Patent Foramen Ovale Closure in Special Clinical Situations: More Questions Than Answers?
Abstract
:1. Introduction
2. Decompression Illness
3. Migraine
Key Recommendations
4. Older Patients
Key Recommendations
5. Thrombophilia
Key Recommendations
6. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Authors | Year | Number of Patients with PFO: Closure/Control | Study Design | Prevention Type | Mean Follow-Up (Years) | Outcome |
---|---|---|---|---|---|---|
Billinger et al. [34] | 2011 | 26/39 | Prospective | Secondary | 5.3 | Closure prevents symptomatic and asymptomatic events |
Honěk et al. [35] | 2014 | 20/27 | Not specified | Primary | None | No difference in venous bubble occurrence but arterial emboli elimination after simulated dives |
Henzel et al. [36] | 2018 | 11/0 | Retrospective | Secondary | 7.6 | PFO closure was reasonably effective in the secondary prevention of DCI |
Koopsen et al. [37] | 2018 | 21/14 | Retrospective | Secondary | 6.8 | PFO closure was effective and safe for secondary prevention with a safe return to unrestricted diving |
Anderson et al. [38] | 2019 | 42/23 | Prospective | Primary n = 11/ Secondary n = 54 | 6 | Healthy divers with large PFOs and relatively serious DCS who will practice advanced diving may benefit more from closure |
Vanden Eede et al. [39] | 2019 | 59/0 | Retrospective | Secondary | 10 | Divers undergoing PFO are not completely protected, with 7% recurrence after closure |
Honěk et al. [40] | 2020 | 55/98 | Prospective | Secondary | 7.1 | Closure in high-grade PFO was more effective than the conservative approach |
Authors | Year | Number of Patients with PFO: Closure (MA+, MA-)/Control (MA+, MA-) | Study Design | Mean Follow-Up (m) | Postprocedural Treatment | Outcome |
---|---|---|---|---|---|---|
Anzola et al. [63] | 2006 | 50 (33, 17)/27 (21, 6) | Prospective | 12 | Aspirin 300 mg/d × 6 m | Closure significantly improves overall migraine occurrence compared to medication |
Vigna et al. [64] | 2009 | 53 (23, 30)/29 (13, 16) | Prospective | 16 | Clopidogrel 75 mg/d × 3 m + Aspirin 100 mg/d × 6 m | Significant decrease in migraine frequency and severity |
Rigatelli et al. [65] | 2010 | 40 (32, 8)/46 (10, 36) | Prospective | 29.2 | None | Very significant reduction in migraine after PFO closure |
Biasco et al. [66] | 2014 | 89 (67, 22)/128 (82, 46) | Retrospective | 46.6 | Clopidogrel 75 mg/d × 3 m + Aspirin 100 mg/d × 6 m | No difference in migraine evolution, migraine elimination was higher in the closure group |
Xing et al. [67] | 2016 | 125 (34, 91)/116 (25, 91) | Prospective | 12 | Aspirin 100 mg/d × 6 m | PFO closure was more effective compared to medical treatment based on the Headache Impact Test-6 |
He et al. [68] | 2019 | 91 (91, 0)/101 (101, 0) | Retrospective | 60 | none | PFO closure was effective in alleviating migraine disability |
Trabattoni et al. [57] | 2022 | 62 (62, 0)/0 | Prospective | 12 | Aspirin 100 mg/d × 6 m | Platelet activation that could play a role in MA+ symptoms is switched off after PFO closure |
Tong et al. [46] | 2023 | 39 (0, 39)/- | Cross-sectional | 20 | Antiplatelet (not specified) | Closure significantly improved migraine symptomatology |
Authors | Year | Number of Patients: ≥60/55 Years Old (Closure/No Closure), <60/55 Years Old (Closure/No Closure) | Study Design | Follow-Up (Years) | Postprocedural Treatment | Outcome |
---|---|---|---|---|---|---|
Scacciatella et al. [77] | 2016 | 151 (151/0), 307 (307/0) | Prospective | 4.5 (mean) | Dual antiplatelet regimen × 3 m followed by single antiplatelet regimen for ≥3 m | PFO closure was as safe as in younger (>55 years old) patients, recurrent cerebral ischemia after closure was more frequent in older patients |
Takafuji et al. [78] | 2019 | 14 (14/0), - | Retrospective | 2.6 (mean) | Prescribed in an individual manner | PFO closure was as effective as in younger patients |
Wintzer et al. [79] | 2020 | 90 (90/0), 385 (385/0) | Prospective | 8 (median) | Aspirin (indefinitely) ± clopidogrel × 6 m | PFO closure was safe and associated with a low rate of recurrence |
Kwon et al. [76] | 2021 | 34 (13/21), 86 (47/39) | RCT | <60 + PFO closure: 2.5, <60 + no closure: 2.9, ≥60 + closure: 4.4, ≥60 + no closure: 2.5 (median) | aspirin 100 mg/d + clopidogrel 75 mg/d for ≥6 m (reccomended regimen) | PFO closure was more beneficial in patients ≥60 years old compared to younger ones |
