The impact of sex on pathophysiological processes, clinical presentation, treatment options, as well as outcomes of degenerative aortic stenosis remain poorly understood. Female patients are well ...represented in transfemoral aortic valve implantation (TAVI) trials and appear to derive favorable outcomes with TAVI. However, higher incidences of major bleeding, vascular complications, and stroke have been reported in women following TAVI. The anatomical characteristics and pathophysiological features of aortic stenosis in women might guide a tailored planning of the percutaneous approach. We highlight whether a sex‐based TAVI management strategy might impact on clinical outcomes. This review aimed to evaluate the impact of sex from diagnosis to treatment of degenerative aortic stenosis, discussing the latest evidence on epidemiology, pathophysiology, clinical presentation, therapeutic options, and outcomes. Furthermore, we focused on technical sex‐oriented considerations in TAVI including the preprocedural screening, device selection, implantation strategy, and postprocedural management.
Background Transcatheter aortic valve replacement (TAVR) requires large-bore access, which is associated with bleeding and vascular complications. ProGlide and Prostar XL are vascular closure devices ...widely used in clinical practice, but their comparative efficacy and safety in TAVR is a subject of debate, owing to conflicting results among published studies. We aimed to compare outcomes with Proglide versus Prostar XL vascular closure devices after TAVR. Methods and Results This large-scale analysis was conducted using RISPEVA, a multicenter national prospective database of patients undergoing transfemoral TAVR treated with ProGlide versus Prostar XL vascular closure devices. Both multivariate and propensity score adjustments were performed. A total of 2583 patients were selected. Among them, 1361 received ProGlide and 1222 Prostar XL. The predefined primary end point was a composite of cardiovascular mortality, bleeding, and vascular complications assessed at 30 days and 1-year follow-up. At 30 days, there was a significantly greater reduction of the primary end point with ProGlide versus Prostar XL (13.8% versus 20.5%, respectively; multivariate adjusted odds ratio, 0.80 95% CI, 0.65-0.99;
=0.043), driven by a reduction of bleeding complications (9.1% versus 11.7%, respectively; multivariate adjusted odds ratio, 0.76 95% CI, 0.58-0.98;
=0.046). Propensity score analysis confirmed the significant reduction of major adverse cardiovascular events and bleeding risk with ProGlide. No significant differences in the primary end point were found between the 2 vascular closure devices at 1 year of follow-up (multivariate adjusted hazard ratio, 0.88 95% CI, 0.72-1.10;
=0.902). Comparable results were obtained by propensity score analysis. During the procedure, compared with Prostar XL, ProGlide yielded significant higher device success (99.2% versus 97.5%, respectively;
=0.001). Conclusions ProGlide has superior efficacy as compared with Prostar XL in TAVR procedures and is associated with a greater reduction of composite adverse events at short-term, driven by lower bleeding complications. Registration Information URL: clinicaltrials.gov; Unique identifier: NCT02713932.
Background
There is little evidence about the prognostic role of mitral regurgitation (MR) in patients with low‐flow, low‐gradient aortic stenosis undergoing transcatheter aortic valve replacement ...(TAVR). The aim of this study was to assess the prevalence and outcome implications of MR severity in patients with low‐flow, low‐gradient aortic stenosis undergoing TAVR, and to evaluate whether MR improvement after TAVR could influence clinical outcome.
Methods and Results
This study included consecutive patients with low‐flow, low‐gradient aortic stenosis undergoing TAVR at 2 Italian high‐volume centers. The study population was categorized according to the baseline MR severity and to the presence of MR improvement at discharge. The primary outcome was the composite of all‐cause death and hospitalization for worsening heart failure up to 1 year. The study included 268 patients; 57 (21%) patients showed MR >2+. Patients with MR >2+ showed a lower 1‐year survival free from the primary outcome (
P
<0.001), all‐cause death (
P
<0.001), and heart failure hospitalization (
P
<0.001) compared with patients with MR ≤2+. At multivariable analysis, baseline MR >2+ was an independent predictor of the primary outcome (
P
<0.001). Among patients with baseline MR >2+, MR improvement was reported in 24 (44%) cases after TAVR. The persistence of MR was associated with a significantly reduced survival free from the primary outcome, all‐cause death, and heart failure hospitalization up to 1 year.
Conclusions
In this study, the presence of moderately severe to severe MR in patients with low‐flow, low‐gradient aortic stenosis undergoing TAVR portends a worse clinical outcome at 1 year. TAVR may improve MR severity in nearly half of the patients, resulting in a potential outcome benefit after discharge.
