Clinical Study On Patent Foramen Ovale Closure Under Only Echocardiography Guidance For Cryptogenic Stroke

Part 1 Efficacy analysis of patent foramen ovale closure under only echocardiography guidance for cryptogenic strokeBackgroundPatent foramen ovale(PFO)is common in the population,with a incidence rate of 25%-34%.When patients with PFO do special actions such as holding breath or coughing violently,the pressure of right atrium will temporarily rise higher than that of left atrium,pushing the primary septum with larger swing to move to the left atrium,thus leading to right to left shunt(RLS).This characteristic of PFO makes it possible to act as a channel of paradoxical embolism,providing favorable conditions for thrombus,air or vasoactive peptide to enter the arterial system from the venous system.PFO is related to a variety of diseases,such as cryptogenic stroke(CS),migraine,decompression illness,peripheral arterial embolism and platypnoea-orthodeoxia syndrome.The patients with PFO and CS can prevent the recurrence of stroke by closing PFO,and transcutaneous interventional closure is the first choice of treatment.The traditional PFO closure is guided by X-ray fluoroscopy,but there are still many shortcomings,such as the radiation damage to the operator and patients,the application of contrast agent will cause adverse effects on the kidney.And the operation is mostly carried out in the catheter room,once serious complications such as the device embolism,heart perforation and so on occur,it is often caught unprepared.In order to avoid the above shortcomings,the PFO occlusion guided by echocardiography as the only imaging tool came into being.Among them,the PFO occlusion guided by only transesophageal echocardiography(TEE)has been carried out in many heart centers in China,while the PFO occlusion guided by only transthoracic echocardiography(TTE)is rarely carried out.In this study,we observed and compared the PFO closure for CS under the guidance of transesophageal echocardiography and transthoracic echocardiography,evaluated the feasibility,safety and effectiveness of this two kinds of operation methods,and summarized the clinical experience,in order to provide some guidance and reference for the future clinical work and the popularization of PFO closure with ultrasound intervention.ObjectiveTo investigate the feasibility,safety and effectiveness of transesophageal echocardiography-only and transthoracic echocardiography-only guided closure of PFO for the treatment of cryptogenic stroke.MethodsPatients with PFO combined with CS who underwent PFO occlusion guided by TEE/TTE in cardiac surgery department of our hospital from January 2017 to January 2019 were selected as the research objects.A total of 126 patients met the inclusion criteria,including 55 males and 71 females,aged 38.79±10.45 years,and 42 patients(33.3%)with PFO suffered from migraine.According to the different guidance methods,patients were divided into TEE group(n=81)and TTE group(n=45).The clinical data and follow-up results of all patients were collected.The clinical data included measurement and count data,such as gender,age,BMI value,anatomical characteristics of PFO,occluder size,preoperative RLS grade,operation time,operating room detention time,postoperative hospital stays,hospitalization costs,surgical complications and preoperative headache impact measurement of patients with HIT-6 score,etc.The follow-up data included the results of re-examination of TTE,contrast TTE(c-TTE)at 3,6 and 12 months after operation,and HIT-6 scores of patients with migraine at 3,6 and 12 months after surgery.Relevant data were statistically analyzed,and differences in baseline characteristics,surgical results and follow-up data were compared between the two groups.Results(1)126 patients in both groups were successfully occluded.In the TTE group,4 patients(4/45,8.9%)were converted to general anesthesia and TEE guided to complete the occlusion.There was a statistically significant difference in BMI value between the TEE group and the TTE group(25.14 ? 2.28 vs.23.45 ? 2.12,P<0.05),but there was no statistical difference in gender,age,previous history and PFO anatomy(P>0.05).(2)In terms of surgical results,the TTE group was significantly lower than the TEE group in terms of operating room retention time,hospitalization costs,and postoperative hospital stays(P<0.05).There was no significant difference in the incidence of postoperative complications,intracardiac operation time(From the percutaneous femoral vein puncture to the removal of the delivery sheath)and the sizes of occluder.(3)During the follow-up period,there was no recurrent strokes or deaths in the two groups,and no occluder displacement,pericardial effusion,aortic erosion,infective endocarditis,occluder thrombosis,hemolysis and other complications.One patient in the TEE group suffered from TIA in 6 months after PFO closure.Examination of c-TTE revealed that there was a large amount of rRLS in this patient,and no new stroke was found by craniocerebral magnetic resonance imaging.One patient in each group developed transient paroxysmal atrial fibrillation within 3 months after PFO closure,and the two patients were all transferred to sinus rhythm after medication.(4)The incidence of rRLS in the 126 patients in the whole group at 3,6 and 12 months after operation was 39.7%(50/126),21.4%(27/126)and 9.5%(12/126),of which the incidences of medium-large residual shunts were 20.6%(26/126),11.1%(14/126)and 4.0%(5/126).The preoperative and postoperative RLS status of TEE group and TTE group was compared,and no statistical difference was found between the two groups(P>0.05).(5)The HIT-6 scores of the 42 patients with CS and migraine at 3,6 and 12 months after operation were significantly lower than those before operation(P<0.05).The follow-up results at 12 months after PFO closure showed that migraine symptoms were significantly relieved or disappeared in 32(76.2%)of the 42 migraine patients.There was no statistically significant difference between migraine patients in the TEE group and the TTE group in the postoperative migraine symptom relief rate(72.4%and 84.6%,P>0.05).conclusion(1)Transcutaneous PFO closure guided solely by echocardiography(TEE/TTE)is a safe,effective and feasible method for PFO,which has a highe success rate and low complication rate,avoides the application of X-ray fluoroscopy and contrast agent.