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YES: New tech promotes treatment where none is needed.
BY SAMUEL P. MARTIN, MD
As science and technology continue to advance, we have the ability to treat more and more conditions with less invasive, better-tolerated procedures. In the realm of vascular disease, this has been evidenced by a variable explosion in the endovascular treatment of arterial disease. With new technology, we have witnessed a tremendous relaxation of former standards in the pursuit of “quality of life.” Our new hammer is ever searching for a nail, resulting in the treatment of “anatomical” disease, such as seen in endovascular stenting of renal artery stenosis.
Nowhere is this trend becoming more evident than in the treatment of May-Thurner anatomy.
Despite years of awareness, there is neither an accepted radiologic definition for May-Thurner syndrome, nor established diagnostic criteria. Fortunately, our ability to image has improved from biplanar venography, formerly the gold standard.
Because May-Thurner is a permanent process, the luminal diameter of the iliac vein should not change with patient positioning. Now, with the recent development of blood pool imaging using contrast agents such as gadofosveset trisodium, magnetic resonance venography (MRV) studies can be performed in supine and prone position on a single dose of contrast. This would seem to obviate the former limitations of biplanar venography or contrast CT or traditional MRV, and would appear to provide an objective means of evaluating May-Thurner anatomy. However, upon evaluation of patients with lower-limb venous disorders, a prevalence of left common iliac vein compression was found in 14%-32% of patients, but a prevalence of May-Thurner syndrome in only 2%-5%, leading to the conclusion that left common iliac vein compression is necessary but not sufficient to cause the syndrome.
Thus, the point to be made: May-Thurner anatomy does not equal May-Thurner syndrome (Diagn Interv Radiol. 2013 Jan-Feb;19[1]:44-8).
Sadly, at the present time, there are no clear-cut guidelines.
With the advent of intravascular ultrasound (IVUS), we are seeing a large number of patients with the suspect anatomy undergoing treatment with balloon angioplasty and stents in the iliac system before adequate treatment of chronic venous insufficiency (CVI) in the extremities. What are the consequences? We have no data on primary or secondary patency of these stents (usually Wallstents). How often is anticoagulation necessary, and, is this permanent? I hate to suggest an industry or monetary motivation, but we are even seeing advertising for stent treatment of May-Thurner syndrome for people who have had treatment of their CVI (often with little or no swelling and minimal pain) with angioplasty and stenting. We also have seen patients who have undergone the procedure and had to have secondary procedures and long-term anticoagulation. Worse, they never had the procedure adequately explained, including potential complications or the possibility of future problems, procedures, or permanent anticoagulation.
So, as we face a situation – May-Thurner anatomy – which exists in more than 20% of our population, it raises several questions that need to be answered as we marshal our ever-increasing health care expenditures. Can we clearly define indications for further investigation and possible intervention, realizing that the syndrome of increased pain, swelling, and risk of thrombosis only exists in 2%-3% of those with the anatomy?
As McDermott and associates have shown in gated MRV studies, conditions such as hydration and especially position can significantly affect anatomical findings. My feelings based on 30-plus years of experience is that treatment of the leg should take precedence, and only after this avenue has been exhausted should one progress to suprainguinal investigation unless there is swelling of the entire leg. What are the long-term consequences of a Wallstent in the venous system, and are we “correcting” one risk by supplanting it with another – the long-term risk of stent thrombosis and subsequent interventions with long-term anticoagulation? There have been no reported cases of pulmonary emboli with May-Thurner and it is thought that the “spur” (synechiae) have some protective properties. In contrast, a stent is a definite theoretical risk for thrombosis, and even embolization.
Dr. Samuel P. Martin is a vascular surgeon in Orlando.
NO: Or rather, ‘maybe,’ by unethical practitioners.
BY ENRICO ASCHER, MD
Significant ipsilateral iliac vein stenosis or occlusion may have continued untoward effects in symptomatic patients particularly those with advanced venous stasis changes including venous ulcerations, skin discoloration, edema and/or pain (CEAP class 3-6). Conversely, successful iliac vein stenting (IVS) has been shown to normalize venous outflow, enhance calf vein muscle pump function, improve venous claudication, decrease pain, ameliorate edema, and accelerate wound healing.
