Transcatheter Mitral Interventions Research Articles

Surgical outcomes of patients at prohibitive risk who are reconsidered for surgery

ObjectivesTranscatheter treatment of advanced mitral and tricuspid valve disease is largely limited to patients at prohibitive surgical risk, although many are not candidates for transcatheter treatment. Here, we describe surgical outcomes of patients at prohibitive risk who were ineligible for transcatheter therapies to guide surgeons in management of this unique population. MethodsPatients at prohibitive risk, defined per surgeon or cardiologist discretion, who were initially referred for a transcatheter mitral or tricuspid intervention in a multidisciplinary atrioventricular valve clinic, were identified from 2019 to 2022. Preoperative risk, operative outcomes, and long-term mortality were evaluated. ResultsA total of 337 patients at prohibitive risk were referred for evaluation in a multidisciplinary atrioventricular valve clinic. Of those, 161 underwent transcatheter therapy, 130 patients underwent continued medical management, and 45 were reevaluated and had high-risk surgery. Among surgical patients, 51% were women with a median age of 76 years (quartile 1-quartile 3, 65-81 years). Most patients presented in heart failure (83%; n = 37 out of 45), and 73% were in New York Heart Association functional class III or IV. Most patients (94%; n = 43) had a mitral valve intervention, of whom 56% (24 out of 43) had a mitral valve replacement. The 30-day mortality rate was 4% (2 out of 45) and major morbidity occurred in 33% (15 out of 45). By Kaplan-Meier analysis, 1-year survival was 86% ± 9%. ConclusionsSelect patients at prohibitive risk who were ineligible for transcatheter mitral or tricuspid valve intervention underwent surgery with overall low operative mortality and excellent 1-year survival. Patients a prohibitive risk whose anatomy is not amenable to transcatheter devices should be reconsidered for surgery.

Quantification of mitral regurgitation after transcatheter edge-to-edge repair: Comparison of echocardiography and patient-specific in silico models

BackgroundDoppler echocardiographic (echo) assessment of residual mitral regurgitation (MR) after transcatheter edge-to-edge repair (TEER) is challenging and often subjective. This study aimed to evaluate the accuracy and feasibility of standardized quantitative echo methods for assessment of MR severity after MitraClip repair by comparing measurements against a reference MR severity obtained from patient-specific in silico models. MethodsPost-procedure hemodynamics were simulated under five different MitraClip configurations in previously validated patient-specific in silico models for the treatment of functional MR. The residual regurgitant volume was calculated as in clinical practice using four quantitative virtual echo methods: pulsed Doppler, volumetric, proximal isovelocity surface area (PISA) and vena contracta area (VCA). Multiple permutations were performed for each method. Virtual echo MR results were evaluated against reference MR values directly extracted from the 5 patient-specific in silico models. ResultsThe echo methods with the greatest accuracy were the three-dimensional (3D) volumetric method (r = 0.957, bias −0.8 ± 1.2 ml, p = 0.01), the 3D VCA method wherein velocity time integrals were evaluated for each jet assessed (r = 0.919, bias −1.5 ± 1.7 ml, p = 0.03), and the 3D PISA method integrating surface areas throughout systole (r = 0.98, bias −2.0 ± 0.9 ml, p = 0.003). The pulsed Doppler and 2D volumetric methods had technical limitations that may result in a high underestimation or overestimation of the MR severity after TEER. In the case of multiple regurgitant jets, a more accurate MR assessment was obtained when all significant jets were evaluated. ConclusionsClinically, the 3D volumetric, 3D VCA and 3D PISA methods gave the most accurate MR quantification after TEER. Three-dimensional echo technologies harbor the potential of becoming the non-invasive imaging tool of choice for MR quantification after complex transcatheter mitral interventions.

Transcatheter Mitral Intervention Relieves Dynamic Outflow Obstruction and Reduces Cardiac Workload in Hypertrophic Cardiomyopathy.

Transcatheter Mitral Intervention Relieves Dynamic Outflow Obstruction and Reduces Cardiac Workload in Hypertrophic Cardiomyopathy.

Effect of Transcatheter Aortic Valve Replacement on Concomitant Mitral Regurgitation andItsImpact on Mortality.

