A novel method of prosthetic leaflet modification to enable transcatheter mitral valve-in-valve replacement.

Left ventricular outflow tract (LVOT) obstruction from the displaced prosthetic anterior mitral leaflet is a life-threatening complication that can occur during valve-in-valve (ViV) transcatheter mitral valve replacement (TMVR). Laceration of the anterior mitral leaflet to prevent outflow obstruction is a well-established transcatheter technique to mitigate the risk of LVOT obstruction in high-risk anatomies. In this report, we present a novel transseptal technique of prosthetic leaflet modification to prevent LVOT obstruction during ViV TMVR.

Role of Cardiac Computed Tomography in Planning Transcatheter Mitral Valve Replacement (TMVR).

PURPOSE OF REVIEW: Transcatheter mitral valve replacement (TMVR) is an evolving and rapidly expanding field within structural interventions, offering renewed treatment options for patients with high-risk mitral valve disease. We aim to highlight and illustrate the importance of cardiac CT in the planning of TMVR. RECENT FINDINGS: As TMVR has evolved, so has the specific nuances of cardiac CT planning, we now understand the importance of accurate annular sizing and valve simulation to predict complications such as neo-LVOT obstruction and paravalvular leak (PVL). More so than any other modality, cardiac CT remains instrumental in accurately planning TVMR from feasibility, device sizing, access, and fluoroscopic angles. Cardiac CT remains the key modality in TMVR evaluation, often the first step in determining patient eligibility through comprehensive procedural planning as well as informing potential outcomes and prognosis. In this review, we discuss the critical role of cardiac computed tomography (CT) and the specific considerations involved in TMVR.

Advanced Echocardiographic Guidance for Transcatheter Tricuspid Edge-To-Edge Repair.

Echocardiography, in all its forms (transthoracic echocardiography [TTE], transesophageal echocardiography [TEE], and intracardiac echocardiography [ICE]), is pivotal for the evaluation, guidance, and follow-up of transcatheter tricuspid edge-to-edge repair (TV-TEER) therapies. Although two-dimensional (2D) echocardiography remains essential, three-dimensional (3D) echo with multiplanar reconstruction (MPR) has revolutionized the field of structural imaging. In addition, the advent of 3D ICE has added an important modality to the imaging toolbox, particularly helpful when intraprocedural TEE images are challenging. In this review, we provide a detailed, step-by-step approach for advanced echocardiographic guidance of TV-TEER using 3D MPR.

Echocardiographic Outcomes With Transcatheter Edge-to-Edge Repair for Degenerative Mitral Regurgitation in Prohibitive Surgical Risk Patients.

BACKGROUND: The CLASP IID randomized trial (Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial) demonstrated the safety and effectiveness of the PASCAL system for mitral transcatheter edge-to-edge repair (M-TEER) in patients at prohibitive surgical risk with significant symptomatic degenerative mitral regurgitation (DMR). OBJECTIVES: This study describes the echocardiographic methods and outcomes from the CLASP IID trial and analyzes baseline variables associated with residual mitral regurgitation (MR) ≤1+. METHODS: An independent echocardiographic core laboratory assessed echocardiographic parameters based on American Society of Echocardiography guidelines focusing on MR mechanism, severity, and feasibility of M-TEER. Factors associated with residual MR ≤1+ were identified using logistic regression. RESULTS: In 180 randomized patients, baseline echocardiographic parameters were well matched between the PASCAL (n = 117) and MitraClip (n = 63) groups, with flail leaflets present in 79.2% of patients. Baseline MR was 4+ in 76.4% and 3+ in 23.6% of patients. All patients achieved MR ≤2+ at discharge. The proportion of patients with MR ≤1+ was similar in both groups at discharge but diverged at 6 months, favoring PASCAL (83.7% vs 71.2%). Overall, patients with a smaller flail gap were significantly more likely to achieve MR ≤1+ at discharge (adjusted OR: 0.70; 95% CI: 0.50-0.99). Patients treated with PASCAL and those with a smaller flail gap were significantly more likely to sustain MR ≤1+ to 6 months (adjusted OR: 2.72 and 0.76; 95% CI: 1.08-6.89 and 0.60-0.98, respectively). CONCLUSIONS: The study used DMR-specific echocardiographic methodology for M-TEER reflecting current guidelines and advances in 3-dimensional echocardiography. Treatment with PASCAL and a smaller flail gap were significant factors in sustaining MR ≤1+ to 6 months. Results demonstrate that MR ≤1+ is an achievable benchmark for successful M-TEER. (Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial [CLASP IID]; NCT03706833).

