Posts Tagged ‘Medicare’

Real Time Coverage @BIOConvention #BIO2019: After Trump’s Drug Pricing Blueprint: What Happens Next? A View from Washington; June 3 2019 1:00 PM Philadelphia PA

Reporter: Stephen J. Williams, PhD @StephenJWillia2


Speaker: Dan Todd, JD

Dan Todd is the Principal of Todd Strategy, LLC, a consulting firm founded in 2014 and based in Washington, DC. He provides legislative and regulatory strategic guidance and advocacy for healthcare stakeholders impacted by federal healthcare programs.

Prior to Todd Strategy, Mr. Todd was a Senior Healthcare Counsel for the Republican staff of the Senate Finance Committee, the Committee of jurisdiction for the Medicare and Medicaid programs. His areas of responsibility for the committee included the Medicare Part B and Part D programs, which includes physician, medical device, diagnostic and biopharmaceutical issues.

Before joining the Finance Committee, Mr. Todd spent several years in the biotechnology industry, where he led policy development and government affairs strategy. He also represented his companies’ interests with major trade associations such as PhRMA and BIO before federal and state representatives, as well as with key stakeholders such as physician and patient advocacy organizations.

Dan also served as a Special Assistant in the Office of the Administrator at the Centers for Medicare & Medicaid Services (CMS), the federal agency charged with the operation of the Medicare and Medicaid programs. While at CMS, Dan worked on Medicare Part B and Part D issues during the implementation of the Medicare Modernization Act from 2003 to 2005.

Cost efficiencies were never measured.

Removing drug rebates would cost 180 billion over 10 years. CBO came up with similar estimate.  Not sure what Congress will do. It appears they will keep the rebates in.

  • House  Dems are really going after PBMs; anytime the Administration makes a proposal goes right into CBO baseline estimates;  negotiations appear to be in very early stages and estimates are up in the air
  • WH close to meet a budget cap but then broke down in next day; total confusion in DC on budget; healthcare is now held up, especially the REBATE rule; : is a shame as panel agrees cost savings would be huge
  • they had initiated a study to tie the costs of PartB to international drug prices; meant to get at disparity on international drug prices; they currently are only mulling the international price index; other option is to reform Part B;  the proposed models were brought out near 2016 elections so not much done; unified agenda;
  • most of the response of Congress relatively publicly muted; a flat fee program on biologics will have big effect on how physicians and health systems paid; very cat and mouse game in DC around drug pricing
  • administration is thinking of a PartB “inflation cap”;  committees are looking at it seriously; not a rebate;  discussion of tiering of physician payments
  • Ways and Means Cmmtte:  proposing in budget to alleve some stresses on PartB deductable amounts;
  • PartD: looking at ways to shore it up; insurers 80% taxpayers 20% responsible; insurers think it will increase premiums but others think will reduce catastrophic costs; big part of shift in spending in Part D has been this increase in catastrophic costs
  • this week they may actually move through committees on this issue; Administration trying to use the budgetary process to drive this bargain;  however there will have to be offsets so there may be delays in process

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Other articles on this Open Access Journal on Healthcare Costs, Payers, and Patient Care Include:

The Arnold Relman Challenge: US HealthCare Costs vs US HealthCare Outcomes

Centers for Medicare & Medicaid Services announced that the federal healthcare program will cover the costs of cancer gene tests that have been approved by the Food and Drug Administration

Trends in HealthCare Economics: Average Out-of-Pocket Costs, non-Generics and Value-Based Pricing, Amgen’s Repatha and AstraZeneca’s Access to Healthcare Policies

Can Blockchain Technology and Artificial Intelligence Cure What Ails Biomedical Research and Healthcare

Live Conference Coverage @Medcity Converge 2018 Philadelphia: Oncology Value Based Care and Patient Management

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Live Conference Coverage @Medcitynews Converge 2018 @Philadelphia: Promising Drugs and Breaking Down Silos

Reporter: Stephen J. Williams, PhD

Promising Drugs, Pricing and Access

The drug pricing debate rages on. What are the solutions to continuing to foster research and innovation, while ensuring access and affordability for patients? Can biosimilars and generics be able to expand market access in the U.S.?

Moderator: Bunny Ellerin, Director, Healthcare and Pharmaceutical Management Program, Columbia Business School
Patrick Davish, AVP, Global & US Pricing/Market Access, Merck
Robert Dubois M.D., Chief Science Officer and Executive Vice President, National Pharmaceutical Council
Gary Kurzman, M.D., Senior Vice President and Managing Director, Healthcare, Safeguard Scientifics
Steven Lucio, Associate Vice President, Pharmacy Services, Vizient

What is working and what needs to change in pricing models?

Robert:  He sees so many players in the onStevencology space discovering new drugs and other drugs are going generic (that is what is working).  However are we spending too much on cancer care relative to other diseases (their initiative Going Beyond the Surface)

Steven:  the advent of biosimilars is good for the industry

Patrick:  large effort in oncology, maybe too much (750 trials on Keytruda) and he says pharma is spending on R&D (however clinical trials take large chunk of this money)

Robert: cancer has gotten a free ride but cost per year relative to benefit looks different than other diseases.  Are we overinvesting in cancer or is that a societal decision

Gary:  maybe as we become more specific with precision medicines high prices may be a result of our success in specifically targeting a mutation.  We need to understand the targeted drugs and outcomes.

Patrick: “Cancer is the last big frontier” but he says prices will come down in most cases.  He gives the example of Hep C treatment… the previous only therapeutic option was a very toxic yearlong treatment but the newer drugs may be more cost effective and safer

Steven: Our blockbuster drugs could diffuse the expense but now with precision we can’t diffuse the expense over a large number of patients

President’s Cancer Panel Recommendation

Six recommendations

  1. promoting value based pricing
  2. enabling communications of cost
  3. financial toxicity
  4. stimulate competition biosimilars
  5. value based care
  6. invest in biomedical research

Patrick: the government pricing regime is hurting.  Alot of practical barriers but Merck has over 200 studies on cost basis

Robert:  many concerns/impetus started in Europe on pricing as they are a set price model (EU won’t pay more than x for a drug). US is moving more to outcomes pricing. For every one health outcome study three studies did not show a benefit.  With cancer it is tricky to establish specific health outcomes.  Also Medicare gets best price status so needs to be a safe harbor for payers and biggest constraint is regulatory issues.

Steven: They all want value based pricing but we don’t have that yet and there is a challenge to understand the nuances of new therapies.  Hard to align all the stakeholders together so until some legislation starts to change the reimbursement-clinic-patient-pharma obstacles.  Possibly the big data efforts discussed here may help align each stakeholders goals.

Gary: What is the data necessary to understand what is happening to patients and until we have that information it still will be complicated to determine where investors in health care stand at in this discussion

Robert: on an ICER methods advisory board: 1) great concern of costs how do we determine fair value of drug 2) ICER is only game in town, other orgs only give recommendations 3) ICER evaluates long term value (cost per quality year of life), budget impact (will people go bankrupt)

4) ICER getting traction in the public eye and advocates 5) the problem is ICER not ready for prime time as evidence keeps changing or are they keeping the societal factors in mind and they don’t have total transparancy in their methodology

Steven: We need more transparency into all the costs associated with the drug and therapy and value-based outcome.  Right now price is more of a black box.

Moderator: pointed to a recent study which showed that outpatient costs are going down while hospital based care cost is going rapidly up (cost of site of care) so we need to figure out how to get people into lower cost setting

Breaking Down Silos in Research

“Silo” is healthcare’s four-letter word. How are researchers, life science companies and others sharing information that can benefit patients more quickly? Hear from experts at institutions that are striving to tear down the walls that prevent data from flowing.

Moderator: Vini Jolly, Executive Director, Woodside Capital Partners
Ardy Arianpour, CEO & Co-Founder, Seqster @seqster
Lauren Becnel, Ph.D., Real World Data Lead for Oncology, Pfizer
Rakesh Mathew, Innovation, Research, & Development Lead, HealthShareExchange
David Nace M.D., Chief Medical Officer, Innovaccer

Seqster: Seqster is a secure platform that helps you and your family manage medical records, DNA, fitness, and nutrition data—all in one place. Founder has a genomic sequencing background but realized sequence  information needs to be linked with medical records.

HealthShareExchange.org :

HealthShare Exchange envisions a trusted community of healthcare stakeholders collaborating to deliver better care to consumers in the greater Philadelphia region. HealthShare Exchange will provide secure access to health information to enable preventive and cost-effective care; improve quality of patient care; and facilitate care transitions. They have partnered with multiple players in healthcare field and have data on over 7 million patients.


