Does Renal Denervation a Reasonable Treatment Option in Hemodialysis-Dependent Patient with Resistant Hypertension? A Narrative Review.

PURPOSE OF REVIEW: This narrative review aims to assess the pathophysiology, diagnosis, and treatment of resistant hypertension (RH) in end-stage kidney disease (ESKD) patients on dialysis, with a specific focus on the effect of renal denervation (RDN) on short-term and long-term blood pressure (BP) control. Additionally, we share our experience with the use of RDN in an amyloidotic patient undergoing hemodialysis with RH. RECENT FINDINGS: High BP, an important modifiable cardiovascular risk factor, is often observed in patients in ESKD, despite the administration of multiple antihypertensive medications. However, in clinical practice, it remains challenging to identify RH patients on dialysis treatment because of the absence of specific definition for RH in this context. Moreover, the use of invasive approaches, such as RDN, to treat RH is limited by the exclusion of patients with reduced renal function (eGFR < 45 mL/min/1.73 m3) in the clinical trials. Nevertheless, recent studies have reported encouraging results regarding the effectiveness of RDN in stage 3 and 4 chronic kidney disease (CKD) and ESKD patients on dialysis, with reductions in BP of nearly up to 10 mmhg. Although multiple underlying pathophysiological mechanisms contribute to RH, the overactivation of the sympathetic nervous system in ESKD patients on dialysis plays a crucial role. The diagnosis of RH requires both confirmation of adherence to antihypertensive therapy and the presence of uncontrolled BP values by ambulatory BP monitoring or home BP monitoring. Treatment involves a combination of nonpharmacological approaches (such as dry weight reduction, sodium restriction, dialysate sodium concentration reduction, and exercise) and pharmacological treatments. A promising approach for managing of RH is based on catheter-based RDN, through radiofrequency, ultrasound, or alcohol infusion, directly targeting on sympathetic overactivity.

Complex coronary bifurcation treatment by a novel stenting technique: Bench test, fluid dynamic study and clinical outcomes.

OBJECTIVES: We assess the mid-term outcomes of ultrathin biodegradable polymer double stenting using a very minimal crushing (Nano-Crush) technique in large complex coronary bifurcation. BACKGROUND: Complex bifurcations have been suggested to be better approached by a planned double stent technique. METHODS: Two hundred and five consecutive patients (107 males and 98 females) referred for large complex coronary bifurcation percutaneous coronary interventions were enrolled. The technique was also evaluated by both a bench test with a silicon tubes phantom resembling a coronary bifurcation and a computed fluid dynamic (CFD) analysis. RESULTS: Left main bifurcation accounted for 40.9% of cases (84 patients). Mean angles between main branch (MB) and side branch (SB) were 63.6 ± 21.3°. SB intravascular ultrasound-calculated MSA was 5.6 ± 1.5 mm2 . Clinical follow-up was available for 100% of patients and at a mean follow-up of 16.2 ± 6.7 months 8 deaths, all due to cardiovascular reason, (3.9%, 4 patients for stroke, two for heart failure, one after surgical aortic valve substitution, and one after acute massive pulmonary embolism) and no presumptive stent thrombosis or target vessel induced ischemia were observed. Angiographic follow-up was available in 108 patients (52.7%) and showed a very low significant restenosis (5 patients, 4.6%). Bench study and CFD evaluation suggested a complete coverage of the SB ostium with a very high strut-free area at the SB. CONCLUSIONS: The revascularization of complex large coronary bifurcation disease using the Nano-crush technique appeared promising thanks to the favorable fluid dynamic profile, complete coverage of the SD ostium, and very small metal amount at the carina.

Ketamine and midazolam differently impact post-intubation hemodynamic profile when used as induction agents during emergency airway management in hemodynamically stable patients with ST elevation myocardial infarction.

