Transcatheter closure of atrial septal defect using intracardiac echocardiography: a two-center, retrospective study.

AIMS: We present the experience and long-term results of intracardiac echocardiography (ICE)-guided closure of ostium secundum atrial septal defects (ASDs) in two Italian centers and investigate its systematic applicability as the gold standard in routine clinical practice. METHODS: We retrospectively evaluated all consecutive patients who underwent an ASD percutaneous closure procedure from March 2008 to February 2020. All patients underwent a preprocedural transesophageal echocardiography (TEE) evaluation. The closures were carried out under fluoroscopic and ICE guidance. A follow-up visit was performed at 1, 3 and 12 months, followed by telephone evaluations approximately every 2 years. RESULTS: Sixty-six patients (29% male individuals), mean age 43 ±â€Š16 years, were treated. In 15 cases, the TEE defect diameter was less than 10 mm, and in 8 of these patients, the ICE intraprocedural sizing increased the maximum diameter by more than 5 mm. Sizing balloon of the defect was performed in 51 cases; 2 patients received an ASD 38 mm device. Eight patients had multiple defects; in three of these, it was necessary to apply two devices. Four patients showed nonsignificant residual shunt; no complications related to the use of ICE were observed. One patient presented the migration of the ASD device into the abdominal aorta, percutaneously retrieved with a snare. No major complications were recorded during the entire follow-up period. CONCLUSION: This study confirms that ICE monitoring during ASD percutaneous closure is well tolerated and effective; it might be achievable as a routine gold standard by operators willing to use ICE systematically in all transcatheter closure interventions of interatrial communications.

A comparison of intracardiac echocardiography and transesophageal echocardiography for guiding device closure of ostium secundum atrial septal defect: A 15-year experience.

BACKGROUND AND AIM: Our aim was to evaluate the fluoroscopy time (FT), procedure time (PT) safety and efficacy when using intracardiac echocardiography (ICE) in comparison to transesophageal echocardiography (TEE) guidance for transcatheter closure of Ostium Secundum Atrial Septal Defect (OS-ASD). METHOD: Ninety patients (n = 90) diagnosed with OS-ASD underwent transcatheter closure between March 2006 and October 2021. Fifty-seven patients were treated under ICE guidance, while 33 patients were treated under TEE guidance. RESULTS: Mean age was 43 ± 15 years and 42 ± 10 years in the ICE and TEE groups, respectively. The majority of patients had a centrally placed defect. Median FT was 8.40 min versus 11.70 min (p < .001) in the ICE group compared to the TEE group, respectively. Median PT was 43 min versus 94 min (p < .001) in the ICE group compared to the TEE group, respectively. Both ICE and TEE provided high quality images. All interventions were completed successfully, except for one patient in the ICE group who experienced a device migration, the development of atrial tachycardia in one patient and atrial fibrillation in two patients in the ICE group which spontaneously cardioverted. There were no other complications. CONCLUSION: This study on a consistent cohort of patients with OS-ASD undergoing percutaneous closure suggests that use of ICE is safe and efficacious. Compared to TEE, ICE demonstrated significantly shorter FT and PT, decreasing the entire duration of the procedure and x-ray exposure. No relevant differences were observed in terms of success rate and complications.

Surgical Mortality Risk Scores in Transcatheter Aortic Valve Implantation: Is Their Early Predictive Value Still Strong?

BACKGROUND: Surgical mortality risk scores, even if not properly designed and rarely tested in the transcatheter aortic valve implantation (TAVI) setting, still guide the heart team in managing significant aortic stenosis. METHODS: After splitting 1763 consecutive patients retrospectively based on their mortality risk thresholds, the composite endpoint early safety (ES) was adjudicated according to Valve Academic Research Consortium (VARC)-2 and -3 consensus documents. RESULTS: ES incidence was higher if VARC-2 rather than VARC-3 defined. Despite only patients showing VARC-2 ES had significantly lower absolute values of all three main risk scores, these last still failed to foresee both VARC-2 and -3 ES in intermediate-risk patients. The receiver operating characteristic analysis also showed a significant correlation, but with poor diagnostic accuracy, among the three scores and only VARC-2 ES; moreover, the absence of VARC-2 ES and low-osmolar contrast media administration were identified as independent predictors of 1-year mortality and absence of VARC-3 ES, respectively. Finally, even a single complication included in the ES definition could significantly affect 1-year mortality. CONCLUSION: Currently, the most used mortality risk scores do not have adequate diagnostic accuracy in predicting ES after TAVI. The absence of VARC-2, instead of VARC-3, ES is an independent predictor of 1-year mortality.

