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Why the study?
Current surgical and transcatheter approaches for LVOT obstruction in HCM or complicating TMVR/TAVR are limited by high surgical risk, unsuitable septal perforators, and heart block.
Does the SESAME transcatheter electrosurgical procedure improve LVOT area and gradients in patients with LVOT obstruction or those undergoing TMVR/TAVR?
Observational (n=76)
No
Does the SESAME transcatheter electrosurgical procedure improve LVOT area and gradients in patients with LVOT obstruction or those undergoing TMVR/TAVR?
Answers are grounded in this paper and cite their sources.
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“There's a steep learning curve and the technique still requires refinement. If you've seen these live cases, it's usually two operators in a biplane lab yelling at the imager back and forth. But we believe with purpose-built, designed devices that we could do this in a single plane, single operator, with less dependance on a supernatural echocardiographer.”
“There's definitely a need for this procedure. Obviously, it's a very challenging procedure. It could also be a dangerous procedure, [but] these investigators have made a lot of progress and I strongly believe that with increased knowledge, and increased learning of this technique, they will show even more improvement in the future.”
The novel SESAME transcatheter electrosurgical procedure successfully reduces LVOT obstruction in HCM and increases LVOT area to facilitate TMVR/TAVR with an acceptable safety profile.
Background Left ventricular outflow tract (LVOT) obstruction is a source of morbidity in hypertrophic cardiomyopathy (HCM) and a life-threatening complication of transcatheter mitral (TMVR) and aortic valve replacement (TAVR). Available surgical and transcatheter approaches are limited by high surgical risk, unsuitable septal perforators, and heart block requiring permanent pacemakers. Objectives We report the initial experience of a novel transcatheter electrosurgical procedure developed to mimic surgical myotomy. Methods We used SEptal Scoring Along Midline Endocardium (SESAME) to treat patients, on a compassionate basis, with symptomatic LVOT obstruction or to create space to facilitate TMVR or TAVR. Results In this single-center retrospective study between 2021–2023, 76 patients underwent SESAME. Eleven (14%) had classic HCM, and the remainder underwent SESAME to facilitate TMVR or TAVR. All had technically successful SESAME myocardial laceration. Measures to predict post-TMVR LVOT significantly improved (neo-LVOT 42(7,117)to 170(95,265)mm2,p<0.001; skirt-neo-LVOT 169(153,193) to 214(180,262)mm2,p<0.001). Among patients with HCM, SESAME significantly decreased invasive LVOT gradients (resting: 54[40,70] to 29[12,36]mmHg,p=0.023; provoked 146[100,180] to 85[40,120]mmHg,p=0.076). Seventy-four (97.4%) survived the procedure. Five suffered 3/76(3.9%) iatrogenic ventricular septal defects that did not require repair, and 3/76(3.9%) ventricular free wall perforations. Neither occurred in patients treated for HCM. Permanent pacemakers were required in 4/76(5.3%), including two after concomitant TAVR. Lacerations were stable and did not propagate after SESAME (remaining septum: 5.9±3.3mm to 6.1±3.2mm,p=0.8). Conclusions With further experience, SESAME may benefit patients requiring septal reduction therapy for obstructive hypertrophic cardiomyopathy, with LVOT obstruction after heart valve replacement, and/or to prepare for transcatheter valve implantation.
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Greenbaum et al. (2024) conducted an observational in Left ventricular outflow tract (LVOT) obstruction (n=76). SEptal Scoring Along Midline Endocardium (SESAME) was evaluated on Technically successful SESAME myocardial laceration.
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