We reported the short- and long-term results of our institutional single center registry Interatrial Septum Interventions Study (ISIS) about the impact of different anatomic characteristics and related device selection in patent foramen ovale (PFO) closure.Over a 9 year period (September 2003-September 2012) we prospectively enrolled 340 consecutive patients (mean age 44 ± 15. 5 years, 198 females) who had been referred to our center for PFO catheter-based closure. The first 105 patients received a single type of device independently from the anatomy (single device strategy). The remaining 235 patients received a different device based on intracardiac echocardiographic study of interatrial septum anatomy (anatomic strategy).Immediate success rate was 100% in both groups, whereas the rate of immediate complications was 10.4% and 2.5% (P<0.01) in the single strategy group and anatomic strategy group, respectively. During a mean follow-up of 59.3 ± 28.9 months, the occlusion rate was 86.6% and 94%, whereas the incidence of recurrences was 1.8% and 0% in the single device strategy group and anatomic strategy group, respectively.The results from ISIS registry showed that anatomy of interatrial septum associated with PFO is quite complex leading to an increased rate of complications and a slightly lower closure rate if treated with a single device strategy.
To assess the impact on stent implantation rate and mid-term outcomes of prolonged high pressure angioplasty of femoropopliteal lesions.We retrospectively enrolled 620 consecutive patients from January 2011 to December 2011 (75.6 ± 12.3 years, 355 males, 76.5% in Rutherford class 5-6), referred for critical limb ischemia and submitted to prolonged high-pressure angioplasty of femoropopliteal lesions. The definition of prolonged high-pressure angioplasty includes dilation to at least 18 atm for at least 120 s. Procedural data, and clinical and instrumental follow-up were analyzed to assess stent implantation rate and mid-term outcomes.The preferred approach was ipsilateral femoral antegrade in 433/620 patients (69.7%) and contralateral cross-over in 164/620 (26.4%) and popliteal retrograde + femoral antegrade in 23/620 (3.7%). Techniques included subintimal angioplasty in 427/620 patients (68.8%) and endoluminal angioplasty in 193/620 patients (31.2%). The prolonged high pressure balloon angioplasty procedure was successful in 86.2% (minor intra-procedural complications rate 15.7 %), stent implantation was performed in 74 patients (11.9%), with a significant improvement of ankle-brachial index (0.29 ± 0.6 vs. 0.88 ± 0.3, P < 00.1) and Rutherford class (5.3 ± 0.8 vs. 0.7 ± 1.9, P < 0.01), a primary patency rate of 86.7%, restenosis of 18.6 % on Doppler ultrasound and a target lesion revascularization of 14.8% at a mean follow-up of 18.1 ± 6.4 months (range 1-24 months). Secondary patency rate was 87.7%.Prolonged high pressure angioplasty of femoropopliteal lesions appears to be safe and effective allowing for an acceptable patency and restenosis rates on mid-term.
Detailed anatomic variants of the interatrial septum in patients with right-to-left shunt and contribution of specific anatomies to the risk of ischaemic recurrences has not yet been comprehensively classified.To report a classification of the anatomic variants of the interatrial septum as observed by intracardiac echocardiography and its correlation with clinical and functional characteristics.We retrospectively reviewed the medical and instrumental data of 520 consecutive patients (mean age 44±15. 5 years, 355 women) who had over a 10-year period undergone intracardiac echocardiography and right-to-left shunt catheter-based closure. The four main features used to analyse were: (a) diameter of the oval fossa, (b) presence and length of the channel, (c) presence and degree of atrial septal aneurysm, and (d) rim thickness. The presence of Eustachian valve was also tabulated.The combinations of interatrial septum anatomical features were classified into six main anatomical subgroups. Recurrent embolism, multiple ischaemic foci on brain magnetic resonance imaging, high grade shunt, and permanent shunt before transcatheter closure procedure were associated with type 2, type 4, and type 6. Type 4 anatomical subtype (OR 4.1, 1.5-8 [95% CI], p<0.001) and type 2+presence of Eustachian valve (OR 4.3, 1.6-9 [95% CI], p<0.001) were the strongest predictors of recurrent ischaemic events before transcatheter closure.Our study showed that interatrial septum anatomy greatly differs among patients with right-to-left shunt, as well as the risk of ischaemic recurrences in different anatomies.
Hypertrophy and lipomatosis of the interatrial septum have been thought to be contraindications for transcatheter patent foramen ovale (PFO) and atrial septal defect closure because of the limits of current devices and the risk of suboptimal results. No reports have been produced yet about PFO closure in patients with such conditions. We retrospectively assessed the safety and effectiveness of PFO closure in patients with hypertrophy or lipomatosis of fossa ovalis rims.We searched our database of 140 consecutive patients (mean age 43 +/- 15. 5 years, 98 female patients) who underwent transcatheter PFO closure for cases of hypertrophy or lipomatosis of the interatrial septum. All patients were screened with transesophageal echocardiography before the operation. All patients underwent intracardiac echocardiography study and attempted closure.Ten patients (7.1%) underwent an attempt at transcatheter closure in the presence of hypertrophy of the rims (eight patients) or lipomatosis (two patients). All patients were aged more than 50 years and has multiple recurrent stroke events (nine patients) or need for a posterior cerebral surgical procedure (one patient) making closure mandatory. After intracardiac echocardiography study and measurements, two 25 mm Amplatzer and eight 25 mm Premere Occlusion System devices have been implanted successfully. On mean follow-up of 36.6 +/- 14.8 months, two patients had a small residual shunt: no recurrence of stroke or aortic erosion or device thrombosis was observed during this period.Transcatheter PFO closure in the presence of hypertrophy or lipomatosis of fossa ovalis rims is not contraindicated per se: careful evaluation of rim thickness with intracardiac echocardiography and selection of soft and asymmetrically opening devices may allow for a safe and effective PFO closure, at least in patients with no severe atrial septal aneurysm.