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Multidisciplinary Approach to Transvenous Lead Extraction: A Single Center’s Experience
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Multidisciplinary Approach to Transvenous Lead Extraction: A Single Center’s Experience Timothy M. Maus M.D., Jesse Shurter MD, Liem Nguyen MD, Ulrika Birgersdotter-Green MD, Victor Gert D. Pretorius MBchB
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PII: DOI: Reference:
S1053-0770(14)00548-5 http://dx.doi.org/10.1053/j.jvca.2014.11.010 YJCAN3133
To appear in:
Journal of Cardiothoracic and Vascular Anesthesia
Cite this article as: Timothy M. Maus M.D., Jesse Shurter MD, Liem Nguyen MD, Ulrika Birgersdotter-Green MD, Victor Gert D. Pretorius MBchB, Multidisciplinary Approach to Transvenous Lead Extraction: A Single Center’s Experience, Journal of Cardiothoracic and Vascular Anesthesia, http://dx.doi.org/10.1053/j.jvca.2014.11.010 This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting galley proof before it is published in its final citable form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
Title: Multidisciplinary Approach to Transvenous Lead Extraction: A Single Center’s Experience
Corresponding Author Timothy M Maus, M.D. University of California, San Diego Thornton Hospital 9300 Campus Point Drive #7651 La Jolla, California 92037-7651
TEL: (858) 657-7412 FAX: (858) 657-6436 [email protected]
Supporting Authors Jesse Shurter, MD; Liem Nguyen, MD; Ulrika Birgersdotter-Green, MD; Victor Gert D. Pretorius, MBchB;
Study Institutions Sulpizio Cardiovascular Center University of California San Diego La Jolla, California
Study Support The study was funded by the University of California San Diego, Department of Anesthesiology. No commercial funding was utilized.
Multidisciplinary Approach to Transvenous Lead Extraction: A Single Center’s Experience ABSTRACT: Objectives: To evaluate the success and complication rates of a single center’s multidisciplinary approach to transvenous lead extraction. Setting: One university hospital. Participants: One hundred and ninety five patients scheduled for transvenous lead extraction. Interventions: A multidisciplinary approach to transvenous lead extraction involving cardiac surgery, electrophysiology, perfusion, and cardiac anesthesiology. Measurements: A case series of three hundred and fifty one lead extractions performed in one hundred and ninety five patients over a forty two month period. Indications, success rates, and complication rates were tracked, retrospectively evaluated and reported. Results: Indications for lead extraction included 53.3% due to lead malfunction, 36.9% due to infection, with the remaining 9.7% from other categories such as venous stenosis. Lead extraction rate was 99.7% with complete removal in 97.7%. Overall major complication rate was 3.08%. After an initial one year period of performing lead extractions, the overall major complication rate reduced to 1.23%. Conclusion: Transvenous lead extraction is generally a safe procedure, however not without complications. A multidisciplinary approach involving cardiac surgery, electrophysiology and cardiac anesthesiology allows for successful management and the ability to rapidly manage major complications. Keywords: Transvenous Lead Extraction, Transesophageal Echocardiography, Multidisciplinary
Introduction With the increased use of cardiovascular implantable electronic devices (CIEDs) there has been a concomitant increase in the need for lead removal for various indications. The Heart Rhythm Society (HRS) divides the indications for extraction into five categories: infection, thrombosis or venous stasis, functional leads, non-functional leads and chronic pain.1 Early lead removal techniques relied on manual traction. In addition to being frequently unsuccessful, this technique had a high morbidity and mortality due to cardiac avulsion, tamponade and death.2 While significant technological advances have been made in transvenous lead extraction, serious complications such as cardiac and vascular avulsion leading to hemothorax or pericardial tamponade and death remain considerably high.3 Even with intraprocedural transesophageal echocardiography, rates of cardiac tamponade and death remain high.1 We report on a single university medical center’s multidisciplinary approach to transvenous lead extraction (TLE), specifically the experience with three hundred and fifty one lead extractions in one hundred and ninety five patients focusing on the indications, complications, and success rates over a forty two month period. As detailed below, the implementation of a standardized and comprehensive multidisciplinary approach to the intraoperative management of these patients has been integral to a successful lead extraction program.
Methods The study was approved by the Institutional Human Research Protections Program with an approved request for waiver of consent. Consecutive patients who underwent TLE at our institution between August 2010 and February 2014 were evaluated retrospectively. Lead extraction was identified in accordance with the HRS consensus statement as those cases involving removal of pacemaker or defibrillator leads implanted greater than 1 year in duration, those necessitating the use of specialized sheaths including counter traction tools, mechanical dilating or laser sheaths, or from a route other than the implant vein. Patients with lead implantation less than 1 year in duration requiring simple traction from lead entry site for removal were excluded from analysis. As well, major complications were defined as per HRS Consensus guidelines as death, cardiac avulsion, vascular avulsion, pulmonary embolism requiring surgical intervention, respiratory arrest or anesthesia complication leading to prolongation of hospitalization, stroke or pacing system related infection of a previously non-infected site. Statistical analysis was performed in Microsoft Excel 2010 (Microsoft Corp, Redmond, WA, USA).
Multidisciplinary Protocol All patients were managed with our institutional multidisciplinary protocol, summarized in Table 1, for lead extraction utilizing a single electrophysiologist, cardiac surgeon and a cardiac anesthesia team. Preprocedural - All patients are evaluated by the electrophysiologist, cardiac surgeon and cardiac anesthesiologist, with particular preoperative evaluation focusing on cardiac function, vascular access sites, pacing dependency, the need for post-operative temporary pacing, and
blood product availability via type and cross of two packed red blood cell units in the operating room refrigerator.
All lead extractions are performed in our institution’s hybrid operating room, where patients receive a radial arterial catheter and central introducer sheath by the anesthesia team. The central sheath is typically placed in the right internal jugular vein and facilitates large bore access as well as hemodynamic drug administration. The introducer sheath is often placed as close to the clavicle as is safely possible to facilitate rewiring if a temporary-permanent transvenous pacing system is to be employed. This pathway may be utilized for those pacing dependent patients having leads extracted due to infectious indications necessitating temporary pacing during antibiotic therapy prior to conversion to a permanent pacing system implantation. Lastly all patients undergo general anesthesia and monitored with transesophageal echocardiography both for cardiovascular monitoring as well as rapid identification of cardiac and hemodynamic complications with particular focus for pericardial and pleural effusions, or evidence of tamponade physiology or pulmonary embolism. Echocardiography also proves useful in vegetation and thrombus identification and their suitability for transvenous extraction in infected patients. TEE may also be utilized to assist in coronary sinus lead placement in the setting of poor fluoroscopic imaging or in the placement of superior vena caval stents post lead extraction in patients presenting with superior vena cava syndrome. Femoral venous access is obtained by the electrophysiology team in the case of needed temporary pacing in pacing dependent individuals during extraction, as well as may be used for volume resuscitation in the setting of superior vena caval injury. Femoral arterial access is obtained by the operating team, which in conjunction with femoral venous access, is utilized
when needed for rapid transition to femoral-femoral cardiopulmonary bypass. Lastly a cardiopulmonary bypass machine is immediately available as well as an accessible perfusionist in the instance of need for extracorporeal circulation.
