Publications by authors named "Gaetano di Palma"

Background: Stent underexpansion increases the risk of cardiac adverse events. At present, there are limited options to treat refractory stent underexpansion. In this context, the intravascular lithotripsy (IVL) system might be a safe and effective strategy.

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Since their introduction Drug Coated Balloons (DCBs) have slowly gained their spot into everyday cath-lab practice, first for treatment of in-stent restenosis (ISR), more recently for small vessels disease; today a growing body of evidence start supporting their use in more complex lesions, from bifurcations, to large vessels, to acute lesions. Although the new generation of DCBs showed a better performance and safety than the older one, the drug of choice has always been the Paclitaxel; last year some concerns were raised on the safety of Paclitaxel devices, in particular the balloons mining their use. Recently Sirolimus ventured in the DCBs world, making its appearance on cath-lab shelves and becoming a good alternative to Paclitaxel (DCB).

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Optimal treatment of renal artery "in-stent restenosis" (ISR) is still debated; drug eluting stents (DES), drug coated balloons (DCB) and scoring balloons have all been used, with mixed long term results. The shockwave lithotripsy for the treatment of heavily calcified atherosclerotic plaques has proven to be an effective tool and preliminary data support its use in case of underexpanded stents. Here we present the case of a 60 year old male with a known significant atherosclerotic renal artery stenosis and refractory hypertension who already underwent bilateral renal angioplasty with bare metal stents (BMS) in 2011 and angioplasty with DCB in 2012 for right renal artery ISR.

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Objective: Our study sought to compare the 12-month clinical outcome of patients treated with paclitaxel-coated balloons (PCB) vs. sirolimus-coated balloons (SCB) during coronary angioplasty.

Background: Drug-coated balloons represent an established therapeutic tool for percutaneous coronary interventions (PCI).

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Carotid artery stenting (CAS) is a valid and effective alternative to endoatherectomy when performed by experienced operators. The conventional approach used is the transfemoral one, but in the last 10 years a transradial (TR) approach, the standard access for cardiac catheterization, became widely adopted for peripheral vascular interventions, included the extracranial carotids. Preliminary experiences suggest this approach as safe and effective, especially in specific anatomical and clinical settings that have been shown to be associated with high risk of complications from the femoral route.

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Objectives: This study sought to compare the performance of a novel drug-coated balloon (DCB) (Elutax SV, Aachen Resonance, Germany), with an everolimus-eluting stent (EES) (Abbott Vascular, Santa Clara, California) in patients with de novo lesions.

Background: Small vessel coronary artery disease (SVD) represents one of the most attractive fields of application for DCB. To date, several devices have been compared with drug-eluting stents in this setting, with different outcomes.

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Aim: To compare the long-term outcomes of patients implanted with Absorb bioresorbable scaffold (BRS) with optimal versus suboptimal technique.

Methods And Results: All patients who received an Absorb between March 2012 and January 2016 were selected from 19 Italian centers databases to assess the impact of an optimal implantation technique (CIAO criteria) on long-term device-oriented composite end-point (DOCE) - including cardiac death (CD), target-vessel myocardial infarction (TV-MI) and ischemia-driven target lesion revascularization (ID-TLR) - on its single components and on scaffold thrombosis (ScT). CIAO criteria consist of predilation (balloon/vessel ratio 1:1), correct sizing (BRS/proximal reference vessel diameter -RVD- ratio 0.

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Aims: The purpose of the EASTBOURNE registry is to evaluate the immediate and long-term clinical performance of a novel sirolimus-coated balloon (SCB) in a real-world population of patients with coronary artery disease. We here present the prespecified interim analysis after the enrollment of the first 642 patients who obtained 1-year clinical follow-up.

Methods: EASTBOURNE is a prospective, international, multicenter, all-comer investigator-driven clinical registry, which is enrolling consecutive patients treated with SCB at 42 European and Asiatic centers.

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Objectives: To test the long-term efficacy of a sirolimus-coated balloon (SCB).

Background: Nanoluté was a prospective registry to evaluate the clinical performance of a novel SCB (Concept Medical Research Private Limited, India) for the treatment of de novo coronary lesions and in-stent restenosis (ISR). We here present the 24 months clinical data.

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Background: Radial artery approach is currently the most common access site for coronary angiography and percutaneous coronary intervention. It rarely results in complications, improves patient comfort, and reduces the duration of hospitalization.

Case Presentation: A 91-year-old woman presented to our institution with ST-segment elevation myocardial infarction (STEMI).

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Aims: To assess the long-term outcomes of patients treated with sirolimus-eluting Stentys stent in a real-life setting.

Background: Few data regarding the safety and effectiveness of self-apposing sirolimus-eluting Stentys stent are available.

