Journal of Vascular Surgery
Volume 51, Issue 2 , Pages 487-493, February 2010

Do no harm

Presented at the Eastern Vascular Society, Philadelphia, Penn, September 25, 2009.

  • Keith D. Calligaro, MD

      Affiliations

    • Corresponding Author InformationReprint requests: Keith D. Calligaro, MD, Section of Vascular Surgery, Pennsylvania Hospital, 700 Spruce St., Ste. 101, Philadelphia, PA 19106

Section of Vascular Surgery, Pennsylvania Hospital, Philadelphia, Pa

Received 11 October 2009; accepted 13 October 2009.

Article Outline

 

Thank you, Dr Makaroun, for your kind remarks. It has been an honor and privilege to serve as President of the Eastern Vascular Surgery this past year. During this address, I will be referring to the Hippocratic Oath, which is attributed to the great Greek physician sometime during 470-370 B.C. Many of us may not have reviewed the oath in quite some time. In part, it states “I swear in the presence of the Almighty and before my family, my teachers, and my peers that according to my ability and judgment I will keep this Oath and Stipulation. To reckon all who have taught me this art equally dear to me as my parents and in the same spirit and dedication to impart a knowledge of the art of medicine to others … and I will seek the counsel of particularly skilled physicians where indicated for the benefit of my patient.” The first two sentences of the Oath mention some of the individuals whom I would like to briefly thank, namely my family, teachers, peers, past trainees, and partners.

I want to acknowledge my partner of almost 20 years, Matt Dougherty. Matt is one of my closest friends and a very loyal partner. He's a technically gifted surgeon and patients love him. I also want to thank all of our past vascular fellows. One of the reasons I really enjoy my job is the opportunity to train these young men and women.

I've been extremely fortunate to have had four outstanding mentors who took particular interest in my professional career. During my general surgery residency in Chicago, Dale Buchbinder was Chief of Vascular Surgery and took me under his wing. His enthusiasm for vascular surgery and its academic nature was a very strong incentive for me to choose vascular as a specialty. I was fortunate enough to train under Dr Veith at Montefiore Medical Center in New York. Dr Veith continues to be one of the most respected vascular surgeons in the country. Dr Veith was instrumental in my becoming the youngest member of the original Vascular Surgery Board of the American Board of Surgery. He is unsurpassed in his devotion and passion for vascular surgery. After my vascular fellowship, I came to Pennsylvania Hospital and joined Dom DeLaurentis. I was thrilled when Dom became President of this Society a few years after I joined him. Dr DeLaurentis appointed me Program Director of our vascular surgery fellowship and later Chief of Vascular Surgery. I want to thank him for always being available to talk things over and for his sage advice. The fourth mentor I want to thank is Enrico Ascher. He helped train me during my fellowship, has helped me immeasurably during my career as a young vascular surgeon, and is also a close friend. I consider Enrico to be one of the brightest and most creative thinkers in vascular surgery. He has a great sense of humor and a great sense of loyalty. Our friendship is one that I will always treasure. Although he was not involved in my training, Bob Hobson was an individual who I greatly respected, and for reasons I am not aware of, took a keen interest in my career. He was one of the great leaders in vascular surgery, and we all miss him.

Lastly, I want to thank my family for being here, especially my wife and my son. Anthony is an 11-year-old sports fanatic who was named to the All-Star team in soccer, basketball, and baseball. He's also a pretty bright kid. But most importantly, he has a great heart and is kind and considerate to his friends. I want to thank my wife Ina for so many things. We celebrated our 25th wedding anniversary three months ago with a big party for many of our friends and family. I'm continuously amazed by everything she fits into every day. Despite a full-time job as Assistant Dean at Temple School of Pharmacy, Ina manages to take care of us, get Anthony to school on time, and be the best wife I could ever hope for. She's my best friend and the most understanding and compassionate person I know. Ina, I love you very much.

Back to Article Outline

Do no harm 

A common practice when giving a Presidential address is to review past addresses to avoid repetition. After first believing I had come up with an original topic, I discovered that the Presidential address to the Eastern Vascular Society by Enrico Ascher, MD, in 2004 also dealt with the Hippocratic Oath.1 However, the emphasis and thrust of Dr Ascher's address was significantly different than mine, as I will be focusing on one particular sentence of the oath. I believe that vascular surgeons need to continually remind ourselves of the essence of the Hippocratic Oath: “I will follow that method of treatment which according to my ability and judgment, I consider for the benefit of my patient and abstain from whatever is harmful.” Many of us interpret these words as meaning “Do No Harm” when considering vascular interventions for our patients. We need to continually ask ourselves if we are indeed helping patients with our various endovascular and open vascular procedures, and every day we face difficult decisions. This topic may not be a popular one, as I am asking the vascular community whether the interventions we perform are truly indicated.

