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CT angiography prior to endovascular aortic surgery is the standard non-invasive imaging method for evaluation of aortic dimensions and access sites. A detailed report is crucial to a proper planning. We assessed Artificial Intelligence (AI)-algorithm accuracy to measure vessels diameters at CT prior to transcatheter aortic valve implantation (TAVI). CT scans of 50 patients were included. Two Radiologists with experience in vascular imaging together manually assessed diameters at nine landmark positions according to the American Heart Association guidelines: 450 values were obtained. We implemented TOST (Two One-Sided Test) to determine whether the measurements were equivalent to the values obtained from the AI algorithm. When the equivalence bound was a range of ± 2 mm the test showed equivalence for every point; if the range was equal to ± 1 mm the two measurements were not equivalent in 6 points out of 9 (p-value > 0.05), close to the aortic valve. The time for automatic evaluation (average 1 min 47 s) was significantly lower compared with manual measurements (5 min 41 s) (p < 0.01). In conclusion, our results indicate that AI-algorithms can measure aortic diameters at CT prior to endovascular surgery with high accuracy. AI-assisted reporting promises high efficiency, reduced inter-reader variabilities and time saving. In order to perform optimal TAVI procedure planning aortic root analysis could be improved, including annulus dimensions.
Subject(s)
Artificial Intelligence , Computed Tomography Angiography , Endovascular Procedures , Humans , Female , Male , Aged , Aged, 80 and over , Algorithms , Transcatheter Aortic Valve Replacement , Aorta/diagnostic imaging , Aorta/surgeryABSTRACT
BACKGROUND: In patients with acute coronary syndromes (ACS), current guidelines recommend a low-density lipoprotein cholesterol (LDL-C) level < 1.4 mmol/L (<55 mg/dL). METHODS: The JET-LDL is a multicenter, observational, prospective registry created to investigate levels of LDL-C in consecutive patients with ACS undergoing PCI at 35 Italian hospitals, and to report their lipid lowering therapies (LLT). Follow-up was planned at 1 and 3 months. LDL-C reduction >50% from baseline or level < 55 mg/dL at 1-month was the primary endpoint. RESULTS: A total of 1095 patients were included: median age was 67 (58-75); 33.7% were already on LLT. Baseline LDL-C levels was 105 (76.5-137) mg/dL. At hospital discharge all patients were on LLT: 98.1% received statins (as mono or combination therapy), ezetimibe and PCSK9i were used in 60.1% and 8.5% of cases, respectively. Primary endpoint was achieved in 62% (95% CI 58-65) of cases. At 1-month LDL-C levels dropped to 53 (38-70) mg/dL (p < 0.001 vs baseline) and it was <55 mg/dL in 53% (95% CI 49-57) of patients; however, PCSK9i were added to 7 further cases. At 3-months 58% (95% CI 55-62) of patients achieved the target level, but PCSK9i was added to only 11 new patients. CONCLUSIONS: In this real-world registry of ACS patients undergoing PCI, recommend LDL-C levels were obtained in 62% of patients, but PCSK9i prescription was limited to 10% of cases. As LLT pattern appeared mainly improved at hospital discharge, an early and strong treatment should be considered.
Subject(s)
Acute Coronary Syndrome , Anticholesteremic Agents , Hydroxymethylglutaryl-CoA Reductase Inhibitors , Percutaneous Coronary Intervention , Aged , Humans , Acute Coronary Syndrome/diagnosis , Acute Coronary Syndrome/drug therapy , Acute Coronary Syndrome/surgery , Anticholesteremic Agents/therapeutic use , Cholesterol, LDL , Hydroxymethylglutaryl-CoA Reductase Inhibitors/therapeutic use , Registries , Treatment Outcome , Middle Aged , Multicenter Studies as Topic , Observational Studies as TopicABSTRACT
Concomitant presence of atrial fibrillation and coronary artery disease requiring percutaneous coronary intervention is a frequent occurrence. The choice of optimal antithrombotic therapy, in this context, is still challenging. To offer the best protection both in terms of stroke and stent thrombosis, triple therapy with oral anticoagulation and dual antiplatelet therapy would be required. Several drug combinations have been tested in recent years, including direct oral anticoagulants, with the aim of balancing ischemic and bleeding risk. Both pharmacokinetic aspects of the molecules and patient's characteristics should be analyzed in choosing oral anticoagulation. Then, as suggested by guidelines, triple therapy should start with a seven-day duration and the aim to prolong to thirty days in high thrombotic risk patients. Dual therapy should follow to reach twelve months after coronary intervention. Even not fully discussed by the guidelines, in order to balance ischemic and bleeding risk it should also be considered: 1) integrated assessment of coronary artery disease and procedural complexity of coronary intervention; 2) appropriateness to maintain the anticoagulant drug dosage indicated in technical data sheet; the lack of data on the suspension of antiplatelet drugs one year after percutaneous intervention; 3) the possibility of combination therapy with ticagrelor; and 4) the need to treat the occurrence of paroxysmal atrial fibrillation during acute coronary syndrome. With data provided clinician should pursue a therapy as personalized as possible, both in terms of drug choice and treatment duration, in order to balance ischemic and bleeding risk.
