Reduction in inappropriate therapy and mortality through ICD programming
Arthur J Moss, Claudio Schuger, Christopher A Beck, Mary W Brown, David S Cannom, James P Daubert, N A Mark Estes 3rd, Henry Greenberg, W Jackson Hall, David T Huang, Josef Kautzner, Helmut Klein, Scott McNitt, Brian Olshansky, Morio Shoda, David Wilber, Wojciech Zareba, MADIT-RIT Trial Investigators, R Goldstein, M Haigney, D Oakes, E Dwyer, F Ehlert, E Lichstein, C Beck, J Bausch, W J Hall, S McNitt, M Brown, M Andrews, D Barber, R Buermann, A Buttaccio, K Kremer, R Lansing, B Mykins, A Oberer, E Perkins, B Polonsky, K Pyykkonen, D Ramsell, W Zareba, I Goldenberg, H Klein, V Kutyifa, S Rosero, C Tompkins, A Moss, C Beck, M Brown, D Cannom, J Daubert, M Estes, H Greenberg, D Huang, J Kautzner, B Olshansky, C Schuger, M Shoda, D Wilber, C Gottlieb, V Swarup, S Greer, S Beau, J Whitehill, A Curnis, M Lunati, K Vernooy, V Khalameizer, J Cook, G Gandhi, M Sweeney, B Koplan, D Switzer, G Yesenosky, S Hessen, P Ludmer, M Stockburger, M Stockburger, L-H Boldt, G Lande, L Feldman, K Thomas, R Hariharan, H Martin, M Rashtian, M Giudici, R Brewer, P B Thomsen, M Hojgaard, D Cannom, P Lai, C Schuger, J Vogt, K Okumura, S Kacet, J-F De La Concha, S Kaab, F Marchlinski, B Coutu, S Varanasi, J Kautzner, L Padeletti, S Musco, C Sheehan, P Delnoy, S Goel, M Swissa, M Kuniss, K Ando, T Lessmeier, T Kimura, D Gohn, S Klein, P Santucci, J Singh, B Pieske, G Klein, H Oswald, T Shinn, G Meininger, G Kidwell, C Gornick, J Lobban, J Gross, R Coyne, S Kamakura, D Sandler, S Favale, E Nsah, D Dan, D Peress, M Boulos, G O'Neill, K Maleki, M Bedi, K Krishnan, C Athill, B Merkely, R Bernstein, A Medina, M Glikson, V Gottipaty, A Gauri, J Wilczek, L Pires, N Sharma, E Aziz, A Arshad, J Kushner, M Cox, B Le, M Geist, M Shoda, K Aonuma, M Link, S Weiner, B Schaer, J Kuschyk, L Mitchell, M Burke, L Rosenthal, J Payne, M Borganelli, S Saba, D Huang, J DiMarco, T Sichrovsky, N Kavesh, Arthur J Moss, Claudio Schuger, Christopher A Beck, Mary W Brown, David S Cannom, James P Daubert, N A Mark Estes 3rd, Henry Greenberg, W Jackson Hall, David T Huang, Josef Kautzner, Helmut Klein, Scott McNitt, Brian Olshansky, Morio Shoda, David Wilber, Wojciech Zareba, MADIT-RIT Trial Investigators, R Goldstein, M Haigney, D Oakes, E Dwyer, F Ehlert, E Lichstein, C Beck, J Bausch, W J Hall, S McNitt, M Brown, M Andrews, D Barber, R Buermann, A Buttaccio, K Kremer, R Lansing, B Mykins, A Oberer, E Perkins, B Polonsky, K Pyykkonen, D Ramsell, W Zareba, I Goldenberg, H Klein, V Kutyifa, S Rosero, C Tompkins, A Moss, C Beck, M Brown, D Cannom, J Daubert, M Estes, H Greenberg, D Huang, J Kautzner, B Olshansky, C Schuger, M Shoda, D Wilber, C Gottlieb, V Swarup, S Greer, S Beau, J Whitehill, A Curnis, M Lunati, K Vernooy, V Khalameizer, J Cook, G Gandhi, M Sweeney, B Koplan, D Switzer, G Yesenosky, S Hessen, P Ludmer, M Stockburger, M Stockburger, L-H Boldt, G Lande, L Feldman, K Thomas, R Hariharan, H Martin, M Rashtian, M Giudici, R Brewer, P B Thomsen, M Hojgaard, D Cannom, P Lai, C Schuger, J Vogt, K Okumura, S Kacet, J-F De La Concha, S Kaab, F Marchlinski, B Coutu, S Varanasi, J Kautzner, L Padeletti, S Musco, C Sheehan, P Delnoy, S Goel, M Swissa, M Kuniss, K Ando, T Lessmeier, T Kimura, D Gohn, S Klein, P Santucci, J Singh, B Pieske, G Klein, H Oswald, T Shinn, G Meininger, G Kidwell, C Gornick, J Lobban, J Gross, R Coyne, S Kamakura, D Sandler, S Favale, E Nsah, D Dan, D Peress, M Boulos, G O'Neill, K Maleki, M Bedi, K Krishnan, C Athill, B Merkely, R Bernstein, A Medina, M Glikson, V Gottipaty, A Gauri, J Wilczek, L Pires, N Sharma, E Aziz, A Arshad, J Kushner, M Cox, B Le, M Geist, M Shoda, K Aonuma, M Link, S Weiner, B Schaer, J Kuschyk, L Mitchell, M Burke, L Rosenthal, J Payne, M Borganelli, S Saba, D Huang, J DiMarco, T Sichrovsky, N Kavesh
Abstract
Background: The implantable cardioverter-defibrillator (ICD) is highly effective in reducing mortality among patients at risk for fatal arrhythmias, but inappropriate ICD activations are frequent, with potential adverse effects.
Methods: We randomly assigned 1500 patients with a primary-prevention indication to receive an ICD with one of three programming configurations. The primary objective was to determine whether programmed high-rate therapy (with a 2.5-second delay before the initiation of therapy at a heart rate of ≥200 beats per minute) or delayed therapy (with a 60-second delay at 170 to 199 beats per minute, a 12-second delay at 200 to 249 beats per minute, and a 2.5-second delay at ≥250 beats per minute) was associated with a decrease in the number of patients with a first occurrence of inappropriate antitachycardia pacing or shocks, as compared with conventional programming (with a 2.5-second delay at 170 to 199 beats per minute and a 1.0-second delay at ≥200 beats per minute).
Results: During an average follow-up of 1.4 years, high-rate therapy and delayed ICD therapy, as compared with conventional device programming, were associated with reductions in a first occurrence of inappropriate therapy (hazard ratio with high-rate therapy vs. conventional therapy, 0.21; 95% confidence interval [CI], 0.13 to 0.34; P<0.001; hazard ratio with delayed therapy vs. conventional therapy, 0.24; 95% CI, 0.15 to 0.40; P<0.001) and reductions in all-cause mortality (hazard ratio with high-rate therapy vs. conventional therapy, 0.45; 95% CI, 0.24 to 0.85; P=0.01; hazard ratio with delayed therapy vs. conventional therapy, 0.56; 95% CI, 0.30 to 1.02; P=0.06). There were no significant differences in procedure-related adverse events among the three treatment groups.
Conclusions: Programming of ICD therapies for tachyarrhythmias of 200 beats per minute or higher or with a prolonged delay in therapy at 170 beats per minute or higher, as compared with conventional programming, was associated with reductions in inappropriate therapy and all-cause mortality during long-term follow-up. (Funded by Boston Scientific; MADIT-RIT ClinicalTrials.gov number, NCT00947310.).
Source: PubMed