Introduction

Growing evidence supports left atrial appendage closure (LAAC) for stroke prevention in patients with non-valvular atrial fibrillation (AF).1 2 Safety and efficacy of the procedure have been improved with recent refinements achieved through successive design iterations, improved preprocedural planning and optimised implant technique.3 4 The recommendation for LAAC in patients with a contraindication to long-term oral anticoagulation was upgraded from 2b to 2a in the recent ACC/AHA guidelines for AF.5 Two large randomised controlled trials (CATALYST NCT04226547 and CHAMPION-AF NCT04394546) are currently ongoing to compare clinical outcomes of patients after LAAC or with direct oral anticoagulants (DOAC). These trials have the potential to impact AF guidelines with a possible expansion of indications.6 In the USA, the number of LAAC procedures has risen dramatically, reaching approximately 40 000 annually, equivalent to 1.2 per 10 000 inhabitants. With the potential for expanded indications in Europe, there will be a need to consider significant reorganisation of healthcare systems, hospitals and patient pathways. This includes scaling up the number of trained implanters, as well as ensuring the availability of anaesthesiologists, nurses and hospital beds. Cardiac centres are already facing increased demand for resource-intensive procedures such as AF ablation, transcatheter aortic valve implantation (TAVI) and mitral and tricuspid valve interventions. With the anticipated growth in LAAC procedure volumes across Europe, strategic planning will be essential to address these logistical and resource challenges. Currently, no data are available to define how LAAC procedures are organised and performed across Europe. In this context, the present European survey was set up by the European LAAC club (a club of expert operators whose aim is to promote clinical research to improve the results of the procedure) to provide insights into how contemporary LAAC procedures are organised and performed with the aim to identify potential areas of improvement that may further improve healthcare impact.

Materials and methodsStudy design and data collection

The European LAAC survey is a non-funded, international, multicentre and observational study. A questionnaire was set up and distributed to centre physicians and teams performing this procedure. Participation was voluntary and anonymous. The survey was responded between 1 March and 31 August 2023. The survey consisted of 48 multiple-choice questions and was compiled in a dedicated database. The questionnaire (online supplemental table S1) was categorised into four main areas: (1) patient pathway and hospital organisation, (2) preprocedural planning, (3) LAAC procedure and (4) post-procedural surveillance and antithrombotic treatment (AT). The participants were asked to submit their answers based on current LAAC practice in their centre for elective LAAC cases. Surveys were included in the present analysis if they had >90% completion and included a response to the question concerning a number of LAAC procedures performed in 2022 and country of origin.

Definitions

Results were analysed overall and according to geographic region and centre procedural volume. Four geographic regions were defined: (1) Central Europe (CE: Austria, Germany, Poland, Switzerland), (2) Northern Europe (NE: Denmark, Finland, Lithuania, Norway), (3) Northwestern Europe (NWE: Belgium, France, the United Kingdom) and (4) Southern Europe (SE: Greece, Italy, Spain). Centre volume was defined by the number of LAAC cases performed in 2022 and divided into four categories defined as the four quartiles: (1) 1–10 cases, (2) 11–20 cases, (3) 21–35 cases and (4) ≥36 cases.

Preprocedure planning was classified as three separate techniques: (1) mostly (≥80%) or only TOE, (2) mostly (≥80%) or only CT and (3) either TOE or CT when local practice was balanced between the two techniques. Procedural anaesthesia was classified into three categories: (1) general anaesthesia, (2) local anaesthesia and (3) local anaesthesia with conscious sedation. Post-procedure transfer location was classified into high care (intensive care unit), medium care (recovery room, cardiac care unit, mid-care unit) and low care (cardiology ward) unit.

The standard antithrombotic regimen following the procedure in European centres included oral anticoagulants and/or antiplatelet agents. Among patients receiving oral anticoagulation, DOACs were predominantly used, administered either at the standard therapeutic dose or at half-dose, often considered for patients with a high bleeding risk. Dual antiplatelet therapy (DAPT) typically consists of a combination of antiplatelet agents, such as clopidogrel (75 mg daily) and aspirin (75–325 mg daily), while single antiplatelet therapy (SAPT) involves the use of one of these agents alone.

