Invasive Transcatheter Aortic Valve Replacement Research Articles

Single femoral artery access is safe and feasible during transcatheter aortic valve replacement: a propensity score matched analysis.

Transcatheter aortic valve replacement (TAVR) potentially may be significantly simplified by using the single artery access (SA) technique, which does not require a secondary artery access. Nevertheless, the safety and efficacy of this technique remains unclear. Our goal was to determine if single artery access TAVR (without upgrading the sheath size) is a feasible, minimally invasive procedure. Patients with symptomatic severe aortic stenosis who underwent TAVR via the femoral artery were consecutively enrolled in this study. Eligible individuals were divided into 2 groups: the SA group and the dual artery access (DA) group. The primary end point was device success (defined by the valve academic research consortium 3, VARC 3). A 6-month follow-up and propensity score matching analyses were performed. After propensity score matching analysis, a total of 130 patients were included: 65 in the SA group and 65 in the DA group. The SA procedure achieved similar device success (95.4% vs. 87.7%; P = 0.115) compared with the DA procedure. The SA procedure shortened the operating time (102 min vs. 125 min; P = 0.001) but did not increase the x-ray time or dose. Both a 20 Fr and a 22 Fr sheath (without upgrading the sheath size) could be used for the SA procedure. There was no major vascular complication occurred in both groups. The incidence of minor main vascular and access complications in the SA group was comparable to those of the DA procedure (0.0% vs. 3.1%; P = 0.156). The SA access procedure is a promising minimally invasive TAVR technique with a low incidence of vascular complications and a high incidence of device success. It is safe and possibly applicable in all TAVR procedures.

CardioVision: A fully automated deep learning package for medical image segmentation and reconstruction generating digital twins for patients with aortic stenosis.

Aortic stenosis (AS) is the most prevalent heart valve disease in western countries that poses a significant public health challenge due to the lack of a medical treatment to prevent valve calcification. Given the aging population demographic, the prevalence of AS is projected to rise, resulting in a progressively significant healthcare and economic burden. While surgical aortic valve replacement (SAVR) has been the gold standard approach, the less invasive transcatheter aortic valve replacement (TAVR) is poised to become the dominant method for high- and medium-risk interventions. Computational simulations using patient-specific models, have opened new research avenues for optimizing emerging devices and predicting clinical outcomes. The traditional techniques of generating digital replicas of patients' aortic root, native valve, and calcification are time-consuming and labor-intensive processes requiring specialized tools and expertise in anatomy. Alternatively, deep learning models, such as the U-Net architecture, have emerged as reliable and fully automated methods for medical image segmentation. Two-dimensional U-Nets have been shown to produce comparable or more accurate results than trained clinicians' manual segmentation while significantly reducing computational costs. In this study, we have developed a fully automatic AI tool capable of reconstructing the digital twin geometry and analyzing the calcification distribution on the aortic valve. The developed automatic segmentation package enables the modeling of patient-specific anatomies, which can then be used to simulate virtual interventional procedures, optimize emerging prosthetic devices, and predict clinical outcomes.

Comparison of steady-state and transient flow measurements for the characterization of paravalvular leakage of transcatheter-aortic valve prostheses

Abstract Severe aortic valve stenosis has been successfully treated with minimally invasive transcatheter aortic valve replacement (TAVR) for more than 20 years. The therapy is applied to an increasing cohort of patients. Nevertheless, paravalvular leakage (PVL) remains one of the main complications after TAVR implantation reducing safety and efficacy of the implant. To improve TAVR performance, virtual patient cohorts can be used to generate a significant amount of data with biologically varying conditions comparable to clinically realworld data. For this purpose, in silico models need to be established which are used to evaluate the possible occurrence of PVL. When establishing in silico models, the question between simplification to reduce computational effort and still valid information from the model must always be clarified. Thus, we investigated the comparability between steadystate and transient PVL measurements as an input parameter for simulations in virtual cohorts. A clinically established TAVR was implanted into different annulus models and tested in a steady-state back-flow test bench and in a pulse duplicator system. As a result, leakage rates were compared and assumptions for the in silico models were derived. Although the trend of PVL is comparable in steady-state and transient conditions, absolute values differ making it difficult to extract generalized assumptions. Especially when PVL increased, e.g. in a larger implantation diameter or in an imperfect annulus, the variation also increased up to 50% of the measured value.

