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Patent foramen ovale (PFO) closure, for the prevention of stroke recurrence in patients with cryptogenic stroke (CS), has evolved from a putative therapy to one grounded in clinical trial evidence.
Earlier “negative” trials comparing the efficacy of PFO closure with medical therapy for preventing stroke recurrence had limitations. Those trials used older-generation devices,
confirm the efficacy of PFO closure in mitigating the risk of recurrent ischemic stroke compared with antiplatelet therapy alone in patients with recent CS.
Advantages and Disadvantages of Routine Intracardiac Echocardiographic Monitoring During PFO Closure
The choice of intraprocedural imaging during PFO closure varies across institutions and operators. Value-based approaches have been gaining traction across health care systems, linking costs to patient-centred clinical outcomes. The routine use of intracardiac echocardiography (ICE) in PFO closure may lend itself to a value-based quality-improvement initiative. Recent guidelines endorse routine intraprocedural use of either ICE, transesophageal echocardiography (TEE), or 3-dimensional TEE to guide PFO closure.
Guidelines for the echocardiographic assessment of atrial septal defect and patent foramen ovale: from the American Society of Echocardiography and Society for Cardiac Angiography and Interventions.
Simplified percutaneous closure of patent foramen ovale and atrial septal defect with use of plain fluoroscopy: single operator experience in 110 consecutive patients.
Propensity-score matched comparison of the Cera PFO Occluder with the Amplatzer PFO Occluder for percutaneous closure of patent foramen ovale without echocardiographic guidance.
By relying on fluoroscopy alone to guide PFO closure, interventionists may overlook certain advantages of ICE. First, contrast angiography as a substitute is limited in its ability to detect residual right-to-left shunts. Recent randomized PFO closure trials that achieved a low rate of residual right-to-left shunts mandated intraprocedural echo guidance.
Guidelines for the echocardiographic assessment of atrial septal defect and patent foramen ovale: from the American Society of Echocardiography and Society for Cardiac Angiography and Interventions.
Simplified percutaneous closure of patent foramen ovale and atrial septal defect with use of plain fluoroscopy: single operator experience in 110 consecutive patients.
Propensity-score matched comparison of the Cera PFO Occluder with the Amplatzer PFO Occluder for percutaneous closure of patent foramen ovale without echocardiographic guidance.
Second, ICE allows operators to detect complications early and intervene accordingly. ICE facilitates the diagnosis of pericardial effusions before the occurrence of tamponade. The transverse pericardial sinus, at the point where the aortic root borders the atrial septum, is especially vulnerable to iatrogenic trauma during PFO intervention. Also, ICE allows intraprocedural detection of intracardiac air bubbles. Likewise, thrombus formation on sheaths, wires, and catheters can be detected promptly with the use of ICE. Third, interval changes, including atrial thrombus formation, can be detected if the baseline TEE was performed a long time before the PFO closure, especially in patients with deep vein thrombosis. Finally, the intraprocedural use of ICE facilitates the detection of additional high-risk PFO features if the baseline TEE was not comprehensive.
The risks attributable to the use of ICE during PFO closure are minimal. ICE requires a second femoral venous access, and vascular access site complications occur in up to 1% of ICE-guided PFO closure procedures,
potentially prolonging hospital stay. In addition, ICE catheter manipulation can occasionally trigger atrial or ventricular arrhythmias requiring treatment, including cardioversion.
Guidelines for the echocardiographic assessment of atrial septal defect and patent foramen ovale: from the American Society of Echocardiography and Society for Cardiac Angiography and Interventions.
Guidelines for the echocardiographic assessment of atrial septal defect and patent foramen ovale: from the American Society of Echocardiography and Society for Cardiac Angiography and Interventions.
and dislodgment of recently placed pacemaker leads. Additional drawbacks include the higher procedural costs of ICE catheter use, longer procedure duration, and, possibly, higher infection risk arising from the use of resterilized ICE catheters (in the absence of robust resterilization processes). Therefore, operators must carefully balance the potential benefits of fluoroscopy-only guided PFO closure against the risks of abandoning routine ICE use. We have listed factors favouring each strategy in Figure 1.
Figure 1Factors favouring the use of fluoroscopy-guided versus intra-cardiac echocardiography (ICE)–guided patent foramen ovale (PFO) closure. TEE, transesophageal echocardiography.
Barker et al.’s Study of Selective Use of ICE for PFO Closure
In this issue of the Canadian Journal of Cardiology, Barker et al. explore the feasibility of a minimalist approach to PFO closure using ICE selectively instead of routinely. They undertook a retrospective review, drawing on their institutional PFO closure experience, to ascertain the safety and short-term outcomes of fluoroscopy-only guided PFO closure.
They analysed data from 467 consecutive patients with CS over 11 years who underwent PFO closure with an Amplatzer device (out of 1035 patients subjected to this procedure over 18 years using 7 device types for various indications). Of these 467 patients, 381 underwent fluoroscopy-only guided closure, and 86 underwent combined fluoroscopy- and ICE-guided PFO closure. Remarkably, the authors were able to systematically decrease the proportion of ICE-guided PFO closures from 25.9% to 5.9% over the course of the study period. There were no significant differences between the 2 groups in the rates of same-day discharges or complications including arrhythmias, device embolization rates, and vascular or neurologic complications. The fluoroscopy-only guided PFO closure group had lower fluoroscopy and procedure time compared with the ICE-guided group. The authors were able to follow 91.6% of patients for a mean of 4 ± 5.9 months. Complete PFO closure was achieved in 94.6% of these patients with no significant difference in the rates of residual shunts between groups (fluoroscopy-guided: 5.8%; ICE-guided: 3.7%; P = 0.4). Other medium-term complications, including the rate of postprocedure atrial fibrillation and stroke, were similar between the 2 groups.