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Background: COVID-19 had an adverse impact on the management and outcome of acute coronary syndromes (ACS), but most available data refer to March-April 2020. Aim: This study aims to investigate the clinical characteristics, time of treatment, and clinical outcome of patients at hospitals serving as macro-hubs during the second pandemic wave of SARS-CoV-2 (November 2020-January 2021). Methods and Results: Nine out of thirteen "macro-hubs" agreed to participate in the registry with a total of 941 patients included. The median age was 67 years (IQR 58-77) and ST-elevation myocardial infarction (STEMI) was the clinical presentation in 54% of cases. Almost all patients (97%) underwent coronary angiography, with more than 60% of patients transported to a macro-hub by the Emergency Medical Service (EMS). In the whole population of STEMI patients, the median time from symptom onset to First Medical Contact (FMC) was 64 min (IQR 30-180). The median time from FMC to CathLab was 69 min (IQR 39-105). A total of 59 patients (6.3%) presented a concomitant confirmed SARS-CoV-2 infection, and pneumonia was present in 42.4% of these cases. No significant differences were found between STEMI patients with and without SARS-CoV-2 infection in treatment time intervals. Patients with concomitant SARS-CoV-2 infection had a significantly higher in-hospital mortality compared to those without (16.9% vs. 3.6%, P < 0.0001). However, post-discharge mortality was similar to 6-month mortality (4.2% vs. 4.1%, P = 0.98). In the multivariate analysis, SARS-CoV-2 infection did not show an independent association with in-hospital mortality, whereas pneumonia had higher mortality (OR 5.65, P = 0.05). Conclusion: During the second wave of SARS-CoV-2 infection, almost all patients with ACS received coronary angiography for STEMI with an acceptable time delay. Patients with concomitant infection presented a lower in-hospital survival with no difference in post-discharge mortality; infection by itself was not an independent predictor of mortality but pneumonia was.
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A left superior vena cava persistence was found in a 61 year-old patient affected by dilated and hypokinetic cardiopathy with severe dysfunction of the left ventricle (left ventricular ejection fraction of 32%) and valvular disease. After a negative coronary angiography, he was implanted with a cardiac resynchronization therapy with defibrillation function device (CRT-D). The present case describes the successful implantation of a biventricular defibrillator in this challenging congenital abnormality of cardiac venous system.
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In Chronic Obstructive Pulmonary Disease (COPD), hypoxemia is associated with multiple underlying mechanisms, of which one of the most significant is ventilation-perfusion (V/Q) mismatch, which is correctable with supplemental oxygen (O2) therapy. Hypoxemia that is refractory to very high concentration of inspired O2 can be indicative of cardiac defect with shunt, e.g., a patent foramen ovale (PFO) with right-to-left (R-T-L) shunt. In hypoxemic COPD patients, the diagnosis of a PFO requires a heightened sense of clinical suspicion along with careful assessment of other underlying possibilities. Platypnea-orthodeoxia and a non-response to the hyperoxia test, while not diagnostic, increase suspicion. A correct diagnosis of interatrial bypass needs to be confirmed with transthoracic echocardiogram and contrast transesophageal echocardiography. Presently, no data are available supporting the effectiveness of PFO closure in COPD patients to relieve symptoms and correct hypoxemia. We report a case of hypoxemic COPD with platypnea-orthodeoxia syndrome due to PFO. The decision of its closure with device after echocardiographic evaluation of right ventricular function has completely corrected refractory hypoxemia with improvement of SpO2 and functional capacity. Thus, in selected COPD with refractory hypoxemia, closure of PFO should be considered as novel therapeutic target with improvement of quality of life and less likelihood of hospitalization.