There may be several reasons for what may be diplomatically called an “overly aggressive approach” by some vascular surgeons. It may be that there is simply a disagreement about the best treatment, and surgeons believe they are honestly helping people. It may be that vascular surgeons want to be busy. Young surgeons feel pressure to operate, surgeons want to work, and there's a certain amount of peer pressure. Lastly, although we may not want to admit it, some surgeons take an aggressive approach for financial reasons. There are bills to pay.

I was privileged to co-author a paper on hospital privileges for vascular surgeons.2 Although the paper did not directly address the proper indications for different procedures, it established guidelines for hospital privileges based on recommended number of interventions for trainees and practitioners. I would like to examine some of the commonly and uncommonly performed procedures that we do and ask if are we helping patients or doing harm to them. Many of the following studies were performed with the intent to determine if these interventions were beneficial or not, and we all need to fully supports these ongoing efforts.

The first procedure I would like to discuss is carotid endarterectomy (CEA). Patients are frequently referred to me for a second opinion after the first vascular surgeon recommended surgery for an asymptomatic “critical carotid artery stenosis.” Would many vascular surgeons recommend carotid surgery for an 85 year old patient with a history of two myocardial infarctions and severe chronic obstructive pulmonary disease (COPD) with a documented asymptomatic 95% internal carotid artery stenosis? The Asymptomatic Carotid Artery Study (ACAS) showed that in asymptomatic patients with 60%-99% stenosis, CEA was associated with approximately a 6% stroke risk after five years compared with approximately 11% for patients treated with best medical treatment (aspirin) at that time.3 Although the study showed a clear benefit of surgery, the reality is that approximately 90% of patients who did not undergo CEA did not suffer an ipsilateral stroke after five years of follow-up. These results suggest that approximately 20 procedures need to be performed to prevent one stroke in five years. We must pause before recommending surgical intervention to prevent stroke in such patients, especially with newer agents such as Clopidogrel (Plavix) that may potentially even further decrease the risk of stroke with medical management. It does not make sense to perform a prophylactic CEA in a poor risk patient or one with an expected limited long-term survival.

Although some risk factors are not under the control of vascular surgeons, such as need for urgent or emergent CEA or history of ipsilateral stroke, others can be used to modify the decision-making process concerning asymptomatic patients. The Vascular Study Group of Northern New England identified preoperative risks for stroke or death in 2,714 patients undergoing 3,092 primary CEAs at 11 hospitals.4 In this study, preoperative risk factors that increased the risk of perioperative stroke included congestive heart failure (CHF), age more than 70 years, and contralateral carotid occlusion. Based on these results, vascular surgeons should seriously consider if prophylactic CEA is indicated in patients older than 70 with either CHF or contralateral occlusion. Do patients with these risk factors truly benefit from prophylactic surgery in terms of long-term benefits?

What impact does renal failure have on CEA? In a report of 22,080 patients who underwent CEA for symptomatic and asymptomatic carotid stenosis at 123 Veterans Affairs Medical Centers as part of the National Surgical Quality Improvement Program (NSQIP), patients with moderate renal insufficiency (glomerular filtration rate [GFR], 30-59 mL/min/1.73 m2) were found to have significantly increased cardiac (1.7% vs. 0.9%, P < .001) and pulmonary (2.1% vs. 1.3%, P < .001) complications compared with controls.5 Patients with severe renal insufficiency (GFR < 30 mL/min/1.73 m2) had significantly higher peri-operative mortality (3.1% vs. 1.0% control, P < .001). Vascular surgeons must question whether we are benefiting or causing harm to patients with renal insufficiency by subjecting them to CEA, even if they are symptomatic, when newer agents such as Clopidogrel are available.

One of the most controversial treatment modalities in vascular surgery today is carotid artery balloon angioplasty and stenting (CAS) compared with CEA. Current Centers for Medicare and Medicaid Services (CMS) policy limits reimbursements for CAS to only high-risk symptomatic patients. Despite these recommendations, a review by Steppacher et al showed that 91% of CAS procedures performed in New York and Florida in 2005 and 2006 by interventional cardiologists, interventional radiologists, and vascular surgeons were performed for asymptomatic disease.6 There is no Level I evidence supporting CAS as superior to medical management for asymptomatic patients. It is difficult to believe that most of these interventionalists were participating in industry-sponsored registries, which reimbursed for CAS in asymptomatic patients as part of a trial. As William Mackey, MD, stated in his Invited Commentary for this article, the fact that so many patients were treated by an intervention with dubious benefit may be due to “…locally prevailing opinion, individual whim, and financial motives.”7

Although many single-center, retrospective studies have suggested very low complication rates, other multi-center trials such as the French Endarterectomy vs Angioplasty in Patients with Symptomatic Severe Carotid Stenosis and the Stent-Supported Percutaneous Angioplasty of the Carotid Artery vs Endarterectomy trial have documented high stroke rates with CAS, especially in comparison to CEA.8, 9 However, these studies were criticized because of the low percentage of patients treated with embolic protection devices.

