Safety and Efficacy of an Innovative Everolimus-Coated Balloon in a Swine Coronary Artery Model.

BACKGROUND: Drug-coated balloons have been used as a non-stenting treatment in coronary and peripheral artery disease. Until recently, only sirolimus- and paclitaxel-coated balloons have been investigated in clinical trials. We evaluated the safety and efficacy of an innovative everolimus-coated balloon (ECB) in a swine coronary artery model. METHODS: thirty-two swine coronary arteries were prepared through dilatation with a non-coated angioplasty balloon in a closed-chest model. During a period of 90 days, the following four groups (four animals per group, two coronary arteries per animal) were compared for safety and efficacy: A, Rontis ECB with 2.5 µg/mm2 of drug per balloon surface; B, Rontis ECB with 7.5 µg/mm2; C, Rontis Europa Ultra bare balloon; and D, Magic Touch, Concept Medical, sirolimus-coated balloon with a drug load of 1.3 µg/mm2. RESULTS: Differences in local biological effects (arterial reaction scores) and surface of intimal area (mm2) were not statistically significant between the treatment groups. Numerically, group A showed the lowest intimal area and intimal mean thickness, while group B showed the lowest stenosis among all groups. CONCLUSIONS: ECB was safe and effective in a porcine coronary artery model. The dose of everolimus may play a role in the biocompatibility of the balloon.

Dual Antiplatelet Therapy and Cancer; Balancing between Ischemic and Bleeding Risk: A Narrative Review.

Cardiovascular (CV) events in patients with cancer can be caused by concomitant CV risk factors, cancer itself, and anticancer therapy. Since malignancy can dysregulate the hemostatic system, predisposing cancer patients to both thrombosis and hemorrhage, the administration of dual antiplatelet therapy (DAPT) to patients with cancer who suffer from acute coronary syndrome (ACS) or undergo percutaneous coronary intervention (PCI) is a clinical challenge to cardiologists. Apart from PCI and ACS, other structural interventions, such as TAVR, PFO-ASD closure, and LAA occlusion, and non-cardiac diseases, such as PAD and CVAs, may require DAPT. The aim of the present review is to review the current literature on the optimal antiplatelet therapy and duration of DAPT for oncologic patients, in order to reduce both the ischemic and bleeding risk in this high-risk population.

Thirty-Days versus Longer Duration of Dual Antiplatelet Treatment after Percutaneous Coronary Interventions with Newer Drug-Eluting Stents: A Systematic Review and Meta-Analysis.

Abbreviation of the duration of dual antiplatelet therapy (DAPT) (one or three months) has been recently proposed, especially for high bleeding risk patients, after percutaneous coronary intervention (PCI) with drug-eluting stent (DES). Three databases were screened for eligible randomized control trials. The primary endpoint was the incidence of net adverse clinical events (NACE). Secondary endpoints consisted of major adverse cardiovascular events (MACE), all-cause and cardiovascular mortality, myocardial infarction, stroke, stent-thrombosis, repeat revascularization and major bleeding. We included four RCTs with a total of 26,576 patients; 13,282 patients were grouped in 30-days DAPT, while the remaining 13,294 were allocated in a longer period of DAPT. One month of DAPT did not significantly reduce NACE (odds ratio [OR]: 0.87, 95% confidence intervals [Cl]: 0.74-1.03); however, major bleedings were significantly reduced by 22% (OR: 0.78, 95% Cl: 0.65-0.94). Mortality or ischemic events (stroke, myocardial infarction, revascularization and stent thrombosis) were not affected. Thus, 30-days DAPT could be considered as safe and feasible after PCI with DES in selected patients, especially those with high bleeding risk. Forthcoming RCTs could shed light on the optimal duration of DAPT.

Safety and efficacy of shortened dual antiplatelet therapy after complex percutaneous coronary intervention: A systematic review and meta-analysis.

BACKGROUND: Optimal duration of dual antiplatelet therapy (DAPT) in patients undergoing complex percutaneous coronary intervention (PCI) remains under investigation. Our aim is to compare shortened (≤3 months) DAPT with longer DAPT in patients undergoing complex PCIs. METHODS: Three major databases (MEDLINE, Cochrane Central Register of Controlled Trials, and Scopus) were screened. The primary endpoint was major bleedings as they are defined by the Bleeding Academic Research Consortium (BARC) 3-5. The secondary endpoints were major adverse cardiovascular events, all-cause and cardiovascular mortality, myocardial infarction, stroke, and stent thrombosis. RESULTS: Five studies were included in our analysis, with a total of 9,115 patients. Our meta-analysis met its primary endpoint, as abbreviated DAPT significantly reduced major bleedings by 43% (95% confidence intervals: 0.35-0.93). Ischemic events and mortality were not affected by the shortening of DAPT. CONCLUSION: Shortened DAPT significantly reduced the odds of major bleedings in patients undergoing complex PCI without increasing the ischemic events or mortality. Thus, it could be considered a safe and feasible option in such patients.

