Safety and incremental prognostic value of stress cardiovascular magnetic resonance in patients with known chronic kidney disease.

BACKGROUND: Cardiovascular disease (CVD) is the main cause of mortality in patients with chronic kidney disease (CKD). Although several studies have demonstrated the consistently high prognostic value of stress cardiovascular magnetic resonance (CMR), its prognostic value in patients with CKD is not well established. We aimed to assess the safety and the incremental prognostic value of vasodilator stress perfusion CMR in consecutive symptomatic patients with known CKD. METHODS: Between 2008 and 2021, we conducted a retrospective dual center study with all consecutive symptomatic patients with known stage 3 CKD, defined by estimated glomerular filtration rate (eGFR) between 30 and 60 ml/min/1.73 m2, referred for vasodilator stress CMR. All patients with eGFR < 30 ml/min/1.73 m2 (n = 62) were excluded due the risk of nephrogenic systemic fibrosis. All patients were followed for the occurrence of major adverse cardiovascular events (MACE) defined as cardiac death or recurrent nonfatal myocardial infarction (MI). Cox regression analysis was used to determine the prognostic value of stress CMR parameters. RESULTS: Of 825 patients with known CKD (71.4 ± 8.8 years, 70% men), 769 (93%) completed the CMR protocol. Follow-up was available in 702 (91%) (median follow-up 6.4 (4.0-8.2) years). Stress CMR was well tolerated without occurrence of death or severe adverse event related to the injection of gadolinium or cases of nephrogenic systemic fibrosis. The presence of inducible ischemia was associated with the occurrence of MACE (hazard ratio [HR] 12.50; 95% confidence interval [CI] 7.50-20.8; p < 0.001). In multivariable analysis, ischemia and late gadolinium enhancement were independent predictors of MACE (HR 15.5; 95% CI 7.72 to 30.9; and HR 4.67 [95% CI 2.83-7.68]; respectively, both p < 0.001). After adjustment, stress CMR findings showed the best improvement in model discrimination and reclassification above traditional risk factors (C-statistic improvement: 0.13; NRI = 0.477; IDI = 0.049). CONCLUSIONS: In patients with known stage 3 CKD, stress CMR is safe and its findings have an incremental prognostic value to predict MACE over traditional risk factors.

Case report: Diagnosis, management and evolution of a bulky and invasive cardiac mass complicated by complete atrioventricular block.

Introduction: Cardiac lymphoma is a rare but serious disease that is usually located in the right heart. The symptoms (dyspnea, respiratory distress, fatigue, syncope…) are not specific and depend on the mass location. Cardiac magnetic resonance has a crucial role in the diagnostic strategy but biopsy is mandatory to confirm the diagnosis. Case presentation: We report the case of a 63-yeart old man who presented with severe dyspnea and complete atrioventricular block (AVB). A bulky and invasive mass was found in the left atrium extending to the right atrium through the interatrial septum. A cardiac lymphoma was suspected by cardiac magnetic resonance (CMR) imaging and confirmed by transvenous biopsy. The patient was treated with urgent chemotherapy (R-CHOP) and pacemaker implantation. After 4 cycles of R-CHOP the patient was in complete remission with total disappearance of the mass and return of a spontaneous sinus rhythm. Conclusion: lymphoma is a therapeutic emergency as appropriate treatment can lead to complete remission even when the mass is extensive and invasive. Complete AVB is a potentially reversible complication of cardiac lymphoma, and the decision to implant a pacemaker must be carefully weighed.

Computed Tomography/Fluoroscopy Fusion and 3D Transesophageal Echocardiography-Guided Percutaneous Paravalvular Leak Closure.

Percutaneous paravalvular leak closure seems a safe alternative to surgery in frail patients. However, it is a challenging procedure that should be tailored to each patient with optimal imaging guidance. Transesophageal echocardiography during the procedure and computed tomography scan/fluoroscopy fusion provide guidance for critical steps, such as PVL localization and crossing. (Level of Difficulty: Advanced.).

Study Evaluating the Use of RenalGuard to Protect Patients at High Risk of AKI.