Intraprocedural - A full skin preparation and drape allows the transvenous lead extraction to be performed as well as the immediate performance of pericardiocentesis, thoracotomy, sternotomy and/or institution of cardiopulmonary bypass if needed. The pacemaker pocket is opened and the device is removed from the pocket and the associated leads. A locking stylet is inserted down the inner canal of the lead all the way to the tip for fixation to form a rail to hold counter traction. Teflon, polypropylene and stainless steel sheaths have largely been replaced by next generation laser and mechanical dilating sheaths due to ease of use and increased efficacy and safety. Laser energy dissolves adhesions through photo chemolysis while the mechanical dilating sheath cuts thought scar tissue and displaces it away from the lead. The techniques of lead preparation, counter traction and dissection remain the same regardless of instruments used.4,5 Occasionally the superior extraction approach from the pacemaker site fails so alternative routes of extraction, such as a femoral approach, should be considered. Open surgical extraction is indicated in patients with leads that are extra anatomic due to misplacement through arterial structures or due to erosion through the venous or myocardial wall. Large vegetations (more than 2 cm) on the lead or the tricuspid valve warrant discussion with the operative team. Vegetations large enough to block the main pulmonary artery or major branch vessels should not be extracted percutaneously. As opposed to a thin “windsock” like vegetation that may be extracted with percutaneous techniques, firm “cauliflower” like vegetations should be removed with an open surgical procedure.1 Upgrading the extraction sheath to a larger size than
recommended can allow extraction of small and thin vegetations along with the lead. As well, identification of cardiac abscess by intraoperative echocardiography should prompt discussion with the operative team before proceeding with extraction as further open surgical therapy may be indicated.
Overall, the above described combination and coordination of electrophysiologist, cardiac surgeon, cardiac anesthesia and perfusionist have constituted the multidisciplinary approach to transvenous lead extraction at our institution and the data presented.
Results Three hundred and fifty one leads were extracted from 195 patients from August 2010 through February 2014. The patients were 71.8% male with a median age of 61 years old; other demographics are noted in Table 2. Utilizing HRS indications for extraction, our population’s indications for lead extraction included lead malfunction (53.3%) and infection (36.9%) which included but was not limited to pocket infection, bacteremia, sepsis, and valvular or lead endocarditis [Table 3]. Other indications constituted 9.7% of cases (e.g. venous stenosis). Clinical success was 99.7% with complete procedural success in 97.7% of cases. Seven cases had small amounts of residual lead material attached to the myocardium which was left in place post-procedure.
The extractions included pacing systems (30.8%), cardiac resynchronization pacing systems (24.6%) and implantable cardiac defibrillation (ICD) systems (45.6%) [Table 3]. An average of 1.8 (range 1-4) leads per patient was extracted with an average of 77.1 months duration of implantation. Two hundred and five leads (58.4%) were removed from the right ventricle, 120
(34.2%) from the right atrium and 26 (7.4%) from the coronary sinus. One hundred and twenty two patients (62.6%) had a device reimplanted in the same operative setting with a future reimplantation planned in 64 patients (32.8%). Nine (4.6%) patients were deemed to not need a device reimplantation due to lack of continued medical need.
The method of extraction included laser sheaths (73.5%), traction based techniques (15.7%), mechanical dilating sheaths (8.5%), and open surgical extraction (2.3%). Laser sheath extraction utilized the Excimer laser system (Spectranetics Corp, Colorado Springs, CO). Traction based techniques included leads removed with specialized sheaths for traction-counter traction and those removed with manual traction during cases where lead extraction was utilized for other leads (e.g. right atrial lead removed with manual traction while right ventricular lead required laser extraction). Mechanical dilating sheaths included the Cook Medical Evolution RL and Evolution Shortie RL (Cook Medical, Bloomington, IN). Open extraction was required for 8 leads in 4 cases [Table 4].
Major complication rate overall was 3.08% [Table 5]. Major complications included two cases involving myocardial injury (1 right ventricle perforation and 1 right atrial tear), and three cases of vascular injury (one left subclavian vein tear, one superior vena caval tear and one case of an arteriovenous fistula that developed between the left subclavian vein and left carotid artery requiring open repair). Lastly a patient developed pulmonary hemorrhage attributed to a difficult intubation requiring postoperative intubation and therapeutic bronchoscopies. There were no procedural related deaths in this case series. Examining the major complication rate over time epochs of one year periods (the last time period is six months), the complication rate reduced
while case load increased. The number of complications (% complication rate) reduced from 4 (12.1%) in the first year epoch to 1 or less (0 – 2.7%) for subsequent time epochs. After an initial one year period, the subsequent overall major complication rate was 1.23%, with similar patient characteristics, lead duration, and leads extracted per patient.
Discussion Lead management refers to the overall lead monitoring, management of associated complications (infection, malfunction, thrombosis and vascular complications), issues related to device upgrades (abandonment vs. extraction) and management of imaging related issues (MRI imaging and delivery of radiation therapy). Decisions are made after assessing the risk of lead abandonment versus the risk of lead extraction. Removal of the leads without any specialized equipment is termed lead explantation. On the other hand use of specialized equipment (locking stylets, specialized sheaths, femoral or jugular extraction tools) is termed lead extraction.1 Most pacemaker leads implanted within a year can be explanted without the use of any specialized equipment. As leads stay in the vascular system longer, a fibrotic reaction occurs around the leads which adheres them to vessel walls, where simple traction techniques can lead to major complications such as vascular and myocardial injuries.
A multidisciplinary team based approach and a continual ongoing quality improvement is integral to our institution’s protocol for TLE. Involvement of a cardiothoracic surgeon well versed in managing complications arising from lead extraction is critical to have safe outcomes. Anesthesia support, access to fluoroscopy and echocardiography, and the role of scrubbed and non-scrubbed personnel are clearly defined in the HRS consensus statement.1 A hybrid operating room, as used at our institution provides an ideal setting for lead extraction, allowing a
seamless transition from percutaneous to open procedures. While it is apparent that many institutions perform this procedure in a standard operating suite with portable fluoroscopy, the hybrid operating room provides a consistent setup with appropriate built-in and available utilities thereby providing an optimal situation for complication management.