Ultrasound-guided femoral approach for coronary angiography and interventions in the porcine model.

Coronary angiography and percutaneous coronary intervention (PCI) procedural details in swine are similar to those performed to humans, since their heart and coronary anatomy closely resembles. However, only a few detailed descriptions of the procedure are available, containing notable differences. We present a feasible and reproducible protocol for percutaneous coronary interventions in porcine experimental models, utilizing ultrasound-guided femoral approach. Nine female pigs were studied to explore the feasibility of superficial femoral arterial (SFA) access for coronary angiography and provisional PCI, as well as the most suitable guiding coronary catheters and angiographic projections for the above interventions. Experiments were performed under general anesthesia, using ultrasound-guided puncture of the SFA to gain arterial access. The Amplatzer AR1® catheter, and the Right Coronary Bypass® catheter were used for the selective engagement of the right and the left coronary artery, respectively. Successful arterial access and subsequent cardiac catheterization were performed in all pigs. Only one animal required a second puncture for femoral artery access. None of the 9 animals presented any significant tachycardia or hypotensive episode. One animal developed an access site-related complication following the first catheterization procedure. During follow-up, 100% success of SFA catheterization was achieved using the same ultrasound-guided technique. The ultrasound-guided superficial femoral artery access for coronary angiography and provisional interventions in porcine models is a quick and safe alternative to the carotid artery approach. The RCB and AR1 catheters may be the best choice for the quick and easy selective coronary engagement of the right and left ostia, respectively.

Could radiation exposure be the Achilles' heel of distal transradial artery access?

Distal transradial access for vascular interventions has gained ground recently. While the novel approach is associated with reduced radial artery occlusion and faster hemostasis, it could be related with prolonged procedural time, higher crossover rate and increased radiation, comparing to conventional transradial approach. Whether the radiation is increased in the procedures performed by the novel approach remains unambiguous. In the specific article, we aim to review the current literature and to propose possible explanations for this phenomenon. Could radiation be the Achilles' heel of distal transradial artery access?

Heart failure and atrial fibrillation: new concepts in pathophysiology, management, and future directions.

A bidirectional pathophysiological link connects heart failure and atrial fibrillation, creating a frequent and challenging comorbidity, which includes neurohormonal hyperactivation, fibrosis development, and electrophysiologic remodeling, while they share mutual risk factors. Management for these devastating comorbidities includes most of the established treatment measures for heart failure as well as rhythm or rate control and anticoagulation mostly for atrial fibrillation, which can be achieved with either pharmaceutical or non-pharmaceutical approaches. The current manuscript aims to review the existing literature regarding the underlying pathophysiology, to present the novel trends of treatment, and to predict the future perspective of these two linked diseases with the numerous unanswered questions.

Distal or Traditional Transradial Access Site for Coronary Procedures: A Single-Center, Randomized Study.

OBJECTIVES: This study aimed to compare the efficacy and safety of the distal transradial approach (dTRA) versus the conventional transradial approach (TRA) for coronary angiography and percutaneous coronary interventions. BACKGROUND: The recommended approach for coronary procedures is TRA. However, it is associated with radial artery occlusion (RAO). The dTRA could potentially decrease the incidence of RAO. METHODS: One thousand forty-two consecutive patients were randomized (1:1) to right dTRA or TRA. The primary endpoint was the rate of RAO, which was evaluated by Doppler ultrasound at 60 days after randomization. RESULTS: Five hundred eighteen and 524 patients were randomized to dTRA and TRA, respectively. Follow-up Doppler evaluation of the radial artery was accomplished in 404 (78.0%) patients in the dTRA group and 392 (74.8%) in the TRA group. The rate of RAO was significantly reduced in the dTRA group compared with TRA group (3.7% vs 7.9%, respectively; P = 0.014). The rate of successful sheath insertion was lower in the dTRA group compared with the TRA group (78.7% vs 94.8%, respectively; P < 0.001). More punctures (median = 2 [IQR: 1-3] vs median = 1 [IQR: 1-2]; P < 0.001) and a longer time (120 vs 75 seconds; P < 0.001) were required for sheath insertion in the dTRA group compared with the TRA group. The hemostasis time was shorter in the dTRA group compared with the TRA group (60 vs 120 minutes; P < 0.001). The dose area product was higher in the dTRA group (median = 32,729 in the dTRA vs 28,909 cGy/cm2 in the TRA group; P = 0.02). No significant differences were observed in the secondary safety endpoints (bleeding [Bleeding Academic Research Consortium ≥2] and severe radial artery spasm). CONCLUSIONS: According to our study, dTRA was associated with a lower rate of forearm RAO, a shorter time of hemostasis, a higher crossover rate and dose area product, and a longer procedural time compared with TRA.