The hemodynamic performance of balloon-expandable aortic bioprostheses in the elderly: a comparison between rapid deployment and transcatheter implantation.

BACKGROUND: Surgical aortic valve replacement with a rapid deployment valve (RDV) is a relatively recent treatment option. The aim of this study was to compare the hemodynamic performance of balloon-expandable (BE)-RDVs and BE-transcatheter heart valves (THVs) in a high surgical risk and frail-elderly population. METHODS: BE-THVs and BE-RDVs were implanted in 138 and 47 patients, respectively, all older than 75 years and with a Canadian Study of Health and Aging category of 5 or above. Echocardiographic assessment was performed at discharge and six months later. RESULTS: At discharge, transprosthetic pressure gradients and indexed effective orifice area (iEOA) were similar in both cohorts. At six-month follow-up, BE-RDVs showed lower peak (14.69 vs. 20.86 mmHg; p < 0.001) and mean (7.82 vs. 11.83 mmHg; p < 0.001) gradients, and larger iEOA (1.05 vs. 0.84 cm2/m2; p < 0.001). Similar findings were also shown considering only small-sized valves. Moderate-to-severe paravalvular leakage was more prevalent in BE-THVs at discharge (14.49 vs. 0.00%; p = 0.032) and, considering exclusively small prostheses, at six months too (57.69 vs. 15.00%; p = 0.014). Nevertheless, BE-THVs determined amelioration in left ventricular ejection fraction (53.79 vs. 60.14%; p < 0.001), pulmonary artery systolic pressure (35.81 vs. 33.15 mmHg; p = 0.042), and tricuspid regurgitation severity (40.58 vs. 19.57%; p = 0.031), from discharge to mid-term follow-up. CONCLUSIONS: BE-RDVs showed better hemodynamic performance, especially when implanted in small annuli. Despite their worse baseline conditions, transcatheter patients still exhibited a greater improvement of their echocardiographic profile at mid-term follow-up.

Safety of reduced or absent antithrombotic therapy after left atrial appendage closure in patients affected by hereditary hemorrhagic telangiectasia and atrial fibrillation.

BACKGROUND: Left atrial appendage (LAA) closure represents a novel therapeutic chance for patients with contraindications to long-term anticoagulation therapy, such as those affected by hereditary hemorrhagic telangiectasia (HHT) and atrial fibrillation (AF). Nevertheless, current experts' indications suggest the postprocedural administration of antithrombotic therapies to minimize the residual thromboembolic risk due to AF and to the need for device endothelialization. The aim of our study was to investigate the safety and effectiveness of LAA closure in preventing arterial thromboembolism in a very high-bleeding risk group, such as HHT patients, who are at risk not to tolerate even the mild postprocedural antithrombotic therapy usually recommended. METHODS: Eight HHT-affected patients with non-valvular AF, high-bleeding risk and/or known intolerance to antiplatelet and anticoagulant therapy were treated with interventional LAA occlusion with the Amplatzer™ Cardiac Plug™ and Amplatzer™ Amulet™ devices. Device implantation was successful in all patients. RESULTS: Postprocedural antiplatelet/anticoagulation therapy was attempted in seven patients: adherence to therapy exceeded 6 months only for one, while four patients suspended all antithrombotic medications within 30 days from the procedure due to an increase in bleeding frequency and/or severity and the other two discontinued treatment within 6 months; a single patient was not prescribed any antithrombotic therapy. At a medium follow-up of 22.4±14.3 months no thromboembolic episodes attributable to AF or device related thrombosis were reported. Two deaths were recorded 1231 and 783 days after the procedure which were classified as unrelated to any cerebral or cardiovascular accident. CONCLUSIONS: Our study suggests that the percutaneous LAA closure in HHT patients with AF could be safe and effective in preventing arterial systemic thromboembolism, also in the presence of reduced or absent postinterventional antithrombotic treatment. LAA occluder implantation can represent a valid and potentially life-saving alternative to lifelong anticoagulant therapy in HHT, as in other very high-bleeding risk patients.

