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)-guided versus transesophageal echocardiography (TEE)-guided 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 ≥75 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 (≥94%) 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™ 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™ 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±8.0years, 62.5% male) underwent LAAO in 15 Italian centers by AMPLATZER™ 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™ 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™ devices showed high procedural success, early safety and mid-term efficacy for the prevention of NVAF-related thromboembolism.

Five-year clinical performance of a biodegradable polymer-coated biolimus-eluting stent in unselected patients.

OBJECTIVE: To evaluate the long-term follow-up of the unrestricted use of a biodegradable polymer-coated drug-eluting stent in patients undergoing percutaneous coronary intervention (PCI). METHODS: The Nobori 2 study was a prospective, multicentre, observational registry evaluating the safety and the efficacy of the biodegradable polymer biolimus-eluting stent (BP-BES) among 3067 patients recruited at 125 international sites. The primary combined endpoint was a composite of cardiac death, myocardial infarction and target-lesion revascularisation (TLR). RESULTS: Five-year follow-up was available in 2738 (89.3%) patients. The combined endpoint occurred in 268 patients (10%, 95% CIs 8.9% to 11.3%) at 5 years, with 3.9% of events during the first year and 6.2% during years 1-5 of follow-up. Cumulative rates of TLR and definite/probable stent thrombosis were 5.3% (95% CI 4.5% to 6.3%) and 1.1% (95% CI 0.8% to 1.6%), respectively. Between 1 and 5 years, TLR and very late stent thrombosis rates were 3.5% (95% CI 2.8% to 4.4%) and 0.6% (95% CI 0.3% to 1.1%), respectively. Previous PCI (HR, 2.05, 95% CI 1.68 to 2.50), moderate-to-severe renal disease (HR, 1.89, 95% CI 1.30 to 2.74) and peripheral vascular disease (HR, 1.86, 95% CI 1.38 to 2.52) were the three most powerful independent predictors of the combined endpoint at 5 years. CONCLUSIONS: The final 5-year follow-up of the Nobori 2 registry demonstrates the safety and effectiveness of the BP-BES in an unselected, broadly inclusive cohort of PCI patients, highlighting the excellent performance of this coronary stent technology after polymer biodegradation. TRIAL REGISTRATION NUMBER: ISRCTN81649913; Results.

Prosthesis embolization into the left ventricle during transcatheter aortic valve implantation.

: Images and movie clips documenting the rare occurrence of a percutaneous prosthesis embolization into the left ventricle are presented. The case outcome and the circumstances leading to the event are discussed.

[TAVI in degenerative aortic stenosis treatment: state of the art and future perspectives]. / TAVI nel trattamento della stenosi aortica degenerativa: stato dell'arte e prospettive.

Degenerative aortic stenosis is the most common form of heart valve disease in developed countries and predominantly affects the elderly. Aortic valve replacement (AVR) has been the gold standard, but recently, transcatheter aortic valve implantation has emerged as an effective therapeutic alternative to conventional AVR for high-risk patients. This review analyzed the literature about AVR, with the objective of evaluating the outcomes of transcatheter aortic valve implantation in patients who are not eligible for surgery showing an improvement in quality of life and middle-term outcomes. The crucial point is the lack of studies with long-term follow-up that could give therapeutic importance to percutaneous valve replacement.

Assessing the role of eptifibatide in patients with diffuse coronary disease undergoing drug-eluting stenting: the INtegrilin plus STenting to Avoid myocardial Necrosis Trial.

BACKGROUND: The optimal antiplatelet regimen in elective patients undergoing complex percutaneous coronary interventions (PCIs) is uncertain. We aimed to assess the impact of glycoprotein IIb/IIIa (GpIIb/IIIa) inhibition with eptifibatide in clinically stable subjects with diffuse coronary lesions. METHODS: Patients with stable coronary artery disease undergoing PCI by means of implantation of >33 mm of drug-eluting stent were single-blindedly randomized to heparin plus eptifibatide versus heparin alone. The primary end point was the rate of abnormal post-PCI creatine kinase-MB mass values. Secondary end points were major adverse cardiovascular events (MACEs) (ie, cardiac death, myocardial infarction, or urgent revascularization) and MACE plus bailout GpIIb/IIIa inhibitor use. RESULTS: The study was stopped for slow enrollment and funding issues after including a total of 91 patients: 44 were randomized to heparin plus eptifibatide, and 47, to heparin alone. Analysis for the primary end point showed a trend toward lower rates of abnormal post-PCI creatine kinase-MB mass values in the heparin-plus-eptifibatide group (18 [41%]) versus the heparin-alone group (26 [55%], relative risk 0.74 [95% CI 0.48-1.15], P = .169). Similar nonstatistically significant trends were found for rates of MACE, their components, or MACE plus bailout GpIIb/IIIa inhibitors (all P > .05). Notably, heparin plus eptifibatide proved remarkably safe because major bleedings or minor bleeding was uncommon and nonsignificantly different in both groups (all P > .05). CONCLUSIONS: Given its lack of statistical power, the INSTANT study cannot definitively provide evidence against or in favor of routine eptifibatide administration in stable patients undergoing implantation of multiple drug-eluting stent for diffuse coronary disease. However, the favorable trend evident for the primary end point warrants further larger randomized studies.

