Dataset Information

Initial experiences of transapical beating-heart mitral valve repair with a novel artificial chordal implantation device.

ABSTRACT:

Background

Severe mitral regurgitation (MR) is associated with progressive heart failure and impairment of survival. Degenerative MR accounts for most MV repair surgeries. Conventional mitral valve repair surgery requires cardiopulmonary bypass and is associated with significant morbidity and risks. Transapical beating-heart mitral valve repair by artificial chordae implantation with transesophageal echocardiography (TEE) guidance has the potential to significantly reduce surgical morbidity. We report the first-in-human experience of degenerative MR repair using a novel artificial chordae implantation device (Mitralstitch^TM system).

Methods

Ten patients with severe MR underwent transapical artificial chordae implantation using MitralstitchTM system. The procedure was performed through a small left thoracotomy under general anesthesia and TEE guidance. Patients underwent transthoracic echocardiography and other assessments during the follow-up.

Results

All 10 patients with an average age of 63.7 ± 9.6 years successfully received transapical artificial chordae implantation. Their MR reduced from severe to none or trace in five patients, mild in five patients before discharge. Five patients received one artificial chordal implantation, four patients received two, and one patient received three and edge-to-edge repair by locking two of them. The safety and efficacy endpoint were achieved in all patients at 1-month follow-up. At 1-year follow-up, six patients had mild MR, three patients had moderate MR, one patient had recurrence of severe MR and underwent surgical repair.

Conclusions

The results of this first-in-human study show safety and feasibility of transapical mitral valve repair using MitralStitch system. Patient selection and technical refinement are crucial to improve the outcomes.

SUBMITTER: Wang S

PROVIDER: S-EPMC9305231 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:BackgroundTranscatheter methods have been rapidly evolving to provide an alternative less invasive therapeutic option, mainly because redo patients often present with multiple comorbidities and high operative risk. We sought to evaluate and compare our experience with transapical transcatheter mitral valve replacement (TA-TMVR) to conventional redo mitral valve replacement in patients presenting with degenerated biological mitral valve prostheses or failed valve annuloplasty.Methods and materialBetween March 2012 and November 2020, 74 consecutive high-risk patients underwent surgical redo mitral valve replacement (n = 33) or TA-TMVR (n = 41) at our institution. All patients presented with a history of a surgical mitral valve procedure. All transcatheter procedures were performed using the SAPIEN XT/3™ prostheses. Data collection was prospectively according to MVARC criteria.ResultsThe mean logistic EuroSCORE-II of the whole cohort was 19.9±16.7%, and the median STS-score was 11.1±12.5%. The mean age in the SMVR group was 63.7±12.8 years and in the TMVR group 73.6±9.7 years. Patients undergoing TA-TMVR presented with significantly higher risk scores. Echocardiography at follow up showed no obstruction of the left ventricular outflow tract, no paravalvular leakage and excellent transvalvular gradients in both groups (3.9±1.2 mmHg and 4.2±0.8 mmHg in the surgical and transcatheter arm respectively). There was no difference in postoperative major adverse events between the groups with no strokes in the whole cohort. Both methods showed similar survival rates at one year and a 30-day mortality of 15.2% and 9.8% in SAVR and TMVR group, respectively. Despite using contrast dye in the transcatheter group, the rate of postoperative acute kidney failure was similar between the groups.ConclusionDespite several contraindications for surgery, we showed the non-inferiority of TA-TMVR compared to conventional surgical redo procedures in high-risk patients. With its excellent hemodynamic and similar survival rate, TA-TMVR offers a feasible alternative to the conventional surgical redo procedure in selected patients.

Project description:Off-pump transapical aortic valve implantation (TA-TAVI) through mini-thoracotomy was first performed in Vancouver, Canada in October 2005. The objective of this manuscript is to describe the Vancouver experience with 178 TA-TAVI cases in symptomatic severe aortic stenosis (AS) since 2005.Baseline characteristics and in-hospital outcomes were calculated for the overall cohort. To compare pre-procedure and post-procedure echocardiographic measurements, one way analysis of variance was utilized, followed by Tukey's HSD. In-hospital outcomes were compared between early and late cohorts using Z-test and chi-squared test as appropriate. Kaplan-Meier analysis was used to generate 3-year survival curves. The Log-rank test was used to compare survival between low-risk and high-risk groups, based on STS score.Between October 2005-March 2012, TA-TAVI was performed in 178 patients. Mean age was 80.5±8.6 years. Congestive heart failure and renal failure were more common in the late cohort, while previous myocardial infarction was more common in the early cohort (P<0.05). Eleven patients (6.2%) had significant intra-operative complications, including death (1.7%), conversion to CPB (3.9%), and valve embolization (1.1%). In-hospital survival was 87.9%. Mean length of hospital stay was 12.2±17.1 days. In-hospital incidence of stroke was 3.4%. Bleeding (20.2% vs. 4.7%) and vascular (14.6% vs. 3.5%) complications were more common in the early cohort. Echocardiography demonstrated a significant increase in aortic valve area and decrease in mean transvalvular gradient post-procedure. These improvements were maintained throughout the 3-year follow-up period. Overall survival was 72.1% at 6 months, 67.7% at 12 months, 55.5% at 24 months, and 47.3% at 36 months. Repeated Kaplan-Meier analysis for the 2 groups stratified by STS score, demonstrated improved survival in the low-risk group (Log-rank P=0.039).Among patients with symptomatic severe AS at high risk for conventional AVR, TA-TAVI is a reasonable therapeutic option with acceptable risk. Long-term survival appears to be superior in lower-risk patients.