Vascular Surgery: International, Multispecialty Position Statement on Carotid Stenting, 2013 and Contributions of a Vascular Surgeon at Peak Career – Richard Paul Cambria, MD

Author and Curator: Aviva Lev-Ari, PhD, RN

Part One:

Vascular Surgery International, Multispecialty Position Statement on Carotid Stenting, 2013

Part Two:

Contributions of a Vascular Surgeon at Peak Career – Richard Paul Cambria, MD, Chief, Division of Vascular and Endovascular Surgery Co-Director, Thoracic Aortic Center @ MGH

I. Recollection of a visit at Dr. Cambria’s Office, 2004

II. Shadowing Dr. Cambria in OR @MGH

III. Dr. Cambria: Selection of Contributions to Scientific Research on Vascular Surgery

IV. Cardiovascular Clinical Observational Experience – Aviva Lev-Ari, PhD, RN 

V. Cases with Complications: CEA and CAS

Part Three:

On 8/1/2013, Cleveland Clinic Reports Equivalence between carotid endarterectomy (CEA) and open-heart surgery (OHS) and carotid artery stenting (CAS) followed by coronary artery bypass graft (CABG) surgery or non-CABG cardiac surgery

 

 

Part One:

Vascular Surgery International, Multispecialty Position Statement on Carotid Stenting, 2013 Part

No other invasive intervention procedure in the history of Vascular Surgery has stormed the profession more than the two treatment options for carotid artery partial to complete blockage than Carotid endarterectomy (CEA) and Carotid angioplasty and stenting (CAS).

The debate required evidence based resolution for the two treatment options in terms of patient outcomes and adverse events. As the title of the Position statement explained below, the verdict is non equivocal: Routine Carotid Stenting is inferior to Carotid endarterectomy (CEA) from a patient safety and outcomes.

A special Report was published in

Stroke. 2013;44:1186-1190; originally published online March 19, 2013

Why Calls for More Routine Carotid Stenting Are Currently Inappropriate : An International, Multispecialty, Expert Review and Position Statement

Anne L. Abbott, MD, PhD, FRACP; Mark A. Adelman, MD; Andrei V. Alexandrov, MD;

P. Alan Barber, PhD, MBChB, FRACP; Henry J.M. Barnett, CC, MD; Jonathan Beard, FRCS, ChM, MEd;

Peter Bell, FRCS, MD, DSC, KBE; Martin Björck, MD, PhD; David Blacker, MD, FRACP;

Leo H. Bonati, MD; Martin M. Brown, MD, FRCP; Clifford J. Buckley, MD, FACS;

Richard P. Cambria, MD; John E. Castaldo, MD; Anthony J. Comerota, MD, FACS, RVT;

E. Sander Connolly, Jr, MD; Ronald L. Dalman, MD, FACS;

Alun H. Davies, MA, DM, FRCS, FHEA, FEBVS, FACPh; Hans‐Henning Eckstein, MD, PhD;

Rishad Faruqi, MD, FRCS (Eng), FRCS (Ed), FACS; Thomas E. Feasby, MD; Gustav Fraedrich, MD;

Peter Gloviczki, MD; Graeme J. Hankey, MD, FRACP; Robert E. Harbaugh, MD, FAANS, FACS;

Eitan Heldenberg, MD; Michael G. Hennerici, MD; Michael D. Hill, MD, MSc, FRCPC;

Timothy J. Kleinig, PhD FRACP, MBBS (Hons), BA;

Dimitri P. Mikhailidis, BSc, MSc, MD, FRSPH, FCP, FFPM, FRCP, FRCPath;

Wesley S. Moore, MD; Ross Naylor, MD, FRCS; Andrew Nicolaides, MS, FRCS, PhD (Hon);

Kosmas I. Paraskevas, MD, PhD; David M. Pelz, MD, FRCPC; James W. Prichard, MD;

Grant Purdie, MD, FRACP; Jean‐Baptiste Ricco, MD, PhD; Peter A. Ringleb, MD, PhD;

Thomas Riles, MD; Peter M. Rothwell, MD, PhD, FRCP, FMedSci;

Peter Sandercock, MA, DM, FRCPE, FMedSci; Henrik Sillesen, MD, DMSc;

J. David Spence, BA, MBA, MD, FRCPC, FCAHS; Francesco Spinelli, MD;

Jonathon Sturm, MBChB, PhD; Aaron Tan, MD, FRACP; Ankur Thapar, BSc, MBBS, MRCS;

Frank J. Veith, MD; Tissa Wijeratne, MD, FRACP; Wei Zhou, MD

[DISCLOSURE for Richard Cambria: He is co‐PI for a future Transcervical Carotid Stenting/Flow Reversal Trial (ROADSTER).]

Special Reports Main Points

Key Words: carotid angioplasty/stenting ◼ carotid endarterectomy ◼ carotid

stenosis ◼ health policy ◼ stroke prevention

In conclusion, current global evidence shows that, even in the best academic centers, CAS is less effective (causing more strokes) and more expensive than CEA. It is premature that some guidelines have recently added support for routine practice CAS as an alternative to CEA for

• asymptomatic43,44 and
• low/ average surgical risk symptomatic patients43–45

because CAS may easily be misinterpreted by readers as being equivalent for

• stroke prevention46 and
• historical procedural standards were cited.

CAS, for these patients, should still only be performed and paid for within well‐designed, adequately powered trials. The US Center for Medicare and Medicaid Services is doing its job and setting an excellent global example. It is protecting Medicare beneficiaries from routine practice procedures, which are currently more likely to harm them and waste finite resources47 that could be used for their advantage. Meanwhile, we need to reassess the current routine practice role of CEA and deliver optimal current medical treatment to all who need it.

To avoid misguidance from calls for more routine practice (nontrial) carotid angioplasty/stenting (CAS), we need to distinguish relevant facts and patients’ best interests from all else (distractions). A recent editorial by White and Jaff1 is one publication which illustrates this need particularly well. First, these authors are correct in reminding us that the responsibility of physicians is to provide best patient care, putting aside personal interest. This is inherent in any profession.2 However, misconception, bias, and conflict of interest exist. Therefore, healthcare payment organizations, such as the US Center for Medicare and Medicaid Services are important gatekeepers to facilitate patient access to interventions that are likely to help them, as opposed to all others.