Statistical analysis

Continuous data are presented as mean and SD in a normal number distribution and as median and IQR for skewed number distribution and were compared with Student’s t-test or the non-parametric Mann-Whitney U test, respectively. Categorical data are described as numbers and percentages and were compared using the χ2 test. All p values are two-sided, and p values <0.05 were considered statistically significant without adjustments for multiple comparisons.

Patient and public involvement

Patients and the public were not involved in this survey focusing on current practices in European centres performing transcatheter LAAC.

ResultsCentres

Out of 400 centres contacted to participate in our survey, 361 provided positive responses. However, four responses were excluded due to incomplete data. A total of 357 participating centres in 14 different countries performed 9447 LAAC procedures in 2022 (figure 1). Almost three-quarters of respondents work in public hospitals (72%, n=256), 27% (n=96) in a private setting and 1% (n=5) in other types of hospitals. The average number of LAAC cases per centre was 26 (median 20; IQR 10–35), with the largest centre performing 225 cases and the smallest 1 case (figure 2). In 2022, the centres with the highest LAAC volume were situated in the NE region (median 29; IQR 6–35) followed by the NWE region (median 25; IQR 15–42), while the regions with the lowest LAAC cases per centre were in CE (median 21; IQR 11–32) and SE (median 16; IQR 10–31) (figure 2). One-third of centres (n=120, 33.6%) have declared having difficulties in increasing the number of procedures (NWE 49.2%, SE 39.8%, CE 25.7% and NE 11.1%), mainly because of insufficient availability of anaesthesiology (n=62/120, 51.7%), cath-lab or hybrid operating room (n=43/120, 35.8%), hospitalisation capacity (n=28/120, 23.3%) or echocardiologists (n=19/120, 15.8%).

Figure 1

(A) Centres responding to the survey in the different European countries and regions. Colour coding for the four different European regions and a number of centres of each country included in this study. (B) Left atrial appendage closure adoption in the different European regions (number of procedures per million inhabitants of the different European regions). LAAC, left atrial appendage closure.

Figure 2

The number of left atrial appendage closure (LAAC) per centre is shown in a box and whisker plot and the volume per centre is shown in cake diagrams for the four different European regions.

Preprocedure planning and workflow

As shown in online supplemental figure S1, patients were mainly referred for LAAC by cardiologists (26%), neurologists (20%), gastroenterologists and internists/geriatricians (20%) and nephrologists (15%) from both in-hospital and out-hospital medical structures and offices with few differences between the four European regions. The majority of centres (n=330, 92%) have a standard preprocedure planning workflow relying on TOE only in 204/330 (62%), CT only in 52/330 (16%) and both techniques in 74/330 (22%) of them (figure 3). A total of 92/330 centres (28%) used CT as the exclusive or preferred technique for procedure planning with a wide variability across European regions (CE 7%, SE 29%, NE 78% and NWE 86%, p<0.0001 between regions). Implanters had access to preprocedure planning at 285/330 sites (86%) and 216/285 (76%) of them performed planning and measurements using available imaging data. Notably, implanters were more likely to perform preprocedure planning themselves in centres using CT (85%) compared with those using TOE (58%) (p<0.0001).

Figure 3

(A) The standard imaging modality for preprocedural planning is shown in the cake diagram for the 357 responding centres and in the bar chart for the four different European regions. (B) Preprocedural planning is done by the implanter among CT centres (CT-users) and transoesophageal echocardiography centres (TOE-users). When the planning was performed by another imaging physician, the implanter declared relying on the conclusion of the report. (C) Tools and softwares used by CT users for preprocedural planning. Dedicated LAA softwares corresponded to 3Mensio, Truplan… Classical DICOM viewers were Osirix, Horos and other online applications. The cath-lab viewer is the imaging software embarked in the cath-lab; external simulations referred to other analyses including artificial intelligence-enabled simulations by FEops or other providers and 3D-printing technologies. ICE, intracardiac echography.

Procedure techniques

LAAC procedures were performed in most cases by interventional cardiology teams only (n=268/357, 75%), and the remainder were performed by electrophysiologists (n=43/357, 13%) or mixed teams of interventionalists, electrophysiologists and/or paediatric cardiologists (figure 4). LAAC was mainly performed in a catheterisation laboratory (n=299/357, 84%) or in a hybrid operating room (n=58/357, 16%).