The above described multidisciplinary approach was instituted in response to the increasing number of patients referred to our institution for lead extraction as well as the potential for catastrophic complications. While in the setting of an increased case load experience, the rate of complications was reduced [Table 5]. The first year experience noted four complications including RV perforation, RA tear, AV fistula development, and left subclavian vein injury. Subsequently an SVC tear was encountered in the third year of experience while in the last six month period the complication of pulmonary hemorrhage was attributed to a difficult intubation as opposed to a complication of the lead extraction procedure itself. Therefore the data are suggestive of an initial learning curve to the lead extraction program as well as a need to maintain vigilance through perioperative preparation for potentially unavoidable complications. The decrease in complication rate with experience has been observed in several other studies.2 The HRS consensus statement describes the major complication rates of several registries and studies, noting a rate ranging from 1.4 to 1.9%.1 Subsequent studies have demonstrated major complication rates of 0.9%,6 1.4%,7 1.51 to 1.6%,8 as well as the multicenter Lexicon study with 1449 patients and a 1.4% major complication rate.3 After our institutions first year learning period, our subsequent major complication rate was reduced to 1.2% which is similar to those previously reported. However our reported mortality rate in this case series was zero while other
studies have reported 0.23%-0.28%.3,7 Continued research may be necessary to further determine the role of a multidisciplinary approach in mortality outcomes. Complications observed in this case series included myocardial and vascular injuries including acute pericardial tamponade, while other known complications during TLE include hemothorax, tricuspid valve injury, and pulmonary embolism. TEE played an instrumental role in the prompt diagnosis of complications in several of these cases. The management of the patient who experienced a right atrial tear during ICD lead extraction exhibited acute hypotension leading to pulseless cardiac arrest immediately upon lead extraction. Interpretation of TEE by the cardiac anesthesiologist demonstrated pericardial tamponade, prompting brief CPR followed by median sternotomy. The patient was managed temporarily with a foley bulb placed in the tear while cardiopulmonary bypass was instituted allowing appropriate repair. Similarly, the patient undergoing attempted right atrial lead extraction with a laser sheath experienced an SVC tear and hypotension, leading to detection of pericardial tamponade on TEE. This prompted median sternotomy for SVC repair and open lead extraction.
Brunner et al. reviewed the outcomes of patients requiring emergent surgical or endovascular intervention for catastrophic complications during TLE and identified 25 cases in their series of 3258 TLE procedures with myocardial, vascular injury or other major complication.9 This group of twenty-five patients had a 36% in house mortality, demonstrating that while low in occurrence, the gravity of the injury is significant. The complications in our series illustrate the importance of rapid diagnosis via TEE in order to promptly institute appropriate treatment and prevent mortality. Hilberath et al. evaluated the utility of rescue TEE in the setting of hemodynamic instability during TLE.10 The authors retrospectively evaluated the
echocardiographic evaluation of 26 cases of intraoperative instability during TLE, finding cases of pericardial tamponade, evidence of hemorrhagic shock, and acute right ventricular dysfunction in nearly half of the cases. Additionally, 54% of the cases had reassuring TEEs which allowed the procedure to continue. The authors conclude that while TLE is a relatively safe procedure, rescue TEE provided the ability to rule out significant cardiovascular injury or aid in the diagnosis and management of those patients with significant injury. Similarly, Endo et al. evaluated the use of TEE guidance in 108 high risk patients undergoing TLE with general anesthesia, noting 6 cases of TEE prompting surgical management or conversion to open lead extraction as well as 11 cases of excluding significant cardiac damage preventing premature termination of the procedure.11 The authors conclude that TEE provided clinically useful information in 16% of their TLE cases in the series, noting that TEE provides valuable real time information, improving efficacy and safety. As well our study continues to demonstrate the role of intraoperative TEE in the detection and management of complications. Further study may be necessary to elucidate the role of TLE with potential for updating guidelines to recommend TEE during lead extraction procedures routinely or for at-risk patients.
Intraoperative TEE provides additional potential benefit beyond complication identification. For example, the pre-procedure exam can provide data on lead vegetations in infected patients that may alter the perioperative management such that large lesions are extracted open versus percutaneously [Figures 1A & 1B]. Perez Baztarrica et al. noted a tendency toward symptomatic pulmonary embolism in patients undergoing transvenous lead extraction with vegetations larger than 20mm.12 In addition, identification of valvular vegetations may lead to changes in postoperative antibiotic therapy or monitoring. Lastly TEE may be employed to guide
concurrent procedures such as a patient requiring SVC stenting for SVC stenosis after 4 leads were extracted successfully [Figures 2A & 2B]. Our institution therefore has incorporated intraoperative TEE monitoring of our patients undergoing TLE for both intraoperative management as well as complication detection.
The limitation of a relatively small patient sample size prevents evaluating more rare complications such as septic emboli or pneumothorax that were not observed in this study. As well the small number of complications observed precludes the ability to provide further detailed analysis of potential risk factors for identifying at-risk patients. However the single center experience provides the opportunity to describe our institution’s protocol and its success.
Conclusion We report our institution’s experience with TLE and specifically our multidisciplinary approach with the tenets of performance in a hybrid operating room, blood availability, vascular access, hemodynamic monitoring inclusive of intraoperative TEE, as well as full disaster planning including appropriate staffing and available cardiopulmonary bypass and perfusion. This protocol has allowed us to safely perform TLE with a success rate and complication similar to other previously published series.
References 1.
Wilkoff BL, Love CJ, Byrd CL, et al. Transvenous lead extraction: Heart Rhythm Society expert
consensus on facilities, training, indications, and patient management: this document was endorsed by the American Heart Association (AHA). Heart Rhythm 2009;6:1085-104. 2.
Maytin M, Epstein LM. The challenges of transvenous lead extraction. Heart 2011;97:425-34.
3.
Wazni O, Epstein LM, Carrillo RG, et al. Lead extraction in the contemporary setting: the
LExICon study: an observational retrospective study of consecutive laser lead extractions. J Am Coll Cardiol 2010;55:579-86. 4.
Wilkoff BL, Byrd CL, Love CJ, et al. Pacemaker lead extraction with the laser sheath: results of
the pacing lead extraction with the excimer sheath (PLEXES) trial. J Am Coll Cardiol 1999;33:1671-6. 5.
Byrd CL, Wilkoff BL, Love CJ, Sellers TD, Reiser C. Clinical study of the laser sheath for lead
extraction: the total experience in the United States. Pacing Clin Electrophysiol 2002;25:804-8. 6.
Kennergren C, Bjurman C, Wiklund R, Gabel J. A single-centre experience of over one thousand
lead extractions. Europace 2009;11:612-7. 7.
Tanawuttiwat T, Gallego D, Carrillo RG. Lead Extraction Experience with High Frequency
Excimer Laser. Pacing Clin Electrophysiol 2014. 8.
Kutarski A, Polewczyk A, Boczar K, Zabek A, Polewczyk M. Safety and effectiveness of
transvenous lead extraction in elderly patients. Cardiol J 2014;21:47-52. 9.
Brunner MP, Cronin EM, Wazni O, et al. Outcomes of patients requiring emergent surgical or
endovascular intervention for catastrophic complications during transvenous lead extraction. Heart Rhythm 2014;11:419-25. 10.
Hilberath JN, Burrage PS, Shernan SK, et al. Rescue transoesophageal echocardiography for
refractory haemodynamic instability during transvenous lead extraction. Eur Heart J Cardiovasc Imaging 2014.
11.
Endo Y, O'Mara JE, Weiner S, et al. Clinical utility of intraprocedural transesophageal
echocardiography during transvenous lead extraction. J Am Soc Echocardiogr 2008;21:861-7. 12.
Perez Baztarrica G, Gariglio L, Salvaggio F, et al. Transvenous extraction of pacemaker leads in
infective endocarditis with vegetations >/=20 mm: our experience. Clin Cardiol 2012;35:244-9.