It is also true that CAS and carotid endarterectomy (CEA) result in better outcomes when patients are carefully selected and skilled operators perform the procedures in experienced centers.1 We would add that key indicators (such as 30‐day periprocedural stroke/death rates) must be accurately measured in routine (real‐world) practice, particularly as stroke and death rates here may be unacceptably higher than in trials. 3–5 Therefore, it is most appropriate, as suggested by White and Jaff,1 that coverage for carotid procedures be dependent on facility accreditation and audited measurement of key standards indicators in all practices performing these procedures.

This is a priority issue. White and Jaff1 also correctly state “a major change in evidence based stroke prevention strategies will require clinical trial data. ,7,8 meta‐analyses, and routine practice.9–14 Most of these data relate to low/average risk symptomatic patients and demonstrate that, for these patients, even in the best academic centers, CAS is consistently associated with significantly higher rates of stroke or death (during or after the periprocedural period) compared with CEA.

It is incorrect that CREST “failed to show a difference in overall stroke rate between CAS and CEA” as stated by White and Jaff.1 In CREST, for average surgical risk symptomatic patients, the periprocedural stroke and death rates were 6.0% for CAS versus 3.2% for CEA (hazard ratio, 1.89; 95% confidence interval, 1.11–3.21; P=0.02).8

The higher periprocedural risk of stroke or death with CAS is particularly evident in the most senior patients (>68–70 years),13,15,16 those undergoing the procedure <7 days of incident cerebral or retinal ischemic symptoms17 (when CEA has the highest stroke prevention potential),18 those undergoing CAS outside clinical trials,19 and those with certain anatomic features.20 No study has shown that CAS is more effective than CEA in preventing stroke. Further, most analyses show that CAS costs considerably more,21–24 despite calculations derived from CREST results.25 No randomized trial has been adequately powered to compare the procedural and longer term risk of CAS on stroke or death in low/average risk asymptomatic patients. However, in CREST, the direction of effect was toward nearly twice the risk (periprocedural stroke/death rate was 2.5% for CAS versus 1.4% for CEA; hazard ratio, 1.88; 95% confidence interval, 0.79–4.42; P=0.15).8 This was consistent with the significantly higher periprocedural stroke rates seen in CREST CAS‐treated symptomatic patients8 and nontrial CAS‐treated asymptomatic patients.9,26

Meanwhile, medical treatment for asymptomatic carotid disease has improved significantly since past randomized trials of medical treatment alone versus additional CEA.27–32 Medical treatment consists of identification of risk factors for heart and vascular disease and risk reduction using healthy lifestyles and appropriate drugs. Improvement in medical treatment is clear from robust analyses of all published comparable, quality stroke rate calculations (including from, and within, randomized surgical trials) of patients with 50% to 99% asymptomatic carotid stenosis. This knowledge is not, as claimed by White and Jaff,1 derived from short‐cut extrapolation from coronary artery trials. Using the same standardized rate calculations, we are now seeing an average annual rate of ipsilateral stroke of ≈0.5% with medical treatment alone.30,33,34 This is about 3X— lower than that of asymptomatic CREST CAS‐treated patients and about half the rate of asymptomatic CREST CEA‐treated patients.7,9 This low rate with medical treatment is likely to fall further with improvements in efficacy, definition, and implementation.

However, recently published rate calculations indicate that, at most, only ≈2.5% of low/average CEA risk patients with 50% to 99% asymptomatic carotid stenosis will receive a stroke prevention benefit from CEA or CAS during their remaining average 10‐year lifetime if they receive good, current medical treatment (assuming the procedural risk of stroke/death is always zero).35 This indicates that a one‐size‐fits‐all procedural approach for these asymptomatic patients is now unlikely to be beneficial overall. We need to be much more selective. Research is required to determine which asymptomatic subgroups now benefit from carotid procedures in addition to current optimal medical treatment.

We have found no direct information about the influence of current medical treatment in patients with low/average CEA risk symptomatic carotid stenosis. However, improving results for medically treated asymptomatic patients27–32 and procedural trial asymptomatic and symptomatic patients8 indicate that a 6% periprocedural risk of

• stroke or
• death (the current standard) is now too high.

New randomized and risk stratification studies are required using current optimal medical treatment and procedural methods.36 For example,

• improved plaque37 and
• thrombus identification38 or
• embolic signal detection39 above and below the stenosis

may help better identify carotid plaques responsible for carotid territory ischemic symptoms. Further, the best approach for patients with high surgical risk carotid stenosis remains uncertain because risk of stroke or death has not been measured with any standard of medical treatment or adequate procedural trials. However, some registries show significantly higher risks of stroke/death with CAS compared with CEA in asymptomatic and symptomatic high surgical risk patients.40

 Incidence of MI

Calls from other authors for more routine CAS on the grounds of lower periprocedural myocardial infarction (MI) rates compared with CEA are distracting.41 MI is not a measure of stroke prevention efficacy, even though it is an important procedural complication. The inclusion of periprocedural MI with stroke and death in the primary outcome measure in CREST resulted in primary outcome equivalence between CAS and CEA. However, it did not result in efficacy equivalence. In CREST, 1.1% (14/1262) of CAS patients had periprocedural clinical MI (biomarkers plus chest pain/ECG evidence) compared with 2.3% (28/1240) of CEA patients7 (P=0.03). However, periprocedural stroke was nearly twice as common (81/2502; 3.2%)7 as periprocedural clinical MI (42/2502; 1.7%) and, as mentioned above, CAS caused almost twice as many of these strokes as CEA. Further, in CREST, the mortality rate up to 4 years was equally poor for CREST patients with periprocedural stroke (20%),42 periprocedural clinical MI (19%),41 or periprocedural biomarker‐positive only MI (25%).41 Finally, nonfatal stroke was associated with a poorer quality of life at 1 year than nonfatal MI.7 Therefore, MI is a measure of carotid procedural risk (not benefit) and must be considered separately from stroke risk.  Moreover, in CREST, CAS‐associated stroke was more troublesome for patients than CEA‐associated MI.

