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1.
Ital J Pediatr ; 49(1): 92, 2023 Jul 22.
Article in English | MEDLINE | ID: mdl-37480082

ABSTRACT

BACKGROUND: Tracheal compression (TC) due to vascular anomalies is an uncommon, but potentially serious cause of chronic respiratory disease in childhood. Vascular slings are congenital malformations resulting from abnormal development of the great vessels; in this group of disorders the most prevalent entity is the aberrant innominate artery (AIA). Here we provide a report on diagnosis and treatment of AIA in nine children with unexplained chronic respiratory symptoms. We describe the cases, perform a literature review, and provide a discussion on the diagnostic workup and treatment that can help manage AIA. METHODS: Clinical history, diagnostic procedures and treatment before and after the AIA diagnosis were retrospectively reviewed in nine children (5 boys and 4 girls), who were referred for recurrent-to-chronic respiratory manifestations over 10 years (2012-2022). We performed a comprehensive report on the ongoing clinical course and treatment as well as an electronic literature search on the topic. RESULTS: Diagnoses at referral, before AIA was identified, were chronic dry barking cough associated with recurrent pneumonia (n = 8, 89%), lobar/segmental atelectasis (n = 3, 33%), atopic/non atopic asthma (n = 3, 33%); pneumomediastinum with subcutaneous emphysema complicated the clinical course in one case. When referred to our Unit, all patients had been previously treated with repeated antibiotic courses (n = 9, 100%), alone (n = 6, 67%) or combined with prolonged antiasthma medications (n = 3, 33%) and/or daily chest physiotherapy (n = 2, 22%), but reported only partial clinical benefit. Median ages at symptom onset and at AIA diagnosis were 1.5 [0.08-13] and 6 [4-14] years, respectively, with a relevant delay in the definitive diagnosis (4.5 years). Tracheal stenosis at computed tomography (CT) was ≥ 51% in 4/9 cases and ≤ 50% in the remaining 5 subjects. Airway endoscopy was performed in 4 cases with CT evidence of tracheal stenosis ≥ 51% and confirmed CT findings. In these 4 cases, the decision of surgery was made based on endoscopy and CT findings combined with persistence of clinical symptoms despite medical treatment. The remaining 5 children were managed conservatively. CONCLUSIONS: TC caused by AIA may be responsible for unexplained chronic respiratory disease in childhood. Early diagnosis of AIA can decrease the use of expensive investigations or unsuccessful treatments, reduce disease morbidity, and accelerate the path toward a proper treatment.


Subject(s)
Asthma , Tracheal Stenosis , Male , Child , Female , Humans , Brachiocephalic Trunk/diagnostic imaging , Retrospective Studies , Tracheal Stenosis/diagnosis , Tracheal Stenosis/etiology , Tracheal Stenosis/therapy , Cough , Disease Progression
3.
EuroIntervention ; 18(7): 574-581, 2022 Sep 20.
Article in English | MEDLINE | ID: mdl-35318955

ABSTRACT

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. AIMS: We aimed to evaluate the safety and efficacy of IVL in addressing resistant stent underexpansion due to heavy underlying calcification. METHODS: This was an international multicentre registry including patients receiving IVL therapy to treat stent underexpansion from December 2017 to August 2020. Angiographic and intracoronary imaging data were collected. The efficacy endpoint was device success (technical success with a final percentage diameter stenosis <50%). The safety endpoint was in-hospital major adverse cardiac events (MACE). RESULTS: Seventy patients were included, the mean age was 73±9.2 years and 76% were male. The median time from stent implantation to IVL therapy was 49 days (0-2,537). Adjuvant treatment with non-compliant balloon dilatations pre- and post-IVL was performed in 72.3% and 76.8% of patients, respectively, and additional stenting was performed in 22.4%. Device success was 92.3%. Minimum lumen diameter increased from 1.49±0.73 mm to 2.41±0.67 mm (p<0.001) and stent expansion increased by 124.93±138.19% (p=0.016). No IVL-related procedural complications or MACE were observed. The use of bailout IVL therapy directly after stenting and the presence of ostial underexpanded lesions negatively predicted lumen diameter gain. CONCLUSIONS: Coronary lithotripsy is safe and effective in increasing lumen and stent dimensions in underexpanded stents secondary to heavily calcified lesions.


