1
High-Risk Lead Extraction Using a Hybrid Approach: The Blade and the Lightsaber JAYANTHI N. KONERU, M.D. and KENNETH A. ELLENBOGEN, M.D. From the Division of Cardiology, Department of Medicine, Medical College of Virginia/VCU School of Medicine, Richmond, Virginia, USA
cardiovascular implantable electronic device, laser extraction, lead extraction, lead infection, pacemaker Editorial Comment “Success is a science; if you have the conditions, you get the result” Oscar Wilde
High-risk lead extraction requires meticulous planning and flawless execution. The mortality and morbidity entailed in caring for these “high-risk” patients is substantial. In most instances, a purely transvenous approach is successful even in high-risk situations, while a minority of cases require a thoughtful team approach to achieve clinical success. In this edition of JCE, Goyal et al. describe one such approach and share their institutional experience with highrisk lead extraction using a sequential transvenous and surgical (mini-thoracotomy) approach.1 In 8 patients, a purely transvenous lead extraction approach was determined to be high risk. The basis for such determination was: (1) cardiac implantable electronic device (CIED) infection with large vegetations (>2 cm); (2) fractured leads; (3) leads with long implant duration (>10 years); and (4) failed prior extraction attempts. We would add, based on our clinical experience, patients with large vegetations and a patent foramen ovale or ASD with significant shunting. Five of the 8 patients had infection as the indication for extraction. These patients subsequently underwent a hybrid extraction procedure. The first portion of the procedure was performed by electrophysiologists, during which the SLS II excimer laser (Spectranetics, Colorado Springs, CO, USA) was utilized to lyse adhesions from the site of vascular entry to the superior vena cava/right atrial junction. The remainder of the procedure was completed by a cardiac surgical team who performed a mini-thoracotomy and right atriotomy, dissecting the remaining lead-tissue adhesions under direct visualization and removing the final portions of all leads. All vegetations, if any, were removed intact before lead removal and all the leads were removed in their entirety. This was a small case series with relatively long lead implant times (mean J Cardiovasc Electrophysiol, Vol. 00, pp. 1–2 No disclosures. Address for correspondence: Kenneth A. Ellenbogen, M.D., Electrophysiology Division, VCU Pauley Heart Center, Medical College of Virginia/VCU School of Medicine, Room 3-223, 3rd Floor, Gateway Building, 1200 E. Marshall Street, Richmond, VA 23219, USA. E-mail: [email protected] doi: 10.1111/jce.12380
implant duration: 13 years). One patient died a week after the extraction, due to persistent sepsis. The authors conclude that hybrid lead extraction is a procedure with acceptable safety and should be considered in high-risk lead extraction scenarios. Does this mean that we should offer all patients who are referred for high-risk lead extraction a hybrid procedure? The answer we believe is “no.” Three of the 8 patients in this case series had leads extracted for reasons other than infection, we assume for compelling indications, although this is not clearly delineated in the paper. The extraction community should be very cognizant of the adage, “Just because we can do something doesn’t mean we should.” Alternative approaches should be considered in scenarios where lead extraction is performed for reasons other than infection. Venoplasty to achieve vascular access has an acceptable risk profile that is better than lead extraction.2 Inside-out access, transatrial and iliac venous implantation have been described, but the number of physicians facile with these techniques is extremely limited.3-5 This case series also reiterates the need for careful lead and device selection decisions at the time of de novo implantation. The routine use of dual coil ICD leads should be strongly discouraged as the incremental risk entailed in extracting these leads is substantial.6 The advent of the subcutaneous ICD has changed the landscape of primary prevention ICDs and should be considered in patients with no indication for pacing, thus avoiding the intravascular space, although the long-term reliability of these devices is currently unknown. This case series raises several issues that deserve further comment, chief among them being the collaboration of electrophysiologist and cardiac surgeon and the venue of the procedure being the operating room. Such collaboration is paramount in ensuring optimal outcomes not only in highrisk cases but also in standard lead extraction procedures.7 It is our practice to extract all leads with an implant duration greater than 1 year in the operating room, with surgical back up, due to the unpredictable nature of this procedure. There is no evidence from large-scale randomized studies to suggest that mini-thoracotomy is better than median sternotomy for hybrid approaches to lead extraction; however, mini-thoracotomy is intuitively a simpler operation with faster patient recovery. Our experience with these hybrid approaches is similar to that of the authors. Additionally, we feel that an intact mediastinum effectively tamponades occult vascular tears that occur from mechanical and laser powered sheaths during transvenous extraction and a median sternotomy might expose these tears especially when patients are systemically heparinized.
