Transcatheter Mitral Valve Implantation Research Articles

GW28-e0641 Transcatheter Mitral Valve Implantation Using the Mithos valve–Pre-Clinical Animal Study

This pre-clinical study was aimed to evaluate the safety and feasibility of transcatheter mitral valve implantation using a novel designed Mithos valve (NewMed Medical Co., Ltd., Shanghai, China) in a porcine model. The Mithos valve is a self-expanding bioprosthesis with cross-linked bovine

Transseptal puncture for structural heart intervention: an old technique with new indications

### Learning objectives To learn how to: Transseptal catheterisation was introduced in the late 50s1 and gained popularity with the introduction of the electrophysiological and structural heart interventions.2–10 Here, we...

The Concept of a Device for the Redo Transcatheter Mitral Valve Implantation

The Concept of a Device for the Redo Transcatheter Mitral Valve Implantation

4107Results of Transcatheter Mitral Valve Implantation in Patients with Bioprosthesis Or Annuloplasty Failure Or Mitral Annulus Calcification

4107Results of Transcatheter Mitral Valve Implantation in Patients with Bioprosthesis Or Annuloplasty Failure Or Mitral Annulus Calcification

Transapical Mitral Valve Implantation for Native Mitral Valve Stenosis Using a Balloon-Expandable Prosthesis

Transcatheter mitral valve implantation (TMVI) is still in its infancy and is mainly limited to valve-in-valve or valve-in-ring implantations. We present the early experience with TMVI for severe calcified native MV stenosis. Between January 2014 and June 2015, 6 of 11 patients screened (mean age, 77.4 ± 6.3 years; 66% men) with severe native mitral valve (MV) stenosis (mean gradient [Pmean], 11.1 ± 2.1 mm Hg; mean effective orifice area [EOA], 0.9 ± 0.12 cm2) underwent transcatheter MV replacement at our institution as a bailout procedure. Conventional surgical procedures were denied in all patients because of severe annular calcification and extensive comorbidities (mean logistic EuroScore, 31.4% ± 8.3%). The Edwards SAPIEN 3 (29 mm) (Edwards Lifesciences, Irvine, CA) was used in all cases. Procedural access was transapical in 5 cases and concomitant to aortic valve replacement through the left atrium through a sternotomy in 1 case. Initial implantation was successful in 100% of the cases. Because of early migration, 1 patient needed a valve-in-valve procedure. Postoperative echocardiography showed no residual mitral regurgitation in 4 cases (66%) and mild regurgitation in 2 cases (34%). Mean gradients were reduced to 4.2 ± 0.6 mm Hg (mean EOA, 2.8 ± 0.4 cm2). No patient had a stroke during hospitalization, and 30-day mortality was seen in 1 patient (17%) resulting from pneumonia. TMV implantation using the SAPIEN 3 aortic prosthesis in patients with heavy annular calcification is feasible and represents a reasonable bailout option for inoperable patients. However, several limitations need to be considered in this special patient population.

Pitfalls in TAMVI: experience with the repositionable Lotus\xae Valve System

BackgroundSimultaneous transapical implantation of transcatheter heart valves in the native mitral and aortic position may be considered as an alternative to surgical valve replacement in high-risk patients presenting with combined valve disease.Case presentationA 59-year-old female with severe aortic stenosis, severe mitral stenosis with mild mitral insufficiency, persistent atrial fibrillation, severe chronic obstructive pulmonary disease and NYHA class of IV was evaluated by our interdisciplinary heart team. Due to the calculated Euroscore II, logistic Euroscore with 10% and 17% a decision was made towards a transapical TAVI approach. The implantation of a Sapien 3 (Edwards Lifesciences) valve in the aortic position was performed and the perioperative TEE showed a good result. The preoperative imaging revealed a narrow LVOT with risk for post interventional left ventricular outflow tract obstruction. Accordingly, it was decided against the use of balloon-expanding valves for the mitral valve position in the interdisciplinary team, as it is not repositionable. Instead, it was decided for the use of a Lotus (Boston Scientific) valve, as it is repositionable and therefore possible to retract in case of LVOT obstruction. In the present case of double valve intervention, the implantation attempt of a fully repositionable transcatheter heart valve into the native mitral annulus resulted in acute LVOT obstruction requiring immediate removal of the device. The patient was extubated and experienced uneventful postoperative recovery.ConclusionsThe case shows that improved preoperative work-up is necessary for better prediction of significant LVOT obstruction following transcatheter mitral valve implantation. In borderline cases, the use of a fully repositionable device is preferred.

