Vinayak Bapat

Early Experience With New Transcatheter Mitral Valve Replacement

BACKGROUNDnTranscatheter mitral valve replacement (TMVR) is a potential therapy for patients with symptomatic, severe mitral regurgitation (MR). The feasibility of this therapy remains to be defined.nnnOBJECTIVESnThe authors report their early experience with TMVR using a new valve system.nnnMETHODSnThe valve is a self-expanding, nitinol valve with bovine pericardial leaflets that is placed using a transapical delivery system. Patients with symptomatic MR who were deemed high or extreme risk by the local heart teams were enrolled in a global pilot study at 14 sites (United States, Australia, and Europe).nnnRESULTSnFifty consecutively enrolled patients (mean age: 73 ± 9 years; 58.0% men; 84% secondary MR) underwent TMVR with the valve. The mean Society for Thoracic Surgery score was 6.4 ± 5.5%; 86% of patients were New York Heart Association functional class III or IV, and the mean left ventricular ejection fraction was 43 ± 12%. Device implant was successful in 48 patients with a median deployment time of 14xa0min (interquartile range: 12 to 17 min). The 30-day mortality was 14%, with no disabling strokes, or repeat interventions. Median follow-up was 173xa0days (interquartile range: 54 to 342xa0days). At latest follow-up, echocardiography confirmed mild or no residual MR in all patients who received implants. Improvements in symptom class (79% in New York Heart Association functional class I or II at follow-up; pxa0<xa00.0001 vs. baseline) and Minnesota Heart Failure Questionnaire scores (56.2 ± 26.8 vs. 31.7 ± 22.1; pxa0=xa00.011) were observed.nnnCONCLUSIONSnTMVR with the valve was feasible in a study group at high or extreme risk for conventional mitral valve replacement. These results inform trial design of TMVR in lower-risk patients with severe mitral valve regurgitation (Evaluation of the Safety and Performance of the Twelve Intrepid Transcatheter Mitral Valve Replacement System inxa0Highxa0Risk Patients with Severe, Symptomatic Mitral Regurgitation - The Twelve Intrepid TMVR Pilot Study; NCT02322840).

Transatrial implantation of a transcatheter heart valve for severe mitral annular calcification

Objective: To assess the outcomes of transatrial implantation of a transcatheter heart valve (THV) for the treatment of mitral valve disease with severe mitral annular calcification (MAC). Methods: Implantation of a balloon‐expandable THV was performed on cardiopulmonary bypass via left atrial exposure in patients considered at risk for left ventricular outflow tract obstruction. The anterior mitral valve leaflet was systematically resected and pledgeted sutures were placed to enhance stability and reduce paravalvular leak. Results: Twenty‐six consecutive symptomatic patients with severe MAC (mean age, 78 ± 7 years; 92% female; mean Society of Thoracic Surgeons score, 9.4 ± 4.8) were included at 6 different centers. Two patients (8%) received an Edwards Sapien XT (Edwards Lifesciences, Irvine, Calif), and 24 (92%) an Edwards Sapien 3 bioprosthesis (Edwards Lifesciences). Concomitant aortic valve replacement was performed in 11 patients. Technical success according to the criteria of the Mitral Valve Academic Research Consortium was achieved in all patients. The mean transmitral gradient decreased from 10 ± 5 to 4 ± 2 mm Hg (P < .001) with trace or mild regurgitation in all patients. An elevated mean transaortic gradient (30 mm Hg) was observed in 1 patient (4%). Five patients died during hospital stay (19%) and 2 additional between discharge and 30 days (30‐day mortality: 27%). Sustained functional improvement was observed in the remaining patients. Conclusions: Transatrial implantation of a THV for the treatment of MAC is associated with high technical success despite unfavorable anatomy. In this early experience of very high surgical risk patients, 30‐day all‐cause mortality was high. Patients at particular risk appear to be those with chronic kidney disease requiring multiple valve surgery.

Commissural Alignment of Bioprosthetic Aortic Valve and Native Aortic Valve Following Surgical and Transcatheter Aortic Valve Replacement and its Impact on Valvular Function and Coronary Filling

OBJECTIVESnThe aim of this study was to assess the commissural alignment between bioprosthetic and native aortic valve leaflets following surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR) and to investigate its impact on valvular function and coronary filling.nnnBACKGROUNDnExpansion and geometry have been shown to affect leaflets of implanted transcatheter aortic bioprosthesis, but commissural alignment has not been studied.nnnMETHODSnPre- and post-procedural multidetector computed tomography (MDCT) of 28 SAVR patients and 212 TAVR patients were analyzed. Commissural alignment between the bioprosthetic (post) and native (pre) aortic valves was categorized as aligned (0° to 15° angle deviation) or as mild (15° to 30°), moderate (30° to 45°), or severe (45° to 60°) commissural misalignment (CMA).nnnRESULTSnWith SAVR, 27 of 28 cases (96%) were aligned and 1 had mild CMA. For all types of transcatheter heart valves (THVs), there was random valve implantation with regard to commissural alignment: 22% of THVs were aligned, 25% had mild CMA, 22% had moderate CMA, and 31% had severe CMA. The degree of commissural alignment was not associated with a difference in transvalvular gradient, paravalvular aortic regurgitation, or simulated coronary filling. However, there was a significantly higher rate of mild central aortic regurgitation in those THVs with moderate or greater CMA compared with those THV with mild or less CMA (7.8% vs. 1.1%; pxa0= 0.03).nnnCONCLUSIONSnCommissural alignment is excellent in case of SAVR but random in case of TAVR. There is no association between CMA and transvalvular gradient or coronary filling; however, there is a significantly higher rate of mild central aortic regurgitation in case of moderate or greater CMA.