Novel Technique for Percutaneous Retrieval of a U-kinked Impella Catheter.

We present a new technique for percutaneous retrieval of a U-kinked displaced Impella catheter. First we used the hooker from the left femoral artery to snare the catheter tip. Both catheter and hooker were pulled down simultaneously from 2 opposite sites until the U-kinking sat astride the aortic bifurcation. Finally the loop was straightened by pulling both catheter and hook. Once unfolded the hook was released, and the catheter was retrieved easily from the right femoral artery. This technique is highly reproducible because of several advantages. It is easy to perform, takes a short time, does not require special devices, and is not expensive.

Magna Graecia transcatheter aortic valve implantation registry: data on contrast medium osmolality and postprocedural acute kidney injury.

A comprehensive description of baseline characteristics, procedural features and outcomes related to the development of acute kidney injury (AKI) after transcatheter aortic valve implantation (TAVI) is reported in our research paper (Impact of contrast medium osmolality on the risk of acute kidney injury after transcatheter aortic valve implantation: insights from the Magna Graecia TAVI registry. Int J Cardiol. DOI: 10.1016/j.ijcard.2020.12.049). Three Italian heart centers were involved in this multicentric observational study. Between March 2011 and February 2019, a total of 888 patients underwent TAVI; according to the inclusion and exclusion criteria, 697 patients were included in the post-hoc analysis. This Data in Brief paper aims to report demographic, clinical, laboratory, echocardiographic, intraprocedural, periprocedural, postprocedural and follow-up data; all of them were prospectively collected from each patient's health record, whereas the analysis was performed retrospectively. Targets of this data analysis were: 1) to evaluate the impact of contrast medium (CM) osmolality on TAVI-related AKI; 2) to identify the most of risk factors involved in the development of such complication, and consequently in the occurrence of 1-year mortality; 3) to estimate the impact of CM osmolality on AKI in specific patient subgroups.

Impact of contrast medium osmolality on the risk of acute kidney injury after transcatheter aortic valve implantation: insights from the Magna Graecia TAVI registry.

BACKGROUND: Acute kidney injury (AKI) after transcatheter aortic valve implantation (TAVI) is frequent and associated with adverse outcomes and mortality; to date, in such setting of patients there is no consistent evidence that either low-osmolar contrast media (LOCM) or iso-osmolar contrast medium (IOCM) are superior to the other in terms of renal safety. METHODS: 697 consecutive patients not in hemodialysis treatment who underwent TAVI (327 males, mean age 81.01 ± 5.75 years, mean european system for cardiac operative risk evaluation II 6.17 ± 0.23%) were enrolled. According to osmolality of the different iodinated CM, the population was divided in 2 groups: IOCM (n = 370) and LOCM group (n = 327). Preoperatively, 40.54% of patients in IOCM vs 39.14% in LOCM group (p = 0.765) suffered from chronic kidney disease (CKD). RESULTS: The incidence of AKI was significantly lower with IOCM (9.73%) than with LOCM (15.90%; p = 0.02), and such significant difference (p < 0.001) in postprocedural change of renal function parameters persisted at discharge too. The incidence of AKI was also significantly lower with IOCM in younger patients, without diabetes, anemia, coronary artery disease history, CKD, chronic or persistent atrial fibrillation, left ventricular ejection fraction ≤35%, and in patients with low operative mortality risk scores, receiving lower amounts of dye (p < 0.05 for all). Importantly, multivariate analysis identified LOCM administration as an independent risk factor for both AKI (p = 0.006) and 1-year mortality (p = 0.001). CONCLUSIONS: The use of IOCM have a favorable impact on renal function with respect to LOCM, but it should be considered especially for TAVI patients at lower AKI risk.