Certain risk factors may play a role in increasing the complication rate of CAS, such as age more than 80 years, atherosclerotic aortic arch, symptoms, and renal failure. In one single-center study, CAS in patients with creatinine > 1.3 mg/dl was associated with 37% complication rate and 11.1% stroke rate.10 Clearly, a peri-procedural stroke rate this high in a particular patient population will not be beneficial, whether they are symptomatic or not.

Many interventionalists originally believed that CAS would benefit “high-risk” elderly patients because of the potential high morbidity of CEA in these patients. However, age has been shown to be a most significant factor in outcome prediction of CAS with patients > 80 years old doing much worse than younger patients as seen during the lead-in phase of the Carotid Revascularization Endarterectomy vs Stenting Trial.11 In this study, the 30-day death/stroke rate for patients > 80 years old was 12.1%. In the Carotid RX Acculink/RX Accunet Post Approval Trial to Uncover Unanticipated or Rare Events 3500 study, the 30-day death/stroke/MI rate was 17.1% in symptomatic elderly patients and 8% in asymptomatic elderly patients.12 Based on these results, CAS should rarely be recommended for patients > 80 years old so as not to do harm to these patients.

In a review of 135,701 patients who underwent CEA or CAS culled from a Nationwide Inpatient Sample in 2005, postoperative stroke rates, mortality rates, and median total hospital charges were significantly higher for patients who underwent stenting compared with open surgery.13 The most dramatic finding was in symptomatic patients who underwent CAS, where the mortality rate was 4.6% and was significantly higher (1.4%) compared with patients who underwent CEA (P < .05). Interventionalists should pause and consider if approximately a 5% mortality rate associated with CAS is truly helpful even in symptomatic patients.

Benefits of renal artery bypasses should also be questioned. The National Inpatient Sample (NIS) was analyzed to identify patients undergoing renal artery bypass between 2000 and 2004.14 Renal artery bypasses were performed in combination with open abdominal aortic aneurysms (AAA; 0.6% of all renal bypasses), thoracoabdominal aortic aneurysm (TAAA) repair (0.3%), or aortobifemoral bypass (29.5%). The hospital mortality rate was 10.1% for renal bypasses performed for atherosclerosis, 11.5% with AAA repair, 9.9% with aortobifemoral bypass, and 9.9% when performed alone. Increased risk was associated with increasing age, female gender, chronic renal failure, congestive heart failure, and chronic lung disease. The authors found that patients treated at high-volume centers had lower mortality rates. Nonetheless, how many vascular surgeons inform their patients that there is approximately a 10% chance of dying from a renal artery bypass?

The number of renal arteries treated by balloon angioplasty and stenting (RA-PTAS) has exploded in recent years as cardiologists, radiologists, and vascular surgeons have embraced this technology.15, 16 In a series from Wake Forest University, a center that is renowned for treating renal artery disease, the results of renal artery balloon angioplasty and stenting were less than overwhelming.17 In 110 RA-PTAS performed on 99 patients, hypertension was cured in 1.1%, improved in 20.5%, and unchanged in 78.4%. Estimated glomerular filtration rate (eGFR) was improved in 27.7%, unchanged in 65.1%, and worsened in 7.2%. Therefore, although the procedure had a low complication rate, RA-PTA improved hypertension or renal function in only approximately one-quarter of patients and did not help or actually harmed three-quarters of patients. The authors concluded that the clinical relevance of early favorable changes after RA-PTAS appeared limited when assessed in a categorical fashion.

Recently some vascular surgeons have questioned whether indications for repair of abdominal aortic aneurysms (AAAs) should be liberalized despite the fact that two randomized studies concluded that early elective open surgery did not confer any late survival advantage in patients with AAAs as small as 4.0-5.5 cm, unless the aneurysm grew quickly or became symptomatic.18, 19 What about the fittest patients with expected excellent long-term survival? Based on a probability index analysis of the UK Small Aneurysm Trial, early elective surgery did not confer any survival benefit even in fit patients with small AAAs.20 A prospective, randomized, multi-center trial was designed to determine if there was a benefit of intervening for small aneurysms with endovascular aortic aneurysm repair (EVAR), since the morbidity and mortality with this intervention has been very low.21 During presentation of late-breaking clinical trials at the Vascular Annual Meeting (June 11-14, 2009), the Positive Impact of Endovascular Options for Treating Aneurysms Early investigators presented data showing there was no difference in aneurysm-related mortality, rupture, or survival between patients randomized to early endovascular repair or ultrasound surveillance for 4.0-5.0 cm AAAs. Based on these results, vascular surgeons should recommend surgery for AAAs < 5.0 cm, regardless of whether open or endovascular repair is being considered, only for rapidly expanding aneurysms or rupture.

