23 results on '"Sacchetta G"'
Search Results
2. MidTerm Clinical Outcome of CATANIA Coronary stent system with Nanothin Polyzene in a real world unselected population
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Tamburino, Corrado, LA MANNA, A, Capodanno, DAVIDE FRANCESCO MARIA, DI SALVO ME, Sanfilippo, A, Caggegi, Am, Barrano, Gb, Monaco, S, Cascone, I, Sacchetta, G, and Corcos, T.
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- 2009
3. LONG TERM RESULTS OF POLYZENE-F STENTS COVERAGE. INSIGHTS FROM THE OCT SUBGROUP OF THE ATLANTA REGISTRY
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Sacchetta, G, Cera, M, Capodanno, DAVIDE FRANCESCO MARIA, LA MANNA, A, DI SALVO ME, ALBERTUCCI M, IMOLA F., Corcos, T, Prati, F, and Tamburino, Corrado
- Published
- 2008
4. VERY LONG TERM RESULTS OF ULM PCI WITH DES VS BMS. SINGLE INSTITUTION EXPERIENCE
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DI SALVO ME, Capodanno, DAVIDE FRANCESCO MARIA, Caggeggi, A, Barrano, G, SACCHETTA G, SEMINARA D., LA MANNA, A, Sgroi, C, Galassi, Ar, and Tamburino, Corrado
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- 2008
5. First-in-Man 1-Year Clinical Outcomes of the Catania Coronary Stent System With Nanothin Polyzene-F in De Novo Native Coronary Artery Lesions The ATLANTA (Assessment of The LAtest Non-Thrombogenic Angioplasty stent) Trial
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Tamburino, Corrado, LA MANNA, A, DI SALVO ME, Sacchetta, G, Capodanno, DAVIDE FRANCESCO MARIA, Mehran, R, Dangas, G, Corcos, T, and Prati, F.
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optical coherence tomography ,nonpolymeric coating ,equipment and supplies ,first in man - Abstract
ObjectivesThis study sought to assess safety and efficacy of implantation of the Catania Coronary Stent System with Nanothin Polyzene-F (CeloNova BioSciences, Newnan, Georgia) in human coronary arteries with clinical data and comprehensive intracoronary imaging.BackgroundNovel approaches to modify stents (e.g., bioactive agents, coatings) have been developed to address the limitations of bare-metal and drug-eluting stents (e.g., restenosis, target lesion revascularization [TLR], late thrombosis).MethodsThis first-in-man study using the Catania stent is a prospective, single center, nonrandomized, single-arm study of 55 patients with symptomatic ischemic heart disease with de novo, obstructive lesions of native coronary arteries.ResultsAcute angiographic success was 100%. A core laboratory analyzed quantitative coronary angiography and intravascular ultrasound data immediately after stenting and at 6-month follow-up. Late lumen loss was 0.60 ± 0.48 mm and the percent neointimal hyperplasia volume was 27.9 ± 16.1%. In 15 of 55 randomly selected patients, 1,904 cross-sections (19,028 struts) were analyzed at 6 months by optical coherence tomography. Overall, 99.5% of struts were covered. Only 29 of 19,028 struts (0.15%) were malapposed. Binary angiographic restenosis was 6.8%. No death, myocardial infarction, or Academic Research Consortium–defined stent thrombosis was observed at 12 months. The incidence of TLR at 12 months was clinically driven TLR 3.6% (2 of 55) and nonclinically driven TLR 7.3% (4 of 55).ConclusionsThis first-in-man showed an excellent early and mid-term safety profile and high-level efficacy of the new Catania stent in the treatment of de novo coronary lesions in a fairly complex population. Polyzene-F coated stents may be an alternative to both bare-metal and drug-eluting stents with reduced late loss, restenosis, and the TLR without long-term dual antiplatelet therapy.
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6. Complete or Culprit-Only PCI in Older Patients with Myocardial Infarction.
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Biscaglia, S., Guiducci, V., Escaned, J., Moreno, R., Lanzilotti, V., Santarelli, A., Cerrato, E., Sacchetta, G., Jurado-Roman, A., Menozzi, A., Amat Santos, I., Díez Gil, J. L., Ruozzi, M., Barbierato, M., Fileti, L., Picchi, A., Lodolini, V., Biondi-Zoccai, G., Maietti, E., and Pavasini, R.
