Atrial Fibrillation Burden and Atrial Shunt Therapy in Heart Failure With Preserved Ejection Fraction

Ravi B. Patel; Vivek Y. Reddy; Jan Komtebedde; Stephan W. Wegerich; Jadranka Sekaric; Vijay Swarup; Antony Walton; Gabriel Laurent; Stanley Chetcuti; Matthias Rademann; Martin Bergmann; Scott McKenzie; Heiko Bugger; Raphael Romano Bruno; Howard C. Herrmann; Ajith Nair; Deepak K. Gupta; Scott Lim; Samir Kapadia; Robert Gordon; Marc Vanderheyden; Thomas Noel; Steven Bailey; Zachary M. Gertz; Jean Noël Trochu; Donald E. Cutlip; Martin B. Leon; Scott D. Solomon; Dirk J. van Veldhuisen; Angelo Auricchio; Sanjiv J. Shah

doi:10.1016/j.jchf.2023.05.024

Atrial Fibrillation Burden and Atrial Shunt Therapy in Heart Failure With Preserved Ejection Fraction

Ravi B. Patel, Vivek Y. Reddy, Jan Komtebedde, Stephan W. Wegerich, Jadranka Sekaric, Vijay Swarup, Antony Walton, Gabriel Laurent, Stanley Chetcuti, Matthias Rademann, Martin Bergmann, Scott McKenzie, Heiko Bugger, Raphael Romano Bruno, Howard C. Herrmann, Ajith Nair, Deepak K. Gupta, Scott Lim, Samir Kapadia, Robert GordonMarc Vanderheyden, Thomas Noel, Steven Bailey, Zachary M. Gertz, Jean Noël Trochu, Donald E. Cutlip, Martin B. Leon, Scott D. Solomon, Dirk J. van Veldhuisen, Angelo Auricchio, Sanjiv J. Shah^*

^*Corresponding author for this work

Medicine, Cardiology Division

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

4 Scopus citations

Abstract

Background: Atrial fibrillation (AF) is a common comorbidity in patients with heart failure with preserved ejection fraction (HFpEF) and in heart failure with mildly reduced ejection fraction (HFmrEF). Objectives: This study sought to describe AF burden and its clinical impact among individuals with HFpEF and HFmrEF who participated in a randomized clinical trial of atrial shunt therapy (REDUCE LAP-HF II [A Study to Evaluate the Corvia Medical, Inc IASD System II to Reduce Elevated Left Atrial Pressure in Patients with Heart Failure]) and to evaluate the effect of atrial shunt therapy on AF burden. Methods: Study investigators characterized AF burden among patients in the REDUCE LAP-HF II trial by using ambulatory cardiac patch monitoring at baseline (median patch wear time, 6 days) and over a 12-month follow-up (median patch wear time, 125 days). The investigators determined the association of baseline AF burden with long-term clinical events and examined the effect of atrial shunt therapy on AF burden over time. Results: Among 367 patients with cardiac monitoring data at baseline and follow-up, 194 (53%) had a history of AF or atrial flutter (AFL), and median baseline AF burden was 0.012% (IQR: 0%-1.3%). After multivariable adjustment, baseline AF burden ≥0.012% was significantly associated with heart failure (HF) events (HR: 2.00; 95% CI: 1.17-3.44; P = 0.01) both with and without a history of AF or AFL (P for interaction = 0.68). Adjustment for left atrial reservoir strain attenuated the baseline AF burden-HF event association (HR: 1.71; 95% CI: 0.93-3.14; P = 0.08). Of the 367 patients, 141 (38%) had patch-detected AF during follow-up without a history of AF or AFL. Atrial shunt therapy did not change AF incidence or burden during follow-up. Conclusions: In HFpEF and HFmrEF, nearly 40% of patients have subclinical AF by 1 year. Baseline AF burden, even at low levels, is associated with HF events. Atrial shunt therapy does not affect AF incidence or burden.

Original language	English (US)
Pages (from-to)	1351-1362
Number of pages	12
Journal	JACC: Heart Failure
Volume	11
Issue number	10
DOIs	https://doi.org/10.1016/j.jchf.2023.05.024
State	Published - Oct 2023

Funding

The authors wish to thank the patients who participated in REDUCE LAP-HF II.

Keywords

atrial fibrillation
burden
clinical trial
heart failure
shunt

ASJC Scopus subject areas

Cardiology and Cardiovascular Medicine

Access to Document

10.1016/j.jchf.2023.05.024

Cite this

Patel, R. B., Reddy, V. Y., Komtebedde, J., Wegerich, S. W., Sekaric, J., Swarup, V., Walton, A., Laurent, G., Chetcuti, S., Rademann, M., Bergmann, M., McKenzie, S., Bugger, H., Bruno, R. R., Herrmann, H. C., Nair, A., Gupta, D. K., Lim, S., Kapadia, S., ... Shah, S. J. (2023). Atrial Fibrillation Burden and Atrial Shunt Therapy in Heart Failure With Preserved Ejection Fraction. JACC: Heart Failure, 11(10), 1351-1362. https://doi.org/10.1016/j.jchf.2023.05.024

