Mitral Valve Transcatheter Edge-to-Edge Repair: 1-Year Outcomes From the MiCLASP Study.

BACKGROUND: Mitral transcatheter edge-to-edge repair (M-TEER) is a guideline-recommended treatment option for patients with severe symptomatic mitral regurgitation (MR). Outcomes with the PASCAL system in a post-market setting have not been established. OBJECTIVES: The authors report 30-day and 1-year outcomes from the MiCLASP (Transcatheter Repair of Mitral Regurgitation with Edwards PASCAL Transcatheter Valve Repair System) European post-market clinical follow-up study. METHODS: Patients with symptomatic, clinically significant MR were prospectively enrolled. The primary safety endpoint was clinical events committee-adjudicated 30-day composite major adverse event rate and the primary effectiveness endpoint was echocardiographic core laboratory-assessed MR severity at discharge compared with baseline. Clinical, echocardiographic, functional, and quality-of-life outcomes were assessed at 1 year. RESULTS: A total of 544 patients were enrolled (59% functional MR, 30% degenerative MR). The 30-day composite major adverse event rate was 6.8%. MR reduction was significant from baseline to discharge and sustained at 1 year with 98% of patients achieving MR ≤2+ and 82.6% MR ≤1+ (all P < 0.001 vs baseline). One-year Kaplan-Meier estimate for survival was 87.3%, and freedom from heart failure hospitalization was 84.3%. Significant functional and quality-of-life improvements were observed at 1 year, including 71.6% in NYHA functional class I/II, 14.4-point increase in Kansas City Cardiomyopathy Questionnaire score, and 24.2-m improvement in 6-minute walk distance (all P < 0.001 vs baseline). CONCLUSIONS: One-year outcomes of this large cohort from the MiCLASP study demonstrate continued safety and effectiveness of M-TEER with the PASCAL system in a post-market setting. Results demonstrate high survival and freedom from heart failure hospitalization, significant and sustained MR reduction, and improvements in symptoms, functional capacity, and quality of life.

Safety of transesophageal echocardiography during transcatheter edge-to-edge tricuspid valve repair: A single-center experience.

Objectives: We aimed to determine transesophageal echocardiography (TEE) related complications during Transcatheter edge-to-edge tricuspid valve repair (TTVR). Background: Transesophageal echocardiography is essential to guide structural heart disease (SHD) interventions. TTVR has become an evolving procedure for high-risk patients not suitable for surgery. Whether this complex procedure is associated with TEE related complications is not known so far. Methods: We retrospectively analyzed 64 consecutive patients undergoing TTVR between 2019 and 2021 with the TriClip system (Abbott, Chicago, IL, USA) at our center. All procedures were performed under general anesthesia (GA). TEE related complications were classified as major and minor complications. Results: Transesophageal echocardiography related complications were observed in two patients (3.1%) with one major complication (1.6%) and one minor complication (1.6%). In one patient perforation of the esophageal mucosa requiring red blood cell transfusion was observed, the other patient had hematemesis due to minor esophageal and gastric lesions without the need for blood transfusion. Both patients recovered during hospital stay with no persistent symptoms at discharge. Conclusions: Transesophageal echocardiography related complications during TTVR are clinically relevant occurring in 3.1% of the patients. Further investigations are needed to identify potential risk factors and patients at high risk to develop a TEE related complication in the course of TTVR.

Comparison of mid-term haemodynamic performance between the BioValsalva and the BioIntegral valved conduits after aortic root replacement.

OBJECTIVES: We retrospectively compared the haemodynamic performance of the BioValsalva (BV) and BioIntegral (BI) biological aortic-valved conduits in the aortic root position. METHODS: Between July 2008 and June 2014, a total of 55 patients underwent aortic root replacement using the BV conduit (n = 27) or the BI conduit (n = 28). The primary study endpoints were haemodynamic performance during follow-up, including mean pressure gradients (MPGs) and effective orifice areas (EOAs). Secondary study endpoints were early postoperative outcomes within 30 days and survival. RESULTS: Both groups did not differ in regard to demographics (BV: median age 71 years, 70.4% female; BI: median age 66 years, 85.7% female, P = 0.15 and P = 0.17) and risk profile (median EuroSCORE-II BV: 3.8 vs 5.3% for BI, P = 0.38). A total of 20% of the total patients (BV 5/27, 18.5% vs BI 6/28, 21.4%) presented with acute type-A aortic dissection. During follow-up, both groups showed no difference in MPGs for all valve sizes [BV, 11.0 mmHg (8.3-14.8 mmHg) vs BI, 11.5 mmHg (9.0-13.0), P = 0.82]. Similar results were achieved for EOAs for all valve sizes [BV, 1.85 cm(2) (1.55-2.21) vs BI, 1.80 cm(2) (1.64-1.83), P = 0.24]. Moreover, there was no statistically significant difference in aortic regurgitation (AR) with none/trace AR in (21/23) 91.3% in BV patients versus (16/21) 76.2% in BI patients (P = 0.23) at follow-up. Both groups showed a high rate of concomitant procedures (BV: 59.3% vs BI: 71.4%, P = 0.40) and emergency indication (BV: 18.5% vs BI: 21.4%, P = 0.79), resulting in an overall 30-day mortality rate of 7.3% (4/55 patients). CONCLUSIONS: The present small single-centre study is one of the first to evaluate and compare the BioValsalva and BioIntegral biological aortic-valved conduit in the aortic root position. Both conduits showed optimal haemodynamic results with a low incidence of aortic regurgitation.

