Massimo Giordan

Permanent Right-to-Left Shunt Is the Key Factor in Managing Patent Foramen Ovale

OBJECTIVES We sought to prospectively evaluate risk of stroke and impact of transcatheter patent foramen ovale (PFO) closure in patients with permanent right-to left shunt compared with those with Valsalva maneuver-induced right-to-left shunt. BACKGROUND Pathophysiology and properly management of PFO still remain far from being fully clarified: in particular, the contribution of permanent right-to-left shunt remains unknown. METHODS Between March 2006 and October 2010, we enrolled 180 (mean age 44 ± 10.9 years, 98 women) of 320 consecutive patients referred to our center for transcatheter PFO closure, who had spontaneous permanent right-to-left shunt on transcranial Doppler and transthoracic/transesophageal echocardiography. All patients fulfilled the standard current indications for transcatheter closure and underwent preoperative transesophageal echocardiography and brain magnetic resonance imaging, with subsequent intracardiac echocardiographic-guided transcatheter PFO closure. We compared the clinical echocardiographic characteristics of these patients (Permanent Group) with the rest of 140 patients with right-to-left shunt only during Valsalva maneuver (Valsalva Group). RESULTS Compared with the Valsalva Group patients, patients of the Permanent Group had increased frequency of multiple ischemic brain lesions on magnetic resonance imaging, previous recurrent stroke, previous peripheral arteries embolism, migraine with aura, and-more frequently-atrial septal aneurysm and prominent Eustachian valve. The presence of permanent shunt confers the highest risk of recurrent stroke (odds ratio: 5.9, 95% confidence interval: 2.0 to 12, p < 0.001). No differences were recorded between the 2 groups with regard to recurrence of ischemic events after the closure procedure. CONCLUSIONS Despite its small-sample nature, our study suggests that patients with permanent right-to-left shunt have potentially a higher risk of paradoxical embolism compared with those without.

Complication with an embolic protection device during carotid angioplasty

A case of carotid artery stenting with an AngioGuard cerebral protection device is described in a patient with tight internal carotid stenosis. Deployment of AngioGuard induced sudden severe vasospasm, with subsequent minor stroke. According to our observations, AngioGuard may cause a vasospastic response with adverse neurologic effects. Catheter Cardiovasc Interv 2004;62:234–236.

Persistent venous valves correlate with increased shunt and multiple preceding cryptogenic embolic events in patients with patent foramen ovale: an intracardiac echocardiographic study.

It has been suggested that prominent Eustachian valve (EV) and Chiaris network (CN) predispose to paradoxical embolism but their presence in patients with presumed paradoxical stroke is not always easily detectable by transesophageal echocardiography (TEE). We sought to prospectively assess the frequency of EV/CN as assessed by intracardiac echocardiography (ICE) in patients submitted to patent foramen ovale (PFO) transcatheter closure in order to investigate their role in determining shunt severity and risk of multiple paradoxical embolisms.

Primary Transcatheter Patent Foramen Ovale Closure Is Effective in Improving Migraine in Patients With High-Risk Anatomic and Functional Characteristics for Paradoxical Embolism

OBJECTIVES In the present study, we sought to assess the effectiveness of migraine treatment by means of primary patent foramen ovale (PFO) transcatheter closure in patients with anatomical and functional characteristics predisposing to paradoxical embolism without previous cerebral ischemia. BACKGROUND The exact role for transcatheter closure of PFO in migraine therapy has yet to be elucidated. METHODS We enrolled 86 patients (68 female, mean age 40.0 +/- 3.7 years) referred to our center over a 48-month period for a prospective study to evaluate severe, disabling, medication-refractory migraine and documented PFO. The Migraine Disability Assessment Score (MIDAS) was used to assess the incidence and severity of migraine. Criteria for intervention included all of the following: basal shunt and shower/curtain shunt pattern on transcranial Doppler and echocardiography, presence of interatrial septal aneurysm and Eustachian valve, 3 to 4 class MIDAS score, coagulation abnormalities, and medication-refractory migraine with or without aura. RESULTS On the basis of our inclusion criteria, we enrolled 40 patients (34 females, mean age 35.0 +/- 6.7 years, mean MIDAS 35.8 +/- 4.7) for transcatheter PFO closure; the remainder continued on previous medical therapy. Percutaneous closure was successful in all cases, with no peri-procedural or in-hospital complications. After a mean follow-up of 29.2 +/- 14.8 months (range 6 to 48 months), PFO closure was complete in 95%; all patients (100%) reported improved migraine symptomatology (mean MIDAS score 8.3 +/- 7.8, p < 0.03). Specifically, auras were eliminated in 100% of patients after closure. CONCLUSIONS Primary transcatheter PFO closure resulted in a very significant reduction in migraine in patients satisfying our criteria.

