[Mid- and long-term outcomes of percutaneous balloon mitral valvuloplasty guided solely by echocardiography].

Objective: To evaluate the mid-and long-term clinical outcomes of percutaneous balloon mitral valvuloplasty (PBMV) guided solely by echocardiography. Methods: A total of 71 patients with moderate to severe mitral stenosis who underwent PBMV guided solely by echocardiography at Fuwai Hospital, Chinese Academy of Medical Sciences, from January 2016 to December 2022 were retrospectively included. The clinical data and follow-up information were collected and analyzed. Results: Finally, 71 patients (11 males and 60 females) aged (48.6±12.4) years, including 3 pregnant women were included. One patient required surgical intervention due to moderate to severe mitral regurgitation, resulting in a procedure success rate of 98.6% (70/71). The procedural duration was (84.1±40.2) minutes, with the balloon diameter of (26.5±1.1) mm and number of dilatations of 2.9±0.7. The mean mitral transvalvular pressure gradient decreased from (12.6±6.1) mmHg (1 mmHg=0.133 kPa) preoperatively to (5.4±2.4) mmHg postoperatively, while the mitral valve orifice area increased from (0.9±0.2) cm² to (1.7±0.3) cm² (both P<0.001). Before discharge, 16 patients developed new mild mitral regurgitation, five developed new moderate mitral regurgitation, and one patient had a small amount of pericardial effusion absorbed by herself. No severe complications such as death, pericardial tamponade, or thromboembolism occurred during the perioperative period. The average follow-up duration was 12-84 (49.7±21.4) months. At two years postoperatively, the mean mitral transvalvular pressure gradient was (6.2±2.5) mmHg, and the mitral valve orifice area was (1.6±0.3) cm². Eight patients underwent surgical mitral valve replacement at an median of [M(Q1, Q3)] 18 (5, 53) months postoperatively, and one patient died during the follow-up period due to non-cardiac reasons. Conclusion: The mid-and long-term outcomes of PBMV guided solely by echocardiography are favorable.

Multicenter Pivotal Study of the Alterra Adaptive Prestent for the Treatment of Pulmonary Regurgitation.

BACKGROUND: A dilated native right ventricular outflow tract (RVOT) presents unique challenges for transcatheter management using balloon-expandable valves. The Alterra Adaptive Prestent was designed to expand transcatheter therapy to treat patients with dilated RVOTs. OBJECTIVES: The aim of this study was to report 2-year outcomes of the main cohort of the ALTERRA (Multicenter Study of Congenital Pulmonic Valve Dysfunction Studying the SAPIEN 3 THV With the Alterra Adaptive Prestent) pivotal trial using the prestent with transcatheter pulmonary valve replacement. METHODS: The prestent device used with the 29 mm SAPIEN 3 transcatheter heart valve (THV) was evaluated for the management of patients with moderate or greater pulmonary valve regurgitation (PR). The primary endpoint was THV dysfunction at 6 months, defined as a nonhierarchical composite of RVOT/pulmonary valve reintervention, moderate or greater total PR on transthoracic echocardiography, and mean RVOT/pulmonary valve gradient 35 mm Hg or greater on transthoracic echocardiography. The primary endpoint and outcomes through 2 years are presented in this analysis. RESULTS: Of 97 patients screened, 60 underwent prestent and THV implantation. There was 1 staged procedure. No patients had THV dysfunction at 6 months. At 2 years, the majority of patients (92.5%) had mild or less PR, with no reports of coronary compression, stent fractures warranting reintervention, or endocarditis. Of the 21 patients (34.4%) who experienced early (days 0-1) arrhythmias, 12 had episodes of nonsustained ventricular tachycardia that resolved with medication. One patient underwent reintervention secondary to an iatrogenic RVOT obstruction; there were no deaths or explantations through 2 years. CONCLUSIONS: The Alterra prestent in combination with the SAPIEN 3 THV has excellent outcomes at 2 years, with no significant valve dysfunction in the main pivotal cohort.