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Objectives: To investigate the safety and clinical efficacy of tirofiban during primary percutaneous coronary interventions (pPCI). Background: Gp IIb/IIIa inhibitors (GPI) use during pPCI has declined over years, mainly for the increased hemorrhagic risk associated to their use and for the availability of potent, fast-acting oral antiplatelet drugs. However, several pharmacodynamic studies showed suboptimal platelet inhibition with P2Y12-blockers, such as prasugrel or ticagrelor. Methods: Patients with ST-segment elevation myocardial infarction (STEMI) undergoing pPCI were prospectively enrolled in a multicenter registry conducted in high-volume centers in Italy. All patients received intraprocedural tirofiban. The primary safety endpoint was the occurrence of in-hospital bleedings according to the Bleeding Academic Research Consortium definition. In-hospital major adverse coronary events (MACE, defined as death, reinfarction, stent thrombosis, and target vessel revascularization), final TIMI flow, myocardial blush grade, and ST-segment resolution were also evaluated. Results: A total of 472 patients (mean age 61 ± 11 years, 83% males) were enrolled in 16 Italian centers from October 2015 to June 2018. Mean basal thrombus grade score was 3.47 ± 1.25. PCI was performed by transradial approach in 88% of patients. We observed a very low rate of 30 days BARC bleedings (2.1%) and MACE (0.8%). Complete (>70%) ST-segment resolution was observed in 67% of patients. Conclusions: In the FASTER registry, the use of tirofiban during primary PCI, performed with a transradial approach in most cases, in patients with high thrombus burden was associated with high rates of complete ST-segment resolution and low rates of in-hospital bleeding and MACE.
Subject(s)
Percutaneous Coronary Intervention , Thrombosis , Aged , Female , Hemorrhage/chemically induced , Hemorrhage/epidemiology , Humans , Male , Middle Aged , Percutaneous Coronary Intervention/adverse effects , Platelet Aggregation Inhibitors/adverse effects , Registries , Reperfusion , Thrombosis/etiology , Tirofiban/adverse effects , Treatment Outcome , Tyrosine/adverse effectsABSTRACT
BACKGROUND: TAVR is a safe alternative to surgical aortic valve replacement (SAVR); however, sex-related differences are still debated. This research aimed to examine gender differences in a real-world transcatheter aortic valve replacement (TAVR) cohort. METHODS: All-comer aortic stenosis (AS) patients undergoing TAVR with a Medtronic valve across 19 Italian sites were prospectively included in the Italian Clinical Service Project (NCT01007474) between 2007 and 2019. The primary endpoint was 1-year mortality. We also investigated 3-year mortality, and ischemic and hemorrhagic endpoints, and we performed a propensity score matching to assemble patients with similar baseline characteristics. RESULTS: Out of 3821 patients, 2149 (56.2%) women were enrolled. Compared with men, women were older (83 ± 6 vs. 81 ± 6 years, p < 0.001), more likely to present severe renal impairment (GFR ≤ 30 mL/min, 26.3% vs. 16.3%, p < 0.001) but had less previous cardiovascular events (all p < 0.001), with a higher mean Society of Thoracic Surgeons (STS) score (7.8% ± 7.1% vs. 7.2 ± 7.5, p < 0.001) and a greater mean aortic gradient (52.4 ± 15.3 vs. 47.3 ± 12.8 mmHg, p < 0.001). Transfemoral TAVR was performed more frequently in women (87.2% vs. 82.1%, p < 0.001), with a higher rate of major vascular complications and life-threatening bleeding (3.9% vs. 2.4%, p = 0.012 and 2.5% vs. 1.4%, p = 0.024). One-year mortality differed between female and male (11.5% vs. 15.0%, p = 0.002), and this difference persisted after adjustment for significant confounding variables (Adj.HR1yr 1.47, 95%IC 1.18-1.82, p < 0.001). Three-year mortality was also significantly lower in women compared with men (19.8% vs. 24.9%, p < 0.001) even after adjustment for age, STS score, eGFR, diabetes and severe COPD (Adj.HR3yr 1.42, 95%IC 1.21-1.68, p < 0.001). These results were confirmed in 689 pairs after propensity score matching. CONCLUSION: Despite higher rates of peri-procedural complications, women presented better survival than men. This better adaptive response to TAVR may be driven by sex-specific factors.
