Patent Foramen Ovale Occlusion Device Research Articles

Snare device retrieval of occluder embolized in patent foramen ovale closure: A case report

Rationale: Transcatheter interventional closure therapy is the main treatment method for patent foramen ovale (PFO). However, occluder abscission is a serious complication in PFO interventional therapy. Thus, timely and effective management of the occluder detachment is crucial for improving patient prognosis. Patient concerns: A 52-year-old female patient was admitted to the Department of Neurology mainly due to “right upper limb weakness for two days, which aggravated for eight hours.” The patient had no history of any other diseases. Diagnoses: The patient was diagnosed with an atrial septal defect (foramen ovale type) and cerebral infarction. Interventions and outcomes: The occluder abscission was successfully removed after several attempts with the help of the snare device. Lessons: When the PFO occlusion device is detached, interventional treatment would lead to minimal trauma, fast postoperative recovery, and a definite therapeutic effect. Based on mastering the indications and standardizing the operational process, this is a safe and effective minimally invasive treatment method.

Impact of frailty index on cardiovascular outcomes and readmissions of patent foramen ovale closure procedure: a propensity matched national analysis.

Transcatheter patent foramen ovale (PFO) occluder device is a procedure mostly performed to prevent secondary stroke as a result of paradoxical emboli traversing an intracardiac defect into the systemic circulation. The complications and outcomes following the procedure remain poorly studied. We aimed to investigate morbidity and mortality associated with occluder device procedures using hospital frailty index score stratification. The Nationwide Readmission Database was employed to identify patients admitted for PFO closure from 2016 to 2020. Two groups divided by index frailty score were compared to report adjusted odds ratio (aOR) for primary and secondary cardiovascular outcomes. Outcomes included in-hospital mortality, acute kidney injury, acute ischemic stroke, and post-procedure bleeding. Statistical analysis was performed using STATA v.17. Of the 2,063 total patients who underwent the procedure, 45% possessed intermediate to high frailty scores while the other 55% had low frailty scores. The first cohort had higher odds of in-hospital mortality (aOR 6.3, 95% CI 2.05-19.5), acute kidney injury (aOR 17.6, 95% CI 9.5-32.5), and stroke (aOR 3.05, 95% CI 1.5-5.8) than the second cohort. There was no difference in the incidence of post-procedural bleeding and cardiac tamponade and 30/90/180-day readmission rates between the two cohorts. Hospitalizations in the first cohort were associated with a higher median length of stay and total cost. High to intermediate frailty scores may predict an increased risk of in-hospital mortality in patients undergoing PFO occluder device procedures.

Abstract 17959: Cardiovascular Outcomes and Readmissions of Atrial Fibrillation Among Patent Foramen Ovale Occluder Device Recipients : A Propensity Matched National Readmission Study

Introduction: Patent foramen ovale (PFO) occluder devices are increasingly utilized minimally invasive procedures used to treat cryptogenic stroke. Data on the impact of Atrial Fibrillation (AF) among PFO occluder device recipients are limited. Methods: The Nationwide Readmissions Database was queried between 2016 to 2019 to identify PFO patients with and without AF. The two groups were compared using propensity score matching (PSM) and multivariate regression models. The outcomes included in-hospital mortality, acute kidney injury (AKI), Mechanical circulatory support use (MCS), Cardiogenic shock (CS) acute ischemic stroke, bleeding and other cardiovascular outcomes. Statistical analysis was performed using STATA v. 17. Results: Out of 6,508 Weighted hospitalizations for PFO occluder device procedure over the study period, 877 (13.4%) had AF compared to 5,631 (86.6%) who did not. On adjusted analysis, PFO with AF group had higher rates of MCS (PSM, 4.5% vs. 2.2 %, p value=0.011) and SCA (PSM, 7.6% vs. 4.6 %, p value=0.015) compared to PFO with no AF. There was no statistically significant difference in the rate of in hospital mortality (PSM, 5.4% vs. 6.4 %, p value=0.39), CS (PSM, 8.3% vs. 5.9 %, p value=0.075), AKI (PSM, 32.4% vs. 32.3 %, p value=0.96), bleeding (PSM, 2.08% vs. 1.3 %, p value=0.235) or the readmission rates among both cohorts. Additionally, AF was associated with higher hospital length of stay (9.5 +/-13.2 vs. 8.2 +/-24.3 days, p value =0.012 ) and total cost ($66,513+/-$80,922 vs. $52,013+/-$125,136, 0.025, p value = 0.025) compared to PFO without AF. Conclusions: The presence of AF among PFO occluder device recipients is associated with increased adverse outcomes including MCS use and SCA with no difference in mortality and the readmission rates among both cohorts. Long term follow up needs further studies.

