Is Cryoballoon Ablation in Community Hospitals the Future for Atrial Fibrillation Treatment?

Richard Schilling; Andreas Bollmann

Disclosures

Europace. 2021;23(11):1689-1690. 

In this issue of Europace, Hoffman et al.[1] have published a study examining acute safety and efficacy of atrial fibrillation (AF) ablation in community hospitals. This concept has obvious benefits, including greater convenience for the patient, the freeing up of space for more complex procedures in large cardiac centres, capacity to meet increasing demand for this highly effective treatment and the potential to make the procedure more cost-effective. There remains some criticism of moving these procedures to centres that may not have the facilities or experience to cope with a catastrophic complication. There has been an evolution to this approach to AF treatment and although this is the first multicentre data examining this, it is worth reflecting on the experience and innovation taking place over the last 20 years that has made this possible.

The barriers to patient management in community hospitals have centred around two areas of concern, the ability to discharge patients home safely without the need for specialist or overnight care and the technical complexity of the procedure itself which will impact on the likelihood of complications.

When we first started performing AF ablation it was usual to schedule one, at most two AF ablation cases a week. The procedures were long, required hospital admission and blocked significant time, often in the single catheter lab made available to pacing and ablation. Although pericardial effusions were not common, they were common enough for electrophysiologists to be considered the most expert in draining tamponade. The long post-procedure process of restarting warfarin and weaning the patient off the subcutaneous heparin could be done at home in the majority of patients, but vascular complications were common and some patients needed more help and support to manage their anticoagulation. The realization that interrupting the anticoagulation made no difference to risk of bleeding (indeed it appeared to reduce femoral bleeding if warfarin was continued and low molecular weight heparin avoided),[2] made the post-operative management of these patients very much easier and more predictable. In 2010, some centres were already discharging their patients home the same day, recognizing that the incidence of late complications was rare.[3] This began to raise the question, if late complication is rare, is it possible to make acute complications rare enough to justify AF ablation being performed in centres without cardiac surgery on site?

Percutaneous coronary angioplasty (PTCA) had already been performed in non-surgical centres for some time, but this had been driven by two things. Firstly, volume and acuity were growing as a result of the advent of PTCA for acute myocardial infarction. Secondly, technology in the form of pre-loaded stents had made it very much easier to rescue patients from acute dissection or even perforation without the need for surgery.

AF ablation is unlikely to ever have an acute indication like PTCA did, but with improved cardiovascular prevention, in most healthcare systems, the demand for PTCA has begun to plateau. Demand for AF ablation, by contrast, continues to grow and it is generally acknowledged that we are nowhere near offering ablation to all of those patients who may benefit from it. As demand has grown, the technical challenges of AF ablation have been reduced by technical improvements in catheter design (force sensing, 3D navigation) or ablation methods (cryoablation). Cryoablation in particular has been demonstrated to 'democratise' AF ablation, allowing less experienced operators and centres to produce outcomes similar to higher volume centres.[4] This combination of factors have created both the need and the potential for AF ablation to expand from highly specialized hospitals.

In 2018, Opel et al.[5] showed that cryoablation of AF could be performed safely and effectively in a community hospital, with outcomes as good or better than the cardiac surgical centre. The catheter lab and the staff had no experience of AF ablation; however, a very simple standard operating procedure which included patient inclusions, protocol for the ablation and the management of complications, gave all team members a clear idea of the patient management and their role in it. Limiting the variation in the procedure allowed experience to build very quickly. A larger centre may do more than 100 AF ablations a year but variation in procedure technique and a larger body of staff rotating through the centre may mean that a smaller centre with a smaller team doing 50 cases a year may have similar experience of the procedure. Complications like pericardial effusion and tamponade are rare. Acquiring experience of managing these are difficult to acquire even in larger centres. This can be mitigated by rehearsal of these complications. This is in contrast to potentially expensive simulation and simply involves walking through the management steps in the operating room, including confirming the location of critical equipment, the role of individual team members and the post-operative patient care plan. Using this approach, it is possible to give a team greater experience of complications than they would ever have when waiting for this to happen for real, even in a larger centre. In practice, this approach proved very effective and when complications did occur, the visiting physicians performing the procedure were not aware that the team had never seen this complication before.

As well as being one of the first multicentre trials to examine AF ablation in non-surgical/community hospitals, by contrast to the 2018 Opel paper which was performed and led by physicians experienced in AF ablation, the paper by Hoffman demonstrates a very important concept, that the physician performing the procedure does not need to be a board-certified electrophysiologist. We would conclude from this, that rather than a long training in the mechanism of arrhythmia, the elucidation and deduction of complex arrhythmia mechanisms, what is required to perform AF ablation effectively and safely is leadership by a clinician interested in the procedure, a good set of structures and protocols and a stable well-rehearsed workforce. This offers real potential for meeting the growing demand for AF ablation over the next decade.

We would conclude with some important caveats. Although we strongly believe that performing single-shot AF ablations in selected community hospitals is feasible, it needs to be pointed out that this study did not provide any mid- and long-term safety and efficacy data. A previous study of 21 141 AF ablations found no difference in cardiac tamponade when using cryoballoons in low (<50 procedures/year) vs. intermediate/high-volume centres.[4] However, up to 10% of those may require cardiac surgery. Therefore, both formalized process for follow-up and submission of those data to national audits (when they exist) and standard operating procedures for acute complications and a quality management program needs to be in place before a hospital adopts this approach.[6] Finally, public performance reporting of single-operator run ablation services may raise some legal and ethical concerns in some countries.

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