(2)Transcutaneous PFO closure guided solely by echocardiography(TEE/TTE)for the treatment of CS has a satisfactory short-term effect.According to the follow-up results at 12 months after the operation,more than 90%of the patients had no residual shunt,and more than 75%of migraine patients with CS had significant remission or disappearance of migraine symptoms.During the follow-up period,there was no recurrence of stroke in all the patients.(3)Transcutaneous PFO closure guided solely by TTE is no need for general anesthesia and tracheal intubation.Compared with the TEE guided percutaneous PFO closure,it has the advantages of smaller trauma,faster recovery and lower cost.(4)Percutaneous PFO closure guided solely by TEE has a wider indication than TTE guided PFO occlusion,and PFO closure guided by TEE is more suitable for patients with obesity,thick chest wall and excessive lung gas.Part 2 Analysis of risk factors for residual shunt after echocardiography-only guided closure of patent foramen ovaleBackgroundClinical practice shows that transcatheter closure of PFO is safe and feasible with high success rate and low complication rate.As a kind of preventive operation,the main purpose of intervention is to eliminate right to left shunts(RLS)and prevent the embolus from causing abnormal embolism through PFO,so as to prevent the recurrence of stroke.However,after successful implementation of PFO closure,a few patients still have stroke recurrence.If the occluder and its endothelialization can completely block the connection between the left and right atria after the PFO has been blocked,patients can stop antithrombotic therapy.However,some patients still could be detected rRLS after 12 months of PFO closure,which may increase the risk of recurrence of paradoxically embolic events.There may be many factors related to the occurrence of rRLS after PFO closure.At present,there are few studies on rRLS after PFO closure in China.In this paper,the risk factors and treatment strategies of rRLS in one year after PFO closure were discussed by observing the changes of residual shunt after echocardiography-only guided PFO closure,so as to provide reference for further clinical work.ObjectiveTo study the risk factors for residual shunt after echocardiography-only guided closure of patent foramen ovale.MethodsPatients with PFO combined with CS who underwent PFO occlusion guided by TEE/TTE in cardiac surgery department of our hospital from January 2017 to January 2019 were selected as the research objects.A total of 126 patients met the inclusion criteria.The clinical data and follow-up results of all patients were collected,including measurement and count data,such as gender,age,weight,BMI value,anatomical characteristics of PFO,occluder sizes,right-to-left shunt grade before and after operation,guidance methods,etc.According to the c-TTE results reviewed 12 months after the operation,the research subjects were divided into residual shunt group(rRLS group)and non-residual shunt group(Non-rRLS group),statistical analysis was performed on the data of the two groups.And t-test or Mann-Whitney U test was used to compare the measurement data between the groups.Categorical variable comparison using chi-square,continuous-corrected chi-square or Fisher's exact test,screening for possible risk factors,and then multi-factor logistics regression analysis was used for possible risk factors to explore independent risk factors for residual shunt in 12 months after PFO closure.ResultsThe incidence of rRLS in 126 patients at 3,6 and 12 months after operation was 39.7%(50/126),21.4%(27/126)and 9.5%(12/126).There were statistically significant differences in PFO size(mm),PFO tunnel length(mm),the combination of ASA,and occluder>25mm(25/35mm,30/30mm)between the rRLS group and the non-rRLS group(P<0.05),but there was no statistical difference in age,gender,BMI value,preoperative RLS grade,previous history(smoking,hypertension,hyperlipidemia,diabetes,migraine),combined with prominent euclidean valve,auxiliary operation of outer sheath delivery and guiding mode(P>0.05).Optimal cut-off values of PFO tunnel length(mm)and PFO diameter(mm)were obtained to predict rRLS with use of ROC curve analysis.The results showed that the optimal cut-off values of PFO tunnel length and PFO diameter were 9.5mm and 3.5mm respectively.With rRLS in 12 months after PFO occlusion as the dependent variable,PFO diameter>3.5mm,PFO tunnel length>9.5mm,the combination of ASA and occluder>25mm as independent variables,Yes or no was denoted by 1 or 0 respectively.Multifactor logistics regression analysis showed that the combination of ASA and PFO tunnel length>9.5mm were independent risk factors for the presence of rRLS in 12 months after PFO closure(P<0.05),of which the combination of ASA(OR=6.061;P=0.021)and PFO tunnel length>9.5mm(OR=7.628;P=0.017).If the occluder>25mm was not included,the anatomic features of PFO(PFO diameter>3.5mm,PFO tunnel length>9.5mm,the combination of ASA)were only used as independent variables,and the rRLS in12 months after PFO occlusion as the dependent variable,multivariate logistic regression analysis was performed.The results showed that PFO diameter>3.5mm,PFO tunnel length>9.5mm and the combination of ASA were independent risk factors for rRLS(P<0.05),and PFO diameter>3.5mm(OR=9.227;P=0.002),PFO tunnel length>9.5mm(OR=5.363;P=0.032),the combination of ASA(OR=6.652;P=0.012).Conclusion(1)PFO closure under echocardiography-only guidance with use of Cardio-O-Fix PFO occluder can effectively occlude PFO.With the passage of time,the complete occlusion rate continued to increase,but there was still a small number(9.5%)of patients had rRLS in 12 months after PFO closure.(2)The rRLS after PFO closure is related to various factors.PFO combined with ASA,long tunnel PFO(tunnel length>9.5mm)and large PFO(PFO diameter>3.5mm)are independent risk factors for rRLS in 12 months after PFO closure.(3)The risk of rRLS can be predicted by evaluating risk factors,the intervention through individualized treatment plans and the selection of appropriate occluder types and sizes may reduce the occurrence of rRLS after operation.