• Am. J. Respir. Crit. Care Med. · Mar 2020

    Randomized Controlled Trial

    Echocardiographic Changes with Positive Airway Pressure Therapy in Obesity Hypoventilation Syndrome. Long-Term Pickwick Randomized Controlled Clinical Trial.

    • Juan F Masa, Babak Mokhlesi, Iván Benítez, Maria Victoria Mogollon, Francisco Javier Gomez de Terreros, Maria Ángeles Sánchez-Quiroga, Auxiliadora Romero, Candela Caballero-Eraso, Maria Luz Alonso-Álvarez, Estrella Ordax-Carbajo, Teresa Gomez-Garcia, Mónica González, Soledad López-Martín, José M Marin, Sergi Martí, Trinidad Díaz-Cambriles, Eusebi Chiner, Carlos Egea, Javier Barca, Francisco-José Vázquez-Polo, Miguel A Negrín, María Martel-Escobar, Ferran Barbe, Jaime Corral, and Spanish Sleep Network.
    • Respiratory Department, San Pedro de Alcántara Hospital, Cáceres, Spain.
    • Am. J. Respir. Crit. Care Med. 2020 Mar 1; 201 (5): 586-597.

    AbstractRationale: Obesity hypoventilation syndrome (OHS) has been associated with cardiac dysfunction. However, randomized trials assessing the impact of long-term noninvasive ventilation (NIV) or continuous positive airway pressure (CPAP) on cardiac structure and function assessed by echocardiography are lacking.Objectives: In a prespecified secondary analysis of the largest multicenter randomized controlled trial of OHS (Pickwick Project; N = 221 patients with OHS and coexistent severe obstructive sleep apnea), we compared the effectiveness of three years of NIV and CPAP on structural and functional echocardiographic changes.Methods: At baseline and annually during three sequential years, patients underwent transthoracic two-dimensional and Doppler echocardiography. Echocardiographers at each site were blinded to the treatment allocation. Statistical analysis was performed using a linear mixed-effects model with a treatment group and repeated measures interaction to determine the differential effect between CPAP and NIV.Measurements and Main Results: A total of 196 patients were analyzed: 102 were treated with CPAP and 94 were treated with NIV. Systolic pulmonary artery pressure decreased from 40.5 ± 1.47 mm Hg at baseline to 35.3 ± 1.33 mm Hg at three years with CPAP, and from 41.5 ± 1.56 mm Hg to 35.5 ± 1.42 with NIV (P < 0.0001 for longitudinal intragroup changes for both treatment arms). However, there were no significant differences between groups. NIV and CPAP therapies similarly improved left ventricular diastolic dysfunction and reduced left atrial diameter. Both NIV and CPAP improved respiratory function and dyspnea.Conclusions: In patients with OHS who have concomitant severe obstructive sleep apnea, long-term treatment with NIV and CPAP led to similar degrees of improvement in pulmonary hypertension and left ventricular diastolic dysfunction.Clinical trial registered with www.clinicaltrials.gov (NCT01405976).

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