Identification of appropriate risk factors can help determine the suitability for recommending aortic surgery. In a derivation cohort of 11,415 open and 11,415 endovascular elective AAAs repairs in Medicare beneficiaries from 2001 to 2004, increased absolute predicted mortality was associated with increasing age, type of repair (open vs endovascular), female gender, dialysis-dependency, congestive heart failure, and vascular disease.22 Would most vascular surgeons recommend open surgical repair for an 82-year-old, dialysis-dependent female with a history of CHF who presented with an asymptomatic 8 cm AAA and who was not a candidate for EVAR? This study predicted that patients > 80 years old with all risk factors were predicted to have a peri-operative mortality of 38% for elective open AAA surgery. The vascular surgeon must give serious consideration whether recommending open surgery is truly in the best interest of patients with some or all of these risk factors.

Several series have documented the high-mortality and paralysis rate associated with open repair of descending thoracic and thoracoabdominal aneurysms in state-wide or national surveys. In a national in-patient sample (NIS) of 1,976 open surgical repair of intact descending thoracic aortic aneurysms between 1988 and 2003, in-hospital mortality for patients 75 years or older was 17.6%.23 Even when all age groups were considered, 30-day mortality for intact thoraco-abdominal aneurysm repair was 19% between 1991 and 2002 in a California state-wide database.24

In an effort to expand the indications for treating thoracoabdominal aneurysms with endografts and avoiding a thoracotomy, hybrid operations have been proposed that combine an open abdominal operation, namely visceral and/or renal debranching, and endovascular grafting of the thoracoabdominal aneurysm. However, the abdominal portion of the operation is time-consuming and complicated, and the appropriateness of performing hybrid procedure should be questioned. In a series from Massachusetts General Hospital, composite mortality and/or permanent paraplegia occurred in 21.7% of 23 high-risk patients who underwent the hybrid repair.25 Also, 10% (7/70) of visceral/renal grafts occluded during follow-up. Even more alarming was a 40% composite mortality and/or permanent paraplegia rate in lower risk patients who underwent the hybrid operation. The authors concluded that the hybrid thoracoabdominal repair in high-risk patients had such significant morbidity and mortality that a non-interventional approach may be the more appropriate choice in many patients. In other words, the authors concluded that many high-risk patients with these aneurysms are best treated by “doing no harm” and not intervening.

Although it is becoming increasingly accepted that repair of descending thoracic aneurysms has better results with endovascular treatment than open surgery, patient selection remains a critically important factor whether any intervention should be recommended, especially when late outcomes are considered. In a series from Stanford of 103 patients, a five-year survival estimate of 31% was reported in patients who were considered inoperable and who were treated with endovascular repair compared with 78% for those who were open surgical candidates.26 Reflecting on this article in a review of endovascular repair of descending thoracic aneurysms, the in-coming President of the Eastern Vascular Society, Michel S. Makaroun, MD, concluded “This brings into question the appropriateness of any treatment in asymptomatic high-risk patients.”27 Again, we need to remind ourselves “Do No Harm.”

The potential high morbidity and mortality of infrainguinal bypass surgery in the very elderly is cause for concern. In a series of 150 lower extremity bypasses performed in patients ≥ 90 years old for limb salvage between 1996 and 2006 from Albany Medical College, the peri-operative mortality was 15% (vs. 3% in 5,443 bypasses in patients < 90 years old) and the one-year mortality was 45% (vs. 11% in patients < 90 years old).28 The authors concluded that the significantly higher mortality rate should “…temper the enthusiasm for an aggressive approach to limb salvage…” in patients ≥ 90 years old. Vascular surgeons should question whether we are doing harm to these elderly patients with attempted open revascularization. In a series from the State University of New York at Buffalo, the perioperative mortality was similarly 16.2% in patients ≥ 80 years old who underwent infrainguinal open revascularization for limb salvage compared with 2.9% (P = .009) in patients < 80 years old.29 These authors concluded that “open procedures carry a high peri-operative morality in the ≥ 80 year old age group and should be avoided if possible.”

Renal failure in octogenarians has a particularly ominous prognosis when open infrainguinal bypass surgery is performed. In a series of 2,404 infrainguinal bypasses gathered from the National Surgical Quality Improvement Program (NSQIP) in 2005 and 2006, the overall mortality was 2.7% and major complication rate was 18.7%.30 The combination of dialysis and age > 80 years resulted in a 13.3 times higher risk of death and 2.2 times higher risk of major complications. The authors concluded that “…stringent indications should be maintained due to the significant associated perioperative morbidity…,” especially in dialysis patients > 80 years old, when considering infrainguinal bypass surgery.

Risk stratification may be possible in patients with critical limb ischemia and may help to identify patients who should not undergo bypass surgery but instead be treated with endovascular intervention or primary amputation. In a series of patients who underwent infrainguinal vein bypass surgery for chronic limb ischemia, data was compiled from the Project of Ex-Vivo Graft Engineering via Transfection III randomized trial (n = 1,404) and a multicenter registry (n = 716) from three vascular centers.31 Their analysis identified a high-risk group of patients with chronic limb ischemia with a >50% chance of death or major amputation at one year. The authors identified dialysis, tissue loss, age ≥75, hematocrit ≤ 30, and advanced coronary artery disease as five significant predictors associated with poor amputation-free survival. Risk stratification methods might help vascular surgeons decide if infrainguinal bypass surgery is indicated, especially for dialysis-dependent patients > 80 years old.

