Coronary intravascular lithotripsy (IVL) may facilitate stent implantation in patients with calcified coronary lesions, and aortic valve replacement may be associated with reduced all-cause mortality in patients with low-gradient aortic stenosis (AS), according to two separate interventional research studies published May 3 in JACC: Cardiovascular Interventions, and being presented at ACC.21.

In one study, Dean J. Kereiakes, MD, FACC, et al., performed an individual patient-level pooled analysis of 628 patients from the Disrupt CAD studies to assess safety and effectiveness of IVL to optimize target lesion preparation and identify predictors of success. Patients were treated with the Shockwave Medical IVL system and coronary IVL catheter for de novo calcified coronary artery disease (CAD).

The results showed that severe calcification was confirmed in 97% of target lesions. The primary safety endpoint of the "freedom from MACE" within 30 days – defined as a composite of cardiovascular-related death, myocardial infarction (MI) or target vessel revascularization – occurred in 92.7% of patients. The primary effectiveness endpoint of procedural success – defined as stent delivery with residual in-stent stenosis ≤30% and no in-hospital MACE – was achieved in 92.4% of patients. Independent predictors of 30-day MACE included prior MI, treatment of bifurcation lesions and longer lesions. Treatment of bifurcation lesion predicted lack of procedural success.

According to the researchers, the findings demonstrate that IVL is safe and effective in patients with severely calcified coronary arteries. They note that variables identified as predictors of MACE or lack of procedural success "should be considered in shared decision-making discussions with patients."

In a separate study, Hiroki Ueyama, MD, et al., looked at impact of aortic valve replacement in patients with each subclass of low-gradient AS and compared outcomes following surgical aortic valve replacement (SAVR) vs. TAVR. The researchers identified 32 studies comparing survival with SAVR, TAVR and conservative management in low-gradient AS patients. The outcome of interest was all-cause mortality.

A total of 32 studies consisting of 6,515 patients were included (1,769 with classical low-flow, low-gradient [LF-LG] AS; 809 with paradoxical LF-LG; 1,468 with normal-flow-LG [NF-LG]; and 4,746 with LG with preserved left ventricular ejection fraction [LVEF]). Compared with conservative management, aortic valve replacement was associated with decreased all-cause mortality classical LF-LG (Hazard Ratio [HR]: 0.42; 95% Confidence Interval [CI]: 0.36-0.48), paradoxical LF LG (HR: 0.41; 95% CI: 0.29-0.57) and NF-LG (HR: 0.41; 95% CI: 0.27-0.62). In addition, SAVR and TAVR were associated with significant decreased all-cause mortality in patients with classical LF-LG, paradoxical LF-LG, and NF-LG. There was no significant difference in SAVR vs. TAVR in all-cause mortality among patients with all subclasses of low-gradient AS.

The researchers conclude their study shows either SAVR or TAVR is associated with a significant decrease in all-cause mortality, compared with conservative management, in patients with all subclasses of low-gradient AS. They note that this finding "likely implies that the protective benefit of intervention in the long-term outweighs the peri-operative mortality risk."

Clinical Topics: Cardiac Surgery, Cardiovascular Care Team, Invasive Cardiovascular Angiography and Intervention, Valvular Heart Disease, Atherosclerotic Disease (CAD/PAD), Aortic Surgery, Cardiac Surgery and VHD, Interventions and Coronary Artery Disease, Interventions and Structural Heart Disease

Keywords: ACC21, ACC Annual Scientific Session, Stroke Volume, Aortic Valve, Transcatheter Aortic Valve Replacement, Coronary Artery Disease, Constriction, Pathologic, Decision Making, Ventricular Function, Left, Aortic Valve Stenosis, Heart Valve Prosthesis, Calcinosis, Myocardial Infarction, Lithotripsy, Stents, Catheters

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