Using social media to recruit study participants for a randomized trial for hypertension.

Aims: The present study aimed to evaluate the potential of social media as an approach to recruit hypertensive subjects. Methods and results: In addition to conventional trial recruitment, Facebook ads were run. Over a 115-day recruitment period, Facebook reached 5.3 million people in 168 separate campaigns run in the proximity of 19 sites in the USA and 14 sites in Europe. A total of 182 839 participants (3.4%) clicked on the ad; of those 10 483 subjects (5.7%) completed a dedicated questionnaire. This resulted in 3632 potential candidates. A total of 285 potential candidates were recruited by various recruitment strategies in the specified time period, of which 184/285 (64.6%) came from Facebook. When comparing Facebook with a 7-day radio spot in the same time period, 48 radio spots were launched; resulting in nine inquiries with eventually five potential candidates and two consents. Conclusion: Targeted social media was a successful and efficient strategy to recruit hypertensive subjects.

Safety and efficacy of endovascular ultrasound renal denervation in resistant hypertension: 12-month results from the ACHIEVE study.

OBJECTIVES: First-generation radiofrequency renal denervation devices may have had limited efficacy due to incomplete circumferential ablation and dependence on individual operator technique. This study evaluated a next-generation catheter-based technology using ultrasound designed to maximize nerve coverage using circumferential ultrasound energy. METHODS: This was a prospective, multicenter, nonrandomized, postmarket study evaluating the safety and efficacy of an endovascular ultrasound renal denervation system (Paradise) in patients who met the European Society of Hypertension/European Society of Cardiology definition of resistant hypertension. Major exclusion criteria included renal artery stenosis and renal insufficiency. Patients were followed for 12 months. Safety and efficacy endpoints included procedural safety and renal artery patency, as well as changes in systolic office and 24-h ambulatory bllod pressure (BP) measurement. RESULTS: A total of 96 patients from eight European sites were included. Mean age was 63.9 years and 41% of patients were female. At baseline, mean 24-h ambulatory BP was 156.2/88.4 ±â€Š15.4/12.7 mmHg, and mean office BP was 176.2/95.0 ±â€Š20.6/16.0 mmHg. Patients were on average on 5.1 ±â€Š2.5 antihypertensive agents. At 12 months, the average 24-h ambulatory BP change was -7.5/-3.8 ±â€Š18.3/10.6 mmHg (P = 0.0007; P = 0.0024) with an average office BP change of -15.0/-7.0 ±â€Š27.0/12.3 mmHg (P < 0.0001 for both). At 12 months, there was a single patient death unrelated to the device or procedure. CONCLUSION: This single-arm study represents the largest cohort of patients treated with endovascular ultrasound renal denervation to date. Within this trial, the therapy appeared safe and resulted in sustained reductions in both office BP and 24-h ambulatory BP through 12 months.

First experience with endovascular ultrasound renal denervation for the treatment of resistant hypertension.

AIMS: To evaluate a novel modality utilising ultrasound for renal denervation designed to reduce the duration of the intervention as well as to increase the consistency of the clinical outcome. METHODS AND RESULTS: Eleven consecutive patients suffering from resistant hypertension as defined by the ESH-ESC guidelines were treated by transcatheter renal denervation using the CE-marked PARADISE™ technology (ReCor Medical, Ronkonkoma, NY, USA). An average of 5.1 ultrasound emissions were delivered in each subject for a total denervation duration of less than four minutes and the treatment was well tolerated by all patients. Both office and home blood pressure measurements showed an immediate, significant and sustained decrease in blood pressure. Three-month results were comparable to published data on radiofrequency renal denervation with an average reduction in office and home blood pressure of -36/-17 mmHg and -22/-12 mmHg, respectively. CONCLUSIONS: Ultrasound renal denervation appears to be a safe and effective treatment for resistant hypertension and further studies will be performed to confirm these preliminary results.

Mitral annular reduction with subablative therapeutic ultrasound: pre-clinical evaluation of the ReCor device.

AIMS: To evaluate the potential for mitral annular (MA) size reduction using a novel device utilising therapeutic ultrasound (TU). METHODS AND RESULTS: The ReCor device (ReCor Medical, Inc., Ronkonkoma, NY, USA, Investigational device, not for use in human application) was studied in a closed chest canine animal model (35 dogs). Under fluoroscopy, a 12 Fr TU balloon catheter was advanced into the left atrium (transseptal approach). The TU balloon was inflated with contrast-saline, positioned at the MA and energy delivered circumferentially, to heat the tissue locally. Five TU applications were delivered (at least 60W for at least 40 sec). Relative to baseline, mitral valve annular diameter reduction (measured by transthoracic echocardiography) was 8.4% immediately post procedure(p<0.001), 8.6% at one week (p<0.001), 8.8% at two weeks (p<0.001), 9.3% at three weeks (p<0.001), 10.8% at four weeks (p<0.001), 8.6% at three months (p<0.001) and 5.7% at six months (p<0.001). Histology showed an increase in elastin associated with tissue thickening at the annular level. Transmission electron microscopy demonstrated a decrease in diameter of individual collagen fibres in treated regions compared to controls. CONCLUSIONS: Therapeutic ultrasound (TU) energy application to the mitral annulus is feasible percutaneously. A reduction in annular dimensions occurs immediately and appears to be durable without peri-annular damage.