Initial international multicenter human experience with a novel epicardial access needle embedded with a real-time pressure/frequency monitoring to facilitate epicardial access: Feasibility and safety

Luigi Di Biase, J. David Burkhardt, Vivek Reddy, Jorge Romero, Petr Neuzil, Jan Petru, Lucie Sadiva, Jan Skoda, Miguel Ventura, Corrado Carbucicchio, Antonio Dello Russo, Zoltan Csanadi, Michela Casella, Gaetano M. Fassini, Claudio Tondo, Frederic Sacher, Mike Theran, Srinivas Dukkipati, Jacob Koruth, Pierre JaisAndrea Natale

Research output: Contribution to journalArticle

Abstract

Background Epicardial ablation is often necessary for the treatment of complex arrhythmias refractory to endocardial ablation. Conventional needle access to the pericardial space is considered quite challenging, and it is often associated with several potential complications, particularly inadvertent right ventricular puncture. The novel EpiAccess needle tip is embedded with a pressure sensor able to report the pressure waveform in real time when used with the EpiAccess System. Objective We prospectively evaluated the feasibility and safety of the EpiAccess System by EpiEP, Inc., with a novel epicardial access needle in a multicenter study. Methods Twenty-five patients with a clinical need for epicardial access were enrolled. The EpiAccess needle and EpiAccess System were used for epicardial access in each case. Successful epicardial access, defined as the ability to introduce a guidewire into the epicardial space, was assessed via the device and confirmed with fluoroscopy. Significant pericardial bleeding was defined as >80 mL of blood by using peer review article definitions. Results Patients were men (76%) with a mean age of 62 years (range 28-84 years). Epicardial access for ventricular tachycardia ablation was indicated in 80% of the patients. Successful epicardial access was obtained in all cases, with pressure monitoring guiding pericardial wire access in all cases. One delayed pericardial effusion occurred. Conclusion Epicardial access with the novel EpiAccess needle and System with real-time pressure monitoring is feasible and safe. The pressure monitoring capability identifies successfully the epicardial space, facilitating access and potentially minimizing complications. This has relevant clinical implications.

Original languageEnglish
Pages (from-to)981-988
Number of pages8
JournalHeart Rhythm
Volume14
Issue number7
DOIs
Publication statusPublished - Jul 1 2017

Keywords

  • Catheter ablation
  • Epicardial access
  • Left atrial appendage closure
  • Micropuncture needle
  • Subxiphoid approach
  • Tuohy needle
  • Ventricular tachycardia

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Physiology (medical)

Fingerprint Dive into the research topics of 'Initial international multicenter human experience with a novel epicardial access needle embedded with a real-time pressure/frequency monitoring to facilitate epicardial access: Feasibility and safety'. Together they form a unique fingerprint.

  • Cite this

    Di Biase, L., Burkhardt, J. D., Reddy, V., Romero, J., Neuzil, P., Petru, J., Sadiva, L., Skoda, J., Ventura, M., Carbucicchio, C., Dello Russo, A., Csanadi, Z., Casella, M., Fassini, G. M., Tondo, C., Sacher, F., Theran, M., Dukkipati, S., Koruth, J., ... Natale, A. (2017). Initial international multicenter human experience with a novel epicardial access needle embedded with a real-time pressure/frequency monitoring to facilitate epicardial access: Feasibility and safety. Heart Rhythm, 14(7), 981-988. https://doi.org/10.1016/j.hrthm.2017.02.033