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Concept: Aortic insufficiency

5

Left ventricular (LV) systolic dysfunction and moderate aortic stenosis (AS) are more frequent with advancing age and often coexist. Afterload reduction is the mainstay of pharmacological treatment of heart failure (HF). Aortic valve replacement (AVR) is only formally indicated for symptomatic severe AS.

Concepts: Cardiology, Heart, Aorta, Left ventricle, Aortic valve, Valvular heart disease, Aortic valve replacement, Aortic insufficiency

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The prognostic importance of left ventricular (LV) mass in nonsevere asymptomatic aortic stenosis has not been documented in a large prospective study.

Concepts: Medical terms, Prognosis, Left ventricle, Asymptomatic, Aortic valve, Valvular heart disease, Aortic valve stenosis, Aortic insufficiency

4

The American College of Cardiology collaborated with the American Association for Thoracic Surgery, American Heart Association, American Society of Echocardiography, European Association for Cardio-Thoracic Surgery, Heart Valve Society, Society of Cardiovascular Anesthesiologists, Society for Cardiovascular Angiography and Interventions, Society of Cardiovascular Computed Tomography, Society for Cardiovascular Magnetic Resonance, and Society of Thoracic Surgeons to develop and evaluate Appropriate Use Criteria (AUC) for the treatment of patients with severe aortic stenosis (AS). This is the first AUC to address the topic of AS and its treatment options, including surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR). A number of common patient scenarios experienced in daily practice were developed along with assumptions and definitions for those scenarios, which were all created using guidelines, clinical trial data, and expert opinion in the field of AS. The 2014 AHA/ACC guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines(1) and its 2017 focused update paper (2) were used as the primary guiding references in developing these indications. The writing group identified 95 clinical scenarios based on patient symptoms and clinical presentation, and up to 6 potential treatment options for those patients. A separate, independent rating panel was asked to score each indication from 1 to 9, with 1-3 categorized as “Rarely Appropriate,” 4-6 as “May Be Appropriate,” and 7-9 as “Appropriate.” After considering factors such as symptom status, left ventricular (LV) function, surgical risk, and the presence of concomitant coronary or other valve disease, the rating panel determined that either SAVR or TAVR is Appropriate in most patients with symptomatic AS at intermediate or high surgical risk; however, situations commonly arise in clinical practice in which the indications for SAVR or TAVR are less clear, including situations in which 1 form of valve replacement would appear reasonable when the other is less so, as do other circumstances in which neither intervention is the suitable treatment option. The purpose of this AUC is to provide guidance to clinicians in the care of patients with severe AS by identifying the reasonable treatment and intervention options available based on the myriad clinical scenarios with which patients present. This AUC document also serves as an educational and quality improvement tool to identify patterns of care and reduce the number of rarely appropriate interventions in clinical practice.

Concepts: Clinical trial, Cardiology, Heart, Surgery, Valvular heart disease, Thoracic surgery, Aortic valve stenosis, Aortic insufficiency

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Use of transcatheter aortic valve replacement (TAVR) for severe aortic stenosis is growing rapidly. However, to our knowledge, the durability of these prostheses is incompletely defined.

Concepts: Left ventricle, Aortic valve, Valvular heart disease, Valve, Valve Corporation, Aortic valve stenosis, Aortic valve replacement, Aortic insufficiency

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A 68 year-old man with a severe ischemic cardiomyopathy underwent left ventricular assist device (LVAD) implantation (Heart Mate II device) for destination therapy. He presented 49 months following LVAD implant with worsening heart failure symptoms and new severe aortic regurgitation. Given high risk for both surgical and transcatheter aortic valve replacement, he was admitted for transcatheter closure of the aortic valve under transesophageal echocardiographic (TEE) guidance. TEE imaging revealed severe aortic regurgitation (see Figure 1A and 1B, and multimedia files 1 and 2). Under TEE and fluoroscopic guidance, a 25 mm Amplatzer cribiform atrial septal defect closure device was advanced across the aortic valve (see figures 1C and 1D, and multimedia files 3 and 4). Immediately following device deployment, TEE revealed a well-seated device with complete aortic valve closure, and trivial aortic regurgitation (see figures 2A-D, and multimedia files 5-7). Subsequent transthoracic echocardiograms obtained from 74 to 172 days post-procedure revealed no residual aortic regurgitation. The patient awoke with diffuse urticaria 244 days following the procedure, and died en route to the emergency department, presumably secondary to a systemic allergic reaction. De novo aortic regurgitation is increasingly recognized in patients with LVADs (1). TEE guided transcatheter aortic valve closure is an option in these high-risk patients (2).

