In this interview, we speak with Steven Kutalek, MD, FACC, FHRS about his use of the PhotonBlade™ Dynamic Precision Illuminator with Enhanced Energy Delivery (Invuity, Inc.) at Hahnemann University Hospital. Dr. Kutalek is the Director of the Cardiac Electrophysiology Laboratory at Hahnemann University Hospital and the Director of Cardiac Electrophysiology and Cardiac EP Fellowship at Drexel University College of Medicine in Philadelphia, Pennsylvania.
Tell us about your EP program.
The electrophysiology program at Hahnemann University Hospital was started in 1981 by Dr. Leonard Horowitz, a pioneer in the EP field. Hahnemann University, a Magnet-certified facility, has been a Center of Excellence in Philadelphia for many years. From the time of its inception to present day, the EP lab has experienced tremendous growth as a major university teaching hospital in one of the country’s busiest EP cities. Our program has a comprehensive approach to patient care, a commitment to fellow education, and a strong base in scientific research. The EP program currently has 3 dedicated interventional EP suites for device implantation and ablation procedures, a non-invasive procedure room for tilts and cardioversions, and a 4-bed prep/recovery room. We work in tandem with a dedicated team of interdisciplinary professionals in various departments (anesthesia, structural heart, cardiothoracic surgery, and echocardiography), utilizing advanced 3D technology to provide safe and cutting-edge services such as adult and pediatric complex ablations, lead extractions, and left atrial appendage closure services to our patients. We perform over 2000 patient procedures per year.
The EP team consists of 9 electrophysiologists and 1 pediatric electrophysiologist at St. Christopher’s Hospital for Children. Gina Pinsky, BSN, RN, manager of the EP labs, is supported by experienced and caring RNs, several per diem RNs, an RCIS technologist, and several pre-procedure cardiac NPs. We also attribute our success to a dedicated support staff and inventory manager. We collaborate with our outpatient office coordinators and cardiac electrophysiology research nurses to coordinate patient services as well as provide patient education for a seamless transition of services for our patients.
The longstanding success of Hahnemann’s EP program over the past 36 years has been instrumental in developing standards of care for the treatment of cardiac arrhythmias, syncope, device implantation techniques and technologies, and lead extraction, and will continue to be a leader in the field of electrophysiology.
What are the most common risks and concerns when dealing with device implant, replacement, revision, or extraction procedures?
Device implantation, replacement, revision, and lead extraction are surgical procedures. Not only do these involve the usual meticulous attention to sterility required in an operative theater, they also involve device insertion, which increases the risk for complications. Among the most important of these periprocedural risks for the device patient are infection, pocket hematoma, and damage to pre-existing leads.
Many of our patients are chronically anticoagulated, which further increases the risk for pocket hematoma. Although we perform our procedures on therapeutic warfarin to reduce the need to convert to other anticoagulants that lead to a higher risk of bleeding, hematoma development is exacerbated by patient comorbidities, including diabetes, renal failure, and poor nutritional state. Prevention of hematoma in these patients is paramount to having a successful long-term outcome. A hematoma provides a great breeding ground for microorganisms, so working hard to prevent this is very important.
Other procedural factors also come into play with regard to reducing long-term infection risk. Reducing procedure time is one of these; we work to minimize “pocket open time” by working efficiently and controlling all bleeding as soon as it occurs, being gentle with the tissues, and planning the approach to minimize inadvertent damage to tissues that require a lot of extra care to control bleeding, especially with subpectoral pockets.
Finally, device complexity has really increased over the years. We now see patients who may have had 5 or 6 prior CIED procedures, and have multiple old leads in place, some with occluded vessels that require a lot of work to properly extract leads for reimplantation conduits. All of this adds to the time needed to complete the procedure. The greater degree of dissection required increases the overall procedural risk to the patient. Further, many of these patients have a lot of excess lead material in the pocket, and these extra coils overlapping one another make dissection really challenging to avoid damage to lead insulation.
What has been your experience with enhanced energy electrosurgery?
Because of the complexity of our device patients, many with comorbidities or with multiple prior surgeries and leads, our greatest concerns when we do these procedures in the EP laboratory are achieving adequate visualization, hemostasis, and not damaging pre-existing leads.
A standard electrocautery system, though effective in hemostasis and a great tool for developing an initial pocket on a new device implant, has limitations in device revision cases. No matter the output setting for cut or coag, the blade is hot, and this can easily burn through lead insulation material. Much of our work in lead extraction involves replacement in referred patients with previously damaged leads after device revision (from sharp dissection, excessive traction, or because of damage from electrocautery).
Using newer technology in device revision cases is paramount to achieving a successful outcome. It dramatically reduces the possibility of damage to pre-existing leads, some with very thin outer insulations (especially coronary sinus leads). However, there are limitations to current systems in terms of visualization and energy delivery control. The amount of energy needs to be dialed in, though what is required depends on a combination of the density of the tissue, grounding pads, and resulting impedances. Therefore, the effect of one power setting for an enhanced energy blade varies from person to person, and excessive heating will not be recognized until the procedure is already underway.
With these systems, focused energy delivery at the tip reduces the amount of collateral damage to tissues — this has been shown through pathological studies. This also allows better control to dissect out leads that overlap one another in the pocket.