Embolic Implications of Combined Risk Factors in Patients with Patent Foramen Ovale (the CARPE Criteria): Consideration for Primary Prevention Closure?

BACKGROUND Large patent foramen ovale (PFO), spontaneous right-to-left shunt, large atrial septal aneurysm (ASA), coagulation abnormalities, and prominent eustachian valve (EV) have all been independently suggested as risk factors for recurrent stroke. We sought to retrospectively evaluate risk of stroke and impact of transcatheter PFO closure in patients with concurrent large PFO, spontaneous right-to-left shunt, large ASA, coagulation abnormalities, and prominent EV. METHODS Between March 2006 and October 2008, 36 (mean age 44 +/- 10.9 years, 28 females) out of 120 consecutive patients referred to our center for transcatheter PFO closure had concomitant diagnosis of (a) large PFO on transcranial Doppler (TCD) and transesophageal echocardiography (TEE), (b) spontaneous right-to-left shunt on TCD, (c) large ASA, (d) prominent EV, and (e) coagulation abnormalities. All patients fulfilled the standard current indications for transcatheter closure and underwent preoperative TEE and brain magnetic resonance imaging (MRI), with subsequent intracardiac echocardiographic-guided transcatheter PFO closure. RESULTS Compared to the remaining PFO population in the same period, patients with all five concomitant features had more ischemic brain lesions on MRI, previous history of recurrent stroke, more frequently a history of venous thromboembolism, and more severe migraine with aura. The concomitance of all the features confers the highest risk of recurrent stroke (OR 9.9, 3.0-18 [95% CI], P < 0.001). CONCLUSIONS Despite its small sample size and nonrandomized retrospective nature, this is the first study to suggest that patients with concurrence of all the investigated characteristics have potentially a higher risk of stroke compared to controls. We thus propose the CARP criteria as a basis for further larger, longitudinal studies to assess the potential benefits of transcatheter closure in this patient subset in the absence of clinical recurrent stroke.

Resolution of migraine by transcatheter patent foramen ovale closure with premere occlusion system in a preliminary series of patients with previous cerebral ischemia

Transcatheter closure of PFO with nitinol devices may be problematic in young patients with migraine due the risk of late erosions. Alternative devices with less amount of metal as the last generation devices may be preferable in such cases. We present the results of transcatheter closure of PFO with the last generation Premere Occlusion System device in a preliminary series of young adults with migraine and previous cerebral ischemia.

Patent oval foramen transcatheter closure: results of a strategy based on tailoring the device to the specific patient’s anatomy

BACKGROUND Usually the literature results for device-closure of patent oval foramen concern a single type of device or different devices implanted without anatomical preferences. We propose a strategy of device type and selection based on intra-cardiac echocardiography measurements of inter-atrial septum characteristics. METHODS We prospectively enrolled 100 consecutive patients with a mean age of 43 plus or minus 15.5 years, 68 females, who had been referred to our centre for catheter-based closure of inter-atrial shunts over a 48-month period. On the basis of intra-cardiac echocardiography findings the operators selected the Amplatzer Occluder family (AGA Medical Corporation) or the Premere Closure System (St Jude Medical Inc.). Determinants of the selection process were presence and extension of atrial septal aneurysm, tunnel length, rims length, and thickness, presence of additional fenestrations. RESULTS According on intra-cardiac echocardiography study, 26 patients have a long channel patent oval foramen, 44 patients had a large atrial septal aneurysm (more than four RL), 24 patients had a moderate atrial septal aneurysm (more than two RL but less than four right-to-left), and six patients had hypertrophic rims. Thus, the Amplatzer PFO Occluder was selected in 24 patients, the Amplatzer ASD Cribriform Occluder in 44 patients, and the Premere device in 32 cases. No aortic erosions, device thrombosis, or recurrent ischaemic cerebral events were observed. Pre-discharge and follow-up occlusion rates were 91% and 96%, respectively. CONCLUSIONS Our study suggested that such strategy driven from identification and measurements of the right atrium and inter-atrial septum components resulted in low complications and high-success rates, mandatory conditions when facing with otherwise healthy subjects, such as the patients with patent oval foramen.

