Minimally Invasive Therapy Offers New Hope for High Blood Pressure | Queen Mary University of London

New Minimally Invasive Therapy Offers Hope for Untreated High Blood Pressure

Hypertension, or high blood pressure, affects a significant portion of the global population, yet a substantial number of cases remain undiagnosed and untreated. Now, a groundbreaking new therapy, known as Targeted Thermal Therapy (Triple T), is offering a potential solution for a specific, often overlooked cause of this widespread condition: primary aldosteronism. Developed by researchers at Queen Mary University of London, Barts Health NHS Trust, and University College London, this minimally invasive procedure promises a faster, safer alternative to traditional surgery, potentially transforming the management of hypertension for millions worldwide.

The innovative treatment, formally called endoscopic ultrasound-guided radiofrequency ablation, has shown promising results in early trials, offering the possibility of restoring normal hormone levels and reducing reliance on blood pressure medication. Published in The Lancet, the research details a technique that selectively destroys the hormone-producing nodules in the adrenal glands responsible for primary aldosteronism, without the need for extensive surgery and its associated recovery period. This breakthrough builds upon decades of research into the hormone aldosterone and its role in regulating blood pressure, a journey that began in London 70 years ago with the initial discovery of the hormone itself.

High blood pressure impacts approximately one in three adults, but primary aldosteronism, a hormonal condition contributing to a significant portion of these cases, remains largely undiagnosed. Estimates suggest that primary aldosteronism accounts for around one in twenty cases of high blood pressure, yet fewer than 1% of affected individuals receive a diagnosis. This underdiagnosis is particularly concerning as patients with primary aldosteronism often exhibit resistance to standard blood pressure medications and face an elevated risk of serious cardiovascular events, including heart attacks, strokes, and kidney failure.

For years, the only definitive cure for primary aldosteronism has been surgical removal of the affected adrenal gland. While effective, this procedure requires general anesthesia, typically involves a two-to-three-day hospital stay, and necessitates several weeks of recovery. Many patients opt to live with the condition rather than undergo such an invasive intervention, leaving them vulnerable to the long-term health consequences of uncontrolled hypertension.

Understanding Primary Aldosteronism and the Role of Triple T

Primary aldosteronism arises from the development of small, benign nodules within one or both adrenal glands. These nodules produce an excess of aldosterone, a hormone that regulates salt and water balance in the body. Elevated aldosterone levels lead to increased sodium retention, which in turn raises blood volume and blood pressure. The condition often goes undetected because symptoms can be vague or absent, and routine blood pressure screenings don’t specifically identify the underlying hormonal cause. Accurate diagnosis requires specialized testing to measure aldosterone and renin levels, often followed by imaging scans to locate the problematic nodules.

Triple T offers a paradigm shift in treatment by directly targeting and eliminating these aldosterone-producing nodules without removing the entire adrenal gland. The procedure leverages advancements in diagnostic imaging, utilizing molecular dyes to precisely identify and locate even the smallest nodules. Crucially, the left adrenal gland’s proximity to the stomach allows for direct access via endoscopy. The technique combines two established medical procedures: radiofrequency or microwave ablation, which generates heat to destroy the targeted tissue, and endoscopic ultrasound, which provides real-time visualization and guidance during the procedure. According to Professor Stephen Pereira, Chief Investigator of the FABULAS study and Professor of Hepatology & Gastroenterology at UCL Institute for Liver and Digestive Health, with appropriate training, this less invasive technique could be widely offered in endoscopy units across the UK and internationally.

During Triple T, a thin, flexible endoscope equipped with an ultrasound probe is passed through the mouth into the stomach. The endoscopist then visualizes the adrenal gland and carefully guides a fine needle into the nodule. Short bursts of heat are delivered, effectively destroying the nodule while preserving the surrounding healthy adrenal tissue. The entire procedure is completed in approximately 20 minutes and requires no external or internal incisions, resulting in a significantly faster recovery time compared to traditional surgery.