PO-04-028 INTERATRIAL SHUNT LEADING TO SEVERE HYPOXEMIA: A RARE COMPLICATION OF PACEMAKER-ASSOCIATED INFECTIVE ENDOCARDITIS

Pacemaker-lead-associated infective endocarditis is a serious complication with high morbidity and mortality. We present a case of persistent hypoxemia from significant right to left atrial shunting across the patent foramen ovale (PFO) as a result of pacemaker-lead-associated infective endocarditis with large vegetations. N/A A 56-year-old female with stroke, sleep apnea, diabetes mellitus, hypertension, and sick sinus syndrome with dual chamber pacemaker implantation, was admitted with acute hypoxic respiratory failure requiring high flow nasal cannula. A chest x-ray did not show any obvious etiology of hypoxemic respiratory failure. Arterial blood gas showed no hypercapnia ruling out hypoventilation as the cause of hypoxemia. A very high A-a gradient was noted, raising suspicion for shunting. Blood cultures were positive for staphylococcus capitis bacteremia. A transesophageal echocardiogram (TEE) showed several large vegetations (Image A) attached to the atrial and ventricular lead, tricuspid valve with associated severe tricuspid regurgitation, and a PFO (Image B) with a large right to left shunt as a result of large right-sided vegetations (Image C). A pacemaker extraction procedure was planned; however, there was a concern for paradoxical septic embolism across the PFO. As such, an ASD occluder device was temporarily placed across the PFO during the procedure to prevent right-to-left embolization. PFO occlusion dramatically improved hypoxemia during the procedure. The infected pacemaker system was then successfully extracted. The PFO occluder device was subsequently removed at the end of the case, given ongoing bacteremia and the risk of device seeding. The patient recovered well with the resolution of hypoxemia and was discharged however presented again one month later with a stroke. TEE exam showed a large echo-dense lesion straddling the atrial septum through the PFO, likely vegetation that embolized to the left circulation causing the stroke (Image D). The patient is currently awaiting cardiac surgery for definitive treatment once medically stable. Pacemaker-associated infective endocarditis can lead to mechanical complications, including tricuspid regurgitation and rarely shunting across the atria, causing severe hypoxemia as in our patient. There are no clear guidelines regarding the management of such atrial defects with shunting peri-device extraction to prevent systemic embolization of vegetations.

Abstract 9436: Treatment Options for Left Atrial Septal Pouch: A Case Report

Introduction: Left Atrial Septal pouch (LASP) is defined as an incomplete closure between the septum primum and septum secundum with an elongated septum secundum. This produces a crevice in the left atrium that functions as a source for static blood and atrial dissociation. This in turn could progress to the formation of thrombi within the left atrium that has the potential to embolize causing ischemic infarcts. Case Description: Here we present a 63 year old Hispanic female with a past medical history of paroxysmal atrial fibrillation on apixaban, recurrent strokes, dyslipidemia, and hypertension who presented with expressive aphasia, and prosopagnosia. Previously, the patient was reported of having two cardioembolic cerebral vascular accidents (CVA). Computed tomography of the brain demonstrated an old infarct of the left posterior parietal lobe. Patient was treated with intra-arterial tissue plasminogen activator of the left posterior cerebral artery and right middle cerebral artery. MRI demonstrated four acute punctate infarcts in the left frontal lobe consistent with embolic infarcts. TEE demonstrated a large patent foramen ovale (PFO), a prominent eustachian valve, and LASP. It was determined that her PFO and LASP were the culprit for her recurrent CVA despite appropriate AC. The PFO/LASP were successfully closed with an Amplatzer PFO occluder device. Patient was discharged home. Discussion: The LASP can function as a source of thrombus formation and atrial disassociation, which can cause embolic CVA. No guidelines exist on how to properly address a LASP. One option would be to use a PFO closure device to close LASP. Other options may include AC despite the absence of atrial fibrillation. Conclusions: In conclusion, further studies are necessary in order to establish the most appropriate management in patients with LASP.