Subject(s)
Angioplasty, Balloon, Coronary , Lithotripsy , Vascular Calcification , Aged , Aged, 80 and over , Coronary Angiography , Female , Humans , Lithotripsy/methods , Male , Middle Aged , Registries , Stents , Treatment Outcome , Vascular Calcification/diagnostic imaging , Vascular Calcification/therapy
4.
Rev Cardiovasc Med ; 22(4): 1323-1330, 2021 Dec 22.
Article in English | MEDLINE | ID: mdl-34957773

ABSTRACT

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).


Subject(s)
Angioplasty, Balloon, Coronary , Cardiovascular Agents , Coronary Restenosis , Cardiovascular Agents/adverse effects , Coated Materials, Biocompatible , Coronary Restenosis/etiology , Coronary Restenosis/prevention & control , Humans , Paclitaxel/adverse effects , Treatment Outcome
5.
Cardiovasc Revasc Med ; 28S: 193-196, 2021 07.
Article in English | MEDLINE | ID: mdl-34031006

ABSTRACT

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. In May 2020 he presented with worsening hypertension and CT scan showed total occlusion of the right with critical ISR of the left renal artery. Because of the high calcium burden he underwent balloon lithotripsy for plaque modification and subsequent renal angioplasty with sirolimus and paclitaxel DCB, with a good angiographic result. This is the first case of recurrent renal ISR successfully treated with Shockwave IVL and double-drug DCB therapy.


Subject(s)
Angioplasty, Balloon, Coronary , Coronary Restenosis , Lithotripsy , Pharmaceutical Preparations , Angioplasty, Balloon, Coronary/adverse effects , Coronary Angiography , Coronary Restenosis/therapy , Humans , Male , Middle Aged
6.
Cardiovasc Revasc Med ; 28: 1-6, 2021 07.
Article in English | MEDLINE | ID: mdl-33888418

ABSTRACT

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). A comparison between PCB and SCB is still lacking. METHODS: We performed an indirect comparison between two cohorts of patients previously included into two investigator-driven registries with clinical primary endpoints, 494 treated with the Elutax SV PCB (AR Baltic, Lithuania) from the DCB RISE registry, and 596 treated with the Magic Touch SCB (Concept Medical, India) from the EASTBOURNE registry. The primary endpoint was the rate of major adverse cardiovascular events (MACE) at 12-month clinical follow-up. RESULTS: After propensity score matching, a total of 580 patients were well matched for baseline clinical and procedural characteristics and were analyzed. At 12 months there was no significant difference between the matched DCB RISE and EASTBOURNE cohorts in terms of the primary endpoint MACE (10.3% DCB RISE vs. 10.7% EASTBOURNE, p = 0.892). No significant difference was observed also regarding the rate of TLR (7.9% DCB RISE vs. 8.3% EASTBOURNE; p = 0.879, respectively). By multivariate analysis, insulin-dependent diabetes was the only predictor of MACE. CONCLUSIONS: In the SIRPAC study, the first indirect comparison between paclitaxel-coated and sirolimus coated balloons, no significant difference in clinical endpoints were found at 12-month follow-up. Randomized studies are necessary to confirm these findings.


Subject(s)
Cardiovascular Agents , Percutaneous Coronary Intervention , Cardiovascular Agents/adverse effects , Coated Materials, Biocompatible , Coronary Vessels , Humans , Paclitaxel/adverse effects , Percutaneous Coronary Intervention/adverse effects , Sirolimus/adverse effects , Time Factors , Treatment Outcome
7.
Catheter Cardiovasc Interv ; 97(7): 1440-1451, 2021 06 01.
Article in English | MEDLINE | ID: mdl-33844439

ABSTRACT

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. Lacking international guidelines, this document, promoted by the Italian Society of Interventional Cardiology - Gruppo Italiano Studi Emodinamici (SICI-GISE), was drawn-up by a panel of interventional cardiologists with a documented experience on the subject, focusing on the indications, techniques and materials that should be used for this type of intervention and the most recent literature on the subject.