Impact of Balloon-Expandable TAVR Valve Deformation and Calcium Distribution on Outcomes in Bicuspid Aortic Valve.

BACKGROUND: Research on the role of transcatheter heart valve (THV) deformation and calcium distribution in patients with bicuspid aortic valves (BAVs) undergoing transcatheter aortic valve replacement (TAVR) remains limited. OBJECTIVES: The aim of this study was to evaluate the impact of THV deformation on clinical outcomes in individuals with BAVs undergoing TAVR and the influence of calcium on these outcomes. METHODS: In total, 229 consecutive patients with BAVs who underwent TAVR with balloon-expandable valves and had computed tomography (CT) performed 30 days post-TAVR were analyzed. Patients were stratified into 3 groups: group 1 (n = 125), with no THV underexpansion or eccentricity; group 2 (n = 69), with underexpansion or eccentricity; and group 3 (n = 35), with both. Calcium distribution was assessed using CT, and its associations with clinical outcomes, including all-cause mortality at 3 years and leaflet thrombosis at 30 days, were determined. A subgroup analysis of patients with type 1 BAVs was conducted. RESULTS: Group 3 exhibited higher rates of all-cause mortality than the other groups, along with the highest risk for hypoattenuated leaflet thickening at 30 days. Multivariate analysis identified annular and left ventricular outflow tract calcification as independent predictors of all-cause mortality and hypoattenuated leaflet thickening. In patients with type 1 BAVs, excessive calcification at the raphe and opposite leaflet were associated with all-cause mortality at 3 years. CONCLUSIONS: THV deformation post-TAVR was significantly linked to all-cause mortality in patients with BAVs. Annular and left ventricular outflow tract calcification correlated with increased risks for all-cause mortality and leaflet thrombosis. (Assessment of Transcatheter and Surgical Aortic Bioprosthetic Valve Thrombosis and Its Treatment With Anticoagulation [RESOLVE]; NCT02318342).

Asymmetrical Expansion of Balloon-Expandable Transcatheter Aortic Valve Prostheses: Implications for Valve Hemodynamic and Clinical Outcomes.

BACKGROUND: Asymmetrical expansion of transcatheter heart valves (THVs), manifesting as stent frame deformation, is an occasional fluoroscopic finding in transcatheter aortic valve replacement (TAVR). OBJECTIVES: The aim of this study was to investigate the impact of asymmetrical expansion of balloon-expandable THVs on hemodynamic valve performance and clinical outcomes. METHODS: In a prospective registry, TAVR asymmetry index was measured using freeze-frame fluoroscopic images and was defined as the ratio of THV heights: [(longer height/shorter height) - 1] × 100. THV hemodynamic performance was measured using echocardiography before hospital discharge. Impaired hemodynamic valve performance was defined as a mean residual THV gradient ≥20 mm Hg and/or moderate or greater paravalvular regurgitation. RESULTS: Among 1,216 patients undergoing transfemoral TAVR for native severe aortic valve stenosis with contemporary balloon-expandable THVs between February 2014 and June 2022, asymmetry index was an excellent predictor of impaired hemodynamic valve performance (area under the receiver-operating characteristic curve: 0.88; 95% CI: 0.84-0.92; P < 0.001). The optimal asymmetry index threshold for predicting impaired THV performance was >5.5% (sensitivity 77%, specificity 86%) and occurred in 17% of patients. Higher asymmetry index, as a continuous variable, was associated with impaired hemodynamic valve performance independent of total aortic valve calcium, bicuspid anatomy, balloon-expandable valve prosthesis type or size, and Society of Thoracic Surgeons Predicted Risk of Mortality score (OR: 1.37; 95% CI: 1.29-1.46; P < 0.001). High TAVR asymmetry index was not associated with all-cause mortality during a median of 376 days of follow-up (HR: 1.00; 95% CI: 0.71-1.41; P = 0.989). CONCLUSIONS: Asymmetrical expansion of balloon-expandable THVs was associated with impaired hemodynamic valve performance but not with clinical outcomes.

Left atrial strain by cardiac MRI feature tracking in mitral stenosis before and after balloon valvuloplasty.