Data can be overwhelming, but it doesn’t have to be this way. To drive healthcare efficiency, we designed a modular suite of products for a smooth transition into a data-driven world within 4 weeks. Why does it take so much money to move data around and so slowly?

What is interoperatibility?

Ardy: We knew in genomics field how to build algorithms to analyze big data but how do we expand this from a consumer standpoint and see and share your data.

Lauren: how can we use the data between patients, doctors, researchers?  On the research side genomics represent only 2% of data.  Silos are one issue but figuring out the standards for data (collection, curation, analysis) is not set. Still need to improve semantic interoperability. For example Flatiron had good annotated data on male metastatic breast cancer.

David: Technical interopatabliltiy (platform), semantic interopatability (meaning or word usage), format (syntactic) interopatibility (data structure).  There is technical interoperatiblity between health system but some semantic but formats are all different (pharmacies use different systems and write different prescriptions using different suppliers).  In any value based contract this problem is a big issue now (we are going to pay you based on the quality of your performance then there is big need to coordinate across platforms).  We can solve it by bringing data in real time in one place and use mapping to integrate the format (need quality control) then need to make the data democratized among players.

Rakesh:  Patients data should follow the patient. Of Philadelphia’s 12 health systems we had a challenge to make data interoperatable among them so tdhey said to providers don’t use portals and made sure hospitals were sending standardized data. Health care data is complex.

David: 80% of clinical data is noise. For example most eMedical Records are text. Another problem is defining a patient identifier which US does not believe in.





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CMS releases MACRA rule proposal: Will HHS force physicians to drop fee for service for fee for outcome?

Streamlined implementation aims to increase flexibility, decrease reporting burden for physicians

The U.S. Department of Health and Human Services unveiled a proposed ruletackling the initial implementation of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA).

According to an HHS announcement accompanying the rule, the primary aim is to simplify and streamline the existing patchwork of value-based payment models that have increasingly replaced the traditional fee-for-service system via a new framework dubbed the Quality Payment Program. This structure provides doctors with two paths for compliance:

The Centers for Medicare & Medicaid Services expects most providers to opt for the MIPS track initially, according to CMS Acting Principal Deputy Administrator and Chief Medical Officer Patrick Conway, M.D., who spoke on a conference call announcing the rule.

Participation in Advanced Alternative Payment models would exempt doctors from MIPS reporting requirements while also qualifying them for financial bonuses in exchange for taking on the risks related with providing “coordinated, high-quality care,” according to CMS. The agency expects both the number of physicians participating in this track and the number of payment models available to grow over time.

CMS also reports that doctors will have the flexibility to switch among various components of the Quality Payment Program as dictated by the needs of their patients or their practices.

Opinions from around the web

In this video, Gilberg, senior vice president for the Medical Group Management Association’s Government Affairs Office, discusses CMS’ Physician Value-based Payment Modifier. In 2015, Medicare will begin applying the modifier under the physician fee schedule to various providers to show value of care.

“Cost and quality … make up the value equation, in the mind of the payer, in terms of Medicare,” said Gilberg.

In addition to explaining how the modifier works, Gilberg also highlights other quality measures facing providers under the Physician Quality Reporting System and via the EHR Incentive Programs, better known as meaningful use.

View Video at


When the Medicare Access and CHIP Reauthorization Act (MACRA) legislation passed in April 2015, everyone cheered the repeal of the Sustainable Growth Rate (SGR) formula for Medicare physician payment. Now, even before the MACRA regulations are even promulgated, it’s time to pay attention because Medicare physician payments in 2019 will be impacted by their performance in 2017, just a year from now.

Other related articles

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Protecting Your Biotech IP and Market Strategy: Notes from Life Sciences Collaborative 2015 Meeting


Protecting Your Biotech IP and Market Strategy: Notes from Life Sciences Collaborative 2015 Meeting

Achievement Beyond Regulatory Approval – Design for Commercial Success

philly2nightStephen J. Williams, Ph.D.: Reporter

The Mid-Atlantic group Life Sciences Collaborative, a select group of industry veterans and executives from the pharmaceutical, biotechnology, and medical device sectors whose mission is to increase the success of emerging life sciences businesses in the Mid-Atlantic region through networking, education, training and mentorship, met Tuesday March 3, 2015 at the University of the Sciences in Philadelphia (USP) to discuss post-approval regulatory issues and concerns such as designing strong patent protection, developing strategies for insurance reimbursement, and securing financing for any stage of a business.

The meeting was divided into three panel discussions and keynote speech:

  1. Panel 1: Design for Market Protection– Intellectual Property Strategy Planning
  2. Panel 2: Design for Market Success– Commercial Strategy Planning
  3. Panel 3: Design for Investment– Financing Each Stage
  4. Keynote Speaker: Robert Radie, President & CEO Egalet Corporation

Below are Notes from each PANEL Discussion:

For more information about the Life Sciences Collaborative SEE

Website: http://www.lifesciencescollaborative.org/

Or On Facebook

Or On Twitter @LSCollaborative

Panel 1: Design for Market Protection; Intellectual Property Strategy Planning

Take-home Message: Developing a very strong Intellectual Property (IP) portfolio and strategy for a startup is CRITICALLY IMPORTANT for its long-term success. Potential investors, partners, and acquirers will focus on the strength of a startup’s IP so important to take advantage of the legal services available. Do your DUE DIGILENCE.


John F. Ritter, J.D.., MBA; Director Office Tech. Licensing Princeton University

Cozette McAvoy; Senior Attorney Novartis Oncology Pharma Patents

Ryan O’Donnell; Partner Volpe & Koenig

Panel Moderator: Dipanjan “DJ” Nag, PhD, MBA, CLP, RTTP; President CEO IP Shaktl, LLC


Dr. Nag:

  • Sometimes IP can be a double edged sword; e.g. Herbert Boyer with Paul Berg and Stanley Cohen credited with developing recombinant technology but they did not keep the IP strict and opened the door for a biotech revolution (see nice review from Chemical Heritage Foundation).
  • Naked patent licenses are most profitable when try to sell IP

John Ritter: Mr. Ritter gave Princeton University’s perspective on developing and promoting a university-based IP portfolio.

  • 30-40% of Princeton’s IP portfolio is related to life sciences
  • Universities will prefer to seek provisional patent status as a quicker process and allows for publication
  • Princeton will work closely with investigators to walk them through process – Very Important to have support system in place INCLUDING helping investigators and early startups establish a STRONG startup MANAGEMENT TEAM, and making important introductions to and DEVELOPING RELATIONSHIOPS with investors, angels
  • Good to cast a wide net when looking at early development partners like pharma
  • Good example of university which takes active role in developing startups is University of Pennsylvania’s Penn UPstart program.
  • Last 2 years many universities filing patents for startups as a micro-entity

Comment from attendee: Universities are not using enough of their endowments for purpose of startups. Princeton only using $500,00 for accelerator program.

Cozette McAvoy: Mrs. McAvoy talked about monetizing your IP from an industry perspective

  • Industry now is looking at “indirect monetization” of their and others IP portfolio. Indirect monetization refers to unlocking the “indirect value” of intellectual property; for example research tools, processes, which may or may not be related to a tangible product.
  • Good to make a contractual bundle of IP – “days of the $million check is gone”
  • Big companies like big pharma looks to PR (press relation) buzz surrounding new technology, products SO IMPORTANT FOR STARTUP TO FOCUS ON YOUR PR

Ryan O’Donnell: talked about how life science IP has changed especially due to America Invests Act

  • Need to develop a GLOBAL IP strategy so whether drug or device can market in multiple countries
  • Diagnostics and genes not patentable now – Major shift in patent strategy
  • Companies like Unified Patents can protect you against the patent trolls – if patent threatened by patent troll (patent assertion entity) will file a petition with the USPTO (US Patent Office) requesting institution of inter partes review (IPR); this may cost $40,000 BUT WELL WORTH the money – BE PROACTIVE about your patents and IP

Panel 2: Design for Market Success; Commercial Strategy Planning

Take-home Message: Commercial strategy development is defined market facing data, reimbursement strategies and commercial planning that inform labeling requirements, clinical study designs, healthcare economic outcomes and pricing targets. Clarity from payers is extremely important to develop any market strategy. Develop this strategy early and seek advice from payers.


