Effusive-constrictive pericarditis after the second dose of BNT162b2 vaccine (Comirnaty): a case report.

BACKGROUND: Whereas effusive-constrictive pericarditis (ECP) can rarely occur in coronavirus disease 2019 (COVID-19), to date no cases of ECP related to severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) vaccine have been documented. CASE SUMMARY: A 59-year-old Caucasian man presented to our emergency department with ECP. Symptoms occurred shortly after the second dose of BNT162b2 (Comirnaty) vaccine. No other aetiological causes were identified. Guidelines-directed therapy for acute pericarditis was implemented, with clinical benefit. DISCUSSION: Systemic inflammatory response to COVID-19 can rarely trigger pericarditis. In our case, a strong temporal relationship between the second dose of BNT162b2 vaccine and symptoms occurrence was documented, indicating a possible rare adverse reaction to the vaccine, similarly to natural infection. Further research is needed to confirm a causal relationship.

Treatment of coronary artery disease with a new-generation drug-coated balloon: final results of the Italian Elutax SV rEgistry-DCB-RISE.

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 13.3 ±â€Š7.4 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.

Clinical and angiographic outcome of a single center, real world population treated with a dedicated technique of implantation for bioresorbable vascular scaffolds. The FAtebenefratelli Bioresorbable Vascular Scaffold (FABS) registry.

OBJECTIVES: With this prospective study we aim at investigating the long-term outcome of a consecutive cohort of patients successfully treated with bioresorbable scaffold (BVS) implantation. BACKGROUND: It is not clearly understood if there is a relation between the technique of BVS implantation and the outcome. METHODS: Between December 2012 and December 2014, all consecutive patients treated with BVS were included in this registry and received an angiographic follow-up. After a run-in phase, all BVS were implanted using a specific technique consisting of aggressive predilation, correct scaffold sizing, visually determined, and high-pressure post-dilation with a noncompliance balloon. Primary endpoint was late lumen loss (LLL) at 1-year angiographic follow-up and ischemia-driven target-lesion revascularization (ID-TLR) at 2-year clinical follow-up. Secondary endpoints were the occurrence of binary restenosis, major adverse cardiac events (MACE), and every single component of MACE (cardiac death, myocardial infarction, TLR) at 2 years. RESULTS: A total of 144 lesions in 122 patients treated consecutively with BVS, were enrolled. Diabetics were 29.5% and acute coronary syndrome at presentation occurred in 29.5% of patients. At the angiographic follow-up LLL was 0.38 ± 0.9. At 2-year clinical follow-up, ID-TLR occurred in eight patients (5.6%). We observed two cases of scaffold thrombosis (1.38%, one early and one very late). At multivariate statistical analysis, STEMI presentation remained a significant predictor for TLR. CONCLUSIONS: In a complex, all-comers real world population, BVS implantation with a specific, and standardized technique showed to be feasible, with acceptable mid-term angiographic and long-term clinical outcome.

Immediate and short-term performance of a novel sirolimus-coated balloon during complex percutaneous coronary interventions. The FAtebenefratelli SIrolimus COated-balloon (FASICO) registry.

BACKGROUND AND PURPOSES: Drug-coated balloons (DCB) currently represent an alternative to drug-eluting stents (DES) for the treatment of in-stent restenosis and they are also variably used for small coronary vessel and bifurcation lesion management. All DCB variably elute paclitaxel as an anti-proliferative drug. The first sirolimus coated balloon (SCB) received the CE mark in 2016, but its clinical performance has not been shown yet. METHODS AND RESULTS: FASICO in an all-comer registry of the first consecutive patients with at least one lesion treated with SCB between March and July 2016 at the first European centre that used this device. All patients were prospectively enrolled in a dedicated database. Primary endpoint was procedural success; co-primary endpoint was the rate of major adverse cardiac events at short-term follow-up. The 32 patients (34 lesions) enrolled had at least 6-month clinical follow up available. Forty-five percent had diabetes and indication to PCI was ISR in 47% of the cases. Lesions were always pre-dilated and device deployment was successful in all the cases. Procedural success was achieved in 100% of patients. We observed 3 cases of TLR at follow-up. CONCLUSIONS: SCB shows high immediate technical performance and adequate short-term efficacy and safety. The ongoing EASTBOURNE registry will shed light on mid-and long-term performance of this device in an adequately powered population.

Final shape of biovascular scaffolds and clinical outcome. Results from a multicenter all-comers study with intravascular imaging.

