Showing papers in "Eurointervention in 2016"

Left atrial appendage occlusion for stroke prevention in atrial fibrillation: multicentre experience with the AMPLATZER Cardiac Plug.

Abstract: AIMS To investigate the safety, feasibility, and efficacy of left atrial appendage occlusion (LAAO) with the AMPLATZER Cardiac Plug (ACP) for stroke prevention in patients with atrial fibrillation (AF). METHODS AND RESULTS Data from consecutive patients treated in 22 centres were collected. A total of 1,047 patients were included in the study. Procedural success was 97.3%. There were 52 (4.97%) periprocedural major adverse events. Follow-up was complete in 1,001/1,019 (98.2%) of successfully implanted patients (average 13 months, total 1,349 patient-years). One-year all-cause mortality was 4.2%. No death at follow-up was reported as device-related. There were nine strokes (0.9%) and nine transient ischaemic attacks (0.9%) during follow-up. The annual rate of systemic thromboembolism was 2.3% (31/1,349 patient-years), which is a 59% risk reduction. There were 15 major bleedings (1.5%) during follow-up. The annual rate of major bleeding was 2.1% (28/1,349 patient-years), which is a 61% risk reduction. Patients with single LAAO on aspirin monotherapy or no therapy and longer follow-up had fewer cerebral and fewer bleeding events. CONCLUSIONS In this multicentre study, LAAO with the ACP showed high procedural success and a favourable outcome for the prevention of AF-related thromboembolism. Modification in antithrombotic therapy after LAAO may result in reduction of bleeding events.

Percutaneous coronary intervention for coronary bifurcation disease: 11th consensus document from the European Bifurcation Club.

Abstract: Coronary bifurcations are involved in 15-20% of all percutaneous coronary interventions (PCI) and remain one of the most challenging lesions in interventional cardiology in terms of procedural success rate as well as long-term cardiac events. The optimal management of bifurcation lesions is, despite a fast growing body of scientific literature, the subject of considerable debate. The European Bifurcation Club (EBC) was initiated in 2004 to support a continuous overview of the field, and aims to facilitate a scientific discussion and an exchange of ideas on the management of bifurcation disease. The EBC hosts an annual, compact meeting, dedicated to bifurcations, which brings together physicians, engineers, biologists, physicists, epidemiologists and statisticians for detailed discussions. Every meeting is finalised with a consensus statement which reflects the unique opportunity of combining the opinions of interventional cardiologists with the opinions of a large variety of other scientists on bifurcation management. The present 11th EBC consensus document represents the summary of the up-to-date EBC consensus and recommendations. It points to the fact that there is a multitude of strategies and approaches to bifurcation stenting within the provisional strategy and in the different two-stent strategies. The main EBC recommendation for PCI of bifurcation lesions remains to use main vessel (MV) stenting with a proximal optimisation technique (POT) and provisional side branch (SB) stenting as a preferred approach. The consensus document covers a moving target. Much more scientific work is needed in non-left main (LM) and LM bifurcation lesions for continuous improvement of the outcome of our patients.

Filter-based cerebral embolic protection with transcatheter aortic valve implantation: the randomised MISTRAL-C trial

Abstract: Aims: Our aim was to determine whether use of the filter-based Sentinel (TM) Cerebral Protection System (CPS) during transcatheter aortic valve implantation (TAVI) can affect the early incidence of new brain lesions, as assessed by diffusion-weighted magnetic resonance imaging (DW-MRI), and neurocognitive performance. Methods and results: From January 2013 to July 2015, 65 patients were randomised 1:1 to transfemoral TAVI with or without the Sentinel CPS. Patients underwent DW-MRI and extensive neurological examination, including neurocognitive testing one day before and five to seven days after TAVI. Follow-up DW-MRI and neurocognitive testing was completed in 57% and 80%, respectively. New brain lesions were found in 78% of patients with follow-up MRI. Patients with the Sentinel CPS had numerically fewer new lesions and a smaller total lesion volume (95 mm(3) [IQR 10-257] vs. 197 mm(3) [95-525]). Overall, 27% of Sentinel CPS patients and 13% of control patients had no new lesions. Ten or more new brain lesions were found only in the control cohort (in 20% vs. 0% in the Sentinel CPS cohort, p=0.03). Neurocognitive deterioration was present in 4% of patients with Sentinel CPS vs. 27% of patients without (p=0.017). The filters captured debris in all patients with Sentinel CPS protection. Conclusions: Filter-based embolic protection captures debris en route to the brain in all patients undergoing TAVI. This study suggests that its use can lead to fewer and overall smaller new brain lesions, as assessed by MRI, and preservation of neurocognitive performance early after TAVI. Clinical Trial Registration: Dutch trial register-ID: NTR4236. URL http://www.trialregister.nl/trialreg/admin/rctsearch.asp?Term=mistral

Transcatheter aortic valve implantation (TAVI) in Germany 2008-2014: on its way to standard therapy for aortic valve stenosis in the elderly?