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MYOCARDIAL infarction , *OLDER patients , *ST elevation myocardial infarction , *PERCUTANEOUS coronary intervention , *ACUTE kidney failure - Abstract
BACKGROUND The benefit of complete revascularization in older patients (≥ 75 years of age) with myocardial infarction and multivessel disease remains unclear. METHODS In this multicenter, randomized trial, we assigned older patients with myocardial infarction and multivessel disease who were undergoing percutaneous coronary intervention (PCI) of the culprit lesion to receive either physiology-guided complete revascularization of nonculprit lesions or to receive no further revascularization. Functionally significant nonculprit lesions were identified either by pressure wire or angiography. The primary outcome was a composite of death, myocardial infarction, stroke, or any revascularization at 1 year. The key secondary outcome was a composite of cardiovascular death or myocardial infarction. Safety was assessed as a composite of contrast-associated acute kidney injury, stroke, or bleeding. RESULTS A total of 1445 patients underwent randomization (720 to receive complete revascularization and 725 to receive culprit-only revascularization). The median age of the patients was 80 years (interquartile range, 77 to 84); 528 patients (36.5%) were women, and 509 (35.2%) were admitted for ST-segment elevation myocardial infarction. A primary-outcome event occurred in 113 patients (15.7%) in the complete-revascularization group and in 152 patients (21.0%) in the culprit-only group (hazard ratio, 0.73; 95% confidence interval [CI], 0.57 to 0.93; P = 0.01). Cardiovascular death or myocardial infarction occurred in 64 patients (8.9%) in the complete-revascularization group and in 98 patients (13.5%) in the culprit-only group (hazard ratio, 0.64; 95% CI, 0.47 to 0.88). The safety outcome did not appear to differ between the groups (22.5% vs. 20.4%; P=0.37). CONCLUSIONS Among patients who were 75 years of age or older with myocardial infarction and multivessel disease, those who underwent physiology-guided complete revascularization had a lower risk of a composite of death, myocardial infarction, stroke, or ischemia-driven revascularization at 1 year than those who received culprit-lesion-only PCI. [ABSTRACT FROM AUTHOR]
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- 2023
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7. Optical coherence tomographic results at six-month follow-up evaluation of the CATANIA coronary stent system with nanothin Polyzene-F surface modification (from the Assessment of The LAtest Non-Thrombogenic Angioplasty Stent [ATLANTA] trial)
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La Manna A, Capodanno D, Cera M, Di Salvo ME, Sacchetta G, Corcos T, Prati F, and Tamburino C
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- 2009
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8. Complete vs Culprit-Only Revascularization in Older Patients With Myocardial Infarction With or Without ST-Segment Elevation.
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Cocco M, Campo G, Guiducci V, Casella G, Cavazza C, Cerrato E, Sacchetta G, Moreno R, Menozzi A, Amat Santos I, Díez Gil JL, Scarsini R, Picchi A, Vadalà G, Pilato G, Colaiori I, Barbierato M, Arioti M, Pavasini R, Lanzilotti V, Menozzi M, Varbella F, Erriquez A, and Biscaglia S
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- Humans, Female, Male, Aged, Percutaneous Coronary Intervention methods, Aged, 80 and over, Treatment Outcome, ST Elevation Myocardial Infarction surgery, ST Elevation Myocardial Infarction mortality, ST Elevation Myocardial Infarction physiopathology, Non-ST Elevated Myocardial Infarction surgery, Non-ST Elevated Myocardial Infarction mortality, Non-ST Elevated Myocardial Infarction physiopathology, Myocardial Revascularization methods
- Abstract
Background: The effectiveness of complete revascularization is well established in patients with ST-segment elevation myocardial infarction (STEMI), but it is less investigated in those with non-ST-segment elevation myocardial infarction (NSTEMI)., Objectives: This study aimed to assess whether complete revascularization, compared with culprit-only revascularization, was associated with consistent outcomes in older patients with STEMI and NSTEMI., Methods: In the FIRE (Functional Assessment in Elderly MI Patients with Multivessel Disease) trial, 1,445 older patients with myocardial infarction (MI) were randomized to culprit-only or physiology-guided complete revascularization, stratified by STEMI (n = 256 culprit-only vs n = 253 complete) and NSTEMI (n = 469 culprit-only vs n = 467 complete). The primary outcome comprised a composite of death, MI, stroke, or revascularization at 1 year. The key secondary outcome included a composite of cardiovascular death or MI at 1 year., Results: In the overall study population, physiology-guided complete revascularization reduced both primary and key secondary outcomes. The primary outcome occurred in 54 (21.1%) STEMI patients randomized to culprit-only vs 41 (16.2%) STEMI patients of the complete group (HR: 0.75; 95% CI: 0.50-1.13) and in 98 (20.9%) NSTEMI patients randomized to culprit-only vs 72 (15.4%) NSTEMI patients of the complete group (HR: 0.71; 95% CI: 0.53-0.97), with negative interaction testing (P for interaction, 0.846). Similarly, no signal of heterogeneity with respect to the initial clinical presentation was observed for the key secondary endpoint (P for interaction, 0.654)., Conclusions: Physiology-guided complete revascularization, compared with culprit-only revascularization, provided consistent benefit across the whole spectrum of patients with MI. (FIRE [Functional Assessment in Elderly MI Patients With Multivessel Disease]; NCT03772743)., Competing Interests: Funding Support and Author Disclosures Sahajanand Medical Technologies Ltd (SMT), Medis Medical Imaging Systems, Eukon S.r.l., Siemens Healthineers, General Electric (GE) Healthcare, and Insight Lifetech provided unrestricted funding to the study sponsor for the conduction of the trial. These companies had no involvement in the trial design, data collection, analysis, interpretation, or writing of the manuscript. Dr Campo has received research grants and personal fees from Abbott Vascular, GADA, Menarini, Amgen, Daichi-Sankyo, and Sanofi, outside the submitted work. Dr Moreno has received speaker/consulting fees from Abbott Vascular, AMGEN, AstraZeneca, Biosensors, Biotronik, Boston Scientific, Daiichi-Sankyo, Edwards, Medtronic, and Philips, outside the submitted work. Dr Biscaglia has received funding from the Italian Health Minister (Ricerca Finalizzata 2021, GR-2021-12372516) for the conduction of the Functional Coronary Angiography Guided Revascularization in STEMI trial; and has received personal fees from Abbott Vascular and Siemens Healthcare, outside the submitted work. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
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- 2024
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9. [Left atrial appendage closure guided with intracardiac echocardiographic probe via transesophageal route].
