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Endovascular surgery: The new challenge
EDITORIAL
Endovascular surgery: The new challenge Robert B. Rutherford, MD, Denver, Colo.
American vascular surgeons have finally gained formal recognition as specialists, and with welldefined training requirements embodied in approved fellowships, qualifying board examinations, a flourishing journal, and more appropriate representation on the governing bodies of Surgery, there is much cause for satisfaction. However, during the years of struggle over the emergence of their specialty, vascular surgeons have also wimessed the introduction of a whole host of intervention devices and therapies such as percutaneous transluminal balloon angioplasty (PTA), intravascular thrombolytic infusions, therapeutic embolization, several atherectomy devices, laser "probes," percutaneous insertion of caval filters, percutaneous thrombectomy, and intravascular stents - - all likely to be used by other specialists. This trend threatens to erode the vascular surgeon's rather exclusive position as the primary specialist in the diagnosis and management of peripheral vascular diseases.
Vascular surgeons havc been instrumental in many of these developments and have willingly helped in others. However, most have given up angiography and therefore do not possess the manipulative skills now associated with intervcntional radiology. When they apply these new forms of intcrvention, most vascular surgeons have to concern thcmselves with proper case selection, with the management of complications, and with monitoring the results of these "low-risk" options, to assess their relative value and assure their propcr placc in our therapeutic armamentarium. After some initial difficulties, good cooperative relationships havc developed among many vascular surgeons and intervcntional radiologists, particularly in the major medical centers. Admission of candidates for thesc procedures to thc vascular surgery servicc has assured proper cvaluation of thc patient and sclection of trcarment before intervention, prompt managemcnt of complications, and the oppommiry for joint assessment of the results. Reprint requests: Robert B. Rutherford, MD, University of Colorado Health Sciences Center, Vascular Surgery Section, 4200 E. Ninth Ave., Box C312, Denver, CO 80262. 208
However, recently this tranquil, almost symbiotic scene has been disrupted by the entry onto the interventionist's stage of an increasing number of cardiologists, generally those who until now have primarily concerned themselves with the diagnosis and management of coronary occlusive disease and, to that end, the use of balloon angioplasty and intraarterial thrombolytic therapy. The stimulus for their sudden interest inperipherM arterial occlusive disease' is not entirely clear: are too many cardiologists being trained in this area, or is there a misperception that peripheral arterial lesions are basically the same as coronary lesions but easier to treat by these same approaches (and thus also ideal for practice or training purposes)? The fact that most of this activity is being seen in the "private sector" suggests that purely economic motives might be responsible. Full-page advertisements in newspapers and' magazines serve orily to reinforce this impression. Because cardiologists regularly see patients with cardiac disease and associated peripheral atherosclerotic occlusive lesions, have full admitting privileges, have some interventional skills, and are able to turn to the cardiovascular surgeons they usually work with for vascular consultation and the management of procedure complications, there seem to be few impediments to their pursuing this new undertaking. In the not too distant past many interventional radiologists have themselves been considered overly aggressive in promulgating interventional therapy. Now they find themselves in the unfamiliar role of moderates, decrying the unselective application of these techniques by those with limited skills and experience in the diagnosis and treatment of peripheral vascular disease. They have appealed to vascular surgeons to join them in this stand. In the absence of any other official or effective organized opposition, a certain degree of panic has developed in many U.S. communities. "If you can't stop them, beat them at their own game," seems to express the sentiment of a significant number of interventional radiologists and vascular surgeons, and in pursuing this approach they are often aided and abetted by equally aggressive hospital boards. EveryT.~ where one sees the scramble to acquire laser probes
Volume 10 Number 2 August 1989
and other interventional devices without heed to published reports of their dubious merits, just to be able to claim, "We've got the latest technology (even if we're not sure if or how it works)." Certainly this unbridled "entrepreneurism" is to be decried in the strongest terms, but this alone will not stem the tide. What should be done? Obviously, wherever possible it would be better to be constructive than obstructive. Blanket criticisms of the above practices are likely to be labeled simply as self-serving attempts to defend one's turf and eliminate Competition. Nevertheless, certain practices can be identified as clearly not in the best interests of patients, and others can be called unethical, if not illegal. One need not be a student of casuistry~ to appreciate this. Appropriate principles and practices not only should be defended but also actively promulgated. Finally, vascular surg e o n s need to identify an appropriate role for themselves in this field and to actively pursue it. To start with, we should support the principle that these procedures, like any vascular operation,
should be very selectively applied and be peoeormed only by thosewith appropriate training and adequate personal experience in interventional techniques, in other words, not simply by anyone belonging to a particular generic specialty. To insist simply that vascular surgeons are the only ones qualified to decide which patients should be treated by which method, or to decide that interventional radiologists are the only ones skilled enough to perform such procedures, will be viewed only as self-serving. "Appropriate" training and "adequate" experience will need reasonable definition, but clearly, attending a 3-day course, certificate or no certificate, should not be misconstrued as qualifying anyone to proceed with the clinical ap,lication of these devices. Furthermore it would seem appropriate that before such interventions, particularly those in which the merits of the procedure are clearly still unproven or open to question, approving vascular consultation should be required. If the physician who is to perform the procedure is a vascular surgeon, then an independent and concurring second opinion should be obtained. It is obviously important that each institution's credentialing committee establish just who is competent to render a "vascular consult" in these circumstances. Clearly, those who qualify for vascular surgical privileges would be qualified to render an opinion here and of course, by approving the procedure, would also commit themselves to help in managing any complications that might arise. Since no other specialty has recognized formal and corn*The study of ethics as related to conscience.
