PMID- 16545654
OWN - NLM
STAT- MEDLINE
DCOM- 20060516
LR  - 20220318
IS  - 1558-3597 (Electronic)
IS  - 0735-1097 (Linking)
VI  - 47
IP  - 6
DP  - 2006 Mar 21
TI  - Treatment of calcific aortic stenosis with the percutaneous heart valve: mid-term 
      follow-up from the initial feasibility studies: the French experience.
PG  - 1214-23
AB  - OBJECTIVES: The aim of this work was to study the feasibility, safety, efficacy, 
      and durability of percutaneous heart valve (PHV) implantation in the aortic 
      position. BACKGROUND: We developed a PHV (equine pericardium valve in a 
      balloon-expandable, stainless-steel stent) to treat patients with inoperable 
      aortic stenosis (AS). METHODS: Thirty-six patients (aortic valve area < or =0.7 
      cm2, New York Heart Association [NYHA] functional class IV, and severe 
      comorbidities), formally declined for surgery, were recruited on a compassionate 
      basis. The PHV was implanted by retrograde or antegrade trans-septal approach. 
      Clinical and echocardiographic outcomes were assessed serially. RESULTS: 
      Twenty-seven patients were implanted successfully (23 antegrade, 4 retrograde) in 
      the subcoronary position with improvement in valve area (0.60 +/- 0.11 cm2 to 
      1.70 +/- 0.10 cm2, p < 0.0001) and transvalvular gradient (37 +/- 13 mm Hg to 9 
      +/- 2 mm Hg, p < 0.0001). Paravalvular aortic regurgitation was grade 0 to 1 (n = 
      10), grade 2 (n = 12), and grade 3 (n = 5). One week post-procedure, improvement 
      in left ventricular function (45 +/- 18% to 53 +/- 14%, p = 0.02) was most 
      pronounced in patients with ejection fraction <50% (35 +/- 10% to 50 +/- 16%, p < 
      0.0001). Thirty-day major adverse events after successful implantation were 26% 
      (pericardial tamponade, stroke, arrhythmia, urosepsis, and one death unexplained 
      at autopsy). Eleven patients are currently alive with follow-up of 9 months (n = 
      2), 10 months (n = 3), 11 months (n = 1), 12 months (n = 2), 23 months (n = 1), 
      and 26 months (n = 2). All patients experienced amelioration of symptoms (>90% 
      NYHA functional class I to II). Percutaneous heart valve function remained 
      unchanged during follow-up, and no deaths were device-related. CONCLUSIONS: 
      Percutaneous heart valve implantation is feasible in inoperable patients with 
      end-stage AS leading to hemodynamic and clinical improvement. Continued advances 
      and improved patient selection should decrease adverse events in the near future.
FAU - Cribier, Alain
AU  - Cribier A
AD  - Department of Cardiology, Charles Nicolle Hospital, Rouen, France. 
      Alain.Cribier@chu-rouen.fr
FAU - Eltchaninoff, Helene
AU  - Eltchaninoff H
FAU - Tron, Christophe
AU  - Tron C
FAU - Bauer, Fabrice
AU  - Bauer F
FAU - Agatiello, Carla
AU  - Agatiello C
FAU - Nercolini, Deborah
AU  - Nercolini D
FAU - Tapiero, Sydney
AU  - Tapiero S
FAU - Litzler, Pierre-Yves
AU  - Litzler PY
FAU - Bessou, Jean-Paul
AU  - Bessou JP
FAU - Babaliaros, Vasilis
AU  - Babaliaros V
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20060209
PL  - United States
TA  - J Am Coll Cardiol
JT  - Journal of the American College of Cardiology
JID - 8301365
SB  - IM
MH  - Aged
MH  - Aged, 80 and over
MH  - *Aortic Valve
MH  - Aortic Valve Stenosis/*complications/*surgery
MH  - Calcinosis/*complications/*surgery
MH  - Feasibility Studies
MH  - Female
MH  - Follow-Up Studies
MH  - Heart Valve Diseases/complications/surgery
MH  - *Heart Valve Prosthesis
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Time Factors
EDAT- 2006/03/21 09:00
MHDA- 2006/05/17 09:00
CRDT- 2006/03/21 09:00
PHST- 2005/12/20 00:00 [received]
PHST- 2006/01/19 00:00 [revised]
PHST- 2006/01/24 00:00 [accepted]
PHST- 2006/03/21 09:00 [pubmed]
PHST- 2006/05/17 09:00 [medline]
PHST- 2006/03/21 09:00 [entrez]
AID - S0735-1097(06)00296-8 [pii]
AID - 10.1016/j.jacc.2006.01.049 [doi]
PST - ppublish
SO  - J Am Coll Cardiol. 2006 Mar 21;47(6):1214-23. doi: 10.1016/j.jacc.2006.01.049. 
      Epub 2006 Feb 9.