PMID- 37092287
OWN - NLM
STAT- MEDLINE
DCOM- 20230712
LR  - 20230718
IS  - 1879-0844 (Electronic)
IS  - 1388-9842 (Linking)
VI  - 25
IP  - 6
DP  - 2023 Jun
TI  - Safety, usability, and performance of a wireless left atrial pressure monitoring 
      system in patients with heart failure: the VECTOR-HF trial.
PG  - 902-911
LID - 10.1002/ejhf.2869 [doi]
AB  - 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.
CI  - (c) 2023 The Authors. European Journal of Heart Failure published by John Wiley & 
      Sons Ltd on behalf of European Society of Cardiology.
FAU - D'Amario, Domenico
AU  - D'Amario D
AD  - Department of Cardiovascular Sciences, Fondazione Policlinico Universitario A. 
      Gemelli IRCCS, Rome, Italy.
AD  - Department of Cardiovascular and Thoracic Sciences, Catholic University of the 
      Sacred Heart, Rome, Italy.
AD  - Department of Translational Medicine, Maggiore della Carita Hospital, University 
      of Eastern Piedmont, Novara, Italy.
FAU - Meerkin, David
AU  - Meerkin D
AD  - Jesselson Integrated Heart Center, Shaare Zedek Medical Center, Hebrew 
      University, Jerusalem, Israel.
FAU - Restivo, Attilio
AU  - Restivo A
AD  - Department of Cardiovascular and Thoracic Sciences, Catholic University of the 
      Sacred Heart, Rome, Italy.
FAU - Ince, Huseyin
AU  - Ince H
AD  - Department of Cardiology, Vivantes Klinikum im Friedrichshain and Am Urban, 
      Berlin, Germany.
AD  - Department of Cardiology, Rostock University, Medical Center, Rostock, Germany.
FAU - Sievert, Horst
AU  - Sievert H
AD  - CardioVascular Center Frankfurt, Frankfurt, Germany.
FAU - Wiese, Andrea
AU  - Wiese A
AD  - Department of Cardiology, Angiology and Intensive Care Medicine, Marienhospital, 
      Hamburg, Germany.
FAU - Schaefer, Ulrich
AU  - Schaefer U
AD  - Innovative Interventional Cardiology, Cardiovascular Center, Bad Bevensen, 
      Germany.
FAU - Trani, Carlo
AU  - Trani C
AD  - Department of Cardiovascular Sciences, Fondazione Policlinico Universitario A. 
      Gemelli IRCCS, Rome, Italy.
AD  - Department of Cardiovascular and Thoracic Sciences, Catholic University of the 
      Sacred Heart, Rome, Italy.
FAU - Bayes-Genis, Antoni
AU  - Bayes-Genis A
AD  - Department of Cardiology, Germans Trias University Hospital, Badalona, Spain.
FAU - Leyva, Francisco
AU  - Leyva F
AD  - Department of Cardiovascular Medicine, Queen Elizabeth Hospital, Birmingham, UK.
FAU - Whinnett, Zachary I
AU  - Whinnett ZI
AD  - National Heart and Lung Institute, Imperial College London, Hammersmith Hospital, 
      London, UK.
FAU - Di Mario, Carlo
AU  - Di Mario C
AD  - Structural Interventional Cardiology Division, Department of Experimental and 
      Clinical Medicine, Careggi University Hospital, Florence, Italy.
FAU - Jonas, Michael
AU  - Jonas M
AD  - Heart Institute, Kaplan Medical Center, Hebrew University School of Medicine, 
      Rehovot, Israel.
FAU - Manhal, Habib
AU  - Manhal H
AD  - Departments of Cardiology, Rambam Medical Centre and B Rappaport Faculty of 
      Medicine, Technion Medical School Haifa, Haifa, Israel.
FAU - Amat-Santos, Ignacio J
AU  - Amat-Santos IJ
AD  - CIBERCV, Cardiology Department, Hospital Clinico Universitario de Valladolid, 
      Valladolid, Spain.
FAU - Del Trigo, Maria
AU  - Del Trigo M
AD  - Interventional Cardiology, Hospital Puerta de Hierro Majadahonda, Madrid, Spain.
FAU - Gal, Tuvia Ben
AU  - Gal TB
AD  - Cardiology Department, Rabin Medical Center, Tel-Aviv University, Petach Tikva, 
      Israel.
