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Testa L.,Instituto Clinico S Ambrogio | Latib A.,San Raffaele Hospital | De Marco F.,Niguarda Ca Granda Hospital | De Carlo M.,Azienda Ospedaliero Universitaria Pisana | And 14 more authors.
Circulation | Year: 2013

Background-Conduction disturbances are relatively common after transcatheter aortic valve implantation. Previous data demonstrated an adverse impact of persistent left bundle-branch block (LBBB) after surgical aortic valve replacement. It is unclear whether new-onset LBBB may also impact the prognosis of patients after transcatheter aortic valve implantation. Methods and Results-Among 1060 patients treated with a CoreValve Revalving System transcatheter aortic valve implantation between October 2007 and April 2011 in high-volume centers in Italy, we analyzed those without LBBB or pacemaker at admission (879 patients [82.9%]). We further excluded those who underwent permanent pacemaker implantation within 48 hours after the procedure (61 patients [7%]), for a final study population of 818 patients. Among them, 224 patients (group A; 27.4%) developed a persistent LBBB and the remaining 594 (group B; 72.6%) did not. Clinical characteristics were similar between groups. A low implantation was significantly more frequent in group A (15% versus 9.8%, P=0.02). No patients were censored before 1 year (median follow-up period 438 days, interquartile range 174-798 days). Survival analyses and inherent log-rank tests showed that LBBB was not associated with higher all-cause mortality, cardiac mortality, or hospitalization for heart failure at 30 days or 1 year. At 30 days, but not at 1 year, group A had a significantly higher rate of pacemaker implantation. Conclusions-In this registry of high-volume centers, persistent LBBB after CoreValve Revalving System transcatheter aortic valve implantation showed no effect on hard end points. On the other hand, LBBB was associated with a higher short-term rate of pacemaker implantation. © 2013 American Heart Association, Inc.


Roy D.A.,St Georges Hospital | Schaefer U.,St Georg Hospital | Guetta V.,Sheba Medical Center | Hildick-Smith D.,University of Sussex | And 17 more authors.
Journal of the American College of Cardiology | Year: 2013

Objectives: This study sought to collect data and evaluate the anecdotal use of transcatheter aortic valve implantation (TAVI) in pure native aortic valve regurgitation (NAVR) for patients who were deemed surgically inoperable Background: Data and experience with TAVI in the treatment of patients with pure severe NAVR are limited. Methods: Data on baseline patient characteristics, device and procedure parameters, echocardiographic parameters, and outcomes up to July 2012 were collected retrospectively from 14 centers that have performed TAVI for NAVR. Results: A total of 43 patients underwent TAVI with the CoreValve prosthesis (Medtronic, Minneapolis, Minnesota) at 14 centers (mean age, 75.3 ± 8.8 years; 53% female; mean logistic EuroSCORE (European System for Cardiac Operative Risk Evaluation), 26.9 ± 17.9%; and mean Society of Thoracic Surgeons score, 10.2 ± 5.3%). All patients had severe NAVR on echocardiography without aortic stenosis and 17 patients (39.5%) had the degree of aortic valvular calcification documented on CT or echocardiography. Vascular access was transfemoral (n = 35), subclavian (n = 4), direct aortic (n = 3), and carotid (n = 1). Implantation of a TAVI was performed in 42 patients (97.7%), and 8 patients (18.6%) required a second valve during the index procedure for residual aortic regurgitation. In all patients requiring second valves, valvular calcification was absent (p = 0.014). Post-procedure aortic regurgitation grade I or lower was present in 34 patients (79.1%). At 30 days, the major stroke incidence was 4.7%, and the all-cause mortality rate was 9.3%. At 12 months, the all-cause mortality rate was 21.4% (6 of 28 patients). Conclusions: This registry analysis demonstrates the feasibility and potential procedure difficulties when using TAVI for severe NAVR. Acceptable results may be achieved in carefully selected patients who are deemed too high risk for conventional surgery, but the possibility of requiring 2 valves and leaving residual aortic regurgitation remain important considerations. © 2013 American College of Cardiology Foundation.


Filosso P.L.,University of Turin | Ruffini E.,University of Turin | Lausi P.O.,University of Turin | Lucchi M.,Azienda Ospedaliero Universitaria Pisana | And 2 more authors.
Lung Cancer | Year: 2014

Thymic epithelial tumors (thymomas, thymic carcinomas and neuroendocrine tumors - NETs) are rare primary mediastinal neoplasms, recently classified as orphan diseases. Their rarity might explain the fact that currently, no official staging system has been defined by the Union Internationale Contre le Cancer (UICC) and the American Joint Commission on Cancer (AJCC). However, the appropriate staging of these tumors has been matter of debate and several proposals have been published over the years, but very few have received a clinical validation.Recently an international database for thymic malignancies has been provided by the International Thymic Malignancy Interest Group (ITMIG); one of its aims is to accomplish a new and evidence based staging system, to allow progress in clinical management in thymic tumors.This paper will review the history of proposed staging systems, comparing resemblances and differences, being a sort of starting point for the development of a new widely accepted clinical staging system. © 2013 Elsevier Ireland Ltd.


