Patent Foramen Ovale Closure Research Articles

Heart-Stroke Team: A multidisciplinary assessment of patent foramen ovale-associated stroke.

Patent foramen ovale (PFO) closure prevents recurrent ischemic stroke in selected patients with a cryptogenic stroke. Trial results tend to be generalized to daily practice, often extending original trial inclusion criteria. This may result in unnecessary closure without benefit, but with risk of complications. We therefore introduced a standardized and structured evaluation by an interdisciplinary Heart-Stroke Team (HST). Our aim was to investigate the proportion of actual PFO closure of all referred patients with a cryptogenic stroke, after evaluation by the HST. We conducted a single-center, retrospective cohort study. Patients with an assumed cryptogenic ischemic stroke or transient ischemic attack (TIA) and a PFO who were referred for PFO closure were analyzed. As part of the HST approach, all patients underwent a standardized work-up, first to demonstrate the ischemic event on neuroimaging, second to evaluate all potential causes of stroke and finally, to assess the possible relation between the PFO and stroke. Outcome was the proportion of patients treated with PFO closure after referral. A total of 195 patients were included. In 124 patients (64%) PFO closure was advised. Fourty-two (22%) patients had a clear alternative cause of stroke and in 13 (7%) patients the initial stroke diagnosis could not be confirmed. After careful analysis of patients referred for PFO closure a relationship between the PFO and stroke could not be demonstrated in 32% of referrals, and 3% preferred best medical treatment over percutaneous closure. This stresses the need for a complete neurovascular work-up and multidisciplinary assessment.

Efficacy and safety of transesophageal ultrasound-guided patent foramen ovale closure for migraine in adolescents.

This retrospective analysis aims to assess the efficacy of transesophageal ultrasound-guided patent foramen ovale (PFO) closure in treating migraine in adolescents and compare the therapeutic outcomes of PFO closure for migraine with and without aura. We conducted a retrospective analysis of 86 cases of adolescents (12-20 years old) who underwent PFO closure for migraine at our institution over the past 3 years. The efficacy was evaluated using the visual analogue scale (VAS), headache impact test (HIT)-6, and pediatric migraine disability assessment (PedMIDAS) scores, as well as by assessing the monthly frequency of migraine attacks, duration of each attack, and overall migraine burden. The patients were divided into two groups: an aura group (55 cases) and a non-aura group (31 cases) to investigate difference in therapeutic efficacy between the groups. The effect of residual shunt on migraine burden was assessed. Among the 86 patients, 46 (54%) experienced complete remission of migraine, while 71 (83%) achieved a >50% reduction in migraine burden during the one-year follow-up period. Patients in the aura group showed more significant improvements in VAS, HIT-6, and PedMIDAS scores, as well as in monthly migraine attack frequency, duration of each attack, and overall migraine burden, than patients in the non-aura group. Moreover, patients with residual shunt did not exhibit statistically significant differences in therapeutic efficacy compared to patients with complete closure. PFO closure can effectively alleviate migraine symptoms in adolescents with migraine with concomitant PFO. The therapeutic efficacy is particularly pronounced for migraine with aura. Furthermore, minor levels of residual shunt have no effect on the improvement in migraine symptoms.

Comparative analysis between transcranial doppler and transesophageal echocardiogram in diagnosing residual shunt after persistent foramen ovale closure

Abstract Background The degree of residual shunt (RS) after patent foramen ovale (PFO) closure is a potent predictor for the recurrence of stroke. Evaluating the extent of residual shunt grade is thus essential. Currently, there is no gold standard on guidelines of how to evaluate RS. Although transesophageal echocardiography (TEE) is known to be most accurate in evaluating RS, it is not routinely performed due to its invasiveness and expensive costs. Conversely, the transcranial doppler (TCD) test is a less invasive convenient test for detecting RS. Accordingly, we sought to comparatively analyze the accuracy of TCD compared to TEE on assessing RS after PFO closure. Methods We analyzed patients who underwent PFO closure for cryptogenic stroke (CS), who received a TCD and TEE test within 1 year of procedure. All patients received TEE and TCD on the same day within one year (288±38 days) after PFO closure. Results We analyzed a total of 55 patients (age: 55.2 ± 11.1, male sex: 74.2%, PFO grade ≥ moderate: 83.6%, follow up duration: 28.9 ± 14.9 months). RS was confirmed in 24 (44%) and 23 (42%) of patients in the TCD and TEE test, respectively. The sensitivity and specificity of TCD was 0.77 and 0.96 for predicting the presence of RS, respectively. The predictive performance of TCD was consistent over age ≤65 (sensitivity 0.73, specificity 0.96) and RS≤mild (sensitivity 0.83, specificity 0.96) subgroups. Positive TCD (adjusted odds ratio 101.2; 95%CI, 9.5-1074.8; p<0.0001) was a highly significant independent predictor for the presence of RS. Conclusion We demonstrate for the first time that TCD may be a reliable non-invasive test for substituting TEE in evaluating RS. Physicians may be able to rule out the presence of RS and minimize the prescription of TEE when TCD test is negative due to the high specificity.

