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ISO 9001 certifications for quality management and assurance are widespread worldwide. Since their introduction, more than two decades ago, their geographical diffusion has been studied and analyse...

Infective endocarditis (IE) is a rare disease with a significant impact and an increasing mortality despite earlier diagnosis and surgical intervention. It is related to several and the main etiological agents are the Gram-positive cocci. The new guidelines propose new diagnostic criteria that consider the potentiality on integrated multimodality imaging. Echocardiography (TTE) plays a key role for the diagnosis of IE and must be performed as soon as IE is suspected. It allows to identify vegetation, abscess, new dehiscence of prosthetic valve and assesses the number, size, shape, location, echogenicity and mobility of vegetations so it also useful for prediction embolic risk. Transesophageal echocardiography (TEE) is indicated when TTE is positive or non diagnostic, in case of suspected complications and when intracardiac device leads are present. We underline the increasing role of three-dimensional (3D) echocardiography in overcoming the limit of 2DTEE in selecting the maximum true diameter of irregular masses (ie, vegetation). We also underline the diagnostic value of multislice computed tomograpfy (MSCT), cerebral magnetic resonance (RMI) and nuclear imaging and also emphasize the emerging role of particular types of endocarditis specially Lead Endocarditis. The aim of this review is to provide an overview of the imaging techniques useful for the diagnosis and identification of any complications. In our opinion, the management of IE is complex, based on an "Endocarditis team " composed by several specialist and an integrated multimodality imaging is essential for the diagnostic approach.

Background: RoPE score calculator has been proposed to stratify the patients in whom PFO may be considered not a confounding but presumably a causative factor.Objectives To implement the RoPE score calculator.Methods. We reviewed the medical data of 1040 consecutive patients (mean age 47.3±17.1 years) prospectively enrolled in two centres over a 13 years period for management of PFO in order to select anatomic and functional parameters to be incorporated in a modified RoPE score. A scoring system (AF-RoPE) was build up and applied in a prospective blind fashion to a cohort of 406 consecutive patients (mean age 43.6 ±17. 5 years, 264 females) with cryptogenic stroke and PFO comparing its performance with the standard RoPE.Results. Multiple stepwise logistic regression analysis demonstrated that right-to-left (R-L) shunt at rest (OR 5.9), huge ASA (> 20 mm) (OR 3.9), long tunnelized PFO (> 12 mm) (OR 3.5), and massive R-L shunt (grade 5 by TCD) (OR 1.9) conferred the highest risk of recurrent stroke. The AF-RoPE score resulted in a more precise separation of patients with RoPE score 8-10. Patients with AF-RoPE score > 11 had more stroke recurrences and more diffuse area of stroke on MRI in the medical history than those ranging 10 to 7 or less.Conclusion. The AF-RoPE score discriminates cryptogenic stroke patients who are more likely to develop recurrent stroke compared with a RoPE score between 8-10. These highest risk patients may be more likely to benefit from PFO closure.

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.

An 84-year-old man affected by arterial hypertension, diabetes mellitus, chronic renal failure on dialysis, chronic ischemic heart disease, permanent atrial fibrillation, previous AICD implantation about one year before, was admitted to the intensive care unit because of typical chest pain and dyspnoea during dialysis treatment with nonspecific ST segment changes at ECG and mild increase of cardiac enzymes. A transthoracic echocardiogram was requested, and it demonstrated a big loculated paracardiac hematoma not easily distinguished from pleural source, with sprays of fibrin localized in correspondence of the free wall of the right ventricle determining a partial compression of the right ventricle with no signs of tamponade. Moreover, a chest CT scan with contrast medium was performed and it confirmed the presence of an intrapericardial hematoma located in correspondence of right heart chambers in the absence of contrast spearing post injection. Subsequently, during the following dialysis treatment the patient developed severe hypotension with chest pain, dyspnoea and paradox pulse treated with liquids infusion with prompt resolution of symptoms followed by a surgical drainage through midline sternotomy. The patient underwent operation and a large organizing thrombus was removed from the pericardial space anterolateral and inferior to the right atrium. The pericardium, which was not thickened, was not removed. His postoperative course was uneventful. This case shows that an intrapericardial hematoma several months following the initial bleeding can present with evolving clinical features and cause an impaired cardiac filling in condition of volume depletion such as dialysis treatment. Although two-dimensional echocardiography represents the first line diagnostic tool in this condition, chest CT scan with contrast medium is frequently used to evaluate patients for pericardial effusion and it is of value in these cases because it permits differentiation of an extracardiac from an intracavitary mass, precise determination of the extracardiac extent of a mass and characterization of a mass as a probable hematoma. Finally, we can conclude that a very low threshold for requesting complimentary imaging studies is essential for prompt diagnosis, and the selection of the diagnostic test depends on the urgency of the clinical presentation. Furthermore, the noninvasive information allowed the surgical team to plan an optimal approach to excising the mass.

