Safety, usability, and performance of a wireless left atrial pressure monitoring system in patients with heart failure: the VECTOR-HF trial.

Autor: D'Amario D; Department of Cardiovascular Sciences, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.; Department of Cardiovascular and Thoracic Sciences, Catholic University of the Sacred Heart, Rome, Italy.; Department of Translational Medicine, Maggiore della Carità Hospital, University of Eastern Piedmont, Novara, Italy., Meerkin D; Jesselson Integrated Heart Center, Shaare Zedek Medical Center, Hebrew University, Jerusalem, Israel., Restivo A; Department of Cardiovascular and Thoracic Sciences, Catholic University of the Sacred Heart, Rome, Italy., Ince H; Department of Cardiology, Vivantes Klinikum im Friedrichshain and Am Urban, Berlin, Germany.; Department of Cardiology, Rostock University, Medical Center, Rostock, Germany., Sievert H; CardioVascular Center Frankfurt, Frankfurt, Germany., Wiese A; Department of Cardiology, Angiology and Intensive Care Medicine, Marienhospital, Hamburg, Germany., Schaefer U; Innovative Interventional Cardiology, Cardiovascular Center, Bad Bevensen, Germany., Trani C; Department of Cardiovascular Sciences, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.; Department of Cardiovascular and Thoracic Sciences, Catholic University of the Sacred Heart, Rome, Italy., Bayes-Genis A; Department of Cardiology, Germans Trias University Hospital, Badalona, Spain., Leyva F; Department of Cardiovascular Medicine, Queen Elizabeth Hospital, Birmingham, UK., Whinnett ZI; National Heart and Lung Institute, Imperial College London, Hammersmith Hospital, London, UK., Di Mario C; Structural Interventional Cardiology Division, Department of Experimental and Clinical Medicine, Careggi University Hospital, Florence, Italy., Jonas M; Heart Institute, Kaplan Medical Center, Hebrew University School of Medicine, Rehovot, Israel., Manhal H; Departments of Cardiology, Rambam Medical Centre and B Rappaport Faculty of Medicine, Technion Medical School Haifa, Haifa, Israel., Amat-Santos IJ; CIBERCV, Cardiology Department, Hospital Clínico Universitario de Valladolid, Valladolid, Spain., Del Trigo M; Interventional Cardiology, Hospital Puerta de Hierro Majadahonda, Madrid, Spain., Gal TB; Cardiology Department, Rabin Medical Center, Tel-Aviv University, Petach Tikva, Israel.; School of Medicine, Tel-Aviv University, Tel-Aviv, Israel., Avraham BB; Cardiology Department, Rabin Medical Center, Tel-Aviv University, Petach Tikva, Israel.; School of Medicine, Tel-Aviv University, Tel-Aviv, Israel., Hasin T; Jesselson Integrated Heart Center, Shaare Zedek Medical Center, Hebrew University, Jerusalem, Israel., Feickert S; Department of Cardiology, Vivantes Klinikum im Friedrichshain and Am Urban, Berlin, Germany.; Department of Cardiology, Rostock University, Medical Center, Rostock, Germany., D'Ancona G; Department of Cardiology, Vivantes Klinikum im Friedrichshain and Am Urban, Berlin, Germany.; Department of Cardiology, Rostock University, Medical Center, Rostock, Germany., Altisent OA; Department of Cardiology, Germans Trias University Hospital, Badalona, Spain.; Interventional Cardiologist, ICCV Hospital Clínic de Barcelona, Barcelona, Spain., Koren O; School of Medicine, Tel-Aviv University, Tel-Aviv, Israel., Caspi O; Departments of Cardiology, Rambam Medical Centre and B Rappaport Faculty of Medicine, Technion Medical School Haifa, Haifa, Israel., Abraham WT; Division of Cardiovascular Medicine, The Ohio State University, Columbus, OH, USA., Crea F; Department of Cardiovascular Sciences, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.; Department of Cardiovascular and Thoracic Sciences, Catholic University of the Sacred Heart, Rome, Italy., Anker SD; Department of Cardiology (CVK) of German Heart Center Charité, Institute of Health Center for Regenerative Therapies (BCRT); German Centre for Cardiovascular Research (DZHK), partner site Berlin, Charité Universitätsmedizin, Berlin, Germany., Kornowski R; Cardiology Department, Rabin Medical Center, Tel-Aviv University, Petach Tikva, Israel., Perl L; Cardiology Department, Rabin Medical Center, Tel-Aviv University, Petach Tikva, Israel.; School of Medicine, Tel-Aviv University, Tel-Aviv, Israel.
Jazyk: angličtina
Zdroj: European journal of heart failure [Eur J Heart Fail] 2023 Jun; Vol. 25 (6), pp. 902-911. Date of Electronic Publication: 2023 May 10.
DOI: 10.1002/ejhf.2869
Abstrakt: Aims: In heart failure (HF), implantable haemodynamic monitoring devices have been shown to optimize therapy, anticipating clinical decompensation and preventing hospitalization. Direct left-sided haemodynamic sensors offer theoretical benefits beyond pulmonary artery pressure monitoring systems. We evaluated the safety, usability, and performance of a novel left atrial pressure (LAP) monitoring system in HF patients.
Methods and Results: The VECTOR-HF study (NCT03775161) was a first-in-human, prospective, multicentre, single-arm, clinical trial enrolling 30 patients with HF. The device consisted of an interatrial positioned leadless sensor, able to transmit LAP data wirelessly. After 3 months, a right heart catheterization was performed to correlate mean pulmonary capillary wedge pressure (PCWP) with simultaneous mean LAP obtained from the device. Remote LAP measurements were then used to guide patient management. The miniaturized device was successfully implanted in all 30 patients, without acute major adverse cardiac and neurological events (MACNE). At 3 months, freedom from short-term MACNE was 97%. Agreement between sensor-calculated LAP and PCWP was consistent, with a mean difference of -0.22 ± 4.92 mmHg, the correlation coefficient and the Lin's concordance correlation coefficient values were equal to 0.79 (p < 0.0001) and 0.776 (95% confidence interval 0.582-0.886), respectively. Preliminary experience with V-LAP-based HF management was associated with significant improvements in New York Heart Association (NYHA) functional class (32% of patients reached NYHA class II at 6 months, p < 0.005; 60% of patients at 12 months, p < 0.005) and 6-min walk test distance (from 244.59 ± 119.59 m at baseline to 311.78 ± 129.88 m after 6 months, p < 0.05, and 343.95 ± 146.15 m after 12 months, p < 0.05).
Conclusion: The V-LAP™ monitoring system proved to be generally safe and provided a good correlation with invasive PCWP. Initial evidence also suggests possible improvement in HF clinical symptoms.
(© 2023 The Authors. European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)
Databáze: MEDLINE
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