Blog entry by Meguid El Nahas

Picture of Meguid El Nahas
by Meguid El Nahas - Tuesday, 30 June 2015, 8:31 AM
Anyone in the world
Lancet. 2015 Apr 25;385(9978):1634-41. doi: 10.1016/S0140-6736(14)62053-5. Epub 2015 Jan 23.

Central arteriovenous anastomosis for the treatment of patients with uncontrolled hypertension (the ROX CONTROL HTN study): a randomised controlled trial.

Abstract

BACKGROUND:

Hypertension contributes to cardiovascular morbidity and mortality. We assessed the safety and efficacy of a central iliac arteriovenous anastomosis to alter the mechanical arterial properties and reduce blood pressure in patients with uncontrolled hypertension.

METHODS:

We enrolled patients in this open-label, multicentre, prospective, randomised, controlled trial between October, 2012, and April, 2014. Eligible patients had baseline office systolic blood pressure of 140 mm Hg or higher and average daytime ambulatory blood pressure of 135 mm Hg or higher systolic and 85 mm Hg or higher diastolic despite antihypertensive treatment. Patients were randomly allocated in a 1:1 ratio to undergo implantation of an arteriovenous coupler device plus current pharmaceutical treatment or to maintain current treatment alone (control). The primary endpoint was mean change from baseline in office and 24 h ambulatory systolic blood pressure at 6 months. Analysis was by modified intention to treat (all patients remaining in follow-up at 6 months). This trial is registered with ClinicalTrials.gov, number NCT01642498.

FINDINGS:

83 (43%) of 195 patients screened were assigned arteriovenous coupler therapy (n=44) or normal care (n=39). Mean office systolic blood pressure reduced by 26·9 (SD 23·9) mm Hg in the arteriovenous coupler group (p<0·0001) and by 3·7 (21·2) mm Hg in the control group (p=0·31). Mean systolic 24 h ambulatory blood pressure reduced by 13·5 (18·8) mm Hg (p<0·0001) in arteriovenous coupler recipients and by 0·5 (15·8) mm Hg (p=0·86) in controls. Implantation of the arteriovenous coupler was associated with late ipsilateral venous stenosis in 12 (29%) of 42 patients and was treatable with venoplasty or stenting.

INTERPRETATION:

Arteriovenous anastomosis was associated with significantly reduced blood pressure and hypertensive complications. This approach might be a useful adjunctive therapy for patients with uncontrolled hypertension.

FUNDING:

ROX Medical.

COMMENTS:

This pilot study pertains to treat resistant hypertension by the creation of an iliac AV shunt...

Whilst seemingly promising, it is another example of the BIG INDUSTRIAL MEDICAL COMPLEX intrusion into clinical practice; the use of a potentially harmful, not to say dangerous, interventions to treat patients who may not need it (those whose SBP is above 140mmHg, whilst their age if over 70....) or who may be controlled otherwise...by a 4th antihypertensive agent...or better compliance...25-30% of so called resistant hypertensives are non compliant:

http://www.ncbi.nlm.nih.gov/pubmed/24694797

The AV shunt intervention exposes patients to a number of serious complications such as DVT as well as potential ischemic lower limb changes...

It is also an example of the BIG INDUSTRIAL MEDICAL COMPLEX influence on publishers...the publication in the Lancet, a seemingly serious journal, of a pilot study with short and inadequate follow-up as well as devoid of control/sham intervention group not to mention compliance to medical checks... In other words, a pilot, proof of concept, study with a number of serious limitations...published in a top medical journal...?!

This intrusion of the INDUSTRIAL MEDICAL COMPLEX was already demonstrated in patients with "resistant" hypertension by the Renal Sympathetic Denervation (RDN) clinical trials, SIMPLICITY...mostly badly designed an uncontrolled until SIMPLICITY HTN 3 showed no benefit...

BUT...the MEDICAL INDUSTRIAL COMPLEX...doesnt rest its case but pursue and encourage the greed of interventionists amongst private physicians...who saw in such method a major source of unethical income...by all sorts of subgroup analyses and posthoc analyses claiming benefits...:

in Japan: http://www.ncbi.nlm.nih.gov/pubmed/26102846

In subgroups: http://www.ncbi.nlm.nih.gov/pubmed/24914028

Younger patients: http://www.ncbi.nlm.nih.gov/pubmed/25565369

Non-African Americans...

Number of bursts...

https://www.gkaonlineacademy.com/blog/item/simplicity3-not-so-simple

etc...

In other words, the MEDICAL INDUSTRIAL COMPLEX feeds on:

1. Pseudo clinical indications

2. Poorly managed patients, by conventional means

3. Credulous physicians who think any new technology is an advance...

4. Greedy physicians who make money out of new interventions at the expense of their patients' safety or benefit...in countries where private medicine thrives...

5. Medical Journals attracted by medical technical innovations...even when poorly designed, or pilot, studies underpin the findings...

IT IS HIGH TIME WE, AS A PROFESSION, PUT PATIENTS BENEFIT AND SAFETY BEFORE GADGETRY AND PROFIT...

 

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