Victor Legrand

Treatment of aortic stenosis with a self-expanding transcatheter valve: the International Multi-centre ADVANCE Study.

AIMnTranscatheter aortic valve implantation has become an alternative to surgery in higher risk patients with symptomatic aortic stenosis. The aim of the ADVANCE study was to evaluate outcomes following implantation of a self-expanding transcatheter aortic valve system in a fully monitored, multi-centre real-world patient population in highly experienced centres.nnnMETHODS AND RESULTSnPatients with severe aortic stenosis at a higher surgical risk in whom implantation of the CoreValve System was decided by the Heart Team were included. Endpoints were a composite of major adverse cardiovascular and cerebrovascular events (MACCE; all-cause mortality, myocardial infarction, stroke, or reintervention) and mortality at 30 days and 1 year. Endpoint-related events were independently adjudicated based on Valve Academic Research Consortium definitions. A total of 1015 patients [mean logistic EuroSCORE 19.4 ± 12.3% [median (Q1,Q3), 16.0% (10.3, 25.3%)], age 81 ± 6 years] were enrolled. Implantation of the CoreValve System led to a significant improvement in haemodynamics and an increase in the effective aortic valve orifice area. At 30 days, the MACCE rate was 8.0% (95% CI: 6.3-9.7%), all-cause mortality was 4.5% (3.2-5.8%), cardiovascular mortality was 3.4% (2.3-4.6%), and the rate of stroke was 3.0% (2.0-4.1%). The life-threatening or disabling bleeding rate was 4.0% (2.8-6.3%). The 12-month rates of MACCE, all-cause mortality, cardiovascular mortality, and stroke were 21.2% (18.4-24.1%), 17.9% (15.2-20.5%), 11.7% (9.4-14.1%), and 4.5% (2.9-6.1%), respectively. The 12-month rates of all-cause mortality were 11.1, 16.5, and 23.6% among patients with a logistic EuroSCORE ≤10%, EuroSCORE 10-20%, and EuroSCORE >20% (P< 0.05), respectively.nnnCONCLUSIONnThe ADVANCE study demonstrates the safety and effectiveness of the CoreValve System with low mortality and stroke rates in higher risk real-world patients with severe aortic stenosis.

Treatment and Clinical Outcomes of Transcatheter Heart Valve Thrombosis

Background—Valve thrombosis has yet to be fully evaluated after transcatheter aortic valve implantation. This study aimed to report the prevalence, timing, and treatment of transcatheter heart valve (THV) thrombosis. Methods and Results—THV thrombosis was defined as follows (1) THV dysfunction secondary to thrombosis diagnosed based on response to anticoagulation therapy, imaging modality or histopathology findings, or (2) mobile mass detected on THV suspicious of thrombus, irrespective of dysfunction and in absence of infection. Between January 2008 and September 2013, 26 (0.61%) THV thromboses were reported out of 4266 patients undergoing transcatheter aortic valve implantation in 12 centers. Of the 26 cases detected, 20 were detected in the Edwards Sapien/Sapien XT cohort and 6 in the Medtronic CoreValve cohort. In patients diagnosed with THV thrombosis, the median time to THV thrombosis post–transcatheter aortic valve implantation was 181 days (interquartile range, 45–313). The most common clinical presentation was exertional dyspnea (n=17; 65%), whereas 8 (31%) patients had no worsening symptoms. Echocardiographic findings included a markedly elevated mean aortic valve pressure gradient (40.5±14.0 mmu2009Hg), presence of thickened leaflets or thrombotic apposition of leaflets in 20 (77%) and a thrombotic mass on the leaflets in the remaining 6 (23%) patients. In 23 (88%) patients, anticoagulation resulted in a significant decrease of the aortic valve pressure gradient within 2 months. Conclusions—THV thrombosis is a rare phenomenon that was detected within the first 2 years after transcatheter aortic valve implantation and usually presented with dyspnea and increased gradients. Anticoagulation seems to have been effective and should be considered even in patients without visible thrombus on echocardiography.