Single centre experience with transapical transcatheter mitral valve implantation.

A transcatheter heart valve technique can be used in failed mitral valve repairs with annuloplasty rings, deterioriated bioprostheses and in mitral annular calcification, all serving as 'docking stations' for balloon-expandable valves. Specially designed transcatheter mitral valve platforms are used in ongoing studies for native mitral valve regurgitation. We present our single centre experience with transcatheter mitral valve implantation-transapical approach procedures in eleven patients. Eleven patients were treated between 2011 and 2016. They had severe mitral regurgitation due to either failed repair annuloplasty rings (N = 6), failed bioprostheses (N = 2) or in the native valve (N = 3), all at high risk for open mitral valve surgery. Three different types of transcatheter valves were used: (1) the SAPIEN XT/SAPIEN 3, (2) the Lotus valve and (3) a Tendyne transcatheter mitral valve. Computed tomography reconstruction, echocardiography, 3D printing and bench tests were done in the preoperative evaluation and procedural planning. Transapical approach access was performed via a left minithoracotomy. Implantation success was 100% with no left ventricular outflow tract obstruction. Good haemodynamics and improved New York Heart Association class were demonstrated in all patients. One patient died before 30 days due to sepsis. One patient had a valve thrombosis when switching from Coumadin to new oral anticoagulant and had a second valve implanted into the first one as a 'valve-in-valve' procedure. The transapical approach is a safe and straight forward procedure for accessing the mitral valve. 'Transcatheter aortic valve implantation' prostheses may be used in redo surgery due to an already sufficient 'docking station'. These specially designed new prostheses may be beneficial for addressing mitral valve regurgitation, but are still under evaluation. Anticoagulation is mandatory.

Simultaneous Transseptal Para-Ring Leak Closure and Transcatheter Mitral Valve Implantation for the Treatment of Surgical Mitral Repair Failure

Repeat cardiac surgery in patients with a previous sternotomy is associated with significant morbidity and mortality. While transcatheter aortic valve implantation in high risk surgical patients is now well established, experience with transcatheter mitral valve replacement is still at an early stage. Although many successful reports of transcatheter mitral valve replacements now exist, the predominant approach has been via a transapical approach. It is likely that, as with the evolution of favoured access routes for transcatheter aortic therapies, future directions for transcatheter mitral valves will focus on smaller delivery systems favouring the transvenous transseptal approach where possible. We present the first reported case of combined transseptal para-ring leak closure followed by transcatheter mitral valve implantation using a 12/5mm Amplatzer III vascular plug and a 29mm SAPIEN 3 valve.

Transcatheter mitral valve implantation: a percutaneous transapical system.

Despite recent achievements, implantation of a transcatheter mitral valved stent remains challenging. In this study, we present a different approach for implantation of a percutaneous mitral valved stent. Percutaneous transapical access is combined with, respectively, a left-transatrial, right-transatrial/transseptal or transfemoral/transseptal approach for mitral valve stent implantation and secure fixation. The apical fixation and occlusion are ensured with an Amplatzer occluder. This novel approach was tested in 22 porcine hearts in an in vitro setting under the guidance of fluoroscopy ( n = 11) and endoscopy ( n = 11). The in vitro setup included continuous flushing at 37 °C. We determined the feasibility, time of implantation, stent deployment and stent fixation. Percutaneous mitral valved stent implantation was successful in all cases. Good handling properties and precise positioning were achieved. Time of implantation was comparable in the fluoroscopic and endoscopic groups at 10:41 ± 3:18 and 10:09 ± 2:42 min, respectively. Apical fixation with the occluder was excellent in all 22 cases. The feasibility of percutaneous mitral valved stent implantation has been demonstrated in preliminary in vitro experiments. Subsequent studies are warranted to determine the efficacy of this minimally invasive catheter-based mitral valved stent implantation.