2
Journal of Cardiovascular Electrophysiology
Vol. No.
We also advocate preoperative gated chest CT with 3-dimensional reconstruction in order to identify those highrisk cases in which leads are suspected to be either extravascular or extracardiac in their course.8 Mini-thoracotomy or median sternotomy assisted extraction is not necessarily devoid of risks, especially in infected patients because disseminated intravascular coagulopathy can be precipitated in these patients when cardiopulmonary bypass is initiated. The authors comment on the size of the vegetation being one of the factors in a priori classification of an extraction as high risk. There is no consensus on what constitutes an acceptable vegetation size for transvenous lead extraction and we feel that the location of the vegetation, as well as coexisting structural pathology, should also be taken into account when classifying these cases.9 A classic example would be a vegetation in the setting of a right to left shunting. Alternative methods and technologies need to be explored when failed extraction results in lead fragments. Occasionally, these can be tackled via the internal jugular vein or the femoral vein, with the help of tools that include snares and bioptomes.10 The clinical course of patients undergoing extraction for infected CIEDs is not benign, as reflected even in this small series of patients. The perioperative mortality of 1/8 (12.5%) is not insignificant and is in consonance with most high volume high-risk lead extraction centers. Acute success of the extraction does not always translate into long-term clinical benefit for patients and the long-term (6 months and 1 year) mortality risk is 3- to 4-fold higher in patients who undergo transvenous lead extraction for infection.11 Realistic expectations should be laid out to patients and their families regarding the guarded long-term prognosis. Occasionally, there are patients in whom extraction can be a futile endeavor and extremely dangerous. Debilitated, frail, and demented geriatric patients with eroded devices and long lead implant times constitute this population. We have deemed lead extractions in these patients medically futile, and recommended a salvage approach with plastic surgical techniques and long-term suppressive antibiotic therapy.12 This approach delivers ethical, compassionate care with preserved quality of life in the very old and frail. Finally, the authors should be commended for sharing their approach to tackling these most challenging cases. The hybrid approach as described in this issue of JCE,1 in
appropriately equipped facilities with well-trained physicians, could provide the ideal conditions for clinical success and an additional layer of safety in the realm of high-risk lead extraction. The authors are to be commended for providing us with one more example of how the best medical care for complex patients is delivered by the team approach. References 1. Goyal SK, Ellis CR, Ball SK, Ahmad R, Hoff SJ, Whalen SP, Rottman J: High-risk lead removal by planned sequential transvenous laser extraction and minimally invasive right thoracotomy. J Cardiovasc Electrophysiol 2014;25: doi:110.1111/jce.12368. 2. Worley SJ, Gohn DC, Pulliam RW, Raifsnider MA, Ebersole BI, Tuzi J: Subclavian venoplasty by the implanting physicians in 373 patients over 11 years. Heart Rhythm 2011;8:526-533. 3. Elayi CS, Allen CL, Leung S, Lusher S, Morales GX, Wiisanen M, Aikat S, Kakavand B, Shah JS, Moliterno DJ, Gurley JC: Inside-out access: A new method of lead placement for patients with central venous occlusions. Heart Rhythm 2011;8:851-857. 4. Byrd CL, Schwartz SJ: Transatrial implantation of transvenous pacing leads as an alternative to implantation of epicardial leads. Pacing Clin Electrophysiol 1990;13:1856-1859. 5. Ellestad MH, French J: Iliac vein approach to permanent pacemaker implantation. Pacing Clin Electrophysiol 1989;12:1030-1033. 6. Epstein LM, Love CJ, Wilkoff BL, Chung MK, Hackler JW, Bongiorni MG, Segreti L, Carrillo RG, Baltodano P, Fischer A, Kennergren C, Viklund R, Mittal S, Arshad A, Ellenbogen KA, John RM, Maytin M: Superior vena cava defibrillator coils make transvenous lead extraction more challenging and riskier. J Am Coll Cardiol 2013;61: 987-989. 