Efficacy and safety of a minimalistic balloon aortic valvuloplasty strategy in a centre without heart surgery.

Background: Balloon aortic valvuloplasty (BAV) is a palliative tool for patients with symptomatic severe aortic stenosis (AS) at prohibitive risk for surgery or as a bridge to surgical aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR). BAV is traditionally performed in hospitals with onsite cardiac surgery due to its potential complications. Aims: The aim of this study was to evaluate the safety of BAV procedures performed by trained high-volume operators in a centre without onsite surgery and to assess the effect of a minimalistic approach to reduce periprocedural complications. Methods: From 2016 to 2021, 187 BAV procedures were performed in 174 patients. Patients were elderly (mean age: 85.0±5.4 years) and had high-risk (mean European System for Cardiac Operative Risk Evaluation score [EuroSCORE] II: 10.1±9.9) features. According to the indications, 4 cohorts were identified: 1) bridge to TAVR (n=98; 56%); 2) bridge to SAVR (n=8; 5%); 3) cardiogenic shock (n=11; 6%); and 4) palliation (n=57; 33%). BAV procedures were performed using the standard retrograde technique via femoral access in 165 patients (95%), although radial access was used in 9 patients (5%). Ultrasound-guided vascular puncture was performed in 118 patients (72%) and left ventricular pacing was administered through a stiff guidewire in 105 cases (60%). Results: BAV safety was confirmed by 1 periprocedural death (0.6%), 1 intraprocedural stroke (0.6%), 2 major vascular complications (1%) and 9 minor vascular complications (5%). Nine cases of in-hospital mortality occurred (5%), predominantly in patients with cardiogenic shock. Conclusions: BAV is a safe procedure that can be performed in centres without onsite cardiac surgery using a minimalistic approach that can reduce periprocedural complications.

Modelling blood flow in coronary arteries: Newtonian or shear-thinning non-Newtonian rheology?

BACKGROUND: The combination of medical imaging and computational hemodynamics is a promising technology to diagnose/prognose coronary artery disease (CAD). However, the clinical translation of in silico hemodynamic models is still hampered by assumptions/idealizations that must be introduced in model-based strategies and that necessarily imply uncertainty. This study aims to provide a definite answer to the open question of how to properly model blood rheological properties in computational fluid dynamics (CFD) simulations of coronary hemodynamics. METHODS: The geometry of the right coronary artery (RCA) of 144 hemodynamically stable patients with different stenosis degree were reconstructed from angiography. On them, unsteady-state CFD simulations were carried out. On each reconstructed RCA two different simulation strategies were applied to account for blood rheological properties, implementing (i) a Newtonian (N) and (ii) a shear-thinning non-Newtonian (non-N) rheological model. Their impact was evaluated in terms of wall shear stress (WSS magnitude, multidirectionality, topological skeleton) and helical flow (strength, topology) profiles. Additionally, luminal surface areas (SAs) exposed to shear disturbances were identified and the co-localization of paired N and non-N SAs was quantified in terms of similarity index (SI). RESULTS: The comparison between paired N vs. shear-thinning non-N simulations revealed remarkably similar profiles of WSS-based and helicity-based quantities, independent of the adopted blood rheology model and of the degree of stenosis of the vessel. Statistically, for each paired N and non-N hemodynamic quantity emerged negligible bias from Bland-Altman plots, and strong positive linear correlation (r > 0.94 for almost all the WSS-based quantities, r > 0.99 for helicity-based quantities). Moreover, a remarkable co-localization of N vs. non-N luminal SAs exposed to disturbed shear clearly emerged (SI distribution 0.95 [0.93, 0.97]). Helical flow topology resulted to be unaffected by blood rheological properties. CONCLUSIONS: This study, performed on 288 angio-based CFD simulations on 144 RCA models presenting with different degrees of stenosis, suggests that the assumptions on blood rheology have negligible impact both on WSS and helical flow profiles associated with CAD, thus definitively answering to the question "is Newtonian assumption for blood rheology adequate in coronary hemodynamics simulations?".