Abstract: AIMS In Germany, all transcatheter aortic valve implantations (TAVI) and surgical aortic valve replacements (sAVR) are registered within an obligatory quality assurance programme led by the independent AQUA Institute. We have summarised patient and procedural characteristics, complication and mortality rates as reported in the annual, German language AQUA quality reports, freely accessible online, in order to provide a comprehensive overview of developments between 2008 and 2014. METHODS AND RESULTS Since 2008, a total of 71,927 isolated sAVR and 48,353 TAVI procedures have been performed in Germany. The numbers of sAVR are steadily declining (2008: 11,205; 2014: 9,953). For TAVI, there has been a 20-fold increase since 2008, from 637 to 13,264 procedures in 2014, surpassing the annual numbers of isolated sAVR since 2013. The age profile of TAVI patients has remained unchanged over time (mean age: 80.9 years), with a recent trend towards lower-risk/intermediate-risk patients. TAVI complications are rapidly decreasing (2012: 9.4%; 2014: 3.9%); annular rupture, aortic dissection and coronary occlusions are rare (<0.3%), with fewer patients requiring surgical conversion to sternotomy (2012: 1.2%; 2014: 0.6%). In-hospital mortality after TAVI has halved in 2014 (4.2%) compared with 2008 (10.4%). CONCLUSIONS Real-world clinical data from the obligatory quality assurance programme document the rapid adoption of TAVI in Germany, shifting treatment of aortic valve stenosis in the elderly from surgery to a catheter-based approach. Since 2008, similar to what happened with PCIs, complications of TAVI have declined considerably along with the need for emergency cardiac surgery. Most importantly, in-hospital mortality has halved from 2008 to 2014, while mortality for sAVR has remained unchanged.

Two-year clinical, angiographic, and serial optical coherence tomographic follow-up after implantation of an everolimus-eluting bioresorbable scaffold and an everolimus-eluting metallic stent: insights from the randomised ABSORB Japan trial.

Abstract: Aims We sought to investigate two-year clinical and serial optical coherence tomography (OCT) outcomes after implantation of a fully bioresorbable vascular scaffold (BVS) or a cobalt-chromium everolimus-eluting stent (CoCr-EES). Methods and results In the ABSORB Japan trial, 400 patients were randomised in a 2:1 ratio to BVS (N=266) or CoCr-EES (N=134). A pre-specified OCT subgroup (N=125, OCT-1 group) underwent angio-graphy and OCT post procedure and at two years. Overall, the two-year TLF rates were 7.3% and 3.8% in the BVS and CoCr-EES arms (p=0.18), respectively. Very late scaffold thrombosis (VLST) beyond one year was observed in 1.6% (four cases: all in non-OCT-1 subgroups) of the BVS arm, while there was no VLST in the CoCr-EES arm. In three cases, OCT at the time of or shortly after VLST demonstrated strut discontinuities, malapposition and/or uncovered struts. However, the vessel healing by two-year OCT was nearly complete in both BVS and CoCr-EES arms with almost fully covered struts, and minimal malapposition. The flow area by two-year OCT was smaller in the BVS arm than in the CoCr-EES arm, mainly due to tissue growth inside the device. However, there were no differences between the BVS and CoCr-EES with regard to the quality of homogenous tissues growing inside the devices. Conclusions The rate of TLF was numerically higher in the BVS arm than in the CoCr-EES arm, although this difference was not statistically significant. VLST was observed only in the BVS arm at a rate of 1.6% between one and two years. Further studies are mandatory to investigate the risk of BVS relative to metallic stents for VLST, and the underlying mechanisms of BVS VLST.

Percutaneous left atrial appendage occlusion: the Munich consensus document on definitions, endpoints and data collection requirements for clinical studies

Abstract: The increasing interest in left atrial appendage occlusion (LAAO) for ischaemic stroke prevention in atrial fibrillation (AF) fuels the need for more clinical data on the safety and effectiveness of this therapy Besides an assessment of the effectiveness of the therapy in specific patient groups, comparisons with pharmacological stroke prophylaxis, surgical approaches and other device-based therapies are warranted This paper documents the consensus reached among clinical experts in relevant disciplines from Europe and North America, European cardiology professional societies and representatives from the medical device industry regarding definitions for parameters and endpoints to be assessed in clinical studies Adherence to these definitions is proposed in order to achieve a consistent approach across clinical studies on LAAO among the involved stakeholders and various clinical disciplines and thereby facilitate continued evaluation of therapeutic strategies available

Long-term ticagrelor monotherapy versus standard dual antiplatelet therapy followed by aspirin monotherapy in patients undergoing biolimus-eluting stent implantation: rationale and design of the GLOBAL LEADERS trial.

Abstract: AIMS The GLOBAL LEADERS trial is a superiority study in patients undergoing percutaneous coronary intervention, with a uniform use of Biolimus A9-eluting stents (BES) and bivalirudin. GLOBAL LEADERS was designed to assess whether a 24-month antithrombotic regimen with ticagrelor and one month of acetylsalicylic acid (ASA), compared to conventional dual antiplatelet therapy (DAPT), improves outcomes. METHODS AND RESULTS Patients (n >16,000) are randomised (1:1 ratio) to ticagrelor 90 mg twice daily for 24 months plus ASA ≤100 mg for one month versus DAPT with either ticagrelor (acute coronary syndrome) or clopidogrel (stable coronary artery disease) for 12 months plus ASA ≤100 mg for 24 months. The primary outcome is a composite of all-cause mortality or non-fatal, new Q-wave myocardial infarction at 24 months. The key safety endpoint is investigator-reported class 3 or 5 bleeding according to the Bleeding Academic Research Consortium (BARC) definitions. Sensitivity analysis will be carried out to explore potential differences in outcome across geographic regions and according to specific angiographic and clinical risk estimates. CONCLUSIONS The GLOBAL LEADERS trial aims to assess the role of ticagrelor as a single antiplatelet agent after a short course of DAPT for the long-term prevention of cardiac adverse events, across a wide spectrum of patients, following BES implantation.

Left atrial appendage occlusion with the AMPLATZER Amulet device: an expert consensus step-by-step approach.

