Incidence and predictors of acute coronary syndrome after transcatheter mitral valve repair.

BACKGROUND: Acute coronary syndrome (ACS) post-transcatheter mitral valve repair (TMVR) carries high mortality. We aim to study the incidence and predictors of ACS in patients who underwent TMVR. RESEARCH DESIGN AND METHODS: We queried the U.S. National Readmission Database to identify all cases of TMVR from 2016 to 2019. We further evaluated the incidence of ACS and used multivariable logistic regression to determine independent predictors of ACS in this population. RESULTS: Among 3,742 patients who underwent TMVR, 264 (7.05%) developed ACS. Among ACS patients, 204 (77%) had non-ST-segment elevation ACS and 66 (25%) had ST-segment elevation ACS. Independent predictors of ACS were acute limb ischemia, cardiogenic shock, history of coronary artery disease (CAD), smoking, cardiac arrest, respiratory failure requiring mechanical ventilation, and acute kidney injury. In-hospital mortality among ACS was three times higher in ACS patients than without ACS (16.76% vs. 5.45%, p-value < 0.01). CONCLUSIONS: ACS is not an uncommon complication after TMVR. The occurrence of ACS after TMVR is associated with high in-hospital mortality, longer length of stay, and higher hospital charges. The strongest predictors of ACS in these patients are the development of acute limb ischemia, cardiogenic shock, and a history of CAD.

Large Field-of-View Intravascular Ultrasound for Mitral and Tricuspid Valve-in-Valve Guidance: A Pilot Study.

Background: Actual expansion of a transcatheter heart valve (THV) might differ from nominal, particularly during nonaortic valve-in-valve for a degenerated bioprosthetic surgical heart valve (SHV). This pilot study compared THV expansion measured using large-field-of-view intravascular ultrasound (IVUS) vs. multi-slice computed tomography (MSCT) and assessed the correlation between THV dimensions and transvalvular gradients. Methods: Fourteen patients were successfully treated with mitral/tricuspid valve-in-valve SAPIEN 3 implantation sized using the true SHV inner diameter; all 14 had baseline MSCT and transvalvular gradients measured at baseline, postprocedure, and at discharge. Periprocedural IVUS (in 6 patients using a Philips 10MHz Vision PV035) was compared with postprocedural MSCT (in 9 patients) with offline measurements performed at 1-mm steps along the THV height. Overall, 190 MSCT and paired 124 IVUS cross-sections were analyzed. Results: There was very good agreement between IVUS THV dimensions and corresponding MSCT measurements (intraclass correlation coefficient ≥0.986 and p < 0.001). IVUS measured THV expansion (percent of the nominal cross-sectional area) was smaller within the inflow and middle of the THV overlapping the ring (85.9% ± 11.3%, 83.8% ± 11.8%) than within the outflow (98.8% ± 12.7%). The residual mean transvalvular gradient increased from periprocedural to predischarge (3.5 ± 2.0 vs. 6.3 ± 1.7 mmHg, p < 0.001). The only independent predictor of predischarge maximal transvalvular gradient was the smallest minimal inner THV frame diameter (r2 = 0.67), predicted by true SHV internal diameter (Beta = 0.066, 95% CI = 0.015-0.117, r2 = 0.49, p = 0.037). Conclusions: This pilot study is the first to report the feasibility of a large field-of-view IVUS for periprocedural measurement of actual THV expansion when deployed valve-in-valve. Minimal inner THV stent frame dimensions correlate with increased postprocedural transvalvular gradients.

Valve-in-valve transcatheter mitral valve replacement versus redo-surgical mitral valve replacement for degenerated bioprosthetic mitral valves: A systematic review and meta-analysis.

