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. 2022 Feb 22;11(5):1164.
doi: 10.3390/jcm11051164.

One-Year Outcomes and Trends over Two Eras of Transcatheter Aortic Valve Implantation in Real-World Practice

Giuliano Costa  1 , Paola D'Errigo  2 , Stefano Rosato  2 , Fausto Biancari  3   4 , Andrea Marcellusi  5 , Giuseppe Tarantini  6 , Gennaro Santoro  7 , Massimo Baiocchi  8 , Diego Maffeo  9 , Claudia Fiorina  10 , Francesco Cerza  11 , Giovanni Baglio  11 , Tatu Juvonen  3   4 , Gabriella Badoni  2 , Roberto Valvo  1 , Fulvia Seccareccia  2 , Marco Barbanti  1 , Corrado Tamburino  1 , On Behalf Of The Observant Ii Research Group
Affiliations

One-Year Outcomes and Trends over Two Eras of Transcatheter Aortic Valve Implantation in Real-World Practice

Giuliano Costa et al. J Clin Med. .

Abstract

Background: Data reflecting the benefit of procedural improvements in real-world transcatheter aortic valve implantation (TAVI) practice are sparse.

Aims: To compare outcomes and trends of two TAVI eras from real Italian practice.

Methods: A total of 1811 and 2939 TAVI patients enrolled in the national, prospective OBSERVANT and OBSERVANT II studies in 2010-2012 and 2016-2018, respectively, were compared in a cohort study. Outcomes were adjusted using inverse propensity of treatment weighting and propensity score matching.

Results: The median age (83.0 (79.0-86.0) vs. 83.0 (79.0-86.0)) and EuroSCORE II (5.2 (3.2-7.7) vs. 5.1 (3.1-8.1)) of OBSERVANT and OBSERVANT II patients were similar. At 1 year, patients of the OBSERVANT II study had a significantly lower risk of all-cause death (10.6% vs. 16.3%, Hazard Ratio (HR) 0.63 (95% Confidence Interval (CI) 0.52-0.76)) and rehospitalization for heart failure (HF) (14.3% vs. 19.5%, Sub-distribution HR 0.71 (95%CI 0.60-0.84)), whereas rates of stroke (3.1% vs. 3.6%) and permanent pacemaker implantation (PPI) (16.6% vs. 18.0%) were comparable between study groups.

Conclusions: Age and risk profile among patients undergoing TAVI in Italy remained substantially unchanged between the 2010-2012 and 2016-2018 time periods. After adjustment, patients undergoing TAVI in the most recent era had lower risk of all-cause death and rehospitalization for HF at 1 year, whereas rates of stroke and PPI did not differ significantly.

Keywords: OBSERVANT; outcomes; transcatheter aortic valve implantation; trends.

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Conflict of interest statement

Corrado Tamburino is a consultant for Medtronic; Marco Barbanti is a consultant for Edwards LifeSciences, Medtronic and Boston Scientifics; Giuseppe Tarantini reports honoraria for lectures/consulting from Edwards LifeSciences, Medtronic and Boston Scientifics and GADA. All other authors have no conflict of interest to declare.

Figures

Figure 1
Figure 1
Study participants flowchart.
Figure 2
Figure 2
Crude baseline differences of patients undergoing transcatheter aortic valve implantation and enrolled in the OBSERVANT and OBSERVANT II studies. CAD, coronary artery disease; COPD, chronic obstructive pulmonary disease; NYHA, New York Heart Association; PAD, peripheral artery disease; PCI, percutaneous coronary intervention.
Figure 3
Figure 3
Crude procedural differences of patients undergoing transcatheter aortic valve implantation and enrolled in the OBSERVANT and OBSERVANT II studies. PCI, percutaneous coronary intervention; TA, trans-apical; TF, trans-femoral; TS, trans-subclavian.
Figure 4
Figure 4
In-hospital clinical and echocardiographic outcomes after adjustment. AKI, acute kidney disease; PPI, permanent pacemaker implantation.
Figure 5
Figure 5
Adjusted 1-year Kaplan–Meier survival curve and landmark analysis for all-cause death. CI, confidence interval; HR, hazard ratio.
Figure 6
Figure 6
Adjusted 1-year Fine and Gray cumulative incidence analysis for rehospitalization for heart failure and stroke. CI, confidence interval; SHR, sub-distribution hazard ratio.
See this image and copyright information in PMC

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