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

Abstract：

INTRODUCTION: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. CONCLUSION: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.

journal_name

J Cardiovasc Electrophysiol

journal_title

Journal of cardiovascular electrophysiology

authors

Killu AM,Naksuk N,Desimone CV,Gaba P,Suddendorf S,Powers J,Ladewig DJ,Lerman LO,Borlaug BA,Asirvatham SJ

doi

10.1111/jce.13108

subject

Has Abstract

pub_date

2017-03-01 00:00:00

pages

357-361

issue

eissn

1045-3873

issn

1540-8167

journal_volume

pub_type

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