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BACKGROUND: A multidisciplinary consensus document (MCD) provided a follow-up strategy after percutaneous coronary intervention (PCI) based on individual risk profiles: A, high; B, intermediate; and C, low. AIM: To assess patterns of follow-up after PCI and to evaluate the potential reduction of cardiologic examinations with the application of the MCD. METHODS: The post-PCI registry was carried out at 31 Italian Hospitals and included consecutive patients undergoing PCI. We collected cardiologic consults (CC), noninvasive stress tests (ST), and echocardiograms (EC) actually performed at 12 months and we compared them with the expected by the MCD. RESULTS: We included 1,113 patients (58% with acute coronary syndrome) that underwent 1,567 CC, 398 ST, and 612 EC. The performed CC and ST were significantly lower compared to the expected, respectively [1.6 (95% CI, 1.5-1.7) vs. 1.9 (95% CI, 1.8-2.0), and 0.40 (95% CI, 0.4-0.5) vs. 0.61 (95% CI, 0.6-0.7), p < .001]; the performed EC were significantly higher [0.6 (95% CI, 0.6-0.7) vs. 0.3 (95% CI, 0.3-0.37), p < .001]. Patients at moderate low risk had an excess of noninvasive tests whereas patients at higher risk received less examinations than the expected. The individual risk profile was an independent predictor of increased number of cardiac examination in patients at intermediate and low risk [profile B, OR 2.56 (95%CI 1.38-4.75); profile C, OR 27.00 (95%CI 8.13-89.62), p < .001]. CONCLUSION: In real world patients undergoing PCI, the intensity of follow-up at 12 months appeared not based on individual risk profile, with a higher numbers of examinations, particularly EC, performed in low risk subjects.
Subject(s)
Percutaneous Coronary Intervention , Follow-Up Studies , Humans , Percutaneous Coronary Intervention/adverse effects , Prospective Studies , Registries , Treatment OutcomeABSTRACT
BACKGROUND: During the COVID-19 outbreak, healthcare Authorities of Lombardy modified the regional network concerning time-dependent emergencies. Specifically, 13 Macro-Hubs were identified to deliver timely optimal care to patients with acute coronary syndromes (ACS). Aim of this paper is to present the results of this experience. METHODS AND RESULTS: This is a multicenter, observational study. A total of 953 patients were included, presenting with STEMI in 57.7% of the cases. About 98% of patients received coronary angiography with a median since first medical contact to angiography of 79 (IQR 45-124) minutes for STEMI and 1262 (IQR 643-2481) minutes for NSTEMI.A total of 107 patients (11.2%) had SARS-CoV2 infection, mostly with STEMI (74.8%). The time interval from first medical contact to cath-lab was significant shorter in patients with COVID-19, both in the overall population and in STEMI patients (87 (IQR 41-310) versus 160 (IQR 67-1220) minutes, P = 0.001, and 61 (IQR 23-98) versus 80 (IQR 47-126) minutes, P = 0.01, respectively). In-hospital mortality and cardiogenic shock rates were higher among patients with COVID-19 compared to patients without (32% vs 6%, P < 0.0001, and 16.8% vs 6.7%, P < 0.0003, respectively). CONCLUSIONS: During the COVID-19 outbreak in Lombardy, the redefinition of ACS network according to enlarged Macro-Hubs allowed to continue with timely ACS management, while reserving a high number of intensive care beds for the pandemic. Patients with ACS and COVID-19 presented a worst outcome, particularly in case of STEMI.
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BACKGROUND: Patients surviving a myocardial infarction (MI) are at a heightened risk for recurrent ischemic events that can be reduced with the long-term addition of a second antithrombotic drug to aspirin. However, data about real prescription of this therapy are lacking and sometimes controversial. METHODS: We aimed to describe the incidence and the determinants of a dual antiplatelet therapy (DAPT) prolongation beyond 12 months in a cohort of consecutive patients undergoing percutaneous coronary intervention (PCI) with prior MI undergoing PCI and features of high ischemic risk intended as age more than 65 years, second MI, type 2 diabetes mellitus, multivessel coronary artery disease (MVCAD) and chronic kidney disease (CKD). We analysed patients enrolled in the prospective 'Post-PCI' registry that included patients treated with PCI for stable coronary artery disease (CAD) or acute coronary syndromes. At 12 months' follow-up, we collected data about DAPT prolongation in patients with prior MI and at least one of the previous features of high risk who did not experience ischemic and bleeding events during the follow-up. RESULTS: Among 1113 patients included in the registry, 778 (72%) presented the inclusion criteria for the present study: 434 (66%) were more than 65 years old, 245 (37%) had a second MI, 189 (29%) diabetes mellitus, 480 (73%) MVCAD and 216 (33%) CKD. Despite a DAPT being prescribed for 1 year in 86% of the patients, it was prolonged for over 12 months in 105 (16%) of them. At multivariable analysis, only second MI and MVCAD were independent predictors of DAPT prolongation in a model including age more than 65 years, diabetes mellitus, CKD and PCI on left main/left anterior descending coronary artery. We found no significant difference in DAPT prolongation according to a DAPT-score value at least 2 or based on the physician who actually performed the follow-up (clinical cardiologist, interventional cardiologist or other). CONCLUSION: In patients with prior MI and features of high ischemic risk undergoing PCI, the rate of DAPT prolongation beyond 12 months was low; recurrent MI and MVCAD appeared as its main determinants.
