Browsing by Author "Frischhertz, Benjamin P."

Now showing 1 - 3 of 3
  • Thumbnail Image
    Item
    COVID-19 in Adults With Congenital Heart Disease
    (Elsevier, 2021-04) Broberg, Craig S.; Kovacs, Adrienne H.; Sadeghi, Soraya; Rosenbaum, Marlon S.; Lewis, Matthew J.; Carazo, Matthew R.; Rodriguez, Fred H.; Halpern, Dan G.; Feinberg, Jodi; Galilea, Francisca Arancibia; Baraona, Fernando; Cedars, Ari M.; Ko, Jong M.; Porayette, Prashob; Maldonado, Jennifer; Sarubbi, Berardo; Fusco, Flavia; Frogoudaki, Alexandra A.; Nir, Amiram; Chaudhry, Anisa; John, Anitha S.; Karbassi, Arsha; Hoskoppal, Arvind K.; Frischhertz, Benjamin P.; Hendrickson, Benjamin; Bouma, Berto J.; Rodriguez-Monserrate, Carla P.; Broda, Christopher R.; Tobler, Daniel; Gregg, David; Martinez-Quintana, Efren; Yeung, Elizabeth; Krieger, Eric V.; Ruperti-Repilado, Francisco J.; Giannakoulas, George; Lui, George K.; Ephrem, Georges; Singh, Harsimran S.; Almeneisi, Hassan MK.; Bartlett, Heather L.; Lindsay, Ian; Grewal, Jasmine; Nicolarsen, Jeremy; Araujo, John J.; Cramer, Jonathan W.; Bouchardy, Judith; Al Najashi, Khalid; Ryan, Kristi; Alshawabkeh, Laith; Andrade, Lauren; Ladouceur, Magalie; Schwerzmann, Markus; Greutmann, Matthias; Meras, Pablo; Ferrero, Paolo; Dehghani, Payam; Tung, Poyee P.; Garcia-Orta, Rocio; Tompkins, Rose O.; Gendi, Salwa M.; Cohen, Scott; Klewer, Scott; Hascoet, Sebastien; Mohammadzadeh, Shabnam; Upadhyay, Shailendra; Fisher, Stacy D.; Cook, Stephen; Cotts, Timothy B.; Aboulhosn, Jamil A.; Medicine, School of Medicine
    Background Adults with congenital heart disease (CHD) have been considered potentially high risk for novel coronavirus disease-19 (COVID-19) mortality or other complications. Objectives This study sought to define the impact of COVID-19 in adults with CHD and to identify risk factors associated with adverse outcomes. Methods Adults (age 18 years or older) with CHD and with confirmed or clinically suspected COVID-19 were included from CHD centers worldwide. Data collection included anatomic diagnosis and subsequent interventions, comorbidities, medications, echocardiographic findings, presenting symptoms, course of illness, and outcomes. Predictors of death or severe infection were determined. Results From 58 adult CHD centers, the study included 1,044 infected patients (age: 35.1 ± 13.0 years; range 18 to 86 years; 51% women), 87% of whom had laboratory-confirmed coronavirus infection. The cohort included 118 (11%) patients with single ventricle and/or Fontan physiology, 87 (8%) patients with cyanosis, and 73 (7%) patients with pulmonary hypertension. There were 24 COVID-related deaths (case/fatality: 2.3%; 95% confidence interval: 1.4% to 3.2%). Factors associated with death included male sex, diabetes, cyanosis, pulmonary hypertension, renal insufficiency, and previous hospital admission for heart failure. Worse physiological stage was associated with mortality (p = 0.001), whereas anatomic complexity or defect group were not. Conclusions COVID-19 mortality in adults with CHD is commensurate with the general population. The most vulnerable patients are those with worse physiological stage, such as cyanosis and pulmonary hypertension, whereas anatomic complexity does not appear to predict infection severity.