Poli et al. [80] | 2021 | 71 (43/28), 123 (103/20) | Prospective | 2.8 (mean) | Aspirin + clopidogrel, possible de-escalation to single regimen after 3 or 6 m | Similar recurrence incidence between the groups |
Nachoski et al. [81] | 2021 | 101 (101/0), 192 (192/0) | Retrospective | 3.6 (mean) | Aspirin 100 mg/d + clopidogrel 75 mg/d × 3 m followed by aspirin monotherapy for ≤6 m | No differences in safety and effectiveness between the groups |
Alperi et al. [82] | 2022 | 388 (388/0), 883 (883,0) | Retrospective | 3 (median) | Prescribed in an individual manner | PFO closure was safe, with a low but higher stroke recurrence rate compared to younger patients |
Chen et al. [83] | 2023 | 78 (35/43), 95 (62/33) | Prospective | 2.5 (mean) | According to clinical guidelines | Reduced risk for the primary outcome after closure in the total cohort; elderly patients with closure had a better functional outcome at 180 days compared to controls |
Authors | Year | Number of Patients: PFO Closure (with/without Thrombophilia), Control (with/without Thrombophilia) | Thrombophilia Type | Prevention (Primary/ Secondary) | Study Design | Follow-Up (m) | Postprocedural Treatment for Thrombophilia Patients | Outcome |
---|---|---|---|---|---|---|---|---|
Giardini et al. [98] | 2004 | 72 (20/52), 0 | NA | Secondary | Retrospective | 19 (median) | Warfarin × 6 m | PFO closure is effective in recurrence prevention |
Kefer et al. [99] | 2012 | 175 (28/147), 0 | HHcy 57.1%, PTM 7.1%, protein C deficiency 3.6%, protein S deficiency 17.9%, FVL 10.7%, aCL antibodies 3.6%, aPL 3.6% | Secondary | Prospective | 60 (mean) | LMWH × 4–6 weeks + aspirin for 6m | PFO closure is safe and effective even in thrombophilia |
Liu et al. [94] | 2020 | 383 (89/294), 208 (45/163) | NA | Secondary | Prospective | 53 (median) | Warfarin × 3 m for single embolic event, lifelong warfarin for ≥2 embolic events | PFO closure reduced the risk of event recurrence compared to medical treatment alone |
Buber et al. [100] | 2021 | 136 (85/51), 0 | APS 31%, FVL 22%, PTM 18%, protein S deficiency 7%, MTHFR mutation 5%, ET 2% | Primary | Retrospective | 46 (mean) | Individual antithrombotic therapy maintenance | PFO closure was associated with a significantly lower risk of stroke/TIA |
Ben-Assa et al. [101] | 2021 | 800 (239/561), 0 | APS 34.3%, Lp(a) elevation 32.6%, HHcy 9.6%, Protein S deficiency 12.6%, FVL 1.3%, PTM 9.2%, AT-III deficiency 7.1%, Protein C deficiency 2.9% | Secondary | Retrospective | 41.9 (median) | Warfarin × 3 m followed by lifelong aspirin 100mg/d for 1 thrombotic episode and non-arterial hypercoagulable state; otherwise, lifelong warfarin | PFO closure was safe and effective in thrombophilia patients |
Abrahamyan et al. [102] | 2023 | 669 (174/495) | Protein C deficiency 27%, Protein S deficiency 37.9%, AT-III deficiency 20.1%, FVL 19%, PTM 12.1%, aCL antibodies 9%, LAC 5% | Secondary | Retrospective | 139.2 (median) | Dual antiplatelet therapy × 6 m followed by aspirin (suggested) | No difference in long-term adverse events between the groups |
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Apostolos, A.; Alexiou, P.; Papanikolaou, A.; Trantalis, G.; Drakopoulou, M.; Ktenopoulos, N.; Kachrimanidis, I.; Vlachakis, P.K.; Tsakiri, I.; Chrysostomidis, G.; et al. Patent Foramen Ovale Closure in Special Clinical Situations: More Questions Than Answers? Life 2024, 14, 706. https://doi.org/10.3390/life14060706
Apostolos A, Alexiou P, Papanikolaou A, Trantalis G, Drakopoulou M, Ktenopoulos N, Kachrimanidis I, Vlachakis PK, Tsakiri I, Chrysostomidis G, et al. Patent Foramen Ovale Closure in Special Clinical Situations: More Questions Than Answers? Life. 2024; 14(6):706. https://doi.org/10.3390/life14060706
Chicago/Turabian StyleApostolos, Anastasios, Polyxeni Alexiou, Amalia Papanikolaou, Georgios Trantalis, Maria Drakopoulou, Nikolaos Ktenopoulos, Ioannis Kachrimanidis, Panayotis K. Vlachakis, Ismini Tsakiri, Grigorios Chrysostomidis, and et al. 2024. "Patent Foramen Ovale Closure in Special Clinical Situations: More Questions Than Answers?" Life 14, no. 6: 706. https://doi.org/10.3390/life14060706