Systematic screening for right-to-left shunt prior to lead extraction

Abstract Funding Acknowledgements Type of funding sources: None. Background Transvenous lead extraction has become a relevant treatment option in patients with device-associated infection, but also in the context of device- and lead dysfunction. Lead extraction can be complicated by a stroke, which may result from paradoxical embolization of lead debrids during lead extraction in the presence of a patent foramen ovale (PFO) with a right-to-left shunt. Purpose Analysis of the presence of a PFO in patients undergoing transvenous lead extraction in a Swiss tertiary centre. Furthermore, different strategies to reduce the risk for stroke due to the presence of a PFO will be summarized. Methods and Results In this retrospective analysis from January 2017 until December 2021, a total of 304 patients who underwent lead extraction were included. In nearly half of the population, lead dysfunction was the leading cause for extraction, while device-associated infection was present in 31 % of the patients. In 14 patients (4.6 %), a right-to-left shunt was detected either during (via transesophageal echocardiography) or prior to the procedure. Prior to the systematic pre-procedural PFO screening, 9 patients with a right-to-left shunt were identified of which 2 patients suffered from a peri-interventional stroke (22 %) while in the population without a PFO no stroke occurred. The remaining 5 patients with a right-to-left shunt were identified prior to the lead extraction procedure (after setting up an institutional PFO screening programm) and were treated accordingly. Since then, no further neurological episodes occurred (Figure 1). If a PFO was identified, an interventional PFO occlusion was performed either prior to the lead extraction (2 of 5 patients) or together with the lead extraction as a single procedure (1 patient). In the 2 other patients, where a device infection was present together with a PFO, the PFO shunt was occluded transiently using a sizing balloon during the lead extraction procedure to avoid to implant a PFO occluder device in an infectious environment. Conclusions Presence of a right-to-left shunt in patients who need to undergo transvenous lead extraction is a known risk factor for embolic strokes. Identification and treatment of this condition prior or during lead extraction is associated with a reduction in stroke events.

Amplatzer Patent Foramen Ovale Occluder Device-Related Complications.

Patent foramen ovale (PFO) is a standard variant that is present in 25% of the whole adult population. In a certain population, PFO can lead to cerebrovascular accidents. Mechanism of cerebrovascular accidents can be by paradoxical embolization from the right circulation or in situ thrombosis. Diagnosis of a PFO-responsible cerebrovascular accident is based on a thorough work-up to exclude other possible etiologies and detect PFO on trans-thoracic or trans-esophageal echocardiography with bubble study and/or Doppler. Over the last few years, multiple studies have supported that percutaneous PFO closure is superior to medical therapy in the secondary prevention of cerebrovascular accidents. However, numerous adverse events have been linked to PFO closure devices in general compared to medical therapy as new-onset atrial fibrillation, residual shunt, device-related thrombus, bleeding, deep vein thrombosis, pulmonary embolism, and inter-atrial septal erosions. Amplatzer device is one of the PFO occluder devices approved by the FDA. Device-related adverse events have been addressed by comparing the Amplatzer device with other PFO occluder devices. Based on the new data, we expect to see more complications related to PFO closure in the coming few years. We reviewed different studies that looked at the PFO closure-related complications and the trials comparing adverse events in the Amplatzer PFO occluder device compared to other devices. Amplatzer PFO occluder device is either superior or non-statistically different from other PFO occluder devices related to new-onset atrial fibrillation and residual shunt. More studies are needed to address the other less common adverse events. Since many of the device-related complications appear many years after device placement, a long-term follow-up is recommended.