Coronary artery ectasia (CAE) is defined as a diffuse or focal dilation of an epicardial coronary artery, which diameter exceeds by at least 1. 5 times the normal adjacent segment. The term ectasia ...refers to a diffuse dilation, involving more than 50% of the length of the vessel, while the term aneurysm defines a focal vessel dilation. CAE is a relatively uncommon angiographic finding and its prevalence ranges between 0.3 and 5% of patients undergoing coronary angiography. Although its pathophysiology is still unclear, atherosclerosis seems to be the underlying mechanism in most cases. The prognostic role of CAE is also controversial, but previous studies reported a high risk of cardiovascular events and mortality in these patients after percutaneous coronary intervention. Despite the availability of different options for the interventional management of patients with CAE, including covered stent implantation and stent-assisted coil embolization, there is no one standard approach, as therapy is tailored to the individual patient. The abnormal coronary dilation, often associated with high thrombus burden in the setting of acute coronary syndromes, makes the interventional treatment of CAE patients challenging and often complicated by distal thrombus embolization and stent malapposition. Moreover, the optimal antithrombotic therapy is debated and includes dual antiplatelet therapy, anticoagulation, or a combination of them. In this review we aimed to provide an overview of the pathophysiology, classification, clinical presentation, natural history, and management of patients with CAE, with a focus on the challenges for both clinical and interventional cardiologists in daily clinical practice.
Improved expertise and technological advancements have enabled the safe and effective performance of complex and high-risk-indicated percutaneous coronary intervention (CHIP) in patients previously ...considered inoperable or high-risk. Mechanical circulatory support (MCS) devices play a crucial role in stabilizing hemodynamics during percutaneous coronary intervention (PCI) -related ischemia, thereby reducing the risk of major adverse events and achieving a more complete revascularization. However, the use of MCS devices in protected PCI is not without risks, including peri-procedural myocardial infarction (MI), bleeding, and access-related complications. Despite numerous observational studies, there is a significant lack of randomized clinical trials comparing different MCS devices in various CHIP scenarios and evaluating their long-term safety and efficacy profiles. This review aims to summarize the current evidence regarding the benefits of MCS devices during CHIPs, offer a practical guide for selecting appropriate devices based on clinical scenarios, and highlight the unanswered questions that future trials need to address.
The treatment of cardiogenic shock in patients with Takotsubo syndrome (TTS) is challenging because it depends on the mechanisms leading to the haemodynamic instability.
We report the case of a ...70‐year‐old woman admitted for TTS complicated by cardiogenic shock. The early echocardiographic identification of left ventricular outflow tract obstruction (LVOTO) and severe mitral regurgitation (MR) prompted us to implant an Impella CP assist device as a bridge‐to‐recovery therapy. After device positioning, the haemodynamic status improved and LVOTO and severe MR disappeared. Because of the persistence of severe hypotension, the mechanical circulatory support was continued in intensive care unit and stopped only 5 days later, when intraventricular gradient spontaneously dropped. The patient was discharged after 1 week in stable conditions.
Our case suggests that Impella circulating support may be a useful bridge‐to‐recovery therapeutic option in selected patients with cardiogenic shock due to TTS complicated by LVOTO and severe MR.
An 86‐year‐old man affected by severe aortic stenosis (AS) was referred to our institution owing to decompensated heart failure. Three months before, the patient was scheduled for transcatheter ...aortic valve implantation (TAVI), which was postponed owing to the coronavirus disease 2019 (COVID‐19) outbreak. Owing to COVID‐19 suspicion, he underwent nasopharyngeal swab and was temporarily isolated. However, the rapid deterioration of clinical and haemodynamic conditions prompted us to perform balloon aortic valvuloplasty (BAV) as bridge to TAVI. The patient's haemodynamics improved; and the next day, the reverse transcriptase–polymerase chain reaction for COVID‐19 was negative. At Day 5, he underwent TAVI procedure. Subsequent clinical course was uneventful. During COVID‐19 pandemic, the deferral of TAVI procedure should be assessed on a case‐by‐case basis to avoid delay in patients at high risk for adverse events. BAV may be an option when TAVI is temporarily contraindicated such as in AS patients suspected for COVID‐19.
•Native aortic valve regurgitation (NAVR) presents technical challenges for TAVR.•This is the largest study on NAVR patients treated with the ACURATE neo valve.•Intraprocedural mortality was 0%, ...device success 87.5% and moderate PVL rate 8.3%.•Device success tended to be higher with perimeter-based >10% oversizing.
Transcatheter aortic valve replacement (TAVR) has been validated for the treatment of severe symptomatic aortic stenosis in patients at high and intermediate surgical risk. Recently, TAVR has been proposed as an alternative to medical therapy in inoperable patients with severe native aortic valve regurgitation (NAVR). This multicenter international registry sought to evaluate safety and efficacy of TAVR with the self-expandable ACURATE neo valve in a cohort of patients with NAVR.
