Dual-chamber pacing-or ventricular backup pacing in patients with an implantable defibrillator: The Dual Chamber and VVI Implantable Defibrillator (DAVID) Trial

Bruce L. Wilkoff, James R. Cook, Andrew E. Epstein, Leon Greene, Alfred P. Hallstrom, Henry Hsia, Steven P. Kutalek, Arjun Sharma, Brian Blatt, Barry Karas, James Kirchhoffer, Deborah Warwick, Mary Duquette, Jean Provencher, Maureen Redmond, John M. Herre, Robert Bernstein, Linette R. Klevan, Kathleen D. Barackman, Jennine ZumbuhlMina K. Chung, Fredrick J. Jaeger, David Martin, Andrea Natale, Walid I. Saliba, Robert A. Schweikert, Mark J. Niebauer, Patrick Joseph Tchou, Raquel Rozich, Marc Roelke, Constantinos A. Costeas, Donald G. Rubenstein, Scott Ruffo, Kelly Kumar, Elizabeth McCarthy, Valerie Pastore, Mark S. Wathen, Jeffrey Rottman, Mark Anderson, John T. Lee, Katherine T. Murray, Dan M. Roden, Nancy Conners, Sandy Saunders, Gearoid P. O'Neill, Anne Skadsen, Shelley Allen, Ellie Vierra, Stephen Greer, Jeffrey Neuhauser, Pam Myers, Celeste Lee, Terri Moore, Richard C. Klein, Roger A. Freedman, Geri Wadsworth, Sharon M. Dailey, G. Neal Kay, Vance J. Plumb, Rosemary S. Bubien, Linda W. Kay, Candace M. Nasser, Jane E. Slabaugh, Robert Leman, Jenifer L. Lake, Julie Clark, Elizabeth Clarke, Laura Finklea, John C. Love, Charles M. Carpenter, Andrew Corsello, Joel E. Cutler, Susan BosworthFarrell, Gregory Michaud, Alfred E. Buxton, Kristin E. Ellison, Frederic Christian, Malcolm M. Kirk, Pamela L. Corcoran, Stephen Rothbart, Roy B. Sauberman, Jennifer McCarthy, Mary Ellen Page, Jonathan S. Steinberg, Frederick Ehlert, Bengt Herweg, Margot Vloka, Ammy Malinay, Edith Menchavez, Michael Rome, Kathy Marks, Alison Swarens, Maribel Hernandez, Roger Marinchak, Douglas Esberg, John Finkle, Glenn Harper, Peter R. Kowey, Colin Movsowitz

Research output: Contribution to journalArticle

Abstract

Context: Implantable cardioverter defibrillator (ICD) therapy with backup ventricular pacing increases survival in patients with life-threatening ventricular arrhythmias. Most currently implanted ICD devices provide dual-chamber pacing therapy. The most common comorbid cause for mortality in this population is congestive heart failure. Objective: To determine the efficacy of dual-chamber pacing compared with backup ventricular pacing in patients with standard indications for ICD implantation but without indications for antibradycardia pacing. Design: The Dual Chamber and VVI Implantable Defibrillator (DAVID) Trial, a single-blind, parallel-group, randomized clinical trial. Setting and Participants: A total of 506 patients with indications for ICD therapy were enrolled between October 2000 and September 2002 at 37 US centers. All patients had a left ventricular ejection fraction (LVEF) of 40% or less, no indication for antibradycardia pacemaker therapy, and no persistent atrial arrhythmias. Interventions: All patients had an ICD with dual-chamber, rate-responsive pacing capability implanted. Patients were randomly assigned to have the ICDs programmed to ventricular backup pacing at 40/min (VVI-40; n=256) or dual-chamber rate-responsive pacing at 70/min (DDDR-70; n=250). Maximal tolerated medical therapy for left ventricular dysfunction, including angiotensin-converting enzyme inhibitors and β-blockers, was prescribed to all patients. Main Outcome Measure: Composite end point of time to death or first hospitalization for congestive heart failure. Results: One-year survival free of the composite end point was 83.9% for patients treated with VVI-40 compared with 73.3% for patients treated with DDDR-70 (relative hazard, 1.61; 95% confidence interval [CI], 1.06-2.44). The components of the composite end point, mortality of 6.5% for VVI-40 vs 10.1% for DDDR-70 (relative hazard, 1.61; 95% CI, 0.84-3.09) and hospitalization for congestive heart failure of 13.3% for VVI-40 vs 22.6% for DDDR-70 (relative hazard, 1.54; 95% CI, 0.97-2.46), also trended in favor of VVI-40 programming. Conclusion: For patients with standard indications for ICD therapy, no indication for cardiac pacing, and an LVEF of 40% or less, dual-chamber pacing offers no clinical advantage over ventricular backup pacing and may be detrimental by increasing the combined end point of death or hospitalization for heart failure.