The aim was to investigate LA strain by feature tracking cardiac MRI in mitral stenosis (MS) patients before and after percutaneous balloon mitral valvuloplasty (PBMV). Patients underwent cardiac MRI before and after successful PBMV (n = 18). Mitral valve area, transmitral velocity and gradients, LA volumes and ejection fraction (LAEF) were measured. LA strain feature tracking analysis was used to calculate LA reservoir, conduit, and booster strain. LA strain, LA volumes, LAEF and mitral valve severity indices were compared before and after PBMV. Correlations between LA strain and other cardiac MRI parameters were assessed. After PBMV, mitral valve area increased from 1.18 ± 0.25 cm2 to 2.26 ± 0.27 cm2, p < 0.001. Transmitral peak velocity decreased from 1.7 ± 0.37 m/s to 1.3 ± 0.27 m/s, p < 0.001. Transmitral peak gradient decreased from 12.4 ± 4.8 mmHg to 6.8 ± 2.9 mmHg, p < 0.001, and mean gradient decreased from 6.9 ± 3.8 mmHg to 2.9 ± 1.4 mmHg, p < 0.001. Maximal LA volume decreased from 73.1 ± 14.2 ml/m2 to 62.7 ± 16.3 ml/m2, p = 0.018; corrected p value = 0.054. LAEF increased from 36.3 ± 8.7% to 44.4 ± 9.5%, p = 0.010. Reservoir strain increased from 11.7 ± 3.1% to 14.9 ± 3.6% after PBMV, p = 0.009, and conduit strain from 3.8 ± 2% to 6 ± 2.3%, p = 0.005. Booster strain insignificantly increased after PBMV. Cardiac MRI feature tracking provides information on the 3 LA functional phases. Significant improvement was observed in reservoir and conduit functions after successful PBMV.

3-Year Outcomes of Balloon-Expandable Valves: 20-mm vs Larger Valves (≥23 mm).

BACKGROUND: A prior Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry-based analysis reported similar 1-year clinical outcomes with small (20-mm) vs large (≥23-mm) balloon-expandable valves (BEV). OBJECTIVES: The aim of this study was to describe mid-term 3-year clinical outcomes for small vs large BEV and the relationship between discharge echocardiographic mean gradient (MG) and different definitions of prothesis-patient mismatch (PPM) with clinical outcomes. METHODS: Using the TVT Registry with Centers for Medicare and Medicaid Services linkage, a propensity-matched analysis of patients receiving 20- vs ≥23-mm BEVs was performed. Spline curves and Kaplan-Meier plots with adjusted HRs determined the relationship between MG and 3-year mortality. RESULTS: In total, 316,091 patients were analyzed; after propensity matching, 8,100 pairs of each group were compared. The 20-mm BEV was associated with higher MGs compared with ≥23-mm BEVs (16.2 ± 7.2 mm Hg vs 11.8 ± 5.7 mm Hg; P < 0.0001). At 3 years, there was no difference in mortality between 20- and ≥23-mm BEVs (31.5% vs 32.5%, respectively; HR: 0.97; 95% CI: 0.90-1.05). Compared with an MG of 10 to 30 mm Hg, an MG <10 mm Hg (HR: 1.25; 95% CI:1.22-1.27) was associated with increased 3-year mortality. Measured severe PPM and predicted no PPM were associated with increased 3-year mortality (33.5% vs 32.9% vs 32.1%; P < 0.0001) and (33.5% vs 31.1% vs 30%; P < 0.0001), respectively. Low MG and severe measured PPM were associated with lower left ventricular ejection fraction (LVEF). CONCLUSIONS: Patients with small-prosthesis BEVs (20 mm) had identical 3-year survival as those with larger (≥23-mm) BEV valves. Severe measured PPM and low MG (<10 mm Hg), but not predicted severe PPM, were associated with lower LVEF and increased mortality, suggesting that LVEF is the culprit for worse outcomes.

Impact of Procedural Success Definitions on Long-Term Outcomes in Patients With Rheumatic Mitral Stenosis Treated With Percutaneous Balloon Mitral Valvuloplasty: A Multicenter, Retrospective Cohort Study.