Incidence of electrical disturbances in patients submitted to transcatheter patent foramen ovale (PFO) closure has not been fully clarified in a large population. The aim of the study is to assess the incidence of atrial fibrillation, supraventricular tachi-arrhythmias, and atrio-ventricular block in the acute and very long-term follow-up.We reviewed the medical and instrumental data of 1000 consecutive patients (mean age 47.3±17.1years) prospectively enrolled in two centers over a 13-year period (February 1999 to February 2012) for right-to-left (R-to-L) shunt ICE-aided catheter-based closure using different devices.Successful transcatheter PFO closure was achieved in 99.8% of the patients. 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%). Postprocedural electrical complications occurred in 5.9% of patients. The only independent predictors of electrophysiological complications were female gender (OR 2.3, 0.5-5.1 [95% CI], p0.001) and device disk30mm (OR 5.0, 1.2-7.2 [95% CI], p0.001). On a mean follow-up of 12 .3±0.6years (minimum 4- maximum 17years), electrical complications occurred in 1.4% of patients including one only case of complete AVB and 5 cases of permanent AF. The only independent predictors were female gender (OR 2.3, 0.5-5.1 [95% CI], p0.001) and device disk30mm (OR 5.0, 1.2-7.2 [95% CI], p0.001).Device-based closure of PFO using different devices, appeared very safe from an electrophysiological point of view with low incidence of electrical disturbances even in the very long-term follow-up.

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.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.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.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.

Intracardiac echocardiographic (ICE) evaluation of secundum atrial septal defect (ASDs) shows several advantages over transesophageal echocardiography (TEE). The aim of our study is to describe the 3-year results of transcatheter ASDs closure using the Amplatzer septal occluder (ASO) and ICE as the sole imaging tool both to select the device size and to monitor the procedure. Under local anesthesia, 135 consecutive eligible patients with ASDs (male/female = 45/90; mean age 42.2 +/- 19.2 years; BSA 1.71 +/- 0.7 m(2); mean pulmonary arterial pressure 30.4 +/- 11.5 mmHg; mean Qp/Qs ratio 2.1 +/- 0.6) underwent transcatheter closure using ASO and ICE. A 9F-9MHz mechanical transducer was used. Two orthogonal views on the transverse aortic valve and on the longitudinal four-chamber planes were obtained for quantitative ICE measurements, from which the diameters of the implanting ASO waist were to be derived. In all cases, we obtained a proper evaluation of ICE ASDs dimensions, leading to an optimal device size selection (mean size 25.0 +/- 6.7 mm). Moreover, the ICE allowed us to monitor device deployment and to verify the effectiveness of the ASDs stented by ASO. There were no complications related to the procedure or to the use of ICE. During a mean follow-up period of 21.5 +/- 12 months, the cumulative complete occlusion rates were 97.7, 97.0, 97.1, and 98% at 24 hours, 3 month, and 1 and 3 years, respectively. ICE is an effective and safe alternative to TEE and balloon-sizing maneuver during ASDs transcatheter closure procedures, allowing us to avoid the need of general anesthesia and leading to a similarly high percentage of occlusion rates with respect to the conventional method.

Objectives We assessed the use of intracardiac echocardiography (ICE) as the primary means for both selection of the Amplatzer Septal Occluder (ASO) and the guidance of transcatheter closure of secundum atrial septal defects (ASDs). Background The standard method for transcatheter closure of ASDs requires balloon-sizing maneuver and transesophageal echocardiographic (TEE) monitoring. The role of ICE during transcatheter closure of ASDs has not yet been established. Methods In 91 patients with ASDs, two standardized orthogonal sections were used to obtain ICE-derived measurements of the fossa ovalis and to assess optimal device deployment: the transverse section on the aortic valve plane, and the longitudinal section on the four-chamber plane. Results In all patients, ICE planes were identified with excellent resolution, providing proper measurements of the fossa ovalis, from which to derive geometric assumptions for the selection of an appropriately sized device. The ASO waist diameter was chosen on the basis of the r value ( r = c 2 + p 2 , where r is the radius of an ideal circle that intersects the elliptical fossa ovalis in its semi-latus rectum, c is the foci half-distance of the fossa ovalis, and p is its semi-latus rectum). During the procedure, the four-chamber plane allowed us to obtain easily interpretable images of all stages of device deployment. Midterm complete occlusion rate was 97.8%. No ICE-related complications occurred. Conclusions The ICE evaluation of ASDs allows quantitative and qualitative information for both proper ASO selection and optimal device placement, thus eliminating the cumbersome balloon-sizing maneuver and the need for general anesthesia during TEE monitoring.

