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.

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).

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.

Comparison of Systematic Predilation, Selective Predilation, and Direct Transcatheter Aortic Valve Implantation With the SAPIEN S3 Valve.

BACKGROUND: Despite previously described feasibility, direct transcatheter aortic valve implantation (TAVI) with the Edwards SAPIEN S3 device (S3-THV) (Edwards Lifesciences, Irvine, CA) has not been compared with either a systematic or a selective predilation approach. METHODS: Patients undergoing predilation were divided into a systematic group (regardless of anatomic features) and a selective group (in the context of high valvular calcium burden). Both groups were matched in a 2:1 fashion to patients who underwent direct TAVI. Outcomes were assessed according to Valve Academic Research Consortium 2 (VARC-2) criteria. RESULTS: Two hundred eighty-one patients underwent TAVI with the S3-THV in our centre. Of these patients, 58 underwent predilation before device implantation (systematic, n = 26; selective, n = 32). Procedural success was achieved in all patients. Patients in the selective predilation group had severe valve calcification volume-more than double that of the systematic group (445 ± 306 mm3 vs 970 ± 578 mm3, respectively; P < 0.0001). There was a trend for less dilation after the procedure in the systematic group compared with the selective group (4% vs 19%, respectively; P = 0.09). Device malposition necessitating a second device to be implanted occurred in 3 cases of direct TAVI (5%) and in none of the patients undergoing predilation (P = not significant). Thirty-day and 1-year mortality rates were similar between the patients who underwent direct TAVI and their predilation counterparts. CONCLUSIONS: In patients with a moderate aortic valve calcification burden, direct TAVI appears to be feasible and safe. In those with high calcium burden, predilation should be considered after taking into account individual risk profiles.

Mitral Annular Calcium and Mitral Stenosis Determined by Multidetector Computed Tomography in Patients Referred for Aortic Stenosis.

Mitral annular calcium (MAC) is a common finding in older patients referred for transcatheter aortic valve implantation (TAVI). Multidetector computed tomography (MDCT) allows fine quantification of the calcific deposits. Our objective was to estimate the prevalence of MAC and associated mitral stenosis (MS) in patients referred for TAVI using MDCT. A cohort of 346 consecutive patients referred for TAVI evaluation was screened by MDCT for MAC: 174 had MAC (50%). Of these patients, 165 patients (95%) had mitral valve area (MVA) assessable by MDCT planimetry (age 83.8 ± 5.9 years). Median mitral calcium volume and MVA were 545 mm3 (193 to 1,253 mm3) and 234 mm2 (187 to 297 mm2), respectively. The MS was very severe, severe, and moderate in 2%, 22%, and 10% patients, respectively. By multivariate analysis, MVA was independently correlated to mitral calcium volume, aortic annular area, and some specific patterns of mitral leaflet calcium. Based on these findings, a formula was elaborated to predict the presence of a significant MS. In conclusion, MDCT allows detailed assessment of MAC in TAVI populations, demonstrating a high prevalence. Mitral analysis should become routine during MDCT screening before TAVI as it may alter therapeutic strategy.

Short and long-term outcomes of alcohol septal ablation with the trans-radial versus the trans-femoral approach: A single center-experience.

BACKGROUND: Although the trans-radial approach (TR) has been applied to various subsets of patients in percutaneous coronary intervention, the feasibility, efficacy, acute procedural and long-term outcomes of TR versus trans-femoral approach (TF) for alcohol septal ablation (ASA) have not yet been determined. OBJECTIVES: The aim of this study was to compare the short and long-term outcomes of ASA with the TR approach compared to the TF approach. METHODS: We retrospectively analyzed 240 patients who underwent an ASA procedure at our institution from November 1999 to November 2015. The TR approach was performed in 172 cases and the TF approach in the remaining 68 cases. RESULTS: The use of TR approach progressively increased from 62% in 1999-2005 to 91% in 2011-2015 (p=0.0001). The TF and TR group had similar age, baseline NYHA class (NYHA 3 or 4) and mean left ventricular outflow tract peak gradient before ASA. Total contrast used (TR: 73.2±47.2ml; TF: 88.7±49.3ml, p=0.11), total radiation Air kerma area product (TR: 43.7±48.0Gycm(-2); TF: 55.9±48.2Gycm(-2); p=0.39) and peak left ventricular outflow tract gradient immediately after ASA (TR: 19.1±19.6mmHg; TF: 20.4±18.0mmHg, p=0.63) were similar in both groups. Procedural success was 91.9% and 91.2% in the TR and TF groups, respectively (p=0.53). At 30days, there was 2 intra-hospital death (1 in TF and 1 in TR), 1 major stroke in the TF group and 1 coronary artery dissection in the TR group. Vascular complications were less frequent in the TR group (0.58% vs. 7.3%; p=0.002). The mean length of follow-up was 4.56±4.34years (IQR 0.69-8.2; median 2.92years; maximum: 15.5years). By Kaplan-Meier estimate, the observed survival in the overall cohort was comparable to the expected survival for a sex and age-matched comparable general French population at 10years (86.9 vs. 83.6%, p=0.88). Survival was similar between the TR and TF group (92.1% vs. 89.7% at 6years, respectively; p=0.71). CONCLUSIONS: Alcohol septal ablation from the radial approach can be performed with similar acute and long-term success, but with lower vascular complications compared to the femoral approach.