Timing on patent foramen ovale closure: early versus delayed closure

Abstract Introduction Pivotal randomized clinical trials showed benefit in patent foramen ovale closure (PFOC) up to 9 months after a cryptogenic stroke or transient ischemic attack (TIA) [1-4]. It might be sensible to indicate PFOC also in non-recent cryptogenic strokes, but evidence is lacking. Purpose We aimed to compare the effectiveness of PFOC according to the time elapsed from the patient’s last episode of cryptogenic cerebrovascular event (CVE) or systemic embolism (SE). Methods A retrospective, international, multicentre, cohort study was performed to compare the outcomes of an early closure (EC, <9 months) or delayed closure (DC, ≥9 months) of patent foramen ovale (PFO) as secondary prevention after the index event. The primary end-point was recurrence of CVE or SE after PFOC. Results A total of 325 and 171 patients were classified in the EC and DC groups, with a median time to PFOC of 3.4 (IQR 1.9-5.5) and 17.5 (IQR 12.2-33.4) months, respectively. No significant differences were observed regarding the type of event indicating PFOC (stroke was the most frequent (77.8% in EC group vs 79.0% in DC group), followed by TIA (19.4% vs 18.7%)); neither about neuroanatomic localization of the lesions, nor contrast transcranial Doppler patterns, nor Risk of Paradoxical Embolism (RoPE) score (7 (IQR 5-8) vs 6 (IQR 5-7), p=0.077). Echocardiographic PFO characteristics of both groups were similar, except for a larger defect size (tunnel width) in the DC group (6 (IQR 4-14) vs 12 (IQR 6-16) mm, p=0.005)). PFOC device, procedural success (99.4 in EC vs 98.8% in DC group) and periprocedural complications (2.1 vs 0.8%) were comparable in both groups. Median follow-up was 2.0 (IQR 1.3-3.8) years in the EC group and 2.2 (IQR 1.2-4.9) in the DC group (p=0.721). No significant differences were observed concerning recurrence of stroke, TIA or SE (3.9% vs 2.6%, p=0.443), time from PFOC to recurrence (0.9 (IQR 0-2.1) vs 6.1 (2.5-8.8) years, p=0.090), death (1.4% vs 1.0%, p=0.697), residual shunt 12 months after PFOC, or antithrombotic treatment during follow-up (Figure 1). Moreover, a subanalysis considering those patients with a very delayed PFOC (≥24 months) after the index event also showed no differences in recurrence rate during follow-up compared to the earlier procedures (4.2% in the <24-month group vs 3.4% ≥24-month group, p=0.770). Conclusions No differences were observed regarding recurrences of CVE/SE in patients undergoing PFOC before and after 9 months from the index event. Despite the absence of evidence from randomized trials, this study suggests that the preventive benefit of PFOC after a cryptogenic CVE/SE may be extended beyond 9 months after the last event.Figure 1:Incidence of recurre

Reporting quality of randomized controlled trials of percutaneous patent foramen ovale closure for the treatment of migraine based on the CONSORT statement

Abstract Background Although several retrospective and non-randomized studies support reduction of migraine frequency and severity after patent foramen ovale (PFO) closure, three randomized controlled trials (RCTs) in this setting have not met their primary efficacy endpoints. In addition, currently there are is no analysis of the quality of RCTs of percutaneous PFO closure for the treatment of migraine. Purpose The present study aims to determine the reporting quality of RCTs focusing on the PFO closure for the treatment of migraine according to the revised CONsolidated Standards Of Reporting Trials (CONSORT) 2010 checklist. Methods Systematic searches of 2 databases (MEDLINE/PubMed and Cochrane library) were conducted. The search strategy identified reports on RCTs involving patients with migraine and PFO who were randomized to transcatheter device closure of PFO or medical treatment in order to investigate the effect of PFO closure for migraine. The primary objective was to establish the mean CONSORT compliance of RCTs of PFO closure for the treatment of migraine and secondary objectives were the calculation of compliance per CONSORT item and effect of CONSORT statement in high-ranked medical journals. Quality of reporting was assessed using a 37-item questionnaire based on the revised CONSORT 2010 checklist. Reporting above 75% of the items was defined as adequate compliance to the CONSORT statement. Results The search identified 3 eligible articles for analysis. The mean compliance was 69.66% ± 4.49%. Among the studies, only 1 RCT (PRIMA Trial) registered a good reporting quality (75% of the CONSORT items), whereas there were no RCTs with a CONSORT compliance less than 50% (Figure 1). Among assessed items, 19 items (51.4%) were reported in all (100%) of the articles. Also, 26 of the 37 items of the checklist (70.3%) were reported in more than half of the studies. The majority of the Results items registered an adequate reporting whereas randomization items were not so sufficiently reported overall (Figure 2). Each one of the RCTs used in the analysis were published in high-ranked medical journals (IF>30). However, none of the studies reported all 37 items achieving 100% CONSORT compliance score. Conclusions Based on the present results, quality of reporting in RCTs focusing on the PFO closure for the treatment of migraine remains suboptimal according to the CONSORT analysis. In this sense, better designed RCTs on the management of migraine by PFO closure are currently needed to guide future clinical practice.Figure 1.Figure 2.