Round and Round the Mitral Valve We Go: The Quest for Effective Transcatheter Mitral Valve Repair

Mitral regurgitation (MR) is the most prevalent valvular heart disease in the western world and is estimated to occur in up to 10% of the population older than 75 years of age. Although surgery is the gold standard therapy for severe MR, approximately 50% of patients do not undergo surgery for a variety of reasons, including high perceived surgical risk. The MitraClip (Abbott, Illinois, USA) was recently approved in the United States for transcatheter treatment of primary MR in patients with prohibitive surgical risk, but anatomical restrictions and concerns regarding efficacy in surgical candidates limit its utility. Optimal medical therapy therefore remains the only treatment option for many patients. With the success of transcatheter aortic valve replacement (TAVR) in offering a less invasive therapy to a broad and increasing population of patients with aortic stenosis, substantial interest has focused on achieving a more ideal transcatheter solution for MR. The mitral valve and associated pathologies are, however, much more complex and this has proven to be a formidable challenge. The complexity of this challenge is related to the diverse etiology, pathophysiology, and anatomical variation of MR. MR can be broadly categorized as being primary (degenerative) or secondary (functional). PrimaryMR results from abnormalities of the leaflets, chordae or papillary muscles, while secondary MR is generally due to diseases of the ventricle that result in tethering of the leaflets. Morphologically, the variation in MR is substantial, unlike in aortic stenosis where variability only arises from the degree of calcification or number of leaflets. For example, leaflet morphology can vary fromnormal leaflets in secondaryMR to the bulky, redundant leaflets observed in Barlow’s disease. Significant variability can exist even within a single disease state; mitral valve prolapse varies from a simple ruptured chord resulting in a localized leaflet prolapse to complex chordal pathology resulting in bileaflet prolapse. The degree, location, and morphology of calcification in the mitral valve apparatus also varies widely. Finally, mitral annular dilatation is common and highly variable. These complex variations cannot be addressed by a single technique even during open mitral surgery. Surgical solutions for MR include both mitral valve repair and replacement. In Primary MR, repair is clearly preferred over replacement, but in secondary MR, replacement may be preferred. This is dependent, however, on the specific anatomy and pathophysiology, the risk profile of the patient, and the skill level of the surgeon. Once selected, surgical mitral repair techniques are varied and range from a simple leaflet resection to sliding annuloplasty and implantation of artificial chordae. Although annuloplasty is almost always performed to increase the durability of a repair, there is no consensus as to which type of ring should be used (rigid, semi-rigid or flexible and complete or incomplete). This lack of clarity is reflected in the fact that more than 20 different types of rings have been used in contemporary practice. The broad array of surgical techniques and tools currently utilized demonstrates the likelihood that no one transcatheter technique will be sufficient. Rather, a “tool box” of different solutions will be required for transcatheter mitral valve therapy to be a viable alternative. This is reflected in the numerous transcatheter therapies for MR that are currently in development, including options for both transcatheter mitral valve replacement (TMVR) and repair (TMVr). TMVR offers the promise of near complete elimination of MR, but the initial clinical experience has been mixed. Several devices have demonstrated potential efficacy, but challenges have emerged with respect to safety, particularly related to the risk of left ventricular outflow obstruction and the feasibility of the transvenous transseptal approach. TMVr approaches, on the other hand, have tended to have a better safety profile, but somewhat limited efficacy; the majority of current devices appear to result in a reduction rather than elimination of MR. The MitraClip device, which mimics a surgical Alfieri stitch, remains the only approved option in the United States, but is limited to patients with prohibitive surgical risk due to inferior efficacy compared to surgical repair in the only large-scale randomized trial. Other TMVr approaches being investigated include strategies for leaflet modification, chordae replacement, and annular reduction. Similar to annuloplasty as a surgical strategy, annular reduction may be an independent treatment for secondary MR and may improve the efficacy of TMVr in Primary MR when added to another strategy. In the current edition of Structural Heart, Rogers and colleagues describe the initial experience with the IRIS ring (Millipede, Inc.), a novel transcatheter mitral valve repair (TMVr) device. This device consists of an adjustable, complete, semi-rigid ring that can potentially be used to perform both mitral and tricuspid annuloplasty. In the first phase of

Transatrial Implantation of the Sapien 3 Heart Valve in Severe Mitral Annular Calcification: Multi-Clinic Experience, Written and Video Description

ABSTRACT There is growing interest in using transcatheter valve therapy to address mitral valve disease in the setting of severe mitral annular calcification (MAC). Using the Sapien XT or Sapien 3 transcatheter heart valve has produced promising results when implanted from a percutaneous transseptal approach and from a surgical transatrial approach. However, there is lack of technical support for these cases from the transatrial side. Our group has a large experience using the Sapien valve for this purpose and have used a specific technique with excellent results. Here we present a step-by-step presentation of the technique in video detail.