A Giant Left Circumflex Coronary Artery Aneurysm.

A patient was referred for aortic valve replacement and aneurysm resection; however, the aneurysm was deemed to be non-resectable due to severe calcification, thus posing a high operative risk. The patient eventually underwent transcatheter aortic valve implantation. Eleven years later, coronary angiography depicted a giant coronary artery aneurysm measuring 63 mm in diameter and containing intraluminal thrombus. To our knowledge, this is the largest giant coronary artery aneurysm reported in the literature.

Anticoagulation for atrial fibrillation in heart failure patients: balancing between Scylla and Charybdis.

The management of heart failure (HF) and atrial fibrillation (AF) in real-world practice remains a debating issue, while the number of HF patients with AF increase dramatically. While it is unclear if rhythm or rate control therapy is more beneficial and under which circumstances, anticoagulation therapy is the cornerstone of the AF-HF patients' approach. Vitamin-K antagonists were the gold-standard during the past, but currently their usage is limited in specific conditions. Non-vitamin K oral anticoagulants (NOACs) have gained ground during the last ten years and considered as gold-standard of a wide spectrum of HF phenotypes. The current manuscript aims to review the current literature regarding the indications and the optimal choice and usage of NOACs in HF patients with AF.

Transradial access through the anatomical snuffbox: Results of a feasibility study.

BACKGROUND: Distal transradial access (dTRA), through the anatomical snuffbox (AS) of the hand, is a novel, potentially beneficial, vascular access for patients undergoing coronary procedures. METHOD: Consecutive patients with an indication for coronary angiography and/or percutaneous coronary intervention (PCI) were enrolled in our tertiary center, from November 2018 to March 2019. The success rate of the procedure, the incidence of local complications, the time required for hemostasis, and the incidence of radial artery occlusion (RAO) were evaluated. RESULTS: Α total of 167 patients were catheterized through the dTRA (79.6% men, 20.4% women), with a median age of 64 years. The indication for catheterization was ACS in 80 (47.9%) patients, stable coronary artery disease in 51 (30.5%) patients, and other reasons in 36 (21.6%) patients. Fifty patients (32.9%) underwent PCI. Successful sheath insertion was recorded in 152 (91.0%) patients. The mean time to hemostasis after sheath removal was 52 ± 11 min. Vascular access site complications were evaluated with ultrasound in 62 (40.8%) of the enrolled patients, 40 ± 15 days after the procedure. Among them, 2 (3.2%) patients presented with arteriovenous fistula, and 2 (3.2%) patients with local occlusion at the puncture site within the AS and distal to the transverse ligament, with preservation of the patency of the radial artery proximal to the radial styloid process. CONCLUSION: The dTRA may be a feasible and safe access site for diagnostic and interventional coronary procedures, with decreased incidence of RAO and time required for hemostasis compared to classical radial artery access.

Internal carotid artery origin of the anterior cerebral artery: A rare anatomic intracranial arterial variation in a child with morning glory disc anomaly and moyamoya vascular pattern; case report and review of literature.

Morning glory disc anomaly (MGDA) characterizes a congenital dysgenetic disorder of the optic disc, coexisting with arterial intracranial abnormalities, including Moyamoya vascular disease, a significantly rare disease in the European populations. We report a 2.5-year-old female child from Greece previously diagnosed with MGDA, who presented with right-hand paresis, accompanied by focal epileptic spasms, followed by an episode of brief absence seizure, as well as some arm clonic spasms. Magnetic resonance angiography scan revealed the presence of an anomalous origin of the anterior cerebral artery (ACA) from the internal carotid artery (ICA) along with vascular abnormalities, compatible with Moyamoya pattern. To the very best of our knowledge, this is the first reported case of anomalous origin of ACA from the supraclinoid ICA accompanied by severe occlusive intracranial disease (moyamoya-like pattern) in a patient with known MGDA, highlighting the embryonic character of the vascular manifestations in MGDA. It also verifies the association of Moyamoya pattern with MGDA, thus linking vascular dysgenesis as a possible cause of MGDA.