Patent foramen ovale closure reduces migraine burden: a meta-analysis

Abstract Background Patent foramen ovale (PFO) closure has been shown to reduce the risk of recurrent stroke in selected patients. On the other hand, the efficacy of PFO closure in reducing migraine attacks remains a matter of debate. Purpose We performed a systematic review and meta-analysis of randomized controlled trials that compared PFO closure plus medical therapy to medical therapy alone for the management of migraine. Methods A comprehensive search was conducted in PubMed through December 10, 2022. The main efficacy endpoints were the complete cessation of migraine, the mean reduction in monthly migraine days and the mean reduction in monthly migraine attacks. The main safety outcome was the occurrence of major procedure related adverse events. Results Our search retrieved 667 results. Three randomized controlled trials including 448 patients were included in the final analysis. Of these, 231 patients (mean age 43.4±10.5 years) underwent PFO closure, while 217 (43.7±10.6) were treated conservatively with medical therapy. In the medical treatment group, 190 patients underwent a sham procedure. The follow-up period ranged from 6 to 12 months. Overall, no significant association between PFO closure and complete migraine cessation was observed [Hazard Ration 3.31, 95% confidence intervals (CI): 0.72 – 15.17 – Figure 1). On the other hand, PFO closure was associated with a significant reduction in the mean number of migraine days per month [mean difference (MD): 1.23, 95% CI: 0.44-2.10, p=0.024, Figure 2A] as well as with a significant decrease in monthly migraine attacks (MD: 0.58, 95%CI : 0.25-0.91, p=0.017, Figure 2B). In respect of efficacy endpoint, a total of 9 transient, procedure related adverse events, including access-site bleeding, hematoma and tachycardia were reported in the implantation group. Conclusions PFO closure plus medical treatment compared to medical treatment alone was related with fewer and shorter migraine attacks. These results suggest clinical benefit of PFO closure in selected patients with migraine.Figure 1.Figure 2.

Impact of the antiplatelet strategy following patent foramen ovale percutaneous closure

Abstract Background Temporary dual antiplatelet therapy (DAPT) is recommended following patent foramen ovale (PFO) percutaneous closure although its benefit, compared to single antiplatelet therapy (SAPT), has not been demonstrated in this setting. Objective We aimed at assessing outcomes following PFO closure according to the antiplatelet strategy at discharge. Methods The ambispective AIR-FORCE cohort included consecutive patients from 7 centers in France and Canada undergoing PFO closure and discharged without anticoagulation. Patients treated in French and Canadian centers were mostly discharged with DAPT and SAPT, respectively. The primary endpoint was the composite of death, stroke, transient ischemic attack, peripheral embolism, myocardial infarction, or BARC type ≥2 bleeding with up to 5 years of follow-up. The impact of the antiplatelet strategy on outcomes was evaluated with a marginal Cox model (cluster analyses per country) with inverse probability weighting according to propensity score. Results A total of 1,532 patients were included from 2001 to 2022, of whom 599 (39.1%) were discharged with SAPT and 933 (60.9%) with DAPT, for ≤3 months in 894/923 (96.9%) cases (Table 1). After a median follow-up of 2.4[1.1-4.4] years, a total of 58 events were observed. In the weighted analysis the rate of the primary endpoint up to 5 years was 7.8% in the SAPT strategy and 7.3% in the DAPT strategy (weighted hazard ratio 1.04, 95% confidence interval 0.59-1.83) (Figure 1). Results were consistent in a sensitivity analysis. Conclusion The strategy of antiplatelet strategy following PFO closure did not seem to impact clinical outcomes, thus challenging the current recommendations of temporary DAPT.Table 1.Baseline characteristicsFigure 1.Central illustration

Long term follow-up of patent foramen closure due to embolic infarction in elderly patients

Abstract Background In patients < 60 years (yrs) with crytogenic embolism associated with a patent foramen ovale (PFO) guidelines recommend interventional closure based on several randomized studies. There is no recommendation for elderly patients, although they seem to carry a similar risk for recurrent events. There are only scarce data on early and particularly late outcome. Methods We therefore retrospectively analyzed the up to 10 years outcome (median 4,2 yrs) in 444 consecutive patients (female, male) according to age at PFO closure. Results From 444 patients in our study population, 155 were >60 years of age (mean age 66,7 (IQR 63,1-71,74), 45% females. Older patients had higher prevalence of cardiovascular risk factors like hypertension, hyperlipidemia and diabetes (p< 0,01 for all vs. younger patients) while smoking was more prevalent in younger patients (p<0,01). No difference in procedural success and periinterventional complications was observed between the two age groups. During follow up of median 4,2 years (5 patients lost to FU) event rate of recurrent stroke, atrial fibrillation and acute myocardial infarction did not differ between older and younger patients. Conclusions Long term outcome was independent of age despite higher CV risk factors burden and supports PFO closure in elderly patients.

