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Background: Left atrial appendage occlusion (LAAO) is performed increasingly, but long-term follow-up imaging data are lacking., Aims: The aim of this study was to evaluate the safety and durability of the Amplatzer Amulet device >4 years after LAAO., Methods: This was a prospective observational cohort study including 52 patients implanted with the Amplatzer Amulet device at Aarhus University Hospital, Denmark. A >4-year follow-up cardiac computed tomography (CT) scan after LAAO was performed and compared with the results from the 2-month and 12-month scans. The primary outcome was left atrial appendage (LAA) sealing based on distal LAA contrast patency and peridevice leakage (PDL), stratified into complete occlusion (grade 0 [G0]) and grade 1-3 leakage (G1-3), respectively. Secondary outcomes were low- and high-grade hypoattenuated thickening (HAT), device-related thrombosis (DRT) and device durability., Results: The median (interquartile range [IQR]) follow-up time from LAAO to the latest CT scan was 5.8 years (4.5; 6.3). At 2-month (n=52), 12-month (n=27) and >4-year CT follow-ups (n=52), rates of both complete occlusion (33%, 37%, 35%) and G2 leaks (52%, 52%, 48%) remained stable. Rates of G1 leaks varied (14%, 4%, 6%) and G3 leaks rose (2%, 7%, 12%) from earliest to latest follow-up. The median left atrial (LA) volume increased from 127 mL (96; 176) to 144 mL (108; 182) and 147 mL (107; 193). No DRT was found. The structural device integrity was preserved., Conclusions: This study indicates a stable LAA sealing status throughout the follow-up period, emphasising the importance of the procedural result in avoiding PDL. Few patients displayed PDL progression, which might partly be related to LA remodelling with increasing volume. The long-term device durability appears excellent. Larger studies are warranted to confirm these findings.

Background: The optimal antithrombotic therapy following left atrial appendage occlusion (LAAO) remains debated. Ideally, this therapy should effectively prevent device-related thrombosis (DRT) while minimising the associated bleeding risk., Aims: We aimed to evaluate the long-term safety and efficacy of a postprocedural single antiplatelet therapy (SAPT) strategy following Amplatzer LAAO in a large consecutive cohort., Methods: This retrospective, single-centre, observational study included all patients discharged on SAPT after LAAO with the Amplatzer Cardiac Plug (ACP) or Amplatzer Amulet between March 2010 and December 2021 at Aarhus University Hospital, Denmark. Baseline, procedural, and imaging data were obtained locally, while clinical outcomes and medication data were extracted from the Danish national health registries., Results: A total of 553 patients underwent Amplatzer LAAO during the specified time frame. Of these, 431 (77.9%) high bleeding risk patients were discharged on SAPT with either acetylsalicylic acid (n=403, 72.9%) or clopidogrel (n=28, 5.1%). At 6 months, 173 (41.7%) patients were not on any antithrombotic therapy. The mean CHA2DS2-VASc and HAS-BLED scores were 3.9±1.5 and 3.4±1.1, respectively. DRT was detected in 6 (1.5%) patients on 8-week follow-up imaging using cardiac computed tomography (n=386, 89.6%) or transoesophageal echocardiography (n=27, 6.3%). The 1-year ischaemic stroke rate was 2.2% (95% confidence interval [CI]: 1.1-4.2). One-year rates for major bleeding and cardiovascular death were 5.9% (95% CI: 4.0-8.9) and 2.9% (95% CI: 1.6-5.1), respectively., Conclusions: SAPT following Amplatzer LAAO displayed rates of DRT and stroke comparable to those reported with more intensive antithrombotic regimens. Meanwhile, we observed low rates of major bleeding.

There is a growing clinical and scientific interest in catheter-directed therapy (CDT) of acute pulmonary embolism (PE). Currently, CDT should be considered for patients with high-risk PE, in whom thrombolysis is contraindicated or has failed. Also, CDT is a treatment option for initially stable patients in whom anticoagulant treatment fails, i.e., those who experience haemodynamic deterioration despite adequately dosed anticoagulation. However, the definition of treatment failure (primary reperfusion therapy or anticoagulation alone) remains an important area of uncertainty. Moreover, several techniques for CDT are available without evidence supporting one over the other, and variation in practice with regard to periprocedural anticoagulation is considerable. The aim of this position paper is to describe the currently available CDT approaches in PE patients and to standardise patient selection, the timing and technique of the procedure itself as well as anticoagulation regimens during CDT. We discuss several clinical scenarios of the clinical evaluation of the "efficacy" of thrombolysis and anticoagulation, including treatment failure with haemodynamic deterioration and treatment failure based on a lack of improvement. This clinical consensus statement serves as a practical guide for CDT, complementary to the formal guidelines.

