Late Breaking Science From TCT 2022 Adds to Evidence Surrounding Structural Heart Disease Treatments

Structural heart disease was the focus of two Late-Breaking Science sessions on Sept. 17 during TCT 2022 in Boston. MicroCT and histology findings of leaflet thickening, as well as surgical vs. percutaneous repair for managing postinfarction ventricular septal defect (PIVSD), were the focus of the HALT and UK PIVSD trials, respectively, while other studies shed light on transcatheter edge-to-edge repair (TEER) using the PASCAL system and the new MitraClip G4 system and TAVR in small aortic annuli.

Highlights from five of the studies include:

In the HALT trial, researchers for the first time compared microCT and histology findings of leaflet thickening and found no relationship between duration of implant and thrombus and inflammation scores. However, they did note that neointimal thickening, structural change, and calcification scores increased with time, and were most pronounced after one year. Additionally, histologic examination confirmed three types of thrombi: acute, organizing, and organized. According to Yu Sato, MD, and colleagues, implants greater than 30 days showed findings consistent with organization while the majority of those greater than one year were either organizing or organized. "These findings may explain why oral anticoagulation therapy is not always effective and suggests that identification of HALT, and response to treatment, may be most effective within the first year after implantation, especially in younger patients," they said.

The UK PIVSD found no difference in post-discharge long-term mortality between patients undergoing surgical or percutaneous repair for PIVSD, although in-hospital mortality was lower for surgery. According to Joel Giblett, MD, et al., "both percutaneous and surgical management are complementary in real world clinical practice and offer significant survival advantage compared to historical data on medical therapy." They noted the findings underscore the importance of shared decision-making between patients and their heart team, as well as the need for further prospective studies in order to guide treatment decisions.

In the FRANCE-TAVI Registry, researchers compared hemodynamic performance and clinical outcomes using self-expandable valve (SEV) or balloon-expandable valve (BEV) platforms in patients with small aortic annuli. According to Walid Ben-Ali, MD, PhD, the first large national all-comer study showed SEV had superior hemodynamic valve performance at one year, while BEV was an independent predictor of one-year moderate or severe prosthesis‐patient mismatch (PPM). He also noted that one-year severe PPM was an independent predictor of three-year all cause mortality.

In the EXPAND G4 Post Approval Study, researchers confirmed the effectiveness and safety of the next generation MitraClip G4 system in treating patients with primary and secondary mitral regurgitation (MR). Highlights from the study, which assessed 30-day outcomes in 1,164 patients from the U.S., Europe, Canada and Japan, include consistent MR reduction with lower adverse events and improved procedural efficiency with lower number of clips, according to Ralph Stephan von Bardeleben, MD. "The EXPAND G4 study demonstrates the MitraClip G4 enables tailoring the therapy to patient"s mitral valve anatomy … and expands the spectrum of "TEER suitable" patients," he said.

The PASCAL IID Registry study provided insights into transcatheter edge-to-edge repair using the PASCAL system in prohibitive risk patients with degenerative mitral regurgitation (DMR) and complex mitral valve anatomy. According to Jörg Hausleiter, MD, the PASCAL IID registry demonstrated favorable safety, including high survival (97.9% ) and a composite major adverse event rate of 11.2% at 30 days; significant and sustained MR reduction; and significant improvements in symptoms and quality of life. "The PASCAL system is beneficial for prohibitive risk DMR patients with complex mitral valve anatomy historically considered less suitable for M-TEER and may expand treatment options for these patients," he said.

Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Valvular Heart Disease, Aortic Surgery, Cardiac Surgery and VHD, Interventions and Imaging, Interventions and Structural Heart Disease, Echocardiography/Ultrasound, Mitral Regurgitation

Keywords: Transcatheter Cardiovascular Therapeutics, TCT22, Aortic Valve, Transcatheter Aortic Valve Replacement, Aortic Valve Stenosis, Heart Valve Prosthesis, Echocardiography, Mitral Valve, Mitral Valve Insufficiency, Heart Valve Prosthesis Implantation, Cardiac Catheterization, Septal Occluder Device

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