Endovascularsurgery:Thenew challenge 209
prehensive training in the diagnosis and treatment of vascular diseases, other "vascular specialists" would have to be considered on the basis of documented individual merit. However, as an additional requirement, if the "vascular" consultant is not a vascular surgeon, the collaboration of one who is willing to care for any complications that arise should also be obtained in advance. In further recognition of the fact that most of these procedures still represent developing technologies of unproven merit, their clinical application should be carried out under institutionally approved protocols with specifically approved indications, informed consent, concurring vascular consultation, and careful documentation of complications, and the degree of initial and long-term benefit should be obtained. Of all the devices and procedures mentioned, the laser "probe" has been the most widely and inappropriately used. As a result of aggressive marketing and advertising by the companies selling these devices and some of the physicians using them, the public has been led to believe that the laser probe is the ultimate in technology and, by inference, they believe those institutions or physicians possessing these devices are where they should go for care. They are unaware that currently the laser probe is not likely to be helpful to them or, at best, that it would simply be used as a means of allowing balloon angioplasty to be performed or even that, having sought care at such an institution, they may become the victim of "bait and switch" tactics and ultimately end up with a bypass. Ideally, peer pressure and patient education will ultimately curb these inappropriate and unethical practices. In the meantime, responsible vascular surgeons should focus more on how they can better manage these cases than on how badly others are behaving. Vascular surgeons need to become involved in this field in a positive way. Young vascular surgeons should be encouraged to become involved in endovascular surgery; fellowships should stress this type of experience and our societies should support such interests with research funds. Many vascular surgeons are understandably discouraged from working in this area because of their lack of "angiographic" skills. For many the loss of these skills is history; for future vascular surgeons to reacquire these skills is problematic. First, it would have to be determined that this is both a realistic and desirable goal. This would require a much heavier commitment of time and effort to diagnostic procedures than many vascular surgeons are wilting to give. Furthermore, without unexpected cooperation from cardiologists, it would be very difficult for young vas-
210 Rutherford
cular surgeons to obtain extensive training in angiography and interventional techniques. However, vascular surgeons can and should pursue and develop any accessible skills that can help them improve the treatment of their patients with vascular occlusive diseases. In this regard, there are two skills that immediately come to mind as worthy of consideration. One is the better use of intraoperative angiography, and the other is the perfection and application of angioscopy. Although many of us are masters of the "one shot" angiogram, few take full advantage of new image-enhancing video techniques and the use of the C-arm to monitor the technical adequacy of intraoperative maneuvers. This, combined with a better (steerable, high-resolution) angioscope, with better perfusion techniques to clear the field, would legitimately allow the vascular surgeon to play a valuable role in this field and perhaps even be in the best position to lead in the development and application of these new interventional devices. A controlled, carefully positioned arteriotomy, performed under proper sterile technique and local or regional anesthesia, is often preferable, in the author's view, to blindly inserting a series of ever larger caliber catheters and devices into an artery through a nick in the skin. The same could be said for venous
Journal of VASCULAR SURGERY
access, judging by the hematomas and local venous thromboses associated with the percutaneous placement of caval filters, dialysis catheters, and the like. The percutaneous approach can be, and has been, carried too far for the sole sake of "avoiding an operation." By use of carefully controlled arteriotomies or venotomies, hematoma, embolism, thrombosis, late strictures, andarteriovenous fistulas could all be greatly reduced. The immediate results of the intervention could be visualized either by angiography or angioscopy or both. This approach not only would allow more controlled application of these techniques but would also better allow combinations of techniques to be used synchronously until an appropriate end point is reached. This will require better diagnostic equipment in operating rooms or better operating facilities in angiography suites. Only the insurance companies' demand for a single physician f¢~" per procedure and our unwillingness to cooperate prevent future ventures in this field from following this direction and becoming much more cooperative ventures between vascular surgeons and interventional radiologists. It would seem that the recent activity of cardiologists has provided a timely impetus for this to be given serious consideration.