Abstract: AIMS This document aims to describe a standardised methodology for performing left atrial appendage occlusion (LAAO) using the AMPLATZER Amulet device, and to provide useful tips and tricks for operators with different levels of experience. METHODS AND RESULTS Physicians who are experts in LAAO and had personal clinical experience with the AMPLATZER Amulet device were asked to contribute in the preparation of this consensus document. Twenty-seven physicians (20 interventional cardiologists and 7 electrophysiologists) from 14 different countries reviewed the manuscript. A step-by-step approach, simulating a real case, was followed. Starting with patient selection and planning, related cardiac imaging is discussed, followed by vascular access - transseptal puncture optimisation. Then, angiographic calibration/sizing and the required fluoroscopy views are explained and a device sizing strategy is proposed. Device preparation and de-airing is briefly described, followed by sheath exchange, device deployment steps, evaluation of device stability and decision for final release. The way to recapture and change a device is then shown, together with some additional tips on how to deal with challenging anatomies like "chicken wing" left atrial appendage. Finally, for operators who are switching from AMPLATZER Cardiac Plug to Amulet, the main differences between the two devices with respect to implantation technique are presented. CONCLUSIONS In conclusion, this document reflects a consensus approach by expert implanters on the steps of LAAO technique and best practices for implantation of the AMPLATZER Amulet device, along with some practical tips to minimise the complication rate.

Long-term invasive follow-up of the everolimus-eluting bioresorbable vascular scaffold: five-year results of multiple invasive imaging modalities.

Abstract: Aims Invasive imaging modalities have shown restoration of vasomotion, prevention of restenosis and, most importantly, increase in lumen area between six months and two years after first-generation everolimus-eluting bioresorbable vascular scaffold (Absorb BVS) implantation. Our aim was to assess whether these positive findings were sustained in the long term. Methods and results Patients included in the ABSORB cohort A from the Thoraxcenter Rotterdam cohort underwent coronary catheterisation including angiography, intravascular ultrasound (IVUS), virtual histology, optical coherence tomography (OCT) and vasomotion testing at five years. Eight out of 16 patients underwent catheterisation and scaffold assessment with multiple imaging modalities. A trend towards an increase in minimum luminal diameter was observed between two and five years by angiography (1.95±0.37 mm vs. 2.14±0.38 mm; p=0.09). IVUS data showed an increase in mean lumen area at five years (6.96±1.13 mm2) compared to six months (6.17±0.74 mm2; p=0.06) and two years (6.56±1.16 mm2; p=0.12), primarily due to a persistent reduction in plaque area size between six months and five years (9.17±1.86 mm2 vs. 7.57±1.63 mm2; p=0.03). The necrotic core area was reduced at five years compared to post-procedural results. In OCT, an increase in mean and minimal luminal area was observed. Moreover, no scaffold struts could be identified and a smooth endoluminal lining was observed. The scaffolded coronary segment did not show signs of endothelial dysfunction with acetylcholine testing. Conclusions At five years, the Absorb BVS is no longer discernible by any invasive imaging method and endothelial function is restored. Late luminal enlargement persists up to five years of follow-up without adaptive vessel remodelling.

Current status of transcatheter valve therapy in Europe: results from an EAPCI survey

Abstract: AIMS Our aim was to identify current discrepancies among European countries, and provide a basis for a general agreement on decision making specifically related to TAVI procedures. The European Association of Percutaneous Coronary Interventions (EAPCI) therefore assessed the current status of transcatheter valve therapy (TAVI) in Europe through a web-based survey. METHODS AND RESULTS Three hundred and one European centres responded to the survey (61.4% of the invited centres). Fewer than 200 TAVI procedures per site had been performed up to the date of response in 47% of centres, while over 500 procedures had been performed in 21% of centres. The Heart Team consisted mostly of interventional cardiologists and cardiac surgeons. In 79% of the centres, specific TAVI protocols are in place. Of note, 45% of centres perform TAVI in intermediate-risk patients, while only 10% do so in low-risk patients. Valve selection was based principally on patient-specific variables (74%), followed by operators' skills (55%), rates of valve-related complications (31%), and device cost (30%). Multislice computed tomography is the imaging modality most frequently performed prior to TAVI. Coronary revascularisation is usually performed before TAVI (86%), while no uniformity was observed in terms of antithrombotic therapy. CONCLUSIONS The EAPCI survey documents the current TAVI practice and penetration in Europe. Despite economic and regulatory difficulties, the procedure is increasingly performed and mostly according to specific protocols. The heterogeneity of the approach apparent in the survey suggests a call for an update in practice recommendations.

Interventional post-myocardial infarction ventricular septal defect closure: a systematic review of current evidence.

Abstract: Aims Interventional closure of post-myocardial infarction ventricular septal defects (VSD) is an alternative treatment option to surgical repair. However, only limited evidence exists concerning the interventional closure of a VSD. This review seeks to establish an overview of the existing literature and to carry out a systematic analysis of the success rate and clinical outcome of this procedure. Methods and results We conducted a comprehensive systematic literature search to evaluate the existing evidence of percutaneous device closure of post-infarction VSD. Patient series with fewer than five reported cases were excluded. In total, 13 series were identified, with an overall inclusion of 273 patients. Mean patient age was 70 years. Cardiogenic shock was present in 48% of cases at the time of intervention. Device closure within the first 14 days (acute phase) after VSD detection was performed in 42% of cases. Technical success rate was high (>75%). Successful device implantation rate was 89%. Overall in-hospital/30-day mortality was 32%. Major complications included device embolisation, ventricular perfora-tion and arrhythmias. Conclusions Percutaneous device closure of post-myocardial infarction VSD is a valuable alternative to surgical repair, with the advantage of immediate shunt reduction to prevent haemodynamic deterioration. A high rate of technically successful percutaneous procedures can be achieved; however, the mortality rate remains high, especially in cardiogenic shock patients.

A meta-analysis of the impact of pre-existing and new-onset atrial fibrillation on clinical outcomes in patients undergoing transcatheter aortic valve implantation.