7. Wood M, Ellenbogen K: Defining the appropriate venue for lead extraction: A place for everything. Heart Rhythm 2011;8:1006-1007. 8. Rodriguez Y, Garisto JD, Carrillo RG: A novel retrograde laser extraction technique using a transatrial approach: An alternative for complex lead extractions. Circ Arrhythm Electrophysiol 2011;4:501-505. 9. Grammes JA, Schulze CM, Al-Bataineh M, Yesenosky GA, Saari CS, Vrabel MJ, Horrow J, Chowdhury M, Fontaine JM, Kutalek SP: Percutaneous pacemaker and implantable cardioverter-defibrillator lead extraction in 100 patients with intracardiac vegetations defined by transesophageal echocardiogram. J Am Coll Cardiol 2010;55: 886-894. 10. Bongiorni MG, Soldati E, Zucchelli G, Di Cori A, Segreti L, De Lucia R, Solarino G, Balbarini A, Marzilli M, Mariani M: Transvenous removal of pacing and implantable cardiac defibrillating leads using single sheath mechanical dilatation and multiple venous approaches: High success rate and safety in more than 2000 leads. Eur Heart J 2008;29:2886-2893. 11. Maytin M, Jones SO, Epstein LM: Long-term mortality after transvenous lead extraction. Circ Arrhythm Electrophysiol 2012;5: 252-257. 12. Kolker AR, Redstone JS, Tutela JP: Salvage of exposed implantable cardiac electrical devices and lead systems with pocket change and local flap coverage. Ann Plast Surg 2007;59:26-29.
High-Risk Lead Extraction Using a Hybrid Approach: The Blade and the Lightsaber JAYANTHI N. KONERU, M.D. and KENNETH A. ELLENBOGEN, M.D. From the Division of Cardiology, Department of Medicine, Medical College of Virginia/VCU School of Medicine, Richmond, Virginia, USA
cardiovascular implantable electronic device, laser extraction, lead extraction, lead infection, pacemaker Editorial Comment “Success is a science; if you have the conditions, you get the result” Oscar Wilde
High-risk lead extraction requires meticulous planning and flawless execution. The mortality and morbidity entailed in caring for these “high-risk” patients is substantial. In most instances, a purely transvenous approach is successful even in high-risk situations, while a minority of cases require a thoughtful team approach to achieve clinical success. In this edition of JCE, Goyal et al. describe one such approach and share their institutional experience with highrisk lead extraction using a sequential transvenous and surgical (mini-thoracotomy) approach.1 In 8 patients, a purely transvenous lead extraction approach was determined to be high risk. The basis for such determination was: (1) cardiac implantable electronic device (CIED) infection with large vegetations (>2 cm); (2) fractured leads; (3) leads with long implant duration (>10 years); and (4) failed prior extraction attempts. We would add, based on our clinical experience, patients with large vegetations and a patent foramen ovale or ASD with significant shunting. Five of the 8 patients had infection as the indication for extraction. These patients subsequently underwent a hybrid extraction procedure. The first portion of the procedure was performed by electrophysiologists, during which the SLS II excimer laser (Spectranetics, Colorado Springs, CO, USA) was utilized to lyse adhesions from the site of vascular entry to the superior vena cava/right atrial junction. The remainder of the procedure was completed by a cardiac surgical team who performed a mini-thoracotomy and right atriotomy, dissecting the remaining lead-tissue adhesions under direct visualization and removing the final portions of all leads. All vegetations, if any, were removed intact before lead removal and all the leads were removed in their entirety. This was a small case series with relatively long lead implant times (mean J Cardiovasc Electrophysiol, Vol. 00, pp. 1–2 No disclosures. Address for correspondence: Kenneth A. Ellenbogen, M.D., Electrophysiology Division, VCU Pauley Heart Center, Medical College of Virginia/VCU School of Medicine, Room 3-223, 3rd Floor, Gateway Building, 1200 E. Marshall Street, Richmond, VA 23219, USA. E-mail: [email protected] doi: 10.1111/jce.12380
