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Surgical extraction of cardiac implantable electronic device leads based on a heart team approach

Published:October 10, 2022DOI:https://doi.org/10.1016/j.jjcc.2022.08.013

      Highlights

      • Treatment strategies should be discussed for each patient in a heart team.
      • Decision-making made by a heart team can provide optimal treatment in each patient.
      • Surgical lead extraction (SLE) was required in 21 of the 384 patients.
      • Emergent open-chest hemostasis was required in 4 of the 363 transvenous patients.
      • Conversion to SLE is smoothly decided after heart team conferences.

      Abstract

      Background

      As cardiac implantable electronic devices, such as pacemakers, cardioverter defibrillators, and cardiac resynchronization therapies, have become more popular, device extraction has become more frequent. At our institution, individual treatment strategies are discussed at a heart team meeting. Transvenous lead extraction (TVLE) is a first-line treatment; however, surgical lead extraction (SLE) is sometimes selected as a primary choice to provide optimal treatment and maintain the medical safety policy. This study aimed to investigate the validity of this heart team decision-making.

      Methods

      From 2013 to 2021, 384 consecutive patients underwent lead extraction at our institution.

      Results

      SLE was proposed as the primary intervention for 21 patients who had high risk of bleeding, difficult TVLE conditions, large vegetations, and other concomitant cardiac diseases. Of the 363 TVLE patients, 10 patients required surgical intervention; 5 had TVLE difficulty followed by SLE and 5 had excessive bleeding. SLE was performed in 26 patients, 19 of whom required valve surgery, and 8 required plication of the great veins. In 4 of the 17 hybrid procedures with SLE and TVLE, excessive bleeding occurred due to laceration of the superior vena cava and innominate vein. Operative mortality was not observed in SLE patients but was observed in 1 of the 4 TVLE patients who required emergent open-chest hemostasis.

      Conclusions

      The heart team discussion was essential to provide optimal treatment and maintain medical safety policies for each patient. SLE should be selected for patients with high risk of TVLE or other cardiac complications such as tricuspid valve incompetence.

      Graphical abstract

      Keywords

      Introduction

      Pacemaker implantation is now the primary treatment for bradycardia. Indeed, implantable cardioverter-defibrillator and cardiac resynchronization therapy (CRT) have been widely used for patients with life-threatening ventricular arrhythmia and severe heart failure [
      • Tarakji K.G.
      • Saliba W.
      • Markabawi D.
      • Rodriguez E.R.
      • Krauthammer Y.
      • Brunner M.P.
      • et al.
      Unrecognized venous injuries after cardiac implantable electronic device transvenous lead extraction.
      ,
      • Brunner M.P.
      • Cronin E.M.
      • Duarte V.E.
      • Yu C.
      • Tarakji K.G.
      • Martin D.O.
      • et al.
      Clinical predictors of adverse patient outcomes in an experience of more than 5000 chronic endovascular pacemaker and defibrillator lead extractions.
      ,
      • Goyal S.K.
      • Ellis C.R.
      • Ball S.K.
      • Ahmad R.
      • Hoff S.J.
      • Whalen S.P.
      • et al.
      High-risk lead removal by planned sequential transvenous laser extraction and minimally invasive right thoracotomy.
      ]. These cardiac electronic implantable devices have saved many patients with severe heart diseases. However, once implanted, the risk of device infection persists until it is extracted [
      • Azarrafiy R.
      • Carrillo R.G.
      Surgical and hybrid lead extraction.
      ,
      • Sood N.
      • Martin D.T.
      • Lampert R.
      • Curtis J.P.
      • Parzynski C.
      • Clancy J.
      Incidence and predictors of perioperative complications with transvenous lead extraction real-world experience with National Cardiovascular Data Registry.
      ]. Multiple lead insertions induce occlusion of great vessels, particularly the superior vena cava (SVC) and innominate veins.
      Problematic leads can be extracted via an intravenous approach using an excimer laser along with other extraction tools [
      • Neuzil P.
      • Taborsky M.
      • Rezek Z.
      • Vopalka R.
      • Sediva L.
      • Niederle P.
      • et al.
      Pacemaker and ICD lead extraction with electrosurgical dissection sheaths and standard transvenous extraction systems: results of a randomized trial.
      ]. However, transvenous lead extraction (TVLE) rarely causes cardiac or great vessel rupture and tricuspid valve destruction, followed by cardiogenic shock or cardiac tamponade [
      • Wilkoff B.L.
      • Love C.J.
      • Byrd C.L.
      • Bongiorni M.G.
      • Carrillo R.G.
      • Crossley 3rd, G.H.
      • 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).
      ]. Large vegetations attached to the lead may cause septic pulmonary embolisms after TVLE. Although TVLE is considered beneficial for old and sick patients, surgical intervention is also important to both extract problematic leads safely and treat concomitant cardiac disease to improve patient life span.
      At our institution, a preoperative heart team meeting has been held every week, and the risk factors for TVLE are discussed for each patient. Surgical lead extraction (SLE) is selected as the primary procedure for patients with a high risk of cardiac rupture or TVLE difficulty and for those who require other concomitant cardiac surgery. The aim of this study was to investigate the outcomes of SLE at our institution and clarify the essential points of a heart team approach in providing the optimal treatment and maintaining medical safety policies for each patient.

