Vascular Complications Among Patients Undergoing Trans-femoral Transcatheter Aortic Valve Implantation: Prostar vs ProGlide Parallel Technique.

Reliable femoral artery closure devices are essential for the success of trans-femoral Transcatheter Aortic Valve Implantation (TAVI) procedures. Accordingly, device choice might affect vascular complications and bleeding rates. This was a retrospective analysis, comparing vascular complication rates among patients who underwent trans-femoral TAVI with vascular access closure using either the ProGlide parallel suture or Prostar closure devices. We included 191 patients: 106 were treated with Prostar and 85 with ProGlide. The ProGlide group had higher rate of diabetes, chronic kidney disease, peripheral arterial disease, and significantly smaller femoral arteries that were treated via larger sheaths. Valve Academic Research Consortium (VARC)-2 major complications were similar between the groups. (4.7% for ProGlide vs 3.8% for Prostar, P=1), with similar incidence of closure device failure (2 vs 3, P=1). No differences were found after univariant analysis and propensity-score matching in the incidence of major and minor bleeding nor in the rate of in-hospital mortality between ProGlide and Prostar (4.7 vs 2.8%, P=.7, 1.2 vs 2.8%, P=.63, and 1.2 vs .0%, P=.45, respectively). Parallel suture technique using two ProGlide sutures showed comparable rates of vascular complications to the Prostar closure device in higher risk population of TAVI patients.

Postprocedural Radial Artery Compression Time In Chronic AnticoaguLated patients using StatSeal: The PRACTICAL-SEAL study.

BACKGROUND: Patients on uniterrupted chronic oral anticoagulation (OAC) therapy are at high-risk of bleeding during cardiac catheterization. We aimed to investigate the safety and efficacy of the StatSeal® disc for adjunct hemostasis in patients undergoing transradial coronary angiography under uninterrupted OAC therapy. METHODS: Patients who underwent transradial cardiac catheterization without interrupted OAC therapy were included in this study. RESULTS: Among 180 patients, 85 (47.2%) patients were on warfarin and 95 (52.8%) patients on novel oral anticoagulants (NOACs). Patients on NOACs were older (72.9 ± 9.6 versus 69.7 ± 10.8 years, P < 0.001) and had more atrial fibrillation/flutter (94.7% versus 62.4%, P < 0.001), whereas patients on Warfarin were more often women (43.5% versus 26.3%, P = 0.02) and had mechanical heart valves (27.1% versus 0%, P < 0.001). Intravenous unfractioned heparin (UFH) was administered in 96.5% of patients on warfarin (3799 ± 1342 units) and 93.7% patients on NOACs (4028 ± 1362 units), P = 0.27. There were no differences in terms of type and sheath size and the need for ad hoc coronary intervention. Time-to-first release of the hemostatic wristband was 56.2 ± 12.6 min and complete hemostasis was achieved in 71.1 ± 13.0 min, with shorter times among patients on NOACs (54.1 ± 11.7 and 58.5 ± 13.2 min, 68.9 ± 11.7 versus 73.6 ± 14.0 min, P = 0.02, for both). There were no significant differences in terms of bleeding. There was no radial artery occlusion among 112 participants who underwent color Doppler ultrasound. CONCLUSION: The present study shows that in patients undergoing transradial coronary angiogram under contemporary uninterrupted OAC therapy and periprocedural administration of UFH, the use of StatSeal® disc for adjunctive hemostasis was associated with short times to complete hemostasis.

Short Durations of Radial Hemostatic Device After Diagnostic Transradial Cardiac Catheterization: The PRACTICAL-2 Randomized Trial.

BACKGROUND: Radial artery occlusion (RAO) is the most common complication following transradial approach (TRA) for cardiac catheterisation. Our aim was to assess if decreasing radial hemostatic device (RHD) time reduces the risk of RAO among individuals receiving small sheath sizes with no adjunctive heparin. METHODS: We randomised 450 individuals undergoing diagnostic cardiac catheterization via TRA to 3 durations of RHD time: 10, 20, or 30 minutes. After these time periods, the RHD was gradually released over 20 minutes. The primary efficacy end point was forearm hematoma grade ≥ 2 (5-10 cm) and the primary safety end point was RAO (as determined by Doppler ultrasound) 1 hour after RHD removal (before discharge). RESULTS: The mean age was 66 years and 64% were male. Five-French sheaths were used in all patients. Hematoma grade ≥ 2 occurred in only 1 patient, who was in the 20-minute group (P = 0.39). RAO occurred in 6.7% of patients in the 10-minute group, 10.7% in the 20-minute group and 6% in the 30-minute group (P = 0.26). CONCLUSIONS: Among patients receiving small-caliber sheaths without adjunctive heparin, the incidence of forearm hematoma and RAO are low. Shorter durations of RHD time did not further reduce the risk of these complications.

