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Division of Cardiothoracic Surgery, Department of Surgery, Duke University Medical Center, Durham, North Carolina
Accepted for publication February 9, 2009.
* Address correspondence to Dr Gaca, Duke University Medical Center, DUMC Box 2816, Durham, NC 27710 (Email: jeffrey.gaca{at}duke.edu).
Presented at the Fifty-fifth Annual Meeting of the Southern Thoracic Surgical Association, Austin, TX, Nov 5–8, 2008.
| Abstract |
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Methods: A retrospective cohort study was performed of 112 consecutive laser-assisted lead extractions at a single university medical center during a 6-year period. Patient and lead characteristics were analyzed as well as indications, outcomes, and major complications.
Results: Successful lead extraction was accomplished in 103 (92%) of the 112 patients. Elective sternotomy after failure of laser-assisted lead removal was successfully performed in 4 patients. Emergent surgical intervention was required in 4 patients for caval perforation (n = 2), subclavian vein injury (n = 1), or right atrial injury (n = 1). Three of the 4 patients requiring emergent intervention died, for an overall series mortality of 2.6%. In July of 2006, a policy of cardiothoracic surgeon presence during the laser-assisted extraction was instituted. Since that time, there has been one emergent sternotomy and one elective sternotomy for lead removal with no procedure-related deaths.
Conclusions: Despite recent advances in laser technology for the removal of pacemaker and defibrillator leads, the potential for major cardiovascular injury and death remains. Involvement of the cardiothoracic surgeon in both the preoperative decision-making process as well as the laser-assisted lead extraction is critical to prevent or emergently treat any major complications.
| Introduction |
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| Patients and Methods |
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All laser extractions were performed in the operating room under general anesthesia using the Spectranectics laser sheath removal system (Colorado Springs, CO). For the period of December 2002 to July 2006, the procedure was performed in the operating room by a cardiologist without the presence of a cardiothoracic surgeon. In July 2006, after several major complications, a policy of cardiothoracic surgeon presence in the operating room during laser lead extraction was instituted. The intraoperative protocol at our institution is as follows: all patients undergoing laser lead extraction are prepared for emergent sternotomy. All patients are typed and screened, a radial arterial line is placed, and in the cases of patients with prior sternotomy, femoral arterial and venous lines are placed. A cardiopulmonary bypass circuit with a staff perfusionist is also available in the room. Continuous transesophageal echocardiography is performed to monitor for pericardial effusion. All procedures are performed under fluoroscopic guidance.
Procedural success and complications were determined according to the North American Society of Pacing and Electrophysiology policy statement on extraction of chronically implanted transvenous pacing and defibrillator leads [10]. In summary, complete success is defined as the removal of all lead material from the vascular space. Partial success is determined as the removal of all but a small portion (<4 cm) of an electrode or coil. Finally, failure of removal is defined as abandoning a significant length of lead (>4 cm) [10]. Procedural complications were classified as major if it resulted in death or serious harm to a structure or required surgical intervention to prevent death.
| Results |
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| Comment |
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Complete removal of the device is indicated if device infection is suspected. Treatment with antibiotics alone is not sufficient and has a relapse rate of 100% [17]. Standard indications for removal of pacemaker leads includes (1) pocket infection or erosion, (2) sepsis not attributable to another source, (3) lead dysfunction resulting in life-threatening arrhythmias, and (4) endocarditis. In certain cases, the risks of persisting with percutaneous strategies for lead removal are deemed excessive and the hardware is retained. This technique is rarely successful at eradicating infection [18]. Therefore, open surgical removal of retained infected leads should be considered. In this study, 4 patients required elective surgical removal of leads for retained pacing hardware. One patient had atrial and ventricular leads that could not be separated within the mediastinum as well as a large vegetation on the tricuspid valve. The second patient also failed laser extraction because of an inability to separate three different leads within the venous system. The third and fourth patients experienced fractures of a lead during an attempted laser lead extraction. All 4 patients underwent elective sternotomy for lead removal without incident.
