Percutaneous Repair or Medical Treatment for Secondary Mitral Regurgitation.

BACKGROUND: In patients who have chronic heart failure with reduced left ventricular ejection fraction, severe secondary mitral-valve regurgitation is associated with a poor prognosis. Whether percutaneous mitral-valve repair improves clinical outcomes in this patient population is unknown. METHODS: We randomly assigned patients who had severe secondary mitral regurgitation (defined as an effective regurgitant orifice area of >20 mm2 or a regurgitant volume of >30 ml per beat), a left ventricular ejection fraction between 15 and 40%, and symptomatic heart failure, in a 1:1 ratio, to undergo percutaneous mitral-valve repair in addition to receiving medical therapy (intervention group; 152 patients) or to receive medical therapy alone (control group; 152 patients). The primary efficacy outcome was a composite of death from any cause or unplanned hospitalization for heart failure at 12 months. RESULTS: At 12 months, the rate of the primary outcome was 54.6% (83 of 152 patients) in the intervention group and 51.3% (78 of 152 patients) in the control group (odds ratio, 1.16; 95% confidence interval [CI], 0.73 to 1.84; P=0.53). The rate of death from any cause was 24.3% (37 of 152 patients) in the intervention group and 22.4% (34 of 152 patients) in the control group (hazard ratio, 1.11; 95% CI, 0.69 to 1.77). The rate of unplanned hospitalization for heart failure was 48.7% (74 of 152 patients) in the intervention group and 47.4% (72 of 152 patients) in the control group (hazard ratio, 1.13; 95% CI, 0.81 to 1.56). CONCLUSIONS: Among patients with severe secondary mitral regurgitation, the rate of death or unplanned hospitalization for heart failure at 1 year did not differ significantly between patients who underwent percutaneous mitral-valve repair in addition to receiving medical therapy and those who received medical therapy alone. (Funded by the French Ministry of Health and Research National Program and Abbott Vascular; MITRA-FR ClinicalTrials.gov number, NCT01920698 .).

Comparison of multislice computed tomography findings between bicuspid and tricuspid aortic valves before and after transcatheter aortic valve implantation.

AIMS: This study sought to compare the multislice computed tomography (MSCT) characteristics of bicuspid aortic valves (BAV) and tricuspid aortic valves (TAV) before and after implantation of the CoreValve (Medtronic, Santa Rosa, California) or the Edwards SapienXT (Edwards Lifesciences, Irvine, CA). METHODS AND RESULTS: From March 2009 to March 2013, a total of 67 TAVI patients who had both pre- and post-procedural MSCT were studied. Eleven patients underwent TAVI in BAV with the CoreValve (n = 6) or SapienXT (n = 5) and 56 patients underwent TAVI in TAV with the CoreValve (n = 38) or SapienXT (n = 18). The BAV group was similar to the TAV group except for a higher pre-procedural mean pressure gradient (53.1 ± 17.4 vs. 48.8 ± 20.4 mm Hg, P = 0.03), a larger annulus perimeter (89.3 ± 9.0 vs. 81.8 ± 8.1 mm, P = 0.03) and a higher aortic valve calcium volume (1262.7 ± 396.0 vs. 556.4 ± 461.9 mm(3) , P < 0.01). In the CoreValve group, post-procedural mean pressure gradient was significantly higher in the BAV group (11.0 ± 2.6 vs. 8.2 ± 2.8 mm Hg, P = 0.04) and a smaller valve area/pre-annulus area ratio was observed at each level of the prosthesis (base of the stent frame 81.7% ± 14.9% vs. 94.7% ± 15.0%, P = 0.06, annulus level 74.3% ± 16.7% vs. 89.9% ± 10.5%, P = 0.03, leaflet level 64.6% ± 13.1% vs. 81.2% ± 13.2%, P < 0.01). This was not observed in the Edwards group. CONCLUSIONS: Compared to TAV, patients with BAV have higher gradients, larger annulus perimeters and more calcified valves. Higher post procedural gradient and valve underexpansion were frequently observed after CoreValve implantation. Further MSCT study is required to demonstrate the efficacy of TAVI in BAV.

