Left Ventricular Lead Position and Outcomes in the Resynchronization-Defibrillation for Ambulatory Heart Failure Trial (RAFT)

Stephen B. Wilton; Derek V. Exner; Jeffrey S. Healey; David Birnie; Malcolm O. Arnold; John L. Sapp; Bernard Thibault; Christopher S. Simpson; Stanley Tung; Eugene Crystal; Soori Sivakumaran; Yaariv Khaykin; Elizabeth Yetisir; George Wells; Anthony S.L. Tang

doi:10.1016/j.cjca.2013.10.009

Left Ventricular Lead Position and Outcomes in the Resynchronization-Defibrillation for Ambulatory Heart Failure Trial (RAFT)

Stephen B. Wilton, Derek V. Exner, Jeffrey S. Healey, David Birnie, Malcolm O. Arnold, John L. Sapp, Bernard Thibault, Christopher S. Simpson, Stanley Tung, Eugene Crystal, Soori Sivakumaran, Yaariv Khaykin, Elizabeth Yetisir, George Wells, Anthony S.L. Tang

Medicine

Medicine

Research output: Contribution to journal › Article › peer-review

19 Citations (Scopus)

Abstract

Background: Conflicting data exist regarding the association between left ventricular (LV) lead position and benefit from cardiac resynchronization therapy. We evaluated the relationships between LV lead positions and the risk of death or hospitalization for heart failure (HF) in the cardiac resynchronization therapy arm of the Resynchronization-Defibrillation for Ambulatory Heart Failure Trial (RAFT). Methods: LV lead position was categorized by site investigator (MD) and in a chest radiograph core laboratory (CXR) as "anterior," "lateral," or "posterior" in the short axis, and "basal," "mid," or "apical" in the long axis. Agreement between MD and CXR LV lead position classification was evaluated and the independent relationship between LV lead position and clinical outcome was assessed using Cox multivariable models. Results: Agreement between MD and CXR LV lead position was poor (κ ≤ 0.26). Over 39 ± 20 months, 140 of 447 (31.3%) patients met the RAFT primary end point (death or HF hospitalization). In adjusted analyses, neither MD-determined nor CXR-determined anterior or apical LV lead position was significantly associated with the primary outcome. However, CXR-defined apical LV lead position was associated with a higher risk of HF hospitalization (hazard ratio, 1.99; P= 0.004). Conclusions: Poor agreement between implanting physician and core lab CXR-based categorizations of LV lead position was observed. Neither categorization method resulted in significant associations between apical or anterior LV lead position and the risk of the composite primary outcome of death or heart failure hospitalization. However, CXR-defined apical lead position was associated with increased risk of HF hospitalization.

Original language	English
Pages (from-to)	413-419
Number of pages	7
Journal	Canadian Journal of Cardiology
Volume	30
Issue number	4
DOIs	https://doi.org/10.1016/j.cjca.2013.10.009
Publication status	Published - Apr 2014

Bibliographical note

Funding Information:
S.B.W.: research grant - St Jude Medical ; D.V.E.: research grants from Medtronic, St Jude Medical, GE Healthcare , HeartForce ; D.B.: research grants from Medtronic; J.S.H.: research grants from Boston Scientific , St Jude Medical; J.L.S.: research grants from St Jude Medical, Biosense Webster , Philips Healthcare , and consultant reimbursement or honoraria from Biosense Webster, Boston Scientific, and Boehringer-Ingelheim; A.S.L.T.: research grants from Medtronic, Biosense Webster, St Jude Medical, and consultant reimbursement or honoraria from Boehringer Ingelheim. The remaining authors have no conflicts of interest to disclose.

Funding Information:
The Canadian Institutes of Health Research and Medtronic of Canada funded the RAFT study. This substudy was funded by Medtronic of Canada. Dr Wilton was supported by the CIHR Randomized Trials Mentoring Program .