 Conclusion

Calls for More Routine Carotid Stenting Are Currently Inappropriate, 3/2013

SOURCE

Stroke. 2013;44:1186-1190

VIEW VIDEO – 

Carotid Artery Disease and Stroke: Prevention and Treatment – John Hopkins

VIEW VIDEO –

Carotid Endarterectomy with Temporary Bypass – A Fifty year old procedure

Docteur Jean VALLA 
Chirurgien Cardiovasculaire et Thoracique
AIHR/ACCA – Ancien Chirurgien des Hôpitaux Universitaires.
Membre de la Société de Chirurgie Thoracique et Cardiovasculaire de Langue Française Conventionné

Carotid artery stenosis is the narrowing of the carotid arteries. These are the main arteries in the neck that supply blood to the brain. Carotid artery stenosis, also called carotid artery disease, is a major risk factor for ischemic stroke.The narrowing is usually caused by plaque in a blood vessel. Plaque forms when cholesterol, fat and other substances build up in the inner lining of an artery.Depending on the degree of stenosis and the patient’s overall condition, carotid artery stenosis can usually be treated with surgery. The procedure is called carotid endarterectomy. It removes the plaque that caused the carotid artery to narrow. Carotid endarterectomy has proven to benefit patients with arteries stenosed (narrowed) by 70 percent or more. For people with arteries narrowed less than 50 percent, anti-clotting medicine is usually prescribed to reduce the risk of ischemic stroke.

VIEW VIDEO –

Carotid angioplasty and stenting (CAS) – Mayo Clinic

In carotid angioplasty and stenting, a long hollow tube called a catheter is inserted in the femoral artery in the groin area. The catheter is then maneuvered through the arteries until it reaches the narrowing in the carotid artery in the neck. An umbrella-shaped filter is inserted beyond the narrowing to catch any plaque or debris that may break off during the procedure. Then, a tiny balloon at the end of the catheter is inflated to push the plaque to the side and widen the vessel. A small metal coil called a stent is inserted into the vessel. The stent serves as a scaffold to help prevent the artery from narrowing again.

Carotid Artery Stenting

Part Two:

Contributions of a Vascular Surgeon at Peak Career – Richard Paul Cambria, MD, Chief, Division of Vascular and Endovascular Surgery Co-Director, Thoracic Aortic Center @ MGH

I. Recollection of a visit at Dr. Cambria’s Office @MGH, 2004

The author arrived for a 4PM appointment @ MGH with a referral from NWH for a Carotid artery duplex scan that in 2004 was not performed at NWH. The consultation appointment with Dr. Kwolek CJ, a vascular surgeon trained under Dr. RP Cambria, took place in Dr. Cambria’s Office. Few minutes into the patient Medical History interview, Dr. Kwolek was called for an emergency in the OR and asked me to wait for him till he comes back. I looked around and found myself in a 14’x22′ Room, the Office of Dr. Richard Cambria @ MGH, Chief Vascular Surgery and among the Top ten in the World. Except for the glass entrance door and the wide window to the right of the entrance – 3 1/2 walls from the ceiling to one yard above the floor where completely covered with framed Awards, licenses, renewed licenses, Pictures with graduating Medical Students, Pictures with Faculty, with Patients and in the OR. I waited for Dr. Kwolek’s return for the completion of my Medical History Interview about 30 minutes. I used that time to walk along the walls in Dr. Cambria’s Office and read the framed Exhibits. It was clear to me that this Office will need, one day, in the future, to become a Museum @MGH, for most significant milestones in Vascular Surgery, a branch of Cardiothoracic Surgery. Dr. Kwolek returned and completed the interview, scheduled my Lab appointment and the next appointment to discuss the duplex scan results.

II. Shadowing Dr. Cambria in OR @MGH

Per section IV, below which described the author’s Cardiovascular Clinical Observational Experience, I recorded my Shadowing experience at the OR @MGH, including Dr. Cambria performing a CEA on a 84 year old women under going aorta valve replacement (performed by Dr. Walker) priot to a CEA performed by Dr. Cambria. It was all captivating to watch his double gloved hands performing sutures on a  >95% blocked carotid artery prior to incision.

The dexterity and the speed of  Dr. Cambria’s fingers’ movement, could only have reminded me of World #1 Harp Player: Nicanor Zabaleta, which I met in person, in the presence of my prominent Harp teacher, on his US Tour in 11/1989. He was awarded the Premio Nacional de Música of Spain in 1982 and six years later, in 1988, he was elected to the Real Academia de Bellas Artes de San Fernando. Dr. Cambria’s and Mr. Zabaleta’s fingers dexterity and eye hand coordination, both are of the rarest endowments in fine motor precision and perfection with Worldly finest outcomes in art, Surgery is Art, the mastering of the Harp is Art, too.

The Author in the OR — Mass General Hospital, Boston

Cardiac Surgery – Operating Room

Supervisor:             Dr. J. Walker, Cardiac Surgeon

Experience: Shadowing Open Heart Surgery at MGH

1/24/2005: Carotid Artery endarterectomy operation by Dr. Richard Cambria

1/24/2005: Mitral Valve Replacement by Dr. Jennifer Walker

1/26/2005: Aorta Valve Replacement and Coronary Artery Bypass Grafting by Dr. Jennifer Walker

[Saphenous vein harvested from the leg and Radial vein harvested from the right arm]

III. Dr. Cambria: Selection of Contributions to Scientific Research on Vascular Surgery

The Author covered In Part One, Dr. Cambria’s participation in and contribution to the International, Multispecialty Position Statement on Carotid Stenting, 2013.

In Part Two Section II, I share with the e-Reader watching Dr. Cambria in the Surgical Theater performing CEA

In Part Two Section III, I am carrying with me the heavy weight of my Recollections from a Visit to his Office in 2004, my experience shadowing Dr. Cambria in the OR @MGH on 1/24/2005. Now I am giving back.

I became aware that both events have impacted  favorably my 7/2013, Editorial decision, for a forthcoming book on Cardiovascular Disease in 2013. The Editorial decision is two fold:

• the selection and representation of a prominent Vascular Surgery Center in the US, @MGH, and
• my personal decision to select a Vascular Surgeon at Peak Career – Richard Paul Cambria, MD @MGH.

