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.

Bordeaux University Hospital LIRYC Institute Pessac France

Cardiac Arrhythmia Research Centre Centro Cardiologico Monzino IRCCS Milan Italy

Debrecen University Debrecen Hungary

EpiEP Inc New Haven Connecticut

Homolka Hospital Prague Czech Republic

Hospital Universidade Coimbra Coimbra Portugal

Montefiore Einstein Center for Heart and Vascular Care Montefiore Medical Hospital Albert Einstein College of Medicine Bronx New York

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

Mount Sinai Hospital New York New York

Texas Cardiac Arrhythmia Institute St David's Medical Center Austin Texas

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

Heart Rhythm. 2017 Jul;14(7):989-990. doi: 10.1016/j.hrthm.2017.03.028. PubMed

References provided by Crossref.org

Epicardial ventricular arrhythmia ablation: a clinical consensus statement of the European Heart Rhythm Association of the European Society of Cardiology and the Heart Rhythm Society, the Asian Pacific Heart Rhythm Society, the Latin American Heart Rhythm Society, and the Canadian Heart Rhythm Society