Independent Clinical and Echocardiographic Predictors of Restenosis After Percutaneous Mitral Balloon Commissurotomy in a Large, Consecutive Cohort Followed for 24 Years.

OBJECTIVE: To enlighten preprocedural risk factors of mitral valve restenosis in a large, single-center cohort of patients submitted to percutaneous mitral balloon commissurotomy (PMBC) for the treatment of mitral stenosis (MS) secondary to rheumatic heart disease. METHODS: This is a database analysis of a single-center, high-volume tertiary institution involving all consecutive PMBC procedures performed in the mitral valve (MV). Restenosis was diagnosed when MV area was <1.5 cm² and/or loss of 50% or more of the immediate procedural result aligned with the return/worsened symptoms of heart failure. The primary endpoint was to determine the preprocedural independent predictors of restenosis after PMBC. RESULTS: Among a total of 1921 PMBC procedures, 1794 consecutive patients without previous intervention were treated between 1987 and 2010. Throughout 24 years of follow-up, MV restenosis was observed in 483 cases (26%). Mean age was 36 years and most (87%) were female. Median follow-up duration was 9.03 years (interquartile range, 0.33-23.38). Restenosis population, however, presented a significantly lower age at the procedure time as well as a higher Wilkins-Block score. At multivariate analysis, independent preprocedure predictors of restenosis were left atrium diameter (hazard risk [HR], 1.03; 95% confidence interval [CI], 1.02-1.05; P<.04), preprocedure maximum gradient (HR, 1.02; 95% CI, 1.00-1.03; P=.04), and higher Wilkins-Block score (>8) (HR, 1.38; 95% CI, 1.14-1.67; P<.01). CONCLUSIONS: At long-term follow-up, MV restenosis was observed in a quarter of the population undergoing PMBC. Preprocedure echocardiographic findings, including left atrial diameter, maximum MV gradient, and Wilkins-Block score were found to be the only independent predictors.

Potential impact on cost-effectiveness estimates of using immature survival data: a case study based on transcatheter edge-to-edge repair (TEER) used for patients with severe mitral regurgitation at high surgical risk.

OBJECTIVE: To review the survival modelling used in cost-effectiveness studies evaluating an interventional procedure and to discuss implications for decision-makers. DESIGN: A case study of three economic evaluations that each used immature data from the EVEREST II High Surgical Risk (HSR) Study of transcatheter edge-to-edge repair (TEER) for patients with severe mitral regurgitation (MR) who were at high risk of surgery. SETTING: Estimation of patient survival in cost-effectiveness studies. PARTICIPANTS: The EVEREST II HSR Study included 78 patients who had TEER of the mitral valve using the MitraClip device and a retrospectively identified control group of 36 patients who received medical management and were followed up for 12 months. Observed survival (TEER arm only) was updated at 5 years. RESULTS: Two studies used 12-month observed mortality from EVEREST II HSR to model survival over lifetime horizons. Observed and modelled survival were associated with considerable uncertainty due to short follow-up and small numbers of participants. Modelling control patients' survival required an approximate 10-fold extrapolation based on 12-month observation of only 38 patients. Observed 5-year survival in the TEER group differed from that less mature follow-up suggesting that survival modelling based on shorter follow-up was unsatisfactory. No public domain data for the control group are available beyond 12-month follow-up so meaningful estimates using mature data for both arms are currently not possible. A third study developed survival models using incompletely reported transitions between MR grades in EVEREST II HSR and mortality rates observed for different MR grades derived from a study in an unrelated population. CONCLUSIONS: Modelling survival in such small samples followed up for only 12 months is associated with great uncertainty, and cost-effectiveness results based on these analyses should be viewed as premature and used cautiously in reimbursement decisions.

Intraprocedural Residual Mitral Regurgitation and Survival After Transcatheter Edge-to-Edge Repair: Prospective German Multicenter Registry (MITRA-PRO).