      Methods

      Study design

      From January 2013 to January 2021, 384 consecutive patients were referred to the Heart Rhythm Center of our institution for extraction of cardiac implantable electronic devices. We retrospectively investigated patients who required SLE. Informed consent for SLE and other concomitant surgical procedures was obtained from each patient. This retrospective observational study was approved by our institutional review board (Institutional Review Board Clinical Research Number M2000-1806).

      Decision-making in the weekly heart team conference

      At our institution, cardiologists, cardiac surgeons, anesthesiologists, medical engineers, and operation nurses conduct a periodic heart team meeting to manage the risk of TVLE. The heart team members share medical information, such as medical history; type of leads; blood examination; X-ray; electrocardiography; coronary angiography; venography; computed tomography findings of each patient. Consecutively, based on the members consensus, patients at high-risk for TVLE are selected to undergo SLE as a primary choice. Although our heart team members recognize that TVLE is the first-line method of the lead extraction, SLE should be selected if patients had lead vegetations larger than 3 cm, difficult conditions for TVLE such as a distal lead tip floating in the cardiac or venous cavity or protrusion of the lead tip through the heart, other concomitant cardiac diseases which required surgical repair such as severe tricuspid valve regurgitation (TR) and mitral regurgitation, and symptomatic occlusion of the SVC and innominate vein. Further, other important predictors of difficult conditions for TVLE at our institution are as follows; atrial tined tips, a long duration from lead implantation to extraction (10 years or more), >4 leads, and low left ventricular dysfunction [
      • Svennberg E.
      • Jacobs K.
      • McVeigh E.
      • Pretorius V.
      • Birgersdotter-Green U.
      Computed tomography–guided risk assessment in percutaneous lead extraction.
      ]. The decision for SLE is made while considering multiple factors.
      Additionally, the members also decide on the time schedule and place for TVLE [operation room (OR) or catheterization laboratory (CL)〕. TVLE for patients with multiple high-risk factors are usually performed in the OR, where a cardiac surgeon always attends the TVLE with cardiologists. When TVLE is performed at the CL, the cardiac surgeon is not present in the CL but is in constant contact with the cardiologists during the procedure.

      TVLE procedures

      For TVLE, an excimer laser system (Spectranetics, Colorado Springs, CO, USA) and other lead extraction devices and other lead extraction devices, such as COOK Evolution RL Rotation (COOK Medical, Bloomington, IN, USA), were used [
      • Goya M.
      • Nagashima M.
      • Hiroshima K.
      • Hayashi K.
      • Makihara Y.
      • Fukunaga M.
      • et al.
      Lead extractions in patients with cardiac implantable electronic device infections: single center experience.
      ]. All patients who underwent TVLE in the OR were systemically anesthetized and intubated. The chest was draped for emergent open-chest hemostasis. For patients who underwent TVLE in the CL, local analgesia was used. Catheter sheath introducers were inserted into the femoral arteries and veins to prepare for emergent introduction of extracorporeal membrane oxygenation (ECMO). TVLE was performed with fluoroscopy and transesophageal echocardiography or intracardiac echocardiography to monitor intrapericardial bleeding. When leads could not be removed with TVLE, the TVLE procedure was terminated and elective SLE was planned for another day.

