. Paul; 4Cardiology Associates of NE Arkansas, Jonesboro Introduction: There is a new opportunity for analyzing and making novel observations regarding implantable cardioverter-defibrillator (ICD) therapies in recipients that transmit device data over a network. Adjudication of a large number of stored ICD electrograms (EGMs) presents a unique challenge. The ALTITUDE study group was designed to use the LATITUDEÒ remote monitoring system (Boston Scientific) to evaluate ICD patient outcomes across the United States. Methods: Of 81,081 patients at the time of episode sampling, 17,709 patients experienced 59,246 shock therapies. A random sample of 2,000 patients having 5,279 shock episodes between June 2001 and October 2008 was selected. The ALTITUDE EGM review committee was comprised of 7 electrophysiologists from 4 institutions. Episodes were classified as appropriate or inappropriate ICD therapies. Light’s Kappa was used to assess agreement. Results: All 7 EPs reviewed 200 EGMs during an initial phase. Inter-observer Kappa scores were 0.85 (95% CI 0.75e0.93) for dual chamber ICDs and 0.59 (95% CI 0.42e0.77) for single chamber. Discrepant interpretations were discussed by the entire adjudication group. The remaining 5,179 EGMs were reviewed using a pre specified duplication rate based on initial agreement levels. All subsequent single chamber EGMs and 5% of dual chamber EGMs were adjudicated by 2 reviewers. Inter-observer and intra-observer Kappa scores for dual chamber ICDs were 0.84 (0.710.91) and 0.89 (0.82-0.95), consistent with substantial agreement. Inter-observer and intra-observer Kappa scores for single chamber ICDs were 0.61 (0.54-0.67) and 0.69 (0.59-0.79). The mean review time for single and dual chamber EGMs was 50.6 + / 39.8 and 60.5 + / 43.6 seconds. Conclusions: This method of adjudication of an extremely large volume of stored EGM data prior to device therapies will allow new observations in regards to device performance and has the potential to improve device programming and design. In addition, insight into mechanisms of arrhythmia onset and termination will create an opportunity to influence outcomes.

223 Device-Based Remote Monitoring as Contemporary Heart Failure Disease Management: Baseline Characteristics of Patients Enrolled in the OptiVol Care Pathway Study W.H. Wilson Tang1, Roy S. Small2, J. Thomas Heywood3, John Andriulli4; 1 Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, OH; 2The Heart Group, Lancaster, PA; 3Scripps Clinic, La Jolla, CA; 4Cooper University Hospital, University of Medciine and Dentistry of New Jersey, Voorhees, NJ Background: Although remote monitoring of intrathoracic impedance trends has been available for the past few years, its clinical utility as part of heart failure disease management has been debated. The ongoing OptiVol Care Pathway study tests the hypothesis that monthly proactive monitoring of such trends can lead to more prompt responses to clinically-relevant heart failure events. We describe the baseline characteristics of subjects randomized in the largest study on device-based remote monitoring in heart failure to date. Methods: Data included in this analysis is representative of 1540 patients (50% CRT-Ds, 50% ICDs, 91% for primary prevention, 36% implanted !6 months) with OptiVol-enabled implanted devices. These subjects were enrolled at 96 sites in the United States, and were randomized by site to remotely monitor their device diagnostics including intrathoracic impedance trends either monthly or quarterly. Results: In this study cohort (mean age 68 years, 73% male, 71% with hypertension, 37% with diabetes mellitus, 44% with history of myocardial infarction), 95% have a history of heart failure, 80% with symptomatic heart failure (NYHA Class II-IV), 32% experienced NYHA Class III-IV symptoms. The mean LV ejection fraction was 34 6 13% and 57% had ischemic cardiomyopathy. Interestingly, 52% had history of atrial arrhythmia, and 60% with history of ventricular arrhythmia. This is a well-treated population, with 76% receiving ACE inhibitors/ angiotensin receptor blockers, 23% receiving vasodilators, 90% receiving betablockers, 24% receiving aldosterone antagonists, and 70% receiving diuretics. Conclusion: Patients in OptiVol Care Pathway are broadly representative of those seen in outpatient clinical practices. Therefore, the results of this trial should be generally applicable to ‘‘real world’’ patients with heart failure, resulting in a better understanding of the clinical perception and actions taken upon review of intrathoracic impedance trends in combination with other device-based diagnostics.

