TAVI also offers new treatment options for patients with aortic regurgitation

Preparations are underway for another significant step forward, with the possibility of using the procedure even in patients with severe aortic insufficiency

by Maria Rita Montebelli

9 June 2026

Doctor with virtual reality in operation room in hospital.Surgeon analyzing patient heart testing result and anatomy on technological digital futuristic virtual interface,VR concept. Yingyaipumi - stock.adobe.com

5' min read

Translated by AI

Versione italiana

Key points

Guidelines open the way for TAVI in cases of aortic regurgitation
The road ahead

5' min read

Translated by AI

Versione italiana

For over twenty years, interventional cardiology has undergone a veritable revolution thanks to ‘surgical-free’ heart valve implants, namely TAVI (transcatheter aortic valve implantation), a minimally invasive procedure that allows a diseased heart valve to be replaced without resorting to traditional cardiac surgery. Initially developed for patients with severe aortic stenosis who were unable to undergo major surgery (due to frailty, age or comorbidities), TAVI has gradually established itself as the standard of care for an ever-increasing number of people across all categories of surgical risk.

But now we are preparing for another significant step forward, with the possibility of using the TAVI procedure even in patients with severe aortic regurgitation, a condition that is much more difficult to treat using percutaneous techniques.

When the valve ‘leaks’: what is aortic regurgitation

“Regurgitation” (insufficiency) occurs when the aortic valve, which acts as a one-way “door” between the left ventricle and the aorta, fails to close completely after the ventricle has “pumped” blood into the aorta. As a result, when the heart relaxes (during diastole), some of this blood flows back from the aorta into the left ventricle, rather than continuing on to the rest of the body. Over time, the left ventricle is forced to work harder and harder to accommodate not only the oxygenated blood coming from the pulmonary veins but also the blood flowing back from the aorta, thus becoming progressively overloaded. There are various possible causes of this condition: congenital valve defects, tissue ageing, infections, inflammatory diseases or conditions affecting the aorta. The disease often progresses slowly and may not cause any obvious symptoms for years. However, when shortness of breath, fatigue, reduced ability to perform physical activity or signs of heart failure appear, the situation becomes serious and intervention is necessary.

In patients with untreated symptomatic severe aortic regurgitation, the risk of mortality increases significantly within the first two years of symptom onset.

Why has TAVI worked well so far for aortic stenosis, but not for aortic regurgitation?

The success of TAVI in aortic stenosis is linked to a particular feature of this condition: the presence of extensive calcifications on the valve. These calcium deposits provide a strong natural anchor point for the prosthesis, which is implanted via a vascular catheter.

In aortic regurgitation, however, the situation is completely different. The valves are often only slightly calcified (or not at all), the valve annulus may be larger and deformed, and alterations to the ascending aorta are often present. In other words, there is no stable structure to which the new valve can be attached.

For this reason, early attempts to use the same prostheses employed in aortic stenosis for aortic regurgitation also yielded unsatisfactory results. In some cases, the valve tended to shift position, failed to seal properly, and left the degree of regurgitation largely unchanged. Complications (ranging from the need for pacemaker implantation to mortality) and the need for reoperation were therefore much more frequent than those observed in patients with aortic stenosis.

The breakthrough: custom-designed valves for regurgitation

However, in recent years, technological research has led to the development of specialised devices designed specifically to address the anatomical characteristics of aortic regurgitation.

The two main innovations are the JenaValve Trilogy and the J-Valve. The first is a supra-annular valve prosthesis made from porcine pericardial tissue and supported by a self-expanding nitinol scaffold; the second is a biological valve, made from bovine pericardium, housed within a nitinol framework and fitted with an outer polyester sheath that ensures a tight seal and reduces the risk of leakage around the prosthesis. Both utilise sophisticated anchoring systems that allow the prosthesis to attach directly to the leaflets of the natural valve, regardless of the presence of calcifications.

These solutions have radically transformed the landscape. Thanks to improved stability and more precise positioning, the new valves have significantly reduced the risk of prosthesis displacement and improved clinical outcomes.

The data that is changing clinical practice

The transformative potential of this innovative technology has been confirmed by the international ALIGN-AR study, which is regarded as the gold standard trial in the field.

The study involved patients with moderate-to-severe or severe aortic regurgitation, many of whom were considered to be at high surgical risk due to advanced age, frailty or the presence of other medical conditions.

The results were particularly encouraging. The procedure, using the JenaValve Trilogy valve, was successfully completed in almost all cases (180 patients enrolled), with a very low mortality rate in the first 30 days and a minimal incidence of significant residual regurgitation. Patients also showed a marked improvement in symptoms, functional capacity and, in general, quality of life.

Echocardiographic assessments also revealed a gradual recovery in cardiac function and a reduction in left ventricular overload, findings that indicate a genuine benefit to the heart and not merely a mechanical correction of the valve.

These new valves, designed to treat aortic regurgitation via TAVI, therefore represent a viable alternative for the most frail patients, who until a few years ago had limited treatment options. Many elderly people or those suffering from various medical conditions are, in fact, unable to undergo traditional cardiac surgery. For these patients, therefore, the possibility of undergoing a minimally invasive procedure represents a significant opportunity. The TAVI procedure is generally performed by inserting a vascular catheter through the femoral artery; from there, the catheter is guided up to the aortic valve, where the new prosthesis is implanted. This type of procedure avoids the need to open the chest (sternotomy or thoracotomy) and therefore has a much shorter recovery time compared to traditional surgery.

Guidelines open the door to TAVI for aortic regurgitation

The evidence accumulated in recent years is now beginning to be reflected in the recommendations of scientific societies. The European guidelines (European Society of Cardiology – ESC/European Association of Cardiothoracic Surgery -EACTS), published in 2025, introduced for the first time a specific recommendation (Class IIb) for the use of TAVI in patients with severe aortic regurgitation who are not candidates for surgery. The next edition of the American guidelines (AHA/ACC), which is expected to be published by 2026, is also expected to include an endorsement of TAVI for the treatment of aortic regurgitation. The UK’s National Institute for Health and Care Excellence (NICE) also recognised the validity of this treatment option in 2025, highlighting the procedure’s role in patients at high surgical risk. This is an important step, as it marks the official recognition of a technology that, until a few years ago, was still considered experimental in this field.

The road ahead

Despite the promising results, experts are urging caution. There is still a lack of randomised trials that directly compare the outcomes of TAVI with those of traditional surgery, and longer follow-up periods are needed to assess the durability of the new prostheses over the years. Furthermore, certain technical challenges remain, particularly in patients with specific anatomical abnormalities of the aorta or valve (the TAVI valves currently available for the correction of aortic regurgitation are designed for tricuspid aortic valves and are not suitable for bicuspid ones).

However, the path forward seems clear. Whilst the first revolution brought about by TAVI was to transform the treatment of aortic stenosis, the second could involve offering a new treatment option to patients with severe aortic regurgitation. For many people with limited treatment options, the new transcatheter valves now represent a real hope for treatment, through less invasive procedures, lower risks and a better quality of life. This demonstrates how technological innovation continues to push forward and redefine the boundaries of cardiovascular medicine.