This trial sought to assess the safety and efficacy of ShortCut, the first dedicated leaflet modification device, prior to transcatheter aortic valve implantation (TAVI) in patients at risk for coronary artery obstruction. This pivotal prospective study enrolled patients with failed bioprosthetic aortic valves scheduled to undergo TAVI and were at risk for coronary artery obstruction. The primary safety endpoint was procedure-related mortality or stroke at discharge or 7 days, and the primary efficacy endpoint was per-patient leaflet splitting success. Independent angiographic, echocardiographic, and computed tomography core laboratories assessed all images. Safety events were adjudicated by a clinical events committee and data safety monitoring board. Sixty eligible patients were treated (77.0 ± 9.6 years, 70% female, 96.7% failed surgical bioprosthetic valves, 63.3% single splitting and 36.7% dual splitting) at 22 clinical sites. Successful leaflet splitting was achieved in all [100%; 95% confidence interval (CI) 94%–100.0%, P < .001] patients. Procedure time, including imaging confirmation of leaflet splitting, was 30.6 ± 17.9 min. Freedom from the primary safety endpoint was achieved in 59 [98.3%; 95% CI (91.1%–100%)] patients, with no mortality and one (1.7%) disabling stroke. At 30 days, freedom from coronary obstruction was 95% (95% CI 86.1%–99.0%). Within 90 days, freedom from mortality was 95% [95% CI (86.1%–99.0%)], without any cardiovascular deaths. Modification of failed bioprosthetic aortic valve leaflets using ShortCut was safe, achieved successful leaflet splitting in all patients, and was associated with favourable clinical outcomes in patients at risk for coronary obstruction undergoing TAVI. This pivotal prospective, multicentre study presents favourable clinical outcomes of ShortCut, the first dedicated leaflet modification device, prior to transcatheter aortic valve implantation (TAVI) in patients scheduled to undergo TAVI and at risk for coronary artery obstruction.

Aims: To explore the characteristics and outcomes of patients undergoing transcatheter edge-to-edge repair (TEER) for primary mitral regurgitation (MR) according to the presence of left ventricular ejection fraction (LVEF) reduction post-procedure. Methods and results: We retrospectively analysed 317 individuals [median age 83 (interquartile range, 75–88) years, 197 (62.1%) males] treated with an isolated, first-time TEER that was concluded by a successful clip deployment. Stratified by LVEF change at 1-month compared with baseline, the cohort was evaluated for residual MR and heart failure (HF) indices up to 1-year, as well as all-cause mortality and HF hospitalizations at 2-years. Overall, 212 (66.9%) patients displayed LVEF reduction, which was mainly driven by lowered total stroke volume and diffuse hypocontractility. While post-procedural MR, transmitral mean pressure gradient, and functional status were comparable in the two study groups, patients with LVEF reduction exhibited a greater decline in filling pressures intra-procedurally; left ventricular mass index, pulmonary arterial systolic pressure, and serum natriuretic peptide level at 1-month; and walking limitation at 1-year. Also, by 2 years, they were less likely to die (13.3% vs. 5.7%, P = 0.019), be readmitted for HF (17.1% vs. 9.0%, P = 0.033), and experience either of the two (23.8% vs. 12.7%, P = 0.012). Lastly, LVEF reduction was the only 1-month echocardiographic parameter to independently confer an attenuated risk for the composite of deaths or HF hospitalizations (HR 0.28, 95% CI 0.10–0.78, P = 0.016). Conclusion: LVEF reduction at 1-month post-TEER for primary MR is associated with better clinical outcomes, possibly reflecting a more pronounced unloading effect of the procedure.

To assess whether intraprocedural transesophageal echocardiographic (TEE)-derived haemodynamic parameters predict outcomes in patients undergoing transcatheter edge-to-edge repair (TEER) for mitral regurgitation (MR). This is a single-centre, retrospective analysis encompassing 458 (IQR, 104–1035) days of follow-up after 926 consecutive patients [481 (52%) with functional MR] referred to an isolated mitral TEER between 2013 and 2020. Cases without actual clip deployment, or in whom prior mitral procedures had taken place, were excluded. The primary outcome was the combined rate of all-cause mortality or heart failure (HF) hospitalizations. Secondary endpoints included single components of the primary outcome, as well as MR severity at one month and one year following the procedure. A multivariable analysis identified two intraprocedural echocardiographic observations made after clip deployment as independent predictors of the primary outcome: an above mild MR (HR for whole study period 1.49, 95% CI 1.05–2.13, P = 0.026) and a 100% or more increase from baseline in the transmitral mean pressure gradient (TMPG) (HR for whole study period 1.32, 95% CI 1.01–1.72, P = 0.039). Also, MR grade of above mild and the absence of a normal pulmonary venous flow pattern (PVFP) bilaterally were associated with an increased risk for HF hospitalizations and greater-than-mild 1-month MR. No prognostic role was demonstrated for the change in MR severity, the absolute TMPG, or the mere improvement in PVFP. Immediate post-TEER MR severity and the relative change in TMPG are predictive of clinical and echocardiographic outcomes following the procedure. Prognostic value of immediate post-clipping haemodynamic parameters obtained by intraprocedural echocardiography in mitral transcatheter edge-to-edge repair. Analysing the data of 926 consecutive mitral transcatheter edge-to-edge procedures performed between 2013 and 2020, several post-clipping haemodynamic variables observed on intraprocedural transesophageal echocardiogram were identified that predicted clinical and echocardiographic outcomes. Of them, above mild residual regurgitation and a 100% or greater rise in transmitral mean pressure gradient were associated with a higher risk for the combined endpoint of all-cause mortality or heart failure hospitalizations at 1-year and along the entire follow-up period. The former, as well as pulmonary venous flow pattern non-normalization (i.e. an S/D velocities ratio of <1 on both sides), also predicted 1-year heart failure hospitalizations and 1-month regurgitation severity above mild. E/A ratio, available for 50% of the cohort, was also predictive of the combined outcome at 1-year. No prognostic role was demonstrated for other echocardiographic parameters explored. Numbers in the cells denote hazard or odds ratios, as appropriate. HF = heart failure; MR = mitral regurgitation; PHT = pressure half-time; PVFP = pulmonary venous flow pattern; TMPG = transmitral mean pressure gradient.