A total of 24 patients with severe NAVR treated by TAVR between September 2016 and October 2018 in 13 European centers were included. Clinical, procedural and follow up data were inserted in a dedicated database. Outcomes were codified according to Valve Academic Research Consortium-2 criteria.
Mean age was 79.4 years, 58.4% were female. Mean EuroSCORE II and STS score were 5% and 3.9%, respectively. Device success was 87.5%. Moderate paravalvular leak (PVL) was found in two (8.3%) of patients, both with a perimeter oversizing index <10%. Implantation of a second device was necessary in three cases (12.5%), one for severe PVL and two for device displacement. New pacemaker implantation rate was 21.1%. At 30 days, stroke and all-cause mortality rates were 0% and 4.1%, respectively.
This multicenter study suggests good feasibility and early safety of transfemoral TAVR with the self-expandable ACURATE neo device in patients with severe NAVR refused for surgery. Rates of moderate PVL, new pacemaker implantation and need for a second valve were higher than those reported for TAVR in aortic stenosis.
The Surgical Treatment for Ischemic Heart Failure (STICH) randomized trial was designed to identify an optimal management strategy for patients with ischemic cardiomyopathy. Baseline ...echocardiographic examinations were required for all patients. The primary aim of this report is to describe the baseline STICH Echocardiography Core Laboratory data. The secondary aim is to provide recommendations regarding how echocardiography should be used in clinical practice and research on the basis of the experience gained from echocardiography in STICH.
Between September 2002 and January 2006, 2,136 patients with ejection fractions (EFs) ≤ 35% and coronary artery disease amenable to coronary artery bypass grafting were enrolled. Echocardiography was acquired by 122 clinical enrolling sites, and measurements were performed by the Echocardiography Core Laboratory after a certification process for all clinical sites.
Echocardiography was available for analysis in 2,006 patients (93.9%); 1,734 (86.4%) were men, and the mean age was 60.9 ± 9.5 years. The mean left ventricular end-systolic volume index, measureable in 72.8%, was 84.0 ± 30.9 mL/m(2), and the mean EF was 28.9 ± 8.3%, with 18.5% of patients having EFs > 35%. Single-plane measurements of left ventricular and left atrial volumes were similar to their volumes by biplane measurement (r = 0.97 and r = 0.92, respectively). Mitral regurgitation severity by visual assessment was associated with a wide range of effective regurgitant orifice area, while effective regurgitant orifice area ≥ 0.2 cm(2) indicated at least moderate mitral regurgitation by visual assessment. Deceleration time of mitral inflow velocity had a weak correlation with EF (r = 0.25) but was inversely related to estimated pulmonary artery systolic pressure (r = -0.49).
In STICH patients with ischemic cardiomyopathy, Echocardiography Core Laboratory analysis of baseline echocardiographic findings demonstrated a wide spectrum of left ventricular shape, function, and hemodynamics, as well as the feasibility and limitations of obtaining essential echocardiographic measurements. It is critical that the use of echocardiographic parameters in clinical practice and research balance the strengths and weaknesses of the technique.
Objectives
The aim of this study was to describe the prevalence of coronary artery ectasia (CAE) in patients with ST‐elevation myocardial infarction (STEMI) and to compare the long‐term outcome of ...subjects with and without CAE undergoing emergent coronary angiography.
Background
The prognostic impact of CAE in STEMI patients has been poorly investigated.
Methods
This retrospective, single‐center, study included consecutive patients with STEMI undergoing emergent coronary angiography from January 2012 to December 2017. The primary endpoint was the assessment of recurrent myocardial infarction (MI) in patients with versus those without CAE at the longest available follow‐up. The propensity score weighting technique was employed to account for potential selection bias between groups.
Results
From 1,674 patients with STEMI, 154 (9.2%) had an angiographic evidence of CAE; 380 patients were included in the no CAE group. CAE patients were more often males and smokers, and showed a lower prevalence of diabetes than no CAE patients. After percutaneous coronary intervention, the corrected thrombolysis in MI frame count (p < .001) and the myocardial blush grade (p < .001) were significantly lower in CAE than in no CAE patients.
The mean follow‐up was 1,218.3 ± 574.8 days. The adjusted risk for the primary outcome resulted significantly higher in patients with CAE compared to those without (adjusted HR: 1.84; p = .017). No differences in terms of all‐cause and cardiac death were found between groups.
Conclusions
In this study, STEMI patients with CAE had a distinct clinical and angiographic profile, and showed a significantly higher risk of recurrent MI than those without CAE.
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