PURPOSE:The aim of this study was to provide 2-year clinical outcomes for patients with Medina 1,1,1 bifurcation lesions treated with a culotte technique, comparing Synergy and Xience drug eluting stent (DES) platforms. A sub-group analysis of 9-month Optical Coherence Tomography (OCT) was performed to assess stent healing. METHODS:A total of 170 patients with non-left main stem Medina 1,1,1 lesions, were randomized to treatment with Synergy or Xience DES. The primary outcome was a composite of death, myocardial infarction, stroke, target vessel failure, stent thrombosis and angiographic restenosis. Qualitative and quantitative analyses of 30 bifurcations were carried out on OCT images taken at 9-month follow-up. RESULTS:After 2 years, the primary outcome had occurred in 17.7% of patients in the Synergy group and 18.8% of patients in the Xience group. The non-inferiority test was met (p = 0.0055). MACCE occurred in 7.3% of all patients by 2 years. OCT analysis found smaller stent and lumen areas in patients treated with Synergy stents. There was a higher proportion of malapposed struts in patients treated with Xience stents. CONCLUSIONS:The first report of the CELTIC bifurcation study demonstrated a low MACCE rate after 9 months. There was little accrual of events after this timepoint. There was no difference in clinical outcomes between the platforms tested. OCT analysis demonstrated excellent healing of both platforms.

OBJECTIVES:This study aimed to present a new approach of thorough preclinical testing of a novel left atrial appendage (LAA) occluder device.BACKGROUND:The development of a safe and effective LAA occluder has been shown to be challenging.METHODS:The novel OMEGATM LAA occluder (Eclipse Medical, Ireland) was tested in a porcine model and three-dimensional (3D) human LAA models - this as a prelude to its first-in-human use.RESULTS:In a first series of in-vivo experiments, the OMEGATM LAA occluder was shown to have a satisfactory device biocompatibility in a porcine model. The design of the OMEGATM device was further refined and optimized following three more series of in-vivo experiments. The second generation OMEGATM device was designed with thinner wires, leading to a profile reduction. Based on in-vitro testing of different OMEGATM device sizes implanted at different depths in human three-dimensional (3D) LAA models, it could be determined that (1) the landing zone should be measured at a median depth of 12 mm from the LAA ostium; (2) the distal self-retaining inverted cup should have 10%-25% compression to minimize device embolization risk; and (3) the disc should be slightly inverted, i.e. pulled into the LAA, to promote complete LAA occlusion. The combined in-vivo and in-vitro testing resulted in an optimized pre-procedural planning of the first-in-human case treated with the OMEGATM device.CONCLUSIONS:This series of carefully planned in-vivo and in-vitro experiments allowed demonstration of the safety and efficacy of the OMEGATM LAA occluder. This approach of thorough preclinical testing of medical devices may reduce the risk of complications in first-in-human cases and may become the standard approach for device development and preclinical testing in the future.

AIMS:Evidence regarding post-procedural antithrombotic regimen other than used in randomized trials assessing percutaneous left atrial appendage (LAA) closure is limited. The present work aimed to compare different antithrombotic strategies applied in the real-world EWOLUTION study. METHODS AND RESULTS:A total of 998 patients with successful WATCHMAN implantation were available for the present analysis. The composite ischaemic endpoint of stroke, transitory ischaemic attack, systemic embolism and device thrombus, and the bleeding endpoint defined as at least major bleeding were assessed during an initial period (from implant until first medication change) and long-term period (from first change up to 2 years). The antithrombotic medication chosen in the initial phase was dual antiplatelet therapy (DAPT) in 60%, oral anticoagulation (OAC) in 27%, single antiplatelet therapy (SAPT) in 7%, and no medication in 6%. In the second long-term phase, SAPT was used in 65%, DAPT in 23%, no therapy in 8%, and OAC in 4%. No significant differences were found between the groups regarding the ischaemic endpoint both in the initial period (Kaplan-Meier estimated rate 2.9% for DAPT vs. 4.3% for OAC vs. 3.9% for SAPT or no therapy) and in the second period (4.2% for SAPT vs. 1.8% for DAPT vs. 3.5% for no therapy). With respect to bleeding events, the only difference was found in the initial phase with a higher incidence in patients under SAPT or no therapy. CONCLUSIONS:Tailored antithrombotic treatment using even very reduced strategies such as SAPT or no therapy showed no significant differences regarding ischaemic complications after LAA closure.

