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Kenneth B. Chapman - One of the best experts on this subject based on the ideXlab platform.
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a paramedian approach for dorsal root ganglion stimulation placement developed to limit Lead migration and Fracture
Pain Practice, 2021Co-Authors: Kenneth B. Chapman, Noud Van Helmond, Matthew A Spiegel, David M Dickerson, Bart Billet, Kiran Patel, Corey W Hunter, Ajay Antony, Timothy R DeerAbstract:Introduction Dorsal root ganglion stimulation (DRG-S), has demonstrated superiority in the treatment of complex regional pain syndrome and causalgia. Lead migration and Fracture impact DRG-S therapeutic stability. Lead anchoring reduces DRG-S Lead migration without increasing Lead Fracture. Lead Fracture may be related to Lead entrapment in the superficial fascial plane. A novel medialized approach for Lead placement and anchoring is presented to address these issues. Methods We suggest an alternative technique for implanting percutaneous DRG-S Leads at the T10-L5 levels. Results A novel medialized ipsilateral technique for Lead placement and anchoring for single, bilateral, and adjacent segment placement is presented. The Tuohy needle puncture site is medial to the pedicle and adjacent to the spinous process, two vertebral levels caudad to the target foramen. Trajectory is maintained in the sagittal plane, to access the caudad interlaminar space near the midline. This technique allows for ipsilateral or contralateral Lead placement. After epidural access, the introducer sheath is rotated toward the targeted foramen and advanced. The guidewire followed by the Lead is passed, and once Lead position is confirmed, tension 'S' loops are created, followed by anchoring to the deep fascia. Conclusion We describe a new paramedian technique for DRG-S Lead placement. We propose it will decrease DRG-S complication rates through anchoring to reduce migration and by avoiding the fascial planes thought to be responsible for Fracture. Long-term outcomes applying our proposed techniques are required for determining the true impact, however, early anecdotal results suggest that these new techniques are favorable.
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Lead migration and Fracture rate in dorsal root ganglion stimulation using anchoring and non anchoring techniques a multicenter pooled data analysis
Pain Practice, 2021Co-Authors: Kenneth B. Chapman, Kiran V. Patel, Noud Van Helmond, Alon Y Mogilner, Ajax Yang, Abhishek Yadav, Timothy R Lubenow, Timothy R Deer, Jan Willem KallewaardAbstract:INTRODUCTION Dorsal root ganglion stimulation (DRG-S) is a neuromodulation technique introduced in the last decade with evolving implant methods. Initial prospective research found low incidences of Lead migration and Lead Fracture with DRG-S. However, several recent studies have highlighted high Lead migration and Lead Fracture rates with DRG-S. We investigated the influence of Lead anchoring on migrations and Fractures. METHODS We performed a retrospective review between 2016 and 2020 of individuals implanted with DRG-S Leads by 4 experienced implanters. The implanters independently changed their standard practice regarding Lead anchoring over time, with opposing trends (no anchoring > anchoring, anchoring > no anchoring). We compared Lead migration and Lead Fracture rates between anchored and unanchored DRG-S Leads in the entire study cohort. Cox regression was performed on Lead migration and Fracture distributions. RESULTS We included 756 Leads (n = 565 anchored and n = 191 unanchored) from 249 patients. In unanchored Leads, migration occurred in 16 Leads (8.4%) from 13 patients (21.0%). In anchored Leads, migration occurred in 8 Leads (1.4%) from 5 patients (2.7%). Fracture in unanchored Leads occurred in 6 Leads (3.1%) from 6 patients (9.7%). Fractures in anchored Leads occurred in 11 Leads (1.9%) from 9 patients (4.8%). The migration survival distributions for the anchored and unanchored Leads were statistically significantly different (p < 0.01) with decreased survival for unanchored Leads (hazard ratio = 5.8, 95% confidence interval [CI] = 2.2-15.5). DISCUSSION We found that anchoring DRG-S Leads significantly reduces Lead migration when compared to Leads placed without an anchor. There was no significant difference in Fracture rate between anchored and unanchored Leads.
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Dorsal Root Ganglion Stimulation Lead Fracture Within the Superficial Fascial Layers in 4 Cases.
