2014 Vascular Annual Meeting

Percutaneous treatment of renal artery occlusive disease is unnecessary and should be abandoned, except in pediatric cases.

BY GEORGE HAMILTON, M.D.

This position is supported by findings from both the ASTRAL trial (N. Engl. J. Med. 2009;361:1953-62) and the CORAL trial (N. Engl. J. Med. 2013 Nov. 18 [doi:10.1056/NEJMoa1310753]).

The ASTRAL trial, a prospective, randomized comparison of best medical therapy with and without stent angioplasty in more than 800 patients, was the largest trial to date when it began back in the 1990s. The well-known results showed no difference in time to first renal event, first vascular and cardiovascular events, and overall survival. Furthermore, there was no difference in these outcomes among patients with greater than 90% stenosis, with the exception of a possible difference in mortality, which trended toward improvement among those with high-grade stenosis.

We concluded that revascularization in the vast majority of patients is unlikely to improve hypertension control or renal function, and that renal artery stenosis is not pathophysiologically important. We also concluded that there is no point in screening for asymptomatic disease; this was back when every patient was getting screened, and treated primarily on the basis of finding a renal arterial stenosis.

Finally, we concluded that properly applied best medical therapy alone was an extremely good treatment.

Several flaws in the trial garnered extensive criticism, however, and the more rigidly designed CORAL trial was expected to address them. The findings confirmed those of the ASTRAL trial. In more than 900 patients from 88 centers, there was absolutely no benefit of intervention with respect to primary and secondary outcomes, including among those with high-grade stenosis.

We can now see on the basis of extensive level 1 evidence that when added to comprehensive, multifactorial medical therapy, intervention yielded no benefit.

So are there certain patient groups who might benefit more from intervention? Among listed indications are high-grade stenosis (which doesn’t apply any longer); short history of progressive failure (which is quite rare); ACE-induced renal failure (which is also quite rare); difficult-to-control hypertension (there really is no such thing now, except in a tiny percentage of patients); and – the least challenged indication – flash pulmonary edema. These remaining indications move our interventions into a very high risk group of patients.

The current debate is focused almost entirely on endovascular intervention, but a systematic review showed that there is long-term benefit in terms of renal function and hypertension with open procedures. Although overall there is increased mortality, this risk is minimized – and not significantly different from endovascular procedures – in those having only renal revascularization vs. those having concomitant aortic procedures. So open surgery remains a possible treatment option, indeed a recent level 1 study comparing stenting and open surgery, showed better long-term results with open surgery (J. Vasc. Surg. 2009;49:667-75). The authors concluded that surgical reconstruction remains the gold standard in treating renal artery stenosis. Although national data suggest an overall mortality of about 10%, it is much lower at specialist, high-volume centers with mortality rates similar to those of stent angioplasty.

Renal stenting is not a low-risk procedure. In all-comers the complication rates, serious complication rates, and mortality rates are significant with short-term equivalence between focused renal arterial surgery and percutaneous intervention.

Returning to the debate, are either methods of revascularization appropriate? Probably not.

Even in flash pulmonary edema, there is little evidence to support revascularization. Few papers exist suggesting a benefit of revascularization in reduction of flash pulmonary edema, but the patient numbers were small, and there was no benefit in terms of preservation of renal function.

The history of evolution and evaluation of the role of renal revascularization is remarkably similar to that of renal denervation, initially and with considerable conviction thought to be a cure for hypertension. However, when properly assessed by prospective randomized comparison there was found to be absolutely no benefit.

So, given the considerable objective evidence from two major trials and revisiting the basics of the pathophysiology of atherosclerotic renovascular disease, to expect benefit from treating the osteal component of renal artery occlusive disease is at best naive, in my opinion. There remains little clinical evidence of benefit for any indication, with the possible exceptions of ACE-induced renal failure and possibly flash pulmonary edema in the presence of bilateral renal arterial stenoses.

Dr. Hamilton is a professor at the Royal Free London Hospital, University College London, United Kingdom.

There are still indications to treat renal artery occlusive disease

BY MATTHEW A. CORRIERE, M.D.

Although renal artery revascularization has been grossly overutilized and is not indicated in the majority of patients with renal artery stenosis, I perform renal artery revascularization as part of my routine clinical practice and believe that there are many instances where revascularization should be considered, particularly when patients have severe symptoms despite aggressive medical therapy. While neither ASTRAL nor CORAL observed any benefit associated with revascularization, both have important limitations that should be kept in mind when interpreting the results of these trials.

These limitations can be broadly categorized as mismatch between indications for revascularization and clinical endpoints, selection biases favoring enrollment of patients with relatively mild symptoms, and inconsistencies between study protocols and contemporary decision-making strategies.

Given that ASTRAL’s primary outcome was change in renal function (defined by a 20% or greater reduction in the mean slope of the reciprocal of serum creatinine), it is important to remember that the inclusion criteria were renal artery stenosis with unexplained renal dysfunction or poorly controlled hypertension. Patients who had hypertension in the absence of significant renal dysfunction were therefore eligible, and 40% of the randomized participants had preserved baseline renal function (based on a serum creatinine of < 150 micromol/liter). Unlike patients with baseline renal dysfunction (which, in theory, might improve with revascularization), these patients with normal renal function who were treated with revascularization risked decline in renal function resulting from procedure-related adverse events without any real chance of renal function improvement. It would certainly be difficult to justify revascularization for the sake of renal function salvage in these patients, and their inclusion within a randomized trial with change in renal function as its primary outcome is problematic for the same reason.

ASTRAL also had an additional, somewhat unorthodox inclusion criterion: uncertainty on the part of the treating physician that the patient “definitely would have a worthwhile clinical benefit from revascularization.” Exclusion of patients considered likely to benefit from revascularization would seem to ensure a selection bias favoring the null hypothesis; this approach may also explain the large proportion of participants with relatively mild occlusive disease (40% had stenotic lesions that were < 70% in severity).

A high rate of both technical failure (12%) and adverse events (20%) associated with revascularization, asymmetric crossover between treatment groups (86 of the 110 patients who did not receive their randomized intervention were in the revascularization group), and lack of standardized protocol for medical therapy further limit the conclusions that can be drawn from the ASTRAL results.

Although this trial does not provide us with compelling evidence that renal revascularization should be abandoned for patients failing appropriate medical therapy, ASTRAL demonstrated that no benefit should be expected from nonselective use of revascularization, which can be associated with significant rates of both technical failure and major adverse events.

The CORAL trial overcame many of the design limitations for which ASTRAL drew criticism. CORAL’s primary endpoint (freedom from major adverse cardiovascular or renal events) allowed potential benefit for participants with either systolic hypertension or chronic kidney disease as their indication for treatment. Although participants with systolic hypertension as their inclusion criterion had to be on at least two antihypertensive medications, it is important to acknowledge the growing number of indications for these medications related to cardiovascular risk reduction in the setting of diabetes, heart disease, and other diagnoses that may be unrelated to any specific blood pressure target. Number of antihypertensive medications is therefore often a crude and potentially invalid indicator of hypertension severity or control.

In CORAL, the initial hypertension inclusion criterion of 155 mm Hg was subsequently abandoned during the trial, suggesting that hypertension in many of these patients may have been mild and/or well controlled. Although medical therapy in CORAL was standardized, it also is notable that all patients had their medical therapy adjusted prior to randomization during a roll-in phase to achieve target blood pressure goals of 130/80 in patients with CKD and/or diabetes or 140/90 otherwise. I would suggest that achievement of these blood pressure targets on the study medications (candesartan ± hydrochlorothiazide plus amlodipine-atorvastatin) might be appropriately considered success of medical therapy for patients with hypertension in the absence of renal dysfunction, making it challenging to defend proceeding with revascularization in this scenario.

The study protocol, although well designed from the perspective of attempting to isolate the effect of renal artery angioplasty and stenting, therefore did not uniformly reflect what would be considered responsible utilization of renal revascularization in a real-world environment.

Patient enrollment in CORAL was also very selective; only 947 of the 5,322 patients who were screened went on to be enrolled and randomized. It is likely that at least some of those patients who were not enrolled (especially those who declined to participate or were withdrawn by their physicians) were failing aggressive medical therapy and therefore unwilling to being excluded from angioplasty and stenting through randomization. These limitations aside, however, CORAL does provide some very useful observations that should inform treatment decisions. The results demonstrate the efficacy of contemporary medical therapy for many patients, and show that revascularization offers no additional benefit when medical therapy achieves an acceptable clinical response (defined by stable renal function and reasonable blood pressure control). Additional subgroup analyses of the CORAL data are anticipated, but will likely be underpowered to draw conclusions in the absence of identified revascularization effects.

So when should revascularization be considered for patients with atherosclerotic renal artery stenosis? In general, medical therapy is adequate for most patients and should be implemented prior to any consideration of procedural intervention. Revascularization should be considered only for patients who have failed appropriate, aggressive medical therapy; the medications used in CORAL can certainly be regarded as adequate initial therapy for symptomatic renal artery stenosis, but many providers (including myself) would argue that additional agents should be considered before proceeding with revascularization.

When decline in renal function is the indication for considering revascularization, alternative causes (such as intrinsic renal disease) should diminish enthusiasm for proceeding with angioplasty and stenting, particularly when the anatomic disease distribution does not affect the entire renal mass (as in patients with two kidneys and unilateral stenosis). Appropriate candidates for revascularization include patients with severely impaired renal function (particularly in the setting of a precipitous functional decline) or severe acute blood pressure elevation associated with hypertensive emergency (such as acute congestive heart failure, encephalopathy, acute coronary syndrome, or other signs and symptoms of target organ damage resulting from hypertension and/or volume overload). Continuation of failed medical therapy is often unacceptable to these “no-options” patients as well as their providers, both of whom presumably would be unlikely to accept randomization to ongoing medical management.

Other populations that are not represented within these trials include patients with renal artery restenosis and those with nonatherosclerotic disease; it is therefore important to exercise caution when generalizing these study results to these distinct groups of patients. Enrolling patients with severe symptoms who have failed medical therapy will likely remain challenging for future randomized studies in the absence of alternative treatment options. Although the benefits of renal angioplasty and stenting for these “no-options” patients remain to be proved, the uncertainty of response to revascularization is often easier to accept than the ongoing morbidity and mortality associated with staying the course when medical therapy has failed.

Dr. Matthew A. Corriere is a vascular surgeon at Wake Forest University School of Medicine, Winston-Salem, N.C.

This article developed from a debate held at the 2014 Vascular Annual Meeting.

Percutaneous treatment of renal artery occlusive disease is unnecessary and should be abandoned, except in pediatric cases.

BY GEORGE HAMILTON, M.D.

This position is supported by findings from both the ASTRAL trial (N. Engl. J. Med. 2009;361:1953-62) and the CORAL trial (N. Engl. J. Med. 2013 Nov. 18 [doi:10.1056/NEJMoa1310753]).

The ASTRAL trial, a prospective, randomized comparison of best medical therapy with and without stent angioplasty in more than 800 patients, was the largest trial to date when it began back in the 1990s. The well-known results showed no difference in time to first renal event, first vascular and cardiovascular events, and overall survival. Furthermore, there was no difference in these outcomes among patients with greater than 90% stenosis, with the exception of a possible difference in mortality, which trended toward improvement among those with high-grade stenosis.

