Key result
The novel multi-track technique using the double-coil Inoue metal wire achieved similar post-procedural mitral valve area (2.01 vs 2.13 cm2, p=0.282) and safety outcomes compared to the conventional technique.
Why the study?
Does the novel multi-track technique using the double-coil Inoue metal wire improve procedural safety and efficacy compared to the conventional multi-track technique in patients with severe rheumatic mitral stenosis?
RCT (n=62)
Open-label
Randomized
No
Does the novel multi-track technique using the double-coil Inoue metal wire improve procedural safety and efficacy compared to the conventional multi-track technique in patients with severe rheumatic mitral stenosis?
Absolute Event Rate: 2.01% vs 2.13%
p-value: p=0.282
The novel multi-track PBMV technique using a double-coil Inoue metal wire is as safe and effective as the conventional technique, while being simpler and potentially more cost-effective.
Supports novel multi-track PBMV as a simpler alternative; confirms comparable efficacy and safety to conventional technique in this RCT.
Percutaneous balloon mitral valvoplasty (PBMV) has become the treatment of choice for severe pliable rheumatic mitral stenosis. The multi-track system is a recent variation of the double-balloon technique and is easier owing to the use of a monorail balloon and a simple, single-guidewire approach. In the present study, we used the double-coil Inoue metal wire with a multi-track balloon instead of the conventional multi-track wire. We studied 62 consecutive patients (55 females) with significant symptomatic rheumatic mitral valve stenosis who underwent multi-track PBMV. Patients were randomized into 2 groups: the first group included 32 patients treated with the novel multi-track technique using the double-coil Inoue metal wire, and the second group included 30 patients treated with the conventional multi-track technique using a balloon endhole catheter and multi-track 0.035 inch stiff wire. None of the patients had cardiac tamponade, systemic thromboembolism, or any groin complications. No statistically significant differences were found between the 2 groups regarding any of the studied variables. There were no in-hospital deaths or complications necessitating emergent cardiac surgery in either group. In conclusion, this new technique with the double-coil Inoue metal wire achieves the double benefit of being as safe as (and indeed easier than) the conventional technique, and it utilizes fewer materials, making the multi-track system more cost-effective.
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Sakr et al. (2013) conducted an RCT in Rheumatic mitral valve stenosis (n=62). Novel multi-track technique using the double-coil Inoue metal wire vs. Conventional multi-track technique using a balloon endhole catheter and 0.035 inch stiff wire was evaluated on Post-dilatation mitral valve area (cm2) (p=0.282). The novel multi-track technique using the double-coil Inoue metal wire achieved similar post-procedural mitral valve area (2.01 vs 2.13 cm2, p=0.282) and safety outcomes compared to the conventional technique.
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