We investigated the incidence of post-intubation hypotension (PIH) in hemodynamically stable patients with STEMI requiring rapid sequences intubation (RSI) and medicated with ketamine or midazolam as induction agent. STEMI patients admitted between 1st January 2009 and 1st January 2017 who did not receive any type of inotropic support before the endotracheal intubation (ETI) was reviewed. PIH was defined as a reduction greater than 20% or a drop of systolic blood pressure (SBP) below 90 mmHg within 10 min from the administration of the induction agent [ketamine (1 mg/kg) or midazolam (0.3 mg/kg)]. Over the study period, 136 patients (66 male and 70 females, mean age 72.25 ± 7.33 years) met the inclusion criteria. Patients treated with midazolam and ketamine were 63 and 73, respectively. PIH was observed in 38 (27.9%) patients after 10 min from ETI. Midazolam patients had a significant lower SBP at both 5 and 10 min after induction (97.75 ± 8.06 vs 100.81 ± 8.08, p = 0.029 and 92.83 ± 7.53 vs 101.58 ± 7.29, p < 0.0001, respectively) (ANOVA p < 0.0001). Age (OR 1.91, 95% CI 1.87-1.97, p = 0.001), history of arterial hypertension (OR 2.27, 95% CI 2.21-2.35, p = 0.0001), multivessel coronary artery disease (OR 2.66, 95% CI 2.58-2.71, p = 0.001), SI ≥0.9 (OR 2.41, 95% CI 2.36-2.48, p < 0.0001) and anterior STEMI (OR 2.51, 95% CI 2.48-2.57, p = 0.0001) resulted independent predictors of PIH in STEMI patients treated with midazolam, as induction agent, before ETI. Midazolam was more likely than ketamine to cause significant PIH when used as an induction agent for RSI in hemodynamically stable patients with STEMI.

Long-Term Outcomes and Complications of Intracardiac Echocardiography-Assisted Patent Foramen Ovale Closure in 1,000 Consecutive Patients.

BACKGROUNDS: Long-term fate of patients submitted to patent foramen ovale (PFO) closure is still unclear. The aim of the study was to evaluate the incidence of atrial fibrillation (AF), aortic or atrial free wall erosion, device thrombosis (DT), new onset or worsening of mitral valve regurgitation (MVR), and recurrent cerebral ischemic events in the long-term follow up after intracardiac echocardiography (ICE)-aided PFO closure in a large population. METHODS: We reviewed the medical and instrumental data of 1,000 consecutive patients (mean age 47.3 ± 17.1 years, females) prospectively enrolled in 2 centres over a 13 years period (February 1999-February 2012) for R-to-L shunt ICE-aided catheter-based closure using different devices. RESULTS: Immediate success was 99.8%. Implanted devices were Amplatzer PFO Occluder in 463 patients (46.3%), Amplatzer ASD Cribriform Occluder in 420 patients (42.0%), Premere Occlusion System in 95 patients (9.5%), and Biostar Occluder in 22 patients (2.2%). On a mean follow-up of 12.3 ± 0.6 years (minimum 4- maximum 17 years), permanent AF occurred in 0.5%, DT was apparent in 0.5%, new onset or worsening of MVR was observed in 0.2%, whereas recurrent cerebral ischemic events were 0.8%. Occlusion rate was 93.8%. No aortic or atrial free wall erosion has been observed. CONCLUSION: ICE-aided closure of PFO using different devices, appeared very safe and effective on very long-term follow up with low incidence of erosion, DT, recurrent ischemic events, MVR new onset or worsening, and permanent AF.

Pathophysiology of paradoxical embolism: evaluation of the role of interatrial septum anatomy based on the intracardiac echocardiography assessment of patients with right-to-left shunting.

BACKGROUND: 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. OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSION: 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.

Clinical, hemodynamic, and intracardiac echocardiographic characteristics of secundum atrial septal defects-related paradoxical embolism in adulthood.

BACKGROUND: Paradoxical embolism associated with secundum atrial septal defect (sASD) is a relatively rare but well-known occurrence. The purpose of our study is to report the clinical, hemodynamic, and anatomical features assessed by intracardiac echocardiography (ICE) of sASD as related to paradoxical embolism. METHODS: Five hundred thirty-seven patients (mean age 48 ± 19.0 years) admitted for transcatheter repair of interatrial shunts were enrolled in a prospective registry over a 10-year period (September 2003-September 2013). All patients underwent transesophageal echocardiography, complete right and left catheterization, prior to the device-based procedure. ICE was performed in all patients in order to investigate the interatrial septum anatomy and to monitor device implantation. These results were compared with the data of patients with patent foramen ovale (PFO) patients and nonemboligenous sASD admitted at the same time period. RESULTS: Twenty-four patients (6.2%) out of 386 who underwent transcatheter repair for paradoxical embolism had a secundum ASD. The defects were cribrosus in 41.6% (10/24). All single sASD (58.3%) had a peculiar anatomical feature a so-called flat elliptical shape with a major axis of 7.6 ± 2.4 and minimal axis of 2.5 ± 1.6 mm. Patients with sASD-related paradoxical embolism had a higher frequency of deep venous thrombosis compared to PFO patients. In comparison to nonemboligenous sASD, such patients had lower mean pulmonary pressure and smaller defects. CONCLUSION: sASD related to paradoxical embolism had peculiar clinical, hemodynamic, and anatomical characteristics, which classified such defects in the middle of the spectrum between nonemboligenous secundum ASD and PFO.