Predictors of target lesion failure after treatment of left main, bifurcation, or chronic total occlusion lesions with ultrathin-strut drug-eluting coronary stents in the ULTRA registry.

BACKGROUND: Data about the long-term performance of new-generation ultrathin-strut drug-eluting stents (DES) in challenging coronary lesions, such as left main (LM), bifurcation, and chronic total occlusion (CTO) lesions are scant. METHODS: The international multicenter retrospective observational ULTRA study included consecutive patients treated from September 2016 to August 2021 with ultrathin-strut (<70 µm) DES in challenging de novo lesions. Primary endpoint was target lesion failure (TLF): composite of cardiac death, target-lesion revascularization (TLR), target-vessel myocardial infarction (TVMI), or definite stent thrombosis (ST). Secondary endpoints included all-cause death, acute myocardial infarction (AMI), target vessel revascularization, and TLF components. TLF predictors were assessed with Cox multivariable analysis. RESULTS: Of 1801 patients (age: 66.6 ± 11.2 years; male: 1410 [78.3%]), 170 (9.4%) experienced TLF during follow-up of 3.1 ± 1.4 years. In patients with LM, CTO, and bifurcation lesions, TLF rates were 13.5%, 9.9%, and 8.9%, respectively. Overall, 160 (8.9%) patients died (74 [4.1%] from cardiac causes). AMI and TVMI rates were 6.0% and 3.2%, respectively. ST occurred in 11 (1.1%) patients while 77 (4.3%) underwent TLR. Multivariable analysis identified the following predictors of TLF: age, STEMI with cardiogenic shock, impaired left ventricular ejection fraction, diabetes, and renal dysfunction. Among the procedural variables, total stent length increased TLF risk (HR: 1.01, 95% CI: 1-1.02 per mm increase), while intracoronary imaging reduced the risk substantially (HR: 0.35, 95% CI: 0.12-0.82). CONCLUSIONS: Ultrathin-strut DES showed high efficacy and satisfactory safety, even in patients with challenging coronary lesions. Yet, despite using contemporary gold-standard DES, the association persisted between established patient- and procedure-related features of risk and impaired 3-year clinical outcome.

Incidence trends and long-term outcomes of myocardial infarction in young adults: Does gender matter?

AIMS: Data about long-term clinical outcomes of young patients experiencing an acute myocardial infarction (MI) and about the potential impact of gender on juvenile MI incidence and prognosis are scant. METHODS AND RESULTS: Hospital Discharge Register records of Piedmont region (Italy) from 2007 to 2018 were interrogated to identify incident juvenile MI cases and MI recurrences. Patients were considered young if the first MI occurred before or at 47 years of age (5th percentile). Incidence of first juvenile MI event and overall survival were the primary outcomes. Gender differences and survival rate after an MI recurrence were secondary outcomes. Out of 114.816 hospitalizations due to MI, 4482 (3.9%) occurred in people aged ≤47. Average incidence rate of juvenile MI over the study period was 24.5 (23.8-25.2) per 100.000 person-years, with a decline among men and a stable trend among women through the years. The risk of in hospital death was higher for women (1.9% vs. 0.9%, p = 0.02), while the survival rate at 10 years after the first MI was 94.8%, without gender differences (HR 1.05: 0.69-1.60). MI recurrence occurred in 348 (7.8%) and was less common in women (HR 0.72: 0.52-0.99). After multivariate adjustment, MI recurrence was associated with a significantly higher risk of death at follow-up as compared with a single MI episode (HR 3.05: 1.9-4.80, all CI 95%). CONCLUSION: Among young patients with MI, women had a higher in-hospital mortality compared to men, but long-term prognosis after hospital discharge did not differ. MI recurrences were associated with increased mortality at follow up.

Percutaneous artErial closure devices and ultrasound-guided Trans-femoRal puncture ObservatioNal InvestigatiOn: Insights from the PETRONIO registry.