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Sacchetta G, Laterra G, Barrano G, Artale C, and Contarini M
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- Humans, Ultrasonography, Interventional methods, Thrombosis prevention & control, Thrombosis etiology, Thrombosis diagnostic imaging, Left Atrial Appendage Closure, Atrial Appendage diagnostic imaging, Atrial Appendage surgery, Echocardiography, Transesophageal methods, Atrial Fibrillation surgery
- Abstract
Atrial fibrillation is the most common cardiac arrhythmia in adults and increases the risk of stroke 5-fold. In patients with non-valvular atrial fibrillation, left atrial appendage is the most common site for cardiac thrombus. For this reason, left atrial appendage closure (LAAC) represents an effective alternative to oral anticoagulants in patients who have relative or absolute contraindications to oral anticoagulation. Transesophageal echocardiography (TEE) is considered the gold standard imaging modality to guide LAAC. However, general anesthesia and tracheal intubation are often required with the TEE approach, increasing risks in elderly patients. There is an unmet need to overcome these limitations identifying an ideal "minimalist approach" to guide LAAC. Intracardiac echocardiography (ICE) represents a minimalist approach but it suffers from the lack of standardization and it may result in an suboptimal image quality compared with TEE. Another innovative approach is represented by the use of ICE via the transesophageal route (ICE-TEE), which has been already validated to identify the presence of left atrial appendage thrombi and to perform other procedures. In this paper, we suggest that ICE-TEE could be a good alternative imaging technique to guide the LAAC procedure without general anesthesia. A trial is ongoing to demonstrate its safety and effectiveness as ultrasound modality to guide LAAC.
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- 2024
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10. Impact of pre-admission physical activity on benefits of physiology-guided complete revascularization in older patients with myocardial infarction: insights from the FIRE trial.
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Pavasini R, Campo G, Serenelli M, Tonet E, Guiducci V, Escaned J, Moreno R, Casella G, Cavazza C, Varbella F, Sacchetta G, Arena M, Santos IA, Ibañes EG, Scarsini R, D'Amico G, Ruiz-Poveda FL, Díez Gil JL, Pignatelli G, Iannopollo G, Colaiori I, Santos RC, Marrone A, Fileti L, Rigattieri S, Barbato E, Ocaranza-Sanchez R, and Biscaglia S
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- Humans, Male, Female, Aged, Aged, 80 and over, Treatment Outcome, Time Factors, Sedentary Behavior, Risk Factors, Myocardial Revascularization methods, Age Factors, Patient Admission, Risk Assessment, Myocardial Infarction physiopathology, Myocardial Infarction mortality, Exercise
- Abstract
Aims: The present analysis from the Functional Assessment in Elderly Myocardial Infarction Patients with Multivessel Disease (FIRE) trial aims to explore the significance of pre-admission physical activity and assess whether the benefits of physiology-guided complete revascularization apply consistently to sedentary and active older patients., Methods and Results: Patients aged 75 years or more with myocardial infarction (MI) and multivessel disease were randomized to receive physiology-guided complete revascularization or culprit-only strategy. The primary outcome was a composite of death, MI, stroke, or any revascularization within a year. Secondary endpoints included the composite of cardiovascular death or MI, as well as single components of the primary endpoint. Pre-admission physical activity was categorized into three groups: (i) absent (sedentary), (ii) light, and (iii) vigorous. Among 1445 patients, 692 (48%) were sedentary, whereas 560 (39%) and 193 (13%) performed light and vigorous physical activity, respectively. Patients engaging in light or vigorous pre-admission physical activity exhibited a reduced risk of the primary outcome compared with sedentary individuals [light hazard ratio (HR) 0.70, 95% confidence interval (CI) 0.55-0.91 and vigorous HR 0.14, 95% CI 0.07-0.91, respectively]. These trends were also observed for death, cardiovascular death, or MI. When comparing physiology-guided complete revascularization vs. culprit-only strategy, no significant interaction was observed for primary and secondary endpoints when stratified by sedentary or active status., Conclusion: In older patients with MI, pre-admission physical activity emerges as a robust and independent prognostic determinant. Physiology-guided complete revascularization stands out an effective strategy in reducing ischaemic adverse events, irrespective of pre-admission physical activity status., Clinical Trial Registration: ClinicalTrials.gov NCT03772743., Competing Interests: Conflict of interest: G.Cam. received research grants and personal fees from ABBOTT VASCULAR, personal fees from MENARINI, personal fees from AMGEN, personal fees from SANOFI, outside the submitted work. S.B. received personal fees from ABBOTT VASCULAR, outside the submitted work., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)
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- 2024
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11. Intracardiac Echocardiographic Probe Used Via Transesophageal to Guide Left Atrial Appendage Occlusion: The DIONISO Study.
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Laterra G, Sacchetta G, Artale C, Barrano G, Mazzone P, Ruscica G, Guarneri MC, Costa S, Barbanti M, and Contarini M
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- Humans, Treatment Outcome, Ultrasonography, Interventional, Equipment Design, Male, Aged, Female, Transducers, Atrial Appendage diagnostic imaging, Atrial Appendage physiopathology, Atrial Fibrillation physiopathology, Atrial Fibrillation diagnostic imaging, Atrial Fibrillation therapy, Echocardiography, Transesophageal, Cardiac Catheterization instrumentation, Predictive Value of Tests
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- 2024
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12. Contrast-enhanced excimer laser stepwise approach during PCI for resistant coronary lesions.
