Infrainguinal Revascularization Modalities

How many years have you been performing complex critical limb ischemia (CLI) revascularization?

I have been in practice 8 years and have been taking care of CLI patients since I started practice. In those 8 years, there has been tremendous advancement of the field. I think first and foremost, there is a much greater awareness of CLI  and commitment to revascularization for these patients. In my opinion, the catalyst for these changes has been the advances in endovascular options. When I started, pedal access was just coming on the scene. Along with improvements in wire and product technology, it has positively impacted the success rates on endovascular CLI interventions.

Performing complex procedures require highly skilled support staff, which you currently have. Tell us how you found the correct staff and how did they reach such a high level of expertise?

I wish I could take credit for the expertise of our staff, but it has for the most part been self-directed. They have a very supportive manager who encourages members to become clinical experts in areas where they have unique interests or talents. Staff members have voiced their interest in supporting advanced peripheral procedures and have sought out training, whether just making sure they are available to scrub our peripheral cases or traveling elsewhere to learn the tricks of advanced CLI intervention. For instance, several of our technologists traveled 3+ hours to attend the comprehensive CLI course at Advanced Cardiac & Vascular Centers for Amputation Prevention with yourself and Dr. Saab. Another of our nurses was instrumental in an institution-wide policy change to allow Precedex for sedation in the cath lab, as he felt it would provide incremental benefit to the long CLI or aneurysm cases we do in the cath lab.  I am very fortunate to work beside such a talented and devoted team.

What types of infrainguinal disease states do you currently treat at your institution?

We treat all types.

Do you have an algorithmic approach to superficial femoral artery (SFA) revascularization? Tell us how you treat lesions from TASC A to TASC D.

I do have an approach, but it doesn’t necessarily follow TASC lesion type. Whether SFA intervention or any other procedure, the first step is to determine if a patient meets criteria to participate in any of the numerous trials in which we are involved. To be successful in clinical trial research and for the findings of the trial to be meaningful, I believe operator bias has to be minimized. Every one of our patients are approached about participating in clinical research, if they meet inclusion criteria. For non-research patients, I take into account the patient’s age, functional status, indication for revascularization (claudication vs CLI), and complexity of the anatomy when determining my treatment strategy. Until recently, I primarily performed drug-coated balloon angioplasty for straightforward lesions in younger claudicants. I have backed off that a bit until the recent association between paclitaxel-coated peripheral devices and long-term mortality is better understood. More complex lesions (long chronic total occlusions [CTOs], heavy calcification), I usually stent. I don’t feel the popliteal space is a “no stent” zone, particularly with stents that have interwoven nitinol technology, providing the necessary flexibility and radial strength. I reserve atherectomy only for the most calcified lesions.

Can you share more about peripheral device research at your hospital?

We have a very active research center with a strong commitment to clinical trials. One of the more exciting protocols we are participating in is DETOUR II, which is looking at a percutaneous fem-pop bypass system using a novel stent graft and the femoral vein to bypass TASC D SFA lesions. We have been a very strong enroller in CREST 2, comparing revascularization with either coronary artery stenting (CAS) or carotid endarterectomy (CEA) to contemporary medical therapy in asymptomatic carotid disease. We also have participated in various drug-coated balloon, drug-eluting stent, and abdominal aortic aneurysm (AAA) trials. I believe the biggest requirement to be successful in research is a commitment to the trial and the device being tested. With new device technology, we are often dealing with first-generation devices that haven’t necessarily had all the kinks worked out. Often conceptually the device or technique makes sense, but there are unpredicted nuances once in-man testing starts. The interventionalists that I know who are excellent researchers understand this. They are problem-solvers dedicated to taking novel concepts and techniques, and making them streamlined and simple enough such that consistent, excellent results can be reproduced across a variety of operator skill levels and patient anatomical challenges.

How much of your time is spent performing peripheral work in the angio suite and how do you spend the remaining time?

I am typically in the lab 2-3 days a week. One day is dedicated to structural procedures. We have a comprehensive structural program at our center. I perform transcatheter aortic valve replacement (TAVR), MitraClip (Abbott Vascular), Watchman (Boston Scientific), paravalvular prosthetic leak (PVL) closure, and atrial septal defect (ASD)/patent foramen ovale (PFO) closures. As they come along, we also perform ventricular septal defect (VSD) repairs and percutaneous balloon mitral valvuloplasty. The other 1-2 days are spent between peripheral procedures and taking call in the lab for all the inpatient needs. About 50% of my total caseload is peripheral work, with 30% dedicated to structural cases, and the remaining 20% doing coronary work. The rest of my week is spent either in general cardiology, structural, or outreach clinics. As we serve a large rural area, I travel to remote locations over 100 miles from our center, which makes for long days. I spend approximately 10% of my time on administrative or research-related activities.

