Northside is First in U.S. to Offer New Trial for Complex Aortic Emergencies

Posted on: Tuesday, February 26, 2013

 

Dr. Joseph Ricotta, of Northside Vascular Surgery, has become the first and only surgeon in the United States to receive approval from the FDA for an Investigational Device Exemption (IDE) to create and implant custom-modified endografts for high-risk patients with thoracoabdominal aortic aneurysms.  Dr. Ricotta performed his first case, as part of his new MOSTEGRA (MOdified STEnt GRAft) clinical trial, Feb. 12, at Northside Hospital-Forsyth in Cumming.

Dr. Ricotta is a nationally and internationally recognized expert in the field of vascular and endovascular surgery.  He has gained vast knowledge and experience working at the nation’s leading vascular surgery institutes (Mayo Clinic, Cleveland Clinic) and brings that expertise to Northside Hospital.

“Despite many advances in the evaluation and care of patients with thoracoabdominal aortic aneurysms, formidable challenges remain,” says Dr. Ricotta.  “Patients, who have these aneurysms and who have underlying serious medical conditions or present as an emergency, simply are not good candidates for the traditional open surgical approach.”

A thoracoabdominal aortic aneurysm (TAAA) is an abnormal ballooning or weakness in the wall of the aorta, the large artery that carries blood from the heart through the chest and abdomen.  It can be caused by a number of issues including high cholesterol, chronic high blood pressure, smoking, a family history of aortic aneurysm and atherosclerosis.  If an aneurysm develops in the aortic artery and bursts, it can cause uncontrollable and life-threatening bleeding.

Approximately 15,000 people die each year from a ruptured aneurysm, and 200,000 new cases are diagnosed annually, primarily affecting men and individuals age 65 years and older.  The traditional method of repairing a TAAA is with open surgery, which carries a high morbidity and mortality risk, including a 50 to 70 percent mortality rate for patients with a ruptured TAAA.  There is currently no commercially available endovascular alternative for the treatment of a TAAA in the U.S.  However, Dr. Ricotta’s MOSTEGRA trial is giving TAAA patients new hope.

“Many of the issues which cause a TAAA are the same issues that make it more challenging to treat conventionally and increase mortality rates,” says Dr. Ricotta.  “For these high-risk patients, fenestrated and branched endografts are being developed as a minimally invasive, totally endovascular alternative for treating complex aortic aneurysms.”

Fenestrated and branched endografts are stents, essentially a tube of fabric and metal that functions as a sleeve inside the aorta and excludes the aneurysm from blood flow.  It has fenestrations (reinforced holes) that are lined up with the blood vessels, to which blood flow is being preserved.  Through these holes, additional stents are placed into the branch arteries to repair the aneurysm.  The stent is inserted through a small puncture in the groin and the entire aneurysm is repaired from the inside of the aorta, rather than cutting open the chest and abdomen; so patients have a much shorter hospital stay and a quicker recovery time.  However, construction of these devices requires that they be custom-made to fit the specific anatomy of each patient.

A commercially manufactured customized fenestrated endograft can take as long as 6 to 12 weeks to create, making it unavailable for patients who require emergency surgery.  For patients, whose aneurysms have not yet ruptured and can wait, they must live with the stress of a “ticking time bomb” that could burst at any time while they are waiting for their device to be manufactured.  According to Ricotta, it is not uncommon for a patient’s aneurysm to rupture while they await customization of their device and surgery.

Dr. Ricotta is currently investigating the use of a surgeon-modified endograft, which can take as little as 30 minutes to create, drastically reducing the waiting period for patients and enabling it to treat aortic emergencies.  The MOSTEGRA trial is the only FDA approved, physician-sponsored clinical trial using the surgeon-modified technique for the treatment of TAAAs in the U.S.  With extensive skill in aortic aneurysm repair, in addition to providing a full spectrum of vascular and endovascular services, Dr. Ricotta brings his experience in clinical research trials, based on years as a national and international participant.

“The value of fenestrated and branched stent grafts in the management of high-risk patients with a TAAA, who are unfit for open surgery, is indisputable,” says Dr. Ricotta.  “But the opportunity to lead research that will benefit these patients and produce another treatment option for them is most rewarding.”

In the Feb. 12 case, the patient was removed from the ventilator at the conclusion of the operation, before she left the operating room, and went home just two days after surgery.  A traditional open surgical procedure would have left her in the hospital for more than one week and on oxygen for most of that time.

For more information about the MOSTEGRA clinical trial or to schedule an appointment with Dr. Ricotta, call 770-292-3490 or visit www.nvs-ga.com

Read more about Northside's Heart & Vascular Institute. 

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