This analysis is the first high-volume North American study to look at fluoroscopy-only guided PFO closure. Strengths of the study include its large sample size, extensive institutional experience, ability to demonstrate a progressive decline in the ICE utilization rates (indicating systematic adoption of fluoroscopy-only guided PFO closure with progressively increasing institutional experience), and the structured depiction of the indications for using ICE. Weaknesses include limitation of the analysis to a single PFO-occluder device type, lack of a systematic protocol to rule out residual interatrial shunts, difficulties in matching (given the small sample size in the ICE-guided group), and lack of quantitative depiction of the operator-level annual- and lifetime-procedural experience.
Implications of the Barker et al. Study for Clinical Practice and Research
Intraprocedural echocardiography utilization during PFO closure procedures varies widely. Some institutions rely entirely on fluoroscopy to guide their PFO closures,
Simplified percutaneous closure of patent foramen ovale and atrial septal defect with use of plain fluoroscopy: single operator experience in 110 consecutive patients.
while others routinely use ICE or TEE for guidance. Although contemporary European PFO closure cohorts have reported good long-term outcomes while using fluoroscopy only in 43.0%-49.2% of closures,
Guidelines for the echocardiographic assessment of atrial septal defect and patent foramen ovale: from the American Society of Echocardiography and Society for Cardiac Angiography and Interventions.
Reduction in total procedure time translates into improved catheterization lab efficiency, which is especially important in large-volume institutions. Barker et al. reported the use of fluoroscopy only to guide PFO closures with the Amplatzer PFO Occluder device.
Simplified percutaneous closure of patent foramen ovale and atrial septal defect with use of plain fluoroscopy: single operator experience in 110 consecutive patients.
used across various observational registries analyzing the safety of fluoroscopy-guided PFO closure. Thus, the study findings cannot be generalized to other newer-generation devices. It is reassuring that the reported incidence of device embolization is low with fluoroscopy-guided PFO closure and is similar to that with ICE guidance.
Outstanding Questions and Future Directions
The main concern with fluoroscopy-guided PFO closure is the incidence of residual interatrial shunts. Notably, fluoroscopy-guided PFO closure was associated with a 16.8% incidence of severe residual shunts on follow-up, with a significant proportion of patients requiring reintervention, in a matched study.
Simplified percutaneous closure of patent foramen ovale and atrial septal defect with use of plain fluoroscopy: single operator experience in 110 consecutive patients.
Barker et al. reported a nonsignificant absolute difference of 2.1% in the residual shunt rates between fluoroscopy- and ICE-guided groups. Comparisons of the incidence of residual shunt after fluoroscopy- and ICE-guided PFO closure are complicated by differences in the diagnostic-workup imaging modalities used. Also, grading systems used for shunt quantification differ across studies. Standardization of protocols to detect and grade residual shunts would enable better comparison between groups and across studies.
In addition, Barker et al. suggested that high-volume operators may be more adept at using fluoroscopy-only guidance for PFO closures. Operator- and institutional-level PFO closure volumes may affect procedural outcomes. Institutional experience with other atrial septal interventions may also influence results. Further studies are required to ascertain the level of operator and institutional experience required to make fluoroscopy guidance the default strategy for PFO closure.
Conclusion
Barker et al. have demonstrated the potential safety of PFO closure with selective, rather than routine, use of ICE for intraprocedural imaging. High-volume structural programs may adopt fluoroscopy-only guided PFO closure with limited use of ICE as a value-based strategy. Concerns regarding a potentially higher incidence of residual shunts, necessitating future reinterventions, remain. Further research into the safety and effectiveness of a fluoroscopy-only guided PFO closure strategy, with stress on proving noninferiority in eliminating residual right-to-left shunts, is warranted. Meanwhile, programs contemplating a transition to fluoroscopy-only guided PFO closure should closely monitor any temporal changes in complication rates.
Funding Sources
The authors have no funding sources to disclose.
Disclosures
The authors have no conflicts of interest to disclose.
References
Collado F.M.S.
Poulin M.F.
Murphy J.J.
Jneid H.
Kavinsky C.J.
Patent foramen ovale closure for stroke prevention and other disorders.
Guidelines for the echocardiographic assessment of atrial septal defect and patent foramen ovale: from the American Society of Echocardiography and Society for Cardiac Angiography and Interventions.
Simplified percutaneous closure of patent foramen ovale and atrial septal defect with use of plain fluoroscopy: single operator experience in 110 consecutive patients.
Propensity-score matched comparison of the Cera PFO Occluder with the Amplatzer PFO Occluder for percutaneous closure of patent foramen ovale without echocardiographic guidance.
Recent randomized trials have confirmed the role of patent foramen ovale (PFO) closure in the secondary prevention of cryptogenic stroke. Guidelines have suggested a central role for intraprocedural imaging using intracardiac echocardiography (ICE). However, this modality may not be required to achieve safe and effective closure. We aimed to examine the periprocedural outcomes of PFO closure retrospectively, using fluoroscopic guidance in patients with cryptogenic stroke, with provisional ICE guidance driven by anatomic and procedural factors.
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