Patient Selection for Mitral Transcatheter Edge-to-Edge Repair.

Mitral regurgitation (MR) is one of the most common valvular heart diseases, with many patients remaining non-suitable for surgical interventions. Transcatheter edge-to-edge repair (TEER) is a rapidly evolving procedure that allows safe and effective reduction of MR in high-risk patients. However, adequate patient selection through clinical assessment and imaging modalities remains a key factor for procedural success. In the following review, we highlight recent developments in TEER technologies that are expanding the target population and currently available imaging modalities that allow detailed evaluation of the mitral valve and surrounding structures for optimal patient selection.

The Added Value of Preprocedural Cardiac Computed Tomography in Planning Left Atrial Appendage Closure With the Watchman FLX Device.

•Cardiac computed tomography (CCT) can be used as a useful complementary tool in preprocedural planning of left atrial appendage closure.•CCT planning includes assessing exclusion criteria, device sizing, sheath selection, anticipating challenging anatomies, and transseptal puncture planning.•Procedural 3D intracardiac echocardiography (3D-ICE) is increasingly being used instead of transesophageal echocardiography. In this setting, preprocedural CCT is useful to compensate for 3D ICE's reduced resolution.

Ross procedure after prosthetic valve thrombosis in a patient with antiphospholipid syndrome and recurrent bleeding.

The Ross procedure allows replacement of a diseased aortic valve with pulmonary root autograft, possibly avoiding the highly thrombotic mechanical valves and immunologic deterioration of tissue valves in antiphospholipid syndrome (APS). Here, we present the use of the Ross procedure in a 42-year-old woman with mild intellectual disability, APS, and a complex anticoagulation history after she presented with thrombosis of her mechanical On-X aortic valve previously implanted for non-bacterial thrombotic endocarditis.

1-Year Outcomes of Transcatheter Tricuspid Valve Repair.

BACKGROUND: Surgical management of isolated tricuspid regurgitation (TR) is associated with high morbidity and mortality, thereby creating a significant need for a lower-risk transcatheter solution. OBJECTIVES: The single-arm, multicenter, prospective CLASP TR (Edwards PASCAL TrAnScatheter Valve RePair System in Tricuspid Regurgitation [CLASP TR] Early Feasibility Study) evaluated 1-year outcomes of the PASCAL transcatheter valve repair system (Edwards Lifesciences) to treat TR. METHODS: Study inclusion required a previous diagnosis of severe or greater TR and persistent symptoms despite medical treatment. An independent core laboratory evaluated echocardiographic results, and a clinical events committee adjudicated major adverse events. The study evaluated primary safety and performance outcomes, with echocardiographic, clinical, and functional endpoints. Study investigators report 1-year all-cause mortality and heart failure hospitalization rates. RESULTS: Sixty-five patients were enrolled: mean age of 77.4 years; 55.4% female; and 97.0% with severe to torrential TR. At 30 days, cardiovascular mortality was 3.1%, the stroke rate was 1.5%, and no device-related reinterventions were reported. Between 30 days and 1 year, there were an additional 3 cardiovascular deaths (4.8%), 2 strokes (3.2%), and 1 unplanned or emergency reintervention (1.6%). One-year postprocedure, TR severity significantly reduced (P < 0.001), with 31 of 36 (86.0%) patients achieving moderate or less TR; 100% had at least 1 TR grade reduction. Freedom from all-cause mortality and heart failure hospitalization by Kaplan-Meier analyses were 87.9% and 78.5%, respectively. Their New York Heart Association functional class significantly improved (P < 0.001) with 92% in class I or II, 6-minute walk distance increased by 94 m (P = 0.014), and overall Kansas City Cardiomyopathy Questionnaire scores improved by 18 points (P < 0.001). CONCLUSIONS: The PASCAL system demonstrated low complication and high survival rates, with significant and sustained improvements in TR, functional status, and quality of life at 1 year. (Edwards PASCAL TrAnScatheter Valve RePair System in Tricuspid Regurgitation [CLASP TR] Early Feasibility Study [CLASP TR EFS]; NCT03745313).