Additionally, IVS can be safely performed in an ambulatory/office setting under local anesthesia with minimal or no sedation. The technical success can exceed 95% and long-term patency rates are excellent. Indeed, IVS is much cheaper and more durable than arterial stenting for claudication.
These advantages cannot and should not be used as an alternative to conservative therapy that includes mild exercise, regular use of appropriately measured elastic stockings, and intermittent leg elevation whenever feasible. Moreover, venous ulcers should be treated with compressive bandages placed by well-trained providers. If all else fails then one should consider the minimally invasive procedures available to treat this debilitating, progressive disease. Unfortunately, the conservative approach fails in a substantial number of patients
It is possible that Dr. Martin is correct regarding advertisements for IVS in the presence of minimal symptoms. There is little one can do about this misleading information.
However, the physician who knowingly implants these stents in patients with no potential benefits or in those who did not have the risks, benefits, and alternatives explained should not be allowed to continue this practice. No longer can one remain silent when confronted with such horrendous unprofessional behavior.
Maybe the SVS should create a hotline that can be utilized by anonymous complainers in an attempt to identify potential abusers who fraudulently have the capacity to expose their patients to potential harm. A letter from the SVS will then be sent to the “guilty” party as an alert. Of course such a suggestion needs to be vetted by expert lawyers prior to implementation. It is only a suggestion. Others should come up with more suggestions to stop or minimize these unlawful practices.
I, too, have heard gossip and more gossip about this or that practitioner performing unnecessary procedures. These have included arterial and venous interventions. They were infrainguinal, suprainguinal or both. Some were stents, some were vein ablations. Is an unnecessary IVS worse than an unnecessary great saphenous vein ablation? What if the patient is a candidate for multiple coronary bypasses and has only one good great saphenous vein? What if the patient needs a limb salvage vein bypass operation as the only solution to maintain limb viability? If someone puts a gun to my head and ask me to choose between two unnecessary procedures I may well opt for the IVS. I am a member of the Save the GSV club founded by Dr. Samson. One can argue that the ablated vein is gone forever; the stent may be salvaged if it occludes. All unnecessary procedures are just unnecessary.
I believe that Dr. Martin makes a point to exhaust all infrainguinal options prior to IVS. In fact, he does not advocate IVS at all in any circumstance. I respect his 3 decades of clinical experience coupled to the fact that iliac vein narrowing is a fairly common finding in the general population. Nevertheless, the literature is getting filled up with large and small series of patients highlighting the importance of IVS as an important tool in our armamentarium against this chronic, debilitating disease that affects an important segment of the working population in this country and abroad. Although a small, prospective, randomized study from Brazil published in the Journal of Vascular Surgery conclusively showed the value of IVS in patients with advanced venous stasis (J Vasc Surg Venous Lymphat Disord. 2015;3:117-8), a larger one involving multiple centers will provide many needed answers.
Dr. Ascher is chief of vascular and endovascular surgery, NYU Lutheran Medical Center.
YES: New tech promotes treatment where none is needed.
BY SAMUEL P. MARTIN, MD
As science and technology continue to advance, we have the ability to treat more and more conditions with less invasive, better-tolerated procedures. In the realm of vascular disease, this has been evidenced by a variable explosion in the endovascular treatment of arterial disease. With new technology, we have witnessed a tremendous relaxation of former standards in the pursuit of “quality of life.” Our new hammer is ever searching for a nail, resulting in the treatment of “anatomical” disease, such as seen in endovascular stenting of renal artery stenosis.
Nowhere is this trend becoming more evident than in the treatment of May-Thurner anatomy.
Despite years of awareness, there is neither an accepted radiologic definition for May-Thurner syndrome, nor established diagnostic criteria. Fortunately, our ability to image has improved from biplanar venography, formerly the gold standard.
Because May-Thurner is a permanent process, the luminal diameter of the iliac vein should not change with patient positioning. Now, with the recent development of blood pool imaging using contrast agents such as gadofosveset trisodium, magnetic resonance venography (MRV) studies can be performed in supine and prone position on a single dose of contrast. This would seem to obviate the former limitations of biplanar venography or contrast CT or traditional MRV, and would appear to provide an objective means of evaluating May-Thurner anatomy. However, upon evaluation of patients with lower-limb venous disorders, a prevalence of left common iliac vein compression was found in 14%-32% of patients, but a prevalence of May-Thurner syndrome in only 2%-5%, leading to the conclusion that left common iliac vein compression is necessary but not sufficient to cause the syndrome.