Original languageEnglish (US)
Pages (from-to)3115-3123
Number of pages9
JournalJournal of the American Medical Association
Volume288
Issue number24
DOIs
StatePublished - Dec 25 2002
Externally publishedYes

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Implantable Defibrillators
Heart Failure
Hospitalization
Confidence Intervals
Stroke Volume
Cardiac Arrhythmias
Therapeutics
Survival
Mortality
Left Ventricular Dysfunction
Angiotensin-Converting Enzyme Inhibitors
Randomized Controlled Trials
Outcome Assessment (Health Care)
Equipment and Supplies

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Dual-chamber pacing-or ventricular backup pacing in patients with an implantable defibrillator : The Dual Chamber and VVI Implantable Defibrillator (DAVID) Trial. / Wilkoff, Bruce L.; Cook, James R.; Epstein, Andrew E.; Greene, Leon; Hallstrom, Alfred P.; Hsia, Henry; Kutalek, Steven P.; Sharma, Arjun; Blatt, Brian; Karas, Barry; Kirchhoffer, James; Warwick, Deborah; Duquette, Mary; Provencher, Jean; Redmond, Maureen; Herre, John M.; Bernstein, Robert; Klevan, Linette R.; Barackman, Kathleen D.; Zumbuhl, Jennine; Chung, Mina K.; Jaeger, Fredrick J.; Martin, David; Natale, Andrea; Saliba, Walid I.; Schweikert, Robert A.; Niebauer, Mark J.; Joseph Tchou, Patrick; Rozich, Raquel; Roelke, Marc; Costeas, Constantinos A.; Rubenstein, Donald G.; Ruffo, Scott; Kumar, Kelly; McCarthy, Elizabeth; Pastore, Valerie; Wathen, Mark S.; Rottman, Jeffrey; Anderson, Mark; Lee, John T.; Murray, Katherine T.; Roden, Dan M.; Conners, Nancy; Saunders, Sandy; O'Neill, Gearoid P.; Skadsen, Anne; Allen, Shelley; Vierra, Ellie; Greer, Stephen; Neuhauser, Jeffrey; Myers, Pam; Lee, Celeste; Moore, Terri; Klein, Richard C.; Freedman, Roger A.; Wadsworth, Geri; Dailey, Sharon M.; Neal Kay, G.; Plumb, Vance J.; Bubien, Rosemary S.; Kay, Linda W.; Nasser, Candace M.; Slabaugh, Jane E.; Leman, Robert; Lake, Jenifer L.; Clark, Julie; Clarke, Elizabeth; Finklea, Laura; Love, John C.; Carpenter, Charles M.; Corsello, Andrew; Cutler, Joel E.; BosworthFarrell, Susan; Michaud, Gregory; Buxton, Alfred E.; Ellison, Kristin E.; Christian, Frederic; Kirk, Malcolm M.; Corcoran, Pamela L.; Rothbart, Stephen; Sauberman, Roy B.; McCarthy, Jennifer; Page, Mary Ellen; Steinberg, Jonathan S.; Ehlert, Frederick; Herweg, Bengt; Vloka, Margot; Malinay, Ammy; Menchavez, Edith; Rome, Michael; Marks, Kathy; Swarens, Alison; Hernandez, Maribel; Marinchak, Roger; Esberg, Douglas; Finkle, John; Harper, Glenn; Kowey, Peter R.; Movsowitz, Colin.

