Application of Surgical Extraction for Pacemaker System Infection

  1, the current situation of CIED infection The clinical application of cardiovascular implantable electronic devices (CIED) has increased significantly in recent years both globally and in China. In China, the number of CIED implants has increased 8.6 times in the past 15 years. According to foreign data, the infection rate of CIEDs is about 2%, and the mortality rate and hospitalization cost are significantly higher once the patients become infected. In order to standardize the treatment of CIED infection, several guiding documents such as “Guidelines for Transvenous Electrode Removal”, “Expert Consensus on the Management of CIED Infection” and “Expert Consensus on Training and Certification of Transvenous Electrode Removal” were issued by AHA/HRS and other organizations abroad in 2009, 2010 and 2012, respectively. In China, since 2013, 3 workshops on infection and management of cardiac rhythm implanted devices have been held led by Prof. Li Xuebin, and Chinese expert consensus has also been issued.  With the increasing number of ICDs, CRTs and other complex devices being implanted and the increasing number of patients who need to replace their implanted devices, it is foreseeable that clinicians in China will face more and more infections in complex pacing systems in the future. Once these complex system infections occur, they are difficult and risky to remove.  Currently, there are still many irregularities in the clinical management of CIED infections in China. The Chinese Expert Consensus on the Infection and Management of Cardiac Implantable Devices 2013 clearly states that once the diagnosis of capsular bag infection, bloodstream infection, and infective endocarditis is established, the infected device should be removed as soon as possible. Because conservative antibiotic treatment of these infections fails almost 100% of the time, and the mortality rate of patients is high when the infected device is not removed in a timely manner. However, in clinical practice, we still see many irregularities such as repeated reimplantation after capsular bag debridement, pacemaker removal with retained lead, pacemaker ectopic, pacemaker deeply buried under the pectoralis major muscle, pacemaker lead disconnected, pacemaker lead disconnected and reimplanted on the opposite side, unsuccessful attempts to remove the lead, and continued conservative drug treatment for infected endocarditis. Such treatment strategies not only lead to a surge in treatment costs and increased pain for patients, but also create enormous difficulties in the next step of management.  At present, the main methods of electrode removal widely used clinically in China are counter-thrust removal (locking wire + dilating sheath) and trans-inferior vena cava removal (locking wire + dilating sheath). A few units have started to use mechanical separation sheath (Evolution) to remove some severely adherent electrodes. The laser sheath (Excimer), a mainstream transvenous pacing electrode removal device, is also being introduced abroad.  2. Indications for surgical removal of pacing implant systems The Chinese Expert Consensus on Infection and Management of Cardiac Rhythm Implantation Devices 2013 clearly defines the indications for surgical removal of infected pacing electrodes. These include: patients requiring other cardiac surgical procedures (valve repair or replacement); infected redundant organisms >2 cm in diameter (dislodgement of redundant organisms may lead to pulmonary embolism); patients with residual electrode leads (prone to recurrence of infection and associated arrhythmias); patients requiring epicardial electrode leads; and patients at high risk for serious complications (electrode implantation for more than 10 years, more than 3 electrodes, dual coil ICD electrodes, etc.). coil ICD electrodes, etc.).  For the first 4 types, it is not controversial that the pacing electrodes are removed by a cardiac surgeon using an open or small incision. As for the last case, the most common so-called serious complication according to foreign data is hemorrhage caused by tearing of the fragile venous tissues of the innominate vein, superior vena cava and right atrium. This type of bleeding is extremely rapid and can cause serious consequences such as pericardial tamponade and hemorrhagic shock within a short period of time, resulting in the death of the patient, with a high mortality rate even in the presence of a surgeon. Several foreign publications have reported the incidence and management of tears in the intrathoracic venous system during electrode removal, but there are no similar published reports in China, indicating that China is still at a relatively early stage in the removal of pacing electrodes and it is necessary to learn from the mature experience abroad to reduce the risk to patients. The importance and precautions of collaboration between cardiologists and cardiac surgeons for patients at risk of venous tears will also be highlighted later.  3. Technical points and precautions for electrode removal in high-risk infections Given the lack of published reports on bleeding from superior vena cava tears during electrode removal in high-risk patients and their management in China, it is necessary to learn from foreign experience to minimize the cost in the learning curve.  