The purpose of this study was to examine the impact of residual mitral regurgitation (MR) on mortality in patients undergoing transcatheter aortic valve replacement (TAVR). MR is common in patients undergoing TAVR. Data on optimal management of patients with significant MR after TAVR are limited. The registry consisted of 16 TAVR centers (n=7,303). Outcomes of patients with≥ moderate versus lesser grade MR after TAVR were compared. In 1,983 (27.2%) patients, baseline MR grade was≥ moderate. MR regressed in 874 (44.1%) patients and persisted in 1,109 (55.9%) after TAVR. Four-year mortality was higher for those with MR persistence, but not for those with MR regression after TAVR, compared with nonsignificant baseline MR (43.8% vs. 35.1% vs. 32.4%; hazard ratio [HR]: 1.38; p=0.008; HR: 1.02; p=0.383, respectively). New York Heart Association functional class III to IV after TAVR was more common in those with MR persistence vs. regression (14.4% vs. 3.9%; p<0.001). In a propensity score-matched cohort (91 patients' pairs), with significant residual MR after TAVR who did or did not undergo staged mitral intervention, staged intervention was associated with a better functional class through 1 year of follow-up (82.4% vs. 33.3% New York Heart Association functional class I or II; p<0.001), and a numerically lower 4-year mortality, which was not statistically significant (64.6% vs. 37.5%; HR: 1.66; p=0.097). Risk stratification based on improvement in MR and symptoms after TAVR can identify patients at increased mortality risk after TAVR. These patients may benefit from a staged transcatheter mitral intervention, but this requires further proof from future studies. (Transcatheter Treatment for Combined Aortic and Mitral Valve Disease. The Aortic+Mitral TRAnsCatheter [AMTRAC] Valve Registry [AMTRAC]; NCT04031274).

Multimodality Imaging in Transcatheter Mitral Interventions.

Multimodality imaging is of imperative value for the planning and guidance of transcatheter mitral valve interventions. This review employs the value of different imaging modalities and future implications for clinical practice.

Fusion imaging for transcatheter mitral and tricuspid interventions.

Image guidance for transcatheter mitral and tricuspid valve intervention commonly utilizes the unique advantages of both fluoroscopy and live echocardiography. In some cases, pre-procedural computed tomography is also needed. Classically, they are displayed separately even if modalities are in simultaneous use. This requires procedural operators to watch separate images displaying complementary information and mentally combine these data sources. New hybrid, or fusion, imaging systems allow for multiple imaging modalities to be overlaid on one another to provide the most relevant information on a single screen. While this technological advancement may have some advantages in certain procedures, more data is needed to understand if these systems will improve procedural or clinical outcomes.

Transcatheter Mitral Valve Implantation with the Medtronic Intrepid™ Transcatheter Mitral Valve Replacement System.

Mitral regurgitation is the most prevalent yet undertreated valvulopathy despite its adverse prognosis. With the emergence of transcatheter mitral interventions, the potential for this huge unmet disease burden to be addressed may finally be realized. Medtronic Intrepid™ Transcatheter Mitral Valve Replacement System represents one of several novel solutions. Based on early data from the pilot study, its efficacy and clinical utility is currently being tested against the mainstay treatment of surgical mitral valve replacement in a randomized trial. While there remain significant challenges before transcatheter mitral intervention can become part of the routine treatment algorithm, the authors are optimistic that transcatheter mitral valve repair and intervention have the potential in revolutionizing the management of severe symptomatic mitral regurgitation.

Fluoroscopic Overlay of Landmarks from Pre-procedural CT Images after 2D3D Image Fusion to Optimize Trans-septal Access During Percutaneous Mitral Interventions