Little is known about the feasibility and effectiveness of perforated secundum atrial septal defects (ASDs) transcatheter closure. This study tested whether this type of fenestration can be percutaneously closed using a single Amplatzer PFO or Cribriform Occluder device in a patch-like fashion under intracardiac echocardiographic (ICE) guidance and monitoring.Twenty-four adult patients with perforated ASDs underwent transcatheter single Amplatzer PFO or Cribriform Occluder device closure by using ICE as the primary imaging tool, both for crossing the flap valve and monitoring each stage of the procedure. The entire atrial septum and fossa ovalis end diastolic dimensions on 2 orthogonal ICE planes, as well as the distance between the eccentric guidewire passage and the more adjacent rim of the fossa ovalis on the longitudinal ICE plane, have been measured.On the basis of the ICE fossa ovalis size and its geometric evaluation, in order to completely cover the fossa ovalis with a single device, 2 Amplatzer PFO Occluders 25 mm, 9 Amplatzer PFO Occluders 35 mm, and 13 Amplatzer Cribriform Occluders (four 25 mm and nine 35 mm) have been implanted successfully. During follow-up (31.4, 7.2 months), complete closure by contrast echo color Doppler occurred in 16/24 (67%) patients after 24 hours, 19/24 (79%) after 1 mouth, 20/24 (83%) after 3 months, 22/24 (92%) after 1 year, and 23/24 (96%) after 2 years.Transcatheter closure of perforated ASDs using a single Amplatzer Occluder device under ICE guidance appears to be a suitable procedure, providing a low rate of residual shunting.

The purpose of this study was to assess the safety and feasibility of percutaneous interventional closure of patent foramen ovale (PFO) with or without atrial septal aneurysm (ASA) in symptomatic patients. Between June 1999 and June 2002, we performed transcatheter closure of PFO in 256 consecutive symptomatic patients (female/male = 1.45; mean age 48 +/- 16 years; range 14-75): ischemic stroke (n = 101), transient ischemic attack (n = 144), peripheral and coronary arterial embolism (n = 17); multiple events (n = 23); platypnea-orthodeoxia syndrome (n = 2); refractory hypoxemia (n = 1); and migraine aura (n = 27). The implanted devices were an Amplatzer PFO Occluder (n = 248), a Gore-HELEX Septal Occluder (n = 4), and PFO STAR (n = 4). Most procedures (n = 176.69%) were done under two-dimensional intracardiac echocardiography (ICE) guidance alone; in the last 30 patients, 3D/4D ICE reconstruction (TomTec Imaging Systems) 6mbH was obtained. In 30 cases, ICE and contrast enhanced-TCD have been used simultaneously in the catheterization laboratory. The devices were placed correctly in all patients. Mean fluoroscopy time was 9.45 +/- 5 minutes (range = 2.5-35 minutes); mean procedural time was 57 +/- 21 minutes (range = 15-135 minutes). Total occlusion rate at follow-up (mean 19 months, range 1-33) was 98.1%. No significant recurrent neurological events were observed. Transcatheter closure of PFO with or without ASA is a safe and effective, minimally invasive procedure that ensures high closure rate and avoids life-long anticoagulation. Mid-term follow-up results appear favorable with respect to recurrent thromboembolic events.

Purpose: This study was designed to assess the balloon sizing maneuvers and deployment of an Amplatzer Septal Occluder (ASO). In addition, intraprocedural balloon sizing was compared with off-line intracardiac echocardiographic measurements. Methods: The intracardiac echocardiography (ICE) measurements were: maximum transverse and longitudinal atrial septal defect (ASD) diameters in the aortic valve and four-chamber planes;area of the ASD and its equivalent circle diameter. Thirteen consecutive patients underwent transcatheter implantation of an ASO device using ICE guidance under local anesthesia. The device matching the balloon sizing diameter of the defect was implanted. Qualitative ICE assessment of the ASO devices implanted was performed off line. Results: The mean equivalent circle diameter predicted by ICE was 24.40 {+-} 5.61 mm and was significantly higher(p 0.027) than the ASD measured by balloonsizing (21.38 {+-} 5.28 mm). Unlike previous studies we did not find any correlation between the two measurements (correlation coefficient = 0.47). Only four of the 13 patients had optimal device positioning as shown by the qualitative ICE evaluation, whereas the remaining nine patients had inadequate device placement. This resulted in a waist diameter that was an average 26.1% undersized in seven patients and 12.7% oversized in two patients. Five of the seven patientsmore » with an undersized device had ASO-atrial septum misalignment with leftward device deviation. Conclusion: The ICE images allowed careful measurement of the dimensions of the ASD and accurately displayed the spatial relations of the ASO astride the ASD.Moreover, use of the ICE measurement led to selection of a different size of device in comparison with those of balloon sizing. The clinical benefit of this new approach needs to be rigorously tested.« less