No abstract

URL: http://www.clinicaltrials.gov. Unique identifier: NCT01660581.

TPVLC with simultaneous deployment of multiple AVP III occluders is feasible with high device success rate and no significant periprocedural complications. The clinical benefits of reduction of HF symptoms and hemolysis are evident after 30 days and persist up to 1 year without recurrence of PVL.

Background: There are limited data regarding the impact of final kissing balloon (FKI) in patients treated with percutaneous coronary intervention using ultrathin stents in left main or bifurcations. Methods: All patients undergoing left main or bifurcations percutaneous coronary intervention enrolled in the RAIN registry (Very Thin Stents for Patients With MAIN or BiF in Real Life: The RAIN, a Multicenter Study) evaluating ultrathin stents were included. Major adverse cardiac event (a composite of all-cause death, myocardial infarction, target lesion revascularization, and stent thrombosis) was the primary end point, while its components, along with target vessel revascularization, were the secondary end points. The main analysis was performed comparing patients with and without FKI after adjustment with inverse probability of treatment weighting. Subgroup analyses were performed according to FKI (short [<3 mm] versus long overlap), strategy (provisional versus 2-stent), routine versus bail-out FKI, and the use of imaging and proximal optimization technique. Results: Two thousand seven hundred forty-two patients were included. At 16 months (8–20) follow-up, inverse probability of treatment weighting adjusted rates of major adverse cardiac event were similar between FKI and no-FKI group (15.1% versus 15.5%; P =0.967), this result did not change with use of imaging, proximal optimization technique, or routine versus bail-out FKI. In the 2-stent subgroup, FKI was associated with lower rates of target vessel revascularization (7.8% versus 15.9%; P =0.030) and target lesion revascularization (7.3% versus 15.2%; P =0.032). Short overlap FKI was associated with a lower rate of target lesion revascularization compared with no FKI (2.6% versus 5.4%; P =0.034), while long overlap was not (6.8% versus 5.4%; P =0.567). Conclusions: In patients with bifurcations or unprotected left main treated with ultrathin stents, short overlap FKI is associated with less restenosis. In a 2-stent strategy, FKI was associated with less target vessel revascularization and restenosis. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03544294.

IntroductionTranscatheter paravalvular leak closure (TPVLC) has become an established treatment option but is mostly performed with off-label use of different non-dedicated occluders. The first one specifically designed for TPVLC is the paravalvular leak device (PLD – Occlutech).AimWe present initial short-term results of a prospective registry intended to assess the safety and efficacy of TPVLC with PLD.Material and methodsWe screened patients with paravalvular leak (PVL) after surgical valve replacement (SVR). Heart failure symptoms and/or hemolytic anemia were indications for TPVLC. Patients were selected according to PVL anatomy by RT 3D TEE. Only those considered appropriate for closure with a single PLD were enrolled. The procedures were performed via transvascular or transapical access using type W (waist) PLDs only.ResultsThirty patients with 34 PVLs (18 aortic, 16 mitral) were included. We implanted 35 PLDs with a total device success rate of 94.3% (100% for aortic, 88.2% for mitral). The procedural success rate, encompassing device success without in-hospital complications, was 94.1% (100% for aortic, 93.8% for mitral). During the follow-up period we recorded an increase of hemoglobin concentration (3.9 to 4.1 g/dl), red blood count (11.6 to 12.2 M/mm3) and functional improvement by NYHA class.ConclusionsParavalvular leak device type W is a promising TPVLC device, but meticulous preselection of patients based on imaging of PVL anatomy is a prerequisite. A PLD should only be chosen for channels shorter than 5 mm. Size of the device should match the PVL cross-sectional area without any oversizing. Such an approach facilitates high device and procedural success rates.