At the annual meeting of the European Society of Cardiology (ESC), being held this weekend in Madrid, new cardiac care guidelines call for a more uniform, simplified and accessible approach to treating valve disease—especially as transcatheter aortic valve replacements begin to outnumber open surgeries on the continent, and as major medtechs collect new green lights in the structural heart field.
Published alongside the European Association for Cardio-Thoracic Surgery, the latest guideline updates since 2021 are based on what the medical groups describe as “an exponential increase in medical knowledge about valvular heart disease,” including recent findings from randomized, controlled trials across the aortic, mitral and tricuspid valves.
They include new recommendations (PDF) for less invasive therapy and diagnostic imaging options—including in the management of coronary artery disease and the prevention of stroke—and urge that patients with complex health needs be treated by multidisciplinary teams in high-volume specialty centers.
“We are seeing different clinical practice to treat patients with valvular heart disease across Europe—from areas where clinical practice is way ahead of guideline recommendations, to places where patients are not getting basic treatments that they would benefit from,” said Michael Borger, co-chair of the guidelines’ expert panel and director of cardiac surgery at the University of Leipzig.
“This means that a patient in Germany might get different treatment from someone with the same medical needs living in the U.K., for example,” added Borger, who said the new data from clinical studies helped the team “reach consensus relatively easily.”
That includes recommendations that patients consider undergoing TAVR procedures earlier in life, with an age cutoff revised to 70 years, down from 75. Surgical treatments are now recommended for people under 70, if their risk for the procedure is low.
“A major aim of this new guidance is to reduce under-treatment, especially in the elderly, because this contributes to unnecessary healthcare resource use and shortened lifespan,” said co-chair Fabien Praz, an interventional cardiologist at Bern University Hospital.
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The changes were welcomed by valvemakers such as Edwards Lifesciences, which said a proactive aortic treatment strategy is a “meaningful step forward from the prior practice of ‘watchful waiting.’”
Earlier this year, Edwards gained an FDA approval opening up its Sapien 3 TAVR systems to patients with aortic stenosis before they begin to show the symptoms of chest pain and shortness of breath. A study presented in 2024, which included nearly four years of median follow-up, showed that earlier TAVR interventions could reduce later hospitalizations linked to heart failure while not increasing the risk of stroke or heart attack.
Elsewhere at the ESC Congress, Edwards presented new data for its Evoque transcatheter tricuspid valve replacement, which received a green light in Europe in 2023 and shortly thereafter in the U.S. According to the company, the implant significantly reduced heart failure hospitalizations among the most severe tricuspid regurgitation patients after 18 months.
“These are important advancements for structural heart disease patients,” Edwards CEO Bernard Zovighian said in a statement. “Consistent with our strategy, the combination of new clinical evidence, indication expansions and guideline changes enable improved clinical outcomes, expanded patient access and overall benefits to the healthcare system.”
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Meanwhile, Abbott announced that it obtained an expanded CE mark for its Navitor TAVR system, broadening its reach among symptomatic patients with severe aortic stenosis to include those at low or intermediate risk levels for open surgery. The implant was previously greenlighted in Europe in 2021 for people at a high or extreme surgical risk. That now puts its patient population on par with Edwards’ Sapien line and Medtronic’s Evolut valves.
Abbott also presented a late-breaking, single-arm study of Navitor at the ESC meeting that supported the move, with 262 patients demonstrating a 2.3% rate of all-cause mortality and cases of disabling stroke within one year. The company has yet to claim the same expanded indication from the FDA.
“The VANTAGE study provides the scientific backbone for expanding Navitor’s indication to low- and intermediate-risk patients,” said the trial’s principal investigator, Nicolas van Mieghem, medical director of the department of interventional cardiology at Erasmus University Medical Centre in the Netherlands. “Up to 50% of younger patients with aortic stenosis will also get coronary artery disease in later years, and Navitor’s design preserves options and ability for lifetime disease management if future cardiac interventions are required.”
Across the Atlantic on the U.S. front, Medtronic reported a new approval from the FDA for its Evolut valves in redo-TAVR procedures—where a new transcatheter implant is delivered inside any already placed and failing aortic valve—among patients at high risk for open-heart surgery. The company collected a CE mark in Europe for the same indication this past May.
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At ESC, researchers also presented data on a minimalist approach to performing TAVR procedures—including using local anesthesia without sedation.
Their study showed those methods were noninferior compared to standard protocols, among a combined primary endpoint measuring cardiovascular events, strokes, infections and other complications after 30 days.
The researchers said the findings were essential as TAVR procedures become more frequent—pushed along by expansions in indications as well as an aging population.
The study also compared Medtronic’s Evolut models to Boston Scientific’s since-discontinued Acurate neo2 valve, which were pulled from the global market earlier this year.
Among a total of 855 patients, 15.4% of those who received the Acurate neo2 implant logged an event in the combined study endpoint, compared to 30.4% of people in the Evolut arm—a significant difference that the researchers attributed to a lower rate of pacemaker implants in the Acurate group.
“Our results indicate that around 80% of patients can be safely managed with the minimalist approach. Further analyses may help to better inform in which subgroups the minimalist approach is most or least suitable,” said study presenter Mohamed Abdel-Wahab, head of the structural heart department at Heart Center Leipzig.
“Regarding devices, we found that Acurate neo2 valves were superior to Evolut valves in our trial, which was conducted by highly experienced operators with careful patient selection,” Abdel-Wahab added. “Acurate neo2 valves have since been withdrawn, but reductions in pacemaker implantation observed with these devices indicate that aspects of their design could be used to inform future valve development.”
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In addition, the ESC published its first combined treatment guidelines addressing myocarditis and pericarditis, featuring a new umbrella term—inflammatory myopericardial syndrome, or IMPS—to help increase awareness of the spectrum of the condition.
The document includes a spotlight on the use of cardiac MRI in diagnosing the disease, and recommendations for patients on returning to work and exercise.
“We hope this valuable new guidance will enable a paradigm shift for patient care allowing the development of combined expertise in the diagnosis and therapy of myocarditis and pericarditis. This will also support a multidisciplinary team approach for more difficult cases,” said Massimo Imazio, head of the cardiothoracic department at the Hospital Santa Maria della Misericordia in Udine, Italy.
The ESC also called for a cultural shift in treating mental health alongside cardiovascular disease—as the risk of one increases the risk of the other, and people suffering from both typically have worse outcomes.
“Clinical cardiovascular practice often overlooks the impact of mental health and the importance of its inclusion in care,” Héctor Bueno, of the Hospital Universitario 12 de Octubre in Madrid, said in a statement, alongside a consensus statement from the ESC joined by European Federation of Psychologists’ Associations, the European Psychiatric Association and the International Society of Behavioral Medicine.
“We need to see cardiovascular health professionals developing collaborations with mental health professionals in psycho-cardio teams to help identify early mental health conditions in our patients and improve care and support for patients and their caregivers,” said Bueno. “We are advising that mental health is actively considered in clinical appointments and that screening for mental health conditions becomes part of the assessment of patients at regular intervals. We are also advocating psychological support for caregivers.”