Subject(s)
Cardiology , Stents , Carotid Arteries , Humans , Italy , Radial Artery/diagnostic imaging , Radial Artery/surgery , Treatment Outcome
8.
Cardiovasc Revasc Med ; 30: 1-8, 2021 09.
Article in English | MEDLINE | ID: mdl-33077393

ABSTRACT

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 0.8-1.2) and high-pressure postdilation with non-compliant (NC) balloon (≥20 atm for balloon/BRS ratio 1:1 or ≥16 atm for a 0.25-0.5 mm oversized balloon). Among the 1.434 patients analyzed, 464 (32.4%) fulfilled all CIAO criteria for every BRS implanted (CIAO 3 group), while 970 (67.6%) did not in at least one of the received BRS (CIAO 0-1-2 group). At 31.0 (interquartile range -IQR- 24.8-38.5) months follow-up, CIAO criteria did not impact on DOCE (8.2% vs. 8.0%, p = 0.92), ID-TLR (6.9% vs. 7.1%, p = 0.72) or ScT (1.9% vs. 1.8%, p = 0.80) in the overall population. At multivariate analysis overall BRS length (p = 0.001), severely calcified lesions (p = 0.03) and absence of CIAO criteria (CIAO 0, p = 0.005) were independent predictors of DOCE in long-term follow-up. CONCLUSION: Our data suggest that strict application of an optimal Absorb implantation technique doesn't improve long-term DOCE or ScT but may mitigate the worse outcome of patients with calcific lesions.


Subject(s)
Coronary Artery Disease , Percutaneous Coronary Intervention , Absorbable Implants , Coronary Artery Disease/diagnostic imaging , Coronary Artery Disease/surgery , Humans , Percutaneous Coronary Intervention/adverse effects , Prosthesis Design , Registries , Time Factors , Treatment Outcome
9.
Heart Lung ; 50(3): 455-460, 2021.
Article in English | MEDLINE | ID: mdl-33268139

ABSTRACT

BACKGROUND: Postoperative pericardial effusion (pPE) still remains a frequent complication after congenital heart surgery and it usually leads to an increased morbidity and re-hospitalization rate. There are only few published papers about pPE clinical course or large randomized studies that analyze its prevalence or preoperative risk factors. In this regard, we report a single-center 10-years retrospective analysis of prevalence, outcomes and risk factors of postoperative pericardial effusion after congenital heart surgery. METHODS: A retrospective analysis was carried out on 624 patients who underwent congenital heart surgery from January 2010 to December 2019. Study population was divided in two groups basing of the presence of pPE during the first 30 days after the surgery and their perioperative data were compared. Univariate and multivariate analysis were used to find possible risk factors for pPE developing. RESULTS: Ninety-four patients were enrolled in pPE group and 530 in ¬ pPE group. Pericardial effusion was assessed as "mild" in 57 patients (60,6%), as "moderate" in 25 (26,6%), and as "severe" in 12 patients (12,8%). Total correction of Tetralogy of Fallot/Pulmonary atresia seems to be associated with a higher prevalence of pPE in the "Infant" subgroup, while atrial septal defect showed to be a risk factor among "Toddler". In addition, pPE was proved to be much more frequent in Fontan patients in all studied subgroups. Univariate and multivariate analysis revealed that total drain amount, Fontan procedure, postoperative Warfarin therapy, Redo-operations and surgical correction of Tetralogy of Fallot/Pulmonary atresia seem to be risk factors for pPE. Postoperative pericardial effusion was diagnosed between the 4th and the 28th postoperative day but in 88,3% of the cases (83/94) it occurred before the 14th day after the operation. In 58 patients, pPE was clinically silent. CONCLUSIONS: Postoperative pericardial effusion was detected in 88.3% of cases within the first 14 days after the operation. About 69% of these patients were asymptomatic therefore it suggests that routinely echocardiogram after intensive care unit discharge could be a useful tool to screen clinically silent pPE at an early stage, especially in high-risk or unstable patients.