Figure Legend Figure 1a. Transesophageal echocardiographic “RV inflow-outflow” view in a patient with D-type Transposition of the great vessels demonstrating a large “cauliflower-like” lead-based vegetation necessitating open lead removal. LA, left atrium; RA, right atrium; LV, morphologic left ventricle; PV, pulmonic valve. Large arrow indicates lead based vegetation. Figure 1b. Transesophageal echocardiographic four-chamber view demonstrating a “windsock-like” lead-based vegetation subsequently removed via transvenous lead extraction. LA, left atrium; RA, right atrium; RV, right ventricle. Figure 2a. Mid-esophageal bicaval view demonstrating residual superior vena caval stenosis status post lead extraction of four leads. LA, left atrium; RA, right atrium; SVC, superior vena cava. Figure 3b. Mid esophageal bicaval view demonstrating relief of superior vena caval stenosis status post TEE guided SVC stent placement. LA, left atrium; RA, right atrium; SVC, superior vena cava. Video Legend Video 2a. Transesophageal echocardiographic “RV inflow-outflow” view in a patient with D-type Transposition of the great vessels demonstrating a large “cauliflower-like” lead-based vegetation necessitating open lead removal. Video 2b. Transesophageal echocardiographic four-chamber view demonstrating a “windsock-like” leadbased vegetation subsequently removed via transvenous lead extraction. Video 3a. Mid-esophageal bicaval view demonstrating residual superior vena caval stenosis status post lead extraction of four leads. Video 3b. Mid esophageal bicaval view demonstrating relief of superior vena caval stenosis status post TEE guided SVC stent placement.
Table 1 Institutional Multidisciplinary Protocol Hybrid Operating Room Size Fluoroscopy
Accommodates OR table, Anesthesia Machine, CPB, TEE Built in fluoroscopy, quick conversion to open procedure
Anesthesiology Preoperative Visit Blood availability Arterial Access Venous Access Echocardiography Hemodynamics
Focus on cardiac history, pacing dependency, need for temporary post op pacing Type and Cross Two Units Packed Red Blood Cells Continuous Blood Pressure Monitoring Large bore access, low lying central access for conversion to temppermanent pacing Transesophageal Echocardiography performed by Cardiac Anesthesia Vasopressor and Inotropic agents available
Cardiac Surgery Skin Preparation Extraction Tools Typical CT Surgical Setup Perfusion Pericardiocentesis
Full skin preparation and drape to allow emergent thoracotomy, sternotomy and/or CPB Direct Traction, Mechanical and Laser sheaths, Femoral Extraction Tools Scrub tables, Sternotomy tools, Scrubbed and Nonscrubbed staff Available Perfusionist and CPB machine Pericardiocentesis Tray
Electrophysiology Femoral Access Temporary Permanent Pacing Reimplantation
Femoral pacing access Utilize existing central line for conversion to temporarypermanent pacing CIED implantation tools
Abbreviations: OR – Operating Room, CPB – Cardiopulmonary Bypass; TEE – Transesophageal Echocardiography, CIED – Cardiovascular Implantable Electronic Devices
Table 2 Clinical Characteristics Patient demographic characteristics Age (y) Male Hypertension Diabetes Mellitus Heart Failure Diagnosis Nonischemic Cardiomyopathy Ischemic Cardiomyopathy Left ventricular ejection fraction (%) Ventricular Tachycardia History Atrial Fibrillation Cerebrovascular Disease Chronic Renal Insufficiency
(n = 195 patients) 61.0 (50.0, 73.0) 140 (71.8) 118 (60.5) 68 (34.9) 113 (58.0) 64 (32.8) 57 (34.4) 45.0 (30.0, 58.0) 67 (34.4) 67 (34.4) 22 (11.3) 40 (20.5)
Continuous variables are presented as median (25th, 75th percentile); categorical variables are presented as n(%).
Table 3 Lead Extraction Data (n = 351 leads in 195 patients) Indication for lead extraction Infection Lead malfunction Other Lead data No. of leads extracted per procedure Extracted from right ventricle Extracted from right atrium Extracted from left ventricle ICD lead (any) extracted during procedure Average Lead Age (months) Technique Laser Sheath Traction Based Technique Mechanical Dilator Sheath Open
72 (36.9) 104 (53.3) 19 (9.7)
1.8 (1.0, 4.0)* 205 (58.4) 120 (34.2) 26 (7.4) 89 (45.6) 77.1 (41.7,100.5)^
258 (73.5) 55 (15.7) 30 (8.5) 8 (2.3)
Categorical variables are presented as n(%); *presented as average (min, max); ^presented as average (25th, 75th percentile)
Table 4 Open Lead Extractions (n=4 patients, 8 leads total) Case
Indication for Open Extraction
Intervention
Case Adhesion of ICD lead to atrial lead within SVC that could not be 1 freed with specialized sheaths
Median Sternotomy, CPB, Lead removal
Case Arteriovenous fistula created during laser extraction of two leads 2 with dense adhesions
Median Sternotomy, CPB, Lead removal, Vascular Repair
Case 3 TEE identification of large vegetation on TV & RV Lead
Median Sternotomy, CPB, Lead removal, TV Repair
Case SVC injury during mechanical dilating sheath extraction of atrial 4 lead yielding tamponade
Median Sternotomy, CPB, Lead removal, Vascular Repair
ICD, implantable cardiac defibrillation; SVC, superior vena cava; CPB, cardiopulmonary bypass; TEE, transesophageal echocardiography; TV, tricuspid valve; RV, right ventricle
Table 5 Transvenous Lead Extraction Experience
Date Epoch 1 (8/10 7/11) Epoch 2 (8/11 7/12) Epoch 3 (8/12 7/13) Epoch 4 (8/13 - 2/14 [6 mos])
Total Total (minus Epoch 1)
C as es
Leads Extrac ted
Major Complic ations
% Complic ation Rate
33
66
4
12.12%
56
107
0
0.00%
69
114
1
1.45%
37
64
1
2.70%
19 5
351
6
3.08%
16 2
285
2
1.23%
Lead Durati on* 76.6 (58.6, 81.2) 84.0 (41.8, 106.3) 70.0 (42.1, 92.5) 78.8 (39.2, 111.4)
77.1 (41.7, 100.5) 77.2 (41.7, 100.8)
Leads Per Patient ^
2.0 (1,4)
1.9 (1,4)
1.7 (1,4)
1.7 (1,4)
1.8 (1,4)
1.9 (1,4)
Patien t Age* 58.8 (44.0, 73.0) 61.2 (46.5, 74.3) 61.1 (53.0, 72.0) 57.7 (50.0, 70.0)
60.1 (50.0, 73.0) 60.4 (50.0, 70.8)
Heart Failure Diagnosis
Ejectio n Fractio n#
48.5%
48.1%
53.6%
46.3%
68.1%
37.8%
54.1%
45.6%
58.0%
43.3%
59.9%
42.4%
* Presented as average (25th, 75th percentile); ^ presented as average (minimum, maximum), # Presented as average percentile.
