A randomized control trial to assess optical coherence tomography parameters of the Xlimus drug-eluting stent: the XLIMIT trial

BackgroundThird generation drug-eluting stents (DES) potentially offer better technical performance and reduced neointimal proliferation than previous generation DES. The XLIMIT non-inferiority trial evaluated the performance of the Xlimus (a novel sirolimus-eluting coronary stent system) in terms of endothelialization and tissue healing compared to the bioresorbable polymer Synergy DES.MethodsA total of 177 patients undergoing percutaneous coronary intervention (PCI) were randomized in a 2:1 ratio (2 Xlimus: 1 Synergy). The primary endpoints, defined as the in-stent neointimal volume weighted by the sum of the lengths of the implanted stent (ISNV) and the in-stent neointimal percent volume obstruction (%VO) were evaluated at 6–9 months by means of optical coherence tomography (OCT). Additional OCT parameters as well as clinical endpoints were also collected.ResultsMost of the patients were males (77.4%), and the mean age was 64 years. One third of the population had stable angina/silent ischemia. A total of 300 stents (237 lesions) were analyzed: 198 (152 lesions) were in the Xlimus group, and 102 (85 lesions) in the Synergy group. The ISNV in the Xlimus group was 30.7 ± 24.5 mm3 while in the Synergy group it was 26.5 ± 26.7 mm3: the difference between the two means was 0.08 (−0, 04–0, 45), p = 0.018, thus meeting the non-inferiority hypothesis. The %VO was 16.3% ± 10.4% and 13.3% ± 10.8% in the Xlimus and Synergy groups, respectively: the difference between the two means was 3.0 (−0, 06–4, 2), (p = 0.01), thus meeting the non-inferiority hypothesis. No difference was found with respect to the secondary OCT endpoints as well as for clinical endpoints.ConclusionsThe study results confirm that the biological interaction of the Xlimus and Synergy DES with the coronary artery is comparable, and that translates in very reassuring OCT parameters at follow-up: as such, the Xlimus is non-inferior to the Synergy.Clinical Trial RegistrationClinicalTrials.gov, identifier (NCT03745053)

"Cardiac allograft vasculopathy: Pathogenesis, diagnosis and therapy"

Cardiac allograft vasculopathy (CAV) is a unique form of accelerated atherosclerosis that represents the main late cause of morbidity and mortality, affecting almost half patients at ten years after heart transplantation (HTx). Unless the pathogenesis of CAV is still not completely understood, it seems to be the result of a complex interplay between immunological and non-immunological factors that induce endothelial injury. Histologically epicardial and intramural vessels present a concentric circumferential intimal thickening caused by smooth muscle cell proliferation, inflammatory cells, and lipid deposition. Coronary angiography is still considered the gold-standard diagnostic tool for CAV detection but has reduced sensibility due to its inability to visualize beyond the arterial lumen. Intravascular ultrasound (IVUS) allows detecting early intimal thickening with high sensitivity. Plaque composition and vulnerability, detectable with virtual histology (VH/IVUS), and optical coherence tomography (OCT) seem to relate to adverse clinical events. Treatment approaches continue to evolve, but prevention and early detection remain the focus. Mammalian target of rapamycin inhibitors can significantly delay the development and the progression of CAV, but their optimal use remains to be established. New encouraging results come from monoclonal autoantibodies. At present percutaneous revascularization procedures seem to have only a palliative meaning, with no clear evidence of survival advantage over medical therapy and should be considered in case of a focal disease. Drug-eluting stents have proven to reduce in-stent restenosis, with a potential role of imaging-guided intervention in this setting. Heart re-transplantation is the only resolutive therapy and is considered in the case of CAV associated with graft dysfunction

New-onset extreme right axis deviation in acute myocardial infarction: clinical characteristics and outcomes

QRS axis deviation can occur during myocardial infarction (MI); to date, little is known about the significance of extreme right axis deviation (ERAD) in the frontal plane, i.e. a shift in QRS axis between +180\ub0 and +270\ub0, during MI. We sought to investigate the clinical characteristics and outcomes of patients with new-onset ERAD in the absence of complete bundle branch blocks (BBB) in the setting of acute coronary syndromes (ACS)

Motor and non-motor outcomes after a rehabilitation program for patients with Functional Motor Disorders: a prospective, observational cohort study

