Morphological stabilization and regression of carotid plaque following therapy with evolocumab in a high-risk patient.

Lipid-lowering therapy is a mainstay for the management of coronary and carotid disease. Actually, progression of atherosclerosis and adverse events are reduced in proportion to the achieved levels of LDL cholesterol (LDL-C). A 67-year-old patient underwent two hospitalizations 6 months apart due to acute coronary syndromes. In the first, PCI with drug-eluting stents (DES) was performed to treat ulcerated stenoses in the left anterior descending artery. In the second, lipid-rich critical disease was found on the right coronary artery and treated with PCI + DES. Later, carotid duplex ultra-sonography (DU) was done due to some episodes of dizziness. It showed an 80% critical stenosis (peak systolic velocity, PSV 239 cm/s) of the left internal carotid artery (LICA) with high-risk features (hypoechogenic and irregular plaque with "fluffy" components). In consideration of the plaque morphology and the unmet LDL-C targets, evolocumab was added to the ongoing statin therapy. In the following months, we observed a parallel trend between carotid plaque regression and LDL-C lowering. Initial plaque remodeling was seen after 5 months: the atheroma appeared fibrotic, with no more fluffy components. At 10 months, in conjunction with the achievement of LDL-C goal (23 mg/dl), a fibrocalcific atheroma was observed; PSV, after an initial rise, fell to 229 cm/s. No further cardiovascular event occurred at 46 months. Last DUS showed a 60% fibrocalcific mid LICA stenosis with PSV of 180 cm/s. Our experience highlights the important role of proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors in promoting remodeling and hopefully regression of atherosclerotic plaques.

CARotid plaqUe StabilizatiOn and regression with evolocumab: Rationale and design of the CARUSO study.

BACKGROUND: While the experience with PCSK9i in patients with coronary artery disease has been wide, and coronary plaque regression has been documented, little is known regarding the role of these drugs on carotid plaque regression. The CARotid plaqUe StabilizatiOn and regression with evolocumab (CARUSO) study is a randomized, single-center, investigator-initiated trial aiming at evaluating carotid plaque morphological stabilization and regression following, respectively, 6 and 12 months of therapy with evolocumab. METHODS: Asymptomatic patients with uni- or bilateral de novo carotid artery stenosis ≥50% and LDL-C values ≥100 mg/dl despite maximum tolerated lipid lowering therapy (LLT) will be randomized to evolocumab 140 mg s.c. every 2 weeks on top of ongoing LLT, or no additional treatment. 100 patients (50 in each arm) will be enrolled. Serial carotid duplex ultra-sonography will be performed to monitor the carotid plaque morphology and stenosis over time. RESULTS: The primary end point of the study is, (a) carotid plaque morphological stabilization at 6 months, defined as defined as the disappearance of ulcerations and fluffy components and the achievement of a regular plaque morphology with prevalence of fibrous atheroma and/or (b) carotid plaque regression at 12 months, defined as reduction of the entity of the stenosis and/or peak systolic velocity by at least 5%, as compared with baseline. CONCLUSION: The CARUSO trial will test the superiority of evolocumab on top of ongoing LLT versus ongoing LLT alone regarding carotid plaque morphological stabilization and regression. The data that support the findings of this study are available on request from the corresponding author. The data are not publicly available due to privacy or ethical restrictions.

One, two, three breakdance and twist.

Wire breakage during percutaneous coronary intervention is a rare event. It occurs especially when treating complex lesions, and it should be prevented with careful planning of each procedural step. We reported a case in which wire breakage occurred when treating the left anterior descending (LAD)/first diagonal bifurcation with the T-stenting technique. After careful evaluation of all the available retrieval techniques and failure of the balloon-catheter trapping, the twin-twisting wires technique (TTWT) was applied. This technique allows the retrieval of a foreign body thanks to its entrapment in the spiral made by two twisting wires. At the first attempt, the broken wire was only withdrawn and not retrieved, while the two twisting wires went broken. The second attempt was performed using stronger wires as twisting wires. The two recently broken fragments were successfully retrieved together with a long proximal remnant of the initially broken wire, which distal tip was further withdrawn. The broken wire was successfully retrieved with the third attempt, together with the previously implanted LAD stent that was accidentally entrapped in the twist. This is the first report of TTWT implementation for the retrieval of a broken wire from a two-stent bifurcation, both proximal and distal wire remnants and a total of three broken wires. The improvements we made to the technique, tips and tricks, caveats, and suggestions for successful wire retrieval and avoidance of the complications that we experienced are described in detail.