Transcatheter Implantation of Mitral Valve Prostheses: Current Status of the Problem

Mitral valve disease is highly prevalent and quickly leads to development of severe heart failure. Mitral valve disease of degenerative or ischemic etiology affects 7.5 and 9.3% of population older than 65 and 75 years, respectively. "Open" (with cardiopulmonary bypass) surgical repair or valve replacement are not possible in almost half of affected patients because of their complications and concomitant diseases responsible for extremely high risk of these interventions. In the last decade, minimally invasive endovascular technology - transcatheter aortic valve implantation (TAVI) - has been widely introduced for correction of aortic valve disease in similar category of patients. However, transcatheter mitral valve implantation (TMVI) has been developed just during recent couple of years.

Percutaneous Approach to the Mitral Valve: The Prince Charles Experience

Purpose: Open-heart surgery remains the gold standard for the treatment of severe mitral valve disease. The modern challenge facing surgeons, to provide a safe intervention for the rising population of high-risk patients presenting for either primary or redo surgery, has led to the development of novel percutaneous approaches to the mitral valve. We describe our initial experience with transcatheter mitral valve replacements in high-risk patients. Methodology: Ten patients (mean age 82 ± 2 years) received transapical transcatheter mitral valve implantation between February 2011 and June 2016. All patients were considered high risk for conventional surgery after evaluation by a multidisciplinary heart team. Implantation of a balloon-expandable heart valve (Sapien) into a degenerated mitral valve bioprosthesis was performed in four patients, whilst six received a self-expanding bioprosthesis (Tendyne) for severe mitral regurgitation. Results: Implantation was successful in all patients, with reduction of median mitral regurgitation from grade 4 (IQR: 3-4) to 0 (p < 0.01). Trace paravalvular regurgitation was seen in 3 patients. In-hospital mortality occurred in 2 patients due to stroke and septic shock, on postoperative days 3 and 13, respectively. Length of stay was 10 (IQR: 8-12) days. NYHA class improved from 3 (IQR: 3-4) to 2 (IQR: 1.5-2, P < 0.01) over a median follow-up of 30 (range 30-958) days. Conclusion: Transapical transcatheter mitral valve replacement may provide an alternative strategy to deal with the increasing rise of high-risk patients presenting for primary and reoperative mitral valve surgery. Our initial experience with this approach has demonstrated its early feasibility in select patients.

TCT-642 Intentional Laceration of the Anterior Mitral valve leaflet to Prevent left ventricular Outflow tract ObstructioN (LAMPOON) during transcatheter mitral valve implantation: preclinical findings

Left ventricular outflow tract (LVOT) obstruction is a life-threatening complication of transcatheter mitral valve implantation (TMVR), caused by septal displacement of the anterior mitral leaflet. We propose a novel transcatheter transection of the anterior mitral leaflet. In vivo procedures in

Surgical antegrade transcatheter mitral valve implantation for symptomatic mitral valve disease and heavily calcified annulus

Surgical techniques for the treatment of mitral valve disease (MVD) have continuously evolved; however, anatomical details like severe annular calcification remain challenging and require sophisticated surgical strategies. Among patients with symptomatic MVD referred for surgical valve repair or replacement, four presented with circumferential calcification of the mitral annulus precluding conventional surgical techniques. Successful treatment by implanting a balloon-expandable transcatheter aortic heart valve using an antegrade surgical access was performed. The perioperative course and follow-up assessment (19.3 ± 21 months) were uneventful. Echocardiographic assessment confirmed a well-seated valve with normal function (mean 4.5 ± 0.6 mmHg). Surgical mitral valve replacement using a balloon-expandable transcatheter aortic bioprosthesis can be a valuable and attractive bailout strategy in patients with a heavily calcified mitral annulus.

Relationship of mitral valve annulus plane and circumflex-right coronary artery plane: Implications for Transcatheter Mitral Valve Implantation.