In: Journal of the American Medical Association, Vol. 288, No. 24, 25.12.2002, p. 3115-3123.

Research output: Contribution to journalArticle

Wilkoff, BL, Cook, JR, Epstein, AE, Greene, L, Hallstrom, AP, Hsia, H, Kutalek, SP, Sharma, A, Blatt, B, Karas, B, Kirchhoffer, J, Warwick, D, Duquette, M, Provencher, J, Redmond, M, Herre, JM, Bernstein, R, Klevan, LR, Barackman, KD, Zumbuhl, J, Chung, MK, Jaeger, FJ, Martin, D, Natale, A, Saliba, WI, Schweikert, RA, Niebauer, MJ, Joseph Tchou, P, Rozich, R, Roelke, M, Costeas, CA, Rubenstein, DG, Ruffo, S, Kumar, K, McCarthy, E, Pastore, V, Wathen, MS, Rottman, J, Anderson, M, Lee, JT, Murray, KT, Roden, DM, Conners, N, Saunders, S, O'Neill, GP, Skadsen, A, Allen, S, Vierra, E, Greer, S, Neuhauser, J, Myers, P, Lee, C, Moore, T, Klein, RC, Freedman, RA, Wadsworth, G, Dailey, SM, Neal Kay, G, Plumb, VJ, Bubien, RS, Kay, LW, Nasser, CM, Slabaugh, JE, Leman, R, Lake, JL, Clark, J, Clarke, E, Finklea, L, Love, JC, Carpenter, CM, Corsello, A, Cutler, JE, BosworthFarrell, S, Michaud, G, Buxton, AE, Ellison, KE, Christian, F, Kirk, MM, Corcoran, PL, Rothbart, S, Sauberman, RB, McCarthy, J, Page, ME, Steinberg, JS, Ehlert, F, Herweg, B, Vloka, M, Malinay, A, Menchavez, E, Rome, M, Marks, K, Swarens, A, Hernandez, M, Marinchak, R, Esberg, D, Finkle, J, Harper, G, Kowey, PR & Movsowitz, C 2002, 'Dual-chamber pacing-or ventricular backup pacing in patients with an implantable defibrillator: The Dual Chamber and VVI Implantable Defibrillator (DAVID) Trial', Journal of the American Medical Association, vol. 288, no. 24, pp. 3115-3123. https://doi.org/10.1001/jama.288.24.3115
Wilkoff, Bruce L. ; Cook, James R. ; Epstein, Andrew E. ; Greene, Leon ; Hallstrom, Alfred P. ; Hsia, Henry ; Kutalek, Steven P. ; Sharma, Arjun ; Blatt, Brian ; Karas, Barry ; Kirchhoffer, James ; Warwick, Deborah ; Duquette, Mary ; Provencher, Jean ; Redmond, Maureen ; Herre, John M. ; Bernstein, Robert ; Klevan, Linette R. ; Barackman, Kathleen D. ; Zumbuhl, Jennine ; Chung, Mina K. ; Jaeger, Fredrick J. ; Martin, David ; Natale, Andrea ; Saliba, Walid I. ; Schweikert, Robert A. ; Niebauer, Mark J. ; Joseph Tchou, Patrick ; Rozich, Raquel ; Roelke, Marc ; Costeas, Constantinos A. ; Rubenstein, Donald G. ; Ruffo, Scott ; Kumar, Kelly ; McCarthy, Elizabeth ; Pastore, Valerie ; Wathen, Mark S. ; Rottman, Jeffrey ; Anderson, Mark ; Lee, John T. ; Murray, Katherine T. ; Roden, Dan M. ; Conners, Nancy ; Saunders, Sandy ; O'Neill, Gearoid P. ; Skadsen, Anne ; Allen, Shelley ; Vierra, Ellie ; Greer, Stephen ; Neuhauser, Jeffrey ; Myers, Pam ; Lee, Celeste ; Moore, Terri ; Klein, Richard C. ; Freedman, Roger A. ; Wadsworth, Geri ; Dailey, Sharon M. ; Neal Kay, G. ; Plumb, Vance J. ; Bubien, Rosemary S. ; Kay, Linda W. ; Nasser, Candace M. ; Slabaugh, Jane E. ; Leman, Robert ; Lake, Jenifer L. ; Clark, Julie ; Clarke, Elizabeth ; Finklea, Laura ; Love, John C. ; Carpenter, Charles