The decision to focus on Peripheral Vascular Surgery @MGH as described in Dr. Richard P Cambria’s research had yielded one Sub-Chapter (5.5) in Chapter 5

Chapter 5

Invasive Procedures by Surgery versus Catheterization

in Volume Three in a forthcoming three volume Series of e-Books on Cardiovascular Diseases

Cardiovascular Diseases: Causes, Risks and Management

This very Sub-Chapter, 5.5, represents milestones in Dr. Cambria as a Vascular Surgeon. His eminent profile as a Vascular Surgery Researcher, is now in: 

 

Volume Three

Management of Cardiovascular Diseases

Justin D. Pearlman MD ME PhD MA FACC, Editor

Leaders in Pharmaceutical Business Intelligence, Los Angeles

Aviva Lev-Ari, PhD, RN

Editor-in-Chief BioMed E-Book Series

Leaders in Pharmaceutical Business Intelligence, Boston

avivalev-ari@alum.berkeley.edu

5.5.1 Vascular Surgery: International, Multispecialty Position Statement on Carotid Stenting, 2013 and Contributions of a Vascular Surgeon at Peak Career – Richard Paul Cambria, MD @MGH

Aviva Lev-Ari, PhD, RN

5.5.2 Carotid Stenting: Vascular surgeons have pointed to more minor strokes in the stenting group and cardiologists to more myocardial infarctions in the CEA cohort.

Aviva Lev-Ari, PhD, RN

5.5.3 Carotid Endarterectomy (CAE) vs. Carotid Artery Stenting (CAS): Comparison of CMMS high-risk criteria on the Outcomes after Surgery:  Analysis of the Society for Vascular Surgery (SVS) Vascular Registry Data

Larry H. Bernstein, MD, FCAP and Aviva Lev-Ari, PhD, RN

Similarly, catheter-based interventions offer less invasive alternatives to open surgery for the abdomenal aorta.

5.5.4 Open Abdominal Aortic Aneurysm (AAA) repair (OAR) vs. Endovascular AAA Repair (EVAR) in Chronic Kidney Disease (CKD) Patients –  Comparison of Surgery Outcomes

Larry H. Bernstein, MD, FCAP and Aviva Lev-Ari, PhD, RN

5.5.5 Effect of Hospital Characteristics on Outcomes of Endovascular Repair of Descending Aortic Aneurysms in US Medicare Population

Larry H. Bernstein, MD, FCAP and Aviva Lev-Ari, PhD, RN

5.5.6 Improved Results for Treatment of Persistent type 2 Endoleak after Endovascular Aneurysm Repair: Onyx Glue Embolization

Larry H Bernstein, MD, FCAP and Aviva Lev-Ari, PhD, RN

5.5.7 Endovascular Lower-extremity Revascularization Effectiveness: Vascular Surgeons (VSs), Interventional Cardiologists (ICs) and Interventional Radiologists (IRs)

Aviva Lev-Ari, PhD, RN

IV. Cardiovascular Clinical Observational Experience – Aviva Lev-Ari, PhD, RN 

• Brigham and Women’s Hospital, Boston. MA

Cardiac ICU, Coronary Care Unit, Medical Rounds [100 hours]            June 2006-November 2006

• Brigham and Women’s Hospital, Boston. MA

CDIC – Cardiovascular Diagnostic and Interventional Center

Angiography & Interventional Radiology [100 hours]            March 2006-August 2006

Experience shadowing the daily activities of three Physician Assistants
1. attended consultation appointments with patient candidate for procedures: fibroid embolization
2. patient candidate for intra-vertebral cement injection in fractured vertebrae in spinal column, L-9 – Kyphoplasty vertebral augmentation
3. drainage of bile leakage – biliary duct obstruction
4. attended invasive procedures in the Angiography Lab
5. attended 7:30AM department meeting on all cases scheduled for procedures in the Lab for the day
6. discussed procedure outcomes and patient follow ups with PAs
7. Shadowing PAs and Interventional Radiologists performing angiography.
– VENOUS ACCESS PROCEDURES – TUNNELED CATHETER AND PORT PLACEMENT
– DIALYSIS ACCESS MANAGEMENT – ARTERIOVENOUS FISTULA/GRAFT.
ANGIOGRAMS/ANGIOPLASTIES

Mass General Hospital, Boston

• Cardiac Catheterization Lab

Supervisor:             Dr. Igor Palacios, Director, Cath Lab

Experience Shadowing in the Cath Lab at MGH

1/19/2005: stenting – MI case, mitral valve opening with balloon

1/20/2005: multiple stenting case, Mitral valve opening, circumflex artery opening with catheter

1/25/2005: stenting case

1/25/2005: Vascular case: Saphenous vein plaque removal (Room 5)

Mass General Hospital, Boston

• Cardiac Surgery – Operating Room

Supervisor:             Dr. J. Walker, Cardiac Surgeon

Experience: Shadowing Open Heart Surgery at MGH

1/24/2005: Carotid Artery endarterectomy operation by Dr. Richard Cambria

1/24/2005: Mitral Valve Replacement by Dr. Jennifer Walker

1/26/2005: Aorta Valve Replacement and Coronary Artery Bypass Grafting by Dr. Jennifer Walker

[Saphenous vein harvested from the leg and Radial vein harvested from the right arm]

• Texas Heart Institute, Houston, TX

Cardiac Surgery – Operating Room at THI

Supervisor:             Terry Crane

Experience: Shadowing Open Heart Surgery at THI

Scheduled for an Interview at THI in the Perfusion Program.

Spent 6 hours in the dome above the Cardiac OR when open-heart surgery on pump was performed, 2/19/2005.

