Author + information
- Received October 18, 2018
- Revision received December 31, 2018
- Accepted January 4, 2019
- Published online February 18, 2019.
- Krishna Kancharla, MDa,b,
- Nancy G. Acker, RNa,
- Zhuo Li, MSc,
- Swetha Samineni, MDd,
- Cheng Cai, MDa,e,
- Raul E. Espinosa, MDa,
- Michael Osborn, MDa,
- Siva K. Mulpuru, MDf,
- Samuel J. Asirvatham, MDa,g,
- Paul A. Friedman, MDa and
- Yong-Mei Cha, MDa,∗ ()
- aDepartment of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota
- bDepartment of Cardiovascular Diseases, University of Pittsburgh, Pittsburgh, Pennsylvania
- cBiostatistics Unit, Mayo Clinic, Jacksonville, Florida
- dInternal Medicine, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania
- eDivision of Cardiology, First Affiliated Hospital of Nanjing Medical University, Nanjing, China
- fDepartment of Cardiovascular Medicine, Mayo Clinic Hospital, Phoenix, Arizona
- gDivision of Pediatric Cardiology, Mayo Clinic, Rochester, Minnesota
- ↵∗Address for correspondence:
Dr. Yong-Mei Cha, Department of Cardiovascular Medicine, Mayo Clinic, 200 First Street SW, Rochester, Minnesota 55905.
Objectives The goal of this study was to evaluate a novel risk stratification scheme to categorize patients on the basis of risk to either an operating room or device laboratory with rescue strategy.
Background Lead extraction can be complicated by lethal issues such as vascular and cardiac rupture. Currently, the optimal site for lead extraction has not been well established.
Methods A risk stratification scheme was developed from previously available risk factors for major complications. Patients were prospectively risk stratified between October 2013 and January 2016. High-risk procedures were performed in the operating room with ready surgical services; intermediate-risk procedures were performed in the device laboratory.
Results In total, 349 leads were removed from 187 patients (age 61.0 ± 17.2 years; 66.3% men) over 27 months. Seventy-two patients (38.5%) were categorized as high risk. Median implant duration of the oldest lead per patient was 11.2 years (interquartile range: 7.9 to 14.9 years) in the operating room group versus 2.6 years (interquartile range: 1.6 to 4.9 years) in the device laboratory group (p < 0.001). Clinical success in the operating room (95.8%) and device laboratory (99.1%) groups was similar (p = 0.16). A higher incidence of major complications occurred in the high-risk group (operating room group: 6.9%; device laboratory: 0.0%; p = 0.007). In-hospital mortality (operating room group: 8.3%; device laboratory: 2.6%; p = 0.09) and long-term (2-year) survival (operating room: 70.8%; device laboratory: 84.4%; p = 0.07) rates were similar.
Conclusions Use of a novel risk stratification scheme in guiding the selection of operating room versus device laboratory for lead extraction is feasible, safe, and efficacious. Intermediate-risk procedures can be performed safely in the device laboratory with rescue strategy, without excess surgical resource utilization.
The need for removal of cardiac implantable electronic devices (CIEDs) has steadily increased over the years (1,2). This outcome is due to an increase in device infections (1), structural defects in leads, and the need for device upgrades in parallel to a larger aging population in the United States with greater comorbidities. Despite improvements in extraction techniques and tools, lead extraction continues to be a challenging procedure with potential for death (3–5). Catastrophic complications include exsanguination from vascular laceration, tricuspid valve avulsion, and cardiac perforation with tamponade (6). The 2009 Heart Rhythm Society (HRS) Expert Consensus on Facilities, Training, Indications, and Patient Management recommends immediate availability of cardiothoracic surgical services for extraction procedures (7). The 2017 updated HRS consensus statement further addresses the importance of availability of a cardiac surgeon and team, with access to equipment to perform emergent sternotomy or thoracotomy within 5 to 10 min, with a focus on maximizing procedure safety and efficacy, irrespective of the location of the procedure (8). Nonetheless, death of patients who have a major complication requiring emergent surgical intervention is 24% intraprocedurally, with an additional 12% during post-procedural hospitalization (9).