M. ; Corsello, Andrew ; Cutler, Joel E. ; BosworthFarrell, Susan ; Michaud, Gregory ; Buxton, Alfred E. ; Ellison, Kristin E. ; Christian, Frederic ; Kirk, Malcolm M. ; Corcoran, Pamela L. ; Rothbart, Stephen ; Sauberman, Roy B. ; McCarthy, Jennifer ; Page, Mary Ellen ; Steinberg, Jonathan S. ; Ehlert, Frederick ; Herweg, Bengt ; Vloka, Margot ; Malinay, Ammy ; Menchavez, Edith ; Rome, Michael ; Marks, Kathy ; Swarens, Alison ; Hernandez, Maribel ; Marinchak, Roger ; Esberg, Douglas ; Finkle, John ; Harper, Glenn ; Kowey, Peter R. ; Movsowitz, Colin. / Dual-chamber pacing-or ventricular backup pacing in patients with an implantable defibrillator : The Dual Chamber and VVI Implantable Defibrillator (DAVID) Trial. In: Journal of the American Medical Association. 2002 ; Vol. 288, No. 24. pp. 3115-3123.
@article{f3a3d915c8b84f81b177e4101b783a1d,
title = "Dual-chamber pacing-or ventricular backup pacing in patients with an implantable defibrillator: The Dual Chamber and VVI Implantable Defibrillator (DAVID) Trial",
abstract = "Context: Implantable cardioverter defibrillator (ICD) therapy with backup ventricular pacing increases survival in patients with life-threatening ventricular arrhythmias. Most currently implanted ICD devices provide dual-chamber pacing therapy. The most common comorbid cause for mortality in this population is congestive heart failure. Objective: To determine the efficacy of dual-chamber pacing compared with backup ventricular pacing in patients with standard indications for ICD implantation but without indications for antibradycardia pacing. Design: The Dual Chamber and VVI Implantable Defibrillator (DAVID) Trial, a single-blind, parallel-group, randomized clinical trial. Setting and Participants: A total of 506 patients with indications for ICD therapy were enrolled between October 2000 and September 2002 at 37 US centers. All patients had a left ventricular ejection fraction (LVEF) of 40{\%} or less, no indication for antibradycardia pacemaker therapy, and no persistent atrial arrhythmias. Interventions: All patients had an ICD with dual-chamber, rate-responsive pacing capability implanted. Patients were randomly assigned to have the ICDs programmed to ventricular backup pacing at 40/min (VVI-40; n=256) or dual-chamber rate-responsive pacing at 70/min (DDDR-70; n=250). Maximal tolerated medical therapy for left ventricular dysfunction, including angiotensin-converting enzyme inhibitors and β-blockers, was prescribed to all patients. Main Outcome Measure: Composite end point of time to death or first hospitalization for congestive heart failure. Results: One-year survival free of the composite end point was 83.9{\%} for patients treated with VVI-40 compared with 73.3{\%} for patients treated with DDDR-70 (relative hazard, 1.61; 95{\%} confidence interval [CI], 1.06-2.44). The components of the composite end point, mortality of 6.5{\%} for VVI-40 vs 10.1{\%} for