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Vizzari G, Caminiti R, Ielasi A, Vetta G, Parlavecchio A, Mazzone P, Sacchetta G, Magnocavallo M, Della Rocca DG, Siviglia M, Versace AG, Contarini M, and Micari A
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- Humans, Retrospective Studies, Male, Female, Aged, Treatment Outcome, Middle Aged, Italy, Coronary Angiography, Predictive Value of Tests, Time Factors, Percutaneous Coronary Intervention instrumentation, Percutaneous Coronary Intervention adverse effects, Stents, Risk Factors, Lasers, Excimer therapeutic use, Atherectomy, Coronary adverse effects, Coronary Artery Disease diagnostic imaging, Coronary Artery Disease therapy, Contrast Media administration & dosage
- Abstract
Background: The treatment of resistant coronary lesions (RCL) is a great challenge for interventional cardiologists. The excimer laser coronary atherectomy (ELCA) is a plaque modification tool based on a main mechanism of photomechanical effect leading to mechanical disruption of the plaque. Contrast dye injection during laser delivery has demonstrated to enhance its power., Aim: To evaluate the effectiveness and safety of the contrast-enhanced ELCA by a stepwise approach in the treatment of RCLs., Methods: We retrospectively examined consecutive patients undergoing contrast-enhanced ELCA-assisted PCI between 2018 and 2021 at two Italian sites. RCLs were defined as novo or in-stent undilatable/uncrossable with conventional balloons (SC/NC balloon). The primary endpoint was ELCA technical success defined as the laser catheter crossing the entire length of the target lesion established by angiographic evidence of the catheter tip in the artery distal to the stenosis., Results: We enrolled 114 patients who underwent contrast-enhanced ELCA-assisted PCI: 58% of the patients had acute coronary syndrome while the left anterior descending artery was the target vessel in 42.1% of cases. The target lesion was most commonly in-stent (56.2%). The 0.9 mm ELCA catheter tip was employed in 89.5% of cases. The most used frequency/fluency profile was 70/70 (39.5%). The use of contrast-enhanced ELCA was associated with high technical, procedural, and clinical success rates (97.4%, 93.7%, and 90.1%, respectively)., Conclusions: The contrast-enhanced ELCA seems to be a safe and effective treatment option for the management of both de novo and in-stent-resistant coronary lesions., (© 2024 Wiley Periodicals LLC.)
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- 2024
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13. QFR for the Revascularization of Nonculprit Vessels in MI Patients: Insights From the FIRE Trial.
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Erriquez A, Campo G, Guiducci V, Casella G, Menozzi M, Cerrato E, Sacchetta G, Moreno R, Arena M, Amat Santos I, Diez Gil JL, Scarsini R, Ruozzi M, Arioti M, Picchi A, Barbierato M, Moscarella E, Musto D'Amore S, Lanzilotti V, Cavazza C, Rezzaghi M, Cocco M, Marrone A, Verardi FM, Escaned J, Barbato E, Colaiori I, Pesenti N, Carrara G, and Biscaglia S
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- Aged, Aged, 80 and over, Female, Humans, Male, Cardiac Catheterization adverse effects, Cardiac Catheterization instrumentation, Coronary Artery Disease diagnostic imaging, Coronary Artery Disease therapy, Coronary Artery Disease physiopathology, Coronary Vessels diagnostic imaging, Coronary Vessels physiopathology, Fractional Flow Reserve, Myocardial, Myocardial Infarction physiopathology, Myocardial Infarction diagnostic imaging, Prospective Studies, Risk Factors, Time Factors, Treatment Outcome, Coronary Angiography, Percutaneous Coronary Intervention adverse effects, Percutaneous Coronary Intervention instrumentation, Predictive Value of Tests
- Abstract
Background: The role of quantitative flow ratio (QFR) in the treatment of nonculprit vessels of patients with myocardial infarction (MI) is a topic of ongoing discussion., Objectives: This study aimed to investigate the predictive capability of QFR for adverse events and its noninferiority compared to wire-based functional assessment in nonculprit vessels of MI patients., Methods: The FIRE (Functional Assessment in Elderly MI Patients With Multivessel Disease) trial randomized 1,445 older MI patients to culprit-only (n = 725) or physiology-guided complete revascularization (n = 720). In the culprit-only arm, angiographic projections of nonculprit vessels were prospectively collected, centrally reviewed for QFR computation, and associated with endpoints. In the complete revascularization arm, endpoints were compared between nonculprit vessels investigated with QFR or wire-based functional assessment. The primary endpoint was the vessel-oriented composite endpoint (VOCE) at 1 year., Results: QFR was measured on 903 nonculprit vessels from 685 patients in the culprit-only arm. Overall, 366 (40.5%) nonculprit vessels showed a QFR value ≤0.80, with a significantly higher incidence of VOCEs (22.1% vs 7.1%; P < 0.001). QFR ≤0.80 emerged as an independent predictor of VOCEs (HR: 2.79; 95% CI: 1.64-4.75). In the complete arm, QFR was used in 320 (35.2%) nonculprit vessels to guide revascularization. When compared with propensity-matched nonculprit vessels in which treatment was guided by wire-based functional assessment, no significant