Safety and Efficacy of Myval Implantation in Patients with Severe Bicuspid Aortic Valve Stenosis-A Multicenter Real-World Experience.

Bicuspid aortic valve (BAV) is the most common valvular congenital anomaly and is apparent in nearly 50% of candidates for AV replacement. While transcatheter aortic valve implantation (TAVI) is a recommended treatment for patients with symptomatic severe aortic stenosis (AS) at all surgical risk levels, experience with TAVI in severe bicuspid AS is limited. TAVI in BAV is still a challenge due to its association with multiple and complex anatomical considerations. A retrospective study has been conducted to investigate TAVI's procedural and 30-day outcomes using the Myval transcatheter heart valve (THV) (Meril Life Sciences Pvt. Ltd. Vapi, Gujarat, India) in patients with severe bicuspid AS. Data were collected on 68 patients with severe bicuspid AS who underwent TAVI with the Myval THV. Baseline characteristics, procedural, 30-day echocardiographic and clinical outcomes were collected. The mean age and STS PROM score were 72.6 ± 9.4 and 3.54 ± 2.1. Procedures were performed via the transfemoral route in 98.5%. Major vascular complications (1.5%) and life-threatening bleeding (1.5%) occurred infrequently. No patient had coronary obstruction, second valve implantation or conversion to surgery. On 30-day echocardiography, the mean transvalvular gradient and effective orifice area were 9.8 ± 4.5 mmHg and 1.8 ± 0.4 cm2, respectively. None/trace aortic regurgitation occurred in 76.5%, mild AR in 20.5% and moderate AR in 3%. The permanent pacemaker implantation rate was 8.5% and 30-day all-cause death occurred in 3.0% of cases. TAVI with the Myval THV in selected BAV anatomy is associated with favorable short-term hemodynamic and clinical outcomes

Determining the Predominant Lesion in Patients With Severe Aortic Stenosis and Coronary Stenoses: A Multicenter Study Using Intracoronary Pressure and Flow

Background: Patients with severe aortic stenosis (AS) often have coronary artery disease. Both the aortic valve and the coronary disease influence the blood flow to the myocardium and its ability to respond to stress; leading to exertional symptoms. In this study, we aim to quantify the effect of severe AS on the coronary microcirculation and determine if this is influenced by any concomitant coronary disease. We then compare this to the effect of coronary stenoses on the coronary microcirculation. Methods: Group 1: 55 patients with severe AS and intermediate coronary stenoses treated with transcatheter aortic valve implantation (TAVI) were included. Group 2: 85 patients with intermediate coronary stenoses and no AS treated with percutaneous coronary intervention were included. Coronary pressure and flow were measured at rest and during hyperemia in both groups, before and after TAVI (group 1) and before and after percutaneous coronary intervention (group 2). Results: Microvascular resistance over the wave-free period of diastole increased significantly post-TAVI (pre-TAVI, 2.71±1.4 mm Hg·cm·s−1 versus post-TAVI 3.04±1.6 mm Hg·cm·s−1 [P=0.03]). Microvascular reserve over the wave-free period of diastole significantly improved post-TAVI (pre-TAVI 1.88±1.0 versus post-TAVI 2.09±0.8 [P=0.003]); this was independent of the severity of the underlying coronary stenosis. The change in microvascular resistance post-TAVI was equivalent to that produced by stenting a coronary lesion with an instantaneous wave-free ratio of ≤0.74. Conclusions: TAVI improves microcirculatory function regardless of the severity of underlying coronary disease. TAVI for severe AS produces a coronary hemodynamic improvement equivalent to the hemodynamic benefit of stenting coronary stenoses with instantaneous wave-free ratio values <0.74. Future trials of physiology-guided revascularization in severe AS may consider using this value to guide treatment of concomitant coronary artery disease

Relationship between treatment delay and final infarct size in STEMI patients treated with abciximab and primary PCI

Background Studies on the impact of time to treatment on myocardial infarct size have yielded   conflicting results. In this study of ST-Elevation Myocardial Infarction (STEMI) treated   with primary percutaneous coronary intervention (PCI), we set out to investigate the   relationship between the time from First Medical Contact (FMC) to the demonstration   of an open infarct related artery (IRA) and final scar size. Between February 2006 and September 2007, 89 STEMI patients treated with primary PCI   were studied with contrast enhanced magnetic resonance imaging (ceMRI) 4 to 8 weeks   after the infarction. Spearman correlation was computed for health care delay time   (defined as time from FMC to PCI) and myocardial injury. Multiple linear regression   was used to determine covariates independently associated with infarct size. Results An occluded artery (Thrombolysis In Myocardial Infarction, TIMI flow 0-1 at initial   angiogram) was seen in 56 patients (63%). The median FMC-to-patent artery was 89 minutes.   There was a weak correlation between time from FMC-to-patent IRA and infarct size,   r = 0.27, p = 0.01. In multiple regression analyses, LAD as the IRA, smoking and an occluded vessel   at the first angiogram, but not delay time, correlated with infarct size. Conclusions In patients with STEMI treated with primary PCI we found a weak correlation between   health care delay time and infarct size. Other factors like anterior infarction, a   patent artery pre-PCI and effects of reperfusion injury may have had greater influence   on infarct size than time-to-treatment per se

Dedicated plug based closure for large bore access -The MARVEL prospective registry

