Objectives
Transcatheter mitral valve repair (TMVR) by edge‐to‐edge therapy is an established treatment for severe mitral valve regurgitation (MR).
Background
Symptomatic and prognostic benefit in functional MR has been shown recently; nevertheless, data on long‐term outcomes are sparse.
Methods and results
We analyzed survival of patients treated with isolated edge‐to‐edge repair from June 2010 to March 2018 (primarily combined edge‐to‐edge repair with other mitral valve interventions was excluded) in a retrospective monocentric study. Overall, 627 consecutive patients (47.0% females, 78.6 years in mean) were included. Leading etiology was functional MR (57.4%). Follow‐up regarding survival was available in 97.0%. While 97.6% were discharged alive, 75.7% were alive after a 1‐year, 54.5% after 3‐year, 37.6% after 5‐year and 21.7% after 7‐year follow‐up. Higher logistic Euroscores and comorbidities such as COPD and renal insufficiency were associated with higher in‐hospital and 1‐year mortality. Importantly, in‐hospital survival increased over the years.
Conclusions
With the present study we established high survival rates at discharge and after 1 year of patients treated with TMVR. This goes along with high implantation numbers, increased interventional experience and a better in‐hospital survival over the years. Long‐term mortality in turn was substantially influenced by comorbidities.
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.
Graphical abstract
IntroductionTo assess the impact of ‘reverse T and Protrusion’ (TAP) technique on the outcome after stenting of true bifurcation lesions of the left main (LM) or proximal epicardial vessels as compared with double kissing (DK)-crush technique.Methods and analysis50 consecutive patients with true coronary bifurcation lesion (Medina 1,1,1 or 0,1,1) of the LM or the proximal main vessels, requiring a two-stent technique as first-line strategy at University Medical Center Mainz, are randomised in a 1:1 ratio to reverse TAP or DK-crush stenting. As recommended by best clinical practice, final angiographic result is evaluated and optical coherence tomographic (OCT) intracoronary imaging is performed to assess and optimise the final result. The primary end point is defined as the percentage of stent expansion in the side branch. Secondary end points consist of angiographic and procedural success (assessed until patient’s discharge), procedural parameters (procedural time, fluoroscopy time, use of devices, X-ray dose) and OCT parameters expressing expansion of the stents. Safety parameters include all adverse events up to 6 months after discharge. A clinical, angiographic and intracoronary imaging control at 6 months is planned.Ethics and disseminationThe protocol complies with good clinical practice and the ethical principles described in the Declaration of Helsinki and is approved by the local ethics committee. The results of the trial will be published as original article(s) in medical journals and/or as presentation at congresses.Trial registration numberClinicalTrials.gov Registry (NCT03714750)
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