Gianpiero D'Amico

Gender-related differences of diabetic patients undergoing percutaneous coronary intervention with drug-eluting stents: a real-life multicenter experience.

BACKGROUND Gender-based differences in diabetic patients are understudied in the field of percutaneous coronary intervention (PCI) with drug-eluting stents. METHODS Data were obtained from a multicenter registry of 2420 consecutive patients with diabetes mellitus (DM) who underwent PCI with paclitaxel- or sirolimus-eluting stents between 2003 and 2009. Among them, 679 (28.1%) women were compared to 1741 (71.9%) men in terms of clinical aspects and major adverse cardiac events (MACE), including all-cause death, myocardial infarction (MI) and target lesion revascularization (TLR). Target vessel revascularization (TVR) and any revascularization were also reported. RESULTS Women were less numerous, older, used more insulin and showed more tortuous coronary arteries, while men were more frequently smokers and received larger stents. At the median follow-up of 24.3 months (interquartile range 12.3-39.7), MACE, TVR and any revascularization did not significantly differ between females and males (19.9% vs 18.7%, 12.2% vs 13.4%, 14.1% vs 15.1%, respectively). At multivariable analysis of the overall cohort, female gender was not a predictor of MACE (hazard ratio [HR] 1.02, 95% confidence interval [CI] 0.92-2.36, p=0.11), death (HR 1.04, 95% CI 0.84-1.24, p=0.86), MI (HR 1.48, 95% CI 0.92-2.36, p=0.11), and TLR (HR 1.14, 95% CI 0.85-1.52, p=0.38). CONCLUSION In this registry of diabetic patients treated by drug-eluting stents, women were less represented, older and needed more insulin compared to men who, on the other hand, received larger stents. Gender-related outcomes were similar and female sex did not predict MACE.

Clinical outcome of patients with de novo coronary bifurcation lesions treated with the Tryton Side Branch Stent. The SAFE-TRY prospective multicenter single arm study.

BACKGROUND Coronary bifurcation lesions represent a difficult problem regularly confronting interventional cardiologist, in part due to the lack of dedicated device. OBJECTIVE To investigate the feasibility, safety and effectiveness of the Tryton Side Branch Stent (Tryton Medical, Durham, NC, USA), a dedicated bare metal stent deployed in conjunction with a standard drug-eluting stent to treat bifurcation lesions. METHODS The SAFE-TRY is a prospective single arm multicenter registry including patients with de novo bifurcation lesions in native coronary arteries and syntax score <32. The primary endpoint was target vessel failure (TVF) at 30 days that comprised cardiac death, target vessel myocardial infarction and clinically driven target vessel revascularization. Secondary endpoints included device, angiographic and procedural success, 9-month major adverse cardiac and cerebrovascular event (MACCE), and stent thrombosis (ST) rates (ClinicalTrials.gov identifier: NCT01174433). RESULTS Among 252 enrolled patients, 24% had diabetes and 35.3% unstable angina. True bifurcation lesions involving both branches occurred in 96.8% of cases with Medina classification 1.1.1 in 62%. The left anterior descending artery and the left main were treated in 70% and 8.3% of the patients, respectively. A 6 Fr guide catheter was used in 61% of the cases. Device, angiographic and procedural success rates were 99.6%, 99.6% and 97.2% respectively. The 30-day TVF was 2.8%; the 9-month MACCE rate was 13.7%, with target lesion revascularization being 4.4%. No definite ST occurred. CONCLUSIONS This prospective, multicenter study confirmed the feasibility, safety and effectiveness of the Tryton Side Branch Stent to treat patients with de novo complex bifurcation lesions.

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.

Percutaneous left atrial appendage occlusion in patients with atrial fibrillation and left appendage thrombus: feasibility, safety and clinical efficacy

AIMS The aim of this study was to investigate the feasibility, safety and efficacy of percutaneous closure for prevention of thromboembolic events in patients with atrial fibrillation (AF) and left atrial appendage (LAA) thrombus. METHODS AND RESULTS The study included consecutive patients with AF and LAA thrombus who underwent transcatheter occlusion in eight high-volume centres. Clinical and transoesophageal echocardiography (TEE) follow-up was carried out as per each centres protocol. Twenty-eight patients were included. The location of the LAA thrombus was distal in 100% of cases. Technical and procedural success was achieved in all patients. A cerebral protection device was used in six cases. There were no periprocedural adverse events. Follow-up was complete in all patients (total 32 patient-years). No death or thromboembolic events were reported. There was one major bleeding during follow-up. Among the 23 patients undergoing TEE, device thrombosis was present in one patient. No significant peri-device leaks were observed. CONCLUSIONS In this multicentre study, percutaneous closure in selected patients with distal LAA thrombus appears to be feasible and safe, and is associated with high procedural success and a favourable outcome for the prevention of AF-related thromboembolism. Special implant techniques avoiding mechanical mobilisation of the thrombotic mass and the liberal use of cerebral embolic protection devices are recommended.