BACKGROUND: Residual mitral regurgitation (MR) is thought to be an important predictor of long-term survival following transcatheter edge-to-edge repair (TEER). Intraprocedural MR assessment using transesophageal echocardiography could be limited by image quality, hemodynamics, and patient sedation. The MitraScore is a validated multimodal approach for intraprocedural MR assessment during TEER. OBJECTIVES: This study aimed to assess the impact of residual MR using the MitraScore on 1-year mortality. METHODS: Patients undergoing mitral TEER were eligible for inclusion in the prospective, multicenter MITRA-PRO registry (A Prospective Registry Study on 1-Year Mortality and the Prognostic Significance of MitraScore After MitraClip Implantation in Patients With Mitral Regurgitation). Patients with a MitraScore ≤3 were defined as patients with mild residual MR after mitral TEER, whereas a MitraScore ≥4 was considered as relevant residual MR. Mortality, rehospitalization, and major adverse events were assessed 1 year after TEER. RESULTS: A MitraScore ≤3 was found in 1,059 patients (71.0%), whereas 432 patients revealed a MitraScore ≥4 (29.0%). One-year mortality was significantly lower in patients with nonrelevant residual MR (MitraScore ≤3 14.6% vs MitraScore≥4 22.1%). An almost linear relationship between intraprocedural MitraScore after TEER and mortality was observed. The combined clinical endpoint of mortality and rehospitalization within the 1-year follow-up was also significantly lower in the MitraScore ≤3 group (31.5%) than in the MitraScore ≥4 group (40.8%). A subgroup analysis confirmed the predictive value of the MitraScore in patients with primary, secondary, or mixed MR etiologies. CONCLUSIONS: Residual MR assessed by intraprocedural MitraScore after TEER predicts 1-year mortality and rehospitalization. Therefore, the multimodal MitraScore improves MR assessment during mitral TEER and might improve patient survival.(A Prospective Registry Study on 1-Year Mortality and the Prognostic Significance of MitraScore After MitraClip Implantation in Patients With Mitral Regurgitation [MITRA-PRO]; DRKS00012288).

Contemporary Outcomes Following Transcatheter Edge-to-Edge Repair: 1-Year Results From the EXPAND Study.

BACKGROUND: The third-generation MitraClip NTR/XTR transcatheter edge-to-edge repair system was introduced to assist in leaflet grasping with the longer clip arms of MitraClip XTR and to improve ease of use with the modified delivery catheter. OBJECTIVES: The EXPAND study evaluated contemporary real-world outcomes in subjects with mitral regurgitation (MR) treated with the third-generation MitraClip NTR/XTR transcatheter edge-to-edge repair system. METHODS: EXPAND is a prospective, multicenter, international, single-arm study that enrolled patients with primary MR and secondary MR at 57 centers. Follow-up was conducted through 12 months. Echocardiograms were analyzed by an echocardiographic core laboratories. Study outcomes included: MR severity, functional capacity measured by New York Heart Association functional class, quality of life measured by Kansas City Cardiomyopathy Questionnaire, heart failure hospitalizations, all-cause mortality. RESULTS: 1,041 patients were enrolled from April 2018 through March 2019, of which 50.5% had primary or mixed etiology. Implant success was 98.9%; 1.5 ± 0.6 clips were implanted per subject. Significant MR reduction from baseline (≥MR 3+: 56.0%) to 30 days (≤MR 1+:88.8%) was maintained through 1 year (MR ≤1+: 89.2%). A total of 84.5% and 93.0% of subjects in primary MR and secondary MR, respectively, had ≤1+ MR at 1 year. Significant improvements were observed in clinical outcomes (New York Heart Association functional class I/II in 80.3%, +21.6 improvement in Kansas City Cardiomyopathy Questionnaire score) at 1 year. All-cause mortality and heart failure hospitalizations at 1 year were 14.9% and 18.9%, respectively, which was significantly lower than previous studies. CONCLUSIONS: The study demonstrates treatment with the third-generation system resulted in substantial reduction of MR in a contemporary real-world practice, compared with the results of earlier EVEREST and COAPT trials.(The MitraClip® EXPAND Study of the Next Generation of MitraClip® Devices [EXPAND]; NCT03502811).

