Transapical implantation of the Intrepid device: Case planning and operative technique.
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ABSTRACT:
SUBMITTER: Hong E
PROVIDER: S-EPMC8299043 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundSevere 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 (MitralstitchTM system).MethodsTen 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.ResultsAll 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.ConclusionsThe 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.
| S-EPMC9305231 | biostudies-literature
Project description:The implantation of a left ventricular assist device (LVAD) has become an essential requirement for managing patients with end-stage heart failure. However, aortic valve insufficiency is a contraindication for LVAD implantation in patients with end-stage heart failure, partly because of the decreasing efficiency of mechanical circulatory support and the eventual development of right ventricular failure. Herein, we present the first case of performing transcatheter aortic valve replacement in valve-in-ring along with LVAD implantation for the treatment of a 60-year-old male suffering from refractory heart failure due to dilated cardiomyopathy and pure aortic insufficiency in need of a new aortic bioprosthesis. A balloon-expandable bioprosthetic transcatheter heart valve was implanted into a previously sewn annulus ring into the aortic root via transaortic access. Subsequently, a centrifugal-flow LVAD was implanted. Postoperatively, the patient was in New York Heart Association Functional Class (NYHA) II with 6-min walk test of 310 m. The patient has completed 6 months of follow-up with no events. This novel and feasible surgical technique reduced the cardiopulmonary bypass time and duration of surgery. Furthermore, it avoids the risk of redo sternotomy and decreases the chances of paravalvular leakage and worsening of aortic regurgitation.
| S-EPMC10117784 | biostudies-literature
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.
| S-EPMC3741746 | biostudies-other
Project description:ObjectivesSeveral studies have shown the potential advantage of less-invasive surgery (LIS) for left ventricular assist device (LVAD) implantation. This study aims to determine the impact of LIS on stroke and pump thrombosis events after LVAD implantation.MethodsBetween January 2015 and March 2021, 335 consecutive patients underwent LVAD implantation using either conventional sternotomy (CS) or the LIS technique. Patient characteristics was prospectively collected. All patients were followed up until October 2021. Logistic multivariate regression and propensity-matched analyses were performed to account for confounding factors.ResultsA total of 242 patients (F = 32; 13.0%) underwent LVAD implantation with CS and 93 patients (F = 8; 8.6%) with the LIS approach. Propensity matching generated two groups, including 98 patients in the CS group and 67 in the LIS group. Intensive care unit stay for the LIS group patients was significantly shorter than that for the CS group patients [2 (IQR: 2-5) days vs. 4 (IQR: 2-12) days, p < 0.01]. There were no significant differences in the incidence of stroke events (14% in CS vs. 16% in the LIS group; p = 0.6) or in pump thrombosis (6.1% in CS vs. 7.5% in the LIS group; p = 0.8) between the groups. The hospital mortality rate in the matched cohort was significantly lower in the LIS group (7.5% vs. 19%; p = 0.03). However, the 1-year mortality rate showed no significant difference between both groups (24.5% in CS and 17.9% in LIS; p = 0.35).ConclusionsThe LIS approach for LVAD implantation is a safe procedure with potential advantage in the early postoperative period. However, the LIS approach remains comparable to the sternotomy approach in terms of postoperative stroke, pump thrombosis, and outcome.
| S-EPMC10213891 | biostudies-literature
Project description:Over the last decade, transcatheter treatment of degenerative aortic valve stenosis has been established as an alternative to surgical aortic valve replacement. Late complications of transcatheter treatment of aortic stenosis (AS) are infrequent. We report an 87-year-old woman treated successfully with 23 mm Sapien 3 transapical transcatheter aortic valve implantation for severe AS. She presented 4 months later with a pulsatile mass in the left breast. After exclusion of other diagnoses, the mass was attributed to a sterile abscess communicating with the pericardial cavity due to post-operative chest infection and pleural effusion. Multimodality imaging helped to define the anatomy of the abscess and the mechanism of the pulsation. This is the first report of a pulsatile sterile abscess occurring as a complication of transapical aortic valve implantation. Multimodality imaging confirmed that the pulsation was due to extension of the abscess into the pericardial cavity, excluded direct communication with the left ventricle, and facilitated successful non-surgical management.