difference was observed (HR: 0.57; 95% CI: 0.28-1.15) in VOCEs., Conclusions: This prespecified subanalysis of the FIRE trial provides evidence supporting the safety and efficacy of QFR-guided interventions for the treatment of nonculprit vessels in MI patients. (Functional Assessment in Elderly MI Patients With Multivessel Disease [FIRE]; NCT03772743)., Competing Interests: Funding Support and Author Disclosures The data supporting this paper are accessible upon reasonable request to the FIRE Study Executive Committee. Sahajanand Medical Technologies Ltd, Medis Medical Imaging Systems, Eukon S.r.l., Siemens Healthineers, General Electric Healthcare, and Insight Lifetech provided unrestricted funding to the study sponsor for the conduction of the trial. These companies had no involvement in the trial design, data collection, analysis, interpretation, or writing of the manuscript. Dr Campo has received research grants and personal fees from Abbott Vascular, GADA, Menarini, Amgen, Daichii-Sankyo, and Sanofi outside of the submitted work. Dr Moreno has received speaker/consulting fees from Abbott Vascular, AMGEN, AstraZeneca, Biosensors, Biotronik, Boston Scientific, Daiichi-Sankyo, Edwards Lifesciences, Medtronic, and Philips outside of the submitted work. Dr Barbato declares speaker fees from Abbott Vascular, Boston Scientific, Insight Lifetech, outside of the submitted work. Dr Biscaglia has received funding from the Italian Health Minister (Ricerca Finalizzata 2021, GR-2021-12372516) for the conduction of the Functional Coronary Angiography Guided Revascularization in STEMI trial; and has received personal fees from Abbott Vascular outside of the submitted work., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)
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- 2024
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14. Complete vs Culprit-Only Revascularization in Older Patients With Myocardial Infarction and High Bleeding Risk: A Randomized Clinical Trial.
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Erriquez A, Campo G, Guiducci V, Escaned J, Moreno R, Casella G, Menozzi M, Cerrato E, Sacchetta G, Menozzi A, Santos IA, Ibañes EG, Scarsini R, Vadalà G, Andò G, Díez-Gil JL, d'Amore SM, Capecchi A, Colaiori I, Gallo F, Pavasini R, Marrone A, Pompei G, Lanzilotti V, Dudek D, Barbato E, Tebaldi M, and Biscaglia S
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- Humans, Male, Female, Aged, Aged, 80 and over, Myocardial Revascularization methods, Percutaneous Coronary Intervention methods, Coronary Angiography, Risk Factors, Myocardial Infarction, Hemorrhage epidemiology
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Importance: Patients with high bleeding risk (HBR) have a poor prognosis, and it is not known if they may benefit from complete revascularization after myocardial infarction (MI)., Objective: To investigate the benefit of physiology-guided complete revascularization vs a culprit-only strategy in patients with HBR, MI, and multivessel disease., Design, Setting, and Participants: This was a prespecified analysis of the Functional Assessment in Elderly MI Patients With Multivessel Disease (FIRE) randomized clinical trial data. FIRE was an investigator-initiated, open-label, multicenter trial. Patients 75 years or older with MI and multivessel disease were enrolled at 34 European centers from July 2019 through October 2021. Physiology treatment was performed either by angiography- or wire-based assessment. Patients were divided into HBR or non-HBR categories in accordance with the Academic Research Consortium HBR document., Interventions: Patients were randomized to either physiology-guided complete revascularization or culprit-only strategy., Main Outcomes and Measures: The primary outcome comprised a composite of death, MI, stroke, or revascularization at 1 year. Secondary outcomes included a composite of cardiovascular death or MI and Bleeding Academic Research Consortium (BARC) types 3 to 5., Results: Among 1445 patients (mean [SD] age, 81 [5] years; 917 male [63%]), 1025 (71%) met HBR criteria. Patients with HBR were at higher risk for the primary end point (hazard ratio [HR], 2.01; 95% CI, 1.47-2.76), cardiovascular death or MI (HR, 1.89; 95% CI, 1.26-2.83), and BARC types 3 to 5 (HR, 3.28; 95% CI, 1.40-7.64). The primary end point was significantly reduced with physiology-guided complete revascularization as compared with culprit-only strategy in patients with HBR (HR, 0.73; 95% CI, 0.55-0.96). No indication of interaction was noted between revascularization strategy and HBR status for primary and secondary end points., Conclusions and Relevance: HBR status is prevalent among older patients with MI, significantly increasing the likelihood of adverse events. Physiology-guided complete revascularization emerges as an effective strategy, in comparison with culprit-only revascularization, for mitigating ischemic adverse events, including cardiovascular death and MI., Trial Registration: ClinicalTrials.gov Identifier: NCT03772743.
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- 2024
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15. Acute and long-term results of percutaneous coronary intervention of bifurcation lesions with the dedicated Bioss Lim C stent: the Italian BIfurcation Observational Spontaneous Study (IBIOSS).