Is postdilatation useful after implantation of the Edwards valve?

BACKGROUND: Few data are available about postdilatation (PD) for the treatment of significant paravalvular aortic regurgitation (AR) after transcatheter aortic valve implantation of the Edwards valve. METHODS AND RESULTS: A total of 470 patients, aged 83.4 ± 6.4 yrs, with logistic European System for Cardiac Operative Risk Evaluation 21.9 ± 12.3, undergoing transcatheter aortic valve implantation with the Edwards valve were evaluated. PD was performed using the balloon delivery system when significant paravalvular AR was identified. The diameter of the valve was measured from cine acquisition at three different levels. PD was performed in 49 (10.4%) patients with grade 2, 3, or 4 AR as 42.1%, 55.3%, and 2.6%, respectively. After PD, a reduction of at least 1 degree of AR was achieved in 81.5% of cases. Residual AR grades 2, 3, and 4 were observed in 36.8%, 10.5%, and 0%, respectively. A significant increase in the prosthesis diameter was observed at the three valve levels (absolute Δ 3.5%-5.4%, P.< 0.01). For the 23 mm valve, mid level of valve increased from 23.0 ± 0.4 to 24.1 ± 0.5 mm (P < 0.01) and for the 26 mm, from 25.2 ± 0.9 to 26.6 ± 0.9 mm (P < 0.01). Occurrence of annulus rupture (4.1% vs. 1.7%, P = 0.24), cerebrovascular accidents (2.0% vs. 2.1%, P = 0.72), need for new pacemaker (8.2% vs. 5.5%, P = 0.31), and 30-day composite endpoint (24.5% vs. 20.2%, P = 0.48) were not significantly different between PD and non-PD groups. CONCLUSIONS: PD for the treatment of significant paravalvular leak proved to be a feasible treatment allowing a significant increase in valve size and decrease in PVL without increase in stroke rates. This promising approach needs further confirmation.

Prognostic value of aortic root calcification volume on clinical outcomes after transcatheter balloon-expandable aortic valve implantation.

BACKGROUND: Few data are available about whether aortic root calcification may impact the outcomes after transcatheter aortic valve implantation (TAVI). OBJECTIVES: This study sought to evaluate the impact of aortic root calcification volume on clinical outcome after TAVI with balloon expandable Edwards Sapien XT valve (Edwards Lifesciences, Irvine, California). METHODS: A total of 162 TAVI patients (aged 84.0 [Interquartile Range (IQR) 81.0-84.0] years, Logistic EuroSCORE 14.5 [IQR 9.8-25.1]) with preprocedural MDCT were studied. Aortic root calcification volume was measured by MDCT image and using the dedicated software for aortic valve assessment (the automated 3mensio™ Valves 5.1, sp1, 3mensio Pie Medical Imaging BV, Maastricht, the Netherlands). A valve calcification index (VCI) was defined as calcification volume (mm(3))/body surface area (mm(2)). RESULTS: VCI was significantly higher among patients with 30-day mortality. A VCI threshold of 517.4 (area under the curve 0.69, 95% CI 0.50-0.87, P = 0.03) predicted a higher incidence of annulus rupture (9.1 vs. 0.9%, P = 0.02) and cardiac tamponade (12.7 vs. 1.9%, P < 0.01), lower device success (83.6% vs. 95.3%, P < 0.01) and 30-day survival rate (80.0% vs. 97.2%, P < 0.01). Multivariate logistic regression analysis showed only ejection fraction and VCI were identified as independent predictors of 30-day mortality (Odds ratio 0.948 [95% confidence interval 0.909-0.988], P = 0.012, Odds ratio 1.003 [95% confidence interval 1.001-1.005], P = 0.013, respectively). CONCLUSIONS: Significantly worse acute clinical outcomes after Edwards valve implantation were observed in patients with large amount of aortic annulus calcifications quantitatively measured by dedicated MDCT software. Application of VCI may prove helpful in prediction of clinical outcomes after TAVI.

