Where Will the SFA Data Ultimately Lead?
- Mon, 7/12/10 - 11:12am
- 2369 reads
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Continuing with the SFA for now, I wanted to ask the following: Where will the data ultimately lead? If someone has the proverbial “crystal ball” that allows one to see the future, where are we heading? This is important, since most every company’s device and device iteration suggests it is or should be considered the “workhorse” in the femoral artery. This is clearly not true.
How is this possible when many devices provide methods to change either arterial compliance or create a channel that needs further intervention either via angioplasty or stenting? Short of simple balloon angioplasty and stenting either as default or bailout — no other device, with few exceptions, is truly standalone. Further, are the devices for getting to the other side important for a “successful” intervention (i.e., crossing wires or devices to stay in the “true lumen”)? Many of my colleagues believe the answer is yes. Many speak to this from time to time. I just don’t know.
Let’s take a look at alternatives such as atherectomy devices currently available in this country: directional atherectomy (SilverHawk), rotational atherectomy (Pathway and CSI) and atheroablative devices (laser). All but the Silverhawk require additional dilation through either a balloon or stent with laser, suggesting in their LACI trial a 96% adjunctive therapy rate. SilverHawk uses adjunctive therapy in up to one-fourth of the cases, so even here, the rate of additional therapy is not insignificant. Additionally, the early data from many, if not all, devices are poor. Many have early registry data with first-pass numbers of 3–4 cm lesion lengths in the SFA. We add to this the stenting data, which currently have lesion lengths of over 10 cm in several trials, and the outcomes and rates of patency cannot be compared. Moreover, we have on the horizon some intriguing data regarding drug-eluting balloons, which seem to suggest that a combined approach either with balloon alone or possibly atherectomy followed with a drug-eluting balloon, may have the best overall impact for clinical as well as anatomic patency.
It seems to me that we really need a head-to-head comparison for all devices and finally put our science to work. We need robust core lab-driven outcomes research to allow direct comparisons for these types of patients, and have the study compare each and every device. Will the “plumbers” agree? Will the surgeons who complain time and again that plumbers of all trades are over-treating be willing to truly enroll patients? What will the total costs of each device be when compared head-to-head? I suspect many will not be happy.
Let me know what you think, and we will reconvene next month.
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Dr. Garcia received his B.A. and M.D. degrees from the University of Arizona. He was an Intern and Resident at Parkland Memorial Hospital, University of Texas at Southwestern in Dallas, Texas. He received his training in Cardiology at the University of Iowa Hospitals and Clinics in Iowa City, Iowa, and as an interventional cardiologist at the Beth Israel Deaconess Medical Center, Harvard Medical School. Further, he received his peripheral vascular training at St. Elizabeth’s Medical Center, Tuft’s University, Boston, Massachusetts. He then served as the Chief of Vascular Medicine and Peripheral Vascular Interventions for the Florida Heart Group in Orlando, Florida. Dr. Garcia returned to Harvard’s Beth Israel Hospital as a full-time interventional cardiologist and Director of the Peripheral Cardiovascular Program and Peripheral Interventions at the Beth Israel Deaconess Medical Center as well as the Director of the Interventional Fellowship Program. This program developed into one of the busiest in the city of Boston, performing over 600 peripheral procedures per year.
Dr. Garcia has now returned to St. Elizabeth’s Medical Center as Chief of the Section of Interventional Cardiology and as Associate Director of the Vascular Medicine Program. Dr. Garcia’s work has largely focused on arterial occlusion-reperfusion models and the efficacy of therapeutic modalities or interventions with regard to free radical generation or endovascular stenting outcomes. Dr. Garcia continues his research interests in a wide variety of studies including acute MI studies, unstable angina studies, interventional trials, peripheral interventional trials, angiogenesis trials, imaging modality studies, and numerous device trials for both the coronary and peripheral circulations. His work has been presented in numerous manuscripts, abstracts, textbooks and textbook chapters.
According to my interventional radiologist, I am a unique case. I had an 8 cm occlusion in my LSFA as a consequence of trauma (2 dogs on leashes wrapped around my thigh and yanked me in a torsional manner in June 2008). It took doctors a year to properly diagnose the cause of my claudication andd peripheral polyneuropathy. When an ortohpeid surgeon finally realized I had no dorsal pedal pulse (the third time he saw me in a year), he sent me to a vascualr surgeon who sent me for a STAT MRA, which showed the occlusion. Since I was only in my late 40s, they decided to stent my artery (2 nitinol stents) and it worked great, until I restenosed 7 months later. The obstruction was due to epitheliazation of the stents, and the lysis was difficult. Multiple attemps with an angiojet failed and 30 hours of pTA lysis with a multi holed catheter was mildly successful, but left me without a posterior tibial pulse, lymphadema and peripheral neuropathy. After multiple falls due to the pain and swelling in my left calf and foot, I fianlly achieved a brief return to normalcy, but quickly developed atrophy and coolnes in my calf and foot. Several neurologists , epidurals and duplex ultrasounds later, my vascular surgeon sent me for a CTA after discovering no doral pedal, posterior fibial or popliteal pulses. The CTA showed a tiny occlusion at the sital end of the 2nd stent (which had moved since being placed 9 months earlier)due to epitheliazation. My vascular surgeon says this is the end of the line and I need a fem-pop bypass, but the neurologist prescribed mentanx and I am doing much better. I am wondering if a less invasive procedure, ie lysis with an excimer laser, my be in order since the stents and everything else is patent.
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