True caring is protecting who is at your side.

The modified jailed balloon technique (MJBT) is a safe and effective tool for preserving immediate and long-term side branch (SB) patency when treating true bifurcation lesions. This technique could be routinely implemented, or selectively chosen when the risk of SB occlusion is high and a two-stent technique is not desirable. A randomized study comparing provisional stenting with the MJBT versus systematic two-stent strategy for the treatment of true bifurcation lesions is warranted.

The first love, you never forget. The last heart valve, you might remember better than the first.

Valve-in-valve (VIV) transcatheter aortic valve replacement (TAVR) does not increase cerebrovascular risk compared with TAVR in native aortic valves; the only predictors of new brain lesions were age and postdilatation. Wise choice of the biological valve at the time of surgical aortic replacement, routine use of cerebral protection devices, and new therapeutic paths may be important. Larger studies are needed, hopefully with systematic postdilatation or bioprosthetic valve fracture in cases of residual high transvalvular gradients after VIV TAVR.

Choose to fly higher rather than pacing around.

Pre-existing right bundle branch block and the depth of the prosthesis in the left ventricle are predictors of permanent pacemaker implantation (PPI) following transcatheter aortic valve replacement. The recapturable capability of the Evolut R system allows higher and more precise valve implantation and this was associated with halved incidence of PPI as compared with the CoreValve. Larger studies are needed to assess the feasibility of systematic very high implantation (depth in the left ventricle outflow tract ≤3 mm) of the Evolut R and the associated rate of PPI.

Transradial versus transfemoral ancillary approach in complex structural, coronary, and peripheral interventions. Results from the multicenter ancillary registry: A study of the Italian Radial Club.

OBJECTIVES: to understand the role of a transradial (TR) secondary approach during complex percutaneous interventions. BACKGROUND: The value of the TR route for ancillary vascular approach has not been adequately validated in this setting, and there is scant data on its role in reducing bleeding complications. METHODS: In the present study we retrospectively included patients undergoing the following interventions requiring two vascular approaches at nine high-volume centers in Italy: structural cardiac interventions, complex PCI, endovascular aortic repair (EVAR) and complex lower limb angioplasty. We compared procedural outcomes according to the type of ancillary vascular approach selected, namely TR or transfemoral/transbrachial (TF/TB). Primary endpoints of the study were procedural success and in-hospital BARC grade 3-5 bleedings. RESULTS: We included 906 patients, 433 receiving TR and 473 TF/TB ancillary approaches. Baseline characteristics did not differ significantly. Patients underwent the following types of intervention: structural 50%, complex coronary PCI 37%, EVAR 11%, peripheral angioplasty 2%. Procedural success was similar (90% in TR and 92% TF/TB, P = NS). In-hospital BARC 3/5 bleedings were more common in TF/TB group as compared to TR group (19.7% vs. 6.7%,P < 0.001). In TF/TB group we also observed a higher postprocedural hemoglobin drop (1.92 vs 1.13 g/dl, P = 0.008) and longer hospital stay as compared to TR group. Similar results were observed in a propensity score-matched population of 450 patients. CONCLUSIONS: In our study TR ancillary approach was associated with a significant reduction in the risk of major bleedings, without jeopardizing the success of complex structural, coronary, and peripheral percutaneous interventions. The value of the transradial route for ancillary vascular approach during percutaneous interventions has not been adequately validated yet. We retrospectively included 906 patients, 433 receiving TR and 473 TF/TB ancillary approach at nine high-volume centers for the following interventions: structural cardiac interventions, complex PCI, EVAR and complex peripheral angioplasty. Procedural success was similar, whereas in-hospital BARC bleedings were more common in the transfemoral/brachial group. Similar results were observed in a propensity score-matched population. In our study TR ancillary approach was associated with a significant reduction in the risk of major bleedings, without jeopardizing the success of complex interventions. © 2017 Wiley Periodicals, Inc.

Interventional Versus Conservative Strategy in Patients With Spontaneous Coronary Artery Dissections: Insights From DISCO Registry.

