Author + information
- Nigel Lever, MBChB∗ ( and )
- Andrew Martin, MBChB
- ↵∗Address for correspondence:
Dr. Nigel Lever, Auckland City Hospital, Park Road, Grafton, Auckland, Auckland 1025, New Zealand.
We can easily forgive a child who is afraid of the dark; the real tragedy of life is when adults are afraid of the light. Lead extraction as part of pacemaker or implantable cardioverter-defibrillator lead management continues to provoke fear and apprehension among the cardiology community. This is driven by the misperception about procedural risk despite recent literature that has shed considerable light on the safety and efficacy of extraction (1). Extraction related complications in fact occur less frequently than for some interventional or catheter ablation procedures. However, should a major complication occur, it is often catastrophic and requires immediate surgical intervention. There are signals that for certain tools or techniques the event rates are greater (1,2).
The most concerning procedural complication is that of vascular injury, in particular involving the extrapericardial superior vena cava (SVC). Compared with myocardial injury, perforation, or tricuspid valve damage, identification and management of vascular injuries is more difficult and more likely to result in death. The rise in the literature pertaining to SVC injuries and their management is a warning (2,3). The fact that these are now becoming more widely recognized, reported, and discussed is a marker of the need to take this issue more seriously. A classification of different types and presentations for SVC injuries has been described as has the concept of balloon tamponade as a temporizing method to allow for surgical exploration and repair (2,4).
Lead extraction expert consensus statements from the Heart Rhythm Society (HRS) and European Heart Rhythm Association (EHRA highlight the importance of tools, techniques, operator volume, and appropriate facilities (5,6). These documents have been produced in an effort to assist clinicians and institutions with clarifying important requirements and necessary supports to enable successful and safe extraction work. What has been more difficult to clarify or quantify is the appropriate venue and cardiothoracic surgical support to undertake extraction work. This is in part due to the heterogeneity in definitions of a hybrid operating room or electrophysiology laboratory suitable for extraction work and managing complications let alone what “surgical standby” really means. Neither the HRS nor the EHRA document mandates what the optimal environment or support should be (5,6).
The history of lead extraction has been one of evolution and pragmatism. Undertaking procedures in the home environment of an electrophysiology laboratory is appealing due to familiarity and what many clinicians have access to and control over. For many centers, access to hybrid rooms competes with other interventional work such as transcatheter aortic valve replacement or surgical procedures, or there are other logistical barriers. An operating room (and cardiothoracic team) on standby for the small chance of being needed is an opportunity cost in terms of other work that could be done which may not be acceptable clinically or fiscally. Clinician surveys indicate that a number of European and North American centers are currently undertaking lead extraction procedures in the electrophysiology laboratory with a wide variety of arrangements for surgical support (7–9). What remains unclear is how many centers are already attempting case selection to identify patients at lower risk, forgoing immediate surgical support for these cases, and practicing “alone.”
Lead extraction requires the involvement of multiple disciplines for the procedure as well as pre- and post-procedural care depending on the indication for extraction and the patients’ condition. The concept of a Lead Extraction Heart Team approach reinforces the HRS and EHRA statements description of which clinical groups are required during an extraction procedure (4,5). Such a team needs to operate in an appropriate facility that is suitable for open chest procedures with satisfactory lighting, sufficient space, high-quality fluoroscopy equipment, services for perfusion, and anesthetic equipment as well as other associated technical requirements. A hybrid operating room fulfills all of these necessities. For extraction procedures to be undertaken in the electrophysiology laboratory the facility must have all of these elements and a surgical team willing to use it. Many electrophysiology laboratories are not designed with consideration for the need to perform cardiac surgical procedures and are therefore not an adequate environment to manage the patient when such a complication occurs. Moving an unstable patient from an electrophysiology laboratory to an alternate venue for cardiothoracic surgery takes significant time; even with great teamwork this delay will adversely affect outcome. Control of SVC bleeding with a tamponade balloon to permit transfer is no guarantee either –balloons can be dislodged.
In this issue of JACC: Clinical Electrophysiology, Kancharla et al. (10) offer a system for stratifying patients to select those who need to have the extraction performed in a hybrid operating room environment versus those considered lower risk (which they called “intermediate”) who could undergo extraction in an electrophysiology laboratory. They report on 187 patients typical of those who most extraction clinicians see. A simple set of criteria to help identify those patients at the highest risk of complication was used and makes good sense clinically. They have shown this method accurately stratifies patients into higher- and lower-risk cohorts; patients in their lower-risk cohort had no major complications. In addition, they have demonstrated that they can achieve the same high level of procedure success in the electrophysiology laboratory that they do in the hybrid operating room environment.
Not surprisingly, their data provide clear evidence that a surgical team is not required when a complication does not occur. What is less clear is how infrequent does the risk of a complication occurring need to be before adopting this strategy of undertaking lead extractions in lower-risk patients without a surgical team immediately available. Because no complication occurred in their intermediate-risk group, these data are unable to provide insight regarding the likelihood of death if a major vascular complication occurs. It is probable that patient outcome following a major complication would be worse if a surgical team is not immediately available. It also plausible that the immediate availability of a surgical team is a more important predictor of a good outcome following a major complication than whether the procedure is undertaken in a hybrid operating room or electrophysiology laboratory.
As yet, there is insufficient information to support this practice being adopted widely throughout the lead extraction community. Further data, particularly relating to the incidence of complications and their outcomes in this lower-risk group are required. This information would allow clinicians, institutions, and patients to really engage in strategic planning and frank discussions regarding management and mitigation of risk. Moreover, what is achievable at an institute such as the Mayo Clinic may not translate or be achievable elsewhere.
Kancharla et al. (10) have provided a step toward a data-driven decision-making process regarding which patients undergoing lead extraction procedures are at sufficiently low risk to justify having their procedure in the electrophysiology laboratory without a surgical team immediately available. Further information about the incidence and outcomes of complications in this lower-risk group are required if this strategy were to be routinely adopted. Until this is available, lead extraction procedures should continue to be performed in an environment and with a team that can provide urgent surgical management should a complication occur. In other words, if you are not in the right home and are alone, you may be asking for trouble. The lead extraction community should continue to design and build the best home and invite the right people in as roommates.
↵∗ Editorials published in JACC: Clinical Electrophysiology reflect the views of the authors and do not necessarily represent the views of JACC: Clinical Electrophysiology or the American College of Cardiology.
Both 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.
- 2019 American College of Cardiology Foundation
- Bongiorni M.G.,
- Kennergren C.,
- Buttler C.,
- et al.
- Lee S.L.,
- Guo X.,
- Cardona R.,
- et al.
- Bashir J.,
- Fedoruk L.M.,
- Ofiesh J.,
- Karim S.S.,
- Tyers F.O.
- Wilkoff B.L.,
- Kennegren C.,
- Love C.J.,
- et al.
- Kusumoto F.M.,
- Schoenfeld M.H.,
- Wilkoff B.L.,
- et al.
- Kancharla K.,
- Acker N.G.,
- Li Z.,
- et al.