Transapical Mitral Valve Replacement Research Articles

Early Feasibility Study with the SATURN Transapical Mitral Valve Replacement Device

PurposeTo report the outcomes of the early feasibility study of transapical transcatheter mitral valve replacement (TMVR) with the SATURN System (InnovHeart, Milano, Italy) to treat patients with severe functional mitral regurgitation. DescriptionFive high surgical risk patients underwent transapical transcatheter mitral valve replacement with the SATURN System at a single center. One-year follow-up is complete for all patients. EvaluationThe valve was implanted successfully in all patients without any major adverse events. All patients were alive at the last follow-up. Kansas City Cardiomyopathy Questionnaire improved from a median of 63.5 (interquartile range, 19.6) at baseline to 99.0 (interquartile range, 21.6) at 1 year. Echocardiographic follow-up demonstrates stable valve function, no transvalvular or paravalvular mitral regurgitation, and absence of left ventricular outflow tract obstruction. ConclusionsAt 1 year after transapical SATURN transcatheter mitral valve replacement, all patients are alive with quality of life improvement and favorable device hemodynamics. These initial results are promising and larger scale studies with continued follow-up are required to further elucidate the efficacy and safety of this novel technology.

Thirty-day and one-year outcomes following transcatheter mitral valve edge-to-edge repair versus transapical mitral valve replacement in patients with left ventricular dysfunction

A comparison of 30-day and 1-year clinical outcomes in patients with pre-existing left ventricular (LV) dysfunction undergoing transcatheter mitral valve edge-to-edge repair (TEER) or transcatheter transapical mitral valve replacement (TMVR) has not previously been reported. We aimed to compare 30-day and 1-year rates of all-cause and cardiovascular mortality as well as rehospitalisation for heart failure (HFH). All patients with severe (≥3+) symptomatic mitral regurgitation (MR) and an LV ejection fraction ≤50% who underwent TEER or TMVR over a 5-year period were evaluated. Ninety-six patients (50 TEER, age 80±9 years, 70% secondary MR and 46 TMVR, age 72±9 years, 91% secondary MR) were studied. Baseline demographic and transthoracic echocardiogram characteristics were well-matched, with the exception of age (TEER 80±9 vs TMVR 72±9; p=0.01). Successful device implantation occurred in 96% of TEER patients and 97.8% of TMVR patients. Ninety-two percent of TEER patients had ≤2+MR predischarge, whilst no TMVR patient had ≥1+MR (p<0.01). No significant difference in the combined endpoint of 30-day all-cause mortality or HFH was observed (p>0.05). At 1 year, freedom from all-cause mortality and HFH was 79.2% across the entire study population but was significantly higher in patients undergoing TEER (TEER: n=45 [90%] hazard ratio 11.26, 95% confidence interval [CI]: 10.59-11.93 vs TMVR: n=39 [67.4%] 95% CI: 10.09-11.33;p=0.008). Despite comparable rates of successful device implantation, MR reduction, and 30-day all-cause mortality/HFH, TEER patients had lower all-cause mortality and HFH rates at 1 year.

Off-label transapical beating-heart transcatheter mitral valve replacement in severe mitral annular calcification

The recent CE mark approval of a novel transapical transcatheter beating-heart replacement system, anchored by an apical pad, expanded the therapeutic options for patients with a significantly diseased mitral valve who are not eligible for conventional surgery. However, this self-expandable bioprosthesis is-despite promising data from the first European real-world experience-not approved for patients with severe mitral annular calcification. In this video tutorial, we provide a step-by-step description of an off-label transapical mitral valve replacement in a patient with severe degenerative mitral valve disease and limited alternative treatment options.

