Transcatheter Mitral Valve Repair via MitraClip in Patients Aged <65 Years: Multicentre 2-year Outcomes.

Background: Transcatheter mitral valve repair (TMVR) using the MitraClip has become a well-established interventional therapy and is usually performed in elderly patients. The objective of this study was to assess 2-year clinical outcomes of TMVR in patients aged <65 years at three heart centres with severe mitral regurgitation (MR) and no surgical options. Methods: A retrospective study analysed data of 36 patients aged <65 years treated with TMVR . All patients were refused surgery by Heart Team decision. Baseline MR was assessed by biplane vena contracta width in two perpendicular views (mean 8.35 ± 1.87 mm). Degenerative MR was detected in 11 patients (30.6%); functional MR was detected in 25 patients (69.4%). Results: Acute procedural success was accomplished in 88.9% of patients. No procedure-related mortality during the first 30 days was detected. Over an average of 2 years of follow-up, all-cause mortality was 19.4% and cardiovascular death was 11.1% owing to advanced heart failure. The average follow-up period was 25.8 months (median was 20 months). Statistically significant difference (p-value <0.01) was detected for N-terminal prohormone of brain natriuretic peptide (pg/ml) at baseline (mean 9,870 ± 10,819; median 7,748) compared to follow-up visits (mean 7,645 ± 11,292; median 3,263). New York Heart Association functional class improvement was achieved in 69% of patients. A second intervention (reclipping) was required in two patients to correct recurrent significant MR. Conclusion: TMVR in patients aged <65 years refused surgical repair provides satisfactory clinical outcomes at 2 years. Future studies should evaluate the outcomes of MitraClip in this population in a larger cohort.

Feasibility and exploratory efficacy evaluation of the Embrella Embolic Deflector system for the prevention of cerebral emboli in patients undergoing transcatheter aortic valve replacement: the PROTAVI-C pilot study.

OBJECTIVES: This study sought to determine the feasibility, safety, and exploratory efficacy of the Embrella Embolic Deflector (EED) system (Edwards Lifesciences, Irvine, California) in patients undergoing transcatheter aortic valve replacement (TAVR). BACKGROUND: Few data exist on the value of using embolic protection devices during TAVR. METHODS: This pilot study included 52 patients who underwent transfemoral TAVR. The EED system was used in 41 patients, whereas 11 patients underwent TAVR without embolic protection (control group). Cerebral diffusion-weighted magnetic resonance imaging (DW-MRI) was performed at baseline and within 7 days and 30 days after TAVR. RESULTS: The EED system was successfully deployed at the level of the aortic arch in all patients with no complications. The deployment of the EED system was associated with high-intensity transient signals (HITS) as evaluated by transcranial Doppler (median: 48 [interquartile range: 17 to 198] HITS), and a higher total number of HITS was observed in the EED group (p < 0.001 vs. control group). DW-MRI performed within 7 days after TAVR showed the presence of new ischemic lesions in all patients in both groups, with a median number of 7 (interquartile range: 3 to 13) lesions per patient. The use of the EED system was associated with a lower lesion volume compared with the control group (p = 0.003). All new cerebral lesions had disappeared on the DW-MRI performed at 30 days after TAVR. Two strokes unrelated to the EED system occurred 2 and 29 days after TAVR. CONCLUSIONS: This study showed the feasibility and safety of using the EED system in TAVR procedures. The EED system did not prevent the occurrence of cerebral microemboli during TAVR or new transient ischemic lesions as evaluated by DW-MRI, but it was associated with a reduction in lesion volume. Further studies are warranted to determine the efficacy of using the EED system during TAVR procedures.

Risk factors for thrombus formation on the Amplatzer Cardiac Plug after left atrial appendage occlusion.

OBJECTIVES: This study sought to identify risk factors for thrombus formation on the Amplatzer Cardiac Plug (ACP) (St. Jude Medical, St. Paul, Minnesota) after left atrial appendage occlusion. BACKGROUND: Left atrial appendage occlusion with the ACP aims to reduce the risk of embolic stroke and bleeding complications associated with vitamin K antagonists in patients with atrial fibrillation. METHODS: We performed transesophageal echocardiography before discharge and after 3, 6, and 12 months in 34 patients with atrial fibrillation undergoing ACP implantation and receiving dual antiplatelet therapy. Clinical, echocardiographic, and hemostaseological parameters were retrospectively analyzed to identify risk factors for thrombus formation. RESULTS: Three patients had thrombi before discharge, 3 more at the 3-month follow-up. No differences were found in left atrial volume, left atrial appendage velocity, spontaneous echo contrast, transmitral gradient, or mitral regurgitation between patients without or with thrombi. CHADS2 (Congestion, Hypertension, Age, Diabetes, and Stroke) score (2.0 ± 1.1 vs. 4.3 ± 1.0), CHA2DS2-VASc (CHADS2 plus Vascular Disease and Sex Category) score (5.2 ± 1.3 vs. 6.8 ± 0.8), and pre-interventional platelet count (215.9 ± 63.9/nl vs. 282.5 ± 84.4/nl) were higher and ejection fraction (50.6 ± 11.4% vs. 39.7 ± 10.6%) lower in those with thrombi. Factor 2, factor 5, or methylenetetrahydrofolate reductase mutations and genetic variants associated with reduced clopidogrel activity were not more frequent in patients with thrombi. CONCLUSIONS: Transesophageal echocardiography identified 17.6% of patients with thrombus formation on the ACP despite dual antiplatelet therapy. CHADS2 and CHA2DS2-VASc scores, platelet count, and ejection fraction are risk factors for such thrombus formation.