PCR London Valves: First clinical data backs use of Jenavalve TAVI system in patients with aortic regurgitation
Ngày 28/11/2021 09:33 | Lượt xem: 208

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.”

Source CardiovascularNews

Duc Tin Clinic

 

Print Chia sẽ qua facebook bài: PCR London Valves: First clinical data backs use of Jenavalve TAVI system in patients with aortic regurgitation Chia sẽ qua google bài: PCR London Valves: First clinical data backs use of Jenavalve TAVI system in patients with aortic regurgitation Chia sẽ qua twitter bài: PCR London Valves: First clinical data backs use of Jenavalve TAVI system in patients with aortic regurgitation Chia sẽ qua MySpace bài: PCR London Valves: First clinical data backs use of Jenavalve TAVI system in patients with aortic regurgitation Chia sẽ qua LinkedIn bài: PCR London Valves: First clinical data backs use of Jenavalve TAVI system in patients with aortic regurgitation Chia sẽ qua stumbleupon bài: PCR London Valves: First clinical data backs use of Jenavalve TAVI system in patients with aortic regurgitation Chia sẽ qua icio bài: PCR London Valves: First clinical data backs use of Jenavalve TAVI system in patients with aortic regurgitation Chia sẽ qua digg bài: PCR London Valves: First clinical data backs use of Jenavalve TAVI system in patients with aortic regurgitation Chia sẽ qua yahoo bài: PCR London Valves: First clinical data backs use of Jenavalve TAVI system in patients with aortic regurgitation Chia sẽ qua yahoo bài: PCR London Valves: First clinical data backs use of Jenavalve TAVI system in patients with aortic regurgitation Chia sẽ qua yahoo bài: PCR London Valves: First clinical data backs use of Jenavalve TAVI system in patients with aortic regurgitation Chia sẽ qua yahoo bài: PCR London Valves: First clinical data backs use of Jenavalve TAVI system in patients with aortic regurgitation

Tin tức liên quan

CUSTOMER REVIEWS

  • I am Nguyen Thanh Sang, born in 1990. Since the examination and treatment at the clinic Duc Tin, I am very grateful to the Doctor for explaining and sharing about my illness. During the treatment time in the clinic I was very caring staff of the clinic. Now my illness has improved in a good way. Expect more and more clinic to be able to save many patients.

    I sincerely thank you !. Tel: 0938303275

  • Huynh Thi Muoi, born in 1940, was examined and treated at Duc Tin Clinic. I am very pleased about how to serve and care patients of the clinic. The doctor is committed to explaining and sharing with the patient.

    Huynh Thi Muoi sincerely thank you! Phone number: 0972868746

  • As I said Duc Tin surgical clinin is where my family trust, hope to visit. Physicians caring, thoughtful, gentle to the patient. Nurses and staff clinic polite, cheerful and thoughtful. This clinic clean, sterile, so I would love to. Tel: +84949914060.

  • The doctor is very caring, attentive and very gentle nurse, courteous, affable with me. The clinic is clean, comfortable, polite. I enjoyed this faith. Every visit I was very relieved disease. Tel: 0839820792.

  • I was patient, had to clinics of Dr. Le Duc Tin. I see very conscientious doctor patient care, answer any questions and very dedicated staff from the receptionist to the children tested, nursing. Clinics very clean and spacious. I'm very satisfied. Tel: +841227880829.

Search
Customer support

    Phone: (028) 3981 2678
    Mobile: 0903 839 878 - 0909 384 389

TOP