NICE AAA GUIDELINES: At the First Frank J. Veith International Society meeting held at the University Club in New York City, Professor Sherif Sultan, MB BCh MCh MD FRCSI DEVS FISVS FASA, DMD FRCS/Vasc EBQS/Vasc FAARM FACS FEVBS PhD presented the state of the NICE AAA Guideline and how it will impact the future of Vascular Surgery.

Professor Sherif A. Sultan* told Medical Device News Magazine: “Conflict of interest and personal agenda are one of the main reasons of such incompetence.” In the below-noted article, Dr. Sultan renders his thoughts and concerns.

In May 2018 the National Institute for Health and Care Excellence (NICE) released a draft for consultation of its updated guidelines for Abdominal Aortic Aneurysm (AAA) diagnosis and management. With a typical “Brexit, house of commons scenario” the publication of the NICE AAA document was postponed three (3) times.

The NICE advice impedes UK AAA management and vigorously withdrawing the predominant intervention for a life-threatening condition, notwithstanding the ample proof of safety and effectiveness of EVAR. This is the first time in the history of the NICE Guidelines that a life-saving procedure has been frozen because of a defectively computed UK economic model.

The NICE committee had used an economic analysis model, which is not validated outside the UK. The UK delivery of vascular services depends on the combined use of a full Vascular Surgery team and a full radiology workforce to run aortic repair cases, which is hardly used in the majority of other countries.

The interpretation of the evidence was undertaken by a committee of vascular surgeons and one radiologist and although one has to respect their professional integrity, there is no doubt that unconscious bias had influenced the committee’s output.

The aortic practices of those involved, whether mostly open or endovascular or no AAA practice at all, should be made transparent, so an enhanced indulgence of how their conclusions were drawn. Moreover, a particular agenda to set up a new EVAR III trial by one member and the conflict of interest and divergence of one of the senior authors with some of his very successful vascular colleagues came to the attention of the public. When the evidence is manipulated, the interpretation of such evidence is arduous and likely to be prejudiced by the favoritism of the failed committee.

NICE justified its evidence synthesis on the basis of high EVAR maintenance costs and reduced durability, using only evidence from historic four randomized trials of OSR versus EVAR, which recruited patients between 1999 and 2008 with a combined study population of only 2,783!

The utmost provocative recommendations are in relation to the use of EVAR versus open surgical repair and post-EVAR surveillance. Elective EVAR is not recommended except for complex FEVAR/ BEVAR/CHEVAR within a randomized clinical trial, and CT-based surveillance is mandated.

However, in January 2018, in total contrast to NICE, the UK health technology assessment had publicized that endograft type and center experience impact outcome and EVAR offers operative mortality advantage over or in patients fit for both procedures. Among patients unfit for open repair, EVAR is associated with a significant long-term reduction in AAA-related Mortality. EVAR has an early survival benefit up to 8 years but lower late survival benefit compared with OR.

In a total NICE denial situation, the UK data for para-renal open AAA repair reports a mortality rate of 14%, which is one of the highest in the world! Although, the national vascular registry for complex open repair versus EVAR, documented that mortality is more than five (5) times higher and three (3) times likely to be readmitted to critical care and twice as likely to return to theatre in open AAA Repair. NHS does not have the infrastructure, the ICU beds or days to offer a safe open UK-AAA program.

Adding salt to a self-inflicted wound, The Interventional Radiology Committee at The Royal College of Radiologists in the UK, had inveterate that the vast majority of EVAR UK procedures are currently done by interventional radiologists, and any reduction in EVAR caseload will make it impossible to gain or maintain EVAR skills. The Interventional Radiology Committee dictated a pragmatic approach which dictates that the limited number of allowed EVAR cases post-implantation of NICE, must be performed by Interventional Radiologists only, in order to concentrate expertise, and vascular surgeons are dismissed as dinosaurs heading to annihilation.

The inevitable consequence of the removal of elective EVAR will be a marked reduction in the number of practitioners able to train or maintain competence to perform the procedure. This will result in loss of patient choice in having EVAR in the emergency setting, with consequent direct increase in mortality in the ruptured AAA patient. This prohibited exploit of EVAR, will lead to open surgery of any ruptured AAA, which is akin to a criminal act.

The guidelines will result in loss of patient choice in the elective setting, where the NICE Committee have arbitrarily chosen improved long-term outcomes seen with open repair to be more important than improved shorter-term outcomes seen with EVAR; this in a population of patients for many of whom long-term survival is not a realistic outlook and therefore irrelevant. Mostly AAA patients do not survive post fifteen (15) years.

The NICE committee concedes that EVAR mortality is superior in the peri-operative period and remain equivalent up to eight (8) years, beyond this open repair has demonstrated superiority. However, a window from eight (8) years to fifteen (15) years is based on few scanty patients and it is not statically powered, moreover, the lack of reporting of re-interventions for open repair, rather than a lack of occurrence of the need for re-intervention.

Although the committee accepts that this is old data, they declare that they found no evidence that newer devices perform better than their earlier counterparts.

Patients who are unsuitable for open repair are not afforded any chance of intervention by the NICE committee largely due to economic reasons and is based on a poorly run EVAR 2 Trial. Re-evaluated EVAR 2 data using a rank-preserving structural failure time (RPSFT) statistic to account for cross-over between treatment groups which changes completely their numbers and subsequent conclusions. NICE recognized the data and commented that credible assumptions underpinning the RPSFT cannot be empirically validated!

The definitive recommendations is in favor of open surgery and it does not encourage physicians to take any patient factors into account when discussing treatment options with patients and goals for shared decision making.

This is in total contrast to the NICE Charter in 2017 which “Highlight the importance of balancing professional judgment and expertise with the needs and wishes of people receiving care”. This lack of patient choice is a human rights infringement akin to a dictatorship.

Read Sultan’s previous NICE related article here.

*Sultan is Professor of Vascular & Endovascular Surgery, National University of Ireland, Chairman of Western Vascular Institute, University Hospital Galway ^NUIG & The Galway Clinic ^RCSI