Low Incidence of Paravalvular Leakage With the Balloon-Expandable Sapien 3 Transcatheter Heart Valve.

BACKGROUND: We evaluated the clinical and hemodynamic performance of the new balloon-expandable Sapien 3 (Edwards Lifesciences, Irvine, CA) transcatheter heart valve (S3 THV). METHODS: Between April 2013 and January 2015, 54 consecutive high-risk patients presenting with aortic stenosis were treated with the new S3 THV. Clinical and hemodynamic data as well as device and procedure variables were obtained at baseline, intraoperatively and at 30-days according to Valve Academic Research Consortium-2. RESULTS: The S3 THV was implanted in 41 patients (44% female) via transapical access and in 13 patients via transaortic access. Patients were a mean ± standard deviation age of 80.3 ± 6.0 years. The mean logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE) I of all patients was 33.3% ± 13.4%, the mean The Society of Thoracic Surgeons Score was 6.7% ± 5.3%, and the mean EuroSCORE II was 7.0% ± 5.5%. All patients underwent successful implantation (23 mm, n = 12; 26 mm, n = 22; 29 mm, n = 20), without any intraprocedural complications or repeat ballooning. At 30 days, 53 patients (97.8%) showed no or mild paravalvular aortic regurgitation, 1 patient (2.2%) showed moderate regurgitation, and no patients had more than moderate postprocedural aortic regurgitation. Stroke incidence was 3.7% (2 of 54), and all-cause mortality was 3.7% (2 of 54, sepsis and multiorgan failure). Two patients required a new pacemaker. At 30 days, all patients were in New York Heart Association Functional Class I or II, and the mean pressure gradients were 10.8 ± 3.6 mm Hg. CONCLUSIONS: The present study shows excellent clinical and hemodynamic outcomes of high-risk transapical valve replacement patients treated with the new S3 THV. The S3 THV shows a low incidence of postoperative aortic regurgitation, with 98% presenting with less than mild aortic regurgitation.

Quantitative Analysis of Aortic Valve Stenosis and Aortic Root Dimensions by Three-Dimensional Echocardiography in Patients Scheduled for Transcutaneous Aortic Valve Implantation.

Accurate assessment of the aortic valve area (AVA) and evaluation of the aortic root are important for clinical decision-making in patients being considered for transcatheter aortic valve implantation (TAVI). Real-time three-dimensional transesophageal echocardiography (RT3D-TEE) provides accurate and reliable quantitative assessment of aortic valve stenosis and the aortic root. We performed two-dimensional transthoracic echocardiography (2D-TTE), real-time 2D transesophageal echocardiography (RT2D-TEE) and RT3D-TEE in 71 consecutive patients referred for TAVI. RT3D-TEE multiplanar reconstruction was used to measure aortic root parameters, including left ventricular outflow tract (LVOT) diameter and area, aortic annulus diameter, aortic annulus area, and AVA. RT3D-TEE methods for planimetry and the LVOT-derived continuity equation for the estimation of AVA showed a good correlation. As iatrogenic coronary ostium occlusion is a potentially life-threatening complication, we evaluated the distances from the aortic annulus to the coronary ostia using RT3D-TEE. Based on our findings, we conclude that the geometry of the aortic root and aortic valve can be reliably and feasibly evaluated using RT3D-TEE, which is important for protecting against potential complications of TAVI, such as underestimation of the size of the aortic annulus that can result in aortic regurgitation and dislocation of the valve, or overestimation can lead to annulus rupture.