Endothelial Dysfunction May Link Interatrial Septal Abnormalities and MTHFR-Inherited Defects to Cryptogenic Stroke Predisposition.

We explored the significance of the L-Arginine/asymmetric dimethylarginine (L-Arg/ADMA) ratio as a biomarker of endothelial dysfunction in stroke patients. To this aim, we evaluated the correlation, in terms of severity, between the degree of endothelial dysfunction (by L-Arg/ADMA ratio), the methylene tetrahydrofolate reductase (MTHFR) genotype, and the interatrial septum (IAS) phenotype in subject with a history of stroke. Methods and Results: L-Arg, ADMA, and MTHFR genotypes were evaluated; the IAS phenotype was assessed by transesophageal echocardiography. Patients were grouped according to the severity of IAS defects and the residual enzymatic activity of MTHFR-mutated variants, and values of L-Arg/ADMA ratio were measured in each subgroup. Of 57 patients, 10 had a septum integrum (SI), 38 a patent foramen ovale (PFO), and 9 an ostium secundum (OS). The L-Arg/ADMA ratio differed across septum phenotypes (p ≤ 0.01), and was higher in SI than in PFO or OS patients (p ≤ 0.05, p ≤ 0.01, respectively). In the PFO subgroup a negative correlation was found between the L-Arg/ADMA ratio and PFO tunnel length/height ratio (p ≤ 0.05; r = - 0.37; R2 = 0.14). Interestingly, the L-Arg/ADMA ratio varied across MTHFR genotypes (p ≤ 0.0001) and was lower in subgroups carrying the most impaired enzyme with respect to patients carrying the conservative MTHFR (p ≤ 0.0001, p ≤ 0.05, respectively). Consistently, OS patients carried the most dysfunctional MTHFR genotypes, whereas SI patients the least ones. Conclusions: A low L-Arg/ADMA ratio correlates with impaired activity of MTHFR and with the jeopardized IAS phenotype along a severity spectrum encompassing OS, PFO with long/tight tunnel, PFO with short/large tunnel, and SI. This infers that genetic MTHFR defects may underlie endothelial dysfunction-related IAS abnormalities, and predispose to a cryptogenic stroke. Our findings emphasize the role of the L-Arg/ADMA ratio as a reliable marker of stroke susceptibility in carriers of IAS abnormalities, and suggest its potential use both as a diagnostic tool and as a decision aid for therapy.

Age-Related 2-Year Mortality After Transcatheter Aortic Valve Replacement: the YOUNG TAVR Registry.

OBJECTIVE: To comparatively assess the natural history of patients of different ages undergoing transcatheter aortic valve replacement (TAVR). PATIENTS AND METHODS: For this study, we used the YOUNG TAVR, an international, multicenter registry investigating mortality trends up to 2 years in patients with aortic valve stenosis treated by TAVR, classified according to 3 prespecified age groups: 75 years or younger (n=179), 76 to 86 years (n=602), and older than 86 years (n=221). A total of 1002 patients undergoing TAVR were included. Demographic, clinical, and outcome data in the youngest group were compared with those of patients 76 to 86 years and older than 86 years. Patients were followed up for up to 2 years. RESULTS: Compared with patients 75 years or younger (reference group), patients aged 76 to 86 years and older than 86 years had nonsignificantly different 30-day mortality (odds ratio, 0.76; 95% CI, 0.41-1.38; P=.37 and odds ratio, 1.27; 95% CI, 0.62-2.60; P=.51, respectively) and 1-year mortality (hazard ratio (HR), 0.72; 95% CI, 0.48-1.09; P=.12 and HR, 1.11; 95% CI, 0.88-1.40; P=.34, respectively). Mortality at 2 years was significantly lower among patients aged 76 to 86 years (HR, 0.62; 95% CI, 0.42-0.90; P=.01) but not among the older group (HR, 1.06; 95% CI, 0.68-1.67; P=.79). The Society of Thoracic Surgeons 30-day mortality score was lower in younger patients who, however, had a significantly higher prevalence of chronic obstructive pulmonary disease (P=.005 vs the intermediate group and P=.02 vs the older group) and bicuspid aortic valves (P=.02 vs both older groups), larger left ventricles, and lower ejection fractions. CONCLUSION: In the present registry, mortality at 2 years after TAVR among patients 75 years or younger was higher compared with that of patients aged 75 to 86 years and was not markedly different from that of patients older than 86 years. The findings are attributable at least in part to a greater burden of comorbidities in the younger age group that are not entirely captured by current risk assessment tools.