  • Thumbnail Image
    Item
    COVID-19-Related Thrombotic and Bleeding Events in Adults With Congenital Heart Disease
    (Elsevier, 2023-11-21) Fusco, Flavia; Krasuski, Richard A.; Sadeghi, Soraya; Rosenbaum, Marlon S.; Lewis, Matthew J.; Carazo, Matthew R.; Rodriguez, Fred H.; Halpern, Dan G.; Feinberg, Jodi L.; Galilea, Francisca A.; Baraona, Fernando; Cedars, Ari M.; Ko, Jong M.; Porayette, Prashob; Maldonado, Jennifer R.; Frogoudaki, Alexandra A.; Nir, Amiram; Chaudhry, Anisa; John, Anitha S.; Karbassi, Arsha; Ganame, Javier; Hoskoppal, Arvind; Frischhertz, Benjamin P.; Hendrickson, Benjamin; Rodriguez-Monserrate, Carla P.; Broda, Christopher R.; Tobler, Daniel; Gregg, David; Martinez-Quintana, Efrén; Yeung, Elizabeth; Krieger, Eric V.; Ruperti-Repilado, Francisco J.; Giannakoulas, George; Lui, George K.; Ephrem, Georges; Singh, Harsimran S.; Hasan, Almeneisi; Bartlett, Heather L.; Lindsay, Ian; Grewal, Jasmine; Nicolarsen, Jeremy; Araujo, John J.; Cramer, Jonathan W.; Bouchardy, Judith; Al Najashi, Khalid; Ryan, Kristi; Alshawabkeh, Laith; Andrade, Lauren; Ladouceur, Magalie; Schwerzmann, Markus; Greutmann, Matthias; Merás, Pablo; Ferrero, Paolo; Dehghani, Payam; Tung, Poyee P.; Garcia-Orta, Rocio; Tompkins, Rose; Gendi, Salwa M.; Cohen, Scott; Klewer, Scott E.; Hascoet, Sebastien; Upadhyay, Shailendra; Fisher, Stacy D.; Cook, Stephen; Cotts, Timothy B.; Kovacs, Adrienne H.; Aboulhosn, Jamil A.; Scognamiglio, Giancarlo; Broberg, Craig S.; Sarubbi, Berardo; Medicine, School of Medicine
    Background: Altered coagulation is a striking feature of COVID-19. Adult patients with congenital heart disease (ACHD) are prone to thromboembolic (TE) and bleeding complications. Objectives: The purpose of this study was to investigate the prevalence and risk factors for COVID-19 TE/bleeding complications in ACHD patients. Methods: COVID-19-positive ACHD patients were included between May 2020 and November 2021. TE events included ischemic cerebrovascular accident, systemic and pulmonary embolism, deep venous thrombosis, myocardial infarction, and intracardiac thrombosis. Major bleeding included cases with hemoglobin drop >2 g/dl, involvement of critical sites, or fatal bleeding. Severe infection was defined as need for intensive care unit, endotracheal intubation, renal replacement therapy, extracorporeal membrane oxygenation, or death. Patients with TE/bleeding were compared to those without events. Factors associated with TE/bleeding were determined using logistic regression. Results: Of 1,988 patients (age 32 [IQR: 25-42] years, 47% male, 59 ACHD centers), 30 (1.5%) had significant TE/bleeding: 12 TE events, 12 major bleeds, and 6 with both TE and bleeding. Patients with TE/bleeding had higher in-hospital mortality compared to the remainder cohort (33% vs 1.7%; P < 0.0001) and were in more advanced physiological stage (P = 0.032) and NYHA functional class (P = 0.01), had lower baseline oxygen saturation (P = 0.0001), and more frequently had a history of atrial arrhythmia (P < 0.0001), previous hospitalization for heart failure (P < 0.0007), and were more likely hospitalized for COVID-19 (P < 0.0001). By multivariable logistic regression, prior anticoagulation (OR: 4.92; 95% CI: 2-11.76; P = 0.0003), cardiac injury (OR: 5.34; 95% CI: 1.98-14.76; P = 0.0009), and severe COVID-19 (OR: 17.39; 95% CI: 6.67-45.32; P < 0.0001) were independently associated with increased risk of TE/bleeding complications. Conclusions: ACHD patients with TE/bleeding during COVID-19 infection have a higher in-hospital mortality from the illness. Risk of coagulation disorders is related to severe COVID-19, cardiac injury during infection, and use of anticoagulants.