Impact of routine use of a cerebral protection device on the TAVR procedure and its short-term outcomes: a single-centre experience

Background Stroke is a major concern in transcatheter aortic valve replacement (TAVR). The introduction of a cerebral protection devices may counteract the evolution towards minimally invasive TAVR. At this time, there is insufficient data to support the routine use of these devices. Methods We aimed to evaluate the outcome of the routine use of the Sentinel Cerebral protection system® (CPS) in patients undergoing TAVR, after completing a CT-based screening process for feasibility of Sentinel implantation. We report our initial experience with the routine implementation of the Sentinel CPS in all anatomically suitable patients undergoing TAVR. We retrospectively compared the procedural characteristics and outcomes between all TAVR patients treated with (n = 78) and without (n = 79) intended Sentinel. Results The Sentinel CPS could successfully be deployed in 99% of intended cases after CT feasibility screening. TAVR procedures with Sentinel CPS were not longer than procedures without Sentinel use (89 ± 20 versus 120 ± 50 min, p = 0.007). Sentinel CPS use was not associated with an increased risk of procedural complications. Stroke was observed in none (0%) of the Sentinel CPS patients, and in 6.3% of the non-Sentinel CPS patients (p = 0.05). The finding of stroke was associated with a high risk of early postprocedural mortality: 60% of stroke patients died within 3 months. Conclusion Routine use of the Sentinel CPS in CT-screened TAVR patients is feasible with high procedural success, without significant adverse events and without counteracting the evolution towards minimally invasive TAVR. Clinically relevant stroke was observed in none of the Sentinel CPS patients.

Severe low-gradient aortic stenosis: impact of inadequate left ventricular responses to high afterload on diagnosis and therapeutic decision-making.

The fact that nearly 50% of patients with an aortic valve (AV) area < 1.0 cm2, consistent with severe aortic stenosis (AS), can have mean trans-AV pressure gradients < 40mmHg, consistent with non-severe AS, indicates that "low-gradient" (LG) severe AS, which is often associated with poor prognosis, deserves particular consideration. Inadequate left ventricular (LV) adaptation to severe AV stenosis resulting from preexistent intrinsic myocardial damages and/or maladaptive LV responses to increased afterload are typical features of severe LG-AS. The diagnosis and management of patients with severe LG-AS are particularly challenging because the discrepancy between the AV area and the trans-AV pressure gradient raises doubts concerning the actual severity of AS and therefore also about the necessity of AV replacement (AVR). LG-AS diagnosis requires integrative multimodality evaluation of both the AV and the LV and therapeutic decision-making necessitates careful individual benefit-risk estimation. Although patients with severe LG-AS associated with low trans-AV flow (i.e., stroke volume ≤ 35ml/m2) have worse outcomes after AVR than those with high-gradient severe AS, even those with reduced LV ejection fraction (LVEF) can have a significant survival benefit particularly by transcatheter AVR. Dobutamine stress echocardiography facilitates distinction between true-severe and pseudo-severe low-flow LG-AS with reduced LVEF. The review aimed to provide an updated theoretical and practical basis for those engaged in this demanding and still current topic due to the new aspects which have emerged in conjunction with both the evolving scientific knowledge about the various LV responses to the increased afterload and the increasing use of the less invasive transcatheter AVR.

Severe aortic stenosis patient risk during the COVID-19 pandemic.

Aortic stenosis (AS) is a progressive aortic valve disease that can lead to heart failure, syncope and sudden death if not treated. Severe AS currently affects more than 2 million people over 65 years of age in the USA. The only treatment option for AS is valve replacement by either surgical aortic valve replacement (AVR) or the less invasive transcatheter aortic valve replacement (TAVR), also called transcatheter aortic valve implantation (TAVI). AVR requires intensive care unit (ICU) admission, whereas TAVR can be performed in a non-ICU setting. Both procedures are commonly associated with complications, such as stroke.1 Bleeding and thrombosis are also potential complications of these procedures. Given the considerable morbidity and mortality, patients with these postoperative complications are admitted to the ICU for management. SARS-CoV-2, which causes COVID-19, has become a pandemic and has caused high mortality rates among the elderly. Currently, there is no vaccine against SARS-CoV-2, and there is no effective treatment to treat patients with severe COVID-19. More than 730 000 people worldwide and over 160 000 in the USA have died from COVID-19 as of 10 August 2020 according to Johns Hopkins Coronavirus Resource Center; these figures are expected to continue to rise until there are effective vaccines and therapies. Treating patients with COVID-19 during this pandemic requires many medical resources. Importantly, acute respiratory distress syndrome and multiorgan failures, believed to be due to systemic and pulmonary thrombosis,2 3 are common symptoms of severe COVID-19 that require treatment in the ICU. Therefore, government officials have recommended ceasing almost all elective surgeries until the COVID-19 pandemic is under control.4 Although many patients with symptomatic AS can delay procedures intended to alleviate their symptoms, some may require life-saving procedures. In cases where life-saving procedures (AVR or TAVR) are required, …

Delirium Incidence and Functional Outcomes After Transcatheter and Surgical Aortic Valve Replacement.