Atrial septal defect and patent foramen ovale: early and long-term effects on endothelial function after percutaneous occlusion procedure.

Percutaneous closure of atrial septal defect (ASD)/patent foramen ovale (PFO) can influence systemic hemodynamics. The aim of this research was to evaluate the influence of the closure procedure on morphological and functional characteristics of systemic vascular walls. Fourteen ASD (mean age 40 ± 16 years) and 14 PFO (45 ± 8 years) patients were enrolled in this retrospective study. All underwent percutaneous closure procedure; physical, clinical and biochemical evaluations; echocardiography; carotid evaluation; and brachial artery flow-mediated vasodilatation (FMD). All the evaluations were performed at the time of enrollment, 24 h post-procedure, at 1-6-12-month follow-up. FMD at enrollment was higher in PFO patients as compared to ASD (8.5% [7.6-10.7%] versus 6.5% [5.6-7.6%], p < 0.0001). FMD values in ASD patients significantly increased during follow-up (enrollment: 6.5% [5.6-7.6%], 12-month follow-up: 8.8% [7.2-10.3%], p < 0.01). PFO patients showed reduced FMD values 24 h after the procedure (enrollment: 8.5% [7.6-10.7%], 24 h post-procedure: 7% [6.3-9%], p < 0.001), while recovering endothelial function during follow-up period to baseline values (FMD at 12-month follow-up: 8.2% [7.6-10.5%]). At one-year follow-up, FMD remained inversely related to systolic pulmonary arterial pressure and right and left atrial/ventricle chambers dimensions (RV proximal diameter efflux tract, right atrium [RA] longitudinal diameter, RA transverse diameter, RA area, left ventricle [LV] end-diastolic diameter, left atrium [LA] anteroposterior diameter, LA area; p < 0.01) in ASD patients. Endothelial function improved after percutaneous closure of ASD, while remaining stable after PFO closure. Therefore, ASD patients seem to improve their cardiovascular risk profile after percutaneous closure of their defect.

Use of a NobleStitch™ EL Device for PFO Closure.

Cryptogenic stroke is the final diagnosis in almost 40% of ischemic acute cerebrovascular events. There is currently no definitive clinical evidence that percutaneous closure of patent foramen ovale (PFO) can prevent the recurrence of stroke or transient ischemic attack (TIA). Identification of the causes of neurologic ischemic syndromes is essential for any strategy intended to prevent the catastrophic consequences of cerebral infarction. Since the initial reports of an unexpectedly high prevalence of PFO in younger patients with cryptogenic stroke in 1988, there has been growing interest and experience in diagnosing and treating these patients, both medically and/or with percutaneous closure, in particular for the potential to eliminate paradoxical embolism via PFO, which is a likely mechanism for stroke in these patients. Selection of the appropriate occluder device is of paramount importance for the success of the procedure. While devices like the Amplatzer™ PFO Occluder (St. Jude Medical), which, based on the extended follow-up of the RESPECT Trial, was approved by the U.S. Food and Drug Administration last year for recurrent stroke prevention, have become generally accepted as being better than medical therapy for patients needing treatment, concerns remain regarding device- and procedure-related complications. NobleStitch™ EL is a novel device that offers a simple non-prosthetic implant method of PFO closure without the inherent risks seen with septal occluders: no risk of device embolization, device thrombosis or late erosion, and probably no risk of arrhythmia. Futhermore, there is no material that would hinder future access to the left atrium and no requirement for anti-coagulation.

