Boy, did we have high hopes.  Back in late 2010, I reported on this great new premise that would let us treat recalcitrant hypertension relatively easily.  Ardian had developed a system that would enervate the renal nerve, which is the primary regulator of blood pressure in the human body (the system is called Symplicity).

This system involves threading a  catheter down to the renal artery, followed by the application of RF (radio-frequency) energy, and voila, the renal nerve connections would be severed.  As such, a permanent reduction in hypertension would be afforded the patient; the risk for strokes, heart attacks, etc. would be a thing of the past.    This is critical because some 10% of the 65 million sufferers (in the US alone) are considered recalcitrant; their blood pressure is not reduced or greatly affected by drug treatment.

In an upcoming article in the New England Journal of Medicine,  Drs. Bhatt and Mauri (Peter Bent Brigham/Harvard); Kandzari (Piedmont Heart, Atlanta); O’Neill (Henry Ford, Detroit); D’Agostino (Boston U); Flack (Wayne State, Detroit); Katzen (Baptist Miami); Leon (Columbia); Liu, Negoita, and Cohen (Medtronic), Oparil (U Alabama Birmingham), Singh(Prairie Heart, Springfield IL); Townsend (U of P, which also included Cohen), and Bakris (U of Chicago) reported their initial trial results; a trial different from all the others.   535 (treatment-resistant) patients underwent a prospective, randomized trial of the system.

The study had two goals; the primary goal was to develop a change in the systolic blood pressure after six months.  The secondary goal involved the changing of the 24 hour ambulatory systolic pressure.  As opposed to the early test results for hte system, only very negligible improvement was noted in the patients who underwent the procedure.

While it has been approved in some 80 countries and effected on thousands of patients, the US was not among those who initially adopted the program.  This is why the clinical trial was effected here.

(OK, folks- here’s another example of a therapy approved around the world and not here- for very good reasons.   The FDA does a generally good job regarding the approval of new therapies and regimes.)

The difference in this study compared to the others was that all the patients underwent surgical procedures- but 2/3 of them actually received the RF energy; the other 1/3 just were catheterized, thinking they, too, had the operation.  The goal of this study was to remove the placebo effect- folks thinking that they had been treated and thereby, in some fashion, actually manifest clinically different results.

Moreover, both sets of groups continued taking multiple drugs to control blood pressure; none were permitted to rely on the operation (sham or not) alone.  Not surprising, both treatment sets exhibited a drop in blood pressure, but neither one was significantly different (about 4 mm Hg difference)- and a mere change of only 10 to 15 mm Hg in their blood pressures was not the goal sought either.

So, it seems this innovation won’t make a big difference to patients.  And, the costs for its development will be rolled into one that will work.

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