Microtransesophageal echocardiographic guidance of patent foramen ovale percutaneous closure

Abstract Introduction The important growth in the number of percutaneous patent foramen ovale (PFO) closure procedures requires to find alternatives to conventional guidance by transesophageal echocardiography (TEE) with general anesthesia (GA). The micro-TEE monitoring, with local anesthesia, could allow a reliable guidance with a reduced procedural length, without the need for GA. The objective of this study is to evaluate the effectiveness and safety of PFO closure guided by micro-TEE compared to conventional TEE under GA. Methods This retrospective single-center observational study included all consecutive patients admitted to our hospital, from January 2019 to June 2021 for PFO closure. The type of guidance was based on PFO’s morphological characteristics and patient’s choice. The primary endpoint was the successful implantation of at least one prosthesis without significant residual shunting (≤ grade 1). Key secondary endpoints were the procedure duration and periprocedural complications. Results A total of 237 patients (44% of female, mean age: 50 ± 14 years) were included, with TEE and micro-TEE guidance in 174 (73%) and 63 (27%) cases, respectively. Smaller devices were more frequently implanted among patients with micro-TEE compared to TEE guidance, with 59% vs. 44% respectively (p=0.04), reflecting cases selection on the basis of prior TEE. Overall, there was no case of procedural failure and the primary endpoint was obtained in 158 (91%) and 60 (95%) patients with TEE and micro-TEE guidance, respectively (p=0.27). Procedural duration was shorter with micro-TEE guidance (median time 8 (7-11)min versus 21 (16-27)min, p=0.01). The rate of peri-procedural complications was low (1.3% overall) and limited to periprocedural atrial arrhythmia, without significant differences in both groups (p>0.99). Conclusions Micro-TEE guidance may result in safe and shorter PFO percutaneous closure compared to TEE guidance with GA.These results obtained on selected patients must be confirmed on larger cohorts.

Anatomical features of PFO in patients with cryptogenic stroke in comparison to autopsy results

Abstract Background In young patients suffering a stroke, well over 30% is considered cryptogenic stroke and may be associated with a PFO. The anatomical characteristics of stroke-related PFOs that allow right-to-left shunting can be assessed with TEE. The prevalence of a PFO in autopsy studies is approximately 25%, suggesting that the a priori chance of finding a possible "bystander-PFO" in young stroke victims is substantial. Purpose To assess the anatomical characteristics of PFO in patients with cryptogenic stroke and compare these with previously published results from autopsy in the general population. Methods Data on all consecutive patients that underwent PFO closure from 2016 to 2022 were collected. Anatomical PFO characteristics, including PFO diameter, tunnel length and the presence of atrial septal aneurysm, were measured with TEE during the closure procedure and analyzed by two cardiologists. Results In total 228 patients were enrolled. The mean age was 43±11 years, 116 patients (50.9%) were male, the mean RoPE-score was 7.0±1.4. The most frequent shunt grade measured with contrast bubble study during Valsalva maneuver was 3 (>25 bubbles, without opacification). Patients were divided in two groups depending on how the PFO diameter was measured, unstretched (n=119) and stretched (n=109). The mean PFO diameter was 5.4±2.6mm in the unstretched group and 10.9±3.6mm in the stretched group compared to 4.9±2.6mm in previous autopsy (p=0.192 and p<0.001, respectively). The percentage of patients with a PFO size larger than 10mm was 2% in autopsy compared to 6% in the unstretched group (p=0.109) and 52% in the stretched group (p<0.001). The mean PFO tunnel length in our combined cohort was 7.8±2.9mm. Conclusion The difference in PFO diameter found in this study indicates that PFOs found during published autopsy series, which are present in approximately 25% of the population, are significantly smaller than those related to a cryptogenic stroke. The exact prevalence of PFOs in the population that are comparable to those in cryptogenic stroke patients remains thus unknown. Future studies should define which characteristics could classify or rule out a PFO prone for associated clinical conditions, such as cryptogenic stroke.Distribution of PFO size

Abstract 11716: Patent Foramen Ovale Closure vs Medical Therapy in Patients ≥ 60 Years of Age With Ischemic Stroke: A Retrospective Cohort Study

