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Original research
Balloon-expandable transfemoral transcatheter aortic valve implantation with or without predilation: findings from the prospective EASE-IT TF multicentre registry
  1. Gerhard Schymik1,
  2. Tanja Rudolph2,
  3. Claudius Jacobshagen3,
  4. Jürgen Rothe4,
  5. Hendrik Treede5,
  6. Sebastian Kerber6,
  7. Derk Frank7,8,
  8. Lenka Sykorova9,
  9. Maki Okamoto10,
  10. Martin Thoenes11,
  11. Cornelia Deutsch12,
  12. Peter Bramlage12 and
  13. Christian Butter10
  1. 1 Medical Clinic IV, Department of Cardiology, Municipal Hospital Karlsruhe, Karlsruhe, Baden-Württemberg, Germany
  2. 2 Heart Center, University of Cologne, Cologne, Germany
  3. 3 Heart Center, University of Göttingen, Göttingen, Germany
  4. 4 Division of Cardiology and Angiology II, University Heart Centre Freiburg-Bad Krozingen, Bad Krozingen, Germany
  5. 5 Universitätsklinik und Poliklinik für Herzchirurgie, Universitätsklinikum Halle, Halle, Germany
  6. 6 Cardiovascular Clinic Bad Neustadt, Bad Neustadt, Germany
  7. 7 Department of Internal Medicine III (Cardiology and Angiology), University Hospital Schleswig-Holstein,Campus Kiel, Kiel, Schleswig-Holstein, Germany
  8. 8 ZHK (German Centre for Cardiovascular Research), Partner Site Kiel/Hamburg/Lübeck, Hamburg, Germany
  9. 9 Edwards Lifesciences, Nyon, Switzerland
  10. 10 Department of Cardiology, Immanuel Clinic Bernau, Heart Center Brandenburg & Medical School Brandenburg Bernau, Bernau, Germany
  11. 11 Edwards Lifesciences, Nyon, Switzerland
  12. 12 Institute for Pharmacology and Preventive Medicine, Cloppenburg, Germany
  1. Correspondence to Dr Peter Bramlage, Institute for Pharmacology and Preventive Medicine, Cloppenburg, Germany; submission{at}ippmed.de

Abstract

Background Predilation of the native valve has long been deemed necessary in transfemoral transcatheter aortic valve implantation (TF-TAVI), despite little trial evidence to support its clinical use. As most evidence is derived from retrospective analyses of observational studies, we conducted a two-armed, prospective multicentre registry.

Methods Patients undergoing TF-TAVI with the Edwards SAPIEN 3 valve, with or without balloon aortic valvuloplasty (BAV), were included and their procedural characteristics, short-term safety and short-term efficacy outcomes compared. We hypothesised that BAV may be safely omitted in many patients and omission could be associated with procedural benefits.

Results Overall, 196 consecutive patients underwent TF-TAVI, 56 with BAV and 140 without. The mean age was 81.2±6.2 years, and the mean logistic EuroSCORE I was 17.1±13.6. Device success according to Valve Academic Research Consortium-2 (VARC-2) was achieved in 96.4%. The median procedural duration was shorter without BAV (56 min vs 90 min; p=0.001), as was fluoroscopy time (10 min vs 13 min; p=0.001). The need for balloon postdilation was less frequent in patients without BAV (15.7% vs 30.4%, p=0.029). There was no difference in the proportion of patients meeting the VARC-2 defined composite safety endpoint at 30 days (9.3% without vs 8.9% with BAV; adjusted OR (adjOR) 2.55; 95% CI 0.56 to 18.84) and at 6 months (15.2% without vs 16.4% with BAV; adjOR 1.66; 95% CI 0.49 to 6.55).

Conclusions In the majority of patients, BAV can be safely omitted from the TAVI procedure without adverse effects. The omission of BAV is associated with shorter procedural duration and could be advantageous for the majority of patients.

Trial registration number NCT02760771.

  • Transcatheter aortic valve implantation (TAVI)
  • transfemoral
  • EASE-IT
  • balloon aortic valvuloplasty (BAV)
  • direct TAVI

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Footnotes

  • Contributors GS, PB, LS, MT and CB were involved in the conception and design of the study. The remaining authors gave feedback on the final protocol and enrolled patients (TKR, CJ, JR, HT, SK, DF), acquired further data (MO) or designed the analysis (GS, PB, CD). All authors (GS, TKR, CJ, JR, HT, SK, DF, LS, MO, MT, CD, PB, CB) agreed on an interpretation of the data. GS, CD and PB drafted the manuscript and all other authors (TKR, CJ, JR, HT, SK, DF, LS, MO, MT, CB) revised the article for important intellectual content. All authors (GS, TKR, CJ, JR, HT, SK, DF, LS, MO, MT, CD, PB, CB) have given final approval of the version submitted. All authors (GS, TKR, CJ, JR, HT, SK, DF, LS, MO, MT, CD, PB, CB) are fully accountable for the content of the manuscript.

  • Funding Unrestricted educational research grant provided by Edwards Lifescience (Nyon, Switzerland) to the Institute for Pharmacology and Preventive Medicine (Cloppenburg, Germany).

  • Competing interests PB is the representative of the Institute for Pharmacology and Preventive Medicine, Cloppenburg (IPPMed), Germany. A research grant was provided by Edwards Lifescience, Nyon, Switzerland, to the Sponsor IPPMed. CB, TR, CJ, JR, HT, SK, DF and GS have received consultancy fees from different companies producing heart valves. LS and MTs are employees of Edwards Lifesciences.

  • Patient consent for publication Not required.

  • Ethics approval Ethical approval was obtained in writing from the appropriate ethics committees prior to patient enrolment and the study was conducted in accordance with the Declaration of Helsinki. All patients provided their written informed consent to participate.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data availability statement Data are available on reasonable request.

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