Background: Residual peri-device leakage (PDL) is frequent after left atrial appendage occlusion (LAAO). Little is known about management strategies, procedural aspects and outcomes of interventional PDL closure., Aims: The aim of this study was to assess the safety and feasibility of PDL closure after LAAO., Methods: Fifteen centres contributed data on baseline characteristics, in-hospital and follow-up outcomes of patients who underwent PDL closure after LAAO. Outcomes of interest included acute success and complication rates and long-term efficacy of the procedure., Results: A total of 95 patients were included and a cumulative number of 104 leaks were closed. The majority of PDLs were detected within 90 days (range 41-231). Detachable coils were the most frequent approach (42.3%), followed by the use of the AMPLATZER Vascular Plug II (29.8%) and the AMPLATZER Duct Occluder II (17.3%). Technical success was 100% with 94.2% of devices placed successfully within the first attempt. There were no major complications requiring surgical or transcatheter interventions. During follow-up (96 days [range 49-526]), persistent leaks were found in 18 patients (18.9%), yielding a functional success rate of 82.7%, although PDLs were significantly reduced in size (pre-leak sizemax: 6.1±3.6 mm vs post-leak sizemax: 2.5±1.3 mm, p<0.001). None of the patients had a leak >5 mm. Major adverse events during follow-up occurred in 5 patients (2 ischaemic strokes, 2 intracranial haemorrhages, and 1 major gastrointestinal bleeding)., Conclusions: Several interventional techniques have become available to achieve PDL closure. They are associated with high technical and functional success and low complication rates.

Background: Major bleeding (MB) events are independent predictors of mortality after cardiac interventional procedures. The clinical relevance of MB following left atrial appendage occlusion (LAAO) remains unclear., Aims: This study aimed to investigate the incidence and clinical impact of MB after LAAO in a real-world population at high risk for bleeding and contraindicated to anticoagulation., Methods: The two-year results of the Amplatzer Amulet Observational Post-Market Study were analysed. An independent committee adjudicated MBs according to the Bleeding Academic Research Consortium scale. Cox proportional hazards regression identified variables associated with MB events and mortality., Results: The MB rate was 7.2%/year, with a rate of 10.1%/year during year one, decreasing to 4.0%/year over year two. The most common bleeding location was gastrointestinal, accounting for 48% of MBs. Pre-LAAO MB was associated with an increased risk for post-LAAO MB (HR 2.34, 95% CI: 1.37-3.99). The occurrence of post-LAAO MB was associated with increased mortality (37.3% vs 12.7%; p<0.0001), driven mainly by events occurring beyond the periprocedural period. The annualised rate of ischaemic stroke or TIA was similar in patients with and without MB (2.3% vs 3.3%; p=0.446). MB post LAAO was a strong independent predictor of mortality (HR 3.07, 95% CI: 2.15-4.40)., Conclusions: In real-world patients at high bleeding risk, MB following LAAO was not uncommon and associated with a significant increase in mortality, without increasing the risk of stroke. ClinicalTrials.gov Identifier: NCT02447081. https://clinicaltrials.gov/ct2/show/NCT02447081.

Aims: Left atrial appendage occlusion (LAAO) is a stroke prevention therapy for patients with non-valvular atrial fibrillation (AF). This study reports one-year outcomes from patients enrolled in the prospective global Amulet registry., Methods and Results: A total of 1,088 patients were recruited, aged 75±9 years; 65% of patients were male. The CHA2DS2-VASc and HAS-BLED scores were 4.2±1.6 and 3.3±1.1, respectively. Eighty-three percent (83%) of patients had contraindications to anticoagulation (OAC); 72% had a history of major bleeding. An AMPLATZER Amulet LAA occluder was successfully implanted in 99% of cases. Transoesophageal echocardiography one to three months after implant showed no residual flow or flow <3 mm in 98.4%. The observed ischaemic stroke rate was 2.9%/year. Device-related thrombus was noted in 1.7% of patients. There were ten cases between 0 and 90 days and eight cases between 91 and 365 days. Patients discharged without OAC (>80%), in particular those on single aspirin therapy, did not appear to have a higher risk of device-related thrombus. In the first year, major bleeding occurred at an annualised rate of 10.3%. All-cause mortality was 8.4% at one year., Conclusions: In the global prospective Amulet registry of patients at high risk of stroke and bleeding, the annualised ischaemic stroke rate was 2.9%. The LAA was sealed in 98.4% after one to three months and device-related thrombus was observed in 1.7% of cases with only a minority of all patients on anticoagulation treatment.