So should a minimally invasive endovascular procedure be performed as the first step in poor risk patients to treat chronic lower extremity arterial occlusive disease? In a series of 306 threatened limbs treated by superficial femoral artery endovascular interventions at Methodist Hospital, patients with poor run-off had five-year cumulative patency rates of 52% ± 7% but had limb salvage rates of only 20% ± 6%, and freedom from recurrent symptoms of only 18% ± 9%.32 The authors concluded that patients with poor run-off may not benefit from percutaneous treatment of superficial femoral artery disease and may be better served by open surgical bypass.

Another issue to take into account in order to “Do No Harm” is that hospital surgical volume for a particular procedure correlates with operative mortality. Birkmeyer showed that mortality for CEA, lower extremity bypass, and open AAA repair was lower in high-volume hospitals in the United States compared with low-volume hospitals.33 A similar finding occurred in a study comparing open AAA repairs between high- and low-volume hospitals, which showed an absolute risk reduction of 3.3% for high-volume hospitals.34 The previously mentioned review from the University of Texas Southwest documented a nearly 5% risk reduction observed for renal artery bypass operations performed on low-risk patients in high-volume hospitals compared with low-volume hospitals.14

Back to Article Outline

What we're doing well 

Although vascular surgeons need to carefully assess whether any intervention is best for the patients we treat every day, we are doing many things well. There is data to support the concept that vascular surgeons act conscientiously and with their patients' best interests at heart. Regional variation in delivery of health care has been documented and may be due to different local practice styles, but geographic variation in CEA has actually been shown to be associated with variance in disease prevalence and not physician preference in a review of Medicare discharge data in the United States in 2003.35 We also may be performing CAS more selectively than other specialists, especially for asymptomatic disease. This may reflect our capability to offer either surgical or endovascular treatment for carotid disease and therefore not have a bias toward one intervention or the other. Although 91% of CAS procedures performed in New York and Florida in 2005 and 2006 by interventional cardiologists, interventional radiologists, and vascular surgeons were performed for asymptomatic disease, the lower proportion of CAS performed by vascular surgeons may be due to more careful patient selection.6

Although vascular surgeons should pause and consider whether poor risk patients will truly benefit from a particular open surgical or endovascular procedures, the results of interventions in properly selected patients performed are excellent and clearly beneficial. There have been numerous reports of outstanding results of CEA from single centers, but regional or national results are just as impressive. The operation has been shown to be extremely beneficial in preventing strokes in symptomatic patients with ≥70% ipsilateral carotid artery stenosis in a prospective randomized study.36 The Vascular Study Group of Northern New England reviewed 2,714 patients undergoing 3,092 primary CEAs at 11 hospitals.4 This study documented a 30-day stroke or death rate of only 1.8%. This finding is quite impressive considering that it was a prospective collection of contemporary data accumulated from 50 surgeons in hospitals of widely varying sizes from both community and academic centers.

Although age > 80 years has frequently been cited up to this point as a marker of worse outcomes for some vascular procedures, selective CEA in these patients may be beneficial, especially considering that stroke is a common cause of disability and death in this age group. In a single-center review from Padua, Italy, the authors carefully selected appropriate patients ≥80 years old for CEA, as noted by the fact that the incidence of cardiac and renal risk factors were the same as compared with patients <80 years old who underwent CEA at the same institution.37 All patients underwent pre- and postoperative evaluation by neurology consultants. The peri-operative stroke and death rate was 0%, the seven year freedom from stroke was 96.6%, and the seven-year freedom from death was 52.4%. Although vascular surgeons need to be careful to do no harm in all age groups, the excellent results from this report and others demonstrate that carefully selected patients ≥80 years old can be treated safely with CEA and enjoy long-term freedom from stroke and death.

Although the indications for CAS remain controversial, vascular surgeons perform these procedures with as low morbidity and mortality rates as other interventionalists.6

Recent reports of elective open surgical and endovascular repair of AAAs also have documented excellent outcomes when performed by vascular surgeons. Thirty-day and one-year mortality of elective open repair was 2.3% and 5.8%, respectively, and after EVAR was 0.5% and 5.7%, respectively, as reported by the Vascular Study Group of Northern New England from 2003 to 2007 with operations performed by 50 surgeons from 11 hospitals.38 Operative mortality for 323 open AAA repairs at 30 days was 2.8% overall based on the Lifeline registry, a closely monitored, audited, pooled, multicenter cohort.39