David Blaszczak; Founder, Precipio Health Strategies

Terri Bernacchi, PharmD, MBA; Founder & President Cambria Health Advisory Professionals

Paul Firuta; President US Commercial Operations, NPS Pharma


Panel Moderator: Matt Cabrey; Executive Director, Select Greater Philadelphia



David Blaszczak:

  • Commercial payers are bundling payment: most important to get clarity from these payers
  • Payers are using clinical trials to alter marketing (labeling) so IMPORTANT to BUILD LABEL in early clinical trial phases (phase I or II)
  • When in early phases of small company best now to team or partner with a Medicare or PBM (pharmacy benefit manager) and payers to help develop and spot tier1 and tier 2 companies in their area

Terri Bernacchi:

  • Building relationship with the payer is very important but firms like hers will also look to patients and advocacy groups to see how they respond to a given therapy and decrease the price risk by bundling
  • Value-based contracting with manufacturers can save patient and payer $$
  • As most PBMs formularies are 80% generics goal is how to make money off of generics
  • Patent extension would have greatest impact on price, value

Paul Firuta:

  • NPS Pharma developing a pharmacy benefit program for orphan diseases
  • How you pay depends on mix of Medicare, private payers now
  • Most important change which could affect price is change in compliance regulations

Panel 3: Design for Investment; Financing Each Stage

Take-home Message: VC is a personal relationship so spend time making those relationships. Do your preparation on your value and your market. Look to non-VC avenues: they are out there.


Ting Pau Oei; Managing Director, Easton Capital (NYC)

Manya Deehr; CEO & Founder, Pediva Therapeutics

Sanjoy Dutta, PhD; Assistant VP, Translational Devel. & Intl. Res., Juvenile Diabetes Research Foundation


Panel Moderator: Shahram Hejazi, PhD; Venture Partner, BioAdvance

  • In 2000 his experience finding 1st capital was what are your assets; now has changed to value


Ting Pau Oei:

  • Your very 1st capital is all about VALUE– so plan where you add value
  • Venture Capital is a PERSONAL RELATIONSHIP
  • 1) you need the management team, 2) be able to communicate effectively                  (Powerpoint, elevator pitch, business plan) and #1 and #2 will get you important 2nd Venture Capital meeting; VC’s don’t decide anything in 1st meeting
  • VC’s don’t normally do a good job of premarket valuation or premarket due diligence but know post market valuation well
  • Best advice: show some phase 2 milestones and VC will knock on your door

Manya Deehr:

  • Investment is more niche oriented so find your niche investors
  • Define your product first and then match the investors
  • Biggest failure she has experienced: companies that go out too early looking for capital

Dr. Dutta: funding from a non-profit patient advocacy group perspective

  • Your First Capital: find alliances which can help you get out of “valley of death
  • Develop a targeted product and patient treatment profile
  • Non-profit groups ask three questions:

1) what is the value to patients (non-profits want to partner)

2) what is your timeline (we can wait longer than VC; for example Cystic Fibrosis Foundation waited long time but got great returns for their patients with Kalydeco™)

3) when can we see return

  • Long-term market projections are the knowledge gaps that startups have (the landscape) and startups don’t have all the competitive intelligence
  • Have a plan B every step of the way

Other posts on this site related to Philadelphia Biotech, Startup Funding, Payer Issues, and Intellectual Property Issues include:

PCCI’s 7th Annual Roundtable “Crowdfunding for Life Sciences: A Bridge Over Troubled Waters?” May 12 2014 Embassy Suites Hotel, Chesterbrook PA 6:00-9:30 PM
The Vibrant Philly Biotech Scene: Focus on KannaLife Sciences and the Discipline and Potential of Pharmacognosy
The Vibrant Philly Biotech Scene: Focus on Computer-Aided Drug Design and Gfree Bio, LLC
The Vibrant Philly Biotech Scene: Focus on Vaccines and Philimmune, LLC
The Bioscience Crowdfunding Environment: The Bigger Better VC?
Foundations as a Funding Source
Venture Capital Funding in the Life Sciences: Phase4 Ventures – A Case Study
10 heart-focused apps & devices are crowdfunding for American Heart Association’s open innovation challenge
Funding, Deals & Partnerships
Medicare Panel Punts on Best Tx for Carotid Plaque
9:15AM–2:00PM, January 27, 2015 – Regulatory & Reimbursement Frameworks for Molecular Testing, LIVE @Silicon Valley 2015 Personalized Medicine World Conference, Mountain View, CA
FDA Commissioner, Dr. Margaret A. Hamburg on HealthCare for 310Million Americans and the Role of Personalized Medicine
Biosimilars: Intellectual Property Creation and Protection by Pioneer and by Biosimilar Manufacturers
Litigation on the Way: Broad Institute Gets Patent on Revolutionary Gene-Editing Method
The Patents for CRISPR, the DNA editing technology as the Biggest Biotech Discovery of the Century



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

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.

 Clinical Trials Results

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.


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


Stroke. 2013;44:1186-1190

Carotid Artery Disease

What is carotid artery disease?

Carotid artery disease, also called carotid artery stenosis, occurs when the carotid arteries, the main blood vessels that carry oxygenated blood to the brain, become narrowed. The narrowing of the carotid arteries is most commonly related to atherosclerosis (a buildup of plaque, which is a deposit of fatty substances, cholesterol, cellular waste products, calcium, and fibrin in the inner lining of an artery). Atherosclerosis, or “hardening of the arteries,” is a vascular disease (disease of the arteries and veins). Carotid artery disease is similar to coronary artery disease, in which blockages occur in the arteries of the heart, and may cause a heart attack.

Illustration of a normal and diseased artery

Click Image to Enlarge

To better understand how carotid artery disease affects the brain, a basic review of the anatomy of the circulation system of the brain follows.

What are the carotid arteries?

The main supply of blood to the brain is carried by the carotid arteries. The carotid arteries branch off from the aorta (the largest artery in the body) a short distance from the heart, and extend upward through the neck carrying oxygen-rich blood to the brain.

There are four carotid arteries: the right and left internal carotid arteries and the right and left external carotid arteries. One pair (external and internal) is located on each side of the neck. Just as a pulse can be felt in the wrists, a pulse can also be felt on either side of the neck over the carotid arteries.

Illustration of the arteries in the brain

Click to Enlarge

Why are the carotid arteries important?

Because the carotid arteries deliver blood to the brain, carotid artery disease can have serious implications by reducing the flow of oxygen to the brain. The brain needs a constant supply of oxygen in order to function. Even a brief interruption in blood supply can cause problems. Brain cells begin to die after just a few minutes without blood or oxygen. If the narrowing of the carotid arteries becomes severe enough to block blood flow, or a piece of atherosclerotic plaque breaks off and obstructs blood flow to the brain, a stroke may occur.

What causes carotid artery disease?

Atherosclerosis is the most common cause of carotid artery disease. It is unknown exactly how atherosclerosis begins or what causes it. Atherosclerosis is a slow, progressive, vascular disease that starts as early as childhood. However, the disease has the potential to progress rapidly. It is generally characterized by the accumulation of fatty deposits along the innermost layer of the arteries. If the disease process progresses, plaque formation may take place. Plaque is made up of deposits of smooth muscle cells, fatty substances, cholesterol, calcium, and cellular waste products. This thickening narrows the arteries and can decrease blood flow or completely block the flow of blood to the brain.

Risk factors associated with atherosclerosis include:

  • Older age
  • Male
  • Family history
  • Race or ethnicity
  • Genetic factors
  • Hyperlipidemia (elevated fats in the blood)
  • Hypertension (high blood pressure)
  • Smoking
  • Diabetes
  • Obesity
  • Diet high in saturated fat
  • Lack of exercise

A risk factor is anything that may directly increase or be associated with a person’s chance of developing a disease. It may be an activity, such as smoking, diet, family history, or many other things. Different diseases have different risk factors.

Although these risk factors increase a person’s risk, they do not necessarily cause the disease. Some people with one or more risk factors never develop the disease, while others develop disease and have no known risk factors. Knowing your risk factors to any disease can help to guide you into the appropriate actions, including changing behaviors and being clinically monitored for the disease.

What are the symptoms of carotid artery disease?

Carotid artery disease may be asymptomatic (without symptoms) or symptomatic (with symptoms). Asymptomatic carotid disease is the presence of a significant amount of atherosclerotic buildup without obstructing enough blood flow to cause symptoms. However, a sufficiently tight stenosis will not always cause symptoms. Symptomatic carotid artery disease may result in either a transient ischemic attack (TIA) and/or a stroke (brain attack).