The logistical approach to lead extraction differs across institutions. One report suggests that 25% of these procedures in the United States are performed without a surgeon or operating room on standby (6). Among institutions that provide surgical backup, some use an operating room or hybrid facility exclusively; others conduct extractions in the device or electrophysiology laboratory. Extraction in the device laboratory affords superior fluoroscopy, immediate access to percutaneous tools and staff experienced in their use, and schedule flexibility. However, cardiac surgical support is generally less promptly available. Currently, no empirically validated protocol clarifies which patients are best served by lead extraction in the operating room, compared with patients whose extraction can be completed safely in the device laboratory. After retrospective review (10) of patients who underwent CIED lead removal from January 2001 to October 2012 at Mayo Clinic (Rochester, Minnesota), and on the basis of previous reports on risk factors, we propose a risk stratification scheme (Table 1) to identify patients as at intermediate and high risk for lead extraction as a guide to performing the extraction in the device laboratory versus the operating room.
Risk stratification scheme
A risk stratification scheme was developed by using previous reports (4,7,11,12) and a retrospective study conducted at Mayo Clinic (10), which identified clinical variables associated with the risk of major events during lead extraction (Table 1). We defined patients with the oldest implanted pacing lead of 1 to 10 years or the oldest intracardiac converter-defibrillator (ICD) lead of 1 to 5 years as intermediate risk and those with an oldest pacing lead >10 years or ICD lead >5 years as high risk for lead extraction. The risk of major complications potentially requiring surgical intervention was estimated as 1.2% for intermediate-risk procedures and 5.3% for high-risk procedures on the basis of the initial retrospective study from our institution. Starting October 2013, patients were prospectively stratified by using this risk scheme, and procedures were performed in the device laboratory with stabilization and rescue strategy for intermediate-risk patients and in the operating room for high-risk patients.
Study population and data collection
As per the 2009 HRS consensus document (7), at the time of the study, lead extraction was defined as removal of a lead implanted >1 year before the procedure date. In this prospective observational study, patients who underwent lead extraction from October 2013 to January 2016 at the Mayo Clinic in Rochester, Minnesota, were included (i.e., intermediate-risk and high-risk procedures). The study was approved by the Mayo Clinic institutional review board. All patients included in the study agreed to Mayo Clinic research participation. Patients gave informed clinical consent for the procedure, including the discussion of procedure details and approach. Medical history, CIED implant history, indication for the lead extraction, techniques and details of extraction, complications, hospital course, and subsequent follow-up were thoroughly reviewed by 2 electrophysiologists (Y.-M.C. and K.K.). Patients whose records showed major or minor complications were cross-reviewed by another reviewer (S.S.). An experienced device nurse (N.G.A.) entered the device- or lead-specific data.
Lead extraction indications and definitions
Indications for lead extraction were classified as pocket site infection, endocarditis or bacteremia, lead malfunction or recall, device system upgrade, and others (e.g., pericarditis, effusion from perforation, tricuspid regurgitation, venous thrombosis). The HRS expert consensus on transvenous lead extraction was used to define (Online Table 1) the procedural outcome and major and minor complications (7). Patient death was determined by review of the electronic health records and the U.S. National Social Security death index.