BACKGROUND: Contrast-induced nephropathy (CIN) can occur after cardiovascular procedures using contrast media, which is associated with increased morbidity and mortality. RenalGuard is a closed-loop system designed to match intravenous hydration with diuretic-induced diuresis that has shown mixed results in the prevention of CIN in previous randomized controlled trials. OBJECTIVES: The STRENGTH (Study Evaluating the Use of RenalGuard to Protect Patients at High Risk of AKI) study assessed whether RenalGuard (PLC Medical Systems) is superior to standard intravenous hydration for CIN prevention in patients with chronic kidney disease undergoing complex cardiovascular procedures. METHODS: STRENGTH is a multicenter, international, open-label, postmarket, prospective, randomized (1:1) study monitored by the Cardiovascular European Research Center (Massy, France) that included a total of 259 patients with moderate to severe chronic kidney disease (estimated glomerular filtration 15-40 mL/min/m2) requiring a complex coronary, structural, or peripheral procedure with an expected contrast injection of at least 3 times the estimated glomerular filtration rate. Patients were randomized to either RenalGuard or intravenous saline hydration according to current guidelines. RESULTS: The primary endpoint, the incidence of CIN at day 3 after the procedure, was similar between the 2 groups (17/107 [15.9%] in the RG group vs 15/110 [13.9%] in the control group; P = 0.62). In addition, none of the secondary endpoints differed between the 2 groups. CONCLUSIONS: In high-risk patients undergoing complex cardiovascular interventions in experienced centers, furosemide-induced high urine output with matched hydration using the RenalGuard system did not reduce the risk of CIN and adverse outcomes at 12 months compared with conventional intravenous hydration.

On-line estimated peak skin dose during percutaneous coronary intervention for chronic total occlusion using new patient dose mapping technology.

BACKGROUND: X-ray exposure during complex percutaneous coronary intervention is a very important issue. AIM: To reduce patient peak skin dose during percutaneous coronary intervention procedures for chronic total occlusion using on-line estimated peak skin dose software (Dose Map). METHODS: Throughout the procedure, Dose Map provided a map of local cumulative peak skin dose. This map was displayed in-room from 1Gy cumulative air kerma, and was updated every 0.5Gy. The operator's actions to minimize deterministic risks following map notification were collected. Skin reaction was evaluated 3 months after the procedure. A comparison with our historical X-ray exposure data (207 patients from January 2013 to July 2014) was performed. RESULTS: From November 2015 to October 2016, 97 patients (Japanese chronic total occlusion score 2.1±1.1; 100 percutaneous coronary intervention procedures for chronic total occlusion) were prospectively enrolled. Fluoroscopy time was 40.8 (21.6-60.3) minutes, cumulative air kerma 1884 (1144-3231) mGy, estimated peak skin dose 962 (604-1474) mGy and kerma area product 115.8 (71.5-206.7) Gy.cm2. Cumulative air kerma was>3Gy in 28% of cases, and>5Gy in 11% of cases. In 68% of cases, at least one action was taken by the operator after map notification to optimize skin dose distribution. Main changes included: gantry angulation (52%); field of view (25%); and collimation (13%). No skin injuries were observed at follow-up. In comparison with our chronic total occlusion historical radiation data, median cumulative air kerma and kerma area product were reduced by 31% and 33%, respectively (P<0.005. CONCLUSION: Online skin dose mapping software allows the distribution of patient skin dose during complex percutaneous coronary intervention procedures, and may minimize X-ray exposure.

Prognostic value of vasodilator stress perfusion CMR in patients with previous coronary artery bypass graft.

AIMS: The accuracy and prognostic value of stress perfusion cardiac magnetic resonance (CMR) are established in coronary artery disease (CAD) patients. Because myocardial contrast kinetics may be altered after coronary artery bypass graft (CABG), most studies excluded CABG patients. This study aimed to assess the prognostic value of vasodilator stress perfusion CMR in CABG patients. METHODS AND RESULTS: Consecutive CABG patients referred for stress CMR were retrospectively included and followed for the occurrence of major adverse cardiovascular events (MACE) including cardiovascular (CV) death or non-fatal myocardial infarction (MI). Cox regression analyses were performed to determine the prognostic association of inducible ischaemia and late gadolinium enhancement (LGE) by CMR. Of 866 consecutive CABG patients, 852 underwent the stress CMR protocol and 771 (89%) completed the follow-up [median (interquartile range) 4.2 (3.3-6.2) years]. There were 85 MACE (63 CV deaths and 22 non-fatal MI). Using Kaplan-Meier analysis, the presence of inducible ischaemia identified the occurrence of MACE [hazard ratio (HR) 3.52, 95% confidence interval (CI): 2.27-5.48; P < 0.001] and CV death (HR 2.55, 95% CI: 1.52-4.25; P < 0.001). In a multivariable stepwise Cox regression including clinical characteristics and CMR indexes, the presence of inducible ischaemia was an independent predictor of a higher incidence of MACE (HR 3.22, 95% CI: 2.06-5.02; P < 0.001) and CV death (HR 2.15, 95% CI: 1.28-3.62; P = 0.003), and the same was observed for LGE (both P = 0.02). CONCLUSION: Stress CMR has a good discriminative prognostic value in patients after CABG, with a higher incidence of MACE and CV death in patients with inducible ischaemia and/or LGE.