• Faulkner Hospital – BWH, Boston, MA — ICU Unit

Practicum Staff Nurse, Clinical Comprehensive Practicum, Sept 2007 – December 2007

V. Cases with Complications: CEA and CAS

#1: Case on Cerebral Hyperperfusion Syndrome following Protected Carotid Artery Stenting

REFERENCES

1. T. M. Sundt Jr., F. W. Sharbrough, and D. G. Piepgras, “Correlation of cerebral blood flow and electroencephalographic changes during carotid endarterectomy. With results of surgery and hemodynamics of cerebral ischemia,” Mayo Clinic Proceedings, vol. 56, no. 9, pp. 533–543, 1981.View at Scopus
2. B. G. H. Schoser, C. Heesen, B. Eckert, and A. Thie, “Cerebral hyperperfusion injury after percutaneous transluminal angioplasty of extracranial arteries,” Journal of Neurology, vol. 244, no. 2, pp. 101–104, 1997. View at Publisher · View at Google Scholar · View at Scopus
3. D. J. H. McCabe, M. M. Brown, and A. Clifton, “Fatal cerebral reperfusion hemorrhage after carotid stenting,” Stroke, vol. 30, no. 11, pp. 2483–2486, 1999. View at Scopus
4. A. Abou-Chebl, J. S. Yadav, J. P. Reginelli, C. Bajzer, D. Bhatt, and D. W. Krieger, “Intracranial hemorrhage and hyperperfusion syndrome following carotid artery stenting: risk factors, prevention, and treatment,” Journal of the American College of Cardiology, vol. 43, no. 9, pp. 1596–1601, 2004. View at Publisher · View at Google Scholar · View at Scopus
5. J.-H. Buhk, L. Cepek, and M. Knauth, “Hyperacute intracerebral hemorrhage complicating carotid stenting should be distinguished from hyperperfusion syndrome,” American Journal of Neuroradiology, vol. 27, no. 7, pp. 1508–1513, 2006. View at Scopus
6. V. Adhiyaman and S. Alexander, “Cerebral hyperperfusion syndrome following carotid endarterectomy,” QJM, vol. 100, no. 4, pp. 239–244, 2007. View at Publisher · View at Google Scholar · View at Scopus
7. W. F. Morrish, S. Grahovac, A. Douen et al., “Intracranial hemorrhage after stenting and angioplasty of extracranial carotid stenosis,” American Journal of Neuroradiology, vol. 21, no. 10, pp. 1911–1916, 2000. View at Scopus
8. R. Gupta, A. Abou-Chebl, C. T. Bajzer, H. C. Schumacher, and J. S. Yadav, “Rate, predictors, and consequences of hemodynamic depression after carotid artery stenting,” Journal of the American College of Cardiology, vol. 47, no. 8, pp. 1538–1543, 2006. View at Publisher · View at Google Scholar · View at Scopus
9. M. B. Sánchez-Arjona, G. Sanz-Fernández, E. Franco-Macias, and A. Gil-Peralta, “Cerebral hemodynamic changes after carotid angioplasty and stenting,” American Journal of Neuroradiology, vol. 28, pp. 640–644, 2007.
10. Y. Kaku, S. I. Yoshimura, and J. Kokuzawa, “Factors predictive of cerebral hyperperfusion after carotid angioplasty and stent placement,” American Journal of Neuroradiology, vol. 25, pp. 1403–1408, 2004.

SOURCE

http://www.hindawi.com/crim/vasmed/2013/207602/?goback=%2Egde_1503357_member_256054772%2Egde_1503357_member_257761884

#2: Case Narrative: Carotid Artery Duplex

Patient came to her appointment as part of a standard pre-operative evaluation for removal of a uterine myoma. She had a history of stroke with residual slurred speech, making it difficult to understand her. Accordingly, I assumed I would see some carotid stenosis, but her ultrasound showed a stunning 70-99% stenosis in her right internal carotid artery and full occlusion of her left internal carotid artery.

Flow in the common carotid arteries looked fine. The plaque itself in the internal carotid arteries was relatively hypoechoic and not easily visualized in brightness mode, so bidirectional color flow at the proximal internal carotid arteries was surprising. Adding power Doppler allowed me to conclude that there was presence of flow on the right, though minimal, and absolutely no flow in the left internal carotid artery.

Upon completion of the exam, I called the ER and spoke with the doctor, who asked me to bring Rose to the ER. Unfortunately, due to the location of the right internal carotid artery stenosis in the bony canal and total occlusion of the left internal carotid artery, surgery was not an option for clearing out the carotid plaque, but doctors believed she could continue functioning well with collateral vasculature carrying blood to her brain.

Thankfully, the patient passed her other pre-operative tests, consented to her surgery, and underwent general anesthesia with no complications. An 8-cm malignant mass was removed from her uterus and her prognosis is good.

 

SOURCE

http://mintmedicaleducation.com/portfolio-view/carotid-artery-duplex/

REFERENCES

1. White CJ, Jaff MR. Catch-22: Carotid stenting is safe and effective (Food

and Drug Administration) but is it reasonable and necessary (Centers for

Medicare and Medicaid Services)? J Am Coll Cardiol Cardiovasc Interv.

2012;5:694–696.

2. Australian Consumer Competition and Consumer Commission Website.

Definition of a profession. Australian Council of Professions: http://

http://www.accc.gov.au/content/index.phtml/itemId/277772. Last accessed 8

Jan, 2013.

3. Abbott AL, Bladin CF, Levi CR, Chambers BR. What should we do with

asymptomatic carotid stenosis? Int J Stroke. 2007;2:27–39.

4. Björck M, Bergqvist D, Eliasson K, Jansson I, Karlstrom L, Kragsterman

B, et al. Twenty years with the Swedvasc Registry. Eur J Vasc Endovasc

Surg. 2008;35:129–130.

5. Nallamothu BK, Gurm HS, Ting HH, Goodney PP, Rogers MA, Curtis

JP, et al. Operator experience and carotid stenting outcomes in Medicare

beneficiaries. JAMA. 2011;306:1338–1343.

6. Centers for Medicare & Medicaid Services. National Coverage

Determination (NDC) for Percutaneous Transluminal Angioplasty

(PTA) (20.7), 2010. US Department of Health & Human Services:

http://www.cms.gov/medicare-coverage-database/details/ncd-details.

aspx?NCDId=201&ver=9. Last accessed Jan 8, 2013.

7. Brott TG, Hobson RW II, Howard G, Roubin GS, Clark WM, Brooks W,

et al.; CREST Investigators. Stenting versus endarterectomy for treatment

of carotid-artery stenosis. N Engl J Med. 2010;363:11–23.

8. Silver FL, Mackey A, Clark WM, Brooks W, Timaran CH, Chiu D,

et al. Safety of stenting and endarterectomy by symptomatic status in

the Carotid Revascularization Endarterectomy versus Stenting Trial

(CREST). Stroke. 2011;42:675–680

9. Abbott AL, Adelman MA, Alexandrov AV, Barnett HJ, Beard J, Bell P,

et al. Why the United States Center for Medicare and Medicaid Services

(CMS) should not extend reimbursement indications for carotid

artery angioplasty/stenting. Eur J Vasc Endovasc Surg. 2012;43:

247–251.

