Author + information
- Received August 22, 2016
- Revision received November 29, 2016
- Accepted December 8, 2016
- Published online March 29, 2017.
- Ammar M. Killu, MBBSa,
- Niyada Naksuk, MDa,
- Zdeněk Stárek, MD, PhD, MScb,
- Christopher V. DeSimone, MD, PhDa,
- Faisal F. Syed, MBChBa,
- Prakriti Gaba, BSc,
- Jiří Wolf, Ingb,
- Frantisek Lehar, MD, PhDb,
- Martin Pesl, MD, PhD, MScb,
- Pavel Leinveber, Ing, PhDb,
- Michal Crha, MVDr, PhD, MScd,
- Dorothy Ladewig, BSe,
- Joanne Powersf,
- Scott Suddendorff,
- David O. Hodge, MSg,
- Gaurav Satam, MSe,
- Miroslav Novák, MD, PhDb,
- Tomas Kara, MD, PhDb,
- Charles J. Bruce, MDa,
- Paul A. Friedman, MDa and
- Samuel J. Asirvatham, MDa,h,∗ ()
- aDepartment of Cardiovascular Diseases, Mayo Clinic, Rochester, Minnesota
- bDepartment of Cardiovascular Diseases, St Anne's University Hospital, Brno, Czech Republic
- cMayo Medical School, Rochester, Minnesota
- dUniversity of Veterinary and Pharmaceutical Sciences Brno, Brno, Czech Republic
- eMayo Clinic Ventures, Rochester, Minnesota
- fDepartment of Cardiovascular Surgery, Mayo Clinic, Rochester, Minnesota
- gDepartment of Health Science Research, Mayo Clinic, Jacksonville, Florida
- hDepartment of Pediatrics and Adolescent Medicine, Mayo Clinic, Rochester, Minnesota
- ↵∗Address for correspondence:
Dr. Samuel J. Asirvatham, Department of Cardiovascular Diseases, Mayo Clinic, 200 1st Street SW, Mary Brigh 4-523, Rochester, Minnesota 55905.
Objectives We aimed to develop a percutaneous defibrillation system with partially insulated epicardial coils to focus electrical energy on the myocardium and prevent or minimize extracardiac stimulation.
Background Epicardial defibrillation systems currently require surgical access.
Methods We tested 2 prototypes created for percutaneous introduction into the pericardial space via a steerable sheath. This testing included a partially insulated defibrillation coil and a defibrillation mesh with a urethane balloon acting as an insulator to the face of the mesh not in contact with the epicardium. The average energy associated with a chance of successful defibrillation 75% of the time was calculated for each experiment.
Results Of 16 animal experiments, 3 pig experiments had malfunctioning mesh prototypes such that results were unreliable; these were excluded. Therefore, 13 animal experiments were analyzed, 6 in canines (29.8 ± 4.0 kg) and 7 in pigs (41.1 ± 4.4 kg). The overall chance of successful defibrillation 75% of the time was 12.8 ± 6.7 J (10.9 ± 9.1 J for canines and 14.4 ± 3.9 J in pigs; p = 0.37). The lowest chance of successful defibrillation 75% of the time obtained in canines was 2.5 J, whereas in pigs it was 9.5 J. The lowest energy resulting in successful defibrillation was 2 J in canines and 5 J in pigs. There was no evidence of coronary vessel injury or trauma to extrapericardial structures.
Conclusions Percutaneous, epicardial defibrillation using a partially insulated coil is feasible and seems to be associated with low defibrillation thresholds. Focusing insulation may limit extracardiac stimulation and potentially lower energy requirements for efficient defibrillation.
Drs. Killu and Naksuk contributed equally to this work.
Funding support provided by the project no. LQ1605 from the National Program of Sustainability II (MEYS CR) and by project FNUSA-ICRC no. CZ.1.05/1.1.00/02.0123 (OP VaVpI).
Dr. DeSimone received a U.S. National Institutes of Health training grant, HL007111. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
The Mayo Clinic owns intellectual property related to the investigated technology reported in the manuscript under WO2015/143327A1; 7,620,458B2; US8,315,716B2. Neither Mayo Clinic nor the inventors will receive compensation for the use of this product with Mayo Clinic patients.
- Received August 22, 2016.
- Revision received November 29, 2016.
- Accepted December 8, 2016.