Subject(s)
Cardiac Surgical Procedures , Heart Defects, Congenital , Pericardial Effusion , Cardiac Surgical Procedures/adverse effects , Child , Heart Defects, Congenital/surgery , Humans , Pericardial Effusion/diagnosis , Pericardial Effusion/epidemiology , Pericardial Effusion/etiology , Postoperative Complications/epidemiology , Postoperative Complications/etiology , Retrospective Studies , Risk Factors
10.
J Cardiovasc Med (Hagerstown) ; 22(2): 94-100, 2021 02 01.
Article in English | MEDLINE | ID: mdl-32740442

ABSTRACT

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. Primary study endpoint is target-lesion revascularization (TLR) at 12 months. Secondary endpoints are procedural success and major adverse cardiac events through 36 months. RESULTS: Diabetes mellitus was present in 41% of patients. Acute coronary syndrome was present in 45% of patients and de novo lesions were 55%; 83% of the in-stent restenosis (ISR) patients had drug-eluting stents restenosis. Lesion predilatation was performed in 95% of the cases and bailout stenting occurred in 7.5%. So far, 642 patients have a complete 12-month follow-up. TLR occurred in 2.5%, myocardial infarction in 2.3%, total death in 1% and major adverse cardiac events in 5.8% of patients. A prespecified analysis of comparison between ISR and de-novo lesions showed a significantly higher occurrence of TLR in the ISR population (5.4 vs. 0.2%, P = 0.0008). CONCLUSION: The current interim analysis of 12-month follow-up of the EASTBOURNE registry shows good immediate performance and an adequate and encouraging safety profile through 12 months for this novel SCB.


Subject(s)
Angioplasty, Balloon, Coronary/instrumentation , Coated Materials, Biocompatible , Coronary Artery Disease/surgery , Drug-Eluting Stents , Registries , Sirolimus/pharmacology , Aged , Coronary Angiography , Coronary Artery Disease/diagnosis , Female , Follow-Up Studies , Humans , Immunosuppressive Agents/pharmacology , Male , Prospective Studies , Time Factors , Treatment Outcome
11.
Eur J Cardiothorac Surg ; 58(6): 1254-1260, 2020 12 01.
Article in English | MEDLINE | ID: mdl-33175141

ABSTRACT

OBJECTIVES: Italy has been one of the countries most severely affected by the coronavirus disease 2019 (COVID-19). The Italian government was forced to introduce quarantine measures quickly, and all elective health services were stopped or postponed. This emergency has dramatically changed the management of paediatric and adult patients with congenital heart disease. We analysed data from 14 Italian congenital cardiac surgery centres during lockdown, focusing on the impact of the pandemic on surgical activity, patients and healthcare providers and resource allocation. METHODS: Fourteen centres participated in this study. The period analysed was from 9 March to 4 May. We collected data on the involvement of the hospitals in the treatment of patients with COVID-19 and on limitations on regular activity and on the contagion among patients and healthcare providers. RESULTS: Four hospitals (29%) remained COVID-19 free, whereas 10 had a 39% reduction in the number of beds for surgical patients, especially in the northern area. Two hundred sixty-three surgical procedures were performed: 20% elective, 62% urgent, 10% emergency and 3% life-saving. Hospital mortality was 0.4%. Compared to 2019, the reduction in surgical activity was 52%. No patients operated on had positive test results before surgery for severe acute respiratory syndrome coronavirus 2, the virus responsible for COVID-19. Three patients were infected during the postoperative period. Twenty-nine nurses and 12 doctors were infected. Overall, 80% of our infected healthcare providers were in northern centres. CONCLUSIONS: Our study shows that the pandemic had a different impact on the various Italian congenital cardiac surgery centres based on the different patterns of spread of the virus across the country. During the lockdown, the system was able to satisfy all emergency clinical needs with excellent results.


Subject(s)
COVID-19/prevention & control , Cardiac Surgical Procedures/trends , Health Care Rationing/trends , Health Services Accessibility/trends , Heart Defects, Congenital/surgery , COVID-19/epidemiology , Cross Infection/epidemiology , Cross Infection/prevention & control , Elective Surgical Procedures/trends , Emergencies , Health Care Rationing/methods , Health Care Rationing/organization & administration , Health Care Surveys , Health Policy , Health Services Accessibility/organization & administration , Humans , Infection Control/methods , Italy/epidemiology , Occupational Diseases/epidemiology , Occupational Diseases/prevention & control , Pandemics , Postoperative Complications/epidemiology , Postoperative Complications/prevention & control , Quarantine
12.
Healthcare (Basel) ; 8(4)2020 Nov 03.
Article in English | MEDLINE | ID: mdl-33153007