AIMS: Radial strength of bioresorbable vascular scaffolds (BVS) implanted in coronary arteries is still under debate. Moreover, their final shape patterns, when implanted in an all-comer, unselected population, have not yet been completely correlated with clinical outcome and should be better investigated. METHODS AND RESULTS: A multicenter collaborative analysis was performed on all consecutive patients with native coronary artery disease undergoing PCI with intravascular imaging-guided BVS implantation. The BVS was arbitrarily categorized as having a final "oval shape" through intravascular imaging, if maximal lumen diameter was longer than 150% of minimal lumen diameter at the target lesion. Primary study-endpoint was device-oriented major adverse events (DOCE) at mid-term follow-up. Sixty-seven consecutive patients were evaluated at 6 European centers. Mean patient age was 58±11years, and 12 patients (18%) had diabetes. Mean percent diameter stenosis was 79±12.5%. Average lesion length was 24.4±13.8mm and 66% of lesions were AHA/ACC type B2/C. Postdilation rate was 91% and all BVS resulted well apposed to the vessel wall. Procedural success was achieved in all patients and 10 (14.9%) had an "oval shape" at intravascular imaging. This occurrence was not associated with an increase in periprocedural myocardial infarction (p=0.37) or DOCE during hospitalization (p=0.65). Seven-month DOCE occurred in 3 patients (5.6%) of the oval shape group, they were target-vessel revascularization and did not differ significantly between patients with vs. without final "oval shape" (p=0.34). We did not register episodes of scaffold thromboses. CONCLUSIONS: In an all-comer population with complex coronary lesions treated with BVS, a final oval shape after postdilation was not rare and not associated with immediate and medium term adverse events.

Effect of Drug-Coated Balloons in Native Coronary Artery Disease Left With a Dissection.

OBJECTIVES: The authors sought to understand the clinical and angiographic outcomes of dissections left after drug-coated balloon (DCB) angioplasty. BACKGROUND: Second-generation DCB may be an alternative to stents in selected populations for the treatment of native coronary lesions. However, the use of these devices may be hampered by a certain risk of acute vessel recoil or residual coronary dissection. Moreover, stenting after DCB has shown limited efficacy. Little is known about when a non-flow-limiting dissection is left after DCB angioplasty. METHODS: This was a prospective observational study whose aim was to investigate the outcome of a consecutive series of patients with native coronary artery disease treated with second-generation DCB and residual coronary dissection at 2 Italian centers. We evaluated patient clinical conditions at 1 and 9 months, and angiographic follow up was undertaken at 6 months. RESULTS: Between July 2012 and July 2014, 156 patients were treated with DCB for native coronary artery disease. Fifty-two patients had a final dissection, 4 of which underwent prosthesis implantation and 48 were left untreated and underwent angiographic follow-up after 201 days (interquartile range: 161 to 250 days). The dissections were all type A to C, and none determined an impaired distal flow. Complete vessel healing at angiography was observed in 45 patients (93.8%), whereas 3 patients had persistent but uncomplicated dissections, and 3 had binary restenosis (6.2%). Late lumen loss was 0.14 mm (-0.14 to 0.42). Major adverse cardiovascular events occurred in 11 patients in the entire cohort and in 4 of the dissection cohort (7.2% vs. 8.1%; p = 0.48). We observed 8 and 3 target lesion revascularizations, respectively (5.3% vs. 6.2%; p = 0.37). CONCLUSIONS: In this cohort of consecutive patients treated with new-generation DCB and left with a final dissection, this strategy of revascularization seemed associated with the sealing of most of dissections and without significant neointimal hyperplasia.

Comparison of risk of acute kidney injury after primary percutaneous coronary interventions with the transradial approach versus the transfemoral approach (from the PRIPITENA urban registry).

The risk of acute kidney injury (AKI) is a major issue after percutaneous coronary interventions (PCIs), especially in the setting of ST-elevation myocardial infarction. Preliminary data from large retrospective registries seem to show a reduction of AKI when a transradial (TR) approach for PCI is adopted. Little is known about the relation between vascular access and AKI after emergent PCI. We here report the results of the Primary PCI from Tevere to Navigli (PRIPITENA), a retrospective database of primary PCI performed at high-volume centers in the urban areas of Rome and Milan. Primary end point of this study was the occurrence of AKI in the TR and transfemoral (TF) access site groups. Secondary end points were major adverse cardiovascular events, stent thrombosis, and Thrombolysis in Myocardial Infarction major and minor bleedings. The database included 1,330 patients, 836 treated with a TR and 494 with a TF approach. After a propensity-matched analysis performed to exclude possible confounders, we identified 450 matched patients (225 TR and 225 TF). The incidence of AKI in the 2 matched groups was lower in patients treated with TR primary PCI (8.4% vs 16.9%, p = 0.007). Major adverse cardiovascular events and stent thrombosis were not different among study groups, whereas major bleedings were more often seen in the TF group. At multivariate analysis, femoral access was an independent predictor of AKI (odds ratio 1.654, 95% confidence interval 1.084 to 2.524, p = 0.042). In conclusion, in this database of primary PCI, the risk of AKI was lower with a TR approach, and the TF approach was an independent predictor for the occurrence of this complication.

Renal artery embolization for kidney trauma.

Kidney trauma occurs in approximately 1-5% of all traumas with the male to female ratio being 3:1. In this paper we reported two cases of male patients with kidney trauma treated by renal artery embolization. Endo-vascular embolization is an efficient method for the treatment of patient with severe renal haemorrhage preserving loss of renal parenchyma and renal function.