Background: Despite its promise in potentiating various treatments, pericardial access is problematic: beyond needle puncture which bears the risk for bleeding, other technologies are cumbersome and impractical.
Methods: In an ongoing first-in-human single-arm trial (EASY-R) we enrolled patients planned for pericardial access. The novel pericardial 21-guage needle (PeriCross; Circa Scientific Inc) is used as follows: 1) the Tunneler assembly cannula and blunt obturator) are advanced sub-xyphoid to reach the outside of the pericardial space, 2) the obturate is removed and the access device is inserted, 3) the tines are advanced to retract the pericardium, 4) the integrated needle punctures the pericardium, and 5) and 0.018” guidewire is advanced into the pericardial space.
Results: Two operators employed the pericardial access device in 21 pts (age 66.8±8.4 yrs [range 48-77]; 12M / 9W; BMI 27.1±4.8 [17.7-34.7]) undergoing epicardial procedures (VT ablation [n=6], AF ablation [n=10], lead extraction [n=2] or diagnostic fluid sampling [n=3]). Under either general anesthesia (n=9) or deep sedation (n=12), with 2.8±2.1 capture attempts, 2.6±1.8 puncture attempts, and 0.7±0.2 mL contrast used, pericardial access was achieved in 21 of 21 pts (100%). The time to achieve access was 3.5±2.2 min (range 1-8), using 2.1±1.1 min fluoroscopy (range 0.7-5.2). There were 3 AEs: 1 hematoma (non-serious), 1 pericardial effusion (not related to procedure/device), and 1 tamponade managed percutaneously (serious, related to device) – this latter AE occurred early in the experience, prompting learnings that avoided additional such AEs.
Conclusion: Pericardial access with a novel tine-based pericardial retraction and needle puncture technology was easy and quick to use to gain pericardial access.