ABSTRACT

Purpose: Redo operations and preoperative antiplatelet/anticoagulant therapy can significantly increase surgical risk in congenital heart surgery. This is a retrospective study on the impact of preoperative aspirin therapy on the outcome of Tetralogy of Redo Fallot patients undergoing right ventricle outflow tract (RVOT) conduit implantation. Methods: Ten-years retrospective analysis of medical records was carried out. A total of 72 patients were divided into two groups: "Daily-on-ASA" group on daily therapy with aspirin (ASA) until 5 days from surgery and "No-Home-ASA" without it. Propensity match analysis was done in order to standardize the populations. Intraoperative and postoperative lengths were compared as well as the need for inotropic support. In addition, differences in blood transfusions and need for Fresh frozen plasma (FFP)/platelets (PLT) were analysed. Findings: Intraoperative lengths were similar between the groups. Not statistically significative differences about postoperative time to extubation (p = 0.34), ICU Stay (p = 0.31) or in-hospital stay (p = 0.36) were found. Drain loss was higher in the "Daily-on-ASA" group (407.9 ± 96.7 mL vs. 349.5 ± 84.3 mL; p = 0.03) as well as blood transfusions (372.7 ± 255.1 mL vs. 220.1 ± 130.3 mL, p = 0.02) and PLT/FFP need (217.7 ± 132.1 mL vs. 118.7 ± 147.1 mL, p = 0.01). No differences were found in postoperative complications or re-explorations for bleeding. Implications: We found no advantages in surgical times and hospital stay comparing redo patients who stopped aspirin versus those that didn't take it in the last 6 months. However, our results suggest that redo patients undergoing RVOT conduit implantation who take daily aspirin are at higher risk of bleeding even if it is stopped 5 days before surgery.

13.
JACC Cardiovasc Interv ; 13(24): 2840-2849, 2020 12 28.
Article in English | MEDLINE | ID: mdl-33248978

ABSTRACT

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. METHODS: The PICCOLETO II (Drug Eluting Balloon Efficacy for Small Coronary Vessel Disease Treatment) trial was an international, investigator-driven, multicenter, open-label, prospective randomized controlled trial where patients with de novo SVD lesions were randomized to DCB or EES. Primary study endpoint was in-lesion late lumen loss (LLL) at 6 months (independent core laboratory), with the noninferiority between the 2 arms hypothesized. Secondary endpoints were minimal lumen diameter, percent diameter stenosis at angiographic follow-up, and the occurrence of major adverse cardiac events at 12 months. RESULTS: Between May 2015 and May 2018, a total of 232 patients were enrolled at 5 centers. After a median of 189 (interquartile range: 160 to 202) days, in-lesion LLL was significantly lower in the DCB group (0.04 vs. 0.17 mm; p = 0.001 for noninferiority; p = 0.03 for superiority). Percent diameter stenosis and minimal lumen diameter were not significantly different. At 12-month clinical follow-up, major adverse cardiac events occurred in 7.5% of the DES group and in 5.6% of the DCB group (p = 0.55). There was a numerically higher incidence of spontaneous myocardial infarction (4.7% vs. 1.9%; p = 0.23) and vessel thrombosis (1.8% vs. 0%; p = 0.15) in the DES arm. CONCLUSIONS: In this multicenter randomized clinical trial in patients with de novo SVD lesions, a new-generation DCB was found superior to EES in terms of LLL as the angiographic pattern and comparable in terms of clinical outcome. (Drug Eluting Balloon Efficacy for Small Coronary Vessel Disease Treatment [PICCOLETO II]; NCT03899818).