DDDR-70 (relative hazard, 1.61; 95{\%} CI, 0.84-3.09) and hospitalization for congestive heart failure of 13.3{\%} for VVI-40 vs 22.6{\%} for DDDR-70 (relative hazard, 1.54; 95{\%} CI, 0.97-2.46), also trended in favor of VVI-40 programming. Conclusion: For patients with standard indications for ICD therapy, no indication for cardiac pacing, and an LVEF of 40{\%} or less, dual-chamber pacing offers no clinical advantage over ventricular backup pacing and may be detrimental by increasing the combined end point of death or hospitalization for heart failure.",
author = "Wilkoff, {Bruce L.} and Cook, {James R.} and Epstein, {Andrew E.} and Leon Greene and Hallstrom, {Alfred P.} and Henry Hsia and Kutalek, {Steven P.} and Arjun Sharma and Brian Blatt and Barry Karas and James Kirchhoffer and Deborah Warwick and Mary Duquette and Jean Provencher and Maureen Redmond and Herre, {John M.} and Robert Bernstein and Klevan, {Linette R.} and Barackman, {Kathleen D.} and Jennine Zumbuhl and Chung, {Mina K.} and Jaeger, {Fredrick J.} and David Martin and Andrea Natale and Saliba, {Walid I.} and Schweikert, {Robert A.} and Niebauer, {Mark J.} and {Joseph Tchou}, Patrick and Raquel Rozich and Marc Roelke and Costeas, {Constantinos A.} and Rubenstein, {Donald G.} and Scott Ruffo and Kelly Kumar and Elizabeth McCarthy and Valerie Pastore and Wathen, {Mark S.} and Jeffrey Rottman and Mark Anderson and Lee, {John T.} and Murray, {Katherine T.} and Roden, {Dan M.} and Nancy Conners and Sandy Saunders and O'Neill, {Gearoid P.} and Anne Skadsen and Shelley Allen and Ellie Vierra and Stephen Greer and Jeffrey Neuhauser and Pam Myers and Celeste Lee and Terri Moore and Klein, {Richard C.} and Freedman, {Roger A.} and Geri Wadsworth and Dailey, {Sharon M.} and {Neal Kay}, G. and Plumb, {Vance J.} and Bubien, {Rosemary S.} and Kay, {Linda W.} and Nasser, {Candace M.} and Slabaugh, {Jane E.} and Robert Leman and Lake, {Jenifer L.} and Julie Clark and Elizabeth Clarke and Laura Finklea and Love, {John C.} and Carpenter, {Charles M.} and Andrew Corsello and Cutler, {Joel E.} and Susan BosworthFarrell and Gregory Michaud and Buxton, {Alfred E.} and Ellison, {Kristin E.} and Frederic Christian and Kirk, {Malcolm M.} and Corcoran, {Pamela L.} and Stephen Rothbart and Sauberman, {Roy B.} and Jennifer McCarthy and Page, {Mary Ellen} and Steinberg, {Jonathan S.} and Frederick Ehlert and Bengt Herweg and Margot Vloka and Ammy Malinay and Edith Menchavez and Michael Rome and Kathy Marks and Alison Swarens and Maribel Hernandez and Roger Marinchak and Douglas Esberg and John Finkle and Glenn Harper and Kowey, {Peter R.} and Colin Movsowitz",
year = "2002",
month = "12",
day = "25",
doi = "10.1001/jama.288.24.3115",
language = "English (US)",
volume = "288",
pages = "3115--3123",
journal = "JAMA - Journal of the American Medical Association",
issn = "0098-7484",
publisher = "American Medical Association",
number = "24",

