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Clinical Trial
. 2022 Mar 18;17(16):1289-1297.
doi: 10.4244/EIJ-D-21-00613.

Clinical outcomes of transcatheter aortic valve implantation in patients younger than 70 years rejected for surgery: the AMTRAC registry

Guy Witberg  1   2 , Uri Landes  1   2 , Pablo Codner  1   2 , Marco Barbanti  3 , Roberto Valvo  3 , Ole De Backer  4 , Joris F Ooms  5 , Angela McInerney  6 , Giulia Masiero  7 , Paul Werner  8 , Xavier Armario  9 , Claudia Fiorina  10 , Dabit Arzamendi  11 , Sandra Santos-Martinez  12 , Jose A Baz  13 , Klemen Steblovnik  14 , Victor Mauri  15 , Matti Adam  16 , Ilan Merdler  16 , Manuel Hein  17 , Philipp Ruile  17 , Marco Russo  18 , Francesco Musumeci  18 , Alexander Sedaghat  19 , Atsushi Sugiura  19 , Carmelo Grasso  3 , Luca Branca  10 , Rodrigo Estévez-Loureiro  13 , Ignacio J Amat-Santos  12 , Darren Mylotte  9 , Martin Andreas  8 , Matjaž Bunc  14 , Giuseppe Tarantini  7 , Luis Nombela-Franco  6 , Lars Søndergaard  4 , Nicolas M Van Mieghem  5 , Ariel Finkelstein  2   16 , Ran Kornowski  1   2
Affiliations
Clinical Trial

Clinical outcomes of transcatheter aortic valve implantation in patients younger than 70 years rejected for surgery: the AMTRAC registry

Guy Witberg et al. EuroIntervention. .

Abstract

Background: The mean age of transcatheter aortic valve implantation (TAVI) patients is steadily decreasing.

Aims: The aim of the study was to describe the characteristics, the indications for and the outcomes of TAVI in patients <70 years old.

Methods: All patients undergoing TAVI (n=8,626) from the 18 participating centres between January 2007 and June 2020 were stratified by age (</>70). For patients <70, the indications for TAVI were extracted from Heart Team discussions and the baseline characteristics and mortality were compared between the two groups.

Results: Overall, 640 (7.4%) patients were <70 (9.1% during 2018-2020, p<0.001); the mean age was 65.0±2.3 years. The younger patients were more often male, with bicuspid valves or needing valve-in-valve procedures. They had a higher prevalence of lung disease and diabetes. In 80.7% of cases, the Heart Team estimated an increased surgical risk and TAVI was selected, reflected by an STS score >4% in 20.4%. Five-year mortality was similar (29.4 vs 29.8%, HR 0.95, p=0.432) in the <70 and >70 groups. In the <70 group, mortality was higher for those referred for TAVI due to an increased surgical risk compared to those referred for other reasons (31.6 vs 24.5%, HR 1.23, p=0.021). Mortality was similar regardless of the STS stratum in patients judged by the Heart Team to be at increased surgical risk (32.6 vs 30.4%, HR 0.98, p=0.715).

Conclusions: Use of TAVI in patients <70 is becoming more frequent. The main reason for choosing TAVI is due to an increased surgical risk not adequately represented by the STS score. The outcomes for these patients are similar to those for older TAVI patients. Dedicated trials of TAVI/SAVR in younger patients are needed to guide decisions concerning expansion of TAVI indications. ((ClinicalTrials.gov: NCT04031274).

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Conflict of interest statement

N.M. Van Miegham received research grant support from Abbott, Boston Scientific, Edwards Lifescience, Medtronic, PulseCath BV and Daiichi Sankyo, advisory fees from Abbott, Boston Scientific, Ancora, Medtronic, PulseCath BV and Daiichi Sankyo. M. Barbanti received consultant fees from Edwards Lifesciences. C. Grasso is a proctor for Abbott Vascular. O. De Backer received research grants and consultant fees from Abbott and Boston Scientific. M. Andreas is a proctor/consultant for Abbott, Medtronic and Edwards Lifesciences, received institutional grant support from Edwards, Abbott, Medtronic and LSI. R. Estévez-Loureiro is a consultant for Abbott Vascular and Boston Scientific. L. Nombela-Franco received consultant fees from Edwards Lifesciences and is a proctor for Abbott. L. Sondergaard received consultant fees and institutional research grants from Abbott, Boston Scientific, Edwards Lifesciences and Medtronic. I. J. Amat-Santos is a proctor for Boston Scientific. M. Bunc is a proctor for Edwards, Medtronic, Abbott, and Meril and is on an advisory board for Medtronic. M. Adam received consultant fees from Medtronic, Edwards Lifescience and Boston Scientific. The other authors have no conflicts of interests to declare.

Figures

Figure 1
Figure 1. Change in volume of TAVI in patients <70 years and their percentage of the total TAVI volume throughout the study period.
TAVI: transcatheter aortic valve implantation
Figure 2
Figure 2. A) Distribution of reasons for preferring TAVI over SAVR in patients <70 years of age as specified by the local Heart Teams.
B) Distribution of reasons for classifying patients <70 years of age as being at increased surgical risk as specified by the local Heart Teams. AS: aortic stenosis; BMI: body mass index; CS: cardiogenic shock; GA: general anaesthesia; LIMA: left internal mammary artery; LV: left ventricle; OHCA: out of hospital cardiac arrest; PHT: pulmonary hypertension; SAVR: surgical aortic valve replacement; STS: Society of Thoracic Surgeons; TAVI: transcatheter aortic valve implantation
Figure 3
Figure 3. A) Overall mortality stratified by age at TAVI.
Red: <70 years of age; blue: ≥70 years of age. B) Overall mortality in patients <70 years of age according to reason for preferring TAVI over SAVR. Red: increased surgical risk; blue: all other reasons. C) Overall mortality in patients <70 years of age referred for TAVI due to increased surgical risk according to definition of increased surgical risk. Red: STS score; blue: Heart Team assessment. HR: hazard ratio; STS: Society of Thoracic Surgeons; TAVI: transcatheter aortic valve implantation
Central illustration
Central illustration. Left panel: Primary differences between the
Right panel: distribution of case volume and fraction of <70 years old patients within the TAVI population at the participating centres (top), distribution of reasons for choosing TAVI over SAVR in this group (middle), and of reasons for classifying patients as being at increased surgical risk by the local Heart Teams (bottom). AS: aortic stenosis; BMI: body mass index; COPD: chronic obstructive pulmonary disease; DM: diabetes mellitus; GA: general anaesthesia; HTN: hypertension; LIMA: left internal mammary artery; LV: left ventricle; MR: mitral regurgitation; SAVR: surgical aortic valve replacement; SE: self-expandable; STS: Society of Thoracic Surgeons; TAVI: transcatheter aortic valve implantation
See this image and copyright information in PMC

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