Clinical performance of a drug-eluting stent with a biodegradable polymer in an unselected patient population: the NOBORI 2 study.

AIMS: Previous studies for approved indications (on-label) have shown the good safety and efficacy profiles of the Nobori DES. We conducted a prospective, multicentre study to validate the clinical performance of this stent in a real-world setting. METHODS AND RESULTS: A total of 3,067 consecutive patients undergoing a percutaneous coronary intervention with the Nobori DES were enrolled in the NOBORI 2 registry. At one and two years, 97% and 95% of patients, respectively, were available for follow-up. The rates of target lesion failure (TLF), cardiac death, myocardial infarction and target lesion revascularisations were: 3.9%, 1.2%, 1.9% and 2.2% at one year and 5.1%, 1.6%, 2.4% and 3.0% at two years. Overall, 2,242 patients (73%) were treated for at least one off-label indication. When comparing off-label and on-label groups, the results were: TLF 4.5% vs. 2.2%, p=0.003 at one year and 5.9% vs. 2.8%, p=0.001 at two years. The rate of stent thrombosis was 0.68%, and 0.80% at one and two years, respectively with no difference between the off-label and on-label groups (0.76% vs. 0.48%, p=0.6 and 0.89% vs. 0.61%, p=0.5). CONCLUSIONS: The promising results previously observed in lower risk patients can be replicated in daily practice. As expected, in off-label indications, rates of adverse events were higher. Nevertheless, our results suggest the good and sustained performance of this stent system in high-risk patients with significant comorbidities and/or complex lesions.

Usefulness of primary angioplasty in nonagenarians with acute myocardial infarction.

The optimal reperfusion strategy in very elderly patients with ST-segment elevation myocardial infarction is still a subject of debate. The aim of this multicenter study was to determine the medium-term outcomes of nonagenarians after primary percutaneous intervention for ST-segment elevation myocardial infarction. A systematic review of the databases of 7 Italian centers showed that these had performed 5,023 primary angioplasties over the previous 5 years, 100 of which (2%) involved patients > or =90 years old. Thirty-five subjects were in Killip class III or IV at time of presentation, 78 had multivessel coronary artery disease, and mean ejection fraction was 0.40 +/- 0.12%. In-hospital mortality was 19% and was significantly higher in patients with shock (58% vs 10%, p <0.001). Survival rate after 6 months was 68%: 16% in those with Killip class IV at admission and 81% in the remaining patients (p <0.001). Cox regression analysis identified 3 independent predictors of 6-month mortality: cardiogenic shock at presentation (hazard ratio [HR] 10.82, 95% confidence interval [CI] 4.51 to 25.93, p <0.001), Thrombolysis In Myocardial Infarction myocardial flow after percutaneous coronary intervention (HR 0.19, 95% CI 0.07 to 0.50, p = 0.001), and abciximab administration (HR 0.32, 95% CI 0.13 to 0.78, p = 0.01). In conclusion, the results of this multicenter study suggest that selected nonagenarians with acute myocardial infarction benefit from successful primary angioplasty. The treatment does not affect the poor prognosis of patients presenting with cardiogenic shock, but the administration of abciximab seems to have a positive effect on 6-month mortality.

Comparison of AngioJet rheolytic thrombectomy before direct infarct artery stenting with direct stenting alone in patients with acute myocardial infarction. The JETSTENT trial.

