Day-Case Patent Foramen Ovale Closure Under Transthoracic Echocardiography and Fluoroscopic Guidance: A Safe and Cost-Effective Approach as Compared to Conventional Hospitalization

  

    

    
Occlutech 
    
Amplatzer 
    
p 
  
  

    
Age    (years)a 
    
46 (SD 19) 
    
52.6 (SD 15) 
    
0.009 
  
  

    
Weight    (kg)a 
    
77 (SD 16) 
    
76.3 (SD 18) 
    
0.82 
  
  

    
Time    of fluoroscopya (minutes) 
    
3.96 (SD 2.37) 
    
3.25 (SD 1.54) 
    
0.044 
  
  

    
Radiation    doseβ    (Gycm2) 
    
Median 5 (IQR 6) 
    
Median 5 (IQR 5) 
    
0.93 
  
  

    
a: Mean ± Standard Deviation; β: Median (Interquartile    Range). 
  

Table 4: Comparison between Occlutech and Amplatzer PFO devices at
implantation in both groups.

Cost effectiveness: The cost of this procedure related to GHM 05K221 (closure of inter-atrial shunt by percutaneous approach) was 2949 euros in 2018 perceived by the hospital finance department without taking the cost of the hospital stay into account. This latter for our institution was 1478.42 euros per day for hospitalization in conventional unit and 649.56 euros for hospitalization in a daycase unit, on which is added the mean cost per procedure of 474.32 euros in our catheterization laboratory. The 3-day strategy of group 2 resulted in a deficit of - 1960 euros per patient, including the cost of the GHM minus the cost of 3 days of hospitalization in conventional unit plus the cost of procedure in catheterization laboratory. On the opposite, the day-case procedure of group 1 resulted in a positive balance of 1825 euros per patient and per procedure, including the cost of the GHM minus the cost of hospitalization in day-case unit and the cost of procedure as above. This resulted in a difference of 3785 euros per procedure and per patient between the 2 strategies for 2018 in our institution, clearly in favor of the day-case procedure.

Discussion

Our study shows that day-case PFO closure under TTE is feasible in the majority of the patients with appropriate image quality [5]. In fact, day-case interventions are becoming more common and increasingly seen as the standard of care, even though they are not mentioned in the current guidelines. Here, some may argue about the necessity of additive imaging modalities, Intra Cardiac Echocardiography (ICE) or TOE, because of specific atrial septal anatomy [4,6]. It seems that this choice may be based on center’s practice [7,8]. It is of interest to notice that need for additive ICE has been reported in 25% of the procedures in Toronto but a decline in its use has also been mentioned to 5% more recently, which is very similar to the use of TOE in 6% of our population [6]. Moreover, day-case PFO closure is safe and effective with no increased risks for the patients such as arrhythmias, vascular lesion, neurologic complication or device embolization. It has several advantages: shorter hospital stay, better patient’s comfort, and lower cost as discussed below. Same-day discharge was also performed by different teams [4-6]. In the large cohort from Toronto including 467 patients, it was achievable in 97.2% of patients [6]. Some may also worry about the risk of device embolization and the need for an early follow-up imaging to detect this (chest X ray or echocardiography the day after implantation). We did not observe any embolization but this point could be easily assessed by TTE performed one or 2 days after implantation by a local cardiologist close to the patient’s home.

