Three-year clinical outcomes after transcatheter aortic valve implantation in patients with bicuspid aortic disease: Comparison between self-expanding and balloon-expandable valves.

INTRODUCTION: Bicuspid aortic valve (BAV) stenosis is a complex anatomical scenario for transcatheter aortic valve implantation (TAVI). Favorable short-term clinical outcomes have been reported with TAVI in this setting, but long-term data are scarce. METHODS: We retrospectively included, in a single-center registry, patients with BAV stenosis who underwent TAVI before 2020. We compared patients treated with self-expanding valves (SEV) versus balloon-expandable valves (BEV). The primary endpoint was a composite of all-cause mortality, stroke and need for aortic valve (AV) reintervention at 3 years. Secondary endpoints included each component of the primary endpoint, cardiovascular mortality, permanent pacemaker implantation (PPI) rate, mean gradient and ≥moderate paravalvular leak (PVL) rate. RESULTS: A total of 150 consecutive patients (SEV = 83, BEV = 67) were included. No significant differences were reported between SEV and BEV groups for the primary composite endpoint (SEV 35.9% vs. BEV 32%, p = 0.66), neither for clinical secondary endpoints (all-cause mortality SEV 28.1% vs. BEV 28%, p = 0.988; cardiovascular mortality SEV 14.1% vs. BEV 20%, p = 0.399; stroke SEV 12.5% vs. BEV 6%, p = 0.342; need for AV reintervention SEV 0% vs. BEV 0%; PPI SEV 28.1% vs. BEV 24%, p = 0.620). A lower mean gradient persisted up to 3 years in the SEV group (SEV 8.8 ± 3.8 mmHg vs. BEV 10.7 ± 3.2 mmHg, p = 0.063), while no significant difference was found in the rate of ≥ moderate PVL (SEV 3/30 vs. BEV 0/25, p = 0.242). CONCLUSIONS: In this single center registry, we observed favorable 3-year clinical outcomes in nonselected BAV patients treated with different generation devices, without significant differences between patients receiving SEV or BEV.

Comparison of ultrasound- versus fluoroscopy-guidEd femorAl access In tranS-catheter aortic valve replacement In the Era of contempoRary devices: The EASIER registry.

BACKGROUND: Vascular complications (VCs) still represent one of the principal concerns of trans-femoral trans-catheter aortic valve replacement (TF-TAVR). New-generation devices can minimize such complications but the arterial access management is left to the operator's choice. This study aims to describe the rate of VCs in a contemporary cohort of patients undergoing TAVR with new-generation devices and to determine whether an ultrasound-guided (USG) vs. a fluoroscopy-guided (FG) femoral access management has an impact on their prevention. METHODS: This is a prospective, observational, multicenter study. Consecutive patients undergoing TAVR with new-generation devices were analyzed from January 2022 to October 2022 in five tertiary care centers. Femoral accesses were managed according to the operator's preferences. All the patients underwent a pre-discharge peripheral ultrasound control. VCs and bleedings were the main endpoints of interest. RESULTS: A total of 458 consecutive patients were enrolled (274 in the USG group and 184 in the FG group). VCs occurred in 6.5 % of the patients (5.2 % minor and 1.3 % major). There was no difference between the USG and the FG groups in terms of any VCs (7.3 % vs. 5.4 %; p = 0.4), or any VARC-3 bleedings (6.9 % vs 6 %, p = 0.9). At logistic regression analysis, the two guidance strategies did not result as predictors of VCs (odds Ratio 0.8, 95 % Confidence Interval 0.46-1.4; P = 0.4). CONCLUSIONS: In a contemporary cohort of patients undergoing TAVR with new-generation devices, the occurrence of VCs is low and mostly represented by minor VCs. USG and FG modalities did not affect the rate of VCs.

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

Background: Third 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. Methods: A 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. Results: Most 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. Conclusions: The 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 Registration: ClinicalTrials.gov, identifier (NCT03745053).

Radial artery occlusion after transradial procedures: impact on 1-year adverse events.

BACKGROUND: Radial artery occlusion after transradial procedures is a frequent iatrogenic thrombotic process. The impact on prognosis has not been investigated. This study sought to investigate whether radial artery occlusion is related to increased risk of major adverse cardiac and cerebrovascular events, defined as death, myocardial infarction, stroke and coronary revascularization. METHODS: Eight hundred thirty-seven consecutive patients who underwent a transradial coronary procedure had patency of radial artery checked at 24 hours. Radial artery occlusion occurred in 41 over 837 patients (4.8%); 764 (91.2%) were available for planned follow-up at 1 year and were included in the analysis. Event-free survival rate between patients with and without radial artery occlusion was calculated using Kaplan-Meier estimates, and Cox proportional-hazards models were used to identify independent risk factors. RESULTS: At a median 370-day follow-up (IQR: 366-375 days), adverse events occurred in 37 patients (4.8%), 2 in patients with radial artery occlusion and 35 in patients without. One-year survival rate was 94.9% vs. 95% (unadjusted HR=1.026, 95% CI: 0.24 to 4.6, P=0.9). After multivariable modeling, age and coronary artery disease extension was associated with increased risk of adverse events. CONCLUSIONS: Age and coronary artery disease extension were independent predictors of adverse events at follow-up. RAO had no prognostic impact.

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.