Background: The benefit of patent foramen ovale (PFO) closure in patients aged ≥60 years with ischemic stroke is uncertain. Purpose: We conducted a retrospective cohort study to compare the outcomes of PFO closure vs medical therapy in this population. Methods: Using the TriNetX research database we identified patients ≥ 60 years with PFO who had an ischemic stroke from 2016 to 2021. Patients were divided into two groups: those undergoing PFO closure within 3 months of the stroke and those who received medical therapy only. Subgroup analyses was performed by age group (60 to 70 and ≥71). Propensity score matching was used to control for age, sex, hypertensive diseases, CKD, diabetes, dyslipidemias, ischemic heart disease, tobacco use, and neoplasms. Outcomes were measured from 1 month to 3 years after the index event and included all-cause mortality, new onset AF/flutter, arterial embolism, and services associated with stroke/embolism (thrombolysis, thrombectomy, administration of thrombolytics, and imaging of head and neck). Results: PFO closure was associated with lower number of services used in stroke/embolism (HR 0.57, 95%CI 0.42-0.78), a similar association was seen in those in the 60-70 age group (HR 0.539, 95%CI 0.373,0.78) but not in those ≥71 years. Arterial embolism was seen in 3.14% of the patients who received antiplatelets or anticoagulants only, but none of the patients who underwent PFO (Table 1) . Conclusions: PFO closure was associated with lower number of services used in stroke/embolism in patients aged ≥60 years with ischemic stroke. Our study could have been underpowered to find differences amongst those ≥71 years old. None of the patients who underwent PFO closure developed arterial embolism. PFO closure may be beneficial for older patients with ischemic stroke and warrant further investigation

Abstract 17951: Infective Endocarditis of an Amplatzer PFO Occluder: A Rare and Devastating Complication

Introduction: Patent foramen ovale (PFO) closure is indicated for secondary prevention of ischemic strokes in select patients. PFO closure devices are rarely complicated by infective endocarditis (IE). We present the case of a patient with a closure device infected by Methicillin-sensitive Staphylococcus Aureus (MSSA). Case: A 60-year-old woman with a history of ischemic stroke status post transcatheter PFO closure with a 25 mm Amplatzer occluder eight months prior to presentation was admitted for a two week history of lower back pain, bilateral lower extremity weakness, and urinary incontinence. She denied dental procedures following device implantation. MRI of the spine revealed L3-L4 osteomyelitis with an adjacent epidural abscess which was immediately drained. Blood and intra-operative cultures revealed MSSA. There was no evidence of endocarditis on transthoracic echocardiogram (TTE). Given persistent bacteremia, a transesophageal echocardiogram (TEE) was performed, revealing large, highly mobile vegetations measuring up to 3 cm in length, attached to both the left and right atrial surfaces of the Amplatzer occluder. Urgent surgical removal of the Amplatzer occluder and PFO closure was performed. She received a 4-week course of Cefazolin. Discussion: Despite periprocedural antibiotics and prophylaxis for dental procedures for six months after implantation, IE of PFO occluders can rarely occur days to years after implantation. In patients with PFO occluders and persistent bacteremia or fevers, TEE is the diagnostic modality of choice as TTE are often negative. Management consists of urgent surgical excision and long-term antibiotics.

Abstract 14453: Patent Foramen Ovale Closure in Patients With and Without Nickel Hypersensitivity Using Two Different Devices

Background: Transcatheter PFO closure has been established as a safe and effective approach for secondary prevention in patients with ESUS. The Amplatzer® PFO occluder and Gore Helex® septal occluder are two FDA-approved devices, which consist of a nickel-titanium alloy frame. While nickel is the first cause of hypersensitivity reaction worldwide, the potential occurrence of nickel hypersensitivity following PFO closure is still under investigation. Aim: Our aim is to investigate whether patients with nickel allergy are more susceptible to experiencing adverse events after device implantation and to explore the potential role of device selection. Methods: We prospectively enrolled patients undergoing PFO closure. Before the procedure, nickel skin patch tests were performed in all the patients. The patients were randomized to receive either Amplatzer® or Gore® device. During a three-month follow-up period, we evaluated the primary endpoint, which was a composite outcome including patient-reported chest pain, palpitations, headaches, and rash. We used the chi-squared test to evaluate the primary endpoint and performed multivariate binary logistic regression analysis to assess the effect of device selection on the primary endpoint. Results: A total of 50 patients (50% female, 45.4±10.3 years old) completed the follow-up and were included in the present analysis. Among them, 29 patients received the Gore device, while the remaining 21 patients received the Amplatzer device. Fourteen patients were diagnosed with nickel hypersensitivity. The primary endpoint was reached in 40% of the analyzed patients. The occurrence of the primary endpoint was significantly higher in patients with nickel hypersensitivity compared to those without (50% vs. 13.3%, p=0.005). Additionally, multivariate binary logistic regression analysis demonstrated no association between device selection and the composite outcome (p=0.892). Conclusions: Our preliminary results indicate that patients with nickel hypersensitivity are more likely to develop symptoms such as chest pain, palpitations, headaches, and rash following the procedure. However, the completion of our study is necessary to obtain more reliable and conclusive results.