ABSTRACT Background: Recent evolution of transcatheter mitral devices and interventions has mandated the need for further optimizing trans-septal access technique with respect to its precise location and distance from the mitral valve annulus. Methods: Based on the individual procedural context, “ideal” trans-septal access site was planned in multi-slice CT images. In addition, relevant landmarks such as mitral annulus, para-valvular leak site, left atrial appendage (LAA) ostium were electronically marked. CT-fluoroscopy image fusion was performed using a commercially available software after acquiring two fluoroscopic images at-least 30° apart. Manual refinement of image fusion was performed by aligning structures such as a prosthetic valve or mitral annular calcification, when necessary. Results: Between June and October 2016, a total of five procedures (n = 3 Mitral paravalvular leak, n = 2 Mitraclip®) were performed in four patients using trans-esophageal echocardiography (TEE) and CT image fusion guidance. Fluoroscopic overlay of landmarks including the optimal trans-septal puncture site from pre-procedural CT images was feasible in all five procedures. Median time for CT-fluoroscopy image fusion was 4:08 minutes. Median time for left atrial access was 7:00 minutes. Median (range) fluoroscopy time and total procedural dose-area-product were 29.9 minutes (15.1–77.5) and 16,638 microGy-m2 (9464–18,990) respectively. Conclusion: In addition to real-time TEE imaging, pre-procedural CT planning, image fusion and overlay of relevant landmarks enhances 2D fluoroscopy and provided additional 3D image guidance. Seamless integration of such multi-modality image information can help further optimize steps such as trans-septal access for complex mitral interventions.

TCT-799 The importance of emerging transcatheter mitral valve technologies in cost-effectiveness and post-procedure outcomes

Mitral intervention has historically been open surgical and has been limited to a small subset of patients who could tolerate surgery and where there was perceived clinical benefit. With the emergence of transcatheter mitral interventions, we sought to compare the types of patients undergoing

Mitral Valve Interventions in Structural Heart Disease.

Analyze the current state of the art and the future perspectives of mitral interventions in clinical setting. A systematic and critical review of the new mitral percutaneous therapies and imaging technologies is the basis to adopt the right treatment for each patient according to specific valve dysfunction and clinical presentation, waiting for definitive guidelines. While surgical mitral repair will remain the gold standard for low-risk healthy patients with degenerative mitral regurgitation (DMR), transcatheter mitral valve repair is becoming first line therapy in high risk patients with functional mitral regurgitation (FMR). The introduction of transcatheter mitral valve replacement will expand indications for advanced DMR and FMR in inoperable patients. The introduction of transcatheter mitral interventions is changing the mitral therapy scenario. Mitral interventionalists might evolve into hybrid professional figures able to offer a tailored approach for each patient, including surgical and percutaneous approaches, depending on the anatomo-functional status of the valve, to clinical conditions, and to the timing of the intervention.

Role of MDCT Imaging in Planning Mitral Valve Intervention.

Recent advancements in transcatheter valvular interventions have resulted in a growing demand for advanced cardiac imaging to help guide these procedures. Both echocardiography and multi-detector computed tomography have played essential roles in the maturation of transcatheter aortic valve replacement and are now building on these experiences and helping inform the nascent field of transcatheter mitral interventions. Advanced imaging is essential to aid in the diagnosis and determination of the mechanism of mitral regurgitation. In addition, they are integral to annular sizing, determination of the suitability of patient anatomy for specific devices and increasingly important in the determination of the risk of left ventricular outflow tract obstruction and providing appropriate patient-specific fluoroscopic angulation in advance of the procedure.

Thrombotic valvular dysfunction with transcatheter mitral interventions for postsurgical failures.

Degenerated surgical mitral valve repairs or surgical prostheses are currently being treated with transcatheter mitral valve replacement (TMVR). We report the procedural and mid-term assessment of thirteen cases. From 12/2013 to 12/2015, 13 consecutive patients with degenerated mitral valve repair or valve replacement were treated. Patients were assessed for mitral valve academic valve consortium (MVARC) defined outcomes. Immediate procedural MVARC defined technical success was 92%. At 30days MVARC device and procedure success were 61% and 84%, respectively. Mean follow-up was 150days [IQR 40-123days]. There were 2 late major adverse outcomes, a noncardiac related death (628days) and a stroke (382days). The mean mitral gradient decreased from 9.5±3.4 to 5.5±2.6mmHg (P<0.01). Three patients were found to have high gradients, two presented with heart failure while another patient was found to have reduced leaflet motion and abnormal thickening postprocedure. The two patients with heart failure were treated with enoxaparin, which caused subsequent resolution of increased valve gradients in one patient. The other patient could not tolerate prolonged treatment from anticoagulation due to gastrointestinal bleeding. Three of 13 patients were treated with dual-antiplatelet therapy and were suspected to have valve thrombosis. Thrombotic related dysfunction post-TMVR occurred in 15% (2/13) of patients and one patient had abnormal leaflet thickening that may have been thrombus related. Dual-antiplatelet therapy was used in all 3 cases suggesting the possible need for oral anticoagulation postmitral valve-in-valve therapy. © 2017 Wiley Periodicals, Inc.

