1-Year Outcomes Following Transfemoral Transseptal Transcatheter Mitral Valve Replacement: The HighLife TSMVR Feasibility Study.

BACKGROUND: A significant number of patients with severe mitral regurgitation (MR) are not suitable for either surgical or transcatheter edge-to-edge repair because of high surgical risk or inappropriate mitral valve anatomy. OBJECTIVES: The aim of this study was to evaluate the HighLife Trans-Septal Mitral Valve Replacement (TSMVR) system in patients with symptomatic MR and high surgical risk. METHODS: This prospective, multicenter, nonrandomized feasibility study evaluated the safety and performance of the HighLife TSMVR system in patients with moderate to severe or severe symptomatic MR during 1-year follow-up. Echocardiographic data were assessed at an independent core laboratory. RESULTS: A total of 30 patients (mean age 75.6 years, 27% women, median Society of Thoracic Surgeons score 5.5%) with severe MR (90% with secondary MR, median left ventricular ejection fraction 43%) were treated at 13 sites. In 27 of the 30 patients, the HighLife TSMVR system was implanted successfully (technical success rate 90%). Device success at 30 days was 83%. After 1 year, 5 patients (17%) had died. None of the patients who underwent implantation required mitral valve reintervention. All patients who underwent implantation had no or trace (78%) or mild (22%) MR, the mean gradient of the HighLife valve was 5.1 mm Hg, and there were no signs of left ventricular outflow tract obstruction (mean gradient 2.0 mm Hg). CONCLUSIONS: The 1-year results from the HighLife TSMVR feasibility study demonstrate a high technical success rate, excellent valve function, no left ventricular outflow tract obstruction, and no need for mitral valve reintervention. Additional patient outcomes and longer follow-up are needed to confirm these findings. (Expanded Study of the HighLife 28mm Trans-Septal Trans-Catheter Mitral Valve in Patients With Moderate-Severe or Severe Mitral Regurgitation and at High Surgical Risk; NCT04029363).

Percutaneous paravalvular leak closure for balloon-expandable transcatheter aortic valve replacement: a comparison with surgical aortic valve replacement paravalvular leak closure.

AIMS: Paravalvular leak (PVL) is frequently observed after transcatheter aortic valve replacement (TAVR) and is related to increased mortality. Percutaneous PVL closure, which is a viable option for this complication, has been performed following surgical aortic valve replacement (SAVR); however, the experience in TAVR remains limited. We sought to compare this technique between post-TAVR and post-SAVR cases. METHODS AND RESULTS: A single-center series of patients consecutively undergoing percutaneous PVL closure was reviewed. Each group had 10 cases and procedural/imaging variables were assessed. Although there was no severe complication during the procedures, procedural success rate was lower in the post-TAVR group (60% vs. 100%; P=.04). There was resistance in all 4 unsuccessful cases, and we were unable to advance the delivery sheath over the wire. Computed tomography revealed that unsuccessful cases had higher calcification volume in the corresponding leaflet (351.4 ± 205.1 mm³ vs. 121.8 ± 111.7 mm³; P=.049). This finding can explain the mechanism of difficulty; the higher volume of calcification increases the resistance while advancing the delivery sheath. CONCLUSION: This is the first study revealing the difficulty of percutaneous PVL closure following TAVR compared with SAVR. However, it is a preferred approach in TAVR patients given their high risk for a surgical procedure. Computed tomography assessment of calcification volume provides important information for preprocedural planning.

Impact of pulmonary hypertension on outcomes in patients with functional mitral regurgitation undergoing percutaneous edge-to-edge repair.