Postdischarge-to-30-Day Mortality Among Patients Receiving MitraClip: A Systematic Review and Meta-Analysis.

Background: MitraClip (MC) implantation is the recommended treatment for severe symptomatic mitral regurgitation in patients not responding to medical therapy and at prohibitive surgical risk. It is important to quantify immediate mortality during postdischarge-to-30-day period so as to improve the procedural outcomes. Hence, we aim to identify the incidence of postdischarge-to-30-day mortality and its associated predictors using the technique of meta-analysis. Methods: We searched Medline, Embase, and Cochrane CENTRAL databases from inception until July 3, 2019 for studies reporting mortality prior to discharge, at 30 days and 1 year after MC implantation. The primary outcome was postdischarge-to-30-day all-cause mortality. Results: Of 2394 references, 15 studies enrolling 7498 patients were included. Random effects analysis showed that all-cause cumulative inpatient, 30-day, and 1-year mortality was 2.40% (2.08, 2.77; I2 = 0%), 4.31% (3.64, 5.09, I2 = 41.9%), and 20.71% (18.32; 23.33, I2 = 81.5%), respectively. The postdischarge-to-30-day mortality was 1.70% (95% confidence interval: 1.0, 2.70; I2 = 84%). A total of 71.50% of deaths (95% confidence interval: 36.80-91.50, I2 = 63%) in the postdischarge-to-30-day period were due to cardiac etiology. On meta-regression, pre-MC left ventricular ejection fraction (p = 0.003), Log.Euroscore (p = 0.047), Society of Thoracic Surgeons Predicted Risk of Mortality (p < 0.001), and prolonged ventilation >48 ​hours (p < 0.001) were found to be its significant predictors. Conclusions: Our meta-analysis reports an additional mortality of ∼2% immediately after MC implantation during the postdischarge-to-30-day period. Majority of deaths occurred due to cardiac causes. Pre-MC left ventricular ejection fraction, Log.Euroscore, Society of Thoracic Surgeons Predicted Risk of Mortality score, and prolonged ventilation were found to be its significant predictors. Further studies are needed to better understand the causes of this early mortality to maximize benefits of this important therapy.

Periprocedural Echocardiographic Guidance of Transcatheter Mitral Valve Edge-to-Edge Repair Using the MitraClip.

Transcatheter edge-to-edge mitral valve repair is a minimally invasive treatment option for selected patients with moderate to severe or severe mitral regurgitation. Although transcatheter edge-to-edge mitral valve repair offers a significant step forward in the management of mitral regurgitation, the rate of procedural-related complications is not trivial. High-quality periprocedural imaging is important for optimal patient selection and procedural success. In this review, we present a step-by-step approach of the recommended echocardiographic views for transcatheter edge-to-edge mitral valve repair.

Severe Atrial Functional Mitral Regurgitation: Clinical and Echocardiographic Characteristics, Management and Outcomes.