10. Meier P, Knapp G, Tamhane U, Chaturvedi S, Gurm HS. Short term

and intermediate term comparison of endarterectomy versus stenting

for carotid artery stenosis: systematic review and meta-analysis of randomised

controlled clinical trials. BMJ. 2010;340:c467.

11. Murad MH, Shahrour A, Shah ND, Montori VM, Ricotta JJ. A systematic

review and meta-analysis of randomized trials of carotid endarterectomy

vs stenting. J Vasc Surg. 2011;53:792–797.

12. Bangalore S, Kumar S, Wetterslev J, Bavry AA, Gluud C, Cutlip DE,

et al. Carotid artery stenting vs carotid endarterectomy: meta-analysis

and diversity-adjusted trial sequential analysis of randomized trials. Arch

Neurol. 2011;68:172–184.

13. Bonati LH, Lyrer P, Ederle J, Featherstone R, Brown MM. Percutaneous

transluminal balloon angioplasty and stenting for carotid artery stenosis.

Cochrane Database Syst Rev. 2012;12:CD000515.

14. Brown MM, Dobson J, Doig D, Featherstone RL, Turner EL; ICSS

Collaborators. Primary analysis of the International Carotid Stenting

Study: A randomised comparison of the effectiveness of carotid stenting

and endarterectomy in preventing long-term stroke in patients with

symptomatic carotid stenosis. Abstract. Cerebrovasc Dis 2012;33:15–16.

15. Bonati LH, Fraedrich G. Age modifies the relative risk of stenting versus

endarterectomy for symptomatic carotid stenosis: a pooled analysis

of EVA-3s, SPACE and ICSS. Eur J Vasc Endovasc Surg. 2011;41:

153–158.

16. Economopoulos KP, Sergentanis TN, Tsivgoulis G, Mariolis AD,

Stefanadis C. Carotid artery stenting versus carotid endarterectomy: a

comprehensive meta-analysis of short-term and long-term outcomes.

Stroke. 2011;42:687–692.

17. Carotid Stenting Trialists’ Collaboration. The risk of carotid artery stenting

compared with carotid endarterectomy is greatest in patients treated

within 7 days of symptoms. J Vasc Surg. 2012: Published online ahead

of print, Dec 10, 2012.

18. Rothwell PM, Eliasziw M, Gutnikov SA, Warlow CP, Barnett HJ.

Endarterectomy for symptomatic carotid stenosis in relation to clinical

subgroups and timing of surgery. Lancet. 2004;363:915–924.

19. Qureshi AI, Chaudhry SA, Hussein HM, Majidi S, Khatri R, Rodriguez

GJ, et al. A comparison of outcomes associated with carotid artery stent

placement performed within and outside clinical trials in the United

States. J Vasc Surg. 2012;56:317–323.

20. Naggara O, Touze E, Beyssen B, Trinquart L, Chatellier G, Meder JF,

et al. Anatomical and technical factors associated with stroke or death

during carotid angioplasty and stenting: Results from the endarterectomy

versus angioplasty in patients with symptomatic severe carotid stenosis

(EVA-3S) trial and systematic review. Stroke. 2011;42:380–388.

21. Eslami MH, McPhee JT, Simons JP, Schanzer A, Messina LM. National

trends in utilization and postprocedure outcomes for carotid artery revascularization

2005 to 2007. J Vasc Surg. 2011;53:307–315.

22. Khan AA, Chaudhry SA, Sivagnanam K, Hassan AE, Suri MF, Qureshi

AI. Cost-effectiveness of carotid artery stent placement versus endarterectomy

in patients with carotid artery stenosis. J Vasc Surg.

2012;117:89–93.

23. Sternbergh WC III, Crenshaw GD, Bazan HA, Smith TA. Carotid endarterectomy

is more cost-effective than carotid artery stenting. J Vasc Surg.

2012;55:1623–1628.

24. McDonald RJ, Kallmes DF, Cloft HJ. Comparison of hospitalization

costs and Medicare payments for carotid endarterectomy and carotid

stenting in asymptomatic patients. Am J Neuroradiol. 2012;33:420–425.

25. Vilain KR, Magnuson EA, Li H, Clark WM, Begg RJ, Sam AD, II,

et al. Costs and cost-effectiveness of carotid stenting versus endarterectomy

for patients at standard surgical risk: Results from the Carotid

Revascularization Endarterectomy versus Stenting Trial (CREST).

Stroke. 2012;43:2408–2416.

26. McPhee JT, Schanzer A, Messina LM, Eslami MH. Carotid artery stenting

has increased rates of postprocedure stroke, death, and resource utilization

than does carotid endarterectomy in the United States, 2005. J

Vasc Surg. 2008;48:1442–1450.

27. Abbott AL. Medical (nonsurgical) intervention alone is now best for prevention

of stroke associated with asymptomatic severe carotid stenosis:

results of a systematic review and analysis. Stroke. 2009;40:e573–e583.

28. Naylor AR, Gaines PA, Rothwell PM. Who benefits most from intervention

for asymptomatic carotid stenosis: patients or professionals? Eur J

Vasc Endovasc Surg. 2009;37:625–632.

29. Spence JD, Coates V, Li H, Tamayo A, Muñoz C, Hackam DG, et al.

Effects of intensive medical therapy on microemboli and cardiovascular

risk in asymptomatic carotid stenosis. Arch Neurol. 2010;67:180–186.

30. Marquardt L, Geraghty OC, Mehta Z, Rothwell PM. Low risk of ipsilateral

stroke in patients with asymptomatic carotid stenosis on best

medical treatment: a prospective, population-based study. Stroke.

2010;41:e11–e17.

31. Naylor AR. Time to rethink management strategies in asymptomatic

carotid artery disease. Nat Rev Cardiol. 2011;9:116–124.

32. Raman G, Kitsios GD, Moorthy D, Hadar N, Dahabreh IJ, O’Donnell

TF, et al. Management of asymptomatic carotid stenosis: Technology

Assessment Report. Tufts Evidence-based Practice Center: Project ID:

CRDT0510. Available at http://www.ahrq.gov/clinic/ta/carotidstenosis.

pdf. Last accessed 8 Jan, 2013.