Quality of Life, Procedural Success, and Clinical Outcomes following Transcatheter Mitral Valve Repair.

Background: Limited data exist regarding the association between the quality of life (QoL) and clinical outcomes following transcatheter mitral valve repair (TMVr). We aimed to evaluate the prognostic significance of QoL assessment following TMVr and to characterize those who had procedural success, yet reported a low Kansas City Cardiomyopathy Questionnaire (KCCQ-12) score. Methods: We reported the experience of Cedars-Sinai Medical Center patients between 2013 and 2020. Patients were allocated into four groups according to the 30-day KCCQ: <25, 25-49, 50-74, and ≥75. Primary outcome included 1-year all-cause death or heart failure (HF) hospitalizations. We also examined the association between QoL and the primary outcome in those with procedural success. Results: A total of 555 patients were included in our analysis, median follow-up of 650 days (IQR 243-1113). The lower KCCQ groups had a higher prevalence of functional mitral regurgitation (65%, 60%, 56%, and 43%, p = 0.001), as well as a higher Society of Thoracic Surgeon (STS) score. These groups had a significantly higher occurrence of 1-year all-cause death or HF hospitalizations in a stepwise fashion (40%, 22%, 16%, and 10%, p < 0.001). Multivariable Cox regression analysis revealed 30-day KCCQ as the strongest predictor of the 1-year primary outcome (HR 0.98, 95%CI (0.97-0.99), p = 0.006). Approximately a quarter of patients with procedural success had a low KCCQ score. These patients had a higher rate of the combined 1-year outcome regardless of procedural success or failure. Conclusion: QoL following TMVr is a powerful prognostic factor. KCCQ assessment is an important indicator for identifying patients prone to adverse outcomes even after procedural success.

Atypical Left Ventricular False Chordae Tendineae.

An 81-year-old female patient with a history of severe secondary mitral regurgitation, hypertension, and paroxysmal atrial fibrillation was seen by the valve team to determine candidacy for transcatheter edge-to-edge repair of the mitral valve. Two-dimensional biplane imaging showed a transverse basal left ventricle false tendon attached to papillary muscles. The position was concerning for interference during deployment of the mitral clip.

Can cartilage intermediate layer protein 1 (CILP1) use as a novel biomarker for canine myxomatous mitral valve degeneration levels or not?

BACKGROUND: Myxomatous mitral valve degeneration (MMVD) is the most common degenerative heart disease in dogs and is associated with irreversible changes in the valve tissue. Although traditional cardiac biomarkers are efficient for diagnosing MMVD, there are limitations, therefore, it is important to find novel biomarkers. Cartilage intermediate layer protein 1 (CILP1), an extracellular matrix-derived protein, acts as a transforming growth factor-ß antagonist and is involved in myocardial fibrosis. This study aimed to evaluate serum CILP1 levels in canines with MMVD. Dogs with MMVD were staged according to the American College of Veterinary Internal Medicine consensus guidelines. Data analysis was performed using the Mann-Whitney U test, Spearman's correlation, and receiver operating characteristic (ROC) curves. RESULTS: CILP1 levels were elevated in dogs with MMVD (n = 27) compared to healthy controls (n = 8). Furthermore, results showed that CILP1 levels were significantly higher in stage C group dogs compared to healthy controls. The ROC curve of CILP1 and NT-proBNP were good predictors of MMVD, although no similarity was observed between the two. Left ventricular end-diastolic diameter normalized to the body weight (LVIDdn) and left atrial to aorta dimension (LA/Ao) showed a strong association with CILP1 levels; however, no correlation was observed between CILP1 levels and vertebral heart size (VHS) and vertebral left atrial score (VLAS). The optimal cut-off value was selected from the ROC curve and dogs were classified according to the cut-off value (1.068 ng/mL, sensitivity 51.9%, specificity 100%). Results showed a significant association of CILP1 with cardiac remodeling indicators, such as VHS, VLAS, LA/Ao, and LVIDdn. CONCLUSIONS: CILP1 can be an indicator of cardiac remodeling in canines with MMVD and therefore, can be used as an MMVD biomarker.

