Long-Term Outcomes of Transcatheter vs Surgical Aortic Valve Replacement: Meta-analysis of Randomized Trials.

Background: We aimed to perform a meta-analysis of randomized trials comparing long-term outcomes of patients undergoing transcatheter aortic valve replacement (TAVR) vs surgical aortic valve replacement (SAVR) for severe aortic stenosis. The short-term efficacy and safety of TAVR are proven, but long-term outcomes are unclear. Methods: We included randomized controlled trials comparing TAVR vs SAVR at the longest available follow-up. The primary end point was death or disabling stroke. Secondary end points were all-cause mortality, cardiac mortality, stroke, pacemaker implantation, valve thrombosis, valve gradients, and moderate-to-severe paravalvular leaks. The study is registered with PROSPERO (CRD42023481856). Results: Seven trials (N = 7785 patients) were included. Weighted mean trial follow-up was 5.76 ± 0.073 years. Overall, no significant difference in death or disabling stroke was observed with TAVR vs SAVR (HR, 1.02; 95% CI, 0.93-1.11; P = .70). Mortality risks were similar. TAVR resulted in higher pacemaker implantation and moderate-to-severe paravalvular leaks compared to SAVR. Results were consistent across different surgical risk profiles. As compared to SAVR, self-expanding TAVR had lower death or stroke risk (P interaction = .06), valve thrombosis (P interaction = .06), and valve gradients (P interaction < .01) but higher pacemaker implantation rates than balloon-expandable TAVR (P interaction < .01). Conclusions: In severe aortic stenosis, the long-term mortality or disabling stroke risk of TAVR is similar to SAVR, but with higher risk of pacemaker implantation, especially with self-expanding valves. As compared with SAVR, the relative reduction in death or stroke risk and valve thrombosis was greater with self-expanding than with balloon-expandable valves.

Long-term gender disparities in new-onset heart failure after acute coronary syndrome.

AIMS: A paucity of studies addressed sex-related differences in clinical outcomes in the long term following acute coronary syndrome (ACS) treated with percutaneous coronary intervention (PCI). In these patients, it remains uncertain whether heart failure (HF) might exert a differential impact on the prognosis in the long term. METHODS: We queried a large-scale database of ACS patients undergoing PCI. The primary endpoint was new-onset HF. Secondary endpoints included mortality, myocardial infarction, re-PCI and ischaemic stroke. Propensity score matching was generated to balance group characteristics. A total of 3334 patients after propensity score matching were analysed. Follow-up was assessed at the 5 year term. RESULTS: At 5 year follow-up, HF risk increased significantly in males versus females {17.9% vs. 14.8%, hazard ratio [HR] [95% confidence interval (CI)] = 1.22 [1.03-1.44], P = 0.02}. At 5 year follow-up, mortality was significantly higher in the male cohort as compared with the female cohort [HR (95% CI) = 1.23 (1.02-1.47), P = 0.02]. On landmark analysis, differences in mortality emerged after the first year and were maintained thereafter. Ischaemic outcomes were comparable between cohorts. CONCLUSIONS: Following ACS, males experienced a greater long-term risk of developing new-onset HF as compared with females. This difference remained consistent across all prespecified subgroups. Mortality was significantly higher in males. No differences were observed in ischaemic outcomes. New-onset HF emerges as a primary contributor to long-term gender disparities after ACS and a strong predictor of mortality in men with HF.

Management of patients treated with oral anticoagulant therapy undergoing percutaneous coronary intervention with stent implantation: the PERSEO Registry.

