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Beating Heart Validation of Safety and Efficacy of a Percutaneous Pericardiotomy Tool.

Authors
  • Killu, Ammar M1
  • Naksuk, Niyada1
  • Desimone, Christopher V1
  • Gaba, Prakriti2
  • Suddendorf, Scott3
  • Powers, Joanne3
  • Ladewig, Dorothy J4
  • Lerman, Lilach O5
  • Borlaug, Barry A1
  • Asirvatham, Samuel J1, 6
  • 1 Department of Cardiovascular Diseases, Department of Internal Medicine, Rochester, Minnesota, USA.
  • 2 Mayo Medical School, Department of Internal Medicine, Rochester, Minnesota, USA.
  • 3 Department of Surgical Research, Department of Internal Medicine, Rochester, Minnesota, USA.
  • 4 Mayo Clinic Ventures, Department of Internal Medicine, Rochester, Minnesota, USA.
  • 5 Division of Nephrology and Hypertension, Department of Internal Medicine, Rochester, Minnesota, USA.
  • 6 Department of Pediatric Cardiology, Rochester, Minnesota, USA.
Type
Published Article
Journal
Journal of Cardiovascular Electrophysiology
Publisher
Wiley (Blackwell Publishing)
Publication Date
Mar 01, 2017
Volume
28
Issue
3
Pages
357–361
Identifiers
DOI: 10.1111/jce.13108
PMID: 27759180
Source
Medline
Keywords
Language
English
License
Unknown

Abstract

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. 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. 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. 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. © 2016 Wiley Periodicals, Inc.

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