P3721Clinical and echocardiographic outcomes after treatment of patent foramen ovale with two transcatheter occlusion devices: mononcenter observational study

Abstract Background Percutaneous closure of patent foramen ovale (PFO) after cryptogenic stroke (CS) is strongly recommended in the current guidelines. Most available evidence has been obtained from randomized studies in which Amplatzer PFO occluder device or Groe occluder device were implanted. Several occluder devices are used off-label for percutaneous treatment of PFO. Rate of recurrent CS and rate of residual shunting after percutaneously occlusion of PFO varies between different occlusion devices. To date, there are no randomized clinical studies that compare the effectivity and safety of several devices in patients with CS. Aim The aim of this study was to compare rate of residual shunting and recurrent CS after percutaneus treatment of PFO with the most common used PFO occluder devises. Methods This was a retrospective, non-randomized, monocenter study. Between 2008 and 2014, all patients with CS or transient ischemic attack (TIA) treated with transcatheter occlusion of PFO with Amplatzer PFO occlusion device or Occlutech occlusion device were included. Patients were followed up at 1 and 6 months with contrast-enhanced transesophageal echocardiography (TEE), and at 3 months with contrast-enhanced transthoracic echocardiography. Primary endpoint was residual shunting at 6 months. Secondary endpoint was recurrent CS or TIA at 6 months after the procedure. Results 220 consecutive patients (57±12 year, 131 men) were treated with Amplanz PFO occlusion device (140 patients) or Occlutech PFO occlusion device (80 patients) after CS or TIA. Procedural success was 100% in both groups. Residual shunting was observed directly after the procedure in 26 patients in the Amplatzer group and 22 patients in the Occlutech group (19% and 27%, respectively; p=0.003), at 1 months follow (15% and 25%, respectively; p=0.064) and at 6 months (9% and 16%, respectively; p=0.024). There was no significant difference between both groups according recurrent CS (0.7% and 0%, respectively; p=0.449). At 6 months follow up atrial fibrillation was detected in 2 patients from Amplatzer group and 5 patients from Occlutech group (1.4% and 6.0%, respectively; p=0.050). Death, aortic erosion and pericardial effusion was not observed in both groups. Clinical and echocardiographic outcome Variable Amplatzer occluder device (N=140) Occlutech occluder device (N=80) p-value Clinical outcome at 6 months follow up Death, n (%) 0 (0%) 0 (0%) 1.000 Stroke, n (%) 1 (1%) 0 (0%) 0.449 Transient ischemic attack, n (%) 0 (0%) 0 (0%) 1.000 Atrial fibrillation, n (%) 2 (1.4%) 5 (6%) 0.050 Aortic erosion, n (%) 0 (0%) 0 (0%) 1.000 Pericardial effusion, n (%) 0 (0%) 0 (0%) 1.000 Echocardiographic Outcome at 6 months follow up Residual shunting after Implantation directly, n (%) 26 (19%) 22 (27%) 0.003 Residual shunting at one month, n (%) 21 (15%) 20 (25%) 0.064 Residual shunting at 6 months, n (%) 13 (9%) 16 (20%) 0.024 Conclusion Percutaneous treatment of PFO after CS or TIA with Amplatzer PFO occluder device was associated with lower rate of residual shunting and lower rate of atrial fibrillation at 6 months follow up, whereas rate of recurrent CS and TIA was comparable between both groups.

When a patent foramen ovale device is no more in place: silent patent foramen ovale occluder device migration to the aortic arch.

When a patent foramen ovale device is no more in place: silent patent foramen ovale occluder device migration to the aortic arch.

Percutaneous Closure of Patent Foramen Ovale in Patients With Migraine: The PREMIUM Trial