Extremely challenging problems such as descending thoracic aortic aneurysms can now be repaired with endografts (TEVAR). This method of treatment is associated with reasonably low mortality and complication rates. In the Medtronic Vascular Talent Thoracic Stent Graft System for the Treatment of Thoracic Aortic Aneurysms trial using the Medtronic Talent graft, 30-day mortality was 2.1%, paraplegia was 1.5%, paraperesis was 7.2%, and stroke was 3.6%. The 12-month results showed a 3.1% aneurysm related mortality with an endoleak rate of 12.2%.40

Although certain patient populations such as the elderly may be at high risk for lower extremity revascularization, endovascular interventions may play an important role in achieving limb salvage when patients are chosen using appropriate selection criteria. In a series of patients with critical limb ischemia with good run-off treated between 2001 and 2007 from the State University of New York at Buffalo, patients ≥80 years treated with endovascular interventions had significantly better overall improvement after two years (83%) than those treated by open revascularization (61%; P = .043).29

Back to Article Outline

Summary 

The following recommendations for elective vascular interventions should be considered my own personal guidelines and are expected to be controversial (Table I). Patients >80 years old and patients with chronic renal failure have been shown to be high risk or have poor long-term outcomes for many interventions. Prophylactic CEA should be performed only in low risk patients with expected good long-term survival and only when associated with low complications. Prophylactic CEA should not be offered to patients with dialysis-dependent renal failure. CAS should not be recommended for patients ≥80 years old, in patients with chronic renal failure, and if CEA can be performed (exceptions include lesions that are surgically inaccessible or patients with history of neck radiation or prior CEA). Renal artery bypass should not performed in patients ≥80 years old, in patients with moderate or severe chronic renal failure, in low-volume hospitals, or concomitantly with aortic surgery, unless an individual institution show excellent short- and long-term outcomes. Renal artery stenting should rarely be performed and possibly only after prospective randomized studies document its efficacy. Open AAA surgery should not be performed in dialysis-dependent patients ≥80 years old. Open TAA surgery should rarely be performed in patients ≥80 years old unless a center has documented excellent results in these patients. TEVAR alone or with hybrid de-branching operations should not be carried out in poor-risk patients. Infrainguinal arterial bypasses should not performed in patients ≥90 years old and superficial femoral artery endovascular interventions should not performed for limb salvage in patients with poor run-off.

Table I. “Do No Harm – when to avoid intervention”
Intervention to avoidPatient characteristics
Carotid endarterectomy – asymptomatic
1.High/intermediate-risk patients with limited long-term survival

2.Dialysis-dependent

Carotid artery stenting
1.≥80 years old

2.Chronic renal failure

3.CEA can otherwise be performed (consider stenting if history of radiation or prior CEA; anatomically inaccessible)

Renal artery bypass
1.≥80 years old

2.Chronic renal failure

3.Low-volume hospitals

4.Concomitant aortic surgery

Renal artery stentingUntil prospective randomized studies show benefit
Open AAA surgery≥80 years old and dialysis-dependent
Open TAA surgery≥80 years old
TEVARHigh-risk
Infrainguinal arterial bypass≥90 years old
Superficial femoral artery endovascularFor limb salvage with poor run-off

AAA, Abdominal aortic aneurysm; CEA, carotid endarterectomy; TAA, thoracic aortic aneurysm; TEVAR, thoracic endovascular aneurysm repair.

Exceptions to these guidelines would be 1) patients considered to have a much better long-term survival than those with similar risk factors and 2) documented excellent results with the procedure in question at that institution.

Exceptions to the above guidelines exist, especially in extremely good risk patients, in patients with expected excellent long-term survival, or when the proposed procedure is to be performed in a hospital with high volume and with documented excellent results.

Back to Article Outline

Conclusion 

These studies demonstrate that risk factor analysis for vascular procedures, specifically for factors such as age, chronic renal failure, congestive heart failure, and hospital volume, play a very significant role in helping determine which patients will be helped by vascular interventions versus those who will be harmed. Therefore, further investigations concerning outcome analysis and risk factor analysis should be encouraged. In closing, one of the most difficult aspects of being a successful and compassionate vascular surgeon is the balance between “Do No Harm” vs. “Do Not Be Afraid” to perform challenging and complex procedures while keeping the patient's best interests in mind. We must still encourage vascular fellows, young vascular surgeons, and even the more mature and experienced surgeons to learn new technology and embrace new ideas.

Back to Article Outline

Author contributions 


Conception and design: KC

Analysis and interpretation: KC

Data collection: KC

Writing the article: KC

Critical revision of the article: KC

Final approval of the article: KC

Statistical analysis: N/A

Obtained funding: N/A

Overall responsibility: KC

Back to Article Outline

 

It has been an honor to serve as the President of the Eastern Vascular Society. Thank you.