Novel Technique for the Treatment of Coronary Artery Perforation.

Coronary artery perforation is a rare complication of percutaneous coronary intervention (PCI); its rate is estimated at 0.4- 0.7% of all PCIs. Fast recognition and response are imperative for the treatment of this potentially life-threatening complication. Available techniques for the treatment of perforations have moderate success rates and often necessitate dedicated equipment and expertise. In the case report presented, we describe a novel technique used to treat coronary perforations with readily available equipment.

Endothelial Dysfunction Is Not Associated With Spontaneous Coronary Artery Dissection.

BACKGROUND: Spontaneous coronary artery dissection (SCAD) is an important cause of acute coronary syndrome, yet its pathophysiology is only partially understood. We sought to assess the association between endothelial dysfunction (ED) and SCAD. METHODS: We prospectively assessed patients presenting with acute coronary syndrome who were diagnosed with SCAD. The control arm had established coronary artery atherosclerotic disease (AD) according to previous coronary angiography. ED was assessed using the EndoPAT 2000 while patients returned to their steady state condition. A total of 16 patients with SCAD and 66 patients with AD were included. RESULTS: Microvascular reactivity as assessed with the EndoPAT was significantly worse in the AD group compared to the SCAD group. The median RHI in the AD group was 1.76 (IQR 1.52, 2.2) vs. a median RHI of 2.08 (IQR 1.73, 2.79) in the SCAD group (p < 0.05). While the RHI values in half of the AD group (33 patients; 50%) were below the cut-off of 1.67 only one patient had an RHI below this cut-off in the SCAD group. CONCLUSIONS: Patients with SCAD were not found to have ED and it is therefore unlikely that ED takes part in SCAD formation.

Small-Size vs Large-Size Burr for Rotational Atherectomy.

BACKGROUND: Rotational atherectomy (RA) has been traditionally performed via the transfemoral approach, mostly utilizing large guide catheters (≥7 Fr), which can accommodate the passage of large burrs (≥1.75 mm). However, contemporary data show that using smaller sheath and catheter sizes reduces the risk of procedural access-site related complications. Therefore, the aim of this study was to assess the feasibility of performing RA using smaller burrs and subsequently smaller-sized sheath catheters. METHODS: A total of 220 patients underwent RA procedures between January 2011 and July 2017. We compared 162 patients who underwent RA using a maximal burr size of 1.5 mm (small-burr group) with 58 patients who underwent RA using burrs >1.5 mm in diameter (large-burr group). Clinical, procedural, safety, and feasibility data were evaluated and compared between the two groups. RESULTS: Baseline characteristics of the two groups were quite similar other than a higher prevalence of smoking (21.0% vs 5.2%; P<.01) and a lower body weight (80.9 ± 17.5 kg vs 86.8 ± 17.2 kg; P=.03) in the small-burr group vs the large-burr group. The indications for the procedure for the small-burr group vs large-burr group were stable angina in 53% vs 62%, unstable angina in 16% vs 17%, non-ST elevation myocardial infarction (MI) in 26% vs 17%, and ST-elevation MI in 3.7% vs 3.4%, respectively (P=NS for all). The target-vessel (TV) diameter was significantly larger in the large-burr group vs the small-burr group (3.5 ± 0.3 mm vs 3.2 ± 0.5 mm, respectively; P<.01). Importantly, a sheath size >6 Fr was used in 56.0% of the small-burr group vs 89.5% of the large-burr group (P<.01). Moreover, in 53% of the small-burr group, a guide catheter >6 Fr was used. Radial access was used in 33% of the small-burr group and 17% of the large-burr group (P=.03). Procedural success was achieved in 93% of the small-burr group and 100% of the large-burr group (P=.07). CONCLUSION: In the majority of cases, RA can be successfully performed using smaller-sized burrs while achieving a high procedural success rate. Notably, our study also highlights the overuse of large sheaths and catheters to deliver small burrs. These results further support the contemporary strategy of using 6 Fr guide catheters, thereby increasing the possibility of using the radial approach for more complex interventional procedures.