Mitral degenerative valve leaflets suspected as primary valvular tumor: a case report.

BACKGROUND: Echocardiography plays an important role in the diagnosis of heart disease. Sometimes, however, it may also provide misdiagnosis information. CASE PRESENTATION: We report a rare case of a misdiagnosis of primary mitral valvular tumor with severe regurgitation by preoperative echocardiography. During the surgery, the true lesion was found to be mitral valve leaflet prolapse due to degenerative mitral valve disease. CONCLUSION: For individual patient, the best clinical decision not only needs the extensive application of echocardiography, but also needs the combination of clinical symptoms and more auxiliary examination.

Elastic recoil signal on tissue doppler imaging of mitral annulus as a qualitative test to identify left ventricular diastolic function.

Introduction: Left ventricular (LV) diastolic dysfunction is common on preoperative screening among patients undergoing surgery. There is no simple screening test at present to suspect LV diastolic dysfunction. This study was aimed to test the hypothesis, whether elastic recoil signal (ERS) on tissue Doppler imaging of mitral annulus (MA TDI) can be used as a qualitative test to differentiate patients from normal LV diastolic function versus patients with LV diastolic dysfunction. Methods: This was a prospective cross-sectional observational study of patients admitted for elective surgeries. Normal diastolic function and categorization of LV diastolic dysfunction into severity grades I, II, or III were performed as per the American Society of Echocardiography/ European Associationof Cardio Vascular Imaging (ASE/EACVI) recommendations for LV diastolic dysfunction. Results: There were 41 (61%) patients with normal LV diastolic function and 26 (39%) patients with various grades of LV diastolic dysfunction. In 38 out of 41 patients with normal LV diastolic function, the characteristic ERS was identified. The ERS was absent in all the patients with any grade of LV diastolic dysfunction. Consistency of identification of ERS on echocardiography was tested with a good interobserver variability coefficient of 0.94 (P-value <0.001). The presence of ERS demonstrated an excellent differentiation to rule out any LV diastolic dysfunction with an area under the receiver operating characteristics curve (AUROC) of 0.96 (CI 0.88-0.99; P value <0.001). Conclusions: To conclude, in a mixed surgical population, the anesthetist could successfully assess LV diastolic dysfunction in the preoperative period and the characteristic ERS on MA TDI signal can be used as a qualitative test to differentiate patients from normal LV diastolic function versus patients with LV diastolic dysfunction using the transthoracic echocardiography (TTE).

The effect of levosimendan on the right ventricular function in patients with right ventricular dysfunction undergoing mitral valve surgery.