Before the day of the procedure, all patients were thoroughly evaluated in the device clinic or by the inpatient electrophysiology consultation service. Evaluation included a comprehensive clinical and device history, procedural risk stratification, determination of cardiovascular surgical candidacy, and assessment of reimplantation need. For the intermediate-risk group, the procedure was performed in the device laboratory with surgical backup. This approach involved alerting a cardiovascular surgical team who were physically available any moment for immediate surgical rescue but not required to be available in the procedure room at the time of the procedure. The designated surgeon is dedicated to respond immediately to performing an emergency surgical procedure for superior vena cava (SVC) tear or myocardial tear. For SVC tear, a balloon occlusion was planned to stabilize the patient before transfer to the operating room. For myocardial tear, pericardiocentesis was planned to stabilize the patient before transfer to the operating room. If the procedure was perceived to be higher risk based on the intraprocedural assessment and difficulty in extracting, the procedure was abandoned in the device laboratory and performed in the operating room. For the high-risk group, the procedure was undertaken in a hybrid operating room with surgical team and perfusion services primed and immediately available. The surgical instruments were opened and available on the procedure table.
All procedures were performed under general or monitored deep anesthesia with anesthesiology support and arterial blood pressure monitoring. Femoral venous accesses were obtained for volume resuscitation, temporary pacing, transfemoral extraction, and SVC wire placement for balloon occlusion in the case of venous laceration. The balloon used in the study period was a peripheral noncompliant balloon (Atlas Gold PTA 20 mm × 40 mm, Bard Peripheral Vascular, Inc., Tempe, Arizona) and was not specifically designed for SVC occlusion; the Bridge Occlusion Balloon (Spectranetics Corporation, Colorado Springs, Colorado) was not available for clinical use during the study period. Transesophageal echocardiography was routinely used for all high-risk procedures and was used at operator discretion in the device laboratory. Sternotomy was performed in cases of suspected SVC tear or unexplained shock. Under exceptional circumstances in which cardiac surgery was required for other reasons, sternotomy and cardiopulmonary bypass were performed deliberately, and percutaneous lead extraction was integrated into that procedure.
Lead extraction technique
A stepwise approach to lead extraction was generally followed. If simple traction failed to free the lead, traction was repeated with a locking stylet. An Excimer Laser Sheath (Class IV laser; laser type: Excimer Laser, OD 5+ at 308 nm; average power: 80 mJ; maximum output pulse: 80 Hz; 125 to 200 ns; CVX-300 Excimer Laser System, Spectranetics Corporation) along with a supporting outer sheath were used in all leads immobilized by fibrous adhesions. A rotational mechanical sheath (TightRail rotating dilator sheath, Spectranetics Corporation) was used in some cases when laser extraction was not successful. Transfemoral extraction techniques (e.g., snare, deflectable catheter, bioptome) were used to facilitate lead removal at the operator’s discretion. If these methods failed, the procedure was converted to an open-chest surgical approach for completion of lead extraction.
Data analysis was conducted using SAS version 9.3 (SAS Institute, Inc., Cary, North Carolina). All tests of significance were 2-sided, with statistical significance set at p < 0.05. Descriptive categorical variables are reported as frequency and percentage; continuous variables are expressed as mean ± SD or median (interquartile range [IQR]). The chi-square test or Fisher exact test was used to compare categorical variables. Continuous variables were compared with a 2-sample t-test or Wilcoxon rank sum test where appropriate.
With our risk stratification scheme, 187 patients were categorized as intermediate or high risk for extraction over a period of 27 months and included for analysis. The mean age of the study patients was 61.0 ± 17.2 years, and 66.3% were male. Seventy-two patients (38.5%) were categorized as high risk and underwent operating room–based extraction. Baseline characteristics are shown in Table 2. No significant differences were observed in baseline medical conditions, left ventricular function, or medical therapy between groups. Indications for extraction are shown in Figure 1. Forty-eight percent of patients had infection/sepsis as the indication for extraction. Indications differed significantly between the groups, with the operating room group having a higher proportion of patients with pocket infection (30.6% vs. 20%) and a lower proportion of patients with system upgrade (1.4% vs. 13.9%) compared with the device laboratory group. The study groups are not equal because they were not randomized to treatment; rather, they were deliberately risk stratified based on the criteria leading to baseline differences.