Strategies to overcome hostile subclavian anatomy during transradial coronary angiography and interventions: impact on fluoroscopy, procedural time, complications, and radial patency.

BACKGROUND: Hostile anatomy of the subclavian artery (severe tortuosity and/or heavy calcification) remains a significant obstacle for the transradial approach during coronary angiography and interventions. OBJECTIVE: To assess impacts on fluoroscopy and procedural times, complications, and radial artery patency in patients with hostile subclavian anatomy by using multiple catheter-guide techniques. METHODS: We retrospectively reviewed the medical and equipment data of 4,580 consecutive patients (mean age 74.4 ± 26.7 years, 49.5% females) who have been referred for transradial coronary angiography and/or interventions within the last 3 years (September 2010-September 2013). In order to overcome the strangling hold of a hostile subclavian artery, 2 techniques have been used: (1) for a coronary angiography-only procedure, a double mother and child technique; (2) for percutaneous coronary intervention, a triple mother and child technique. RESULTS: Ninety-five patients (2.1%) from the entire study population exhibited a hostile subclavian artery. Fifty-two patients (1.1%) underwent coronary angiography only and 43 patients (1%) underwent interventions requiring the use of the above double or triple mother and child techniques, respectively. The 2 techniques were successful in 94.7% of patients (90/95 patients). The procedural time was significantly longer in the patients with hostile subclavian artery while there were no differences in the fluoroscopy time. The radial artery was patent at 30 days in 92.6% of patients (88/95 patients). CONCLUSION: Our data showed that in the presence of hostile subclavian anatomy, the mother and child techniques appeared safe and effective, allowing for the completion of the intended procedure.

Usefulness of intracardiac echocardiography with a mechanical probe for catheter-based interventions: a 10-year prospective registry.

BACKGROUND: The clinical outcome benefit of intracardiac echocardiography (ICE) with a mechanical probe during congenital heart disease interventions has not been fully investigated. We reported the long-term results of a prospective registry of interatrial shunt closure guided by mechanical ICE. METHODS: We enrolled 537 patients (mean age 48 ± 19.0 years, 378 females) submitted to ICE-aided procedures in a prospective registry over a 10-year period (September 2003-September 2013). All patients underwent transesophageal echocardiography (TEE) before the planned procedure. We evaluated (1) structure identification capability, (2) fossa ovale and interatrial septum component measurement, (3) procedure monitoring capability, (4) procedural and fluoroscopy times, and radiograph dose, (5) probe-related complications. RESULTS: ICE was successfully performed and was able to correctly identify the structures previously assessed by TEE in all patients. In 24 patients (4.5%), ICE allowed better anatomy definition than TEE. In 35 other patients (6.5%), ICE identified structures not observed by TEE, which led to change indications to interventions or the operative technique to be used. In 131 patients (24.4%), ICE evaluation led to change the planned device to be implanted. There was only one probe-related complication (0.2%). CONCLUSIONS: Mechanical ICE may offer a valid alternative to conventional TEE in guiding congenital heart disease interventional procedures.

Impact of interatrial septum anatomic features on short- and long-term outcomes after transcatheter closure of patent foramen ovale: single device type versus anatomic-driven device selection strategy.

BACKGROUNDS: 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. METHODS: 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). RESULTS: 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. CONCLUSION: 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.

Safety and long-term outcome of modified intracardiac echocardiography-assisted "no-balloon" sizing technique for transcatheter closure of ostium secundum atrial septal defect.