BACKGROUND: The optimal management of patients with spontaneous coronary artery dissection remains debated. METHODS: Patients enrolled in the DISCO (Dissezioni Spontanee Coronariche) Registry up to December 2020 were included. The primary end point was major adverse cardiovascular events, a composite of all-cause death, nonfatal myocardial infarction, and repeat percutaneous coronary intervention (PCI). Independent predictors of PCI and medical management were investigated. RESULTS: Among 369 patients, 129 (35%) underwent PCI, whereas 240 (65%) were medically managed. ST-segment-elevation myocardial infarction (68% versus 35%, P<0.001), resuscitated cardiac arrest (9% versus 3%, P<0.001), proximal coronary segment involvement (32% versus 7%, P<0.001), and Thrombolysis in Myocardial Infarction flow 0 to 1 (54% versus 20%, P<0.001) were more frequent in the PCI arm. In-hospital event rates were similar. Between patients treated with PCI and medical therapy, there were no differences in terms of major adverse cardiovascular events at 2 years (13.9% versus 11.7%, P=0.467), all-cause death (0.7% versus 0.4%, P=0.652), myocardial infarction (9.3% versus 8.3%, P=0.921) and repeat PCI (12.4% versus 8.7%, P=0.229). ST-segment-elevation myocardial infarction at presentation (odds ratio [OR], 3.30 [95% CI, 1.56-7.12]; P=0.002), proximal coronary segment involvement (OR, 5.43 [95% CI, 1.98-16.45]; P=0.002), Thrombolysis in Myocardial Infarction flow grade 0 to 1 and 2 (respectively, OR, 3.22 [95% CI, 1.08-9.96]; P=0.038; and OR, 3.98 [95% CI, 1.38-11.80]; P=0.009) and luminal narrowing (OR per 5% increase, 1.13 [95% CI, 1.01-1.28]; P=0.037) were predictors of PCI, whereas the 2B-angiographic subtype predicted medical management (OR, 0.25 [95% CI, 0.07-0.83]; P=0.026). CONCLUSIONS: Clinical presentation and procedural variables drive the choice of the initial therapeutic approach in spontaneous coronary artery dissection. If PCI is needed, it seems to be associated with a similar risk of short-to-mid-term adverse events compared to medical treatment. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT04415762.

Vascular Access in Patients With Peripheral Arterial Disease Undergoing TAVR: The Hostile Registry.

BACKGROUND: The optimal access route in patients with severe peripheral artery disease (PAD) undergoing transcatheter aortic valve replacement (TAVR) remains undetermined. OBJECTIVES: This study sought to compare clinical outcomes with transfemoral access (TFA), transthoracic access (TTA), and nonthoracic transalternative access (TAA) in TAVR patients with severe PAD. METHODS: Patients with PAD and hostile femoral access (TFA impossible, or possible only after percutaneous treatment) undergoing TAVR at 28 international centers were included in this registry. The primary endpoint was the propensity-adjusted risk of 30-day major adverse events (MAE) defined as the composite of all-cause mortality, stroke/transient ischemic attack (TIA), or main access site-related Valve Academic Research Consortium 3 major vascular complications. Outcomes were also stratified according to the severity of PAD using a novel risk score (Hostile score). RESULTS: Among the 1,707 patients included in the registry, 518 (30.3%) underwent TAVR with TFA after percutaneous treatment, 642 (37.6%) with TTA, and 547 (32.0%) with TAA (mostly transaxillary). Compared with TTA, both TFA (adjusted HR: 0.58; 95% CI: 0.45-0.75) and TAA (adjusted HR: 0.60; 95% CI: 0.47-0.78) were associated with lower 30-day rates of MAE, driven by fewer access site-related complications. Composite risks at 1 year were also lower with TFA and TAA compared with TTA. TFA compared with TAA was associated with lower 1-year risk of stroke/TIA (adjusted HR: 0.49; 95% CI: 0.24-0.98), a finding confined to patients with low Hostile scores (Pinteraction = 0.049). CONCLUSIONS: Among patients with PAD undergoing TAVR, both TFA and TAA were associated with lower 30-day and 1-year rates of MAE compared with TTA, but 1-year stroke/TIA rates were higher with TAA compared with TFA.

"No-Reflow" Phenomenon: A Contemporary Review.