implant duration: 13 years). One patient died a week after the extraction, due to persistent sepsis. The authors conclude that hybrid lead extraction is a procedure with acceptable safety and should be considered in high-risk lead extraction scenarios. Does this mean that we should offer all patients who are referred for high-risk lead extraction a hybrid procedure? The answer we believe is “no.” Three of the 8 patients in this case series had leads extracted for reasons other than infection, we assume for compelling indications, although this is not clearly delineated in the paper. The extraction community should be very cognizant of the adage, “Just because we can do something doesn’t mean we should.” Alternative approaches should be considered in scenarios where lead extraction is performed for reasons other than infection. Venoplasty to achieve vascular access has an acceptable risk profile that is better than lead extraction.2 Inside-out access, transatrial and iliac venous implantation have been described, but the number of physicians facile with these techniques is extremely limited.3-5 This case series also reiterates the need for careful lead and device selection decisions at the time of de novo implantation. The routine use of dual coil ICD leads should be strongly discouraged as the incremental risk entailed in extracting these leads is substantial.6 The advent of the subcutaneous ICD has changed the landscape of primary prevention ICDs and should be considered in patients with no indication for pacing, thus avoiding the intravascular space, although the long-term reliability of these devices is currently unknown. This case series raises several issues that deserve further comment, chief among them being the collaboration of electrophysiologist and cardiac surgeon and the venue of the procedure being the operating room. Such collaboration is paramount in ensuring optimal outcomes not only in highrisk cases but also in standard lead extraction procedures.7 It is our practice to extract all leads with an implant duration greater than 1 year in the operating room, with surgical back up, due to the unpredictable nature of this procedure. There is no evidence from large-scale randomized studies to suggest that mini-thoracotomy is better than median sternotomy for hybrid approaches to lead extraction; however, mini-thoracotomy is intuitively a simpler operation with faster patient recovery. Our experience with these hybrid approaches is similar to that of the authors. Additionally, we feel that an intact mediastinum effectively tamponades occult vascular tears that occur from mechanical and laser powered sheaths during transvenous extraction and a median sternotomy might expose these tears especially when patients are systemically heparinized.
2
Journal of Cardiovascular Electrophysiology
Vol. No.
We also advocate preoperative gated chest CT with 3-dimensional reconstruction in order to identify those highrisk cases in which leads are suspected to be either extravascular or extracardiac in their course.8 Mini-thoracotomy or median sternotomy assisted extraction is not necessarily devoid of risks, especially in infected patients because disseminated intravascular coagulopathy can be precipitated in these patients when cardiopulmonary bypass is initiated. The authors comment on the size of the vegetation being one of the factors in a priori classification of an extraction as high risk. There is no consensus on what constitutes an acceptable vegetation size for transvenous lead extraction and we feel that the location of the vegetation, as well as coexisting structural pathology, should also be taken into account when classifying these cases.9 A classic example would be a vegetation in the setting of a right to left shunting. Alternative methods and technologies need to be explored when failed extraction results in lead fragments. Occasionally, these can be tackled via the internal jugular vein or the femoral vein, with the help of tools that include snares and bioptomes.10 The clinical course of patients undergoing extraction for infected CIEDs is not benign, as reflected even in this small series of patients. The perioperative mortality of 1/8 (12.5%) is