Abstract 15696: Simultaneous Presentation of ST-Elevation Myocardial Infarction, Ischemic Stroke, and Pulmonary Embolism in a Patient With Thrombus-in-Transit Across a Patent Foramen Ovale

Case Description: A 70-year-old woman with a history of hypertension, hypothyroidism, and sigmoid colectomy, presented to the ER with altered mental status, slurred speech, and left-sided weakness. She was hemodynamically stable, and exam was notable for dysarthria, left-sided facial droop, and left-sided upper and lower extremity weakness. ECG showed ST-elevation in leads I, aVL, and V1-V3, and ST-depression in II, III, and aVF. CT Head was without intracranial hemorrhage. Emergency coronary angiography showed subtotal thrombotic occlusion of the left main, LAD, and LCX arteries consistent with embolic etiology. Coronary thrombectomy re-established TIMI 3 flow. The patient then underwent CTA of the head and neck, which visualized both right anterior M2 occlusion and large pulmonary emboli in the right and left main PAs. She underwent emergency mechanical thrombectomy of the right MCA. With induction of anesthesia she suffered PEA arrest, for which she received 5 minutes of CPR and epinephrine and ROSC was obtained. She then underwent successful thrombectomy of the right anterior M2. Patient then underwent bilateral pulmonary thrombectomy and IVC filter placement. Over the ensuing 24 hours she weaned from pressors, was extubated, and was alert with only mild left hemiparesis. Bilateral lower extremity venous dopplers were negative for DVT, and an echocardiogram showed a serpiginous echodensity in both atria and across the intra-atrial septum, consistent with a large thrombus-in-transit through a PFO. CT Surgery was consulted, and patient underwent successful bi-atrial thrombectomy with PFO closure. Discussion: Simultaneous thromboembolic MI, stroke and PE is an exceedingly rare and catastrophic clinical presentation. Initial management should involve a promptly-assembled multidisciplinary team to determine if the patient is a candidate for procedural or operative intervention, and, if so, to determine the order in which they should be completed. Subsequently, a workup should be initiated to determine an underlying cause of the presentation, including appropriate thrombophilia workup and imaging. If feasible, surgical thrombectomy and PFO closure may be indicated to prevent further embolic phenomena.

Abstract 17264: PFO Cover Index by 3D-TEE Predicts Residual Shunting After Transcatheter Closure

Introduction: Proper defect sizing and device size selection are imperative for ensuring successful clinical outcomes after transcatheter patent foramen ovale (PFO) closure. However, with current sizing techniques, residual shunting remains as high as 25% and is associated with an increased risk of recurrent neurologic events. Since 2017, we adopted a PFO sizing strategy based on right atrial (RA) tunnel “width” oversizing utilizing three-dimensional transesophageal echocardiography (3D-TEE). Hypothesis: We hypothesized that the PFO tunnel width at the RA opening and a cover index based on this dimension would predict residual shunting at long term follow-up. Methods: Sixty-four patients underwent transcatheter PFO closure (60 patients utilizing a 3D-TEE based oversizing strategy) at our institution between 2015 and 2022. PFO tunnel length, tunnel width at RA opening, and tunnel width at left atrial opening were determined by 3D-TEE either before or at the time of closure. We determined an absolute PFO “cover index” for each patient as follows: RA disc diameter - RA tunnel width. Receiver operating characteristic (ROC) curve analysis was used to determine the predictive ability of 3D-TEE derived PFO dimensions and the PFO cover index to predict residual shunting at follow-up. Results: Fifty-one of sixty-four patients had a long-term follow-up bubble study (mean follow-up time 8.0±3.7 months). Of the 47 patients closed utilizing a 3D-TEE based sizing strategy and with a follow-up bubble study, only 5 patients (10.6%) had residual shunting at follow-up. Of the three 3D-TEE based PFO dimensions, only the RA tunnel width was predictive of residual shunting at follow-up (AUC 0.84, p=0.004). A cutoff of 15.5 mm or greater for RA tunnel width had the best combination of sensitivity (86%) and specificity (73%). The PFO cover index was also strongly predictive of residual shunting at follow-up (AUC 0.87, p=0.002). A cutoff of 9.5 mm or less had the best combination of sensitivity (86%) and specificity (82%). Conclusions: A larger PFO tunnel width at the right atrial opening and a lower cover index based on this dimension predict residual shunting at follow-up. Our findings have important implications for improving sizing strategies for transcatheter PFO closure.