      Surgical procedures

      Emergent open-chest hemostasis

      When cardiac bleeding followed by cardiac tamponade was recognized during the TVLE procedure in the OR, the chest was quickly opened, and the bleeding site was sutured. If an emergent event occurred in the CL, ECMO was introduced prior to the open-chest procedure if possible, and then the patient was safely transferred to the OR for surgical hemostasis. If quick introduction of ECMO was difficult, open-chest hemostasis was performed even in the CL.
      If the leads remained at the time of emergent hemostatic surgery, the lead extraction procedure was continued transvenously or surgically.

      Elective SLE

      Elective SLE was performed in patients with difficulty of TVLE or other concomitant heart diseases. The heart was exposed via median sternotomy. The inferior vena cava (IVC), intrapericardial SVC, SVC distal to the azygous vein, right SVC distal to the innominate vein, and innominate vein were exposed. After heparinization, an arterial cannula was inserted at the ascending aorta. A venous cannula was inserted into the IVC via the right atrium (RA), and another venous cannula was inserted directly into the right SVC distal to the innominate vein. Transcutaneous cannulation to the right internal jugular vein was also acceptable. When adequate venous return could not be obtained, an additional venous cannula or suction tube was inserted into the upper RA. After adequate cardiopulmonary bypass (CPB) flow was confirmed, the RA, SVC, and innominate veins were opened to extract the leads.

      Hybrid lead extraction

      To reduce the dissection area around the SVC and innominate vein, a hybrid procedure was often applied. After the heart was exposed, the leads were dissected using the TVLE procedure from the skin to the SVC inside the pericardium. Thereafter, SLE was performed in the same manner as ordinary valve surgery in one-stage surgery.

      Tricuspid valve surgery

      Tricuspid valve surgery is required in patients with preoperative TR, infective endocarditis, and severe adhesion of the leads to the leaflet, chorda, or papillary muscle. Vegetations were often peeled off from the leads and the valves. Further, to control TR, tricuspid annular plication (TAP) was often necessary. Artificial bands were ideally used. However, when the annulus was infected, a partial auto-pericardial band was used for partial TAP. In addition, leaflet repair procedures were necessary when a lead was extensively attached to the leaflets, chorda, or papillary muscle. Leaflet closure techniques such as edge-to-edge closure or clover technique were also applied to adjust the height of the leaflets. Tricuspid valve replacement was avoided as much as possible in this patient cohort.
      In patients with functional TR, patch augmentation of the leaflet or subvalvular surgical techniques were added to obtain better coaptation of the leaflets [
      • Takeshita M.
      • Arai H.
      • Nagaoka E.
      • Mizuno T.
      Papillary muscle relocation and annular repositioning for functional tricuspid regurgitation.
      ].

      Vein patch plasty

      Vein patch plasty with bovine pericardium patch® (Edwards Lifesciences, Irvine, CA, USA) was performed in patients with stenotic or occluded innominate veins and SVCs.

      Endpoint

      The primary clinical endpoint was all-cause mortality. The secondary composite endpoints were residual severe TR and heart failure during the follow-up period. Data on the indications for surgery, concomitant cardiac surgery, morbidities, and mortalities were collected from the patients' medical records. Further, TR severity was graded from 0 to 4 by transthoracic echocardiography (TTE) as follows: 0, none or trivial; 1, mild; 2, moderate; 3, moderate to severe; and 4, severe. TTE was performed preoperatively, postoperatively before discharge, and once a year if possible.

      Statistical analysis

      Continuous variables are expressed as mean ± standard deviation for normal distribution values and median (25th, 75th percentile) for non-normal distribution values. Categorical variables are expressed as numbers and percentages. All analyses were performed using SPSS (SPSS Japan, Tokyo, Japan). Survival outcomes are expressed using Kaplan-Meier survival curves generated by SPSS. Statistical significance was set at p < 0.05.