The Association of Different Right Atrium Anatomical-Functional Characteristics Correlates with the Risk of Paradoxical Stroke: An Intracardiac Echocardiographic Study

BACKGROUND The contribution of different right atrium anatomical-functional characteristics to the risk of paradoxical stroke has not been extensively investigated, probably in part because of the limits of standard echocardiography. OBJECTIVE We sought to assess, using intracardiac echocardiography (ICE), the right atrium anatomical-functional characteristics and their role in the pathophysiology of paradoxical embolism in a sample of patent foramen ovale (PFO) patients undergoing transcatheter PFO closure. METHODS Over a 36-month period, we prospectively enrolled 114 consecutive patients (mean age 38+/- 10.5 years, 67 female) referred to our center for PFO catheter-based closure. On ICE study, all sensible characteristics other than PFO and mild ASA were recorded, including prominent EV or large CN, basal shunt without Valsalva maneuver, moderate to severe ASA, and multiperforated fossa ovalis. RESULTS After TEE and ICE study and measurements, a prominent EV or CN was diagnosed on ICE in 73%, a basal shunt was present in 48%, a moderate to severe ASA in 47%, and a multiperforated FO in 24% of patients. A tight correlation between number of concurrent factors and proportion of patients with curtain pattern on TC Doppler, larger right-to-left shunt, recurrent cerebral paradoxical embolism before closure, and migraine with aura was clearly evident (r > or = 0.97). Basal shunt and concurrent > or = 3 anatomical functional right atrium characteristics resulted as independent predictors of recurrent paradoxical embolisms. CONCLUSIONS Our data suggest that right atrium anatomical-functional characteristics other than PFO and mild ASA as assessed by ICE deeply affect the pathophysiology of paradoxical stroke.

Migraine–Patent Foramen Ovale Connection: Role of Prominent Eustachian Valve and Large Chiari Network in Migrainous Patients

Background:We postulated that eustachian valve (EV) and Chiari network (CN) play a role in the pathophysiology of both migraine and paradoxical embolism. We sought to prospectively investigate the potential role of EV/CN in migraine–patent foramen ovale (PFO) connection assessing their prevalence by intracardiac echocardiography (ICE) in patients with migraine submitted to PFO transcatheter closure. Methods:Over a 24-month period, we prospectively enrolled 50 consecutive patients (mean age 37 ± 12.5 years, 38 females) with previous stroke and migraine referred to our centre for PFO catheter-based closure. Migraine with aura (MwA) and migraine without aura (MwoA) were diagnosed according to the International Headache Society criteria and Migraine Disability Assessment Score (MIDAS). Patients who met the inclusion criteria for closure underwent ICE study and closure attempt. Results:After ICE study, a prominent EV or CN were diagnosed on ICE in 41 patients (82%): 100% in MwA patients, 60% in MwoA patients (p < 0.001) and in 55.5% of patients with no migraine. Patients with EV and CN had more frequently a curtain pattern on TC Doppler, a larger right-to-left shunt, more recurrent cerebral paradoxical embolism before closure, and a higher preoperative MIDAS score. Patients with EV/CN had a larger decrease in MIDAS score after closure. Conclusions:This study suggests that EV and CN have a deep impact on MwA and paradoxical embolism pathophysiology: EV, CN, and MwA should be considered as adjunctive risk factors for paradoxical embolism in the work-up of both symptomatic and asymptomatic PFO patients.

Five-year follow-up of transcatheter intracardiac echocardiography-assisted closure of interatrial shunts

OBJECTIVE We sought to prospectively evaluate long-term follow-up results of intracardiac echocardiography-aided transcatheter closure of interatrial shunts in adults. BACKGROUND Intracardiac echocardiography improves the safety and effectiveness of transcatheter device-based closure of interatrial shunts, but its impact on long-term follow-up is unknown. METHODS Over a 5-year period, we prospectively enrolled 258 consecutive patients (mean age 48 ± 19.1 years, 169 females) who had been referred to our centre for catheter-based closure of interatrial shunts. All patients were screened with transesophageal echocardiography before the operation. Eligible patients underwent intracardiac echocardiography study and attempted closure. RESULTS After intracardiac echocardiography study and measurements, 18 patients did not proceed to transcatheter closure due to unsuitable rims, atrial myxoma not diagnosed by preoperative transesophageal echocardiography or inaccurate transesophageal echocardiography measurement of defects more than 40 mm. The remaining 240 patients underwent transcatheter closure: transesophageal echocardiography-planned device type and size were modified in 108 patients (45%). Rates of procedural success, predischarge occlusion and complication were 100%, 94.2% and 5%, respectively. On mean follow-up of 65 ± 15.3 months, the follow-up occlusion rate was 96.5%. There were no cases of aortic/atrial erosion, device thrombosis or atrioventricular valve inferences. CONCLUSIONS Intracardiac echocardiography-guided interatrial shunt transcatheter closure is safe and effective and appears to have excellent long-term results, potentially minimizing the complications resulting from incorrect device selection and sizing.