BACKGROUND: It is uncertain which percutaneous balloon mitral valvuloplasty (PBMV) success definitions should be used because there are no studies comparing the effects of these definitions on subsequent outcomes. We evaluated the association between 3 success definitions and long-term clinical outcomes in patients with rheumatic mitral stenosis who underwent PBMV. METHODS AND RESULTS: This multicenter retrospective study included patients with severe rheumatic mitral stenosis who underwent PBMV. Three definitions were used as follows: (A) post-PBMV mitral valve area (MVA) ≥1.5 cm2 or ≥50% increase in MVA with MR <3+; (B) post-PBMV MVA ≥1.5 cm2 and MR ≤2+; and (C) post-PBMV MVA ≥1.5 cm2 or ≥50% increase in MVA, with no more than 1-grade increment in MR. Multivariable Cox regression analyses were performed to evaluate the associations between PBMV success and the composite of all-cause mortality, mitral surgery, and repeat PBMV. Successful PBMV, according to definitions A, B, and C was associated with a lower risk of the composite outcomes (definition A-hazard ratio [HR], 0.55 [95% CI, 0.43-0.69], definition B-HR, 0.55 [95% CI, 0.43-0.69], definition C-HR, 0.55 [95% CI, 0.44-0.69]). Patients meeting all 3 success definitions had the lowest risk compared with those who did not meet any definition or met 1 or 2 definitions. CONCLUSIONS: All 3 success definitions had a prognostic impact on outcomes. Patients who achieved post-PBMV MVA ≥1.5 cm2, irrespective of the percentage increase in MVA, and MR ≤grade 2, with no more than a 1-grade increment in MR, had the most favorable outcomes.

Impact of Tricuspid Regurgitation on Outcomes of Transcatheter Aortic Valve Replacement With Balloon-Expandable Valves.

BACKGROUND: Tricuspid regurgitation (TR) is highly prevalent in the transcatheter aortic valve replacement (TAVR) population, but clear management guidelines are lacking. OBJECTIVES: The aims of this study were to elucidate the prevalence and consequences of severe TR in patients with aortic stenosis undergoing TAVR and to examine the change in TR post-TAVR, including predictors of improvement and its impact on longer term mortality. METHODS: Using Centers for Medicare and Medicaid Services-linked TVT (Transcatheter Valve Therapy) Registry data, a propensity-matched analysis was performed among patients undergoing TAVR with baseline mild, moderate, or severe TR. Kaplan-Meier estimates were used to assess the impact of TR on 3-year mortality. Multivariable analysis identified predictors of 30-day TR improvement. RESULTS: Of the 312,320 included patients, 84% had mild, 13% moderate, and 3% severe TR. In a propensity-matched cohort, severe baseline TR was associated with higher in-hospital mortality (2.5% vs 2.1% for moderate TR and 1.8% for mild TR; P = 0.009), higher 1-year mortality (24% vs 19.6% for moderate TR and 16.6% for mild TR; P < 0.0001), and 3-year mortality (54.2% vs 48.5% for moderate TR and 43.3% for mild TR; P < 0.0001). Among the patients with severe TR at baseline, 76.4% improved to moderate or less TR 30 days after TAVR. Baseline mitral regurgitation moderate or greater, preserved ejection fraction, higher aortic valve gradient, and better kidney function predicted TR improvement after TAVR. However, severe 30-day residual TR was associated with higher 1-year mortality (27.4% vs 18.7% for moderate TR and 16.8% for mild TR; P < 0.0001). CONCLUSIONS: Severe baseline and 30-day residual TR after TAVR are associated with increased mortality up to 3 years. This analysis identifies a higher risk group that could be evaluated for the recently approved tricuspid interventions.

Comparison of Mitral Valve Repair Versus Percutaneous Mitral Balloon Commissurotomy for Patients With Rheumatic Heart Disease: A Single-Centre Study.

