Initial international multicenter human experience with a novel epicardial access needle embedded with a real-time pressure/frequency monitoring to facilitate epicardial access

Feasibility and safety

Luigi Di Biase, J. David Burkhardt, Vivek Reddy, Jorge E. Romero, Petr Neuzil, Jan Petru, Lucie Sadiva, Jan Skoda, Miguel Ventura, Corrado Carbucicchio, Antonio Dello Russo, Zoltan Csanadi, Michela Casella, Gaetano M. Fassini, Claudio Tondo, Frederic Sacher, Mike Theran, Srinivas Dukkipati, Jacob Koruth, Pierre Jais & 1 others Andrea Natale

Research output: Contribution to journalArticle

5 Citations (Scopus)

Abstract

Background Epicardial ablation is often necessary for the treatment of complex arrhythmias refractory to endocardial ablation. Conventional needle access to the pericardial space is considered quite challenging, and it is often associated with several potential complications, particularly inadvertent right ventricular puncture. The novel EpiAccess needle tip is embedded with a pressure sensor able to report the pressure waveform in real time when used with the EpiAccess System. Objective We prospectively evaluated the feasibility and safety of the EpiAccess System by EpiEP, Inc., with a novel epicardial access needle in a multicenter study. Methods Twenty-five patients with a clinical need for epicardial access were enrolled. The EpiAccess needle and EpiAccess System were used for epicardial access in each case. Successful epicardial access, defined as the ability to introduce a guidewire into the epicardial space, was assessed via the device and confirmed with fluoroscopy. Significant pericardial bleeding was defined as >80 mL of blood by using peer review article definitions. Results Patients were men (76%) with a mean age of 62 years (range 28-84 years). Epicardial access for ventricular tachycardia ablation was indicated in 80% of the patients. Successful epicardial access was obtained in all cases, with pressure monitoring guiding pericardial wire access in all cases. One delayed pericardial effusion occurred. Conclusion Epicardial access with the novel EpiAccess needle and System with real-time pressure monitoring is feasible and safe. The pressure monitoring capability identifies successfully the epicardial space, facilitating access and potentially minimizing complications. This has relevant clinical implications.

Original languageEnglish (US)
Pages (from-to)981-988
Number of pages8
JournalHeart Rhythm
Volume14
Issue number7
DOIs
StatePublished - Jul 1 2017

Fingerprint

Needles
Safety
Pressure
Peer Review
Aptitude
Pericardial Effusion
Pericardium
Fluoroscopy
Computer Systems
Ventricular Tachycardia
Punctures
Multicenter Studies
Cardiac Arrhythmias
Hemorrhage
Equipment and Supplies
Therapeutics

Keywords

  • Catheter ablation
  • Epicardial access
  • Left atrial appendage closure
  • Micropuncture needle
  • Subxiphoid approach
  • Tuohy needle
  • Ventricular tachycardia

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Physiology (medical)

Cite this

Initial international multicenter human experience with a novel epicardial access needle embedded with a real-time pressure/frequency monitoring to facilitate epicardial access : Feasibility and safety. / Di Biase, Luigi; Burkhardt, J. David; Reddy, Vivek; Romero, Jorge E.; Neuzil, Petr; Petru, Jan; Sadiva, Lucie; Skoda, Jan; Ventura, Miguel; Carbucicchio, Corrado; Dello Russo, Antonio; Csanadi, Zoltan; Casella, Michela; Fassini, Gaetano M.; Tondo, Claudio; Sacher, Frederic; Theran, Mike; Dukkipati, Srinivas; Koruth, Jacob; Jais, Pierre; Natale, Andrea.

In: Heart Rhythm, Vol. 14, No. 7, 01.07.2017, p. 981-988.

Research output: Contribution to journalArticle

Di Biase, L, Burkhardt, JD, Reddy, V, Romero, JE, Neuzil, P, Petru, J, Sadiva, L, Skoda, J, Ventura, M, Carbucicchio, C, Dello Russo, A, Csanadi, Z, Casella, M, Fassini, GM, Tondo, C, Sacher, F, Theran, M, Dukkipati, S, Koruth, J, Jais, P & Natale, A 2017, 'Initial international multicenter human experience with a novel epicardial access needle embedded with a real-time pressure/frequency monitoring to facilitate epicardial access: Feasibility and safety', Heart Rhythm, vol. 14, no. 7, pp. 981-988. https://doi.org/10.1016/j.hrthm.2017.02.033
Di Biase, Luigi ; Burkhardt, J. David ; Reddy, Vivek ; Romero, Jorge E. ; Neuzil, Petr ; Petru, Jan ; Sadiva, Lucie ; Skoda, Jan ; Ventura, Miguel ; Carbucicchio, Corrado ; Dello Russo, Antonio ; Csanadi, Zoltan ; Casella, Michela ; Fassini, Gaetano M. ; Tondo, Claudio ; Sacher, Frederic ; Theran, Mike ; Dukkipati, Srinivas ; Koruth, Jacob ; Jais, Pierre ; Natale, Andrea. / Initial international multicenter human experience with a novel epicardial access needle embedded with a real-time pressure/frequency monitoring to facilitate epicardial access : Feasibility and safety. In: Heart Rhythm. 2017 ; Vol. 14, No. 7. pp. 981-988.
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abstract = "Background Epicardial ablation is often necessary for the treatment of complex arrhythmias refractory to endocardial ablation. Conventional needle access to the pericardial space is considered quite challenging, and it is often associated with several potential complications, particularly inadvertent right ventricular puncture. The novel EpiAccess needle tip is embedded with a pressure sensor able to report the pressure waveform in real time when used with the EpiAccess System. Objective We prospectively evaluated the feasibility and safety of the EpiAccess System by EpiEP, Inc., with a novel epicardial access needle in a multicenter study. Methods Twenty-five patients with a clinical need for epicardial access were enrolled. The EpiAccess needle and EpiAccess System were used for epicardial access in each case. Successful epicardial access, defined as the ability to introduce a guidewire into the epicardial space, was assessed via the device and confirmed with fluoroscopy. Significant pericardial bleeding was defined as >80 mL of blood by using peer review article definitions. Results Patients were men (76{\%}) with a mean age of 62 years (range 28-84 years). Epicardial access for ventricular tachycardia ablation was indicated in 80{\%} of the patients. Successful epicardial access was obtained in all cases, with pressure monitoring guiding pericardial wire access in all cases. One delayed pericardial effusion occurred. Conclusion Epicardial access with the novel EpiAccess needle and System with real-time pressure monitoring is feasible and safe. The pressure monitoring capability identifies successfully the epicardial space, facilitating access and potentially minimizing complications. This has relevant clinical implications.",
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T1 - Initial international multicenter human experience with a novel epicardial access needle embedded with a real-time pressure/frequency monitoring to facilitate epicardial access