AD  - School of Medicine, Tel-Aviv University, Tel-Aviv, Israel.
FAU - Avraham, Binyamin Ben
AU  - Avraham BB
AD  - Cardiology Department, Rabin Medical Center, Tel-Aviv University, Petach Tikva, 
      Israel.
AD  - School of Medicine, Tel-Aviv University, Tel-Aviv, Israel.
FAU - Hasin, Tal
AU  - Hasin T
AD  - Jesselson Integrated Heart Center, Shaare Zedek Medical Center, Hebrew 
      University, Jerusalem, Israel.
FAU - Feickert, Sebastian
AU  - Feickert S
AD  - Department of Cardiology, Vivantes Klinikum im Friedrichshain and Am Urban, 
      Berlin, Germany.
AD  - Department of Cardiology, Rostock University, Medical Center, Rostock, Germany.
FAU - D'Ancona, Giuseppe
AU  - D'Ancona G
AD  - Department of Cardiology, Vivantes Klinikum im Friedrichshain and Am Urban, 
      Berlin, Germany.
AD  - Department of Cardiology, Rostock University, Medical Center, Rostock, Germany.
FAU - Altisent, Omar Abdul-Jawad
AU  - Altisent OA
AD  - Department of Cardiology, Germans Trias University Hospital, Badalona, Spain.
AD  - Interventional Cardiologist, ICCV Hospital Clinic de Barcelona, Barcelona, Spain.
FAU - Koren, Oran
AU  - Koren O
AD  - School of Medicine, Tel-Aviv University, Tel-Aviv, Israel.
FAU - Caspi, Oren
AU  - Caspi O
AD  - Departments of Cardiology, Rambam Medical Centre and B Rappaport Faculty of 
      Medicine, Technion Medical School Haifa, Haifa, Israel.
FAU - Abraham, William T
AU  - Abraham WT
AD  - Division of Cardiovascular Medicine, The Ohio State University, Columbus, OH, 
      USA.
FAU - Crea, Filippo
AU  - Crea F
AD  - Department of Cardiovascular Sciences, Fondazione Policlinico Universitario A. 
      Gemelli IRCCS, Rome, Italy.
AD  - Department of Cardiovascular and Thoracic Sciences, Catholic University of the 
      Sacred Heart, Rome, Italy.
FAU - Anker, Stefan D
AU  - Anker SD
AD  - Department of Cardiology (CVK) of German Heart Center Charite, Institute of 
      Health Center for Regenerative Therapies (BCRT); German Centre for Cardiovascular 
      Research (DZHK), partner site Berlin, Charite Universitatsmedizin, Berlin, 
      Germany.
FAU - Kornowski, Ran
AU  - Kornowski R
AD  - Cardiology Department, Rabin Medical Center, Tel-Aviv University, Petach Tikva, 
      Israel.
FAU - Perl, Leor
AU  - Perl L
AD  - Cardiology Department, Rabin Medical Center, Tel-Aviv University, Petach Tikva, 
      Israel.
AD  - School of Medicine, Tel-Aviv University, Tel-Aviv, Israel.
CN  - VECTOR-HF Trial Investigators
LA  - eng
SI  - ClinicalTrials.gov/NCT03775161
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20230510
PL  - England
TA  - Eur J Heart Fail
JT  - European journal of heart failure
JID - 100887595
SB  - IM
MH  - Humans
MH  - *Atrial Pressure
MH  - Cardiac Catheterization/methods
MH  - *Heart Failure
MH  - Prospective Studies
MH  - Pulmonary Wedge Pressure
OTO - NOTNLM
OT  - Device
OT  - Digital health
OT  - Haemodynamic remote monitoring
OT  - Heart failure
OT  - Remote care
EDAT- 2023/04/24 06:42
MHDA- 2023/07/12 06:42
CRDT- 2023/04/24 04:23
PHST- 2023/04/09 00:00 [revised]
PHST- 2022/09/23 00:00 [received]
PHST- 2023/04/17 00:00 [accepted]
PHST- 2023/07/12 06:42 [medline]
PHST- 2023/04/24 06:42 [pubmed]
PHST- 2023/04/24 04:23 [entrez]
AID - 10.1002/ejhf.2869 [doi]
PST - ppublish
SO  - Eur J Heart Fail. 2023 Jun;25(6):902-911. doi: 10.1002/ejhf.2869. Epub 2023 May 
      10.