ASJC Scopus Subject Areas

Cardiology and Cardiovascular Medicine

PubMed: MeSH publication types

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

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10.1016/j.cjca.2013.10.009

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Wilton, S. B., Exner, D. V., Healey, J. S., Birnie, D., Arnold, M. O., Sapp, J. L., Thibault, B., Simpson, C. S., Tung, S., Crystal, E., Sivakumaran, S., Khaykin, Y., Yetisir, E., Wells, G., & Tang, A. S. L. (2014). Left Ventricular Lead Position and Outcomes in the Resynchronization-Defibrillation for Ambulatory Heart Failure Trial (RAFT). Canadian Journal of Cardiology, 30(4), 413-419. https://doi.org/10.1016/j.cjca.2013.10.009

Wilton, SB, Exner, DV, Healey, JS, Birnie, D, Arnold, MO, Sapp, JL, Thibault, B, Simpson, CS, Tung, S, Crystal, E, Sivakumaran, S, Khaykin, Y, Yetisir, E, Wells, G & Tang, ASL 2014, 'Left Ventricular Lead Position and Outcomes in the Resynchronization-Defibrillation for Ambulatory Heart Failure Trial (RAFT)', Canadian Journal of Cardiology, vol. 30, no. 4, pp. 413-419. https://doi.org/10.1016/j.cjca.2013.10.009

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abstract = "Background: Conflicting data exist regarding the association between left ventricular (LV) lead position and benefit from cardiac resynchronization therapy. We evaluated the relationships between LV lead positions and the risk of death or hospitalization for heart failure (HF) in the cardiac resynchronization therapy arm of the Resynchronization-Defibrillation for Ambulatory Heart Failure Trial (RAFT). Methods: LV lead position was categorized by site investigator (MD) and in a chest radiograph core laboratory (CXR) as {"}anterior,{"} {"}lateral,{"} or {"}posterior{"} in the short axis, and {"}basal,{"} {"}mid,{"} or {"}apical{"} in the long axis. Agreement between MD and CXR LV lead position classification was evaluated and the independent relationship between LV lead position and clinical outcome was assessed using Cox multivariable models. Results: Agreement between MD and CXR LV lead position was poor (κ ≤ 0.26). Over 39 ± 20 months, 140 of 447 (31.3%) patients met the RAFT primary end point (death or HF hospitalization). In adjusted analyses, neither MD-determined nor CXR-determined anterior or apical LV lead position was significantly associated with the primary outcome. However, CXR-defined apical LV lead position was associated with a higher risk of HF hospitalization (hazard ratio, 1.99; P= 0.004). Conclusions: Poor agreement between implanting physician and core lab CXR-based categorizations of LV lead position was observed. Neither categorization method resulted in significant associations between apical or anterior LV lead position and the risk of the composite primary outcome of death or heart failure hospitalization. However, CXR-defined apical lead position was associated with increased risk of HF hospitalization.",

author = "Wilton, {Stephen B.} and Exner, {Derek V.} and Healey, {Jeffrey S.} and David Birnie and Arnold, {Malcolm O.} and Sapp, {John L.} and Bernard Thibault and Simpson, {Christopher S.} and Stanley Tung and Eugene Crystal and Soori Sivakumaran and Yaariv Khaykin and Elizabeth Yetisir and George Wells and Tang, {Anthony S.L.}",

note = "Funding Information: S.B.W.: research grant - St Jude Medical ; D.V.E.: research grants from Medtronic, St Jude Medical, GE Healthcare , HeartForce ; D.B.: research grants from Medtronic; J.S.H.: research grants from Boston Scientific , St Jude Medical; J.L.S.: research grants from St Jude Medical, Biosense Webster , Philips Healthcare , and consultant reimbursement or honoraria from Biosense Webster, Boston Scientific, and Boehringer-Ingelheim; A.S.L.T.: research grants from Medtronic, Biosense Webster, St Jude Medical, and consultant reimbursement or honoraria from Boehringer Ingelheim. The remaining authors have no conflicts of interest to disclose. Funding Information: The Canadian Institutes of Health Research and Medtronic of Canada funded the RAFT study. This substudy was funded by Medtronic of Canada. Dr Wilton was supported by the CIHR Randomized Trials Mentoring Program . ",

year = "2014",

month = apr,

doi = "10.1016/j.cjca.2013.10.009",

language = "English",

volume = "30",

pages = "413--419",

journal = "Canadian Journal of Cardiology",

issn = "0828-282X",

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number = "4",

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TY - JOUR

T1 - Left Ventricular Lead Position and Outcomes in the Resynchronization-Defibrillation for Ambulatory Heart Failure Trial (RAFT)

AU - Wilton, Stephen B.

AU - Exner, Derek V.

AU - Healey, Jeffrey S.

AU - Birnie, David

AU - Arnold, Malcolm O.

AU - Sapp, John L.

AU - Thibault, Bernard

AU - Simpson, Christopher S.