Value of FEops HEARTguide patient-specific computational simulations in the planning of left atrial appendage closure with the Amplatzer Amulet closure device: rationale and design of the PREDICT-LAA study.

BACKGROUND: Optimal preprocedural planning is essential to ensure successful device closure of the left atrial appendage (LAA). DESIGN: The PREDICT-LAA study is a prospective, international, multicentre, randomised controlled trial (ClinicalTrials.gov NCT04180605). Two hundred patients eligible for LAA closure with an Amplatzer Amulet device (Abbott, USA) will be enrolled in the study. Patients will be allocated to a computational simulation arm (experimental) or standard treatment arm (control) using a 1:1 randomisation. For patients randomised to the computational simulation arm, preprocedural planning will be based on the analysis of cardiac computed tomography (CCT)-based patient-specific computational simulations (FEops HEARTguide, Ghent, Belgium) in order to predict optimal device size and position. For patients in the control arm, preprocedural planning will be based on local practice including CCT analysis. The LAA closure procedure and postprocedural antithrombotic therapy will follow local practice in both arms. The primary endpoint of the study is incomplete LAA closure and device-related thrombus as assessed at 3 months postprocedural CCT. Secondary endpoints encompass procedural efficiency (number of devices used, number of repositioning, procedural time, radiation exposure, contrast dye), procedure-related complications within 7 days postprocedure and a composite of all-cause death and thromboembolic events at 12 months. CONCLUSION: The objective of the PREDICT-LAA study is to test the hypothesis that a preprocedural planning for LAA closure with the Amplatzer Amulet device based on patient-specific computational simulations can result in a more efficient procedure, optimised procedural outcomes and better clinical outcomes as compared with a standard preprocedural planning. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT04180605).

Implementation of the transradial approach as an alternative vascular access for transcatheter aortic valve replacement guidance: Experience from a high-volume center.

OBJECTIVE: This study sought to assess the potential benefits of the transradial approach (TRA) as an alternative vascular access to the classical contralateral femoral approach for transcatheter aortic valve replacement (TAVR). BACKGROUND: Vascular and bleeding complications in TAVR have gradually decreased owing to operator experience and downsizing of the delivery system. However, about 1/4 of vascular access site complications are related to the transfemoral (TF) secondary access. METHODS: We compared the outcomes at 30 days according to VARC-2 after TAVR of a prospective cohort of 217 consecutive patients undergoing right or left TRA as the second vascular access (TRA-TF TAVR) and a retrospective cohort of 194 consecutive patients undergoing TF approach as a second vascular access (TF-TF TAVR). RESULTS: Baseline clinical characteristics and risk scores were well matched in both groups. Procedural success rate was 99.7%. Fluoro time was significantly lower in the TF-TF TAVR group (16.9 ± 7.2 vs. 19.1 ± 7.8 min, P = 0.003); however, there was no significant difference in x-ray exposure, procedure time or amount of contrast used. In the TRA-TF TAVR group, there were no complications related to the TRA access and there were less vascular and bleeding complications (18.0% vs. 9.7%, P = 0.014; 17.0% vs. 9.2%, P = 0.026, respectively), although blood transfusion requirement or hospitalization duration stay were similar in both groups. CONCLUSIONS: TRA approach as alternative secondary vascular access in TAVR is safe and feasible and is associated with a significant decrease in vascular and bleeding complications. Further, large-scale studies are warranted to confirm the potential benefit of this approach.

Drug-eluting stents in elderly patients with coronary artery disease (SENIOR): a randomised single-blind trial.

