Sirolimus-Coated Balloon in Femoropopliteal Steno-Occlusive Disease: Efficacy, Safety, and 1-Year Outcomes. An All-Comers Registry.

PURPOSE: The aim of this study was to assess the efficacy and safety of the novel SLR (SELUTION sustained-limus-release) drug-coated balloon (DCB) in the treatment of the femoropopliteal steno-occlusive disease. MATERIALS AND METHODS: From February 2021 to March 2022, 80 consecutive patients (age: 69.5±8.23 years; total number of lesions: 80) with a steno-occlusive lesion of superficial femoral artery were enrolled at our center. A total of 60 patients (75%) had claudication, whereas 20 (25%) had chronic limb-threatening ischemia (CLTI). The mean lesion length was 171±82.22 mm. The primary efficacy outcome was primary patency at 12 months, defined as freedom from restenosis determined by a duplex ultrasound peak systolic velocity ratio ≤2.4. The secondary efficacy outcome was freedom from clinically-driven target lesion revascularization (CD-TLR) at 12 months. The primary safety outcome was a composite of freedom from device- and procedure-related mortality, major target limb amputation, and clinically-driven target lesion urgent revascularization (endovascular or bypass graft) at 30 days and 12 months. RESULTS: Device success was achieved in all 80 patients. One death on day 7 from cardiovascular complications was ruled procedure-related because it occurred within the first 30 days from the discharge. Two patients with CLTI experienced planned minor amputations of target limb, and one patient underwent urgent bypass graft of the target vessel for early occlusion at 60 days from the index procedure. The primary safety outcome was 98.7% and 97.5% at 30 days and 12 months, respectively. At 1 year, primary patency was 86.3%, and freedom from CD-TLR was 96.2%. CONCLUSION: These findings suggest that using a novel sirolimus-coated balloon is a safe and effective treatment option for femoropopliteal steno-occlusive lesions in a variety of clinical and anatomical settings. These results will need to be confirmed by long-term follow-up and randomized controlled trials. CLINICAL IMPACT: In femoropopliteal steno-occlusive lesions paclitaxel drug-coated devices have been proved to be able to achieve a better vessel patency during follow-up compared with uncoated balloon, but according to a recent meta-analysis they may carry an elevated risk of late mortality. Sirolimus results in a wider therapeutic range with a 3-fold higher margin of safety. Sirolimus coated devices have recently been proposed as an alternative. This study suggests that using a novel sirolimus-coated balloon is a safe and effective treatment option for femoropopliteal steno-occlusive lesions.

Fluoroscopy Time as a New Predictor of Short-Term Outcomes after Transcatheter Aortic Valve Replacement.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) is an almost totally cine-fluoroscopic guided procedure. The amount of radiation used during the procedure is strictly related to the fluoroscopy time (FT), that has already been demonstrated to be associated with outcomes and complexity of coronary procedures. The aim of our study is to demonstrate the relationship between FT and the short-term outcomes after TAVR defined by to the Valve Academic Research Consortium (VARC)-2 and -3 consensus documents. METHODS: After splitting 1797 consecutive patients into tertiles of FT, the composite endpoint early safety (ES) was adjudicated according to VARC-2 and VARC-3 definitions, whereas the composite endpoints device success (DS) and technical success (TS) according to VARC-3 criteria. RESULTS: The absence of all these outcomes (VARC-2 ES amd VARC-3 TS, DS, and ES) was significantly associated with longer FT: this association was independent from both intraprocedural complications and other intraprocedural factors linked to longer FT, and still persisted after propensity score matching analysis. Notwithstanding, after receiver operating characteristic analysis, FT had adequate diagnostic accuracy in identifying the absence of only VARC-3 TS and VARC-2 ES. CONCLUSION: Longer FT is related with periprocedural and short-term outcomes after the procedure, especially in those that are more challenging. A FT duration of more than 30 min has an adequate accuracy in identifying VARC-3 technical failure (TS and DS) and absence of VARC-2 ES, selecting patients who are likely to take advantage from more careful in-hospital follow-up.

Clinical outcomes following different stenting techniques for coronary bifurcation lesions: a systematic review and network meta-analysis of randomised controlled trials.