A&A practice, 2020Co-Authors: Kenneth B. Chapman, Kiran V. Patel, Noud Van Helmond, George C. Chang ChienAbstract:We present 4 cases of dorsal root ganglion stimulation Lead Fracture. In these cases, the surgical technique involved (1) traversing fascial layers for placement of Leads via a Tuohy needle in the upper low back, (2) subcutaneous tunneling from the implantable pulse generator site to the Lead puncture site without dissecting below the superficial fascial plane at the puncture site, and (3) connection of the Lead/extension with the generator. All Fractures occurred adjacent to the original Lead puncture site. These cases suggest Lead entrapment within the membranous fascial plane, with tension on a thin Lead, is a mechanism underlying Lead Fracture.
Ali Dodgekhatami - One of the best experts on this subject based on the ideXlab platform.
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left heart atrial and ventricular epicardial pacing through a left lateral thoracotomy in children a safe approach with excellent functional and cosmetic results
European Journal of Cardio-Thoracic Surgery, 2005Co-Authors: Ali Dodgekhatami, Alexander Kadner, Hitendu Dave, Mariette Rahn, Rene Pretre, Urs BauersfeldAbstract:Objective: Left heart atrial and ventricular epicardial pacing through a left lateral thoracotomy is an alternative approach for Lead insertion in children, avoiding venous access complications and right ventricular stimulation, without compromising sporting or musical activities. We analyzed the survival and performance of left atrial and left ventricular epicardial pacing Leads, and present mid-term follow-up data. Methods: Seventy-five bipolar steroid eluting pacing Leads (Medtronic CapSure Epi 4968) were implanted in 41 children, aged 8.6C5.1 years. Pacing systems included 34 DDDR and 7 VVIR. Pacing Leads were inserted through a muscle-sparing left lateral thoracotomy, and sutured to the left atrial appendage or atrium, and to the left ventricle. The generators were buried behind the abdominal muscles or between the thoracic muscle layers. Congenital heart disease with previous cardiac surgery was present in 25 children. Indications for pacing were post-operative heart block (nZ14), sinus node disease (nZ13), congenital heart block (nZ9), and various (nZ5). Threshold values and measured data were obtained at 6month intervals. The mean follow-up was 3.8C2.9 years. Results: There was no mortality or major morbidity, with excellent functional and cosmetic results. Lead survival was 94 and 86% for atrial Leads, and 97 and 86% for ventricular Leads, at 1 and 5 years, respectively. There were five reoperations for Lead Fracture (nZ2), insulation break (nZ1), oversensing (nZ1), and infection (nZ1). Device reprogramming was required in three instances. In the absence of acute Lead failure, mid-term follow-up shows very satisfactory and stable Lead performance. Conclusions: Left heart atrial and ventricular epicardial pacing Leads inserted through a left lateral thoracotomy demonstrate a high probability of survival, with favorable pacing characteristics, and optimal sensing thresholds at mid-term follow-up. Epicardial left heart pacing is reliable, and easy access can be achieved through a cosmetic and functional muscle-sparing left lateral thoracotomy. Q 2005 Elsevier B.V. All rights reserved.
Urs Bauersfeld - One of the best experts on this subject based on the ideXlab platform.
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left heart atrial and ventricular epicardial pacing through a left lateral thoracotomy in children a safe approach with excellent functional and cosmetic results
European Journal of Cardio-Thoracic Surgery, 2005Co-Authors: Ali Dodgekhatami, Alexander Kadner, Hitendu Dave, Mariette Rahn, Rene Pretre, Urs BauersfeldAbstract:Objective: Left heart atrial and ventricular epicardial pacing through a left lateral thoracotomy is an alternative approach for Lead insertion in children, avoiding venous access complications and right ventricular stimulation, without compromising sporting or musical activities. We analyzed the survival and performance of left atrial and left ventricular epicardial pacing Leads, and present mid-term follow-up data. Methods: Seventy-five bipolar steroid eluting pacing Leads (Medtronic CapSure Epi 4968) were implanted in 41 children, aged 8.6C5.1 years. Pacing systems included 34 DDDR and 7 VVIR. Pacing Leads were inserted through a muscle-sparing left lateral thoracotomy, and sutured to the left atrial appendage or atrium, and to the left ventricle. The generators were buried behind the abdominal muscles or between the thoracic muscle layers. Congenital heart disease with previous cardiac surgery was present in 25 children. Indications for pacing were post-operative heart block (nZ14), sinus node disease (nZ13), congenital heart block (nZ9), and various (nZ5). Threshold values and measured data were obtained at 6month intervals. The mean follow-up was 3.8C2.9 years. Results: There was no mortality or major morbidity, with excellent functional and cosmetic results. Lead survival was 94 and 86% for atrial Leads, and 97 and 86% for ventricular Leads, at 1 and 5 years, respectively. There were five reoperations for Lead Fracture (nZ2), insulation break (nZ1), oversensing (nZ1), and infection (nZ1). Device reprogramming was required in three instances. In the absence of acute Lead failure, mid-term follow-up shows very satisfactory and stable Lead performance. Conclusions: Left heart atrial and ventricular epicardial pacing Leads inserted through a left lateral thoracotomy demonstrate a high probability of survival, with favorable pacing characteristics, and optimal sensing thresholds at mid-term follow-up. Epicardial left heart pacing is reliable, and easy access can be achieved through a cosmetic and functional muscle-sparing left lateral thoracotomy. Q 2005 Elsevier B.V. All rights reserved.