Figure 4

(A) Implanter team and theatre for LAAC procedures. (B) Type of anaesthesia and (C) imaging modality for procedure guidance is shown in cake diagrams for the 357 responding centres and in bar charts for the four different European regions. EP, electrophysiologists; HOR, Hybrid Operating Room; IC, interventional cardiologists; ICE, intracardiac echography; LAAC, left atrial appendage closure; OAC, oral anticoagulants; PED, pediatricians; TOE, transoesophageal echocardiography.

Across all centres, general anaesthesia was the most widely adopted anaesthetic strategy (50%) for routine LAAC (figure 4). Local anaesthesia with conscious sedation was the default strategy in 34% and local anaesthesia only was used in a minority of centres (16%). Local anaesthesia was less implemented for regular LAAC cases in centres performing ≤10 cases per year (10%, n=10) as compared with centres performing ≥36 cases (29%, n=24) and was mainly used in NE (27%) and CE (20%).

As shown in figure 4, conventional TOE was used as a standard technique to guide device implantation in the majority of centres (89%). Alternate imaging techniques used to guide the procedure were intracardiac echography (ICE) (5%), TOE with micro or mini probes (4%), or CT/fluoroscopy fusion (2%). With a few exceptions, these techniques were not used as standard imaging techniques to guide a significant number of LAAC procedures, but as an alternative, for example in patients with severe comorbidities and challenging general anaesthesia. Further details on procedural techniques are shown in online supplemental table S2.

Once the procedure was completed, patients were more often (67%) monitored in an intensive/cardiac care unit and most were discharged on the day after the procedure (72%). Same-day discharge was rarely carried out (n=19; 5%), but 16% (n=57) of participants would consider this strategy in selected cases.

Post-implantation management

Most participants used DAPT as a standard post-implantation antithrombotic regimen (n=259; 73%), most often followed for 6 weeks to 3 months (n=286; 80%) (figure 5). SAPT was the most frequent alternative strategy and was mainly used in NE and in NWE. Most centres would consider an alternative regimen for very high bleeding-risk patients (n=277; 78%), using a less potent ATT regimen (n=194; 70%) and/or shorter treatment duration (n=85; 31%). Routine imaging follow-up was used in most centres (n=330; 92%) and mainly relied on TOE (n=237; 72%) and CT (n=39; 12%) with wide variations between the European regions (figure 5). Timing for imaging was more frequently between 6 weeks and 3 months (61%) or within 6 weeks after the procedure (27%), and less frequently beyond 3 months after the procedure (12%).

Figure 5

(A) Standard antithrombotic regimen and (B) standard treatment duration are shown in cake diagrams for the 357 responding centres. (A) The standard antithrombotic regimen is shown in bar chart for the four different European regions. (B) Imaging modality for post-implantation surveillance is shown in the cake diagram for the 357 responding centres and in the bar chart for the four different European regions. DAPT, dual antiplatelet therapy; NATT, no anti-thrombotic treatment; OAC, oral anticoagulants; SAPT, single antiplatelet therapy; TOE, transoesophageal echocardiography.

Economic considerations

There was a wide heterogeneity in procedure reimbursement across European countries (online supplemental table S3). Many countries have considered a diagnostic-related group (DRG) that was used to determine hospital payments, some of them being very inclusive, whereas the cost of the device or physicians’ fees were paid from country to country on top of the global tariff. In addition, some centres have declared having difficulties increasing the number of procedures because of a lack of reimbursement, especially in SE.

Discussion

This survey provides a contemporary overview of different aspects of the LAAC procedure, including preprocedure planning, procedural techniques and guidance, and post-procedural management. Previous European surveys included a smaller number of sites and focused on procedure indications and post-procedure anticoagulation strategy.7 8 This survey was successfully conducted throughout Europe, including data from 357 centres in 14 European countries. The key observations were (1) half of the centres performed ≤20 LAAC cases per year; (2) preprocedure planning was more frequently performed by TOE (72%); (3) compared with centres primarily using TOE, preprocedure planning was more commonly performed by the implanter in centres that relied predominantly on CT imaging; (4) LAAC procedures were mainly performed in cath-labs (84%) under general anaesthesia (50%) and standard TOE was the most frequent imaging modality to guide the procedure (89%), far ahead of ICE (5%) and micro-TOE (4%); (5) The standard post-implantation drug regimen was DAPT (73%) maintained for 6 weeks to 3 months followed by SAPT. TOE was the main technique for follow-up imaging (71%).

