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Building a Safe and Successful Extraction Program: Experience at Houston Methodist The Woodlands Hospital
In this interview, we speak with Rajesh Venkataraman, MD, FHRS from Houston Methodist the Woodlands Hospital in The Woodlands, Texas.
Tell us about your background in electrophysiology and lead extraction.
I finished my cardiology and EP fellowship from the University of Alabama at Birmingham in 2013. While at the University of Alabama at Birmingham, I had the privilege of working with Dr. Neal Kay, who is one of the leading physicians in electrophysiology, and I actually switched my focus to electrophysiology as a result. I trained primarily in laser lead extractions.
Lead extraction can be a challenging procedure, but when it’s done properly, it can provide immense value to the patient. It is not unusual for us now in our practice to see patients with 5, 6, or even 7 leads in the left chest. Some patients have leads in the left and right side, and it is sad that these patients were not referred to someone who could appropriately extract.
How long have you been performing lead extractions? How many procedures have you performed?
I moved to Houston in 2013, and was with the University of Texas Health Science Center at Houston until December 2017. I began using Cook Medical’s rotational tools in conjunction with other EP faculty at UT Houston. We primarily extracted leads in the hybrid OR at Memorial Hermann-Texas Medical Center (TMC). Over the last 7 years, I have extracted well over 100 leads with 100% success. The oldest lead that I have extracted was a 31-year-old passive right ventricular lead.
In January 2018, I moved to Houston Methodist The Woodlands Hospital. This is a community hospital with 3 cath labs and a dedicated hybrid OR. I primarily perform lead extractions in the hybrid OR with our CV surgeon, Dr. Lucas Duvall. We have since extracted 25+ leads in the last 12 months.
Houston is a very large city, and our hospital is based in The Woodlands, which is in north Houston and is easily 45 miles from the TMC hospitals. Our extraction program provides this service for our patients in north Houston and helps them avoid the longer drive to TMC in downtown Houston.
Further, having the ability to successfully and safely extract leads vastly improves patient care. We are able to upgrade devices from pacemakers to defibrillators as well as retain MRI compatibility, which is lost with capped leads. Venous occlusion no longer prevents us from upgrading patients in the community hospital setting. We have also been successful in referrals for extractions from cities outside Houston.
What is your primary approach for extracting leads?
Our approach is tailored to a community hospital. It’s not unusual for larger university hospitals to perform late cases on weekdays, given that surgical backup is usually almost always available.
We perform almost all of our cases as elective first cases in the hybrid OR with general anesthesia. We typically hold warfarin and target an INR <1.5; we also hold NOACs for a minimum of 24 hours prior to the procedure. All patients are typed and screened and crossmatched for 2 units of packed RBCs. A radial arterial line is also placed by anesthesia staff for continuous hemodynamic monitoring.
All cases are done with the cardiac electrophysiologist and cardiothoracic surgeon scrubbed in together. We are both employed and essentially alternate billing for these procedures. A perfusion team is on standby. We chose this approach to ensure the best possible outcome with the least delay in any form of surgical emergency.
Typically, the surgeon will start with obtaining venous (5 French) and arterial access (4 Fr) in the femoral vein and artery. A temporary transvenous pacemaker will also be advanced if pacing support is anticipated. Obtaining venous access in the femoral vein is critical for us, since we advocate snaring all leads that are over 5 years old.
Concomitantly, the EP will open the pocket, begin dissecting down to the pocket and exposing the leads, and then start with lead prep. We exclusively use Cook Medical’s rotational extraction tools. We typically prep every lead that requires extraction with the following methodical order: advance usual stylet, attempt retraction of helix, cut the lead ahead of the suture sleeve, advance the locking stylet, and secure it with multiple One-Tie’s. Once all the leads are prepped, we will start extraction with the appropriate Cook Medical extraction device.
We have also been very successful in snaring any lead that is over 5 years old. Regardless of the ability of the locking stylet to traverse to the tip, it’s not uncommon for the stylet to sometimes back up into the lead, thus losing our ability to provide traction. This actually increases the possibility of lead disintegration or fragmentation, or even an unsuccessful extraction. The surgeon advances the Needle’s Eye Snare (Cook Medical) over a 13 Fr sheath and will start attempting the snare immediately after lead prep. Once the lead is snared, he provides addition countertraction for the extraction from the pectoral region.
How have those devices helped you in developing a successful extraction program?
The Cook Medical extraction platform has served us well. This does not require a capital purchase of a laser machine, when viewed with utilization, especially for a community hospital. The Evolution RL sheaths (Cook Medical) come in 9 Fr, 11 Fr, and 13 Fr sizes.
Cook Medical’s sheaths also have very unique “short and long” versions. As the name indicates, the Evolution Shortie RL is short, and it’s an excellent tool to get under the clavicle to reach the subclavian. This region tends to be very scarred in most patients, and long sheaths typically cannot smoothly traverse this region.
We almost always use an Evolution Shortie RL to get across the initial subclavicular region. The long sheath is then used to remove the lead. We emphasize the importance of keeping taut traction on the lead, and typically using the outer to cleave through the SVC-RA junction instead of blindly advancing the sheath itself.