Device and lead characteristics
Patients in the operating room group had a higher proportion of ICD and cardiac resynchronization therapy–defibrillator systems (69.5% vs. 48.7%; p = 0.01) than the device laboratory group. In total, 349 leads were removed, with a median of 2.0 (range: 1.0 to 5.0) leads per procedure. Median implant-to-removal time (i.e., lead dwell time) of the oldest lead per patient was 11.2 years (IQR: 7.9 to 14.9 years) in the operating room group and 2.6 years (IQR: 1.6 to 4.9 years) in the device laboratory group (p < 0.001). Of patients in the operating room group, 69.4% had a defibrillator lead extracted during the procedure compared with 38.3% of patients in the device laboratory group (p < 0.001). Device and lead characteristics are shown in Table 3.
Extraction technique and outcomes
Laser tools were used in 91.7% of operating room patients versus 46.1% of patients in the device laboratory group (p < 0.001) (Online Table 2a). Powered tools (laser or mechanical rotational sheath) were needed for 75.9% of the pacemaker leads in the operating room group compared with 40.5% in the device laboratory group (p < 0.0001). Power tools were needed for 87.5% of the ICD leads in the operating room group compared with 63.6% in the device laboratory group (p = 0.005). Remaining leads were removed with traction only (Online Table 2b).
Complete success was achieved in 87.3% of patients in the operating room group compared with 95.7% in the device laboratory group (p = 0.10). A combined laser and sternotomy approach was performed for 3 patients. One of these 3 patients had undergone a previously failed extraction in the device laboratory due to calcified fibrosis, leading to a combined transvenous extraction and sternotomy because of perceived high risk. The other 2 patients needed concomitant surgical intervention in addition to lead extraction. Two of the three patients underwent epicardial lead implantation for future device therapy.
A higher proportion of major complications occurred in the high-risk group (operating room group: 6.9%; device laboratory group: 0%; p = 0.007) than in the intermediate-risk group. Procedural outcomes, complications, and follow-up are shown in Table 4. Eight patients in the operating room group had complications (5 [6.9%] with major complications and 3 [4.2%] with minor complications) (Online Table 3). The median lead dwell time of the oldest lead for patients with complications or extraction failure (17.2 [IQR: 12.6 to 20.4] years; n = 9) was longer than for patients without complications or failure (10.3 [IQR: 7.6 to 14.3] years; n = 63) in the operating room group (p = 0.02). Online Table 4 presents a comparison between the operating room subgroups.
Three patients (4.2%) in the operating room group had an SVC or subclavian tear. The first patient (operating room Patient #1) had a history of D-transposition of the great arteries and required lead extraction for SVC baffle obstruction and SVC syndrome. Attempts to free the single-coil right ventricular ICD lead with laser application through the obstructed baffle within the stent resulted in a right hemothorax. SVC balloon occlusion was attempted from right internal jugular access but failed. A lateral thoracotomy was achieved and a lateral SVC tear repaired. The patient died of disseminated intravascular coagulation. The second patient (operating room Patient #2) was elected for lead extraction for Riata ICD (St. Jude Medical, St. Paul, Minnesota) lead malfunction. During laser-based attempts, a lateral SVC tear and pericardial effusion developed. The lateral SVC tear was repaired with a bovine pericardial patch, and a right ventricular perforation was noted and repaired. The post-surgical course was complicated with cerebral ischemia and need for hemodynamic support. Care was withdrawn because of futility. The third patient (operating room Patient #3) had a 12-year-old fracture of a Sprint Fidelis (Medtronic, Minneapolis, Minnesota) dual-coil ICD lead, causing inappropriate shocks. The patient had severe bleeding related to subclavian vein tear, and surgical repair was performed immediately, with no further consequences. Two patients in the operating room group had severe tricuspid regurgitation because of leaflet avulsion, one requiring immediate surgical replacement of the valve, and the other patient had delayed replacement for drug refractory heart failure.