OBJECTIVE: To evaluate the safety of a single and combined use of ultrasound-guided femoral puncture (U) and percutaneous arterial closure devices (P) in femoral artery procedures (FAP) compared to fluoroscopic guidance (F) and manual compression (M) in a large radial-focused interventional centre. BACKGROUND: U and P, taken individually, have improved safety in femoral arterial access procedures compared to traditional techniques. METHODS: All FAP performed between July 2017 and December 2018 in our centre were divided into three phases: (a) control period with F and M mainly performed; (b) phase out period where U and P were introduced; (c) intervention period where a 6-month expertise on the novel techniques was acquired. The overall population was further stratified into subgroups: F/M, U/M, F/P, U/P. The primary study endpoint was in-hospital access site bleeding events (BE) according to the BARC criteria. The secondary endpoint was vascular site complications (VASC). RESULTS: Four hundred eighteen procedures (14%) out of 3025 were performed via FA access during the study period. The overall access-site in-hospital BE were 97 (23%). Decreasing rates of BE (phase 1: n = 46, 29%; phase 2: n = 38, 22% e phase 3: n = 13, 15%; p = 0.027) and VASC were observed during the three periods. BE occurred significantly more often in F/M group (F/M: n = 48; 32%; U/M: n = 12, 16%; F/P: n = 18, 21%; U/P: n = 19, 17%; p = 0.008). F/M subgroup was an independent predictor of BE both in multivariable analysis and propensity score matching analysis. CONCLUSIONS: The introduction of ultrasound-guided femoral puncture and percutaneous arterial closure devices has reduced access site bleedings with a progressive improvement after the first 6 months learning period.

Long-term (≥15 years) Follow-up of Percutaneous Coronary Intervention of Unprotected Left Main (From the GRAVITY Registry).

Long term survival and its determinants after Percutaneous Coronary Intervention (PCI) on Unprotected Left Main Coronary Artery (ULMCA) remain to be appraised. In 9 European Centers 470 consecutive patients performing PCI on ULMCA between 2002 and 2005 were retrospectively enrolled. Survival from all cause and cardiovascular (CV) death were the primary end points, while their predictors at multivariate analysis the secondary ones. Among the overall cohort 81.5% of patients were male and mean age was 66 ± 12 years. After 15 years (IQR 13 to 16), 223 patients (47%) died, 81 (17.2%) due to CV etiology. At multivariable analysis, older age (HR 1.06, 95%CI 1.02 to 1.11), LVEF < 35% (HR 2.97, 95%CI 1.24 to 7.15) and number of vessels treated during the index PCI (HR 1.75, 95%CI 1.12 to 2.72) were related to all-cause mortality, while only LVEF <35% (HR 4.71, 95%CI 1.90 to 11.66) to CV death. Repeated PCI on ULMCA occurred in 91 (28%) patients during the course of follow up and did not significantly impact on freedom from all-cause or CV mortality. In conclusion, in a large, unselected population treated with PCI on ULMCA, 47% died after 15 years, 17% due to CV causes. Age, number of vessels treated during index PCI and depressed LVEF increased risk of all cause death, while re-PCI on ULMCA did not impact survival.

Return towards normality in admissions for myocardial infarction after the lockdown removal for COVID-19 outbreak in Italy.

