Feasibility and Findings of Including Self-Identified Adult Congenital Heart Disease Patients in the INVESTED Trial

Payam Dehghani; Varun Srivatsav; Orly Vardeny; Jasmine Grewal; Alexander R Opotowsky; Isabelle Vonder Muhll; Michelle Keir; Robin Ducas; Jyotpal Singh; KyungMann Kim; Jacob Joseph; Jamil Aboulhosn; Tom Havighurst; Sheila M Hegde; Deepak L Bhatt; Scott Solomon; Michael Farkouh; Shaun G Goodman; Tabitha G Moe; Jacob A Udell

doi:10.1016/j.jacadv.2024.100897

Feasibility and Findings of Including Self-Identified Adult Congenital Heart Disease Patients in the INVESTED Trial

JACC Adv. 2024 Mar 14;3(4):100897. doi: 10.1016/j.jacadv.2024.100897. eCollection 2024 Apr.

Authors

Payam Dehghani¹, Varun Srivatsav², Orly Vardeny³, Jasmine Grewal⁴, Alexander R Opotowsky⁵, Isabelle Vonder Muhll⁶, Michelle Keir⁷, Robin Ducas⁸, Jyotpal Singh¹, KyungMann Kim⁹, Jacob Joseph¹⁰, Jamil Aboulhosn¹¹, Tom Havighurst⁹, Sheila M Hegde¹², Deepak L Bhatt¹³, Scott Solomon¹², Michael Farkouh¹⁴, Shaun G Goodman^{15

16}, Tabitha G Moe¹⁷, Jacob A Udell¹⁸

Affiliations

¹ Division of Cardiology, Department of Medicine, Prairie Vascular Research Inc, Regina, Saskatchewan, Canada.
² Department of Medicine, University of Saskatchewan, Saskatoon, Saskatchewan, Canada.
³ Minneapolis VA Center for Care Delivery and Outcomes Research, University of Minnesota, Minneapolis, Minnesota, USA.
⁴ Division of Cardiology, Department of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.
⁵ Department of Pediatrics, Heart Institute, Cincinnati Children's Hospital, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA.
⁶ Division of Cardiology, University of Alberta, Edmonton, Alberta, Canada.
⁷ Libin Cardiovascular Institute, University of Calgary, Calgary, Alberta, Canada.
⁸ Section of Cardiology, Department of Internal Medicine, University of Manitoba, Winnipeg, Manitoba, Canada.
⁹ Department of Biostatistics and Medical Informatics, University of Wisconsin-Madison, Madison, Wisconsin, USA.
¹⁰ Cardiology Section, VA Providence Healthcare System, Providence, Rhode Island, USA.
¹¹ Ahmanson/UCLA Adult Congenital Heart Center, Ronald Reagan/UCLA Medical Center, Los Angeles, California, USA.
¹² Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, Massachusetts, USA.
¹³ Mount Sinai Heart, Icahn School of Medicine at Mount Sinai Health System, New York, New York, USA.
¹⁴ Academic Affairs, Cedars-Sinai Health System, Los Angeles, California, USA.
¹⁵ Division of Cardiology, St. Michael's Hospital, Unity Health Toronto, Peter Munk Cardiac Centre, University Health Network, University of Toronto, Toronto, Ontario, Canada.
¹⁶ Canadian VIGOUR Centre, University of Alberta, Edmonton, Alberta, Canada.
¹⁷ Arizona Cardiology Group, University of Arizona College of Medicine-Phoenix, Phoenix, Arizona, USA.
¹⁸ Faculty of Medicine, Division of Cardiology, Department of Medicine, Women's College Hospital, University of Toronto, Toronto, Ontario, Canada.

Abstract

Background: Adult congenital heart disease (ACHD) patients have significant morbidity and rise in cardiac admissions. Their outcome with high-dose influenza vaccination is unknown in comparison to those without ACHD.

Objectives: The purpose of this study was to compare all-cause mortality or cardiopulmonary hospitalizations in self-identified ACHD versus non-ACHD patients receiving high- or low-dose influenza vaccination within the INfluenza Vaccine to Effectively Stop cardioThoracic Events and Decompensated heart failure trial.

Methods: We prospectively included ACHD patients in the INVESTED (INfluenza Vaccine to Effectively Stop cardioThoracic Events and Decompensated heart failure) trial. The primary endpoint was all-cause death or hospitalization for cardiovascular or pulmonary causes.

Results: Of the 272 ACHD patients, 132 were randomly assigned to receive high-dose trivalent and 140 to standard-dose quadrivalent influenza vaccine. Compared to the non-ACHD cohort (n = 4,988), ACHD patients were more likely to be younger, women, smokers, have atrial fibrillation, and have a qualifying event of heart failure. The primary outcome was 49.8 events versus 42.8 events per 100 person-years (adjusted HR: 1.17; 95% CI: 0.95-1.45; P = 0.144) in the ACHD group and non-ACHD group, respectively. The interaction between ACHD status and randomized treatment effect was not significant for the primary outcome (P = 0.858). Vaccine-related adverse events were similar in both groups.

Conclusions: Patients who self-identify as being ACHD had similar primary outcome of all-cause death or hospitalization for cardiovascular or pulmonary causes compared to non-ACHD cohort. High-dose influenza vaccination was similar to standard-dose influenza vaccination on the primary outcome in patients who self-identify as ACHD.

Keywords: adult congenital heart disease; influenza; vaccination.