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Briguori C, Capodanno D, Contarini M, Donahue ME, Evola S, Garro N, Greco F, LA Manna A, Murè P, Nicosia A, Migliore G, Sacchetta G, Signore N, Tamburino C, Vizzari G, and Biondi-Zoccai G
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- Humans, Female, Male, Aged, Prospective Studies, Italy, Treatment Outcome, Coronary Artery Disease therapy, Middle Aged, Prosthesis Design, Time Factors, Drug-Eluting Stents, Percutaneous Coronary Intervention adverse effects, Stents
- Abstract
Background: Percutaneous coronary intervention (PCI) for bifurcation lesions still represents a clinical challenge. The Bioss Lim C is a dedicated device for bifurcation lesions, features a tapered shape and large cells, and thus appears as a promising adjunct to the current interventional cardiologists' armamentarium. We aimed at conducting a prospective multicenter study focusing on early and long-term results after Bioss Lim C implantation for true coronary bifurcation lesions., Methods: Patients with true bifurcation lesions in whom Bioss Lim C implantation was attempted were enrolled in four Italian centers. An explicit bifurcation management approach was recommended, leaving however the choice between one- vs. two-stent strategies at operator's discretion. Acute and long-term results were systematically appraised, focusing on an acute composite of complex side branch (SB) rewiring, SB pinching, or SB occlusion (primary efficacy endpoint), as well as major adverse events (MACE, i.e. death, myocardial infarction [MI], or target vessel revascularization [TVR]), individual components of MACE, and stent thrombosis., Results: A total of 207 patients were included, with age of 67.3±10.8 years, and 40 (19.3%) women. The target lesion was located in the left main in 48 (23.2%) patients, whereas proximal reference vessel diameter was 3.69±0.48 mm, and lesion length 20.3±3.4 mm. According to the Medina classification, most patients (60 [30.9%]) had 1-1-1 lesions. Drug-eluting stent implantation in the SB was carried out in 19 (9.3%) subjects, and kissing balloon inflation was used in 67 (32.5%). The primary efficacy endpoint occurred in 27 (13.0%), with side branch (SB) occlusion in two (1.0%), SB pinching in 23 (11.1%), and complex SB rewiring in six (2.9%), and was most frequent in patients with lower body mass index or dyslipidemia. After 24.1±19.5 months, MACE were adjudicated in 23 (11.1%) subjects, with death in 10 (4.8%), MI in six (2.9%), and TVR in seven (3.4%), as well as stent thrombosis in one (0.5%)., Conclusions: This study supports a wider adoption of the Bioss Lim C dedicated bifurcation device, thanks to the favorable acute results as well as long-term clinical outcomes, as well as its versatility for the stenting strategy provisionally or eventually adopted by operators.
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- 2024
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16. Intracardiac echocardiography probe via oesophageal to guide percutaneous left atrial appendage closure procedure: a case series.
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Laterra G, Artale C, Sacchetta G, and Contarini M
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Background: Left atrial appendage closure (LAAC) can be an alternative to oral anticoagulant therapy in patients with non-valvular atrial fibrillation, characterized by high risk of stroke (CHA2D2VASC ≥ two for men and CHA2D2VA2SC ≥ three for women) and high risk of bleeding (HASBLED = 3)., Case Summary: We describe three case reports in which an intracardiac echocardiography probe was used via the oesophageal route as an alternative to traditional transoesophageal echocardiography (TEE) or ICE methods to guide LAAC. Guiding the procedure via conventional TEE, even if feasible, could be difficult in these patients due to different causes: one patient was affected by Brugada syndrome while the other two patients reported oropharyngeal abnormalities. For these reasons, we performed an alternative use of the ICE probe to guide the entire LAAC procedure., Discussion: Currently, LAAC is performed using intracardiac or transoesophageal echocardiography. This alternative use of ICE probe via oesophageal (ICE-TEE) is reported in previous studies that describe the feasibility of this technique both in excluding the presence of thrombus in left atrial appendage before cardioversion and in guiding percutaneous foramen ovale closure. Therefore, the ICE probe has been used as an intraoperative transoesophageal echocardiographic probe to repair congenital heart disease in infants or children with oropharyngeal abnormalities.This case series reports the first use of ICE-TEE to guide the entire LAAC procedure, guaranteeing the visualization of all echocardiographic views needed to perform it. The present case series highlights the potential of ICE-TEE to safely perform both pre-procedural and intraoperative evaluations in LAAC procedure., Competing Interests: Conflict of interest: None declared., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology.)
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- 2023
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17. Imaging Modality to Guide Left Atrial Appendage Closure: Current Status and Future Perspectives.
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Laterra G, Dattilo G, Correale M, Brunetti ND, Artale C, Sacchetta G, Pistelli L, Borgi M, Campanella F, Cocuzza F, Lo Nigro MC, and Contarini M
- Abstract
Atrial fibrillation (AF) is the most common cardiac arrhythmia in adults. The left atrial appendage (LAA) is the most likely source of thrombus formation in patients with non-valvular atrial fibrillation (NVAF). Left atrial appendage closure (LAAC) represents an effective alternative to NOAC in patients with NVAF. Expert consensus documents recommend intraprocedural imaging by means of either transesophageal echocardiography (TEE) or intracardiac echocardiography (ICE) in addition to standard fluoroscopy to guide LAAC. TEE-guided LAAC usually requires general anesthesia. The ICE technique is a "minimalist approach", without general anesthesia, but ICE imaging techniques are not yet simplified and standardize, and the ICE may result in inferior image quality compared with that of TEE. Another "minimalist approach" can be the use of ICE via the esophageal route (ICE-TEE), that jet is validated to identify the presence of LAA thrombi in patients and to perform other procedures. In our cath laboratory ICE-TEE to guide LAAC is used in some complex patients. Indeed, our single center experience suggests that ICE-TEE could be a good alternative imaging technique to guide LAAC procedure without general anesthesia.