In patients on oral anticoagulant (OAC) therapy undergoing percutaneous coronary intervention with stent (PCI), international guidelines endorse the use of direct oral anticoagulants (DOAC) rather than vitamin K antagonists (VKA) and dual antithrombotic therapy (DAT) rather than triple antithrombotic therapy (TAT). Aim of this study was to evaluate contemporary real-world data on antithrombotic regimens and outcome in patients on OAC undergoing PCI with stent. Consecutive patients on OAC undergoing PCI were enrolled in the multicentre, prospective, observational PERSEO registry (NCT03392948). Primary end-point was net adverse clinical events (NACE) with VKA vs DOAC, whereas a secondary pre-specified end-point was NACE with DAT vs TAT both at 1-year follow-up. From February 2018 to February 2022, 1234 consecutive patients were included. The main indication for OAC was atrial fibrillation (86%) and the mean CHA2DS2VASc and HAS-BLED scores were 4±2 and 3.6±1, respectively. Of the 1228 patients discharged alive, 222 (18%) were on VKA and 1006 (82%) on DOAC (p<0.01). DAT was employed in 197 patients whereas TAT in 1028. At follow-up, NACE rate was significantly higher with VKA compared to DOAC (23% vs 16%, p=0.013) and confirmed after propensity score adjustment. TAT and DAT did not differ as regards NACE rate (17% vs 19%, p=0.864) even though, compared to TAT, DAT was associated with less major bleedings (2% vs 5%, p= 0.014), confirmed after propensity score adjustment. In conclusion, in patients on OAC undergoing PCI, DOAC, compared to VKA, was associated with a significantly lower occurrence of NACE and DAT reduced bleedings compared to TAT.

Efficacy and Safety of P2Y12 monotherapy vs standard DAPT in patients undergoing percutaneous coronary intervention: meta-analysis of randomized trials.

BACKGROUND: Debates persist regarding the optimal duration of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) in coronary artery disease (CAD). Recent trials have introduced a novel approach involving P2Y12 inhibitor monotherapy with ticagrelor or clopidogrel, after a short DAPT. However, the effectiveness and safety of this strategy remains to be established. We aimed to perform a meta-analysis comparing monotherapy with P2Y12 inhibitors versus standard DAPT in patients undergoing PCI at 12 months. METHODS: Multiple databases were searched. Six RCTs with a total of 24877 patients were included. The primary endpoint was all-cause mortality at 12 months of follow-up. The secondary endpoints were cardiovascular mortality, myocardial infarction, probable or definite stent thrombosis, stroke events, and major bleeding. The study is registered with PROSPERO (CRD42024499529). RESULTS: Monotherapy with P2Y12 inhibitor ticagrelor significantly reduced both allcause mortality (HR 0.71, 95 CI [0.55-0.91], P = 0.007) and cardiovascular mortality (HR 0.66, 95% CI [0.49-0.89], P = 0.006) compared to standard DAPT. In contrast, clopidogrel monotherapy did not demonstrate a similar reduction. The decrease in mortality associated with ticagrelor was primarily due to a lower risk of major bleeding (HR 0.56, 95% CI [0.43-0.72], P < 0.001), while the risk of myocardial infarction (MI) remained unchanged (HR 0.90, 95% CI [0.73-1.11], P = 0.32). The risk of stroke was found to be similar across treatments. CONCLUSIONS: In comparison to standard DAPT, P2Y12 inhibitor monotherapy with ticagrelor may lead to a reduced mortality. The clinical benefits are driven by a reduction of bleeding risk without ischemic risk trade-off.

Clinical application of virtual reality in patients with cardiovascular disease: state of the art.

Virtual reality offers a multisensory experience to patients, allowing them to hear, watch, and interact in a virtual environment. Immersive virtual reality is particularly suitable for the purpose of completely isolating patients from the external environment to transport them away from the suffering related to the disease. On this state of the art, we summarize the available literature on the effectiveness of virtual reality on various physical and psychological outcomes in patients with atherosclerotic cardiovascular disease. Virtual reality has been employed in the cardiovascular field in various settings such as cardiac rehabilitation, interventional cardiology, and cardiac surgery. This technology offers promising opportunities to improve several outcomes related to cardiovascular disease, but further research is needed to entirely capture its benefits and to standardize the intervention.

Intramural aortic stenting of an anomalous right coronary artery arising from the left valsalva sinus: A leap into the dark?

A 69-year-old man with unstable angina underwent coronary angiography showing no lesion in the left coronary artery and critical stenosis in the proximal right coronary artery (RCA) arising from the left sinus of Valsalva.

Percutaneous Left Atrial Appendage Occlusion: What the Practising Physician Should Know.