We concluded that revascularization in the vast majority of patients is unlikely to improve hypertension control or renal function, and that renal artery stenosis is not pathophysiologically important. We also concluded that there is no point in screening for asymptomatic disease; this was back when every patient was getting screened, and treated primarily on the basis of finding a renal arterial stenosis.

Finally, we concluded that properly applied best medical therapy alone was an extremely good treatment.

Several flaws in the trial garnered extensive criticism, however, and the more rigidly designed CORAL trial was expected to address them. The findings confirmed those of the ASTRAL trial. In more than 900 patients from 88 centers, there was absolutely no benefit of intervention with respect to primary and secondary outcomes, including among those with high-grade stenosis.

We can now see on the basis of extensive level 1 evidence that when added to comprehensive, multifactorial medical therapy, intervention yielded no benefit.

So are there certain patient groups who might benefit more from intervention? Among listed indications are high-grade stenosis (which doesn’t apply any longer); short history of progressive failure (which is quite rare); ACE-induced renal failure (which is also quite rare); difficult-to-control hypertension (there really is no such thing now, except in a tiny percentage of patients); and – the least challenged indication – flash pulmonary edema. These remaining indications move our interventions into a very high risk group of patients.

The current debate is focused almost entirely on endovascular intervention, but a systematic review showed that there is long-term benefit in terms of renal function and hypertension with open procedures. Although overall there is increased mortality, this risk is minimized – and not significantly different from endovascular procedures – in those having only renal revascularization vs. those having concomitant aortic procedures. So open surgery remains a possible treatment option, indeed a recent level 1 study comparing stenting and open surgery, showed better long-term results with open surgery (J. Vasc. Surg. 2009;49:667-75). The authors concluded that surgical reconstruction remains the gold standard in treating renal artery stenosis. Although national data suggest an overall mortality of about 10%, it is much lower at specialist, high-volume centers with mortality rates similar to those of stent angioplasty.

Renal stenting is not a low-risk procedure. In all-comers the complication rates, serious complication rates, and mortality rates are significant with short-term equivalence between focused renal arterial surgery and percutaneous intervention.

Returning to the debate, are either methods of revascularization appropriate? Probably not.

Even in flash pulmonary edema, there is little evidence to support revascularization. Few papers exist suggesting a benefit of revascularization in reduction of flash pulmonary edema, but the patient numbers were small, and there was no benefit in terms of preservation of renal function.

The history of evolution and evaluation of the role of renal revascularization is remarkably similar to that of renal denervation, initially and with considerable conviction thought to be a cure for hypertension. However, when properly assessed by prospective randomized comparison there was found to be absolutely no benefit.

So, given the considerable objective evidence from two major trials and revisiting the basics of the pathophysiology of atherosclerotic renovascular disease, to expect benefit from treating the osteal component of renal artery occlusive disease is at best naive, in my opinion. There remains little clinical evidence of benefit for any indication, with the possible exceptions of ACE-induced renal failure and possibly flash pulmonary edema in the presence of bilateral renal arterial stenoses.

Dr. Hamilton is a professor at the Royal Free London Hospital, University College London, United Kingdom.

There are still indications to treat renal artery occlusive disease

BY MATTHEW A. CORRIERE, M.D.

Although renal artery revascularization has been grossly overutilized and is not indicated in the majority of patients with renal artery stenosis, I perform renal artery revascularization as part of my routine clinical practice and believe that there are many instances where revascularization should be considered, particularly when patients have severe symptoms despite aggressive medical therapy. While neither ASTRAL nor CORAL observed any benefit associated with revascularization, both have important limitations that should be kept in mind when interpreting the results of these trials.

These limitations can be broadly categorized as mismatch between indications for revascularization and clinical endpoints, selection biases favoring enrollment of patients with relatively mild symptoms, and inconsistencies between study protocols and contemporary decision-making strategies.

Given that ASTRAL’s primary outcome was change in renal function (defined by a 20% or greater reduction in the mean slope of the reciprocal of serum creatinine), it is important to remember that the inclusion criteria were renal artery stenosis with unexplained renal dysfunction or poorly controlled hypertension. Patients who had hypertension in the absence of significant renal dysfunction were therefore eligible, and 40% of the randomized participants had preserved baseline renal function (based on a serum creatinine of < 150 micromol/liter). Unlike patients with baseline renal dysfunction (which, in theory, might improve with revascularization), these patients with normal renal function who were treated with revascularization risked decline in renal function resulting from procedure-related adverse events without any real chance of renal function improvement. It would certainly be difficult to justify revascularization for the sake of renal function salvage in these patients, and their inclusion within a randomized trial with change in renal function as its primary outcome is problematic for the same reason.

ASTRAL also had an additional, somewhat unorthodox inclusion criterion: uncertainty on the part of the treating physician that the patient “definitely would have a worthwhile clinical benefit from revascularization.” Exclusion of patients considered likely to benefit from revascularization would seem to ensure a selection bias favoring the null hypothesis; this approach may also explain the large proportion of participants with relatively mild occlusive disease (40% had stenotic lesions that were < 70% in severity).

A high rate of both technical failure (12%) and adverse events (20%) associated with revascularization, asymmetric crossover between treatment groups (86 of the 110 patients who did not receive their randomized intervention were in the revascularization group), and lack of standardized protocol for medical therapy further limit the conclusions that can be drawn from the ASTRAL results.

Although this trial does not provide us with compelling evidence that renal revascularization should be abandoned for patients failing appropriate medical therapy, ASTRAL demonstrated that no benefit should be expected from nonselective use of revascularization, which can be associated with significant rates of both technical failure and major adverse events.

The CORAL trial overcame many of the design limitations for which ASTRAL drew criticism. CORAL’s primary endpoint (freedom from major adverse cardiovascular or renal events) allowed potential benefit for participants with either systolic hypertension or chronic kidney disease as their indication for treatment. Although participants with systolic hypertension as their inclusion criterion had to be on at least two antihypertensive medications, it is important to acknowledge the growing number of indications for these medications related to cardiovascular risk reduction in the setting of diabetes, heart disease, and other diagnoses that may be unrelated to any specific blood pressure target. Number of antihypertensive medications is therefore often a crude and potentially invalid indicator of hypertension severity or control.

In CORAL, the initial hypertension inclusion criterion of 155 mm Hg was subsequently abandoned during the trial, suggesting that hypertension in many of these patients may have been mild and/or well controlled. Although medical therapy in CORAL was standardized, it also is notable that all patients had their medical therapy adjusted prior to randomization during a roll-in phase to achieve target blood pressure goals of 130/80 in patients with CKD and/or diabetes or 140/90 otherwise. I would suggest that achievement of these blood pressure targets on the study medications (candesartan ± hydrochlorothiazide plus amlodipine-atorvastatin) might be appropriately considered success of medical therapy for patients with hypertension in the absence of renal dysfunction, making it challenging to defend proceeding with revascularization in this scenario.

The study protocol, although well designed from the perspective of attempting to isolate the effect of renal artery angioplasty and stenting, therefore did not uniformly reflect what would be considered responsible utilization of renal revascularization in a real-world environment.

Patient enrollment in CORAL was also very selective; only 947 of the 5,322 patients who were screened went on to be enrolled and randomized. It is likely that at least some of those patients who were not enrolled (especially those who declined to participate or were withdrawn by their physicians) were failing aggressive medical therapy and therefore unwilling to being excluded from angioplasty and stenting through randomization. These limitations aside, however, CORAL does provide some very useful observations that should inform treatment decisions. The results demonstrate the efficacy of contemporary medical therapy for many patients, and show that revascularization offers no additional benefit when medical therapy achieves an acceptable clinical response (defined by stable renal function and reasonable blood pressure control). Additional subgroup analyses of the CORAL data are anticipated, but will likely be underpowered to draw conclusions in the absence of identified revascularization effects.

So when should revascularization be considered for patients with atherosclerotic renal artery stenosis? In general, medical therapy is adequate for most patients and should be implemented prior to any consideration of procedural intervention. Revascularization should be considered only for patients who have failed appropriate, aggressive medical therapy; the medications used in CORAL can certainly be regarded as adequate initial therapy for symptomatic renal artery stenosis, but many providers (including myself) would argue that additional agents should be considered before proceeding with revascularization.

When decline in renal function is the indication for considering revascularization, alternative causes (such as intrinsic renal disease) should diminish enthusiasm for proceeding with angioplasty and stenting, particularly when the anatomic disease distribution does not affect the entire renal mass (as in patients with two kidneys and unilateral stenosis). Appropriate candidates for revascularization include patients with severely impaired renal function (particularly in the setting of a precipitous functional decline) or severe acute blood pressure elevation associated with hypertensive emergency (such as acute congestive heart failure, encephalopathy, acute coronary syndrome, or other signs and symptoms of target organ damage resulting from hypertension and/or volume overload). Continuation of failed medical therapy is often unacceptable to these “no-options” patients as well as their providers, both of whom presumably would be unlikely to accept randomization to ongoing medical management.

Other populations that are not represented within these trials include patients with renal artery restenosis and those with nonatherosclerotic disease; it is therefore important to exercise caution when generalizing these study results to these distinct groups of patients. Enrolling patients with severe symptoms who have failed medical therapy will likely remain challenging for future randomized studies in the absence of alternative treatment options. Although the benefits of renal angioplasty and stenting for these “no-options” patients remain to be proved, the uncertainty of response to revascularization is often easier to accept than the ongoing morbidity and mortality associated with staying the course when medical therapy has failed.

Dr. Matthew A. Corriere is a vascular surgeon at Wake Forest University School of Medicine, Winston-Salem, N.C.

This article developed from a debate held at the 2014 Vascular Annual Meeting.

Percutaneous treatment of renal artery occlusive disease is unnecessary and should be abandoned, except in pediatric cases.

BY GEORGE HAMILTON, M.D.

This position is supported by findings from both the ASTRAL trial (N. Engl. J. Med. 2009;361:1953-62) and the CORAL trial (N. Engl. J. Med. 2013 Nov. 18 [doi:10.1056/NEJMoa1310753]).

The ASTRAL trial, a prospective, randomized comparison of best medical therapy with and without stent angioplasty in more than 800 patients, was the largest trial to date when it began back in the 1990s. The well-known results showed no difference in time to first renal event, first vascular and cardiovascular events, and overall survival. Furthermore, there was no difference in these outcomes among patients with greater than 90% stenosis, with the exception of a possible difference in mortality, which trended toward improvement among those with high-grade stenosis.

We concluded that revascularization in the vast majority of patients is unlikely to improve hypertension control or renal function, and that renal artery stenosis is not pathophysiologically important. We also concluded that there is no point in screening for asymptomatic disease; this was back when every patient was getting screened, and treated primarily on the basis of finding a renal arterial stenosis.

Finally, we concluded that properly applied best medical therapy alone was an extremely good treatment.

Several flaws in the trial garnered extensive criticism, however, and the more rigidly designed CORAL trial was expected to address them. The findings confirmed those of the ASTRAL trial. In more than 900 patients from 88 centers, there was absolutely no benefit of intervention with respect to primary and secondary outcomes, including among those with high-grade stenosis.

We can now see on the basis of extensive level 1 evidence that when added to comprehensive, multifactorial medical therapy, intervention yielded no benefit.