Collectively, we observed wide heterogeneity in hospital organisations, preprocedure planning, procedure guidance and post-procedure management across European regions. A sharp increase in LAAC procedure volume is predicted within the next decades due to accumulating evidence on the safety and efficacy of LAAC, expanding indications and an ageing population.9 The rate of procedural complications has been decreased with the learning curve of dedicated teams, but minimalistic procedures still need to be incorporated into daily practice to further increase procedural safety and improve patients’ outcomes.4 The current study reports how LAAC procedures are organised across Europe for the first time and provides important insight concerning potential areas of improvement within current LAAC processes.

Healthcare systems and hospitals organisation in European countries

This survey indicates that there is a wide heterogeneity across different European regions in terms of therapy adoption. There is a widening gap between the USA and Europe in LAAC procedural volume. In Europe, the increase in procedural volume is low (a median of 20 procedures per centre) limited by two main reasons. The first being reimbursement restricted to patients with formal contraindication to anticoagulants (except for Denmark and Switzerland), and the second related to limitations in hospital organisation with insufficient availability of cath-lab capacity and staff (especially anaesthetists and echocardiologists). European guideline recommendations for LAAC are expected to be upgraded if there are positive results from OPTION, CHAMPION-AF and CATALYST. This will potentially trigger a huge demand for LAAC with a subsequent requirement for more implanters and much more hospital procedural capacity. The number of inhabitants per centre performing LAAC is widely differing, ranging between 2.0 million in Denmark, 1.4 in France, 1.2 in Spain, 1.0 in Italy and 0.5 in Germany. National healthcare policies have different objectives from one country to another. Obviously, the high number of centres offering LAAC in Germany aims to cover most regions of the country, resulting in many low-volume centres with <20 procedures per year. Conversely, the Danish system is different, as the number of hospitals has decreased from 128 to 21 in Denmark within the last 40 years, allowing for the concentration of efforts on very few high-volume centres (>100 procedures per year) to offer reimbursement for innovative and costly tools such as ICE. Other countries, such as France, have limited the number of centres to those having on-site cardiac surgery based on the early era of LAAC with much more complications than now. Currently, practices have been developed considering reimbursement options but also local availability (CT for preprocedure planning, anaesthetists, echocardiologists, etc), and centres have developed specific expertise, such as preprocedure planning with CT in Denmark, France, Italy and Spain or procedure guidance with ICE in Denmark.10–15 Different policies may influence the procedural environment (local or general anaesthesia), and the potential constraints might limit the development of the technique. One of these is the very limited adaptation to same-day discharge procedures in Europe (<5%), a strategy that offers the opportunity to improve resource utilisation without compromising patient safety.10 11 16

Heterogeneous practices in preprocedure planning

One of the main messages to emerge from this survey is the great heterogeneity of practices in European regions. The use of preprocedure CT makes it easy to obtain 3D images of the LAA and surrounding structures.12–14 Images and frames may be studied with different dedicated softwares such as 3Mensio (Pie Medical Imaging, Maastricht, the Netherlands) enabling accurate analysis of the LAA and its relationship with surrounding structures, thus facilitating device sizing,14 as well as transseptal planning options and sheath selection; CT-users consider this analysis to be a determinant element in facilitating the procedure.12 14 In addition, and as shown in the present study, CT-users have easier access to images and are more inclined to become actively involved and plan the procedure themselves, in contrast to most TOE-users who frequently rely on planning reports. The active involvement of the implanter in the planning process has been recently shown to be a significant contributor to improve procedural outcomes.15 17 Moreover, CT images may be used for anatomical analysis and computer simulations based on artificial intelligence (AI) so that the implanter can correctly select the size and location of the device in the appendage based on patient-specific data (digital twin). This is associated with improved procedural efficiency, with the use of fewer devices and fewer device repositioning per procedure in the PREDICT-LAA trial.18 A parallel with TAVI procedures can be speculated, as the use of a careful preprocedure CT-based LAAC intervention may be associated with a minimalistic approach and better patients’ outcomes.19 This was demonstrated for TAVI procedures where CT-scan is nowadays fully incorporated in the preprocedure workflow in most centres, and this still needs to be widely implemented for LAAC procedures. Indeed, most implanters consider that the use of 2D angiography and/or 2D TOE is no longer acceptable to plan LAAC procedures in contemporary practice, and the use of 3D imaging capacities, either with TOE or CT, should be mandatory to increase the procedure safety and efficiency.20