Further, routine use of the snare has made us proficient in this approach. Snaring pulls the lead down and straightens the lead in the SVC-RA junction, which likely reduces the risk of SVC tears. The Needle’s Eye Snare also uniquely comes in a straight and curved sheath, which can help quickly snare the lead.
Do you have a process in place for training your team on extraction?
Our team is composed of the electrophysiologist, the CV surgeon, and the cath lab team. When the Houston Methodist the Woodlands Hospital opened in 2017, the cath lab team that I work with was already familiar with extraction at other hospitals, and so there was no need for training. We follow the same protocol again and again, which includes having the EP open the pocket, the surgeon getting access in the femoral vein and artery, and then snaring every lead that is older than 5 years old.
Typically, we hear that high volumes are important for proficiency in extraction. Can you tell us how your experience has been different?
Without any question, higher volume centers have historically been more proficient in extraction due to multiple reasons. However, this was primarily due to the readily available surgical backup. Also, since patients were referred to tertiary care centers, these physicians typically had more experience.
It is notable that cardiac procedures (eg, ventricular tachycardia ablation, left atrial appendage occlusion, or even TAVR) that were only offered in tertiary care hospitals are now routinely performed in community hospitals.
It is critical for lower volume centers to have strict adherence to protocol, since complications will stand out given overall lower numbers.
It is also important to understand the reasons for proficiency at higher volume centers and recreate it in the community, which is precisely our approach. Our team-based approach ensures the presence of both the EP and surgeon in the room as a team. We have a state-of-the-art hybrid OR with excellent fluoroscopy, which ensures that we are not compromising x-ray quality. The anesthesia team has a CV anesthesiologist with a TEE probe in the room that is ready to be advanced in case tamponade needed to be confirmed. We use the same tools and snare all leads, and essentially have created a standard approach as noted above. Notably, having both operators in the room ensures that the procedure is not slowed down by the operator moving from the groin to the chest, and vice versa. Being prepared with a standard approach every time has ensured 100% success in all our cases, with almost no major complications.
What do you think are the biggest challenges for lower volume lead extraction centers? Can you talk about the importance of setting up a solid extraction team and having available surgical backup?
Undoubtedly, the biggest challenge is in building a team approach with a hybrid OR capability and reliable CV surgical backup.
The extraction team is comprised of both the cath lab and OR team. Both teams have to work together and not feel like they are on an outside turf. We have standardized our protocol with diligence to detail. The cath lab team has even set up a mobile cart with all of our extraction tools (eg, Wholey wires, super stiff wires, and venoplasty balloons) in case it is required for venoplasty in the hybrid OR. The patient is prepped from the groin to the neck by the OR team in the usual prep for a CVOR case.
Surgical backup is a very contentious issue. Many hospitals have the surgeon “available on call” vs “available on site” vs “sitting in the control room,” etc. There are also issues with reimbursement since the incidence of opening the chest for surgical complications remains quite low. Hence, the potential for surgeons to be on standby could be non-productive for them. We chose an approach in which both the EP and surgeon scrub in on all cases, and alternate billing the cases. This has eliminated the issue of non-productivity. We are also well aware that in a community hospital, our outcomes will be closely watched for complications and success rates. Having 2 operators scrubbed in has made our procedure quicker, with 100% success in removing all leads in entirety. Safety is undoubtedly enhanced as well, given that having the CV surgeon in the room reduces the reaction time to a surgical emergency such as an SVC tear. Thankfully, we have never had to experience any major complication that required sternotomy.
Let me share an example of our team approach. We had a 72-year-old female with a dual ICD in place and was pacemaker dependent, who presented for CRT-D upgrade. Her left subclavian was fully occluded, and we proceeded with extraction of her RV ICD lead with Cook Medical extraction tools. The lead was 9 years old and had to be snared; the patient also had extensive subclavian scarring. The lead was freed up into the RA, and at this point, the lead snapped with almost the entire lead still grasped by the snare. The lead was able to be pulled out into the IVC, but given that it had bunched up entirely, a femoral venous cutdown was required to remove the lead. Since the surgeon was scrubbed in at the groin and had snared the lead, he was able to easily proceed with cutdown, while I was able to proceed with venoplasty and concomitantly place the CRT-D. The entire procedure was completed safely within 2 hours despite requiring a cutdown.
How do you think your experiences could influence physicians in a similar setting? What advice would you give to those who want to set up a similar program?
I firmly believe that an extraction program is critical to a full EP service line. As more and more patients survive longer with cardiac devices, complications such as lead failures, infection, and venous occlusions are inevitable and will require extraction. A community hospital can very safely provide lead extractions if the program is very carefully structured with a protocol-based approach. Partnering with a CV surgeon who is also invested in the program is critical. Structuring incentives and reimbursement has to be done correctly to satisfy all parties. As Napoleon Hill once said, “If the mind can conceive and believe, it can achieve.”
What sets your lead extraction practice at Houston Methodist The Woodlands Hospital apart from other programs of a similar size?
I think what sets us apart is that we have now extracted over 25 leads with 100% success and no complications. We also have a team-based approach, where both the CV surgeon and EP are present 100% of the time during the procedure, which I believe allows for more positive outcomes in our OR.
Disclosures: The author has no conflicts of interest to report regarding the content herein.
This article is published with support from Cook Medical.