New stent for transapical mitral valve replacement in acute swine experiment

BackgroundMany patients with mitral regurgitation are denied open-heart surgery due to perceived high risk. Transcatheter mitral valve replacement is a therapeutic alternative for patients at high surgical risk. This study aimed to assess the feasibility of a new self-expanding valved stent for transcatheter mitral valve replacement via apex in an acute animal model.MethodsEight porcine experiments were performed in the acute study. A left thoracotomy was performed, and the new self-expanding transcatheter valved stent was deployed under fluoroscopic guidance in the native mitral annulus via apex. Hemodynamic data were recorded before and after implantation. Mitral annulus diameter and valve area were measured using echocardiography. Transvalvular and left ventricular outflow tract pressure gradients were measured using invasive methods.ResultsSeven animals underwent successful transapical mitral valve replacement; the implantation was unsuccessful in one animal. The mean procedure time, defined from placement to tightening of the purse-string suture, was 17.14 ± 7.86 min. Hemodynamic data before and after transapical mitral valve replacement showed no difference in statistical analysis. The mean diameter of the self-expanding device after implantation was 2.58 ± 1.04 cm; the mean functional area was 2.70 ± 0.26 cm2. Trace-to-mild central and paravalvular leaks were detected in 7 valves. The mean pressure gradient across the self-expanding device was 2.00 ± 0.82 mmHg; the corresponding gradient across the LVOT was 3.28 ± 1.11 mmHg. Postmortem evaluation confirmed precise device positioning in 7 animals with no signs of LVOT obstruction.ConclusionTranscatheter mitral replacement of the new valved stent was confirmed feasible in acute preclinical models. The new stent reveals optimal design parameters.

Transcatheter Mitral Valve Replacement in Patients With Previous Aortic Valve Replacement.

Transcatheter mitral valve replacement (TMVR) may mature to become a therapeutic option for high-risk patients with severe mitral regurgitation (MR), particularly in patients at high or prohibitive surgical risk. MR patients with preexisting aortic valve prosthesis have been excluded from most TMVR trials because of the potential risks of left ventricular outflow tract obstruction or interaction between the TMVR anchoring mechanism and the aortic prosthesis. We describe the procedural and short-term outcomes of transapical TMVR with the Tiara valve in patients experiencing severe symptomatic MR with previous aortic valve replacement (AVR). Twelve consecutive high surgical risk patients (11 men; mean age, 75±6 years) with aortic valve prosthesis and severe MR underwent TMVR with Tiara valve. Aortic valves were mechanical in 5 and biological in 7 patients, while 1 patient had previously undergone implantation of a transcatheter valve within a failed bioprosthetic surgical valve. Six patients (50%) had undergone redo surgical aortic valve replacement. Clinical characteristics of the group include prior mitral valve repair in 2, prior coronary bypass grafting surgery in 5, chronic atrial fibrillation in 7, renal failure in 9, and pacemaker/cardiac resynchronization device in 9 patients. Mean Society of Thoracic Surgery score and EuroSCORE II were 10.5±4.4 and 12.4±3.7, respectively. Mean baseline left ventricular ejection fraction was 35.5±5.3% (range, 30%-45%). The Tiara valve was implanted uneventfully in all patients. Device migration or left ventricular outflow tract obstruction was not observed. No patient required conversion to open heart surgery or periprocedural hemodynamic support. Procedural success was 100% with no death, MI, stroke, major bleeding, or access site complications at 30 days. MR was eliminated in all 12 patients immediately after implantation. Transapical mitral valve replacement with the Tiara valve in high-risk patients with severe MR and aortic valve prostheses is technically feasible and can be performed safely.

Right Ventricular Remodelling in Patients Undergoing Mitral Valve Replacement With the Tendyne Mitral Valve System

Background: Transcatheter, transapical mitral valve replacement (TMVR) with the Tendyne mitral valve is a novel treatment option for patients with severe mitral regurgitation (MR) who are deemed high-risk for cardiac surgery. Chronic severe MR leads to the development of pulmonary hypertension, increased right ventricular (RV) afterload, and RV dysfunction. The effect of TMVR on RV function using transthoracic echocardiography (TTE) has not been studied.

Initial Experience With a Percutaneous Approach to Redo Mitral Valve Surgery: Management and Procedural Success.