      Results

      Preoperative characteristics

      Preoperative patient characteristics are described in Table 1. A total of 384 consecutive patients were included in the study. Their mean age was 68.0 ± 14.7 years, and the male/female ratio was 279/105. Lead extraction was performed due to infection in 72.4 % of the 384 patients, lead failure in 20.8 %, and upgrade to CRT in 4.2 %; the remaining patients underwent lead extraction because of concomitant valve disease, occlusion of the SVC or innominate veins, or pain. The total number of leads was 790 (2.0 ± 0.8 per patient, range: 1–5). The mean duration from lead implantation to extraction in TVLE patients was 95.3 ± 80.4 months.
      Table 1Preoperative patients' characteristics.
      TotalSurgical LETransvenous LE
      Number of patients38431353
      Age, years68.0 ± 14.867.7 ± 12.668.0 ± 15.0
      Gender (Male: Female)279: 10524: 7255: 98
      Blood hypertension17014156
      Coronary artery disease63558
      Valvular disease41932
      Diabetes Mellitus87978
      LVEF (%)54.1 ± 15.649.8 ± 14.354.5 ± 15.7
      BNP230.4 ± 378.8194.5 ± 225.3234.1 ± 391.2
      Serum Cre (mg/dl)1.04 ± 0.460.97 ± 0.361.04 ± 0.46
      Hemodialysis patients13013
      Vegetations381127
      Reason for lead extraction
      Infection278 (72.4 %)24254
      Lead failure80 (20.8 %)476
      Upgrade to CRT16 (4.2 %)016
      Lead-induced valve disease4 (1.0 %)22
      Vein occlusion3 (0.8 %)12
      Pain3 (0.8 %)03
      Generator type
      Pacemaker222 (57.9 %)19203
      ICD108 (28.1 %)8100
      CRT54 (14.0 %)450
      Number of leads (number of leads per patient)790

      (2.0 ± 0.8, 1–5)
      71

      (2.3 ± 1.1, 1–5)
      719

      (2.0 ± 0.8, 1–5)
      Lead position
      RA287 (36.3 %)26261
      RV431 (54.6 %)38393
      Dual chamber23 (2.9 %)320
      LV49 (6.2 %)445
      Lead tip type
      Tined401 (50.8 %)29372
      Screw308 (39.0 %)29279
      LV52 (6.6 %)448
      Undescribed29 (3.7 %)920
      Duration of leads (months)95.3 ± 80.4136.7 ± 75.991.3 ± 79.7
      Longest duration of leads107.5 ± 85.8

      (max 415)
      154.7 ± 81.6

      (max 322)
      102.5 ± 84.7

      (max 415)
      LE, lead extraction; LV, left ventricle; EF, ejection fraction; BNP, brain natriuretic peptide; CRT, cardiac resynchronization therapy; ICD, implantable cardioverter defibrillator; RA, right atrium; RV, right ventricle.

      Decision-making in the heart team conference

      In our heart team conference, surgical intervention was proposed as the primary procedure for 21 patients, and a patient was excluded because an epicardial cardioverter–defibrillator was surgically removed due to constrictive pericarditis [
      • Mizuno T.
      • Goya M.
      • Hirao K.
      • Arai H.
      Implantable epicardial cardioverter–defibrillator-induced localized constrictive pericarditis.
      ]. TVLE was converted to surgical intervention in 10 (3.0 %) of 363 primary TVLE patients. Further, TVLE was converted to emergent SLE in 2 of the 10 patients, and elective SLE was scheduled in 4 of the 10 patients (Fig. 1). In brief, surgical intervention was required in 31 of the 384 patients (8.1 %), and SLE was required in 26 patients. The primary reasons for surgical intervention are described in Table 2.
      Fig. 1
      Fig. 1Treatment tree of the patients.
      TVLE, transvenous lead extraction; SLE, surgical lead extraction; RA, right atrium; RV, right ventricle; Lt, left; SCA, subclavian artery; SCV, subclavian vein; SVC, superior vena cava.
      Table 2Detailed information on patients who required surgical intervention.
      ReasonNumber of patients
      Infection including lead vegetations11
      Difficult condition for TVLE5
      Concomitant valve incompetence4
      Occlusion of the SVC or innominate veins1
      After TVLE
      Bleedingcardiac tamponade4
      Injury of the lt. SCA1
      TVLE failure5
      TVLE, transvenous lead extraction; SCA, subclavian artery; SVC, superior vena cava.
      The mean duration from lead implantation to extraction was longer in SLE patients (136.7 ± 75.9 months) than in TVLE patients (91.3 ± 79.7 months).