}

TY - JOUR

T1 - Dual-chamber pacing-or ventricular backup pacing in patients with an implantable defibrillator

T2 - The Dual Chamber and VVI Implantable Defibrillator (DAVID) Trial

AU - Wilkoff, Bruce L.

AU - Cook, James R.

AU - Epstein, Andrew E.

AU - Greene, Leon

AU - Hallstrom, Alfred P.

AU - Hsia, Henry

AU - Kutalek, Steven P.

AU - Sharma, Arjun

AU - Blatt, Brian

AU - Karas, Barry

AU - Kirchhoffer, James

AU - Warwick, Deborah

AU - Duquette, Mary

AU - Provencher, Jean

AU - Redmond, Maureen

AU - Herre, John M.

AU - Bernstein, Robert

AU - Klevan, Linette R.

AU - Barackman, Kathleen D.

AU - Zumbuhl, Jennine

AU - Chung, Mina K.

AU - Jaeger, Fredrick J.

AU - Martin, David

AU - Natale, Andrea

AU - Saliba, Walid I.

AU - Schweikert, Robert A.

AU - Niebauer, Mark J.

AU - Joseph Tchou, Patrick

AU - Rozich, Raquel

AU - Roelke, Marc

AU - Costeas, Constantinos A.

AU - Rubenstein, Donald G.

AU - Ruffo, Scott

AU - Kumar, Kelly

AU - McCarthy, Elizabeth

AU - Pastore, Valerie

AU - Wathen, Mark S.

AU - Rottman, Jeffrey

AU - Anderson, Mark

AU - Lee, John T.

AU - Murray, Katherine T.

AU - Roden, Dan M.

AU - Conners, Nancy

AU - Saunders, Sandy

AU - O'Neill, Gearoid P.

AU - Skadsen, Anne

AU - Allen, Shelley

AU - Vierra, Ellie

AU - Greer, Stephen

AU - Neuhauser, Jeffrey

AU - Myers, Pam

AU - Lee, Celeste

AU - Moore, Terri

AU - Klein, Richard C.

AU - Freedman, Roger A.

AU - Wadsworth, Geri

AU - Dailey, Sharon M.

AU - Neal Kay, G.

AU - Plumb, Vance J.

AU - Bubien, Rosemary S.

AU - Kay, Linda W.

AU - Nasser, Candace M.

AU - Slabaugh, Jane E.

AU - Leman, Robert

AU - Lake, Jenifer L.

AU - Clark, Julie

AU - Clarke, Elizabeth

AU - Finklea, Laura

AU - Love, John C.

AU - Carpenter, Charles M.

AU - Corsello, Andrew

AU - Cutler, Joel E.

AU - BosworthFarrell, Susan

AU - Michaud, Gregory

AU - Buxton, Alfred E.

AU - Ellison, Kristin E.

AU - Christian, Frederic

AU - Kirk, Malcolm M.

AU - Corcoran, Pamela L.

AU - Rothbart, Stephen

AU - Sauberman, Roy B.

AU - McCarthy, Jennifer

AU - Page, Mary Ellen

AU - Steinberg, Jonathan S.

AU - Ehlert, Frederick

AU - Herweg, Bengt

AU - Vloka, Margot

AU - Malinay, Ammy

AU - Menchavez, Edith

AU - Rome, Michael

AU - Marks, Kathy

AU - Swarens, Alison

AU - Hernandez, Maribel

AU - Marinchak, Roger

AU - Esberg, Douglas

AU - Finkle, John

AU - Harper, Glenn

AU - Kowey, Peter R.