Subject(s)
Drug-Eluting Stents , Angioplasty, Balloon, Coronary , Cardiac Catheters , Cardiovascular Agents , Coated Materials, Biocompatible , Coronary Restenosis , Coronary Vessels , Germany , Humans , Pharmaceutical Preparations , Prospective Studies , Prosthesis Design , Risk Factors , Time Factors , Treatment Outcome
14.
Catheter Cardiovasc Interv ; 96(5): E496-E500, 2020 11.
Article in English | MEDLINE | ID: mdl-32191384

ABSTRACT

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. METHODS: All patients treated with SCB for any type of coronary indication between July 2012 and September 2015 were enrolled at Indian centers and clinically followed up to 24 months. Primary endpoints were major adverse cardiovascular events (MACE) defined as a composite of cardiac death, target lesion revascularization (TLR), and target vessel-myocardial infarction (MI). RESULTS: A total of 484 SCBs were used in 408 patients to treat 435 lesions. In detail, the SCB was used for 183 patients with ISR, 185 with de novo small vessel disease, and 40 with de novo large vessel disease. Mean balloon length and diameter (average ± SD) were 22.3 ± 7.1 mm and 2.7 ± 0.40 mm, respectively. All patients with 24 months follow-up were included. Overall MACE rate was 4.2% (n = 17) with three cardiac deaths (0.7%), 13 TLR (3.2%), and one MI (0.2%). CONCLUSION: The Nanoluté prospective registry is the first long-term clinical evidence of the safety and feasibility of this type of SCB, both in patients with ISR or de novo lesions.


Subject(s)
Angioplasty, Balloon, Coronary/instrumentation , Cardiovascular Agents/administration & dosage , Coated Materials, Biocompatible , Coronary Artery Disease/therapy , Coronary Restenosis/therapy , Sirolimus/administration & dosage , Aged , Angioplasty, Balloon, Coronary/adverse effects , Coronary Artery Disease/diagnostic imaging , Coronary Artery Disease/mortality , Coronary Restenosis/diagnostic imaging , Coronary Restenosis/mortality , Equipment Design , Female , Humans , India , Male , Middle Aged , Myocardial Infarction/etiology , Prospective Studies , Registries , Risk Factors , Time Factors , Treatment Outcome
15.
Coron Artery Dis ; 31(1): 27-34, 2020 01.
Article in English | MEDLINE | ID: mdl-31658146

ABSTRACT

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. Major adverse cardiovascular events (MACE, a composite of cardiac death, myocardial infarction, target lesion revascularization, stent thrombosis) were the primary end-point, single components of MACE were the secondary ones. RESULTS: After 13 months (interquartile range 5-32), MACE was 14%. Stent thrombosis occurred in 3.9% of the patients (2.5% definite stent thrombosis and 1.4% probable stent thrombosis), 66% of them presenting with ST-segment elevation myocardial infarction (STEMI) at admission. Cardiovascular death, target lesion revascularization and myocardial infarction was 4.7%, 8.3%, and 7.2%, respectively. At multivariate analysis, risk of MACE was increased by diabetes (hazard ratios 4.76; P = 0.002) but was not affected by the indication leading to sirolimus-eluting Stentys stent implantation (marked vessel tapering vs. coronary ecstasies, hazard ratios 0.74, P = 0.71). CONCLUSION: Sirolimus-eluting Stentys stent may represent a potential solution for specific coronary anatomies such as bifurcation, ectasic, or tapered vessels. Risk of stent thrombosis appears related to clinical presentation with STEMI and to anatomic features, stressing the importance of the use of intracoronary imaging for self-expandable stents implantation.


Subject(s)
Acute Coronary Syndrome/surgery , Coronary Artery Disease/surgery , Drug-Eluting Stents , Percutaneous Coronary Intervention/methods , ST Elevation Myocardial Infarction/surgery , Aged , Antibiotics, Antineoplastic/administration & dosage , Cardiovascular Diseases/mortality , Female , Humans , Male , Middle Aged , Myocardial Infarction/epidemiology , Myocardial Revascularization/statistics & numerical data , Postoperative Complications/epidemiology , Registries , Retrospective Studies , Sirolimus/administration & dosage , Thrombosis/epidemiology , Treatment Outcome
16.
Heart Fail Rev ; 25(6): 1027-1035, 2020 11.
Article in English | MEDLINE | ID: mdl-31734755