Thus, the point to be made: May-Thurner anatomy does not equal May-Thurner syndrome (Diagn Interv Radiol. 2013 Jan-Feb;19[1]:44-8).
Sadly, at the present time, there are no clear-cut guidelines.
With the advent of intravascular ultrasound (IVUS), we are seeing a large number of patients with the suspect anatomy undergoing treatment with balloon angioplasty and stents in the iliac system before adequate treatment of chronic venous insufficiency (CVI) in the extremities. What are the consequences? We have no data on primary or secondary patency of these stents (usually Wallstents). How often is anticoagulation necessary, and, is this permanent? I hate to suggest an industry or monetary motivation, but we are even seeing advertising for stent treatment of May-Thurner syndrome for people who have had treatment of their CVI (often with little or no swelling and minimal pain) with angioplasty and stenting. We also have seen patients who have undergone the procedure and had to have secondary procedures and long-term anticoagulation. Worse, they never had the procedure adequately explained, including potential complications or the possibility of future problems, procedures, or permanent anticoagulation.
So, as we face a situation – May-Thurner anatomy – which exists in more than 20% of our population, it raises several questions that need to be answered as we marshal our ever-increasing health care expenditures. Can we clearly define indications for further investigation and possible intervention, realizing that the syndrome of increased pain, swelling, and risk of thrombosis only exists in 2%-3% of those with the anatomy?
As McDermott and associates have shown in gated MRV studies, conditions such as hydration and especially position can significantly affect anatomical findings. My feelings based on 30-plus years of experience is that treatment of the leg should take precedence, and only after this avenue has been exhausted should one progress to suprainguinal investigation unless there is swelling of the entire leg. What are the long-term consequences of a Wallstent in the venous system, and are we “correcting” one risk by supplanting it with another – the long-term risk of stent thrombosis and subsequent interventions with long-term anticoagulation? There have been no reported cases of pulmonary emboli with May-Thurner and it is thought that the “spur” (synechiae) have some protective properties. In contrast, a stent is a definite theoretical risk for thrombosis, and even embolization.
Dr. Samuel P. Martin is a vascular surgeon in Orlando.
NO: Or rather, ‘maybe,’ by unethical practitioners.
BY ENRICO ASCHER, MD
Significant ipsilateral iliac vein stenosis or occlusion may have continued untoward effects in symptomatic patients particularly those with advanced venous stasis changes including venous ulcerations, skin discoloration, edema and/or pain (CEAP class 3-6). Conversely, successful iliac vein stenting (IVS) has been shown to normalize venous outflow, enhance calf vein muscle pump function, improve venous claudication, decrease pain, ameliorate edema, and accelerate wound healing.
Additionally, IVS can be safely performed in an ambulatory/office setting under local anesthesia with minimal or no sedation. The technical success can exceed 95% and long-term patency rates are excellent. Indeed, IVS is much cheaper and more durable than arterial stenting for claudication.
These advantages cannot and should not be used as an alternative to conservative therapy that includes mild exercise, regular use of appropriately measured elastic stockings, and intermittent leg elevation whenever feasible. Moreover, venous ulcers should be treated with compressive bandages placed by well-trained providers. If all else fails then one should consider the minimally invasive procedures available to treat this debilitating, progressive disease. Unfortunately, the conservative approach fails in a substantial number of patients
It is possible that Dr. Martin is correct regarding advertisements for IVS in the presence of minimal symptoms. There is little one can do about this misleading information.
However, the physician who knowingly implants these stents in patients with no potential benefits or in those who did not have the risks, benefits, and alternatives explained should not be allowed to continue this practice. No longer can one remain silent when confronted with such horrendous unprofessional behavior.
Maybe the SVS should create a hotline that can be utilized by anonymous complainers in an attempt to identify potential abusers who fraudulently have the capacity to expose their patients to potential harm. A letter from the SVS will then be sent to the “guilty” party as an alert. Of course such a suggestion needs to be vetted by expert lawyers prior to implementation. It is only a suggestion. Others should come up with more suggestions to stop or minimize these unlawful practices.