R. Hauser et al. searched the US FDA for the keywords “lead extraction and death” and “lead extraction and injury” and retrieved data from The data were retrieved from 1995-2008. The results showed that there were 58 deaths and 48 related losses during the period, and 27 deaths and 13 related injuries in the 2 years from 2007 to 2008. Of the 27 patients who died in 2007-2008, laser sheaths and mechanical sheath devices were used in 23 cases. A total of 62 patients underwent emergency surgery, of whom 35 survived (56%). Intraoperatively, the major injuries were found to be lacerations of the right atrium, superior vena cava, and unnamed artery. The authors concluded that high risk factors for venous tears during electrode removal surgery included the type of electrode implanted and time of implantation, calcification around the electrode, presence of multiple electrodes, female gender, and surgeon experience. Of these factors, only the last one, the experience of the surgeon, is controllable.  A 2014 data set from Cleveland, USA, reported a total of 3258 pacing electrode removals from 1996-2012, of which 25 (0.8%) had serious intraoperative complications requiring urgent surgical management. Of these 25 cases, 9 patients died (36%) and the site of damage was in the superior vena cava in 64% of cases. The authors concluded that there was a high correlation between advanced age, infection, and emergency chest opening in the catheterization laboratory and death.  As evidenced by the above bulk case reports from abroad, the overall incidence of hemorrhage from superior vena cava tear during transvenous pacing electrode extraction is low, but when it does occur, the mortality rate is extremely high, even when emergency surgery is performed. Therefore, to further improve the safety of electrode removal procedures, some teams have adopted a more cautious strategy of requiring surgeons to intervene deeply in electrode removal procedures to reduce mortality.  The first strategy is to have the entire cardiac surgery team (surgeons, nurses, anesthesia, and extracorporeal circulation) on standby in the catheterization laboratory while the cardiologist performs the electrode removal procedure, allowing the surgeon to intervene quickly in case of intraoperative accidents, gaining valuable time to resuscitate the patient.Justine M et al. reported a group of experiences from the University of Nebraska, USA, which from 2004-2014 Between 2004 and 2014, 307 pacing electrode removal procedures were performed in high-risk patients, of which 4 patients had superior vena cava tears (1.3%) All 4 patients survived because the surgical team was well prepared and was able to quickly get on the table to establish extracorporeal circulation and repair the injured vessel. The authors’ criteria for defining high-risk patients in this group were: electrodes implanted for longer than 12 months or dual-coil ICD electrodes implanted for longer than 6 months. Because surgeons do not wash their hands on the table before surgery and patients require a certain amount of preparation time after an accident, the average time required between the onset of circulatory collapse and the establishment of extracorporeal circulation was 25 minutes in these four patients. Although all four patients were successfully resuscitated, this strategy requires a high level of rapid response and coordination proficiency from the entire surgical team, and there is no guarantee that the same good results can be obtained in units with average technical skills.  Another strategy is that since the electrode removal surgery is so dangerous in case of superior vena cava injury, if the electrode removal is performed directly by the surgeon in the operating room with all the extracardiac surgical team in place, in case of emergency, the surgical team can open the chest and establish extracorporeal circulation in a shorter period of time, which in theory will have a better guarantee for the patient’s safety. In practice, this is the approach taken at two cardiac centers, the University of Alberta in Canada and Sahlgrenska in Sweden, and Wang et al. reported 118 patients at the University of Alberta from 2004-2011 in which electrode removal was performed with a laser device and operated by cardiac surgeons in the operating room. Five of these patients had superior vena cava tears (3.6%), and all were successfully resuscitated due to adequate preparation, from the time the patient experienced circulatory collapse to the time extracorporeal circulation was established in an average of 6 minutes.  Analysis of these two ideas shows that for high-risk patients, more aggressive intervention of the pacing electrode removal procedure by an experienced surgical team can improve the management of risky accidents and ensure patient safety. However, there is no doubt that this would take up more medical resources. Since the incidence of severe venous tear bleeding during electrode removal is not high, but when it occurs, the mortality rate is extremely high, it is worth studying how medical resources should be appropriately allocated in this situation under our current national conditions.  Personally, I think that if we can further improve the level of prediction of high-risk patients, we can screen high-risk patients more efficiently. For patients who are expected to have dense adhesions between the electrode and the vein, and who are at higher risk when removed, they need to be performed in a hospital with a better level of cardiac surgery technology, and during the surgery, depending on the situation, the surgical team should be required to be on site to escort the patient and make a comprehensive preoperative plan, so that in case of danger, the patient can be handled in an organized manner, thus ensuring maximum patient safety.