Computed tomography optimised fluoroscopy guidance for transcatheter mitral therapies.

Our aim was to illustrate the pragmatic use of pre-procedural multislice computed tomography (MSCT) to facilitate fluoroscopy guidance of transcatheter mitral valve interventions. A dedicated software package (3mensio Structural Heart) is used to analyse MSCT studies and localise anatomical entities by fluoroscopy which would otherwise be invisible (e.g., interatrial septum, paravalvular leaks, mitral leaflets), and to provide optimal C-arm gantry angles to facilitate crucial steps of catheter-based mitral interventions. For any given anatomical structure that has been identified by MSCT scan, a line of perpendicularity can be drawn representing an infinite combination of RAO-LAO with cranial-caudal angles. Safety and ergonomic considerations drive the selected angulation to be used in the cathlab. The location of the fossa ovalis can be projected onto the fluoroscopy screen to help direct the needle for transseptal puncture. For MitraClip implantations a C-arm gantry projection that is either coaxial or perpendicular to the mitral coaptation plane helps to orientate the clip before entering the left ventricle to grasp the mitral leaflets. A periprosthetic mitral leak can be localised relative to the prosthesis in the proposed C-arm angle. Pre-procedural MSCT is thus complementary to transoesophageal echocardiography for transcatheter mitral interventions. Determination of optimal C-arm angulations helps localise anatomical entities by fluoro-scopy and may expedite complex mitral interventions.

Measuring risk in valvular interventions: from low risk to futility.

Current risk scores are based on cardiac surgical procedures and therefore have limited application in transcatheter aortic or mitral interventions. Their ability to predict outcome in high-risk patients remains poor and the question of utility or futility of an intervention can only be decided by a team of physicians with diverse expertise.

Mitral valve disease, atrial fibrillation, and device therapy

Download the Issue @ a Glance podcast Subscribe to the EHJ Podcast ![Graphic][1] Transcatheter mitral interventions have been developed to address an unmet need, and as alternatives to surgery in patients at high risk or considered inoperable.1,2 Beyond MitraClip therapy, alternative repair technologies are being developed to expand the armamentarium of transcatheter intervention. Recently, the feasibility of transcatheter mitral valve implantation in native non-calcified valves was reported in patients at very high operative risk. These issues are critically discussed in a timely Clinical Review article entitled ‘ The future of transcatheter mitral valve interventions: competitive or complementary role of repair vs replacement? ’ by Francesco Maisano from the University Hospital Zurich in Switzerland.3 The authors review the current state-of-the-art of mitral valve intervention, and identify potential future scenarios that might benefit most from the transcatheter repair and replacement devices under development. He also acknowledges the small body of scientific evidence4,5 on hard outcomes during long-term follow-up of these novel procedures. Atrial tachyarrhythmias are often associated with mitral valve disease, but are also frequent in elderly patients without it. As both arrhythmias are associated with a risk of stroke, anticoagulation is considered mandatory in those with a high CHA2DS2VASC score.6,7 In the first research paper entitled ‘ Randomized trial of atrial arrhythmia monitoring to guide anticoagulation in patients with implanted defibrillator and cardiac resynchronization devices ’, Jonathan L. Halperin from Mount Sinai School of Medicine in New York8 hypothesized that the introduction and termination of anticoagulation based upon arrhythmia monitoring would reduce both stroke … [1]: /embed/inline-graphic-1.gif

The future of transcatheter mitral valve interventions: competitive or complementary role of repair vs. replacement?

Transcatheter mitral interventions has been developed to address an unmet clinical need and may be an alternative therapeutic option to surgery with the intent to provide symptomatic and prognostic benefit. Beyond MitraClip therapy, alternative repair technologies are being developed to expand the transcatheter intervention armamentarium. Recently, the feasibility of transcatheter mitral valve implantation in native non-calcified valves has been reported in very high-risk patients. Acknowledging the lack of scientific evidence to date, it is difficult to predict what the ultimate future role of transcatheter mitral valve interventions will be. The purpose of the present report is to review the current state-of-the-art of mitral valve intervention, and to identify the potential future scenarios, which might benefit most from the transcatheter repair and replacement devices under development.