Deferral vs. performance of percutaneous coronary intervention of functionally non-significant coronary stenosis: 15-year follow-up of the DEFER trial

AIMSnStenting an angiographically intermediate but functionally non-significant stenosis is controversial. Nevertheless, it has been questioned if deferral of a functionally non-significant lesion on the basis of fractional flow reserve (FFR) measurement, is safe, especially on the long term. Five-year follow-up of the DEFER trial showed that outcome after deferral of percutaneous coronary intervention (PCI) of an intermediate coronary stenosis based on FFR ≥ 0.75 is excellent and was not improved by stenting. The aim of this study was to investigate the validity of this position on the very long term.nnnMETHODS AND RESULTSnIn 325 patients scheduled for PCI of an intermediate stenosis, FFR was measured just before the planned intervention. If FFR was ≥0.75, patients were randomly assigned to deferral (Defer group; n = 91) or performance (Perform group; n = 90) of PCI. If FFR was <0.75, PCI was performed as planned (Reference group; n = 144). Clinical follow-up was 15 years. There were no differences in baseline clinical characteristics between the randomized groups. Complete 15-year follow-up was obtained in 92% of patients. After 15 years of follow-up, the rate of death was not different between the three groups: 33.0% in the Defer group, 31.1% in the Perform group, and 36.1% in the Reference group (Defer vs. Perform, RR 1.06, 95% CI: 0.69-1.62, P = 0.79). The rate of myocardial infarction was significantly lower in the Defer group (2.2%) compared with the Perform group (10.0%), RR 0.22, 95% CI: 0.05-0.99, P = 0.03.nnnCONCLUSIONnDeferral of PCI of a functionally non-significant stenosis is associated with a favourable very long-term follow-up without signs of late catch-up phenomenon.

Device-associated thrombus formation after left atrial appendage occlusion: A systematic review of events reported with the Watchman, the Amplatzer Cardiac Plug and the Amulet

This study aimed to provide a systematic review of device‐associated thrombosis (DAT) after left atrial appendage occlusion (LAAO) with the Watchman, Amplatzer Cardiac Plug, and Amulet devices.

Impact of gender difference in hospital outcomes following percutaneous coronary intervention. Results of the Belgian Working Group on Interventional Cardiology (BWGIC) registry

AIMSnTo determine whether there are gender-based differences in in-hospital outcomes among patients undergoing percutaneous coronary intervention (PCI).nnnMETHODS AND RESULTSnWe studied a large cohort using clinical data from a registry of 130,985 PCI procedures in Belgium, from January 2006 to February 2011. Compared to males, females were significantly older (70.3 vs. 64.8 years), and were more frequently diabetic or hypertensive. Men smoked more and more frequently had previous myocardial infarction (MI), previous PCI or previous coronary artery bypass graft (CABG) surgery. Coronary artery disease (CAD) was less severe in women, and PCI to the left anterior descending artery was more common in female patients. Unadjusted in-hospital mortality rates were higher in females versus males (2.5% for women and 1.6% for men, p<0.0001). After multivariable analysis, female gender remained an independent predictor of mortality (odds ratio 1.35, 95% CI: 1.22-1.49, p<0.0001).nnnCONCLUSIONSnGender-based differences in hospital mortality rates after PCI were observed in this large registry. Female sex remained an independent predictor of mortality after multivariable adjustment.