BACKGROUND: Percutaneous mitral balloon commissurotomy (PMBC) is the standard treatment option for patients with rheumatic mitral stenosis (MS), according to current guidelines. This study aimed to compare the outcomes of rheumatic mitral valve repair (rMVR) and PMBC in this patient population. METHODS: Baseline, clinical, and follow-up data from 703 patients with rheumatic heart disease who underwent PMBC or rMVR at the current centre were collected and analysed. A 1:1 propensity score (PS) matching method was used to balance the differences in baseline characteristics between the two groups. The primary outcome was mitral valve reoperation, and the secondary outcome was all-cause mortality. RESULTS: Propensity score matching generated 101 patient pairs for comparison. In the matched population, there were no significant differences in the early clinical outcomes between the groups. The median follow-up time was 40.9 months. Overall, patients in the rMVR group had a statistically significantly lower risk of mitral valve reoperation than those in the PMBC group (HR 0.186; 95% CI 0.041-0.835; p=0.028). Regarding all-cause mortality, no statistically significant differences were observed between the rMVR and PMBC groups (HR 4.065; 95% CI 0.454-36.374; p=0.210). CONCLUSIONS: Compared with PMBC, rMVR has more advantages for the correction of valve lesions; therefore, it may offer a better prognosis than PMBC in select patients with rheumatic MS. However, this finding needs to be verified in future studies with larger sample sizes and longer follow-up periods.

Balloon aortic valvuloplasty bridge to transcatheter aortic valve replacement is associated with worse in-hospital mortality.

BACKGROUND: Balloon aortic valvuloplasty (BAV) has gained renewed interest as a bridge to transcatheter aortic valve replacement (TAVR) for patients with aortic stenosis (AS). However, it is unclear whether they patients should undergo TAVR directly or receive a staged bridge to BAV before TAVR is unclear. We used a national database to examine the association between BAV and TAVR in patients with TAVR and its effect on in-hospital mortality. METHODS: Using the nationwide inpatient database of the Japanese registry of all cardiac and vascular diseases and the combination of the diagnosis procedure combination, we retrospectively analyzed 27,600 patients with AS who underwent TAVR between October 2013 and March 2021. Outcomes of the direct TAVR group (n = 27,387) were compared with those of the BAV bridge to TAVR group (n = 213), which received BAV at least 1 day before TAVR. RESULTS: The median age was 85 (interquartile range: 82-88) years, with 33.3% (n = 9188) being male. Unplanned/emergent admissions increased with TAVR, whereas the use of BAV bridge to TAVR decreased. The in-hospital mortality rate was 1.3% and decreased over time. However, the BAV bridge to TAVR had a significantly higher in-hospital mortality than direct TAVR (5.6% vs. 1.3%; p < .0001). Factors associated with in-hospital mortality included age, body mass index, chronic renal disease, percutaneous coronary intervention, and BAV bridge to TAVR. CONCLUSIONS: In unplanned/emergent and planned admission settings, the in-hospital mortality rate for BAV bridge to TAVR is worse than that for direct TAVR. Practical criteria for BAV bridge to TAVR should be proposed to improve outcomes.

Correlation of transthoracic echocardiographic and angiographic measurements of pulmonary valve annular diameter in dogs with pulmonary stenosis.