33. Goessens BM, Visseren FL, Kappelle LJ, Algra A, van der Graaf Y.

Asymptomatic carotid artery stenosis and the risk of new vascular events

in patients with manifest arterial disease: the SMART study. Stroke.

2007;38:1470–1475.

34. Markus HS, King A, Shipley M, Topakian R, Cullinane M, Reihill

S, et al. Asymptomatic embolisation for prediction of stroke in the

Asymptomatic Carotid Emboli Study (ACES): a prospective observational

study. Lancet Neurol. 2010;9:663–671.

35. Abbott AL. Proximal internal carotid artery stenosis: Time to capitalise

on current knowledge. In: Davies AH, ed. Fast Facts. 2012.

36. European Carotid Surgery Trial 2 (ECST‐2) website. 2012. Available at

http://www.ecst2.com. Last accessed 8 Jan, 2013.

37. Nicolaides AN, Kakkos SK, Kyriacou E, Griffin M, Sabetai M, Thomas

DJ, et al. Asymptomatic internal carotid artery stenosis and cerebrovascular

risk stratification. J Vasc Surg. 2010;52:1486–1496 e1481–1485

38. Wang X, Hagemeyer CE, Hohmann JD, Leitner E, Armstrong PC,

Jia F, et al. Novel single-chain antibody-targeted microbubbles for

molecular ultrasound imaging of thrombosis: validation of a unique

noninvasive method for rapid and sensitive detection of thrombi and

monitoring of success or failure of thrombolysis in mice. Circulation.

2012;125:3117–3126.

39. Abbott AL. Transcranial doppler and risk stratification in patients

with internal carotid stenosis. . In: Nicolaides A, Beech K, Pattichis C,

Kyriacou E, eds. Ultrasound and Carotid Bifurcation Atherosclerosis.

London: Springer; 2011.

40. Giles KA, Hamdan AD, Pomposelli FB, Wyers MC, Schermerhorn ML.

Stroke and death after carotid endarterectomy and carotid artery stenting

with and without high risk criteria. J Vasc Surg. 2010;52:1497–1504.

41. Blackshear JL, Cutlip DE, Roubin GS, Hill MD, Leimgruber PP, Begg

RJ, et al.; CREST Investigators. Myocardial infarction after carotid stenting

and endarterectomy: results from the carotid revascularization endarterectomy

versus stenting trial. Circulation. 2011;123:2571–2578.

42. Brooks W, Mohr JP, Voeks JH, Clark WM, Silver FL, Mackey A, et al; for

the CREST Investigators. Stroke type, laterality and severity following

carotid artery stenting (CAS) and carotidendarterectomy (CEA) in the

carotid revascularization endarterectomy versus stenting trial (CREST).

Stroke. 2011;42:e42–e110 (abstract).

43. Brott TG, Halperin JL, Abbara S, Bacharach JM, Barr JD, Bush RL, et al.

2011 ASA/ACCF/AHA/AANN/AANS/ACR/ASNR/CNS/SAIP/SCAI/

SIR/SNIS/SVM/SVS guideline on the management of patients with extracranial

carotid and vertebral artery disease. Stroke. 2011;42:e420–463.

44. Tendera M, Aboyans V, Bartelink ML, Baumgartner I, Clément D, Collet

JP, et al.; European Stroke Organisation; ESC Committee for Practice

Guidelines. ESC Guidelines on the diagnosis and treatment of peripheral

artery diseases: Document covering atherosclerotic disease of extracranial

carotid and vertebral, mesenteric, renal, upper and lower extremity

arteries: the Task Force on the Diagnosis and Treatment of Peripheral

Artery Diseases of the European Society of Cardiology (ESC). Eur

Heart J. 2011;32:2851–2906.

45. Furie KL, Kasner SE, Adams RJ, Albers GW, Bush RL, Fagan SC, et

al. Guidelines for the prevention of stroke in patients with stroke or

transient ischemic attack: A guideline for healthcare professionals from

the American Heart Association/American Stroke Association. Stroke.

2011;42:227–276.

46. Paraskevas KI, Veith FJ, Riles TS, Moore WS. Is carotid artery stenting a

fair alternative to carotid endarterectomy for symptomatic carotid artery

stenosis? A commentary on the AHA/ASA guidelines. J Vasc Surg.

2011;54:541–543; discussion 543.

47. Redberg RF. Squandering medicare’s money. New York Times.

25th May 2011. Available at http://www.nytimes.com/2011/05/26/

opinion/26redberg.html. Last accessed Jan 8, 2013.

Part Three:

Cleveland Clinic Reports Equivalence between carotid endarterectomy (CEA) and open-heart surgery (OHS) and carotid artery stenting (CAS) followed by coronary artery bypass graft (CABG) surgery or non-CABG cardiac surgery

Stent first, then heart surgery, for patients with severe carotid/coronary disease

AUGUST 1, 2013

Michael O’Riordan

Cleveland, OH – With the absence of randomized, controlled clinical trials to address the optimal management of patients with severe carotid and coronary artery disease, a new retrospective study suggests the best tactic is a staged approach that sees the patient undergo carotid artery stenting (CAS) followed by coronary artery bypass graft (CABG) surgery or non-CABG cardiac surgery [1].

Investigators report that a combined approach that includes carotid endarterectomy (CEA) and open-heart surgery (OHS) is equivalent in terms of short-term outcomes with the staged CAS-OHS procedure. Beyond one year, however, the staged CAS-OHS approach resulted in the lowest risk of all-cause mortality, stroke, and MI when compared with a combined CEA-OHS procedure and staged CEA-OHS.

“The surgeons get very worried about doing operations on these patients because they don’t want to do a beautiful job on the bypass only to have the patient have a stroke,” lead investigator Dr Mehdi Shishehbor(Cleveland Clinic, OH) told heartwire.

Shishehbor said that when patients are undergoing open-heart surgery, whether it’s CABG or valve surgery, they are screened for carotid artery disease, given the heightened risk of stroke when undergoing heart surgery. As a result, various teams from neurology, vascular surgery, and interventional cardiology are called to address the safety of the surgery in the setting of severe carotid disease, said Shishehbor.