Abstract: AIMS Little is known about the prognostic role of pre-existing atrial fibrillation (AF) and new-onset AF (NOAF) in transcatheter aortic valve implantation (TAVI). Therefore, the aim of this meta-analysis was to compare the short- and long-term clinical outcomes of patients undergoing TAVI with and without pre-existing and new-onset AF. METHODS AND RESULTS Twenty-six studies, enrolling 14,078 patients undergoing TAVI, of whom 33.4% had pre-existing AF and 17.5% had NOAF, were analysed for early and long-term all-cause mortality, cardiovascular mortality and cerebrovascular events (CVE). In patients with pre-existing AF, 30-day all-cause mortality was similar to patients in sinus rhythm (SR). Conversely, long-term all-cause and cardiovascular mortality were significantly greater in pre-existing AF patients than in patients with SR (20 studies; 8,743 patients; HR: 1.68; p<0.00001, and three studies; 1,138 patients; HR: 2.07; p=0.01, respectively). Pre-existing AF was not a predictor of CVE at long-term follow-up. NOAF patients showed similar short- and long-term all-cause mortality when compared to patients in SR, whereas they experienced a significantly higher incidence of CVE at short-term follow-up (six studies; 2,025 patients; HR: 2.86; p<0.00001). A non-significant increase in the incidence of CVE was observed at long-term follow-up. CONCLUSIONS Pre-existing AF is a predictor of all-cause mortality in patients undergoing TAVI. NOAF is related to the occurrence of CVE at short-term follow-up. Similarly to surgical aortic valve replacement (SAVR), the optimal management and risk stratification of these patients should be further investigated.

Very high-pressure dilatation for undilatable coronary lesions: indications and results with a new dedicated balloon

Abstract: Aims: Calcific coronary lesions impose a rigid obstacle to optimal balloon and stent expansion and the 20 to 30 atm limit that non-compliant (NC) balloons reach can be insufficient. The aim of our study was to evaluate the safety and efficacy of a new dedicated super high pressure NC balloon (OPN NC ® ; SIS Medical AG, Winterthur, Switzerland). Methods and results: We retrospectively evaluated a consecutive series of 91 lesions in which conventional NC balloons at maximal pressure failed to achieve an adequate post-dilatation luminal gain and were therefore treated with an OPN NC balloon up to 40 atm. Angiographic success was defined as residual angiographic diameter stenosis <30%. MLD and %DS were measured at baseline, after NC balloon, OPN NC balloon and stent implantation. Angiographic success was achieved in 84 lesions (92.3%). All of the remaining lesions received rotational atherectomy with the exception of two cases in which rotational atherectomy was not attempted because of small vessel size and excessive tortuosity. MLD and acute gain were significantly greater and % DS was significantly lower post OPN NC balloon compared with conventional NC balloon inflation (p<0.001). No coronary perforations occurred. No acute or 30-day follow-up MACE was reported. Conclusions: When conventional NC balloons fail, the new OPN NC dedicated high pressure balloon provides an effective and safe alternative strategy for the dilatation of resistant coronary lesions.

Novel PARADIGM in carotid revascularisation: Prospective evaluation of All-comer peRcutaneous cArotiD revascularisation in symptomatic and Increased-risk asymptomatic carotid artery stenosis using CGuard™ MicroNet-covered embolic prevention stent system.

Abstract: AIMS Our aim was to determine (1) periprocedural and 30-day clinical safety and efficacy of the CGuard MicroNet-covered embolic prevention carotid stent system (MN-EPS) in routine use for unselected carotid stenosis (CS) patients undergoing CAS, as well as (2) feasibility of MN-EPS post-dilatation optimisation to minimise residual stenosis after CAS. METHODS AND RESULTS This was a non-industry-funded, prospective academic study in all-referrals-tracked symptomatic and asymptomatic CS. In asymptomatic lesions, intervention was mandated only in case of increased stroke risk CS features. There was independent neurologist evaluation before CAS, at 48 hours and 30 days. There was external source data verification, angiographic core lab, and statistical analysis. Over 11 months, 108 referrals were recommended by the NeuroVascular Team for revascularisation: 101 (51-86 years, 55 symptomatic, evolving stroke in nine) underwent 106 (100% MN-EPS use) neuroprotection device-assisted (46% proximal, 54% distal) CAS; CEA was performed in seven. MN-EPS device success was 99.1%. Angiographic diameter stenosis was reduced from 83±9% to 6.7±5% (p<0.001). No MN-EPS foreshortening/elongation occurred (30 mm long was 29.82±0.68 mm; 40 mm long was 39.89±0.59 mm). The periprocedural death/major stroke/MI rate was 0%. One event, with no change in NIHSS or modified Rankin Scale and no clinical sequel, was adjudicated by the clinical events committee as minor stroke (0.9%). By 30 days there were no new events (0%). CONCLUSIONS These increased risk consecutive patient data (1) indicate safety and efficacy of routine MN-EPS use in achieving endovascular reconstruction across all-comer CS lesion subsets, and (2) are consistent with MN-EPS protection against cerebral events extending throughout the stent healing period.

Patient-specific image-based computer simulation for theprediction of valve morphology and calcium displacement after TAVI with the Medtronic CoreValve and the Edwards SAPIEN valve.

Abstract: __Aims:__ Our aim was to validate patient-specific software integrating baseline anatomy and biomechanical properties of both the aortic root and valve for the prediction of valve morphology and aortic leaflet calcium displacement after TAVI. __Methods and results:__ Finite element computer modelling was performed in 39 patients treated with a Medtronic CoreValve System (MCS; n=33) or an Edwards SAPIEN XT (ESV; n=6). Quantitative axial frame morphology at inflow (MCS, ESV) and nadir, coaptation and commissures (MCS) was compared between multislice computed tomography (MSCT) post TAVI and a computer model as well as displacement of the aortic leaflet calcifications, quantified by the distance between the coronary ostium and the closest calcium nodule. Bland-Altman analysis revealed a strong correlation between the observed (MSCT) and predicted frame dimensions, although small differences were detected for, e.g., Dmin at the inflow (mean±SD MSCT vs. model: 21.6±2.4 mm vs. 22.0±2.4 mm; difference±SD: 0.4±1.3 mm, p<0.05) and Dmax (25.6±2.7 mm vs. 26.2±2.7 mm; difference±SD: 0.6±1.0 mm, p<0.01). The observed and predicted calcium displacements were highly correlated for the left and right coronary ostia (R2=0.67 and R2=0.71, respectively p<0.001). __Conclusions:__ Dedicated software allows accurate prediction of frame morphology and calcium displacement after valve implantation, which may help to improve outcome.