@article{844cef3c0aa14c2ab527d5b120937f66,

title = "Atrial Fibrillation Burden and Atrial Shunt Therapy in Heart Failure With Preserved Ejection Fraction",

abstract = "Background: Atrial fibrillation (AF) is a common comorbidity in patients with heart failure with preserved ejection fraction (HFpEF) and in heart failure with mildly reduced ejection fraction (HFmrEF). Objectives: This study sought to describe AF burden and its clinical impact among individuals with HFpEF and HFmrEF who participated in a randomized clinical trial of atrial shunt therapy (REDUCE LAP-HF II [A Study to Evaluate the Corvia Medical, Inc IASD System II to Reduce Elevated Left Atrial Pressure in Patients with Heart Failure]) and to evaluate the effect of atrial shunt therapy on AF burden. Methods: Study investigators characterized AF burden among patients in the REDUCE LAP-HF II trial by using ambulatory cardiac patch monitoring at baseline (median patch wear time, 6 days) and over a 12-month follow-up (median patch wear time, 125 days). The investigators determined the association of baseline AF burden with long-term clinical events and examined the effect of atrial shunt therapy on AF burden over time. Results: Among 367 patients with cardiac monitoring data at baseline and follow-up, 194 (53%) had a history of AF or atrial flutter (AFL), and median baseline AF burden was 0.012% (IQR: 0%-1.3%). After multivariable adjustment, baseline AF burden ≥0.012% was significantly associated with heart failure (HF) events (HR: 2.00; 95% CI: 1.17-3.44; P = 0.01) both with and without a history of AF or AFL (P for interaction = 0.68). Adjustment for left atrial reservoir strain attenuated the baseline AF burden-HF event association (HR: 1.71; 95% CI: 0.93-3.14; P = 0.08). Of the 367 patients, 141 (38%) had patch-detected AF during follow-up without a history of AF or AFL. Atrial shunt therapy did not change AF incidence or burden during follow-up. Conclusions: In HFpEF and HFmrEF, nearly 40% of patients have subclinical AF by 1 year. Baseline AF burden, even at low levels, is associated with HF events. Atrial shunt therapy does not affect AF incidence or burden.",

keywords = "atrial fibrillation, burden, clinical trial, heart failure, shunt",

author = "Patel, {Ravi B.} and Reddy, {Vivek Y.} and Jan Komtebedde and Wegerich, {Stephan W.} and Jadranka Sekaric and Vijay Swarup and Antony Walton and Gabriel Laurent and Stanley Chetcuti and Matthias Rademann and Martin Bergmann and Scott McKenzie and Heiko Bugger and Bruno, {Raphael Romano} and Herrmann, {Howard C.} and Ajith Nair and Gupta, {Deepak K.} and Scott Lim and Samir Kapadia and Robert Gordon and Marc Vanderheyden and Thomas Noel and Steven Bailey and Gertz, {Zachary M.} and Trochu, {Jean No{\"e}l} and Cutlip, {Donald E.} and Leon, {Martin B.} and Solomon, {Scott D.} and {van Veldhuisen}, {Dirk J.} and Angelo Auricchio and Shah, {Sanjiv J.}",

note = "Publisher Copyright: {\textcopyright} 2023 American College of Cardiology Foundation",

year = "2023",

month = oct,

doi = "10.1016/j.jchf.2023.05.024",

language = "English (US)",

volume = "11",

pages = "1351--1362",

journal = "JACC: Heart Failure",

issn = "2213-1779",

publisher = "Elsevier Inc.",

number = "10",

}

Patel, RB, Reddy, VY, Komtebedde, J, Wegerich, SW, Sekaric, J, Swarup, V, Walton, A, Laurent, G, Chetcuti, S, Rademann, M, Bergmann, M, McKenzie, S, Bugger, H, Bruno, RR, Herrmann, HC, Nair, A, Gupta, DK, Lim, S, Kapadia, S, Gordon, R, Vanderheyden, M, Noel, T, Bailey, S, Gertz, ZM, Trochu, JN, Cutlip, DE, Leon, MB, Solomon, SD, van Veldhuisen, DJ, Auricchio, A & Shah, SJ 2023, 'Atrial Fibrillation Burden and Atrial Shunt Therapy in Heart Failure With Preserved Ejection Fraction', JACC: Heart Failure, vol. 11, no. 10, pp. 1351-1362. https://doi.org/10.1016/j.jchf.2023.05.024

TY - JOUR

T1 - Atrial Fibrillation Burden and Atrial Shunt Therapy in Heart Failure With Preserved Ejection Fraction

AU - Patel, Ravi B.

AU - Reddy, Vivek Y.

AU - Komtebedde, Jan

AU - Wegerich, Stephan W.

AU - Sekaric, Jadranka

AU - Swarup, Vijay

AU - Walton, Antony

AU - Laurent, Gabriel

AU - Chetcuti, Stanley

AU - Rademann, Matthias

AU - Bergmann, Martin

AU - McKenzie, Scott

AU - Bugger, Heiko

AU - Bruno, Raphael Romano

AU - Herrmann, Howard C.