BACKGROUND: Investigations demonstrated a decrease of admissions for myocardial infarction (MI) during the CoronaVirus Disease-19 (COVID-19) outbreak. No study has evaluated the time required to reverse this downward curve of MI admissions. METHODS: This is a retrospective analysis on patients (N = 2415) admitted to the Emergency Departments for acute MI in nine Italian centers. Primary endpoint was the incidence rates (IRs) of MI admissions in the post-lockdown COVID-19 period (case-period: from May 4 to July 12, 2020) vs. the following control periods: January 1-February 19, 2020 (pre-lockdown period); February 20-May 3, 2020 (intra-lockdown period); May 4-July 12, 2019 (inter-year non-COVID-19 period). RESULTS: IR of admissions for MI in the post-lockdown period was higher than the intra-lockdown period (IR ratio, IRR: 1.60, 95% CI 1.42-1.81; p = 0.0001), was lower than the pre-lockdown period (IRR: 0.86, 0.77-0.96; p = 0.009) and similar to the inter-year non-COVID-19 period (IRR: 0.96, 0.87-1.07; p = 0.47). Within the case period, the increase in MI admissions was more pronounced in earlier vs later weeks (IRR 1.19, 95% CI 1.02-1.38, p = 0.024) and, compared to the inter-year control period, was significant for non ST-segment elevation MI (IRR: 1.25, 95% CI 1.08-1.46, p = 0.004), but was not observed for ST-segment elevation MI (STEMI), where hospitalizations were reduced (IRR 0.76, 95% CI 0.65-0.88, p = 0.0001). CONCLUSIONS: Our study first indicates an increase in the number of admissions for MI after the removal of the national lockdown for COVID-19 in Italy. This increase was prevalent in the first weeks following the lockdown removal, but was under-represented in STEMI patients.

Gender differences in acute coronary syndromes patterns during the COVID-19 outbreak.

BACKGROUND: Mortality from acute coronary syndromes (ACS) is strictly related to early management. As female patients usually experience longer delays before diagnosis and treatment, we assessed whether women were more affected by the dramatic drop in hospital admissions for ACS during the Covid-19 pandemic. METHODS: We performed a retrospective analysis of clinical and angiographic characteristics of consecutive patients who were admitted for ACS at 15 hospitals in Northern Italy comparing men and women data. The study period was defined as the time between the first confirmed case of Covid-19 in Italy (February 20, 2020) and March 31, 2020. We compared hospitalization rates between the study period and two control periods: the corresponding period during the previous year (February 20 to March 31, 2019) and the earlier period during the same year (January 1 to February 19, 2020). Incidence rate ratios comparing the study period with each of the control periods were calculated with the use of Poisson regression. RESULTS: Of the 547 patients who were hospitalized for ACS during the study period, only 127 (23%) were females, accounting for a mean of 3.1 admissions per day, while ACS hospitalized males were 420, with a mean of 10.2 admissions per day. There was a significant decrease driven by a similar reduction in ST-segment elevation myocardial infarction (STEMI) and non-ST-segment elevation myocardial infarction (NSTEMI) diagnosis in both sexes compared to the control periods. A trend toward a greater reduction in admitted females was shown in the intra-year control period (46% admission reduction in females vs 37% in males, with females accounting for 26% of ACS, P=0.10) and a significant reduction when compared to the previous year control period (40% admission reduction in females vs 23% in males, with females accounting for 28% of ACS, P=0.03), mainly related to Unstable Angina diagnosis. CONCLUSION: The Covid-19 pandemic period closed the gap between men and women in ACS, with similar rates of reduction of hospitalized STEMI and NSTEMI and a trend toward greater reduction in UA admission among women. Furthermore, many typical differences between males and females regarding ischemic heart disease presentations and vessel distribution were leveled.

[Early invasive strategy (<24 h) in high-risk non-ST-elevation acute coronary syndrome: when the guideline recommendations need to be contextualized]. / Strategia invasiva precoce (<24 h) nelle sindromi coronariche acute senza sopraslivellamento del tratto ST ad alto rischio, ovvero quando le raccomandazioni delle linee guida dovrebbero essere contestualizzate.

The advantages of an early invasive strategy in non-ST-elevation acute coronary syndromes (NSTE-ACS) are well documented. Less clear is the ideal time to perform it (within 24 h, within 72 h, or during hospitalization after positive non-invasive testing for ischemia). In particular, the class IA recommendation for coronary angiography within 24 h in patients with high-risk NSTE-ACS is controversial. Randomized clinical trials and meta-analyses show neutral effects on mortality, while significant positive results are observed only for secondary outcomes (mainly ischemic recurrences). Favorable effects on major cardiovascular events are reported only in the subgroup analysis of a single randomized trial (TIMACS) or in several trials included in the meta-analyses. Thus, these results are far from conclusive and should stimulate new randomized clinical studies to support them. In fact, the logistical implications that this recommendation implies deserve stronger evidence. It is clear that all patients with NSTE-ACS, especially if high-risk, should have the opportunity to undergo a coronary angiogram during hospitalization. However, in the real world, the strict timeline of the international guidelines may be difficult to follow. Therefore, indications that take into account resource availability and the organizational context should be developed. Several regional indications suggest that even in high-risk patients the 24 h time limit for the invasive strategy should not be mandatory, but timing of angiography should be calibrated on clinical presentation and logistical resources, without any a priori automatism.

