Incremental Value of Implantable Cardiac Device Diagnostic Variables Over Clinical Parameters to Predict Mortality in Patients With Mild to Moderate Heart Failure

Jaimie Manlucu, Vinod Sharma, Jodi Koehler, Eduardo N Warman, George A Wells, Lorne J Gula, Raymond Yee, Anthony S Tang, Jaimie Manlucu, Vinod Sharma, Jodi Koehler, Eduardo N Warman, George A Wells, Lorne J Gula, Raymond Yee, Anthony S Tang

Abstract

Background Heart failure remains a leading cause of morbidity and mortality. Clinical prediction models provide suboptimal estimates of mortality in this population. We sought to determine the incremental value of implantable device diagnostics over clinical prediction models for mortality. Methods and Results RAFT (Resynchronization/Defibrillation for Ambulatory Heart Failure Trial) patients with implanted devices capable of device diagnostic monitoring were included, and demographic and clinical parameters were used to compute Meta-Analysis Global Group in Chronic Heart Failure (MAGGIC) heart failure risk scores. Patients were classified according to MAGGIC score into low (0-16), intermediate (17-24), or high (>24) risk groups. Mortality was evaluated from 6 months postimplant in accordance with the RAFT protocol. In a subset of 1036 patients, multivariable analysis revealed that intermediate and high MAGGIC scores, fluid index, atrial fibrillation, and low activity flags were independent predictors of mortality. A device-integrated diagnostic parameter that included a fluid index flag and either a positive atrial fibrillation flag or a positive activity flag was able to significantly differentiate higher from lower risk for mortality in the intermediate MAGGIC cohort. The effect was more pronounced in the high-risk MAGGIC cohort, in which device-integrated diagnostic-positive patients had a shorter time to death than those who were device-integrated diagnostic negative. Conclusions Device diagnostics using a combination of fluid index trends, atrial fibrillation burden, and patient activity provide significant incremental prognostic value over clinical heart failure prediction scores in higher-risk patients. This suggests that combining clinical and device diagnostic parameters may lead to models with better predictive power. Whether this risk is modifiable with early medical intervention would warrant further studies. Clinical Trial Registration URL : http://www.clinicaltrials.gov . Unique identifier: NCT00251251.

Keywords: device diagnostics; heart failure; implantable cardioverter‐defibrillator; model; mortality; prognostic factor.

Figures

Figure 1
Figure 1
Meta‐Analysis Global Group in Chronic Heart Failure score. ACEI indicates angiotensin‐converting enzyme inhibitor; ARB, angiotensin receptor blocker; BMI, body mass index; COPD, chronic obstructive pulmonary disease; EF, ejection fraction; HF, heart failure; NYHA, New York Heart Association; SBP, systolic blood pressure. Reprinted from Pocock et al4 with permission. Copyright ©2013, Oxford University Press.
Figure 2
Figure 2
Illustration of patient deaths in various Meta‐Analysis Global Group in Chronic Heart Failure (MAGGIC) groups and with device‐integrated diagnostic (DID)–negative (DID−) and DID‐positive (DID+) status.
Figure 3
Figure 3
Kaplan‐Meier survival analysis for all‐cause mortality stratified according to Meta‐Analysis Global Group in Chronic Heart Failure (MAGGIC) score classification (A) and device‐integrated diagnostic (DID) classification (B). DID+ indicates DID positive; DID−, DID negative.
Figure 4
Figure 4
Kaplan‐Meier survival curves in intermediate Meta‐Analysis Global Group in Chronic Heart Failure (MAGGIC) score (A) and high MAGGIC score (B) groups stratified according to device‐integrated diagnostic (DID) positive (DID+) or DID negative (DID−). The combined prognostic value of a positive fluid index plus either an atrial fibrillation or an activity flag is observed in both groups, but most evident in the high‐risk cohort.