Comparison of Outcomes of Percutaneous MitraClip Versus Surgical Repair or Replacement for Degenerative Mitral Regurgitation in Octogenarians

Octogenarians affected by mitral regurgitation (MR) are an increasing high-risk population. MitraClip repair is emerging as a promising option for this kind of patients. In this retrospective study, the outcomes of patients aged ≥80 years, affected by isolated degenerative MR, who underwent isolated transcatheter (n = 25) or surgical (n = 35, 29 repairs and 6 replacements) mitral intervention from September 2008 to February 2014 were compared. MitraClip patients had higher mean age (84.5 ± 3.2 vs 81.9 ± 2.0 years, p <0.01), median Logistic Euroscore 19.4 (11.1 to 29.0) versus 8.4 (7.0 to 10.1) (p <0.01), median Society of Thoracic Surgeons predicted mortality 5.3 (3.5 to 6.6) versus 2.7 (2.3 to 3.9) (p <0.01), and more advanced New York Heart Association class (III to IV in 68% vs 37%, p = 0.02). At 30 days, 1 death occurred in the MitraClip group (p = 0.2). MitraClip was associated with significantly less complications (p <0.05) but more residual MR >2 (p <0.01). Two-year actuarial survival rate was 90% for MitraClip versus 97% for surgery (p <0.01). Higher Society of Thoracic Surgeons mortality was associated with reduced follow-up survival rate (p = 0.01). Two-year actuarial freedom from MR >2 was 70% versus 100%, respectively (p <0.01). New York Heart Association class and quality of life improved after MitraClip and were similar to surgical patients. Recurrent MR >2 was not significantly associated with follow-up mortality in this elderly setting. After the introduction of MitraClip, octogenarian patients with isolated degenerative MR receiving mitral treatment significantly increased (p <0.01). In conclusion, MitraClip patients, despite being older, more symptomatic, and affected by more co-morbidities showed significantly reduced postoperative complications. Two-year mortality was higher in the MitraClip group likely because of co-morbidities. Transcatheter mitral repair resulted in more octogenarians being treated compared with the past.

Recommendations for transoesophageal echocardiography: EACVI update 2014

With this document, we update the recommendations for transoesophageal echocardiography (TOE) of the European Association of Cardiovascular Imaging. The document focusses on the areas of interventional TOE, in particular transcatheter aortic, mitral, and left atrial appendage interventions, as well as on the role of TOE in infective endocarditis, adult congenital heart disease, and aortic disease.

Incidental Moderate Mitral Regurgitation in Patients Undergoing Aortic Valve Replacement for Aortic Stenosis: Review of Guidelines and Current Evidence

Recent evidence has shown that moderate mitral regurgitation is common and clinically relevant in patients presenting for surgical and transcatheter aortic valve replacement for aortic stenosis. Prospective multicenter clinical trials are now indicated to resolve the clinical equipoise about whether or not mitral valve intervention also is indicated at the time of aortic valve intervention. Advances in three-dimensional transesophageal echocardiography, transcatheter mitral interventions, and surgical aortic valve replacement, including the advent of sutureless valves, likely will expand the therapeutic possibilities for moderate mitral regurgitation in the setting of aortic valve interventions for severe aortic stenosis.

Aortic stenosis and mitral regurgitation: implications for transcatheter valve treatment

Moderate or severe mitral regurgitation (MR) is a common finding in patients with severe aortic stenosis (AS). The combination may be a relative indication for double valve surgery, particularly when MR is severe, degenerative, associated with left atrial dilation, chronic atrial fibrillation, or mitral annular calcium. However, in patients for whom open surgery is not desirable, TAVI may provide a reasonable therapeutic strategy with an expectation in selected patients that MR may improve, be better tolerated, or be amenable to staged transcatheter mitral interventions. In this paper, we briefly review the surgical experience with concomitant AS and MR and discuss the potential implications of transcatheter-based heart valve techniques in this patient group.