Non-valvular AF is a common clinical condition associated with an increased risk of thromboembolic complications. As a consequence, oral anticoagulant therapy (OAT) is the cornerstone of non-valvular AF management. Despite the well-established efficacy of OAT, many patients cannot receive this preventive therapy due to bleeding or a high risk of bleeding. The fact that more than 90% of thrombi are formed in the left atrial appendage has led to the development of alternative methods to reduce the embolic risk. Left atrial appendage occlusion (LAAO) is a non-pharmacological option for preventing cardioembolic events in patients with non-valvular AF with a contraindication to OAT. The demand for LAAO procedures is growing exponentially and clinicians should consider this alternative option when managing patients with a contraindication to OAT. This review summarises the current thinking about LAAO.

Platelet inhibition with orodispersible ticagrelor in acute coronary syndromes according to morphine use: the TASTER study final results.

AIM: To date, it is still unknown whether orodispersible tablet (ODT) ticagrelor might represent a suitable way to reach a proper antiaggregation in acute coronary syndrome (ACS) patients receiving morphine. Aim of the present study was to evaluate platelet inhibition with 180 mg ticagrelor loading dose (LD) administered as ODT compared with standard coated tablet ticagrelor formulation in ACS patients undergoing percutaneous coronary intervention (PCI) according to morphine use. METHODS AND RESULTS: One-hundred and 30 patients presenting with STEMI or very high-risk NSTE-ACS were randomly assigned to receive ODT or standard ticagrelor LD. Potential morphine-ticagrelor interaction was assessed by stratified randomization according to morphine use. Platelet reactivity was evaluated by Platelet Reactivity Units (PRU) VerifyNow™ 1, 2, 4, and 6 h after ticagrelor LD. The primary endpoint was residual platelet reactivity 1 h after LD across the two ticagrelor formulation and according to morphine use. Safety endpoints were major bleedings and other in-hospital ticagrelor administration-related adverse events. One hour after LD, PRU median value was higher in morphine-treated patients (N = 32) as compared with patients not receiving morphine (N = 98; PRU = 187 [70-217]) vs. 73 [7-187]; P = 0.012). In patients with morphine, 1-h PRU values were similar between study groups (192 [114-236] vs. 173 [16-215] in ODT and standard tablet ticagrelor, respectively). Similarly, in patients without morphine, 1-h PRU values were not significantly different between study groups (69 [8-152] vs. 110 [6-193] in ODT and standard tablet ticagrelor, respectively). Platelet reactivity appeared similar in the 2 study arms at 2, 4, and 6 h after LD. No significant difference was observed among patients with or without morphine regarding in-hospital adverse events or drug side-effects, even if a reinfarction due to acute stent thrombosis was observed in a patient treated with morphine. CONCLUSIONS: There was no difference between ODT and standard ticagrelor tablets in terms of post-LD residual platelet reactivity, percentage of platelet inhibition or safety regardless to morphine use.

Design of the PERSEO Registry on the management of patients treated with oral anticoagulants and coronary stent.

AIM: Percutaneous coronary intervention with stent implantation (PCI-S) in patients requiring chronic oral anticoagulant therapy (OAC) is associated with an increased risk of bleeding and ischemic complications. Different randomized studies showed a significant advantage of a double antithrombotic therapy and superiority of direct oral anticoagulant (DOAC) compared with warfarin, but real-world data are limited. Aim is to evaluate the antithrombotic management and clinical outcome of patients with an indication for OAC who undergo PCI-S in a 'real-world' setting. METHODS: The multicentre prospective observational PERSEO (PERcutaneouS coronary intErventions in patients treated with Oral anticoagulant therapy) Registry (ClinicalTrials.gov Identifier: NCT03392948) has been designed to enrol patients requiring OAC treated by PCI-S in 25 Italian centres. A target of at least 1080 patients will be followed for 1 year and data on thromboembolic and bleeding events and changes in antithrombotic therapy will be registered. The primary end point is a combined measure of efficacy and safety outcome (NACE), including major bleeding events and major adverse cardiac and cerebral events at 1-year follow-up in patients treated with DOAC (and dual or triple antiplatelet therapy) compared with the corresponding strategies with vitamin K antagonists. A secondary prespecified analysis has been defined to evaluate NACE in dual versus triple antithrombotic therapy after hospital discharge at 1-year follow-up. CONCLUSION: The PERSEO Registry will investigate in a 'real world' setting the safety and efficacy of DOAC versus warfarin and dual versus triple antithrombotic therapy in patients with indication for oral anticoagulant therapy who undergo PCI-S.