BackgroundMigraine is a prevalent and disabling disorder. Patent foramen ovale (PFO) has been associated with migraine, but its role in the disorder remains poorly understood. ObjectivesThis study examined the efficacy of percutaneous PFO closure as a therapy for migraine with or without aura. MethodsThe PREMIUM (Prospective, Randomized Investigation to Evaluate Incidence of Headache Reduction in Subjects With Migraine and PFO Using the AMPLATZER PFO Occluder to Medical Management) was a double-blind study investigating migraine characteristics over 1 year in subjects randomized to medical therapy with a sham procedure (right heart catheterization) versus medical therapy and PFO closure with the Amplatzer PFO Occluder device (St. Jude Medical, St. Paul, Minnesota). Subjects had 6 to 14 days of migraine per month, had failed at least 3 migraine preventive medications, and had significant right-to-left shunt defined by transcranial Doppler. Primary endpoints were responder rate defined as 50% reduction in migraine attacks and adverse events. Secondary endpoints included reduction in migraine days and efficacy in patients with versus without aura. ResultsOf 1,653 subjects consented, 230 were enrolled. There was no difference in responder rate in the PFO closure (45 of 117) versus control (33 of 103) groups. One serious adverse event (transient atrial fibrillation) occurred in 205 subjects who underwent PFO closure. Subjects in the PFO closure group had a significantly greater reduction in headache days (–3.4 vs. –2.0 days/month, p = 0.025). Complete migraine remission for 1 year occurred in 10 patients (8.5%) in the treatment group versus 1 (1%) in the control group (p = 0.01). ConclusionsPFO closure did not meet the primary endpoint of reduction in responder rate in patients with frequent migraine. (Prospective, Randomized Investigation to Evaluate Incidence of Headache Reduction in Subjects With Migraine and PFO Using the AMPLATZER PFO Occluder to Medical Management [PREMIUM]; NCT00355056)

Interventional closure of patent foramen ovale with Nit-occlud® device in prevention of recurrent neurologic events-Long-term results.

Patent foramen ovale (PFO) was found to be associated with the increased risk of recurrent strokes or transient ischemic attacks (TIA) and there is a need of secondary prevention. Numerous devices have been developed and used for treatment. The aim of the study was to evaluate the safety and effectiveness of a new PFO occluder Nit-Occlud PFO Occlusion Device (PFM medical, Germany). Between January 2012 and August 2016, 151 patients (mean age 41 ± 11 years) who had suffered from a cryptogenic thromboembolic event underwent transcatheter PFO closure with the PFM Nit-Occlud PFO device. The procedure was successful in 150 patients (99.3%). Mean clinical follow-up time was 24.4 ± 16.1 months. Echocardiographic follow-up was done at 6 weeks and 6 months post intervention by transesophageal contrast echocardiography in 90 (60%) of patients. Clinical end-point was death, non-fatal stroke, or TIA. No major periprocedural or in-hospital complications occurred. Stroke or TIA reoccurred generally in 5 (3.3%) patients (2 strokes and 3 TIA's). In one patient (0.7%) device, thrombosis was observed. Closure was sufficient with only minimal right-to-left residual shunt in seventeen cases of 90 examined patients (19%) after 6 weeks and in one patient (1.1%) 6 months post implantation. The Nit-Occlud PFO device and its delivery system are safe and provides sufficient closure of PFO in patients who suffered from cryptogenic stroke, TIA or paradoxical peripheral embolism. It is associated with high procedural success and favorable rates of complete closure.

FDA Approval of PFO Occlusion Device to Prevent Recurrent Stroke

The FDA has approved a patent foramen ovale (PFO) occlusion device to help prevent recurrent stroke in patients with a PFO who've had an ischemic

Initial experience with the novel patent foramen ovale occlusion device Nit-Occlud® in patients with stroke or transient ischemic attack.

Patent foramen ovale (PFO) is associated with cryptogenic strokes and transient ischemic attacks (TIAs). This study examined the initial experience with a new PFO occluder, the Nit-Occlud® PFO Occlusion Device. Sixty-three patients with history of cryptogenic stroke or TIA and PFO underwent percutaneous closure of the defect with the Nit-Occlud® PFO Occlusion Device. The primary endpoint was successful implantation without recurrent event, device malfunction, embolization, or the need for a replacement device over 6 ± 2 weeks. All patients underwent transesophageal echocardiography (TEE) at 6-weeks, and 42 patients had repeat TEE at 6-months. Clinical follow-up at 18.7 ± 7.4 months was also performed. The device was successfully implanted in 62 (98.4%) patients with no relevant procedural complications. At 6-week follow-up, 60 (95.2%) patients met the primary endpoint. A residual shunt at rest and with Valsalva was noted in 8 (12.7%) and 31 (49.2%) patients respectively at 6-week TEE. At 6-months, 1 of 42 (2.4%) and 9 of 42 (21.4%) patients had a residual shunt at rest and with Valsava, respectively. At 18 months, 5/63 patients had recurrent events (3 TIAs, 2 strokes). No device-related complications occurred. One patient developed atrial fibrillation. In patients with cryptogenic stroke or TIA and a PFO, the Nit-Occlud® PFO Occlusion Device appears to be both a safe and effective means to occlude the PFO. It is associated with high procedural success and favorable rates of complete closure.