      Outcomes of surgical intervention

      Emergent surgical intervention

      Bleeding complications were observed in 5 of the 363 TVLE patients (1.4 %). Emergent open-chest hemostasis was required in 4 patients (1.1 %); all these 4 patients fully recovered without neurological deficits. Among these 4 patients, 1 simultaneously required emergent SLE on CPB. Bleeding occurred from the RA or SVC in 4 of the 271 atrial leads. All four leads had a tined tip, and the mean duration from lead implantation to extraction was 156 (range; 100–201) months. In the other patient, a large pseudoaneurysm was observed in the left shoulder after TVLE because the left subclavian artery was shaved and lacerated by the laser sheath during the TVLE procedure. The subclavian artery and vein were repaired to stop bleeding.
      In addition to the above-mentioned 5 patients with bleeding, 1 patient required emergent conversion to SLE because the infected leads could not be extracted in TVLE, and circulation deteriorated with septic shock.

      Elective SLE including the hybrid lead extraction

      Elective SLE was performed in 24 patients. In patients with old leads, thick and hard calcified tissue coated the leads and had to be dismantled with strong power to remove the leads (Fig. 2). Large vegetations were removed with the leads and tricuspid annulus. In 1 patient, pus was ejected out of the papillary muscle after extraction of the infected lead (Fig. 3).
      Fig. 2
      Fig. 2A patient in whom TVLE failed due to long duration from lead implantation to its extraction (15 years). (A) Thick calcified tissue covered the lead (white arrow). This calcified tissue is one of the reasons for TVLE failure. (B) The lead was dismantled of thick calcified tissue (white dotted arrow). The calcified tissue had been broken and the lead had been uncovered before removal.
      TVLE, transvenous lead extraction.
      Fig. 3
      Fig. 3A patient who required tricuspid valve repair due to lead infection even without preoperative tricuspid valve regurgitation. (A) A RV lead with a tined tip was deeply adhered to a papillary muscle (white arrow: a RV lead). (B) Pus poured out from the papillary muscle after the pacemaker lead was pulled out (white dotted arrow: pus). (C) The infected papillary muscle and the leaflet which lost the support tissue such were resected to completely remove infected tissue. (D) The remaining posterior leaflet and septal leaflet were sutured to stop regurgitation.
      PM, papillary muscle; RV, right ventricle.
      The hybrid lead extraction procedure was performed in 17 patients. Lead extraction was easily completed using ordinary CPB techniques for valve surgery. However, TVLE-related bleeding complication was observed in four hybrid lead extraction procedures (23.5 %). In a patient who had a tined right ventricular (RV) lead tip (145 months old), a hole opened at the time of lead extraction and bleeding occurred. In the other 3 patients, bleeding occurred from the laceration of the SVC and innominate veins during the hybrid surgery (Fig. 4). The bleeding sites were safely closed with bovine pericardium on CPB, as CPB had been prepared beforehand in the hybrid procedure.
      Fig. 4
      Fig. 4Laceration of the innominate vein after TVLE at the time of hybrid lead extraction. (A) Leads were exposed outside the vein (white arrow). (B) Laceration of the SVC and innominate vein after TVLE. The dotted white arrow showed the internal cavity of the innominate vein and SVC. (C) Vein patch plasty with bovine pericardium (white arrows). TVLE, transvenous lead extraction; SVC, superior vena cava.

