Top Structural Heart News of 2022
A milestone for TAVI, new PFO guidelines, more support for Ross, and implications of cardiac damage rounded out the year.
In the year of TAVI’s big anniversary (TAVITurnsTwenty; 26 Down), one of the most-awaited trials presented at TCT 2022 was PROTECTEDTAVR (3 Down), which missed its primary endpoint by failing to show a difference in post-TAVI stroke rates with or without use of cerebral embolic protection. The findings raised a few eyebrows and set off discussions on what the trial showed versus how it was interpreted.
It’s been a few years since conscious sedation (46 Across) first made waves in the TAVI space; now select sites are also exploring the approach as an option for high-surgical-risk patients undergoing edge-to-edge tricuspid repair (TEER). Meanwhile, some of the first RCTs for full transcatheter mitral valve replacement are now getting underway, including the SUMMIT (48 Down) trial for severe mitral regurgitation that’s randomizing patients to valve replacement or TEER.
Fracturing a surgical aortic valve to facilitate valve-in-valve (ViV; 64 Down) TAVI is a technique that’s been gaining steam in recent years, but in 2022, investigators saw a signal that, depending on the timing, fracture was associated with greater risk of in-hospital mortality in a real-world data set. The researchers maintained there remains a role for this technique in patients who can’t have surgery and who have small prior surgical valves.
Structural heart imaging has continued to evolve as a key component of valve interventions and studies are continuing to demonstrate why. One small multicenter study suggested that while transthoracic echocardiography (TTE; 21 Across) will always be the “front door” for assessment, cardiovascular magnetic resonance (CMR) imaging added to clinical and echocardiographic findings may enhance risk assessment for those with chronic aortic regurgitation and minimal or no symptoms.
Meanwhile, data continue to accumulate in support of the Ross (18 Down) procedure. In a propensity-matched comparison from Toronto General Hospital of patients ages 16 to 60 years who underwent either the Ross procedure or bioprosthetic AVR surgery, all-cause mortality was lower over 14 years of follow-up for Ross patients.
INVICTUS (25 Across) threw investigators for a loop when it showed that patients with atrial fibrillation caused by rheumatic heart disease are at higher risk of having major CV events with direct oral anticoagulants compared with vitamin K antagonists. The chair of the trial’s steering committee reported being “absolutely floored by the results.”
Data from the PARTNER trials argued the importance of early cardiac damage on outcomes. In a presentation at EuroPCR 2022, changes in existing cardiac damage after aortic valve replacement (AVR, 34 Across) were associated with an increased 2-year mortality risk.
Beyond valvular procedures, patent foramen ovale (PFO; 55 Down) closure continues to make headlines. This year it was a new Society for Cardiovascular Angiography and Interventions expert consensus guideline addressing decision-making for patient subsets not included in the published, randomized clinical trials of PFO closure.
Did we miss any important structural heart news in our Cardiology Crossword Challenge? TCTMD checked in with Philippe Généreux, MD (Morristown Medical Center, NJ), to find out what we overlooked and where the field might be headed in 2023. In addition to the news noted above, he pointed to a second cardiac damage study: this one showed that patients who undergo surgery or TAVI and had cardiac damage at baseline then, a year later, have worse self-reported quality of life than those with no or lesser signs of damage—supporting the case for earlier interventions.
He also pointed to the surprising 5-year results of SURTAVI, which were presented earlier this year at the American College of Cardiology 2022 Scientific Session. Combined data from multiple trials showed that structural valve deterioration at 5 years was 4.38% with surgery versus 2.57% with a self-expanding TAVI device (P = 0.0095).
“In the structural heart world, in the TAVI world, this trial was important, even though some people disagree with the methodology or claim it was cherry-picking of data, etc,” Généreux said. “We need long-term data and we need to see lower risk compared with surgery, so this was important to show potentially better durability with TAVI. We’re going to be seeing 5-year data soon from PARTNER 3 in the low-risk patients, so that’s something to look toward in the future for more insight into TAVI safety and durability.”
In the TEER world, he said another key study was CLASP IID, the first RCT to directly compare two TEER therapies—the Pascal (Edwards Lifesciences) and MitraClip (Abbott)—for degenerative mitral regurgitation. Just 2 days before the presentation, the US Food and Drug administration approved the Pascal device.
“Having a second device for treating degenerative MR is clinically relevant because TEER is a growing area of interest for everybody right now,” Généreux added.
L.A. McKeown is a Senior Medical Journalist for TCTMD, the Section Editor of Cath Lab Forum, and Senior Medical…Read Full Bio