Prospective comparison of discrimination algorithms to prevent inappropriate ICD therapy: Primary results of the Rhythm ID Going Head to Head Trial

被引:40
作者
Gold, Michael R. [1 ]
Ahmad, Saleem [2 ]
Browne, Kevin [3 ]
Berg, Kellie Chase [4 ]
Thackeray, Lisa [5 ]
Berger, Ronald D. [6 ]
机构
[1] Med Univ S Carolina, Charleston, SC 29425 USA
[2] Kettering Med Ctr, Kettering, OH USA
[3] Lakeland Reg Med Ctr, Lakeland, FL USA
[4] Boston Sci, St Paul, MN USA
[5] Integra Grp, Brooklyn Pk, MN USA
[6] Johns Hopkins Med Inst, Baltimore, MD 21205 USA
关键词
ICDs; supraventricular tachycardia; inappropriate therapy; IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR; DUAL-CHAMBER; VENTRICULAR-TACHYCARDIA; SINGLE-CHAMBER; ARRHYTHMIA DETECTION; RANDOMIZED-TRIAL; SHOCKS; AMIODARONE; FAILURE;
D O I
10.1016/j.hrthm.2011.10.004
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
BACKGROUND Inappropriate therapy for supraventricular arrhythmias remains a significant source of morbidity in implantable cardioverter-defibrillator (ICD) recipients. OBJECTIVE The Rhythm ID Goes Head to Head Trial (RIGHT) was designed to compare rhythm discrimination and inappropriate therapies among patients with ICDs from 2 manufacturers. METHODS Patients with standard ICD indications were randomized to receive a Guidant VITALITY 2 with Rhythm ID or selective Medtronic pulse generators using the Enhanced PR Logic or Wavelet discrimination algorithms. A single-or dual-chamber device was implanted based on clinical indications and programmed in 2 detection zones with detection enhancements enabled for rates between 150 and 200 bpm. Algorithm performance was compared between randomization groups, stratified by single or dual chamber, for the primary end point of first inappropriate therapy (shock or antitachycardia pacing) for supraventricular arrhythmias. RESULTS There were 1962 patients enrolled and followed for 18.3 +/- 9.2 months, with no difference in all-cause mortality between groups. There were 3973 treated episodes where electrograms were available and adjudicated. The primary end point of inappropriate therapy occurred in 246 of 985 VITALITY 2 patients vs 187 of 977 specific Medtronic ICD patients (hazard ratio = 1.34; confidence interval = 1.11-1.62; P = .003). Differences in inappropriate therapy were confined to single-chamber ICDs. Inappropriate shocks were more frequent in VITALITY 2 ICDs (hazard ratio = 1.63; confidence interval = 1.29 -2.06; P < .001), with most therapies and performance differences occurring at slower rhythms (rates < 175 bpm). CONCLUSION Rhythm discrimination performed better in the specific Medtronic than in VITALITY 2 ICDs evaluated, particularly for single-chamber devices. Inappropriate therapies, and differences in performance, may be reduced with the use of rate cutoff above 175 bpm.
引用
收藏
页码:370 / 377
页数:8
相关论文
共 29 条
[1]   Arrhythmia detection by dual-chamber implantable cardioverter defibrillators -: A review of current algorithms [J].
Aliot, E ;
Nitzsché, R ;
Ripart, A .
EUROPACE, 2004, 6 (04) :273-286
[2]   Clinical investigation of a new dual-chamber implantable cardioverter defibrillator with improved rhythm discrimination capabilities [J].
Bailin, SJ ;
Niebauer, M ;
Tomassoni, G ;
Leman, R .
JOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY, 2003, 14 (02) :144-149
[3]   Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure [J].
Bardy, GH ;
Lee, KL ;
Mark, DB ;
Poole, JE ;
Packer, DL ;
Boineau, R ;
Domanski, M ;
Troutman, C ;
Anderson, J ;
Johnson, G ;
McNulty, SE ;
Clapp-Channing, N ;
Davidson-Ray, LD ;
Fraulo, ES ;
Fishbein, DP ;
Luceri, RM ;
Ip, JH .
NEW ENGLAND JOURNAL OF MEDICINE, 2005, 352 (03) :225-237
[4]   The rhythm ID going head to head trial (RIGHT): Design of a randomized trial comparing competitive rhythm discrimination algorithms in implantable cardioverter defibrillators [J].
Berger, Ronald D. ;
Lerew, Darin R. ;
Smith, Joseph M. ;
Pulling, Chris ;
Gold, Michael R. .
JOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY, 2006, 17 (07) :749-753
[5]  
ClinicalTrials. gov, MULT AUT DEF IMPL TR
[6]   Continuous template collection and updating for electrogram morphology discrimination in implantable cardioverter defibrillators [J].
Compton, SJ ;
Merrill, JJ ;
Dorian, P ;
Cao, J ;
Zhou, D ;
Gillberg, JM .
PACE-PACING AND CLINICAL ELECTROPHYSIOLOGY, 2006, 29 (03) :244-254
[7]   Comparison of β-blockers, amiodarone plus β-blockers, or sotalol for prevention of shocks from implantable cardioverter defibrillators -: The optic study.: A randomized trial [J].
Connolly, SJ ;
Dorian, P ;
Roberts, RS ;
Gent, M ;
Bailin, S ;
Fain, ES ;
Thorpe, K ;
Champagne, J ;
Talajic, M ;
Coutu, B ;
Gronefeld, GC ;
Hohnloser, SH .
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2006, 295 (02) :165-171
[8]   Inappropriate implantable cardioverter-defibrillator shocks in MADIT II [J].
Daubert, James P. ;
Zareba, Wojciech ;
Cannom, David S. ;
McNitt, Scott ;
Rosero, Spencer Z. ;
Wang, Paul ;
Schuger, Claudio ;
Steinberg, Jonathan S. ;
Higgins, Steven L. ;
Wilber, David J. ;
Klein, Helmut ;
Andrews, Mark L. ;
Hall, W. Jackson ;
Moss, Arthur J. .
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, 2008, 51 (14) :1357-1365
[9]   Do current dual chamber cardioverter defibrillators have advantages over conventional single chamber cardioverter defibrillators in reducing inappropriate therapies? A randomized, prospective study [J].
Deisenhofer, I ;
Kolb, C ;
Ndrepepa, G ;
Schreieck, J ;
Karch, M ;
Schmieder, S ;
Zrenner, B ;
Schmitt, C .
JOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY, 2001, 12 (02) :134-142
[10]   Real World Evaluation of Dual-Zone ICD and CRT-D Programming Compared to Single-Zone Programming: The ALTITUDE REDUCES Study [J].
Gilliam, F. Roosevelt, III ;
Hayes, David L. ;
Boehmer, John P. ;
Day, John ;
Heidenreich, Paul A. ;
Seth, Milan ;
Jones, Paul W. ;
Stein, Kenneth M. ;
Saxon, Leslie A. .
JOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY, 2011, 22 (09) :1023-1029