BACKGROUND: Rehabilitation has proven effective in improving motor symptoms (i.e., weakness, tremor, gait and balance disorders) in patients with Functional Motor Disorders (FMDs). Its effects on non-motor symptoms (NMSs) such as fatigue, pain, depression, anxiety and alexithymia, have not been explored yet.OBJECTIVE: To explore the effects of a validated inpatient 5-day rehabilitation program, followed by a home-based self-management plan on functional motor symptoms, NMSs, self-rated perception of change, and quality of life (QoL).METHODS: 33 FMD patients were enrolled. Measures for motor symptoms and NMSs were primary outcomes. Secondary outcomes included measures of self-perception of change and QoL. Patients were evaluated pre-treatment (T0), post-treatment (T1), and 3-month follow-up (T2).RESULTS: There was an overall significant decrease in functional motor symptoms, general, physical, and reduced-activity fatigue (for all, p\u200a< \u200a0.001). Post hoc comparison showed significant improvements at T1, whereas effects remained significant at T2 for motor symptoms and physical fatigue. Gait and balance, alexithymia, and physical functioning (QoL) significantly improved at T2. More than 50% of patients reported marked improvement at T1 and T2.CONCLUSIONS: Our study suggests the benefits of rehabilitation and self-management plan on functional motor symptoms and physical fatigue in the medium-term. More actions are needed for the management of pain and other distressing NMSs in FMDs

Midventricular Takotsubo cardiomyopathy complicated by a ventricular septal rupture: a surgical management

Takotsubo cardiomyopathy, also known as 'Broken Heart Syndrome', is a form of acute heart failure, featured by a reversible impairment in cardiac contractility. About 20% of patients during hospitalization experience complications including cardiogenic shock, stroke, left ventricular thrombosis or death. Ventricular rupture has already been reported in Takotsubo cardiomyopathy in patients with typical apical ballooning pattern. We report one of the first cases of a midventricular ballooning Takotsubo cardiomyopathy in a 57-year-old woman complicated by ventricular septal rupture, successfully repaired with a surgical interrupted suture technique. \ua9 2019 Wolters Kluwer Health, Inc. All rights reserved

Predictors of patent and occlusive hemostasis after transradial coronary procedures

Objectives To assess the independent predictors of patent and occlusive hemostasis (PH and OH, respectively) during radial hemostasis after coronary procedures. Background Radial artery occlusion (RAO) is a thrombotic complication of transradial catheterization that can lead to permanent occlusion of the radial artery. Sheath-vessel diameter ratio, postprocedure compression time, occlusive hemostasis, inadequate, and excessive anticoagulation are all predictors of RAO. Methods As a part of a previously published study investigating the relationship between residual anticoagulation and risk of RAO, 837 patients undergoing transradial diagnostic coronary angiography or percutaneous coronary interventions were enrolled. Cumulative heparin dose used during the procedure and ACT measured before sheath removal were recorded. PH with reverse Barbeau test was attempted in all patients (NCT02762344). Results PH was less frequently obtained for increasing cumulative heparin dose and ACT values (p < .0001 andp= .0034, respectively). At logistic regression analysis both cumulative heparin dose and ACT values were independent predictors of OH (OR 1.017, 95% IC 1.011-1.023p < .0001 and OR 1.004, 95% IC 1.001-1.006,p= .0004) while adjusted probability for RAO showed exponential relationship with both parameters. Conclusions The level of anticoagulation is strongly related to the incidence of RAO, and should be taken into account when choosing hemostasis protocol

Predictors of patent and occlusive hemostasis after transradial coronary procedures