224 Timecourse of Weight and Intrathoracic Impedance Changes during Volume Overload John Andriulli1, John McKenzie2, George H. Crossley3, Mary Anne Papp4, Jason Sims5, Sanjeev K. Gulati6; 1Southern New Jersey Cardiac, Vorhees, NJ; 2Glendale Memorial Hospital & Medical Center, Glendale, CA; 3Mid-State Cardiology of St. Thomas Heart, Nashville, TN; 4Medical College of Wisconsin, Milwaukee, WI; 5 Medtronic, Mounds View, MN; 6Sanger Heart & Vascular Institute, Charlotte, NC Background: Acute increases in weight are an important sign of worsening heart failure (HF). Recent data indicates that intrathoracic impedance (Z), a measure of thoracic fluid, predicts worsening HF with 70e80% sensitivity. However, the relationship between weight and Z is unknown. We compared Z changes with weight changes in HF patients. We expect that acute weight changes will associate with Z, but only if due to fluid accumulation. Methods: Subjects (n 5 102, 68 6 13 yr,

S70 Journal of Cardiac Failure Vol. 16 No. 8S August 2010 70% male) were enrolled at ICD or CRT-D implant. Inclusion criteria included baseline: BNP O 80pg/ml; QRSO130ms; LVEF!35%; and 6-MHW!450 m. Daily weights were recorded in a diary, while daily Z was stored by the device for 1 year of follow up. We compared daily weights and daily Z as patients progressed towards an OptiVol fluid index crossing (FIX), which is proven to predict future HF events. Patients with less than 75% of weight data within 30 days before a FIX were excluded from analysis. Results: The graph below represents trends in daily weight and Z thirty days before a FIX (n 5 18). As expected, approximately 18 days before a FIX the Z begins to decrease. In contrast, weight begins to change about 11 days before a FIX. Compared to 30 days before, on the day of FIX patient weight increased 3.2 6 2.2 lbs, while Z had dropped 5.6 6 0.6 ohms. Importantly, the second graph details that only 70% of patients had greater than 50% compliance with daily weight data. Conclusion: Intrathoracic impedance and daily weight exhibit similar trends during volume accumulation. However, Z begins to change approximately 7 days before weight. It may be that combining weight and Z may increase the specificity of either measure. However, daily weights are impeded by patient compliance. Device diagnostics, including intrathoracic impedance, may improve remote management of heart failure patients, irrespective of patient compliance.