Abstract 16411: Patent Foramen Ovale Combined With Solitary Pulmonary Arteriovenous Malformation

Introduction: A transthoracic echocardiogram (TTE) with bubble study is standard during evaluation of patients presenting with cryptogenic stroke to evaluate for the presence of a patent foramen ovale (PFO). However, other uncommon conditions, such as solitary pulmonary arteriovenous malformations (sPAVM), can also present with stroke and abnormal bubble study. We examine a case of a woman who presented with an acute ischemic stroke and was found to have both a PFO and sPAVM. Case: A 64-year-old woman with hypertension presented with acute onset facial droop, left arm paresis, and aphasia. A computed tomography (CT) scan of her head did not show an intracerebral hemorrhage or large vessel occlusion. However, magnetic resonance imaging showed acute infarction of the right thalamus. During initial work up, a chest x-ray was also obtained and there was concern for possible pulmonary malignancy. A subsequent contrast-enhanced CT of her chest revealed a right lower lobe PAVM. A TTE with bubble study showed bubbles in the left atrium, which was attributed to PAVM. Interventional radiology was consulted, and the patient underwent PAVM embolization. TTE was repeated and continued to show bubbles in the left atrium. Transesophageal echocardiogram (TEE) revealed an atrial septal aneurysm with PFO. After interdisciplinary discussion and shared decision making, she eventually underwent successful transcatheter PFO closure with an Amplatzer PFO occluder. Genetic testing for hereditary hemorrhagic telangiectasia was negative. Discussion: This case highlights the importance of evaluating for less common causes of stroke such as sPAVMs and multidisciplinary approach to complex cases. The American Heart/Stroke Associations recommend PFO closure for patients presenting with ischemic stroke and no other identifiable cause. However, there is not clear guidance on the management of patients who present with stroke and have both PFO and PAVMs. Although PFOs are commonly ruled out with TTE/TEE and bubble study, there may be utility in also ruling out PAVMs as they are an important and reversible cause of paradoxical emboli. Further studies should the evaluate the management of patients with both PAVM and PFO with a focus on the optimal strategy for sequence of closure.

Abstract 17578: Improving Access to Care With a Structural Heart Disease Program in a Metropolitan Public Healthcare System

Background: Public hospitals face challenges in providing access to structural heart interventions due to limited resources. Our aim is to describe the implementation and outcomes of a comprehensive, multi-disciplinary Structural Heart Disease Program (SHDP) in the largest public healthcare system in the United States, as a strategy to mitigate healthcare disparities and improve access to care. Methods: The SHDP at Bellevue Hospital serves as the referral center for 11 public hospitals in New York. It launched in 2022 and added a hybrid OR in March 2023. We collected clinical, demographic, and socioeconomic data for patients undergoing structural heart interventions. Results: A total of 56 patients were included from January 2022 to June 2023. The median age was 60 years (22-93 years), 59% were women, 41% were Black, 38% Hispanic, 11% White and 9% Asian. Most patients were immigrants (71%), 28.5% were uninsured, 37.5% were undocumented and 41% required an English interpreter. Only 21% of patients completed high school and 9% completed college. The most common procedure was PFO closure (30%) followed by M-TEER and BAV (Figure 1). For TAVRs and M-TEERs combined, the 30-day re-admission rate was 7.1% (n=1) and 30-day mortality was 0%, with no differences by ethnic group. Length of stay varied by procedure and there were low rates of procedural complications (Table 1). Conclusions: Our multidisciplinary SHDP program demonstrates feasibility to provide care to underserved populations in a public healthcare system with excellent outcomes. Further study of strategies aimed at improving access to structural heart interventions is warranted.

Abstract 15756: To Close or Not to Close: A Case of Multisystem Immune Checkpoint Inhibitor Toxicity and PFO

Introduction: Recent emergence of immune checkpoint inhibitors (ICIs) in oncologic treatments has led to increasing research on their side effect profile. Myocarditis occurs in roughly 0.04-1.14% of patients treated with ICIs and is associated with up to 50% mortality. We present a case of multisystem ICI toxicity requiring comprehensive evaluation to ultimately reveal a PFO shunt as the cause of persistent hypoxemia. Case: A 67-year-old male with Stage IIIC cutaneous melanoma presented with non-radiating pleuritic chest pain, diplopia, dyspnea and syncope. ECG showed high grade AV block and right bundle branch block. Labs showed elevated troponin, creatinine kinase and inflammatory markers. An echocardiogram showed edematous myocardium, a small pericardial effusion, and akinetic apical/inferior septal segments. Despite diuresis, 5g of methylprednisolone, IV immunoglobulin plus mycophenolate and resolution of AV block, the patient had hypoxemia on 100% FiO2. He underwent a CTA (which ruled out PE and ICI-induced pneumonitis) and fluoroscopic sniff test (revealing bilateral moderate diaphragm paresis). A recent cardiac catheterization on prior admission showed no obstructive coronary disease. Arterial blood gas showed pO2 120 mmHg without hypercapnia on 100% FiO2. We suspected a shunt as the underlying cause and obtained a bubble study disclosing a large (> 25 bubble) PFO with right-to-left shunt. Results: Given the timing of symptoms, it was determined that pembrolizumab administration caused myocarditis and myositis with diaphragmatic paresis. In patients with pulmonary disease or diaphragmatic paresis, elevated intrathoracic and pulmonary artery pressures have been a proposed mechanism of acute worsening of right-to-left shunt resulting in hypoxemia. The patient underwent right heart catheterization and PFO closure using Gore Cardioform septal occluder with resolution of hypoxemia. A repeat echocardiogram obtained 1 month later was normal. Conclusion: All concerning clinical symptoms in the setting of ICI use require a thorough evaluation. In this case, persistent hypoxemia despite treatment for ICI toxicity unmasked a large PFO requiring closure. A multisystem approach should be used to assess suspected ICI myocarditis.

