Alberto Pozzoli

First-in-man implantation of a tricuspid annular remodeling device for functional tricuspid regurgitation

Tricuspid regurgitation (TR) is a common finding in patients with left-sided disease, and is associated with poor outcome and predicts poor survival, heart failure, and reduced functional capacity [(1)][1]. It is common after mitral valve treatment in rheumatic or ischemic mitral regurgitation, if

Percutaneous tricuspid valve therapies: the new frontier

Moderate-to-severe tricuspid regurgitation (TR) affects ∼1.6 million patients in the USA, of whom only 8000 undergo tricuspid surgery annually; this results in an extremely large number of untreated patients with significant TR. Therefore, there is a large unmet clinical need for patients with severe TR who are not referred for conventional surgery, mainly due to expected high surgical risk. Percutaneous procedures are an attractive alternative to surgery for patients deemed to be high-risk surgical candidates. Whereas over the past few years, the development and clinical use of percutaneous approaches to the aortic valve and mitral valve have been widespread, few data are available about the feasibility and the efficacy of the percutaneous tricuspid valve treatment. This review will explore the available technologies, which are today under evaluation and the preliminary clinical results.

Surgical treatment of paravalvular leak: Long-term results in a single-center experience (up to 14 years)

OBJECTIVES The aim of this study is to report the long-term outcomes (median follow-up time, 7 years; range, 1 month to 14 years) of patients who underwent surgery for paravalvular leak in our single-center experience. METHODS From October 2000 to November 2007, 122 consecutive patients underwent surgery for symptomatic paravalvular leak (40 patients with aortic paravalvular leak; 82 with mitral paravalvular leak). In 7 patients (5.7%, all mitral), surgery was performed on the beating heart through a right thoracotomy. In 35% of patients, multiple paravalvular leaks were present. RESULTS The mean age of patients was 62 ± 11 years, and European System for Cardiac Operative Risk Evaluation II was 7.2% ± 6%. Most of the patients were in New York Heart Association functional class III or IV (60%). Symptomatic hemolysis was present in 31% of the patients, and 41% of the patients had more than 1 previous cardiac operation. Paravalvular leak repair was feasible in 79 patients (65%), whereas in 43 patients (35%) prosthesis re-replacement was required. Thirty-day mortality was 10.7% (13/122 patients; 5% for aortic paravalvular leak and 13% for mitral paravalvular leak; P = .1); 2 patients (1.6%) with residual severe mitral paravalvular leak underwent successful redo surgery before discharge. Median length of stay was 7 days. Overall actuarial survival was 39% ± 6% at 12 years; freedom from cardiac death was 54% ± 7% at 12 years. Only 1 patient underwent redo surgery during follow-up. Multivariable analysis identified preoperative chronic renal failure (hazard ratio, 2.6; 95% confidence interval, 1.4-4.9; P = .03) and more than 1 previous cardiac reoperation (hazard ratio, 2.3; 95% confidence interval, 1.3-4; P = .03) as independent predictors of death at follow-up. CONCLUSIONS The operative mortality of surgical treatment of paravalvular leak is still high. Long-term outcomes remain suboptimal in these challenging patients, especially in the presence of multiple previous cardiac operations and associated co-pathologies. These results support the importance of alternative therapeutic options.

Thoracoscopic Appendage Exclusion With an Atriclip Device As a Solo Treatment for Focal Atrial Tachycardia

A 15-year-old boy with incessant drug-refractory atrial tachycardia was referred to our department for an ablation procedure. The tachycardia was diagnosed at 13 years of age during routine medical screening for soccer competition. Despite the administration of metoprolol, verapamil, and flecainide, the arrhythmia persisted and ventricular response was not controlled. Physical examination was normal except for a heart rate of 130 bpm; no signs of congestive heart failure were found. Blood examinations revealed normal thyroid function. Twelve-lead ECG showed a narrow QRS tachycardia with positive P waves in II-III-aVF-V1-V2 leads, negative P waves in I-aVL leads, and a short PR interval (Figure 1), suggesting a left atrial origin.1,2 Transthoracic echocardiography showed normal left ventricular size with normal systolic function and normal atrial volumes. Figure 1. Twelve-lead ECG showed a narrow QRS tachycardia with positive P waves in II-III-aVF-V1-V2 leads, negative …

Conventional surgery and transcatheter closure via surgical transapical approach for paravalvular leak repair in high-risk patients: results from a single-centre experience.