OBJECTIVES: The aim of this study was to determine whether rheolytic thrombectomy (RT) before direct infarct artery stenting as compared with direct stenting (DS) alone results in improved myocardial reperfusion and clinical outcome in patients with acute myocardial infarction. BACKGROUND: The routine removal of thrombus before infarct artery stenting is still a matter of debate. METHODS: This is a multicenter, international, randomized, 2-arm, prospective study. Eligible patients were patients with acute myocardial infarction, angiographic evidence of thrombus grade 3 to 5, and a reference vessel diameter ≥2.5 mm. Coprimary end points were early ST-segment resolution and (99m)Tc-sestamibi infarct size. An α value = 0.05 achieved by both coprimary surrogate end points or an α value = 0.025 for a single primary surrogate end point would be considered evidence of statistical significance. Other surrogate end points were Thrombolysis In Myocardial Infarction (TIMI) flow grade 3, corrected TIMI frame count, and TIMI grade 3 blush. Clinical end points were a composite of major adverse cardiovascular events at 1, 6, and 12 months. RESULTS: From December 2005 to September 2009, 501 patients were randomly allocated to RT before DS or to DS alone. The ST-segment resolution was more frequent in the RT arm as compared with the DS alone arm: 85.8% and 78.8%, respectively (p = 0.043), while no difference between groups were revealed in the other surrogate end points. The 6-month major adverse cardiovascular events rate was 11.2% in the thrombectomy arm and 19.4% in the DS alone arm (p = 0.011). The 1-year event-free survival rates were 85.2 ± 2.3% for the RT arm, and 75.0 ± 3.1% for the DS alone arm (p = 0.009). CONCLUSIONS: Although the primary efficacy end points were not met, the results of this study support the use of RT before infarct artery stenting in patients with acute myocardial infarction and evidence of coronary thrombus. (AngioJet Rheolytic Thrombectomy Before Direct Infarct Artery Stenting in Patients Undergoing Primary PCI for Acute Myocardial Infarction [JETSTENT]; NCT00275990).

Endovascular graft deployment in the false lumen of type B dissection.

OBJECTIVES: Thoracic endovascular aortic repair (TEVAR) is particularly indicated in a patient with complicated type B dissection. The object of this communication is to report a case of deployment of the endograft in the false lumen, to propose a protocol in order to prevent it and discuss the possible surgical options when this complication has occurred. METHODS: A case of complicated acute type B dissection is described where the endovascular prosthesis was positioned in the false lumen. The literature on the subject is briefly reviewed for the insertion techniques and conversion to surgery. RESULTS: The occurrence was recognized and treated with replacement of the entire aorta from the sinotubular junction to a level of the eighth thoracic vertebra under deep circulatory arrest with selective antegrade cerebral perfusion. CONCLUSIONS: TEVAR for complicated type B dissection should be carried out according to a precise and stepwise protocol in institutions familiar with all the different options of conversion to open repair.

A randomized trial comparing eptifibatide vs. placebo in patients with diffuse coronary artery disease undergoing drug-eluting stent implantation: design of the INtegrilin plus STenting to Avoid myocardial Necrosis Trial.

BACKGROUND: Despite the availability of several potent antithrombotic agents, the optimal antiplatelet regimen in elective patients undergoing complex percutaneous coronary interventions is still debated. Aim of the INtegrilin plus STenting to Avoid myocardial Necrosis Trial will be to assess the safety and efficacy of routine usage of the glycoprotein IIb/IIIa inhibitor eptifibatide in patients already treated with aspirin and clopidogrel and undergoing implantation of at least two drug-eluting stents in the same lesion, thus identifying a clinically stable but anatomically complex patient subset. DESIGN: This will be a single-blind, placebo-controlled multicenter randomized trial. METHODS: Patients with stable coronary artery disease, who are undergoing percutaneous coronary intervention by means of implantation of greater than 33 mm of drug-eluting stents (e.g. with two 23-mm drug-eluting stents or one 32-mm and one 12-mm drug-eluting stent), will be randomized, after administration of aspirin and clopidogrel (600 mg loading dose recommended), to eptifibatide and unfractioned heparin according to the ESPRIT protocol or placebo and unfractioned heparin. Blood draws for creatine kinase-MB mass, total creatine kinase, and cardiac troponin levels will be taken at baseline, 6 and 12 h postprocedurally. Patients will be followed for clinical events by direct visit or phone contact up to 6 months. The primary endpoint of the study will be the rate of abnormal values of creatine kinase-MB mass after percutaneous coronary intervention. Secondary endpoints will be the composite of cardiac death, nonfatal myocardial infarction, urgent target vessel revascularization, and thrombotic bailout glycoprotein IIb/IIIa inhibitor therapy within 180 days, and in-hospital, 1-month and 6-month major adverse cardiovascular events, defined as the composite of cardiac death, nonfatal myocardial infarction or urgent target vessel revascularization. IMPLICATIONS: The INtegrilin plus STenting to Avoid myocardial Necrosis Trial study will test for the first time the beneficial impact of routine glycoprotein IIb/IIIa inhibition on top of dual oral antiplatelet treatment in clinically stable yet anatomically complex patients undergoing drug-eluting stents implantation. Results of this single-blind randomized trial will provide important insights to improve the management strategy of patients and outcomes in the current drug-eluting stents era.