Can we predict postprocedural paravalvular leak after Edwards SAPIEN transcatheter aortic valve implantation?

BACKGROUND: Postprocedural paravalvular leak (PVL) ≥ 2 has been shown to be associated with worse outcomes after transcatheter aortic valve implantation (TAVI). This study sought to identify predictive factors of postprocedural PVL ≥ 2 after TAVI with the Edwards valve. METHODS AND RESULTS: A total of 176 patients with Edwards TAVI (aged 83.4 ± 7.4 years, Logistic EuroSCORE [the Logistic European System for Cardiac Operative Risk Evaluation] 18.8 ± 12.0, transfemoral 54.5%) who had preprocedural multidetector computed tomography (MDCT) were studied. A PVL ≥ 2 was observed in 12.5% of cases. By multivariate analysis, only the valve calcification index (VCI) defined as aortic root calcification volume/body surface area (odds ratio [OR] = 1.002, 95% confidence interval [CI] = 1.001-1.004, P = 0.006) and the valve diameter/the calculated average annulus diameter (CAAD) by MDCT (OR = 0.683, 95% CI = 0.474-0.984, P = 0.041) were identified as independent predictors of postprocedural PVL ≥ 2. A score predicting postprocedural PVL ≥ 2 (PVL score) was determined by allotting one point when the valve diameter/CAAD ratio was <1.055 and one point when VCI was >418.4 mm(3) /m(2) , and summing all points accrued. Area under receiver-operator characteristic curves of PVL score was 0.71 (95% CI = 0.59-0.83, P < 0.01). The incidence of PVL ≥ 2 was 5.3% in patients with a PVL score of 0, 11.8% for a PVL score of 1 and 37.5% for a PVL score of 2. CONCLUSIONS: The only predictors of PVL ≥ 2 after Edwards valve implantation are the valve diameter/CAAD and VCI. The PVL score could prove to be an excellent tool for predicting the risk of PVL.

Transcatheter aortic valve implantation in patients of small body size.

AIMS: The aim of this study was to evaluate the efficacy and safety of transcatheter aortic valve implantation (TAVI) in patients of small body size (SB). METHODS AND RESULTS: Between October 2006 and November 2011, 424 patients undergoing TAVI were evaluated. Patients with a small body surface area (BSA; <1.75 m(2)) were defined as the "SB group" (n = 215) and the remaining large BSA patients as the "LB group" (n = 209). In the SB group, mean annulus diameter measured by CT and minimal femoral artery diameter were significantly smaller (23.1 ± 1.92 vs. 24.3 ± 1.91 mm, P < 0.01; 7.59 ± 1.06 vs. 8.29 ± 1.34 mm, P < 0.01, respectively). The logistic EuroSCORE was similar between groups (22.5 ± 10.4 vs. 23.4 ± 12.0; P = 0.43). Equivalent device success (91.2% vs. 91.4%; P = 0.94) and 30-day survival rates (85.1% vs. 87.6%; P = 0.46) were achieved in both groups. Vascular complications and the 30-day combined safety end point rate were significantly higher in the SB group (13.0% vs. 4.3%, P < 0.01; 27.4% vs. 18.3%, P = 0.03, respectively). Similar post-procedural mean pressure gradient was achieved in both groups (10.2 ± 4.3 vs. 11.0 ± 4.6 mmHg; P = 0.12). Multivariate analysis showed that BSA was one of the independent predictors of 30-day combined safety end point (Odds ratio: 0.20; 95% confidence interval (CI): 0.05-0.88; P = 0.03). However, Kaplan-Meier analysis revealed no significant difference in mid-term survival rate between groups (log-rank P = 0.64). CONCLUSIONS: TAVI in SB patients resulted in similar clinical outcomes with effective post-procedural hemodynamics compared with LB patients. Care should be taken to avoid vascular complications in SB patients.