- Published
- 2023
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18. Real-world experience with the new Watchman FLX device: Data from two high-volume Sicilian centers. The FLX-iEST registry.
- Author
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Vizzari G, Grasso C, Sardone A, Mazzone P, Laterra G, Frazzetto M, Sacchetta G, Micari A, Tamburino C, and Contarini M
- Subjects
- Cardiac Catheterization adverse effects, Echocardiography, Transesophageal adverse effects, Hospital Mortality, Humans, Registries, Treatment Outcome, Atrial Appendage diagnostic imaging, Atrial Fibrillation complications, Atrial Fibrillation diagnosis, Atrial Fibrillation therapy, Stroke etiology
- Abstract
Introduction: The Watchman-FLX left atrial appendage closure (LAAC) device presents innovative features: higher conformability, reduced length, closed distal "flex-ball" during deployment, and flattened surface. We report our real-world experience with the Watchman-FLX device in two centers with consolidated LAAC expertise., Methods: We enrolled 200 consecutive Watchman-FLX patients (2019-2021) in a nonrandomized double-center registry; procedural data and follow-up for midterm clinical outcomes were collected. A control group of 100 patients treated with first-generation Watchman (2.5) was included., Results: According to mean CHAD
2 DS2 -VASc (5 ± 1.40) and HAS-BLED (3.8 ± 1.01) scores, the population included in this study was at high risk: 29% had a previous stroke and 56.5% a bleeding event. Main LAAC indications were symptomatic hemorrhage (39.5%), need for triple antithrombotic therapy (39%), gastrointestinal bleeding (32%), and oral anticoagulation intolerance (18%). Transesophageal echocardiography guidance was followed in 93% of cases (48% in general anesthesia and 45% under conscious sedation). Repositioning an FLX device was required in 20% of cases and no complication occurred. In 96% of patients, the first selected device was delivered, while in 4% a device size change was required after the first choice (7% with Watchman 2.5). Peridevice leaks (<5 mm) were found postimplant in two cases (1%). Overall, the procedural success rate was 99.5%. One patient's procedure was unsuccessful (0.5%), due to left atrial appendage (LAA) anatomy; differently, the mean failure rate with Watchman 2.5 was 2%. No device embolization was reported. Complications (8.5%) were mainly related to the access site (3%); major bleedings (1%), and in-hospital death (0.5%) rarely occurred. After a follow-up of 272 ± 173 days, 2.3% of cases experienced a non-device-related stroke and 0.6% fatal bleeding., Conclusion: Our registry showed a high procedural success rate of the Watchman-FLX in a high-risk population. According to our experience, the main advantages include easy implanting and repositioning, absence of embolization, good LAA sealing, and low rate of complications in the follow-up period., (© 2022 Wiley Periodicals LLC.)- Published
- 2022
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19. Comparison of quantitative flow ratio, Pd/Pa and diastolic hyperemia-free ratio versus fractional flow reserve in non-culprit lesion of patients with non ST-segment elevation myocardial infarction.
- Author
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Tebaldi M, Biscaglia S, Erriquez A, Penzo C, Tumscitz C, Scoccia A, Quadri G, Sacchetta G, Folla A, Vadalà G, Fileti L, and Campo G
- Subjects
- Coronary Angiography, Coronary Vessels diagnostic imaging, Humans, Predictive Value of Tests, Reproducibility of Results, Severity of Illness Index, Treatment Outcome, Coronary Stenosis, Fractional Flow Reserve, Myocardial, Non-ST Elevated Myocardial Infarction diagnostic imaging, Non-ST Elevated Myocardial Infarction therapy
- Abstract
Objectives: To investigate the correlation between quantitative flow ratio (QFR), Pd/Pa, diastolic hyperemia-free ratio (DFR) and fractional flow reserve (FFR, gold standard) in non-culprit lesion (NCL) of patients with non ST-segment elevation myocardial infarction (NSTEMI)., Background: The non-hyperemic pressure ratio (NHPR) and the angiography-based indexes have been developed to overcome the limitation of the use of the FFR., Methods: Between January and December 2019, 184 NCL from 116 NSTEMI patients underwent physiologic assessment and were included in the study. NCLs were investigated with QFR, Pd/Pa, DFR, and FFR. Mean values of QFR, Pd/Pa, DFR and FFR were 0.85 ± 0.10, 0.92 ± 0.07, 0.93 ± 0.05 and 0.84 ± 0.07, respectively., Results: DFR and FFR showed a good correlation (r = 0.76). Bland and Altman plot showed a mean difference of 0.080. DFR Diagnostic accuracy was 88%. The area under the ROC curve (AUC) for DFR was 0.946 (95%CI 0.90-0.97, p = .0001). Similar findings were reported for Pd/Pa (r = 0.73; mean difference 0.095, diagnostic accuracy 84%, AUC 0.909 [95%CI 0.85-0.94, p = .0001]) and QFR (r = 0.68; mean difference 0.01; diagnostic accuracy 88%, AUC 0.964 [95% CI 0.91-0.98, p = .0001]). FFR, QFR, Pd/Pa and DFR identified 31%, 32%, 30% and 32% potentially flow-limiting lesions, respectively., Conclusions: In NSTEMI patients, QFR, Pd/Pa and DFR showed equivalence as compared to gold standard FFR in the discrimination of non-culprit lesions requiring revascularization., (© 2020 Wiley Periodicals LLC.)