A transient ischemic attack (TIA) is a sudden or temporary loss of blood flow to an area of the brain, usually lasting a few minutes to one hour. Symptoms go away entirely within 24 hours, with complete recovery. Symptoms of a TIA may include, but are not limited to, the following:

  • Sudden weakness or clumsiness of an arm and/or leg on one side of the body
  • Sudden paralysis (inability to move) of an arm and/or leg on one side of the body
  • Loss of coordination or movement
  • Confusion, decreased ability to concentrate, dizziness, fainting, and/or headache
  • Numbness or loss of sensation (feeling) in the face
  • Numbness or loss of sensation in an arm and/or leg
  • Temporary loss of vision or blurred vision
  • Inability to speak clearly or slurred speech

TIA may be related to severe narrowing or blockage or from small pieces of an atherosclerotic plaque breaking off, traveling through the bloodstream, and lodging in small blood vessels in the brain. With TIA, there is rarely permanent brain damage.

Call for medical help immediately if you suspect a person is having a TIA, as it may be a warning sign that a stroke is about to occur. Not all strokes, however, are preceded by TIAs.

Stroke is another indicator of carotid artery disease. The symptoms of a stroke are the same as for a TIA. A stroke is loss of blood flow (ischemia) to the brain that continues long enough to cause permanent brain damage. Brain cells begin to die after just a few minutes without oxygen. The area of dead cells in tissues is called an infarct.

The area of the brain that suffered the loss of blood flow will determine what the physical or mental disability may be. This may include impaired ability with movement, speech, thinking and memory, bowel and bladder function, eating, emotional control, and other vital body functions. Recovery from the specific ability affected depends on the size and location of the stroke. A stroke may result in problems, such as weakness in an arm or leg or may cause paralysis, loss of speech, or even death.

The symptoms of carotid artery disease may resemble other medical conditions or problems. Always consult your doctor for a diagnosis.

How is carotid artery disease diagnosed?

In addition to a complete medical history and physical examination, diagnostic procedures for carotid artery disease may include any, or a combination, of the following:

  • Auscultation (listening to) of carotid arteries. Placement of a stethoscope over the carotid artery to listen for a particular sound called a bruit (pronounced brew-ee). A bruit is an abnormal sound that is produced by blood passing through a narrowed artery. A bruit is generally considered a sign of an atherosclerotic artery; however, an artery may be diseased without producing this sound.
  • Carotid artery duplex scan. A type of vascular ultrasound study performed to assess the blood flow of the carotid arteries. A carotid artery duplex scan is a noninvasive (the skin is not pierced) procedure. A probe called a transducer sends out ultrasonic sound waves at a frequency too high to be heard. When the transducer (like a microphone) is placed on the carotid arteries at certain locations and angles, the ultrasonic sound waves move through the skin and other body tissues to the blood vessels, where the waves echo off of the blood cells. The transducer picks up the reflected waves and sends them to an amplifier, which makes the ultrasonic sound waves audible. Absence or faintness of these sounds may indicate an obstruction to the blood flow.
  • Magnetic resonance imaging (MRI). A diagnostic procedure that uses a combination of large magnets, radiofrequencies, and a computer to produce detailed images of organs and structures within the body. To have this test done, you lie inside a big tube while magnets pass around your body. It is very loud. Sometimes it is done with IV contrast injected into your veins and sometimes not.
  • Magnetic resonance angiography (MRA). A noninvasive diagnostic procedure that uses a combination of magnetic resonance technology (MRI) and intravenous (IV) contrast dye to visualize blood vessels. Contrast dye causes blood vessels to appear opaque on the MRI image, allowing the doctor to visualize the blood vessels being evaluated.
  • Computed tomography scan (also called a CT or CAT scan). A diagnostic imaging procedure that uses a combination of X-rays and computer technology to produce horizontal, or axial, images (often called slices) of the body. A CT scan shows detailed images of any part of the body, including the bones, muscles, fat, and organs. CT scans are more detailed than general X-rays. Like an MRI, it is sometimes done with IV contrast injected into your veins and sometimes not.
  • Angiography. An invasive procedure used to assess the degree of blockage or narrowing of the carotid arteries by taking X-ray images while a contrast dye in injected. The contrast dye helps to visualize the shape and flow of blood through the arteries as X-ray images are made.

Treatment for carotid artery disease

Specific treatment for carotid artery disease will be determined by your doctor based on:

  • Your age, overall health, and medical history
  • Extent of the disease
  • Your signs and symptoms
  • Your tolerance of specific medications, procedures, or therapies
  • Expectations for the course of the disease
  • Your opinion or preference

Carotid artery disease (asymptomatic or symptomatic) in which the narrowing of the carotid artery is less than 50 percent is most often treated medically. Asymptomatic disease with less than 70 percent narrowing may also be treated medically, depending on the individual situation.

Medical treatment for carotid artery disease may include:

  • Modification of risk factors. Risk factors that may be modified include smoking, elevated cholesterol levels, elevated blood glucose levels, lack of exercise, poor dietary habits, and elevated blood pressure.
  • Medications. Medications that may be used to treat carotid artery disease include:
    • Antiplatelet medications. Medications used to decrease the ability of platelets in the blood to stick together and cause clots. Aspirin, clopidogrel, and dipyridamole are examples of antiplatelet medications.
    • Antihyperlipidemics. Medications used to lower lipids (fats) in the blood, particularly cholesterol. Statins are a group of antihyperlipidemic medications, and include simvastatin, atorvastatin, and pravastatin, among others. Studies have shown that certain statins can decrease the thickness of the carotid artery wall and increase the size of the lumen (opening) of the artery.
    • Antihypertensives. Medications used to lower blood pressure. There are several different groups of medications which act in different ways to lower blood pressure.

In people with narrowing of the carotid artery greater than 50 to 69 percent, a more aggressive treatment may be recommended, particularly in people with symptoms. Surgical treatment decreases the risk for stroke after symptoms such as TIA or minor stroke, especially in people with an occlusion (blockage) of more than 70 percent who are good candidates for surgery.

Surgical treatment of carotid artery disease includes:

Carotid endarterectomy (CEA). Carotid endarterectomy is a procedure used to remove plaque and clots from the carotid arteries, located in the neck. Endarterectomy may help prevent a stroke from occurring in people with symptoms with a carotid artery narrowing of 70 percent of more.

Illustration of Carotid Endarterectomy

Illustration of Carotid Endarterectomy (Click to Enlarge)

Carotid artery angioplasty with stenting (CAS). Carotid angioplasty with stenting is an option for patients who are high risk for carotid endarterectomy. This is a minimally invasive procedure in which a very small hollow tube, or catheter, is advanced from a blood vessel in the groin to the carotid arteries. Once the catheter is in place, a balloon may be inflated to open the artery and a stent is placed. A stent is a cylinder-like tube made of thin metal-mesh framework used to hold the artery open. Because there is a risk of stroke from bits of plaque breaking off during the procedure, an apparatus, called an embolic protection device, may be used. An embolic protection device is a filter (like a small basket) that is attached on a guidewire to catch any debris that may break off during the procedure.

Carotid artery angioplasty with stenting

Carotid Artery Angioplasty with Stenting (CAS) Click to Enlarge



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


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.


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


5.5 Peripheral Vascular Disease and Vascular Surgery 

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.

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

Case Reports in Vascular Medicine
Volume 2013 (2013), Article ID 207602, 4 pages

Cerebral Hyperperfusion Syndrome following Protected Carotid Artery Stenting

Department of Cardiology and Angiology, Allgemeines Krankenhaus Viersen, Hoserkirchweg 63, 47147 Viersen, Germany

Received 2 May 2013; Accepted 26 June 2013

Academic Editors: K. A. Filis and N. Papanas

Copyright © 2013 Rainer Knur. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.


The cerebral hyperperfusion syndrome is a very rare complication after revascularization of the carotid artery and accompanied by postoperative or postinterventional hypertension in almost all patients. We report a case of a 77-year-old man who developed a complete aphasia and increased right-sided weakness following endovascular treatment of severe occlusive disease of the left internal carotid artery. We discuss the risk and management of cerebral hyperperfusion syndrome after carotid artery stenting.


Neurological complications following carotid artery stenting (CAS) are usually ischemic in nature, due to embolization or occlusion of the carotid artery. However, in a small subset of patients, cerebral hyperperfusion causes postinterventional neurological dysfunction, characterized by ipsilateral headache, focal seizure activity, focal neurological deficit, and ipsilateral intracerebral edema or hemorrhage. A high clinical suspicion and early diagnosis will allow early initiation of therapy and preventing fatal brain swelling or bleeding in patients with peri- and postinterventional cerebral hyperperfusion syndrome (CHS).