AU - Movsowitz, Colin

PY - 2002/12/25

Y1 - 2002/12/25

N2 - Context: Implantable cardioverter defibrillator (ICD) therapy with backup ventricular pacing increases survival in patients with life-threatening ventricular arrhythmias. Most currently implanted ICD devices provide dual-chamber pacing therapy. The most common comorbid cause for mortality in this population is congestive heart failure. Objective: To determine the efficacy of dual-chamber pacing compared with backup ventricular pacing in patients with standard indications for ICD implantation but without indications for antibradycardia pacing. Design: The Dual Chamber and VVI Implantable Defibrillator (DAVID) Trial, a single-blind, parallel-group, randomized clinical trial. Setting and Participants: A total of 506 patients with indications for ICD therapy were enrolled between October 2000 and September 2002 at 37 US centers. All patients had a left ventricular ejection fraction (LVEF) of 40% or less, no indication for antibradycardia pacemaker therapy, and no persistent atrial arrhythmias. Interventions: All patients had an ICD with dual-chamber, rate-responsive pacing capability implanted. Patients were randomly assigned to have the ICDs programmed to ventricular backup pacing at 40/min (VVI-40; n=256) or dual-chamber rate-responsive pacing at 70/min (DDDR-70; n=250). Maximal tolerated medical therapy for left ventricular dysfunction, including angiotensin-converting enzyme inhibitors and β-blockers, was prescribed to all patients. Main Outcome Measure: Composite end point of time to death or first hospitalization for congestive heart failure. Results: One-year survival free of the composite end point was 83.9% for patients treated with VVI-40 compared with 73.3% for patients treated with DDDR-70 (relative hazard, 1.61; 95% confidence interval [CI], 1.06-2.44). The components of the composite end point, mortality of 6.5% for VVI-40 vs 10.1% for DDDR-70 (relative hazard, 1.61; 95% CI, 0.84-3.09) and hospitalization for congestive heart failure of 13.3% for VVI-40 vs 22.6% for DDDR-70 (relative hazard, 1.54; 95% CI, 0.97-2.46), also trended in favor of VVI-40 programming. Conclusion: For patients with standard indications for ICD therapy, no indication for cardiac pacing, and an LVEF of 40% or less, dual-chamber pacing offers no clinical advantage over ventricular backup pacing and may be detrimental by increasing the combined end point of death or hospitalization for heart failure.

AB - Context: Implantable cardioverter defibrillator (ICD) therapy with backup ventricular pacing increases survival in patients with life-threatening ventricular arrhythmias. Most currently implanted ICD devices provide dual-chamber pacing therapy. The most common comorbid cause for mortality in this population is congestive heart failure. Objective: To determine the efficacy of dual-chamber pacing compared with backup ventricular pacing in patients with standard indications for ICD implantation but without indications for antibradycardia pacing. Design: The Dual Chamber and VVI Implantable Defibrillator (DAVID) Trial, a single-blind, parallel-group, randomized clinical trial. Setting and Participants: A total of 506 patients with indications for ICD therapy were enrolled between October 2000 and September 2002 at 37 US centers. All patients had a left ventricular ejection fraction (LVEF) of 40% or less, no indication for antibradycardia pacemaker therapy, and no persistent atrial arrhythmias. Interventions: All patients had an ICD with dual-chamber, rate-responsive pacing capability implanted. Patients were randomly assigned to have the ICDs programmed to ventricular backup pacing at 40/min (VVI-40; n=256) or dual-chamber rate-responsive pacing at 70/min (DDDR-70; n=250). Maximal tolerated medical therapy for left ventricular dysfunction, including angiotensin-converting enzyme inhibitors and β-blockers, was prescribed to all patients. Main Outcome Measure: Composite end point of time to death or first hospitalization for congestive heart failure. Results: One-year survival free of the composite end point was 83.9% for patients treated with VVI-40 compared with 73.3% for patients treated with DDDR-70 (relative hazard, 1.61; 95% confidence interval [CI], 1.06-2.44). The components of the composite end point, mortality of 6.5% for VVI-40 vs 10.1% for DDDR-70 (relative hazard, 1.61; 95% CI, 0.84-3.09) and hospitalization for congestive heart failure of 13.3% for VVI-40 vs 22.6% for DDDR-70 (relative hazard, 1.54; 95% CI, 0.97-2.46), also trended in favor of VVI-40 programming. Conclusion: For patients with standard indications for ICD therapy, no indication for cardiac pacing, and an LVEF of 40% or less, dual-chamber pacing offers no clinical advantage over ventricular backup pacing and may be detrimental by increasing the combined end point of death or hospitalization for heart failure.

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DO - 10.1001/jama.288.24.3115

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