Introduction Many patients who present to E/D with low or intermediate risk cardiac presentations can be safely managed with out-patient ambulatory diagnostics strategy. The lack of definitive outpatient pathways to safely manage these patients has a significant impact on admissions and length of stay adding to the current bed crisis and overcrowding of Emergency Department (E/D). A novel collaborative approach to this problem involved the implementation of a Cardiology ANP led Virtual Clinic outpatient ambulatory pathway which facilitates the referral of non ACS chest discomfort, rate controlled atrial fibrillation/flutter/pSVT, stable heart failure, HTN, incidental murmur, low risk collapse/syncope from the ED and provides patients with rapid access to a comprehensive range of outpatient cardiology diagnostics prior to referral to OPD when necessary. Aims/Objectives To determine the benefit of an ANP-led Virtual Cardiology Clinic to the patient and the organisation. Methodology Clinic referrals from January 2017 - December 2017 were audited. Data was collected prospectively as patients were referred to the service and those referred patients underwent case review (History/exam/Bloods/CXR/ECG) and when required, were contacted by phone. If indicated, appropriate diagnostics were requested, results reviewed then referred on to consultant clinic only if indicated. Results/Discussion 894 patients were referred. 9 patients (1%) recalled to ED. A significant 254 (28%) were deemed not to require diagnostics and discharged to GP. 732 diagnostic tests were performed on 640 patients including 201 functional stress tests (13 abnormal), 38 coronary day case angiograms (10 of which required PCI), 292 Holters, 97 ECHOs (13 minor abnormalities), 68 CTCA, 12 DCCV, 73 24 hour BP. 186 patients were subsequently referred to cardiology OPD. There were 2,145 acute beds saved (based on 2.4 LOS) with estimated savings of €2,4000,000. Conclusion The Cardiology ANP led Virtual Clinic is a safe and efficient pathway that pre – filters ED referrals resulting in reduced waiting time in the Emergency Department, unnecessary travel back to the hospital (further reducing travel time, costs, waiting times), unnecessary referral to cardiology outpatients (reducing outpatient department overcrowding and waiting times). In a 12-month period, this initiative has saved Beaumont Hospital an estimated 2.4 million Euro and 2,145 acute hospital bed days. Implications Cardiology ANP led Virtual Clinics have the potential for a significant impact around the country with regards to the appropriate and efficient management of acute cardiology presentations to E/D with early access to outpatient cardiology ambulatory diagnostics and appropriate referral to outpatient consultant cardiology clinics or d/c to GP.

Aspirin non-response is associated with poor outcome but there is no agreement between the different methods to asses it. Weight has been shown to be a predictor of poor response but only using one method. In this study, we determine the effects of weight on different assays of platelet function. The response to aspirin was determined in 138 cardiology patients using serum thromboxane, arachidonic acid-induced platelet aggregation and VerifyNow©. Twenty-five percent of patients showed an inadequate response to aspirin in at least one assay on the initial test. After ensuring patient compliance only 5% of patients were considered to be non-responders. Only 9% of non-responders were non-responsive in all three assays. When switched to plain aspirin, only 2% of patients were non-responsive. All patients responded adequately to 150 mg aspirin. The non-responders were significantly heavier than responders (78.5 kg ± 14.0 (SD); BMI: 28.4 kg/m2± 4.4 v's 102.6 kg ± 20.6, P = .0016; BMI: 38.3 kg/m2 ± 7.6, P= .0015). A rule-based approach of using plain aspirin in patients over 90 kg or BMI 32 along with patient education to ensure compliance will ensure that all patients respond to their aspirin without the need for testing.