Heterogeneous practices in LAAC procedures

The heterogeneity of procedural imaging guidance across European countries and centres is another crucial piece of information in the present study. The use of conventional TOE frequently implies general anaesthesia to improve patient and physician comfort with a safer and shorter procedure. Other imaging modalities such as ICE or miniaturised TOE have been used to perform LAAC procedures in a conscious patient with or without the need of additional adequate sedation.21–24 Moreover, the use of ICE prevents the need of anaesthesia support and helps eliminate constraints for centres, therefore allowing them to expand the LAAC programme.25 Until now, these techniques have provided 2D images of the LAA with limited information on the surrounding structures but are convenient for guiding transeptal puncture and device deployment. New developments including 3D and 4D capabilities are underway, with the potential to replace conventional TOE probes and associated settings for these procedures.26 27 Because of reimbursement constraints, only a few centres have used these miniaturised echocardiographic capabilities that have the potential to increase the safety of these procedures as well as patient adherence to less invasive interventions. Furthermore, reducing invasiveness may increase the rate of same-day discharge procedures.

Heterogeneous practices in post-procedure management and treatment

The heterogeneity of post-procedural AT regimen and imaging follow-up is another major finding of the present study. In brief, countries from CE and SE used DAPT as the standard antithrombotic regimen and TOE as the preferred imaging option for follow-up, whereas countries from NE and NWE preferred SAPT and CT, respectively. This heterogeneity is mainly the result of the lack of dedicated data from randomised controlled trials investigating the optimal post-procedural treatment. Evidence is missing and data are needed in this field. Recent observational data indicates that a DAPT regimen may not be ideal in view of the residual risk of DRT and increased risk of bleeding. Emerging alternative treatment options include SAPT and low-dose DOAC therapy. Several studies are ongoing to further investigate this bleeding-thrombotic trade-off after the LAAC procedure. At present, two randomised studies are assessing direct-acting oral anticoagulants versus DAPT following LAAO for 8 week (ANDES trial, ClinicalTrials.gov: NCT03568890) or 12 week durations (ADALA trial, EudraCT 2018-001013-32). FADE-DRT (NCT04502017) is a randomised open-labelled trial comparing three arms after LAAC: (1) OAC for 6 weeks then DAPT until 6 months, (2) OAC for 6 weeks, then DAPT or half-dose OAC in clopidogrel non-responders, (3) half-dose DOAC. The ASPIRIN-LAAO trial (NCT3821883) is a double-blind randomised trial at 6 months after LAAC comparing long-term versus discontinuation of aspirin. Although TOE emerged as the preferred option to assess the result of LAAC procedures at follow-up in Europe, there is also a clear difference between European regions with CE and SE using TOE as standard post-procedural imaging, whereas countries from NE and NWE are increasingly relying on cardiac CT for post-procedural follow-up imaging. Conditions for reimbursement, local availability and expertise are probably the main reasons for this variability. Although equity between TOE and CT findings for post-implantation assessment is widely accepted, there are no standardised equivalent TOE and CT definitions for PDL or DRT, or what should be considered an acceptable result in terms of stroke prevention.

Study limitations

Although we collected data from 357 centres from 14 European countries, an official database of European LAAC centres is unavailable, and some centres may therefore have been overlooked in the invitation to participate in this survey. Selection bias is possible, favouring centres with an underlying interest in scientific research. The questionnaire related only to the implanter’s practice at the time the survey was completed. Data on LAAC volume and practice in earlier periods were not included. The procedural volume of individual implanters may be lower than represented since this depends on the distribution of procedures in each centre.

Conclusion

Left atrial appendage closure has become a widespread procedure in Europe. There is great heterogeneity in preprocedural planning, procedural techniques and guidance, as well as in the post-procedural antithrombotic regimen between European regions. As guidelines might be updated based on the results of pivotal trials, with an increasing number of procedures, centres and physicians, there is a need to evaluate patient outcomes and cost-effectiveness after different practices.