  • Thumbnail Image
    Item
    Results of the Fontan Udenafil Exercise Longitudinal (FUEL) Trial
    (American Heart Association, 2020-02-25) Goldberg, David J.; Zak, Victor; Goldstein, Bryan H.; Schumacher, Kurt R.; Rhodes, Jonathan; Penny, Daniel J.; Petit, Christopher J.; Ginde, Salil; Menon, Shaji C.; Kim, Seong-Ho; Kim, Gi Beom; Nowlen, Todd T.; DiMaria, Michael V.; Frischhertz, Benjamin P.; Wagner, Jonathan B.; McHugh, Kimberly E.; McCrindle, Brian W.; Shillingford, Amanda J.; Sabati, Arash A.; Yetman, Anji T.; John, Anitha S.; Richmond, Marc E.; Files, Matthew D.; Payne, R. Mark; Mackie, Andrew S.; Davis, Christopher K.; Shahanavaz, Shabana; Hill, Kevin D.; Garg, Ruchira; Jacobs, Jeffrey P.; Hamstra, Michelle S.; Woyciechowski, Stacy; Rathge, Kathleen A.; McBride, Michael G.; Frommelt, Peter C.; Russell, Mark W.; Urbina, Elaine M.; Yeager, James L.; Pemberton, Victoria L.; Stylianou, Mario P.; Pearson, Gail D.; Paridon, Stephen M.; Pediatrics, School of Medicine
    Background: The Fontan operation creates a total cavopulmonary connection, a circulation in which the importance of pulmonary vascular resistance is magnified. Over time, this circulation leads to deterioration of cardiovascular efficiency associated with a decline in exercise performance. Rigorous clinical trials aimed at improving physiology and guiding pharmacotherapy are lacking. Methods: The FUEL trial (Fontan Udenafil Exercise Longitudinal) was a phase III clinical trial conducted at 30 centers. Participants were randomly assigned udenafil, 87.5 mg twice daily, or placebo in a 1:1 ratio. The primary outcome was the between-group difference in change in oxygen consumption at peak exercise. Secondary outcomes included between-group differences in changes in submaximal exercise at the ventilatory anaerobic threshold, the myocardial performance index, the natural log of the reactive hyperemia index, and serum brain-type natriuretic peptide. Results: Between 2017 and 2019, 30 clinical sites in North America and the Republic of Korea randomly assigned 400 participants with Fontan physiology. The mean age at randomization was 15.5±2 years; 60% of participants were male, and 81% were white. All 400 participants were included in the primary analysis with imputation of the 26-week end point for 21 participants with missing data (11 randomly assigned to udenafil and 10 to placebo). Among randomly assigned participants, peak oxygen consumption increased by 44±245 mL/min (2.8%) in the udenafil group and declined by 3.7±228 mL/min (-0.2%) in the placebo group (P=0.071). Analysis at ventilatory anaerobic threshold demonstrated improvements in the udenafil group versus the placebo group in oxygen consumption (+33±185 [3.2%] versus -9±193 [-0.9%] mL/min, P=0.012), ventilatory equivalents of carbon dioxide (-0.8 versus -0.06, P=0.014), and work rate (+3.8 versus +0.34 W, P=0.021). There was no difference in change of myocardial performance index, the natural log of the reactive hyperemia index, or serum brain-type natriuretic peptide level. Conclusions: In the FUEL trial, treatment with udenafil (87.5 mg twice daily) was not associated with an improvement in oxygen consumption at peak exercise but was associated with improvements in multiple measures of exercise performance at the ventilatory anaerobic threshold.