Six-months clinical and intracoronary imaging follow-up after reverse T and protrusion or double-kissing and crush stenting for the treatment of complex left main bifurcation lesions.

Background: There is a debate regarding the best stent strategy for unprotected distal left main (LM) bifurcation disease. Among two-stent techniques, double-kissing and crush (DKC) is favored in current guidelines but is complex and requires expertise. Reverse T and Protrusion (rTAP) was shown to be a comparable strategy regarding short-term efficacy and safety, but with reduced procedural complexity. Aim: To compare rTAP vs. DKC by optical coherence tomography (OCT) on the intermediate term. Methods: 52 consecutive patients with complex unprotected LM stenoses (Medina 0,1,1 or 1,1,1) were randomized to either DKC or rTAP and followed-up for a median of 189[180-263] days for clinical and OCT outcomes. Results: At follow-up OCT showed similar change in the side branch (SB) ostial area (primary endpoint). The confluence polygon showed a higher percentage of malapposed stent struts in the rTAP group that did not reach statistical significance (rTAP: 9.7[4.4-18.3] % vs. DKC: 3[0.07-10.9] %; p = 0.064). It also showed a trend towards larger neointimal area relative to the stent area (DKC: 8.8 [6.9 to 13.4] % vs. rTAP: 6.5 [3.9 to 8.9] %; p = 0.07), and smaller luminal area (DKC: 9.54[8.09-11.07] mm2 vs. rTAP: 11.21[9.53-12.42] mm²; p = 0.09) in the DKC group. The minimum luminal area in the parent vessel distal to the bifurcation was significantly smaller in the DKC group (DKC: 4.64 [3.64 to 5.34] mm² vs. rTAP: 6.76 [5.20 to 7.29] mm²; p = 0.03). This segment also showed a trend for smaller stent areas (p = 0.05 to 0.09), and a bigger neointimal area relative to the stent area (DKC: 8.94 [5.43 to 10.5]% vs. rTAP: 4.75 [0.08 to 8.5]%; p = 0.06) in the DKC patients. The incidence of clinical events was comparably low in both groups. Conclusion: At 6-months, OCT showed a similar change in the SB ostial area (primary endpoint) in rTAP compared to DKC. There was also a trend for smaller luminal areas in the confluence polygon and the distal parent vessel, and a larger neointimal area relative to the stent area, in DKC, along with a tendency for more malapposed stent struts in rTAP. Clinical Trial Registration: https://clinicaltrials.gov/ct2/show/NCT03714750, identifier: NCT03714750.

Randomized non-inferiority TrIal comParing reverse T And Protrusion versus double-kissing and crush Stenting for the treatment of complex left main bifurcation lesions.

BACKGROUND: The treatment of left main bifurcation stenoses remains challenging. AIMS: We compare the "Reverse T and Protrusion" (reverse-TAP) technique to Double-Kissing and crush (DK-crush). METHODS: The study was designed as non-inferiority trial, the primary endpoint was percentage stent expansion in the ostial side branch at optical coherence tomography. RESULTS: 52 consecutive patients (13 females, 17 diabetics, Syntax score 25 [22-29]) with complex coronary bifurcation lesions of the left main were randomized in a 1:1 ratio to Reverse-TAP or DK-crush stenting. The intervention was performed according to protocol in all patients in both randomization groups. Side branch stent expansion was 75 [67-90]% in the DK-crush group and 86 [75-95]% in the reverse-TAP group (one-sided 97.5% lower parametric confidence interval: - 0.28%; P < 0.01 for non-inferiority; P = 0.037 for superiority). Side branch balloon pressure during final kissing was higher in the DK-crush group (14 [12-16] vs. reverse-TAP: 13 [12-14]; P = 0.043). Procedural time was shorter with reverse-TAP (DK-crush: 32 [24-44] min vs reverse-TAP: 25 [22-33] min; P = 0.044). Other procedural parameters were not different between groups. There was no difference in any of the safety endpoints up to 1 month. CONCLUSIONS: A reverse-TAP strategy for the interventional treatment of complex coronary lesions was non-inferior and superior to DK-crush for the primary endpoint side branch expansion while requiring less time. A larger study testing long-term clinical outcomes is warranted. TRAIL REGISTRATION: NCT: NCT03714750.