Bioprosthetic mitral valve degeneration is traditionally treated with Redo-SMVR, but the latest ViV-TMVR procedure offers a less invasive and lower risk alternative. A systematic literature search was conducted on Cochrane Central, Scopus, and Medline (PubMed interface) electronic databases from inception till 15th April 2024. We used risk ratios (RR) for dichotomous outcomes and mean differences (MD) for continuous outcomes. We included a total of eleven studies with 11,931 patients in the final quantitative and qualitative analysis. When comparing ViV-TMVR with Redo-SMVR, no significant difference was found for 30-day mortality (P = 0.13) and 1-year mortality (P = 0.91), whereas patients in the ViV-TMVR showed significantly reduced incidence of stroke (P < 0.00001), In-hospital mortality (P), bleeding complications (P = 0.003), AKI (P = 0.0006), arrhythmias (P = 0.01), LVOT obstruction (P = 0.04), and PPI (P < 0.00001). Furthermore, no significant difference was observed between either group when comparing vascular complications (P = 0.97), 2-year mortality (P = 0.60) and 3-year mortality. ViV-TMVR was associated with a significant risk of paravalvular leakage (P = 0.008). Although, ViV-TMVR reduces the risk of complications associated with Redo-SMVR, larger studies are imperative to reach conclusive results.

Economic Disparities in Utilization and Outcomes of Structural Heart Disease Interventions in the United States.

Background: Disparities in access to care cause negative health consequences for underserved populations. Economic disparities in structural heart disease (SHD) interventions are not well characterized. Objectives: The objective of this study was to evaluate economic disparities in the utilization and outcomes of SHD interventions in the United States. Methods: We queried the National Inpatient Sample (2016-2020) to examine economic disparities in the utilization, in-hospital outcomes, length of stay, and cost of SHD interventions among patients ≥65 years of age. Outcomes were determined using logistic regression models. Results: A total of 401,005 weighted hospitalizations for transcatheter aortic valve replacement, left atrial appendage occlusion, transcatheter mitral valve repair, and transcatheter mitral valve replacement were included. Utilization rates (number of procedures performed per 100,000 hospitalizations) were higher in patients with high income compared with medium and low income for transcatheter aortic valve replacement (559 vs 456 vs 338), left atrial appendage occlusion (148 vs 136 vs 99), transcatheter mitral valve repair (65 vs 54 vs 41), and transcatheter mitral valve replacement (7.7 vs 6.7 vs 1.2) (all P < 0.01). Low- and medium-income patients had distinctive demographic and clinical risk profiles compared with high-income patients. There were no significant differences in the adjusted in-hospital mortality, key complications, or length of stay between high-, medium-, and low-income patients following any of the 4 SHD interventions. High-income patients incurred a modestly higher cost with any of the 4 SHD interventions compared with medium- and low-income patients. Conclusions: Economic disparities exist in the utilization of SHD interventions in the United States. Nonetheless, adjusted in-hospital outcomes were comparable among high-, medium-, and low-income patients. Multifaceted implementation strategies are needed to attenuate these utilization disparities.

Antithrombotic Therapy Following Structural Heart Disease Interventions: Current Status and Future Directions.

Interventions in structural heart disease cover many catheter-based procedures for congenital and acquired conditions including valvular diseases, septal defects, arterial or venous obstructions, and fistulas. Among the available procedures, the most common are aortic valve implantation, mitral or tricuspid valve repair/implantation, left atrial appendage occlusion, and patent foramen ovale closure. Antithrombotic therapy for transcatheter structural heart disease interventions aims to prevent thromboembolic events and reduce the risk of short-term and long-term complications. The specific approach to antithrombotic therapy depends on the type of intervention and individual patient factors. In this review, we synopsize contemporary evidence on antithrombotic therapies for structural heart disease interventions and highlight the importance of a personalized approach. These recommendations may evolve over time as new evidence emerges and clinical guidelines are updated. Therefore, it's crucial for healthcare professionals to stay updated on the most recent guidelines and individualize therapy based on patient-specific factors and procedural considerations.

TMVR after TA-TAVR: a re-redo surgery-case report.