INTRODUCTION/OBJECTIVES: Dogs with severe pulmonary stenosis (PS) are routinely treated with balloon valvuloplasty. Success and safety of these procedures require an accurate assessment of the pulmonary valve annulus (PVA) diameter for proper balloon catheter selection. PVA diameter is assessed with angiography (PVA-Ang) and transthoracic echocardiography (PVA-TTE), and both may impact procedural planning for balloon valvuloplasty. The objective of this study was to describe the relationship between PVA-Ang and PVA-TTE in dogs with PS. ANIMALS, MATERIALS AND METHODS: Observational, retrospective study of 59 client-owned dogs. Medical records of dogs diagnosed with PS were reviewed. Images from selective right ventricular angiography and transthoracic echocardiography were reviewed. The PVA diameters were measured at the time of angiography (PVA-Ang) and by a single operator for this study (PVA-TTE). Image quality scores were assigned to echocardiographic images of the PVA based on visualization of PVA margins and valve leaflet hinge points. RESULTS: In 41/59 (70%) dogs, the diameter of the PVA-Ang was larger than the PVA-TTE, and the (range 0.1 to 8.4 mm) worse echocardiographic image quality, the difference in measurement between modalities increased. Dogs with poor echocardiographic image quality had greater differences (range -7.7 to 8.4 mm) between PVA-Ang and PVA-TTE compared to those with excellent image quality (range -2.2 to 3.8 mm), and the absolute differences between poor (median 2.8 mm, range 1.5-8.4 mm) and excellent (median 1.4 mm, 0.2-3.8 mm) image quality were significant (P=0.005). CONCLUSIONS: Diameters of PVA-Ang are greater than PVA-TTE in most dogs, and these differences are most apparent with worse echocardiographic image quality. These differences may be clinically relevant to interventional procedure planning.

Incidence and predictors of adverse outcomes in patients with rheumatic mitral stenosis following percutaneous balloon mitral valvuloplasty: a study from a tertiary center in Thailand.

BACKGROUND: Rheumatic mitral stenosis (MS) remains a common and concerning health problem in Asia. Percutaneous balloon mitral valvuloplasty (PBMV) is the standard treatment for patients with symptomatic severe MS and favorable valve morphology. However, studies on the incidence and predictors of adverse cardiac outcomes following PBMV in Asia have been limited. This study aims to evaluate the incidence and predictors of adverse outcomes in patients with rheumatic MS following PBMV. METHODS: A retrospective cohort study was conducted on patients with symptomatic severe MS who underwent successful PBMV between 2002 and 2020 at a tertiary academic institute in Thailand. Patients were followed up to assess adverse outcomes, defined as a composite of cardiac death, heart failure hospitalization, repeat PBMV, or mitral valve surgery. Univariable and multivariable analyses were performed to identify predictors of adverse outcomes. A p-value of < 0.05 was considered statistically significant. RESULTS: A total of 379 patients were included in the study (mean age 43 ± 11 years, 80% female). During a median follow-up of 5.9 years (IQR 1.7-11.7), 74 patients (19.5%) experienced adverse outcomes, with an annualized event rate of 2.7%. Multivariable analysis showed that age (hazard ratio [HR] 1.03, 95% confidence interval [CI] 1.008-1.05, p = 0.006), significant tricuspid regurgitation (HR 2.17, 95% CI 1.33-3.56, p = 0.002), immediate post-PBMV mitral valve area (HR 0.39, 95% CI 0.25-0.64, p = 0.01), and immediate post-PBMV mitral regurgitation (HR 1.91, 95% CI 1.18-3.07, p = 0.008) were independent predictors of adverse outcomes. CONCLUSIONS: In patients with symptomatic severe rheumatic MS, the incidence of adverse outcomes following PBMV was 2.7% per year. Age, significant tricuspid regurgitation, immediate post-PBMV mitral valve area, and immediate post-PBMV mitral regurgitation were identified as independent predictors of these adverse outcomes.

Impact of commissural calcification on clinical outcome of percutaneous balloon mitral valvuloplasty; a retrospective cohort study of 876 patients.