BACKGROUND: Elderly patients regularly receive bare-metal stents (BMS) instead of drug-eluting stents (DES) to shorten the duration of double antiplatelet therapy (DAPT). The aim of this study was to compare outcomes between these two types of stents with a short duration of DAPT in such patients. METHODS: In this randomised single-blind trial, we recruited patients from 44 centres in nine countries. Patients were eligible if they were aged 75 years or older; had stable angina, silent ischaemia, or an acute coronary syndrome; and had at least one coronary artery with a stenosis of at least 70% (≥50% for the left main stem) deemed eligible for percutaneous coronary intervention (PCI). Exclusion criteria were indication for myocardial revascularisation by coronary artery bypass grafting; inability to tolerate, obtain, or comply with DAPT; requirement for additional surgery; non-cardiac comorbidities with a life expectancy of less than 1 year; previous haemorrhagic stroke; allergy to aspirin or P2Y12 inhibitors; contraindication to P2Y12 inhibitors; and silent ischaemia of less than 10% of the left myocardium with a fractional flow reserve of 0·80 or higher. After the intended duration of DAPT was recorded (1 month for patients with stable presentation and 6 months for those with unstable presentation), patients were randomly allocated (1:1) by a central computer system (blocking used with randomly selected block sizes [two, four, eight, or 16]; stratified by site and antiplatelet agent) to either a DES or similar BMS in a single-blind fashion (ie, patients were masked), but those assessing outcomes were masked. The primary outcome was to compare major adverse cardiac and cerebrovascular events (ie, a composite of all-cause mortality, myocardial infarction, stroke, or ischaemia-driven target lesion revascularisation) between groups at 1 year in the intention-to-treat population, assessed at 30 days, 180 days, and 1 year. This trial is registered with ClinicalTrials.gov, number NCT02099617. FINDINGS: Between May 21, 2014, and April 16, 2016, we randomly assigned 1200 patients (596 [50%] to the DES group and 604 [50%] to the BMS group). The primary endpoint occurred in 68 (12%) patients in the DES group and 98 (16%) in the BMS group (relative risk [RR] 0·71 [95% CI 0·52-0·94]; p=0·02). Bleeding complications (26 [5%] in the DES group vs 29 [5%] in the BMS group; RR 0·90 [0·51-1·54]; p=0·68) and stent thrombosis (three [1%] vs eight [1%]; RR 0·38 [0·00-1·48]; p=0·13) at 1 year were infrequent in both groups. INTERPRETATION: Among elderly patients who have PCI, a DES and a short duration of DAPT are better than BMS and a similar duration of DAPT with respect to the occurrence of all-cause mortality, myocardial infarction, stroke, and ischaemia-driven target lesion revascularisation. A strategy of combination of a DES to reduce the risk of subsequent repeat revascularisations with a short BMS-like DAPT regimen to reduce the risk of bleeding event is an attractive option for elderly patients who have PCI. FUNDING: Boston Scientific.

Time-Course Reduction in Patient Exposure to Radiation From Coronary Interventional Procedures: The Greater Paris Area Percutaneous Coronary Intervention Registry.

BACKGROUND: The frequency of complex percutaneous coronary interventions (PCIs) has increased in the last few years, with a growing concern on the radiation dose received by the patients. Multicenter data from large unselected populations on patients' radiation doses during coronary angiography (CA) and PCI and temporal trends are lacking. This study sought to evaluate the temporal trends in patients' exposure to radiation from CA and PCI. METHODS AND RESULTS: Data were taken from the CARDIO-ARSIF registry that prospectively collects data on all CAs and PCIs performed in the 36 catheterization laboratories in the Greater Paris Area, the most populated regions in France with about 12 million inhabitants. Kerma area product and Fluoroscopy time from 152 684 consecutive CAs and 103 177 PCIs performed between 2009 and 2013 were analyzed. A continuous trend for a decrease in median [interquartile range] Kerma area product was observed, from 33 [19-55] Gy cm2 in 2009 to 27 [16-44] Gy cm2 in 2013 for CA (P<0.0001), and from 73 [41-125] to 55 [31-91] Gy cm2 for PCI (P<0.0001). Time-course differences in Kerma area product remained highly significant after adjustment on Fluoroscopy time, PCI procedure complexity, change of x-ray equipment, and other patient- and procedure-related covariates. CONCLUSIONS: In a large patient population, a steady temporal decrease in patient radiation exposure during CA and PCI was noted between 2009 and 2013. Kerma area product reduction was consistent in all types of procedure and was independent of patient-related factors and PCI procedure complexity.

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.

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.

A Clinical and Angiographic Scoring System to Predict the Probability of Successful First-Attempt Percutaneous Coronary Intervention in Patients With Total Chronic Coronary Occlusion.

