PMID- 27025435
OWN - NLM
STAT- MEDLINE
DCOM- 20160414
LR  - 20160330
IS  - 1474-547X (Electronic)
IS  - 0140-6736 (Linking)
VI  - 387
IP  - 10025
DP  - 2016 Mar 26
TI  - Unidirectional left-to-right interatrial shunting for treatment of patients with 
      heart failure with reduced ejection fraction: a safety and proof-of-principle 
      cohort study.
PG  - 1290-7
LID - S0140-6736(16)00585-7 [pii]
LID - 10.1016/S0140-6736(16)00585-7 [doi]
AB  - BACKGROUND: In patients with heart failure, interventions to reduce elevated left 
      atrial pressure improve symptoms and reduce the risk of hospital admission. We 
      aimed to assess the safety and potential efficacy of therapeutic left-to-right 
      interatrial shunting in patients with heart failure with reduced ejection 
      fraction. METHODS: We did this proof-of-principle cohort study at one centre in 
      Canada. Patients (aged >/=18 years) with New York Heart Association (NYHA) class 
      III chronic heart failure with reduced ejection fraction were enrolled under the 
      Canadian special access programme. Shunt implants were done after transseptal 
      catheterisation with transoesophageal echocardiographic guidance under general 
      anaesthesia. Patients had clinical and echocardiography evaluations at baseline 
      and months 1 and 3 after shunt implantation. FINDINGS: Between Oct 10, 2013, and 
      March 27, 2015, we enrolled ten patients. The device was successfully implanted 
      in all patients; no device-related or procedural adverse events occurred during 
      follow-up. Transoesophageal echocardiography at 1 month showed that all shunts 
      were patent, with no thrombosis or migration. From baseline to 3 month follow-up, 
      we recorded improvements in NYHA classification (from class III to class II in 
      seven [78%] of nine patients, from class III to class I in one [11%] patient, and 
      no change in one [11%] patient; p=0.0004); quality of life, as assessed by the 
      Duke Activity Status Index (from a mean score of 13 [SD 6.2] to 24.8 [12.9]; 
      p=0.016) and the Kansas City Cardiomyopathy Questionnaire (from a mean score of 
      44.3 [SD 9.8] to 79.1 [13.0]; p=0.0001); and 6 min walk test distance (from a 
      mean of 244 m [SD 112] to 318 m [134]; p=0.016). Pulmonary capillary wedge 
      pressure was reduced from a mean of 23 mm Hg (SD 5) at baseline to 17 mm Hg (8) 
      at 3 months (p=0.035), with no changes in right atrial pressure, pulmonary 
      arterial pressure, or pulmonary resistance. No patient was admitted to hospital 
      for worsening heart failure. One (10%) patient was admitted to hospital with 
      gastrointestinal bleeding at month 1; one (10%) patient died after incessant 
      ventricular tachycardia storm, which led to terminal heart failure 2 months 
      post-procedure. INTERPRETATION: This first-in-man experience with an implanted 
      left-to-right interatrial shunt demonstrates initial safety and early beneficial 
      clinical and haemodynamic outcomes in patients with heart failure with reduced 
      ejection fraction. Further large-scale randomised studies are warranted. FUNDING: 
      V-Wave.
CI  - Copyright (c) 2016 Elsevier Ltd. All rights reserved.
FAU - Del Trigo, Maria
AU  - Del Trigo M
AD  - Quebec Heart and Lung Institute, Laval University, Quebec City, QC, Canada.
FAU - Bergeron, Sebastien
AU  - Bergeron S
AD  - Quebec Heart and Lung Institute, Laval University, Quebec City, QC, Canada.
FAU - Bernier, Mathieu
AU  - Bernier M
AD  - Quebec Heart and Lung Institute, Laval University, Quebec City, QC, Canada.
FAU - Amat-Santos, Ignacio J
AU  - Amat-Santos IJ
AD  - Quebec Heart and Lung Institute, Laval University, Quebec City, QC, Canada.
FAU - Puri, Rishi
AU  - Puri R
AD  - Quebec Heart and Lung Institute, Laval University, Quebec City, QC, Canada.
FAU - Campelo-Parada, Francisco
AU  - Campelo-Parada F
AD  - Quebec Heart and Lung Institute, Laval University, Quebec City, QC, Canada.
FAU - Altisent, Omar Abdul-Jawad
AU  - Altisent OA
AD  - Quebec Heart and Lung Institute, Laval University, Quebec City, QC, Canada.
FAU - Regueiro, Ander
AU  - Regueiro A
AD  - Quebec Heart and Lung Institute, Laval University, Quebec City, QC, Canada.
FAU - Eigler, Neal
AU  - Eigler N
AD  - V-Wave, Caesarea, Israel.
FAU - Rozenfeld, Erez
AU  - Rozenfeld E
AD  - V-Wave, Caesarea, Israel.
FAU - Pibarot, Philippe
AU  - Pibarot P
AD  - Quebec Heart and Lung Institute, Laval University, Quebec City, QC, Canada.
FAU - Abraham, William T
AU  - Abraham WT
AD  - Ohio State University, Columbus, OH, USA.
FAU - Rodes-Cabau, Josep
AU  - Rodes-Cabau J
AD  - Quebec Heart and Lung Institute, Laval University, Quebec City, QC, Canada. 
      Electronic address: josep.rodes@criucpq.ulaval.ca.
LA  - eng
PT  - Clinical Study
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - Lancet
JT  - Lancet (London, England)
JID - 2985213R
SB  - IM
CIN - Lancet. 2016 Mar 26;387(10025):1253-5. PMID: 27025419
CIN - Nat Rev Cardiol. 2016 Jun;13(6):312-3. PMID: 27079923
MH  - Canada
MH  - Cardiac Surgical Procedures/methods
MH  - Cohort Studies
MH  - Female
MH  - Heart Atria/surgery
MH  - Heart Failure/physiopathology/*surgery
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Prostheses and Implants
MH  - Prosthesis Design
MH  - Stroke Volume
EDAT- 2016/03/31 06:00
MHDA- 2016/04/15 06:00
CRDT- 2016/03/31 06:00
PHST- 2016/03/31 06:00 [entrez]
PHST- 2016/03/31 06:00 [pubmed]
PHST- 2016/04/15 06:00 [medline]
AID - S0140-6736(16)00585-7 [pii]
AID - 10.1016/S0140-6736(16)00585-7 [doi]
PST - ppublish
SO  - Lancet. 2016 Mar 26;387(10025):1290-7. doi: 10.1016/S0140-6736(16)00585-7.