Novel monorail infusion catheter for volumetric coronary blood flow measurement in humans: in vitro validation

Abstract: AIMS: The aim of this study is to validate a novel monorail infusion catheter for thermodilution-based quantitative coronary flow measurements. METHODS AND RESULTS: Based on the principles of thermodilution, volumetric coronary flow can be determined from the flow rate of a continuous saline infusion, the temperature of saline when it enters the coronary artery, and the temperature of the blood mixed with the saline in the distal part of the coronary artery. In an in vitro set-up of the systemic and coronary circulation at body temperature, coronary flow values were varied from 50-300 ml/min in steps of 50 ml/min. At each coronary flow value, thermodilution-based measurements were performed at infusion rates of 15, 20, and 30 ml/min. Temperatures and pressures were simultaneously measured with a pressure/temperature sensor-tipped guidewire. Agreement of the calculated flow and the measured flow as well as repeatability were assessed. A total of five catheters were tested, with a total of 180 measurements. A strong correlation (ρ=0.976, p<0.0001) and a difference of -6.5±15.5 ml/min were found between measured and calculated flow. The difference between two repeated measures was 0.2%±8.0%. CONCLUSIONS: This novel infusion catheter used in combination with a pressure/temperature sensor-tipped guidewire allows accurate and repeatable absolute coronary flow measurements. This opens a window to a better understanding of the coronary microcirculation.

Emergency transcatheter aortic valve replacement in patients with cardiogenic shock due to acutely decompensated aortic stenosis.

Abstract: AIMS To assess outcomes of TAVR as a rescue therapy in patients with cardiogenic shock due to acutely decompensated aortic stenosis. METHODS AND RESULTS Of 771 high-risk patients who underwent TAVR, 27 (3.5%; 78±9 years; 12 men) were treated emergently due to acutely decompensated aortic stenosis with cardiogenic shock. SAPIEN and CoreValve prostheses were implanted in 11 and 16 patients, respectively: the transfemoral access route was used in 25. Three patients died within 72 hours of successful valve deployment, and a further six died within a month, giving a 30-day mortality of 33.3%, which was significantly higher than in electively treated patients (7.7%, p<0.0001). Univariate predictors of 30-day mortality in cardiogenic-shock patients were baseline cardiac output <3.0 l/min, reduced cardiac power index, impaired renal function, and mechanical ventilation, as well as severe acute kidney injury after TAVR. Estimated one-year survival was 59.3% in emergently and 82.7% in electively treated patients (p=0.0009). However, 30-day landmark analysis showed no difference in cumulative survival between TAVR modalities. In cardiogenic-shock patients without concomitant reduced cardiac output and impaired renal function at baseline (n=22), estimated one-year survival was 72.7%. CONCLUSIONS TAVR should be considered a reasonable rescue therapy in patients with cardiogenic shock secondary to decompensated aortic stenosis.

Magmaris preliminary recommendation upon commercial launch: a consensus from the expert panel on 14 April 2016.

Abstract: Bioresorbable scaffolds represent an exciting milestone in the development of coronary stent technology with the potential to substantially improve the management of patients with coronary artery disease. In an attempt to provide first recommendations for the technology, experienced experts involved in the first-in-man studies met in Zurich on the 14 April 2016 in order to reach consensus on a responsible market introduction. This document will be updated regularly as new information from clinical trials becomes available and should be understood as a review of current data, opportunities, expectations, advice, and recommendations for future investigations.

Five-year outcomes from a trial of three limus-eluting stents with different polymer coatings in patients with coronary artery disease: final results from the ISAR-TEST 4 randomised trial.

Abstract: Both biodegradable polymer sirolimus-eluting stents and permanent polymer everolimus-eluting stents offer potential for enhanced late outcomes in comparison with earlier-generation permanent polymer sirolimus-eluting stents. However, long-term comparative efficacy data among these devices remain a scientific gap. We aimed to compare the efficacy and safety of biodegradable polymer sirolimus-eluting stents (Yukon Choice PC) versus permanent polymer everolimus-eluting stents (XIENCE) versus permanent polymer sirolimus-eluting stents (CYPHER) at five-year follow-up.Overall, 2,603 patients were randomised to treatment with the Yukon Choice PC (n=1,299), XIENCE (n=652) or CYPHER (n=652) stents. The primary endpoint was the device-oriented composite of cardiac death, target vessel-related myocardial infarction (MI), or target lesion revascularisation (TLR). The main secondary endpoint was definite/probable stent thrombosis (ST). Follow-up was performed up to five years. Concerning the primary endpoint, there was no significant difference between Yukon Choice PC and XIENCE stents (20.5% vs. 19.5%, HR=1.04, 95% CI: 0.84-1.29; p=0.71) or between CYPHER and XIENCE stents (23.5% vs. 19.5%, HR=1.21, 95% CI: 0.95-1.53; p=0.12). In terms of safety, rates of ST were similar with both Yukon Choice PC and XIENCE (1.2% vs. 1.4%; HR=0.83, 95% CI: 0.37-1.91; p=0.67) but numerically higher with CYPHER as compared to XIENCE (2.4% vs. 1.4%, HR=1.67, 95% CI: 0.73-3.82; p=0.22).Biodegradable polymer Yukon Choice PC and permanent polymer XIENCE stents showed comparable clinical outcomes at five years. Permanent polymer CYPHER stents showed numerically higher rates of device-related adverse events. Trials registration: ClinicalTrials.gov (identifier: NCT00598676).