Updating the evidence on patent foramen ovale closure versus medical therapy in patients with cryptogenic stroke: a systematic review and comprehensive meta-analysis of 2,303 patients from three randomised trials and 2,231 patients from 11 observational studies

We aimed at updating the evidence coming from randomised and observational studies of patent foramen ovale (PFO) closure compared to medical therapy in patients with cryptogenic stroke (CS). Comparative studies of PFO closure versus medical therapy published or presented through March 2013 were identified. Data from 2,303 patients in three randomised clinical trials (RCTs) and from 2,231 patients in 11 observational studies were included. In RCTs, the stroke hazard ratio (HR) for PFO closure versus medical therapy was 0.62 (95% confidence interval [CI]: 0.34-1.11; p=0.10 in the random effects model) with no significant heterogeneity or systematic bias. There was no significant difference in transient ischaemic attacks (TIA) (HR 0.77, 95% CI: 0.46-1.32; p=0.34) and no study-related deaths occurred. Pooling trials of the AMPLATZER PFO occluder device resulted in a significant reduction of stroke (HR 0.44, 95% CI: 0.20-0.95; p=0.04). Procedural success, new onset atrial fibrillation and cardiac thrombus were observed more frequently with the STARFlex compared with the AMPLATZER device. In observational studies, with high potential for baseline confounders, PFO closure was found to reduce the risk of recurrent stroke significantly (HR 0.23, 95% CI: 0.11-0.49; p<0.01 in the random effects model), with no significant effect on TIAs. In RCTs, unlike observational studies, PFO closure compared with medical therapy failed to achieve a statistically significant reduction in recurrent stroke. However, pooling RCTs of the AMPLATZER PFO occluder device yielded a statistically significant reduction in stroke over medical treatment that may warrant further investigation.

Iatrogenic erosion of the septum primum resulting in an atrial septal defect with left‐to‐right shunt: A rare pitfall of patent foramen ovale percutaneous closure

Iatrogenic erosion of the septum primum after foramen ovale closure is an anecdotal event. We report the case of a 39-year-old woman admitted to our institution for multifocal cryptogenic cerebral ischemia and a patent foramen ovale (PFO) associated with an aneurysm of the septum primum. The patient underwent percutaneous closure of the PFO with an Amplatzer PFO Occluder device. At the 6-months follow up, the device was in the right position, but a jagged defect of the septum primum and evidence of significant left-to-right shunting was detected. The atrial septal defect was then repaired by a surgical approach. Although this event is not life-threatening, it should be considered as a therapeutic pitfall, resulting in a risk of paradoxical embolism recurrences and long-term hemodynamic impairment. © 2013 Wiley Periodicals, Inc.

Delayed intracardial shunting and hypoxemia after massive pulmonary embolism in a patient with a biventricular assist device

We describe the interdisciplinary management of a 34-year-old woman with dilated cardiomyopathy three months postpartum on a cardiac biventricular assist device (BVAD) as bridge to heart transplantation with delayed onset of intracardial shunting and subsequent hypoxemia due to massive pulmonary embolism. After emergency surgical embolectomy pulmonary function was highly compromised (PaO2/FiO2 54) requiring bifemoral veno-venous extracorporeal membrane oxygenation. Transesophageal echocardiography detected atrial level hypoxemic right-to-left shunting through a patent foramen ovale (PFO). Percutaneous closure of the PFO was achieved with a PFO occluder device. After placing the PFO occluder device oxygenation increased significantly (Δ paO2 119 Torr). The patient received heart transplantation 20 weeks after BVAD implantation and was discharged from ICU 3 weeks after transplantation.An increase in pulmonary vascular resistance in patients on BVAD can reopen a PFO resulting in atrial right-to-left shunting and subsequent hypoxemia. The case demonstrates the usefulness of transesophageal echocardiography examinations in the detection of this unexpected event. Percutaneous placement of a PFO occluder device is an appropriate strategy to stop intracardiac shunting through PFO in fixed elevation of pulmonary vascular resistance.