Percutaneous Edge-to-Edge Transcatheter Mitral Valve Repair: Current Indications and Future Perspectives.

Mitral regurgitation (MR) is the most prevalent valvular heart disease (VHD) and represents an important cause of heart failure. Medical therapy has a limited role in improving symptoms and does not hinder the progression of valvular disease. Surgery is the treatment of choice for severe symptomatic MR; valve repair is currently the preferred surgical approach because it reduces peri-operative mortality and ensures a good medium- to long-term survival outcome. Nevertheless, a non-negligible proportion of patients with indications for surgical correction are considered to be at prohibitive perioperative risk, mainly because of old age and multiple comorbidities. The introduction of percutaneous interventions to clinical practice has changed the natural history of this population. Percutaneous edge-to-edge transcatheter mitral valve repair (Mitraclip®, Abbott Vascular, Menlo Park, CA) is a state-of-the-art therapy for approaching MR in patients with a high surgical risk. Despite having been only recently introduced, this transvenous transfemoral percutaneous intervention has already been performed in more than 40,000 subjects worldwide, with reassuring post-operative results in terms of safety, feasibility, mortality and morbidity. Since Mitraclip® is considered to be minimally invasive, it is currently indicated in "frail" patients with severe comorbidities. We provide a critical review of the literature to clarify current indications, procedural details, patient selection criteria, and future perspectives for this innovative technique.

[Acute aortic dissection during ineffective attempt of transcatheter implant of a fully resheathable, respositionable and retrievable aortic valve]. / Dissezione aortica acuta durante tentativo inefficace di impianto transcatetere di protesi aortica totalmente riposizionabile e recuperabile.

Aortic injury is a rare but severe complication that may occur during transcatheter aortic valve implantation (TAVI). Few patients with type A dissection are treated surgically because of the high rate of postoperative mortality and neurological complications in this high-risk population; thoracic endovascular aortic repair is rare too, and technically challenging because of the anatomical variations of spiral type A aortic dissection. Sometimes a watchful waiting strategy could be the best solution. We report the case of an acute, extended aortic type A dissection occurred during a TAVI procedure, probably due to the rupture of the dedicated sheath, and conservatively managed.

Accuracy of Intravascular Ultrasound Evaluation for the Assessment of Native Valve Measures in Patients Undergoing TAVI: Preliminary Results.