BACKGROUND: Controversy still exists regarding the optimal treatment of coronary bifurcation lesions. AIMS: We aimed to analyse the evidence from randomised controlled trials (RCTs) to compare outcomes following different bifurcation stenting techniques. METHODS: We systematically searched for RCTs comparing different techniques published up to July 2022. We then conducted a pairwise meta-analysis to compare outcomes between provisional stenting (PS) versus upfront 2-stent techniques. Moreover, we performed a network meta-analysis (NMA) to compare all strategies with each other. The primary endpoint was major adverse cardiac events (MACE). RESULTS: Twenty-four RCTs (6,890 patients) analysed PS, T-stenting, double-kissing (DK)-crush, crush, or culotte stenting. The pairwise meta-analysis did not reveal a significant difference between the PS and 2-stent techniques. However, the prespecified sensitivity analysis, which included RCTs exclusively enrolling patients with true bifurcation lesions, showed a lower rate of MACE following 2-stent techniques, and meta-regression indicated that a longer side branch lesion was associated with a greater benefit from the 2-stent strategy, which was the most apparent in RCTs with a mean lesion length >11 mm. NMA revealed that DK-crush was associated with the lowest MACE rate (odds ratio 0.47, 95% confidence interval: 0.36-0.62; p<0.01; PS as a reference). CONCLUSIONS: Overall, 2-stent techniques were not significantly better than PS in terms of clinical outcomes. However, the results of the sensitivity analysis suggested that there might be a benefit of a 2-stent approach in selected patients with true bifurcation lesions, especially in the case of long side branch lesions. An NMA revealed that DK-crush was associated with the lowest event rates when compared with other techniques.

Impact of Age at the Time of the First ST-Elevation Myocardial Infarction on 10-Year Outcomes (from the EXAMINATION-EXTEND Trial).

The aim of this substudy of the EXAMINATION-EXTEND was to analyze 10-year outcomes according to the patient's age at the time of the first ST-elevation myocardial infarction (STEMI). Of 1,498 patients with STEMI included in the EXAMINATION-EXTEND study, those with a previous history of coronary ischemic even or ischemic stroke were excluded from this analysis. The remaining 1,375 patients were divided into 4 age groups: <55, 55 to 65, 65 to 75, and >75 years. The primary end point was 10-year patient-oriented composite end point (POCE) of all-cause death, any MI, or any revascularization. At 10-year follow-up, patients aged <55 years (adjusted hazard ratio [HR] 0.24, 95% confidence interval [CI] 0.18 to 0.31, p = 0.001), 55 to 65 years (adjusted HR 0.26, 95% CI 0.20 to 0.34, p = 0.001), and 65 to 75 years (adjusted HR 0.38, 95% CI 0.30 to 0.50, p = 0.001) showed lower risk of POCE than those aged >75 years, led by a lower incidence of all-cause death (<55 : 6% vs 55 to 65: 11.9% vs 65 to 75: 25.7% vs >75 years: 61.6%, p = 0.001). Cardiac death was more prevalent in the older group (<55: 3.7% vs 55 to 65: 5.8% vs 65 to 75: 10.9% vs >75 years: 35.5%, p = 0.001). In the landmark analyses, between 5- and 10-year follow-up, young patients exhibited a higher incidence of any revascularization (<55: 7.4% vs 55 to 65: 4.9% vs 65 to 75: 1.8% vs >65 years: 1.6%, p = 0.001). In conclusion, in patients with a first STEMI, advanced age was associated with high rates of POCE at 10-year follow-up due to all-cause and cardiac death. Conversely, younger patients exhibited a high risk of revascularization at long-term follow-up.

Early acute kidney injury after transcatheter aortic valve implantation: predictive value of currently available risk scores.

BACKGROUND: Acute kidney injury (AKI) after transcatheter aortic valve implantation (TAVI) is a frequent complication associated with adverse outcomes and mortality. Various scores have been developed to predict this complication in the coronary setting. However, none have ever been tested in a large TAVI population. This study aimed to evaluate the power of four different scores in predicting AKI after TAVI. METHODS: Overall, 1535 consecutive TAVI patients from the observational multicentric "Magna Graecia" TAVI registry were included in the analysis. Of the study population, 235 (15.31%) developed AKI early. The Mehran, William Beaumont Hospital, CR4EATME3AD3, and ACEF scores were calculated retrospectively. RESULTS: The patients who developed TAVI-related AKI had significantly higher absolute values of all risk scores than those who did not. The receiver-operating characteristic analysis also showed a significant correlation between these four scores and AKI, but without a significant difference among all of them (p value = 0.176). Nevertheless, based on their area under the curve values (≤0.604 for all), none had adequate diagnostic accuracy in predicting TAVI-related AKI. Importantly, multivariate analysis identified myocardial revascularization close to the TAVI procedure and implantation of self-expanding prostheses, as well as atrial fibrillation, low-osmolar contrast media administration, corrected contrast medium volume, and any transfusion (p value < 0.05 for all) as independent risk factors for AKI. CONCLUSIONS: Although high values of current AKI risk scores are significantly associated with the development of this complication, these are not sufficiently accurate. Further studies are needed so that a TAVI-dedicated AKI risk score may be created.