Familial Spontaneous Coronary Artery Dissection and the SMAD-3 Mutation.

Spontaneous coronary artery dissection (SCAD) is a cause of about 4% of acute coronary syndrome. The pathophysiology of SCAD is not yet fully understood. Loeys-Dietz syndrome is a connective tissue disorder characterized by aortic aneurysms, arterial tortuosity, and aortic dissections. It is caused by mutations in the genes affecting the transforming growth factor ß pathway. We describe a family with a SMAD3 gene mutation and Loeys-Dietz syndrome presenting with recurrent SCAD episodes.

The Evolut R and Evolut PRO transcatheter aortic valve systems.

INTRODUCTION: Transcatheter aortic valves have evolved over the last 15 years. Second- and third- generation devices have considerably improved, and a range of newer devices have also been introduced with the aim of decreasing the incidence of paravalvular leak, reducing the need for permanent pacemaker implantation and minimizing procedure- and device-related complications. Areas covered: In this review, we highlight the special features of the latest generation of self-expanding Evolut PRO (Medtronic, Minneapolis, Minnesota) transcatheter aortic valve system. A detailed literature search on the Medtronic Evolut R and Evolut PRO transcatheter aortic valves was undertaken using Ovid, PubMed and Web of Science. Expert commentary: In a single, small study, the Evolut PRO has shown significant improvement over the Evolut R in terms of reduced paravalvular leak and pacemaker implantation. Larger scaled studies are needed to ascertain the performance of the Evolut PRO.

Newer-generation of Edwards transcatheter aortic valve systems: SAPIEN 3, Centera, and SAPIEN 3 Ultra.

INTRODUCTION: Transcatheter aortic valve implantation (TAVI) has become the standard of care for patients with severe symptomatic aortic stenosis at moderate to high surgical risk. Newer devices are now available and broader indications are expected in the near future. Areas covered: The Placement of Aortic Transcatheter Valves (PARTNER) trials initially proved the efficacy of TAVI with the balloon-expandable Edwards SAPIEN valve in patients deemed in-operable and at high-risk, and later on in intermediate-risk patients using the balloon-expandable SAPIEN-XT valve. These trials had laid the groundwork for advancements incorporated in the balloon-expandable SAPIEN-3 system such as the introduction of the anti-leak skirt and improved delivery system. In this review, we summarize the available data on the SAPIEN-3 transcatheter heart valve system and we highlight the special features of the newly designed self-expanding Edwards CENTERA valve, and the latest generation of balloon-expanable SAPIEN-3 Ultra™ system. A detailed literature search on these devices was undertaken using Ovid, PubMed, and Web of Science. Expert commentary: Data from clinical trials show that TAVI with newer-generation of Edwards transcatheter heart valve systems have shown significant improvement in terms of reduced paravalvular leak and have been associated with extremely good clinical outcomes.

The mechanically expandable LOTUS Valve and LOTUS Edge transcatheter aortic valve systems.

INTRODUCTION: The Lotus valve system (Boston Scientific, Marlborough, Massachusetts, USA) consists of a braided wire Nitinol™ frame with three bovine pericardial leaflets. The valve is deployed by controlled mechanical expansion which allows recapturing/repositioning and full retrievability. Areas covered: While this system offers a unique seal, which conforms to irregular surfaces, thereby minimizing paravalvular leak, its main downfall is a high rate of new pacemaker implantation. This had been partially addressed with the design of the Depth Guard™ mechanism to optimize deployment by early anchoring and limiting the depth of implant. Further developments in the Lotus valve's structure and design lay the foundations for the new Lotus Edge™ valve which is designed to maintain the benefits of the first-generation of the device, while improving deliverability and optimizing deployment with the aim to reduce pacemaker implantation rates. Expert commentary: Data from clinical trials show that TAVI with the Lotus valve system is associated with low rates of all-cause mortality and paravalvular leak although with high rates of permanent pacemaker requirement. Therefore, continuing modifications in device design such as the Lotus Edge™ valve with the addition of the Depth Guard™ are highly awaited with a view to decrease pacemaker rates.

The ACURATE neo transcatheter aortic valve system.