So are there certain patient groups who might benefit more from intervention? Among listed indications are high-grade stenosis (which doesn’t apply any longer); short history of progressive failure (which is quite rare); ACE-induced renal failure (which is also quite rare); difficult-to-control hypertension (there really is no such thing now, except in a tiny percentage of patients); and – the least challenged indication – flash pulmonary edema. These remaining indications move our interventions into a very high risk group of patients.

The current debate is focused almost entirely on endovascular intervention, but a systematic review showed that there is long-term benefit in terms of renal function and hypertension with open procedures. Although overall there is increased mortality, this risk is minimized – and not significantly different from endovascular procedures – in those having only renal revascularization vs. those having concomitant aortic procedures. So open surgery remains a possible treatment option, indeed a recent level 1 study comparing stenting and open surgery, showed better long-term results with open surgery (J. Vasc. Surg. 2009;49:667-75). The authors concluded that surgical reconstruction remains the gold standard in treating renal artery stenosis. Although national data suggest an overall mortality of about 10%, it is much lower at specialist, high-volume centers with mortality rates similar to those of stent angioplasty.

Renal stenting is not a low-risk procedure. In all-comers the complication rates, serious complication rates, and mortality rates are significant with short-term equivalence between focused renal arterial surgery and percutaneous intervention.

Returning to the debate, are either methods of revascularization appropriate? Probably not.

Even in flash pulmonary edema, there is little evidence to support revascularization. Few papers exist suggesting a benefit of revascularization in reduction of flash pulmonary edema, but the patient numbers were small, and there was no benefit in terms of preservation of renal function.

The history of evolution and evaluation of the role of renal revascularization is remarkably similar to that of renal denervation, initially and with considerable conviction thought to be a cure for hypertension. However, when properly assessed by prospective randomized comparison there was found to be absolutely no benefit.

So, given the considerable objective evidence from two major trials and revisiting the basics of the pathophysiology of atherosclerotic renovascular disease, to expect benefit from treating the osteal component of renal artery occlusive disease is at best naive, in my opinion. There remains little clinical evidence of benefit for any indication, with the possible exceptions of ACE-induced renal failure and possibly flash pulmonary edema in the presence of bilateral renal arterial stenoses.

Dr. Hamilton is a professor at the Royal Free London Hospital, University College London, United Kingdom.

There are still indications to treat renal artery occlusive disease

BY MATTHEW A. CORRIERE, M.D.

Although renal artery revascularization has been grossly overutilized and is not indicated in the majority of patients with renal artery stenosis, I perform renal artery revascularization as part of my routine clinical practice and believe that there are many instances where revascularization should be considered, particularly when patients have severe symptoms despite aggressive medical therapy. While neither ASTRAL nor CORAL observed any benefit associated with revascularization, both have important limitations that should be kept in mind when interpreting the results of these trials.

These limitations can be broadly categorized as mismatch between indications for revascularization and clinical endpoints, selection biases favoring enrollment of patients with relatively mild symptoms, and inconsistencies between study protocols and contemporary decision-making strategies.

Given that ASTRAL’s primary outcome was change in renal function (defined by a 20% or greater reduction in the mean slope of the reciprocal of serum creatinine), it is important to remember that the inclusion criteria were renal artery stenosis with unexplained renal dysfunction or poorly controlled hypertension. Patients who had hypertension in the absence of significant renal dysfunction were therefore eligible, and 40% of the randomized participants had preserved baseline renal function (based on a serum creatinine of < 150 micromol/liter). Unlike patients with baseline renal dysfunction (which, in theory, might improve with revascularization), these patients with normal renal function who were treated with revascularization risked decline in renal function resulting from procedure-related adverse events without any real chance of renal function improvement. It would certainly be difficult to justify revascularization for the sake of renal function salvage in these patients, and their inclusion within a randomized trial with change in renal function as its primary outcome is problematic for the same reason.

ASTRAL also had an additional, somewhat unorthodox inclusion criterion: uncertainty on the part of the treating physician that the patient “definitely would have a worthwhile clinical benefit from revascularization.” Exclusion of patients considered likely to benefit from revascularization would seem to ensure a selection bias favoring the null hypothesis; this approach may also explain the large proportion of participants with relatively mild occlusive disease (40% had stenotic lesions that were < 70% in severity).

A high rate of both technical failure (12%) and adverse events (20%) associated with revascularization, asymmetric crossover between treatment groups (86 of the 110 patients who did not receive their randomized intervention were in the revascularization group), and lack of standardized protocol for medical therapy further limit the conclusions that can be drawn from the ASTRAL results.

Although this trial does not provide us with compelling evidence that renal revascularization should be abandoned for patients failing appropriate medical therapy, ASTRAL demonstrated that no benefit should be expected from nonselective use of revascularization, which can be associated with significant rates of both technical failure and major adverse events.

The CORAL trial overcame many of the design limitations for which ASTRAL drew criticism. CORAL’s primary endpoint (freedom from major adverse cardiovascular or renal events) allowed potential benefit for participants with either systolic hypertension or chronic kidney disease as their indication for treatment. Although participants with systolic hypertension as their inclusion criterion had to be on at least two antihypertensive medications, it is important to acknowledge the growing number of indications for these medications related to cardiovascular risk reduction in the setting of diabetes, heart disease, and other diagnoses that may be unrelated to any specific blood pressure target. Number of antihypertensive medications is therefore often a crude and potentially invalid indicator of hypertension severity or control.

In CORAL, the initial hypertension inclusion criterion of 155 mm Hg was subsequently abandoned during the trial, suggesting that hypertension in many of these patients may have been mild and/or well controlled. Although medical therapy in CORAL was standardized, it also is notable that all patients had their medical therapy adjusted prior to randomization during a roll-in phase to achieve target blood pressure goals of 130/80 in patients with CKD and/or diabetes or 140/90 otherwise. I would suggest that achievement of these blood pressure targets on the study medications (candesartan ± hydrochlorothiazide plus amlodipine-atorvastatin) might be appropriately considered success of medical therapy for patients with hypertension in the absence of renal dysfunction, making it challenging to defend proceeding with revascularization in this scenario.

The study protocol, although well designed from the perspective of attempting to isolate the effect of renal artery angioplasty and stenting, therefore did not uniformly reflect what would be considered responsible utilization of renal revascularization in a real-world environment.

Patient enrollment in CORAL was also very selective; only 947 of the 5,322 patients who were screened went on to be enrolled and randomized. It is likely that at least some of those patients who were not enrolled (especially those who declined to participate or were withdrawn by their physicians) were failing aggressive medical therapy and therefore unwilling to being excluded from angioplasty and stenting through randomization. These limitations aside, however, CORAL does provide some very useful observations that should inform treatment decisions. The results demonstrate the efficacy of contemporary medical therapy for many patients, and show that revascularization offers no additional benefit when medical therapy achieves an acceptable clinical response (defined by stable renal function and reasonable blood pressure control). Additional subgroup analyses of the CORAL data are anticipated, but will likely be underpowered to draw conclusions in the absence of identified revascularization effects.

So when should revascularization be considered for patients with atherosclerotic renal artery stenosis? In general, medical therapy is adequate for most patients and should be implemented prior to any consideration of procedural intervention. Revascularization should be considered only for patients who have failed appropriate, aggressive medical therapy; the medications used in CORAL can certainly be regarded as adequate initial therapy for symptomatic renal artery stenosis, but many providers (including myself) would argue that additional agents should be considered before proceeding with revascularization.

When decline in renal function is the indication for considering revascularization, alternative causes (such as intrinsic renal disease) should diminish enthusiasm for proceeding with angioplasty and stenting, particularly when the anatomic disease distribution does not affect the entire renal mass (as in patients with two kidneys and unilateral stenosis). Appropriate candidates for revascularization include patients with severely impaired renal function (particularly in the setting of a precipitous functional decline) or severe acute blood pressure elevation associated with hypertensive emergency (such as acute congestive heart failure, encephalopathy, acute coronary syndrome, or other signs and symptoms of target organ damage resulting from hypertension and/or volume overload). Continuation of failed medical therapy is often unacceptable to these “no-options” patients as well as their providers, both of whom presumably would be unlikely to accept randomization to ongoing medical management.

Other populations that are not represented within these trials include patients with renal artery restenosis and those with nonatherosclerotic disease; it is therefore important to exercise caution when generalizing these study results to these distinct groups of patients. Enrolling patients with severe symptoms who have failed medical therapy will likely remain challenging for future randomized studies in the absence of alternative treatment options. Although the benefits of renal angioplasty and stenting for these “no-options” patients remain to be proved, the uncertainty of response to revascularization is often easier to accept than the ongoing morbidity and mortality associated with staying the course when medical therapy has failed.

Dr. Matthew A. Corriere is a vascular surgeon at Wake Forest University School of Medicine, Winston-Salem, N.C.

This article developed from a debate held at the 2014 Vascular Annual Meeting.

Surgical repair remains the optimal method to treat a popliteal artery aneurysm.

Popliteal artery aneurysm, or PAA, is the most common peripheral aneurysm, but data on this disease are nonetheless limited. A report from the VASCUNET collaboration of registries showed that 1,471 repairs were performed among a population of 58 million people in eight countries, for a rate of 9.6 per million. Most (72%) were elective, and 78% were open repairs (Eur. J. Vasc. Endovasc. Surg. 2014;47:164-71).

Although the endovascular approach has been increasingly used since 2000, outcomes have varied considerably across studies.

A review of 163 relevant studies from more than 1,600 that have been published since 1994 showed extensive heterogeneity with respect to the inclusion of symptomatic vs. asymptomatic patients, emergent vs. elective cases, poor runoff vs. good runoff, types of stents used, and types of conduits used for open repair. This renders the validity of the meta-analysis of these studies uncertain.

However, based on the few studies with complete data concerning mortality, major adverse events, primary and secondary patency, and limb salvage – with separate analysis for elective and emergency repairs – it appears that the availability of the great saphenous vein (GSV) is an important determinant when deciding whether to perform an open repair, that the posterior approach is preferred (except in cases of aneurysms extending to the adductor canal or trifurcation vessels), and that elective open repair is associated with significantly better outcomes than endovascular repair on a number of measures.

For example, no difference was seen in mortality in 23 selected studies, but the 3-year primary patency was significantly better with open repair (85% vs. 58%), while the 3-year rate of major adverse events, including mortality, major amputation, graft thrombosis, and reintervention was lower (20% vs. 38%).

These findings were confirmed in a study of 149 elective repairs. In that series, major adverse events were significantly more common in endovascular vs. open cases (hazard ratio, 2.1), and poor runoff was associated with a higher risk of major adverse events regardless of the technique used (J. Vasc. Surg. 2014 60:631-8.e2).

A recent decision analysis model applied to patients with asymptomatic PAA also demonstrated that elective open repair with a GSV bypass is the preferred treatment for all outcomes, with stenting recommended in high-risk patient or those without a suitable vein (J. Vasc. Surg. 2014;59:651-62).

One concern with endovascular repair is the risk of stent fracture, particularly in younger more active patients as data suggest that the more active the individual, the greater the risk of stent fracture. In one study, the frequency of stent fracture in younger patients was 17%. This suggests that stenting is probably not the best technique to be used in active individuals.