PURPOSE:Bifurcation stenting is thought to be associated with delayed healing and a subsequent risk of stent failure. The aim of this study was to further evaluate healing of thin-strut bioabsorbable polymer everolimus-eluting stents (EES) post bifurcation stenting by optical coherence tomography (OCT) including grey-scale signal intensity (GSI) analysis. METHODS:Patients undergoing bifurcation stenting with a planned two-stent approach using EES with OCT follow-up at 3-6 months post-stenting were included in this study. Morphometric analysis of contiguous cross-sections was performed at 1 mm longitudinal intervals within the stented segment. GSI analysis of neointimal regions of interest (ROI) overlying stent struts was performed for each of these cross-sections. Tissue coverage was classified as mature or immature. RESULTS:Data on a total of 31 lesions (17 cases) was available at a median of 168 days post stenting. Mean length of stented segments was 27.7 ± 16.6 mm. The mean minimum stent area was 6.50 ± 2.71 mm2 while the mean stent area was 8.69 ± 3.08 mm2. Amongst a total of 847 assessed frames, 9716 struts were visible. Overall strut coverage was 95.9%; 0.3% of struts were malapposed. The mean thickness of neointimal coverage was 100.95 ± 42.03 μm and the mean percentage area stenosis was 9.03 ± 7.80%. A total of 53.79% of ROIs were classified as mature. CONCLUSIONS:After implantation of EES in bifurcation lesions, rates of uncovered and malapposed struts were low. GSI analysis showed that more than half of neointimal areas analyzed were classified as mature in keeping with advanced vessel healing.

Background: Left atrial appendage occlusion with WATCHMAN has emerged as viable alternative to vitamin K antagonists in randomized controlled trials. Evaluating real-life clinical outcomes in atrial fibrillation patients receiving the WATCHMAN left atrial appendage closure technology was designed to collect prospective multicenter outcomes of thromboembolic events, bleeding, and mortality for patients implanted with a WATCHMAN in routine daily practice. Methods: One thousand twenty patients with a WATCHMAN implant procedure were prospectively followed in 47 centers. Left atrial appendage occlusion indication was based on the European Society of Cardiology guidelines. Follow-up and imaging were performed per local practice up to a median follow-up of 2 years. Results: Included population was old (age 73.4±8.9 years), at high risk for stroke (311 prior ischemic stroke/transient ischemic attack and 153 prior hemorrhagic stroke) and bleeding (318 prior major bleeding), with CHA2DS2-VASc score ≥5 in 49%, hypertension, abnormal renal/liver function, stroke, bleeding history or predisposition, Labile international normalized ratio, elderly, drugs/alcohol concomitantly ≥3 in 40% and oral anticoagulation contraindication in 72%. During follow-up, 161 patients (16.4%) died, 22 strokes were observed (1.3/100 patient-years, 83% reduction versus historic data), and 47 major nonprocedural bleeding events (2.7/100 patient-years, 46% reduction versus historic data). Stroke and bleeding rates were consistently lower than historic data in those with prior ischemic (−76% and −41%) or hemorrhagic (−81% and 67%) stroke and prior bleeding (−85% and −30%). Lowest bleeding rates were seen in patients with early discontinuation of dual antiplatelet therapy. Patients with early discontinuation of antithrombotic therapy showed lower bleeding rates, while they were highest for those with prior bleeding. Device thrombus was observed in 34 patients (4.1%) and was not correlated to drug regimen during follow-up (P=0.28). Conclusions: During the complete 2-year follow-up of Evaluating Real-Life Clinical Outcomes in Atrial Fibrillation Patients Receiving the WATCHMAN Left Atrial Appendage Closure Technology, patients with a WATCHMAN left atrial appendage occlusion device had consistently low rates of stroke and nonprocedural bleeding, although most were contraindicated to oral anticoagulation and used only single antiplatelet therapy or nothing. Clinical Trial Registration: URL: https://clinicaltrials.gov. Unique identifier: NCT01972282.