Reinterventions after percutaneous mitral commissurotomy during long-term follow-up, up to 20 years: the role of repeat percutaneous mitral commissurotomy.

AIMS: We analysed reinterventions performed during long-term follow-up after percutaneous mitral commissurotomy (PMC) with a particular focus on freedom from mitral surgery and late results of repeat PMC. METHODS AND RESULTS: In 912 patients who had good immediate results of PMC (valve area ≥1.5 cm² with mitral regurgitation ≤2/4), we analysed survival without reintervention (surgery or repeat PMC) and survival without surgery alone, with a follow-up up to 20 years. The median age was 48 years, and 251 patients (27%) had calcified valves. During a median follow-up of 12 years, 351 patients (38%) underwent a reintervention: surgery was performed in 266 (76%) patients and repeat PMC in 85 (24%). Cardiovascular survival without reintervention (surgery or repeat PMC) was 38 ± 2% at 20 years. When analysing cardiovascular survival without surgery, this rate increased to 46 ± 2% at 20 years. In the 504 patients aged <50 years at the time of their initial PMC, 20-year rates were 45 ± 3% for cardiovascular survival without reintervention and 57 ± 3% for cardiovascular survival without surgery. Of the 85 patients who underwent repeat PMC, cardiovascular survival without surgery was 60 ± 7% at 10 years. CONCLUSION: After successful PMC, reintervention is frequently needed. However, almost half of the patients remained free from surgery at 20 years. Repeat PMC was performed in one out of four cases of reintervention in this study, thereby allowing for postponement of surgery in a substantial number of patients.

Late results of percutaneous mitral commissurotomy up to 20 years: development and validation of a risk score predicting late functional results from a series of 912 patients.

BACKGROUND: Long-term follow-up after percutaneous mitral commissurotomy enables predictive factors of late results to be identified. METHODS AND RESULTS: Late results of percutaneous mitral commissurotomy were assessed in 1024 consecutive patients. Good immediate results, defined as valve area ≥1.5 cm(2) without mitral regurgitation >2/4, were obtained in 912 patients (89%). These 912 patients were randomly split into 2 cohorts comprising 609 and 303 patients that were used to develop and validate, respectively, a scoring system predicting late functional results. The 20-year rate of good functional results (survival without cardiovascular death, mitral surgery, or repeat percutaneous mitral commissurotomy and in New York Heart Association class I or II) was 30.2 ± 2.0%. A multivariable Cox model identified 7 predictive factors of poor late functional results: higher final mean gradient (P<0.0001), interaction between age and final mitral valve area (P<0.0001) showing that the impact of valve area decreases with age, interaction between sex and valve calcification (P<0.0001) showing that the impact of valve anatomy is stronger in men, and interaction between rhythm and New York Heart Association class showing an impact of New York Heart Association class only in patients in atrial fibrillation (P<0.0001). A 13-point score enabled 3 risk groups to be defined, corresponding to predicted good functional results of 55.1%, 29.1%, and 10.5% at 20 years in the validation cohort. CONCLUSIONS: Twenty years after percutaneous mitral commissurotomy in a population of patients with varied characteristics, 30% still had good functional results. Prediction of late functional results is multifactorial and strongly determined by age and the quality of immediate results. A simple validated scoring system is useful for estimating individual patient outcome.

Potential mechanism of annulus rupture during transcatheter aortic valve implantation.

Although annulus rupture is one of the most severe complications of transcatheter aortic valve implantation (TAVI), the incidence and mechanism of this complication remain unclear. Out of 387 consecutive TAVI cases in our institution, the incidence of annulus rupture was 1.0% (4/387). The first two patients died because of hemodynamic collapse due to tamponade on day 0. Both surviving patients had undergone preprocedural multidetector computed tomography which revealed large calcifications in the epicardial fat part of the aortic annulus. In both cases, annulus rupture occurred after deployment of a balloon expandable valve suggesting that mechanical compression of this "vulnerable area" by calcification may cause annulus rupture.