Fabio G.,Azienda Ospedaliero Universitaria Pisana | Pietro B.,Azienda Ospedaliero Universitaria Pisana | Pietro B.,University of Pisa
Current Opinion in Critical Care | Year: 2014

PURPOSE OF REVIEW: This review analyses the application of perioperative echocardiography as an important tool in the management of haemodynamic impairment. RECENT FINDINGS: Recently, echocardiography has demonstrated utility in preoperative assessment for both cardiac and noncardiac surgery. There is also evidence that, using diagnostic methods, echocardiography could be used as an image-based technique comparable with standard catheter-based monitoring techniques in high-risk patients. Echocardiography can be performed both intraoperatively and during the postoperative period in the ICU and is therefore being considered a potential tool to assess haemodynamic instability. SUMMARY: Echocardiography has recently gained popularity among anaesthesiologists and intensive care practitioners because it provides a pathophysiological picture of haemodynamic impairment, allowing a more detailed understanding of the static or dynamic parameters on which clinicians usually rely when making decisions. © 2014 Lippincott Williams & Wilkins.


Cantarovich D.,General and Transplant Surgery | Perrone V.,Azienda Ospedaliero Universitaria Pisana
Seminars in Nephrology | Year: 2012

Recent findings from the Diabetes Control and Complications Trial and Epidemiology of Diabetes Interventions and Complications study showed that long-term improved glycemic control in patients with type 1 diabetes with normal renal function and normoalbuminuria can delay development of impaired renal function by at least 6.5 years, although the reduction in the relative risk of end-stage renal disease (ESRD) was not significant. The unanswered question is: can improvement of glycemic control delay the onset of ESRD in patients with established diabetic nephropathy? In this context, pancreas transplantation (PATx) can be considered the most effective intervention to restore normoglycemia. Can this aggressive/experimental intervention be applied to arrest/retard renal function decline? To answer this question, this review summarizes the relevant findings from observational studies conducted in cohorts of patients, followed up for 4 to 15 years, who underwent PATx. These noncontrolled studies provided positive answers to the earlier question, principally concerning a significant decrease in albumin excretion levels. However, current drugs used to prevent rejection could impair renal function, principally in recipients with low pretransplant estimated glomerular filtration rate (ie, <60 mL/min). Unfortunately, all these studies had shortcuts that qualify interpretation of the findings. First, it is unclear how much initial estimated glomerular filtration rate loss results from nephrotoxic effect of antirejection drugs, and how much results from improved glycemia and its impact on the reduction of hyperfiltration. Second, the study designs did not consider the wide variation in rates of renal function loss observed in patients with established nephropathy (ie, one third are nonprogressors, one third are slow progressors, and one third are rapid progressors). Third, all studies were observational in nature and clinical trials are needed to properly evaluate the effectiveness of normalization of hyperglycemia through PATx on postponing the onset of ESRD in type 1 diabetes.© 2012.


Calicchio F.,Azienda Ospedaliero Universitaria Pisana
Journal of Cardiovascular Medicine | Year: 2016

OBJECTIVES: The aim of this study is to investigate the role and short-term results of balloon aortic valvuloplasty (BAV) before noncardiac surgery in a high selected cohort of patients. BACKGROUND: Aortic stenosis is one of the most common valvular heart diseases and a well recognized risk factor for perioperative mortality. METHODS: Between May 2012 and July 2013 we enrolled 15 consecutive patients with severe aortic stenosis to allow urgent major noncardiac surgery. They had been excluded from surgical aortic valve replacement and transcatheter aortic valve implantation. RESULTS: Fifteen patients underwent BAV as a bridge to noncardiac surgery. They were elderly (mean age 81?±?5 years) and predominantly men (66%) with high surgery risk (mean logistic EuroSCORE: 31.1?±?18.2%). Three patients underwent vascular surgery, five underwent thoracic surgery, five were subjected to major abdominal surgery and in the last two patients orthopedic surgery and mastectomy were performed. No adverse events were observed in the perioperative period. Six patients (40%) were in New York Heart Association class III or IV. Mean aortic valve area was 0.52?±?0.1?cm/m; mean aortic pressure gradient was 55.6?±?10.8?mmHg. BAV was performed successfully in all patients. The mean peak-to-peak gradient assessed by catheterization significantly reduced after BAV (from 69.0?±?22.1 to 29.7?±?9.3?mmHg; P?