Five patients in the device laboratory group experienced minor complications; none had a major complication. The proportions of patients with major and minor complications based on use of risk stratification are presented in Figure 2.
Hospital stay and survival
The median length of hospital stay was similar between the groups (operating room group: 8 [IQR: 2 to 13] days; device laboratory group: 7 [IQR: 2 to 14.5] days). Mortality rate during hospitalization was not significantly different (operating room group: 8.3%; device laboratory group: 2.6%; p = 0.09) between groups. In total, 9 patients (4.8%) died during hospitalization. Two patients (1.1%) died after SVC tear, 4 patients died of septic shock, and 3 died of decompensated heart failure. No significant difference between groups was observed in 2-year survival (operating room group: 70.8%; device laboratory group: 84.4%; p = 0.07) (Figure 3).
Applicability of risk stratification for lead extraction
Lead extraction is a complex, high-risk intervention. Although the operating room setting offers immediate surgical intervention, its use adds to scheduling complexity, cost, and resource utilization. In many institutions, the device laboratory typically has superior fluoroscopy and more ready access to percutaneous tools and support staff trained in their use. A hybrid laboratory with surgical capability and superior fluoroscopy, with staff trained in both lead extraction and cardiac surgical services, can provide optimal balance. This study prospectively confirmed the utility of a risk stratification scheme developed from a retrospective analysis to guide site selection for lead extraction practice at our institution. Five major complications (2.7%), including 2 procedure-related deaths (1.1%), occurred. All of these occurred in the group categorized as high risk for extraction through the risk stratification scheme. The patients were treated in the operating room from the outset, facilitating surgical intervention. The extraction success was similar to previous studies using powered tools for lead extraction (3,5,11,13,14). The major complication rate in the published registries was 1.4% to 2.5% compared with 2.7% in our study. The complication rate is similar with limitation of sample size and centers’ referral bias for comparison. We found that with adoption of the risk stratification, approximately two-thirds of patients underwent extraction in the device laboratory with rescue strategies, without major complications or need for emergent intervention. Both groups of patients had a higher 1-year mortality similar to the previous studies, which is likely a reflection of the risk associated with the comorbidities that predispose to device infection and sepsis needing lead extraction (15,16).
Although catastrophic complications are infrequent, they are on the increase (14), and the mortality rate of patients with such complications is high despite surgical rescue (9). The Manufacturer and User Facility Device Experience series, based on reports to the U.S. Food and Drug Administration, suggest that the majority of deaths were caused by lacerations of the right atrium, SVC, or innominate vein, in which 44% of patients died despite emergency surgical repair (17). These data emphasize the need to identify those patients at risk for catastrophic complications before the procedure. Previous studies (13,18,19) have reported risk factors for major complications, such as female sex, renal function, heart failure, implant duration of the lead, and ICD lead removal.
Currently, no optimal site or protocol has been established for lead extraction. An observational study reported no significant difference in extraction success or major complications between operating room–based and device laboratory–based extraction practice as they transitioned from the first to the second over the years (12). Extraction in an operating room setting, with quick cardiac surgical support for all cases, is limited by operating room availability and the complexity of coordination of schedules with surgical teams; these factors may delay care and render it more expensive, thereby causing reduced efficiency. This point highlights the need for a strategy to strike an optimal balance between safety and efficacy. In the present prospective study, the scheme effectively stratified 61% of the patients as intermediate risk, who then safely underwent extraction in the device laboratory without a delay in operating room services. The risk stratification scheme promotes a collaborative approach in a health care team with diverse skill sets and helps in configuration of a strategy to obtain optimal balance between efficacy and safety in lead extraction practice.