Multidisciplinary Approach to Transvenous Lead Extraction: A Single Center’s Experience Timothy M. Maus M.D., Jesse Shurter MD, Liem Nguyen MD, Ulrika Birgersdotter-Green MD, Victor Gert D. Pretorius MBchB
www.elsevier.com/locate/buildenv
PII: DOI: Reference:
S1053-0770(14)00548-5 http://dx.doi.org/10.1053/j.jvca.2014.11.010 YJCAN3133
To appear in:
Journal of Cardiothoracic and Vascular Anesthesia
Cite this article as: Timothy M. Maus M.D., Jesse Shurter MD, Liem Nguyen MD, Ulrika Birgersdotter-Green MD, Victor Gert D. Pretorius MBchB, Multidisciplinary Approach to Transvenous Lead Extraction: A Single Center’s Experience, Journal of Cardiothoracic and Vascular Anesthesia, http://dx.doi.org/10.1053/j.jvca.2014.11.010 This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting galley proof before it is published in its final citable form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
Title: Multidisciplinary Approach to Transvenous Lead Extraction: A Single Center’s Experience
Corresponding Author Timothy M Maus, M.D. University of California, San Diego Thornton Hospital 9300 Campus Point Drive #7651 La Jolla, California 92037-7651
TEL: (858) 657-7412 FAX: (858) 657-6436 [email protected]
Supporting Authors Jesse Shurter, MD; Liem Nguyen, MD; Ulrika Birgersdotter-Green, MD; Victor Gert D. Pretorius, MBchB;
Study Institutions Sulpizio Cardiovascular Center University of California San Diego La Jolla, California
Study Support The study was funded by the University of California San Diego, Department of Anesthesiology. No commercial funding was utilized.
Multidisciplinary Approach to Transvenous Lead Extraction: A Single Center’s Experience ABSTRACT: Objectives: To evaluate the success and complication rates of a single center’s multidisciplinary approach to transvenous lead extraction. Setting: One university hospital. Participants: One hundred and ninety five patients scheduled for transvenous lead extraction. Interventions: A multidisciplinary approach to transvenous lead extraction involving cardiac surgery, electrophysiology, perfusion, and cardiac anesthesiology. Measurements: A case series of three hundred and fifty one lead extractions performed in one hundred and ninety five patients over a forty two month period. Indications, success rates, and complication rates were tracked, retrospectively evaluated and reported. Results: Indications for lead extraction included 53.3% due to lead malfunction, 36.9% due to infection, with the remaining 9.7% from other categories such as venous stenosis. Lead extraction rate was 99.7% with complete removal in 97.7%. Overall major complication rate was 3.08%. After an initial one year period of performing lead extractions, the overall major complication rate reduced to 1.23%. Conclusion: Transvenous lead extraction is generally a safe procedure, however not without complications. A multidisciplinary approach involving cardiac surgery, electrophysiology and cardiac anesthesiology allows for successful management and the ability to rapidly manage major complications. Keywords: Transvenous Lead Extraction, Transesophageal Echocardiography, Multidisciplinary
Introduction With the increased use of cardiovascular implantable electronic devices (CIEDs) there has been a concomitant increase in the need for lead removal for various indications. The Heart Rhythm Society (HRS) divides the indications for extraction into five categories: infection, thrombosis or venous stasis, functional leads, non-functional leads and chronic pain.1 Early lead removal techniques relied on manual traction. In addition to being frequently unsuccessful, this technique had a high morbidity and mortality due to cardiac avulsion, tamponade and death.2 While significant technological advances have been made in transvenous lead extraction, serious complications such as cardiac and vascular avulsion leading to hemothorax or pericardial tamponade and death remain considerably high.3 Even with intraprocedural transesophageal echocardiography, rates of cardiac tamponade and death remain high.1 We report on a single university medical center’s multidisciplinary approach to transvenous lead extraction (TLE), specifically the experience with three hundred and fifty one lead extractions in one hundred and ninety five patients focusing on the indications, complications, and success rates over a forty two month period. As detailed below, the implementation of a standardized and comprehensive multidisciplinary approach to the intraoperative management of these patients has been integral to a successful lead extraction program.
Methods The study was approved by the Institutional Human Research Protections Program with an approved request for waiver of consent. Consecutive patients who underwent TLE at our institution between August 2010 and February 2014 were evaluated retrospectively. Lead extraction was identified in accordance with the HRS consensus statement as those cases involving removal of pacemaker or defibrillator leads implanted greater than 1 year in duration, those necessitating the use of specialized sheaths including counter traction tools, mechanical dilating or laser sheaths, or from a route other than the implant vein. Patients with lead implantation less than 1 year in duration requiring simple traction from lead entry site for removal were excluded from analysis. As well, major complications were defined as per HRS Consensus guidelines as death, cardiac avulsion, vascular avulsion, pulmonary embolism requiring surgical intervention, respiratory arrest or anesthesia complication leading to prolongation of hospitalization, stroke or pacing system related infection of a previously non-infected site. Statistical analysis was performed in Microsoft Excel 2010 (Microsoft Corp, Redmond, WA, USA).
Multidisciplinary Protocol All patients were managed with our institutional multidisciplinary protocol, summarized in Table 1, for lead extraction utilizing a single electrophysiologist, cardiac surgeon and a cardiac anesthesia team. Preprocedural - All patients are evaluated by the electrophysiologist, cardiac surgeon and cardiac anesthesiologist, with particular preoperative evaluation focusing on cardiac function, vascular access sites, pacing dependency, the need for post-operative temporary pacing, and
blood product availability via type and cross of two packed red blood cell units in the operating room refrigerator.
All lead extractions are performed in our institution’s hybrid operating room, where patients receive a radial arterial catheter and central introducer sheath by the anesthesia team. The central sheath is typically placed in the right internal jugular vein and facilitates large bore access as well as hemodynamic drug administration. The introducer sheath is often placed as close to the clavicle as is safely possible to facilitate rewiring if a temporary-permanent transvenous pacing system is to be employed. This pathway may be utilized for those pacing dependent patients having leads extracted due to infectious indications necessitating temporary pacing during antibiotic therapy prior to conversion to a permanent pacing system implantation. Lastly all patients undergo general anesthesia and monitored with transesophageal echocardiography both for cardiovascular monitoring as well as rapid identification of cardiac and hemodynamic complications with particular focus for pericardial and pleural effusions, or evidence of tamponade physiology or pulmonary embolism. Echocardiography also proves useful in vegetation and thrombus identification and their suitability for transvenous extraction in infected patients. TEE may also be utilized to assist in coronary sinus lead placement in the setting of poor fluoroscopic imaging or in the placement of superior vena caval stents post lead extraction in patients presenting with superior vena cava syndrome. Femoral venous access is obtained by the electrophysiology team in the case of needed temporary pacing in pacing dependent individuals during extraction, as well as may be used for volume resuscitation in the setting of superior vena caval injury. Femoral arterial access is obtained by the operating team, which in conjunction with femoral venous access, is utilized
when needed for rapid transition to femoral-femoral cardiopulmonary bypass. Lastly a cardiopulmonary bypass machine is immediately available as well as an accessible perfusionist in the instance of need for extracorporeal circulation.
