title: 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.
abstract: 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.
  
  
  
  We prospectively evaluated the feasibility and safety of the EpiAccess System by EpiEP, Inc., with a novel epicardial access needle in a multicenter study.
  
  
  
  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.
  
  
  
  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.
  
  
  
  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.
authors.affiliation: Montefiore-Einstein Center for Heart and Vascular Care, Montefiore Medical Hospital, Albert Einstein College of Medicine, Bronx, New York; Texas Cardiac Arrhythmia Institute, St. David's Medical Center, Austin, Texas; Department of Biomedical Engineering, University of Texas, Austin, Texas; Department of Cardiology, University of Foggia, Foggia, Italy.
authors.forename: Luigi
authors.initials: L
authors.lastname: Di Biase
authors.affiliation: Texas Cardiac Arrhythmia Institute, St. David's Medical Center, Austin, Texas.
authors.forename: J David
authors.initials: JD
authors.lastname: Burkhardt
authors.affiliation: Mount Sinai Hospital, New York, New York.
authors.forename: Vivek
authors.initials: V
authors.lastname: Reddy
authors.affiliation: Montefiore-Einstein Center for Heart and Vascular Care, Montefiore Medical Hospital, Albert Einstein College of Medicine, Bronx, New York.
authors.forename: Jorge
authors.initials: J
authors.lastname: Romero
authors.affiliation: Homolka Hospital, Prague, Czech Republic.
authors.forename: Petr
authors.initials: P
authors.lastname: Neuzil
authors.affiliation: Homolka Hospital, Prague, Czech Republic.
authors.forename: Jan
authors.initials: J
authors.lastname: Petru
authors.affiliation: Homolka Hospital, Prague, Czech Republic.
authors.forename: Lucie
authors.initials: L
authors.lastname: Sadiva
authors.affiliation: Homolka Hospital, Prague, Czech Republic.
authors.forename: Jan
authors.initials: J
authors.lastname: Skoda
authors.affiliation: Hospital Universidade Coimbra, Coimbra, Portugal.
authors.forename: Miguel
authors.initials: M
authors.lastname: Ventura
authors.affiliation: Cardiac Arrhythmia Research Centre, Centro Cardiologico Monzino IRCCS, Milan, Italy.
authors.forename: Corrado
authors.initials: C
authors.lastname: Carbucicchio
authors.affiliation: Cardiac Arrhythmia Research Centre, Centro Cardiologico Monzino IRCCS, Milan, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Dello Russo
authors.affiliation: Debrecen University, Debrecen, Hungary.
authors.forename: Zoltan
authors.initials: Z
authors.lastname: Csanadi
authors.affiliation: Cardiac Arrhythmia Research Centre, Centro Cardiologico Monzino IRCCS, Milan, Italy.
authors.forename: Michela
authors.initials: M
authors.lastname: Casella
authors.affiliation: Cardiac Arrhythmia Research Centre, Centro Cardiologico Monzino IRCCS, Milan, Italy.
authors.forename: Gaetano M
authors.initials: GM
authors.lastname: Fassini
authors.affiliation: Cardiac Arrhythmia Research Centre, Centro Cardiologico Monzino IRCCS, Milan, Italy.
authors.forename: Claudio
authors.initials: C
authors.lastname: Tondo
authors.affiliation: Bordeaux University Hospital, LIRYC Institute, Pessac, France.
authors.forename: Frederic
authors.initials: F
authors.lastname: Sacher
authors.affiliation: EpiEP, Inc., New Haven, Connecticut.
authors.forename: Mike
authors.initials: M
authors.lastname: Theran
authors.affiliation: Mount Sinai Hospital, New York, New York.
authors.forename: Srinivas
authors.initials: S
authors.lastname: Dukkipati
authors.affiliation: Mount Sinai Hospital, New York, New York.
authors.forename: Jacob
authors.initials: J
authors.lastname: Koruth
authors.affiliation: Bordeaux University Hospital, LIRYC Institute, Pessac, France.
authors.forename: Pierre
authors.initials: P
authors.lastname: Jais
authors.affiliation: Texas Cardiac Arrhythmia Institute, St. David's Medical Center, Austin, Texas; Department of Biomedical Engineering, University of Texas, Austin, Texas; California Pacific Medical Center, San Francisco, California; Stanford University, Stanford, California; Case Western University, Cleveland, Ohio; Scripps Clinic, San Diego, California; Dell Medical School, Austin, Texas. Electronic address: dr.natale@gmail.com.
authors.forename: Andrea
authors.initials: A
authors.lastname: Natale
mesh_terms: D017115:Catheter Ablation / Q000379:methods*; D005240:Feasibility Studies; D005260:Female; D005471:Fluoroscopy / Q000379:methods; D006352:Heart Ventricles / Q000000981:diagnostic imaging; D006801:Humans; D007431:Intraoperative Complications / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control; D008297:Male; D008875:Middle Aged; D016343:Monitoring, Intraoperative / Q000379:methods; D009339:Needles / Q000592:standards*; D010043:Outcome and Process Assessment, Health Care; D010490:Pericardial Effusion / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control; D010496:Pericardium / Q000000981:diagnostic imaging / Q000293:injuries; D011677:Punctures / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods; D017180:Tachycardia, Ventricular / Q000175:diagnosis / Q000601:surgery
keywords: Catheter ablation; Epicardial access; Left atrial appendage closure; Micropuncture needle; Subxiphoid approach; Tuohy needle; Ventricular tachycardia