Sicilian DES Registry: prospective in-hospital and 9-month clinical and angiographic follow-up in selected high restenosis risk patients.

OBJECTIVE: This is a multicentre, open label, prospective non-randomized registry, with 9-month angiographic follow-up, conducted to evaluate the safety and effectiveness of drug-eluting stents (DES) when used in high restenosis risk patients from the real world. METHODS: From June 2004 to February 2005, a total of 1622 consecutive patients were enrolled to the Sicilian DES Registry, according to specific inclusion criteria. Both paclitaxel-eluting and sirolimus-eluting stents were used. The analysis was performed on 1472 patients because 150 patients were excluded from the study. The primary endpoint was to evaluate the rate of major adverse cardiac events (MACE) within 9 months after DES implantation. Major adverse cardiac events were defined as cardiac death, non-Q-wave or Q-wave myocardial infarction (MI) and target vessel revascularization (TVR). The secondary endpoints were procedural success, angiographic binary restenosis and stent thrombosis within 9 months post-procedure. RESULTS: Patients were more frequently male; 472 (32.1%) were diabetics, of whom 130 (27.5%) were treated with insulin. Mean ejection fraction of the left ventricle was 51.5 +/- 8.7%. Multivessel disease was found and treated in 627 patients (42.6%). A total of 2439 lesions were treated with DES. Final angiographic success was achieved in 2422 (99.3%) lesions. Procedural success was achieved in 1422 (96.6%) patients. The 9-month cumulative incidence of MACE was 7.3% with 0.8% of cardiac deaths, 0.8% non-fatal MI, 7.9% TVR. Binary restenosis was observed in 101 patients (8.3%). Stent thrombosis was documented in 11 patients (0.8%). CONCLUSIONS: Drug-eluting stents appear to be safe and associated with a low incidence of MACE at 9-month follow-up, even in patients selected for their complexity.

Invasive strategy following fibrinolysis in ST-elevation acute myocardial infarction.

BACKGROUND: A recognized drawback of ST-elevation acute myocardial infarction (STEMI) after fibrinolysis is persistent coronary occlusion or a less than TIMI 3 flow. The present study describes the results of systematic pre-discharge coronary angiography and revascularization, whenever indicated, following fibrinolytic therapy for STEMI. METHODS: Consecutive patients admitted with the diagnosis of STEMI between April 1, 2000 and April 30, 2002 were included in the study. Patients with contraindications to thrombolytic therapy and/or patients not eligible for angiography were excluded. All patients received "accelerated" treatment with alteplase and had a coronary angiography at least 24 hours later, in order to perform, if anatomically feasible, angioplasty with stenting. Angioplasty of non-infarct-related coronary arteries was allowed. The mortality, reinfarction and new revascularization rates were evaluated during index hospitalization and up to 30 days and 6 months. RESULTS: Eighty patients underwent cardiac catheterization at a median of 6.5 days following admission; in 86.3% of cases a patent infarct-related artery was found; in 71% of patients a coronary angioplasty was performed, with stenting in 88% of cases. Procedure-related complications were infrequent. No deaths occurred during hospitalization and at 30 days; at 6 months the mortality rate was 1.3%. In-hospital reinfarction occurred in 3.8% of patients, in 4% at 30 days and in 5.3% at 6 months. The rate of any new revascularization was 2.6% at 30 days and 11% at 6 months. CONCLUSIONS: Although obtained in a small observational study, our data, unlike those from previous studies, suggest that an invasive strategy after fibrinolysis in STEMI is safe and associated with low mortality and morbidity rates in the short and medium-terms.