Studies Assess Impacts of New, Evolving Devices and Therapies on High-Risk Structural Heart Disease Patients

Given the rapid speed at which devices and therapies are evolving as the result of new technologies and science, it is more critical than ever to understand the impacts on patient outcomes over time. The following are highlights from several new studies presented Sept. 18 during TCT 2022 that add to the growing body of evidence surrounding new and evolving devices and therapies being used to treat high-risk patients with structural heart disease.

Results from the FLASH Registry, which were presented for the first time at TCT and published in EuroIntervention, assessed outcomes in 800 patients with acute pulmonary embolism (PE) who underwent mechanical thrombectomy with the FlowTriever system. Researchers looked at a composite of major adverse events, including device-related mortality or major bleeding within 48 hours of the procedure, and intraprocedural device- or procedure-related adverse events. According to Catalin Toma, MD, the findings "confirmed the safety of the system" and also showed rapid hemodynamic improvement at the end of the procedure, which continued through six months of follow up. Looking ahead, Toma said that "ongoing randomized trials including PEERLESS will provide important insights regarding the device's safety and effectiveness compared to other treatments."

An analysis of cardiac damage and quality of life in patients with severe aortic stenosis (AS) who underwent aortic valve replacement in the PARTNER 2A, 2B and 3 trials found that cardiac damage classified by baseline AS state "has an important impact on health status, both cross-sectionally and after AVR." In presenting the findings, Philippe Genereux, MD, FACC, also noted that regression of cardiac damage within one-year post-AVR was associated with greater health status improvement compared with patients whose cardiac damage stage was unchanged or worsened. He suggested that detecting and addressing AS before irreversible cardiac damage develops may improve long-term outcomes after AVR, but also said that "longer follow-up is needed to better characterize the impacts of AS stage and AVR on quality-of-life outcomes."

In another trial, researchers sought to clarify the risks of TAVR explant compared with redo-surgical aortic valve replacement (SAVR) in patients with AS. According to Robert B. Hawkins, MD, MSc, the findings show that "TAVR explant remains a low volume operation with increased risk when compared with redo-SAVR cases." He suggested that consideration be given to centralizing these cases at high-volume centers of excellence and stressed the need to disclose risks to patients and account for these risks "in plans for lifetime management" of the disease. For example, a "surgery first" approach should be strongly considered for patients who are likely to outlive their first valve replacement and are not TAVR in TAVR candidates, he said. From there, "surgeons could then design operation for future valve-in-valve TAVR (VIV-TAVR) with aggressive root enlargement and an internally mounted bioprosthesis."

Insights were also shared from real-world data looked at the frequency and safety of bioprosthetic valve fracture (BVF) in patients undergoing VIV-TAVR with SAPIEN 3 or SAPIEN 3 Ultra (S3/U) between December 2020 and March 2022. The primary safety endpoint was all-cause in-hospital mortality, while the hemodynamic endpoint was echocardiographic aortic valve area and mean gradient. Findings, presented by Santiago Garcia, MD, FACC, found BVF was associated with early hazard of in-hospital mortality and modest differences in echocardiographic gradients and aortic valve area, although "far less than previously reported." Garcia also noted that the risk of mortality appears higher when BVF is performed prior to VIV-TAVR and stressed that long-term risks and benefits of BVF needs to be further characterized. He added that the findings suggest an "opportunity to standardize BVF indications, technique and post-procedural management."

In a large real-world study using the CONFIDENCE Registry, the Portico self-expanding, intra-annular valve, with first-generation Portico DS and second-generation FlexNav DS, delivered excellent clinical results in high and extreme surgical risk patients. In presenting the findings, Helge Möllmann, MD, said mild or less paravalvular leak (PVL) was observed in 97.9% of patients at 30 days – a finding that was consistent across all valve size, while low all-cause death and cardiovascular mortality was observed at one year. Additionally, Möllmann said higher valve implantation resulted in lower permanent pacemaker implantation rates and hemodynamic performance at 30-days was "excellent" across all valve sizes with single digit gradients and large effective orifice areas.

Meanwhile, findings from the global Intrepid Pilot Study assessed mid-term (three year) echocardiographic outcomes in patients with severe mitral regurgitation (MR) following transapical mitral valve replacement. In presenting the results, Renuka Jai, MD, said that echocardiographic outcomes at three years showed stable valve function with low mean MV gradients, as well as persistent MR reduction with only one patient experiencing ≥ moderate PVL. She also noted significant reduction in left ventricular end diastolic volume from baseline.

Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Vascular Medicine, Aortic Surgery, Interventions and Vascular Medicine

Keywords: Transcatheter Cardiovascular Therapeutics, TCT22, Thrombectomy, Pulmonary Embolism, Registries, Aortic Valve, Quality of Life

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