BACKGROUND: The need for sizing the secundum atrial septal defect (ASD) with the balloon sizing technique is still debated at least in adult patients. We sought to prospectively evaluate the effectiveness of intracardiac echocardiography (ICE)-aided sizing technique for transcatheter closure of secundum ASD, without using a balloon sizing. METHODS: In a prospective 5-year registry, we enrolled 81 patients (mean age 48 ± 13.7 years, 54 females) who had been referred to three different centers for atheter-based closure of secundum ASD. Eligible patients underwent ICE study and closure attempt. In a preliminary group of 21 patients, sizing balloon was performed under ICE guidance to assess the value of rim thickness necessary for device anchorage. In the remaining 60 patients, the retrieved value of the rim thickness was measured on ICE and used as key points to measure the defect and select the device. RESULTS: In the preliminary group of patients, the value of thickness at point of initial deflection by the balloon was 1.23 ± 0.1 mm. ASD diameter in the study group was measured at the point of rim with at least 1.2 mm and the mean ASD diameter was 26.2 ± 10.1 mm. Rates of procedural success, predischarge occlusion, and major complications rate were 100%, 93.3%, and 0%, respectively. On mean follow-up of 5.4 ± 1.8 years, the occlusion rate was 98.7% with no long-term complications. CONCLUSIONS: Our novel ICE-sizing technique appears to be safe and effective in adult patients, thus eventually minimizing overestimation, costs, and potential complications of balloon sizing.

Premere occlusion system for transcatheter patent foramen ovale closure: mid-term results of a single-center registry.

BACKGROUND: Transcatheter closure of patent foramen ovale (PFO) with rigid devices may be problematic in patients with long channel PFO: alternative devices with asymmetrical opening and more physiological positioning may be preferable in such cases. We present the mid-term results of transcatheter closure of PFO with Premere Occlusion System, a device studied for this specific anatomy, in a single-center registry of adults with previous cerebral ischemia. METHODS: During a 53-months period (July 1, 2005 to December 1, 2009) 70 patients (48 females and 22 males, mean age 38 ± 6.7 years) with previous stroke were admitted in our center for transcatheter closure of PFO with Premere Occlusion System on the basis of absence of moderate or severe atrial septal aneurysm (ASA) on Transesophageal echocardiography and intracardiac echocardiography (< 3RL or 3LR ASA and length of PFO channel >10 mm). RESULTS: The procedure was successful in all of the patients with no peri-operative and in-hospital complications. Forty-six 20 mm and twenty-four 25 mm Premere devices were implanted. Rates of procedural success, predischarge occlusion, and complication were: 100%, 95.7% and 0%, respectively. On mean follow-up of 40 ± 10.9 months (range 6-54), the follow-up occlusion rate was 98.5%. During follow-up, no cases of permanent atrial fibrillation, aortic/atrial erosion, device thrombosis, or atrioventricular valve inferences were noted. CONCLUSION: The mid-term outcomes of our registry suggests that the Premere Occlusion System may be an excellent device for patients with long-channel PFO and absence of moderate/severe ASA, offering a physiological and anatomically respective closure of PFO also in patients with hypertrophic rims.

Endovascular treatment of diabetic foot syndrome: results from a single center prospective registry using mixed coronary and peripheral techniques and equipment.

To assess the long-term results of interventional treatment of diabetic foot using mixed coronary and peripheral equipments and techniques. The interventional diabetic foot syndrome treatment is rapidly becoming the therapy of choice in such patients, but proper materials and techniques are still debated. From January 2006 to December 2010, we prospectively enrolled 220 diabetic patients (78.5 ± 15.8 years, 107 females, all with Fontaine III or IV class), referred to our center for diabetic foot syndrome and severe limb ischemia. Mixed coronary and peripheral guidewires and balloons techniques were used. Doppler ultrasonography and foot transcutaneous oxygen pressure (TCPO2) before and after the procedure were calculated as well as the amputation rate. The preferred approach was ipsilateral femoral antegrade in 170/220 patients (77.7%), contralateral cross-over in 40/220 patients (18.8%), and popliteal retrograde + femoral antegrade in 10/220 patients (4.5%). The techniques included combined use of coronary and dedicated peripheral guidewires and coronary and peripheral dedicated balloons. Balloon angioplasty was performed in 252 legs (32 patients with bilateral disease): the procedure was successful in 239/252 legs with an immediate success rate of 94.8% and a significant improvement in TCPO2 and ankle-brachial index with ulcer healing in 233/252 legs (92.4%). The freedom from major amputation was 82.8% at a mean follow-up of 3.1 ± 1.8 years (range 1 to 5 years). The endovascular diabetic foot syndrome treatment using mixed coronary and peripheral materials and techniques seems to lead to high immediate success and limb salvage rates compared to historical series.

Feasibility, safety and long-term outcomes of complex left main bifurcation treatment using the nano-inverted-t stenting: a multicentre prospective registry.

