Objective: Patients with heart failure (HF) are at an increased risk of hospital admissions. The aim of this report is to describe the feasibility, safety and accuracy of a novel wireless left atrial pressure (LAP) monitoring system in patients with HF.Methods: The V-LAP Left Atrium Monitoring systEm for Patients With Chronic sysTOlic & Diastolic Congestive heart Failure (VECTOR-HF) study is a prospective, multicenter, single-arm, open label, first-in human clinical trial to assess the safety, performance and usability of the V-LAP system (Vectorious Medical Technologies) in patients with New York Heart Association class III HF. The device was implanted in the interatrial septum via a percutaneous, trans-septal approach guided by fluoroscopy and echocardiography. Primary endpoints included the successful deployment of the implant, the ability to perform initial pressure measurements and safety outcomes.Results: To date, 24 patients have received implants of the LAP-monitoring device. No device related complications have occurred. LAP was reported accurately, agreeing well with wedge pressure at 3 months (Lin concordance correlation coefficient = 0.850). After 6 months, New York Heart Association class improved in 40% of the patients (95% CI = 16.4%-63.5%), while the 6-minute walk test distance had not changed significantly (313.9 +/- 144.9 vs 232.5 +/- 129.9 meters; P = 0.076).Conclusion: The V-LAP left atrium monitoring system appears to be safe and accurate.

The V-LAP System for Remote Left Atrial Pressure Monitoring of Patients With Heart Failure: Remote Left Atrial Pressure Monitoring / Perl, Leor; Meerkin, David; D'amario, Domenico; Avraham, Binyamin Ben; Gal, Tuvia Ben; Weitsman, Tatyana; Hasin, Tal; Ince, Hüseyin; Feickert, Sebastian; D'ancona, Giuseppe; Schaefer, Ulrich; Sievert, Horst; Leyva, Francisco; Whinnett, Zachary I; Di Mario, Carlo; Jonas, Michael; Glikson, Michael; Habib, Manhal; Caspi, Oren; Koren, Oran; Abraham, William T; Kornowski, Ran; Crea, Filippo. - In: JOURNAL OF CARDIAC FAILURE. - ISSN 1071-9164. - STAMPA. - 28:(2022), pp. 963-972. [10.1016/j.cardfail.2021.12.019]

The V-LAP System for Remote Left Atrial Pressure Monitoring of Patients With Heart Failure: Remote Left Atrial Pressure Monitoring

D'ancona, Giuseppe;Di Mario, Carlo;
2022

Abstract

Objective: Patients with heart failure (HF) are at an increased risk of hospital admissions. The aim of this report is to describe the feasibility, safety and accuracy of a novel wireless left atrial pressure (LAP) monitoring system in patients with HF.Methods: The V-LAP Left Atrium Monitoring systEm for Patients With Chronic sysTOlic & Diastolic Congestive heart Failure (VECTOR-HF) study is a prospective, multicenter, single-arm, open label, first-in human clinical trial to assess the safety, performance and usability of the V-LAP system (Vectorious Medical Technologies) in patients with New York Heart Association class III HF. The device was implanted in the interatrial septum via a percutaneous, trans-septal approach guided by fluoroscopy and echocardiography. Primary endpoints included the successful deployment of the implant, the ability to perform initial pressure measurements and safety outcomes.Results: To date, 24 patients have received implants of the LAP-monitoring device. No device related complications have occurred. LAP was reported accurately, agreeing well with wedge pressure at 3 months (Lin concordance correlation coefficient = 0.850). After 6 months, New York Heart Association class improved in 40% of the patients (95% CI = 16.4%-63.5%), while the 6-minute walk test distance had not changed significantly (313.9 +/- 144.9 vs 232.5 +/- 129.9 meters; P = 0.076).Conclusion: The V-LAP left atrium monitoring system appears to be safe and accurate.
2022
28
963
972
Perl, Leor; Meerkin, David; D'amario, Domenico; Avraham, Binyamin Ben; Gal, Tuvia Ben; Weitsman, Tatyana; Hasin, Tal; Ince, Hüseyin; Feickert, Sebastian; D'ancona, Giuseppe; Schaefer, Ulrich; Sievert, Horst; Leyva, Francisco; Whinnett, Zachary I; Di Mario, Carlo; Jonas, Michael; Glikson, Michael; Habib, Manhal; Caspi, Oren; Koren, Oran; Abraham, William T; Kornowski, Ran; Crea, Filippo
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Utilizza questo identificatore per citare o creare un link a questa risorsa: https://hdl.handle.net/2158/1307560
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