Introduction and objectives: Elderly patients with atrial fibrillation are at greater risk of both cardioembolic events and major bleeding than younger patients. Left atrial appendage occlusion (LAAO) could be an attractive alternative for these patients, but there are limited data on outcomes with LAAO in patients >= 85 years old. The aim of the present study was to assess the safety and efficacy of LAAO in patients >= 85 years old. Methods: A total of 1025 patients included in the EWOLUTION registry who underwent LAAO were analyzed and 84 patients >= 85 years old were identified and compared with the younger cohort. Results: Patients >= 85 years old had higher estimated stroke and hemorrhagic risks than younger patients (CHA(2)DS(2)-VASc: 5.2 +/- 1.2 vs 4.4 +/- 1.6, P < .0001; HAS-BLED: 2.7 +/- 1.1 vs 2.3 +/- 1.2; P = .003; >= 85 years vs < 85 years). Procedural success was high and similar in both groups (98.8% vs 98.5%; P = .99). There were no differences in 7-day device- or procedure-related adverse event rates (2.6% in >= 85 years vs 3.1% in < 85 years; P = .80). Despite the higher baseline stroke risk, there was no difference at follow-up between the groups in the annualized stroke rate (0.8/100 patient-years in >= 85 years vs 1.3/100 patient-years in < 85 years; P = .649). Conclusions: LAAO in patients >= 85 years is safe and effective even though these patients are at high risk for embolic and hemorrhagic events. LAAO may be a reasonable alternative to oral anticoagulation in these patients. (C) 2019 Sociedad Espanola de Cardiologia. Published by Elsevier Espana, S.L.U. All rights reserved.

Diabetics are at increased risk after stent implantation and potentially sensitive to the type of stent and dual anti-platelet therapy (DAPT). The randomized, double-blind LEADERS FREE trial compared 2432 patients at high bleeding risk (HBR) receiving either a polymer-free BA9-coated stent (DCS) or a bare metal stent (BMS) with 1 month of DAPT, and showed superior safety and efficacy of the DCS at 2 years. We report outcomes at 2 years of the pre-specified diabetic subgroup.

Aims: The aim of this study was to provide contemporary outcome data for patients with de novo coronary disease and Medina 1,1,1 lesions who were treated with a culotte two-stent technique, and to compare the performance of two modern-generation drug-eluting stent (DES) platforms, the 3-connector XIENCE and the 2-connector SYNERGY. Methods and results: Patients with Medina 1,1,1 bifurcation lesions who had disease that was amenable to culotte stenting were randomised 1:1 to treatment with XIENCE or SYNERGY DES. A total of 170 patients were included. Technical success and final kissing balloon inflation occurred in >96% of cases. Major adverse cardiovascular or cerebrovascular events (MACCE: a composite of death, myocardial infarction [MI], cerebrovascular accident [CVA] and target vessel revascularisation [TVR]) occurred in 5.9% of patients by nine months. The primary endpoint was a composite of death, MI, CVA, target vessel failure (TVF), stent thrombosis and binary angiographic restenosis. At nine months, the primary endpoint occurred in 19% of XIENCE patients and 16% of SYNERGY patients (p=0.003 for non-inferiority for platform performance). Conclusions: MACCE rates for culotte stenting using contemporary everolimus-eluting DES are low at nine months. The XIENCE and SYNERGY stents demonstrated comparable performance for the primary endpoint.

Aims: The study aimed to confirm the efficacy and safety of WATCHMAN LAA closure in atrial fibrillation patients unsuitable for oral anticoagulation. Methods and results: The EWOLUTION registry prospectively collects all clinical data on 1,005 European patients implanted with a WATCHMAN device. Following the procedure, 605 patients (60.2%) received dual antiplatelet therapy according to the local standard; DAPT was discontinued in 85% of patients within one year. CHA(2)DS(2)-VASc and HAS-BLED scores were 4.61.6 and 2.41.2, respectively. The periprocedural SAE rate was 3.3% (2.0% major adverse cardiac events), mostly resolving without sequelae. Device embolisation or pericardial effusion occurred in one (0.2%) and two (0.3%) patients, respectively. TEE (median 62 days post implant, IQR: 47-97) confirmed effective sealing (no leak >5 mm) in 99.2% of patients. Device thrombus was present in 22 patients (4.0%), one patient developed a stroke. One-year mortality in the DAPT group was 9.6% (N=58) reflecting the advanced age and comorbidities in this population. The ischaemic stroke rate at one year was 1.4% (expected based on CHA(2)DS(2)-VASc: 7.5%), none fatal. The major bleeding rate was 2.5%, or 2.1% excluding periprocedural events (expected rate on VKA based on HAS-BLED: 5.1%). Conclusions: LAA closure with the WATCHMAN device followed by DAPT therapy in a high-risk patient population is safe. At one year, the intervention is associated with a substantial risk reduction regarding ischaemic stroke and major bleeding compared to the expected rate based on CHA(2)DS(2)-VASc and HAS-BLED scores.

