First clinical results of transcatheter aortic valve implantation (TAVI) using the Jenavalve system (Jenavalve) in patients with severe aortic regurgitation show that the device is safe and efficient in high-risk patients, significantly improves New York Heart Association (NYHA) classification.
Matti Adam (University Heart Centre, Cologne, Germany) presented data on the use of the transfemoral TAVI device as a late-breaking study at PCR London Valves 2021 (21–23 November, London, UK and virtual).
“We know that treatment options for severe aortic regurgitation in patients not suitable for cardiac surgery are limited,” Adam said in his presentation. “We also know that patients with severe aortic regurgitation and preserved left ventricular [LV] function benefit from aortic valve replacement [AVR], and they have a 29% higher mortality if we don’t do AVR at 10 years,” he said, adding that this represents a clinical need, as these patients are worse off if they do not have access to aortic valve replacement.
In high-risk patients, Adam said, TAVI with current devices is off-label and bears substantially increased peri-procedural risks given the lack of calcification and, therefore, limited prosthesis fixation. “We are not yet at the prime time with the devices that we have available,” Adam commented.
This prompted the examination of the transfemoral Jenavalve device, which has previously been evaluated transapically as an earlier technical version. “What is special about the design is that the prosthesis carries three locators which allow the valve to clip onto the aortic leaflets and implant the prosthesis in an anatomically correct manner,” Adam detailed, adding that this feature promotes fixation, sealing and alignment with the device.
In total outcomes were reported in 10 patients, all of whom were high-risk patients with aortic regurgitation who received the valve under compassionate use criteria. The mean study age was 70 years [58-82], three patients were female, seven had severe aortic regurgitation and three patients had moderate aortic regurgitation. All patients were highly symptomatic and were in NYHA class III/IV. Median annulus size was 26.4mm (23.9–29.4mm).
Outlining the results, Adam explained that the study’s primary efficacy endpoint was technical success with a reduction of aortic regurgitation grade of at least one at discharge.
JenaValve implant was attempted in all patients, with one valve-in-valve case requiring bailout treatment with a Sapien 3 [Edwards Lifesciences] prosthesis, and no moderate or severe aortic regurgitation was reported. In total, the efficacy endpoint was met in nine out of the 10 patients.
With regard to safety endpoints, patients were monitored for major adverse events including death, myocardial infarction, cardiothoracic surgery or stroke at 30 days. Adam reported that no cardiovascular mortality occurred, vascular access complications or acute myocardial infarction (MI) though two cerebrovascular events did occur, meaning the safety endpoint was met in eight out of 10 patients.
All patients were alive at follow-up and seven out of the ten patients reported functional improvement to NYHA class I or II, Adam explained, commenting that this represented a significant improvement of clinical presentation of all patients.
In conclusion, he commented: “This first, real-world data study suggests that transcatheter treatment of severe AR using the JenaValve system is safe and efficient in high risk compassionate use patients.
“All patients are alive and the majority of patients improved significantly in NYHA class at follow-up, despite significant comorbidities.
“Future studies are needed to prove safety and efficacy in larger cohorts, especially in cohorts at lower risk, so no valve in valve and no LVAD. Basically, the patients you want to treat for AR in a regular setting.”