OBJECTIVES: This study sought to develop a scoring model predicting percutaneous coronary intervention (PCI) success in chronic total occlusions. BACKGROUND: Coronary chronic total occlusion is the lesion subtype in which angioplasty is most likely to fail. Chronic total occlusion for PCI (CTO-PCI) failure is associated with higher 1-year mortality and major adverse cardiac events compared with successful CTO-PCI. Although several independent predictors of final procedural success have been identified, no study has yet produced a model predicting final procedural outcome. METHODS: Data from 1,657 consecutive patients who underwent a first-attempt CTO-PCI were prospectively collected. The scoring model was developed in a derivation cohort of 1,143 patients (70%) using a multivariable stepwise analysis to identify independent predictors of CTO-PCI failure. The model was then validated in the remaining 514 (30%). RESULTS: The overall procedural success rate was 72.5%. Independent predictors of CTO-PCI failure were identified and included in the clinical and lesion-related score (CL-score) as follows: previous coronary artery bypass graft surgery +1.5 (odds ratio [OR]: 2.49, 95% confidence interval [CI]: 1.56 to 3.96), previous myocardial infarction +1 (OR: 1.6, 95% CI: 1.17 to 2.2), severe lesion calcification +2 (OR: 2.72, 95% CI :1.78 to 4.16), longer CTOs +1.5 (≥20 mm OR: 2.04, 95% CI: 1.54 to 2.7), non-left anterior descending coronary artery location +1 (OR: 1.56, 95% CI: 1.14 to 2.15), and blunt stump morphology +1 (OR: 1.39, 95% CI: 1.05 to 1.81). Score values of 0 to 1, >1 and <3, ≥3 and <5, and ≥5 identified subgroups at high, intermediate, low, and very low probability, respectively, of CTO-PCI success (derivation cohort: 84.9%, 74.9%, 58%, and 31.9%; p < 0,0001; validation cohort: 88.3%, 73.1%, 59.4%, and 46.2%; p < 0.0001). CONCLUSIONS: This clinical and angiographic score predicted the final CTO-PCI procedural outcome of our study population.

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.

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.

Two-year outcomes of everolimus vs. paclitaxel-eluting stent for the treatment of unprotected left main lesions: a propensity score matching comparison of patients included in the French Left Main Taxus (FLM Taxus) and the LEft MAin Xience (LEMAX) registries.

AIMS: With newer drug-eluting stents (DES), PCI has appeared as an acceptable alternative to cardiac surgery in the treatment of unprotected left main (ULM) lesions. Using data from the French Left Main Taxus and the LEft MAin Xience registries, we compared two-year outcomes in consecutive patients from 2003-2008 using everolimus-eluting stents (EES) vs. paclitaxel-eluting stents (PES). METHODS AND RESULTS: We performed a matched comparison according to SYNTAX score, distal LM stenosis, provisional side-branch T-stenting and single stent use, focusing on the primary endpoints of target vessel MI (TVMI) and target vessel failure (TVF). After propensity score matching, there were 172 patients in each group. There was no difference in gender (76.5% male), age (69.5 ± 11.3 years), diabetes (26.2% vs. 24.4%, p=0.71), NSTEMI (40.7% vs. 40.7%, p=1), or LVEF <40% (11.0% vs. 6.7%, p=0.22). Patients with distal LM lesions (75.9%) were treated using provisional T-stenting in 91.1%. The side branch was stented in 22% of all patients (p=0.51). Cumulative two-year events showed significant differences in TVMI (9.9% vs. 4.1%, p=0.04) and TVF (16.3% vs. 7.6%, p=0.01) for PES and EES, respectively. CONCLUSIONS: ULM stenting with EES is safer and more effective than PES with a reduction in TLF by 53% at two years.

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.

Duration of balloon inflation for optimal stent deployment: five seconds is not enough.

OBJECTIVES: To assess the effect of the duration of stent inflation on stent expansion using digital stent enhancement (DSE). BACKGROUND: Optimal stent expansion and apposition to the vessel wall are of critical importance to optimize the results of percutaneous coronary intervention (PCI). However, it is not known if stent inflation duration impacts on stent expansion. METHODS: We performed a prospective cohort study in patients undergoing PCI. Quantitative coronary angiography and DSE data were analyzed. DSE was performed at 5, 15, and 25 sec during stent implantation, after target balloon inflation pressure was achieved. RESULTS: One hundred and four consecutive patients (150 lesions) were enrolled. The mean age was 66.9 ± 11.1 years. Complex lesions (ACC/AHA B2/C) occurred in 26.9%. Stents used: Cypher Select (54.1%), Xience V (30.6%), and Taxus Liberté (15.3%). The minimal stent diameter increased significantly with the duration of stent inflation: 2.60 ± 0.51, 2.76 ± 0.51, and 2.82 ± 0.52 mm at 5, 15, and 25 sec (P < 0.0001). Similarly, maximal stent diameter increased with the duration of stent inflation: 3.21 ± 0.51, 3.32 ± 0.52, and 3.36 ± 0.54 mm (P < 0.0001). The average stent diameter also increased with longer stent inflation (P < 0.0001). Using MUSIC criteria 24.0, 53.3, and 68.0% of stents were appropriately expanded at 5, 15, and 25 sec (P < 0.0001). CONCLUSIONS: The duration of stent balloon inflation has a significant impact on stent expansion. Stent deployment for >25 sec is recommended.

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.