Conduction disorders after transcatheter aortic valve implantation: A comparison between SAPIEN 3 and SAPIEN 3 Ultra balloon-expandable valves.

Background: Conduction disorders (CD) are the most common complications after Transcatheter Aortic Valve Implantation (TAVI). The last generation of Edwards balloon expandable valves, the SAPIEN 3 Ultra (S3U), is provided with an external sealing skirt that aims to further reduce paravalvular leakage (PVL) compared to SAPIEN 3 (S3) and could potentially lead to higher CD rate. We sought to investigate the rate of new-onset CD in patients undergoing TAVI with the S3 or S3U valve. Methods: We included 582 consecutive patients undergoing TAVI in a single high-volume Center. Patients with previously implanted pacemaker and Valve in valve procedures were excluded. CD rate was evaluated early after implantation and at discharge. Results: No significant difference in the overall CD rate was found between S3 and S3U patients both immediately after the procedure (S3 45.5% vs. S3U 41.8%, p = 0.575) and at discharge (S3 30.4% vs. S3U 35.6%, p = 0.348) with low rate of permanent pacemaker implantation (S3 6.3% vs. S3U 5.5%, p = 0.749). No significant differences were found also in patients with pre-existing atrial fibrillation (S3 8.2% vs. S3U 5%, p = 0.648). A significantly lower rate of PVL was found with S3U compared to S3 (S3 42% vs. S3U 26%, p = 0.007). According to the manufacturer's guidelines we confirmed that S3U were implanted in a significantly higher position compared to S3 (S3 4.89 ± 1.57 mm vs. S3U 4.47 ± 1.36 mm, p = 0.001). Conclusion: No significant difference in the rate of CD, including the need for PPM implantation, was found in patients undergoing TAVI with the S3 compared to S3U. Moreover, S3U significantly reduced the PVL rate.

Liver Stiffness, Not Fat Liver Content, Predicts the Length of QTc Interval in Patients with Chronic Liver Disease.

The severity of fatty liver at ultrasound has been associated with QT length, a finding invoked to explain the excess cardiovascular risk of patients with fatty liver. However, the ability of ultrasound to stage accurately the severity of fatty liver is limited, with fibrosis a major confounder. Here, we aimed to verify the alleged relationship between fat liver content and QT length using a technique apt at discriminating steatosis from fibrosis noninvasively, i.e., transient elastography (TE) with measure of liver stiffness (LS) and controlled attenuation parameter (CAP). A prospectively collected derivation cohort of 349 patients with chronic liver disease (CLD) of any etiology (N = 105 with nonalcoholic fatty liver) was studied to identify clinical, laboratory, and instrumental predictors of the corrected QT interval (QTc) and QTc prolongation, including LS and CAP. The results were validated on a subgroup of patients belonging to the derivation cohort (out of sample validation), as well as on a completely different group of N = 149 subjects with CLD (out of time validation). QTc values were directly related to liver stiffness (LS; ρ = 0.137; p = 0.011), heart rate (HR; ρ = 0.307; p < 0.001), and age (ρ = 0.265; p < 0.001) and were significantly longer in females (p < 0.001). In contrast, QTc was not associated with the value of controlled attenuation parameter (ρ = 0.019; p = 0.718); moreover, no discernible differences in QTc length were noted based on CLD etiology. QTc was prolonged in 24/349 patients (6.9%); age, HR, and LS were independent predictors of QTc prolongation (χ 2 = 23.7, p < 0.001). Furthermore, QTc values (after logarithmic transformation) were predicted by a model including age, gender, HR, and LS (F = 14.1, R 2 = 0.198, p < 0.001). These latter results were validated by both out-of-sample and out-of-time methods. In conclusion, TE findings strongly suggest that among patients with CLD, fibrosis, not steatosis, is a major determinant of QTc length.