In 1981, Sundt et al. [1] described a triad of complications that included atypical migrainous phenomena, transient focal seizure activity, and intracerebral hemorrhage after CEA and used the term cerebral hyperperfusion syndrome (CHS). The first report on CHS after CAS was published by Schoser et al. [2]. They described a 59-year-old woman with ipsilateral putaminal hemorrhage that was diagnosed on the 3rd day after CAS of a high-grade stenosis of the left ICA. Outcome in this case was not fatal. The patient recovered with a mild upper limb paresis. McCabe et al. [3] were the first to report the occurrence of fatal ICH soon after CAS. Only a few hours after the procedure, neurological symptoms occurred without any prodromata (severe headache, nausea, and seizures) postulated by Sundt et al. [1] to be an obligate component of CHS. CT of the brain revealed extensive ICH and the patient died 18 days later. Abou-Chebl et al. [4] reported a retrospective single-center study on 450 patients who had been treated with CAS. Three patients (0.67%) developed ICH after the intervention. Further reports on results and complications after CAS have been published [5]. Nearly all reports on CHS after carotid revascularizations in general and CAS in particular have in common patients who had high-grade stenoses in the treated vessel.

CHS following surgical or endovascular treatment of severe carotid occlusive disease is thought to be the result of impaired cerebral autoregulation, hypertension, ischemia-reperfusion injury, oxygen-derived free radicals, baroreceptor-dysfunction, and intraprocedural ischemia [6]. Chronic cerebral hypoperfusion due to critical stenosis leads to production of vasodilatory substances. Autoregulatory failure results in the cerebral arterioles being maximally dilated over a long period of time, with subsequent loss of their ability to constrict when normal perfusion pressure is restored. The degree of microvascular dysautoregulation is proportional to the duration and severity of ischemia determined by the severity of ipsilateral stenosis and poor collateral flow.

Hypertension plays an important role in the development of CHS. In the absence of cerebral autoregulation, cerebral blood flow is directly dependent on the systemic blood pressure. The restoration of normal blood flow to chronically underperfused brain can result in edema, capillary breakthrough, and perivascular and macroscopic hemorrhages aggravated by peri- and postinterventional hypertension [67]. The risk factors for CHS after CAS are summarized in Table 1.

Table 1: Risk factors for CHS [68].

The classic clinical presentation includes ipsilateral headache, seizures or focal neurological deficit, and ipsilateral intracerebral edema or hemorrhage. The diagnosis can be made readily with color Doppler ultrasound of the carotid artery and especially with transcranial Doppler (TCD) of the middle cerebral artery [9]. An increase in peak blood flow velocity of >100% is predictive of postinterventional hyperperfusion. Diffusion weighted MRI or single photon emission computed tomography (SPECT) could also be performed for diagnosis [10]. Angiography normally shows normal findings.

The prognosis of CHS depends on timely recognition of hyperperfusion and adequate treatment of hypertension before cerebral edema or hemorrhage develops. The prognosis following intracerebral bleeding is very poor, with mortality over 50% and significant morbidity of 80% in the survivors [46]. The prognosis of CHS in patients without cerebral edema or hemorrhage is clearly better especially when they are identified and treated early. The most important aspects in preventing and treating this syndrome are early identification, careful monitoring, and control of blood pressure ideally in a high-dependency unit setting. In our special case, early diagnosis of CHS and immediate intensive medical treatment of blood pressure could prevent devastating cerebral edema or hemorrhage following CAS.


CHS, which is characterized by ipsilateral headache, hypertension, seizures, and focal neurological deficits, is a rare but devastating complication following carotid artery stenting. Hypertension is the most important risk factor. The diagnosis can be confirmed quickly by TCD, DWI, or SPECT. Especially peri- or postinterventional TCD monitoring should be available to identify patients with hyperperfusion who may benefit from intensive blood pressure management ideally in a specialized intensive care unit.


CAS: Carotid artery stenting
CCA: Common carotid artery
CEA: Carotid endarterectomy
CHS: Cerebral hyperperfusion syndrome
CT: Computed tomography
CVR: Cerebrovascular reactivity
DWI: Diffusion-weighted imaging
ICA: Internal carotid artery
ICH: Intracerebral haemorrhage
MRI: Magnetic resonance imaging
SPECT: Single photon emission computed tomography
TCD: Transcranial Doppler.


  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.



#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.







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.


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:


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:


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:


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.


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

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


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.


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.


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.


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.


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.


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

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.”

Confounded by registry requirements
Shishehbor is also concerned about the scrutiny carotid stenting is under from the Centers for Medicare & Medicaid Services (CMS). Currently, the CMS reimburses procedures for asymptomatic patients only if they are included in one of the industry-funded and -maintained registries. He believes the scrutiny has led to a dwindling number of clinicians with the expertise capable of doing the procedure, and this is concerning, since the present analysis shows there are cohorts of asymptomatic patients who would benefit from the treatment.In addition, to be included in a registry, an asymptomatic patient must receive DAPT with aspirin andclopidogrel for four weeks. If the patient does not meet the DAPT requirements, they can’t be included in the registry. However, Shishehbor said, many of these patients have significant coronary disease and can’t wait four weeks. As a result, they are treated with a combined CEA-OHS approach, an approach that is associated with a higher risk of stroke.
Shishehbor reports serving as a speaker and consultant for Abbot VascularMedtronicand 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 speakers bureau for Medtronic. Disclosures for the coauthors are listed in the paper.


  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


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Carotid Endarterectomy (CEA) 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

Writer and Curator: Larry H. Bernstein, MD, FCAP


Curator: Aviva Lev-Ari, PhD, RN 

UPDATED on 9/25/2021

1-Year Results From a Prospective Experience on CAS Using the CGuard Stent System: The IRONGUARD 2 Study


J Am Coll Cardiol Intv, 14 (17) 1917–1923



The aim of this study was to evaluate the 1-year safety and efficacy of a dual-layered stent (DLS) for carotid artery stenting (CAS) in a multicenter registry.


DLS have been proved to be safe and efficient during short-term follow-up. Recent data have raised the concern that the benefit of CAS performed with using a DLS may be hampered by a higher restenosis rate at 1 year.


From January 2017 to June 2019, a physician-initiated, prospective, multispecialty registry enrolled 733 consecutive patients undergoing CAS using the CGuard embolic prevention system at 20 centers. The primary endpoint was the occurrence of death and stroke at 1 year. Secondary endpoints were 1-year rates of transient ischemic attack, acute myocardial infarction, internal carotid artery (ICA) restenosis, in-stent thrombosis, and external carotid artery occlusion.


At 1 year, follow-up was available in 726 patients (99.04%). Beyond 30 days postprocedure, 1 minor stroke (0.13%), four transient ischemic attacks (0.55%), 2 fatal acute myocardial infarctions (0.27%), and 6 noncardiac deaths (1.10%) occurred. On duplex ultrasound examination, ICA restenosis was found in 6 patients (0.82%): 2 total occlusions and 4 in-stent restenoses. No predictors of target ICA restenosis and/or occlusion could be detected, and dual-antiplatelet therapy duration (90 days vs 30 days) was not found to be related to major adverse cardiovascular event or restenosis occurrence.


This real-world registry suggests that DLS use in clinical practice is safe and associated with minimal occurrence of adverse neurologic events up to 12-month follow-up.


UPDATED on 8/5/2020

USPSTF advises against carotid artery stenosis screening

By Theresa Pablos, AuntMinnie staff writer

August 5, 2020 — The U.S. Preventive Services Task Force (USPSTF) is poised to once again recommend against screening for asymptomatic carotid artery stenosis. The task force reaffirmed its D rating in a draft recommendation statement published on August 4.

The USPSTF last weighed in on the topic in 2014, concluding with moderate certainty that the harms of screening for carotid artery stenosis in the general population outweighed the benefits. In its new draft recommendation statement, the agency reaffirmed that position, stating there was not enough new evidence to change its previous recommendation against screening with either carotid duplex ultrasound, CT angiography, or MR angiography.

“The USPSTF found no new substantial evidence that could change its recommendation and therefore reaffirms its recommendation,” the task force wrote.

In theory, screening the general population for stenosis could lead to early detection of narrowed blood vessels, thus enabling medical professionals to conduct potentially life-saving interventions, such as carotid endarterectomy (CEA) and carotid artery stenting (CAS). But the USPSTF concluded that the evidence it reviewed didn’t readily support that hypothesis.