Visualization in the small pocket, especially in a tough extraction case with multiple pre-existing leads, can also be difficult due to overhead lighting and the close proximity of the operator to the incision. This makes it more challenging to see into the corners to engage bleeders and reduce hematoma risk, and makes collateral lead damage more likely. Current electrocautery systems offer little to improve visualization in the pocket.
Tell us about PhotonBlade.
The PhotonBlade combines an advanced energy delivery tip with lighting for direct visualization. The design is very similar to a standard electrocautery blade, with a stiff handle that contains buttons for cut and coag. The PhotonBlade also has a third button that activates a light at the tip of the handle, proximal to the business end of the blade, to allow visualization inside the pocket. The light is very bright, carried to the tip through optical fibers. The tip design focuses energy for directed heat delivery at a controlled level, with the goal of maintaining a relatively low tip temperature during most parts of the procedure, especially when working around other leads. Our aim is always to provide enough energy to operate, but low enough to avoid damage to lead insulation.
What aspects of PhotonBlade appeal to you the most as a device implanter?
There are 2 main clinical aspects that appeal to me. First, the visualization with the lighted tip is fantastic. Not only is the light bright enough that I can see into the deepest crevices of the pockets that I am operating on, but it is diffuse enough to fill the pocket with lighting that is just not possible with overheads. With this, I feel that I have a better handle on finding the source of bleeders. My patient has a better chance to leave the lab with a completely dry pocket without pressure dressing. Also, I have confidence that the patient will not develop an expanding hematoma, even if anticoagulation is on board.
Second, the electrocautery focuses energy to the tip so that I have an excellent cutting edge with good control, as well as safety so that I do not damage other leads. As the old adage goes, sharper knives are safer because they require less pressure to cut with. The tip cuts smoothly and rapidly, even in dense scar tissue, yet I feel I have better control since my contact time with lead insulation is reduced. In this way, I feel that there is less heating on the lead surface itself, and lead damage is prone to be less likely since the tip is moving more rapidly over the lead surface with its good cutting edge. This clearly is related to the lead tip design.
Finally, from a lab utility and flow perspective, the PhotonBlade operates from any commercially available electrosurgical generator. This universal compatibility eases case planning and scheduling for me and my EP lab staff, making any room functional for the most complex procedure, while giving me the visualization and tools of my choice. It eliminates the need for hunting down proprietary generators or support equipment that may already be in use in another part of the hospital, and this reduces further delays for completing a case.
In what types of procedures do you prefer to use PhotonBlade?
This technology has its greatest application in device revision procedures, although it could certainly be used in initial implantations as well. For us, being able to use this technology in our complex lead extraction cases, or cases where we need to upgrade a system and there are already pre-existing leads, would be the greatest application. We also use it in patients at a high bleeding risk, on anticoagulation, or especially with prosthetic mitral valves who require higher dose anticoagulants. We do not yet have enough experience with this technology in patients on dialysis, although this is another group with increased bleeding risk in which it may be useful. The same may be true for LVAD patients with platelet dysfunction and anticoagulation.
How is PhotonBlade different from any previous electrosurgical tool you’ve used?
Its ability to cut through dense scar tissue seems improved from other electrosurgical devices I’ve used. The design of the cutting edge is different, and this is clear when operating. It’s very effective for slicing through heavy fibrosis in a pocket — much more easily than with other blade types. In this regard, I feel safer with the PhotonBlade when I am maneuvering over pre-existing leads, especially during difficult lead extraction cases where I want to preserve functional leads. In these cases, if I were to cause cautery damage to other leads that do not need to be removed and would otherwise have been left in place, the procedure would become a lot more complex and increase patient risk.
Do you have any clinical use tips or watchouts for those who are trying PhotonBlade for the first time?
I would start with a lower power setting than you think might be required. The PhotonBlade is quite effective at lower power in that it provides very focused energy delivery at the tip. Starting at a low power setting will minimize tip temperature while still cutting through tissue. Start low, and gradually increase the power setting for effect.
As with any cautery system, be gentle with existing leads. Any cautery blade, including the PhotonBlade, will damage lead insulation if temperatures are set too high and if contact time over the lead is too long. Keep the blade moving over existing leads as you would with any other blade.
Any last comments about PhotonBlade or enhanced energy devices in general?
The PhotonBlade is a great system. It offers great visualization and a precise cutting edge that gives me confidence when working around existing leads. The direct lighting is a game changer, and this is made more attractive by the ease with which it cuts through dense fibrotic scar. It’s a great device for complex device and lead management cases.
Disclosure: Dr. Kutalek has no conflicts of interest to report regarding the content herein. Outside the submitted work, he reports he is a consultant for Invuity, Inc.
This article is published with support from Invuity, Inc.
About the Company
Invuity, Inc. is a leading medical technology company focused on developing and marketing advanced surgical devices to improve the ability of physicians to perform minimal access surgery through smaller and hidden incisions. The company's patented Intelligent Photonics™ technology delivers enhanced visualization which facilitates surgical precision, efficiency and safety. In addition, the company utilizes comprehensive strategic marketing programs to create stronger institutional partnerships. Clinical applications include electrophysiology, spine, orthopedic, cardiothoracic, and general surgery. Additional applications include procedures for women's health, encompassing breast cancer and breast reconstruction surgery, gynecology and thyroid surgery. Invuity is headquartered in San Francisco, CA. For more information, visit: www.invuity.com