Mitral Valve Catheter-Based Interventions: Auxiliary Techniques and Work in Progress

Mitral valve disease is the one of the most common of the valvular heart disorders, particularly in aging populations, with a prevalence of more than 10% in people aged more than 75 years [1]. Heart failure is one of the most frequent causes of functional mitral valve regurgitation (MR) [2]. Enriquez-Sarano and colleagues estimated that moderate to severe mitral regurgitation will double its prevalence by 2030, affecting more than 4 million people [1, 3]. Interestingly, MR is the second most common valve disease requiring surgery in Europe as most of the patients are managed conservatively [3]. MR is divided into either primary (a structural or degenerative abnormality of the mitral valve apparatus) or secondary (a disease of the left ventricle (LV) that interferes with the function and integrity of the mitral valve apparatus) MR [1, 3]. Mitral stenosis is usually due to rheumatic disease, but heavy calcification of the mitral leaflets might involve the subvalvar apparatus [1, 4].

Outcomes of transcatheter mitral valve replacement for degenerated bioprostheses, failed annuloplasty rings, and mitral annular calcification

AimsnWe sought to evaluate the outcomes of transcatheter mitral valve replacement (TMVR) for patients with degenerated bioprostheses [valve-in-valve (ViV)], failed annuloplasty rings [valve-in-ring (ViR)], and severe mitral annular calcification [valve-in-mitral annular calcification (ViMAC)].nnnMethods and resultsnFrom the TMVR multicentre registry, procedural and clinical outcomes of ViV, ViR, and ViMAC were compared according to Mitral Valve Academic Research Consortium (MVARC) criteria. A total of 521 patients with mean Society of Thoracic Surgeons score of 9.0u2009±u20097.0% underwent TMVR (322 patients with ViV, 141 with ViR, and 58 with ViMAC). Trans-septal access and the Sapien valves were used in 39.5% and 90.0%, respectively. Overall technical success was excellent at 87.1%. However, left ventricular outflow tract obstruction occurred more frequently after ViMAC compared with ViR and ViV (39.7% vs. 5.0% vs. 2.2%; Pu2009<u20090.001), whereas second valve implantation was more frequent in ViR compared with ViMAC and ViV (12.1% vs. 5.2% vs. 2.5%; Pu2009<u20090.001). Accordingly, technical success rate was higher after ViV compared with ViR and ViMAC (94.4% vs. 80.9% vs. 62.1%; Pu2009<u20090.001). Compared with ViMAC and ViV groups, ViR group had more frequent post-procedural mitral regurgitation ≥moderate (18.4% vs. 13.8% vs. 5.6%; Pu2009<u20090.001) and subsequent paravalvular leak closure (7.8% vs. 0.0% vs. 2.2%; Pu2009=u20090.006). All-cause mortality was higher after ViMAC compared with ViR and ViV at 30u2009days (34.5% vs. 9.9% vs. 6.2%; log-rank Pu2009<u20090.001) and 1u2009year (62.8% vs. 30.6% vs. 14.0%; log-rank Pu2009<u20090.001). On multivariable analysis, patients with failed annuloplasty rings and severe MAC were at increased risk of mortality after TMVR [ViR vs. ViV, hazard ratio (HR) 1.99, 95% confidence interval (CI) 1.27-3.12; Pu2009=u20090.003; ViMAC vs. ViV, HR 5.29, 95% CI 3.29-8.51; Pu2009<u20090.001].nnnConclusionnThe TMVR provided excellent outcomes for patients with degenerated bioprostheses despite high surgical risk. However, ViR and ViMAC were associated with higher rates of adverse events and mid-term mortality compared with ViV.

Letter by Tang et al Regarding Article, “The Fluid Mechanics of Transcatheter Heart Valve Leaflet Thrombosis in the Neosinus”

We read with great interest the article by Midha and colleagues1 on thrombus formation in the neosinus after transcatheter aortic valve replacement. The authors reported that thrombus formation was associated with a nominal or overexpanded Sapien 3 (S3) valve (Edwards Lifesciences LLC, Irvine, CA) and deeper implantation of the CoreValve (Medtronic Inc, Galway, Ireland). They also reported that intraannular or subannular leaflet position and reduced cardiac output increased stasis in the neosinus and native sinuses. We have 3 questions for the authors. First, the mean expansion of S3 by diameter in the thrombus group was 95.2±5.2%, which was similar to that reported by the same group using the RESOLVE registry …