Aims: To provide a systematic review of catheter-based therapies of acute pulmonary embolism., Methods and Results: Studies published in peer-reviewed journals before February 2017 were included and categorized according to the mechanism of thrombus removal: fragmentation, rheolytic therapy, aspiration or catheter-directed thrombolysis. Strengths, challenges and the level of evidence of each device were evaluated. We found 16 different catheter-based therapies for acute PE; all but one being used off-label. The majority of procedures involve catheter-directed thrombolysis. Aspiration therapy shows promise, but limited data are available. Rheolytic therapy should be used with caution, if at all, due to the high number of associated complications., Conclusions: Catheter-based therapies show promise as a treatment for acute PE, though evidence is lacking. Further research into the efficacy and safety of devices is needed.

Aims: Transcatheter valve-in-valve (VIV) implantation is usually discouraged in small surgical tissue valves. We report our first ten cases of fracturing small dysfunctional Mitroflow bioprostheses by high-pressure balloon dilatation to increase the internal diameter of the surgical valve before VIV (BF-VIV)., Methods and Results: BF-VIV was performed in 10 patients (mean age 84±4 years) with failing Mitroflow valves size 19 mm (n=3, threshold of fracture 15 atm) and 21 mm (n=7, threshold of fracture 13 atm). An Edwards SAPIEN 3 or XT 20 mm or 23 mm transcatheter valve was implanted inside the fractured Mitroflow bioprosthesis. The procedure improved aortic valve area (0.7±0.3 vs. 1.1±0.3 cm2, p=0.001), reduced peak aortic valve gradient (66±27 vs. 29±7 mmHg, p=0.002), resolved aortic regurgitation and improved patients' NYHA functional class (p=0.005). One patient had a minor stroke with complete resolution of symptoms and another patient required a pacemaker due to AV block. All patients were still alive at the end of follow-up (438±255 days)., Conclusions: Initial experience with transcatheter BF-VIV suggests that this method is feasible and safe, and that it improves aortic valve haemodynamics and clinical functional capacity. BF-VIV is a promising alternative to repeat surgery in patients with small failing Mitroflow bioprostheses.

Aims: Patients with degraded bioprosthetic heart valves (BHV) who are not candidates for valve replacement may benefit from transcatheter valve-in-valve (VIV) therapy. However, in smaller-sized surgical BHV the resultant orifice may become too narrow. To overcome this, the valve frame can be fractured by a high-pressure balloon prior to VIV. However, knowledge on fracture pressures and mechanics are prerequisites. The aim of this study was to identify the fracture pressures needed in BHV, and to describe the fracture mechanics., Methods and Results: Commonly used BHV of small sizes were mounted on a high-pressure balloon situated in a biplane fluoroscopic system with a high-speed camera. The instant of fracture was captured along with the balloon pressure. The valves were inspected for material protrusion and later dissected for fracture zone investigation and description. The valves with a polymer frame fractured at a lower pressure (8-10 atm) than those with a metal stent (19-26 atm). None of the fractured valves had elements protruding., Conclusions: VIV procedures in small-sized BHV may be performed after prior fracture of the valve frame by high-pressure balloon dilatation. This study provides tentative guidelines for expected balloon sizes and pressures for valve fracturing.

