Universität zu Köln

Sharif, Faisal, Rosenkranz, Stephen, Bartunek, Jozef, Kempf, Tibor ORCID: 0000-0001-6901-8442, Assmus, Birgit, Mahon, Niall G. and Mullens, Wilfried (2022). Safety and efficacy of a wireless pulmonary artery pressure sensor: primary endpoint results of the SIRONA 2 clinical trial. ESC Heart Fail., 9 (5). S. 2862 - 2873. SAN FRANCISCO: WILEY PERIODICALS, INC. ISSN 2055-5822

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Abstract

Aims Implantable pulmonary artery pressure (PAP) sensors have been shown to reduce heart failure hospitalizations (HFH) in selected patients. The goal of this study was to evaluate the safety and efficacy of a novel wireless PAP monitoring system in patients with heart failure (HF). Methods and results This is a prospective, multi-centre, open-label, single-arm trial evaluating the safety and efficacy of the Cordella (TM) PA Sensor System including the comprehensive Cordella (TM) Heart Failure System (CHFS) in patients with New York Heart Association (NYHA) Class III heart failure with a heart failure hospitalization and/or increase of N-terminal pro-Brain Natriuretic Peptide (NT-proBNP) within 12 months of enrolment. The primary efficacy endpoint was the accuracy of PA sensor mean PAP measurements, compared with fluid-filled catheter mean PAP measurements obtained by standard right heart catheterization (RHC) at 90 days post-implant, assessed in all patients with a successful implant. The primary safety endpoint was freedom from adverse events associated with use of the Cordella PA Sensor System through 30 days post-implant, assessed in all patients who entered the cath lab for PA sensor implant. The PA sensor was successfully implanted in 70 patients. Equivalence between the PA sensor and RHC for mean pulmonary artery pressures was excellent with measurements confined within the equivalence bounds of -4.0 to 4.0 mmHg (mean PAP: 0.0 to 2.9 mmHg, P = 0.003). The device safety profile was excellent with 98.6% freedom from Device System Related Complications, defined as invasive treatment, device explant or death. There were no pressure sensor failures. Patients' adherence to daily measurement transmissions of PAP and vital signs was 94%. Conclusions This trial supports the safety and efficacy of the Cordella PA Sensor System and in conjunction with the CHFS enables comprehensive HF management in NYHA class III heart failure patients.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Sharif, Faisal UNSPECIFIED UNSPECIFIED UNSPECIFIED Rosenkranz, Stephen UNSPECIFIED UNSPECIFIED UNSPECIFIED Bartunek, Jozef UNSPECIFIED UNSPECIFIED UNSPECIFIED Kempf, Tibor UNSPECIFIED orcid.org/0000-0001-6901-8442 UNSPECIFIED Assmus, Birgit UNSPECIFIED UNSPECIFIED UNSPECIFIED Mahon, Niall G. UNSPECIFIED UNSPECIFIED UNSPECIFIED Mullens, Wilfried UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-690888
DOI:	10.1002/ehf2.14006
Journal or Publication Title:	ESC Heart Fail.
Volume:	9
Number:	5
Page Range:	S. 2862 - 2873
Date:	2022
Publisher:	WILEY PERIODICALS, INC
Place of Publication:	SAN FRANCISCO
ISSN:	2055-5822
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language HEART-FAILURE; MANAGEMENT Multiple languages Cardiac & Cardiovascular Systems Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/69088