Enrollment patients, who had degenerative MRI, were ineligible for randomization in CLASP IID due to their complexity.
BOSTON, MA – Patients with symptomatic degenerative mitral valve regurgitation (MR) who have a complex anatomy that makes them ineligible for inclusion in a CLASP IID trial can be safely and effectively treated with Pascal’s Edge-to-Edge System (TEER) (Edwards Lifesciences), according to For data from the Pascal IID record.
The Pascal machine has just been approved for degenerative MR by US Food and Drug Administration Earlier this month, based on data from CLASP IID A randomized trial comparing the two devices directly and showing no inferiority. As reported by TCTMD, the trial results were released to the public two days later on the opening day of the TCT 2022 meeting.
Historically, patients were considered suitable for TEER based on their anatomy using “traffic light“: Those patients with similar anatomical features to patients in the pivotal COAPT trial were classified as green by The 2021 consensus document was published in skeletal heart, while others, indicated in yellow, have features that make the procedure more complex but can still benefit from TEER. Those with a preventatively complex anatomy, classified as ‘red class’ patients, were deemed unsuitable for clip repair.
“That data . . . makes me feel better about myself and my program because it captures the real-world population that we see — very programmatically — we use green, yellow, and red patient selection based on anatomy,” Michael Young, MD (Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire), during a press conference at TCT 2022. “I feel like a lot of friendly patients who have had surgeries [have] Very yellow/orange, if not reddish, kind of anatomy. [While] There are of course other techniques. . . which may offer complementary arterial routes, the technology we have now appears to be safe.”
Submit the results of the Pascal IID Register, Jörg Hausleiter, MD (Klinikum der Universität München, Munich, Germany), He said the findings suggest that “Pascal’s system is a beneficial regimen for patients at high risk in terms of MR with complex mitral valve anatomy. In patients deemed less suitable for tip-to-tip catheter repair, these findings may expand the different options for patients in this highly complex group.” of the sick.”
Pascal record IID
The PASCAL IID registry enrolled 98 patients (median age 81.1 years; 61.2% male) who were not eligible for inclusion in the CLASP IID trial on the basis of their complex anatomy. At baseline, 69.4% of patients were considered NYHA class III/IV, mean STS score was 4.6, 69.4% had atrial fibrillation, and MR score was 3+ in 27.3% and 4+ in 71.2%. Complex anatomical features include:
- At least two significant independent aircraft (30.1%)
- Mitral valve aperture area <4.0 cm2 (15.9%)
- Bellaflet involvement/multi-bishop prolapse (15.0%)
- Large aircraft in the business district (11.5%)
- Bulk width 15 mm and/or bulk gap 10 mm (9.7%)
- Other (17.7%)
The procedure was successful in 92.9% of patients with a mean procedural time of 111.0 minutes and device time of 79.5 minutes. An average of 1.6 devices were implanted per patient, and the average length of hospital stay was 1 day. Most patients got the original Pascal device (55.4%), 33.7% got the Pascal Ace, and 10.9% got both.
At 6 months, the compound rate of major adverse events was 11.2%, including one CV death, one stroke, one myocardial infarction, one need for renal replacement therapy, non-selective mitral re-intervention, and seven acute bleeding episodes. This translated to a controlled rate of freedom from adverse events of 85.6%.
There were significant decreases in MR of discharge within 6 months (s <0.001 for all). At 6 months, 56.1% and 92.4% of patients were classified as MR 1+ or 2+, respectively. The lowest post-procedure gradients were kept below 5 mmHg.
In addition, NYHA functional class improved: 84.2% of patients were classified as I or II at 6 months, up from 31.6% at baseline (s <0.001). There was also a significant improvement in the Kansas City Cardiomyopathy Questionnaire (mean 57 vs 72; s <0.001), while increases in 6-minute walking distance and EuroQol 5 Dimensions Health questionnaire scores were not statistically significant.
Results for “highly complementary”
During the press conference, coordinator David Cohen, MD (St. Francis Hospital, Roslin, NY) described the results as “very complementary to the randomized data.”
Hausletter agreed but explained that these patients “were more complex in terms of their anatomy but also in terms of clinical risk. This was a much larger number of frail patients.”
Also commenting on the media, Federico Asch, MD (MedStar Health/Georgetown University, Washington, DC), called this “fantastic data.” However, he noted, “This refers to the fact that the definition of complexity [used for TEER] Old and. . . Actually outdated. Asch added that patients who were considered complex even just 10 years ago may not be “as complex as we thought.”
“Maybe we have improved the technology, maybe the device has improved, maybe we are not afraid of them anymore. But it is clear that these patients are still in good shape,” he said. Perhaps we need to change our thresholds for these different parameters.”