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.

The MITRA-FR study: design and rationale of a randomised study of percutaneous mitral valve repair compared with optimal medical management alone for severe secondary mitral regurgitation.

AIMS: Percutaneous mitral valve repair (pMVR) is a new therapeutic option for mitral valve regurgitation. Positive preliminary results in non-randomised studies have been published supporting the use of the MitraClip system in patients with secondary mitral regurgitation (MR) and poor left ventricular (LV) function contraindicated to surgery. The aim of the MITRA-FR study is to provide a higher level of evidence for the efficacy of the MitraClip device in this setting. METHODS AND RESULTS: The MITRA-FR study is a national, multicentre, investigator-initiated, open-label, randomised trial to evaluate the benefits and safety of pMVR using the MitraClip system plus optimal medical therapy (OMT) compared with OMT alone (control) in patients with severe symptomatic secondary MR contraindicated to surgical repair. The trial aims to enrol 144 MitraClip-treated subjects and 144 control (OMT alone) patients. The primary endpoint is a composite of all-cause mortality and unplanned hospitalisations for heart failure at 12 months after randomisation CONCLUSIONS: MITRA-FR is a randomised controlled national trial designed to evaluate the performance of pMVR in comparison to OMT in patients with severe symptomatic secondary MR contraindicated to cardiac surgery.

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.

Relationship between valve calcification and long-term results of percutaneous mitral commissurotomy for rheumatic mitral stenosis.

BACKGROUND: Indications of percutaneous mitral commissurotomy (PMC) remain debated in calcific mitral stenosis. We analyzed long-term results of PMC for calcific mitral stenosis and the factors associated with late functional results. METHODS AND RESULTS: We compared the characteristics and outcome of 314 patients undergoing PMC for calcific mitral stenosis with 710 patients with noncalcified valves followed up to 20 years. Calcification was defined by fluoroscopy, and its extent was graded from 1 to 4. Good immediate results (valve area ≥ 1.5 cm(2) with mitral regurgitation ≤ 2/4) were obtained in 251 patients (80%) with calcified valves and 661 (93%) with noncalcified valves (P < 0.001). The hazard ratio for good functional results (survival without cardiovascular death, without mitral reintervention, and in New York Heart Association class I or II) was 2.5 (95% confidence interval [2.1-2.9]; P < 0.0001) in patients with calcified valves (12 ± 3% at 20 years) relative to the noncalcified group (38 ± 2% at 20 years). In the 251 patients with calcified valves who had good immediate results, 15-year rates of good functional results were 35 ± 4% for minor (grade 1) calcification, 24 ± 6% for grade 2, and 10 ± 6% for severe (grades 3-4) calcification. Factors associated with poor late functional results on multivariable analysis were calcification extent, older age, higher New York Heart Association class, atrial fibrillation, and higher mean gradient after PMC. CONCLUSIONS: Although late results of PMC are less satisfying in calcific mitral stenosis, long-term functional outcome depends on calcification extent, patient characteristics, and immediate results of PMC. These findings support the use of PMC as first-line treatment in selected patients with calcific mitral stenosis.

Left ventricular metastasis from ocular melanoma: a new, rare, and unusual pathway?

Melanoma is a neoplasm known for its propensity for cardiac involvement. When there exists an isolated metastasis to the heart, the melanoma tends to involve the right heart. Rarely does melanoma metastasize to the left ventricle. We report the first case of choroidal melanoma that had indeed metastasized to the left ventricle and was associated with a patent foramen ovale, which may explain its initially surprising location on this side of the heart.