Percutaneous left atrial appendage occlusion in patients with non-valvular atrial fibrillation: implantation and up to four years follow-up of the AMPLATZER Cardiac Plug.

Abstract: AIMS Percutaneous left atrial appendage occlusion (LAAO) may be considered for stroke prophylaxis in patients with non-valvular atrial fibrillation (NVAF). Data on device implantation safety and feasibility and long-term follow-up are limited. METHODS AND RESULTS LAAO was performed using the AMPLATZER Cardiac Plug (ACP) device in 134 NVAF patients with long-term OAC contraindication, with median (interquartile range) CHA2DS2-VASc and HAS-BLED scores of four (3-5) and three (2-3.75), respectively. Follow-up data were collected over a mean follow-up period of 680 days (range: 42 days to 4.3 years) comprising a total implant experience of 238 patient-years. Device implantation was successful in 95.5% of the procedures and associated with a rate of major procedural complications of 2.2%. At the most recent follow-up, almost all patients were receiving antiplatelet therapy. Ischaemic stroke was observed at an annual rate of 0.8% and the annual rate of any thromboembolic (TE) event was 2.5%. Major bleeding during follow-up occurred at an annual rate of 1.3%. CONCLUSIONS LAAO is a safe and effective stroke prevention therapy in a high-risk NVAF cohort, both at implantation and over longer follow-up periods. The long-term assessed ischaemic stroke rate in patients treated with LAAO is markedly reduced compared to the expected rate based on the patients' risk scores.

Design and rationale for a randomised comparison of everolimus-eluting stents and coronary artery bypass graft surgery in selected patients with left main coronary artery disease: The EXCEL trial

Abstract: Aims Coronary artery bypass graft (CABG) surgery is the standard of care for revascularisation of patients with left main coronary artery disease (LMCAD). Recent studies have suggested that percutaneous coronary intervention (PCI) with drug-eluting stents (DES) may provide comparable outcomes in selected patients with LMCAD without extensive CAD. We therefore designed a trial to investigate whether PCI with XIENCE cobalt-chromium everolimus-eluting stents (CoCr-EES) would result in non-inferior or superior clinical outcomes to CABG in selected patients with LMCAD. Methods and results The Evaluation of XIENCE versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization (EXCEL) trial is a prospective, open-label, multicentre, international study of 1,900 randomised subjects. Patients with significant LMCAD with a SYNTAX score ≤32 and local Heart Team consensus that the subject is appropriate for revascularisation by both PCI and CABG are consented and randomised 1:1 to undergo PCI using CoCr-EES or CABG. All patients undergo follow-up for five years. The primary endpoint is the three-year composite rate of death, stroke or myocardial infarction, assessed at a median follow-up of at least three years (with at least two-year follow-up in all patients), powered for sequential non-inferiority and superiority testing. Conclusions The EXCEL study will define the contemporary roles of CABG and PCI using XIENCE CoCr-EES in patients with LMCAD disease with low and intermediate SYNTAX scores.

Anaesthetic management of transcatheter aortic valve implantation: results from the Italian CoreValve registry.

Abstract: Aims: Transcatheter aortic valve implantation (TAVI) represents a valid therapeutic alternative for patients with severe aortic stenosis at high surgical risk. However, there is no general consensus regarding the role of anaesthesia in TAVI management. The goal of this clinical project was to assess the safety and non-inferiority of local anaesthesia (LA) versus general anaesthesia (GA) in a large cohort of patients undergoing TAVI. Methods and results: All 1,316 consecutive patients who underwent TAVI at seven high-volume Italian centres were enrolled. The anaesthetic regimen consisted of GA in 355 (26.9%) patients or LA in 961 (73.0%) patients. Baseline demographics were similar between the two groups except for a higher median logistic EuroSCORE (p=0.004) and peripheral artery disease (p<0.001) in the GA group. The two groups showed similar device success with no significant difference in terms of mortality, stroke and myocardial infarction. The overall procedural time was longer with the use of GA (p<0.001). The LA group showed a lower incidence of major access-site complications (p=0.01) and major (p=0.03) and life-threatening bleedings (p<0.001) with a lower occurrence of acute kidney injury stage 3 (p=0.002). Consistently, we observed a significantly shorter length of hospital stay in LA patients (8 days [7-13] vs. 7 days [6-10], GA vs. LA; p<0.001). As the GA patients were found to be at higher risk due to a higher prevalence of peripheral artery disease we carried out a propensity matching to obtain two comparable groups. This sub-analysis confirmed the same results previously observed in the overall population. As expected, in the GA group we observed longer procedural time, higher use of a surgical vascular access, higher incidence of acute kidney injury stage 3 and higher rate of bleeding and major vascular access-site complications. Conclusions: Our study indicates that, in experienced centres which have gone beyond their initial learning curve with TAVI, the use of local anaesthesia in a selected patient population can be associated with good clinical outcomes. Nevertheless, as severe procedural complications are possible, an anaesthesiologist should always be present as part of the team.