Use of cangrelor in patients with acute coronary syndromes undergoing percutaneous coronary intervention: Study design and interim analysis of the ARCANGELO study.

BACKGROUND: The itAlian pRospective Study on CANGrELOr (ARCANGELO) was aimed to assess the safety of using cangrelor during percutaneous coronary intervention (PCI) in patients with acute coronary syndromes (ACS) in the daily practice. HYPOTHESIS: The safety of cangrelor after the transition to oral P2Y12 inhibitors was evaluated as the incidence of bleeding outcomes in the 30 days following PCI according to postauthorization safety study guidelines. METHODS: Adults with ACS who were treated with cangrelor in one of the 28 centers involved in the study. Patients who consented to participate were followed in the 30 days following their PCI. Bleedings (Bleeding Academic Research Consortium [BARC] classification), major adverse cardiac events (MACEs), and adverse events were recorded. The interim results at two-thirds of the enrollment period are presented. RESULTS: A total of 17 bleedings were observed in the 320 patients who completed the study at this stage. All bleedings were classified as BARC Type 1-2, except for one case of Type 3a (vessel puncture site hematoma). Four patients experienced MACEs (2 acute myocardial infarctions, 1 sudden cardiac death, 1 noncardiovascular death due to respiratory distress, and multiorgan failure). None of the bleedings was rated as related to cangrelor. CONCLUSIONS: The interim results of the ARCANGELO study provide a preliminary confirmation that the use of cangrelor on patients with ACS undergoing PCI is not associated with severe bleedings.

Stent Dislodgment and Retrieval During Percutaneous Coronary Intervention.

During PCI, stent entrapment and dislodgment in the coronary arteries is a rare but potentially fatal complication that can lead to emergent cardiac surgery. Percutaneous stent retrieval is an alternative way to solve this challenging complication while avoiding cardiac surgery.

Impact of glucose-6-phosphate dehydrogenase deficiency on the severity of coronary atherosclerosis in patients with acute coronary syndromes.

AIMS: The impact of glucose-6-phosphate dehydrogenase (G6PD) deficiency on coronary atherosclerosis has not been clearly investigated so far. We aimed to assess the effects of G6PD deficiency on the extent and complexity of coronary atherosclerosis in a large unselected cohort of consecutive patients with acute coronary syndromes (ACS). METHODS: We studied 623 consecutive patients presenting with ACS and undergoing coronary angiography and percutaneous coronary intervention (PCI). G6PD activity was quantitatively measured in all individuals using a biochemical assay based on the G6PD/6GPD ratio in erythrocytes. Individuals were defined as deficient when the ratio was less than 0.80. The severity and complexity of coronary atherosclerosis were assessed by SYNTAX score at baseline angiography. RESULTS: Fifty-six patients (9%) showed G6PD deficiency. Severe (i.e. enzymatic activity < 0.10) G6PD deficiency was detected in 33 (5.3%) individuals, mainly of male sex (n = 32). Overall, the cardiovascular risk profile was similar between patients with G6PD deficiency and controls. Patients with G6PD deficiency showed similar severity and complexity of coronary atherosclerosis as compared to control patients; accordingly, the SYNTAX score (15 vs. 14.5, P = 0.90, respectively, in G6PD-deficent patients and controls), and all its components were similar between deficient individuals and controls. The only independent predictor of a SYNTAX score of more than 22 was patients' age (odds ratio 1.035, 95% confidence interval 1.018-1.051; P < 0.001). CONCLUSION: G6PD deficiency does not impact on the extent and complexity of coronary atherosclerosis assessed by coronary angiography in patents presenting with ACS.

Acute Stent Thrombosis: Severe In-Stent Malapposition and Insufficient Platelet Inhibition as Partners in Crime!

