Literature DB >> 15776209

The learning curve for investigational surgery: lessons learned from laparoscopic diaphragm pacing for chronic ventilator dependence.

R P Onders1, A F DiMarco, A R Ignagni, J T Mortimer.   

Abstract

BACKGROUND: Electrical stimulation of the phrenic nerve motor point of the diaphragm through laparoscopic implantation of a pacing system is an option for high spinal cord-injured patients with chronic respiratory insufficiency. This study assesses the operative learning curve for the initial series of patients.
METHOD: A series of six patients underwent laparoscopic placement of a diaphragm pacing system. The operative procedure was divided into the following four steps for analysis and rapid adjustment after each operation: exposure of the diaphragm, mapping of the phrenic nerve motor point, implantation of the pacing electrodes, and final routing of the wires to the external system.
RESULTS: The first case required two operations, and the second case was unsuccessful because of a nonfunctioning phrenic nerve that led to a change in the preoperative screening criteria. The operative time decreased from 469 min for the first operation to 165 min for the sixth operation. The significant time decrease can be attributed to changes in the mapping and routing aspects of the operation. Key changes during this series that helped to reduce the operative time include abandonment of a software-dependent mapping technique, development of a grid algorithm for mapping, software improvement to increase the speed of stimulation and mapping, refinement of the mapping probe to maintain adequate suction on the diaphragm, shortening of the electrode lengths, and experience with the implantation of connections to the external electrodes. Presently, all five of the successfully implanted patients can be maintained on prolonged ventilatory support with the device.
CONCLUSION: Analysis of every step of this investigational procedure enabled us to make rapid changes in surgical protocol, leading to decreases in operative times and expectant improvements in patient safety and efficacy. In this series, analysis was the key to developing a low-risk cost-effective outpatient diaphragm pacing system.

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Year:  2005        PMID: 15776209     DOI: 10.1007/s00464-004-8934-6

Source DB:  PubMed          Journal:  Surg Endosc        ISSN: 0930-2794            Impact factor:   4.584


  9 in total

1.  Laparoscopic implant instrument for the placement of intramuscular electrodes in the diaphragm.

Authors:  H Aiyar; T A Stellato; R P Onders; J T Mortimer
Journal:  IEEE Trans Rehabil Eng       Date:  1999-09

2.  Laparoscopic placement of electrodes for diaphragm pacing using stimulation to locate the phrenic nerve motor points.

Authors:  B D Schmit; T A Stellato; M E Miller; J T Mortimer
Journal:  IEEE Trans Rehabil Eng       Date:  1998-12

3.  Phrenic nerve pacing in a tetraplegic patient via intramuscular diaphragm electrodes.

Authors:  Anthony F DiMarco; Raymond P Onders; Krzysztof E Kowalski; Michael E Miller; Sandra Ferek; J Thomas Mortimer
Journal:  Am J Respir Crit Care Med       Date:  2002-12-15       Impact factor: 21.405

4.  Long-term intramuscular electrical activation of the phrenic nerve: efficacy as a ventilatory prosthesis.

Authors:  D K Peterson; M L Nochomovitz; T A Stellato; J T Mortimer
Journal:  IEEE Trans Biomed Eng       Date:  1994-12       Impact factor: 4.538

5.  Diaphragm activation with intramuscular stimulation in dogs.

Authors:  M L Nochomovitz; A F Dimarco; J T Mortimer; N S Cherniack
Journal:  Am Rev Respir Dis       Date:  1983-03

Review 6.  When can I be proficient in laparoscopic surgery? A systematic review of the evidence.

Authors:  Haitham Dagash; Moti Chowdhury; Agostino Pierro
Journal:  J Pediatr Surg       Date:  2003-05       Impact factor: 2.545

7.  Characterization of the human diaphragm muscle with respect to the phrenic nerve motor points for diaphragmatic pacing.

Authors:  Raymond P Onders; Harish Aiyar; J Thomas Mortimer
Journal:  Am Surg       Date:  2004-03       Impact factor: 0.688

8.  Mapping the phrenic nerve motor point: the key to a successful laparoscopic diaphragm pacing system in the first human series.

