Win ratio analysis of transvenous phrenic nerve stimulation to treat central sleep apnoea in heart failure
Abstract Aims Central sleep apnoea (CSA) is present in 20–40% of heart failure (HF) patients and is associated with poor clinical outcomes and health status. Transvenous phrenic nerve stimulation (TPNS) is an available treatment for CSA in HF patients. The impact on HF outcomes is incompletely under...
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| Format: | Article |
| Language: | English |
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Wiley
2025-02-01
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| Series: | ESC Heart Failure |
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| Online Access: | https://doi.org/10.1002/ehf2.15074 |
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| author | William T. Abraham Olaf Oldenburg Mitja Lainscak Rami Khayat Jerryll Asin Piotr Ponikowski Robin Germany Scott McKane Maria Rosa Costanzo |
| author_facet | William T. Abraham Olaf Oldenburg Mitja Lainscak Rami Khayat Jerryll Asin Piotr Ponikowski Robin Germany Scott McKane Maria Rosa Costanzo |
| author_sort | William T. Abraham |
| collection | DOAJ |
| description | Abstract Aims Central sleep apnoea (CSA) is present in 20–40% of heart failure (HF) patients and is associated with poor clinical outcomes and health status. Transvenous phrenic nerve stimulation (TPNS) is an available treatment for CSA in HF patients. The impact on HF outcomes is incompletely understood. The win ratio (WR) allows inclusion of multiple endpoint components, considers the relative severity of each component, and permits assessment of recurrent events in evaluation of clinical benefit. Methods and results A WR hierarchy was pre‐defined for analysis of the HF subgroup of the remedē® System Pivotal Trial. The analysis used three hierarchical components to compare all treated to all control subjects: longest survival, lowest HF hospitalization rate, and ≥2‐category difference in Patient Global Assessment at 6 months. Sensitivity analyses were performed substituting Epworth Sleepiness Scale and 4% oxygen desaturation index for the third component, and a 4‐component WR hierarchy was also evaluated. Ninety‐one HF subjects, 43 receiving TPNS and 48 in the control group, provided 2064 pairwise comparisons. More patients treated with TPNS experienced clinical benefit compared with control (WR 4.92, 95% confidence interval 2.27–10.63, P < 0.0001). There were 1111 (53.83%) winning pairwise comparisons for the treatment group and 226 (10.95%) for the control group. Similarly, large WRs were observed for all additional WR hierarchies. Conclusions This WR analysis of the remedē® System Pivotal Trial suggests that TPNS may be superior to untreated CSA in HF patients with CSA using a hierarchical clinical benefit endpoint composed of mortality, HF hospitalization, and health status. |
| format | Article |
| id | doaj-art-0147dfa2d2f64e9d9234a793e9bf498d |
| institution | OA Journals |
| issn | 2055-5822 |
| language | English |
| publishDate | 2025-02-01 |
| publisher | Wiley |
| record_format | Article |
| series | ESC Heart Failure |
| spelling | doaj-art-0147dfa2d2f64e9d9234a793e9bf498d2025-08-20T02:25:59ZengWileyESC Heart Failure2055-58222025-02-01121808610.1002/ehf2.15074Win ratio analysis of transvenous phrenic nerve stimulation to treat central sleep apnoea in heart failureWilliam T. Abraham0Olaf Oldenburg1Mitja Lainscak2Rami Khayat3Jerryll Asin4Piotr Ponikowski5Robin Germany6Scott McKane7Maria Rosa Costanzo8Division of Cardiovascular Medicine and the Davis Heart and Lung Research Institute The Ohio State University College of Medicine Columbus Ohio USADepartment of Cardiology Ludgerus‐Kliniken Münster GermanyFaculty of Medicine University of Ljubljana, Division of Cardiology, General Hospital Murska Sobota Ljubljana SloveniaDivision of Pulmonary and Critical Care Medicine and the UCI Sleep Disorders Center University of California Irvine Irvine California USADepartment of Pulmonary Diseases and Center for Sleep Medicine Amphia Ziekenhuis Breda NetherlandsInstitute of Heart Diseases University Hospital of Wroclaw Medical University Wroclaw PolandDivision of Cardiovascular Medicine University of Oklahoma College of Medicine Oklahoma City Oklahoma USAZOLL Respicardia Minnetonka Minnesota USAMidwest Cardiovascular Institute Naperville Illinois USAAbstract Aims Central sleep apnoea (CSA) is present in 20–40% of heart failure (HF) patients and is associated with poor clinical outcomes and health status. Transvenous phrenic nerve stimulation (TPNS) is an available treatment for CSA in HF patients. The impact on HF outcomes is incompletely understood. The win ratio (WR) allows inclusion of multiple endpoint components, considers the relative severity of each component, and permits assessment of recurrent events in evaluation of clinical benefit. Methods and results A WR hierarchy was pre‐defined for analysis of the HF subgroup of the remedē® System Pivotal Trial. The analysis used three hierarchical components to compare all treated to all control subjects: longest survival, lowest HF hospitalization rate, and ≥2‐category difference in Patient Global Assessment at 6 months. Sensitivity analyses were performed substituting Epworth Sleepiness Scale and 4% oxygen desaturation index for the third component, and a 4‐component WR hierarchy was also evaluated. Ninety‐one HF subjects, 43 receiving TPNS and 48 in the control group, provided 2064 pairwise comparisons. More patients treated with TPNS experienced clinical benefit compared with control (WR 4.92, 95% confidence interval 2.27–10.63, P < 0.0001). There were 1111 (53.83%) winning pairwise comparisons for the treatment group and 226 (10.95%) for the control group. Similarly, large WRs were observed for all additional WR hierarchies. Conclusions This WR analysis of the remedē® System Pivotal Trial suggests that TPNS may be superior to untreated CSA in HF patients with CSA using a hierarchical clinical benefit endpoint composed of mortality, HF hospitalization, and health status.https://doi.org/10.1002/ehf2.15074Central sleep apnoeaHeart failureTransvenous phrenic nerve stimulationWin ratio |
| spellingShingle | William T. Abraham Olaf Oldenburg Mitja Lainscak Rami Khayat Jerryll Asin Piotr Ponikowski Robin Germany Scott McKane Maria Rosa Costanzo Win ratio analysis of transvenous phrenic nerve stimulation to treat central sleep apnoea in heart failure ESC Heart Failure Central sleep apnoea Heart failure Transvenous phrenic nerve stimulation Win ratio |
| title | Win ratio analysis of transvenous phrenic nerve stimulation to treat central sleep apnoea in heart failure |
| title_full | Win ratio analysis of transvenous phrenic nerve stimulation to treat central sleep apnoea in heart failure |
| title_fullStr | Win ratio analysis of transvenous phrenic nerve stimulation to treat central sleep apnoea in heart failure |
| title_full_unstemmed | Win ratio analysis of transvenous phrenic nerve stimulation to treat central sleep apnoea in heart failure |
| title_short | Win ratio analysis of transvenous phrenic nerve stimulation to treat central sleep apnoea in heart failure |
| title_sort | win ratio analysis of transvenous phrenic nerve stimulation to treat central sleep apnoea in heart failure |
| topic | Central sleep apnoea Heart failure Transvenous phrenic nerve stimulation Win ratio |
| url | https://doi.org/10.1002/ehf2.15074 |
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