Back to Article Outline

References 

  1. Ascher E. Nostrums, quackery, and ethics in vascular surgery: How to remain true to the path of Hippocrates and still feed our families. J Vasc Surg. 2004;40:389–394
  2. Calligaro KD, Toursarkissian B, Clagett GP, Towne J, Hodgson K, Moneta G, et al. Guidelines for hospital privileges in vascular and endovascular surgery: recommendations of the Society for Vascular Surgery. J Vasc Surg. 2008;47:1–5
  3. Executive Committee for the Asymptomatic Carotid Atherosclerosis Study. Endarterectomy for asymptomatic carotid artery stenosis. JAMA. 1995;273:1421–1428
  4. Goodney PP, Likosky DS, Cronenwett JL Vascular Study Group of Northern New England. Factors associated with stroke or death after carotid endarterectomy in Northern New England. J Vasc Surg. 2008;48:1139–1145
  5. Sidawy AN, Aidinian G, Johnson ON, White PW, DeZee KJ, Henderson WG. Effect of chronic renal insufficiency on outcomes of carotid endarterectomy. J Vasc Surg. 2008;48:1423–1430
  6. Steppacher R, Csikesz N, Eslami M, Arous E, Messina L, Schanzer A. An analysis of carotid artery stenting procedures performed in New York and Florida (2005-2006): procedure indication, stroke rate, and mortality rate are equivalent for vascular surgeons and non-vascular surgeons. J Vasc Surg. 2009;49:1379–1386
  7. Mackey W. Invited commentary for: Steppacher R, Csikesz N, Eslami M, Arous E, Messina L, Schanzer A. An analysis of carotid artery stenting procedures performed in New York and Florida (2005-2006): Procedure indication, stroke rate, and mortality rate are equivalent for vascular surgeons and non-vascular surgeons. J Vasc Surg. 2009;49:1379–1386
  8. Mas JL, Chatellier G, Beyson B, et al. Endarterectomy versus angioplasty in patients with symptomatic severe carotid stenosis. NEJM. 2006;355:1660–1671
  9. The SPACE Collaborative Group. 30 day results from the SPACE trial of stent-protected angioplasty versus carotid endarterectomy in symptomatic patients: a randomised non-inferiority trial. Lancet. 2006;368:1239–1247
  10. Jackson BM, English SJ, Fairman RM, Karmacharya J, Carpenter JP, Woo EY. Carotid artery stenting: identification of risk factors for poor outcomes. J Vasc Surg. 2008;48:74–79
  11. Hobson RW, Howard VJ, Roubin GS, Brott TG, Ferguson RD, Popma JJ, et al. CREST Investigators Carotid artery stenting is associated with increased complications in octogenarians: 30 day stroke and death rates in the CREST lead-in phase. J Vasc Surg. 2004;40:1106–1111
  12. McCormick DJ, Vlad TFasseas. Carotid artery stenting will replace carotid endarterectomy. Perspect Vasc Surg Endovasc Ther. 2007;19:223–227
  13. McPhee JT, Schanzer A, Messina LM, Eslami MH. Carotid artery stenting has increased rates of post-procedure stroke, death, and resource utilization than does carotid endarterectomy in the United States, 2005. J Vasc Surg. 2008;48:1442–1450
  14. Modrall JG, Rosero EB, Smith SS, Arko FR, Valentine RJ, Clagett GP, et al. Operative mortality for renal artery bypass in the United States: results from the National Inpatient sample. J Vasc Surg. 2008;48:317–322
  15. Knipp BS, Dimick JB, Eliason JL, Cown JA, Henke PK, Proctor MS, et al. Diffusion of new technology for the treatment of renovascular hypertension in the United States: surgical revascularization versus catheter-based therapy, 1988-2001. J Vasc Surg. 2004;40:717–723
  16. Murphy TP, Soarses G, Kim M. Increase in utilization of percutaneous renal artery interventions by Medicaire beneficiaries, 1996-2000. AJR Am J Roentgenol. 2004;183:561–568
  17. Corriere MA, Pearce JD, Edwards MS, Stafford JM, Hansen KJ. Endovascular management of atherosclerotic renovascular disease: Early results following primary intervention. JVS. 2008;48:580–588
  18. The United Kingdom Small Aneurysm Trial Participants. Long-term outcomes of immediate repair compared with surveillance of small abdominal aortic aneurysms. N Engl J Med. 2002;346:1445–1452
  19. Lederle FA, Wilson SE, Johnson GR, Reinke DB, Littooey FN, Acher CW, et al. Immediate repair compared with surveillance of small abdominal aortic aneurysms. N Engl J Med. 2002;346:1437–1444
  20. Brown LC, Thompson SG, Greenhalgh RM, Powell JT UK Small Aneurysm Trial Participants. Fit patients with small abdominal aortic aneurysms (AAA) do not benefit from early intervention. J Vasc Surg. 2008;48:1375–1381