The FABULAS Trial: Promising Results and Patient Impact

The feasibility of Triple T was rigorously evaluated in the FABULAS (Feasibility study of radiofrequency endoscopic ABlation, with ULtrasound guidance, as a non-surgical, Adrenal Sparing treatment for aldosterone-producing adenomas) study, involving 28 patients with primary aldosteronism. These patients had been identified as having a hormone-producing nodule in their left adrenal gland through advanced molecular scanning techniques. The results, published in The Lancet, demonstrated that the procedure was both safe and effective. A majority of participants experienced normalization of their hormone levels within six months of treatment, and many were able to discontinue their blood pressure medications without recurrence of the condition.

The success of the FABULAS trial is particularly noteworthy given the challenges associated with diagnosing and treating primary aldosteronism. Professor Morris Brown, co-senior author of the study and Professor of Endocrine Hypertension at Queen Mary University of London, highlighted the historical context, noting that it has been 70 years since the discovery of aldosterone and the identification of the first patient with hypertension caused by an aldosterone-producing tumor. He further stated that Jerome Conn, the physician who treated that first patient, predicted that a significant percentage of hypertension cases might be linked to curable nodules in the adrenal glands. “We are now able to realise this prospect, offering 21st-century breakthroughs in diagnosis and treatment,” Professor Brown explained.

The impact of Triple T extends beyond clinical outcomes. Michelina Alfieri, a participant in the FABULAS trial, shared her personal experience, describing how the treatment alleviated debilitating headaches that had plagued her for years. “Before the study, I suffered from debilitating headaches for years despite multiple GP visits. As a full-time worker and single parent, my daily life was severely affected. This non-invasive treatment provided an immediate recovery — I was back to my normal routine straight away. I’m incredibly grateful to the team for giving me this choice,” she said.

Looking Ahead: The WAVE Trial and Future Implications

Building on the success of FABULAS, a larger, randomized controlled trial called WAVE is currently underway. This trial will compare the effectiveness of Triple T to traditional adrenal surgery in a cohort of 120 patients. The results of the WAVE trial, expected in 2027, will provide crucial evidence to further validate the benefits of Triple T and potentially establish it as a standard of care for primary aldosteronism. The National Institute for Health and Care Research (NIHR) is supporting the WAVE trial through the Barts and Cambridge Biomedical Research Centres (BRCs), alongside funding from Barts Charity and the British Heart Foundation.

Professor Mark Gurnell, Clinical Endocrinology Lead at Addenbrooke’s Hospital and Professor of Clinical Endocrinology at the University of Cambridge, emphasized the importance of advancements in diagnostic imaging. He explained that the development of novel PET tracer molecules has enabled non-invasive diagnosis and precise targeting of adrenal nodules for the first time. This improved diagnostic capability is a key enabler of the Triple T procedure, allowing clinicians to accurately identify and treat the source of aldosterone overproduction.

The potential implications of widespread adoption of Triple T are significant. By offering a less invasive and faster-recovery alternative to surgery, this therapy could improve the quality of life for millions of individuals suffering from primary aldosteronism. By effectively addressing this often-overlooked cause of hypertension, Triple T could contribute to a reduction in the incidence of cardiovascular diseases and a decrease in the reliance on long-term blood pressure medication. The development of this innovative treatment represents a major step forward in the fight against hypertension and underscores the importance of continued research into the underlying causes of this prevalent condition.

Key Takeaways

• Minimally Invasive Treatment: Triple T offers a less invasive alternative to traditional surgery for primary aldosteronism.
• Improved Recovery: The procedure requires no incisions and boasts a significantly faster recovery time.
• Effective Hormone Control: Early trials demonstrate successful normalization of hormone levels in most patients.
• Potential for Medication Reduction: Many patients were able to discontinue blood pressure medications after treatment.
• Ongoing Research: The WAVE trial will further evaluate the efficacy of Triple T compared to surgery.

The results of the WAVE trial, anticipated in 2027, will be pivotal in determining the future role of Triple T in the management of primary aldosteronism. As research continues and the technique becomes more widely available, it holds the promise of transforming the lives of countless individuals affected by this curable form of hypertension. We encourage readers to share their thoughts and experiences with hypertension and its treatment in the comments below.