In some instances, open surgical removal is indicated without attempting percutaneous extraction. This should be considered in patients with large vegetations greater than 2 cm as well as in patients likely to require valve repair or replacement [18, 19]. Although not seen in this study, massive pulmonary embolus or pulmonary valve occlusion can occur [20]. During the period of this study, 2 additional patients underwent elective removal of leads owing to vegetation size greater then 2 cm, neither of whom required repair or replacement of the tricuspid valve. The risk of complications is also increased when the number of leads is increased. With the removal of one or two leads per patient the major complication rate is 1.9%; however, when three or more leads are removed the major complication rate increases to 8.6% [21]. Therefore, elective sternotomy for lead removal should be considered in patients with vegetations 2 cm or greater or in patients with multiple leads that are unlikely to be removed safely by percutaneous techniques.
With the advent of laser techniques the need for open surgical removal of leads has greatly diminished. However, as detailed in this study, open surgical removal can be required in both elective and emergent cases. Most authors advocate that laser-assisted extraction should only be performed at experienced centers with access to cardiothoracic surgery support [6, 9]. However, there is no consensus in the literature concerning the ideal venue for performing these procedures (catheterization laboratory or operating room) or the level of participation of the cardiothoracic surgeon in these procedures. The North American Society of Pacing and Electrophysiology Lead Extraction Conference policy statement does not mandate cardiac surgery participation in lead extraction nor does it require these procedures to be performed in the operating room. It states that the institution should have an accredited cardiac surgery program on site and capable of initiating an emergent procedure promptly [10]. It is clear that the majority of these procedures are performed by cardiologists with the role of the thoracic surgeon remaining relatively undefined. Recent Medicare data demonstrate that thoracic surgeons perform approximately 9% of all pacemaker and defibrillator implants and 17% of all percutaneous removals [16]. At our institution before July 2006, these procedures were performed in the operating room by cardiologists with surgeons on call for emergencies. However, as a result of several cases requiring emergent surgical intervention outlined in this study, attending cardiothoracic surgeon presence in the operating room during laser lead extraction was initiated in July 2006. We believe this approach to lead extraction allows for quick and decisive action in potentially life-threatening conditions. It is also our belief that the cardiothoracic surgeon should be involved in the preoperative evaluation of the patient to identify patients in whom primary surgery is indicated, or to develop an operative plan should laser extraction fail. Alternatively, it would seem appropriate that surgeons perform these procedures whether by percutaneous extraction or by open operation.
At our institution laser lead extraction is performed jointly by cardiology and cardiothoracic surgeons in the operating room with central venous access, invasive blood pressure monitoring, transesophageal echocardiography, and cardiopulmonary bypass standby. Although it is possible to perform these procedures in the cardiac catheterization laboratory, we, like others, believe that patients who require emergent intervention would likely die if this were attempted outside of the operating room [6].
In summary, the advent of laser-assisted technology has diminished, but not eliminated, the number of patients requiring open extraction of pacemaker and defibrillator leads. The major complication rate from laser-assisted extraction is low; however, we believe that fatal complications are preventable if a thoracic surgeon is physically present, and that perhaps this event could be mitigated against through elective selection of high-risk patients for planned operative removal.
| Discussion |
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This is a very important retrospective study that looks at the mortality in lead extraction patients before and after initiation of this policy of having a cardiac surgeon in the operating room as opposed to being on call at a distance, and the authors have clearly documented the catastrophic events in 3 of the 4 patients where the surgeon was available but not immediately present; 3 or 4 of those patients died. Following the policy change, a catastrophic collapse from an atrial disruption was effectively repaired with an immediate sternotomy. I think the authors appropriately recognize the importance of a cooperative evaluation between the electrophysiologist and the cardiac surgeon before the procedure in order to identify some of these factors that can help plan the open approach or at least plan a different approach for backup.
At our institution I have had the advantage of being both the extracting physician and the backup surgeon at the same time, which gives me the advantage of being able to successfully argue with myself before surgery about what to do but the disadvantage of having no one to blame but myself for these adverse events, and I can tell that they do occur. And in a similar series of about 150 lead extractions, I have had two cavoatrial disruptions, which is the usual site, both of which are easily recognized by the immediate pericardial effusion—you see that happen before the vital signs start going down—and an immediate sternotomy, digital pressure with one digit usually suffices to control the hemorrhage, and then you can repair and continue with the lead extraction, and both of those patients fortunately went home in 5 days.
I continue to be amazed with this knowledge that patients around the country are having these procedures performed in EP (electrophysiology) labs, in cath labs with various at-a-distance backup, and it is my sincere hope that this paper will help to establish a change in the standard of care, to have the surgeon immediately available in an operating room so that these patients can be protected and can have a good chance of surviving these events, which will continue to occur, not to mention the medicolegal risk that we all face. I have several questions for the authors.