Is EuroSCORE II better than EuroSCORE in predicting mortality after transcatheter aortic valve implantation?

OBJECTIVES: The purpose of this study was to examine the performance of the European system for cardiac operative risk evaluation II (ESII) in patients undergoing transcatheter aortic valve implantation (TAVI). BACKGROUND: The ESII was developed recently to improve the predictive value of the original logistic EuroSCORE (LES). METHODS: Between October 2006 and November 2011, 453 consecutive patients with severe aortic stenosis undergoing TAVI with either the Edwards valve or the Corevalve were included in the current analysis. The performance of the ESII, LES, and society of thoracic surgeons predicted risk of mortality score (STS) was evaluated. RESULTS: Mean age was 83.1 ± 6.4 years. The Edwards valve was used in 382 patients (84.3%) of the cohort, transfemoral approach (TF) in 55.0%, transapical approach (TA) in 25.2%, transaortic approach (TAo) 17.8%, transsubclabian approach (SC) 2.0%. The observed 30-day mortality was 12.6% (11.2, 18.4, 7.4, and 22.2% for TF, TA, TAo, SC, respectively). The mean LES, STS, and ESII were 22.4 ± 12.1, 8.1 ± 6.0, and 8.1 ± 5.2, respectively. The Hosmer-Lemeshow test showed ESII was inadequately calibrated for 30-day mortality compared with other risk scores (ESII P = 0.09, LES P = 0.84, STS P = 0.34). By using the area under the receiver operating characteristic curve (AUC), ESII better predicted 30-day mortality, albeit poorly, compared to LES and STS (AUC = 0.68, 0.65, and 0.60, respectively). In the TF cohort, ESII was better in predicting 30-day mortality compared to LES and STS (AUC = 0.74, 0.61, 0.60, respectively). CONCLUSIONS: Although the ESII demonstrated better predictive performance especially in the TF cohort, ESII is still inadequate in predicting mortality after TAVI as are LES and STS.

Impact of procedural success on clinical outcome after MitraClip: Results from the MITRA-FR trial.

BACKGROUND: Differences in procedural success rates have been proposed to explain the divergent results between the MITRA-FR trial (Percutaneous Repair with the MitraClip Device for Severe Functional/Secondary Mitral Regurgitation) and the COAPT trial (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation). AIM: To examine whether MITRA-FR patients who had successful clip implantation achieved a better outcome than the control group. METHODS: Based on the per protocol population of MITRA-FR, we compared the outcome in 71 patients in whom optimal clip implantation was achieved (group 1: mitral regurgitation grade ≤ 1 + at discharge) with that in 23 patients with non-optimal clip implantation (group 2: mitral regurgitation grade ≥ 2 + at discharge) and that in 137 patients in the control group (group 3). The primary endpoint was all-cause death or unplanned hospitalization for heart failure at 24 months. RESULTS: Event-free survival was not different across the groups (42±6% in group 1, 30±10% in group 2 and 31±4% in group 3; log-rank P=0.32). In multivariable analyses, after adjustment for age, sex, rhythm, aetiology, left ventricular ejection fraction and mitral regurgitation severity, group was not associated with variations in outcome: using Group 3 as reference, hazard ratio 0.86, 95% confidence interval 0.58-1.27 (P=0.43) in group 1; and hazard ratio 0.98 95% confidence interval 0.54-1.76 (P=0.94) in group 2. CONCLUSIONS: The clinical outcome of patients in whom optimal procedural result was achieved at discharge was not different compared with the control group. Our results do not support the hypothesis that the differences in rates of residual mitral regurgitation at discharge between MITRA-FR and COAPT explain the divergent results between the two trials.

Impact of Mitral Regurgitation Severity and Left Ventricular Remodeling on Outcome After MitraClip Implantation: Results From the Mitra-FR Trial.

