Physical Counterpressure Manoeuvre Trial - PC-Trial

Mar 12, 2006
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Date Presented:
01/01/2006
Date Published:
01/01/2006
Date Updated:
03/12/2006
Original Posted Date:
03/12/2006
References

Description:

The goal of the trial was to evaluate treatment with physical counterpressure maneuvers (PCM) compared with optimal conventional therapy among patients with recurrent vasovagal syncope.

Study Design

Study Design:

Patients Enrolled: 223
Mean Follow Up: Mean follow-up 14 months
Mean Patient Age: Mean age 38.6 years
Female: 62

Patient Populations:

Age 16-70 years with recurrent vasovagal syncope and recognizable prodromal symptoms

Exclusions:

Suspected or overt heart disease with a high likelihood of cardiac syncope; orthostatic hypotension; episodes of loss of consciousness different from syncope; vascular steal syndrome; patients psychologically, physically, or cognitively unable to participate; doubtful compliance; inaccessibility to follow-up; life expectancy of <1 year.

Primary Endpoints:

Total syncopal burden

Secondary Endpoints:

Time to first recurrent syncopal episode

Drug/Procedures Used:

Patients were randomized to physical counterpressure maneuvers using biofeedback in addition to optimal conventional therapy (n=98) or optimal conventional therapy alone (n=110). PCM included leg crossing with tensing of leg muscles, hand grasping, and arm tensing.

Principal Findings:

Of the patients randomised to PCM, 77.4% used at least one maneuvers during follow-up, with the first choice of maneuver arm tensing (36.0%), hand grip (25.8%), and leg crossing (23.6%). A syncopal recurrence episode occurred less frequently in the PCM group compared with the control group (32% vs 51%, p<0.01). Yearly syncope-burden during follow-up was significantly lower in the PCM group compared with the control group (median 0.0, interquartile [IQ] range 0.0-0.7 vs median 0.6, IQ range 0.0-1.3; p<0.01). There was no difference in pre-syncope recurrence (82.7% for PCM vs 73.6% for control, p=0.12). Recurrence-free survival was longer in the treatment group (hazard ratio 0.59; log rank p=0.018). No adverse events were reported.

Interpretation:

Among patients with recurrent vasovagal syncope, treatment with physical counterpressure maneuvers using biofeedback in addition to optimal conventional therapy was associated with a reduction in syncopal recurrence compared with optimal conventional therapy alone.

Few treatment options are available for patients with syncopal recurrence. PCM had previously been demonstrated to abort vasovagal episodes in the laboratory setting, but the present trial is the first randomized study to evaluate PCM in a real world setting.

References:

van Dijk N, et al. Effectiveness of Physical Counterpressure Maneuvers in Preventing Vasovagal Syncope. J Am Coll Cardiol 2006;48:1652-7.

Presented by Dr. N. van Dijk at the March 2006 i2 Summit Annual Scientific Session, Atlanta, GA.

Keywords: Follow-Up Studies, Syncope, Vasovagal, Tilt-Table Test, Prodromal Symptoms, Hand Strength


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