1Herzzentrum Leipzig - Universität Leipzig Universitätsklinik für Herzchirurgie Leipzig, Deutschland; 2Louis Stokes Cleveland VA Medical Center, Department of Veterans Affairs Ohio, USA; 3Klinikum Karlsburg / Klinik für Herz-, Thorax- und Gefäßchirurgie Karlsburg, Deutschland; 4Klinikum Links der Weser Klinik für Kardiologie und Angiologie Bremen, Deutschland; 5Universitätsklinikum Heidelberg Klinik für Herzchirurgie Heidelberg, Deutschland; 6Universitätsklinikum Tübingen Klinik für Thorax-, Herz- Gefäßchirurgie Tübingen, Deutschland; 7LMU Klinikum der Universität München Herzchirurgische Klinik und Poliklinik München, Deutschland; 8Universitätsmedizin der Johannes Gutenberg-Universität Mainz Klinik und Poliklinik für Herz- und Gefäßchirurgie Mainz, Deutschland; 9Universitätsklinikum Köln Klinik für Herzchirurgie, herzchirurgische Intensivmedizin und Thoraxchirurgie Köln, Deutschland; 10Medizinische Hochschule Hannover Klinik für Herz-, Thorax-, Transplantations- und Gefäßchirurgie, OE 6217 Hannover, Deutschland; 11Universitätsklinikum Heidelberg Klinik für Innere Med. III, Kardiologie, Angiologie u. Pneumologie Heidelberg, Deutschland; 12Universitätsklinikum Magdeburg A.ö.R. Klinik für Herz- und Thoraxchirurgie Magdeburg, Deutschland; 13Herzzentrum Leipzig - Universität Leipzig Klinik für Innere Medizin/Kardiologie Leipzig, Deutschland; 14Klinikum Links der Weser Klinik für Herzchirurgie Bremen, Deutschland; 15Herzzentrum Leipzig / Klinik für Anästhesie Leipzig, Deutschland; 16Universitätsklinikum Köln Klinik und Poliklinik für Herz- und Thoraxchirurgie, Herzzentrum Köln, Deutschland; 17Deutsches Herzzentrum München Klinik für Herz- und Gefäßchirurgie München, Deutschland; 18Universitäres Herz- und Gefäßzentrum Hamburg Klinik und Poliklinik für Herz- und Gefäßchirurgie Hamburg, Deutschland; 19Universitätsklinikum Jena Klinik für Herz- und Thoraxchirurgie Jena, Deutschland; 20Universitätsklinikum Jena Klinik für Innere Medizin I - Kardiologie Jena, Deutschland; 21Universitätsmedizin der Johannes Gutenberg-Universität Mainz Kardiologie 1, Zentrum für Kardiologie Mainz, Deutschland
Background: In transcatheter aortic valve implantation (TAVI), intraprocedural complications which are only manageable by conversion to emergent open-heart surgery (E-OHS) occasionally occur. Contemporary data on the incidence and outcome of TAVI patients undergoing E-OHS are scarce. From a collaborative effort pooling data from 14 German centres, we herein present outcomes of patients undergoing E-OHS due to intraprocedural complications during TAVI.
Methods: Eligible patients underwent elective transfemoral TAVI for native aortic stenosis with intraprocedural complications requiring immediate E-OHS. Exclusion criteria were i) non-transfemoral access, ii) critical clinical status prior to TAVI with severe hemodynamic and respiratory insufficiency (e.g., cardiogenic shock, mechanical ventilation), iii) minor interventional procedures widely performed during TAVI without E-OHS (e.g. pacemaker implant, pericardiocentesis, chest tube insertion), and iv) open heart surgery performed post-TAVI procedure (e.g. TAVI explant due to paravalvular leak or infective endocarditis). All TAVI procedures were performed in hybrid operating rooms with immediate surgical backup on-site. The primary outcome was all-cause 1-year mortality. Secondary outcomes were intraprocedural mortality and in-hospital mortality.
Results: Between January 2009 and June 2021, a total of 40,557 patients underwent transfemoral TAVI at 14 German centres. Of these, 216 (0.5%) patients underwent E-OHS, and 152 patients met the inclusion criteria. The median age of this cohort was 81 years (interquartile range [IQR] 78 - 84), and 63.2% of all patients were female (n=96). The median EuroSCORE II was 7.0% (IQR 3.5 – 13.8). The proportion of patients at low risk (EuroSCORE II <4%), intermediate risk (EuroSCORE II 4 – 8%), and high risk (EuroSCORE II >8%) was 30.3% (n=46), 24.3% (n=37), and 45.4% (n=69), respectively.
Intraprocedural mortality was 12.5% (n=19), and in-hospital mortality 49.3% (n=75). While intraprocedural mortality did not differ between the risk groups (p=0.92), in-hospital mortality increased with increasing EuroSCORE II (EuroSCORE II <4%: 34.8%, EuroSCORE II 4 – 8%: 48.6%, EuroSCORE II >8%: 59.4%; p=0.04).
Overall, the Kaplan-Meier estimated rate of 1-year mortality was 57.2% (EuroSCORE II <4%: 44.4%, EuroSCORE II 4 – 8%: 55.5%, EuroSCORE II >8%: 67.5%; p=0.03). In patients surviving the index hospitalization, 1-year mortality was 15.3%. Mortality at 1 year in patients alive at hospital discharge was 12.1% in low risk patients, 13.3% in intermediate risk patients, and 21.4% in high risk patients (p=0.81).
Conclusion: Half of all patients undergoing E-OHS for a major TAVI complication survive the early postoperative period. Patients with low/intermediate surgical risk requiring E-OHS had a considerably better short-term clinical outcomes compared to patients at high surgical risk. In patients surviving the initial periprocedural period, event rates following hospital discharge after E-OHS are low. Consequently, in the setting of a Heart Team approach with immediate surgical back-up, E-OHS due to potentially lethal TAVI complications is not a futile clinical situation, with acceptable short- and long-term outcomes.