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Physical Counterpressure Maneuver (PC) Trial

Physical Counterpressure Maneuver (PC) Trial. Presented at The American College of Cardiology Scientific Session 2006 Presented by Dr. N. van Dijk. PC-Trial: Background.

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Physical Counterpressure Maneuver (PC) Trial

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  1. Physical Counterpressure Maneuver (PC) Trial Presented at The American College of Cardiology Scientific Session 2006 Presented by Dr. N. van Dijk

  2. PC-Trial: Background • This trial set out to evaluate treatment with physical counterpressure manoeuvres (PCM) compared with optimal conventional therapy among patients with recurrent vasovagal syncope Presented at ACC 2006

  3. PC-Trial: Study Design 223 patients age 16-70 years with recurrent vasovagal syncope and recognizable prodromal symptoms Randomized. Mean follow-up 14 months Physical counterpressure maneuvers using biofeedback in addition to optimal conventional therapy n=98 PCM included: leg crossing with tensing of leg muscles, hand grasping, and arm tensing Optimal conventional therapy alone n=101 • Primary Endpoint: Total syncopal burden • Secondary Endpoint: Time to first recurrent syncopal episode Presented at ACC 2006

  4. PC-Trial: Primary Endpoint Syncopal Recurrence Episode (%) p<0.01 • A syncopal recurrence episode occurred less frequently in the PCM group compared with the control group (32% vs. 51%; p<0.01) Presented at ACC 2006

  5. PC-Trial: Secondary Endpoints Median Reduction in Yearly Syncope-Burden p<0.01 • Median yearly syncope-burden during follow-up was significantly lower in the PCM group compared with the control group (0.0 vs. 0.6; p<0.01) Presented at ACC 2006

  6. PC-Trial: Secondary Endpoints (cont.) Pre-Syncope Recurrence (%) p=0.12 • There was no difference in pre-syncope recurrence for the PCM group and the control group (82.7% vs. 74%; p=0.12) Presented at ACC 2006

  7. PC-Trial: Secondary Endpoints (cont.) • Interquartile range [IQ] for yearly syncope-burden during follow-up was 0.0-0.7 for the PCM group and 0.0-1.3 for the control group • Recurrence-free survival was longer in the treatment group (hazard ratio 0.59; log rank p=0.018) • No adverse events were reported Presented at ACC 2006

  8. PC-Trial: Limitations • 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. Presented at ACC 2006

  9. PC-Trial: Summary • Among patients with recurrent vasovagal syncope, treatment with physical counterpressure manoeuvres using biofeedback in addition to optimal conventional therapy was associated with a reduction in syncopal recurrence compared with optimal conventional therapy alone. Presented at ACC 2006

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