ABSTRACT

Ventricular assist device (VAD) implantation is a widely used procedure in children with cardiac failure refractory to medical therapy as a long-term bridge to recovery or transplant. This strategy has proved to be of an enormous advantage in the cure of these children. The aim of this review is to evaluate the current strategies used for clinical monitoring of paediatric patients with a VAD, focusing on the management of several aspects such as anticoagulant and antiplatelet therapy, haemorrhagic and thrombotic complications, as well as the effects that VADs have on the exposure, effectiveness and the safety of drugs. The sources used for this research are MEDLINE, PubMed and Cochrane Library. The use of key words such as "paediatric ventricular assist device", "clinical management", "anticoagulant therapy" and "infections" retrieved 146 papers. With the application of the inclusion criteria, 42 articles have been selected, but following further analysis, only 21 were eligible. The post-implant process is still complicated due to the lack of guidelines regarding clinical management and for the frequent occurrence of adverse events including bleeding, infection and thromboembolic episodes. From these findings, we can highlight the importance of establishing a suitable antithrombotic therapy, as well as ensuring that the prevention and treatment of infection are paramount during the management of these patients. The clinical management of VAD paediatric children is complex and challenging. At the moment, there are no guidelines regarding strategies to adopt, but from the analysed surveys, it has been possible to highlight a relative coherence between adopted therapies in different centres worldwide.


Subject(s)
Cardiac Surgical Procedures/methods , Heart Defects, Congenital/surgery , Heart Failure/prevention & control , Heart Ventricles/physiopathology , Heart-Assist Devices , Humans
17.
Eur J Cardiothorac Surg ; 57(3): 565-573, 2020 03 01.
Article in English | MEDLINE | ID: mdl-31603499

ABSTRACT

OBJECTIVES: Repair of Tetralogy of Fallot (TOF) has currently excellent results with either transventricular or transatrial approach. However, it is unclear as to which has better late outcomes and what role of residual pulmonary valve (PV) regurgitation in the long term is. We report on late clinical outcomes after repair in a large series of patients with TOF, focusing on the type of surgical technique. METHODS: This analysis is a retrospective multicentre study on patients undergoing TOF repair in infancy. The exclusion criteria of the study were TOF with pulmonary atresia or absent PV. RESULTS: We selected 720 patients who had undergone TOF repair (median age 5.7 months, interquartile range 3.7-11.7). Preoperative cyanotic spells occurred in 18%. A transatrial repair was performed in 433 (60.1%) patients. The PV was preserved in 249 (35%) patients, while the right ventricular outflow tract was reconstructed with a transannular patch (60.4%) or a conduit (4.6%) in the rest of the patients. At a median follow-up of 4 years (range 1-21, 86% complete), 10 (1.6%) patients died, while 39 (6.3%) patients required surgical reoperation and 72 (11.7%) patients required an interventional procedure. The propensity match analysis showed that the incidence of postoperative complications and adverse events at follow-up were significantly increased in patients undergoing transventricular approach repair with transannular patch (P = 0.006) and PV preservation was a significant protective factor against postoperative complications (P = 0.009, odds ratio 0.5) and late adverse events (P = 0.022). CONCLUSIONS: Surgical repair of TOF in infancy is a safe procedure, with good late clinical outcomes. However, transatrial approach and PV preservation at repair are associated with lower early and late morbidity.


Subject(s)
Cardiac Surgical Procedures , Pulmonary Valve , Tetralogy of Fallot , Cardiac Surgical Procedures/adverse effects , Follow-Up Studies , Humans , Infant , Reoperation , Retrospective Studies , Tetralogy of Fallot/surgery , Treatment Outcome
18.
Egypt Heart J ; 71(1): 16, 2019 Sep 11.
Article in English | MEDLINE | ID: mdl-31659537

ABSTRACT

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). The right radial access was chosen for the performance of percutaneous coronary intervention. After the introduction of 6 F sheath, there was difficulty in the advancement of 0.035 J wire that was exchanged with a Terumo hydrophilic wire. After the procedure and before sheath removal, radial arteriography was done and revealed perforation. Protamine sulfate was administered and prolonged balloon inflation was attempted but failed to seal the perforation, so a 7-F-long vascular sheath was inserted to internally tamponade the vessel, and the patient was sent to the coronary care unit for monitoring. Over the next 3 days, serial radial angiographies were done revealing the persistence of the perforation, and on the fourth day, angiography revealed multiple thrombi. Thrombus aspiration was done using Pronto V4 extraction catheter (Vascular Solutions, USA) and was followed by the deployment of a covered stent. The stent was dislodged and successfully snared. Finally, the perforation was sealed spontaneously and there were no signs of intra-arterial thrombi. CONCLUSION: Despite the very low complication rate of radial approach, the interventional cardiologist should be aware of any possible complication, and how to avoid or, eventually, manage it.