Rizzo S.,Azienda Ospedaliero Universitaria Pisana | Belting C.,Azienda Ospedaliero Universitaria Pisana | Cinelli L.,Azienda Ospedaliero Universitaria Pisana | Allegrini L.,Azienda Ospedaliero Universitaria Pisana | And 3 more authors.
American Journal of Ophthalmology | Year: 2014

• Purpose: To study the anatomic and functional outcomes of Argus II Retinal Prosthesis System implantation in patients with retinitis pigmentosa. • Design: Interventional case series. • Methods: The study population included 6 patients with visual acuity no better than light perception. After the Argus II Retinal Prosthesis System was implanted, complications and anatomic and functional results were studied. The main outcome measures were mobility, square localization, direction of motion, grating visual acuity, and Goldmann visual field, all of which were assessed. Optical coherence tomography was performed. • Results: Implantation of the Argus II Retinal Prosthesis System was safely performed in all patients. One patient experienced postoperative elevation in intraocular pressure, which was controlled medically. In 1 patient, moderate detachment of the choroid occurred postoperatively, and it resolved spontaneously. One patient withdrew from the study. Wound dehiscence, endophthalmitis or retinal detachment was not observed. All patients were able to locate a bright light on the ceiling and a dark line on the floor after the surgery. Performance in square localization tests improved in 4 patients, and direction of motion improved in 3 patients. One patient achieved grating visual acuity. Goldmann visual field test results improved in all patients. • Conclusions: The patients showed improvement in visual tasks after the surgery, and the device was well tolerated and functional over a 1-year follow-up period. A rigorous patient-selection process is necessary to maximize patient compliance with the rigorous follow-up testing schedule. Both patients and medical staff should be prepared for a lengthy, arduous rehabilitation process. © 2014 by Elsevier Inc. All Rights Reserved.


Perrini P.,Azienda Ospedaliero Universitaria Pisana
Journal of Neurological Surgery, Part B: Skull Base | Year: 2015

Duraplasty is a step commonly used for the treatment of Chiari I malformation after foramen magnum decompression. A variety of dural substitutes are currently available for dural closure to minimize the complications related to cerebrospinal fluid (CSF). We describe a technique of harvesting occipital pericranium for duraplasty associated with preservation of a wide cuff of muscle at the superior nuchal line that allows anatomical muscle closure at the end of the procedure. Five symptomatic patients with Chiari I malformation and one patient with syringomyelia-Chiari I complex were operated on with this technique. The indications to perform a duraplasty were accidental arachnoid breaching in three patients during an extra-arachnoidal approach and arachnoidal dissection due to intraoperative findings of arachnoid pathology in the remaining three patients. The overall morbidity of this technique was nil. In all patients the postoperative magnetic resonance imaging scan demonstrated significant expansion of the cisterna magna with no evidence of pseudomeningocele. Duraplasty with autologous pericranium and standardized closure of soft tissues seem promising in reducing the CSF-related complications during Chiari surgery.


Patent
Azienda Ospedaliero Universitaria Pisana | Date: 2014-09-17

The present invention refers to a process, and to the related apparatus, for the in vitro preparation of a biomimetic tissue prostheses of the tympanic membrane from mesenchymal stem cells; such prostheses are used for repairing or reconstructing the injured tympanic membrane in patients needing it, for example as a consequence of various trauma or pathologies.


Patent
Azienda Ospedaliero Universitaria Pisana | Date: 2010-04-14

A ventilation apparatus (1) for pulmonary scintigraphy, having an inhalation collector (10) to which an element of inhalation (20), a feed duct (31), defining a flow of marked aerosol (55), and an outlet duct (32), for disposal of exhaled flow and any aerosol surplus, are connected. The feeding air may be of bi-level type, whereby the air flow rate when breathing out is low, even if always positive. The collector (10) has a first interposition element (21) located at the connection with the air feeding tube (31) that only allows inlet flow towards the patient. A second interposition element (22) is located at the connection with outlet duct (32). The presence of one-way valve(s) (21, 22) allows breathing of the marked aerosol in the bronchial branches of the patient (20) in a completely natural manner following physiologic respiration and avoiding hyper-accumulation of marker in the largest bronchial branches. Scintigraphy is also allowed during non-invasive mechanical ventilation, carried out through the ventilation apparatus (1).

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