The current data suggest that the best outcomes are achieved with elective open repair using the great saphenous vein. However, patency rates above 80% at 2 years have been reported recently for elective endovascular repair associated with dual antiplatelet therapy, thus it is possible that new stent grafts and best medical therapy could improve the results of endovascular repair.

Open repair also appears to be best in most emergent cases. In one meta-analysis of 11 studies involving 223 patients, graft thrombosis occurred in 8% of open cases vs. 53% of endovascular cases, patency at 6 months was 82% vs. 68%, and reintervention rates were 25% vs. 43% in open vs. endovascular cases, respectively.

Thrombolysis was associated with a significant improvement in 1-year primary graft patency rates compared with surgery alone, but this did not affect the amputation rate, and endovascular repair does not appear to improve the severe prognosis of acute ischemia in patients with PAA.

Despite the deceiving results of endovascular repair in those with acute ischemia, this technique could, however, be very useful in other emergent situations. For example, very old patients presenting with a ruptured PAA and a good runoff could benefit from an endovascular repair.

In summary, no level 1 evidence regarding open vs. endovascular repair for popliteal artery aneurysms can be obtained; most studies are retrospective and lack important characteristics. Based on the data that do exist, however, open repair with a vein bypass appears to be the best technique for most patients with PAA. Stenting should be reserved for high-risk and elderly asymptomatic patients. As for those with acute limb ischemia, no strong recommendation can be made based on the available data.

Dr. Jean-Baptiste Ricco is professor and chief of vascular surgery at the University of Poitiers, France. He reported having no disclosures. This and the accompanying perspective by Dr. Marone were based upon their live debate at the 2014 Vascular Annual Meeting.

Endovascular repair of PAA is an effective and durable treatment.

Outcomes following endovascular repair of PAA are at least equivalent to those following open repair with respect to patency and limb salvage in elective cases.

In the Swedish Vascular Registry – the largest report of open repair, representing 717 limbs treated with a mean follow-up of 7.2 years – the primary patency rate at 1 year for cases performed with a medial approach was 90% with vein conduit, and 72% with prosthetic conduit. For cases involving a posterior approach, the rates were 85% with vein conduit, and 81% with prosthetic conduit. The amputation rate was 9.6% at 1 year and 11% at last follow-up.

Furthermore, open surgical procedures are associated with a high wound complication rate. The average across studies is 7%, and was as high as 28% in some series. Open procedures are also associated with variable graft patency, continued aneurysm expansion (which occurred in a third of limbs treated with a medial approach in one series), and a significant amputation rate.

Data regarding endovascular PAA repair are encouraging. In the only prospective randomized trial to date, no significant difference was seen at 46 months with respect to primary patency (100% with open repair vs. 93.3% with endovascular repair), or limb salvage (100% for both).

Hospital length of stay, however, was significantly shorter with endovascular repair (7.7 days vs. 4.3 days), as was operative time (155 minutes vs. 75 minutes).

An update to that 2005 study (J. Vasc. Surg. 2005;42:185-93) showed no difference in patency at 72 months.

While there is a paucity of level 1 evidence (only 15 patients were included in each arm of that study), prospective cohort studies and institutional reviews also demonstrate the value of endovascular repair. Secondary patency at 1 and 3 years were 87% and 85%, respectively, in a 2013 study (Ann. Vasc. Surg. 2013;27:259-65), and the 1- and 2-year amputation rates were 2% and 3%, respectively.

In another series, 1-year primary patency was 92.9% with endovascular repair, compared with 83.3% with open repair, and 3-year patency was 63.7% vs. 77.8%. The differences were not statistically significant.

Length of stay was 3.9 days vs. 9.5 days. Eight wound infections and 2 hematomas occurred in the open repair patients, and two patients experienced enlargement requiring decompression.

The University of Pittsburgh experience with 50 endovascular repairs and 111 open repairs performed between 2004 and 2010 showed that morbidity was 14% vs. 32% for endovascular vs. open repair, and mortality was 2% vs. 3.6%, respectively, at 29-month follow-up. Wound infection rates were 2% and 16.2%, respectively, length of stay was 1 vs. 4 days, and reintervention and thrombosis rates did not differ significantly (12.2% vs. 10.8%, and 8 vs. 12 patients).

No significant differences were seen in aneurysm growth, primary assisted patency at 3 years, secondary patency at 3 years, or amputation rates at 1 year or 3 years.

A 2013 update also showed no differences in these outcomes.

In summary, endovascular repair of PAA is acceptable, with outcomes comparable to or better than open repair in elective cases. Long-term durability has been demonstrated, limb preservation is equivalent to open repair, and thrombotic complications are rare and can be treated successfully with re-intervention.

Furthermore, endovascular repair can be performed without the need for general anesthesia, lower morbidity can be expected perioperatively, hospital length of stay is shorter, and patients have a quicker return of functional status.

Dr. Luke Marone is a vascular surgeon at the University of Pittsburgh School of Medicine. He disclosed he is a consultant for Abiomed and Abbott.

Surgical repair remains the optimal method to treat a popliteal artery aneurysm.

Popliteal artery aneurysm, or PAA, is the most common peripheral aneurysm, but data on this disease are nonetheless limited. A report from the VASCUNET collaboration of registries showed that 1,471 repairs were performed among a population of 58 million people in eight countries, for a rate of 9.6 per million. Most (72%) were elective, and 78% were open repairs (Eur. J. Vasc. Endovasc. Surg. 2014;47:164-71).

Although the endovascular approach has been increasingly used since 2000, outcomes have varied considerably across studies.

A review of 163 relevant studies from more than 1,600 that have been published since 1994 showed extensive heterogeneity with respect to the inclusion of symptomatic vs. asymptomatic patients, emergent vs. elective cases, poor runoff vs. good runoff, types of stents used, and types of conduits used for open repair. This renders the validity of the meta-analysis of these studies uncertain.

However, based on the few studies with complete data concerning mortality, major adverse events, primary and secondary patency, and limb salvage – with separate analysis for elective and emergency repairs – it appears that the availability of the great saphenous vein (GSV) is an important determinant when deciding whether to perform an open repair, that the posterior approach is preferred (except in cases of aneurysms extending to the adductor canal or trifurcation vessels), and that elective open repair is associated with significantly better outcomes than endovascular repair on a number of measures.

For example, no difference was seen in mortality in 23 selected studies, but the 3-year primary patency was significantly better with open repair (85% vs. 58%), while the 3-year rate of major adverse events, including mortality, major amputation, graft thrombosis, and reintervention was lower (20% vs. 38%).

These findings were confirmed in a study of 149 elective repairs. In that series, major adverse events were significantly more common in endovascular vs. open cases (hazard ratio, 2.1), and poor runoff was associated with a higher risk of major adverse events regardless of the technique used (J. Vasc. Surg. 2014 60:631-8.e2).

A recent decision analysis model applied to patients with asymptomatic PAA also demonstrated that elective open repair with a GSV bypass is the preferred treatment for all outcomes, with stenting recommended in high-risk patient or those without a suitable vein (J. Vasc. Surg. 2014;59:651-62).

One concern with endovascular repair is the risk of stent fracture, particularly in younger more active patients as data suggest that the more active the individual, the greater the risk of stent fracture. In one study, the frequency of stent fracture in younger patients was 17%. This suggests that stenting is probably not the best technique to be used in active individuals.

The current data suggest that the best outcomes are achieved with elective open repair using the great saphenous vein. However, patency rates above 80% at 2 years have been reported recently for elective endovascular repair associated with dual antiplatelet therapy, thus it is possible that new stent grafts and best medical therapy could improve the results of endovascular repair.

Open repair also appears to be best in most emergent cases. In one meta-analysis of 11 studies involving 223 patients, graft thrombosis occurred in 8% of open cases vs. 53% of endovascular cases, patency at 6 months was 82% vs. 68%, and reintervention rates were 25% vs. 43% in open vs. endovascular cases, respectively.

Thrombolysis was associated with a significant improvement in 1-year primary graft patency rates compared with surgery alone, but this did not affect the amputation rate, and endovascular repair does not appear to improve the severe prognosis of acute ischemia in patients with PAA.

Despite the deceiving results of endovascular repair in those with acute ischemia, this technique could, however, be very useful in other emergent situations. For example, very old patients presenting with a ruptured PAA and a good runoff could benefit from an endovascular repair.

In summary, no level 1 evidence regarding open vs. endovascular repair for popliteal artery aneurysms can be obtained; most studies are retrospective and lack important characteristics. Based on the data that do exist, however, open repair with a vein bypass appears to be the best technique for most patients with PAA. Stenting should be reserved for high-risk and elderly asymptomatic patients. As for those with acute limb ischemia, no strong recommendation can be made based on the available data.

Dr. Jean-Baptiste Ricco is professor and chief of vascular surgery at the University of Poitiers, France. He reported having no disclosures. This and the accompanying perspective by Dr. Marone were based upon their live debate at the 2014 Vascular Annual Meeting.

Endovascular repair of PAA is an effective and durable treatment.

Outcomes following endovascular repair of PAA are at least equivalent to those following open repair with respect to patency and limb salvage in elective cases.

In the Swedish Vascular Registry – the largest report of open repair, representing 717 limbs treated with a mean follow-up of 7.2 years – the primary patency rate at 1 year for cases performed with a medial approach was 90% with vein conduit, and 72% with prosthetic conduit. For cases involving a posterior approach, the rates were 85% with vein conduit, and 81% with prosthetic conduit. The amputation rate was 9.6% at 1 year and 11% at last follow-up.

Furthermore, open surgical procedures are associated with a high wound complication rate. The average across studies is 7%, and was as high as 28% in some series. Open procedures are also associated with variable graft patency, continued aneurysm expansion (which occurred in a third of limbs treated with a medial approach in one series), and a significant amputation rate.

Data regarding endovascular PAA repair are encouraging. In the only prospective randomized trial to date, no significant difference was seen at 46 months with respect to primary patency (100% with open repair vs. 93.3% with endovascular repair), or limb salvage (100% for both).

Hospital length of stay, however, was significantly shorter with endovascular repair (7.7 days vs. 4.3 days), as was operative time (155 minutes vs. 75 minutes).

An update to that 2005 study (J. Vasc. Surg. 2005;42:185-93) showed no difference in patency at 72 months.

While there is a paucity of level 1 evidence (only 15 patients were included in each arm of that study), prospective cohort studies and institutional reviews also demonstrate the value of endovascular repair. Secondary patency at 1 and 3 years were 87% and 85%, respectively, in a 2013 study (Ann. Vasc. Surg. 2013;27:259-65), and the 1- and 2-year amputation rates were 2% and 3%, respectively.

In another series, 1-year primary patency was 92.9% with endovascular repair, compared with 83.3% with open repair, and 3-year patency was 63.7% vs. 77.8%. The differences were not statistically significant.

Length of stay was 3.9 days vs. 9.5 days. Eight wound infections and 2 hematomas occurred in the open repair patients, and two patients experienced enlargement requiring decompression.

The University of Pittsburgh experience with 50 endovascular repairs and 111 open repairs performed between 2004 and 2010 showed that morbidity was 14% vs. 32% for endovascular vs. open repair, and mortality was 2% vs. 3.6%, respectively, at 29-month follow-up. Wound infection rates were 2% and 16.2%, respectively, length of stay was 1 vs. 4 days, and reintervention and thrombosis rates did not differ significantly (12.2% vs. 10.8%, and 8 vs. 12 patients).

