First patient at UNC to receive new stent graft for pararenal AAA is doing ‘great’ one-year later

Benny Hedrick of High Point, NC received the Zenith p-Branch® stent graft at UNC Hospitals in July 2012 to treat his life-threatening pararenal aortic aneurysm.

A clinical trial to test an “off-the-shelf” stent graft for pararenal aortic aneurysms, which involve the arteries that feed the kidneys and/or intestines, is underway at the University of North Carolina-Chapel Hill.   Mark Farber, MD, director of Aortic Disease Management in the UNC Center for Heart and Vascular Care, is the physician-sponsor of this study.

The trial is studying the kidney and abdominal organ (visceral) function following the endovascular procedure to repair a pararenal aortic aneurysm (PRAA) using the Zenith p-Branch® Pararenal Endovascular Graft, manufactured by Cook® Medical, Inc.

When the trial started in 2012, only three medical centers in the United States had access to the Zenith p-Branch through special investigator programs, one of which was the trial at UNC led by Dr. Farber.  Since that time, the Cook Medical-sponsored national study opened for patient enrollment.

An aortic aneurysm is a swelling in a section of the aorta, which is the human body’s main artery and provides oxygen-rich blood from the heart to the body. An aneurysm stretches and weakens the aorta, and if left untreated, the aneurysm can burst, causing severe bleeding that can quickly lead to death.   A pararenal aortic aneurysm is in the section of the aorta located below the diaphragm.

The Zenith p-Branch stent graft may be an improvement over other stent grafts used for aortic aneurysms in that it does not need to be customized for the patient, thus earning the nickname as an “off-the-shelf” graft.  The Zenith p-Branch stent graft has two different designs, with different locations for the pivoting renal “windows,” allowing it to fit more patients.

“This trial may ultimately allow for the minimally invasive treatment of patients with complex aneurysmal disease without the need for waiting,” says Dr. Farber.  “Its unique design may allow us to treat patients that otherwise have no options other than open surgery or watchful waiting."

FarberHedrick PRAA patientHedrick  PRAA kids

Shown from left: Mark Farber, MD, Medical Director, UNC Aortic Disease Management; Benny Hedrick (and wife, Debra), first patient at UNC to receive Zenith p-Branch stent graft; Hedrick's son-in-law Neil, daughter Casey, and granddaughter Kate were instrumental in finding treatment for Hedrick's pararenal aortic aneurysm.

Benny Hedrick’s aneurysm was discovered during an annual check-up with his cardiologist in May 2012.  His cardiologist felt something in his abdomen that “wasn’t quite right” and sent him for additional tests and consultation with surgeons in High Point.  Hedrick was diagnosed with a PRAA, an aneurysm that typically involves or approaches the renal arteries.  Historically, the morbidity and mortality rates associated with the repair of a PRAA have been relatively high.

“My aneurysm was up against my renal artery,” explains Hedrick. “Because of the location, it was the opinion of the surgeons that I had to have an open abdomen surgery to repair it.”

Having already survived two heart attacks, Hedrick knew there were a lot of potential issues with an open surgery and decided to get a second opinion.

Hedrick’s son-in-law had a friend who recommended that he see Robert R. Mendes, MD at Rex Vascular Surgical Specialists.  Dr. Mendes performed a CT scan and ultrasound and came to a different conclusion about surgery.

“Dr. Mendes told me that my aneurysm could be fixed with a stent graft, which would be put into place without open surgery,” said Hedrick. “They could operate through my arteries.”

Dr. Mendes, a former resident, fellow, and attending physician at UNC under Dr. Farber, set up an appointment with him for Hedrick.

“After my tests and exams, Dr. Farber asked if I’d be part of the clinical trial for the p-Branch stent.  I felt like he was the right doctor for this.  He knows a lot, he’s very confident and very good,” states Hedrick.

The Zenith p-Branch stent graft is guided to the spot of the aneurysm via a catheter placed into the patient’s groin.  This endovascular technique is minimally-invasive, allowing patients, in general, to return home sooner with less pain, faster healing, and generally provides the least amount of disruption to their lives.

During the current study, once the stent graft is in place, the graft’s orientation and configuration is evaluated with respect to kidney function and device performance. Detailed imaging is performed prior to and after endovascular repair so important data concerning the stent graft can be studied.  Using this data, it may be possible to determine changes in kidney function with respect to the Zenith p-Branch’s design characteristics.

Hedrick’s surgery went very well with no complications.  Two days later, he went home and was back to work in five weeks.   

Dr. Farber says, “Feasibility and early results show promise for Zenith p-Branch repair of PRAA.  This initial result for ‘off-the-shelf’ devices demonstrates possible treatment for up to 60 to 70 percent of patients with PRAA.”  Dr. Farber adds, “Additional device modifications and design may be required for other types of aortic aneurysms.”

All of Hedrick’s follow-up appointments have been excellent. “I feel great, and I’m having no issues at all.”

Testing of the Zenith p-Branch stent graft will continue at UNC at least through July 2015.  To be part of the p-Branch study at UNC, contact Dianne Glover, RN, Research Program Manager for UNC Aortic Disease Management, at (919) 843-1278 or dianne_glover@med.unc.edu.

 

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