The task force has consistently found limited evidence in favor of asymptomatic carotid artery stenosis screening, especially when compared with other medical therapies, such as statins and antihypertensive agents. And the evidence has been particularly lacking since the USPSTF’s last review in 2014.

USPSTF draft recommendation rationale for asymptomatic carotid artery stenosis
Detection Ultrasonography has reasonable sensitivity and specificity for detecting clinically relevant carotid artery stenosis, but it also yields many false-positive results in the general population.
Scanning the neck for carotid bruits has poor accuracy for clinically relevant carotid artery stenosis.
Benefits Direct evidence does not indicate that screening for asymptomatic carotid artery stenosis can improve stroke, mortality, or other adverse health outcomes.
Carotid endarterectomy (CEA) or carotid artery angioplasty and stenting (CAS) provides little or no benefit for improving stroke, myocardial infarction, mortality, or other adverse outcomes compared with current medical therapy.
Harms While direct evidence does not show that screening for asymptomatic carotid artery stenosis can cause harm, there are known harms with confirmatory testing and interventions.
Direct evidence supports that treating asymptomatic patients with CEA or CAS could cause harms, including stroke or death.
Harms related to screening and treating asymptomatic carotid artery stenosis have small-to-moderate magnitude.

After searching the scientific literature, USPSTF investigators found no recent eligible studies that directly investigated the benefits or harms of asymptomatic carotid artery stenosis screening. The two studies that were conducted on the topic in the past six years were both prematurely terminated and produced mixed results.

When looking at the benefits and harms of CEA or CAS, the authors found an additional two national datasets and three surgical registries that met their inclusion criteria. Rates of 30-day postoperative stroke or death after CEA ranged from 1.4% to 3.5% depending on the registry or database. Similarly, 30-day stroke or death after CAS ranged from 2.6% to 5.1%.

Based on the evidence — or lack thereof — the investigators concluded there wasn’t enough new information to change the D rating for asymptomatic carotid artery stenosis screening. However, they pointed out that two clinical trials are currently underway, which may shed light on the topic in the future.

“There were few new trials, all with methodologic concerns, examining the important question of the comparative effectiveness and harms of revascularization plus best medical treatment compared with best medical treatment alone,” they wrote. “The ongoing CREST-2 and ECST-2 trials will be the largest trials to address this issue.”

The draft recommendation is available for public comment through August 31. After the comment period has ended, the task force will publish its final recommendation.

USPSTF opens review of carotid stenosis screening
The U.S. Preventive Services Task Force (USPSTF) has posted a draft research plan on screening for asymptomatic carotid artery stenosis, an exam that…
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The U.S. Preventive Services Task Force (USPSTF) has finalized its draft recommendation advising against the use of widespread ultrasound screening for…
USPSTF advises against carotid artery screening
The U.S. Preventive Services Task Force (USPSTF) has issued a draft recommendation against ultrasound screening for asymptomatic carotid artery stenosis…
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The U.S. Preventive Services Task Force (USPSTF) plans to review its guidelines on the use of imaging to screen patients for asymptomatic carotid artery…



UPDATED on 8/20/2018

Transcarotid Artery Revascularization Shows Favorable Outcomes in Patients With Carotid Artery Disease

First large body of real-world clinical evidence showing benefits of TCAR versus surgery presented at SVS 2018 Annual Meeting

Transcarotid Artery Revascularization Shows Favorable Outcomes in Patients With Carotid Artery Disease

July 30, 2018 — Silk Road Medical Inc. recently announced the presentation of real-world data for the treatment of patients with carotid artery disease at risk for stroke at the Society for Vascular Surgery 2018 Vascular Annual Meeting (VAM), June 20-23 in Boston. In a headline presentation, Marc Schermerhorn, M.D., of Beth Israel Deaconess Medical Center (Boston) shared, for the first time, results from the ongoing TransCarotid Artery Revascularization (TCAR) Surveillance Project, a key initiative of the Society for Vascular Surgery’s Vascular Quality Initiative (VQI).

The trial evaluated patients over a two-year period, with 1,182 patients receiving TCAR compared to 10,797 patients receiving carotid endarterectomy (CEA).

“Our overall findings showed that while patients receiving TCAR were sicker and more likely to be symptomatic with a higher degree of stenosis, the stroke and death rate compared to CEA was the same,” Schermerhorn said. “With TCAR, there were significantly lower cranial nerve injuries, less time spent in the operating room and fewer patients with a prolonged length of stay. I believe that clinicians should more widely adopt the TCAR technology as it has demonstrated both safety and efficacy and is an excellent alternative to CEA.”

Significant findings from the study showed TCAR to have:

  • Comparable rates of in-hospital stroke or death to CEA (TCAR, 1.6 percent; CEA, 1.4 percent, p=.33);
  • Lower rates of acute cranial nerve injury (TCAR, 0.6 percent; CEA, 1.8 percent, p<.001);
  • Shorter operative times (TCAR, 78 min; CEA, 111 min, p<.001); and
  • Shorter hospital stays, despite patients being older and sicker (percent of hospitals stays longer than one night: TCAR, 27%; CEA, 30%, p=0.046).

TCAR is a clinically proven procedure combining surgical principles of neuroprotection with minimally invasive endovascular techniques to treat blockages in the carotid artery at risk of causing a stroke. The TCAR Surveillance Project is the largest single body of evidence reported since the launch of TCAR in 2016.

Additional TCAR presentations highlighted at SVS VAM 2018 demonstrated similar results:

“Vascular Live: Latest Stroke Prevention Data Signals Standard of Care Potential in Carotid Revascularization” provided an interim update on the ROADSTER 2 Per Protocol data set. The ROADSTER 2 trial is a post-market study intended to enroll a minimum of 600 patients and with at least 70 percent enrollment completed by newly trained operators. Peter Schneider, M.D., of Kaiser Permanente (Honolulu) and co-principal investigator for the ROADSTER 2 trial, presented interim results on 470 patients. Schneider highlighted a 30-day stroke rate of 0.6 percent and a stroke/death rate of 0.9 percent, consistent with the outcomes seen in the pivotal ROADSTER trial.

“A Multi-Institutional Analysis of Contemporary Outcomes after TransCarotid Artery Revascularization versus Carotid Endarterectomy” compared outcomes of TCAR to CEA across four institutions. Alex King of University Hospitals Cleveland Medical Center (Ohio) presented results showing that patients undergoing TCAR (n=292), had similar 30-day stroke rates (TCAR, 1 percent; CEA, 1.1 percent, p=1.00) compared with patients undergoing CEA (n=371), despite being more likely to have significant comorbidities. Acute (TCAR, 0.3 percent; CEA, 4.1 percent, p<.01) and six-month cranial nerve injury rates (TCAR, 0 percent; CEA: 1.9 percent, p=0.02) were shown to be lower with TCAR vs CEA.

The Enroute Transcarotid Stent is intended to be used in conjunction with the Enroute Transcarotid Neuroprotection System (NPS) during the TCAR procedure. The Enroute Transcarotid NPS is used to directly access the common carotid artery and initiate high rate temporary blood flow reversal to protect the brain from stroke while delivering and implanting the Enroute Transcarotid Stent.

For more information: www.silkroadmed.com

This is a review of the impact of the Centers for Medair and Medicaid Services on carotid artery endovascular outcomes carried out by the Division of Vascular and Endovascular Surgery at Harvard Medical School, Partners.

The impact of Centers for Medicare and Medicaid Services high-risk criteria on outcome after carotid endarterectomy and carotid artery stenting in the SVS Vascular Registry.