Objectives To study safety and performance of the MANTA Vascular closure device (VCD) under real world conditions in 10 centers.Background The MANTA is a novel plug-based device for large bore arteriotomy closure.Methods We included all eligible patients who underwent transfemoral large bore percutaneous procedures. Exclusion criteria were per operator's discretion and included severe calcification or marked tortuosity of the access vessel, presence of marked obesity/cachexia or a systolic blood pressure above 180 mmHg. The primary performance endpoint was time to hemostasis. Primary and secondary safety endpoints were major and minor access site related vascular complications up to 30 days, respectively. Vascular complications were adjudicated by an independent clinical event committee according to VARC-2 criteria. We performed multivariable logistic regression to estimate the effect of baseline and procedural characteristics on any and major vascular complications.Results Between February 2018 and July 2019 500 patients were enrolled undergoing Transcatheter aortic valve replacement (TAVR, N = 496), Balloon aortic valvuloplasty (BAV, N = 2), Mechanical circulatory support (MCS, N = 1) or Endovascular aneurysm repair (EVAR, N = 1). Mean age was 80.8 +/- 6.6 years with a median STS-score of 2.7 [IQR 2.0-4.3] %. MANTA access site complications were major in 20 (4%) and minor in 28 patients (5.6%). Median time to hemostasis was 50 [IQR 20-120] sec. Severe femoral artery calcification, scar presence in groin, longer procedure duration, female gender and history of hypertension were independent predictors for vascular complications.Conclusion In this study, MANTA appeared to be a safe and effective device for large bore access closure under real-world conditions

Increasing socioeconomic inequalities in first acute myocardial infarction in Scotland, 1990–92 and 2000–02

&lt;p&gt;Background: Despite substantial declines, Ischaemic Heart Disease (IHD) remains the largest cause of death in Scotland and mortality rates are among the worst in Europe. There is evidence of strong, persisting regional and socioeconomic inequalities in IHD mortality, with the majority of such deaths being due to Acute Myocardial Infarction (AMI). We examine the changes in socioeconomic and geographic inequalities in first AMI events in Scotland and their interactions with age and gender.&lt;/p&gt; &lt;p&gt;Methods: We used linked hospital discharge and death records covering the Scottish Population (5.1 million). Risk ratios (RR) of AMI incidence by area deprivation and age for men and women were estimated using multilevel Poisson modelling. Directly standardised rates were presented within these stratifications.&lt;/p&gt; &lt;p&gt;Results: During 1990–92 74,213 people had a first AMI event and 56,995 in 2000–02. Adjusting for area deprivation accounted for 59% of the geographic variability in AMI incidence rates in 1990–92 and 33% in 2000–02. Geographic inequalities in male incidence reduced; RR for smaller areas (comparing area on 97.5th centile to 2.5th) reduced from 1.42 to 1.19. This was not true for women; RR increased from 1.45 to 1.59. The socioeconomic gradient in AMI incidence increased over time (p-value &#60; 0.001) but this varied by age and gender. The gradient across deprivation categories for male incidence in 1990–92 was most pronounced at younger ages; RR of AMI in the most deprived areas compared to the least was 2.6 (95% CI: 1.6–4.3) for those aged 45–59 years and 1.6 (1.1–2.5) at 60–74 years. This association was also evident in women with even stronger socioeconomic gradients; RRs for these age groups were 4.4 (3.4–5.5), and 1.9 (1.7–2.2). Inequalities increased by 2000–02 for both sexes; RR for men aged 45–59 years was 3.3 (3.0–3.6) and for women was 5.6 (4.1–7.7)&lt;/p&gt; &lt;p&gt;Conclusion: Relative socioeconomic inequalities in AMI incidence have increased and gradients are steepest in young women. The geographical patterning of AMI incidence cannot be fully explained by socioeconomic deprivation. The reduction of inequalities in AMI incidence is key to reducing overall inequalities in mortality and must be a priority if Scotland is to achieve its health potential.&lt;/p&gt

Randomised comparison of provisional side branch stenting versus a two-stent strategy for treatment of true coronary bifurcation lesions involving a large side branch: the Nordic-Baltic Bifurcation Study IV

Background It is still uncertain whether coronary bifurcations with lesions involving a large side branch (SB) should be treated by stenting the main vessel and provisional stenting of the SB (simple) or by routine two-stent techniques (complex). We aimed to compare clinical outcome after treatment of lesions in large bifurcations by simple or complex stent implantation.Methods The study was a randomised, superiority trial. Enrolment required a SB >= 2.75 mm, >= 50% diameter stenosis in both vessels, and allowed SB lesion length up to 15 mm. The primary endpoint was a composite of cardiac death, non-procedural myocardial infarction and target lesion revascularisation at 6 months. Two-year clinical follow-up was included in this primary reporting due to lower than expected event rates.Results A total of 450 patients were assigned to simple stenting (n = 221) or complex stenting (n=229) in 14 Nordic and Baltic centres. Two-year follow-up was available in 218 (98.6%) and 228 (99.5%) patients, respectively. The primary endpoint of major adverse cardiac events (MACE) at 6 months was 5.5% vs 2.2% (risk differences 3.2%, 95% CI -0.2 to 6.8, p=0.07) and at 2 years 12.9% vs 8.4% (HR 0.63, 95% CI 0.35 to 1.13, p = 0.12) after simple versus complex treatment. In the subgroup treated by newer generation drug-eluting stents, MACE was 12.0% vs 5.6% (HR 0.45, 95% CI 0.17 to 1.17, p = 0.10) after simple versus complex treatment.Conclusion In the treatment of bifurcation lesions involving a large SB with ostial stenosis, routine two-stent techniques did not improve outcome significantly compared with treatment by the simpler main vessel stenting technique after 2 years