No significant differences were seen in aneurysm growth, primary assisted patency at 3 years, secondary patency at 3 years, or amputation rates at 1 year or 3 years.

A 2013 update also showed no differences in these outcomes.

In summary, endovascular repair of PAA is acceptable, with outcomes comparable to or better than open repair in elective cases. Long-term durability has been demonstrated, limb preservation is equivalent to open repair, and thrombotic complications are rare and can be treated successfully with re-intervention.

Furthermore, endovascular repair can be performed without the need for general anesthesia, lower morbidity can be expected perioperatively, hospital length of stay is shorter, and patients have a quicker return of functional status.

Dr. Luke Marone is a vascular surgeon at the University of Pittsburgh School of Medicine. He disclosed he is a consultant for Abiomed and Abbott.

Surgical repair remains the optimal method to treat a popliteal artery aneurysm.

Popliteal artery aneurysm, or PAA, is the most common peripheral aneurysm, but data on this disease are nonetheless limited. A report from the VASCUNET collaboration of registries showed that 1,471 repairs were performed among a population of 58 million people in eight countries, for a rate of 9.6 per million. Most (72%) were elective, and 78% were open repairs (Eur. J. Vasc. Endovasc. Surg. 2014;47:164-71).

Although the endovascular approach has been increasingly used since 2000, outcomes have varied considerably across studies.

A review of 163 relevant studies from more than 1,600 that have been published since 1994 showed extensive heterogeneity with respect to the inclusion of symptomatic vs. asymptomatic patients, emergent vs. elective cases, poor runoff vs. good runoff, types of stents used, and types of conduits used for open repair. This renders the validity of the meta-analysis of these studies uncertain.

However, based on the few studies with complete data concerning mortality, major adverse events, primary and secondary patency, and limb salvage – with separate analysis for elective and emergency repairs – it appears that the availability of the great saphenous vein (GSV) is an important determinant when deciding whether to perform an open repair, that the posterior approach is preferred (except in cases of aneurysms extending to the adductor canal or trifurcation vessels), and that elective open repair is associated with significantly better outcomes than endovascular repair on a number of measures.

For example, no difference was seen in mortality in 23 selected studies, but the 3-year primary patency was significantly better with open repair (85% vs. 58%), while the 3-year rate of major adverse events, including mortality, major amputation, graft thrombosis, and reintervention was lower (20% vs. 38%).

These findings were confirmed in a study of 149 elective repairs. In that series, major adverse events were significantly more common in endovascular vs. open cases (hazard ratio, 2.1), and poor runoff was associated with a higher risk of major adverse events regardless of the technique used (J. Vasc. Surg. 2014 60:631-8.e2).

A recent decision analysis model applied to patients with asymptomatic PAA also demonstrated that elective open repair with a GSV bypass is the preferred treatment for all outcomes, with stenting recommended in high-risk patient or those without a suitable vein (J. Vasc. Surg. 2014;59:651-62).

One concern with endovascular repair is the risk of stent fracture, particularly in younger more active patients as data suggest that the more active the individual, the greater the risk of stent fracture. In one study, the frequency of stent fracture in younger patients was 17%. This suggests that stenting is probably not the best technique to be used in active individuals.

The current data suggest that the best outcomes are achieved with elective open repair using the great saphenous vein. However, patency rates above 80% at 2 years have been reported recently for elective endovascular repair associated with dual antiplatelet therapy, thus it is possible that new stent grafts and best medical therapy could improve the results of endovascular repair.

Open repair also appears to be best in most emergent cases. In one meta-analysis of 11 studies involving 223 patients, graft thrombosis occurred in 8% of open cases vs. 53% of endovascular cases, patency at 6 months was 82% vs. 68%, and reintervention rates were 25% vs. 43% in open vs. endovascular cases, respectively.

Thrombolysis was associated with a significant improvement in 1-year primary graft patency rates compared with surgery alone, but this did not affect the amputation rate, and endovascular repair does not appear to improve the severe prognosis of acute ischemia in patients with PAA.

Despite the deceiving results of endovascular repair in those with acute ischemia, this technique could, however, be very useful in other emergent situations. For example, very old patients presenting with a ruptured PAA and a good runoff could benefit from an endovascular repair.

In summary, no level 1 evidence regarding open vs. endovascular repair for popliteal artery aneurysms can be obtained; most studies are retrospective and lack important characteristics. Based on the data that do exist, however, open repair with a vein bypass appears to be the best technique for most patients with PAA. Stenting should be reserved for high-risk and elderly asymptomatic patients. As for those with acute limb ischemia, no strong recommendation can be made based on the available data.

Dr. Jean-Baptiste Ricco is professor and chief of vascular surgery at the University of Poitiers, France. He reported having no disclosures. This and the accompanying perspective by Dr. Marone were based upon their live debate at the 2014 Vascular Annual Meeting.

Endovascular repair of PAA is an effective and durable treatment.

Outcomes following endovascular repair of PAA are at least equivalent to those following open repair with respect to patency and limb salvage in elective cases.

In the Swedish Vascular Registry – the largest report of open repair, representing 717 limbs treated with a mean follow-up of 7.2 years – the primary patency rate at 1 year for cases performed with a medial approach was 90% with vein conduit, and 72% with prosthetic conduit. For cases involving a posterior approach, the rates were 85% with vein conduit, and 81% with prosthetic conduit. The amputation rate was 9.6% at 1 year and 11% at last follow-up.

Furthermore, open surgical procedures are associated with a high wound complication rate. The average across studies is 7%, and was as high as 28% in some series. Open procedures are also associated with variable graft patency, continued aneurysm expansion (which occurred in a third of limbs treated with a medial approach in one series), and a significant amputation rate.

Data regarding endovascular PAA repair are encouraging. In the only prospective randomized trial to date, no significant difference was seen at 46 months with respect to primary patency (100% with open repair vs. 93.3% with endovascular repair), or limb salvage (100% for both).

Hospital length of stay, however, was significantly shorter with endovascular repair (7.7 days vs. 4.3 days), as was operative time (155 minutes vs. 75 minutes).

An update to that 2005 study (J. Vasc. Surg. 2005;42:185-93) showed no difference in patency at 72 months.

While there is a paucity of level 1 evidence (only 15 patients were included in each arm of that study), prospective cohort studies and institutional reviews also demonstrate the value of endovascular repair. Secondary patency at 1 and 3 years were 87% and 85%, respectively, in a 2013 study (Ann. Vasc. Surg. 2013;27:259-65), and the 1- and 2-year amputation rates were 2% and 3%, respectively.

In another series, 1-year primary patency was 92.9% with endovascular repair, compared with 83.3% with open repair, and 3-year patency was 63.7% vs. 77.8%. The differences were not statistically significant.

Length of stay was 3.9 days vs. 9.5 days. Eight wound infections and 2 hematomas occurred in the open repair patients, and two patients experienced enlargement requiring decompression.

The University of Pittsburgh experience with 50 endovascular repairs and 111 open repairs performed between 2004 and 2010 showed that morbidity was 14% vs. 32% for endovascular vs. open repair, and mortality was 2% vs. 3.6%, respectively, at 29-month follow-up. Wound infection rates were 2% and 16.2%, respectively, length of stay was 1 vs. 4 days, and reintervention and thrombosis rates did not differ significantly (12.2% vs. 10.8%, and 8 vs. 12 patients).

No significant differences were seen in aneurysm growth, primary assisted patency at 3 years, secondary patency at 3 years, or amputation rates at 1 year or 3 years.

A 2013 update also showed no differences in these outcomes.

In summary, endovascular repair of PAA is acceptable, with outcomes comparable to or better than open repair in elective cases. Long-term durability has been demonstrated, limb preservation is equivalent to open repair, and thrombotic complications are rare and can be treated successfully with re-intervention.

Furthermore, endovascular repair can be performed without the need for general anesthesia, lower morbidity can be expected perioperatively, hospital length of stay is shorter, and patients have a quicker return of functional status.

Dr. Luke Marone is a vascular surgeon at the University of Pittsburgh School of Medicine. He disclosed he is a consultant for Abiomed and Abbott.

BOSTON – Endovascular interventions for ruptured visceral artery aneurysms are associated with reduced morbidity and mortality, compared with open interventions, according to findings from a retrospective chart review.

Both endovascular and open repairs are safe and durable for intact visceral artery aneurysms, Dr. Ankur J. Shukla reported at a the 2014 Vascular Annual Meeting.

Of 261 patients who presented with visceral artery aneurysms (VAAs), 174 underwent repair: 74 who presented with ruptured VAA and 100 who presented with intact VAA. The majority – 73% of ruptured VAA and 62% of intact VAA – were repaired with an endovascular approach.

Among those with ruptured VAA, 30-day mortality was 7.4% following endovascular repair, compared with 28.6% following open repair, a significant difference, said Dr. Shukla of the University of Pittsburgh Medical Center.

Survival at 3 years of ruptured VAA was about 70% vs. 46.4% in the endovascular and open repair groups, respectively, he said.

About 65% of patients with ruptured VAA presented with pain, and about 30% presented in hemodynamic shock. The most commonly identified etiology was "inflammatory/pancreatitis inflammatory," and 80% of the aneurysms were pseudoaneurysmal in nature.

A large proportion of the aneurysms were in the splenic and arterial beds, but 26% were located in the pancreaticoduodenal arcade, and those had a mean size of 12.7 mm. Most (95%) were pseudoaneurysms.

The outcomes with ruptured VAA were quite good, Dr. Shukla said, noting that the technical success rate was 98.7%.

Although the 30-day reintervention rate with endovascular repair was higher, the difference between the groups was not statistically significant, and there was a trend toward a lower rate of major complications with endovascular repair.

Factors found to be predictors of mortality risk were older age and steroid use, while endovascular repair was found to be protective.

As for the patients with intact VAA, most presented without symptoms, and the most common etiology was atherosclerosis.

"When we looked at the distribution, this was very consistent with what has been reported in the literature, with the splenic and arterial beds really making up the lion’s share of this group. Notable is the fact that 6.7% of our patients had intact aneurysms in the pancreaticoduodenal arcade," he said.

Outcomes in those with intact aneurysms were good. A slightly higher 30-day reintervention rate in those who underwent endovascular repair did not reach statistical significance, and both the endovascular and open repair groups had low rates of major complications.

Survival at 3 years for intact aneurysms did not differ in the endovascular and open repair groups. This was partly due to a 0% 30-day mortality, and – despite the fact that the overall mortality in those with intact aneurysms was 10% – there was zero overall aneurysm-related mortality, he said.

Patients in the study were treated at a single institution between 2003 and 2013. Most were in their mid to late 50s, and there were more men and more individuals on immunosuppressive therapy in the ruptured VAA group. However, comorbidities were similar in the ruptured and intact VAA groups.

Visceral artery aneurysms occur only rarely, affecting 0.1% to 2% of the general population, but because of the increasing use of noninvasive imaging, more of these aneurysms are being detected incidentally.

When they are not found incidentally, they often go undetected and present when they rupture, Dr. Shukla said.