OBJECTIVES: This study aimed to identify a subset of patients based on echocardiographic parameters who might have benefited from transcatheter correction using the MitraClip system in the MITRA-FR (Percutaneous Repair with the MitraClip Device for Severe Functional/Secondary Mitral Regurgitation) trial. BACKGROUND: It has been suggested that differences in the degree of mitral regurgitation (MR) and left ventricular (LV) remodeling may explain the conflicting results between the MITRA-FR and the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) trials. METHODS: In a post hoc analysis, we evaluated the interaction between the intervention and subsets of patients defined based on MR severity (effective regurgitant orifice [ERO], regurgitant volume [RVOL] and regurgitant fraction [RF]), LV remodeling (end-diastolic and end-systolic diameters and volumes) and combination of these parameters with respect to the composite of death from any cause or unplanned hospitalization for heart failure at 24 months. RESULTS: We observed a neutral impact of the intervention in subsets with the highest MR degree (ERO ≥30 mm2, RVOL ≥45 ml or RF ≥50%) as in patients with milder MR degree. The same was seen in subsets with the milder LV remodeling using either diastolic or systolic diameters or volumes. When parameters of MR severity and LV remodeling were combined, there was still no benefit of the intervention including in the subset of patients with an ERO/end-diastolic volume ratio ≥ 0.15 despite similar ERO and LV end-diastolic volume compared with COAPT patients. CONCLUSIONS: In the MITRA-FR trial, we could not identify a subset of patients defined based on the degree of the regurgitation, LV remodeling or on their combination, including those deemed as having disproportionate MR, that might have benefited from transcatheter correction using the MitraClip system. (Multicentre Study of Percutaneous Mitral Valve Repair MitraClip Device in Patients With Severe Secondary Mitral Regurgitation [MITRA-FR]; NCT01920698).

Current treatment of symptomatic aortic stenosis in elderly patients: Do risk scores really matter after 80 years of age?

BACKGROUND: According to the guidelines, surgical aortic valve replacement (SAVR) is recommended in patients at low surgical risk (EuroSCORE II<4%), whereas for other patients, the decision between transcatheter aortic valve implantation (TAVI) and surgery should be made by the Heart Team, with TAVI being favoured in elderly patients. AIM: The RAC prospective multicentre survey assessed the respective contributions of age and surgical risk scores in therapeutic decision making in elderly patients with severe symptomatic aortic stenosis. METHODS: In September and October 2016, 1049 consecutive patients aged ≥ 75 years were included in 32 centres with on-site TAVI and surgical facilities. The primary endpoint was the decision between medical management, TAVI or SAVR. RESULTS: Mean age was 84±5 years and 53% of patients were female. The surgical risk was classified as high (EuroSCORE II>8%) in 18% of patients, intermediate (EuroSCORE II 4-8%) in 34% and low (EuroSCORE II≤4%) in 48%. TAVI was preferred in 71% of patients, SAVR in 19% and medical treatment in 10%. The choice of TAVI over SAVR was associated with older age (P<0.0001) and a higher EuroSCORE II (P=0.008). However, the weight of EuroSCORE II in therapeutic decision making markedly decreased after the age of 80 years. Indeed, 77% of patients aged ≥ 80 years were referred for TAVI, despite a low estimated surgical risk. CONCLUSIONS: The impact of risk scores depends strongly on age, and decreases considerably after 80 years, most patients being referred for TAVI, independent of their estimated surgical risk. Despite medical advancements, 10% of patients were still denied any intervention.

Left Atrial Appendage Closure in Patients With Atrial Fibrillation at Very High Bleeding Risk Without Postimplantation Antithrombotic Therapy.