The role of double stenting techniques in distal bifurcation left main (LM) disease has gaining interest over the latest years. We present the 3-year multicentre registry outcomes of dual stenting using ultra-thin strut stents and the Nano-Inverted-T (NIT) technique in complex unprotected true LM bifurcation disease. We analysed the procedural and medical data of consecutive patients enrolled between 1st January 2014 and 1st December 2019 in a multicentre registry for complex LM bifurcation disease treated with the double stenting technique called NIT due contraindications and/ or refusal to surgical treatment. Target lesion failure (TLF) was defined as the composite of cardiovascular death, target-vessel MI (TVMI) and clinically driven target lesion revascularization (TLR). Among two hundred-ninety-five patients (138 males, mean age 70.3 ± 12.8 years), post-operative success was achieved in 100% of cases. Contrast volume, procedural time, and radiation exposure were 139.2 ± 23.4 ml, 15.3 ± 4.9 min, and 1080 ± 1034 cGy/m2, respectively. At a mean follow-up of 39.5 ± 0.6 months TLF rate was 6.1% (n = 18) while TLR and cardiovascular mortality rates were 3.0 (n = 9) and 2.6% (n = 8), respectively. Clinically-driven angiographic follow-up was available in 26.4% of patients at a mean time from the procedure of 7.5 ± 0.4 months. Clinically restenosis rate was 3.3%.Revascularization of complex LM bifurcation disease using the NIT double stenting technique resulted feasible and safe with a low incidence of TLF, excellent survival rate and no stent thrombosis.

Ultrathin Biodegradable-Polymer Orsiro Drug-Eluting Stent Performance in Real Practice Challenging Settings.

BACKGROUND: The Orsiro cobalt-chromium stent platform (Biotronik, Bülach, Switzerland) is one of the first devices in the era of ultrathin struts. However, data regarding the efficacy of Orsiro stent in patients with challenging anatomical conditions obtained from daily clinical practice are scant. METHODS: We retrospectively reviewed the long-term outcomes, defined as target lesion revascularization (TLR), target vessel revascularization (TVR), stent thrombosis (ST) and cardiovascular (CV) mortality over a six years period, in 1161 consecutive patients (mean age 64.3 ± 11.2 years old, 681 males) treated with 2327 Orsiro stents in our institution who presented with challenging anatomic/angiographic features. RESULTS: The mean number of implanted stents was 1.7 ± 2.1 whereas the mean stent diameter and length were 3.6 ± 1.1 and 32.7 ± 15.6 mm, respectively. Mean follow-up duration was 35.6 ± 17 months (range 1-77 months); 923 patients (79.5%) reached the 3-year follow-up. The global rates of TLR, TVR, ST and CV mortality were 0.1%, 1.37%, 0.002%, and 1.9%, respectively with scarce statistically significant differences in multivessel disease, severe calcification, and lesion length > 41 mm. Multivariate regression analysis revealed that age, stent dislodgement, early stent thrombosis (p = 0.001) and lesion length ≥ 41 mm (p = 0.001) were independent predictors of TVR. Similarly, the occurrence of TLR was independently predicted by age, severe calcification, use of IVUS and Rotablator (p = 0.002), early stent thrombosis, LM bifurcation and length ≥ 41 mm (p = 0.001). CONCLUSIONS: The Orsiro stent confirmed a very high efficacy profile in all anatomical scenarios with very low rates of clinically driven TLR and TVR, CV mortality and ST at 3-years.

Incomplete aneurysm coverage after patent foramen ovale closure in patients with huge atrial septal aneurysm: effects on left atrial functional remodeling.

BACKGROUND: Large devices are often implanted to treat patent foramen ovale (PFO) and atrial septal aneurysm (ASA) with increase risk of erosion and thrombosis. Our study is aimed to assess the impact on left atrium functional remodeling and clinical outcomes of partial coverage of the approach using moderately small Amplatzer ASD Cribriform Occluder in patients with large PFO and ASA. METHODS: We prospectively enrolled 30 consecutive patients with previous stroke (mean age 36 +/- 9.5 years, 19 females), significant PFO, and large ASA referred to our center for catheter-based PFO closure. Left atrium (LA) passive and active emptying, LA conduit function, and LA ejection fraction were computed before and after 6 months from the procedure by echocardiography. The preclosure values were compared to values of a normal healthy population of sex and heart rate matched 30 patients. RESULTS: Preclosure values demonstrated significantly greater reservoir function as well as passive and active emptying, with significantly reduced conduit function and LA ejection fraction, when compared normal healthy subjects. All patients underwent successful transcatheter closure (25 mm device in 15 patients, 30 mm device in 6 patients, mean ratio device/diameter of the interatrial septum = 0.74). Incomplete ASA coverage in both orthogonal views was observed in 21 patients. Compared to patients with complete coverage, there were no differences in LA functional parameters and occlusion rates. CONCLUSIONS: This study confirmed that large ASAs are associated with LA dysfunction. The use of relatively small Amplatzer ASD Cribriform Occluder devices is probably effective enough to promote functional remodeling of the left atrium.

