title: Beating Heart Validation of Safety and Efficacy of a Percutaneous Pericardiotomy Tool.
abstract: BACKGROUND
  Epicardial procedures frequently require pericardial manipulation. We aimed to develop a nonsurgical percutaneous pericardial modification tool that may (1) facilitate epicardial-based procedures by enabling adhesiolysis or (2) attenuate the myocardial constraining effect of the pericardium.
  
  
  METHODS
  Three novel devices were developed to enable pericardiotomy, all of which can be deployed in over-the-wire fashion following percutaneous epicardial access. The grasper permits us to seize the pericardial membrane providing leverage for incision. The scissors enables anterograde cutting maneuvers. The reverse-slitter allows retrograde incisions; in addition, this device has a deflectable tip that increases the potential cutting area. We optimized these tools for safety by including electrodes to test for phrenic nerve stimulation as well as myocardial stimulation to determine directionality of the cutting devices. The base of the scissors and reverse-slitter are also blunt ensuring that the cutting element is always away from the myocardium.
  
  
  RESULTS
  Following 5 nonbeating heart bench test experiments for prototype development, 11 animal (9 canine, 2 swine) studies were performed. Of these 2 were proof-of-concept open chest studies; the remaining 9 were entirely closed-chest, percutaneous procedures allowing for remodification of the prototypes. The tools successfully permitted incision of the pericardium in all studies. Hemodynamic measurements were assessed postincision and showed no compromise of systolic function. No coronary artery or phrenic nerve damage was seen in any study.
  
  
  CONCLUSIONS
  Percutaneous pericardiotomy is feasible and appears to be safe. It may provide leverage in epicardial-based procedures and offer treatment options in disease processes characterized by pericardial restraint.
authors.affiliation: Department of Cardiovascular Diseases, Department of Internal Medicine, Rochester, Minnesota, USA.
authors.forename: Ammar M
authors.initials: AM
authors.lastname: Killu
authors.affiliation: Department of Cardiovascular Diseases, Department of Internal Medicine, Rochester, Minnesota, USA.
authors.forename: Niyada
authors.initials: N
authors.lastname: Naksuk
authors.affiliation: Department of Cardiovascular Diseases, Department of Internal Medicine, Rochester, Minnesota, USA.
authors.forename: Christopher V
authors.initials: CV
authors.lastname: Desimone
authors.affiliation: Mayo Medical School, Department of Internal Medicine, Rochester, Minnesota, USA.
authors.forename: Prakriti
authors.initials: P
authors.lastname: Gaba
authors.affiliation: Department of Surgical Research, Department of Internal Medicine, Rochester, Minnesota, USA.
authors.forename: Scott
authors.initials: S
authors.lastname: Suddendorf
authors.affiliation: Department of Surgical Research, Department of Internal Medicine, Rochester, Minnesota, USA.
authors.forename: Joanne
authors.initials: J
authors.lastname: Powers
authors.affiliation: Mayo Clinic Ventures, Department of Internal Medicine, Rochester, Minnesota, USA.
authors.forename: Dorothy J
authors.initials: DJ
authors.lastname: Ladewig
authors.affiliation: Division of Nephrology and Hypertension, Department of Internal Medicine, Rochester, Minnesota, USA.
authors.forename: Lilach O
authors.initials: LO
authors.lastname: Lerman
authors.affiliation: Department of Cardiovascular Diseases, Department of Internal Medicine, Rochester, Minnesota, USA.
authors.forename: Barry A
authors.initials: BA
authors.lastname: Borlaug
authors.affiliation: Department of Cardiovascular Diseases, Department of Internal Medicine, Rochester, Minnesota, USA.|Department of Pediatric Cardiology, Rochester, Minnesota, USA.
authors.forename: Samuel J
authors.initials: SJ
authors.lastname: Asirvatham
mesh_terms: D000818:Animals; D006328:Cardiac Catheterization / Q000295:instrumentation* / Q000379:methods; D004285:Dogs; D004867:Equipment Design; D006339:Heart Rate; D008422:Materials Testing; D023421:Models, Animal; D010492:Pericardiectomy / Q000295:instrumentation* / Q000379:methods; D010496:Pericardium / Q000000981:diagnostic imaging / Q000601:surgery*; D013525:Surgical Instruments; D034421:Sus scrofa
keywords: adhesion; epicardial; percutaneous; pericardial; surgery