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Title: | Twelve-month follow-up results from the SIRONA 2 clinical trial | Authors: | Sharif, Faisal Rosenkranz, Stephen Bartunek, Jozef Kempf, Tibor Assmus, Birgit Mahon, Niall G. Hiivala, Nicholas J. MULLENS, Wilfried |
Issue Date: | 2024 | Publisher: | WILEY PERIODICALS, INC | Source: | ESC Heart Failure, | Status: | Early view | Abstract: | AimsIn the SIRONA 2 trial, the safety and efficacy of pulmonary artery (PA) pressure (PAP)-guided heart failure (HF) management using a novel PAP sensor were assessed at 30 and 90 days, respectively, and both endpoints were met. The current study examines the prespecified secondary endpoints of safety and accuracy of the PA sensor along with HF hospitalizations and mortality, HF symptoms, functional capacity, quality of life, and patient compliance through 12 months. Methods and resultsSIRONA 2 is a prospective, multi-centre, open-label, single-arm trial evaluating the Cordella (TM) PA Sensor System in 70 patients with New York Heart Association (NYHA) functional class III HF with a prior HF hospitalization and/or increase of N-terminal pro-brain natriuretic peptide within 12 months of enrolment. Sensor accuracy was assessed and compared with measurements obtained by standard right heart catheterization (RHC). Safety was defined as freedom from prespecified adverse events associated with use of the Cordella PA Sensor System and was assessed in all patients who entered the cath lab for PA sensor implant. HF hospitalizations and mortality, HF symptoms, functional capacity, quality of life, and patient compliance were also assessed. At 12 months, there was good agreement between the Cordella PA Sensor System and RHC, with the average difference for mean PAP being 2.9 +/- 7.3 mmHg. The device safety profile was excellent with 98.4% freedom from device/system-related complications. There were no pressure sensor failures. HF hospitalizations and mortality were low with a rate of 0.33 event per patient year. Symptoms as assessed by NYHA (P < 0.0001) and functional capacity as measured by 6 min walk test (P = 0.02) were significantly improved. Patients' adherence to daily transmissions of PAP and vital signs measurements was 95%. ConclusionsLong-term follow-up of the SIRONA 2 trial supports the safety and accuracy of the Cordella PA Sensor System in enabling comprehensive HF management in NYHA class III HF patients. | Notes: | Mullens, W (corresponding author), Ziekenhuis Oost Limburg, Dept Cardiovasc Med, Schiep Bos 6, B-3600 Genk, Belgium. wilfried.mullens@gmail.com |
Keywords: | Remote patient monitoring;Heart failure;GDMT;Pulmonary artery pressure | Document URI: | http://hdl.handle.net/1942/42403 | ISSN: | 2055-5822 | e-ISSN: | 2055-5822 | DOI: | 10.1002/ehf2.14657 | ISI #: | 001150751800001 | Rights: | 2024 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology. This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made. | Category: | A1 | Type: | Journal Contribution |
Appears in Collections: | Research publications |
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Twelve‐month follow‐up results from the SIRONA 2 clinical trial.pdf | Early view | 1.31 MB | Adobe PDF | View/Open |
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