Transcatheter mitral valve implantation (TMVI) is a novel technology for patients with severe mitral valve disease but at high surgical risk. Imaging guidance during the procedure is critical for successful device deployment. Identification of the mitral annular plane (MAP) with fluoroscopy during the procedure is limited by lack of clearly defined landmarks. We hypothesized that a plane defined by left circumflex-right coronary arteries (LCX-RCA) would have a consistent relationship to MAP. We studied 25 patients with gated cardiac computed tomography. We identified the MAP and the LCX-RCA plane in mid systole and diastole. The distance between the two planes in prespecified four points (anterior, posterior, medial, and lateral) in the apical 2 and 3-chamber views. Alignment of the planes was described by cranial/caudal angulation for both planes in RAO 30° and LAO 90° (lateral) angulation. Mean age was 81 ± 9 years, 56% of patients had ≥2+ mitral regurgitation. In mid systole, the distances between the LCX-RCA plane and the MAP in the four points were < 5 mm in 92% of patients. In mid diastole, distances were < 5 mm in 100% of patients. In mid systole, the correlation between the caudal/cranial orientations of the 2 planes was 0.85 and 0.80 in the LAO 90° and RAO 30°, respectively (P = <0.001). In mid diastole, this was 0.92 and 0.92 in the LAO 90° and RAO 30°, respectively (P = <0.001). LCX-RCA plane has a close and consistent relationship to the MAP and can be useful to guide TMVI. Accurate imaging of mitral valve annular plane during TMVI procedure is challenging. MAP guided by fluoroscopy might be crucial to guide successful prosthesis deployment. A plane defined by the left circumflex- right coronary arteries in the atrioventricular grove has a consistent relationship with MAP; this can be used aided by pre-procedural MDCT to guide TMVI procedure. © 2016 Wiley Periodicals, Inc.

Transcatheter Mitral Valve Implantation: 30-day Outcome of First-in-Man Experience With an Apically Tethered Device.

A small number of transcatheter mitral valve implants (TMVIs) have been reported using devices designed to treat secondary mitral regurgitation (MR). However, MR has many etiologies, and patients have a broad spectrum of annular size, geometry, and lesions. There are a number of technical challenges for TMVI including left ventricular outflow tract obstruction and paravalvular MR. Thirty days' outcome of first-in-man implants with a novel TMVI device is reported. The Tendyne TMVI system consists of a porcine pericardial valve in a tethered nitinol frame. An apical tether fixed to an epicardial pad stabilizes the device. The device is fully repositionable and retrievable even after complete deployment. Preoperative assessment was performed with 3-dimensional (3D) transesophageal echocardiogram and multislice computed tomography to define annular dimensions, geometry, and guide surgical access. Three patients were deemed not to be candidates for conventional surgery or for treatment with any Conformitè Européenne-marked device by Heart Team Evaluation. They were a 68-year-old woman with prior coronary artery bypass grafts and severe functional MR; a 75-year-old man with prior coronary bypass grafts, significant renal dysfunction, and severe degenerative MR; and a frail 86-year-old man with severe degenerative MR. Each had a TMVI via a transapical approach through a left minithoracotomy. Apical tether tension was adjusted to optimize device position. Implantation was guided by 2D and 3D transesophageal echocardiogram. The apical pad facilitated LV apical closure. There were no procedural complications. No patient had hemodynamically significant residual MR or left ventricular outflow tract obstruction, and there was no significant mitral gradient. All patients were discharged to their own home (the third on the fifth postoperative day), all with significant improvement in their symptoms. All were alive and well 30 days after implant. Two patients with existing conduction abnormalities had cardiac resynchronisation therapy after the procedure, and one patient had para valvular leak (PVL) with evidence of hemolysis at 30 days, which reduced in severity with conservative treatment. The first-in-man experience with the Tendyne TMVI system is promising. Valve stabilization by an apical tether is a novel way to address some of the challenges of TMVI. The unique Tendyne design features may offer potential for its use across a wide range of mitral valve pathologies.