Primary percutaneous angioplasty (pPCI), represents the reperfusion strategy of choice for patients with STEMI according to current international guidelines of the European Society of Cardiology. Coronary no-reflow is characterized by angiographic evidence of slow or no anterograde epicardial flow, resulting in inadequate myocardial perfusion in the absence of evidence of mechanical vessel obstruction. No reflow (NR) is related to a functional and structural alteration of the coronary microcirculation and we can list four main pathophysiological mechanisms: distal atherothrombotic embolization, ischemic damage, reperfusion injury, and individual susceptibility to microvascular damage. This review will provide a contemporary overview of the pathogenesis, diagnosis, and treatment of NR.

[The importance of intensive lipid-lowering therapy after acute coronary syndrome: changing the paradigm to improve the achievement of targets]. / L'importanza di una terapia ipolipemizzante intensiva dopo sindrome coronarica acuta: cambiare il paradigma per migliorare il raggiungimento dei target.

BACKGROUND: Despite the availability of effective lipid-lowering drugs, only few high-risk patients attain their LDL cholesterol (LDL-C) guideline-recommended risk-based goal because of underprescription of combination therapy. We present an 18-month experience with variation of prescription protocols after publication of the 2019 ESC/EAS guidelines for the management of dyslipidemias. METHODS: Overall, 621 consecutive patients hospitalized for acute coronary syndrome at Mauriziano Hospital in Turin, Italy, between January 2020 and June 2021 were enrolled. Lipid-lowering therapy recommended at discharge was registered to evaluate how many patients received statin monotherapy, statin plus ezetimibe combination or triple therapy with high-intensity statin plus ezetimibe and proprotein convertase subtilisin/kexin type 9 inhibitor (PCSK9i). At 6-month follow-up, the reduction in LDL-C, adverse events, compliance and cardiovascular recurrences was analyzed. RESULTS: Of 621 patients enrolled, 7 died during hospitalization. During the entire study period, 33% of patients received statin monotherapy, 50% were discharged on statin-ezetimibe combination, and PCSK9i (evolocumab) was prescribed to 17% of patients. Between April 2020 and June 2021, when new recommendations were introduced into clinical practice, 20% of patients received evolocumab, 56% combination therapy and only 24% were discharged on statin monotherapy. At the beginning of observation, evolocumab was prescribed to 3% of patients hospitalized for acute coronary syndrome, while at the end of the study period 27% of patients were discharged on PCSK9i, with an increase of the prescription rate by 759%; in the same period, prescription of statin monotherapy decreased by 75%. At 6-month follow-up, LDL-C reduction was 77% in patients treated with PCSK9i vs 48% in patients taking statin-ezetimibe combination therapy (p<0.001). All patients on evolocumab reached the guideline-directed goals and a low rate of adverse events was reported, mainly represented by local injection site reactions. Six patients experienced acute coronary syndrome recurrence; only one of them was treated with evolocumab. CONCLUSION: Prescription of intensive lipid-lowering therapy after acute coronary syndrome, eventually with introduction of PCSK9i during hospitalization or at discharge, leads to attainment of guideline-recommended goals for all patients, with a low incidence of adverse events and optimal compliance.

Early angio-guided complete revascularization versus culprit vessel PCI followed by ischemia-guided staged PCI in STEMI patients with multivessel disease.

BACKGROUND: Optimal management of multivessel disease (MVD) in ST-segment elevation myocardial infarction (STEMI) patients treated by primary percutaneous coronary intervention (PCI) is still unclear. OBJECTIVES: To compare short- and long-term clinical outcomes of early-staged, angio-guided approach and delayed, ischemia-guided treatment of non-infarct-related arteries (IRAs). METHODS: Consecutive patients with STEMI and MVD treated with primary PCI in 6 tertiary care centers were retrospectively selected and analyzed. Major adverse cardiac events (MACE) were defined as the composite end-point of death, MI, and repeat revascularization. All the events were adjudicated according to the Academic Research Consortium (ARC) definitions. RESULTS: In the time period 2004-2008, 800 primary PCIs in STEMI patients with MVD were performed. Four hundred and seventeen were addressed to early-staged, angio-guided PCI of non-IRAs (CR group) and 383 to an incomplete revascularization (IncR group). During the hospital stay, no difference in terms of death and repeat revascularization was found between groups but the incidence of periprocedural MI/reinfarction and MACE was significantly higher in the CR group (13.9% vs. 3.1%, P = 0.01 and 14.1% vs. 9.1%, P = 0.017, respectively). At a mean follow-up of 642 ± 545 days, no difference in terms of death and MI was found between the CR and IncR group. The MACE-free survival was significantly higher in the IncR group (73.8% vs. 57%, log rank 0.05), mainly driven by the lower incidence of re-PCI. CONCLUSIONS: Early complete revascularization based only on angiographic findings in patients with STEMI and MVD is associated with an excess of periprocedural/re-MI and with a significantly higher incidence of MACE at follow-up.