OBJECTIVES: We assess the proportion, baseline characteristics, and outcomes of a cohort of very high bleeding risk (HBR) patients discharged with no antithrombotic therapy after left atrial appendage closure (LAAC). BACKGROUND: The optimal antithrombotic therapy after LAAC remains controversial. However, a substantial proportion of patients have HBR and are contraindicated to any antithrombotic therapy. Data regarding the feasibility and safety of such a strategy are scarce. METHODS: All patients who underwent LAAC at our institution between October 2013 and December 2018 were included. Clinical, procedural, and imaging data were collected prospectively, and patients receiving no antithrombotic therapy were compared with those receiving at least 1 agent. RESULTS: A total of 152 patients were included. At discharge, 72 (47.3%) received single-antiplatelet therapy (SAPT), 57 (37.5%) received dual-antiplatelet therapy (DAPT), and 22 (14.5%) received no antithrombotic therapy (NATT). One patient received a combination of aspirin and vitamin K antagonist. There were no differences regarding baseline characteristics between NATT patients and the others. At a median follow-up of 16 months, 25 patients died. There were no differences between NATT patients and others regarding all-cause mortality (9.1% vs 18.8%, respectively; P=.07) or ischemic stroke (0.0% vs 4.2%, respectively; P=.20). There were 4 episodes of major bleeding, but none occurred in the NATT group, and no device-related thrombosis was seen on computed tomography scan performed within 12 weeks after LAAC. CONCLUSIONS: In highly selected patients at very HBR, discontinuation of any antithrombotic therapy after LAAC appears safe and feasible.

Transcatheter valve implantation for patients with aortic stenosis: a position statement from the European Association of Cardio-Thoracic Surgery (EACTS) and the European Society of Cardiology (ESC), in collaboration with the European Association of Percutaneous Cardiovascular Interventions (EAPCI).

AIMS: To critically review the available transcatheter aortic valve implantation techniques and their results, as well as propose recommendations for their use and development. METHODS AND RESULTS: A committee of experts including European Association of Cardio-Thoracic Surgery and European Society of Cardiology representatives met to reach a consensus based on the analysis of the available data obtained with transcatheter aortic valve implantation and their own experience. The evidence suggests that this technique is feasible and provides haemodynamic and clinical improvement for up to 2 years in patients with severe symptomatic aortic stenosis at high risk or with contraindications for surgery. Questions remain mainly concerning safety and long-term durability, which have to be assessed. Surgeons and cardiologists working as a team should select candidates, perform the procedure, and assess the results. Today, the use of this technique should be restricted to high-risk patients or those with contraindications for surgery. However, this may be extended to lower risk patients if the initial promise holds to be true after careful evaluation. CONCLUSION: Transcatheter aortic valve implantation is a promising technique, which may offer an alternative to conventional surgery for high-risk patients with aortic stenosis. Today, careful evaluation is needed to avoid the risk of uncontrolled diffusion.

Device-Related Thrombus After Left Atrial Appendage Closure.

Although left atrial appendage closure (LAAC) has proved non-inferior to oral anticoagulants in patients with AF, there has been recent concern about the occurrence of late complications, especially device-related thrombus (DRT), which was associated with increased risk of stroke. In this article, the incidence, risk factors and time course of DRT after LAAC are discussed, as well as the potential benefits of dedicated strategies in the management of DRT, which remain speculative, especially in patients with a contraindication to oral anticoagulants. In these patients, decision-making should be based on a multidisciplinary evaluation of the ischaemic/bleeding balance on an individual basis.

Temporal Trends on Percutaneous Mitral Commissurotomy: 30 Years of Experience.