Subject(s)
Dual Anti-Platelet Therapy , Myocardial Infarction/therapy , Percutaneous Coronary Intervention , Aged , Drug Administration Schedule , Dual Anti-Platelet Therapy/adverse effects , Dual Anti-Platelet Therapy/mortality , Female , Hemorrhage/chemically induced , Humans , Italy , Male , Middle Aged , Myocardial Infarction/diagnostic imaging , Myocardial Infarction/mortality , Percutaneous Coronary Intervention/adverse effects , Percutaneous Coronary Intervention/mortality , Recurrence , Registries , Retrospective Studies , Risk Assessment , Risk Factors , Time Factors , Treatment OutcomeSubject(s)
Coronavirus Infections/diagnosis , Pneumonia, Viral/diagnosis , ST Elevation Myocardial Infarction/diagnosis , Aged , Aged, 80 and over , Betacoronavirus/isolation & purification , COVID-19 , Coronary Angiography , Coronavirus Infections/complications , Coronavirus Infections/virology , Echocardiography , Female , Humans , Male , Middle Aged , Pandemics , Pneumonia, Viral/complications , Pneumonia, Viral/virology , Risk Factors , SARS-CoV-2 , ST Elevation Myocardial Infarction/complicationsSubject(s)
Cardiology Service, Hospital , Civil Defense/organization & administration , Communicable Disease Control/organization & administration , Coronavirus Infections , Pandemics , Patient Care Management , Percutaneous Coronary Intervention , Pneumonia, Viral , ST Elevation Myocardial Infarction , Betacoronavirus/isolation & purification , COVID-19 , Cardiology Service, Hospital/organization & administration , Cardiology Service, Hospital/trends , Coronavirus Infections/diagnosis , Coronavirus Infections/epidemiology , Coronavirus Infections/prevention & control , Humans , Italy/epidemiology , Pandemics/prevention & control , Patient Care Management/methods , Patient Care Management/organization & administration , Patient Care Management/trends , Percutaneous Coronary Intervention/methods , Percutaneous Coronary Intervention/standards , Pneumonia, Viral/diagnosis , Pneumonia, Viral/epidemiology , Pneumonia, Viral/prevention & control , SARS-CoV-2 , ST Elevation Myocardial Infarction/epidemiology , ST Elevation Myocardial Infarction/therapy , Spatial Analysis , Time-to-TreatmentABSTRACT
Valve-in-valve (ViV) transcatheter aortic valve implantation (TAVI) is an effective treatment for aortic bioprosthetic valve degeneration. ViV-TAVI could lead to coronary occlusion. We describe the case of a patient treated with double chimney technique to protect coronary ostia followed by post-dilation for high residual transvalvular gradient using "three-kissing balloon" approach. (Level of Difficulty: Advanced.).
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The objective of this study is to evaluate completeness of coronary revascularization in patients with complex stable coronary artery disease (SCAD) who underwent percutaneous coronary interventions (PCI), but a surgical revascularization indicated according to 2018 European Society of Cardiology guidelines. The optimal mode of revascularization for SCAD should take into account clinical, anatomic, and procedural characteristics-including anticipated completeness of revascularization-and modality of treatment should be discussed by a Heart Team. Among patients enrolled in the APpropriAteness of percutaneous Coronary interventions in patients with ischemic heart disease study, we identified patients with complex SCAD. Rates of ad-hoc PCI and documented heart team discussion were reported stratified by guideline recommended mode of revascularization. Completeness of revascularization was assessed by an angiographic core laboratory using residual SS (rSS) ≤ 8 and SYNTAX Revascularization Index (SRI) ≥ 70%. Among 336 PCI patients with SCAD, 182 (54.2%) had complex coronary disease and 152 underwent ad-hoc PCI (83.5%). Patients for whom surgery was the recommended revascularization option (9.3%) had a significantly and substantial higher rate of incomplete revascularization than patients for whom either mode of revascularization or PCI was recommended (61.3% vs 23.6% with rSS > 8, p < 0.001 and 77.4% vs 44.6% with SRI < 70%, p < 0.001). Patients with complex SCAD receiving percutaneous myocardial revascularization when surgery was recommended have substantially incomplete myocardial revascularization. These data support multidisciplinary decision-making in these patients and suggest considering anticipated completeness when deciding mode of coronary revascularization.
