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

Ammar M. Killu, Niyada Naksuk, Christopher V. Desimone, Prakriti Gaba, Scott Suddendorf, Joanne Powers, Dorothy J. Ladewig, Lilach O Lerman, Barry A Borlaug, Samuel J Asirvatham

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

Percutaneous Pericardiotomy Tool: 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.

Original languageEnglish (US)
JournalJournal of Cardiovascular Electrophysiology
DOIs
StateAccepted/In press - 2016

Fingerprint

Pericardiectomy
Safety
Phrenic Nerve
Pericardium
Equipment and Supplies
Thorax
Canidae
Coronary Vessels
Myocardium
Electrodes
Swine
Hemodynamics
Membranes

Keywords

  • Adhesion
  • Epicardial
  • Percutaneous
  • Pericardial
  • Surgery

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Physiology (medical)

Cite this

Beating Heart Validation of Safety and Efficacy of a Percutaneous Pericardiotomy Tool. / Killu, Ammar M.; Naksuk, Niyada; Desimone, Christopher V.; Gaba, Prakriti; Suddendorf, Scott; Powers, Joanne; Ladewig, Dorothy J.; Lerman, Lilach O; Borlaug, Barry A; Asirvatham, Samuel J.

In: Journal of Cardiovascular Electrophysiology, 2016.

Research output: Contribution to journalArticle

Killu, Ammar M. ; Naksuk, Niyada ; Desimone, Christopher V. ; Gaba, Prakriti ; Suddendorf, Scott ; Powers, Joanne ; Ladewig, Dorothy J. ; Lerman, Lilach O ; Borlaug, Barry A ; Asirvatham, Samuel J. / Beating Heart Validation of Safety and Efficacy of a Percutaneous Pericardiotomy Tool. In: Journal of Cardiovascular Electrophysiology. 2016.
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abstract = "Percutaneous Pericardiotomy Tool: 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.",
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