Objectives To assess the independent predictors of patent and occlusive hemostasis (PH and OH, respectively) during radial hemostasis after coronary procedures. Background Radial artery occlusion (RAO) is a thrombotic complication of transradial catheterization that can lead to permanent occlusion of the radial artery. Sheath-vessel diameter ratio, postprocedure compression time, occlusive hemostasis, inadequate, and excessive anticoagulation are all predictors of RAO. Methods As a part of a previously published study investigating the relationship between residual anticoagulation and risk of RAO, 837 patients undergoing transradial diagnostic coronary angiography or percutaneous coronary interventions were enrolled. Cumulative heparin dose used during the procedure and ACT measured before sheath removal were recorded. PH with reverse Barbeau test was attempted in all patients (NCT02762344). Results PH was less frequently obtained for increasing cumulative heparin dose and ACT values (p < .0001 andp= .0034, respectively). At logistic regression analysis both cumulative heparin dose and ACT values were independent predictors of OH (OR 1.017, 95% IC 1.011-1.023p < .0001 and OR 1.004, 95% IC 1.001-1.006,p= .0004) while adjusted probability for RAO showed exponential relationship with both parameters. Conclusions The level of anticoagulation is strongly related to the incidence of RAO, and should be taken into account when choosing hemostasis protocol

Observations from a real-time, iFR-FFR "hybrid approach" in patients with severe aortic stenosis and coronary artery disease undergoing TAVI

BACKGROUND: The complexity of coronary physiology in presence of severe aortic stenosis (AS) raises concerns about the reliability of pressure-derived indexes in this clinical setting. Furthermore, neither fractional flow reserve (FFR) nor instantaneous wave-free period (iFR) has been validated in AS. Combining iFR and FFR in a tailored decision-making strategy may help to increase simplicity, accuracy and safety of physiology-guided revascularization in AS. METHODS: In this prospective observational study iFR and FFR were measured before and after TAVI during the same procedure in patients with severe AS and concomitant coronary artery disease (CAD). All decisions about revascularization were based on post-TAVI FFR assessment. The best iFR "defer" and "treatment" values were identified according to their baseline negative (NPV) and positive predictive values (PPV) respectively. A post-hoc analysis was then performed to compare the hybrid iFR-FFR approach with the FFR-only strategy. RESULTS: Sixty-two patients underwent pre- and post-TAVI pressure-wire assessment and were included in the analysis. A "defer iFR value" >0.93 yielded a NPV of 98.4% (91.7%-99.9%) to exclude FFR non-significant stenosis (>0.80), and a "treatment iFR value" <0.83 had a PPV of 91.3% (72%-98.9%) to identify FFR-significant stenosis ( 640.80). A hybrid decision-making strategy based on iFR and FFR spared 63% of patients from adenosine, while maintaining 97% overall agreement with FFR lesions classification. CONCLUSION: A hybrid iFR-FFR diagnostic strategy is feasible and safe in patients with severe AS undergoing TAVI and allows to spare the majority of patients from adenosine, while maintaining a high agreement with FFR classification of coronary lesions

Radial artery occlusion after conventional and distal radial access: Impact of preserved flow and time-to-hemostasis in a propensity-score matching analysis of 1163 patients

Objectives: To compare incidence of forearm radial artery occlusion (RAO) and hemostasis characteristics between distal and conventional transradial approach (DRA and TRA, respectively). Background: DRA has the potential advantage of reducing RAO. DRA effectively reduces time-to-hemostasis, however its role on preserving flow in the radial artery (PF) during hemostasis and consequent impact on RAO remains speculative. Methods: Eight hundred thirty-seven patients with TRA were previously enrolled in a prospective registry investigating the relationship of residual anticoagulation and RAO. Three hundred twenty-six additional patients with DRA were added to the cohort and matched to the original cohort by propensity score. The composite end-point of RAO at forearm and distal site of puncture (dRAO) was evaluated as secondary end-point. Results: RAO occurred in 4.8% (41 of 837) of patients undergoing TRA and in 0% (0 of 326) of those undergoing DRA (p < 0.0001). DRA was associated with higher percentage of PF (97.2% vs. 78.5% in TRA group, p < 0.0001) and reduced time-to-hemostasis (147 ± 99 min vs. 285 ± 138 min, p < 0.0001). After matching, hemostasis characteristics were still significant different (PF 95.7% vs. 90.1%, p = 0.023, and 190 ± 92 vs. 323 ± 162 min, p < 0.0001) with reduction in the incidence of RAO (0 of 213, 0% vs. 7 of 213, 3.3%, p = 0.0015). dRAO occurred in one case (0.3% and 0.5% after matching, p < 0.0001 and p = 0.032 compared to TRA). Conclusions: DRA was associated with lower rates of RAO compared to TRA. This effect is potentially explained by reduced time-to-hemostasis and maintained flow at the wrist during hemostasis