"Because of the increasing utilization and improvement of endovascular technology, we now have a lot of options to fix these aneurysms. But the outcomes are not well defined. Even less well defined is the outcome of ruptured visceral artery aneurysms," he said, noting that most studies have a small sample size or look only at endovascular or open repairs.

Overall, the current study showed that there is "an acute and sharp drop-off in survival with open repair," related, most likely, to operative mortality, he said.

"Based on the findings, we recommend aggressive treatment of pseudoaneurysms and true aneurysms in the pancreaticoduodenal arcade, and advocate for an endovascular-first approach to treating ruptured visceral artery aneurysms, acknowledging that success in this is really predicated on good planning based on advanced imaging and endovascular set-up," he concluded.

Dr. Shukla reported having no disclosures

BOSTON – Endovascular interventions for ruptured visceral artery aneurysms are associated with reduced morbidity and mortality, compared with open interventions, according to findings from a retrospective chart review.

Both endovascular and open repairs are safe and durable for intact visceral artery aneurysms, Dr. Ankur J. Shukla reported at a the 2014 Vascular Annual Meeting.

Of 261 patients who presented with visceral artery aneurysms (VAAs), 174 underwent repair: 74 who presented with ruptured VAA and 100 who presented with intact VAA. The majority – 73% of ruptured VAA and 62% of intact VAA – were repaired with an endovascular approach.

Among those with ruptured VAA, 30-day mortality was 7.4% following endovascular repair, compared with 28.6% following open repair, a significant difference, said Dr. Shukla of the University of Pittsburgh Medical Center.

Survival at 3 years of ruptured VAA was about 70% vs. 46.4% in the endovascular and open repair groups, respectively, he said.

About 65% of patients with ruptured VAA presented with pain, and about 30% presented in hemodynamic shock. The most commonly identified etiology was "inflammatory/pancreatitis inflammatory," and 80% of the aneurysms were pseudoaneurysmal in nature.

A large proportion of the aneurysms were in the splenic and arterial beds, but 26% were located in the pancreaticoduodenal arcade, and those had a mean size of 12.7 mm. Most (95%) were pseudoaneurysms.

The outcomes with ruptured VAA were quite good, Dr. Shukla said, noting that the technical success rate was 98.7%.

Although the 30-day reintervention rate with endovascular repair was higher, the difference between the groups was not statistically significant, and there was a trend toward a lower rate of major complications with endovascular repair.

Factors found to be predictors of mortality risk were older age and steroid use, while endovascular repair was found to be protective.

As for the patients with intact VAA, most presented without symptoms, and the most common etiology was atherosclerosis.

"When we looked at the distribution, this was very consistent with what has been reported in the literature, with the splenic and arterial beds really making up the lion’s share of this group. Notable is the fact that 6.7% of our patients had intact aneurysms in the pancreaticoduodenal arcade," he said.

Outcomes in those with intact aneurysms were good. A slightly higher 30-day reintervention rate in those who underwent endovascular repair did not reach statistical significance, and both the endovascular and open repair groups had low rates of major complications.

Survival at 3 years for intact aneurysms did not differ in the endovascular and open repair groups. This was partly due to a 0% 30-day mortality, and – despite the fact that the overall mortality in those with intact aneurysms was 10% – there was zero overall aneurysm-related mortality, he said.

Patients in the study were treated at a single institution between 2003 and 2013. Most were in their mid to late 50s, and there were more men and more individuals on immunosuppressive therapy in the ruptured VAA group. However, comorbidities were similar in the ruptured and intact VAA groups.

Visceral artery aneurysms occur only rarely, affecting 0.1% to 2% of the general population, but because of the increasing use of noninvasive imaging, more of these aneurysms are being detected incidentally.

When they are not found incidentally, they often go undetected and present when they rupture, Dr. Shukla said.

"Because of the increasing utilization and improvement of endovascular technology, we now have a lot of options to fix these aneurysms. But the outcomes are not well defined. Even less well defined is the outcome of ruptured visceral artery aneurysms," he said, noting that most studies have a small sample size or look only at endovascular or open repairs.

Overall, the current study showed that there is "an acute and sharp drop-off in survival with open repair," related, most likely, to operative mortality, he said.

"Based on the findings, we recommend aggressive treatment of pseudoaneurysms and true aneurysms in the pancreaticoduodenal arcade, and advocate for an endovascular-first approach to treating ruptured visceral artery aneurysms, acknowledging that success in this is really predicated on good planning based on advanced imaging and endovascular set-up," he concluded.

Dr. Shukla reported having no disclosures

BOSTON – Endovascular interventions for ruptured visceral artery aneurysms are associated with reduced morbidity and mortality, compared with open interventions, according to findings from a retrospective chart review.

Both endovascular and open repairs are safe and durable for intact visceral artery aneurysms, Dr. Ankur J. Shukla reported at a the 2014 Vascular Annual Meeting.

Of 261 patients who presented with visceral artery aneurysms (VAAs), 174 underwent repair: 74 who presented with ruptured VAA and 100 who presented with intact VAA. The majority – 73% of ruptured VAA and 62% of intact VAA – were repaired with an endovascular approach.

Among those with ruptured VAA, 30-day mortality was 7.4% following endovascular repair, compared with 28.6% following open repair, a significant difference, said Dr. Shukla of the University of Pittsburgh Medical Center.

Survival at 3 years of ruptured VAA was about 70% vs. 46.4% in the endovascular and open repair groups, respectively, he said.

About 65% of patients with ruptured VAA presented with pain, and about 30% presented in hemodynamic shock. The most commonly identified etiology was "inflammatory/pancreatitis inflammatory," and 80% of the aneurysms were pseudoaneurysmal in nature.

A large proportion of the aneurysms were in the splenic and arterial beds, but 26% were located in the pancreaticoduodenal arcade, and those had a mean size of 12.7 mm. Most (95%) were pseudoaneurysms.

The outcomes with ruptured VAA were quite good, Dr. Shukla said, noting that the technical success rate was 98.7%.

Although the 30-day reintervention rate with endovascular repair was higher, the difference between the groups was not statistically significant, and there was a trend toward a lower rate of major complications with endovascular repair.

Factors found to be predictors of mortality risk were older age and steroid use, while endovascular repair was found to be protective.

As for the patients with intact VAA, most presented without symptoms, and the most common etiology was atherosclerosis.

"When we looked at the distribution, this was very consistent with what has been reported in the literature, with the splenic and arterial beds really making up the lion’s share of this group. Notable is the fact that 6.7% of our patients had intact aneurysms in the pancreaticoduodenal arcade," he said.

Outcomes in those with intact aneurysms were good. A slightly higher 30-day reintervention rate in those who underwent endovascular repair did not reach statistical significance, and both the endovascular and open repair groups had low rates of major complications.

Survival at 3 years for intact aneurysms did not differ in the endovascular and open repair groups. This was partly due to a 0% 30-day mortality, and – despite the fact that the overall mortality in those with intact aneurysms was 10% – there was zero overall aneurysm-related mortality, he said.

Patients in the study were treated at a single institution between 2003 and 2013. Most were in their mid to late 50s, and there were more men and more individuals on immunosuppressive therapy in the ruptured VAA group. However, comorbidities were similar in the ruptured and intact VAA groups.

Visceral artery aneurysms occur only rarely, affecting 0.1% to 2% of the general population, but because of the increasing use of noninvasive imaging, more of these aneurysms are being detected incidentally.

When they are not found incidentally, they often go undetected and present when they rupture, Dr. Shukla said.

"Because of the increasing utilization and improvement of endovascular technology, we now have a lot of options to fix these aneurysms. But the outcomes are not well defined. Even less well defined is the outcome of ruptured visceral artery aneurysms," he said, noting that most studies have a small sample size or look only at endovascular or open repairs.

Overall, the current study showed that there is "an acute and sharp drop-off in survival with open repair," related, most likely, to operative mortality, he said.

"Based on the findings, we recommend aggressive treatment of pseudoaneurysms and true aneurysms in the pancreaticoduodenal arcade, and advocate for an endovascular-first approach to treating ruptured visceral artery aneurysms, acknowledging that success in this is really predicated on good planning based on advanced imaging and endovascular set-up," he concluded.

Dr. Shukla reported having no disclosures

BOSTON – Medical therapy for acute uncomplicated type B aortic dissections was effective in the short term, but was associated with low 6-year intervention-free survival in a review of 298 cases.

Furthermore, patients who received medical therapy without operative intervention had increased mortality at 6 years, compared with those who received intervention, Dr. Christopher A. Durham reported at the Vascular Annual Meeting.

During a mean follow-up of nearly 4.3 years, medical therapy failed in almost 60% of the patients; 114 died after an average of 2.7 years, and 87 required aortic intervention.

Aneurysmal degeneration was the indication for intervention in 65% of patients requiring intervention, and six of these patients experienced a ruptured aneurysm. "Only six of these patients underwent stent placement, with the remainder receiving open aortic replacement," said Dr. Durham of Massachusetts General Hospital, Boston.

The average time to operation in this subset of patients was 2.3 years. Visceral malperfusion was the indication for intervention in 18 patients (21%), and most underwent an endovascular intervention including either stenting or endovascular fenestration. A less common indication for intervention was retrograde type A dissection development in two patients. These patients underwent open replacement.

The average time to intervention in the subset of patients whose indication was not aneurysmal degeneration was 24 days. Early treatment failure – within 15 days of presentation – occurred in 37 patients (12%) and included 12 deaths and 25 interventions.

"In this group of patients who ultimately required an intervention within the acute period, aneurysmal degeneration was the indication in 25% of patients, all of whom were treated with an open approach," Dr. Durham said. Visceral malperfusion was the indication in half of the early interventions.

The 30-day mortality rate among patients with early intervention after initial medical therapy was 12%.

Freedom from intervention was 74% at 6 years, with most interventions occurring within the first 12 months. Intervention-free survival was 55% at 3 years and 41% at 6 years. Only end-stage renal disease was found to be predictive of failure, and age over 70 years was protective against failure (hazard ratio, 0.97), Dr. Durham said, adding that no variables associated with progression to intervention were identified.

Notably, although survival was similar during the first 3 years in those who remained on medical management and those who required intervention (73% and 78%, respectively), survival at 6 years was 58% and 76% in the groups, respectively.

"These data join emerging data demonstrating a survival benefit in patients undergoing intervention when compared to those who are treated with medical therapy alone," he said.

Study subjects were all patients who were initially managed medically for acute uncomplicated type B aortic dissection between March 1999 and March 2011 in a health care system. The patients had a mean age of 66 years at presentation, about 62% were men, and most were white. Nearly 75% had hypertension, and most of those were on therapy. About 5% had end-stage renal disease.

Failure of medical therapy was defined as any death or aortic-related intervention. Early failure was defined as failure within 15 days of presentation.

"Aortic dissection is the most common catastrophic event affecting the aorta, with an incidence exceeding that of ruptured abdominal aortic aneurysm.

"The majority of patients with type B aortic dissections, where the entry tear originates distal to the left subclavian artery, are treated with medical therapy," he said. In fact, medical management aimed at lowering the systolic blood pressure and pulse remains the standard of care, and a number of studies have demonstrated a favorable 1-year survival – ranging from 70% to 90% – with medical therapy alone in this population.