Authors:  Raymond P Onders; Anthony F Dimarco; Anthony R Ignagni; Harish Aiyar; J Thomas Mortimer
Journal:  Surgery       Date:  2004-10       Impact factor: 3.982

9.  Long-term intramuscular electrical activation of the phrenic nerve: safety and reliability.

Authors:  D K Peterson; M L Nochomovitz; T A Stellato; J T Mortimer
Journal:  IEEE Trans Biomed Eng       Date:  1994-12       Impact factor: 4.538

  9 in total
  9 in total

1.  Medical devices: adapting to the comparative effectiveness landscape.

Authors:  Anita Mohandas; Kathleen A Foley
Journal:  Biotechnol Healthc       Date:  2010

2.  Diaphragm pacing with natural orifice transluminal endoscopic surgery: potential for difficult-to-wean intensive care unit patients.

Authors:  R Onders; M F McGee; J Marks; A Chak; R Schilz; M J Rosen; A Ignagni; A Faulx; M J Elmo; S Schomisch; J Ponsky
Journal:  Surg Endosc       Date:  2006-12-20       Impact factor: 4.584

3.  Method to test the long-term stability of functional electrical stimulation via multichannel electrodes (e.g., applicable for laryngeal pacing) and to define best points for stimulation: in vivo animal analysis.

Authors:  Bernd Faenger; Dirk Arnold; Nikolaus P Schumann; Orlando Guntinas-Lichius; Hans-Christoph Scholle
Journal:  Eur Arch Otorhinolaryngol       Date:  2016-07-19       Impact factor: 2.503

4.  Diaphragm pacing stimulation system for tetraplegia in individuals injured during childhood or adolescence.

Authors:  Raymond P Onders; Mary Jo Elmo; Anthony R Ignagni
Journal:  J Spinal Cord Med       Date:  2007       Impact factor: 1.985

5.  Complete worldwide operative experience in laparoscopic diaphragm pacing: results and differences in spinal cord injured patients and amyotrophic lateral sclerosis patients.

Authors:  Raymond P Onders; Maryjo Elmo; Saeid Khansarinia; Brock Bowman; John Yee; Jeremy Road; Barbara Bass; Brian Dunkin; Páll E Ingvarsson; Margrét Oddsdóttir
Journal:  Surg Endosc       Date:  2008-12-06       Impact factor: 4.584

6.  An Autopsy Case of Amyotrophic Lateral Sclerosis with Diaphragm Pacing.

Authors:  Hisashi Ito; Tetsumasa Kamei; Sanae Odake; Masayuki Nakano; Riki Okeda; Shunsaku Kohriki; Jun Kawachi; Raymond P Onders; Fumihito Yoshii
Journal:  Intern Med       Date:  2016-12-01       Impact factor: 1.271

7.  Observational study of early diaphragm pacing in cervical spinal cord injured patients to decrease mechanical ventilation during the COVID-19 pandemic.

Authors:  Raymond P Onders; MaryJo Elmo; Brian Young; Glen Tinkoff
Journal:  Surgery       Date:  2022-09-07       Impact factor: 4.348

8.  Protocol for diaphragm pacing in patients with respiratory muscle weakness due to motor neurone disease (DiPALS): a randomised controlled trial.

Authors:  Christopher J McDermott; Chin Maguire; Cindy L Cooper; Roger Ackroyd; Wendy O Baird; Simon Baudouin; Andrew Bentley; Stephen Bianchi; Stephen Bourke; Mike J Bradburn; Simon Dixon; John Ealing; Simon Galloway; Dayalan Karat; Nick Maynard; Karen Morrison; Naveed Mustfa; John Stradling; Kevin Talbot; Tim Williams; Pamela J Shaw
Journal:  BMC Neurol       Date:  2012-08-16       Impact factor: 2.474

9.  Diaphragmatic pacing stimulation in spinal cord injury: anesthetic and perioperative management.

Authors:  Miguel L Tedde; Paulo Vasconcelos Filho; Ludhmila Abrahão Hajjar; Juliano Pinheiro de Almeida; Gustavo Fagundes Flora; Erica Mie Okumura; Eduardo A Osawa; Julia Tizue Fukushima; Manoel Jacobsen Teixeira; Filomena Regina Barbosa Gomes Galas; Fabio Biscegli Jatene; José Otávio Costa Auler
Journal:  Clinics (Sao Paulo)       Date:  2012-11       Impact factor: 2.365

  9 in total

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