Schermerhorn ML, Fokkema M, Goodney P, Dillavou ED, Jim J, Kenwood CT, Siami FS, White RA; SVS Outcomes Committee.
 J Vasc Surg. 2013 May;57(5):1318-24.   http://dx.doi.org/10.1016/j.jvs.2012.10.107. Epub 2013 Feb 11.
The Centers for Medicare and Medicaid Services (CMS) require high-risk (HR) criteria for carotid artery stenting (CAS) reimbursement. The impact of these criteria on outcomes after carotid endarterectomy (CEA) and CAS remains uncertain. Additionally, if these HR criteria are associated with more adverse events after CAS, then existing comparative effectiveness analysis of CEA vs CAS may be biased. We sought to elucidate this using data from the SVS Vascular Registry.
We analyzed 10,107 patients undergoing CEA (6370) and CAS (3737), stratified by CMS HR criteria. The primary endpoint was composite death, stroke, and myocardial infarction (MI) (major adverse cardiovascular event [MACE]) at 30 days. We compared baseline characteristics and outcomes using univariate and multivariable analyses.
CAS patients were more likely than CEA to have
  • preoperative stroke (26% vs 21%) or
  • transient ischemic attack (23% vs 19%) .
Although age ≥ 80 years was similar, CAS patients were more likely to have all other HR criteria.
For CEA, HR patients had higher MACEs than normal risk in both
  • symptomatic (7.3% vs 4.6%; P < .01) and
  • asymptomatic patients (5% vs 2.2%; P < .0001).
For CAS, HR status was not associated with a significant increase in MACE for
  • symptomatic (9.1% vs 6.2%; P = .24) or
  • asymptomatic patients (5.4% vs 4.2%; P = .61).
All CAS patients had MACE rates similar to HR CEA. After multivariable risk adjustment, CAS had higher rates than CEA
  • for MACE (odds ratio [OR], 1.2; 95% confidence interval [CI], 1.0-1.5),
  • death (OR, 1.5; 95% CI, 1.0-2.2), and
  • stroke (OR, 1.3; 95% CI,1.0-1.7),
whereas there was no difference in MI (OR, 0.8; 95% CI, 0.6-1.3).
Among CEA patients, MACE was predicted by:
  • age ≥ 80 (OR, 1.4; 95% CI, 1.02-1.8),
  • congestive heart failure (OR, 1.7; 95% CI, 1.03-2.8),
  • EF <30% (OR, 3.5; 95% CI, 1.6-7.7),
  • angina (OR, 3.9; 95% CI, 1.6-9.9),
  • contralateral occlusion (OR, 3.2; 95% CI, 2.1-4.7), and
  • high anatomic lesion (OR, 2.7; 95% CI, 1.33-5.6).
Among CAS patients, recent MI (OR, 3.2; 95% CI, 1.5-7.0) was predictive, and
  • radiation (OR, 0.6; 95% CI, 0.4-0.8) and
  • restenosis (OR, 0.5; 95% CI, 0.3-0.96) …..were protective for MACE
Although CMS HR criteria can successfully discriminate a group of patients at HR for adverse events after CEA, certain CMS HR criteria are more important than others. However, CEA appears safer for the majority of patients with carotid disease. Among patients undergoing CAS, non-HR status may be limited to restenosis and radiation.
This study was preceded by another publication 5-years earlier involving ML Schermerhorn, of the study above.

Risk-adjusted 30-day outcomes of carotid stenting and endarterectomy: results from the SVS Vascular Registry.

Sidawy AN, Zwolak RM, White RA, Siami FS, Schermerhorn ML, Sicard GA; Outcomes Committee for the Society for Vascular Surgery.
Department of Surgery, Washington VA Medical Center, Washington, DC, USA.
J Vasc Surg. 2009 Jan;49(1):71-9. http:/dx.doi.org/10.1016/j.jvs.2008.08.039. Epub 2008 Nov 22.
As of December 26, 2007, 6403 procedures with discharge data were entered by 287 providers at 56 centers on 2763 CAS patients (1450 with 30-day outcomes, 52.5%) and 3259 CEA patients (1368 with 30-day outcomes, 42%).
Of the total cohort, 98% of CEA and 70.7% of CAS (P < .001) were performed for atherosclerotic disease.
  • Restenosis accounted for 22.3% and
  • post-radiation induced stenosis in 4.5% of CAS patients.
Preprocedure lateralizing neurologic symptoms were present in a greater proportion of – CAS patients (49.2%) than CEA patients (42.4%, P < .001).
CAS patients also had higher preprocedure prevalence of
  1. coronary artery disease (CAD),
  2. MI,
  3. congestive heart failure (CHF),
  4. chronic obstructive pulmonary disease (COPD), and
  5. cardiac arrhythmia.
For CAS, death/stroke/MI at 30 days was
  • 7.13% for symptomatic patients and 4.60% for asymptomatic patients (P = .04).
For CEA, death/stroke/MI at 30 days was
  • 3.75% in symptomatic patients and 1.97% in asymptomatic patients (P = .05).
After risk-adjustment for age, history of stroke, diabetes, and American Society of Anesthesiologists (ASA) grade (ie, factors found to be significant confounders in outcomes using backwards elimination),
logistic regression analysis suggested better outcomes following CEA.
When CAS and CEA were compared in the treatment of atherosclerotic disease only, the difference in outcomes between the two procedures was more pronounced, with
  • death/stroke/MI 6.42% after CAS vs 2.62% following CEA, P < .0001.
With continued enrollment and follow-up, analysis of SVS-VR will supplement randomized trials by providing real-world comparisons of CAS and CEA with sufficient numbers to serve as an outcome assessment tool of important patient subsets and across the spectrum of peripheral vascular procedures.
J Vasc Surg. 2012 May;55(5):1313-20; discussion 1321. doi: 10.1016/j.jvs.2011.11.128. Epub 2012 Mar 28.

Society for Vascular Surgery (SVS) Vascular Registry evaluation of comparative effectiveness of carotid revascularization procedures stratified by Medicare age.

Jim JRubin BGRicotta JJ 2ndKenwood CTSiami FSSicard GASVS Outcomes Committee.


Washington University School of Medicine, St. Louis, Mo., USA.



Recent randomized controlled trials have shown that age significantly affects the outcome of carotid revascularization procedures. This study used data from the Society for Vascular Surgery Vascular Registry (VR) to report the influence of age on the comparative effectiveness of carotid endarterectomy (CEA) and carotid artery stenting (CAS).


VR collects provider-reported data on patients using a Web-based database. Patients were stratified by age and symptoms. The primary end point was the composite outcome of death, stroke, or myocardial infarction (MI) at 30 days.


As of December 7, 2010, there were 1347 CEA and 861 CAS patients aged < 65 years and 4169 CEA and 2536 CAS patients aged ≥ 65 years. CAS patients in both age groups were more likely to have a disease etiology of radiation or restenosis, be symptomatic, and have more cardiac comorbidities. In patients aged <65 years, the primary end point (5.23% CAS vs 3.56% CEA; P = .065) did not reach statistical significance. Subgroup analyses showed that CAS had a higher combined death/stroke/MI rate (4.44% vs 2.10%; P < .031) in asymptomatic patients but there was no difference in the symptomatic (6.00% vs 5.47%; P = .79) group. In patients aged ≥ 65 years, CEA had lower rates of death (0.91% vs 1.97%; P < .01), stroke (2.52% vs 4.89%; P < .01), and composite death/stroke/MI (4.27% vs 7.14%; P < .01). CEA in patients aged ≥ 65 years was associated with lower rates of the primary end point in symptomatic (5.27% vs 9.52%; P < .01) and asymptomatic (3.31% vs 5.27%; P < .01) subgroups. After risk adjustment, CAS patients aged ≥ 65 years were more likely to reach the primary end point.


Compared with CEA, CAS resulted in inferior 30-day outcomes in symptomatic and asymptomatic patients aged ≥ 65 years. These findings do not support the widespread use of CAS in patients aged ≥ 65 years.

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Bioabsorbable Drug Coating Scaffolds, Stents and Dual Antiplatelet Therapy (Aviva Lev-Ari)
Vascular Repair: Stents and Biologically Active Implants (larryhbern)
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Biomaterials Technology: Models of Tissue Engineering for Reperfusion and Implantable Devices for Revascularization (larryhbern)
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The ACUITY-PCI score: Will it Replace Four Established Risk Scores — TIMI, GRACE, SYNTAX, and Clinical SYNTAX  (A Lev-Ari)
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English: FIG. 513 – The internal carotid and v...

English: FIG. 513 – The internal carotid and vertebral arteries. Right side. Deutsch: Rechte Arteria carotis (Photo credit: Wikipedia)

Carotid Plaque Atherosclerotic plaque from a c...

Carotid Plaque Atherosclerotic plaque from a carotid endarterectomy specimen. This shows the bifurcation of the common into the internal and external carotid arteries. (Photo credit: Wikipedia)

Right common carotid artery - The Anatomy of t...

Right common carotid artery – The Anatomy of the Arteries Visual Guide, page 5 (of 57) (Photo credit: Rob Swatski)

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Reporter: Aviva Lev-Ari, PhD, RN


Medicare Reveals Hospital Charge Information

By David Pittman, Washington Correspondent, MedPage Today

Published: May 08, 2013


WASHINGTON — The Obama administration made public on Wednesday previously unpublished hospital charges for the 100 most common inpatient treatments in 2011, saying a similar release of physician data is on the horizon.