Background Percutaneous mitral commissurotomy ( PMC ) was the first available transcatheter technique for treatment of mitral valve diseases. Experience has led to extending the indications to patients with less favorable characteristics. We aimed to analyze (1) the temporal trends in characteristic and outcomes of patients undergoing PMC in a single center over 30 years and (2) the predictive factors of poor immediate results of PMC . Methods and Results From 1987 to 2016, 1 full year for each decade was analyzed: 1987, 1996, 2006, and 2016. Poor immediate results of PMC were defined as a mitral valve area <1.5 cm2 or MR (mitral regurgitation) grade >2. Mitral anatomy was assessed using the Cormier classification and the fluoroscopic extent of calcification. Six hundred three patients were included: 111, 202, 205, and 85, respectively. Mean age increased >10 years over time ( P<0.0001). Mitral anatomy was less favorable over the years: the presence of calcification increased from 25% of patients at the beginning of PMC to >40% during the past decade ( P<0.0001) with a 3-fold increase in severe mitral calcification. Consistently, the proportion of good immediate results decreased over time ( P<0.05) but remained at 76% in 2016. Multivariate analysis showed 3 predictive factors of poor immediate results: smaller baseline mitral valve area ( P<0.0001), pre- PMC MR grade 2 ( P<0.01), and the presence or amount of calcification ( P<0.001). Conclusions This clinic's patients became significantly older with more frequent and severe calcification in the past decade. Predictive factors of poor immediate results were related to valve anatomy, including calcification. Despite challenges raised by severe calcification, PMC was still successful in >3 out of 4 patients in recent years.

Percutaneous repair or medical treatment for secondary mitral regurgitation: outcomes at 2 years.

AIMS: The MITRA-FR trial showed that among symptomatic patients with severe secondary mitral regurgitation, percutaneous repair did not reduce the risk of death or hospitalization for heart failure at 12 months compared with guideline-directed medical treatment alone. We report the 24-month outcome from this trial. METHODS AND RESULTS: At 37 centres, we randomly assigned 304 symptomatic heart failure patients with severe secondary mitral regurgitation (effective regurgitant orifice area >20 mm2 or regurgitant volume >30 mL), and left ventricular ejection fraction between 15% and 40% to undergo percutaneous valve repair plus medical treatment (intervention group, n = 152) or medical treatment alone (control group, n = 152). The primary efficacy outcome was the composite of all-cause death and unplanned hospitalization for heart failure at 12 months. At 24 months, all-cause death and unplanned hospitalization for heart failure occurred in 63.8% of patients (97/152) in the intervention group and 67.1% (102/152) in the control group [hazard ratio (HR) 1.01, 95% confidence interval (CI) 0.77-1.34]. All-cause mortality occurred in 34.9% of patients (53/152) in the intervention group and 34.2% (52/152) in the control group (HR 1.02, 95% CI 0.70-1.50). Unplanned hospitalization for heart failure occurred in 55.9% of patients (85/152) in the intervention group and 61.8% (94/152) in the control group (HR 0.97, 95% CI 0.72-1.30). CONCLUSIONS: In patients with severe secondary mitral regurgitation, percutaneous repair added to medical treatment did not significantly reduce the risk of death or hospitalization for heart failure at 2 years compared with medical treatment alone.

Transcatheter valve implantation for patients with aortic stenosis: a position statement from the European Association of Cardio-Thoracic Surgery (EACTS) and the European Society of Cardiology (ESC), in collaboration with the European Association of Percutaneous Cardiovascular Interventions (EAPCI).

AIMS: To critically review the available transcatheter aortic valve implantation techniques and their results, as well as propose recommendations for their use and development. METHODS AND RESULTS: A committee of experts including European Association of Cardio-Thoracic Surgery and European Society of Cardiology representatives met to reach a consensus based on the analysis of the available data obtained with transcatheter aortic valve implantation and their own experience. The evidence suggests that this technique is feasible and provides haemodynamic and clinical improvement for up to 2 years in patients with severe symptomatic aortic stenosis at high risk or with contraindications for surgery. Questions remain mainly concerning safety and long-term durability, which have to be assessed. Surgeons and cardiologists working as a team should select candidates, perform the procedure, and assess the results. Today, the use of this technique should be restricted to high-risk patients or those with contraindications for surgery. However, this may be extended to lower risk patients if the initial promise holds to be true after careful evaluation. CONCLUSION: Transcatheter aortic valve implantation is a promising technique, which may offer an alternative to conventional surgery for high-risk patients with aortic stenosis. Today, careful evaluation is needed to avoid the risk of uncontrolled diffusion.