One-year outcomes in 1,010 unselected patients treated with the PROMUS Element everolimus-eluting stent: the multicentre PROMUS Element European Post-Approval Surveillance Study

AIMSnThe PROMUS™ Element™ European Post-Approval Surveillance Study (PE-Prove) is a prospective, open-label, multicentre observational study designed to assess outcomes following PROMUS Element everolimus-eluting stent implantation in an unselected patient population.nnnMETHODS AND RESULTSnA total of 1,010 patients were enrolled at 40 clinical sites in Europe, including 24.9% with medically treated diabetes, 50.0% with Type B2/C lesions, 6.1% with chronic total occlusion, 17.8% with acute myocardial infarction (MI ≤24 hours pre-procedure), and 20.1% with unstable angina. The target lesion was the culprit for ST-segment elevation MI in 7.3% of patients. The one-year, per patient target vessel failure rate was 6.2% (60/975), 3.4% (33) being related to the PROMUS Element stent. Rates of cardiac death, MI, and Academic Research Consortium (ARC) definite/probable stent thrombosis were 1.7%, 3.5%, and 0.6%, respectively. The target vessel revascularisation rate was 3.2% (31/975), 2.1% (20) being related to the PROMUS Element stent.nnnCONCLUSIONSnIn a large and relatively complex group of real-world patients, coronary artery revascularisation with the PROMUS Element everolimus-eluting stent provides favourable results with low event rates consistent with those reported for other contemporary drug-eluting stents.

Midterm Clinical Outcome Following Edwards Sapien or Medtronic CoreValve Transcatheter Aortic Valve Implantation (TAVI): Results of the Belgian TAVI Registry

To assess midterm (3 years) clinical outcomes of transcatheter aortic valve implantation (TAVI) in Belgium using the Edwards SAPIEN valve or the Medtronic CoreValve transcatheter heart valve (THV).

The STIB score: a simple clinical test to predict clopidogrel resistance.

Background High platelet reactivity (HPR) to clopidogrel is associated with an increased risk of ischaemic complications during and after coronary interventions and concerns up to 50% of patients undergoing PCI. Aim of the study The aim of the study was to identify patients with HPR to clopidogrel using bedside clinical information obtained in the Stent Thrombosis In Belgium (STIB) trial. Methods Data on platelet reactivity using the VerifyNow® point-of-care assay were obtained in 844 patients undergoing PCI for stable coronary artery disease 12 to 24 hours after a 600-mg loading dose of clopidogrel was given. Demographic, clinical and baseline routine biological tests were obtained and compared with P2Y12 reaction units (PRU). Patients with PRU > 230 (HPR) were considered as non-responders to clopidogrel. Results HPR was observed in 424/844 pts. Age, weight, body mass index (BMI), HPR to aspirin, diabetes, renal failure (MDRD < 60 ml/min), haemoglobin (Hb), haematocrit, fi brinogen, glycaemia and glycated haemoglobin were associated with HPR to clopidogrel. In multivariate analysis, only Hb (OR: 0.77), BMI (OR: 1.06) and diabetes (OR: 1.62) emerged as independent risk factors. Hb < 13.9 g/dl, BMI > 28 kg/m2 and presence of diabetes were equally associated to predict HPR and can be added to derive a simple score to predict clopidogrel resistance. Although 38.5% of patients without a single clinical predictor still have HPR, 2/3 patients with 2 or 3 risk factors are resistant to clopidogrel. Conclusions STIB HPR score allows identifi cation of patients with a high probability of resistance to clopidogrel based on diabetes, Hb < 13.9 g/dl and BMI < 28 kg/m2. This bedside clinical test could be useful for the identifi cation of patients in whom another P2Y12 inhibitor should be recommended before and after PCI.

One-year clinical outcomes after sirolimus-eluting coronary stent implantation in diabetics enrolled in the worldwide e-SELECT registry.

Diabetes mellitus has worse outcome after percutaneous coronary intervention.

Unintentional "Ventriculo-Phlebo-Myo-Pericardiography"

An 83-year-old woman with severe aortic stenosisxa0was referred for invasive evaluation. A left Amplatz II catheter was needed to cross the stenotic aortic valve. Thereafter, an exchange wire was used to insert a pigtail catheter in thexa0left ventricular (LV) cavity. The operator did not realize that