Sex differences in baseline profiles and long-term outcomes in patients undergoing PFO closure after cryptogenic stroke

Catharina Hamm (Bad Nauheim)1, M. Weferling (Bad Nauheim)1, M. Haas (Bad Nauheim)1, D. Grün (Bad Nauheim)1, C. Liebetrau (Frankfurt am Main)2, S. T. Sossalla (Gießen)3, C. W. Hamm (Gießen)3, O. Dörr (Gießen)3

1Kerckhoff Klinik GmbH Abteilung für Kardiologie Bad Nauheim, Deutschland; 2CCB am AGAPLESION BETHANIEN KRANKENHAUS Frankfurt am Main, Deutschland; 3Universitätsklinikum Gießen und Marburg GmbH Medizinische Klinik I - Kardiologie und Angiologie Gießen, Deutschland


Background: Stroke is one of the most common causes of mortality worldwide and is responsible for millions of deaths. Cryptogenic stroke, defined as brain infarction not related to atherothrombosis, small vessels, or embolism, is considered to be a cause about one third of the cases. 

Data from randomized trials demonstrate that patent foramen ovale (PFO) closure with transcatheter techniques is superior to medical therapy alone for secondary prevention of paradoxical embolism. Sex differences have been emphasized in congenital heart disease and stroke, but there are limited data available on their role in PFO closure for secondary prevention of stroke/embolism. Key guidelines on the management of PFO do not comment on sex-specific measures.

Aims: The aim of this study was to investigate sex differences in baseline characteristics, procedural features, complication rates, and long-term outcomes in patients undergoing PFO closure for paradoxical embolism. 


Methods: Data from adult patients with cryptogenic embolism and PFO who underwent PFO closure at two high volume centers between 2012-2019 were analyzed retrospectively. Baseline data including risk factors, medical history, and diagnostic and procedural information were assessed.


Results: Out of 444 consecutive patients in our cohort 176 (39.6%) were female, 155 (35,2%) were older than 60 years. The mean age of the study cohort was 54.4 years. A total of 72.5% underwent closure for cryptogenic stroke and 15.6% for peripheral embolisms including embolic myocardial infarction. There were some sex-related differences at baseline with respect to cardiovascular risk profile. Men had numerically higher prevalence of smoking (12.5% vs. 20.8% p= 0.07) and diabetes mellitus (8.6% vs. 4.5%, p=0.12). Coronary heart disease was significantly more prevalent in males (p<0.001). 

Success rate was high in both groups with 97.8% in men and 98.3% in women. The most frequently used device was the Amplatzerâ (62% women vs. 59% men); the proportion of men with closure devices >25 mm was double the rate for females (35% vs. 17%). We did not detect different complication rates or in-hospital outcomes between sexes. 

At long-term follow-up (mean 4.1 years) stroke recurrence (3.4% in each) and atrial fibrillation (5.2% in women; 7.5% in men, p =0,35) rates showed no significant differences between men and women. 


Conclusions: In contrast to other interventional procedures in the field of cardiology, there are no systematic data on sex differences in patients undergoing PFO closure, highlighting the need for more systematic studies to extract sex differences in PFO populations. 

In this study, except for the prevalence of preexisting coronary heart disease, no significant differences in baseline profiles and cardiovascular risk factors were observed between men and women. Procedural success and periinterventional complication rate did not differ between the sexes. Long-term follow-up data showed no statistical differences regarding recurrence of stroke or new-onset atrial fibrillation between men and women. 


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