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226 Documentation of QRS Duration and NYHA Class in HF Patients after a Performance Improvement Initiative: IMPROVE HF N.M. Albert1, A. Curtis2, M. Gheorghiade3, J. Heywood4, P. Johnson Inge5, M. McBride5, M. Mehra6, C. O’Connor7, D. Reynolds8, M. Walsh9, C. Yancy10, G. Fonarow11; 1CCF, Cleveland, OH; 2USF, Tampa, FL; 3Northwestern U, Chicago, IL; 4Scripps Clinic, La Jolla, CA; 5Outcome Sci, Cambridge, MA; 6U MD, Baltimore; 7DCRI, Durham, NC; 8U OK, Oklahoma City; 9The Care Group, Indianapolis, IN; 10Baylor, Dallas, TX; 11UCLA, Los Angeles Introduction: Documentation of NYHA functional class (FC) and QRS duration are important to determine eligibility for some therapies for pts with HF and reduced LVEF. Hypothesis: A performance improvement (PI) intervention would increase documentation of NYHA-FC and QRS duration for outpts with HF and systolic dysfunction. Methods: IMPROVE HF is a prospective study evaluating the effect of a practice-based PI intervention on adherence to guideline-recommended therapies for pts with HF and LVEF #35%. Chart reviews of paired pt samples were conducted at baseline, 12 and 24 mo post intervention initiation at 167 practices. Percent absolute and relative improvements in documentation were compared from baseline to 24 mo. Multivariate models identified significant predictors of baseline documentation rates. Results: Data were available for 7605 of 15,177 pts. Baseline documentation rate was 35.9% for quantified NYHA-FC and 68.2% for QRS duration. There was a 10.5% relative decrease in quantified NYHA-FC documentation and a 22.2% increase for QRS documentation from baseline to 24 mo (both P ! 0.001). Significant independent predictors of documentation of NYHA-FC were White race, history of diabetes, no prior PCI, documentation of BNP, HF clinic in practice, fewer pts treated annually, and location. Significant predictors of QRS duration documentation were location, teaching practice, and HF or device clinic in practice. NYHA-FC documentation was associated with less QRS duration documentation. Conclusions: Despite recommendations to document NYHA-FC during each outpt visit, it is infrequently documented in cardiology practices and did not improve with the intervention. Documentation of QRS duration significantly improved.

Influence of Race on Improvements in Use of Guideline Recommended Heart Failure Therapies: Findings from IMPROVE HF D.W. Reynolds1, N.M. Albert2, A.B. Curtis3, M. Gheorghiade4, J.T. Heywood5, P. Johnson Inge6, M.L. McBride6, M.R. Mehra7, C.M. O’Connor8, M.N. Walsh9, C.W. Yancy10, G.C. Fonarow11; 1U of OK, Oklahoma City, OK; 2CCF, Cleveland, OH; 3USF, Tampa, FL; 4Northwestern U, Chicago, IL; 5Scripps Clinic, La Jolla, CA; 6Outcome Sciences, Cambridge, MA; 7U of MD, Baltimore, MD; 8DCRI, Durham, NC; 9The Care Group, Indianapolis, IN; 10Baylor, Dallas, TX; 11UCLA, Los Angeles, CA Introduction: Race has been associated with variations in use of guideline-recommended therapies for HF patients. The effect of a practice-based performance improvement intervention on use of evidence-based care is unknown for patients of black or white race or those with race not documented. Methods: IMPROVE HF (15,177 patients, 167 practices) evaluated the impact of a performance improvement intervention on use of guideline-recommended care for eligible outpatients with HF or prior MI and LVEF # 35%. Changes from baseline to 24 mo in use of CRT, ICD, ACEI/ARB, b-blocker, aldosterone antagonist, anticoagulation for AF, and HF education were analyzed by race (black, white, not documented). Results: At baseline, 1401 pts were black (9.2%), 6430 were white (42.4%), 265 (1.7%) were other, and race was not documented for 7081 (46.7%). Blacks were more likely to be female, younger, have nonischemic HF etiology, and higher rates of diabetes. Blacks were significantly more likely to be seen in practices in the South, teaching facilities, or with device clinics. Baseline treatment rates differed among groups for 5 of 7 measures. Improvements were equitable for guideline-recommended therapies between the 3 groups except for lesser increase in b-blockers and greater increase in HF education for black pts. Conclusions: IMPROVE HF resulted in substantial and equitable improvements, with only 2 exceptions, in the use of guideline-recommended HF therapies for blacks, whites, and patients whose race was not documented.

227 External Wireless Monitoring of Bioimpedance in Heart Failure Patients: Results from the ACUTE Study Wilson W.H. Tang1, Vijay K. Chopra2, Niranjan Chakravarthy3, Imad Libbus3, Rodolphe P. Katra3; 1Cleveland Clinic, Cleveland, OH; 2The Medicity, New Delhi, India; 3Corventis, Inc, St. Paul, MN Background: Remote monitoring in heart failure (HF) patients (pts) has largely relied on information from implanted devices or immobile external monitoring devices, which have limited accessibility. The study objective is to correlate physiological