Hugh Calkins - One of the best experts on this subject based on the ideXlab platform.
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prospective randomized comparison of the safety and effectiveness of placement of endocardial pacemaker and defibrillator Leads using the extrathoracic subclavian vein guided by contrast venography versus the cephalic approach
Pacing and Clinical Electrophysiology, 2001Co-Authors: Hugh Calkins, Brian Ramza, Jeffrey A Brinker, Water Atiga, Kevin J Donahue, Emmanuel Nsah, Eric Taylor, Henry R Halperin, John H Lawrence, Gordon F TomaselliAbstract:The purpose of this prospective randomized study was to compare the safety and efficacy of the cephalic approach versus a contrast-guided extrathoracic approach for placement of endocardial Leads. Despite an increased incidence of Lead Fracture, the intrathoracic subclavian approach remains the dominant approach for placement of pacemaker and implantable defibrillator Leads. Although this complication can be prevented by Lead placement in the cephalic vein or by Lead placement in the extrathoracic subclavian or axillary vein, these approaches have not gained acceptance. A total of 200 patients were randomized to undergo placement of pacemaker or implantable defibrillator Leads via the contrast-guided extrathoracic subclavian vein approach or the cephalic approach. Lead placement was accomplished in 99 of the 100 patients randomized to the extrathoracic subclavian vein approach as compared to 64 of 100 patients using the cephalic approach. In addition to a higher initial success rate, the extrathoracic subclavian vein medial approach was determined to be preferable as evidenced by a shorter procedure time and less blood loss. There was no difference in the incidence of complications. In conclusion, these results demonstrate that Lead placement in the extrathoracic subclavian vein guided by contrast venography is effective and safe. It was also associated with no increased risk of complications as compared with the cephalic approach. These findings suggest that the contrast-guided approach to the extrathoracic portion of the subclavian vein should be considered as an alternative to the cephalic approach.
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prospective randomized comparison of the safety and effectiveness of placement of endocardial pacemaker and defibrillator Leads using the extrathoracic subclavian vein guided by contrast venography versus the cephalic approach
Pacing and Clinical Electrophysiology, 2001Co-Authors: Hugh Calkins, Brian Ramza, Jeffrey A Brinker, Water Atiga, Kevin J Donahue, Emmanuel Nsah, Eric Taylor, Henry R Halperin, John H Lawrence, Gordon F TomaselliAbstract:CALKINS, H., et al.: Prospective Randomized Comparison of the Safety and Effectiveness of Placement of Endocardial Pacemaker and Defibrillator Leads Using the Extrathoracic Subclavian Vein Guided by Contrast Venography Versus the Cephalic Approach. The purpose of this prospective randomized study was to compare the safety and efficacy of the cephalic approach versus a contrast-guided extrathoracic approach for placement of endocardial Leads. Despite an increased incidence of Lead Fracture, the intrathoracic subclavian approach remains the dominant approach for placement of pacemaker and implantable defibrillator Leads. Although this complication can be prevented by Lead placement in the cephalic vein or by Lead placement in the extrathoracic subclavian or axillary vein, these approaches have not gained acceptance. A total of 200 patients were randomized to undergo placement of pacemaker or implantable defibrillator Leads via the contrast-guided extrathoracic subclavian vein approach or the cephalic approach. Lead placement was accomplished in 99 of the 100 patients randomized to the extrathoracic subclavian vein approach as compared to 64 of 100 patients using the cephalic approach. In addition to a higher initial success rate, the extrathoracic subclavian vein medial approach was determined to be preferable as evidenced by a shorter procedure time and less blood loss. There was no difference in the incidence of complications. In conclusion, these results demonstrate that Lead placement in the extrathoracic subclavian vein guided by contrast venography is effective and safe. It was also associated with no increased risk of complications as compared with the cephalic approach. These findings suggest that the contrast-guided approach to the extrathoracic portion of the subclavian vein should be considered as an alternative to the cephalic approach.