The collateral circulation of coronary chronic total occlusions

Abstract: Aims Despite advances in understanding the physiological role of collaterals in coronary chronic total occlusions (CTOs), collateral anatomy remains poorly defined. Our aim was to define the anatomy and interventional utility of collaterals within a large population of patients with CTOs. Methods and results We studied the coronary angiograms of 481 patients with 519 CTOs at six centres in the U.K. over four years. Detailed angiographic analysis was performed by interventional cardiologists specialising in CTO percutaneous coronary intervention (PCI). All visible collaterals with a collateral connection (CC) grade ≥1 were recorded. A subgroup of CTOs (n=277) was assessed for interventional capability, defined as whether the collateral supply was able to facilitate retrograde access. We described 45 different collateral patterns: 20 in right coronary artery (RCA), 13 in left anterior descending (LAD), and 12 in circumflex artery CTOs. Septal collaterals from the LAD to the right posterior descending artery (RPDA), and from the posterior descending artery to the LAD were most common, and most often considered as having "interventional capability". Conclusions This is the largest analysis of collateral circulation anatomy in a population of patients with CTOs. We anticipate that these data will be of significant benefit in angiographic analysis and procedure planning for CTO PCI.

Comparative analysis method of permanent metallic stents (XIENCE) and bioresorbable poly-L-lactic (PLLA) scaffolds (Absorb) on optical coherence tomography at baseline and follow-up

Abstract: Aims: Fully bioresorbable Absorb poly-L-lactic-acid (PLLA) scaffolds (Abbott Vascular, Santa Clara, CA, USA) are a novel approach for the treatment of coronary narrowing. Due to the translucency of the material (PLLA), the optical coherence tomography (OCT) measurement methods used in the ABSORB trials were unique but not applicable for permanent metallic stents. When the Absorb scaffold and metallic stents are compared in the context of randomised trials, it is challenging to compare the two devices using the conventional methods. The primary purpose of this report is to explain the biases in conventional methodologies applied for metallic stents and for PLLA scaffolds at baseline and follow-up, and to propose a new standard methodology that enables us to compare two different devices using an almost identical and methodological language. Methods and results: A consensus amongst multiple core labs and expert researchers of OCT was reached on a new standard OCT measurement methodology that enables us to compare these two different devices. In brief, the proposed OCT methods are summarised as follows. 1) Both endoluminal and abluminal scaffold/stent contours should be traced. 2) Consistently, endoluminal and abluminal incomplete stent apposition areas should be measured. 3) The area occupied by scaffold/stent struts should be quantified directly or virtually. 4) The strut area should be systematically excluded from the flow area as well as the neointimal area. 5) Additional information on the degree of embedment could be reported using the interpolated lumen contour. Interobserver variability of the proposed method was excellent (intraclass correlation 0.89-100). Conclusions: A standardised OCT measurement methodology is proposed. This should be implemented in ongoing and future trials comparing the Absorb scaffolds and metallic stents.

Randomised comparison of a bioresorbable everolimus-eluting scaffold with a metallic everolimus-eluting stent for ischaemic heart disease caused by de novo native coronary artery lesions: the 2-year clinical outcomes of the ABSORB II trial

Abstract: Aims The one-year randomised data of the ABSORB II trial showed that the everolimus-eluting bioresorbable scaffold and the everolimus-eluting metallic stent were comparable for the composite secondary clinical outcomes of patient-oriented composite endpoint (PoCE) and device-oriented composite endpoint (DoCE)/target lesion failure (TLF), MACE and TVF. This report describes the two-year clinical outcomes of the ABSORB II trial. Methods and results Patients were randomly assigned in a 2:1 ratio to receive treatment with an everolimus-eluting bioresorbable scaffold (Absorb; Abbott Vascular, Santa Clara, CA, USA) or treatment with an everolimus-eluting metallic stent (XIENCE; Abbott Vascular). The trial enrolled 501 patients. Clinical follow-up at two years was available in 320 patients in the Absorb BVS arm and 160 patients in the XIENCE arm. At two years, the PoCE for the Absorb and XIENCE arms was 11.6% and 12.8% (p=0.70) and the DoCE/TLF was 7.0% and 3.0% (p=0.07), respectively. The hierarchical ID-MACE rate was 7.6% vs. 4.3% (p=0.16) and the rate of TVF was 8.5% vs. 6.7% (p=0.48). The definite/probable thrombosis rate was 1.5% in the Absorb arm vs. 0% in the XIENCE arm (p=0.17). Thirty-six percent and 34% of patients remained on DAPT at two years, respectively. Ninety-two percent of patients in both arms remained on aspirin. Conclusions Two-year clinical results demonstrate sustained low rates of PoCE, MACE, DoCE and TVF with the Absorb BVS as compared to the XIENCE stent.

Multicentre clinical study evaluating a novel resheathable annular functioning self-expanding transcatheter aortic valve system: safety and performance results at 30 days with the Portico system.

Abstract: Aims The aim of this study was to evaluate the safety and performance of the resheathable and repositionable St. Jude Medical Portico self-expanding transfemoral TAVI system. Methods and results This prospective, single-arm, multicentre study evaluated the 18 Fr Portico system with either a 23 or a 25 mm valve. Patient follow-up was at 30, 90, 180 days and one year. Results up to 30 days are presented. Adverse events were categorised by VARC definitions and adjudicated by an independent events committee. Echocardiography was evaluated by an independent laboratory and all patients underwent neurological assessment at baseline, post procedure, at 30 days and one year. The primary endpoint was all-cause mortality at 30 days. A total of 102 patients (mean age 84.1±4.8 years; 97% female; median STS score 5.6) were enrolled. The 30-day mortality, disabling stroke and major vascular complications were 2.9%, 2.9% and 5.9%, respectively. Resheathing and repositioning (23.8%) was successful in all instances. Paravalvular leak at 30 days was none/trace in 30.4%, mild in 65.8% and moderate in 3.8%. Mean gradient improved from 45.3±13.8 to 8.9±3.8 mmHg and valve area improved from 0.6±0.2 to 1.7±0.4 cm2. Permanent pacemaker implantation was required in 9.8% of patients. Conclusions The novel Portico TAVI system is safe and effective at treating high-risk patients with symptomatic severe aortic stenosis, allowing safe repositioning and optimisation of device position.

