From Resistance to Standard of Care: Gaining Acceptance for Technology to Prevent Stroke

An Expert's Experience and Tips

M. Vincent Weaverby M. Vince Weaver, MD, Guest Editor
Vascular Surgeon

I still remember scrubbing into my very first endovascular repair of an aortic aneurysm case with Dr. Peter Faries during my vascular surgery fellowship at Mount Sinai. As a young surgeon, every procedure was new to me, and I loved the idea of reading the latest clinical trial publications, learning new techniques, using innovative medical devices, treating conditions that were previously untreatable, and improving patient outcomes.

Dr. Andrew Olinde recruited me to join the Vascular Specialty Center after my fellowship. As a native Louisianan, I was excited to bring my newfound knowledge back to Baton Rouge. One such innovation is Transcarotid Artery Revascularization, or TCAR. I was introduced by a colleague from my vascular surgery fellowship days. She had been involved in the ROADSTER 2 clinical study and was very impressed with the results. This piqued my interest because of the inherent risks of carotid endarterectomy (CEA) and carotid artery stenting (CAS).

It’s not surprising that when I first brought up the idea of TCAR, which is a form of CAS, there was a lot of resistance. While my partners were supportive, every step was fraught with naysayers in the physician community. They had seen carotid stenting failures and, despite initial positive clinical results from the pivotal IDE trial, there was healthy skepticism. But the procedure’s unique mechanism of action made sense to me: Direct carotid access avoids unnecessary manipulation and flow reversal temporarily redirects blood flow away from the brain during stent implantation.

Just like in my fellowship training, I reached out to the experts in the procedure, exploring every detail and nuance with other vascular surgeons who had done hundreds of cases. I completed training on the product, and most importantly, I immediately took what I learned and put it into practice. Within the first 30 days, I successfully completed five cases, using the same OR team so that we all became comfortable with the procedure.

As I became facile with the procedure, I carefully watched the developing clinical evidence. Study after study demonstrated consistent results, with the most recent dataset comparing over 2,500 TCAR patients to 43,000 open surgical patients demonstrating equivalent results. Despite the fact that TCAR patients were older, sicker and more symptomatic, they actually had lower rates of cranial nerve injuries, shorter operating times and hospital stays, and less use of general anesthesia than CEA patients.

Ultimately, excellent patient outcomes convinced my colleagues around Baton Rouge that TCAR has a bright future. As the clinical data continued to build and patients expressed enthusiasm for this less invasive procedure, the community has now rallied around this new therapy and other vascular surgeons are introducing TCAR into their practices. And that was my goal all along: It’s great to be first, but I hoped everyone would come on board.

From a novel concept to the standard of care, this is how progress in the medical field continues unabated. And this is what I learned about the process along the way:

  1. Educate yourself about the technology. Learn about the science behind the technology and its safety. Review published literature. Attend presentations at medical meetings. Talk to your colleagues.

  2. Gain support from your own practice. Educate your partners about the technology and its benefits, and get their backing before you reach out to the larger community.

  3. Get hospital buy-in. Bring the technology to hospital administration, and go through committee to get hospital approval. Be prepared with safety and outcomes data, reimbursement details and any other economic impact, such as operating room volume (with TCAR, operating room time is freed up, since we can do two cases in the amount of time it would take to do one CEA).

  4. Participate in training and schedule cases right away. Attend training offered by industry to become more familiar with the technical aspects of the procedure and have your first cases lined up to happen within 48 hours of coming back so you don’t forget anything you’ve learned.

  5. Complete 15 cases as soon as possible. This will enable you to speak intelligently about the procedure and build clinical credibility, as well as learn which patients would benefit most from TCAR and where CEA would still be the most appropriate option.

  6. Notify the community. As soon as you complete 15 cases, work with your marketing team to promote and educate the community, referring physicians and other doctors. Schedule one-on-one and small group meetings with the physician community. Attend hospital staff meetings. Host journal clubs for residents and fellows.

Vince Weaver, MD, is a vascular surgeon at Vascular Specialty Center in Baton Rouge, Louisiana.

 

 

4 COMMENTS

  1. Dear COLLEAGUE. I RECOMMEND YOU TO READ PERSPECTIVES IN VASCULAR SURGERY “,history of flow reversal “ to learn the real history

    FLOW REVERSAL WAS INVENTED BY JUAN PARODI in 1998 when he did the first case through a small incision and connecting the CCA with the jugurar vein (see photos) interposing a short wide tubing with a filter and a three way stopcok and clamping the CCA. The second development was the percutaneous device bought by GORE
    Parodi did two cases in Toledo, Spain. Enrique Criado assisted him and in few weels filed a patent using the femoral vein instead of the jugular to go around of Parodi’s patent. Parodi visited Coppi in Modena and he copied the percutaneous device and put the device the name of his wife MOMA. IT IS ETHICAL TO GIVE CREDIT TO THE REAL INVENTORS

  2. The steps offered in your article, especially the hospital buy-in is the most important tip especially reimbursement details. Good advice.

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