Effect of renal denervation on blood pressure in the presence of antihypertensive drugs: 6-month efficacy and safety results from the SPYRAL HTN-ON MED proof-of-concept randomised trial.

: Previous catheter-based renal denervation studies have reported variable efficacy results. We aimed to evaluate safety and blood pressure response after renal denervation or sham control in patients with uncontrolled hypertension on antihypertensive medications with drug adherence testing. : In this international, randomised, single-blind, sham-control, proof-of-concept trial, patients with uncontrolled hypertension (aged 20-80 years) were enrolled at 25 centres in the USA, Germany, Japan, UK, Australia, Austria, and Greece. Eligible patients had an office systolic blood pressure of between 150 mm Hg and 180 mm Hg and a diastolic blood pressure of 90 mm Hg or higher; a 24 h ambulatory systolic blood pressure of between 140 mm Hg and 170 mm Hg at second screening; and were on one to three antihypertensive drugs with stable doses for at least 6 weeks. Patients underwent renal angiography and were randomly assigned to undergo renal denervation or sham control. Patients, caregivers, and those assessing blood pressure were masked to randomisation assignments. The primary efficacy endpoint was blood pressure change from baseline (measured at screening visit two), based on ambulatory blood pressure measurements assessed at 6 months, as compared between treatment groups. Drug surveillance was used to assess medication adherence. The primary analysis was done in the intention-to-treat population. Safety events were assessed through 6 months as per major adverse events. This trial is registered with ClinicalTrials.gov, number NCT02439775, and follow-up is ongoing. : Between July 22, 2015, and June 14, 2017, 467 patients were screened and enrolled. This analysis presents results for the first 80 patients randomly assigned to renal denervation (n=38) and sham control (n=42). Office and 24 h ambulatory blood pressure decreased significantly from baseline to 6 months in the renal denervation group (mean baseline-adjusted treatment differences in 24 h systolic blood pressure -7·0 mm Hg, 95% CI -12·0 to -2·1; p=0·0059, 24 h diastolic blood pressure -4·3 mm Hg, -7·8 to -0·8; p=0.0174, office systolic blood pressure -6·6 mm Hg, -12·4 to -0·9; p=0·0250, and office diastolic blood pressure -4·2 mm Hg, -7·7 to -0·7; p=0·0190). The change in blood pressure was significantly greater at 6 months in the renal denervation group than the sham-control group for office systolic blood pressure (difference -6·8 mm Hg, 95% CI -12·5 to -1·1; p=0·0205), 24 h systolic blood pressure (difference -7·4 mm Hg, -12·5 to -2·3; p=0·0051), office diastolic blood pressure (difference -3·5 mm Hg, -7·0 to -0·0; p=0·0478), and 24 h diastolic blood pressure (difference -4·1 mm Hg, -7·8 to -0·4; p=0·0292). Evaluation of hourly changes in 24 h systolic blood pressure and diastolic blood pressure showed blood pressure reduction throughout 24 h for the renal denervation group. 3 month blood pressure reductions were not significantly different between groups. Medication adherence was about 60% and varied for individual patients throughout the study. No major adverse events were recorded in either group. : Renal denervation in the main renal arteries and branches significantly reduced blood pressure compared with sham control with no major safety events. Incomplete medication adherence was common. : Medtronic.<br/

Surgical treatment of rectal prolapse: experience and late results with 51 patients Tratamento cirúrgico da procidência retal: experiência e resultados tardios de 51 pacientes

The "best" surgical technique for the management of complete rectal prolapse remains unknown. Due to its low incidence, it is very difficult to achieve a representative number of cases, and there are no large prospective randomized trials to attest to the superiority of one operation over another. PURPOSE: Analyze the results of surgical treatment of complete rectal prolapse during 1980 and 2002. METHOD: Retrospective study. RESULTS: Fifty-one patients underwent surgical treatment during this period. The mean age was 56.7 years, with 39 females. Besides the prolapse itself, 33 patients complained of mucous discharge, 31 of fecal incontinence, 14 of constipation, 17 of rectal bleeding, and 3 of urinary incontinence. Abdominal operations were performed in 36 (71%) cases. Presacral rectopexy was the most common abdominal procedure (29 cases) followed by presacral rectopexy associated with sigmoidectomy (5 cases). The most common perineal procedure was perineal rectosigmoidectomy associated with levatorplasty (12 cases). Intraoperative bleeding from the presacral space developed in 2 cases, and a rectovaginal fistula occurred in another patient after a perineal rectosigmoidectomy. There were 2 recurrences after a mean follow-up of 49 months, which were treated by reoperation. CONCLUSION: Abdominal and perineal procedures can be used to manage complete rectal prolapse with safety and good long-term results. Age, associated medical conditions, and symptoms of fecal incontinence or constipation are the main features that one should bear in mind in order to choose the best surgical approach.<br>A técnica cirúrgica mais apropriada para a correção da procidência retal permanece motivo de controvérsia. Por se tratar de afecção pouco freqüente, há dificuldade de avaliação de número adequado de pacientes em estudos randomizados e existe pouca evidência para comprovar a superioridade de alguma das técnicas. OBJETIVO: Analisar os resultados de eficácia e segurança do tratamento cirúrgico da procidência retal em pacientes operados entre 1980 e 2002. MÉTODO: Estudo retrospectivo. RESULTADOS: Cinqüenta e um pacientes foram operados. A idade média foi de 56,7 anos e 39 eram mulheres. Além do prolapso, 33 pacientes queixavam-se de eliminação de muco, 31 tinham incontinência anal, 14 apresentavam constipação, 17 com sangramento retal e 3 incontinência urinária. Operações abdominais foram realizadas em 36 (71%) casos, sendo a retopexia sem prótese a operação mais realizada (29 casos) seguida pela retossigmoidectomia com retopexia (5 casos). A operação perineal mais realizada foi a retossigmoidectomia com plastia dos elevadores (12 casos). O sangramento sacral foi a única complicação intra-operatória e ocorreu em dois casos. Como complicação pós-operatória, houve um caso de fístula retovaginal após operação de retossigmoidectomia perineal. Após seguimento médio de 49 meses, observamos recidiva da procidência em 2 casos. CONCLUSÕES: Operações abdominais e perineais podem ser utilizadas com segurança e eficácia no tratamento cirúrgico da procidência do reto. A idade, a presença de afecções associadas, comorbidades e os sintomas de constipação e incontinência são as principais variáveis envolvidas na escolha da operação. As operações de retopexia abdominal e retossigmoidectomia perineal estão associadas a bons resultados