Initial French experience of percutaneous mitral valve repair with the MitraClip: a multicentre national registry.

BACKGROUND: Percutaneous mitral valve repair (MVR) using the MitraClip(®) is a new option for severe mitral regurgitation (MR). AIM: To describe initial French experience regarding short-term and mid-term safety and efficacy. METHODS: A multicentre cohort reported experience of percutaneous MVR using the MitraClip(®) in French centres from December 2010 to September 2012. All patients were judged inoperable or at high surgical risk. Short-term and mid-term safety and efficacy results are presented. RESULTS: Sixty-two patients (72.7±11.4years; 71.7% men; 81.0% New York Heart Association [NYHA] class III or IV; logistic Euroscore 18.7±13.1%; 93.3% MR≥grade 3; 73.8% secondary MR) underwent percutaneous MVR using the MitraClip(®) under general anaesthesia. Procedural success was 95.2% (83.1% of patients received one clip; 16.9% received two clips). At discharge, 88.2% of implanted patients had a residual MR≤grade 2. Transthoracic echocardiography showed a significant decrease in ejection fraction (39.9±14.8% pre vs. 36.2±14.3% post), end-diastolic diameter (63.8±10.6mm vs. 61.4±12.3mm, respectively) and systolic pulmonary pressure (52.1±13.9mmHg vs. 44.7±10.9mmHg, respectively). The in-hospital mortality rate was 3.2%. The survival rate at 6-month follow-up was estimated at 83.1%, with 90.9% of patients in NYHA class I or II and residual MR≤grade 2 in 80% of cases. CONCLUSION: This initial French experience, despite being in its learning phase, showed promising results in patients considered ineligible for surgery, as observed in more experienced centres. Randomized studies are mandatory to confirm these preliminary data.

Long-term efficacy of percutaneous mitral commissurotomy for restenosis after previous mitral commissurotomy.

OBJECTIVE: We analysed long-term results of percutaneous mitral commissurotomy (PMC) performed because of mitral restenosis after previous commissurotomy. DESIGN: Follow-up of a prospective cohort. SETTING: Tertiary university hospital. PATIENTS: We studied 163 consecutive patients who underwent PMC because of restenosis occurring 16 ± 8 years after previous commissurotomy (closed-heart in 121, open-heart in 30 and PMC in 12). Mean age was 48 ± 14 years; 62 patients (38%) had valve calcification. Restenosis was due to bicommissural fusion in all cases. INTERVENTION: PMC using a single or double balloon in 80 patients and the Inoue balloon in 83. RESULTS: Good immediate results (IR) (valve area ≥ 1.5 cm2 with MR ≤ 2/4) were obtained in 135 pts (83%). 20-year rates were 27.9 ± 4.7% for cardiovascular survival without mitral surgery and 14.8 ± 3.9% for good functional results (cardiovascular survival without reintervention on the mitral valve and in New York Heart Association (NYHA) class I or II). After good IR, 20-year rates were 33.2 ± 5.5% for cardiovascular survival without surgery and 17.9 ± 4.7% for good functional results. After good IR, multivariate predictive factors of poor late functional results were higher NYHA class (p = 0.01), atrial fibrillation (p = 0.0002) and higher mean mitral gradient after PMC (p = 0.004). CONCLUSIONS: In patients with restenosis after mitral commissurotomy, PMC provides good IR in most cases. After good IR, one patient out of three remains free from surgery and one out of five has good functional results at 20 years. These findings support the use of PMC after previous commissurotomy, particularly in selected patients with few symptoms and in sinus rhythm.

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.

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.

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.

True percutaneous approach for transfemoral aortic valve implantation using the Prostar XL device: impact of learning curve on vascular complications.