The massive data file reveals wide variation in charges for these 100 services listed in hospitals’ “chargemasters” — industry jargon for what hospitals charge. The data set represents added transparency the administration hopes will influence consumer behavior.

“Making this available for free for the first time will save consumers money by arming them with information that can help them make better choices,” Health and Human Services Secretary Kathleen Sebelius said in a call with reporters Wednesday.

The data only include inpatient hospital services, but when asked about physician fees and other inpatient services, a top Centers for Medicare & Medicaid Services (CMS) official said those data could come later as the agency expands its price transparency initiative.

“We don’t have a set timetable for expansion for this data release,” Jonathan Blum, PhD, acting principal deputy administrator at CMS, said on the same call as Sebelius. “I think it is fair to say we intend to build upon this data release.”

Blum said multiple times in his call with reporters that CMS will study the impact this information has on consumer behavior and what value the public places on it.

Journalist Steven Brill — who wrote a March 4 Time magazine cover story on healthcare-pricing practices largely credited for CMS’ action Wednesday — said in a blog that Sebelius and CMS should next focus on outpatient services.

“The Feds need to publish chargemaster and Medicare pricing for the most frequent outpatient procedures and diagnostic tests at clinics — two huge profit venues in the medical world,” Brill wrote. “This will be harder — the government doesn’t collect that data as comprehensively — but those outpatient centers and clinics provide a huge portion of American medical care.”

A quick scan of the hospital data released Wednesday reveals wide variation for the same procedure in the same town.

For example, St. Dominic Hospital in Jackson, Miss., charged nearly $26,000 to implant a pacemaker while the University of Mississippi Medical Center across town charged more than $57,000 for the same procedure.

In Washington, the George Washington University Hospital charged nearly $69,000 for a lower-leg joint replacement without major complications. That same procedure cost just under $30,000 at Sibley Memorial Hospital — a nonprofit community hospital 5 miles away.

A joint replacement ranged from $5,300 at a hospital in Ada, Okla., to $223,000 at a hospital in Monterey Park, Calif., CMS said.

“Hospitals that charge two or three times the going rate rightfully face greater scrutiny,” Sebelius said.

Said Blum, “We’re really trying to help elevate the conversation and continue the conversation and to ask questions why there is so much variation.”

Common explanations for the varying costs — patients’ health status, hospital payer mix, teaching status — don’t seem accurate or clear from data CMS released, Blum said, adding that making such information public will help researchers, consumers, and others better ask questions and engage in debate over costs.

Opponents to such transparency note that chargemaster prices are irrelevant to most patients. Private insurance companies and Medicare negotiate their own prices with hospitals.

Instead, it’s only the uninsured who face the prices on the chargemaster.

“Most perniciously, uninsured people are the ones who usually pay the highest prices for their hospital care,” Ron Pollack, executive director of the liberal patient rights group Families USA here,said in a statement. “It is absurd – and, indeed, unconscionable – that the people least capable of paying for their hospital care bear the largest, and often unaffordable, cost burdens.”

The American Hospital Association (AHA) said healthcare’s “charge” system is a matter of financing that urgently needs updating.

“The complex and bewildering interplay among ‘charges,’ ‘rates,’ ‘bills’ and ‘payments’ across dozens of payers, public and private, does not serve any stakeholder well, including hospitals,”AHA president and chief executive Rich Umbdenstock said in a statement. “This is especially true when what is most important to a patient is knowing what his or her financial responsibility will be.”

The Federation of American Hospitals declined to comment.


David Pittman


David Pittman is MedPage Today’s Washington Correspondent, following the intersection of policy and healthcare. He covers Congress, FDA, and other health agencies in Washington, as well as major healthcare events. David holds bachelors’ degrees in journalism and chemistry from the University of Georgia and previously worked at the Amarillo Globe-News in Texas,Chemical & Engineering News and most recently FDAnews.


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New York Methodist Hospital in Park Slope, Bro...

New York Methodist Hospital in Park Slope, Brooklyn (Photo credit: Wikipedia)

Larry H Bernstein, MD, FCAP, Triplex Medical Science

New York Methodist Hospital-WeillCornell, an 850+ bed tertiary care hospital in Park Slope, Brooklyn. one of 5 prominent hospitals in NY state has an annual Memorial Lecture in recognition of the former Chief of Orthopedic Surgery.  The brother of the deceased is the democratic State Senate leader, Sheldon Silver, from the lower east side of Manhattan.  He tells the joke about his brother, the doctor,  keeping him focused on the health needs of the community.  There is the old Yiddish joke about the mother who recieves a call ferom Washington informing her that her son is elected President (of course this Prez must go to bed every night asking, who needs this!  The mother responds, “That’s wonderful, but you know his brother is a DOCTOR!”   We have something like that with the Chicago Emanuel brothers.

If you asked her today, she would say, OY! My son the doctor.  We are somehow adapting at the same time we are reacting.

This article just appeared in Medscape online.


Official photographic portrait of US President...

Official photographic portrait of US President Barack Obama (born 4 August 1961; assumed office 20 January 2009) (Photo credit: Wikipedia)



IPAB Repeal Reintroduced in Senate
Robert Lowes
Feb 15, 2013

Editors’ Recommendations
Imaging Fees for Physicians Get Pushed Over Fiscal Cliff
Presidential Election: Healthcare Game Changer or Time-out?
House Repeals IPAB, Passes Malpractice Damages Cap




English: This is an image of Donald Berwick, w...

English: This is an image of Donald Berwick, who is the Administrator for the US Federal Center for Medicare and Medicaid Services (CMS). CMS is part of the US Department of Health and Human Services. The source website is federally managed by the Department of Health and Human Services. (Photo credit: Wikipedia)


English: Barack Obama signing the Patient Prot...

English: Barack Obama signing the Patient Protection and Affordable Care Act at the White House Español: Barack Obama firmando la Ley de Protección al Paciente y Cuidado de Salud Asequible en la Casa Blanca (Photo credit: Wikipedia)

Sticking to their party’s game plan to dismantle the Affordable Care Act (ACA) piece by piece, Sen. John Cornyn (R-TX) and Sen. Orrin Hatch (R-UT) Thursday reintroduced a bill to repeal a controversial Medicare cost control mechanism in the law that is widely opposed by organized medicine.

The cost control mechanism is the Independent Advisory Payment Board (IPAB). The 15-member board must include physicians, but healthcare providers of any stripe must not constitute the majority of the board. Its mission is to advise Congress on how to curb the per capita growth of Medicare spending if it exceeds growth rate targets set by the law. If Congress does not implement IPAB recommendations, it must either enact legislation that saves just as much or let the Department of Health and Human Services make the cuts.

The IPAB, which a reintroduced GOP bill in the House also seeks to repeal, has come under fire from political conservatives and medical societies for offering too much power to a collection of “bureaucrats” who are largely unaccountable to Congress. Critics also warn that it will end up rationing care and subjecting physicians to unfair pay cuts just as Medicare’s sustainable growth rate formula has done.

The ACA explicitly prohibits the IPAB from rationing care or recommending any measures that would reduce Medicare eligibility and benefits or increase costs borne by beneficiaries. Supporters say that the IPAB would perform a salutary end-run around a Congress that is under the sway of healthcare industry lobbyists who protect provider reimbursement to the detriment of the public good.

The Senate bill to repeal the IPAB has 31 sponsors, all Republican. Even if the bill passed in the Senate with Democratic support and sailed through the Republican-controlled House, President Barack Obama is poised to veto it, according to a previous White House pronouncement.

The president has yet to nominate anyone to serve on the IPAB. His appointments under the law require the advice and consent of the Senate. Given that Republicans command enough votes to filibuster any nomination, the IPAB could remain 15 empty chairs, although the president could temporarily fill them through appointments made while the Senate is in recess.

In another new attack on the ACA, Rep. Charles Boustany Jr (R-LA) and Rep. Jim Matheson (D-UT) reintroduced a bill today to repeal an excise tax on health insurers in the law that will raise roughly $100 billion in revenue over 10 years. In addition, earlier this month, a bipartisan group of senators introduced legislation to eliminate an ACA tax on medical devices, which some physicians say will boost the price of diagnostic imaging and other medical equipment during a time of declining reimbursement. The Congressional Budget Office estimates that the device tax will bring $30 billion into the federal treasury.

Any repeal of tax provisions in the ACA presents a Congress committed to deficit reduction with the thorny problem of offsetting revenue losses with either spending cuts or revenue increases elsewhere in the federal budget.


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