Coronary Protection to Prevent Coronary Obstruction During TAVR: A Multicenter International Registry.

OBJECTIVES: The aim of this study was to investigate the safety and efficacy of coronary protection by preventive coronary wiring and stenting across the coronary ostia in patients at high risk for coronary obstruction after transcatheter aortic valve replacement (TAVR). BACKGROUND: Coronary obstruction following TAVR is a life-threatening complication with high procedural and short-term mortality. METHODS: Data were collected retrospectively from a multicenter international registry between April 2011 and February 2019. RESULTS: Among 236 patients undergoing coronary protection with preventive coronary wiring, 143 had eventually stents implanted across the coronary ostia after valve deployment. At 3-year follow-up, rates of cardiac death were 7.8% in patients receiving stents and 15.7% in those not receiving stents (adjusted hazard ratio: 0.42; 95% confidence interval: 0.14 to 1.28; p = 0.13). There were 2 definite stent thromboses (0.9%) in patients receiving stents, both occurring after TAVR in "valve-in-valve" procedures. In patients not receiving stents, there were 4 delayed coronary occlusions (DCOs) (4.3%), occurring from 5 min to 6 h after wire removal. Three cases occurred in valve-in-valve procedures and 1 in a native aortic valve procedure. Distance between the virtual transcatheter valve and the protected coronary ostia <4 mm was present in 75.0% of patients with DCO compared with 30.4% of patients without DCO (p = 0.19). CONCLUSIONS: In patients undergoing TAVR at high risk for coronary obstruction, preventive stent implantation across the coronary ostia is associated with good mid-term survival rates and low rates of stent thrombosis. Patients undergoing coronary protection with wire only have a considerable risk for DCO.

Protamine usage following implantation of drug-eluting stents: a word of caution.

The treatment of hemorrhagic complications of percutaneous interventions with protamine is an accepted practice. Concerns exist about the increased thrombo-genicity of drug-eluting stents. We report two cases of acute stent thrombosis following drug-eluting stent implantation related to protamine administration.

History of vasomotor symptoms, extent of coronary artery disease, and clinical outcomes after acute coronary syndrome in postmenopausal women.

OBJECTIVE: Vasomotor symptoms (VMS) during menopausal transition have been linked to a higher burden of cardiovascular risk factors, subclinical vascular disease, and subsequent vascular events. We aim to investigate the association of VMS with the extent of coronary disease and their prognostic role after an acute coronary syndrome. METHODS: The Ladies Acute Coronary Syndrome study enrolled consecutive women with an acute coronary syndrome undergoing coronary angiography. A menopause questionnaire was administered during admission. Angiographic data underwent corelab analysis. Six out of 10 enrolling centers participated in 1-year follow-up. Outcome data included the composite endpoint of all-cause mortality, recurrent myocardial infarction, stroke, and rehospitalization for cardiovascular causes within 1 year. RESULTS: Of the 415 women with available angiographic corelab analysis, 373 (90%) had complete 1-year follow-up. Among them, 202 women had had VMS during menopausal transition. These women had the same mean age at menopause as those without VMS (50 years in both groups), but were younger at presentation (median age 71 vs 76 years; P < 0.001), despite a more favorable cardiovascular risk profile (chronic kidney dysfunction 4.5% vs 15.9%; P = 0.001; prior cerebrovascular disease 4.5 vs 12.2%; P = 0.018). Extent of coronary disease at angiography was similar between groups (mean Gensini score 49 vs 51; P = 0.6; mean SYNTAX score 14 vs 16; P = 0.3). Overall cardiovascular events at 1 year did not differ between groups (19% vs 22%; P = 0.5). CONCLUSIONS: In postmenopausal women with an acute coronary syndrome, a history of VMS was associated with younger age at presentation, despite a lower vascular disease burden and similar angiographically defined coronary disease as compared with women without VMS. No difference could be found in terms of overall clinical outcomes. These results should be interpreted cautiously as all analyses were unadjusted and did not account for risk factor differences between women with and without a history of VMS.