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safety and effectiveness of placement of pacemaker and defibrillator Leads in the axillary vein guided by contrast venography
American Journal of Cardiology, 1997Co-Authors: Brian Ramza, Jeffrey A Brinker, Emmanuel Nsah, John H Lawrence, Gordon F Tomaselli, Lawrence Rosenthal, Richard Hui, Scott Savader, Ronald D Berger, Hugh CalkinsAbstract:Despite evidence of an increased incidence of Lead Fracture, the infraclavicular subclavian approach remains the dominant approach for placement of pacemaker and implantable defibrillator Leads. Although this complication can be prevented by Lead placement in the cephalic vein or by recently described approaches for Lead placement in the axillary vein, these approaches have not gained widespread acceptance. The purpose of this study was to evaluate the safety and efficacy of an alternative technique for Lead placement that uses contrast-guided venipuncture of the axillary vein with a 5Fr micropuncture introducer set. A total of 50 patients underwent an attempt at placement of pacemaker or implantable defibrillator Leads via the axillary vein using this new technique. Patients were randomized into 2 groups based on whether the initial attempt at axillary vein access was performed medial or lateral to the rib cage margin. Lead placement was successfully accomplished in 49 of the 50 patients using this technique. Initial success was achieved in each of 25 patients randomized to the medial approach compared with 18 of 24 patients randomized to the lateral approach to the axillary vein (75%). In each of the 6 patients in whom the initial technique failed, Lead placement was subsequently achieved with the medial approach. In addition to a higher initial success rate, the medial approach was determined to be preferable as evidenced by a shorter Lead placement time, a smaller number of contrast injections, and a reduced requirement for additional micropuncture guidewires. There were no major complications associated with either approach. Contrast-guided venipuncture of the axillary vein is a safe and effective approach to placement of endocardial Leads.
Hitendu Dave - One of the best experts on this subject based on the ideXlab platform.
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left heart atrial and ventricular epicardial pacing through a left lateral thoracotomy in children a safe approach with excellent functional and cosmetic results
European Journal of Cardio-Thoracic Surgery, 2005Co-Authors: Ali Dodgekhatami, Alexander Kadner, Hitendu Dave, Mariette Rahn, Rene Pretre, Urs BauersfeldAbstract:Objective: Left heart atrial and ventricular epicardial pacing through a left lateral thoracotomy is an alternative approach for Lead insertion in children, avoiding venous access complications and right ventricular stimulation, without compromising sporting or musical activities. We analyzed the survival and performance of left atrial and left ventricular epicardial pacing Leads, and present mid-term follow-up data. Methods: Seventy-five bipolar steroid eluting pacing Leads (Medtronic CapSure Epi 4968) were implanted in 41 children, aged 8.6C5.1 years. Pacing systems included 34 DDDR and 7 VVIR. Pacing Leads were inserted through a muscle-sparing left lateral thoracotomy, and sutured to the left atrial appendage or atrium, and to the left ventricle. The generators were buried behind the abdominal muscles or between the thoracic muscle layers. Congenital heart disease with previous cardiac surgery was present in 25 children. Indications for pacing were post-operative heart block (nZ14), sinus node disease (nZ13), congenital heart block (nZ9), and various (nZ5). Threshold values and measured data were obtained at 6month intervals. The mean follow-up was 3.8C2.9 years. Results: There was no mortality or major morbidity, with excellent functional and cosmetic results. Lead survival was 94 and 86% for atrial Leads, and 97 and 86% for ventricular Leads, at 1 and 5 years, respectively. There were five reoperations for Lead Fracture (nZ2), insulation break (nZ1), oversensing (nZ1), and infection (nZ1). Device reprogramming was required in three instances. In the absence of acute Lead failure, mid-term follow-up shows very satisfactory and stable Lead performance. Conclusions: Left heart atrial and ventricular epicardial pacing Leads inserted through a left lateral thoracotomy demonstrate a high probability of survival, with favorable pacing characteristics, and optimal sensing thresholds at mid-term follow-up. Epicardial left heart pacing is reliable, and easy access can be achieved through a cosmetic and functional muscle-sparing left lateral thoracotomy. Q 2005 Elsevier B.V. All rights reserved.