Groundbreaking procedure using novel ‘paper-clip’ style device to treat high blood pressure
Issued by University of Leicester Press Office on 19 September 2013
“We hope this groundbreaking treatment will provide a life-line to patients who have had all the drugs prescribed and yet their blood pressure remain uncontrolled” -Professor André Ng, University of Leicester/Glenfield Hospital
Image of Professor André Ng available on request at: firstname.lastname@example.org
Researchers at the University of Leicester and Glenfield Hospital have successfully used a novel “paper-clip” sized vascular coupling device to tackle resistant high blood pressure.
The operation was carried out on Monday 16 September at Glenfield Hospital by Professor André Ng, Professor of Cardiac Electrophysiology at the University of Leicester and Consultant Cardiologist at Glenfield Hospital.
The trial – called ROX CONTROL HTN - is a prospective randomized international multicentre study designed to evaluate a novel treatment, called the ROX coupler, in patients with resistant hypertension. The ROX Coupler is a small metal stent made of nitinol which when deployed, acts like a “paper-clip” joining an artery and a vein together in the groin area (called iliac vessels). This allows blood to flow between the high pressure artery and the low pressure vein. The Coupler is inserted and put in place via key-hole procedure at the groin under local anaesthesia.
Professor Ng said: “Our research at the University of Leicester aims to find novel ways of tackling hypertension.
“We carried out this procedure on our first patient, a 56 year old male, here at Glenfield Hospital, which went extremely well. After the initial preparation, it took me and my team just over an hour to put the implant in place. Almost immediately the patient’s blood pressure went down to more acceptable levels which we anticipate to further improve with time. The patient was kept overnight for observation but will be discharged the following day if everything is well.”
“Results from the pilot study already done on this new technology look promising. There is a very early response with a reduction in blood pressure in resistant hypertensive patients which appears to be maintained in medium term at least. We hope to uncover the mechanisms by which this works and that is the whole purpose of the randomised trial to establish the safety of this new technology, the characteristics of the response and more insight into the way it works.
The patient, from Leicester, said: “The procedure is remarkable. I know it is still early days but I have already seen a significant reduction in my blood pressure points. I am amazed!”
Professor Ng added: “Uncontrolled hypertension can lead to many other medical conditions with dire consequences. Patients with resistant hypertension have blood pressure way above normally accepted levels despite multiple medications in combination. New forms of effective treatment are always welcome and that is the reason why we, at the University of Leicester and Leicester’s Hospitals, are conducting properly designed trials to assess the efficacy.
“We hope this groundbreaking treatment will provide a lifeline to patients who have had all the drugs prescribed and yet their blood pressure remains uncontrolled. It is an example of how research at the University of Leicester is being applied to benefit patients at Glenfield Hospital. We also really like the fact that the procedure is reversible.”
Professor Ng said: “It is clear that a novel approach beyond the use of drugs needs to be developed to treat this condition. That is why this trial between the University of Leicester and Leicester’s Hospitals is so important.”
The study is conducted at Leicester with the support of the National Institute for Health Research (NIHR) Leicester Cardiovascular Biomedical Research Unit (BRU). The ROX CONTROL HTN study is sponsored by ROX Medical (San Clemente, California, USA), the developer of the ROX coupler device.
Professor Ng leads studies in the novel therapeutic interventions theme of the National Institute for Health Research Leicester Cardiovascular Biomedical Research Unit and has previously carried out the world's first remote heart procedure using a robotic arm alongside 3-D mapping in 2010 and also UK first implant of a novel vagus nerve stimulator in heart failure in 2012.
NOTE TO NEWSDESK:
Professor Ng’s availability:
Thursday Sept 19: 14:00-17:00
Fri: Sept 20: 14:00-17:00
To interview Professor Ng contact:
- Rosalind Ward, Communications Officer at the University Hospitals of Leicester NHS Trust
- Ather Mirza, News Centre, University of Leicester email@example.com;
High blood pressure is a common clinical problem with 16 million people in the UK suffering from it. If left untreated or poorly controlled, this can lead to an array of other conditions including coronary heart disease, stroke, heart rhythm disturbances and kidney disease, with significant morbidity and mortality.
Hypertension has often been described as the “silent killer” as many patients who have high blood pressure may have no symptoms until they develop complications from these other conditions. An enormous amount of effort has been spent developing effective medication to treat high blood pressure and many drugs have been studied and used over the years.
However, a significant proportion of hypertensive patients require a combination of drugs to keep blood pressure in check. In some, even 3 or more different types of medication used are not adequate to bring blood pressure to acceptable levels, a condition which is termed “resistant hypertension”.
Patients who may be eligible for enrolling in ROX CONTROL HTN include those who are aged 18 and over, have been diagnosed with hypertension with blood pressure above acceptable levels despite full tolerated doses of three or more antihypertensive medications of different classes, one of which is a diuretic, for 2 or more weeks. For more information on the ROX CONTROL HTN study at the University of Leicester, email firstname.lastname@example.org
About the NIHR
The National Institute for Health Research (NIHR) is funded by the Department of Health to improve the health and wealth of the nation through research. Since its establishment in April 2006, the NIHR has transformed research in the NHS. It has increased the volume of applied health research for the benefit of patients and the public, driven faster translation of basic science discoveries into tangible benefits for patients and the economy, and developed and supported the people who conduct and contribute to applied health research. The NIHR plays a key role in the Government's strategy for economic growth, attracting investment by the life-sciences industries through its world-class infrastructure for health research. Together, the NIHR people, programmes, centres of excellence and systems represent the most integrated health research system in the world. For further information, visit the NIHR website (www.nihr.ac.uk<http://www.nihr.ac.uk>).