First, in reviewing the manuscript, I noted that 31% of your patients in this series had had prior sternotomy. Do you routinely obtain CT (computed tomographic) scans prior to these procedures so that you can evaluate which patients can have a rapid, safe repeat sternotomy versus those who might have an alternative approach considered, such as a rapid right anterior thoracotomy, which gives you clear access to the likely site of bleeding, which would be the atrium or the cavoatrial junction?
Second, have you been able to leverage your participation in these cases into an ability to have some of your cardiac and thoracic fellows obtain some lead extraction experience in the operating room theater, because many of them will have an opportunity as they go into perhaps community associations where they can proceed with this good technical skill that is going to be used with increasing frequency?
Third, although it is not immediately addressed in your paper and not the intent, what has been your approach to the patients with endocarditis who are relatively pacemaker-dependent and will require repeat lead insertions, specifically, the renal failure patients with end-stage dialysis? Do you consider alternative epicardial pacing modes in order to avoid repetitive transvenous lead insertions, which will almost certainly become reinfected?
And then finally, can you address for the members here the difficult reimbursement issues that are involved in this where a surgeon may be asked to stand by for a considerable period of time, and with current coding status, modifiers for assistant or co-surgeons can generally not be utilized in the category of pacemaker and defibrillator lead extraction procedures.
Again, thank you for allowing me to discuss this paper.
DR GACA: I think the last point is one of the purposes of this paper, to be honest with you. There are significant hurdles to reimbursement and coding, and we wanted to develop literature to try to take this to people who establish these coding rules to get those changed.
I will answer the next one in reverse order. You will notice in our series we put seven epicardial systems in, and yes, that is our approach in the renal failure patients. We do prefer epicardial systems for those people.
And the second question about our fellows and also our faculty participation in these procedures, I participate fully in these procedures, and I think that I would encourage other surgeons to do so as well, because not only is it safe, it allows you to gain experience with wires and catheters and fluoroscopy, all the things that are important to the future of our specialty. So, yes, we are having increasing experience with this.
Now, your point about the patient in the redo sternotomy situation is a very insightful one. We do not routinely get CT scans. What we do routinely do is place femoral, venous, and arterial lines for percutaneous bypass if there is a problem. There is some thought, although not proven in the study because our numbers are small and the event rate is small, that people who already had cardiac surgery are somewhat more protected due to adhesions from lead extraction. And your point about the problem with cavoatrial disruptions is a very important one; it almost always is the atrial lead that is the problem. It is either you rip the SVC (superior vena cava) off the atrium or you just rip the atrium wide open, and it is almost never the ventricular lead. So there is some thought that dense adhesions there may be protective. We haven't had a problem with anyone who has had a prior sternotomy yet, and we do not routinely get CT scans.
DR CHARLES HUDDLESTON (St. Louis, MO): It was my impression that prior sternotomy was in fact protective. There are very large series of lead extractions reported where all of the catastrophic events in those series occurred in the non–prior sternotomy patients.
Jennifer Sue Lawton (St. Louis, MO): I and one of my partners, Mark Moon, do all of the lead extractions at Washington University. I agree with Dr Williams that a cardiac surgeon should be removing these leads. We have done hundreds of these, and we have had devastating complications, not only in first-time sternotomies but in redo sternotomies. I have avulsed the innominate artery from the aortic arch. I have created venous to arterial fistulas not only in the subclavian artery but also the carotid, and that is a case where I am very happy not only that I have a bypass machine, I have a sternal saw and I have my vascular surgeon colleagues across the hall. I had one vascular surgeon come in and stent a subclavian artery fistula immediately at the time the patient was on the table, and that was very handy. I think that having a cardiac surgeon stand by in the cath lab is not only a waste of time but dangerous. You might be able to open the sternum quickly in a first-time sternotomy, but there are going to be patients you will lose because you don't have a pump.
DR GACA: I think the major point of this paper is this shouldn't be done in the cath lab. It should be done in the operating room. The quicker you can get to the problem, the less of a problem it is.
| References |
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This article has been cited by other articles:
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J. M. Kratz and J. M. Toole Pacemaker and Internal Cardioverter Defibrillator Lead Extraction: A Safe and Effective Surgical Approach Ann. Thorac. Surg., November 1, 2010; 90(5): 1411 - 1417. [Abstract] [Full Text] [PDF] |
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