Feature | TCT 2022: My Interventional Takeaways
A lot of science related to coronary and structural interventions was delivered at TCT 2022, back in person and held in Boston. And there were several trials that offer new therapies and practice-changing insights for patients with advanced ischemic and structural heart disease. I'm delighted to share my highlights and takeaways from the conference.
Vascular access is an ongoing topic, with a decrease in femoral vascular access for routine and urgent coronary angiograms because of the increase in radial artery access. However, attention has returned to femoral artery access because of structural heart interventions. In patients undergoing femoral arterial access for coronary angiography or intervention, the UNIVERSAL trial compared fluoroscopic guidance plus ultrasonography guidance vs. fluoroscopic guidance alone.
UNIVERSAL showed that routine ultrasonography with fluoroscopy-guided femoral artery access did not reduce a composite of major bleeding and major vascular complications vs. fluoroscopic guidance alone within 30 days (12.9% vs. 16.1%, respectively; p=0.25).
It is worth noting that the ultrasonography group in UNIVERSAL had less accidental venipuncture and greater first-pass success without a significant difference in time to obtain femoral artery access. The access was with a small sheath size in the majority of patients. Very few patients with large bore access were included in this study and it is possible that a greater benefit may be observed in this setting with routine ultrasonography guidance. UNIVERSAL is the first study to show no benefits for ultrasound-guided access.
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My take on this trial is that I will continue to use ultrasound for all femoral artery access due to the improvement in the first-pass success and accidental access of the vein. Until more evidence emerges or a meta-analysis is published that combines the data from the UNIVERSAL trial with data from other trials, it seems a reasonable approach is ultrasound-guided access for the femoral artery for coronary angiography and intervention and for large-bore vascular access for mechanical circulatory support and structural heart intervention.
Turning to degenerative severe mitral valve disease, a new transcatheter edge-to-edge repair (TEER) system called PASCAL was studied in the CLASP IID trial. The researchers randomized 180 patients (mean age 81 years, 33% women) with degenerative mitral regurgitation (DMR) who were at prohibitive surgical risk (3+ or 4+ DMR) to the PASCAL or MitraClip system.
The trial demonstrated that the PASCAL system was noninferior to the MitraClip system for the primary safety endpoint of major adverse events (cardiovascular mortality, stroke, myocardial infarction (MI), new need for renal replacement therapy, severe bleeding, nonelective mitral valve reintervention for 30 days), occurring in 3.4% and 4.8% of the patient groups, respectively (p for noninferiority <0.05). Cardiovascular mortality occurred in 0.9% and 1.6% of the respective groups. Although CLASP IID was a noninferiority trial, it will expand treatment options for patients with severe degenerative valve disease.
Continuing with mitral valve interventions, a study using data from 3,797 patients with cardiogenic shock and severe MR in the STS/ACC TVT Registry found that TEER reduced MR and lowered the risk of mortality and heart failure hospitalizations. All-cause mortality was lower along with a lower rate of the composite of mortality or heart failure admissions in patients who received TEER.
The long-term follow-up from the BEST trial that compared multivessel PCI with an everolimus-eluting stent against CABG in patients with coronary artery disease was presented at TCT 2022. As a reminder, this trial was terminated early in October 2013 due to slow enrollment; 880 of the planned 1,776 patients had been enrolled at that time.
At 11.8 years of follow-up, PCI, compared with CABG, was associated with more spontaneous MI (7.1% vs. 3.8%) and any repeat revascularization procedure (22.6% vs. 12.7%). Long-term mortality was similar between treatment groups (20.5% vs. 19.9%). While most previous studies have reported excess strokes with CABG, the frequency was similar in both groups in the BEST study. It's important to note this study was conducted in South Korea and its findings may mainly apply to patients of Asian descent.
The PROTECTED TAVR trial with 3,000 patients found the routine use of intraprocedural cerebral embolic protection (CEP) did not reduce the primary outcome of risk of stroke within 72 hours among patients undergoing transfemoral TAVR for aortic stenosis (2.3% vs. 2.9% with control). However, although this was a negative trial, there was a significant reduction in the secondary outcome of disabling strokes in the CEP vs. control group (0.5% vs. 1.3%; p<0.05).
A substudy from the FAME 3 trial assessed the impact of post-PCI fractional flow reserve (FFR) and intravascular imaging on patient and lesion outcomes. As a reminder, the results of FAME 3 indicated that FFR-guided PCI using current-generation drug-eluting stents did not meet the criteria for noninferiority compared with CABG among patients with angiographic three-vessel disease. In this new analysis, only 61% had a post-PCI FFR measurement as this was not required by the study protocol (43% one-vessel, 42% two-vessel, 15% three-vessel). Results showed the median post-PCI FFR was 0.89 and 10% of patients had a post-PCI FFR of ≤0.80.
Furthermore, an abnormal FFR post PCI was a significant predictor of target vessel failure using a cutoff value of 0.88 at the vessel level and 0.85 at the patient level. Whether or not the FFR findings were used by the operator to make any changes or undertake more interventions was unclear in this study. Moreover, only 11.1% of patients had intravascular imaging post PCI. Among the patients who did and did not have intravascular imaging guidance, the rate of cardiac death, all MIs or repeat revascularization was similar.
This article was authored by M. Chadi Alraies, MD, FACC, medical director of the cardiac cath lab, cardiac rehab and interventional cardiology research at Detroit Medical Center, Harper University Hospital, in Detroit, Michigan.
Clinical Topics: Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Prevention, Valvular Heart Disease, Vascular Medicine, Acute Heart Failure, Interventions and Imaging, Interventions and Structural Heart Disease, Interventions and Vascular Medicine, Angiography, Nuclear Imaging
Keywords: ACC Publications, Cardiology Magazine, Angiography, Coronary Angiography, Secondary Prevention, Heart Valve Diseases, Heart Failure, STS/ACC TVT Registry, Transcatheter Cardiovascular Therapeutics, TCT22, Aneurysm, Percutaneous Coronary Intervention, Fractional Flow Reserve, Myocardial
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