Endovascular surgery: The new challenge Robert B. Rutherford, MD, Denver, Colo.
American vascular surgeons have finally gained formal recognition as specialists, and with welldefined training requirements embodied in approved fellowships, qualifying board examinations, a flourishing journal, and more appropriate representation on the governing bodies of Surgery, there is much cause for satisfaction. However, during the years of struggle over the emergence of their specialty, vascular surgeons have also wimessed the introduction of a whole host of intervention devices and therapies such as percutaneous transluminal balloon angioplasty (PTA), intravascular thrombolytic infusions, therapeutic embolization, several atherectomy devices, laser "probes," percutaneous insertion of caval filters, percutaneous thrombectomy, and intravascular stents - - all likely to be used by other specialists. This trend threatens to erode the vascular surgeon's rather exclusive position as the primary specialist in the diagnosis and management of peripheral vascular diseases.
Vascular surgeons havc been instrumental in many of these developments and have willingly helped in others. However, most have given up angiography and therefore do not possess the manipulative skills now associated with intervcntional radiology. When they apply these new forms of intcrvention, most vascular surgeons have to concern thcmselves with proper case selection, with the management of complications, and with monitoring the results of these "low-risk" options, to assess their relative value and assure their propcr placc in our therapeutic armamentarium. After some initial difficulties, good cooperative relationships havc developed among many vascular surgeons and intervcntional radiologists, particularly in the major medical centers. Admission of candidates for thesc procedures to thc vascular surgery servicc has assured proper cvaluation of thc patient and sclection of trcarment before intervention, prompt managemcnt of complications, and the oppommiry for joint assessment of the results. Reprint requests: Robert B. Rutherford, MD, University of Colorado Health Sciences Center, Vascular Surgery Section, 4200 E. Ninth Ave., Box C312, Denver, CO 80262. 208
However, recently this tranquil, almost symbiotic scene has been disrupted by the entry onto the interventionist's stage of an increasing number of cardiologists, generally those who until now have primarily concerned themselves with the diagnosis and management of coronary occlusive disease and, to that end, the use of balloon angioplasty and intraarterial thrombolytic therapy. The stimulus for their sudden interest inperipherM arterial occlusive disease' is not entirely clear: are too many cardiologists being trained in this area, or is there a misperception that peripheral arterial lesions are basically the same as coronary lesions but easier to treat by these same approaches (and thus also ideal for practice or training purposes)? The fact that most of this activity is being seen in the "private sector" suggests that purely economic motives might be responsible. Full-page advertisements in newspapers and' magazines serve orily to reinforce this impression. Because cardiologists regularly see patients with cardiac disease and associated peripheral atherosclerotic occlusive lesions, have full admitting privileges, have some interventional skills, and are able to turn to the cardiovascular surgeons they usually work with for vascular consultation and the management of procedure complications, there seem to be few impediments to their pursuing this new undertaking. In the not too distant past many interventional radiologists have themselves been considered overly aggressive in promulgating interventional therapy. Now they find themselves in the unfamiliar role of moderates, decrying the unselective application of these techniques by those with limited skills and experience in the diagnosis and treatment of peripheral vascular disease. They have appealed to vascular surgeons to join them in this stand. In the absence of any other official or effective organized opposition, a certain degree of panic has developed in many U.S. communities. "If you can't stop them, beat them at their own game," seems to express the sentiment of a significant number of interventional radiologists and vascular surgeons, and in pursuing this approach they are often aided and abetted by equally aggressive hospital boards. EveryT.~ where one sees the scramble to acquire laser probes
Volume 10 Number 2 August 1989
and other interventional devices without heed to published reports of their dubious merits, just to be able to claim, "We've got the latest technology (even if we're not sure if or how it works)." Certainly this unbridled "entrepreneurism" is to be decried in the strongest terms, but this alone will not stem the tide. What should be done? Obviously, wherever possible it would be better to be constructive than obstructive. Blanket criticisms of the above practices are likely to be labeled simply as self-serving attempts to defend one's turf and eliminate Competition. Nevertheless, certain practices can be identified as clearly not in the best interests of patients, and others can be called unethical, if not illegal. One need not be a student of casuistry~ to appreciate this. Appropriate principles and practices not only should be defended but also actively promulgated. Finally, vascular surg e o n s need to identify an appropriate role for themselves in this field and to actively pursue it. To start with, we should support the principle that these procedures, like any vascular operation,
should be very selectively applied and be peoeormed only by thosewith appropriate training and adequate personal experience in interventional techniques, in other words, not simply by anyone belonging to a particular generic specialty. To insist simply that vascular surgeons are the only ones qualified to decide which patients should be treated by which method, or to decide that interventional radiologists are the only ones skilled enough to perform such procedures, will be viewed only as self-serving. "Appropriate" training and "adequate" experience will need reasonable definition, but clearly, attending a 3-day course, certificate or no certificate, should not be misconstrued as qualifying anyone to proceed with the clinical ap,lication of these devices. Furthermore it would seem appropriate that before such interventions, particularly those in which the merits of the procedure are clearly still unproven or open to question, approving vascular consultation should be required. If the physician who is to perform the procedure is a vascular surgeon, then an independent and concurring second opinion should be obtained. It is obviously important that each institution's credentialing committee establish just who is competent to render a "vascular consult" in these circumstances. Clearly, those who qualify for vascular surgical privileges would be qualified to render an opinion here and of course, by approving the procedure, would also commit themselves to help in managing any complications that might arise. Since no other specialty has recognized formal and corn*The study of ethics as related to conscience.
