Renal denervation for resistant hypertension using an irrigated radiofrequency balloon: 12-month results from the Renal Hypertension Ablation System (RHAS) trial.

AIMS: Renal denervation using the point-by-point application of radiofrequency energy delivered by the first-generation Symplicity system is effective in lowering office blood pressure but may be time-consuming. The OneShot Renal Denervation System with a balloon-mounted spiral electrode potentially shortens and simplifies the procedure. This study is a hypothesis-generating first-in-human study to assess feasibility, and to provide preliminary efficacy and safety data. METHODS AND RESULTS: Eligible patients had a baseline office systolic blood pressure ≥160 mmHg (or ≥150 mmHg for diabetics) and were on two or more antihypertensive medications. Nine patients were enrolled. The primary endpoint, the insertion of the OneShot balloon into each renal artery and the delivery of radiofrequency energy, was achieved in 8/9 (89%) of patients. The one failure (the first patient) was due to generator high-impedance safety shut-off threshold set too low for humans. Adverse events were minor. No patient developed renal artery stenosis. Baseline BP was 185.67 ± 18.7 mmHg and the reductions at 1, 3, 6 and 12 months were 30.1 ± 13.6 (p=0.0004), 34.2 ± 20.2 (p=0.002), 33.6 ± 32.2 (p=0.021) and 30.6 ± 22.0 (p=0.019). CONCLUSIONS: The OneShot renal denervation system successfully delivered radiofrequency energy to the renal arteries in a short and straightforward procedure. Australian New Zealand Clinical Trials Registry - URL: anzctr.org.au. Trial identification: ACTRN12611000987965.

A proposed new international convention supporting the rights of pregnant women and girls and their newborn infants.

For a multitude of eminently modifiable reasons, death rates for pregnant women and girls and their newborn infants in poorly resourced countries remain unacceptably high. The concomitant high morbidity rates compound the situation. The rights of these vulnerable individuals are incompletely protected by existing United Nations human rights conventions, which many countries have failed to implement. The authors propose a novel approach grounded on both human rights and robust evidence-based clinical guidelines to create a 'human rights convention specifically for pregnant women and girls and their newborn infants'. The approach targets the 'right to health' of these large, vulnerable and neglected populations. The proposed convention is designed so that it can be monitored, audited and evaluated objectively. It should also foster a sense of national ownership and accountability as it is designed to be relevant to local situations and to be incorporated into local clinical governance systems. It may be of particular value to those countries that are not yet on target to meet the Millennium Development Goals (MDGs), especially MDGs 4 and 5, which target child and maternal mortality, respectively. To foster a sense of international responsibility, two additional initiatives are integral to its philosophy: the promotion of twinning between well and poorly resourced regions and a raising of awareness of how some well-resourced countries can damage the health of mothers and babies, for example, through the recruitment of health workers trained by national governments and taken from the public health system.

Strengthening the emergency healthcare system for mothers and children in The Gambia.

A system to improve the management of emergencies during pregnancy, childbirth, infancy and childhood in a region of The Gambia (Brikama) with a population of approximately 250,000 has been developed.This was accomplished through formal partnership between the Gambian Ministry of Health, the World Health Organisation, Maternal Childhealth Advocacy International and the Advanced Life Support Group.Since October 2006, the hospital in Brikama has been renovated and equipped and more efficiently provided with emergency medicines. An emergency ambulance service now links the community with the hospital through a mobile telephone system. Health professionals from community to hospital have been trained in obstetric, neonatal and paediatric emergency management using skills' based education. The programme was evaluated in log books detailing individual resuscitations and by external assessment.The hospital now has constant water and electricity, a functioning operating theatre and emergency room; the maternity unit and children's wards have better emergency equipment and there is a more reliable supply of oxygen and emergency drugs, including misoprostol (for treating post partum haemorrhage) and magnesium sulphate (for severe pre-eclampsia). There is also a blood transfusion service.Countrywide, 217 doctors, nurses, and midwives have undergone accredited training in the provision of emergency maternal, newborn and child care, including for major trauma. 33 have received additional education through Generic Instructor Courses and 15 have reached full instructor status. 83 Traditional Birth Attendants and 48 Village Health Workers have been trained in the recognition and initial management of emergencies, including resuscitation of the newborn. Eleven and ten nurses underwent training in peri-operative nursing and anaesthetics respectively, to address the acute shortage required for emergency Caesarean section.Between May 2007 and March 2010, 109 patients, mostly pregnant mothers, were stabilised and transported to hospital by the new emergency ambulance service.293 resuscitation attempts were documented in personal logbooks.A sustainable system for better managing emergencies has been established and is helping to negate the main obstacle impeding progress: the country's lack of available trained medical and nursing staff. However, insufficient attention was paid to improving staff morale and accommodation representing significant failings of the programme.