OBJECTIVES: This study was designed to compare the clinical and echocardiographic characteristics, management, and outcomes of severe atrial functional mitral regurgitation (AFMR) to primary mitral regurgitation (PMR). BACKGROUND: AFMR remains poorly defined clinically. METHODS: Consecutive patients who underwent transesophageal echocardiography at our institution between 2011 and 2018 for severe mitral regurgitation with preserved left ventricular function were screened. We excluded patients with endocarditis, any form of cardiomyopathy, or prior mitral intervention. The absence of leaflet pathology defined AFMR. Outcomes included death and heart failure hospitalizations. RESULTS: A total of 283 patients were included (AFMR = 14%, PMR = 86%). Compared to PMR, patients with AFMR had more comorbidities, including hypertension (94.9% vs. 76.2%; p = 0.015), diabetes mellitus (46.2% vs. 18.4%; p < 0.001), long-standing atrial fibrillation (28.2% vs. 13.1%; p = 0.015), prior nonmitral cardiac surgery (25.6% vs. 9.8%; p = 0.004), and pacemaker placement (33.3% vs. 13.5%; p = 0.002). They also had higher average E/e' (median [interquartile range]:16.04 [13.1 to 22.46] vs. 14.1 [10.89 to 19]; p = 0.036) and worse longitudinal left atrial strain peak positive value (16.86 ± 12.15% vs. 23.67 ± 14.09%; p = 0.002) compared to PMR. During follow-up (median: 22 months), patients with AFMR had worse survival (log-rank p = 0.009) and more heart failure hospitalizations (log-rank p = 0.002). They were also less likely to undergo mitral valve intervention (59.0% vs. 83.6%; p = 0.001), although surgery was associated with improved survival (log-rank p = 0.021). On multivariable regression analysis, AFMR was independently associated with mortality [adjusted odds ratio: 2.61, 95% confidence interval: 1.17 to 5.83; p = 0.02]. CONCLUSIONS: AFMR constitutes an under-recognized high-risk group, with significant comorbidities, limited therapeutic options, and poor outcomes.

Contemporary review of percutaneous therapy for tricuspid valve regurgitation.

Introduction: Moderate to severe tricuspid regurgitation (TR) is a poor prognostic factor regardless of right ventricular function. However, a majority of patients are managed medically rather than undergoing isolated tricuspid valve surgery due to high in-hospital mortality. Percutaneous therapy in the form of transcatheter tricuspid valve repair or replacement is an attractive option for this high risk multimorbid cohort.Areas covered: A literature search was performed for tricuspid valve repair or replacement using MEDLINE, Current Contents Connect, Google Scholar, EMBASE, Cochrane library, PubMed, ScienceDirect, and Web of Science (Till 10/19). This review outlines the anatomical challenges specific to the tricuspid valve, provides an insight into patient selection for percutaneous treatment, and summarizes the current evidence for the available devices.Expert opinion: With the recent understanding that percutaneous repair of TR is feasible and provides better patient outcomes, we must more closely evaluate our patients with tricuspid regurgitation and consider treatment. MitraClip in the tricuspid position (TriClip) is the most widely used TV repair device, and several prospective trials are currently investigating various devices in this arena that hopefully will hopefully provide greater insight into patient selection and anatomically specific device choice.

Be Prepared for the Unexpected: Importance of Careful Intraprocedural Transesophageal Echocardiography Assessment During MitraClip.

Transesophageal echocardiography plays a central role in the evaluation and guidance of mitral valve interventions. Our case highlights the importance of thorough intraprocedural valve evaluation using 3-dimensional and multiplanar reconstruction transesophageal echocardiography, discovering an unexpected mechanism for mitral regurgitation, to guide an alternative intervention strategy by an experienced interventional team. (Level of Difficulty: Intermediate.).

Atrial Fibrillation and Transcatheter Repair of Functional Mitral Regurgitation: Evidence From a Meta-Regression.