Introduction International registry data audits for centres performing CTO (chronic total occlusion) PCI consistently report a success rate of approximately 75% to 85%, with the vast majority of centres using femoral access. TFA is used due to the belief that TRA might compromise catheter support and certain device utilization. To investigate whether success rates, and other measures of effectiveness such as time taken per procedure and contrast use, are affected by access point we have performed a retrospective study of all consecutive CTO PCI over a 6 year period. Methods We performed a retrospective analysis of all consecutive CTO procedures in two institutions from June 2010 until December 2016. During this period we reviewed 270 cases of CTO from the two hospitals; one of which was a large public teaching hospital and the other was a private institution. For the purposes of this study we only included those CTO lesions with a TIMI flow of 0, which were present for more than 3 months, longer than 20 mm and required bilateral access utilizing hybrid techniques. We subsequently divided the cases by access point into transradial and transfemoral groups with a successful reopening was defined as a restoration of TIMI 3 flow and <50% residual stenosis. Results During the period of our study we identified 270 cases of complex PCI CTO involving 233 patients. The average age of patients was 68 years, the majority were men (86%), 141 (61%) had hypertension, 54 (23%) had diabetes mellitus, 119 (51%) had dyslipidaemia, 90 (39%) had had a previous myocardial infarction and 41 (18%) were current smokers. Table 1 shows the results from our study divided by access site. TRA was used in the majority of our cases at 58% with no major differences between the two cohorts, apart from a higher number of previously failed cases being attempted with TFA. The overall success rate with TRA was 89% versus 77% for TFA cases. The TRA group had lower procedure times (2 hours versus 3 hours) and lower contrast use (378 ml versus 422 ml) than the TFA group. There was a lower complication rate in the TRA group 6.4% versus 14% especially in regards to contrast induced nephropathy and vascular complications.Abstract 60 Table 1 Baseline characteristics by access site Baseline characteristics Transradial Transfemoral P value Total (lesions) 156 (58%) 114 (42%) Male 136 (87) 97 (84) 0.62 Age 68.7±9.2 68.3±11.9 0.73 Risk Factors Hypertension 98 (67) 67 (58) 0.50 Dyslipidaemia 78 (53) 60 (52) 0.67 Diabetes Mellitus 32 (22) 31 (27) 0.20 Smoking 27 (34) 20 (17) 0.96 LVEF<40 3 (2) 6 (5) 0.13 Prior MI 53 (36) 53 (46) 0.38 Prior CABG 17 (13) 21 (18) 0.08 CTO Target Vessel RCA 108 (69) 80 (70) 0.86 LAD 28 (18) 23 (20) 0.64 LCX 20 (13) 11 (10) 0.42 Multiple CTO 6 (4) 4 (4) 0.65 Previous Failed CTO 20 (13) 31 (27) <0.001 Conclusion The main finding from our study is that it is feasible to reopen the majority of complex CTO cases with TRA and it can be adopted as a default strategy. Using TRA in the majority of our cases did not impact on success rates, procedure time nor contrast used. The baseline characteristics of the patients were very similar indicating that the TRA is suitable for the majority of patients. Our study adds further evidence that TRA is safe and effective for the majority of complex CTO cases with a reduction in complication’s and improved patient outcomes.