OBJECTIVES: The purpose of this study was to evaluate the incidence of vascular complications and the predictors of Prostar failure for a "true percutaneous approach" in transfemoral transcatheter aortic valve implantation (TAVI). BACKGROUND: Safety and efficacy of a true percutaneous approach in transfemoral-TAVI has not been described in a large prospective cohort. METHODS: Among 264 patients included in our prospective TAVI database (October 2006 to December 2010), transfemoral-TAVI was performed in 170 patients. True percutaneous approach was performed in 142 consecutive patients since March 2008. Successful closure with Prostar was defined as adequate hemostasis without Prostar-related vascular complications. We compared the incidence of vascular complications in our early and late experience. RESULTS: Patients were 83.0±7.2 years old and with a EuroSCORE of 24.0±11.6%. The Edwards valve (Edwards Lifesciences, Irvine, California) (18- to 24-F) was used in 109 cases and the CoreValve (Medtronic, Minneapolis, Minnesota) (18-F) in 31. The sheath outer diameter to minimal femoral diameter ratio (SFAR) was 0.96±0.14. Successful closure was achieved in 90.7%, and was significantly increased (95.7% vs. 85.7%, p=0.047) in the late experience group. Cross-over to surgery was required in 3.6%. Vascular complications occurred in 20.0%, and were significantly lower in the late experience group (11.4% vs. 28.6%, p=0.012). Major vascular complications (2.9% vs. 14.3%, p=0.018) were decreased in the late experience group. Early experience (hazard ratio [HR]: 3.66, 95% confidence interval [CI]: 1.04 to 13.89, p=0.047) and SFAR (HR: 110.80, 95% CI: 1.15 to 10,710.73, p=0.044) predicted Prostar failure by univariate analysis. CONCLUSIONS: Experience reduced major vascular complications in a true percutaneous approach for transfemoral-TAVI. Further application of this less invasive strategy is feasible and may be beneficial, in this high-risk patient cohort.

Sex-related differences in clinical presentation and outcome of transcatheter aortic valve implantation for severe aortic stenosis.

OBJECTIVES: The purpose of this study was to clarify the impact of sex-related differences in transcatheter aortic valve implantation (TAVI) for high-risk patients with severe aortic stenosis. BACKGROUND: Although TAVI is becoming a mature technique, the impact of sex differences remains unclear. METHODS: The TAVI patients were included prospectively in a dedicated database from October 2006. The proportion of women (n = 131) was similar to that of men (n = 129). The Edwards valve (85.4%) and CoreValve (14.6%) were used through the transfemoral (65.0%), subclavian (3.1%), or transapical (31.9%) approach. All events were defined according to Valve Academic Research Consortium criteria. RESULTS: Age was similar (83.1 ± 6.3 years), but women had less coronary and peripheral disease, less previous cardiac surgery, higher ejection fraction, and lower EuroSCORE (European System for Cardiac Operative Risk Evaluation [22.3 ± 9.0% vs. 26.2 ± 13.0%, p = 0.005]). Minimal femoral size (7.74 ± 1.03 mm vs. 8.55 ± 1.34 mm, p < 0.001), annulus size (20.9 ± 1.4 vs. 22.9 ± 1.7 mm, p < 0.001), and valve size (23.9 ± 1.6 mm vs. 26.3 ± 1.5 mm, p < 0.001) were smaller in women. Device success was similar (90.8% vs. 88.4%, p = 0.516) despite more frequent iliac complications (9.0% vs. 2.5%, p = 0.030). Residual mean aortic pressure gradient (11.6 ± 4.9 vs. 10.9 ± 4.9, p = 0.279) was also similar. The 1-year survival rate was higher for women, 76% (95% confidence interval: 72% to 80%), than for men, 65% (95% confidence interval: 60% to 69%); and male sex (hazard ratio: 1.62, 95% confidence interval: 1.03 to 2.53, p = 0.037) was identified as a predictor of midterm mortality by Cox regression analysis. CONCLUSIONS: Female sex is associated with better baseline clinical characteristics and improved survival, and is identified as a predictor of midterm survival after TAVI.

[Percutaneous aortic valve implantation: results and perspectives]. / Valves aortiques percutanées: résultats actuels et perspectives.

As the French population is aging, a growing number of elderly patients with symptomatic severe aortic stenosis are going to require therapeutic management. Approximately 30 to 40% of these patients do not undergo surgical treatment and a high proportion is considered to be at high risk for surgery. The transluminal aortic valve implantation technique has been increasingly used over the past few years, thus providing a solution to a major therapeutic issue in our industrialized countries. While the cardiology community was rapidly convinced of its efficacy, remaining doubts regarding the outcome of this technique in terms of mortality were erased by the recent publication of results achieved in cohort B of the Partner US trial. This new approach is clearly here to stay and should soon reach a maturity phase with respect to its indications, the selection of patients and technical aspects.