I see no reason why jugular venoplasty is not being performed on patients with outflow obstructions under the same Special Access program.
Because venous obstructions that cause a new condition now described by some as CCSVI are also found in healthy people and there is no evidence that they cause any "serious or life threatening illness", or any illness of any significance or insignificance at all. As Dr. Sclafani emphasizes, he treats "CCSVI NOT MS".
The obvious difference is that hypertension has well documented ill effects if not controlled. That, and renal denervation has studies done elsewhere documenting its impact on high blood pressure. Something else that venoplasty for CCSVI lacks as well.
It seems pretty clear to me why these situations are not comparable and why this could not be used as an example to argue for coverage of venoplasty for CCSVI under Canadian healthcare on a compassionate basis. You are comparing two circumstances that are vastly dissimilar.
I am a PI for SUNY Downstate on the Symplicity trial. This trial is the third study being done by the owners of the patent.
the first trial was by the start up company Ardian. and published by Krum
Catheter-based renal sympathetic denervation for resistant
hypertension: a multicentre safety and proof-of-principle
Henry Krum, Markus Schlaich, Rob Whitbourn, Paul A Sobotka, Jerzy Sadowski, Krzysztof Bartus, Boguslaw Kapelak, Anthony Walton,
Horst Sievert, Suku Thambar, William T Abraham, Murray Esler
Background Renal sympathetic hyperactivity is associated with hypertension and its progression, chronic kidney
disease, and heart failure. We did a proof-of-principle trial of therapeutic renal sympathetic denervation in patients
with resistant hypertension (ie, systolic blood pressure ≥160 mm Hg on three or more antihypertensive medications,
including a diuretic) to assess safety and blood-pressure reduction eff ectiveness.
Methods We enrolled 50 patients at fi ve Australian and European centres; 5 patients were excluded for anatomical
reasons (mainly on the basis of dual renal artery systems). Patients received percutaneous radiofrequency
catheter-based treatment between June, 2007, and November, 2008, with subsequent follow-up to 1 year. We assessed
the eff ectiveness of renal sympathetic denervation with renal noradrenaline spillover in a subgroup of patients.
Primary endpoints were offi ce blood pressure and safety data before and at 1, 3, 6, 9, and 12 months after procedure.
Renal angiography was done before, immediately after, and 14–30 days after procedure, and magnetic resonance
angiogram 6 months after procedure. We assessed blood-pressure lowering eff ectiveness by repeated measures
ANOVA. This study is registered in Australia and Europe with ClinicalTrials.gov, numbers NCT 00483808 and NCT
Findings In treated patients, baseline mean offi ce blood pressure was 177/101 mm Hg (SD 20/15), (mean 4·7 antihypertensive
medications); estimated glomerular fi ltration rate was 81 mL/min/1·73m² (SD 23); and mean reduction
in renal noradrenaline spillover was 47% (95% CI 28–65%). Offi ce blood pressures after procedure were reduced by
–14/–10, –21/–10, –22/–11, –24/–11, and –27/–17 mm Hg at 1, 3, 6, 9, and 12 months, respectively. In the fi ve
non-treated patients, mean rise in offi ce blood pressure was +3/–2, +2/+3, +14/+9, and +26/+17 mm Hg at 1, 3, 6, and
9 months, respectively. One intraprocedural renal artery dissection occurred before radiofrequency energy delivery,
without further sequelae. There were no other renovascular complications.
Interpretation Catheter-based renal denervation causes substantial and sustained blood-pressure reduction, without
serious adverse events, in patients with resistant hypertension. Prospective randomised clinical trials are needed to
investigate the usefulness of this procedure in the management of this condition.
Funding Ardian Inc.
This was the basis for a randomized trial in Europe and Australia that showed efficacy in treatment by reducing blood pressure. They did not have to show a reduction in stroke, heart attacks, kidney failure. I cannot find a paper on that randomized prospective trial, but several short papers by various groups in italy, netherlands, spain to same a few.
becoming The device was then released by Ardian in Europe and is now becoming a mainstream therapy for patients who fail drug therapy (that is, remain hypertensive despite three or more medications including a diuretic.
The Device and the company were bought by Medtronic, a large conglomerate in cardiovascular instrumentation for treatments and diagnostics.Now FDA has approved a trial of the device in the united states. It is a well designed study.
That trial is a double blinded trial, comparing optimized medical therapy against RF ablation of the renal sympathetic nerves in a 1:2 ratio.
i think that the letter is on target, not however, in any way disparaging the sympathectomy work
while there are three times as many papers in the literature since 2009 on sympathectomy than on ccsvi. However there are more randomized papers in ccsvi. many papers in the european experience of hypertension are small short series.
I think that the letter was dead on