Introduction Bifurcation stenting has historically been associated with higher rates of adverse clinical events. Optical coherence tomography (OCT) surveillance including grey-scale signal intensity (GSI) analysis provides information on vessel wall healing and can differentiate mature from immature tissue coverage after stent implantation. We sought to evaluate OCT-assessed healing of a novel thin-strut bioresorbable polymer everolimus-eluting stent after 3–6 months post bifurcation stenting. Methods Patients receiving bifurcation stenting with a planned two-stent approach using a thin-strut bioresorbable polymer everolimus-eluting stent and having an OCT surveillance data collected at 3–6 months post stenting follow-up were included in this study. OCT was performed using commercially-available frequency domain OCT imaging system. Raw data of OCT image acquisitions were collected and sent to a centralized core laboratory. Morphometric analysis of contiguous cross-sections was performed at 1 mm longitudinal intervals within the stented segment (QIvus 3.0.26.0 software). GSI analysis of tissue overlying stent struts was also performed. For each cross-section, the neointimal region of interest (ROI) above each covered stent strut was delineated and 256-level GSI was measured for every pixel within the ROI (Image J software). Tissue coverage was classified as mature or immature according to a standard cut-off values derived from prior published studies (91.6 if strut calibration, 109.7 if guidewire calibration). Results Data on a total of 31 vessels from 17 treated patients was available at a median of 5 months post stenting. Morphometric analysis revealed the mean length of stented segments to be 27.68 ±16.35 mm. The mean minimum lumen area was 5.97 ±2.97 mm ² while the minimum stent area was 6.67 ±2.63 mm ². Average lumen area was 8.27 ±2.97 mm2 while the average stent area was 9.02 ±2.95 mm2. The total number of frames assessed was 869, with a total of 9,975 visible struts. Overall strut coverage was 96.93%, while 0.34% of struts were malapposed. The mean thickness of neointimal coverage was 101.47 ±42.16µm, while the mean neointimal area was 0.75 ±0.49 mm2 and the mean percentage stenosis 9.18±7.45%. A total of 28 lesions and 7,971 neo-intimal regions of interest (ROIs) were assessed using GSI analysis. The mean GSI score was 95.11. A total of 53.79% of ROIs were classified as mature. Scatter plot of the GSI scores is depicted in Figure 1, Panel A, while the distribution of immature and mature ROIs is displayed in Figure 1, Panel B. Conclusions At 3–6 months after implantation of thin-strut bioresorbable polymer EES in bifurcation lesions using a planned two stent approach, antirestenotic efficacy was high and rates of uncovered and malapposed struts was low. GSI analysis showed that more than half of neointimal areas analysed were classified as mature in keeping with well advanced vessel healing.

BACKGROUND:Left atrial appendage (LAA) occlusion with WATCHMAN has emerged as viable alternative to vitamin K antagonists in randomized controlled trials. OBJECTIVE:EWOLUTION was designed to provide data in routine practice from a prospective multicenter registry. METHODS:A total of 1025 patients scheduled for a WATCHMAN implant were prospectively and sequentially enrolled at 47 centers. Indication for LAA closure was based on European Society of Cardiology guidelines. Follow-up and transesophageal echocardiography (TEE) were performed per local practice. RESULTS:The baseline CHA2DS2-VASc score was 4.5 ± 1.6; the mean age was 73.4 ± 9 years; previous transient ischemic attack/ischemic stroke was present in 312 (30.5%), 155 (15.1%) had previous hemorrhagic stroke, and 320 (31.3%) had a history of major bleeding; and 750 (73%) were deemed unsuitable for oral anticoagulation therapy. WATCHMAN implant succeeded in 1005 (98.5%) of patients, without leaks >5 mm in 1002 (99.7%) with at least 1 TEE follow-up in 875 patients (87%). Antiplatelet therapy was used in 784 (83%), while vitamin K antagonists were used in only 75 (8%). At 1 year, mortality was 98 (9.8%), reflecting the advanced age and comorbidities in this population. Device thrombus was observed in 28 patients at routine TEE (3.7%) and was not correlated with the drug regimen (P = .14). Ischemic stroke rate was 1.1% (relative risk 84% vs estimated historical data); the major bleeding rate was 2.6% and was predominantly (2.3%) nonprocedure/device related. CONCLUSION:LAA closure with the WATCHMAN device has a high implant and sealing success. This method of stroke risk reduction appears to be safe and effective with an ischemic stroke rate as low as 1.1%, even though 73% of patients had a contraindication to and were not using oral anticoagulation.