References

    1. Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, de Ferranti S, Despres JP, Fullerton HJ, Howard VJ, Huffman MD, Judd SE, Kissela BM, Lackland DT, Lichtman JH, Lisabeth LD, Liu S, Mackey RH, Matchar DB, McGuire DK, Mohler ER III, Moy CS, Muntner P, Mussolino ME, Nasir K, Neumar RW, Nichol G, Palaniappan L, Pandey DK, Reeves MJ, Rodriguez CJ, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Willey JZ, Woo D, Yeh RW, Turner MB. Heart disease and stroke statistics—2015 update: a report from the American Heart Association. Circulation. 2015;131:e29–e322.
    1. Roger VL. Epidemiology of heart failure. Circ Res. 2013;113:646–659.
    1. Alba AC, Agoritsas T, Jankowski M, Courvoisier D, Walter SD, Guyatt GH, Ross HJ. Risk prediction models for mortality in ambulatory patients with heart failure: a systematic review. Circ Heart Fail. 2013;6:881–889.
    1. Pocock SJ, Ariti CA, McMurray JJ, Maggioni A, Kober L, Squire IB, Swedberg K, Dobson J, Poppe KK, Whalley GA, Doughty RN. Predicting survival in heart failure: a risk score based on 39 372 patients from 30 studies. Eur Heart J. 2013;34:1404–1413.
    1. Sartipy U, Dahlstrom U, Edner M, Lund LH. Predicting survival in heart failure: validation of the MAGGIC heart failure risk score in 51,043 patients from the Swedish Heart Failure Registry. Eur J Heart Fail. 2014;16:173–179.
    1. Small RS, Wickemeyer W, Germany R, Hoppe B, Andrulli J, Brady PA, Labeau M, Koehler J, Sarkar S, Hettrick DA, Tang WH. Changes in intrathoracic impedance are associated with subsequent risk of hospitalizations for acute decompensated heart failure: clinical utility of implanted device monitoring without a patient alert. J Card Fail. 2009;15:475–481.
    1. Whellan DJ, Ousdigian KT, Al‐Khatib SM, Pu W, Sarkar S, Porter CB, Pavri BB, O'Connor CM. 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. J Am Coll Cardiol. 2010;55:1803–1810.
    1. Perego GB, Landolina M, Vergara G, Lunati M, Zanotto G, Pappone A, Lonardi G, Speca G, Iacopino S, Varbaro A, Sarkar S, Hettrick DA, Denaro A. Implantable CRT device diagnostics identify patients with increased risk for heart failure hospitalization. J Interv Card Electrophysiol. 2008;23:235–242.
    1. Sharma V, Rathman LD, Small RS, Whellan DJ, Koehler J, Warman E, Abraham WT. Stratifying patients at the risk of heart failure hospitalization using existing device diagnostic thresholds. Heart Lung. 2015;44:129–136.
    1. Whellan DJ, Sarkar S, Koehler J, Small RS, Boyle A, Warman EN, Abraham WT. Development of a method to risk stratify patients with heart failure for 30‐day readmission using implantable device diagnostics. Am J Cardiol. 2013;111:79–84.
    1. Sarkar S, Koehler J. A dynamic risk score to identify increased risk for heart failure decompensation. IEEE Trans Biomed Eng. 2013;60:147–150.
    1. Cowie MR, Sarkar S, Koehler J, Whellan DJ, Crossley GH, Tang WH, Abraham WT, Sharma V, Santini M. 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. Eur Heart J. 2013;34:2472–2480.
    1. Gula LJ, Wells GA, Yee R, Koehler J, Sarkar S, Sharma V, Skanes AC, Sapp JL, Redfearn DP, Manlucu J, Tang AS. A novel algorithm to assess risk of heart failure exacerbation using ICD diagnostics: validation from RAFT. Heart Rhythm. 2014;11:1626–1631.
    1. Sack S, Wende CM, Nagele H, Katz A, Bauer WR, Barr CS, Malinowski K, Schwacke H, Leyva F, Proff J, Berdyshev S, Paul V. Potential value of automated daily screening of cardiac resynchronization therapy defibrillator diagnostics for prediction of major cardiovascular events: results from Home‐CARE (home monitoring in cardiac resynchronization therapy) study. Eur J Heart Fail. 2011;13:1019–1027.
    1. Tang WH, Warman EN, Johnson JW, Small RS, Heywood JT. Threshold crossing of device‐based intrathoracic impedance trends identifies relatively increased mortality risk. Eur Heart J. 2012;33:2189–2196.
    1. Tang AS, Wells GA, Arnold M, Connolly S, Hohnloser S, Nichol G, Rouleau J, Sheldon R, Talajic M. Resynchronization/defibrillation for ambulatory heart failure trial: rationale and trial design. Curr Opin Cardiol. 2009;24:1–8.
    1. Tang AS, Wells GA, Talajic M, Arnold MO, Sheldon R, Connolly S, Hohnloser SH, Nichol G, Birnie DH, Sapp JL, Yee R, Healey JS, Rouleau JL. Cardiac‐resynchronization therapy for mild‐to‐moderate heart failure. N Engl J Med. 2010;363:2385–2395.
    1. Wang L. Fundamentals of intrathoracic impedance monitoring in heart failure. Am J Cardiol. 2007;99:3G–10G.
    1. Woo GW, Petersen‐Stejskal S, Johnson JW, Conti JB, Aranda JA Jr, Curtis AB. Ventricular reverse remodeling and 6‐month outcomes in patients receiving cardiac resynchronization therapy: analysis of the miracle study. J Interv Card Electrophysiol. 2005;12:107–113.
    1. St John Sutton M, Ghio S, Plappert T, Tavazzi L, Scelsi L, Daubert C, Abraham WT, Gold MR, Hassager C, Herre JM, Linde C; REsynchronization reVErses Remodeling in Systolic left vEntricular dysfunction (REVERSE) Study Group . Cardiac resynchronization induces major structural and functional reverse remodeling in patients with New York Heart Association class I/II heart failure. Circulation. 2009;120:1858–1865.
    1. St John Sutton MG, Plappert T, Abraham WT, Smith AL, DeLurgio DB, Leon AR, Loh E, Kocovic DZ, Fisher WG, Ellestad M, Messenger J, Kruger K, Hilpisch KE, Hill MR; Multicenter InSync Randomized Clinical Evaluation Study Group . Effect of cardiac resynchronization therapy on left ventricular size and function in chronic heart failure. Circulation. 2003;107:1985–1990.
    1. Solomon SD, Foster E, Bourgoun M, Shah A, Viloria E, Brown MW, Hall WJ, Pfeffer MA, Moss AJ; MADIT‐CRT Investigators . Effect of cardiac resynchronization therapy on reverse remodeling and relation to outcome: multicenter automatic defibrillator implantation trial: cardiac resynchronization therapy. Circulation. 2010;122:985–992.
    1. McAlister FA, Ezekowitz J, Hooton N, Vandermeer B, Spooner C, Dryden DM, Page RL, Hlatky MA, Rowe BH. Cardiac resynchronization therapy for patients with left ventricular systolic dysfunction: a systematic review. JAMA. 2007;297:2502–2514.
    1. Bristow MR, Saxon LA, Boehmer J, Krueger S, Kass DA, De Marco T, Carson P, DiCarlo L, DeMets D, White BG, DeVries DW, Feldman AM; Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure (COMPANION) Investigators . Cardiac‐resynchronization therapy with or without an implantable defibrillator in advanced chronic heart failure. N Engl J Med. 2004;350:2140–2150.

Source: PubMed

赞助者和合作者

医疗条件

药物干预

3
订阅