Do You Feel That the Perspective of 'What's Best for the Patient' Is Threatened in Light of the Constant Stream of New Treatments?

As new technologies and procedures are introduced, the question of what’s best for the patient is extremely important. Physicians must be clear about why they want to offer alternatives to the standard of care. Is there really no other option for the patient? Is the new device or procedure the safest and most efficacious approach? And what about wanting to be “first on the block” to try a new treatment? While it is clear medical technology cannot advance if clinicians aren’t willing to try new approaches, we must evaluate every patient individually and ask ourselves, is this the best I can do? This philosophy extends to our choices about becoming involved with manufacturers as well. Manufacturers motivate clinicians in a number of ways, whether it is by offering them the chance to use a device first and/or by granting a financial interest in the product. Under such conditions, we must be extremely rigorous with ourselves in scrutinizing what is in the patient’s best interest. Perhaps the best advice is to do unto others as you would have them do to you. Ask yourself, if I were the patient, or if the patient were a family member, what would I choose? -- Richard Heuser, MD Phoenix Heart Center at St. Joseph’s Hospital and Medical Center richardheuser@phoenixheartcenter.com

I am concerned that new technologies and procedures are being advertised to the general public as ready for clinical use, before they have been fully tested for safety and efficacy in academically respected medical centers. I am also uneasy when interventionists are tempted to test new interventional techniques on patients without having first received basic training in the procedure or having the proper manual skills. It is obviously important for interventionists to keep up with the latest technology by hearing and observing the experts at work, and if necessary going to workshops where they can test their competence on models or animals. Needless to say, patients should be wary of undergoing cutting-edge procedures without first asking for a second opinion; they should also be fully knowledgeable about the interventionist’s level of experience, success and morbidity rate for these or related techniques. -- Constantin Cope, MD Professor Emeritus, University of Pennsylvania. Bend, OR • ccope1@bendbroadband.com

I think you have asked 2 important questions, deserving 2 different answers: 1. “Is the constant stream of new technologies threatening to obscure or contaminate the fundamental issue of what’s best for the patient?” I’d say: possibly so! It continues to bother me to see so many interventional physicians who are ready if not anxious to “try” every new gadget put before them — regardless of data, regulatory approval, or anything else! A new tool — that seems to be the only criterion! While I may be exaggerating a bit to make a point, it is undeniable that the temptation we are all exposed to (to use new technologies) is powerful. And there may be a number of agenda-related reasons why this is so: to please a vendor we may want to get close to, to gain the favor of a company that may eventually put us on the short list as a site for their clinical trial, or just because we feel the drive and ‘pressure’ to be doing something ‘different.’ Generally speaking, none of those reasons is good enough. Ever. Selection of a particular device or treatment strategy should always be based on evidence if possible. We must exercise a great deal of judgement and constraint, and be absolutely candid in communicating doubt and uncertainty when obtaining informed consent, particularly when the procedure is going to be done outside the confines of a well-controlled clinical trial. 2. ‘In this context, what can I suggest physicians to do in order to remain appropriately focused?’ Well, I would reiterate the above-stated first. Second: I would try to keep a healthy balance between ‘traditional’ and ‘new and exciting.’ This is to say I would listen to the reps, ‘magnet Faculty’ at various events, and ‘avant-garde publications,’ ie, read them throughly, ask questions and read their material, BUT then, I would temper that with the solid understanding that I should probably not change my ways or adopt a new device on the basis of only 6-month data! SFA revascularization comes immediately to mind as an area where such scenarios are emerging at this time. There may be exceptions to this rule, especially in situations where the present standard of care offers little hope. ‘Game-changing’ technologies do occur from time to time; for instance, the development of stent devices overall, or DES technology for coronary revascularization, and a good number of others. But for the most part, ‘progress’ and ‘advances’ are realized through slow and almost painful ‘little steps’ that often take time and many failures. You need not be part of this — unless you are one of those endo-luminaries. -- Frank J. Criado, MD, Editor-in-Chief Director, Center for Vascular Intervention; Chief, Division of Vascular Surgery; Union Memorial Hospital/MedStar Health, Baltimore, MD • frank.criado@medstar.net