AU - Tung, Stanley

AU - Crystal, Eugene

AU - Sivakumaran, Soori

AU - Khaykin, Yaariv

AU - Yetisir, Elizabeth

AU - Wells, George

AU - Tang, Anthony S.L.

N1 - Funding Information: S.B.W.: research grant - St Jude Medical ; D.V.E.: research grants from Medtronic, St Jude Medical, GE Healthcare , HeartForce ; D.B.: research grants from Medtronic; J.S.H.: research grants from Boston Scientific , St Jude Medical; J.L.S.: research grants from St Jude Medical, Biosense Webster , Philips Healthcare , and consultant reimbursement or honoraria from Biosense Webster, Boston Scientific, and Boehringer-Ingelheim; A.S.L.T.: research grants from Medtronic, Biosense Webster, St Jude Medical, and consultant reimbursement or honoraria from Boehringer Ingelheim. The remaining authors have no conflicts of interest to disclose. Funding Information: The Canadian Institutes of Health Research and Medtronic of Canada funded the RAFT study. This substudy was funded by Medtronic of Canada. Dr Wilton was supported by the CIHR Randomized Trials Mentoring Program .

PY - 2014/4

Y1 - 2014/4

N2 - Background: Conflicting data exist regarding the association between left ventricular (LV) lead position and benefit from cardiac resynchronization therapy. We evaluated the relationships between LV lead positions and the risk of death or hospitalization for heart failure (HF) in the cardiac resynchronization therapy arm of the Resynchronization-Defibrillation for Ambulatory Heart Failure Trial (RAFT). Methods: LV lead position was categorized by site investigator (MD) and in a chest radiograph core laboratory (CXR) as "anterior," "lateral," or "posterior" in the short axis, and "basal," "mid," or "apical" in the long axis. Agreement between MD and CXR LV lead position classification was evaluated and the independent relationship between LV lead position and clinical outcome was assessed using Cox multivariable models. Results: Agreement between MD and CXR LV lead position was poor (κ ≤ 0.26). Over 39 ± 20 months, 140 of 447 (31.3%) patients met the RAFT primary end point (death or HF hospitalization). In adjusted analyses, neither MD-determined nor CXR-determined anterior or apical LV lead position was significantly associated with the primary outcome. However, CXR-defined apical LV lead position was associated with a higher risk of HF hospitalization (hazard ratio, 1.99; P= 0.004). Conclusions: Poor agreement between implanting physician and core lab CXR-based categorizations of LV lead position was observed. Neither categorization method resulted in significant associations between apical or anterior LV lead position and the risk of the composite primary outcome of death or heart failure hospitalization. However, CXR-defined apical lead position was associated with increased risk of HF hospitalization.

AB - Background: Conflicting data exist regarding the association between left ventricular (LV) lead position and benefit from cardiac resynchronization therapy. We evaluated the relationships between LV lead positions and the risk of death or hospitalization for heart failure (HF) in the cardiac resynchronization therapy arm of the Resynchronization-Defibrillation for Ambulatory Heart Failure Trial (RAFT). Methods: LV lead position was categorized by site investigator (MD) and in a chest radiograph core laboratory (CXR) as "anterior," "lateral," or "posterior" in the short axis, and "basal," "mid," or "apical" in the long axis. Agreement between MD and CXR LV lead position classification was evaluated and the independent relationship between LV lead position and clinical outcome was assessed using Cox multivariable models. Results: Agreement between MD and CXR LV lead position was poor (κ ≤ 0.26). Over 39 ± 20 months, 140 of 447 (31.3%) patients met the RAFT primary end point (death or HF hospitalization). In adjusted analyses, neither MD-determined nor CXR-determined anterior or apical LV lead position was significantly associated with the primary outcome. However, CXR-defined apical LV lead position was associated with a higher risk of HF hospitalization (hazard ratio, 1.99; P= 0.004). Conclusions: Poor agreement between implanting physician and core lab CXR-based categorizations of LV lead position was observed. Neither categorization method resulted in significant associations between apical or anterior LV lead position and the risk of the composite primary outcome of death or heart failure hospitalization. However, CXR-defined apical lead position was associated with increased risk of HF hospitalization.

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DO - 10.1016/j.cjca.2013.10.009

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SN - 0828-282X

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JO - Canadian Journal of Cardiology

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Left Ventricular Lead Position and Outcomes in the Resynchronization-Defibrillation for Ambulatory Heart Failure Trial (RAFT)

Abstract

Bibliographical note

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PubMed: MeSH publication types

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