not insignificant and is in consonance with most high volume high-risk lead extraction centers. Acute success of the extraction does not always translate into long-term clinical benefit for patients and the long-term (6 months and 1 year) mortality risk is 3- to 4-fold higher in patients who undergo transvenous lead extraction for infection.11 Realistic expectations should be laid out to patients and their families regarding the guarded long-term prognosis. Occasionally, there are patients in whom extraction can be a futile endeavor and extremely dangerous. Debilitated, frail, and demented geriatric patients with eroded devices and long lead implant times constitute this population. We have deemed lead extractions in these patients medically futile, and recommended a salvage approach with plastic surgical techniques and long-term suppressive antibiotic therapy.12 This approach delivers ethical, compassionate care with preserved quality of life in the very old and frail. Finally, the authors should be commended for sharing their approach to tackling these most challenging cases. The hybrid approach as described in this issue of JCE,1 in
appropriately equipped facilities with well-trained physicians, could provide the ideal conditions for clinical success and an additional layer of safety in the realm of high-risk lead extraction. The authors are to be commended for providing us with one more example of how the best medical care for complex patients is delivered by the team approach. References 1. Goyal SK, Ellis CR, Ball SK, Ahmad R, Hoff SJ, Whalen SP, Rottman J: High-risk lead removal by planned sequential transvenous laser extraction and minimally invasive right thoracotomy. J Cardiovasc Electrophysiol 2014;25: doi:110.1111/jce.12368. 2. Worley SJ, Gohn DC, Pulliam RW, Raifsnider MA, Ebersole BI, Tuzi J: Subclavian venoplasty by the implanting physicians in 373 patients over 11 years. Heart Rhythm 2011;8:526-533. 3. Elayi CS, Allen CL, Leung S, Lusher S, Morales GX, Wiisanen M, Aikat S, Kakavand B, Shah JS, Moliterno DJ, Gurley JC: Inside-out access: A new method of lead placement for patients with central venous occlusions. Heart Rhythm 2011;8:851-857. 4. Byrd CL, Schwartz SJ: Transatrial implantation of transvenous pacing leads as an alternative to implantation of epicardial leads. Pacing Clin Electrophysiol 1990;13:1856-1859. 5. Ellestad MH, French J: Iliac vein approach to permanent pacemaker implantation. Pacing Clin Electrophysiol 1989;12:1030-1033. 6. Epstein LM, Love CJ, Wilkoff BL, Chung MK, Hackler JW, Bongiorni MG, Segreti L, Carrillo RG, Baltodano P, Fischer A, Kennergren C, Viklund R, Mittal S, Arshad A, Ellenbogen KA, John RM, Maytin M: Superior vena cava defibrillator coils make transvenous lead extraction more challenging and riskier. J Am Coll Cardiol 2013;61: 987-989. 7. Wood M, Ellenbogen K: Defining the appropriate venue for lead extraction: A place for everything. Heart Rhythm 2011;8:1006-1007. 8. Rodriguez Y, Garisto JD, Carrillo RG: A novel retrograde laser extraction technique using a transatrial approach: An alternative for complex lead extractions. Circ Arrhythm Electrophysiol 2011;4:501-505. 9. Grammes JA, Schulze CM, Al-Bataineh M, Yesenosky GA, Saari CS, Vrabel MJ, Horrow J, Chowdhury M, Fontaine JM, Kutalek SP: Percutaneous pacemaker and implantable cardioverter-defibrillator lead extraction in 100 patients with intracardiac vegetations defined by transesophageal echocardiogram. J Am Coll Cardiol 2010;55: 886-894. 10. Bongiorni MG, Soldati E, Zucchelli G, Di Cori A, Segreti L, De Lucia R, Solarino G, Balbarini A, Marzilli M, Mariani M: Transvenous removal of pacing and implantable cardiac defibrillating leads using single sheath mechanical dilatation and multiple venous approaches: High success rate and safety in more than 2000 leads. Eur Heart J 2008;29:2886-2893. 11. Maytin M, Jones SO, Epstein LM: Long-term mortality after transvenous lead extraction. Circ Arrhythm Electrophysiol 2012;5: 252-257. 12. Kolker AR, Redstone JS, Tutela JP: Salvage of exposed implantable cardiac electrical devices and lead systems with pocket change and local flap coverage. Ann Plast Surg 2007;59:26-29.