OBJECTIVES Paravalvular leaks (PVL) occur in up to 17% of all surgically implanted prosthetic valves. Re-operation is associated with high morbidity and mortality. Transcatheter closure via a surgical transapical approach (TAp) is an emerging alternative for selected high-risk patients with PVL. The aim of this study was to compare the in-hospital outcomes of patients who underwent surgery and TA-closure for PVL in our single-centre experience. METHODS From October 2000 to June 2013, 139 patients with PVL were treated in our Institution. All the TA procedures were performed under general anaesthesia in a hybrid operative room: in all but one case an Amplatzer Vascular Plug III device was utilized. RESULTS Hundred and thirty-nine patients with PVL were treated: 122 patients (87.3%) underwent surgical treatment (68% mitral PVL; 32% aortic PVL) and 17 patients (12.2%) underwent a transcatheter closure via a surgical TAp approach (all the patients had mitral PVL; one case had combined mitral and aortic PVLs); in 35% of surgical patients and in 47% of TAp patients, multiple PVLs were present. The mean age was 62.5 ± 11 years; the Logistic EuroScore was 15.4 ± 3. Most of the patients were in New York Heart Association (NYHA) functional class III-IV (57%). Symptomatic haemolysis was present in 35% of the patients, and it was particularly frequent in the TAp (70%). Many patients had >1 previous cardiac operation (46% overall and 82% of TAp patients were at their second of re-operation). Acute procedural success was 98%. In-hospital mortality was 9.3%; no in-hospital deaths occurred in patients treated through a TAp approach. All the patients had less than moderate residual valve regurgitation after the procedure. Surgical treatment was identified as a risk factor for in-hospital death at univariate analysis (OR: 8, 95% CI: 1.8-13; P = 0.05). Overall actuarial survival at follow-up was 39.8 ± 7% at 12 years and it was reduced in patients who had >1 cardiac re-operation (42 ± 8 vs. 63 ± 6% at 9 years; P = 0.009). CONCLUSIONS A transcatheter closure via a surgical TAp approach appears to be a safe and effective therapeutic option in selected high-risk patients with PVL and is associated with a lower hospital mortality than surgical treatment, in spite of higher predicted risk. Long-term survival remains suboptimal in these challenging patients.

Persistent lone atrial fibrillation: Clinicopathologic study of 19 cases

BACKGROUND The extent to which atrial myocardium is remodeled in patients with persistent lone atrial fibrillation (LAF) is largely unknown. OBJECTIVE The purpose of this study was to perform a clinicopathologic investigation in patients with persistent LAF. METHODS We characterized structural and molecular remodeling in atrial biopsies from 19 patients (17 males, mean age 49 years) with persistent (>7 days; n = 8) or long-lasting persistent (>1 year; n = 11) LAF who underwent surgical ablation. Atrial tissue from 15 autopsy samples without clinicopathologic evidence of heart disease served as controls. RESULTS Morphometric analysis showed cardiomyocyte hypertrophy and greater amounts of myolytic damage and interstitial fibrosis in persistent LAF patients compared to controls (P <.0001). Atrial tissue levels of heme oxygenase-1 and 3-nitrotyrosine were increased in persistent LAF patients (P <.001), consistent with oxidative stress. Levels of superoxide dismutase-2, interleukin-8, interleukin-10, tumor necrosis factor-α, and thiobarbituric acid reactive substance were greater in controls than in persistent LAF patients. Immunoreactive signal for connexin43 was reduced more frequently in persistent LAF patients than controls. There was no correlation between features of structural or molecular remodeling and clinical parameters, including persistent LAF duration. CONCLUSION In persistent LAF patients, the atria are modified by structural remodeling and molecular changes of oxidative stress. Tissue changes in persistent LAF appear to occur early after its onset and are qualitatively no different than those observed in patients with atrial fibrillation related to conventional risk factors. These findings suggest that different types of atrial fibrillation are associated with the same spectrum of tissue lesions. Early intervention to restore sinus rhythm in persistent LAF patients may prevent irreversible tissue change, especially interstitial fibrosis.