Aims: The global, prospective AMPLATZER Amulet observational study documents real-world periprocedural, transoesophageal echocardiographic (TEE) and clinical outcomes from left atrial appendage occlusion (LAAO) using the AMPLATZER Amulet device. The aim of this report is to describe the periprocedural and early clinical/TEE results from this study., Methods and Results: This multicentre prospective real-world registry included 1,088 patients (75±8.5 years, 64.5% male, CHA2DS2-VASc: 4.2±1.6, HAS-BLED: 3.3±1.1) with non-valvular atrial fibrillation; 82.8% of patients were considered to have an absolute or relative contraindication to long-term anticoagulation and 72.4% had had a previous major bleeding. Periprocedural results, clinical outcomes up to the first three months and the available TEE results from the first scheduled follow-up (one to three months post implant) are reported. Successful device implantation was achieved in 99.0% of patients. During the procedure and index hospitalisation, major adverse events occurred in 3.2% of patients. Patients were discharged on a single antiplatelet agent (23.0%), dual antiplatelets (54.3%) or an oral anticoagulant (18.9%). TEE follow-up 67±23 days post procedure in 673 patients showed adequate (<3 mm jet) occlusion of the appendage in 98.2% of patients and device thrombus in 10 patients (1.5%), as evaluated by core laboratory analysis., Conclusions: This large real-world prospective registry of catheter-based LAAO using the AMPLATZER Amulet device reports a high implant success rate and a low periprocedural complication rate in a population with a high risk of stroke and bleeding. Transoesophageal echo data confirm good closure rates during follow-up and low rates of device-associated thrombus.

Aims: The aim of this study was to investigate the prognosis in patients with atrial fibrillation (AF) and intracerebral haemorrhage (ICH) having a left atrial appendage occlusion (LAAO) versus patients receiving standard medical therapy., Methods and Results: A total of 151 patients from the Nordic countries with AF and previous ICH who underwent LAAO using the AMPLATZER Cardiac Plug or the AMPLATZER AMULET were compared to a propensity score-matched group of 151 patients receiving standard medical therapy. The two groups were matched so that their risks for stroke and bleeding were similar (CHA2DS2-VASc and HAS-BLED scores). The standard care patients were identified from the Danish Stroke Registry among 787 patients with AF and ICH. The primary endpoint was a composite of all-cause mortality, ischaemic stroke and major bleeding. Patients with AF and a prior ICH treated with LAAO had a lower risk of the composite outcome as compared to patients treated with standard medical care (events/1,000 years [95% confidence interval]: 53.3 [44.3-64.1] vs. 366.7 [298.2-450.9]; hazard ratio 0.16 [0.07-0.37])., Conclusions: LAAO is suggested to be of major clinical benefit in AF patients having sustained an ICH. These results have to be confirmed in a randomised clinical trial.

Interventional cardiology in Denmark has been carried out since the mid 1980s. Interventional cardiology is only performed at a few high-volume centres. Healthcare coverage is universal and is essentially free of charge. Hospitals are mostly publicly owned and financed by fixed budgets and, in part, an activity-based funding system. Approximately 30,000 coronary angiographies (CAG), 10,000 percutaneous coronary interventions (PCIs) of which approximately 25% are primary PCIs, and 500 transcatheter aortic valve implantations (TAVIs) are carried out each year. The numbers of CAG and PCI have reached a plateau in recent years, whereas structural heart interventions, in particular TAVI, are increasing. Around 90% of all patients treated with PCI have a stent implanted, with more than 95% of these being drug-eluting stents. There is a low but increasing use of bioabsorbable scaffolds and drug-eluting balloons.

Aims: The aim of the study was to evaluate the safety and efficacy of left atrial appendage occlusion (LAAO) with the AMPLATZER Cardiac Plug (ACP) or Amulet using aspirin alone (ASA) as post-implantation antithrombotic treatment., Methods and Results: This was a single-centre, prospective, non-randomised study on LAAO with the ACP or Amulet in a consecutive cohort (n=110) treated by ASA alone post implantation. The primary outcome was device-related thrombosis, while secondary outcomes were ischaemic stroke or major bleeding. Clinical follow-up was conducted after six weeks and 12 months with TEE and cardiac CT. One hundred and seven patients were included in the analysis. Three patients were excluded due to a mechanical valve prosthesis. CHA2DS2-VASc score was 4.4±1.6 and HAS-BLED 4.1±1.1. Successful implantation was obtained in all patients with a periprocedural complication rate of 4.6%. Median follow-up was 2.3 years, with a total of 265 patient-years. Device-related thrombosis was detected in 2/107 (1.9%) cases. Stroke occurred in 6/107 patients, with an annualised rate of 2.3%, which is a 61% risk reduction compared to the predicted rate. Annual risk of major bleeding was reduced by 57%., Conclusions: LAAO with the ACP or Amulet was safely performed with ASA monotherapy after implantation without an increased risk of device-related thrombosis or stroke.

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.

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.