Subject(s)
Coronary Artery Bypass/standards , Coronary Artery Disease/therapy , Guideline Adherence/standards , Percutaneous Coronary Intervention/standards , Practice Guidelines as Topic/standards , Practice Patterns, Physicians'/standards , Aged , Clinical Decision-Making , Coronary Angiography/standards , Coronary Artery Bypass/adverse effects , Coronary Artery Disease/diagnostic imaging , Female , Humans , Male , Middle Aged , Patient Selection , Percutaneous Coronary Intervention/adverse effects , Retrospective Studies , Risk Factors , Treatment OutcomeSubject(s)
Coronary Artery Disease/therapy , Decision Support Techniques , Hemorrhage/chemically induced , Percutaneous Coronary Intervention/adverse effects , Platelet Aggregation Inhibitors/adverse effects , Practice Patterns, Physicians' , Clinical Decision-Making , Drug Therapy, Combination , Humans , Italy , Platelet Aggregation Inhibitors/administration & dosage , Predictive Value of Tests , Registries , Risk Assessment , Risk Factors , Treatment OutcomeABSTRACT
Spontaneous coronary artery dissection (SCAD) is a non-atherosclerotic coronary artery pathology and an important cause of coronary artery disease in young women with an average age of 40 to 50 years with few or no cardiovascular risk factors. There has been a surge in the diagnosis of SCAD due to an increased use of coronary angiography and the clinical availability and application of high-resolution intracoronary imaging. SCAD is due to the separation of coronary wall layers with the formation of intramural hematoma, compression of the true lumen and secondary myocardial ischemia. Coronary angiography is the first-line imaging, also useful are intravascular ultrasound and optical coherence tomography. Therapy is conservative in most cases because of the high percentage of spontaneous healing of the vascular wall. The prognosis is good, although the disease is burdened by a high prevalence of major adverse coronary events, including recurrence of coronary dissection, thus making careful follow-up essential in survivors of the acute event. Given that the presence of SCAD may be associated with aneurysm formation and dissections of other arteries, screening of the arterial tree may be useful, especially of the supra-aortic trunks and splanchnic circulation.
Subject(s)
Coronary Angiography/methods , Coronary Vessel Anomalies/epidemiology , Vascular Diseases/congenital , Adult , Coronary Artery Disease/etiology , Coronary Vessel Anomalies/diagnostic imaging , Coronary Vessel Anomalies/therapy , Female , Humans , Middle Aged , Prognosis , Recurrence , Risk Factors , Tomography, Optical Coherence/methods , Ultrasonography/methods , Vascular Diseases/diagnostic imaging , Vascular Diseases/epidemiology , Vascular Diseases/therapyABSTRACT
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. METHODS: Between 2012 and 2015, all patients treated with Elutax SV DCB (Aachen Resonance, Germany) at nine Italian centers were enrolled in this retrospective registry. Primary outcome was the occurrence of target-lesion revascularization (TLR) at the longest available follow-up. Secondary endpoints were procedural success and occurrence of device-oriented adverse cardiovascular events including cardiac death, target-vessel myocardial infarction, stroke, and TLR. A minimum 6-month clinical follow-up was required. RESULTS: We enrolled 544 consecutive patients treated at 583 sites. Fifty-three per cent of the patients had ISR, and the rest native vessel coronary artery disease. Procedural success occurred in 97.5%. At the longest available clinical follow-up (average 13.3â±â7.4 months), 5.9% of the patients suffered a TLR and 7.1% a device-oriented adverse cardiovascular event. We did not register cases of target-vessel abrupt occlusion. At multivariate analysis, severe calcification at the lesion site was the first determinant for the occurrence of TLR. CONCLUSION: This registry on the performance of a new-generation DCB shows an adequate profile of safety and efficacy at mid-term clinical follow-up.