      Concomitant valve procedure including tricuspid valve surgery

      Overall, 4 patients with preoperative severe valve disease required surgical repair, and the additional 15 patients also required valve surgery due to preoperative TR or destruction by lead extraction or infection. TAP was performed in 11 patients (pericardial band in 2 patients and artificial tricuspid band in 9 patients). Leaflet suture was performed in 5 patients because the chorda and papillary muscles were resected to completely remove infected tissue. An edge-to-edge procedure including the clover technique was required in 8 patients to adjust the height of the leaflets and control TR. Procedures for functional TR were required in 5 patients (subvalvular procedures in 3 patients and leaflet augmentation with auto-pericardium in 2 patients).
      Mitral annular plication was concomitantly required in 6 of the 19 patients, aortic valve replacement in 1, and coronary artery bypass grafting in 1.

      Vein patch plasty

      Vein patch plasty with bovine pericardium was performed in 8 patients (25.0 %), including 3 patients with laceration of the SVC and innominate vein. Of these, 1 patient had SVC syndrome. In the other 7 patients, the SVC or innominate vein was opened or lacerated, and patch plasty was required to maintain or enlarge the internal cavity of the veins (Fig. 4).

      Perioperative mortality and morbidity

      No operative mortality was observed in the patients who had undergone elective SLE. However, operative mortality was observed in 1 of the 5 patients who had undergone emergent open-chest surgery. The patient fully recovered from the emergent event but died of acute myocardial infarction a week after the emergent surgery.
      Mean preoperative TR grade in 19 patients who had undergone tricuspid valve surgery was 2.3 (Grade 0: 0 patients, Grade 1: 6, Grade 2: 7, Grade 3: 1, and Grade 4: 5 patients). After surgery, the TR grade improved to 0.8 before discharge (Grade 0: 3, Grade 1: 13, Grade 2: 1, no TTE data: 2). However, mid-term TR grade worsened in 5 patients. Among the 4 patients who preoperatively had had severe valve disease, 3 required tricuspid valve repair. Of them, TR worsened in 2 patients. The other 2 patients underwent partial pericardial band annuloplasty because of annular infection, and the TR worsened in both the patients. The 2 patients should have undergone artificial annuloplasty band. TR also worsened in 1 of the 9 patients who had not undergone annuloplasty. The reason for postoperative TR worsening was exacerbation of functional TR. No patients were readmitted due to heart failure during the follow-up.