Methods: 278 patients (30% stable coronary artery disease, 70% acute coronary syndromes, and 54% on unprotected left main) treated with sirolimus eluting Stentys stent were retrospectively included in the self-aPposing, bAlloon-delivered, siRolimus-eluting stent for the Treatment of the coronary Artery disease multicenter registry.

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Aims: To evaluate the angiographic performance of a novel sirolimus-coated balloon (SCB) in de novo coronary lesions.

Methods: Out of an all-comer prospective registry of patients treated with the SCB at our center from April 2016 to September 2017, we selected those treated for a de novo stenosis on a native vessel, with a scheduled angiographic control at at least 4 months after the index procedure. We performed a centralized, blinded core-lab adjudicated quantitative coronary angiography analysis.

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Background: The aim of the Nanoluté registry was to observe the clinical performance of a novel sirolimus coated balloon (SCB) (Concept Medical Research Private Limited, India) for the treatment of coronary de-novo and restenotic lesions.

Methods: All patients treated with SCB between July 2012 and September 2015 were enrolled at Indian centres and clinically followed for 1, 3, 6 and 12 months post-procedure. Primary endpoints were procedural success and device-oriented adverse cardiac events (DOCE) at 12 months.

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Background: In the recent years percutaneous treatment of the left main stem (LM) has gained a precise role as a result of consistent scientific evidence vs. coronary artery bypass. A self-apposing stent offers an improved adaptation to the vessel wall, especially in case of tapered vessels; aim of this study was to investigate the role of a novel self-apposing, sirolimus-eluting stent (Stentys, France) for the treatment of LM coronary artery disease.

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Background: Patients with small vessel disease (SVD) are at higher risk of adverse events after PCI compared to non-SVD patients. In this subset, the use of bioresorbable vascular scaffolds (BVS) has raised particular concern.

Objective: We aimed to compare outcomes of Absorb BVS versus a 2nd-generation metallic everolimus-eluting stents (EES) in the SVD setting, by pooling patients from three large, prospective studies.

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Coronary Sinus Reducer (Neovasc, Inc., Richmond B.C.

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Drug-coated balloons (DCB) have been developed in recent years to overcome some of the drug-eluting stents limitations. There is an established indication for the use of DCB in the treatment of in-stent restenosis and they are also variably used in various setting, in particular small coronary vessels and bifurcations. Until 2016, all DCBs available in Europe eluted paclitaxel, a highly lipophilic drug with narrow therapeutic window.

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Aims: Drug-coated balloons (DCBs) are a recognized alternative to stents for the treatment of in-stent restenosis (ISR), and there is some initial clinical evidence about their efficacy for the treatment of small coronary vessels. Newer-generation DCBs were developed to overcome the reduced deliverability of the previous generation, also warranting a more effective drug delivery to vessel wall. However, the vast majority of new-generation DCBs still lack of reliability due to paucity of clinical data.

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Coronary lesions at bifurcation sites are frequent and still remain a challenging subset for the interventional cardiologist. Although in the last years the provisional stenting technique has shown more consistent results, coronary bifurcation interventions still share a worse procedural success rate and increased rates of mid- and long-term cardiac events. Most of the dedicated devices proposed in the last few years have failed to show improved results when compared with standard devices.

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Percutaneous treatment of the unprotected left main trunk (ULM), defined as a vessel without patent bypass graft either to the left circumflex (LCX) or left anterior descending (LAD) artery, has gained a precise role thanks to recent scientific evidence. Although new generation drug-eluting stents have already proven to be safer, there is still a consistent risk of restenosis and late adverse events. The optimal management of a ULM restenosis is still debated.

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Drug-coated balloons (DCB) are being used for in-stent restenosis treatment and there is some preliminary experience in other coronary settings, including small vessels and side branches. Scoring balloons (SB) are a useful tool for the preparation of fibro-calcific lesions. Because of the controlled micro-dissections that SB induce, it has been hypothesized that they may have a role in helping paclitaxel deliverability inside the vessel wall.

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Objectives: With this prospective study we aim at investigating the long-term outcome of a consecutive cohort of patients successfully treated with bioresorbable scaffold (BVS) implantation.

Background: It is not clearly understood if there is a relation between the technique of BVS implantation and the outcome.

Methods: Between December 2012 and December 2014, all consecutive patients treated with BVS were included in this registry and received an angiographic follow-up.

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Objectives: to understand the role of a transradial (TR) secondary approach during complex percutaneous interventions.

Background: The value of the TR route for ancillary vascular approach has not been adequately validated in this setting, and there is scant data on its role in reducing bleeding complications.

Methods: In the present study we retrospectively included patients undergoing the following interventions requiring two vascular approaches at nine high-volume centers in Italy: structural cardiac interventions, complex PCI, endovascular aortic repair (EVAR) and complex lower limb angioplasty.

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