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J Am Coll Cardiol. 2017 Dec 5;70(22):2752-2763. doi: 10.1016/j.jacc.2017.10.006.

Transcatheter Aortic Valve Replacement in Pure Native Aortic Valve Regurgitation.

Author information

1
Department of Interventional Cardiology, Cedars-Sinai Heart Institute, Los Angeles, California.
2
Department of Cardiology, Asklepios Klink St. Georg, Hamburg, Germany.
3
Clinic for Cardiovascular Surgery, German Heart Center Munich, Germany.
4
Department of General and interventional Cardiology, University Heart Center, Hamburg, Germany.
5
Cardiothoracic Department, Spedali Civili Brescia, Brescia, Italy.
6
Hospital Universitaro Virgen de la Victoria, Spain.
7
Hamburg University Cardiovascular Center, Hamburg, Germany.
8
Institute of Heart Sciences, Hospital Clínico Universitario de Valladolid, Valladolid, Spain.
9
Department of Cardiology, Clinique Pasteur, Toulouse, France.
10
Division of Cardiology, Pulmonology, and Vascular Medicine, University Hospital Dusseldorf, Dusseldorf, Germany.
11
Department of Thoracic and Cardiovascular Surgery, Heart and Diabetes Center NRW, Ruhr-University Bochum, Bad Oeynhausen, Germany.
12
Interventional Cardiology Unit, EMO-GVM Centro Cuore Columbus & San Raffaele Scientific Institute, Milan, Italy San Raffaele Hospital, Milan, Italy.
13
Clinic for Cardiovascular Surgery, German Heart Center Munich, Germany; German Center for Cardiovascular Research, Partner Site Munich Heart Alliance, Munich, Germany.
14
University Heart Center, University Hospital Zurich, Zurich, Switzerland.
15
Sussex Cardiac Centre, Brighton and Sussex University Hospitals NHS Trust, Brighton, United Kingdom.
16
Department of Cardiology, University of Texas Health Science Center, Houston, Texas.
17
Kerckhoff Heart and Thorax Center, Department of Cardiology/Cardiac Surgery, Bad Nauheim, Germany.
18
Cardiac Surgery Unit, Cardiocentro Ticino Foundation, Lugano, Switzerland.
19
Division of Cardiology, Ferrarotto Hospital, University of Catania, Catania, Italy.
20
Department of Cardiology, Leiden University Medical Center, Leiden 2333 ZA, the Netherlands.
21
Istituto Clinico Sant'Ambrogio, Gruppo Ospedaliero San Donato, Milan, Italy.
22
Department Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy.
23
The Valve and Structural Heart Interventional Center, University Hospitals Case Medical Center, Cleveland, Ohio.
24
Department of Cardiology, National University Heart Centre, Singapore.
25
Department of Cardiology, Hospital General Universitario Gregorio Maranon, Madrid, Spain.
26
Cardiology Department, University Hospital of Vigo, Vigo, Spain.
27
Division of Cardiology, Sunnybrook Health Science Centre, Toronto, Ontario, Canada.
28
Heart Center Brandenburg in Bernau and Brandenburg Medical School, Bernau, Germany.
29
Department of Cardiology and Vascular Medicine, CardioVascular Center, Frankfurt, Germany.
30
German Center for Cardiovascular Research, Partner Site Munich Heart Alliance, Munich, Germany; Klinik für Herz- und Kreislauferkrankungen, Deutsches Herzzentrum München, Technische Universität München, Munich, Germany.
31
Department of Cardiology, St Thomas' Hospital, London, United Kingdom.
32
Department of Cardiology, CHU Lille, Inserm, U1011, Université Lille, Lille, France.
33
Heart Center, Segeberger Kliniken, Bad Segeberg, German.
34
Division of Cardiology, Hospital Clinicio San Carlos, Madrid, Spain.
35
Department of Cardiac Surgery, University of Halle, Halle, Germany.
36
Department of Cardiac, Thoracic and Vascular Sciences, University Hospital of Padova, Padova, Italy.
37
Division of Cardiology, Heart Center, Cheng Hsin General Hospital, Taipei, Taiwan.
38
Department of Cardiology, IRCCS Pol San Donato, San Donato Milanese, Milan, Italy.
39
Interventional Cardiology, Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands.
40
Division of Cardiovascular Diseases, Intermountain Heart Institute, Salt Lake City, Utah.
41
Hospital Universitario Central de Asturias, Oviedo, Spain.
42
Department of Cardiovascular Disease, Baylor Scott and White Health Care System, Plano, Texas.
43
Department of Interventional Cardiology, Cedars-Sinai Heart Institute, Los Angeles, California. Electronic address: Raj.Makkar@cshs.org.

Abstract

BACKGROUND:

Limited data exist about safety and efficacy of transcatheter aortic valve replacement (TAVR) in patients with pure native aortic regurgitation (AR).

OBJECTIVES:

This study sought to compare the outcomes of TAVR with early- and new-generation devices in symptomatic patients with pure native AR.

METHODS:

From the pure native AR TAVR multicenter registry, procedural and clinical outcomes were assessed according to VARC-2 criteria and compared between early- and new-generation devices.

RESULTS:

A total of 331 patients with a mean STS score of 6.7 ± 6.7 underwent TAVR. The early- and new-generation devices were used in 119 patients (36.0%) and 212 patients (64.0%), respectively. STS score tended to be lower in the new-generation device group (6.2 ± 6.7 vs. 7.6 ± 6.7; p = 0.08), but transfemoral access was more frequently used in the early-generation device group (87.4% vs. 60.8%; p < 0.001). Compared with the early-generation devices, the new-generation devices were associated with a significantly higher device success rate (81.1% vs. 61.3%; p < 0.001) due to lower rates of second valve implantation (12.7% vs. 24.4%; p = 0.007) and post-procedural AR ≥ moderate (4.2% vs. 18.8%; p < 0.001). There were no significant differences in major 30-day endpoints between the 2 groups. The cumulative rates of all-cause and cardiovascular death at 1-year follow-up were 24.1% and 15.6%, respectively. The 1-year all-cause mortality rate was significantly higher in the patients with post-procedural AR ≥ moderate compared with those with post-procedural AR ≤ mild (46.1% vs. 21.8%; log-rank p = 0.001). On multivariable analysis, post-procedural AR ≥ moderate was independently associated with 1-year all-cause mortality (hazard ratio: 2.85; 95% confidence interval: 1.52 to 5.35; p = 0.001).

CONCLUSIONS:

Compared with the early-generation devices, TAVR using the new-generation devices was associated with improved procedural outcomes in treating patients with pure native AR. In patients with pure native AR, significant post-procedural AR was independently associated with increased mortality.

KEYWORDS:

aortic regurgitation; transcatheter valve implantation

PMID:
29191323
DOI:
10.1016/j.jacc.2017.10.006
[Indexed for MEDLINE]
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