INTRODUCTION: Transcatheter aortic valve implantation (TAVI) technique represents a real revolution in the field of interventional cardiology and medicine, in particular for the treatment of severe aortic valve stenosis in elderly patients or in patients when the periprocedural risk for the traditional surgical option is considered too high, as an alternative to the traditional aortic valve replacement. Although experience on the valves of the last generation is still limited in terms of time, the data currently available are definitely moving in the direction of a minimum hospital mortality (1%) as well as a drastic reduction in the incidence of complications when compared to the devices of the previous generation. Finally, the evolution of specified materials of the newest generation have greatly enhanced safety and efficacy of TAVI procedures in the last years. In order to ensure the selection of the most appropriate valve and the success of the procedure, the role of cardiac imaging (computed tomography scan evaluation and angiography) is crucial. These examinations require the use of contrast medium in patients suffering from renal dysfunction at the baseline. The need for fluoroscopy and angiography using contrast agents to aid positioning of the valve may lead to contrast-induced nephropathy (CIN) as one form or one etiology of acute kidney injury (AKI), which is associated with increased morbidity and mortality. The aim of our study is to investigate the accuracy of intravascular ultrasound (IVUS-a technique which does not need contrast) for the assessment of native valve measures in patients undergoing TAVI by comparing values obtained with IVUS to those ones previously obtained in the same patients with computed tomography (CT) scans. MATERIAL AND METHODS: We enrolled 25 consecutive patients (10 males, average age 81.3±5,1 years) who underwent TAVI with femoral access in our Cardiac Surgery Cath-Lab (University of Bari) from January to October 2015 (Logistic EuroSCORE 21.6±15.4%; STS score mortality 20.9±14.9%). Each patient scheduled for TAVI underwent coronary angiography and high resolution angio-CT in order to obtain a complete evaluation (diameters, perimeters, and areas at annulus level, -3mm level, +15mm level, height of coronary ostia, shape, and conformation of left ventricle outflow tract, conformation, and calcifications of aortic and ileo-femoral axis) to choose the most suitable prosthetic aortic valve for each patient. In all patients, during the procedure (before the prosthetic valve implantation), we executed a manual IVUS pullback (from left ventricle outflow tract to ascending aorta) by using a 7F IVUS probe (Volcano Corporation, San Diego, CA). On the recorded IVUS pullback, a second operator (who did not know the values obtained by CT measurements) identified the aortic annulus and, at this level, measured: minimum and maximum diameter; perimeter; derived perimeter, and area. The t-student test has been used to compare the averages of these IVUS values to the CT ones. A p value< 0.05 was considered as statistically significant. RESULTS: Independently from the kind and size of implanted prosthetic valve, no statistical differences were found when the averages of all considered parameters (obtained both with CT and IVUS) were compared. The following are the results obtained: minimum diameter (CT: 19,62mm±1,10 vs. IVUS: 19,55mm±1,40; p=0.41); maximum diameter (CT: 24,73mm±2,42 vs. IVUS: 25,9mm±1,80; p=0.08); perimeter (CT: 72,05mm±4,36 vs. IVUS: 73,32mm±6,09; p=0.164); derived perimeter (CT: 22,94mm±1,40 vs. IVUS: 23,32mm ± 1,95; p=0,198); and area (CT: 3,99cm2 ±0,97 vs. IVUS: 4,06 cm2 ± 0,47; p=0,073) (Figs. 1-3). CONCLUSIONS: These preliminary data suggest accurate IVUS measures when compared to CT in the evaluation of valve parameters considered (minimum and maximum diameters, area, perimeter, and derived perimeter at the annulus level). In order to confirm these findings and to give them statistical significance, it will be necessary to increase the sample size.

'Broken-heart' syndrome: ventricular septal perforation in a takotsubo cardiomyopathy.

Takotsubo cardiomyopathy (TTC) is a form of acute left ventricular dysfunction usually reversible and with favorable prognosis. Ventricular septal perforation (VSP) is a very rare life-threatening complication. Percutaneous closure of VSP, despite being challenging, is a possible alternative to surgical repair. We present the first case of an 84-year-old patient with a TTC-related VSP treated by percutaneous approach. The case highlights the need of reconsidering the worldwide accepted consideration of TTC as benignant and allows some speculations on the optimal management of VSP in terms of timing, patient selection and possible alternative interventions.

Fourth-generation endovascular stent-graft: the concept of laminar flow.

The stent graft is a noncompliant system inserted in a semi-compliant structure. This generates a mismatch. The media also shows a composite movement and is oriented 45° resulting in an arterial spiral movement that contributes to maintaining the clockwise orientation of laminar flow with an 80° deflection. Our multilayer stent is constituted by a single Nitinol thread, worked on 3 surfaces in order to realize a proper exoskeleton that reproduces the architecture of the tunica media, in particular its flexo-torsional forces, thus restoring the energy transmission and the match between the wall and the blood flow. A first in vivo implantation was performed by using an experimental pig model in our veterinary department. The pig underwent general anesthesia and the right femoral artery was surgically exposed in order to accommodate a 12F long introducer sheath. Under fluoroscopy three multilayer stents were consecutively implanted from the aortic isthmus to the iliac bifurcation in an overlap fashion. All the intercostal artery and visceral branches were covered by the overlapped stents. The final control angiography revealed an optimal sealing of the implanted stent with an evident flexotorsional oscillatory movement, which follows the conical architecture of the thoracic aorta and the complete patency of all the branches that arise from the aorta. After two months, the multilayer showed a normal endothelialization process with an optimal adhesion to the aortic wall both proximally and distally without provoking any inflammatory response or thickness wall alterations. The perfect and homogenous endothelialization preserved the patency of all the collateral branches arising from the treated aorta, in particular all the intercostal arteries, celiac trunk, and renal arteries. The disease of the aorta essentially concerns the tunica media as it causes disruption of the media components. This exoskeleton works like a neo-tunica media, is perfectly endothelialized, and seems to optimally transmit the flexotorsional forces, restoring the match between wall and flow that represents the primary condition for laminar flow and branch perfusion.