Endovascularsurgery:Thenew challenge 209
prehensive training in the diagnosis and treatment of vascular diseases, other "vascular specialists" would have to be considered on the basis of documented individual merit. However, as an additional requirement, if the "vascular" consultant is not a vascular surgeon, the collaboration of one who is willing to care for any complications that arise should also be obtained in advance. In further recognition of the fact that most of these procedures still represent developing technologies of unproven merit, their clinical application should be carried out under institutionally approved protocols with specifically approved indications, informed consent, concurring vascular consultation, and careful documentation of complications, and the degree of initial and long-term benefit should be obtained. Of all the devices and procedures mentioned, the laser "probe" has been the most widely and inappropriately used. As a result of aggressive marketing and advertising by the companies selling these devices and some of the physicians using them, the public has been led to believe that the laser probe is the ultimate in technology and, by inference, they believe those institutions or physicians possessing these devices are where they should go for care. They are unaware that currently the laser probe is not likely to be helpful to them or, at best, that it would simply be used as a means of allowing balloon angioplasty to be performed or even that, having sought care at such an institution, they may become the victim of "bait and switch" tactics and ultimately end up with a bypass. Ideally, peer pressure and patient education will ultimately curb these inappropriate and unethical practices. In the meantime, responsible vascular surgeons should focus more on how they can better manage these cases than on how badly others are behaving. Vascular surgeons need to become involved in this field in a positive way. Young vascular surgeons should be encouraged to become involved in endovascular surgery; fellowships should stress this type of experience and our societies should support such interests with research funds. Many vascular surgeons are understandably discouraged from working in this area because of their lack of "angiographic" skills. For many the loss of these skills is history; for future vascular surgeons to reacquire these skills is problematic. First, it would have to be determined that this is both a realistic and desirable goal. This would require a much heavier commitment of time and effort to diagnostic procedures than many vascular surgeons are wilting to give. Furthermore, without unexpected cooperation from cardiologists, it would be very difficult for young vas-
210 Rutherford
cular surgeons to obtain extensive training in angiography and interventional techniques. However, vascular surgeons can and should pursue and develop any accessible skills that can help them improve the treatment of their patients with vascular occlusive diseases. In this regard, there are two skills that immediately come to mind as worthy of consideration. One is the better use of intraoperative angiography, and the other is the perfection and application of angioscopy. Although many of us are masters of the "one shot" angiogram, few take full advantage of new image-enhancing video techniques and the use of the C-arm to monitor the technical adequacy of intraoperative maneuvers. This, combined with a better (steerable, high-resolution) angioscope, with better perfusion techniques to clear the field, would legitimately allow the vascular surgeon to play a valuable role in this field and perhaps even be in the best position to lead in the development and application of these new interventional devices. A controlled, carefully positioned arteriotomy, performed under proper sterile technique and local or regional anesthesia, is often preferable, in the author's view, to blindly inserting a series of ever larger caliber catheters and devices into an artery through a nick in the skin. The same could be said for venous
Journal of VASCULAR SURGERY
access, judging by the hematomas and local venous thromboses associated with the percutaneous placement of caval filters, dialysis catheters, and the like. The percutaneous approach can be, and has been, carried too far for the sole sake of "avoiding an operation." By use of carefully controlled arteriotomies or venotomies, hematoma, embolism, thrombosis, late strictures, andarteriovenous fistulas could all be greatly reduced. The immediate results of the intervention could be visualized either by angiography or angioscopy or both. This approach not only would allow more controlled application of these techniques but would also better allow combinations of techniques to be used synchronously until an appropriate end point is reached. This will require better diagnostic equipment in operating rooms or better operating facilities in angiography suites. Only the insurance companies' demand for a single physician f¢~" per procedure and our unwillingness to cooperate prevent future ventures in this field from following this direction and becoming much more cooperative ventures between vascular surgeons and interventional radiologists. It would seem that the recent activity of cardiologists has provided a timely impetus for this to be given serious consideration.