Transcatheter Mitral Valve Implantation: 30-day Outcome of First-in-Man Experience with an Apically Tethered Device

Transcatheter Mitral Valve Implantation: 30-day Outcome of First-in-Man Experience with an Apically Tethered Device

Percutaneous Transvenous Transseptal Transcatheter Valve Implantation inFailedBioprosthetic Mitral Valves, RingAnnuloplasty, and Severe MitralAnnular Calcification.

This study sought to examine the feasibility, safety, and intermediate-term outcomes in patients undergoing percutaneous transvenous transcatheter mitral valve implantation in failed bioprosthesis, ring annuloplasty, and calcific mitral stenosis. Surgical mitral valve replacement in patients with previous surgery or severe mitral annular calcification (MAC) is often associated with high or prohibitive risk. Percutaneous transfemoral antegrade transseptal implantation of Edwards SAPIEN prosthesis (Edwards Lifesciences, Irvine, California) was performed in 48 patients with degenerated mitral bioprosthesis (n= 33), previous ring annuloplasty (n= 9), and severe MAC (n= 6). The mean Society of Thoracic Surgeons risk score was 13.2 ± 7.4% with a mean age 76 ± 11 years. Acute procedural success was achieved in 42 of 48 patients (88%) in the overall group and 31 of 33 (94%) in the failed bioprosthetic mitral valve group and success rate of 11 of 15 (73%) in patients with failed annuloplasty rings and MAC. After successful procedure, no patients had > mild residual mitral prosthetic or periprosthetic regurgitation; mean transvalvular gradients were 6 ± 2.5 mmHg. Thirty-day survival free of death and cardiovascular surgery was 85% in the overall group and 91% in the failed bioprosthetic mitral valve subgroup. Transfemoral percutaneous transvenous mitral valve implantation in high-risk patients with degenerated bioprosthesis is safe, effective, and associated with rapid improvement in hemodynamics, short length of stays, and improved functional status. Percutaneous mitral valve implantation in patients with failed annuloplasty rings and severe MAC is a promising therapy with significant short-term morbidity and mortality that requires further study.

THE TENDYNE EARLY FEASIBILITY TRIAL OF TRANSCATHETER MITRAL VALVE IMPLANTATION

Severe mitral regurgitation (MR) is associated with a high morbidity and a 5yr mortality >50%. Options for high surgical risk patients are limited. Transcatheter mitral valve implantation (TMVI) is a promising new approach for these patients. To evaluate the safety and efficacy of Tendyne TMVI in

New expandable mitral annuloplasty ring facilitates transcatheter mitral valve implantation: proof of concept.

Transcatheter mitral valve-in-ring (TMVIR) implantation with transcatheter heart valve (THV) prostheses can be performed in patients with recurrent mitral regurgitation (MR) following annuloplasty. However, an oval configuration and sometimes the rigidity of surgical rings can often lead to suboptimal THV expansion, resulting in considerable paravalvular or central leakage. Therefore, our aim was to develop an annuloplasty ring that fully adjusts to THV implantation. A three-dimensional annuloplasty ring was separated into four pieces at defined locations, the sections were reconnected with heat-shrinkable tubing and rearranged into the original shape. A non-tear stainless steel circular cord of defined length was inserted into the ring's sewing cuff to serve as a limiting structure for THV expansion. We implanted this ring in the mitral position into an isolated pig heart, deployed a THV into the ring, and investigated its function. Fluoroscopy showed that, upon THV deployment, the four breaking points of the ring separated as expected, and the ring expanded in a circular fashion to full expansion of the limiting cord. It securely anchored the THV to the ring, leaving no paravalvular gaps. We developed an expandable mitral ring to which the THV attached without leakage. This may impact on the future design of annuloplasty rings. Further studies should evaluate the safety of increasing the perimeter of a mitral ring and its durability.

Predicting LVOT Obstruction in Transcatheter Mitral Valve Implantation: Concept of the Neo-LVOT

Outflow tract obstruction is a feared and potentially lethal complication of transcatheter mitral valve replacement (TMVR), mitral valve-in-valve (ViV), and valve-in-ring (ViR) procedures as well as implantation of transcatheter heart valves in calcific mitral valve disease. These procedures