Introduction Data regarding incidence of para-device leaks, persistent inter-atrial septal (IAS) defects and thrombus post-Watchman device implantation for atrial fibrillation is limited. We aimed to observe the incidence of para-device leaks, persistent IAS defects and thrombus detected by transoesophageal echocardiography (TOE), post-Watchman implantation. Methods We retrospectively identified all patients (n=112) who had a Watchman device implanted between 2014–2016 at 2 Beaumont Hospital and Mater Private Hospital by a single operator. Within this cohort, patients who had undergone post-procedural TOE were analyzed for evidence of para-device leaks, IAS defects (including patent foramen ovale (PFO)) and thrombus. Mean LA pressure was at least 12 mmHg for all patients to ensure volume loading for adequate sizing. Data were expressed as mean ± SD and %. Results Baseline demographic of all patients were age, 77 ± 7 years; male, 71%; CHADSVASC2 score, 4.3 ± 1.4; with left ventricular ejection fraction 51 ± 8%. All patients had a 14 F catheter across the inter-atrial septum to facilitate Watchman device delivery with mean size 26.8 ± 3.5 mm. Post-procedurally, 84% were on dual antiplatelet therapy and 16% were anti-coagulated for minimum duration of 8.6 ± 4.5 and 8.8 ± 4.3 weeks, respectively. 67% (n=75) had post-procedural TOE performed with duration from time of implant of 5.3 ± 4.2 months. Within this group, there was a 32% (n=24) incidence of para-device leaks post-Watchman implant. Size of leaks measured <2 mm (17%, n=13), 2–5 mm (13%, n=10), 5–10 mm (1%, n=1). Locations of para-device leaks identified were inferior (11%, n=8), superior (15%, n=11), non-specific (7%, n=5). In addition, one patient had device thrombus. Incidence of PFO pre-Watchman was 16%. There was a 17% (n=8) incidence of de novo IAS defects post-Watchman implant after comparison with pre-procedural TOE. Mean IAS defect size pre- and post-Watchman was 0.12 ± 0.38 vs 0.29 ± 0.58 cm, respectively. This change in IAS defect size of 0.13 ± 0.57 trended towards significance (p=0.09). Conclusions A modest incidence of para-device leaks and rare but significant incidence of para-device thrombus was observed by TOE post-Watchman implantation. Further work is required to correlate potential implications of these findings on longer term outcomes related to recurrent strokes. The significance of persistent IAS defects post device implant also requires further investigation in longitudinal registry follow-up.

Current guidelines recommend anticoagulation prior to cardioversion in patients with atrial fibrillation of >48 h or unknown duration to reduce thromboembolic risk. Therapeutic anticoagulation with warfarin, with INR between 2 and 3, is consistently achieved in approximately 60% of patients.

Background: Treatment of coronary bifurcation lesions with stenting has been associated with increased complication rate and remains a major challenge in intervention cardiology. Introduction of DES reduced restenosis in the main branch. However, restenosis at the ostium of the side branch remains a problem. As part of an international registry we evaluated the clinical safety and efficacy of Tryton a dedicated side branch stent. In this study we sought to determine the clinical outcome of facilitated culottes in coronary artery bifurcation stenting using Tryton stent. Methods: We prospectively looked at 169 consecutive patients who had bifurcation lesion and treated with Tryton stent. Results: Males constitute 80.5% with mean age of 68 and 33.7% were age above 70 years. The target lesion was LAD/Diagonal bifurcation in 54.5%, LCX/OM in 30.3% and RCA bifurcation in 14.1%. All were de novo lesions and cases of CTO, graft lesions and ISR were not included. Stent was successfully implanted in 99.4% and there was one case of proximal migration of stent after fully deployed. Dissection at distal edge of Tryton occurred in 8 cases and treated with DES. Clinical follow up was completed in all patients and all stayed on aspirin and clopidogrel. Over a period of 12-24 months follow up, there was no cardiac death, emergency CABG or acute/subacute stent thrombosis. Over all incidence of major adverse cardiac event (MACE) was 10.1% and target vessel revascularisation was encountered in 5.6%. There were 18 admissions for non-related medical conditions and 12 cases for elective PCI to a different coronary artery. Conclusion: Facilitated Culottes stenting using the Tryton stent combined with a ‘workhorse DES’ is feasible and safe in a broad spectrum of ‘unselected bifurcation lesions’. This technique, completed with systematic ‘four step kissing’ balloon dilatation is associated with favourable clinical outcomes, with low rate of MACE and TLR, comparable with our prior experience with ‘conventional culottes’ stenting using DES.