“These patients are the sickest of the sick in the sense that they have two conditions that are occurring concomitantly,” he said. “These are not patients who just have carotid disease. There are many patients who have moderate or mild carotid disease who undergo open-heart surgery with no problem. These are people with severe disease, those with more than 80% stenosis in one of their carotid arteries or maybe both. They also have severe coronary artery disease. These are people with left-main or three-vessel disease who are destined to undergo bypass.”

The whole point is to prevent stroke

In the study, published this week in the Journal of the American College Cardiology, the investigators reported data on 350 patients who underwent carotid revascularization and cardiac surgery. These included 45 patients who were treated with a staged CEA-OHS approach (OHS performed a median of 14 days after CEA), 110 who were treated with a staged CAS-OHS procedure (OHS performed a median of 47 days after CEA), and 195 patients treated with a combined CEA-OHS procedure. OHS is defined as CABG, CABG plus other cardiac procedures, or non-CABG cardiac surgery (isolated valve or aortic-repair surgery). In total, just 8% of procedures were non-CABG surgeries.

In a propensity-adjusted analysis analyzed by intention-to-treat, the 30-day risk of death, stroke, and MI was similar between the staged CAS-OHS and combined CEA-OHS procedures. The highest risk of the composite end point was observed in patients who underwent staged CEA-OHS.

At one year and beyond (median follow-up was 3.7 years), the staged CAS-OHS patients had the lowest risk of death, stroke, and MI. Compared with staged CEA-OHS, those treated with CAS-OHS had a 67% lower risk of death, stroke, and MI and a 65% lower risk compared with combined CEA-OHS.

Unadjusted comparison of primary/secondary end points

Event	Staged CEA-OHS,n=45 (%)	Combined CEA-OHS,n=195 (%)	Staged CAS-OHS,n=110 (%)	p
Overall 30-d risk post-OHS	31	10	10	0.003
Death	7	5	6	0.75
Stroke	2	7	2	0.11
MI	24	0.5	3	<0.001
Overall composite risk 1 y and beyond	27	39	12	<0.001
Death	38	39	11	<0.001
Stroke	2.2	1.5	0	0.37
MI	0	3.1	2.7	0.5

“In the long term, stenting [followed by OHS] definitely did better than the combined approach,” said Shishehbor. “What’s also important is that with the combined approach, the reason they didn’t do very well is because they had a higher rate of stroke in the perioperative period. . . . Remember the whole point of doing this is to prevent stroke. This is why we feel the combined approach is a little bit inferior to the staged CAS/open-heart-surgery approach. If you have a 7% risk of stroke in the 30-day perioperative period, that doesn’t appear to be the best option for the majority of patients.”

To heartwire, Shishehbor said that while the patients were well matched, the patients undergoing stenting tended to be sicker. For example, they were more likely to have symptomatic carotid stenosis and were more likely to have undergone a previous carotid revascularization. Shishehbor also said that clinical events occurring between the initial carotid artery revascularization procedure and OHS were included in the analysis. These deaths, strokes, and MIs were identified and accounted for in the data.

In an editorial accompanying the study [2], Drs Ehtisham Mahmud and Ryan Reeves (University of California, San Diego) say the work by the Cleveland Clinic group is strengthened by the propensity-adjusted analysis and long follow-up beyond the perioperative period. Most important, they say the study provides clarity for the management of patients with carotid and coronary disease.

• “For patients presenting with an acute coronary syndrome requiring urgent coronary revascularization in whom waiting three to four weeks is not safe, combined CEA-OHS is the optimum revascularization strategy, though associated with higher neurological ischemic events,” write Mahmud and Reeves.
• “However, for patients with a stable or an accelerating anginal syndrome who can wait three to four weeks to complete dual antiplatelet therapy [DAPT] after carotid stenting, staged CAS followed by OHS leads to superior early and long-term outcomes.”

Since completing the analysis, Shishehbor said there have been discussions with colleagues in vascular surgery, vascular medicine, cardiac surgery, and cardiology to establish the optimum way to treat patients with severe carotid and coronary disease. “The bottom line is that there will never be a randomized, clinical trial in this setting,” he told heartwire. “I hope there would be, but I doubt it. So I think papers like this are critical because we’re doing these procedures to prevent stroke. It’s important that we pick the right procedure for the right patient.”

Shishehbor reports serving as a speaker and consultant for Abbot Vascular, Medtronic, and Gore but waives all compensation for his work. Mahmud reports trial support from Boston Scientific and Abbott Vascular. In addition,he consults for Cordis and the Medicines Company and serves on the speaker‘s bureau for Medtronic. Disclosures for the coauthors are listed in the paper.

 Sources

1. Shishehbor MH, Venkatachalam S, Sun Z, et al. A direct comparison of early and late outcomes with three approaches to carotid revascularization and open heart surgery. J Am Coll Cardiol 2013; available at: http://content.onlinejacc.org.
2. Mahmud E, Reeves R. Carotid revascularization prior to open heart surgery: The data driven treatment strategy. J Am Coll Cardiol 2013; available at: http://content.onlinejacc.org.

Related links

• Restenosis similar with carotid stenting or surgery: CREST
  [heartwire > Medscape Medical News; Feb 01, 2012]
• Carotid stent or surgery? New meta-analysis sends mixed messages
  [heartwire > Medscape Medical News; Oct 12, 2010]
• CREST trial published, but debate continues on stenting vs surgery for symptomatic carotid disease
  [heartwire > Medscape Medical News; May 27, 2010]
• CREST: Stenting and endarterectomy show similar net safety and efficacy for carotid stenosis
  [heartwire > Medscape Medical News; Feb 26, 2010]
• No relationship between significant carotid stenosis and stroke after cardiac surgery
  [Interventional/Surgery > Interventional/Surgery; Sep 28, 2009]
• Yet again, CMS declines to expand carotid-stenting coverage
  [Brain/Kidney/Peripheral > Brain/Kidney/Peripheral; Sep 17, 2009]
• CMS once again reopening decision over coverage of carotid-stenting procedures
  [Brain/Kidney/Peripheral > Brain/Kidney/Peripheral; Mar 25, 2009]

 

Read Full Post »