Medical science has been in a constant flux since historic times. The evolution of “healing” strategies has been founded on a single concept: “what’s best for the patient.” Ever since, professionals in medicine have sacrificed their careers for the betterment of healthcare. Among the various medical specialties, the vascular field has realized a significant impact, arising from the revolution in the interventional arena. A combination of forces, consisting of a significant advancement in the technical capabilities provided by the medical industry and our eagerness as clinicians to transform this into a reality, makes this period an exciting phase in medical history. One should bear in mind that every new invention has always had its own limitations and there is no exception to the current interventional devices, as demonstrated in the following true case scenario. This is an example from my practice, regarding a patient I saw a few weeks ago. A 56-year-old female was referred for lifestyle debilitating left lower extremity claudication, with a moderately-reduced ABI. She has requested the best endovascular option after educating herself on the internet. Her medical history consists of tobacco abuse, diabetes mellitus, renal failure and coronary artery disease requiring two percutaneous coronary interventions (one of which was complicated by a inadvertent semi-occlusion of the right common femoral artery with a collagen arteriotomy closure device. It required surgical treatment which consisted of common femoral artery excision with a vein graft end-to-end anastamosis). Due to significant calcification of the left femoral system, arterial duplex examination and arteriography were unable to identify the location of disease in the left femoral system. However, physiologic measurement of a 58 mm Hg pressure gradient was demonstrable across the left common femoral artery, which correlated with her symptomatology. As we know when considered in isolation, common femoral artery disease can be treated with three different modalities: a) Medical therapy b) Endovascular intervention c) Surgery. As always when we recommend therapeutic options for our patients, our unanimous choice should be “what’s best for the patient.” Even though the patient has lifestyle debilitating symptoms with an identifiable hemodynamically significant stenosis and has requested an invasive strategy for revascularization, we cannot offer her an endovascular option. The interventional armamentarium in the current era, utilizing angiographic and intravascular ultrasound guidance to name a few, are – atherectomy devices, excimer laser, cutting balloon, cryoplasty, traditional balloon angioplasty, and stenting, all of which have their own limitations in this patient: a) Lower procedural success b) Greater complication rate c) Poor short and long term durability d) Critically important anastamotic site for lower extremity surgical bypass when the limb is threatened e) Access site for future vascular procedures Common femoral artery endarterectomy as a surgical alternative is limited due to the severe vessel calcification. In conclusion, my discussion with the patient consisted of “what’s best for her,” which consisted of medical therapy for non-limb threatening status and about our current limitations, despite the availability of exciting new technologies in the interventional field. -- Bhagat K. Reddy, MD Director of Vascular Medicine & Interventions CDS, Piedmont Hospital Atlanta, GA bkrmd7@yahoo.com

The explosion of knowledge and technologies over the past recent years has enhanced the abilities of the endovascular specialist to treat patients very effectively, leading to a longer and better quality of life. The improvement in procedures and the tools to perform them have led to an exponential growth in the number of peripheral vascular procedures over the past 5–10 years. Growing, however, is not without pain. The two fundamental problems we are currently facing, in my opinion, are: 1) The expenses associated with these technologies, that have, in many instances, exceeded the abilities of third-party payers to match; 2) The tremendous amount of knowledge that has accumulated in a short period of time, leaving behind confusion about the best therapy. For instance, drug-eluting stents (DES) are a powerful technology that nearly eliminated restenosis, the Achilles’ tendon of angioplasty for many years. The cost of this technology is prohibitive, however, and physicians are challenged daily to keep the utilization of these stents to a minimum to limit cost while also being asked to provide the best of care to their patients. The same applies to the placement of biventricular pacemakers and internal defibrillators, or to the use of certain expensive adjunctive therapies such as abciximab in the cardiac catheterization laboratory. Devices currently available to the endovascular specialist to treat peripheral vascular disease are an example of increasing cost and confusion. Tools to treat superficial femoral artery disease, for instance, are multiple, such as the Silverhawk atherectomy catheter, the Polar catheter, the Safe-Cross, the Outback Re-Entry Catheter, laser catheters and various stents. Endovascular specialists are caught in the middle of deciding the best treatment to their patients with these emerging different technologies, which to the most part lack well-designed randomized trials against the most basic and cheapest device — the plain old angioplasty balloon. As technology is destined to continue to grow and different devices and drugs continue to flood the market, it is imperative for the endovascular specialist to continue to practice evidence-based therapies. Also, various endovascular societies need to ensure that we continue to have clear practice guidelines based on high level of evidence. In addition, endovascular specialists need to maintain objectivity and scientific rigor in dealing with patients and colleagues, and do not allow marketing influences to affect their best judgment. Furthermore, working closely with hospitals in developing common strategies to limit expenses and practicing cost-effective medicine is imperative, and can be achieved with standardizations of practices and good leadership. Last but not least, treating patients with compassion and having their welfare on top of our wish list should remain our unchallenged mission. As the endovascular field continues to prosper and grow, endovascular specialists are urged to continue with the highest standards of practice based on strong evidence and away from marketing influences, and ensure a collaborative environment with their centers to continue to limit costs and ensure quality. -- Nicolas W. Shammas, MS, MD Cardiovascular Medicine, P.C. Genesis Heart Institute Davenport, IA shammas@mchsi.com