Transcatheter aortic valve implantation: 3-year outcomes of self-expanding CoreValve prosthesis.

AIMS: The paucity of evidences about the long-term durability of currently available transcatheter prostheses is one of the main issues of transcatheter aortic valve implantation (TAVI). We sought to assess 3-year clinical and echocardiographic outcomes of patients undergoing TAVI with the third generation CoreValve prosthesis (Medtronic Incorporation, MN, USA). METHODS AND RESULTS: From the Italian CoreValve registry, 181 who underwent TAVI from June 2007 to August 2008 and eligible for 3-year follow-up were analysed. All outcomes were defined according to the Valve Academic Research Consortium. All-cause mortality at 1, 2, and 3 years was 23.6, 30.3, and 34.8%, respectively. Cardiovascular death at 1, 2, and 3 years was 11.2, 12.1, and 13.5%, respectively. The actuarial survival free from a composite of death, major stroke, myocardial infarction, and life-threatening bleeding was 69.6% at 1 year, 63.5% at 2 years, and 59.7% at 3 years. Patients with renal insufficiency had a higher mortality at 3-year follow-up (49.0 vs. 29.2%, P = 0.007); moreover, patients experiencing post-procedural major or life-threatening bleeding had a higher rate of mortality already seen at 30 days (21.6 vs. 2.8%; P < 0.001) and this result was sustained at 3-year follow-up (62.2 vs. 27.7%; P < 0.001). Mean pressure gradients decreased from 52.2 ± 18.1 mmHg (pre-TAVI) to 10.3 ± 3.1 mmHg (1-year post-TAVI) (P < 0.001); aortic valve area increased from 0.6 ± 0.2 cm(2) (pre-TAVI) to 1.8 ± 0.4 cm(2) (1-year post-TAVI); these results remained stable over the 3 years of follow-up. Paravalvular leak was observed in the majority of patients. There were no cases of progression to moderate or severe regurgitation. No cases of structural valve deterioration were observed. CONCLUSION: This multicentre study demonstrates that TAVI with the 18-Fr CoreValve ReValving System is associated with sustained clinical and functional cardiovascular benefits in high-risk patients with symptomatic aortic stenosis up to 3-year follow-up. Non-cardiac causes accounted for the majority of deaths at follow-up.

Hemostasis alterations in patients with acute aortic dissection.

BACKGROUND: Surgery for acute aortic dissection (AAD) is frequently complicated by excessive postoperative bleeding and blood product transfusion. Blood flow through the nonendothelialized false lumen is a potential trigger for the activation of the hemostatic system; however, the physiopathology of the aortic dissection induced coagulopathy has never been precisely studied. The aim of the present study is the evaluation of the coagulation and fibrinolytic systems and platelet activation in patients undergoing surgery for AAD. METHODS: Eighteen patients undergoing emergent surgery for Stanford type A AAD were enrolled in the study. The activation of the coagulation and fibrinolytic systems and platelet activation were evaluated at 6 different time points before, during, and after the operation, measuring prothrombin fragment 1.2 (F1.2), plasmin-antiplasmin complex, and platelet factor 4, respectively. RESULTS: All measured biomarkers were increased before, during, and after the operations indicating a systemic activation of coagulation, fibrinolysis, and platelets. These changes were pronounced even preoperatively (T0), and soon after the beginning of cardiopulmonary bypass (T1) when the influence of hypothermia and prolonged cardiopulmonary bypass time were not yet involved. Time from symptom onset to intervention inversely correlated with preoperative F1.2 (r=-0.75; p=0.002) and plasmin-antiplasmin levels (r=-0.57; p=0.034). CONCLUSIONS: Blood flow through the false lumen is a powerful activator of the hemostatic system even before the operation. This remarkable activation may influence postoperative outcome of AAD patients.