AU - Nair, Ajith

AU - Gupta, Deepak K.

AU - Lim, Scott

AU - Kapadia, Samir

AU - Gordon, Robert

AU - Vanderheyden, Marc

AU - Noel, Thomas

AU - Bailey, Steven

AU - Gertz, Zachary M.

AU - Trochu, Jean Noël

AU - Cutlip, Donald E.

AU - Leon, Martin B.

AU - Solomon, Scott D.

AU - van Veldhuisen, Dirk J.

AU - Auricchio, Angelo

AU - Shah, Sanjiv J.

PY - 2023/10

Y1 - 2023/10

N2 - Background: Atrial fibrillation (AF) is a common comorbidity in patients with heart failure with preserved ejection fraction (HFpEF) and in heart failure with mildly reduced ejection fraction (HFmrEF). Objectives: This study sought to describe AF burden and its clinical impact among individuals with HFpEF and HFmrEF who participated in a randomized clinical trial of atrial shunt therapy (REDUCE LAP-HF II [A Study to Evaluate the Corvia Medical, Inc IASD System II to Reduce Elevated Left Atrial Pressure in Patients with Heart Failure]) and to evaluate the effect of atrial shunt therapy on AF burden. Methods: Study investigators characterized AF burden among patients in the REDUCE LAP-HF II trial by using ambulatory cardiac patch monitoring at baseline (median patch wear time, 6 days) and over a 12-month follow-up (median patch wear time, 125 days). The investigators determined the association of baseline AF burden with long-term clinical events and examined the effect of atrial shunt therapy on AF burden over time. Results: Among 367 patients with cardiac monitoring data at baseline and follow-up, 194 (53%) had a history of AF or atrial flutter (AFL), and median baseline AF burden was 0.012% (IQR: 0%-1.3%). After multivariable adjustment, baseline AF burden ≥0.012% was significantly associated with heart failure (HF) events (HR: 2.00; 95% CI: 1.17-3.44; P = 0.01) both with and without a history of AF or AFL (P for interaction = 0.68). Adjustment for left atrial reservoir strain attenuated the baseline AF burden-HF event association (HR: 1.71; 95% CI: 0.93-3.14; P = 0.08). Of the 367 patients, 141 (38%) had patch-detected AF during follow-up without a history of AF or AFL. Atrial shunt therapy did not change AF incidence or burden during follow-up. Conclusions: In HFpEF and HFmrEF, nearly 40% of patients have subclinical AF by 1 year. Baseline AF burden, even at low levels, is associated with HF events. Atrial shunt therapy does not affect AF incidence or burden.

AB - Background: Atrial fibrillation (AF) is a common comorbidity in patients with heart failure with preserved ejection fraction (HFpEF) and in heart failure with mildly reduced ejection fraction (HFmrEF). Objectives: This study sought to describe AF burden and its clinical impact among individuals with HFpEF and HFmrEF who participated in a randomized clinical trial of atrial shunt therapy (REDUCE LAP-HF II [A Study to Evaluate the Corvia Medical, Inc IASD System II to Reduce Elevated Left Atrial Pressure in Patients with Heart Failure]) and to evaluate the effect of atrial shunt therapy on AF burden. Methods: Study investigators characterized AF burden among patients in the REDUCE LAP-HF II trial by using ambulatory cardiac patch monitoring at baseline (median patch wear time, 6 days) and over a 12-month follow-up (median patch wear time, 125 days). The investigators determined the association of baseline AF burden with long-term clinical events and examined the effect of atrial shunt therapy on AF burden over time. Results: Among 367 patients with cardiac monitoring data at baseline and follow-up, 194 (53%) had a history of AF or atrial flutter (AFL), and median baseline AF burden was 0.012% (IQR: 0%-1.3%). After multivariable adjustment, baseline AF burden ≥0.012% was significantly associated with heart failure (HF) events (HR: 2.00; 95% CI: 1.17-3.44; P = 0.01) both with and without a history of AF or AFL (P for interaction = 0.68). Adjustment for left atrial reservoir strain attenuated the baseline AF burden-HF event association (HR: 1.71; 95% CI: 0.93-3.14; P = 0.08). Of the 367 patients, 141 (38%) had patch-detected AF during follow-up without a history of AF or AFL. Atrial shunt therapy did not change AF incidence or burden during follow-up. Conclusions: In HFpEF and HFmrEF, nearly 40% of patients have subclinical AF by 1 year. Baseline AF burden, even at low levels, is associated with HF events. Atrial shunt therapy does not affect AF incidence or burden.

KW - atrial fibrillation

KW - burden

KW - clinical trial

KW - heart failure

KW - shunt

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DO - 10.1016/j.jchf.2023.05.024

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AN - SCOPUS:85171574408

SN - 2213-1779

VL - 11

SP - 1351

EP - 1362

JO - JACC: Heart Failure

JF - JACC: Heart Failure

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Atrial Fibrillation Burden and Atrial Shunt Therapy in Heart Failure With Preserved Ejection Fraction

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