In-hospital and long-term outcomes of HIV-positive patients undergoing PCI according to kind of stent: a meta-analysis.

BACKGROUND: Pathogenesis of cardiovascular disease in HIV-positive patients is related to the interaction between traditional and HIV-specific factors. Limited data are available regarding the prognosis of HIV-positive patients undergoing percutaneous coronary intervention (PCI). METHODS: All observational studies evaluating the prognosis of HIV-positive patients treated with PCI were included. In-hospital and long-term major adverse cardiac events (MACE) [composite endpoint of all-cause death or myocardial infarction (MI)] were the primary endpoints, whereas in-hospital and long-term all-cause death, cardiovascular death, MI, stent thrombosis, target vessel revascularization (TVR), target lesion revascularization (TLR), and bleeding complications were the secondary ones. FINDINGS: In all, 1243 patients in nine studies were included, with a mean age of 54 years. Among them, 12% were female and 91% were admitted for acute coronary syndromes. In-hospital MACE occurred in 6.0% (5.4-6.6), death in 4.2% (2.6-5.9), and MI in 1.3% (0-2.8), whereas major bleeding occurred in 2.0% (1.7-2.3) of the patients. After 2 years (1.6-3.1), long-term MACE occurred in 17.4% (11.9-22.3), all-cause death in 8.7% (3.2-14.2), and MI in 7.8% (5.5-10.1) of the patients, whereas stent thrombosis and TVR in 3.4% (1.5-5.3) and 10.5% (7.5-13.4), respectively. In patients treated with drug-eluting stents (DES), the rate of long-term MACE was 22.3% (10.1-34.4), with an incidence of 4.9% (0.0-11.4) of MI and 5.7% (2.3-13.7, all 95% confidence intervals of TLR. INTERPRETATION: HIV-positive patients have a high risk of in-hospital and long-term MACE after PCI, partially reduced by the use of DES. Further studies on the risk of recurrent ischemic events with current generation stents are needed, to offer a tailored therapy in this high-risk population.

Network meta-analysis comparing iFR versus FFR versus coronary angiography to drive coronary revascularization.

AIMS: Instantaneous free-wave ratio (iFR) has been recently demonstrated non-inferior to fractional flow reserve (FFR) to drive coronary revascularization; however, no study has compared iFR versus coronary angiography (CA). We performed a network meta-analysis to evaluate efficacy and safety of iFR- versus CA-guided strategy. METHODS AND RESULTS: We searched for randomized trials and studies with propensity score matching in The Cochrane Collaboration Central Register of Controlled Trials, EMBASE, and MEDLINE/Pubmed. CA, FFR, and iFR were the three competitive arms, MACE (a composite endpoint of death, myocardial infarction [MI], and target vessel revascularization [TVR]) was the primary endpoint, while its single components the secondary ones. Subgroup analysis was performed for patients presenting with stable coronary artery disease. Eight studies were selected: 4126 patients were evaluated with FFR, 2160 with iFR, and 2214 with CA, acute coronary syndrome (ACS) was the most frequent admission diagnosis. After 12 months, rates of MACE and all-cause death did not differ between groups (respectively OR 1.04 and OR 0.86 for iFR vs FFR). Both FFR and iFR reduced TVR compared to CA (respectively OR 0.68 and OR 0.70). In patients with stable CAD both FFR and iFR reduced risk of subsequent MI compared to CA (respectively OR 0.66 and OR 0.79). CONCLUSION: Compared to CA alone, both FFR and iFR are safe and effective in guiding coronary revascularization at 12 months. In patients with stable CAD, both FFR and iFR-guided revascularization reduce the risk of subsequent MI at 12 months.