INTRODUCTION: The field of transcatheter aortic valve implantation (TAVI) has seen an exponential expansion in TAVI devices for the treatment of severe symptomatic aortic stenosis. Areas covered: The ACURATE neo (Boston Scientific, MA, USA) is a second-generation self-expanding transcatheter aortic valve system. The valve presents a supra-annular design, and comprises three stabilization arches for axial alignment, an upper-crown for capping the aortic annulus, and a lower-crown that is opened over the native aortic valve for full deployment. This device minimally protrudes into the left ventricular outflow-tract, thereby minimizing the risk of conduction abnormalities. The ACURATE neo can be delivered by transfemoral and transapical approaches with a unique 'top-down' deployment. Information was gathered from published manuscripts obtained using standard databases (MEDLINE) and trial data presented at conferences. Expert commentary: Data from observational series show that TAVI with the ACURATE neo is associated with low rates of all-cause mortality, paravalvular leak, and permanent pacemaker requirement. Randomized data comparing the ACURATE neo valve with contemporary valves and long-term durability data are awaited. Continuing modifications in device and delivery system design are anticipated with a view to further reduction in paravalvular leak.

Transradial Approach for Left Ventricular Endomyocardial Biopsy.

BACKGROUND: Left ventricular endomyocardial biopsy (LV-EMB) may offer a superior diagnostic yield compared with right ventricular endomyocardial biopsy (RV-EMB) in conditions predominantly affecting the LV but is underused compared with RV-EMB. Despite the steep uptake of radial approach in coronary interventions, LV-EMB is usually performed via the femoral artery in contemporary practice. Therefore, the aim of this study was to assess the safety and feasibility of LV-EMB via a transradial approach in a multicentre registry. METHODS: One-hundred and two patients who underwent LV-EMB via transradial approach were included. Clinical characteristics, procedural, safety and feasibility data were evaluated. RESULTS: LV-EMB was successfully performed via transradial access in 101 (99%) patients. Mild or moderate radial artery spasm occurred in 12 (12%) patients, but only 1 (0.98%) patient required conversion to femoral access due to severe spasm. A total of 80 (78%) patients had LV-EMB via a sheathless guide catheter. Among those, 77 (96.3%) patients had 7.5-French sheathless guides, and 3 (3.8%) patients had 8.5-French sheathless guides inserted. Radial sheaths were used in the remaining 22 patients, with 5-French sheaths in 21 of 22 patients. Heparin was administered to 93.1% of patients at a median dose of 5000 (3000-5000) IU. The remaining patients followed a provisional strategy upon patent hemostasis achievement. No access site-related complications were reported. There were no major complications (pericardial tamponade, life-threatening arrhythmia, cerebrovascular accident or death). CONCLUSIONS: In a population of patients undergoing transradial LV-EMB, the procedural success rate was high and showed an excellent safety profile. Further studies comparing transradial and transfemoral routes may help expand the use of transradial access for LV-EMB.

Intravascular imaging for cardiac arrest with "normal" coronary arteriography.

Spontaneous coronary artery dissection (SCAD) is an under-recognised presentation of acute coronary syndrome. A high index of suspicion is essential. If diagnostic doubt is high, intracoronary imaging, performed carefully, can be useful, although it can result in worsening of the clinical condition. The current report exemplifies the complexity of diagnosis and management of SCAD in a patient with out-of-hospital cardiac arrest and non-diagnostic angiography.

[THE EFFECT OF AIR POLLUTION ON CARDIOVASCULAR DISEASES].

INTRODUCTION: The effect of air pollution on lung diseases has been recognized for many years. During the past few years a growing body of evidence suggests a connection between air pollution and cardiovascular diseases. Amongst the different air pollutants, much attention has been focused on particulate matter which is defined as a large group of different compounds suspended in the air in the form of minute solid particles or liquid droplets. Particulate matter is broadly categorized according to aerodynamic size. Thus PM2.5 consists of fine particles, smaller than 2.5 micron and PM10 comprises fine particles and coarser particles between 2.5 and 10 micron. Bigger particles cannot usually enter airways and lungs due to their size and so their direct medical effect is minimal. In this review we will elaborate on the effect of air pollution on cardiovascular diseases, the different mechanisms by which particle exposure elicits cardiovascular morbidity and mortality, the way air pollution is currently perceived and its future role as a risk factor.