  21. Ouriel K, Clair DG, Kent KC, Zarins CK Positive Impact of Endovascular Options for Treating Aneurysms Early (PIVOTAL) Investigators. Endovascular repair compared with surveillance for patients with small abdominal aortic aneurysms. J Vasc Surg. 2009;50:449
  22. Giles KA, Schermerhorn ML, O'Malley J, Cotterill P, Jhaveri A, Pomposelli FB, et al. Risk prediction for perioperative mortality of endovascular vs open repair of abdominal aortic aneurysms using the Medicare population. J Vasc Surg. 2009;50:256–262
  23. Schermerhorn ML, Giles KA, Hamdan AD, Dalhberg SE, Hagberg R, Pomposelli F. Population-based outcomes of open descending thoracic aortic aneurysm repair. J Vasc Surg. 2008;48:821–827
  24. Rigberg DA, McGory MI, Zingmond DS, Maggard MA, Agustin M, Lawrence PF, et al. Thirty-day mortality statistics underestimate the risk of repair of thoracoabdominal aortic aneurysms: A statewide experience. J Vasc Surg. 2006;43:217–223
  25. Patel R, Conrad MF, Paruchuri V, Kwolek CJ, Chung TK, Cambria RP. Thoracoabdominal aneurysm repair: Hybrid versus open repair. J Vasc Surg. 2009;50:15–22
  26. Demers P, Miller DC, Mitchell RS, Kee ST, Sze D, Razavi MK, et al. Midterm results of endovascular repair of descending thoracic aortic aneurysms with first-generation stent grafts. J Thorac Cardiovasc Surg. 2004;127:664–673
  27. Chaer RA, Makaroun MS. Late failure after endovascular repair of descending thoracic aneurysms. Semin Vasc Surg. 2009;22:81–86
  28. Hnath J, Roddy SP, Darling C, Paty PSK, Taggert JB, Mehta M. Comparative results of open lower extremity revascularization in nonagenarians. J Vasc Surg. 2009;49:1459–1464
  29. Dosluoglu HH, Lall P, Cherr GS, Harris LM, Dryski ML. Superior limb salvage with endovascular therapy in octogenarians with critical limb ischemia. J Vasc Surg. 2009;50:305–316
  30. LaMuraglia GM, Conrad MF, Chung T, Hutter M, Watkins MT, Cambria RP. Significant perioperative morbidity accompanies contemporary infrainguinal bypass surgery: An NSQIP report. J Vasc Surg. 2009;50:299–304
  31. Schanzer A, Mega J, Meadows J, Samson RH, Bandyk DF, Conte MS. Risk stratification in critical limb ischemia: derivation and validation of a model to predict amputation-free survival using multicenter surgical outcomes data. J Vasc Surg. 2008;48:1464–1471
  32. Davies MG, Saad WE, Peden EK, Mohiuddin IT, Naoum JJ, Lumsden AB. Impact of runoff on superficial femoral artery endoluminal interventions for rest pain and tissue loss. J Vasc Surg. 2008;48:619–626
  33. Birkmeyer JD, Siewers AE, Finlayson EV, Stukel TA, Lucas FL, Batista I, et al. Hospital volume and surgical mortality in the United States. New Engl J Med. 2002;346:1128–1137
  34. Dimick JB, Cown JA, Stanley JC, Henke PK, Pronovost PJ, Upchurch GR. Surgeon specialty and provider volumes are related to outcome of intact abdominal aortic aneurysm repair in the United States. J Vasc Surg. 2003;38:739–744
  35. Magner D, Mirocha J, Gewertz BL. Regional variation in the utilization of carotid endarterectomy. J Vasc Surg. 2009;49:893–901
  36. North American Symptomatic Carotid Endarterectomy Trial Collaborators. Beneficial effect of carotid endarterectomy in symptomatic patients with high grade stenosis. NEJM. 1991;325:445–453
  37. Balotta E, Da Giau G, Ermani M, Meneghetti G, Saladini M, Manara R, et al. Early and long-term outcomes of carotid endarterectomy in the very elderly: An 18-year single-center study. J Vasc Surg. 2009;50:518–525
  38. Beck AW, Goodney PP, Nolan BW, Likosky DS, Eldrup-Jorgensen J, Cronenwett JL. Predicting 1-year mortality after elective abdominal aortic aneurysm repair. J Vasc Surg. 2009;49:838–844
  39. Zwolak RM, Sidawy AN, Greenberg RK, Schermerhorn ML, Shackelton R, Siami FS. Lifeline registry of endovascular aneurysm repair: open repair surgical controls in clinical trials. J Vasc Surg. 2008;48:5111–5118
  40. Fairman RM, Criado F, Farber M, Kwolek C, Mehta M, White R, et al. VALOR Investigators Pivotal results of the Medtronic Vascular Talent thoracic stent graft system: The VALOR Trial. J Vasc Surg. 2008;48:546–554

 Competition of interest: none.

 The editors and reviewers of this article have no relevant financial relationships to disclose per the JVS policy that requires reviewers to decline review of any manuscript for which they may have a competition of interest.

PII: S0741-5214(09)02254-X

doi:10.1016/j.jvs.2009.10.106

Journal of Vascular Surgery
Volume 51, Issue 2 , Pages 487-493, February 2010

Article Tools