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Age-Related Outcomes after Transcatheter Aortic Valve Implantation: Insights from the SwissTAVI Registry

Introduction: Transcatheter aortic valve implantation (TAVI) is the preferred treatment for elderly patients with severe aortic stenosis and is expanding into lower age groups. We investigated age-related outcomes of patients undergoing TAVI as assessed in a nationwide, prospective, multicenter cohort study. 
 
Methods: We analyzed data from the SwissTAVI Registry. Clinical outcomes were compared between patients aged 70years or younger (n=324), 70-79years (n=1913), 80-89years (n=4353) and older than 90years (n=507). Observed deaths were correlated with expected deaths in the general Swiss population using standardized mortality ratios (SMR). 
 
Results: Between 02/2011 and 06/2018, 7097 patients (age 82·0±6.4years, 49·6%females) underwent TAVI at 15 hospitals in Switzerland. Procedural characteristics were similar; however, older patients more often had discharge to the referring hospital or a rehabilitation facility after TAVI. Using adjusted analyses, a linear trend for mortality (30-day HRadj 1·45; 95%CI 1·18-1·77; 1-year HRadj 1·12; 95%CI 1·01-1·24), cerebrovascular accidents (30-day HRadj 1·35; 95%CI 1·09-1·66; 1-year HRadj 1·21; 95%CI 1·02-1·45) and pacemaker implantation (30-day HRadj 1·23; 95%CI 1·12-1·34; 1-year HRadj 1·19; 95%CI 1·09-1·30) was observed with increasing age. Furthermore, SMRs were 12·63(95%CI 9·06-17·58), 4·09(3·56-4·74), 1·63(1·50-1·78) and 0·93(0·76-1·14) for TAVI patients in relation to the Swiss population <70, 70-79, 80-89 and ≥90 years of age, respectively. 
 
Conclusions: Age is associated with a linear trend for mortality, stroke and pacemaker implantation after TAVI. While younger TAVI patients were at increased risk of mortality when compared with expected rates of mortality from the general Swiss population, this analysis showed no additional effect for patients aged ≥90 years. 
 
Trial Registration: ClinicalTrials.gov registration number NCT013682. 
 
Funding Statement: The SwissTAVI Registry is supported by a study grant from the Swiss Heart Foundation and the Swiss Working Group of Interventional Cardiology and Acute Coronary Syndromes, and is sponsored by research grants from Medtronic, Edwards Lifesciences, Boston Scientific and Abbott. 
 
Declaration of Interests: S. Stortecky has received research grants to the institution from Edwards Lifesciences, Medtronic, Abbott Vascular and Boston Scientific, serves as consultant for BTG and Teleflex and has received speaker fees from BTG and Boston Scientific. 
 
C. Templin reports receiving fees outside the submitted work for serving on advisory boards from Astra Zeneca and Amgen; serving as a consultant for Schnell Medical and Shockwave; travel support from Abbott Vascular, Biosensors, Boston Scientific, Edwards Lifesciences, and Medtronic; and research grant support from Abbott Vascular. 
 
S. Toggweiler serves as a consultant and proctor for Boston Scientific, Biosensors / New Valve Technology, as a proctor for Abbott Vascular, as a consultant for Carag, has received speaker honoraria from Medtronic and is a board member of and holds equity in Hi-D Imaging. 
 
D. Heg is affiliated with CTU Bern, University of Bern, which has a staff policy of not accepting honoraria or consultancy fees. However, CTU Bern is involved in design, conduct, or analysis of clinical studies funded by not-for-profit and for-profit organizations. In particular, pharmaceutical and medical device companies provide direct funding to some of these studies. For an up-to-date list of CTU Bern’s conflicts of interest see http://www.ctu.unibe.ch/research/declaration_of_interest/index_eng.html. 
 
T. Pilgrim has received research grants to the institution from Biotronik and Boston Scientific, speaker fees from Boston Scientific and Biotronik and consultancy for HighLife SAS. 
 
O. Muller serves as consultant for Abbott and received speaker fees from Edwards Lifesciences. 
 
E. Ferrari is a proctor and consultant for Edwards Lifesciences. 
 
C. Huber was a proctor for Edwards Lifesciences and Boston Scientific / Symetis. 
 
R. Jeger has received institutional research grants from B. Braun Melsungen AG and received speakers honoraria from B. Braun Melsungen AG, Cardionovum and Nipro. 
 
M. Roffi has received institutional research grants from Boston Scientific, Biotronik, Terumo, Medtronic and GE Healthcare. 
 
D. Tuller received speaker fees from Edwards Lifesciences, Boston Scientific and received reimbursement for travel expenses from Edwards Lifesciences, Boston Scientific and Medtronic. 
 
S. Noble reports personal fees from Medtronic, grants from Edwards, during the conduct of the study; 
 
F. Nietlispach has served as consultant for Abbott, Edwards Lifesciences and Medtronic. 
 
P. Wenaweser is a proctor for Edwards Lifesciences and Medtronic and has served as consultant for Edwards Lifesciences, Medtronic and Cardinal Health (fellow training). 
 
Stephan Windecker reports research and educational grants to the institution from Abbott, Amgen, BMS, Bayer, Boston Scientific, Biotronik, Cardinal Health, CardioValve, CSL Behring, Daiichi Sankyo, Edwards Lifesciences, Johnson&Johnson, Medtronic, Querbet, Polares, Sanofi, Terumo, Sinomed. Stephan Windecker serves as unpaid member of the steering / executive group of trials funded by Abbott, Abiomed, Amgen, BMS, Boston Scientific, Biotronik, Cardiovalve, Edwards Lifesciences, MedAlliance, Medtronic, Polares, Sinomed, V-Wave and Xeltis, but has not received personal payments by any pharmaceutical company or device manufacturer. He is also member of the steering / executive committee group of several investigated-initiated trials that receive funding by industry without impact on his personal remuneration. 
 
All other authors have no competing interests to declare. 
 
Ethics Approval Statement: The SwissTAVI Registry protocol was approved by the local ethics committee at each participating center, and all patients provided written informed consent.