Introduction: Transcatheter mitral valve replacement (TMVR) is a valuable treatment option in patients with severe mitral regurgitation. Prior transapical transcatheter aortic valve replacement (TA-TAVR) may complicate the procedure and is therefore considered a relative contraindication. In this case report, the authors describe the successful TMVR as a tertiary cardiac surgery and transapical redo procedure. Case Summary: An 83-year-old male patient, suffering from dyspnoea and angina, was diagnosed with severe mitral valve regurgitation (MR). He had already undergone cardiac surgery in the form of coronary artery bypass grafting at the age of 64 and TA-TAVR at 79 years. After a failed attempt at mitral valve transcatheter edge-to-edge repair, he opted for TMVR. Pre-TMVR computed tomography simulation was used to analyse possible interactions between the prostheses and to predict the neo-left ventricular outflow tract (neo-LVOT). The operation was carried out without complications. There was no bleeding and the LV function remained unchanged. On MRI, the valves were perfectly aligned without any signs of paravalvular leakage or LVOT obstruction. The patient was discharged seven days postoperatively. At the one-year follow up, there was no need for rehospitalisation and the patient had clinically improved (from NYHA IV to II). Echocardiography demonstrated a mean transvalvular gradient of under 5 mmHg and no residual MR. Conclusion: A redo transapical access for TMVR as a tertiary cardiac operation can be easily performed. Pre-operative CT suggested good alignment of the aortic and mitral valved stent which was confirmed postoperatively.

New echocardiographic screening tool for left ventricular tract obstruction risk assessment in TMVR.

BACKGROUND: Transcatheter mitral valve replacement (TMVR) is an alternative to conventional surgery to treat severe mitral disease but its use is limited by the risk of left ventricular outflow tract obstruction (LVOTO). Screening depends on ECG-gated computed tomography (CT) that is not widely available and requires contrast. We developed and validated a transthoracic echocardiographic (TTE) method to assess the risk of LVOTO after TMVR with the Tendyne System. METHODS: We measured the LVOT longitudinal area on preoperative TTE dataset of patients screened for TMVR. The LVOT was measured as the box-area included by the aortic valve annulus, the anterior mitral leaflet (AML), the c-septum distance line, and the respective length of the AML on the interventricular septum. We analyzed the correlation between the TTE LVOT-box and the CT-measured neoLVOT area. Prediction performance for eligible patients was tested with ROC curves. RESULTS: Thirty-nine patients were screened, out of 14 patients (36%) not eligible for TMVR, 8 had risk of LVOTO. We found a linear correlation between the TTE LVOT-box and the CT-measured Neo-LVOT (r = 0.6, p = 0.002). ROC curve showed that the method is specific and sensitive and the cut-off value of the measure LVOT-box is 350 mm2. CONCLUSIONS: The proposed method is reliable to evaluate the risk of LVOTO after TMR with the Tendyne System. It is quick and easy and can be used as a first-line assessment in the outpatient clinic. Patients with LVOT-box <350 mm2 should not be further screened with ECG-gated cardiac CT.

Rheumatic and Degenerative Mitral Stenosis: From an Iconic Clinical Case to the Literature Review.

Mitral stenosis (MS) poses significant challenges in diagnosis and management due to its varied etiologies, such as rheumatic mitral stenosis (RMS) and degenerative mitral stenosis (DMS). While rheumatic fever-induced RMS has declined in prevalence, DMS is rising with aging populations and comorbidities. Starting from a complex clinical case of DMS, the aim of this paper is to review the literature on mitral stenosis by analyzing the available tools and the differences in terms of diagnosis and treatment for rheumatic and degenerative stenosis. Emerging transcatheter techniques, such as transcatheter mitral valve replacement (TMVR) and lithotripsy-facilitated percutaneous mitral commissurotomy (PMC), represent promising alternatives for DMS patients deemed unfit for surgery. In particular, intravascular lithotripsy (IVL) has shown potential in facilitating percutaneous interventions by fracturing calcific deposits and enabling subsequent interventions. However, larger prospective studies are warranted to validate these findings and establish IVL's role in DMS management. To further enhance this technique, research could focus on investigating the long-term outcomes and durability of mitral lithotripsy, as well as exploring its potential in combination with PMC or TMVR.

2-Year Clinical and Echocardiography Follow-Up of Transcatheter Mitral Valve Replacement With the Transapical Intrepid System.