Left atrial dysfunction in patients with patent foramen ovale and atrial septal aneurysm scheduled for transcatheter closure may play a role in aura genesis.

BACKGROUND: It has been suggested that a left atrial (LA) dysfunction induced by large shunt and large atrial septal aneurysm (ASA) may act as a concurrent mechanism of arterial embolism in patients with patent foramen ovale (PFO) and prior stroke. We aimed to evaluate the potential contribution of this mechanism as trigger of migraine in patients with PFO. METHODS: From January 2007 to September 2009, we prospectively enrolled subjects with migraine who underwent percutaneous PFO closure. Echocardiographic parameter of LA dysfunction was evaluated: pre- and postoperative values were compared to values of different sex and heart rate matched populations: 30 healthy patients, 21 migraine patients without PFO (MwoPFO), and a group of 25 PFO patients without migraine (PFOwoM). The Migraine Disability Assessment Score (MIDAS) was used to assess the incidence and severity of migraine. RESULTS: Forty-five patients (38 females, mean age 38 +/- 6.7 years, mean MIDAS 35.8 +/- 4.7, and 28 patients with migraine with aura) fulfilled the inclusion criteria. After successful percutaneous closure (mean follow-up of 18.2 +/- 4.8 months), PFO closure remained complete in 95%; 35 of 45 patients reported resolution or amelioration of migraine (mean MIDAS score 12.3 +/- 8.8, P < 0.03). All patients with aura reported aura resolution. Preclosure values demonstrated significantly greater LA dysfunction, when compared with healthy and MwoPFO groups. Among patients in the study group, only patients with migraine with aura showed LA dysfunction comparable to PFOwoM patients. CONCLUSION: This study suggests that LA dysfunction probably does not contribute to migraine itself but may play a role in the genesis of aura symptoms.

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.

[Patent foramen ovale: a benign anatomical variant that can become a disease]. / Il forame ovale pervio: quando una variante anatomica diventa patologia.

Patent foramen ovale (PFO) is mostly considered a benign anatomical variant but in presence of a significant right to left shunt, it can represent the substrate for embolic disease as cryptogenetic stroke, decompression syndrome, myocardial infarction with normal coronary arteries, etc. A diffuse therapeutic option consists in the PFO transcatheter closure: a procedure with no dedicated guidelines. We retrospectively studied demographic characteristics, clinical remarks, indications and morphological findings in 143 patients who underwent percutaneous PFO closure in the Interventional Cardiology Unit of the Rovigo General Hospital between 2006 and 2009.

Light anti-thrombotic regimen for prevention of device thrombosis and/or thrombotic complications after interatrial shunts device-based closure.

AIMS: The optimal antiplatelet therapy after atrial septal defect (ASD) or patent foramen ovale device closure (PFO) remain to be established. We evaluated the safety and effectiveness of 6-month 100 mg Aspirin (ASA) regimen in the very long-term follow up after intracardiac echocardiography (ICE) -aided interatrial shunt closure in a large retrospective cohort. METHODS: Single-center retrospective analysis which included medical and instrumental data of 789 consecutive patients referred to our institution over a 15 years period due interatrial shunt catheter-based closure. RESULTS: Finally, 734 patients were included in the analysis (mean age 46.1 ± 14.6 years, 398 females): ASD and PFO closure were successfully performed in 281 and 453 patients, respectively. Over the follow-up period, no major bleeding events were observed while the rate of minor bleeding events was 0.9%. Tolerance problems were detected in 3.4% of cases (n==28). In 11 patients (1.5%) an abnormal complete blood count was detected and monitored up to normalization. On a mean follow -up of 10.3 ± 3.0 years (range 1-15), 10 patients (1.36%) had a persistent moderate shunt 12 months after closure and maintained Aspirin 100 mg life-long, whereas the remaining 724 suspended the treatment after 6 months. Device thrombosis in ASD and PFO groups were 0% and 0.2%, respectively. A cerebral ischemic event occurred in 0.4% of the entire cohort. CONCLUSIONS: A regimen of 100 mg of ASA for six months after ASD/PFO closure appeared to be both safe and effective in preventing device thrombosis and major bleedings.