Independent impact of extent of coronary artery disease and percutaneous revascularisation on 30-day and one-year mortality after TAVI: a meta-analysis of adjusted observational results.

AIMS: The impact of the severity of coronary artery disease (CAD) and percutaneous coronary interventions (PCI) on outcomes after transcatheter aortic valve implantation (TAVI) remains a matter of debate. We therefore performed a meta-analysis to evaluate the impact of CAD, of its severity and of PCI on mortality after TAVI. METHODS AND RESULTS: All published studies evaluating the impact of CAD on 30-day and one-year mortality after TAVI at multivariable analysis were included. The primary endpoint was the impact of CAD severity (assessed with the SYNTAX score [SS]) on one-year mortality by pooling with logarithmic transformation results of multivariable adjusted effect estimates from each individual study. Secondary endpoints were the impact of the presence of CAD on 30-day and one-year mortality at multivariable analysis and the impact of residual SYNTAX score (rSS) on one-year mortality at multivariable analysis. A total of 8,334 patients with a median age of 81.3 (81-82) years and STS score of 6.2% (IQR 6.0-6.7) from 13 studies were included. Patients with an SS >22 showed higher one-year mortality at multivariable analysis (OR 1.71 [1.24-2.36]). The presence of CAD did not impact on 30-day and one-year mortality at multivariable analysis (respectively, OR 1.57 [0.71-3.46] and OR 1.25 [0.74-2.11]). Regarding PCI, patients with rSS <8 showed lower one-year mortality (OR 0.34 [0.012-0.93]). CONCLUSIONS: The risk of death after TAVI is closely related to the complexity of CAD. Patients with an SS >22 present higher mortality. SS may represent a useful tool to select patients undergoing TAVI who could benefit from coronary revascularisation. In this regard, reaching an rSS <8 reduced one-year mortality. Randomised controlled trials are needed to confirm these results.

Safety of FFR-guided revascularisation deferral in Anatomically prognostiC diseasE (FACE: CARDIOGROUP V STUDY): A prospective multicentre study.

BACKGROUND: FFR-guided coronary intervention is recommended for patients with intermediate stenoses. However, concerns exist with this approach in anatomically prognostic disease. METHODS: In this prospective, multicentre study, we consecutively enrolled patients found to have FFR negative lesions in anatomically significant sites: left main; proximal LAD; last remaining patent vessel; and multiple vessels with concomitant impaired left ventricular systolic function (EF < 40%). As per recommendation, revascularisation was deferred, and patients included into a registry. The primary endpoint was MACE (death, myocardial infarction and unplanned target lesion revascularization). Secondary endpoints were the above individual components. Subgroup analyses were performed for clinical presentation (stable vs. ACS), localization of lesion (ostial vs. non ostial) and renal function. RESULTS: The registry included 292 patients with 297 deferred stenoses. After 1-year, the primary endpoint occurred in 5% of patients, mainly driven by TLR (2.7%). Cardiovascular death occurred in 0.8% and AMI in 0.8%. During a follow-up of 22.2 ±â€¯11 months, MACE occurred in 11.6%. Cardiovascular death occurred in 1.8% and AMI in 2.1%. After multivariate analysis, impaired renal function (OR 1.99; CI 95% 1.74-5.41; p = 0.046) and ostial disease (OR 2.88; CI 95% 1.04-7.38; p = 0.041) were found to be predictors of MACE. Impaired renal function also predicted TLR (OR 2.43; CI 95% 1.17-5.02; p = 0.017). CONCLUSION: FFR-guided revascularisation deferral is safe in the majority of anatomically prognostic disease. However, further evaluation is required in the risk stratification of those patients with ostial disease and renal disease. Registered on ClinicalTrials, NCT02590926.