Acute stent thrombosis is a rare event. When it occurs, procedure- and patient-related factors need to be assessed. First, our case showed that wiring was only successful with a chronic total occlusion-derived technique, indirectly demonstrating a stent-related problem. In fact, OCT showed a remarkable in-stent malapposition. Second, insufficient platelet inhibition was another important factor that contributed to acute stent thrombosis, since morphine negatively affected ticagrelor absorption and onset of action.

Incidental finding and conservative management of left main coronary atresia in an adult patient: a case report.

BACKGROUND: Left main (LM) coronary atresia (LMCA) is a rare coronary anomaly where the LM is congenitally absent and a variable clinical spectrum can follow. The diagnosis of LMCA is generally made in youth because of the development of symptoms, but very rarely in adulthood. In symptomatic patients, surgical revascularization is recommended, whereas, in asymptomatic patients with LMCA and without inducible myocardial ischaemia, preventive surgical treatment is controversial. CASE SUMMARY: A 58-year-old male patient with aortic ectasia detected during an echocardiogram performed to evaluate a hypertension-related preclinical cardiac damage and, due to this finding, an echocardiographic follow-up was suggested. Three years later, he was admitted to undergo coronary angiography (CA) after the computed tomography finding of a suspected occlusion of the LM with collateral circulation from right coronary artery (RCA) to left anterior descending and circumflex arteries. CA confirmed an LMCA and the RCA provided blood supply to the left coronary artery through collaterals whose calibre was similar to that of the target left-sided vessels. No obstructive coronary artery disease was detected. In order to detect potential myocardial ischaemia, a technetium-tetrofosmin cardiac single-photon emission computed tomography during maximal exercise-stress test was performed and it did not show a perfusion defect. Medical management with scheduled follow-up visits was deemed to be the best therapeutic option. DISCUSSION: LMCA is a rare anomaly where LM is absent and the RCA provides collateral circulation for left coronary artery. In asymptomatic patients, preventive surgical treatment is controversial.

Balloon Angioplasty of the Radial Artery to Solve a Challenging Radial Sheath Insertion.

The inability to advance the dedicated wire of the transradial sheath in a radial artery with a good pulsatile blood flow is a very rare event. In this case, the advancement of a high-performance 0.014 inch coronary wire is the only option to gain the vessel. Then, if the transradial sheath is stuck in the proximal radial artery wall, balloon angioplasty of the radial artery may allow successful reinsertion of the transradial sheath. This technique allows the preservation of radial artery access, avoiding a shift to an alternative arterial approach.

Antiplatelet Therapy with Cangrelor in Patients Undergoing Surgery after Coronary Stent Implantation: A Real-World Bridging Protocol Experience.

Objective The aim of the study is to describe the real-world use of the P2Y 12 inhibitor cangrelor as a bridging strategy in patients at high thrombotic risk after percutaneous coronary intervention (PCI) and referred to surgery requiring perioperative withdrawal of dual antiplatelet therapy (DAPT). Materials and Methods We collected data from nine Italian centers on patients with previous PCI who were still on DAPT and undergoing nondeferrable surgery requiring DAPT discontinuation. A perioperative standardized bridging protocol with cangrelor was used. Results Between December 2017 and April 2019, 24 patients (mean age 72 years; male 79%) were enrolled. All patients were at high thrombotic risk after PCI and required nondeferrable intermediate to high bleeding risk surgery requiring DAPT discontinuation (4.6 ± 1.7 days). Cangrelor infusion was started at a bridging dose (0.75 µg/kg/min) 3 days before planned surgery and was discontinued 6.6 ± 1.5 hours prior to surgical incision. In 55% of patients, cangrelor was resumed at 9 ± 6 hours following surgery for a mean of 39 ± 38 hours. One cardiac death was reported after 3 hours of cangrelor discontinuation prior to surgery. No ischemic outcomes occurred after surgery and up to 30-days follow-up. The mean hemoglobin drop was <2 g/dL; nine patients received blood transfusions consistent with the type of surgery, but no life-threatening or fatal bleeding occurred. Conclusion Perioperative bridging therapy with cangrelor is a feasible approach for stented patients at high thrombotic risk and referred to surgery requiring DAPT discontinuation. Larger studies are warranted to support the safety of this strategy.