Outcome in TAVI patients with symptomatic aortic stenosis not fulfilling PARTNER study inclusion criteria

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Abstract
Background: Transcatheter aortic valve implantation (TAVI) has rapidly evolved to the standard‐of‐care for inoperable patients with severe, symptomatic aortic valve stenosis, and to an alternative treatment option for high‐risk patients. However, the randomized PARTNER trial excluded patients with conditions frequently encountered in daily clinical practice.Methods: From 2006 to 2011, 467 high‐risk patients, who underwent transfemoral TAVI (Edwards Sapien n = 166; Medtronic CoreValve n = 301) at two German centers were divided into a “PARTNER‐like” (n = 227) and a “Real‐World” cohort (n = 240), based on the original PARTNER trial in‐ and exclusion criteria. Differences in 30‐day and 2‐year mortality and morbidity were assessed.Results: Mean age of patients was 80 ± 8 years with a logistic EuroSCORE of 22 ± 16%. The most frequent exclusion criteria were previous PCI (15.4%), prior valve surgery (13.7%), chronic renal failure (12.0%), and severe mitral regurgitation (10.8%). Despite significant differences in baseline data, estimated perioperative mortality in terms of STS and logistic EuroScore was identical between both groups. However, patients in the “Real‐World” cohort had a non‐significant trend towards a higher 30‐day mortality (10.0% vs. 6.7%, P = 0.088) and a significantly higher 2‐year mortality (23.3% vs. 14.5%, P = 0.016) compared with patients of the “PARTNER‐like” cohort.Conclusion: Patients meeting PARTNER study exclusion criteria had an acceptable outcome at 30 days and 2 years, however, with significant differences to “PARTNER‐like” patients. Still, our results indicate that also real‐life patients with relevant comorbidities, who would have been excluded from the randomized PARTNER trials, benefit from TAVI with acceptable short‐ and long‐term outcome.

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