Abstract 13710: Cardiac Platypnea-Orthodeoxia Syndrome: How the Stars Aligned

Case description: A 79-year-old man with recurrent falls, dyslipidemia and recent exercise intolerance presented after a fall. He was putting on shoes, lost his balance and fell. There was no pre-syncope, syncope, dyspnea, chest pain, palpitations or dizziness. On admission, vital signs were normal except oxygen saturation (O2 sat) 79% on room air (and no improvement with supplemental O2). An arterial blood gas (ABG) revealed partial pressure of oxygen 42 mmHg with oxygen saturation 80%. He had lower thoracic spine tenderness, normal respiratory and cardiac exam. CT head showed no acute intracranial abnormalities. CTA chest had no pulmonary embolism, arterio-venous malformations or parenchymal lung disease. There was a thoracic aorta aneurysm (4.5cm at aortic root and 5.1cm at posterior arch). Subsequently, O2 sat was 92% supine and 79% standing. He also had a compression fracture of T12 and spinal asymmetry. A transesophageal echocardiogram (TEE) showed an aneurysmal, hypermobile interatrial septum with early right to left shunt with agitated saline due to a large patent foramen ovale (PFO). Right heart catheterization revealed no pulmonary hypertension and confirmed a step down from the pulmonary vein to left atrium (delta O2 sat 6%). A 30mm Gore Cardioform occluder was used to close the defect and immediately supplemental oxygen was removed, and O2 sat on room air was 95%. Follow up echocardiogram showed no residual shunt and exercise intolerance resolved. Discussion: Unexplained positional hypoxemia raised our suspicion for cardiac POS. Hypoxemia is caused by right to left shunting via the PFO, exacerbated by the thoracic aortic aneurysm and spinal changes such as the T12 fracture and spinal asymmetry. Going from being recumbent to erect there is stretching of the atria causing his PFO to enlarge, increasing the shunt. Additionally, the dilated thoracic aorta exerts mechanical pressure on the right atrium (RA) and interatrial septum, increasing PFO patency and augmenting flow from the inferior vena cava through the PFO. The spinal abnormality may cause more aortic distortion and exert forces on the RA, exacerbating shunting. Percutaneous PFO closure is the treatment of choice with closure immediately leading to significant improvement of hypoxemia.

Heart Brain Clinic: An Integrated Approach to Stroke Care.

Multidisciplinary clinics have been shown to improve care. Patients with patent foramen ovale (PFO)-associated stroke need evaluation by cardiology and neurology specialists. We report our experience creating a multidisciplinary Structural Heart Brain Clinic (HBC) with a focus on patients with PFO-associated stroke. Demographic and clinical data were retrospectively collected for patients with PFO-associated ischemic stroke. Patients with PFO-associated stroke were divided into a standard care group and Heart Brain Clinic group for analysis. Outcome measures included time from stroke to PFO closure and number of clinic visits before decision regarding closure. Nonparametric analysis evaluated differences in median time to visit and clinical decision, while the chi square analysis compared differences in categorical variables between groups. From February 2017 to December 2021, 120 patients were evaluated for PFO-associated stroke. The Structural HBC began in 12/2018 with coordination between Departments of Neurology and Cardiology. For this analysis, 41 patients were considered in the standard care group and 79 patients in the HBC group. During data analysis, 107 patients had received recommendations about PFO closure. HBC patients required fewer clinic visits (p = 0.001) before decision about closure; however, among patients who underwent PFO closure, there was no significant difference in weeks from stroke to PFO closure. Clinicians were more likely to recommend against PFO closure among patients seen in HBC compared with those seen in standard care (p = 0.021). Our data demonstrate that a multidisciplinary, patient-centered approach to management of patients with PFO-associated ischemic stroke is feasible and may improve the quality of care in this younger patient population. The difference in recommendation to not pursue PFO closure between groups may reflect selection and referral bias. Additional work is needed to determine whether this approach improves other aspects of care and outcomes.