Transcatheter aortic valve replacement (TAVR) may be associated with less delirium and allow faster recovery than surgical aortic valve replacement (SAVR). To examine the association of delirium and its severity with clinical and functional outcomes after SAVR and TAVR. Prospective cohort study. An academic medical center. A total of 187 patients, aged 70 years and older, undergoing SAVR (N = 77) and TAVR (N = 110) in 2014 to 2016. Delirium was assessed daily using the Confusion Assessment Method (CAM), with severity measured by the CAM-Severity (CAM-S) score (range = 0-19). Outcomes were prolonged hospitalization (9 days or more); institutional discharge; and functional status, measured by ability to perform 22 daily activities and physical tasks over 12 months. SAVR patients had a higher incidence of delirium than TAVR patients (50.7% vs 25.5%; P < .001), despite younger mean age (77.9 vs 83.7 years) and higher baseline Mini-Mental State Examination score (26.9 vs 24.7). SAVR patients with delirium had a shorter duration (2.2 vs 3.4 days; P = .04) with a lower mean CAM-S score (4.5 vs 5.7; P = .01) than TAVR patients with delirium. The risk of prolonged hospitalization in no, mild, and severe delirium was 18.4%, 30.8%, and 61.5% after SAVR (P for trend = .009) and 26.8%, 38.5%, and 73.3% after TAVR (P for trend = .001), respectively. The risk of institutional discharge was 42.1%, 58.3%, and 84.6% after SAVR (P for trend = .01) and 32.5%, 69.2%, and 80.0% after TAVR (P for trend <.001), respectively. Severe delirium was associated with delayed functional recovery after SAVR and persistent functional impairment after TAVR at 12 months. Less invasive TAVR was associated with lower incidence of delirium than SAVR. Once delirium developed, TAVR patients had more severe delirium and worse functional status trajectory than SAVR patients did. NCT01845207.

Transcatheter Aortic Valve Replacements: Current Trends and Future Directions.

Since the 1960s when the first aortic surgical aortic valve replacement (SAVR) was performed, continuous growth in the field of valvular technology has occurred. Although SAVR remains a lifesaving procedure, minimally invasive transcatheter aortic valve replacement has revolutionized and expanded aortic valve replacement to patients who were not previously SAVR candidates, increasing their quality of life and survival. Since its introduction in the United States in 2011, the technology and practice have rapidly expanded. Hybrid techniques have been developed that combine surgical access to the vasculature with valvular deployment over transcatheter systems. This literature review aims to describe the differences between the current available valve technologies, review approaches to surgical technique, discuss anesthetic considerations, and look forward to future directions, trends, and challenges.

Is transcatheter aortic valve replacement a safe treatment for elderly patients with severe aortic valve stenosis?

This article's purpose is to make advanced practice nurses (APNs) aware of a minimally invasive transcatheter aortic valve replacement (TAVR) for treating symptomatic severe aortic valve stenosis in elderly patients. These patients are not safe surgical candidates because of their age and prohibitive risk profile, but they can benefit from valve replacement. A systematic literature review was completed by searching online databases such as CINAHL, PubMed, and Google. Research articles from 2008 to 2014 were retrieved from various medical journals such as The American Journal of Cardiology, Yale Journal of Biology and Medicine, Journal of the American Medical Association, and New England Journal of Medicine. Key words used in the search were aortic valve replacement, elderly patients, and severe aortic stenosis (AS). Minimally invasive TAVR is highly superior to the medical treatment including aortic valvuloplasty and is noninferior to the surgical aortic valve replacement for the treatment of symptomatic severe aortic valve stenosis in elderly patients who are not safe surgical candidates. APNs have the education and skills to diagnose AS. Hence, they should stay abreast of new treatments and provide safe care and referrals for their patients diagnosed with severe AS.