Preexisting pulmonary hypertension (PH) is associated with poor outcomes after surgical mitral valve repair for functional mitral regurgitation (FMR). However its clinical impact on MitraClip therapy remains unknown. The aim of this study was therefore to evaluate the impact of preexisting PH on MitraClip therapy for patients with FMR. Ninety-one consecutive patients who had FMR and who underwent the MitraClip procedure were studied. They were divided into 2 groups on the basis of pulmonary artery systolic pressure: the PH group (n = 48) and the non-PH group (n = 43). PH was defined as pulmonary artery systolic pressure >50 mm Hg using Doppler echocardiography. Procedural success (defined as magnetic resonance reduction to grade 2+ or less) and 30-day mortality were similar in the 2 groups. At 12 months, New York Heart Association functional class had improved to class I or II in most patients in the PH (from 2.9% to 94.3%) and non-PH (from 9.4% to 96.9%) groups. The mean pulmonary artery systolic pressure of the PH group significantly decreased from baseline but remained higher than that of the non-PH group (50.8 ± 15.3 vs 36.7 ± 11.6 mm Hg, p <0.001). After a mean of 25.0 ± 16.9 months of follow-up, Kaplan-Meier analysis demonstrated significantly higher all-cause mortality in the PH group. In Cox regression analysis, preexisting PH was the most powerful predictor of all-cause mortality (hazard ratio 3.731, 95% confidence interval 1.653 to 8.475, p = 0.002). In conclusion, MitraClip therapy reduced FMR and alleviated symptoms with an excellent early safety profile in the PH and non-PH groups. However, preexisting PH was associated with worse all-cause mortality.

Successful closure of residual leak following LARIAT procedure in a patient with high risk of stroke and hemorrhage.

Percutaneous left atrial appendage suture ligation with the LARIAT® device (Sentre HEART, Redwood City, CA) was successfully performed on an 84-year-old woman with non-valvular atrial fibrillation who developed intracranial hemorrhage on warfarin. However, a large gap developed at follow-up precluding warfarin cessation. To the best of our knowledge, this case report represents the first description of the use of a Gore® Helex® Septal Occluder (W. L. Gore and Associates, Newark, Delaware) as a novel approach to close a gap following percutaneous LAA suture ligation.

Device- and LAA-Specific Characteristics for Successful LAA Closure: Tips and Tricks.

Transcatheter left atrial appendage closure for stroke prevention with nonvalvular atrial fibrillation is an emerging alternative to oral anticoagulation. Several devices and approaches have been developed to achieve optimal closure. This article describes in detail the key procedural steps and the tips and tricks required to succeed in this transcatheter technique. The 4 devices covered are the WATCHMAN, AMPLATZER Cardiac Plug, Coherex WaveCrest generation 1.3, and the LARIAT suture delivery device.

Percutaneous closure of iatrogenic ventricular septal defect following surgical aortic valve replacement using two different approaches.

Iatrogenic ventricular septal defect (VSD) is a rare complication following surgical aortic valve replacement (SAVR). In this report, we describe two cases of iatrogenic VSD following SAVR (both mechanical and bioprosthetic aortic valve), which were successfully closed with two different percutaneous techniques (retro-aortic and transseptal approach). The report discusses the differences in the techniques and the literature supporting the procedure.

Perioperative rupture of the LIMA graft leading to cardiogenic shock, emergency angiography, and stenting with a polytetrafluoroethylene-covered stent.

A 58-year-old man underwent an elective coronary bypass graft for severe four-vessel stenosis. Cardiogenic shock developed just after coronary bypass grafting with a left internal mammary artery (LIMA) to left anterior descending (LAD) artery and superficial venous graft to 1st and 2nd obtuse marginal (OM1/OM2) arteries the posterior descending artery (PDA) was too small to graft. Despite significant inotropes and an intra-aortic balloon pump, the patient deteriorated in intensive care unit with cardiogenic shock and ventricular arrhythmia. Urgent coronary angiography revealed a rupture or torn LIMA graft with extravasation of contrast into the left pleural cavity. There was no distal LIMA to LAD flow probably due to graft thrombosis. Revascularisation was performed on the severe ostial native LAD stenosis with a drug eluting stent. The rupture graft was then stented with a polytetrafluoroethylene-covered stent, which stopped the bleeding, and latter, led to total graft thrombosis. The patient improved significantly and supportive inotropes could be weaned down. At 11 month follow-up, the patient had mild left ventricular dysfunction, widely patent ostial LAD stent and thrombosed LIMA graft.