New devices for TAVI: technologies and initial clinical experiences

Treatment of aortic stenosis in high-risk surgical patients has been modified in the past 10 years owing to the introduction of transcatheter aortic valve implantation (TAVI). Several issues affecting outcomes with implantation of the first-generation TAVI devices remain unresolved, including haemorrhagic and vascular complications, neurological events, rhythm disturbances, and paravalvular leakage. Further technological improvements are, therefore, required before the indications for TAVI can be extended to young and low-risk patients with aortic stenosis. Many new-generation TAVI devices are currently in the early stages of clinical evaluation. Modifications in the new devices include the ability to reposition the valve before final deployment, features to reduce paravalvular leakage, and the introduction of low-profile delivery systems. The aim of this Review is to provide an overview of the new-generation transcatheter valvular technologies, including initial clinical reports.

Surgical vs. transcatheter pulmonary vein isolation as first invasive treatment in patients with atrial fibrillation: a matched group comparison

AIMS Pulmonary vein isolation (PVI) can be considered for treatment of symptomatic atrial fibrillation (AF). Nowadays, in addition to transcatheter ablation, thoracoscopic surgical PVI is available. The aim of this study is to compare clinical outcome of surgical with transcatheter PVI as first invasive treatment strategy of AF. METHODS AND RESULTS From June 2009 to November 2011, 33 patients underwent minimally invasive surgical PVI, and were matched (1:2 fashion) retrospectively according to age, sex, and AF type, with 66 patients who underwent transcatheter PVI. Success was defined as freedom from atrial arrhythmias on 24 h Holter monitoring without use of anti-arrhythmic drugs (AADs) at 1 year. Mean age was 52 ± 10 years, 82% were male. Paroxysmal AF was present in 76 patients (77%), persistent AF in 23 (23%) patients. None underwent prior ablations, and failed on 1.2 ± 0.6 AADs. At 12 months, complete freedom from atrial arrhythmias without AADs in the surgical PVI group was 88% compared with 41% in the transcatheter PVI group (P < 0.001). Freedom from atrial arrhythmias with AADs was 91 vs. 62%, in the surgical vs. transcatheter PVI group, respectively (P = 0.002). Complications occurred in seven (21%) surgical PVI patients, and three (5%) transcatheter PVI patients (P = 0.015). CONCLUSION In present matched study comparing a surgical with transcatheter PVI treatment strategy in symptomatic AF patients failed on AADs, but without prior ablations, a surgical PVI strategy was more effective to prevent recurrence of atrial arrhythmias, than a transcatheter PVI treatment strategy. However, complications were more frequent with surgical PVI.

Supporting the dynamics of knowledge sharing within organizations

The paper proposes an architecture to memorize the knowledge generated and used by the members of an organization in their cooperative work. The main focus is on the identification of mechanisms to enhance organization members capability to reconstruct the dynamic evolution of the knowledge generated through computer supported human to human communication within the organization. These mechanisms are triggered by communicative events in a user transparent way. The notion of degree of consciousness of knowledge sharing is proposed as a basic means to allow members to look for the most appropriate context of each communicative event. This context is where the reconstruction becomes sensible in relation to the user needs.

Electrophysiological efficacy of Epicor high-intensity focused ultrasound

OBJECTIVES Clinical success of atrial fibrillation (AF) ablation depends on persistent blocking of electrical conduction across the ablation lines. Epicor high-intensity focused ultrasound (HIFU) ablation has been credited with a variable clinical efficacy. The aim of this work is to ascertain the electrophysiological (EP) efficacy of such lesions, by assessing pulmonary vein isolation (PVI) after open chest HIFU ablation, in the clinical setting. METHODS Ten consecutive mitral patients (mean age: 57±10 years) with paroxysmal AF undergoing concomitant ablation with the Epicor ablation system (St. Jude Inc.®, Minneapolis, MN, USA) were enrolled for EP assessment. During surgery, pairs of additional temporary wires were positioned on the right PVs (RPVs) and on the roof of the left atrium (RLA), before epicardial ablation. Exit block (no capture during PV pacing) of RPV and of RLA was assessed before, after ablating and immediately after closure of the chest, in order to check the correct positioning of the wires. EP assessment was repeated before discharge and at 3 weeks. RESULTS Baseline RPV pacing threshold (PT) was 3.5±2 mA (range 1.5-8), of RLA 1.73±1.1 mA (range 0.7-4.3 mA). PVI was not reached any time after HIFU ablation. At the pre-discharge EP study, the absence of isolation was observed in all cases. At 3 weeks, the PTs were 6.8±5.8 mA on RPV (range 2-16) and 6.4±5.3 mA (range 1-19) on RLA. All patients were discharged in sinus rhythm. CONCLUSIONS PVI was not achieved after Epicor HIFU ablations, up to 3 weeks after surgery.