Patterns and trends of transcatheter aortic valve implantation in Italy: Insights from RISPEVA

Aims Clinical trials have shown that transcatheter aortic valve implantation for aortic stenosis compares favorably to surgical replacement in high-risk patients and is superior to medical therapy in those at prohibitive risk. There is uncertainty however on patterns and trends in transcatheter aortic valve implantation, especially focusing on Italy. Methods The RISPEVA study is a prospective Italian registry including 21 institutions. Patients have been enrolled since late 2012, and data collection includes several baseline, procedural, in-hospital, and follow-up details. For the present analysis on patterns and trends, we focused on patients enrolled between 2012 and 2015, and as primary variable on the prevalence of high versus prohibitive surgical risk, limiting our scope to procedural outcomes. Results A total of 1157 patients were included. The temporal breakdown was 376 (33%) patients enrolled in 2013, 408 (35%) in 2014, and 373 (32%) in 2015. Several patient features differed over time, including risk score, peripheral artery disease, end-stage pulmonary disease, and prior valvuloplasty (all P < 0.05). Several procedural features differed significantly over time, including sheath size, use of general anesthesia, Prostar closure device, predilation, antiembolic device, new TAVI device, and multiple prostheses (all P < 0.05). No significant temporal differences were found for major clinical outcomes, whereas the occurrence of moderate or severe postprocedural regurgitation and pacemaker dependency decreased over the years (both P < 0.05). Conclusion According to the RISPEVA results, the Italian uptake of TAVI is steady, with evident trends toward less invasive approaches and fitter patients

Intracardiac Versus Transesophageal Echocardiographic Guidance for Left Atrial Appendage Occlusion: The LAAO Italian Multicenter Registry

Objectives: This study sought to evaluate the feasibility, safety, and efficacy of intracardiac echocardiography (ICE)\u2013guided versus transesophageal echocardiography (TEE)\u2013guided left atrial appendage occlusion (LAAO) by the use of Amplatzer Cardiac Plug or Amulet devices included in a large Italian registry. Background: TEE is widely used for LAAO procedure guidance. ICE may be a potential alternative imaging modality in LAAO. Methods: Data from 604 LAAO procedures performed in 16 Italian centers were reviewed. ICE-guided LAAO was performed in 187 patients, whereas TEE was used in 417 patients. Procedural success was defined as LAAO without occurrence of pericardial tamponade, stroke, systemic embolism with end organ damage, major bleeding, and device embolization. Stroke, transient ischemic attack, major bleeding, overall and cardiovascular death were analyzed. Results: CHA2DS2-VASc (congestive heart failure, hypertension, age 6575 years, diabetes mellitus, prior stroke or transient ischemic attack or thromboembolism, vascular disease, age 65 to 74 years, sex category) and HAS-BLED (hypertension, abnormal renal and liver function, stroke, bleeding, labile international normalized ratio, elderly, drugs or alcohol) scores were similar between the ICE and TEE groups. TEE implied lower procedural (delta 12 min) and fluoroscopy time (delta 5 min) when compared with ICE. Procedural success was similarly high ( 6594%) between the TEE and ICE groups with a complication rate of 6.5% for TEE versus 4.2% for ICE (odds ratio: 1.468; 95% confidence interval: 0.681 to 3.166; p = 0.327). At median follow-up of 451 days (interquartile range: 162 to 899 days), the rate of cerebral ischemic events was similar between TEE-guided and ICE-guided procedures. Conclusions: ICE-guided LAAO by means of Amplatzer devices may represent a second alternative imaging modality after an appropriate learning curve and bearing in mind that pre-procedural computed tomography imaging is mandatory. When comparing ICE with TEE, TEE remains the gold standard

Left atrial appendage closure using AMPLATZER\ue2\u84\ua2 devices: A large, multicenter, Italian registry

BACKGROUND: Left atrial appendage occlusion (LAAO) has been proven to be effective for stroke prophylaxis in patients with non-valvular atrial fibrillation (NVAF). We aim to assess the safety and efficacy of LAAO by AMPLATZER\u2122 devices in a large, multicenter, single-nation cohort of NVAF patients at high-risk of stroke and bleeding. METHODS: From December 2008 to April 2015 613 NVAF patients (75.1\ub18.0years, 62.5% male) underwent LAAO in 15 Italian centers by AMPLATZER\u2122 devices. There were no restrictions on any personal/institutional protocols with respect to indications, pre-procedural planning, device implantation, drug therapy and follow-up. All the baseline characteristics, imaging, procedural and follow-up data were collected in a single dataset. RESULTS: AMPLATZER\u2122 devices were successfully implanted in 95.4% of cases. Major complications occurred during 38 procedures (6.2%) and included more frequently major bleeding (3.3%) and pericardial tamponade (2.0%). At a mean follow-up of 20months, the overall annual rates of stroke and thromboembolic events, including those periprocedural, was 1.67% and 2.90%, respectively, consisting in a reduction in the rate of stroke and TIA of 66% compared with the risk-based expectation. Among the 218 patients undergoing transesophageal echocardiography at 6months of follow-up, device thrombosis was present in 1.8% of the patients whilst a significant or mild to moderate peri-device leak was found in 0.5% and 11.9% of cases, respectively. CONCLUSIONS: In this large, multicenter, single-nation study, LAAO with the AMPLATZER\u2122 devices showed high procedural success, early safety and mid-term efficacy for the prevention of NVAF-related thromboembolism

[Updated SICI-GISE position paper on institutional and operator requirements for transcatheter aortic valve implantation]

Transcatheter aortic valve implantation (TAVI) has revolutionized the management of patients with symptomatic severe aortic stenosis and has become the standard of care for inoperable patients and the preferred therapy for those at increased surgical risk with peculiar clinical and anatomic features. Technology advances, growing experience and accumulating data prompted the update of the 2011 Italian Society of Interventional Cardiology (SICI-GISE) position paper on institutional and operator requirements to perform TAVI. The main objective of this document is to provide a guidance to assess the potential of institutions and operators to initiate and maintain an efficient TAVI program