Symptoms-to-emergency-call timing delay in acute coronary syndrome before and during COVID-19: independent predictors and their impact on mortality.

BACKGROUND: The COVID-19 pandemic severely impacted global health. The aim of this study was to compare predictors of symptoms-to-emergency-call timing delay in acute coronary syndrome (ACS) and their impact on mortality before and during the COVID-19 outbreak. METHODS: We collected sociodemographic, clinical data, procedural features, preadmission and intra-hospital outcomes of consecutive patients admitted for ACS in seventeen Italian centers from March to April 2018, 2019, and 2020. RESULTS: In 2020, a 32.92% reduction in ACS admissions was observed compared to 2018 and 2019. Unstable angina, typical and atypical symptoms, and intermittent angina were identified as significant predictors of symptoms-to-emergency-call timing delay before and during the COVID-19 pandemic (P<0.005 for all the items). Differently from 2018-2019, during the pandemic, hypertension and dyspnea (P=0.002 versus P=0.490 and P=0.001 vs. P=0.761 for 2018-2019 and 2020, respectively) did not result as predictors of delay in symptoms-to-emergency-call timing. Among these predictors, only the atypical symptoms (HR 3.36; 95% CI: 1.172-9.667, P=0.024) in 2020 and the dyspnea (HR 2.64; 95% CI: 1.345-5.190, P=0.005) in 2018-2019 resulted significantly associated with higher mortality. Finally, the family attendance at the onset of the symptoms resulted in a reduction in symptoms-to-emergency-call timing (in 2020 P<0.001; CI: -1710.73; -493.19) and in a trend of reduced mortality (HR 0.31; 95% CI: 0.089-1.079, P=0.066) in 2020. CONCLUSIONS: During the COVID-19 outbreak, atypical symptoms and family attendance at ACS onset were identified, respectively, as adverse and favorable predictors of symptoms-to-emergency-call timing delay and mortality.

Impact of Diabetes on 10-Year Outcomes Following ST-Segment-Elevation Myocardial Infarction: Insights From the EXAMINATION-EXTEND Trial.

Background Long-term outcomes of ST-segment-elevation myocardial infarction in patients with diabetes have been barely investigated. The objective of this analysis from the EXAMINATION-EXTEND (10-Years Follow-Up of the EXAMINATION trial) trial was to compare 10-year outcomes of patients with ST-segment-elevation myocardial infarction with and without diabetes. Methods and Results Of the study population, 258 patients had diabetes and 1240 did not. The primary end point was patient-oriented composite end point of all-cause death, any myocardial infarction, or any revascularization. Secondary end points were the individual components of the primary combined end point, cardiac death, target vessel myocardial infarction, target lesion revascularization, and stent thrombosis. All end points were adjusted for potential confounders. At 10 years, patients with diabetes showed a higher incidence of patient-oriented composite end point compared with those without (46.5% versus 33.0%; adjusted hazard ratio [HR], 1.31 [95% CI, 1.05-1.61]; P=0.016) mainly driven by a higher incidence of any revascularization (24.4% versus 16.6%; adjusted HR, 1.61 [95% CI, 1.19-2.17]; P=0.002). Specifically, patients with diabetes had a higher incidence of any revascularization during the first 5 years of follow-up (20.2% versus 12.8%; adjusted HR, 1.57 [95% CI, 1.13-2.19]; P=0.007) compared with those without diabetes. No statistically significant differences were found with respect to the other end points. Conclusions Patients with ST-segment-elevation myocardial infarction who had diabetes had worse clinical outcome at 10 years compared with those without diabetes, mainly driven by a higher incidence of any revascularizations in the first 5 years. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT04462315.

Sex Differences in 10-Year Outcomes Following STEMI: A Subanalysis From the EXAMINATION-EXTEND Trial.

