Rationale Despite a significant association between obesity hypoventilation syndrome (OHS) and cardiac dysfunction, no randomised trials have assessed the impact of non-invasive ventilation (NIV) or CPAP on cardiac structure and function assessed by echocardiography.
Objectives We performed a secondary analysis of the data from the largest multicentre randomised controlled trial of OHS (Pickwick project, n=221) to determine the comparative efficacy of 2 months of NIV (n=71), CPAP (n=80) and lifestyle modification (control group, n=70) on structural and functional echocardiographic changes.
Methods Conventional transthoracic two-dimensional and Doppler echocardiograms were obtained at baseline and after 2 months. Echocardiographers at each site were blinded to the treatment arms. Statistical analysis was performed using intention-to-treat analysis.
Results At baseline, 55% of patients had pulmonary hypertension and 51% had evidence of left ventricular hypertrophy. Treatment with NIV, but not CPAP, lowered systolic pulmonary artery pressure (−3.4 mm Hg, 95% CI −5.3 to –1.5; adjusted P=0.025 vs control and P=0.033 vs CPAP). The degree of improvement in systolic pulmonary artery pressure was greater in patients treated with NIV who had pulmonary hypertension at baseline (−6.4 mm Hg, 95% CI −9 to –3.8). Only NIV therapy decreased left ventricular hypertrophy with a significant reduction in left ventricular mass index (−5.7 g/m2; 95% CI −11.0 to –4.4). After adjusted analysis, NIV was superior to control group in improving left ventricular mass index (P=0.015). Only treatment with NIV led to a significant improvement in 6 min walk distance (32 m; 95% CI 19 to 46).
Conclusion In patients with OHS, medium-term treatment with NIV is more effective than CPAP and lifestyle modification in improving pulmonary hypertension, left ventricular hypertrophy and functional outcomes. Long-term studies are needed to confirm these results.
- sleep apnoea
- non invasive ventilation
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Contributors Substantial contributions to study conception and design, acquisition of data, or analysis and interpretation of data: JFM, JC, MVM , BM , MLA-A, Estrella Ordax, Maria F Troncoso, MG, SL-M, JMM, Sergi Marti, TDí-C, EC, CE, Joaquin Teran, NG-M, Angeles Martínez, PDL, Teresa Gomez-Garcia , Santiago J. Carrizo, OR, Maria Antonia Romero PT, CS, MD, Francisco Rivas, AR , CC , Jose Maria Benítez, RG , AS-Recuerda, SG, Monica Bengoa, RG and Maria Angeles Sánchez-Quiroga . Drafting the article or revising the article critically for important intellectual content: JFM; BM, JC; MVM , Roberto M. Lang , Jose M Marin, OR, AR, CC ; EC; Joaquin Teran, Maria L Alonso; NG-M; M-Angeles Sánchez-Quiroga MD and PDL. Final approval of the version to be published: JFM, BM , JC; MVM and RML . Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved: JFM. JFM has full access to all data from the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Funding Instituto de Salud Carlos III (Fondo de Investigaciones Sanitarias, Ministerio de Sanidad y Consumo) PI050402, Spanish Respiratory Foundation 2005 (FEPAR) and Air Liquide Spain. Funders provided only financial support. They did not participate in the design or conduct of the study, collection, management, analysis, interpretation of the data, preparation, review or approval of the manuscript.
Competing interests None declared.
Ethics approval Comité Ético de Investigación Clínica (CEIC) ID: 28042009.
Provenance and peer review Not commissioned; externally peer reviewed.
Collaborators The Spanish Sleep Network: Rocio Gallego, San Pedro de Alcántara Hospital, Cáceres, Spain, CIBER de enfermedadesrespiratorias (CIBERES), Madrid, Spain; Javier Barca, Extremadura University,Cáceres, Spain; Estrella Ordax, University Hospital, Burgos, Spain, CIBERES, Madrid, Spain; Nicolás González-Mangado, IIS Fundación Jiménez Díaz, Madrid,Spain, (CIBERES), Madrid, Spain; Maria-Ángeles Martinez-Martinez, Valdecilla Hospital, Santander, Spain; Olga Cantalejo, Valdecilla Hospital, Santander,Spain; Elena Ojeda, Gregorio Marañon Hospital, Madrid, Spain; Santiago J Carrizo Miguel, Servet Hospital, Zaragoza, Spain, CIBERES, Madrid, Spain; Begoña Gallego, Miguel Servet Hospital, Zaragoza, Spain; Sergi Martí, Vall d’Hebron Hospital, Barcelona, Spain, CIBERES, Madrid, Spain; Mª Antonia Ramón, Vall d’Hebron Hospital, Barcelona, Spain, CIBERES, Madrid, Spain; Josefa Díaz-de-Atauri, Doce de Octubre Hospital, Madrid, Spain, CIBERES, Madrid, Spain; Jesús Muñoz-Méndez, Doce de Octubre Hospital, Madrid, Spain, CIBERES, Madrid,Spain; Cristina Senent, San Juan Hospital, Alicante, Spain; Jose N Sancho-Chust, San Juan Hospital, Alicante, Spain; Francisco J Rivas, Alava University Hospital IRB, Vitoria, Spain, CIBERES, Madrid, Spain; Emilia Barrot, Virgen del Rocío Hospital, Sevilla, Spain; José M Benítez, Virgen de la Macarena Hospital, Sevilla, Spain; Jesús Sanchez-Gómez, Virgen de la Macarena Hospital, Sevilla, Spain; Rafael Golpe, Lucus Augusti University Hospital, Lugo, Spain; AnaSantiago-Recuerda, La Paz Hospital, Madrid, Spain; Silvia Gomez, Arnau de Vilanova Hospital, Lleida, Spain, CIBERES, Madrid, Spain. Mónica Bengoa, University Hospital, Las Palmas, Spain.
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