BACKGROUND: Thirty-day outcomes with the investigational Intrepid transapical (TA) transcatheter mitral valve replacement (TMVR) system have previously demonstrated good technical success, but longer-term outcomes in larger cohorts need to be evaluated. OBJECTIVES: The authors sought to evaluate the 2-year safety and performance of the Intrepid TA-TMVR system in patients with symptomatic, ≥moderate-severe mitral regurgitation (MR) and high surgical risk. METHODS: Patient eligibility was determined by local heart teams and approved by a central screening committee. Clinical events were adjudicated by an independent clinical events committee. Echocardiography was evaluated by an independent core laboratory. RESULTS: The cohort included 252 patients that were enrolled at 58 international sites before February 2021 as part of the global Pilot Study (n = 95) or APOLLO trial (primary cohort noneligible + TA roll-ins, n = 157). Mean age was 74.2 years, mean STS-PROM was 6.3%, 60.3% were male, and 80.6% were in NYHA functional class III/IV. Most presented with secondary MR (70.1%), and nearly all had ≥moderate-severe MR (98.4%). All-cause mortality was 13.1% (30-day), 27.3% (1-year), and 36.2% (2-year). The 30-day ≥major bleeding event rate was 22.3%. Heart failure rehospitalization was 9.6% (30-day) and 36.2% (2-year). At 2 years, >50% of patients were alive with improvement in NYHA functional class (82.1%, class I/II), and all patients with available echocardiograms had ≤mild MR. CONCLUSIONS: This analysis represents the largest reported TA-TMVR experience with the longest follow-up in high-risk ≥moderate-severe MR patients. Early mortality and heart failure rehospitalizations were significant, exacerbated by early TA-related bleeding events; however, meaningful improvements in clinical outcomes and marked reductions in MR severity were observed through 2 years.

Standardization and validation of neoLVOT assessment using three-dimensional trans-esophageal echocardiography before trans-catheter mitral valve replacement.

BACKGROUND: Trans-catheter mitral valve replacement (TMVR) procedures had emerged as an alternative solution for patients who are at high risk for mitral valve surgery. Although cardiac computed tomography (CT) remains the standard method for procedural planning, there is no full agreement on the best systolic phase for quantitation of the neoLVOT. Furthermore, a new three-dimensional trans-esophageal echocardiography (3DTEE) based software was developed to serve as filter and or an alternative for patients who cannot have CT due to any contraindication. AIM: To determine the systolic phase of the cardiac cycle that shows the narrowest NeoLVOT area in order to standardize the way of using these software and then to validate the 3DTEE-based software against the CT-based one as a gold standard, in mitral valve annulus (MA) and NeoLVOT assessment. METHODS: A single center, observational, retrospective study. Initially, a sample of 20 patients (age 62 ± 4 years, 70% men) had CT-based analysis at mid-diastole (80%), early-systole (10%), mid-systole (20%), late-systole (30%-40%), in order to detect the best systolic phase at which the neoLVOT area is the narrowest after TMVR. Then, the end systolic phase was standardized for the analysis of 49 patients (age 57 ± 6 years, 60% men), using both the commercially available CT-based software and the newly available 3DTEE-based software (3mensio Structural Heart, Pie Medical Imaging, The Netherlands). The 3DTEE derived parameters were compared with the gold standard CT-based measurements. RESULTS: The neoLVOT area was significantly narrower at end-systole (224 ± 62 mm2), compared to early-systole (299 ± 70 mm2) and mid-systole (261 ± 75 mm2), (p = .005). Excellent correlation was found between 3DTEE and CT measurements for MA AP diameter (r = .96), IC diameter (r = .92), MA area (r = .96), MA perimeter (r = .94) and NeoLVOT area (r = .96), (all p-values < .0001). Virtual valve sizing was based on annulus measurement and was identical between CT and 3DTEE. Interobserver and intraobserver agreements were excellent for all the measurements with ICCs > .80. CONCLUSIONS: End-systole is the phase that shows the narrowest neoLVOT and hence should be the standard phase used during the analysis. The 3DTEE based analysis using this new software is reliable compared to the CT-based analysis and can be serve as an alternative analysis tool in patients who cannot have CT for any clinical contraindication or as a screening test and/or filter for all patients before proceeding to a detailed CT scan.

Outcomes of COMBO therapy for severe mitral regurgitation compared with transcatheter edge-to-edge repair.