| S-EPMC6601158 | biostudies-literature
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.
| S-EPMC8386843 | biostudies-literature
Project description:Mitral valve repair (MVR) is undisputedly associated with better clinical and functional outcomes than any other type of valve substitute. Conventional mitral valve surgery in dedicated high-volume centers can assure excellent results in terms of mortality and freedom from mitral regurgitation (MR) recurrence but requires cardiopulmonary bypass (CPB) and cardioplegic heart arrest. Trying to replicate the percentage of success of surgical MVR is the aim of all new transcatheter mitral dedicated devices. In particular, transapical beating-heart mitral valve repair by artificial chordae implantation with transesophageal echocardiography guidance is an expanding field. The safety and feasibility of the procedure have already been largely demonstrated with Neochord and more recently with Harpoon systems. Wang et al. present the outcomes of the first-in-human experience using a novel artificial chordae implantation device, the Mitralstitch system. Despite a quite small cohort of only 10 patients treated, 1-year results are satisfying and comparable with the early experience with former devices (4 patients with moderate or more MR recurrence). The comparison with surgical MVR is still unfavorable and requires further studies and significant procedure improvement. However, the device permits the treatment of anterior and posterior leaflets prolapse and performs quite easily edge-to-edge reparation. It will be interesting to evaluate longer follow-up in larger cohorts of patients as well as the possibility to shift to the transfemoral approach.
| S-EPMC9303263 | biostudies-literature
Project description:The GORE EXCLUDER Iliac Branch Endoprosthesis (IBE; W. L. Gore and Associates, Flagstaff, AZ, USA) applicability is limited by the aorto-iliac length (AOL). The shortage may be a major exclusion criterion. An 85-year-old male presented with an abdominal aortic and left common iliac arterial aneurysm. The left-side AOL was 146-mm, which was deemed 19-mm too short for IBE usage. To increase implantation length, the contra-lateral connection stent graft was deployed along the implantation line, wound half-circumferentially around the ipsilateral limb. Any form of endoleak, limb occlusion, and device migration has not been observed for twelve months.
| S-EPMC6766775 | biostudies-literature
Project description:BackgroundThe conventional venous access for cardiovascular implantable electronic device (CIED) is the subclavian vein, which is often accompanied by high complication rate. The aim of this study was to assess the efficacy and safety of optimized axillary vein technique.MethodsA total of 247 patients undergoing CIED implantation were included and assigned to the axillary vein group or the subclavian vein group randomly. Success rate of puncture and complications in the perioperative period and follow-ups were recorded.ResultsThe overall success rate (95.7% vs. 96.0%) and one-time success rate (68.4% vs. 66.1%) of punctures were similar between the two groups. In the subclavian vein group, pneumothorax occurred in three patients. The subclavian gaps of three patients were too tight to allow operation of the electrode lead. In contrast, there were no puncture-associated complications in the axillary vein group. In the patient follow-ups, two patients in the subclavian vein group had subclavian crush syndrome and both of them received lead replacement. The incidence of complications during the perioperative period and follow-ups of the axillary vein group and the subclavian vein group was 1.6% (2/125) and 8.2% (10/122), respectively (χ2 = 5.813, P = 0.016).ConclusionOptimized axillary vein technique may be superior to the conventional subclavian vein technique for CIED lead placement.Trial registrationwww.clinicaltrials.gov, NCT02358551; https://clinicaltrials.gov/ct2/show/NCT02358551?term=NCT02358551& rank=1.
| S-EPMC5126153 | biostudies-literature
Project description: Not available
| S-EPMC8308182 | biostudies-literature