Vol. 47 | No. 1 | January-June 2019 Back

Open Access

Estimation of OptiVol Alert for Identifying Heart Failure in Conventional Bradyarrhythmia Pacing Patients with Preserved Left Ventricular Function: A Multicenter Prospective Cohort Study (OptiVol Study)

Abstract

BACKGROUND: The usefulness of OptiVol, an algorithm to detect heart failure (HF)  using continuous intrathoracic impedance monitoring, is established in high-power device  patients with reduced left ventricular ejection fraction (LVEF). However, the utility of OptiVol in  conventional bradyarrhythmia pacing patients with preserved LVEF is not established. 

OBJECTIVES: This study aimed to describe the utility of the OptiVol alert feature in monitoring  HF in conventional pacemaker or implantable-cardioverter defibrillator (ICD) patients with  preserved LVEF. 

METHODS: Forty-three patients implanted with a conventional pacemaker or ICD with the  OptiVol function were enrolled. Of these, 39 completed the observation period. OptiVol fluid index and cumulative percentage of right ventricular pacing (%RVp) were obtained every three  months for 12 months after device implantation. The sensitivity, specificity, positive predictive  value (PPV) and negative predictive value (NPV) to predict HF hospitalization of the OptiVol alert  defined by an OptiVol fluid index >100Ω-day or >60Ω-day were compared. The combination of  OptiVol positivity and right ventricular pacing site and/or %RVp >40% for the prediction of HF  hospitalization were also assessed. 

RESULTS: Three patients (7.6%) had HF hospitalization within one year after device  implantation. The sensitivity, specificity, PPV and NPV of OptiVol alert definition with OptiVol  fluid index >100Ω-day were 100%, 64%, 19%, and 100%, while those of OptiVol alert  definition with OptiVol fluid index >60Ω-day were 100%, 42%, 13% and 100%, respectively.  These parameters were improved by the combination of OptiVol fluid index >100Ω-day and  RV apex pacing and/or %RVp >40%, attaining values of 100%, 97%, 75%, and 100%,  respectively; by the combination of OptiVol alert and RV apex pacing; or their combination.  

CONCLUSION: The OptiVol alert using cut-off value of 100Ω-day would be useful for the prediction  of HF hospitalization in conventional bradyarrhythmia pacing patients with preserved LVEF. The  utility of OptiVol alert would be emphasized in patients with RV apex pacing and/or %RVp >40%. 

KEYWORDS: Heart failure; bradycardia; cardiac pacing; OptiVol; intrathoracic impedance

