Kerstin Piayda1, Katharina Hellhammer2, Verena Veulemans2, Horst Sievert3, Sameer Gafoor4, Shazia Afzal2, Inga Hennig2, Matthias Makosch2, Amin Polzin2, Christian Jung2, Ralf Westenfeld2, Malte Kelm5, Tobias Zeus2. 1. Division of Cardiology, Pulmonology and Vascular Medicine, Medical Faculty, Heinrich Heine University Düsseldorf, Düsseldorf, Germany. Electronic address: kerstin.piayda@med.uni-duesseldorf.de. 2. Division of Cardiology, Pulmonology and Vascular Medicine, Medical Faculty, Heinrich Heine University Düsseldorf, Düsseldorf, Germany. 3. CardioVascularCenter Frankfurt, Frankfurt, Germany; Anglia Ruskin University, Chelmsford, United Kingdom. 4. CardioVascularCenter Frankfurt, Frankfurt, Germany; Swedish Heart and Vascular, Seattle, Washington. 5. Division of Cardiology, Pulmonology and Vascular Medicine, Medical Faculty, Heinrich Heine University Düsseldorf, Düsseldorf, Germany; Cardiovascular Research Institute Düsseldorf, Düsseldorf, Germany.
Abstract
OBJECTIVES: This study sought to predict whether different methods of calculating the implantation depth (ID) influence clinical and hemodynamic outcome reporting in patients undergoing transcatheter aortic valve replacement (TAVR) with a self-expandable device. BACKGROUND: Different approaches exist to calculate the ID, which may influence uniform and reliable reporting because the updated Valve Academic Research Consortium (VARC-2) criteria do not provide specific instructions. METHODS: The clinical and hemodynamic outcomes of 258 patients undergoing TAVR with a third-generation self-expandable device were analyzed with regard to the method used to assess the ID as follows: arithmetic mean, the arithmetic mean of the measured distances from the noncoronary cusp and the left coronary cusp to the distal prosthesis end; noncoronary cusp distance, the distance from the noncoronary cusp to the distal prosthesis end; and deepest edge, the deepest edge of the distal prosthesis end. RESULTS: Regardless of the measurement method, the optimal ID (OID) was reached in <30% (arithmetic mean, 25.4%; noncoronary cusp distance, 28.4%; deepest edge, 20.5%; p = 0.008). The deepest edge method is the most stringent to differentiate the relevant outcome parameters, such as the need for permanent pacemaker implantation (OID 3.7% vs. no OID 14.6%; p = 0.033). The hemodynamic outcome (i.e., mean pressure gradient reduction after TAVR: OID 7.4 ± 3.4 mm Hg vs. no OID 8.3 ± 4.0 mm Hg; p = 0.093) was not affected. CONCLUSIONS: The OID was reached in <30% of TAVR procedures. The various methods applied for ID calculation significantly influence the outcome reporting and do not allow a uniform perception of the ID. (Multi Modal Cardiac Imaging Prior Transcatheter Aortic Valve Implantation; NCT01805739).
OBJECTIVES: This study sought to predict whether different methods of calculating the implantation depth (ID) influence clinical and hemodynamic outcome reporting in patients undergoing transcatheter aortic valve replacement (TAVR) with a self-expandable device. BACKGROUND: Different approaches exist to calculate the ID, which may influence uniform and reliable reporting because the updated Valve Academic Research Consortium (VARC-2) criteria do not provide specific instructions. METHODS: The clinical and hemodynamic outcomes of 258 patients undergoing TAVR with a third-generation self-expandable device were analyzed with regard to the method used to assess the ID as follows: arithmetic mean, the arithmetic mean of the measured distances from the noncoronary cusp and the left coronary cusp to the distal prosthesis end; noncoronary cusp distance, the distance from the noncoronary cusp to the distal prosthesis end; and deepest edge, the deepest edge of the distal prosthesis end. RESULTS: Regardless of the measurement method, the optimal ID (OID) was reached in <30% (arithmetic mean, 25.4%; noncoronary cusp distance, 28.4%; deepest edge, 20.5%; p = 0.008). The deepest edge method is the most stringent to differentiate the relevant outcome parameters, such as the need for permanent pacemaker implantation (OID 3.7% vs. no OID 14.6%; p = 0.033). The hemodynamic outcome (i.e., mean pressure gradient reduction after TAVR: OID 7.4 ± 3.4 mm Hg vs. no OID 8.3 ± 4.0 mm Hg; p = 0.093) was not affected. CONCLUSIONS: The OID was reached in <30% of TAVR procedures. The various methods applied for ID calculation significantly influence the outcome reporting and do not allow a uniform perception of the ID. (Multi Modal Cardiac Imaging Prior Transcatheter Aortic Valve Implantation; NCT01805739).
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