Background: There are different types of transcatheter mitral valve repair (TMVr) currently in clinical use, including leaflet approximation, annular cinching, and restoration of the chordal apparatus of the mitral valve (MV). While the concomitant combination (COMBO) therapy of mitral transcatheter edge-to-edge repair (M-TEER) with another TMVr concept has been proven feasible, potentially offering patient-tailored treatment for severe mitral regurgitation (MR), a comparison with M-TEER alone has not been made. Aims: To evaluate the procedural and clinical outcome of COMBO therapies compared with M-TEER alone. Methods: We included consecutive patients undergoing COMBO and M-TEER between March 2015 and April 2018 at our Heart Valve Center, while excluding patients presenting a case of redo or with previous MV surgery. Procedural outcomes and all-cause mortality were compared between COMBO therapy vs. M-TEER alone. Results: A total of 357 patients (mean age 78.9 ± 7.0 years, 53.2% male, M-TEER n = 322, COMBO n = 35; COMBO: MitraClip and the Carillon mitral contour system n = 26, MitraClip and Cardioband n = 5, and MitraClip and NeoChord n = 4) were analyzed. Patients with COMBO therapy had larger left chamber sizes, a lower left ventricular systolic ejection fraction (LVEF; COMBO: 37.4 ± 13.8%, M-TEER: 47.9 ± 14.3%, p < 0.001), and a more severe MR grade (p < 0.001). There were no significant differences in the prevalence of residual MR ≧2+. However, the need for re-intervention, always employing M-TEER, was more common in the COMBO group. During a mean 3.6-year long-term follow-up, there was no significant difference of all-cause mortality between both groups (Log rank p = 0.921). Conclusions: COMBO therapy may still be a beneficial therapy option for patients with severe MR who already have a more dilated left ventricle (LV), a more severe MR, and a more pronounced LV systolic dysfunction. The higher need for re-intervention in the COMBO group may signal more complex anatomies and possibly underlines the necessity of treating significant MR earlier. Future research is required to establish the COMBO approach as a toolbox-like treatment option, thus offering a patient-tailored approach depending on the individual anatomy and pathology.

Optimal antithrombotic strategy following valve-in-valve transcatheter aortic and mitral valve replacement.

The treatment of aortic and mitral valve disease requiring replacement has shifted to an increasing use of bioprosthetic heart valves. Due to their limited durability, there is a growing need for reintervention in the setting of failing bioprosthesis. Even though the gold standard for the treatment of failed bioprosthesis remains surgical repair or replacement, valve-in-valve (ViV) transcatheter aortic and mitral valve replacement have emerged as safe and effective alternatives for patients who are at high or prohibitive risk for surgery. Both procedures are associated with a substantial risk of postprocedural thromboembolic events and valvular thrombosis that is often higher than transcatheter replacement of native valves. With guidelines lacking specific protocols and a limited number of available studies, the optimal postprocedural antithrombotic therapy remains to be clarified. Multiple factors including valvular hemodynamics, the characteristics of the failing surgical valve, and the choice of the new transcatheter heart valve (THV) must be considered. Additionally, patients are often at an advanced age with multiple comorbidities and may require oral anticoagulation (OAC) due to other indications such as atrial fibrillation. Although the recommended antithrombotic strategy for native transcatheter aortic valve replacement (TAVR) is antiplatelet monotherapy with aspirin or a P2Y12 inhibitor in the absence of another anticoagulation indication, the use of oral anticoagulants including vitamin K antagonists (VKAs) and direct thrombin inhibitors has been shown to be effective in reducing valvular thrombosis and are commonly used after ViV procedures. Prospective studies investigating these results specifically for ViV transcatheter aortic and mitral valve replacement are needed to identify the optimal antithrombotic therapy.

Transseptal BATMAN for High-Risk Valve-in-Ring Procedures: A Case Series.

Valve-in-ring procedures represent a feasible solution for high-risk patients with surgical repair failure. The risk of left ventricular outflow tract obstruction increases the challenge, and transcatheter approaches to prevent it are technically demanding and often do not resolve it. We demonstrate the feasibility and safety of a transseptal balloon-assisted translocation of the anterior mitral leaflet for valve-in-ring implantation.