Intraprocedural - A full skin preparation and drape allows the transvenous lead extraction to be performed as well as the immediate performance of pericardiocentesis, thoracotomy, sternotomy and/or institution of cardiopulmonary bypass if needed. The pacemaker pocket is opened and the device is removed from the pocket and the associated leads. A locking stylet is inserted down the inner canal of the lead all the way to the tip for fixation to form a rail to hold counter traction. Teflon, polypropylene and stainless steel sheaths have largely been replaced by next generation laser and mechanical dilating sheaths due to ease of use and increased efficacy and safety. Laser energy dissolves adhesions through photo chemolysis while the mechanical dilating sheath cuts thought scar tissue and displaces it away from the lead. The techniques of lead preparation, counter traction and dissection remain the same regardless of instruments used.4,5 Occasionally the superior extraction approach from the pacemaker site fails so alternative routes of extraction, such as a femoral approach, should be considered. Open surgical extraction is indicated in patients with leads that are extra anatomic due to misplacement through arterial structures or due to erosion through the venous or myocardial wall. Large vegetations (more than 2 cm) on the lead or the tricuspid valve warrant discussion with the operative team. Vegetations large enough to block the main pulmonary artery or major branch vessels should not be extracted percutaneously. As opposed to a thin “windsock” like vegetation that may be extracted with percutaneous techniques, firm “cauliflower” like vegetations should be removed with an open surgical procedure.1 Upgrading the extraction sheath to a larger size than
recommended can allow extraction of small and thin vegetations along with the lead. As well, identification of cardiac abscess by intraoperative echocardiography should prompt discussion with the operative team before proceeding with extraction as further open surgical therapy may be indicated.
Overall, the above described combination and coordination of electrophysiologist, cardiac surgeon, cardiac anesthesia and perfusionist have constituted the multidisciplinary approach to transvenous lead extraction at our institution and the data presented.
Results Three hundred and fifty one leads were extracted from 195 patients from August 2010 through February 2014. The patients were 71.8% male with a median age of 61 years old; other demographics are noted in Table 2. Utilizing HRS indications for extraction, our population’s indications for lead extraction included lead malfunction (53.3%) and infection (36.9%) which included but was not limited to pocket infection, bacteremia, sepsis, and valvular or lead endocarditis [Table 3]. Other indications constituted 9.7% of cases (e.g. venous stenosis). Clinical success was 99.7% with complete procedural success in 97.7% of cases. Seven cases had small amounts of residual lead material attached to the myocardium which was left in place post-procedure.
The extractions included pacing systems (30.8%), cardiac resynchronization pacing systems (24.6%) and implantable cardiac defibrillation (ICD) systems (45.6%) [Table 3]. An average of 1.8 (range 1-4) leads per patient was extracted with an average of 77.1 months duration of implantation. Two hundred and five leads (58.4%) were removed from the right ventricle, 120
(34.2%) from the right atrium and 26 (7.4%) from the coronary sinus. One hundred and twenty two patients (62.6%) had a device reimplanted in the same operative setting with a future reimplantation planned in 64 patients (32.8%). Nine (4.6%) patients were deemed to not need a device reimplantation due to lack of continued medical need.
The method of extraction included laser sheaths (73.5%), traction based techniques (15.7%), mechanical dilating sheaths (8.5%), and open surgical extraction (2.3%). Laser sheath extraction utilized the Excimer laser system (Spectranetics Corp, Colorado Springs, CO). Traction based techniques included leads removed with specialized sheaths for traction-counter traction and those removed with manual traction during cases where lead extraction was utilized for other leads (e.g. right atrial lead removed with manual traction while right ventricular lead required laser extraction). Mechanical dilating sheaths included the Cook Medical Evolution RL and Evolution Shortie RL (Cook Medical, Bloomington, IN). Open extraction was required for 8 leads in 4 cases [Table 4].
Major complication rate overall was 3.08% [Table 5]. Major complications included two cases involving myocardial injury (1 right ventricle perforation and 1 right atrial tear), and three cases of vascular injury (one left subclavian vein tear, one superior vena caval tear and one case of an arteriovenous fistula that developed between the left subclavian vein and left carotid artery requiring open repair). Lastly a patient developed pulmonary hemorrhage attributed to a difficult intubation requiring postoperative intubation and therapeutic bronchoscopies. There were no procedural related deaths in this case series. Examining the major complication rate over time epochs of one year periods (the last time period is six months), the complication rate reduced
while case load increased. The number of complications (% complication rate) reduced from 4 (12.1%) in the first year epoch to 1 or less (0 – 2.7%) for subsequent time epochs. After an initial one year period, the subsequent overall major complication rate was 1.23%, with similar patient characteristics, lead duration, and leads extracted per patient.
Discussion Lead management refers to the overall lead monitoring, management of associated complications (infection, malfunction, thrombosis and vascular complications), issues related to device upgrades (abandonment vs. extraction) and management of imaging related issues (MRI imaging and delivery of radiation therapy). Decisions are made after assessing the risk of lead abandonment versus the risk of lead extraction. Removal of the leads without any specialized equipment is termed lead explantation. On the other hand use of specialized equipment (locking stylets, specialized sheaths, femoral or jugular extraction tools) is termed lead extraction.1 Most pacemaker leads implanted within a year can be explanted without the use of any specialized equipment. As leads stay in the vascular system longer, a fibrotic reaction occurs around the leads which adheres them to vessel walls, where simple traction techniques can lead to major complications such as vascular and myocardial injuries.
A multidisciplinary team based approach and a continual ongoing quality improvement is integral to our institution’s protocol for TLE. Involvement of a cardiothoracic surgeon well versed in managing complications arising from lead extraction is critical to have safe outcomes. Anesthesia support, access to fluoroscopy and echocardiography, and the role of scrubbed and non-scrubbed personnel are clearly defined in the HRS consensus statement.1 A hybrid operating room, as used at our institution provides an ideal setting for lead extraction, allowing a
seamless transition from percutaneous to open procedures. While it is apparent that many institutions perform this procedure in a standard operating suite with portable fluoroscopy, the hybrid operating room provides a consistent setup with appropriate built-in and available utilities thereby providing an optimal situation for complication management.