PFO closure drawbacks

PFO closure carries few drawbacks. One is the persistence of shunt on follow-up control with the potential risk for recurrent thromboembolic events [9]. In the present study, a residual shunt was observed in 16% of patients at one month, which is very similar to other publications [4,10,11]. In fact, residual shunt requiring another procedure is very rare, around 0.4% [2] as the majority of the persistent shunts will disappear with time. However, the best way as well as the appropriate timing for shunt detection remains debatable. Another matter of concern is transient myocardial ischemia during device placement, also reported by others [1,9]. Most of them were not associated with any hemodynamical compromise and lasted few seconds. This clearly emphasizes the need for systematic attention to eliminate bubbles within the system and during all steps of the procedure. Arrhythmia is another complication and not rare after closure. In few patients, these palpitations were related to AF/ flutter that were not noticed before PFO closure despite systematic realization of ECG Holter monitoring. In fact, the AF detection may be correlated to the duration of the ECG monitoring. Longer monitoring ideally for at least 72 H should be recommended. The incidence of AF/Flutter, 4.6% in our population, has been reported between 0.4-6.6% [1-4,6,7,9,11-18]. Trabattoni has mentioned more supraventricular arrhythmias with Amplatzer versus Figulla but difference was not significant concerning paroxysmal AF [16], as similarly noted in the present study. In the same way, Tsivgoulis has reported lower risk of new-onset AF with Amplatzer and Gore devices compared to Starflex [17]. However, all patients were in sinus rhythm at one month control in our experience and it has also been reported no recurrence of AF during a median follow-up of 4.4 years after device implantation [1].

Comparison between Amplatzer and Occlutech PFO devices

A comparison was done between the 2 most employed nitinol PFO devices: Occlutech and Amplatzer (Table 4). Both occluders achieved good results in terms of procedural success with a low rate of complication and a high rate of full occlusion. In fact, no inferiority of Occlutech devices compared to the Amplatzer devices could be established, as already noted [5,9,13,16]. Both devices are effective and safe for transcatheter PFO occlusion. In fact, these results are not surprising because both Figulla and Amplatzer devices share many similarities. They are both designed as self-expandable, doubledisc structure made of nitinol with very similar disc sizes and waist lengths. The notable difference is the coating of the Figulla nitinol wire mesh by titanium oxide that may decrease dissolution of nickel ion, accelerate endothelial growth and minimize risk of thrombus formation. In the same way, no significant difference in results could be observed between Amplatzer and Lifetch PFO devices [19]. Further experience will be necessary to draw more definite conclusion concerning all types of devices employed here.

Cost reduction

At last, we have clearly shown a cost reduction of the daycase procedure in comparison to the classic approach with 3-day hospitalization and this strategy is effective if no complication occurs as observed in the majority of patients. In our practice, all patients were aware before catheterization of the possibility of prolonged hospitalization if any complication occurred. Moreover, most of patients appreciated not to stay overnight in the hospital. However, there are different limitations to the one-day strategy as noticed in about one sixth of the patients. First, day-case procedure is not suitable for those who are living alone or far away from the hospital. Second, for more complex anatomy according to our pre-selection, there is a need for a better imaging system during device release such as TOE or ICE than the classic TTE [6]. These imaging modalities have also been proposed in anatomical difficulties such as persistent Eustachian valve, long PFO tunnel, ASA with excessive mobility, hypertrophy of the interatrial septum [5,6,12,13]. However, these 2 imaging methods present also risks such as need for general anesthesia with prolonged procedure recovery times with TOE guidance or additional vascular puncture and significant cost for ICE. The results of our study showed that PFO closure under fluoroscopy and TTE guidance is easier, convenient and less invasive when compared to other strategies involving either TOE or ICE guidance [5,12] and probably applicable in many centers around the world .

Limitations

This study has several limitations. First, it is an observational, retrospective, single center study with lack of randomization for patient selection and device implantation. Second, the sample size is relatively limited. Third, absence of prolonged Holter monitoring before and after implantation may have underestimated the rate of AF/flutter. Fourth, assessment of residual shunt by TTE instead of TOE with contrast study and provocative maneuvers may also underestimate the rate of shunt. Fifth, parts of the costs (conventional, day-case unit) are specific to our institution/country and vary among each National Health Service according to reimbursement modalities. Finally, all patients were referred to our tertiary center for PFO occlusion creating a possible selection bias.

Conclusion

Day-case transcatheter PFO closure using TTE and fluoroscopy guidance is safe, simple, effective with a low rate of complications, and applicable in more than 80% of patients. The one-day strategy generates a positive balance of 1825 euros in 2018 for our center much more cost-effective than the previous conventional organization with 3-day hospitalization. Moreover, this approach is safe in terms of success of implantation, with few complications, either with Occlutech or Amplatzer PFO devices. Day-case procedures are well suited for most PFO closures, and guidelines are needed to improve the initial screening of patients for this procedure.

References

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