      Discussion

      This study examined the validity of this heart team decision-making and found that SLE was proposed as the primary intervention in a heart team meeting for 21 of the 384 consecutive patients, to provide the optimal treatment and maintain medical safety policies. Additionally, 10 of the 363 patients who had undergone TVLE required surgical intervention because of bleeding or difficulty of TVLE.
      At our institution, cardiologists, cardiac surgeons, anesthesiologists, cardiac engineers, and operation nurses attend our heart team meeting every week. The purpose of the meeting is to provide optimal treatment for patients who require lead extraction and maintain our medical safety policy. The points to discuss are problems in each patient including risk factors for bleeding, difficulty of TVLE, and required heart valve and vein plication procedures other than lead extraction. The procedures, concomitant surgical intervention, the place to perform the procedure, and scheduling of cardiac surgeons to attend each TVLE are decided. The cardiac surgeon stands by inside the OR during the TVLE procedure with the cardiologists, and they can discuss withdrawal of the TVLE procedure without hesitation when TVLE procedure is not going smoothly. The surgeon can also quickly start opening the chest in an emergency. Sood et al. reported that 34 % of patients who required emergent cardiac surgery after TVLE died during surgery [
      • Sood N.
      • Martin D.T.
      • Lampert R.
      • Curtis J.P.
      • Parzynski C.
      • Clancy J.
      Incidence and predictors of perioperative complications with transvenous lead extraction real-world experience with National Cardiovascular Data Registry.
      ]. At our institution, however, all 4 patients who had undergone emergent open-chest hemostasis survived the surgery without any neurological complications. In addition, TVLE was abandoned and converted to elective SLE in 5 patients. These 5 patients would have experienced an emergency if TVLE was continued without the cardiac surgeon. From this viewpoint, our heart team approach functions well to save patients from emergencies such as catastrophic bleeding.
      Even with strong medical safety policies, excessive bleeding occurred in 5 TVLE patients and in 4 hybrid lead extraction patients. Bleeding by TVLE occurred from the RA, RV, laceration of the SVC and innominate vein, and left subclavian artery. Frequent bleeding sites were at the atrial wall and the RV wall where the lead tips were attached. Old tined tips, especially those attached to the atrial wall, are considered a high risk for catastrophic bleeding. Laceration of the SVC and innominate veins is another mechanism of bleeding during TVLE. Laser dissectors or other mechanical lead dissectors always shave the venous wall along the great curvature. The upper side wall of the innominate veins and the right sidewall of the SVC are shaved and injured. During the TVLE procedure, torn veins are covered by the surrounding fat tissue and bleeding is not observed. Then, in the hybrid lead extraction, the preparation procedure for CPB uncovers the contained laceration portion, and bleeding starts during the procedure. It is assumed that laceration of the SVC and innominate veins occurs more frequently than clinically catastrophic bleeding after TVLE. Tarakji et al. reported that transmural venous tissue had been attached to 9.3 % of the extracted leads in 15.6 % of their patients, but clinically catastrophic bleeding occurred in only 1.1 % of their patients [
      • Tarakji K.G.
      • Saliba W.
      • Markabawi D.
      • Rodriguez E.R.
      • Krauthammer Y.
      • Brunner M.P.
      • et al.
      Unrecognized venous injuries after cardiac implantable electronic device transvenous lead extraction.
      ]. In a hybrid lead extraction procedure, the laceration of veins is always an important note. When the leads cannot be dissected easily around the innominate vein and SVC, TVLE should be withdrawn and converted to elective SLE with vein patch plication to avoid catastrophic bleeding.
      Tricuspid valve repair was required in 19 of 26 patients who underwent SLE (73.1 %). At our institution, the causes of TR were lead-induced anatomical changes in the valve including severe adhesion of the lead to the valve, disturbance of leaflet movement by leads, annular dilation with or without valve tethering due to heart failure, and the TVLE procedure itself [
      • Park S.J.
      • Gentry III, J.L.
      • Varma N.
      • Wazni O.
      • Tarakji K.G.
      • Mehta A.
      • et al.
      Transvenous extraction of pacemaker and defibrillator leads and the risk of tricuspid valve regurgitation.
      ,
      • Mazine A.
      • Bouchard D.
      • Moss E.
      • Marquis-Gravel G.
      • Perrault L.P.
      • Demers P.
      • et al.
      Transvalvular pacemaker leads increase the recurrence of regurgitation after tricuspid valve repair.
      ]. A variety of TV repair techniques is required to control TR: TAP to plicate the annulus, leaflet suture to repair the leaflets, edge-to-edge techniques to adjust the height of the valve, and subvalvular techniques to control tethering. Replacement of the tricuspid valve should be avoided in this patient cohort.

      Study limitations

      This was a single-center, retrospective, observational study. This study focused on reporting the outcomes of SLE according to the heart team discussion for each patient at our institution because it is difficult to plan a randomized prospective study investigating the clinical effects of decision-making in multidisciplinary heart team conferences. Much more information remains to be elucidated for uncovering high-risk factors of TVLE and avoiding emergency in TVLE.

      Conclusion

      Decision-making according to our heart team meeting was effective for providing the optimal treatment strategy and maintaining medical safety policies for each patient as it decreased the rate of emergency in TVLE to 1.4 %. Accordingly, the discussion should be further improved to precisely identify patients who require SLE rather than TVLE to avoid emergent surgical intervention.

      Sources of funding

      This project was not supported by any grants or funding.

      Disclosures

      None. Neither the corresponding author nor any of the coauthors, including their family members, received either grants or funding, or had an indirect financial relationship with any commercial entity.

      Acknowledgment

      The information of the surgical techniques in this manuscript was presented at the 10th annual scientific meeting of Japanese Society of Heart Valve Disease in 2019.

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