The above described multidisciplinary approach was instituted in response to the increasing number of patients referred to our institution for lead extraction as well as the potential for catastrophic complications. While in the setting of an increased case load experience, the rate of complications was reduced [Table 5]. The first year experience noted four complications including RV perforation, RA tear, AV fistula development, and left subclavian vein injury. Subsequently an SVC tear was encountered in the third year of experience while in the last six month period the complication of pulmonary hemorrhage was attributed to a difficult intubation as opposed to a complication of the lead extraction procedure itself. Therefore the data are suggestive of an initial learning curve to the lead extraction program as well as a need to maintain vigilance through perioperative preparation for potentially unavoidable complications. The decrease in complication rate with experience has been observed in several other studies.2 The HRS consensus statement describes the major complication rates of several registries and studies, noting a rate ranging from 1.4 to 1.9%.1 Subsequent studies have demonstrated major complication rates of 0.9%,6 1.4%,7 1.51 to 1.6%,8 as well as the multicenter Lexicon study with 1449 patients and a 1.4% major complication rate.3 After our institutions first year learning period, our subsequent major complication rate was reduced to 1.2% which is similar to those previously reported. However our reported mortality rate in this case series was zero while other
studies have reported 0.23%-0.28%.3,7 Continued research may be necessary to further determine the role of a multidisciplinary approach in mortality outcomes. Complications observed in this case series included myocardial and vascular injuries including acute pericardial tamponade, while other known complications during TLE include hemothorax, tricuspid valve injury, and pulmonary embolism. TEE played an instrumental role in the prompt diagnosis of complications in several of these cases. The management of the patient who experienced a right atrial tear during ICD lead extraction exhibited acute hypotension leading to pulseless cardiac arrest immediately upon lead extraction. Interpretation of TEE by the cardiac anesthesiologist demonstrated pericardial tamponade, prompting brief CPR followed by median sternotomy. The patient was managed temporarily with a foley bulb placed in the tear while cardiopulmonary bypass was instituted allowing appropriate repair. Similarly, the patient undergoing attempted right atrial lead extraction with a laser sheath experienced an SVC tear and hypotension, leading to detection of pericardial tamponade on TEE. This prompted median sternotomy for SVC repair and open lead extraction.
Brunner et al. reviewed the outcomes of patients requiring emergent surgical or endovascular intervention for catastrophic complications during TLE and identified 25 cases in their series of 3258 TLE procedures with myocardial, vascular injury or other major complication.9 This group of twenty-five patients had a 36% in house mortality, demonstrating that while low in occurrence, the gravity of the injury is significant. The complications in our series illustrate the importance of rapid diagnosis via TEE in order to promptly institute appropriate treatment and prevent mortality. Hilberath et al. evaluated the utility of rescue TEE in the setting of hemodynamic instability during TLE.10 The authors retrospectively evaluated the
echocardiographic evaluation of 26 cases of intraoperative instability during TLE, finding cases of pericardial tamponade, evidence of hemorrhagic shock, and acute right ventricular dysfunction in nearly half of the cases. Additionally, 54% of the cases had reassuring TEEs which allowed the procedure to continue. The authors conclude that while TLE is a relatively safe procedure, rescue TEE provided the ability to rule out significant cardiovascular injury or aid in the diagnosis and management of those patients with significant injury. Similarly, Endo et al. evaluated the use of TEE guidance in 108 high risk patients undergoing TLE with general anesthesia, noting 6 cases of TEE prompting surgical management or conversion to open lead extraction as well as 11 cases of excluding significant cardiac damage preventing premature termination of the procedure.11 The authors conclude that TEE provided clinically useful information in 16% of their TLE cases in the series, noting that TEE provides valuable real time information, improving efficacy and safety. As well our study continues to demonstrate the role of intraoperative TEE in the detection and management of complications. Further study may be necessary to elucidate the role of TLE with potential for updating guidelines to recommend TEE during lead extraction procedures routinely or for at-risk patients.
Intraoperative TEE provides additional potential benefit beyond complication identification. For example, the pre-procedure exam can provide data on lead vegetations in infected patients that may alter the perioperative management such that large lesions are extracted open versus percutaneously [Figures 1A & 1B]. Perez Baztarrica et al. noted a tendency toward symptomatic pulmonary embolism in patients undergoing transvenous lead extraction with vegetations larger than 20mm.12 In addition, identification of valvular vegetations may lead to changes in postoperative antibiotic therapy or monitoring. Lastly TEE may be employed to guide
concurrent procedures such as a patient requiring SVC stenting for SVC stenosis after 4 leads were extracted successfully [Figures 2A & 2B]. Our institution therefore has incorporated intraoperative TEE monitoring of our patients undergoing TLE for both intraoperative management as well as complication detection.
The limitation of a relatively small patient sample size prevents evaluating more rare complications such as septic emboli or pneumothorax that were not observed in this study. As well the small number of complications observed precludes the ability to provide further detailed analysis of potential risk factors for identifying at-risk patients. However the single center experience provides the opportunity to describe our institution’s protocol and its success.
Conclusion We report our institution’s experience with TLE and specifically our multidisciplinary approach with the tenets of performance in a hybrid operating room, blood availability, vascular access, hemodynamic monitoring inclusive of intraoperative TEE, as well as full disaster planning including appropriate staffing and available cardiopulmonary bypass and perfusion. This protocol has allowed us to safely perform TLE with a success rate and complication similar to other previously published series.
References 1.
Wilkoff BL, Love CJ, Byrd CL, et al. Transvenous lead extraction: Heart Rhythm Society expert
consensus on facilities, training, indications, and patient management: this document was endorsed by the American Heart Association (AHA). Heart Rhythm 2009;6:1085-104. 2.
Maytin M, Epstein LM. The challenges of transvenous lead extraction. Heart 2011;97:425-34.
3.
Wazni O, Epstein LM, Carrillo RG, et al. Lead extraction in the contemporary setting: the
LExICon study: an observational retrospective study of consecutive laser lead extractions. J Am Coll Cardiol 2010;55:579-86. 4.
Wilkoff BL, Byrd CL, Love CJ, et al. Pacemaker lead extraction with the laser sheath: results of
the pacing lead extraction with the excimer sheath (PLEXES) trial. J Am Coll Cardiol 1999;33:1671-6. 5.
Byrd CL, Wilkoff BL, Love CJ, Sellers TD, Reiser C. Clinical study of the laser sheath for lead
extraction: the total experience in the United States. Pacing Clin Electrophysiol 2002;25:804-8. 6.
Kennergren C, Bjurman C, Wiklund R, Gabel J. A single-centre experience of over one thousand
lead extractions. Europace 2009;11:612-7. 7.
Tanawuttiwat T, Gallego D, Carrillo RG. Lead Extraction Experience with High Frequency
Excimer Laser. Pacing Clin Electrophysiol 2014. 8.
Kutarski A, Polewczyk A, Boczar K, Zabek A, Polewczyk M. Safety and effectiveness of
transvenous lead extraction in elderly patients. Cardiol J 2014;21:47-52. 9.
Brunner MP, Cronin EM, Wazni O, et al. Outcomes of patients requiring emergent surgical or
endovascular intervention for catastrophic complications during transvenous lead extraction. Heart Rhythm 2014;11:419-25. 10.
Hilberath JN, Burrage PS, Shernan SK, et al. Rescue transoesophageal echocardiography for
refractory haemodynamic instability during transvenous lead extraction. Eur Heart J Cardiovasc Imaging 2014.
11.
Endo Y, O'Mara JE, Weiner S, et al. Clinical utility of intraprocedural transesophageal
echocardiography during transvenous lead extraction. J Am Soc Echocardiogr 2008;21:861-7. 12.
Perez Baztarrica G, Gariglio L, Salvaggio F, et al. Transvenous extraction of pacemaker leads in
infective endocarditis with vegetations >/=20 mm: our experience. Clin Cardiol 2012;35:244-9.
