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The Progression of Percutaneous Strategies for EVAR
Percutaneous endovascular aneurysm repair has evolved over the past 2 decades.
Twenty years ago, percutaneous endovascular aneurysm repair was performed for the first time. Now, as its benefits are becoming more apparent, it is close to achieving status as the standard of care for treatment of abdominal aortic aneurysm.
The first-ever percutaneous endovascular aneurysm repair (PEVAR) was performed at Baylor St. Luke’s Medical Center in Houston on June 4, 1996, by Zvonimir Krajcer, MD.
Since then, “we have done more than 2,000 percutaneous endovascular aneurysm repair procedures, with very good results,” Krajcer, program director of peripheral vascular interventions as Texas Heart Institute and Baylor St. Luke’s Medical Center, told Cardiology Today’s Intervention. “Our goal is to educate physicians in the United States and abroad about this technique and to popularize it so it can be used by almost all operators.”
History of PEVAR
The first endovascular aneurysm repair (EVAR) procedure was performed in 1990 by Argentine physician Juan C. Parodi, MD. Although it was less invasive than traditional open surgery, EVAR required surgical incision in the groin and general anesthesia.
“At that time, the stent grafts we used were about 8 mm in size, which was painful and required general anesthesia,” Krajcer said in an interview. “My goal was to reduce discomfort for our patients because surgical incisions and general anesthesia carry risks, particularly in patients who have significant comorbid conditions such as CAD, HF, diabetes and many other conditions.”
Krajcer designed a smaller graft (14F, or 4.7 mm in diameter), which could be placed via a percutaneous approach using only two small puncture sites at both groins.
“We did that first [PEVAR] in 1996 under local anesthesia with just mild sedation and numbing medication,” he said.
Additionally, the procedure was done in the catheterization lab rather than an OR, which is typically where EVAR procedures are performed.
“Procedures done in the [OR] are three to six times more expensive than those done in a cath lab or an interventional suite,” Krajcer said. “OR procedures require more personnel, and whenever you have more personnel, the costs are higher. Additionally, PEVAR does not require the patient to be transferred to the recovery room or ICU, which is also significantly costlier than transfer to a regular room.”
The advantage of PEVAR, according to Allan S. Stewart, MD, director of aortic surgery in the department of cardiothoracic surgery at The Mount Sinai Hospital and associate professor in the department of cardiothoracic surgery at Icahn School of Medicine at Mount Sinai, is that it prevents the need for a groin incision, which “is a substantial source of morbidity to the patient. Groin incisions are associated with risk for infection and are painful. Percutaneous approaches reduce the need for hospital stay and allow a quicker return to independent function.”
Use Today
EVAR is now preferred over open repair for most patients with AAA, and PEVAR may soon be preferred over EVAR with surgical incision as the technology continues to evolve, Stewart told Cardiology Today’s Intervention.
“Open surgery is reserved for aneurysms that cannot be treated by EVAR and for failures of EVAR that cannot be rescued by an endovascular approach,” he said. “Many centers still perform surgical groin incisions to expose the access artery, usually the common femoral artery. Surgical incisions ensure that the access point is correct and allow for direct repair of the vessel after EVAR in the event of existing peripheral vascular disease.”
However, he said, “the incidence of open exposure is declining as EVAR delivery systems continue to decrease in size. I suspect that PEVAR will soon be the standard of care as arterial closure devices are perfected and access sizes of even the largest devices are further reduced.”
Krajcer has served as the principal investigator on two clinical trials that have validated the PEVAR approach. Results of the first, the randomized PEVAR trial, were published in 2014 and showed a significant reduction in complication rates with a percutaneous approach vs. a surgical approach. Preliminary results of the second trial, the LIFE trial, have been published, and final data are expected to be published soon, Krajcer said.
“This trial [LIFE] showed, again, that there are great benefits to the use of a percutaneous approach and general anesthesia, but it also showed that we can save close to $4,000 per patient in costs to the hospital if we do this procedure under the least invasive approach and in so-called ‘fast-track’ protocol, which means discharging the patient from the hospital within 23 hours after the procedure.”
As it is currently performed, PEVAR enables a much shorter recovery time for patients, eliminating grogginess and nausea caused by general anesthesia and enabling patients to ambulate within 4 hours after the procedure.
Among patients with AAA, the best candidates for PEVAR are those without significant peripheral artery disease, Stewart said.
“Additionally, the size of the aorta should allow placement of a device that has a small delivery system, minimizing the risk for trauma to the femoral artery,” he said. “Finally, there should be a fairly straight path to the aorta, which will mitigate the need for significant tension on the delivery system.”
However, Stewart said, PEVAR may not be appropriate in patients with more complex disease.
“Treatment of larger aneurysms of the suprarenal aorta and thoracoabdominal aneurysms are being routinely approached with endovascular systems,” he said. “These devices often have multiple branches on the stent and require advanced skill levels. Often these devices are larger and require access of both femoral arteries. While I am confident that, over time, the delivery systems will be miniaturized, currently these aneurysms are best treated with open exposure of the access vessel.”
Adoption Prospects
Krajcer said the adoption of PEVAR has increased significantly since its introduction in 1996. Ten years ago, roughly 2% of operators were performing PEVAR, whereas today almost 60% of operators use this approach, he said.
Adoption of PEVAR will rise “as closure devices become more reproducible and delivery systems are reduced in size,” Stewart said. “Current trainees are well-versed in PEVAR, so as the older generation of physicians retire, there will be an increase in adoption.”
Krajcer said his goal is to encourage more widespread adoption of PEVAR in coming years. He hopes that the procedure will soon acquire a billing code so U.S. hospitals and operators can be reimbursed for PEVAR.
“In 1996, this was a novel procedure, and there was a significant skepticism about it and a concern for patient safety. Now, we have proven in multiple publications that this approach not only saves money for hospitals, but is also of great benefit to patients,” Krajcer said. “This approach is not only fast-track EVAR but also the least invasive EVAR, and I think it will become the gold standard for the treatment of EVAR patients.” — by Jennifer Byrne and Erik Swain
- References:
- Krajcer Z, et al. J Cardiovasc Surg. 2011;52:651-659.
- Krajcer Z, et al. Texas Heart Inst J. 2013;40:560-561.
- Nelson PR, et al. J Vasc Surg. 2014;doi:10.1016/j.jvs.2013.10.101.
- For more information:
- Zvonimir Krajcer, MD, can be reached at 6624 Fannin St. #2780, Houston, TX 77030; email: zkrajcer@leachmancardiology.com.
- Allan S. Stewart, MD, can be reached at 1190 Fifth Ave., GP2W, New York, NY 10029; email: allan.stewart@mountsinai.org.
Disclosure: Krajcer is principal investigator of the PEVAR and LIFE trials and reports speaking for Endologix. Stewart reports no relevant financial disclosures.