Efficacy and safety of potent platelet P2Y12 receptor inhibitors in elderly versus nonelderly patients with acute coronary syndrome: A systematic review and meta-analysis

Background The use of the potent oral P2Y12 inhibitors prasugrel and ticagrelor in patients with acute coronary syndromes (ACS) has a favorable net clinical effect compared with clopidogrel and is recommended as first‐line therapy. However, the impact of these agents on ischemic and bleeding events in elderly ACS patients is not well defined. Methods We performed a systematic review of articles comparing potent P2Y12 inhibitors to clopidogrel in elderly and nonelderly patients (defined according to each study) with ACS in terms of efficacy (composite of cardiovascular death, myocardial infarction, or stroke) and safety (major bleeding) end points. Results A total of 7,860 elderly and 37,857 nonelderly patients from 7 studies (5 randomized control trials and 2 observational studies) were included. Potent P2Y12 inhibitors significantly reduced efficacy end point in nonelderly patients (relative risk [RR] 0.85, 95% CI 0.79–0.93) and less so in elderly patients (RR 0.95, 95% CI 0.86–1.05). No significant differences were found between potent P2Y12 inhibitors and clopidogrel in terms of safety end point in both elderly (RR 1.19, 95% CI 0.95–1.49) and nonelderly patients (RR 1.16, 95% CI 0.95–1.41). There were no significant interactions between age and treatment effect in both analyses (efficacy Pint = .16; safety Pint = .83). Conclusions The effect of more potent P2Y12 inhibitors compared with clopidogrel on efficacy and safety end points is consistent in elderly and younger patients. These data imply that potent P2Y12 inhibitors should not be withheld from eligible patients solely because of advanced age.

Impact of atrial fibrillation on outcomes of patients treated by transcatheter aortic valve implantation: A systematic review and meta-analysis

BACKGROUND Conflicting data have been reported related to the impact of atrial fibrillation (AF) on the outcomes after transcatheter aortic valve implantation (TAVI). We aimed to assess the prognosis of TAVI-treated patients according to the presence of pre-existing or new-onset AF. METHODS Studies published between April 2002 and November 2016 and reporting outcomes of pre-existing AF, new-onset AF, or sinus rhythm in patients undergoing TAVI were identified with an electronic search. Pairwise and network meta-analysis were performed. Outcomes of interest were short- and long-term mortality, stroke, and major bleeding. RESULTS Eleven studies (11,033 individuals) were eligible. Compared to sinus rhythm, short-term and long-term mortality were significantly higher in new-onset AF (short-term OR 2.9, P=.002; long-term OR 2.3, P<.0001) and pre-existing AF groups (short-term OR 2.7, P=.004; long-term OR 2.8, P<.0001). Compared to sinus rhythm, new-onset AF increased the risk of stroke at early (OR 2.1, P<.0001) and late follow-up (OR 1.92, P<.0001), and the risk of early bleedings (OR 1.65, P=.002), while pre-existing AF increased the risk of late stroke (OR 1.3, P=0.03), but not the risk of bleeding. Compared to pre-existing AF, new-onset AF correlated with higher risk of early stroke (OR 1.7, P=.002) and major bleedings (OR 1.7, P=.002). CONCLUSIONS AF is associated with impaired outcomes after TAVI, including mortality, stroke and (limited to new-onset AF) major bleedings. Compared to pre-existing AF, new-onset AF correlates with higher risk of early stroke and major bleedings. Improved management of AF in the TAVI setting, including tailored antithrombotic treatment strategies, remains a relevant need.

Left atrial appendage closure: beyond the artifact.

: Transesophageal echocardiography (TEE) represents the gold standard technique to detect left atrial appendage (LAA) thrombosis. Several conditions may be erroneously interpreted as LAA thrombus at TEE, including artifacts mimicking thrombi. We report a case of a 78-year-old man with atrial fibrillation and contraindication to anticoagulation who was referred to our institution for percutaneous left appendage closure with a transcatheter trans-septal approach. Intraoperative transesophageal echocardiography revealed a thrombus-mimicking image, related to reverberations of left upper pulmonary vein ridge, located at twice the distance of the ridge from the transducer.

Reply: Treatment Strategies for Patients With ST-Segment Elevation Myocardial Infarction and Multivessel Disease: Is Staged PCI Truly the Best Option?

We thank Dr. Tamis-Holland and colleagues for their interest in our article [(1)][1]. We recognize that combining prospective observational studies with randomized controlled trials (RCTs) might be a limitation, but this was done to increase the statistical power of our observations. We acknowledge

Endomyocardial biopsy under echocardiographic monitoring

Endomyocardial biopsy is a common procedure for monitoring cardiac allograft rejection; several techniques have been described so far, throughout different access sites and under echocardiographic or X-ray control. We describe the routine technique adopted at our centre based on echo-guided puncture of jugular vein and echocardiographic assessment of endomyocardial sampling with direct visualization of the bioptome tip. We also report the most common complications of the procedure, especially concerning the risk of iatrogenic tricuspid regurgitation, and same examples of histopathological findings drawn from our own iconographic collection.

‘full polymeric jacket’ with bioresorbable vascular scaffolds in a diabetic patient affected by multivessel coronary disease: 1-year optical coherence tomography follow-up

© 2017 Italian Federation of C of right coronary artery (RCA) (Fig. 1A-C); SYNTAX score was 39. Left ventricular ejection fraction was 45%. The patient was refused by surgeon and referred to multivessel and multilesion percutaneous coronary intervention (PCI) with everolimus-eluting bioresorbable vascular scaffolds (BVS) (Absorb, Abbott Vascular, Santa Clara, California, USA). After lesion preparation with semicompliant/noncompliant balloons, three 3.0 28 mm BVS were deployed from the distal in the left anterior descending, a single BVS 2.5 28 mm in the obtuse marginal branch, another three 3.0 28 mm BVS were deployed from the distal to proximal RCA. Angiographic result is shown in Fig. 1d–f. Repeat coronary angiography at 12 months excluded any in-scaffold restenosis (Fig. 2A, B). Optical coherence