"However, at what cost?" Dr. Durham asked.

"The principal late complication of aortic dissection is aneurysmal degeneration of the outer wall of the false lumen, which has been reported to occur in up to 40% of medically treated patients," he said, adding that, because of a paucity of contemporary data regarding the natural history of medically treated patients, it has been unclear whether the natural history has been altered with current medical therapy.

The current findings suggest that operative intervention is associated with a survival benefit.

As Food and Drug Administration "approval has just been granted for thoracic stent grafts to be used in aortic dissection, it is clear that endovascular coverage of proximal aortic entry tears will become more common in the acute phase. As such, further study is needed to determine which patients presenting with type B dissections will benefit from early intervention," he said.

Dr. Durham reported having no disclosures.

Editor’s Note: The treatment of type B dissection is a controversial subject and this controversy will be addressed in an upcoming Point/Counterpoint article in Vascular Specialist.

BOSTON – Medical therapy for acute uncomplicated type B aortic dissections was effective in the short term, but was associated with low 6-year intervention-free survival in a review of 298 cases.

Furthermore, patients who received medical therapy without operative intervention had increased mortality at 6 years, compared with those who received intervention, Dr. Christopher A. Durham reported at the Vascular Annual Meeting.

During a mean follow-up of nearly 4.3 years, medical therapy failed in almost 60% of the patients; 114 died after an average of 2.7 years, and 87 required aortic intervention.

Aneurysmal degeneration was the indication for intervention in 65% of patients requiring intervention, and six of these patients experienced a ruptured aneurysm. "Only six of these patients underwent stent placement, with the remainder receiving open aortic replacement," said Dr. Durham of Massachusetts General Hospital, Boston.

The average time to operation in this subset of patients was 2.3 years. Visceral malperfusion was the indication for intervention in 18 patients (21%), and most underwent an endovascular intervention including either stenting or endovascular fenestration. A less common indication for intervention was retrograde type A dissection development in two patients. These patients underwent open replacement.

The average time to intervention in the subset of patients whose indication was not aneurysmal degeneration was 24 days. Early treatment failure – within 15 days of presentation – occurred in 37 patients (12%) and included 12 deaths and 25 interventions.

"In this group of patients who ultimately required an intervention within the acute period, aneurysmal degeneration was the indication in 25% of patients, all of whom were treated with an open approach," Dr. Durham said. Visceral malperfusion was the indication in half of the early interventions.

The 30-day mortality rate among patients with early intervention after initial medical therapy was 12%.

Freedom from intervention was 74% at 6 years, with most interventions occurring within the first 12 months. Intervention-free survival was 55% at 3 years and 41% at 6 years. Only end-stage renal disease was found to be predictive of failure, and age over 70 years was protective against failure (hazard ratio, 0.97), Dr. Durham said, adding that no variables associated with progression to intervention were identified.

Notably, although survival was similar during the first 3 years in those who remained on medical management and those who required intervention (73% and 78%, respectively), survival at 6 years was 58% and 76% in the groups, respectively.

"These data join emerging data demonstrating a survival benefit in patients undergoing intervention when compared to those who are treated with medical therapy alone," he said.

Study subjects were all patients who were initially managed medically for acute uncomplicated type B aortic dissection between March 1999 and March 2011 in a health care system. The patients had a mean age of 66 years at presentation, about 62% were men, and most were white. Nearly 75% had hypertension, and most of those were on therapy. About 5% had end-stage renal disease.

Failure of medical therapy was defined as any death or aortic-related intervention. Early failure was defined as failure within 15 days of presentation.

"Aortic dissection is the most common catastrophic event affecting the aorta, with an incidence exceeding that of ruptured abdominal aortic aneurysm.

"The majority of patients with type B aortic dissections, where the entry tear originates distal to the left subclavian artery, are treated with medical therapy," he said. In fact, medical management aimed at lowering the systolic blood pressure and pulse remains the standard of care, and a number of studies have demonstrated a favorable 1-year survival – ranging from 70% to 90% – with medical therapy alone in this population.

"However, at what cost?" Dr. Durham asked.

"The principal late complication of aortic dissection is aneurysmal degeneration of the outer wall of the false lumen, which has been reported to occur in up to 40% of medically treated patients," he said, adding that, because of a paucity of contemporary data regarding the natural history of medically treated patients, it has been unclear whether the natural history has been altered with current medical therapy.

The current findings suggest that operative intervention is associated with a survival benefit.

As Food and Drug Administration "approval has just been granted for thoracic stent grafts to be used in aortic dissection, it is clear that endovascular coverage of proximal aortic entry tears will become more common in the acute phase. As such, further study is needed to determine which patients presenting with type B dissections will benefit from early intervention," he said.

Dr. Durham reported having no disclosures.

Editor’s Note: The treatment of type B dissection is a controversial subject and this controversy will be addressed in an upcoming Point/Counterpoint article in Vascular Specialist.

BOSTON – Medical therapy for acute uncomplicated type B aortic dissections was effective in the short term, but was associated with low 6-year intervention-free survival in a review of 298 cases.

Furthermore, patients who received medical therapy without operative intervention had increased mortality at 6 years, compared with those who received intervention, Dr. Christopher A. Durham reported at the Vascular Annual Meeting.

During a mean follow-up of nearly 4.3 years, medical therapy failed in almost 60% of the patients; 114 died after an average of 2.7 years, and 87 required aortic intervention.

Aneurysmal degeneration was the indication for intervention in 65% of patients requiring intervention, and six of these patients experienced a ruptured aneurysm. "Only six of these patients underwent stent placement, with the remainder receiving open aortic replacement," said Dr. Durham of Massachusetts General Hospital, Boston.

The average time to operation in this subset of patients was 2.3 years. Visceral malperfusion was the indication for intervention in 18 patients (21%), and most underwent an endovascular intervention including either stenting or endovascular fenestration. A less common indication for intervention was retrograde type A dissection development in two patients. These patients underwent open replacement.

The average time to intervention in the subset of patients whose indication was not aneurysmal degeneration was 24 days. Early treatment failure – within 15 days of presentation – occurred in 37 patients (12%) and included 12 deaths and 25 interventions.

"In this group of patients who ultimately required an intervention within the acute period, aneurysmal degeneration was the indication in 25% of patients, all of whom were treated with an open approach," Dr. Durham said. Visceral malperfusion was the indication in half of the early interventions.

The 30-day mortality rate among patients with early intervention after initial medical therapy was 12%.

Freedom from intervention was 74% at 6 years, with most interventions occurring within the first 12 months. Intervention-free survival was 55% at 3 years and 41% at 6 years. Only end-stage renal disease was found to be predictive of failure, and age over 70 years was protective against failure (hazard ratio, 0.97), Dr. Durham said, adding that no variables associated with progression to intervention were identified.

Notably, although survival was similar during the first 3 years in those who remained on medical management and those who required intervention (73% and 78%, respectively), survival at 6 years was 58% and 76% in the groups, respectively.

"These data join emerging data demonstrating a survival benefit in patients undergoing intervention when compared to those who are treated with medical therapy alone," he said.

Study subjects were all patients who were initially managed medically for acute uncomplicated type B aortic dissection between March 1999 and March 2011 in a health care system. The patients had a mean age of 66 years at presentation, about 62% were men, and most were white. Nearly 75% had hypertension, and most of those were on therapy. About 5% had end-stage renal disease.

Failure of medical therapy was defined as any death or aortic-related intervention. Early failure was defined as failure within 15 days of presentation.

"Aortic dissection is the most common catastrophic event affecting the aorta, with an incidence exceeding that of ruptured abdominal aortic aneurysm.

"The majority of patients with type B aortic dissections, where the entry tear originates distal to the left subclavian artery, are treated with medical therapy," he said. In fact, medical management aimed at lowering the systolic blood pressure and pulse remains the standard of care, and a number of studies have demonstrated a favorable 1-year survival – ranging from 70% to 90% – with medical therapy alone in this population.

"However, at what cost?" Dr. Durham asked.

"The principal late complication of aortic dissection is aneurysmal degeneration of the outer wall of the false lumen, which has been reported to occur in up to 40% of medically treated patients," he said, adding that, because of a paucity of contemporary data regarding the natural history of medically treated patients, it has been unclear whether the natural history has been altered with current medical therapy.

The current findings suggest that operative intervention is associated with a survival benefit.

As Food and Drug Administration "approval has just been granted for thoracic stent grafts to be used in aortic dissection, it is clear that endovascular coverage of proximal aortic entry tears will become more common in the acute phase. As such, further study is needed to determine which patients presenting with type B dissections will benefit from early intervention," he said.

Dr. Durham reported having no disclosures.

Editor’s Note: The treatment of type B dissection is a controversial subject and this controversy will be addressed in an upcoming Point/Counterpoint article in Vascular Specialist.

BOSTON – In skilled hands, various vascular reconstructive methods used during pancreatic resections for adenocarcinoma result in early survival rates that are comparable to those in patients who undergo resection without vascular reconstruction, according to a retrospective review of cases.

This is important because up to 25% of cases in high-volume centers are borderline for resection using pancreaticoduodenectomy (Whipple procedure) because of vascular involvement. Resection is the only curative option for the disease, Dr. Michael D. Sgroi said at a meeting hosted by the Society for Vascular Surgery.

Of 270 Whipple procedures and total pancreatectomy procedures performed from January 2003 to February 2013 at a single institution, 147 were for pancreatic adenocarcinoma that involved the surrounding vasculature (T3 lesions); 60 of these involved vascular reconstructions (including 49 venous and 11 arterial reconstructions) and 87 were Whipple procedures without reconstruction, The venous reconstructions included 37 primary repairs, four reconstructions with CryoVein, three repairs using an autologous vein patch, three autologous saphenous reconstructions, and two portacaval shunts. The arterial reconstructions included seven hepatic artery reconstructions, and four were superior mesenteric artery reconstructions.

All were performed by the vascular surgery service, said Dr. Sgroi of the department of surgery, University of California, Irvine Medical Center, Orange.

Overall survival was greater than 18 months in the vascular reconstruction group, with no statistically significant difference seen between the various types of procedures or compared with the Whipple-only group. One perioperative death occurred (1.7%), and survival at 1 year for all reconstructions was 70.3% – a rate similar to the 72.6% survival among patients with T3 lesions who did not undergo vascular reconstruction.

Survival in the two groups remained similar at 3 years, but a survival advantage among those in the Whipple-only group emerged by year 4 and was statistically significant by year 5, Dr. Sgroi said.

No factors were found to be significantly associated with outcome, but there was a trend toward significance for positive lymph nodes and positive margins as predictors of survival. Positive margins were present in 22% of patients in the vascular reconstruction group, compared with only 11% of those in the Whipple-only group, he noted.

"Pancreatic adenocarcinoma is one of the most deadly neoplasms, with 1- and 5-year survival rates for all stages being 25% and 5%, respectively," he said, noting that resection is associated with high rates of morbidity.

Currently the only curative option for this disease is a margin-negative resection, but because most cases are not detected until they are in later stages, only about 20% of patients undergo resection, he said.