BACKGROUND: Percutaneous balloon mitral valvuloplasty (PBMV) is the ACC/AHA class I recommendation for treating symptomatic rheumatic mitral stenosis with suitable valve morphology, less than moderate MR and absence of left atrium clot. The mitral valve restenosis and significant mitral regurgitation (MR) are known adverse outcomes of PBMV. This study aimed to evaluate the outcomes of PBMV in patients with severe mitral stenosis and the effect of Commissural Calcification (CC) on the outcomes. METHODS: In this single-center retrospective cohort study, 876 patients who underwent PBMV were categorized into three groups based on their Wilkins score (Group I: score ≤ 8, Group II: score 9-10, and Group III: score 11-12). Patients were evaluated before, early after PBMV and at 6- and 24-month follow-ups. Main clinical outcomes were defined as significant restenosis and or symptomatic significant MR (moderate to severe and severe MR) or candidate for mitral valve replacement (MVR). The outcomes were compared between patients with and without CC. RESULTS: A total of 876 patients with mean age 46.4 ± 12.3 years (81.0% females) were categorized based on Wilkins score. 333 (38.0%) were in Group I, 501 (57.2%) were in Group II, and 42 (4.8%) were in Group III. CC was present in 175 (20.0%) of the patients, among whom 95 (54.3%) had calcification of the anterolateral commissure, 64 (36.6%) had calcification of the posteromedial commissure, and in 16 (9.1%) patients both commissures were calcified. There was a significant difference in Wilkins score between patients with and without CC (P < 0.001). CC was associated with higher odds of significant symptomatic MR at early and mid-term follow up (OR: 1.69, 95%CI 1.19-2.41, P = 0.003; and OR: 3.90, 95%CI 2.61-5.83, P < 0.001, respectively), but not with restenosis (P = 0.128). Wilkins Groups II and III did not show higher odds of significant symptomatic MR compared to Group I at early (II: P = 0.784; III: P = 0.098) and mid-term follow up (II: P = 0.216; III: P = 0.227). Patients in Wilkins Group II had higher odds of restenosis compared to Group I (OR: 2.96,95%CI: 1.35-6.27, P = 0.007). CONCLUSION: Commissural calcification (CC) is an independent predictor of the significant symptomatic MR (an important determinant of adverse outcome) following PBMV in the early and mid-term follow-up. Mitral valve restenosis occurs more in patients with higher Wilkins score compared to group I with score ≤ 8. Combined Wilkins score and CC should be considered for patient suitability for PBMV.

Controlled mitral valvuloplasty using steerable catheter- waist- formed balloon system: A clinical case series.

As the general population ages, the incidence of degenerative mitral stenosis (MS) among patients has increased. Percutaneous mitral valvuloplasty (PMV) has emerged as a well-established option for mitral rheumatic stenosis with specific characteristics. However, a blank therapeutic space must be filled with the treatment options for degenerative or rheumatic mitral stenosis in patients with many comorbidities and contraindication for valvuloplasty. We here present a comprehensive overview of the current possibilities, despite their scarce success. That is the reason why we propose a case series to facilitate a better understanding of our innovative technique in this challenging clinical context.

Balloon predilation or direct valve implantation in TAVI for women: Insights from the DIRECTAVI study.

BACKGROUND: The randomized DIRECTAVI trial demonstrated safety and feasibility of transcatheter aortic valve implantation (TAVI) without balloon aortic valvuloplasty (BAV) using SAPIEN 3 balloon-expandable devices. However, the female population with smaller anatomy may have potential higher risk of residual gradient and/or mismatch. PURPOSE: We assessed the impact of BAV on the procedural success rate and clinical outcomes in the female population of the DIRECTAVI trial. METHODS: Between May 2016 and May 2018, 91 of the 250 patients included in the DIRECTAVI trial were women (38.6%), 45 of them (49.5%) were enrolled in the BAV group and 46 of them (50.5%) in the direct TAVI group. The primary endpoint was procedural success rate in women (Valve Academic Research Consortium-2 criteria). The secondary endpoint included evaluation of PPM and 1-month major adverse events according to the implantation stategy in women and comparison between men and women regarding major endpoints. RESULTS: The primary endpoint occurred in 29 women (64.4%) in the BAV group and in 34 women (73.9%) in the direct TAVI group (mean difference 9.47%; 95% confidence interval: 6.5%-25.4%; p = 0.045 for non-inferiority of the direct strategy). One-month major adverse events were similar between the 2 women groups. Procedural success was lower in women vs men (p = 0.01) due to higher incidence of moderate mismatches in women (p = 0.001) but with no significant difference regarding the implantation strategy (p = 0.4). CONCLUSION: Direct implantation of the balloon-expandable SAPIEN 3 valve was non-inferior to predilatation on procedural success in women. Incidence of moderate mismatch was higher in women but was not related to the implantation strategy.