BACKGROUND: Short-term outcomes following ST-segment elevation myocardial infarction (STEMI) in women are worse than in men, with a higher mortality rate. It is unknown whether sex plays a role in very long term outcomes. OBJECTIVES: The aim of this study was to assess whether very long term outcomes following STEMI treatment are influenced by sex. METHODS: EXAMINATION-EXTEND (10-Year Follow-Up of the EXAMINATION Trial) was an investigator-driven 10-year follow-up of the EXAMINATION (A Clinical Evaluation of Everolimus Eluting Coronary Stents in the Treatment of Patients With ST-Segment Elevation Myocardial Infarction) trial, which randomly 1:1 assigned 1,498 patients with STEMI to receive either everolimus-eluting stents or bare-metal stents. The present study was a subanalysis according to sex. The primary endpoint was the composite patient-oriented endpoint (all-cause death, any myocardial infarction, or any revascularization) at 10 years. Secondary endpoints were individual components of the primary endpoint. All endpoints were adjusted for age. RESULTS: Among 1,498 patients with STEMI, 254 (17%) were women. Overall, women were older, with more arterial hypertension and less smoking history than men. At 10 years, no difference was observed between women and men for the patient-oriented composite endpoint (40.6% vs 34.2%; adjusted HR: 1.14; 95% CI: 0.91-1.42; P = 0.259). There was a trend toward higher all-cause death in women vs men (27.6% vs 19.4%; adjusted HR: 1.30; 95% CI: 0.99-1.71; P = 0.063), with no difference in cardiac death or other endpoints. CONCLUSIONS: At very long term follow-up, there were no differences in the combined patient-oriented endpoint between women and men, with a trend toward higher all-cause death in women not driven by cardiac death. The present findings underline the need for focused personalized medicine in women after percutaneous revascularization aimed at both cardiovascular and sex-specific risk factor control and targeted treatment. (10-Years Follow-Up of the EXAMINATION Trial [EXAMINAT10N]; NCT04462315).

The Incidence and Impact of In-Hospital Bleeding in Patients with Acute Coronary Syndrome during the COVID-19 Pandemic.

BACKGROUND: The COVID-19 pandemic increased the complexity of the clinical management and pharmacological treatment of patients presenting with an Acute Coronary Syndrome (ACS). AIM: to explore the incidence and prognostic impact of in-hospital bleeding in patients presenting with ACS before and during the COVID-19 pandemic. METHODS: We evaluated in-hospital Thrombolysis In Myocardial Infarction (TIMI) major and minor bleeding among 2851 patients with ACS from 17 Italian centers during the first wave of the COVID-19 pandemic (i.e., March-April 2020) and in the same period in the previous two years. RESULTS: The incidence of in-hospital TIMI major and minor bleeding was similar before and during the COVID-19 pandemic. TIMI major or minor bleeding was associated with a significant threefold increase in all-cause mortality, with a similar prognostic impact before and during the COVID-19 pandemic. CONCLUSIONS: the incidence and clinical impact of in-hospital bleeding in ACS patients was similar before and during the COVID-19 pandemic. We confirmed a significant and sizable negative prognostic impact of in-hospital bleeding in ACS patients.

Coronary Microvascular Angina: A State-of-the-Art Review.

Up to 60-70% of patients, undergoing invasive coronary angiography due to angina and demonstrable myocardial ischemia with provocative tests, do not have any obstructive coronary disease. Coronary microvascular angina due to a dysfunction of the coronary microcirculation is the underlying cause in almost 50% of these patients, associated with a bad prognosis and poor quality of life. In recent years, progress has been made in the diagnosis and management of this condition. The aim of this review is to provide an insight into current knowledge of this condition, from current diagnostic methods to the latest treatments.

Acute and Chronic Effects of COVID-19 on the Cardiovascular System.

COVID-19 has shown significant morbidity with the involvement of multiple systems, including the cardiovascular system. Cardiovascular manifestations in the acute phase can include myocardial injury itself, myocardial infarction, venous thromboembolic events, myocarditis, Takotsubo syndrome, and different arrhythmic events. Myocardial injury defined by the rise of cardiac biomarkers in blood has been found in multiple studies with a prevalence of about 20%. Its presence is related to worse clinical outcomes and in-hospital mortality. The mechanisms of myocardial injury have been the subject of intense research but still need to be clarified. The characterization of the cardiac affectation with echocardiography and cardiac magnetic resonance has found mixed results in different studies, with a striking incidence of imaging criteria for myocarditis. Regarding post-acute and chronic follow-up results, the persistence of symptoms and imaging changes in recovered COVID-19 patients has raised concerns about the duration and the possible significance of these findings. Even though the knowledge about this disease has increased incredibly in the last year, many aspects are still unclear and warrant further research.

Magna Graecia transcatheter aortic valve implantation registry: data on contrast medium osmolality and postprocedural acute kidney injury.