The CLEAR-ROAD study: evaluation of a new dual layer micromesh stent system for the carotid artery.

Abstract: Aims The aim of this study was to evaluate the 30-day clinical outcome of treatment using the Roadsaver carotid stent in non-consecutive subjects at high risk for carotid endarterectomy requiring revascularisation. Methods and results The CLEAR-ROAD study is a prospective, multinational, single-arm, physician-initiated study planned to include 100 patients in nine centres in Belgium, Italy and Germany. The primary endpoint was the 30-day rate of major adverse events (MAE), defined as the cumulative incidence of any death, stroke or myocardial infarction (MI). The use of embolic protection devices (EPDs) was not mandatory; 31.0% of the patients were symptomatic and in 58.0% of the patients EPDs were used. Technical success was achieved in all cases. The 30-day MAE rate was 2.1% (one patient experienced MI followed by death; another patient experienced a stroke within the first 30 days after procedure). While no statistical analysis could be performed, subgroup data suggested that there were no notable differences in the 30-day MAE rate between symptomatic and asymptomatic patients, or between EPD use. Conclusions The 30-day clinical outcome of 100 patients treated with a dual layer micromesh carotid stent (Roadsaver) shows promising results. The Roadsaver stent is a safe and effective device for endovascular treatment of subjects at high risk for carotid endarterectomy.

Carotid artery stenting with a new-generation double-mesh stent in three high-volume Italian centres: clinical results of a multidisciplinary approach.

Abstract: Aims Carotid artery stenting (CAS) is still associated with higher periprocedural cerebrovascular events (CEs) compared to vascular surgery. The Roadsaver carotid artery stent is a double layer micromesh stent which reduces plaque prolapse and embolisation by improving plaque coverage. Its clinical impact on neurological outcome was unknown. The aim of this study was therefore to report the clinical results of a large real-world population from three different centres receiving a Roadsaver stent to treat carotid artery disease. Methods and results One hundred and fifty (150) patients (age 74±8 yrs, 75% male, symptomatic 29%) treated with CAS using the Roadsaver carotid stent in three high-volume Italian centres were included in the study. Intraprocedural optical coherence tomography (OCT) evaluation was performed in 26 patients, with an off-line analysis by a dedicated core laboratory. All patients underwent duplex ultrasound and neurological evaluation at 24 hours and at 30 days. CAS was technically successful in all cases (stent diameter: 8.6±0.8 mm, stent length: 25.0±4.5 mm). No in-hospital or 30-day CEs were observed. OCT evaluation detected a low rate of plaque prolapse (two patients, 7.7%). Duplex ultrasound showed stent and external carotid artery patency in all cases both before discharge and at 30-day follow-up. Conclusions The Roadsaver stent is a safe and promising technology for CAS, with a low percentage of plaque prolapse and good short-term clinical outcome. Larger studies with longer follow-up are necessary to confirm this favourable clinical outcome.

The impact of in-stent neoatherosclerosis on long-term clinical outcomes: an observational study from the Kobe University Hospital optical coherence tomography registry

Abstract: Aims Although pathological studies have indicated the development of neoatherosclerosis (NA) after stenting, its risk factors and impact on future clinical events remain unclear. We aimed to clarify the possible risk factors for NA development and to evaluate the impact of NA in a large Japanese observational OCT database of patients with coronary heart disease. Methods and results One hundred and seventy-five consecutive patients (314 lesions) who underwent OCT examination >1 year after bare metal or drug-eluting stent implantation were enrolled. We assessed the presence of NA by follow-up OCT and compared adverse clinical events between NA+ and NA- patients. Forty-six patients had NA at the follow-up OCT. These patients had higher low-density lipoprotein (LDL) cholesterol and C-reactive protein (CRP) levels at follow-up. In multivariate logistic analysis, LDL cholesterol and CRP levels at follow-up were independently associated with the presence of NA (odds ratio [OR]: 1.022, p=0.008, OR 1.022, p=0.001, respectively). Moreover, patients with NA had a higher incidence of major adverse cardiac events (MACE) at follow-up. Multivariate Cox hazard analysis showed that the presence of NA was an independent risk factor for MACE (hazard ratio: 2.909, p=0.012). Conclusions High LDL cholesterol and CRP levels may be risk factors for NA development in patients treated with coronary stents. Moreover, the presence of NA was independently associated with MACE, suggesting the need for careful clinical follow-up of these patients.

A computational atlas of normal coronary artery anatomy.

Abstract: AIMS The aim of this study was to define the shape variations, including diameters and angles, of the major coronary artery bifurcations. METHODS AND RESULTS Computed tomographic angiograms from 300 adults with a zero calcium score and no stenoses were segmented for centreline and luminal models. A computational atlas was constructed enabling automatic quantification of 3D angles, diameters and lengths of the coronary tree. The diameter (mean±SD) of the left main coronary was 3.5±0.8 mm and the length 10.5±5.3 mm. The left main bifurcation angle (distal angle or angle B) was 89±21° for cases with, and 75±23° for those without an intermediate artery (p<0.001). Analogous measurements of diameter and angle were tabulated for the other major bifurcations (left anterior descending/diagonal, circumflex/obtuse marginal and right coronary crux). Novel 3D angle definitions are proposed and analysed. CONCLUSIONS A computational atlas of normal coronary artery anatomy provides distributions of diameter, lengths and bifurcation angles as well as more complex shape analysis. These data define normal anatomical variation, facilitating stent design, selection and optimal treatment strategy. These population models are necessary for accurate computational flow dynamics, can be 3D printed for bench testing bifurcation stents and deployment strategies, and can aid in the discussion of different approaches to the treatment of coronary bifurcations.