Challenging Treatment of a Secondary Endoleak in a Fenestrated Endograft

To describe the novel use of an Amplatzer occluder device to seal a secondary endoleak arising at a scallop in a fenestrated stent-graft. A 67-year-old man with comorbidities precluding standard endovascular repair of a pararenal aortic aneurysm was treated with a fenestrated endoprosthesis containing one fenestration for the left renal artery and one scallop for the celiac trunk; the right renal and superior mesenteric arteries were occluded at presentation. Interval imaging at 2 years showed a proximal type I endoleak at the celiac trunk scallop associated with expansion of the aneurysm sac. Attempted repair with an aortic extension cuff and a "chimney" stent was unsuccessful. An Amplatzer Patent Foramen Ovale occluder device was deployed across the endoleak to provide aneurysm sac exclusion, which has been maintained at 6-month follow-up. Treatment of a secondary type I endoleak after implantation of a fenestrated endoprosthesis is challenging. The novel use of an Amplatzer occluder in this setting may be applicable to other situations in which an endovascular solution is desirable for complications of complex endovascular aneurysm repair.

Hypoxemia Complicating LVAD Insertion: Novel Application of the Amplatzer PFO Occlusion Device

We report a case of profound systemic hypoxemia complicating left ventricular assist device (LVAD) insertion due to right to left shunting through a patent foramen ovale (PFO) in association with a Chiari network. The patient was successfully managed with percutaneous closure of the interatrial defect using an Amplatzer PFO occlusion device and judicious reduction in LVAD flows.

Profound hypoxaemia corrected by PFO closure device in carcinoid heart disease

A 66-year-old man with known metastatic carcinoid tumor presented with increasing dyspnoea, right heart failure and marked hypoxaemia which did not correct with oxygen. Echocardiography demonstrated severe tricuspid regurgitation, moderate pulmonary regurgitation and marked right heart dilatation. The inter-atrial septum was aneurysmal, with a large patent foramen ovale (PFO) with continuous right to left shunting. Cardiac catheterization demonstrated oxygen saturations of 96% in the pulmonary veins and 74% in the left atrium with a significant right to left shunt. During percutaneous closure of the PFO, anaesthetic induction resulted in marked systemic hypotension and worsening hypoxia related to systemic vasodilatation and increased shunting. PFO flow was temporarily obstructed with a sizing balloon resulting in a rapid increase in arterial oxygen saturation from 60% to >90%, but marked systemic hypotension due to acute left ventricular preload reduction, requiring volume replacement and adrenaline. Following deployment of a PFO occluder device, prominent pulsatile splaying of the right and left discs was noted due to the severe tricuspid regurgitation, resulting in some residual inter-atrial shunting. Arterial oxygen saturation was 83%, increasing to 92% at day 4 post-procedure as tissue organization occurred within the device, and the patient reported improvement in dyspnoea.

Perforation of Aortic Root as Secondary Complication after Implantation of Patent Foramen Ovale Occlusion Device in a 31‐Year‐Old Woman

Transesophageal echocardiography (TEE) revealed a 3-mm-large patent foramen ovale (PFO). No other reason for these neurological events could be found and the patient underwent percutaneous closure of the PFO with a CARDIA Star 03/30 device without periprocedural complications. Four weeks later, the patient underwent a routine control of device without any adverse clinical symptoms. Surprisingly, echocardiography revealed a perforation of the aortic root by an umbrella strut with a small shunt from the aortic root to the right atrium. Magnetic resonance imaging (MRI) confirmed the diagnosis of device malposition. Consecutively, the patient underwent minimal invasive surgery. After removal of the single perforating strut, the bleeding lesion was closed. The patient remained free of any additional complications during the postoperative course and up until now has had uneventful follow-ups.