19.
Cells ; 8(9)2019 09 16.
Article in English | MEDLINE | ID: mdl-31527430

ABSTRACT

The nucleolus is a distinct sub-cellular compartment structure in the nucleus. First observed more than 200 years ago, the nucleolus is detectable by microscopy in eukaryotic cells and visible during the interphase as a sub-nuclear structure immersed in the nucleoplasm, from which it is not separated from any membrane. A huge number of studies, spanning over a century, have identified ribosome biogenesis as the main function of the nucleolus. Recently, novel functions, independent from ribosome biogenesis, have been proposed by several proteomic, genomic, and functional studies. Several works have confirmed the non-canonical role for nucleoli in regulating important cellular processes including genome stability, cell-cycle control, the cellular senescence, stress responses, and biogenesis of ribonucleoprotein particles (RNPs). Many authors have shown that both canonical and non-canonical functions of the nucleolus are associated with several cancer-related processes. The association between the nucleolus and cancer, first proposed by cytological and histopathological studies showing that the number and shape of nucleoli are commonly altered in almost any type of cancer, has been confirmed at the molecular level by several authors who demonstrated that numerous mechanisms occurring in the nucleolus are altered in tumors. Recently, therapeutic approaches targeting the nucleolus in cancer have started to be considered as an emerging "hallmark" of cancer and several therapeutic interventions have been developed. This review proposes an up-to-date overview of available strategies targeting the nucleolus, focusing on novel targeted therapeutic approaches. Finally, a target-based classification of currently available treatment will be proposed.


Subject(s)
Antineoplastic Agents/pharmacology , Cell Nucleolus/drug effects , Neoplasms/pathology , Neoplasms/therapy , Animals , Cell Nucleolus/metabolism , Cell Nucleolus/pathology , Humans , Neoplasms/metabolism , Ribosomal Protein L3
20.
J Cardiovasc Med (Hagerstown) ; 20(7): 471-476, 2019 Jul.
Article in English | MEDLINE | ID: mdl-30994510

ABSTRACT

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. Primary endpoint was late lumen loss. Secondary endpoints were binary restenosis and target-lesion revascularization. RESULTS: A total of 27 patients with native coronary arteries treated with SCB and with angiographic follow-up entered the study; seven patients were excluded because a stent was implanted at the lesion site during the index procedure. The degree of calcification (assessed with coronary angiography) was high in six patients (30%) and the average lesion length was 20.52 ±â€Š6.88 mm. The reference vessel diameter was 2.32 ±â€Š0.44 mm and the percentage diameter stenosis was 67 ±â€Š12. Procedural success was obtained in all patients. After a median of 6.6 ±â€Š2.5 months, late lumen loss was 0.09 ±â€Š0.34 mm and the percentage diameter stenosis was 31 ±â€Š18. We observed two cases (10%) of binary restenosis which underwent subsequent target-lesion revascularization: in one a drug-eluting stent was implanted, whereas the other patient was treated with paclitaxel-coated balloon. No myocardial infarction or death was observed during follow-up. CONCLUSION: The use of a novel SCB in native coronary arteries was associated with good angiographic outcome at 6-month follow-up.


Subject(s)
Angioplasty, Balloon, Coronary/instrumentation , Cardiac Catheters , Cardiovascular Agents/administration & dosage , Coated Materials, Biocompatible , Coronary Angiography , Coronary Artery Disease/therapy , Sirolimus/administration & dosage , Aged , Angioplasty, Balloon, Coronary/adverse effects , Cardiovascular Agents/adverse effects , Coronary Artery Disease/diagnostic imaging , Coronary Restenosis/diagnostic imaging , Coronary Restenosis/etiology , Coronary Restenosis/therapy , Female , Humans , Italy , Male , Middle Aged , Predictive Value of Tests , Prospective Studies , Prosthesis Design , Registries , Risk Factors , Sirolimus/adverse effects , Time Factors , Treatment Outcome
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