T2 - Feasibility and safety

AU - Di Biase, Luigi

AU - Burkhardt, J. David

AU - Reddy, Vivek

AU - Romero, Jorge E.

AU - Neuzil, Petr

AU - Petru, Jan

AU - Sadiva, Lucie

AU - Skoda, Jan

AU - Ventura, Miguel

AU - Carbucicchio, Corrado

AU - Dello Russo, Antonio

AU - Csanadi, Zoltan

AU - Casella, Michela

AU - Fassini, Gaetano M.

AU - Tondo, Claudio

AU - Sacher, Frederic

AU - Theran, Mike

AU - Dukkipati, Srinivas

AU - Koruth, Jacob

AU - Jais, Pierre

AU - Natale, Andrea

PY - 2017/7/1

Y1 - 2017/7/1

N2 - Background Epicardial ablation is often necessary for the treatment of complex arrhythmias refractory to endocardial ablation. Conventional needle access to the pericardial space is considered quite challenging, and it is often associated with several potential complications, particularly inadvertent right ventricular puncture. The novel EpiAccess needle tip is embedded with a pressure sensor able to report the pressure waveform in real time when used with the EpiAccess System. Objective We prospectively evaluated the feasibility and safety of the EpiAccess System by EpiEP, Inc., with a novel epicardial access needle in a multicenter study. Methods Twenty-five patients with a clinical need for epicardial access were enrolled. The EpiAccess needle and EpiAccess System were used for epicardial access in each case. Successful epicardial access, defined as the ability to introduce a guidewire into the epicardial space, was assessed via the device and confirmed with fluoroscopy. Significant pericardial bleeding was defined as >80 mL of blood by using peer review article definitions. Results Patients were men (76%) with a mean age of 62 years (range 28-84 years). Epicardial access for ventricular tachycardia ablation was indicated in 80% of the patients. Successful epicardial access was obtained in all cases, with pressure monitoring guiding pericardial wire access in all cases. One delayed pericardial effusion occurred. Conclusion Epicardial access with the novel EpiAccess needle and System with real-time pressure monitoring is feasible and safe. The pressure monitoring capability identifies successfully the epicardial space, facilitating access and potentially minimizing complications. This has relevant clinical implications.

AB - Background Epicardial ablation is often necessary for the treatment of complex arrhythmias refractory to endocardial ablation. Conventional needle access to the pericardial space is considered quite challenging, and it is often associated with several potential complications, particularly inadvertent right ventricular puncture. The novel EpiAccess needle tip is embedded with a pressure sensor able to report the pressure waveform in real time when used with the EpiAccess System. Objective We prospectively evaluated the feasibility and safety of the EpiAccess System by EpiEP, Inc., with a novel epicardial access needle in a multicenter study. Methods Twenty-five patients with a clinical need for epicardial access were enrolled. The EpiAccess needle and EpiAccess System were used for epicardial access in each case. Successful epicardial access, defined as the ability to introduce a guidewire into the epicardial space, was assessed via the device and confirmed with fluoroscopy. Significant pericardial bleeding was defined as >80 mL of blood by using peer review article definitions. Results Patients were men (76%) with a mean age of 62 years (range 28-84 years). Epicardial access for ventricular tachycardia ablation was indicated in 80% of the patients. Successful epicardial access was obtained in all cases, with pressure monitoring guiding pericardial wire access in all cases. One delayed pericardial effusion occurred. Conclusion Epicardial access with the novel EpiAccess needle and System with real-time pressure monitoring is feasible and safe. The pressure monitoring capability identifies successfully the epicardial space, facilitating access and potentially minimizing complications. This has relevant clinical implications.

KW - Catheter ablation

KW - Epicardial access

KW - Left atrial appendage closure

KW - Micropuncture needle

KW - Subxiphoid approach

KW - Tuohy needle

KW - Ventricular tachycardia

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