- Published
- 2021
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20. A Prospective, observational, Italian multi-center registry of self-aPposing® cOronary Stents in patients presenting with ST-segment Elevation Myocardial InfarcTION: The iPOSITION registry.
- Author
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Giuliani L, Archilletti F, Andò G, Rossi S, Sacchetta G, De Iaco G, Saporito F, Contarini M, Parisi R, Gallina S, Zimarino M, Gutiérrez-Chico JL, and Maddestra N
- Subjects
- Death, Humans, Prospective Studies, Registries, Stents, Treatment Outcome, Drug-Eluting Stents, Myocardial Infarction, Percutaneous Coronary Intervention adverse effects, Percutaneous Coronary Intervention methods, ST Elevation Myocardial Infarction diagnosis, ST Elevation Myocardial Infarction surgery, Thrombosis
- Abstract
Background: Primary percutaneous coronary intervention (pPCI) in ST-segment elevation myocardial infarction (STEMI) can be challenging for high thrombus burden and catecholamine-induced vasoconstriction. The Xposition-S stent was designed to prevent stent undersizing and minimize strut malapposition. We evaluated 1-year clinical outcomes of a nitinol, self-apposing®, sirolimus-eluting stent, pre-mounted on a novel balloon delivery system, in de novo lesions of patients presenting with STEMI undergoing pPCI., Methods: The iPOSITION is a prospective, multicenter, post-market, observational study. The primary endpoint, target lesion failure (TLF), was defined as the composite of cardiac death, recurrent target vessel myocardial infarction (TV-MI), and clinically driven target lesion revascularization (TLR)., Results: The study enrolled 247 STEMI patients from 7 Italian centers. Both device and procedural success occurred in 99.2% of patients, without any death, TV-MI, TLR, or stent thrombosis during the hospital stay and at 30-day follow-up. At 1 year, TLF occurred in 2.6%, cardiac death occurred in 1.7%, TV-MI occurred in 0.4%, and TLR in 0.4% of patients. The 1-year stent thrombosis rate was 0.4%., Conclusions: The use of an X-position S self-apposing® stent is feasible in STEMI pPCI, with excellent post-procedural results and 1-year outcomes.
- Published
- 2021
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21. Myocardial ischemia due to a recanalized chronic coronary thrombus: Angiographic and optical coherence tomography imaging insights.
- Author
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Sacchetta G, Scalise RFM, Garcia Ruiz V, Barrano G, Garro N, Costa F, and Contarini M
- Abstract
Chronic organized thrombus as a result of prior untreated myocardial infarction can determine myocardial ischemia. This entity appears as an angiographically irregular and hazy image; optical coherence tomography is useful to evaluate these ambiguous lesions and guide interventional treatment., Competing Interests: None declared., (© 2020 The Authors. Clinical Case Reports published by John Wiley & Sons Ltd.)
- Published
- 2020
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22. Impellent impeller-Switching intra-aortic balloon pump to IMPELLA-CP after ST-segment elevation myocardial infarction and refractory cardiogenic shock.
- Author
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Contarini M, Costa F, Garcia Ruiz MV, Scalise RFM, De Velli G, Murè P, Mazzone P, Sacchetta G, and Andò G
- Abstract
Cardiogenic shock is a dreadful complication of myocardial infarction. Despite widespread use and availability, intra-aortic balloon pump (IABP) does not reduce mortality nor improves outcomes. Advanced mechanical circulatory support with IMPELLA system can substantially support hemodynamics and improve short-term prognosis in patients with myocardial infarction and cardiogenic shock., Competing Interests: None declared.
- Published
- 2019
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23. The "mini-crush technique" for the treatment of coronary trifurcation lesions.
- Author
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Galassi AR, Tomasello SD, Sacchetta G, Seminara D, Canonico L, and Tamburino C
- Subjects
- Aged, Coronary Angiography, Coronary Artery Disease diagnostic imaging, Feasibility Studies, Female, Follow-Up Studies, Humans, Male, Middle Aged, Treatment Outcome, Angioplasty, Balloon, Coronary methods, Coronary Artery Disease pathology, Coronary Artery Disease therapy, Coronary Vessels pathology
- Abstract
Aims: Recent evidence suggest that coronary bifurcation lesions might be treated by DES using "the mini-crush technique" with low rate of MACE and restenosis both at main and side branches. However, the treatment of a coronary trifurcation lesion is more problematic. Here we assess the feasibility of the "mini-crush technique" for treating trifurcation lesions., Methods and Results: We report on the treatment of trifurcation lesions using DES in all branches by the mini-crush technique in five consecutive patients (65+/-11.5 years) from December 2004 till March 2006. Independently, from the anatomical type of trifurcation, the mini-crush procedure was performed in all cases. After predilatation of all branches, positioning of stents in both side branches at a distance of 1-2 mm proximally to the carina of the trifurcation was performed. Side-branch stents were then deployed sequentially and crushed at the same time by a balloon positioned in the main branch. Afterwards, the main branch stent was advanced to cover the ostium of both side branches and deployed. The jailed wire technique was employed in all cases, and if possible in both branches. Final triple kissing balloon was employed in all cases. The "mini-crush technique" was performed safely in all the five patients obtaining an excellent angiographic result at 8.0+/-1.0 months follow-up angiography., Conclusions: The "mini-crush technique" with DES can be safely performed giving complete coverage of the ostium of side branches and optimising side branch access.
- Published
- 2008
- Full Text
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