A comprehensive description of baseline characteristics, procedural features and outcomes related to the development of acute kidney injury (AKI) after transcatheter aortic valve implantation (TAVI) is reported in our research paper (Impact of contrast medium osmolality on the risk of acute kidney injury after transcatheter aortic valve implantation: insights from the Magna Graecia TAVI registry. Int J Cardiol. DOI: 10.1016/j.ijcard.2020.12.049). Three Italian heart centers were involved in this multicentric observational study. Between March 2011 and February 2019, a total of 888 patients underwent TAVI; according to the inclusion and exclusion criteria, 697 patients were included in the post-hoc analysis. This Data in Brief paper aims to report demographic, clinical, laboratory, echocardiographic, intraprocedural, periprocedural, postprocedural and follow-up data; all of them were prospectively collected from each patient's health record, whereas the analysis was performed retrospectively. Targets of this data analysis were: 1) to evaluate the impact of contrast medium (CM) osmolality on TAVI-related AKI; 2) to identify the most of risk factors involved in the development of such complication, and consequently in the occurrence of 1-year mortality; 3) to estimate the impact of CM osmolality on AKI in specific patient subgroups.

Second generation drug-eluting stents: a focus on safety and efficacy of current devices.

Introduction: Percutaneous coronary intervention (PCI) represents the most frequent procedure performed in medicine. Second generation drug eluting stents (DES) have been developed to reduce the rates of late and very late complications of first generation DES.Areas covered: To improve long-term efficacy and safety of patients undergoing PCI, second generation DES have been developed with novel stent platforms, biocompatible durable and biodegradable polymers and newer antiproliferative agents. In this review we provide an overview of second generation DES and their clinical trials, discussing safety and effectiveness of these devices, and outlining clinical indication for use.Expert commentary: Numerous clinical trials have demonstrated the safety and efficacy of second generation DES over the last decade. These devices represent the gold standard treatment in stable and acute coronary syndromes.

Impact of contrast medium osmolality on the risk of acute kidney injury after transcatheter aortic valve implantation: insights from the Magna Graecia TAVI registry.

BACKGROUND: Acute kidney injury (AKI) after transcatheter aortic valve implantation (TAVI) is frequent and associated with adverse outcomes and mortality; to date, in such setting of patients there is no consistent evidence that either low-osmolar contrast media (LOCM) or iso-osmolar contrast medium (IOCM) are superior to the other in terms of renal safety. METHODS: 697 consecutive patients not in hemodialysis treatment who underwent TAVI (327 males, mean age 81.01 ± 5.75 years, mean european system for cardiac operative risk evaluation II 6.17 ± 0.23%) were enrolled. According to osmolality of the different iodinated CM, the population was divided in 2 groups: IOCM (n = 370) and LOCM group (n = 327). Preoperatively, 40.54% of patients in IOCM vs 39.14% in LOCM group (p = 0.765) suffered from chronic kidney disease (CKD). RESULTS: The incidence of AKI was significantly lower with IOCM (9.73%) than with LOCM (15.90%; p = 0.02), and such significant difference (p < 0.001) in postprocedural change of renal function parameters persisted at discharge too. The incidence of AKI was also significantly lower with IOCM in younger patients, without diabetes, anemia, coronary artery disease history, CKD, chronic or persistent atrial fibrillation, left ventricular ejection fraction ≤35%, and in patients with low operative mortality risk scores, receiving lower amounts of dye (p < 0.05 for all). Importantly, multivariate analysis identified LOCM administration as an independent risk factor for both AKI (p = 0.006) and 1-year mortality (p = 0.001). CONCLUSIONS: The use of IOCM have a favorable impact on renal function with respect to LOCM, but it should be considered especially for TAVI patients at lower AKI risk.

Percutaneous exclusion of ascending aorta pseudoaneurysms: still an interventional challenge?

Ascending aortic pseudoaneurysm is a rare pathology that could have multiple etiologies such as thoracic trauma, infection, and percutaneous or surgical procedures. In patients with aortic pseudoaneurysms, open surgical or endovascular interventions are always indicated, if feasible and independent of size. Several types of endovascular treatment have been reported in the literature, but they have been mostly restricted to those cases when traditional surgery has a prohibitive risk. We report the case of a 75-year-old man with a sinotubular junction pseudoaneurysm, likely developed after coronary artery bypass grafting, which was successfully treated by implanting a multifenestrated cribriform septal occluder, a device already used in few similar cases. .