Improving safety in lead extraction practice
In the present study, the 2 patients who had SVC tears subsequently died of this complication and despite immediate availability of surgical services. The high burden of death for patients with vascular rupture from lead extraction urges a multidimensional approach. The U.S. Food and Drug Administration recently approved the Spectranetics Bridge Balloon catheter (20), providing an effective tool to minimize SVC bleeding and bridge for surgical repair. To further improve safety for the high-risk group, additional risk stratification is needed to identify patients who may need alternative strategies for extraction. One such alternative strategy is a combined transvenous and surgical approach for extraction in a subset of patients who are at low likelihood of successful extraction and a high risk of complications.
With the use of the risk stratification scheme, the intermediate-risk group did not experience major complications during this study period. However, this finding is limited by the sample size. With limited surgical backup, risk reduction is critical in this group and depends on adequate risk stratification and availability of a rescue strategy. One patient in the study group was rescheduled for an operating room–based hybrid extraction after an initial extraction attempt in the device laboratory, due to perceived high risk from calcifications. Such rescheduling was rarely needed, however, emphasizing the continued appraisal of risk intraprocedurally and adequate procurement of resources even in the lower risk group. The use of stabilizing solutions (e.g., balloon occlusion for venous tear, pericardiocentesis for tamponade) has the potential for further risk reduction in all subgroups while planning definitive interventions. Preparedness and rescue strategies are essential for procedures performed in the device laboratory. As recommended by the 2017 HRS consensus statement (8), irrespective of the location of extraction, the immediate rescue strategy is essential in the event of a catastrophic complication because there is never a no-risk group for lead extraction.
These results are from a single tertiary center with a lead extraction practice comprising a local and referral patient population. This study does not address which extraction system is superior for a particular patient but rather evaluates a risk stratification scheme to safely allocate resources for lead extraction. The risk stratification safety and efficacy could also be influenced by the experience of the operator and the volume of extraction procedures performed at a center.
Use of a risk stratification scheme in guiding the selection of operating room versus device laboratory for lead extraction is feasible, safe, and efficacious. Intermediate-risk procedures can be performed safely in the device laboratory with rescue strategy and less robust surgical backup, which could facilitate the provision of care in a timely manner without delay in scheduling. High-risk cases, when conducted in the operating room under the expertise of a multidisciplinary team, allow immediate surgical intervention, and this merits the use of limited operating room resources and expertise in tertiary centers. We believe risk stratification guidance in resource utilization optimizes safety and efficiency in caring for patients who require lead extraction.
COMPETENCY IN MEDICAL KNOWLEDGE: The practice of lead extraction has been continually changing with new advancements in the field. The current practice of percutaneous extraction techniques limits the need for open surgical extraction. This study used a novel risk stratification tool to prospectively categorize risk and allocate rescue strategies and surgical services for anticipated complications. The study adds to the available literature that the risk of lead extraction is prospectively predictable. The study supports the use of multidisciplinary team expertise for higher risk patients. In the setting of adequate rescue strategies in place with backup surgical services, intermediate-risk patients can be cared for in the device laboratory.
TRANSLATIONAL OUTLOOK: The optimal strategy based on development and continued refinement of the risk stratification models should be pursued to achieve safety and efficacy in lead management. The high mortality rate due to large-vessel rupture at multiple centers despite surgical availability urges the need for further risk stratification and alternative strategies for very-high-risk patients. Protocols to improvise prompt diagnosis of major complications, immediate stabilization, and rescue solutions will reduce mortality related to lead extraction procedure.
The authors have reported that they have no relationships relevant to the contents of this paper to disclose.
All authors attest they are in compliance with human studies committees and animal welfare regulations of the authors’ institutions and Food and Drug Administration guidelines, including patient consent where appropriate. For more information, visit the JACC: Clinical Electrophysiology author instructions page.
- Abbreviations and Acronyms
- cardiac implantable electronic device
- Heart Rhythm Society
- implantable cardioverter-defibrillator
- interquartile range
- superior vena cava
- Received October 18, 2018.
- Revision received December 31, 2018.
- Accepted January 4, 2019.
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