OBJECTIVES: The aim of this study was to assess the impact of atrial fibrillation (AF) on mortality and efficacy in patients with functional mitral regurgitation (FMR) undergoing MitraClip implantation. BACKGROUND: AF is a common arrhythmia in patients with severe FMR undergoing transcatheter mitral valve repair with the MitraClip device. Although AF has been consistently shown to be associated with poor outcomes after mitral valve surgery, the impact of AF on outcomes of MitraClip placement in patients with FMR has not been well studied. METHODS: Prospective, retrospective registries, observational studies, and randomized controlled trials on MitraClip reporting AF and FMR as one of the variables from inception until January 2019 were included. RESULTS: Of the initial 1,694 studies, 15 studies met the inclusion criteria. From a total of 5,184 patients, 2,105 patients were identified to have FMR and AF. All-cause 30-day mortality in patients with FMR was 3.7% (95% confidence interval: 2.87 to 4.66) and 1-year mortality was 17.9% (95% confidence interval: 16.01 to 19.71). The meta-regression analysis studying the impact of AF among patients with FMR treated with the MitraClip demonstrated no difference in mortality at 30 days but demonstrated significantly increased mortality at 1 year (95% confidence interval: 0.0006 to 0.0027) (p = 0.004). AF did not influence procedural success. CONCLUSIONS: This meta-regression identifies AF as an independent negative predictor of long-term mortality after MitraClip implantation in patients with FMR. The mechanism of worse outcomes in patients with AF requires further study.

Functional tricuspid regurgitation: Feasibility of transcatheter interventions.

Functional tricuspid regurgitation (TR) develops secondary to annular dilation and leaflet tethering as a result of right ventricular remodeling. Invasive surgery for isolated TR is rarely performed due to high inpatient mortality. Transcatheter tricuspid valve intervention is an appealing solution but is challenging as crucial structures are closely related to the tricuspid valve, and intracardiac devices pose further challenges to device delivery and implantation.

Isolated surgical tricuspid repair versus replacement: meta-analysis of 15 069 patients.

Objectives: Tricuspid valve disease is increasingly encountered, but surgery is rarely performed in isolation, in part because of a reported higher operative risk than other single-valve operations. Although guidelines recommend valve repair, there is sparse literature for the optimal surgical approach in isolated tricuspid valve disease. We performed a meta-analysis examining outcomes of isolated tricuspid valve repair versus replacement. Methods: We searched Pubmed, Embase, Scopus and Cochrane from January 1980 to June 2019 for studies reporting outcomes of both isolated tricuspid valve repair and replacement, excluding congenital tricuspid aetiologies. Data were extracted and pooled using random-effects models and Review Manager 5.3 software. Results: There were 811 article abstracts screened, from which 52 full-text articles reviewed and 16 studies included, totalling 6808 repairs and 8261 replacements. Mean age ranged from 36 to 68 years and females made up 24%-92% of these studies. Pooled operative mortality rates and odds ratios (95% confidence intervals) for isolated tricuspid repair and replacement surgery were 8.4% vs 9.9%, 0.80 (0.64 to 1.00). Tricuspid repair was also associated with lower in-hospital acute renal failure 12.4% vs 15.6%, 0.82 (0.72 to 0.93) and pacemaker implantation 9.4% vs 21.0%, 0.37 (0.24 to 0.58), but higher stroke rate 1.5% vs 0.9%, 1.63 (1.10 to 2.41). There were no differences in rates of prolonged ventilation, mediastinitis, return to operating room or late mortality. Conclusion: Isolated tricuspid valve repair was associated with significantly reduced in-hospital mortality, renal failure and pacemaker implantation compared with replacement and is therefore recommended where feasible for isolated tricuspid valve disease, although its higher stroke rate warrants further research.

Management of MitraClip Single-Leaflet Detachment with an Additional Clip and an Amplatzer Vascular Plug.

Single-leaflet detachment of the MitraClip is a mechanism of early failure, but management is challenging and often requires surgical repair. This case report describes a novel transcatheter approach to repairing severe mitral regurgitation after MitraClip single-leaflet detachment by placement of an additional clip and an Amplatzer vascular plug. (Level of Difficulty: Advanced.).