I, too, have heard gossip and more gossip about this or that practitioner performing unnecessary procedures. These have included arterial and venous interventions. They were infrainguinal, suprainguinal or both. Some were stents, some were vein ablations. Is an unnecessary IVS worse than an unnecessary great saphenous vein ablation? What if the patient is a candidate for multiple coronary bypasses and has only one good great saphenous vein? What if the patient needs a limb salvage vein bypass operation as the only solution to maintain limb viability? If someone puts a gun to my head and ask me to choose between two unnecessary procedures I may well opt for the IVS. I am a member of the Save the GSV club founded by Dr. Samson. One can argue that the ablated vein is gone forever; the stent may be salvaged if it occludes. All unnecessary procedures are just unnecessary.
I believe that Dr. Martin makes a point to exhaust all infrainguinal options prior to IVS. In fact, he does not advocate IVS at all in any circumstance. I respect his 3 decades of clinical experience coupled to the fact that iliac vein narrowing is a fairly common finding in the general population. Nevertheless, the literature is getting filled up with large and small series of patients highlighting the importance of IVS as an important tool in our armamentarium against this chronic, debilitating disease that affects an important segment of the working population in this country and abroad. Although a small, prospective, randomized study from Brazil published in the Journal of Vascular Surgery conclusively showed the value of IVS in patients with advanced venous stasis (J Vasc Surg Venous Lymphat Disord. 2015;3:117-8), a larger one involving multiple centers will provide many needed answers.
Dr. Ascher is chief of vascular and endovascular surgery, NYU Lutheran Medical Center.
YES: New tech promotes treatment where none is needed.
BY SAMUEL P. MARTIN, MD
As science and technology continue to advance, we have the ability to treat more and more conditions with less invasive, better-tolerated procedures. In the realm of vascular disease, this has been evidenced by a variable explosion in the endovascular treatment of arterial disease. With new technology, we have witnessed a tremendous relaxation of former standards in the pursuit of “quality of life.” Our new hammer is ever searching for a nail, resulting in the treatment of “anatomical” disease, such as seen in endovascular stenting of renal artery stenosis.
Nowhere is this trend becoming more evident than in the treatment of May-Thurner anatomy.
Despite years of awareness, there is neither an accepted radiologic definition for May-Thurner syndrome, nor established diagnostic criteria. Fortunately, our ability to image has improved from biplanar venography, formerly the gold standard.
Because May-Thurner is a permanent process, the luminal diameter of the iliac vein should not change with patient positioning. Now, with the recent development of blood pool imaging using contrast agents such as gadofosveset trisodium, magnetic resonance venography (MRV) studies can be performed in supine and prone position on a single dose of contrast. This would seem to obviate the former limitations of biplanar venography or contrast CT or traditional MRV, and would appear to provide an objective means of evaluating May-Thurner anatomy. However, upon evaluation of patients with lower-limb venous disorders, a prevalence of left common iliac vein compression was found in 14%-32% of patients, but a prevalence of May-Thurner syndrome in only 2%-5%, leading to the conclusion that left common iliac vein compression is necessary but not sufficient to cause the syndrome.
Thus, the point to be made: May-Thurner anatomy does not equal May-Thurner syndrome (Diagn Interv Radiol. 2013 Jan-Feb;19[1]:44-8).
Sadly, at the present time, there are no clear-cut guidelines.
With the advent of intravascular ultrasound (IVUS), we are seeing a large number of patients with the suspect anatomy undergoing treatment with balloon angioplasty and stents in the iliac system before adequate treatment of chronic venous insufficiency (CVI) in the extremities. What are the consequences? We have no data on primary or secondary patency of these stents (usually Wallstents). How often is anticoagulation necessary, and, is this permanent? I hate to suggest an industry or monetary motivation, but we are even seeing advertising for stent treatment of May-Thurner syndrome for people who have had treatment of their CVI (often with little or no swelling and minimal pain) with angioplasty and stenting. We also have seen patients who have undergone the procedure and had to have secondary procedures and long-term anticoagulation. Worse, they never had the procedure adequately explained, including potential complications or the possibility of future problems, procedures, or permanent anticoagulation.
So, as we face a situation – May-Thurner anatomy – which exists in more than 20% of our population, it raises several questions that need to be answered as we marshal our ever-increasing health care expenditures. Can we clearly define indications for further investigation and possible intervention, realizing that the syndrome of increased pain, swelling, and risk of thrombosis only exists in 2%-3% of those with the anatomy?