Figure Legend Figure 1a. Transesophageal echocardiographic “RV inflow-outflow” view in a patient with D-type Transposition of the great vessels demonstrating a large “cauliflower-like” lead-based vegetation necessitating open lead removal. LA, left atrium; RA, right atrium; LV, morphologic left ventricle; PV, pulmonic valve. Large arrow indicates lead based vegetation. Figure 1b. Transesophageal echocardiographic four-chamber view demonstrating a “windsock-like” lead-based vegetation subsequently removed via transvenous lead extraction. LA, left atrium; RA, right atrium; RV, right ventricle. Figure 2a. Mid-esophageal bicaval view demonstrating residual superior vena caval stenosis status post lead extraction of four leads. LA, left atrium; RA, right atrium; SVC, superior vena cava. Figure 3b. Mid esophageal bicaval view demonstrating relief of superior vena caval stenosis status post TEE guided SVC stent placement. LA, left atrium; RA, right atrium; SVC, superior vena cava. Video Legend Video 2a. Transesophageal echocardiographic “RV inflow-outflow” view in a patient with D-type Transposition of the great vessels demonstrating a large “cauliflower-like” lead-based vegetation necessitating open lead removal. Video 2b. Transesophageal echocardiographic four-chamber view demonstrating a “windsock-like” leadbased vegetation subsequently removed via transvenous lead extraction. Video 3a. Mid-esophageal bicaval view demonstrating residual superior vena caval stenosis status post lead extraction of four leads. Video 3b. Mid esophageal bicaval view demonstrating relief of superior vena caval stenosis status post TEE guided SVC stent placement.
Table 1 Institutional Multidisciplinary Protocol Hybrid Operating Room Size Fluoroscopy
Accommodates OR table, Anesthesia Machine, CPB, TEE Built in fluoroscopy, quick conversion to open procedure
Anesthesiology Preoperative Visit Blood availability Arterial Access Venous Access Echocardiography Hemodynamics
Focus on cardiac history, pacing dependency, need for temporary post op pacing Type and Cross Two Units Packed Red Blood Cells Continuous Blood Pressure Monitoring Large bore access, low lying central access for conversion to temppermanent pacing Transesophageal Echocardiography performed by Cardiac Anesthesia Vasopressor and Inotropic agents available
Cardiac Surgery Skin Preparation Extraction Tools Typical CT Surgical Setup Perfusion Pericardiocentesis
Full skin preparation and drape to allow emergent thoracotomy, sternotomy and/or CPB Direct Traction, Mechanical and Laser sheaths, Femoral Extraction Tools Scrub tables, Sternotomy tools, Scrubbed and Nonscrubbed staff Available Perfusionist and CPB machine Pericardiocentesis Tray
Electrophysiology Femoral Access Temporary Permanent Pacing Reimplantation
Femoral pacing access Utilize existing central line for conversion to temporarypermanent pacing CIED implantation tools
Abbreviations: OR – Operating Room, CPB – Cardiopulmonary Bypass; TEE – Transesophageal Echocardiography, CIED – Cardiovascular Implantable Electronic Devices
Table 2 Clinical Characteristics Patient demographic characteristics Age (y) Male Hypertension Diabetes Mellitus Heart Failure Diagnosis Nonischemic Cardiomyopathy Ischemic Cardiomyopathy Left ventricular ejection fraction (%) Ventricular Tachycardia History Atrial Fibrillation Cerebrovascular Disease Chronic Renal Insufficiency
(n = 195 patients) 61.0 (50.0, 73.0) 140 (71.8) 118 (60.5) 68 (34.9) 113 (58.0) 64 (32.8) 57 (34.4) 45.0 (30.0, 58.0) 67 (34.4) 67 (34.4) 22 (11.3) 40 (20.5)
Continuous variables are presented as median (25th, 75th percentile); categorical variables are presented as n(%).
Table 3 Lead Extraction Data (n = 351 leads in 195 patients) Indication for lead extraction Infection Lead malfunction Other Lead data No. of leads extracted per procedure Extracted from right ventricle Extracted from right atrium Extracted from left ventricle ICD lead (any) extracted during procedure Average Lead Age (months) Technique Laser Sheath Traction Based Technique Mechanical Dilator Sheath Open
72 (36.9) 104 (53.3) 19 (9.7)
1.8 (1.0, 4.0)* 205 (58.4) 120 (34.2) 26 (7.4) 89 (45.6) 77.1 (41.7,100.5)^
258 (73.5) 55 (15.7) 30 (8.5) 8 (2.3)
Categorical variables are presented as n(%); *presented as average (min, max); ^presented as average (25th, 75th percentile)
Table 4 Open Lead Extractions (n=4 patients, 8 leads total) Case
Indication for Open Extraction
Intervention
Case Adhesion of ICD lead to atrial lead within SVC that could not be 1 freed with specialized sheaths
Median Sternotomy, CPB, Lead removal
Case Arteriovenous fistula created during laser extraction of two leads 2 with dense adhesions
Median Sternotomy, CPB, Lead removal, Vascular Repair
Case 3 TEE identification of large vegetation on TV & RV Lead
Median Sternotomy, CPB, Lead removal, TV Repair
Case SVC injury during mechanical dilating sheath extraction of atrial 4 lead yielding tamponade
Median Sternotomy, CPB, Lead removal, Vascular Repair
ICD, implantable cardiac defibrillation; SVC, superior vena cava; CPB, cardiopulmonary bypass; TEE, transesophageal echocardiography; TV, tricuspid valve; RV, right ventricle
Table 5 Transvenous Lead Extraction Experience
Date Epoch 1 (8/10 7/11) Epoch 2 (8/11 7/12) Epoch 3 (8/12 7/13) Epoch 4 (8/13 - 2/14 [6 mos])
Total Total (minus Epoch 1)
C as es
Leads Extrac ted
Major Complic ations
% Complic ation Rate
33
66
4
12.12%
56
107
0
0.00%
69
114
1
1.45%
37
64
1
2.70%
19 5
351
6
3.08%
16 2
285
2
1.23%
Lead Durati on* 76.6 (58.6, 81.2) 84.0 (41.8, 106.3) 70.0 (42.1, 92.5) 78.8 (39.2, 111.4)
77.1 (41.7, 100.5) 77.2 (41.7, 100.8)
Leads Per Patient ^
2.0 (1,4)
1.9 (1,4)
1.7 (1,4)
1.7 (1,4)
1.8 (1,4)
1.9 (1,4)
Patien t Age* 58.8 (44.0, 73.0) 61.2 (46.5, 74.3) 61.1 (53.0, 72.0) 57.7 (50.0, 70.0)
60.1 (50.0, 73.0) 60.4 (50.0, 70.8)
Heart Failure Diagnosis
Ejectio n Fractio n#
48.5%
48.1%
53.6%
46.3%
68.1%
37.8%
54.1%
45.6%
58.0%
43.3%
59.9%
42.4%
* Presented as average (25th, 75th percentile); ^ presented as average (minimum, maximum), # Presented as average percentile.