You are well known to be a very skilled operator and proficient in many different, complex revascularization areas. Of all the areas you treat, which one do you find yourself most passionate about?

I enjoy carotid and aortic interventions, but for different reasons. Carotid work is technically demanding. Technique is critical. I take CAS procedures very seriously, as missteps have devastating consequences. There is not a lot of variation or creativity in my CAS procedures. I usually use the same staff, and they are well versed in the steps of the procedure and what I am doing. I enjoy aortic work because there is a lot of creativity involved, especially in challenging anatomy. I love the pre-procedure planning that is required to treat complex aneurysms. It is extremely satisfying to develop an unique treatment plan and get the result you are hoping for.

Is pressure placed upon you by hospital administration in regard to cost and time spent treating complex PAD patients?

I have been extremely fortunate to work with an administration that supports our mission and is committed to meeting the cardiovascular needs of northern Michigan. I have had very little resistance from our local administrative team when I have requested new products or made a case for program development when there has been a gap in our service line. There have been several times when I have entered the C-suite to make my case, but ultimately the answer has always been “yes.”  Our current service line director and CMO are huge champions of what we are trying to accomplish.

Is it fair to say that performing PAD procedures is more challenging than coronary procedures?

I won’t go so as far to say that PAD work is more challenging. The CTO and CHIP (Complex High-Risk Indicated Procedure/Patients) work our coronary colleagues do is impressive and continues to push the envelope, especially with how unstable some of these patients are. What I will say is there is a creativity required for peripheral work that isn’t necessarily present in coronary work. There are so many different vascular beds, each with unique anatomical challenges and individual product lines. An AAA repair requires a totally different skill set than a retrograde CLI case. Additionally, for many peripheral procedures, there isn’t a consensus or undisputed treatment strategy. For me, that is what makes peripheral work so stimulating. Cases are so different from one to the next. Not to mention, technology in the peripheral space continues to develop at a lightning pace.

How are you able to spread yourself between the many demands of PAD revascularization, coronary revascularization, and structural heart therapy? Do you think it is realistic that the newly trained interventional cardiologist be able to provide comprehensive care to all areas early in their career?

I would never discourage anyone from trying to participate in all three spaces, but it is challenging for a several reasons. First, you have to be fortunate to practice in a location where someone isn’t already in place. This is especially challenging in the structural arena. Second, with the notion that volume equates to quality, it is becoming more difficult to find the time to do all the high-end peripheral and structural cases to meet the case volumes for maintaining privileges or in some instances, national coverage determination (NCD) requirements for programs to remain credentialed. Lastly, it just requires a lot of work to stay proficient with so many diverse procedures. A lot of my extra time is spent reading, attending conferences, or reviewing new products. That being said, I wouldn’t have it any other way. I am extremely blessed to be able to make a good living doing something that challenges and rewards me on a daily basis.

Can you share a case example demonstrating the value of commitment to a long, complex PAD case?

Figures 1-3 aren’t from a CLI case, but I chose this case to show just how diverse and challenging peripheral work can be. This was a 74-year-old gentleman who underwent uncomplicated endovascular aneurysm repair (EVAR) for a 5.5 cm AAA. His six-month follow-up computed tomography angiography (CTA) showed a persistent type II endoleak with expansion of his aneurysm sac to 5.7 cm.  He was brought to the lab where 9 French (Fr) right groin access was obtained. A Tourguide steerable sheath (Medtronic) was used to engage the superior mesenteric artery (red arrow, Figure 1). We used a .014-inch Runthrough wire (Terumo) to wire into the marginal artery through the left branch of the middle colic artery. We switched out for a .018-inch Nitrex wire (Medtronic) and brought a 5 Fr Glidecath (Terumo) into the transverse artery (green arrow, Figure 1). Using the Nitrex wire, we continued into the ascending branch of the left colic artery (black arrow, Figure 2). Selective angiography was performed that showed the endoleak from the left colic artery (blue arrow, Figure 2) into the inferior mesenteric artery (IMA), (green arrow, Figure 2) and into the sac (red arrow, Figure 2). The IMA was successfully coiled with a 6 mm x 20 mm Azur CX (Terumo) and 4 mm x 5 mm Azur Hydrogel coil (Terumo) (Figure 3). On the one-year CTA, the aneurysm sac measured 5.4 cm. 

Disclosures: Dr. Ricci reports consulting fees from PQ Bypass and honoria from Edwards Lifesciences.

Dr. Jason Ricci can be contacted at jricci@northernhealth.org.

Dr. J.A. Mustapha can be contacted at jmustapha@acvcenters.com