  1. Roger VL, Go AS, Lloyd-Jones DM, Benjamin EJ, Berry JD, Borden WB, et al. Heart disease and stroke statistics-2012 update: a report from the American Heart Association. Circulation 2012;125:e2–220. https://doi.org/10.1161/ 14.CIR.0b013e31823ac046
  2. Andersen HR, Nielsen JC, Thomsen PE, Thuesen L, Mortensen PT, Vesterlund T, et al. Long-term follow up of patients from a randomised trial of atrial versus ventricular pacing for sick-sinus syndrome (Danish). Lancet 15. 1997;350:1210–6. 10.1016/S0140-6736(97)03425-9
  3. Wilkoff BL, Cook JR, Epstein AE, Greene HL, Hallstrom AP, Hsia H, et al. Dual-chamber pacing or ventricular backup pacing in patients with an implantable defibrillator: the Dual Chamber and VVI Implantable Defibrillator (DAVID) Trial. JAMA 2002;288:3115–23.
  4. Sweeney MO, Hellkamp AS, Ellenbogen KA, Greenspon AJ, Freedman RA, Lee KL, et al. Adverse effect of ventricular pacing on heart failure and atrial fibrillation among patients with normal baseline QRS duration in a clinical trial of pacemaker therapy for sinus node dysfunction (MOST substudy). Circulation 2003;107:2932– 7. 10.1161/01.CIR.0000072769.17295.B1
  5. Steinberg JS, Fischer A, Wang P, Schuger C, Daubert J, McNitt S, et al. The clinical implications of cumulative right ventricular pacing in the multicenter automatic defibrillator trial II. J Cardiovasc Electrophysiol 2005;16:359–65. 10.1046/j.1540-8167.2005.50038.x
  6. Boerth RC, Covell JW. Mechanical performance and efficiency of the left ventricle during ventricular stimulation. Am J Physiol 1971;221:1686–91. 10.1152/ 19.ajplegacy.1971.221.6.1686
  7. Lieberman R, Padeletti L, Schreuder J, Jackson K, Michelucci A, Colella A, et al. Ventricular pacing lead location alters systemic hemodynamics and left ventricular function in patients with and without reduced ejection fraction. J Am 20. Coll Cardiol 2006;48:1634–41. 10.1016/j.jacc.2006.04.099
  8. Victor F, Mabo P, Mansour H, Pavin D, Kabalu G, de Place C, et al. A randomized comparison of permanent septal versus apical right ventricular pacing: short-term results. J Cardiovasc Electrophysiol 2006;17:238–42. 21. 10.1111/j.1540-8167.2006.00358.x
  9. Khurshid S, Epstein AE, Verdino RJ, Lin D, Goldberg LR, Marchlinski FE, et al. Incidence and predictors of right ventricular pacing-induced cardiomyopathy. Heart Rhythm 22. 2014;11:1619–25. 10.1016/j.hrthm.2014.05.040
  10. Yu CM, Chan JY, Zhang Q, Omar R, Yip GW, Hussin A, et al. Biventricular pacing in patients with bradycardia and normal ejection fraction (PACE2009). N Engl J Med 2009;361:2123–34. 10.1056/NEJMoa0907555
  11. Dreger H, Maethner K, Bondke H, Baumann G, Melzer C. Pacing-induced cardiomyopathy in patients with right ventricular stimulation for >15 years. Europace 2012;14:238–42. 10.1093/europace/eur258
  12. Olshansky B, Day JD, Lerew DR, Brown S, Stolen KQ; INTRINSIC RV Study Investigators. Eliminating right ventricular pacing may not be best for patients requiring implantable cardioverter-defibrillators. Heart Rhythm 2007;4:886–91. 10.1016/j.hrthm.2007.03.031
  13. Hayashi Y, Takagi M, Kakihara J, Sakamoto S, Tatsumi H, Doi A, et al. Impact of simple electrocardiographic markers as predictors for deterioration of left ventricular function in patients with frequent right ventricular apical pacing. Heart Vessels 2017;33:299–308. 10.1007/s00380-017-1052-x
  14. Shimony A, Eisenberg MJ, Filion KB, Amit G, et al. Beneficial effects of right ventricular non-apical vs. apical pacing: a systematic review and meta-analysis of randomized-controlled trials. Europace 2012;14:81–91. 10.1093/europace/eur240
  15. de Cock CC, Giudici MC, Twisk JW. Comparison of the haemodynamic effects of right ventricular outflow-tract pacing with right ventricular apex pacing: a quantitative review. Europace 2003;5:275–8.
  16. Yu CM, Wang L, Chau E, Chan RH, Kong SL, Tang MO, et al. Intrathoracic impedance monitoring in patients with heart failure: correlation with fluid status and feasibility of early warning preceding hospitalization. Circulation 2005;112:841–8. 10.1161/CIRCULATIONAHA.104.492207
  17. Abraham WT, Compton S, Haas G, Foreman B, Canby RC, Fishel R, et al. Intrathoracic impedance vs daily weight monitoring for predicting worsening heart failure events: results of the Fluid Accumulation Status Trial (FAST). Congest Heart Fail 2011r;17:51–5. 10.1111/j.1751- 7133.2011.00220.x
  18. Maines M, Catanzariti D, Cemin C, Vaccarini C, Vergara G. Usefulness of intrathoracic fluids accumulation monitoring with an implantable biventricular defibrillator in reducing hospitalizations in patients with heart failure: a case control study. J Interv Card Electrophysiol 2007;19:201–7. 10.1007/s10840-007-9155-4
  19. Conraads VM, Tavazzi L, Santini M, Oliva F, Gerritse B, Yu CM, et al. Sensitivity and positive predictive value of implantable intrathoracic impedance monitoring as a predictor of heart failure hospitalizations: the SENSE-HF trial. Eur Heart J 2011;32:2266–73. 10.1093/eurheartj/ehr050
  20. Hindricks G, Taborsky M, Glikson M, Heinrich 4, Schumacher B, Katz A, et al. Implant-based multiparameter telemonitoring of patients with heart failure (IN-TIME): a randomised controlled trial. Lancet. 2014;384:583–90. 10.1016/S0140-6736(14)61176-4
  21. Soga Y, Ando K, Arita T, Hyodo M, Goya M, Iwabuchi M, et al. Efficacy of fluid assessment based on intrathoracic impedance monitoring in patients with systolic heart failure. Circ J 2011;75:129–34.
  22. Sahalos JN, Nicolaidis A, Gotsis N. The electrical impedance of the human thorax as a guide in evaluation of intrathoracic fluid volume. Phys Med Biol 1986;31:425–39.
  23. Van de Water JM, Mount BE, Schuster R, Leacock FS. Monitoring the chest with impedance. Chest 1973;64:597–603.
  24. Yang XW, Hua W, Ding LG, Wang J, Zheng LH, Li CQ, et al. OptiVol fluid index predicts acute decompensation of heart failure with a high rate of unexplained events. J Geriatr Cardiol 2013;10:253–7.
  25. Zhang XH, Chen H, Siu CW, Yiu KH, Chan WS, Lee KL, et al. New-onset heart failure after permanent right ventricular apical pacing in patients with acquired high-grade atrioventricular block and normal left ventricular function. J Cardiovasc Electrophysiol 2008;19:136–41.

Open Access This article is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License, which permits use, share — copy and redistribute the material in any medium or format, adapt — remix, transform, and build upon the material, as long as you give appropriate credit, provide a link to the license, and indicate if changes were made. You may do so in any reasonable manner, but not in any way that suggests the licensor endorses you or your use. You may not use the material for commercial purposes. If you remix, transform, or build upon the material, you must distribute your contributions under the same license as the original. You may not apply legal terms or technological measures that legally restrict others from doing anything the license permits. The images or other third party material in this article are included in the article’s Creative Commons license, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons license and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this license, visit https://creativecommons.org/licenses/by-nc-sa/4.0/.