Luigi Di Biase1, J David Burkhardt2, Vivek Reddy3, Jorge Romero4, Petr Neuzil5, Jan Petru5, Lucie Sadiva5, Jan Skoda5, Miguel Ventura6, Corrado Carbucicchio7, Antonio Dello Russo7, Zoltan Csanadi8, Michela Casella7, Gaetano M Fassini7, Claudio Tondo7, Frederic Sacher9, Mike Theran10, Srinivas Dukkipati3, Jacob Koruth3, Pierre Jais9, Andrea Natale11. 1. 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. 2. Texas Cardiac Arrhythmia Institute, St. David's Medical Center, Austin, Texas. 3. Mount Sinai Hospital, New York, New York. 4. Montefiore-Einstein Center for Heart and Vascular Care, Montefiore Medical Hospital, Albert Einstein College of Medicine, Bronx, New York. 5. Homolka Hospital, Prague, Czech Republic. 6. Hospital Universidade Coimbra, Coimbra, Portugal. 7. Cardiac Arrhythmia Research Centre, Centro Cardiologico Monzino IRCCS, Milan, Italy. 8. Debrecen University, Debrecen, Hungary. 9. Bordeaux University Hospital, LIRYC Institute, Pessac, France. 10. EpiEP, Inc., New Haven, Connecticut. 11. 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.
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.
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.