The purpose of the study was to report the anesthetic management and immediate procedural success in the initial 20 patients undergoing percutaneous transapical mitral valve replacement. Retrospective review of collected data. University-affiliated heart center. Twenty patients with mitral regurgitation or stenosis due to a degenerated valve or ring in the mitral position. TEE-guided transapical mitral valve replacement under general anesthesia and early extubation by means of an established fast-track protocol. Twenty patients underwent transapical mitral valve replacement by a beating heart procedure, avoiding cardiopulmonary bypass. The valve was either deployed due to a previously implanted bioprosthetic valve (valve-in-valve group), which degenerated, or a ring (valve-in-ring group), which predominantly showed regurgitation. There was a significant increase in the mitral valve opening area in stenosed valve pathology from 1.3-1.9 sq. cm (p = 0.004), and an increase in ejection fraction from 40% to 45% (p = 0.52). In the valve-in-ring group, valve area increased from 2.0 sq. cm to 2.6 sq. cm (p = 0.21), with an increase in ejection fraction from 30% to 35% (p = 0.18). Eighteen patients underwent successful deployment of the valve. The anesthesia duration for the procedure lasted 185.5 ± 25.4 minutes. There was a significant increase in opening area of the valve and improvement in ejection fraction in this patient group. TEE and fluoroscopy-guided imaging is necessary for the procedure's success and is an evolving alternative treatment for high-risk mitral valve patients who would otherwise be considered inoperable for routine surgery using sternotomy.

Off-pump transapical mitral valve replacement: evaluation after one month

The present study investigates outcomes one month after implanting pigs with a novel mitral valved stent. A novel nitinol stent custom designed for this study included a bovine pericardial valve. Six pigs received a valved stent into the mitral position by means of the transapical implantation technique. Afterwards, haemodynamic stability and valve function were assessed, immediately after implantation (n = 6), 4 weeks (n = 4) and 8 weeks (n = 1) thereafter using transoesophageal echocardiography (TEE), ventriculography and cardiac computed tomography (CT). Four of 6 surviving pigs were sacrificed at 4 weeks after implantation and one at 8 weeks thereafter. Optimal deployment and positioning were obtained in all but one animal. This animal died of unrecognized imperfect valved stent positioning after 4 days. The average mean gradient across the new valves and the left ventricular outflow tract (LVOT) were small. Mild regurgitation developed after valved stent deployment in one of six animals just after 1 h, and in none thereafter. All animals exhibited normal haemodynamics after mitral valved stent implantation, and stability was maintained throughout the monitoring period. Migration, embolization and paravalvular leakage were not evident in the remaining animals after 4 and 8 weeks. Gross evaluation revealed that 50-70% of the atrial element was covered by tissue growth at 4 weeks/8 weeks. This study demonstrates adequate deployment and anchorage of a unique, repositionable mitral valved stent. A good valve function was revealed in animals observed for 4 weeks and in one pig after 8 weeks.

Off-pump transapical mitral valve replacement☆

Percutaneous valve replacement was recently introduced, and reports of early clinical experience have already been published. To date, this technique is limited to the replacement of pulmonary and aortic valves in a strictly selected group of patients. The aim of this study was to analyse a self-expanding valved stent for minimally invasive replacement of the mitral valve in animals. A newly designed nitinol stent was specially designed for this experimental acute study. It comprised of a left ventricular tubular stent with star shaped left atrial anchoring springs and carried a trileaflet bovine pericardial valve. A polytetrafluoroethylene membrane was sutured to envelop the atrial springs and the outside of the ventricular stent. The ventricular anchoring system was the same as in our previously reported results with a similar mitral valved stent. Seven pigs underwent minimally invasive off-pump mitral valved stent implantation. This was performed through a lower mini-sternotomy and a standard transapical approach under transoesophageal echocardiographic (TEE) guidance was used. The valved stent is fully retrievable and precise deployment and accurate adjustment of its intra-annular position is achievable to eliminate paravalvular leakage. The deployment time ranged from 127 to 255s and the blood loss from 70 to 220cc. One animal died of intractable ventricular fibrillation. Mitral regurgitation in all surviving animals was minimal (trace in 5/6 and mild in 1/6 during echo examination; on the contrast ventriculogram no mitral insufficiency was observed except in one documented as mild paravalvular regurgitation). These animals remained haemodynamically stable (6/6) and without TEE or ventriculographic changes for 1h. Implantation of a tricuspid bovine pericardial valved stent in the mitral position is feasible in pigs through a transcatheter approach. This was possible through a smaller delivery system than previously reported. Additional studies are required to demonstrate long-term feasibility, durability, and heart function.