As McDermott and associates have shown in gated MRV studies, conditions such as hydration and especially position can significantly affect anatomical findings. My feelings based on 30-plus years of experience is that treatment of the leg should take precedence, and only after this avenue has been exhausted should one progress to suprainguinal investigation unless there is swelling of the entire leg. What are the long-term consequences of a Wallstent in the venous system, and are we “correcting” one risk by supplanting it with another – the long-term risk of stent thrombosis and subsequent interventions with long-term anticoagulation? There have been no reported cases of pulmonary emboli with May-Thurner and it is thought that the “spur” (synechiae) have some protective properties. In contrast, a stent is a definite theoretical risk for thrombosis, and even embolization.
Dr. Samuel P. Martin is a vascular surgeon in Orlando.
NO: Or rather, ‘maybe,’ by unethical practitioners.
BY ENRICO ASCHER, MD
Significant ipsilateral iliac vein stenosis or occlusion may have continued untoward effects in symptomatic patients particularly those with advanced venous stasis changes including venous ulcerations, skin discoloration, edema and/or pain (CEAP class 3-6). Conversely, successful iliac vein stenting (IVS) has been shown to normalize venous outflow, enhance calf vein muscle pump function, improve venous claudication, decrease pain, ameliorate edema, and accelerate wound healing.
Additionally, IVS can be safely performed in an ambulatory/office setting under local anesthesia with minimal or no sedation. The technical success can exceed 95% and long-term patency rates are excellent. Indeed, IVS is much cheaper and more durable than arterial stenting for claudication.
These advantages cannot and should not be used as an alternative to conservative therapy that includes mild exercise, regular use of appropriately measured elastic stockings, and intermittent leg elevation whenever feasible. Moreover, venous ulcers should be treated with compressive bandages placed by well-trained providers. If all else fails then one should consider the minimally invasive procedures available to treat this debilitating, progressive disease. Unfortunately, the conservative approach fails in a substantial number of patients
It is possible that Dr. Martin is correct regarding advertisements for IVS in the presence of minimal symptoms. There is little one can do about this misleading information.
However, the physician who knowingly implants these stents in patients with no potential benefits or in those who did not have the risks, benefits, and alternatives explained should not be allowed to continue this practice. No longer can one remain silent when confronted with such horrendous unprofessional behavior.
Maybe the SVS should create a hotline that can be utilized by anonymous complainers in an attempt to identify potential abusers who fraudulently have the capacity to expose their patients to potential harm. A letter from the SVS will then be sent to the “guilty” party as an alert. Of course such a suggestion needs to be vetted by expert lawyers prior to implementation. It is only a suggestion. Others should come up with more suggestions to stop or minimize these unlawful practices.
I, too, have heard gossip and more gossip about this or that practitioner performing unnecessary procedures. These have included arterial and venous interventions. They were infrainguinal, suprainguinal or both. Some were stents, some were vein ablations. Is an unnecessary IVS worse than an unnecessary great saphenous vein ablation? What if the patient is a candidate for multiple coronary bypasses and has only one good great saphenous vein? What if the patient needs a limb salvage vein bypass operation as the only solution to maintain limb viability? If someone puts a gun to my head and ask me to choose between two unnecessary procedures I may well opt for the IVS. I am a member of the Save the GSV club founded by Dr. Samson. One can argue that the ablated vein is gone forever; the stent may be salvaged if it occludes. All unnecessary procedures are just unnecessary.
I believe that Dr. Martin makes a point to exhaust all infrainguinal options prior to IVS. In fact, he does not advocate IVS at all in any circumstance. I respect his 3 decades of clinical experience coupled to the fact that iliac vein narrowing is a fairly common finding in the general population. Nevertheless, the literature is getting filled up with large and small series of patients highlighting the importance of IVS as an important tool in our armamentarium against this chronic, debilitating disease that affects an important segment of the working population in this country and abroad. Although a small, prospective, randomized study from Brazil published in the Journal of Vascular Surgery conclusively showed the value of IVS in patients with advanced venous stasis (J Vasc Surg Venous Lymphat Disord. 2015;3:117-8), a larger one involving multiple centers will provide many needed answers.
Dr. Ascher is chief of vascular and endovascular surgery, NYU Lutheran Medical Center.