"As the morbidity and mortality rates have declined postoperatively following Whipple operations, the National Comprehensive Cancer Network guidelines have also changed to now consider borderline resectable or stage 2 tumors for resection. These are tumors that have portal vein, superior mesenteric vein, or confluence involvement as well as arterial involvement of less than 180 degrees of the common hepatic or right hepatic artery," he explained, adding that "in general, superior mesenteric artery or celiac access involvement is a contraindication to surgery, and these cases now account for about 25% of all Whipples performed in high-volume institutions."

The various approaches to reconstruction that can be performed have been used with acceptable patency rates and outcomes, and multiple single-institution reviews have demonstrated that both venous and arterial resections performed concomitantly with Whipple procedures have equivalent morbidity and mortality rates to Whipple performed without reconstruction.

"A flaw of these studies has always been that their sample size is small, diminishing the power of the study," Dr. Sgroi noted.

Further complicating the issue are two recent manuscripts demonstrating significantly increased morbidity and mortality with vascular reconstruction, while a review of the National Surgical Quality Improvement Program database showed that when vascular surgeons are involved, outcomes are comparable with and without reconstruction – with the exception of increased blood loss and time in the operating room with vascular reconstruction.

The findings of the current study support the latter finding.

Notably, with the advances in chemotherapy agents it is now protocol that all patients at the University of California, Irvine receive neoadjuvant chemotherapy, and survival was improved in those who received both vascular reconstruction and neoadjuvant chemotherapy, compared with those who received vascular reconstruction without neoadjuvant chemotherapy.

"We believe that experience matters with this operation and that there is a learning curve," he said.

An example involves the need for packed red blood cells. The average number of units of packed red blood cells given with each case declined over time, and now less than one unit is used per case, he noted.

"Pancreatic adenocarcinoma is a dismal disease with poor long-term survival. Performing a Whipple on T3 lesions with vascular invasion will allow for an increased amount of surgical resections, and it is possible to achieve equivalent survival outcomes, compared with patients who receive a Whipple only," he said, adding that further study is needed to determine if any of the multiple vascular reconstruction options is superior to the others.

"It is our recommendation that a multidisciplinary team with surgeons experienced with vascular reconstruction perform these operations, and that, if possible, these patients be referred to a high-volume institution for the best outcome," he concluded.

Dr. Sgroi reported having no disclosures.

BOSTON – In skilled hands, various vascular reconstructive methods used during pancreatic resections for adenocarcinoma result in early survival rates that are comparable to those in patients who undergo resection without vascular reconstruction, according to a retrospective review of cases.

This is important because up to 25% of cases in high-volume centers are borderline for resection using pancreaticoduodenectomy (Whipple procedure) because of vascular involvement. Resection is the only curative option for the disease, Dr. Michael D. Sgroi said at a meeting hosted by the Society for Vascular Surgery.

Of 270 Whipple procedures and total pancreatectomy procedures performed from January 2003 to February 2013 at a single institution, 147 were for pancreatic adenocarcinoma that involved the surrounding vasculature (T3 lesions); 60 of these involved vascular reconstructions (including 49 venous and 11 arterial reconstructions) and 87 were Whipple procedures without reconstruction, The venous reconstructions included 37 primary repairs, four reconstructions with CryoVein, three repairs using an autologous vein patch, three autologous saphenous reconstructions, and two portacaval shunts. The arterial reconstructions included seven hepatic artery reconstructions, and four were superior mesenteric artery reconstructions.

All were performed by the vascular surgery service, said Dr. Sgroi of the department of surgery, University of California, Irvine Medical Center, Orange.

Overall survival was greater than 18 months in the vascular reconstruction group, with no statistically significant difference seen between the various types of procedures or compared with the Whipple-only group. One perioperative death occurred (1.7%), and survival at 1 year for all reconstructions was 70.3% – a rate similar to the 72.6% survival among patients with T3 lesions who did not undergo vascular reconstruction.

Survival in the two groups remained similar at 3 years, but a survival advantage among those in the Whipple-only group emerged by year 4 and was statistically significant by year 5, Dr. Sgroi said.

No factors were found to be significantly associated with outcome, but there was a trend toward significance for positive lymph nodes and positive margins as predictors of survival. Positive margins were present in 22% of patients in the vascular reconstruction group, compared with only 11% of those in the Whipple-only group, he noted.

"Pancreatic adenocarcinoma is one of the most deadly neoplasms, with 1- and 5-year survival rates for all stages being 25% and 5%, respectively," he said, noting that resection is associated with high rates of morbidity.

Currently the only curative option for this disease is a margin-negative resection, but because most cases are not detected until they are in later stages, only about 20% of patients undergo resection, he said.

"As the morbidity and mortality rates have declined postoperatively following Whipple operations, the National Comprehensive Cancer Network guidelines have also changed to now consider borderline resectable or stage 2 tumors for resection. These are tumors that have portal vein, superior mesenteric vein, or confluence involvement as well as arterial involvement of less than 180 degrees of the common hepatic or right hepatic artery," he explained, adding that "in general, superior mesenteric artery or celiac access involvement is a contraindication to surgery, and these cases now account for about 25% of all Whipples performed in high-volume institutions."

The various approaches to reconstruction that can be performed have been used with acceptable patency rates and outcomes, and multiple single-institution reviews have demonstrated that both venous and arterial resections performed concomitantly with Whipple procedures have equivalent morbidity and mortality rates to Whipple performed without reconstruction.

"A flaw of these studies has always been that their sample size is small, diminishing the power of the study," Dr. Sgroi noted.

Further complicating the issue are two recent manuscripts demonstrating significantly increased morbidity and mortality with vascular reconstruction, while a review of the National Surgical Quality Improvement Program database showed that when vascular surgeons are involved, outcomes are comparable with and without reconstruction – with the exception of increased blood loss and time in the operating room with vascular reconstruction.

The findings of the current study support the latter finding.

Notably, with the advances in chemotherapy agents it is now protocol that all patients at the University of California, Irvine receive neoadjuvant chemotherapy, and survival was improved in those who received both vascular reconstruction and neoadjuvant chemotherapy, compared with those who received vascular reconstruction without neoadjuvant chemotherapy.

"We believe that experience matters with this operation and that there is a learning curve," he said.

An example involves the need for packed red blood cells. The average number of units of packed red blood cells given with each case declined over time, and now less than one unit is used per case, he noted.

"Pancreatic adenocarcinoma is a dismal disease with poor long-term survival. Performing a Whipple on T3 lesions with vascular invasion will allow for an increased amount of surgical resections, and it is possible to achieve equivalent survival outcomes, compared with patients who receive a Whipple only," he said, adding that further study is needed to determine if any of the multiple vascular reconstruction options is superior to the others.

"It is our recommendation that a multidisciplinary team with surgeons experienced with vascular reconstruction perform these operations, and that, if possible, these patients be referred to a high-volume institution for the best outcome," he concluded.

Dr. Sgroi reported having no disclosures.

BOSTON – In skilled hands, various vascular reconstructive methods used during pancreatic resections for adenocarcinoma result in early survival rates that are comparable to those in patients who undergo resection without vascular reconstruction, according to a retrospective review of cases.

This is important because up to 25% of cases in high-volume centers are borderline for resection using pancreaticoduodenectomy (Whipple procedure) because of vascular involvement. Resection is the only curative option for the disease, Dr. Michael D. Sgroi said at a meeting hosted by the Society for Vascular Surgery.

Of 270 Whipple procedures and total pancreatectomy procedures performed from January 2003 to February 2013 at a single institution, 147 were for pancreatic adenocarcinoma that involved the surrounding vasculature (T3 lesions); 60 of these involved vascular reconstructions (including 49 venous and 11 arterial reconstructions) and 87 were Whipple procedures without reconstruction, The venous reconstructions included 37 primary repairs, four reconstructions with CryoVein, three repairs using an autologous vein patch, three autologous saphenous reconstructions, and two portacaval shunts. The arterial reconstructions included seven hepatic artery reconstructions, and four were superior mesenteric artery reconstructions.

All were performed by the vascular surgery service, said Dr. Sgroi of the department of surgery, University of California, Irvine Medical Center, Orange.

Overall survival was greater than 18 months in the vascular reconstruction group, with no statistically significant difference seen between the various types of procedures or compared with the Whipple-only group. One perioperative death occurred (1.7%), and survival at 1 year for all reconstructions was 70.3% – a rate similar to the 72.6% survival among patients with T3 lesions who did not undergo vascular reconstruction.

Survival in the two groups remained similar at 3 years, but a survival advantage among those in the Whipple-only group emerged by year 4 and was statistically significant by year 5, Dr. Sgroi said.

No factors were found to be significantly associated with outcome, but there was a trend toward significance for positive lymph nodes and positive margins as predictors of survival. Positive margins were present in 22% of patients in the vascular reconstruction group, compared with only 11% of those in the Whipple-only group, he noted.

"Pancreatic adenocarcinoma is one of the most deadly neoplasms, with 1- and 5-year survival rates for all stages being 25% and 5%, respectively," he said, noting that resection is associated with high rates of morbidity.

Currently the only curative option for this disease is a margin-negative resection, but because most cases are not detected until they are in later stages, only about 20% of patients undergo resection, he said.

"As the morbidity and mortality rates have declined postoperatively following Whipple operations, the National Comprehensive Cancer Network guidelines have also changed to now consider borderline resectable or stage 2 tumors for resection. These are tumors that have portal vein, superior mesenteric vein, or confluence involvement as well as arterial involvement of less than 180 degrees of the common hepatic or right hepatic artery," he explained, adding that "in general, superior mesenteric artery or celiac access involvement is a contraindication to surgery, and these cases now account for about 25% of all Whipples performed in high-volume institutions."

The various approaches to reconstruction that can be performed have been used with acceptable patency rates and outcomes, and multiple single-institution reviews have demonstrated that both venous and arterial resections performed concomitantly with Whipple procedures have equivalent morbidity and mortality rates to Whipple performed without reconstruction.

"A flaw of these studies has always been that their sample size is small, diminishing the power of the study," Dr. Sgroi noted.

Further complicating the issue are two recent manuscripts demonstrating significantly increased morbidity and mortality with vascular reconstruction, while a review of the National Surgical Quality Improvement Program database showed that when vascular surgeons are involved, outcomes are comparable with and without reconstruction – with the exception of increased blood loss and time in the operating room with vascular reconstruction.

The findings of the current study support the latter finding.

Notably, with the advances in chemotherapy agents it is now protocol that all patients at the University of California, Irvine receive neoadjuvant chemotherapy, and survival was improved in those who received both vascular reconstruction and neoadjuvant chemotherapy, compared with those who received vascular reconstruction without neoadjuvant chemotherapy.

"We believe that experience matters with this operation and that there is a learning curve," he said.

An example involves the need for packed red blood cells. The average number of units of packed red blood cells given with each case declined over time, and now less than one unit is used per case, he noted.

"Pancreatic adenocarcinoma is a dismal disease with poor long-term survival. Performing a Whipple on T3 lesions with vascular invasion will allow for an increased amount of surgical resections, and it is possible to achieve equivalent survival outcomes, compared with patients who receive a Whipple only," he said, adding that further study is needed to determine if any of the multiple vascular reconstruction options is superior to the others.

"It is our recommendation that a multidisciplinary team with surgeons experienced with vascular reconstruction perform these operations, and that, if possible, these patients be referred to a high-volume institution for the best outcome," he concluded.

Dr. Sgroi reported having no disclosures.