Bailout From Sinus Jailing: In-Series TAVR-in-TAVR to Avoid Coronary Flow Obstruction.

Redo transcatheter aortic valve replacement (TAVR) may pose the risk of coronary flow obstruction. We report 2 cases of severe TAVR regurgitation due to different physiopathological mechanisms in which TAVR-in-TAVR could be at high risk for sinus sequestration. Both cases were successfully treated by in-series implantation of a second transcatheter heart valve, thus avoiding sinus sequestration. (Level of Difficulty: Intermediate.).

Coronary Sinus Reducer for the Treatment of Chronic Refractory Angina: Will This Challenge the Treatment of Coronary Chronic Total Occlusions?

PURPOSE OF REVIEW: The prevalence of angina despite optimal medical therapy is high among patients with coronary chronic total occlusions. Despite advancements in techniques and operator's experience, percutaneous revascularization of coronary chronic total occlusions is still associated with a not negligible risk of failures and complications. The Coronary Sinus Reducer, a new device developed to improve angina, has shown promising results in terms of efficacy and safety in patients with refractory symptoms. The aim of this review is to summarize the evidence so far available and to guide clinicians in the selection of patients with chronic total occlusions that could benefit more from Coronary Sinus Reducer implantation. RECENT FINDINGS: A recently published study suggests a clear value of this device in patients with chronic total occlusions. This is likely to be related to the presence of a well-developed collateral circulation. A careful evaluation of risks and benefits of both myocardial revascularization and Coronary Sinus Reducer implantation should be done in all the cases in order to better define the optimal strategy for the patient. The Coronary Sinus Reducer implantation has a rationale in patients with chronic total occlusion as an alternative or additional therapy to myocardial revascularization.

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 and p = .0034, respectively). At logistic regression analysis both cumulative heparin dose and ACT values were independent predictors of OH (OR 1.017, 95% IC 1.011-1.023 p < .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.

Transradial artery access for percutaneous cardiovascular procedures: state of the art and future directions.

The transradial access (TRA) for cardiac catheterization and percutaneous coronary intervention (PCI) has been widely adopted in the last decades since its first description in the late 40s. The transradial approach has been associated with favorable outcomes as compared with transfemoral access (TFA) in several registries and randomized clinical trials, mainly due to the lower incidence of access-site bleedings, vascular complications and improved patient comfort. This review aimed to summarize the body of evidence supporting the use of TRA, to discuss clinical implications, possible technical limitations and future directions, such as the implementation of TRA as the primary access for complex procedures and structural interventions.

"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.

BACKGROUND: 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° and +270°, 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). METHODS: A single-center retrospective observational study was conducted, including patients with new-onset ERAD in the absence of complete BBB admitted for ACS to our Cardiac Intensive Care Unit. Clinical, electrocardiographic, echocardiographic, angiographic features at baseline and cardiovascular events during hospitalization and at mid-term follow-up were collected. RESULTS: The study population consisted of 30 consecutive patients (23 men) from January 2014 to September 2018. The most frequent clinical presentation was ST-segment elevation MI (n = 22, 73.4%) and the most frequent electrocardiographic MI location was anterolateral (n = 11, 36.7%). Left anterior descending (LAD) was the most frequent infarct-related artery (n = 21, 70%); 15 patients (50%) had multivessel coronary artery disease. Cardiac arrest due to ventricular fibrillation (VF) at presentation (n = 5, 16.6%), cardiogenic shock during the hospital stay (n = 10, 33.3%), cardiac arrest due to VF after revascularization (n = 6, 20%) and cardiac death (n = 7, 23.3%) were common. CONCLUSION: New-onset ERAD during MI may be related to extensive myocardial ischemia and/or necrosis causing an "electrical escaping" with an extreme dislocation of the QRS axis. In our limited series we found several acute arrhythmic and hemodynamic complications and high mortality.

The Activated Clotting Time Paradox: Relationship Between Activated Clotting Time and Occlusion of the Radial Artery When Used as Vascular Access for Percutaneous 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, and insufficient anticoagulation are all predictors of RAO. However, excessive anticoagulation can lead to longer time to achieve complete hemostasis and less patent hemostasis rate. This study was designed to assess the relationship among residual anticoagulation at the end of a percutaneous coronary procedure and the risk of RAO. METHODS: Eight hundred thirty-seven patients undergoing transradial catheterization were enrolled. Activated clotting time (ACT) was measured before sheath removal. Patients were divided into 3 groups according to ACT values (ACT <150 s, ACT between 150 and 249 s, ACT >250 s), patent hemostasis with reverse Barbeau test was attempted in all patients, and compression device removed as soon as possible. Within 24 hours, patency of radial artery was checked by Doppler using reverse Barbeau technique. RESULTS: Incidence of RAO was higher for the extreme ACT values. Patent hemostasis were less frequently obtained and time to hemostasis significantly longer for increasing ACT values (P=0.004 for trend and <0.0001 for trend, respectively). At logistic regression analysis, ACT values <150 s were an independent predictor of RAO (odds ratio, 3.53; 95% IC, 1.677-7.43; P=0.001) while adjusted probability for RAO confirmed U-shaped relationship with ACT values. CONCLUSIONS: The level of anticoagulation is strongly related to incidence of RAO and should be measured objectively by ACT. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02762344.

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 (≤0.80). 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.