Author + information
- Received December 14, 2011
- Revision received March 13, 2012
- Accepted April 4, 2012
- Published online May 1, 2012.
- Alexander Lauten, MD⁎,⁎ (, )
- Ralf Zahn, MD†,
- Martin Horack, MD‡,
- Horst Sievert, MD§,
- Axel Linke, MD∥,
- Markus Ferrari, MD⁎,
- Axel Harnath, MD¶,
- Eberhard Grube, MD#,
- Ulrich Gerckens, MD⁎⁎,
- Karl-Heinz Kuck, MD††,
- Stefan Sack, MD‡‡,
- Jochen Senges, MD‡,
- Hans R. Figulla, MD⁎,
- German Transcatheter Aortic Valve Interventions Registry Investigators
- ↵⁎Reprint requests and correspondence:
Dr. Alexander Lauten, Department of Internal Medicine I, University Heart Center Jena, Erlanger Allee 101, 07747 Jena, Germany
Objectives The purpose of this study was to evaluate the efficacy and outcome of transcatheter aortic valve implantation (TAVI) in patients with low-flow, low-gradient aortic stenosis (LG-AS).
Background Patients with LG-AS have a poor prognosis with medical treatment and a high risk for surgical aortic valve replacement.
Methods Between January 2009 and June 2010, a total of 1,302 patients underwent TAVI for severe AS and were prospectively included in the multicenter German TAVI registry.
Results LG-AS was present in 149 patients (11.4%; mean age: 80.2 ± 6.3 years). In this subgroup, the EuroSCORE was significantly higher (26.8 ± 16.6 vs. 20.0 ± 13.3; p < 0.0001) compared with patients with high-gradient AS (HG-AS). The procedural success rate (LG-AS: 95.3% vs. HG-AS: 97.5%; p = 0.13) and the rate of TAVI-associated complications were comparable in both groups (new pacemaker: 27.0% vs. 28.1%; p = 0.76; cerebrovascular events: 3.4% vs. 3.1%, p = 0.83). However, post-operative low-output syndrome occurred more frequently in the LG-AS-group (LG-AS: 14.9% vs. HG-AS: 5.7%, p < 0.0001), and mortality at 30 days and 1 year was significantly higher in this subgroup (LG-AS: 12.8% and 36.9% vs. HG-AS: 7.4% and 18.1%; p < 0.001 and p < 0.0001, respectively). Post-operative New York Heart Association functional class improved, and self-assessed quality of life increased significantly, demonstrating a substantial benefit in the LG-AS group at 30 days and 1 year after TAVI.
Conclusions In high-risk patients with LG-AS, TAVI is associated with a significantly higher mortality at 30 days and at 1 year. However, long-term survivors benefit from TAVI with functional improvement and a significantly increased quality of life. Therefore, in view of the poor prognosis with medical treatment, TAVI should be considered an option in high-risk patients with LG-AS.
Drs. Sievert, Linke, Grube, Gerckens, and Sack worked as proctors for either Medtronic or Edwards Lifesciences LLC, or both and received speakers honoraria. Dr. Sievert is member of the scientific advisory board of JenaValve Technology. Dr. Sievert also received study honoraries, travel expenses, and consulting fees from: Abbott, Access Closure, AGA, Angiomed, Arstasis, Atritech, Atrium, Avinger, Bard, Boston Scientific, BridgePoint, Cardiac Dimensions, CardioKinetix, CardioMEMS, Coherex, Contego, CSI, EndoCross, EndoTex, Epitek, Evalve, ev3, FlowCardia, Gore, Guidant, Guided Delivery Systems, Inc., InSeal Medical, Lumen Biomedical, HLT, Kensey Nash, Kyoto Medical, Lifetech, Lutonix, Medinol, Medtronic, NDC, NMT, OAS, Occlutech, Osprey, Ovalis, Pathway, PendraCare, Percardia, pfm Medical, Rox Medical, Sadra, Sorin, Spectranetics, SquareOne, Trireme, Trivascular, Velocimed, Veryan Stock options: Cardiokinetix, Access Closure, Velocimed, Lumen Biomedical, and Coherex. Drs. Ferrari and Figulla are co-founders and co-inventors of JenaValve Technology as well as medical advisors to JenaValve Technology, a company that develops transcatheter implantable aortic valves. Dr. Grube is also a consultant to Medtronic. Dr. Kuck is a consultant for Biosense Webster, St. Jude Medical, Stereotaxis, and Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received December 14, 2011.
- Revision received March 13, 2012.
- Accepted April 4, 2012.
- 2012 American College of Cardiology Foundation