Background: Right ventricular (RV) dysfunction is an important predictor of both immediate and long-term outcomes in valve surgeries. Levosimendan has proven beneficial in improving RV function. Aims: The objective was to study the effect of the addition of levosimendan to the conventional treatment on RV function in patients with RV dysfunction undergoing mitral valve (MV) surgeries. Setting and Design: Prospective randomized double-blinded controlled study at a tertiary care institution. Materials and Methods: Sixty adult patients aged 15-65 years, with preoperative transthoracic echocardiography (TTE) findings of RV dysfunction posted for elective MV surgery, were randomized into levosimendan (L) group and placebo (P) group. Patients in the L group were administered levosimendan at a rate of 0.1 mcg/kg/min after induction for 24 hrs, whereas patients in the P group were given multivitamin infusion at the same rate. Both the groups received standard inotropic therapy. The hemodynamic and echocardiographic parameters of RV function (RV size, Inferior vena cava (IVC) diameter, RV fractional area change (RVFAC) Tricuspid annular plane systolic excursion (TAPSE), and Systolic Pulmonary Artery Pressure (SPAP) were compared between the groups at 6 hrs, 24 hrs, and 7th day postoperatively. Results: All hemodynamic and echocardiographic parameters of RV function like RV size, IVC diameter, RVFAC, TAPSE, and SPAP improved from baseline to 24 hrs in both groups. Levosimendan caused a significant improvement in RV function compared to the P group at 24 hrs and 7th day postoperatively. Conclusions: The present study concludes that levosimendan is a promising option in patients with RV dysfunction undergoing MV surgeries.

Concomitant transcatheter transfemoral double native valve replacement for severe aortic stenosis and severe mitral stenosis with mitral annular calcification.

Concomitant mitral and aortic valve stenosis in a patient with mitral annular calcification and porcelain aorta poses a unique problem to the surgical team. Transcatheter aortic and mitral valve replacements in native valves offer a viable option for such selected group of patients. We present the case of a 54-year-old male who presented with severe aortic stenosis (AS) and severe mitral stenosis (MS) but was deemed high risk for surgery owing to intense calcification of the aorta and mitral annular calcification, and successfully underwent transcatheter double native valve replacement.

Safety and Feasibility of Staged Versus Concomitant Transcatheter Edge-to-Edge Mitral Valve Repair After Transcatheter Aortic Valve Implantation.

The data on the safety and feasibility of performing concomitant or staged transcatheter edge-to-edge repair (TEER) of the mitral valve with transcatheter aortic valve implantation (TAVI) remains limited. The Nationwide Readmission Database was used to identify TEER and TAVI procedures from October 1, 2015 to December 31, 2019, using the International Classification of Diseases, Tenth Revision, Clinical Modification administrative data. A total of 627 weighted cases of TEER and TAVI procedures were included in the analysis. Of those cases, 453 underwent staged TEER after TAVI, whereas 174 had concomitant TAVI and TEER during the same admission. Patients who underwent staged procedures were mostly men (64.8%, p = 0.02) and had a higher median age of 85 years (interquartile range 79 to 88) versus 82 years (interquartile range 72 to 86) in the concomitant procedure group. The adjusted propensity-matched mortality rate was similar for staged versus same-admission procedures (6.1% vs 7.0%, p = 0.79). In-hospital complication rates, including acute kidney injury, vascular complications, need for percutaneous coronary intervention, mechanical support, and pacemaker implantation, were higher for the same-admission TEER and TAVI group than TEER performed as a staged procedure. Nonhome facility discharges and length of hospital stay (15 vs 4 days) were also significantly higher for the concomitant same-admission TEER and TAVI groups. In conclusion, there was no difference in in-hospital mortality rate between patients who underwent concomitant or staged TEER and TAVI procedures, whereas complication rates were significantly higher in the concomitant group.

A mitral valve repair update: simple, intuitive and physiological techniques, using running sutures (part I).

Today's mitral valve techniques are pluralistic, and the result of variable contributions over decades. However, they are often associated with subjectivity, and inter-surgeon variability, as well as differing outcomes. Here, we propose a set of conceptual techniques, which aim to simplify and standardize mitral valve repair, of which some we have already verified in practice.

Mitral valve repair update: simple, intuitive and physiological techniques, using running sutures (part II).

Modern mitral valve techniques are variable and, mostly, well-validated. However, they are skill dependent, and some lack of standardization, regarding the number and positioning of the cords, or the management of the targeted pathology. We continue the introduction of novel, perhaps more intuitive, aiming to simplify mitral valve repair, while achieving a reproducible result, of which some we have already verified.