Concepts: Cardiology, Heart failure, Heart, Left ventricle, Ventricular assist device, Aortic valve, Aortic valve replacement, Aortic insufficiency

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Aims: Transcatheter aortic valve implantation (TAVI) has become a viable option for selected high-risk patients with severe and symptomatic aortic stenosis. First- and second-generation TAVI devices are either self- or balloon-expandable, and are often not repositionable or not fully retrievable, leading to suboptimal positioning in some cases. This may result in paravalvular regurgitation, AV conduction delay, or compromise of coronary perfusion. A broader application of TAVI requires advances in both valve and delivery systems. Therefore, in order to facilitate accurate positioning, to minimise paravalvular leakage, possibly to reduce the risk of AV conduction delay, and possibly to be able to abort the procedure, a “next-generation” TAVI system has been developed which is repositionable and retrievable, the TRINITY heart valve system. Methods and results: The TRINITY heart valve system was implanted in a first-in-human study using the transapical approach to demonstrate feasibility and procedural success. All endpoints were adjudicated according to VARC definitions at seven and 30 days. The TRINITY heart valve system was implanted in a 74-year-old patient with severe symptomatic aortic valve stenosis. In this case, repositioning of the TRINITY resulted in optimal position without paravalvular leakage and with perfect function. Conclusions: The TRINITY heart valve is a repositionable and retrievable TAVI system. Both the implantation result and short-term clinical and haemodynamic outcome were excellent.

Concepts: Cardiology, Heart, Tricuspid valve, Left ventricle, Valvular heart disease, Artificial heart valve, Aortic valve stenosis, Aortic insufficiency

3

The risk and benefit of mechanical interventions in valvular heart disease have been primarily described among patients with normal ejection fraction. The advent of nonsurgical mechanical interventions for aortic stenosis (transcatheter aortic valve replacement) may alter the risk-benefit ratio for patients who would otherwise be at increased risk for valve surgery. This review describes the epidemiology and pathophysiology of aortic stenosis with heart failure and reduced ejection fraction and summarizes the current registry and clinical trial data applicable to this frequently encountered high-risk group. It concludes with discussion of ongoing trials, new approaches, emerging indications, and a potential clinical algorithm incorporating optimal mechanical intervention for patients with aortic stenosis and concomitant reduced ejection fraction.

Concepts: Clinical trial, Cardiology, Ejection fraction, Valvular heart disease, Aortic insufficiency

3

Little is known about the association between bicuspid aortic valve (BAV) morphologic findings and the degree of valvular dysfunction, presence of aortopathy, and complications, including aortic valve surgery, aortic dissection, and all-cause mortality.

Concepts: The Association, Aortic dissection, Aortic valve, Degree of a polynomial, Valve, Aortic insufficiency, Bicuspid aortic valve, Check valve

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Little is known about the level of public knowledge and concern towards aortic valve disease. Therefore, a survey was conducted to evaluate the awareness of the general population regarding different diseases with special emphasis on aortic stenosis (AS).

Concepts: Disease, Death, Senescence, Understanding, Aortic valve, Valvular heart disease, Aortic valve stenosis, Aortic insufficiency

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IMPORTANCE Transcatheter aortic valve replacement (TAVR) was approved by the US Food and Drug Administration for the treatment of severe, symptomatic aortic stenosis and inoperable status (in 2011) and high-risk but operable status (starting in 2012). A national registry (the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy [STS/ACC TVT] Registry) was initiated to meet a condition for Medicare coverage and also facilitates outcome assessment and comparison with other trials and international registries. OBJECTIVE To report the initial US commercial experience with TAVR. DESIGN, SETTING, AND PARTICIPANTS We obtained results from all eligible US TAVR cases (n=7710) from 224 participating registry hospitals following the Edwards Sapien XT device commercialization (November 2011-May 2013). MAIN OUTCOMES AND MEASURES Primary outcomes included all-cause in-hospital mortality and stroke following TAVR. Secondary analyses included procedural complications and outcomes by clinical indication and access site. Device implantation success was defined as successful vascular access, deployment of a single device in the proper anatomic position, appropriate valve function without either moderate or severe AR, and successful retrieval of the delivery system. Thirty-day outcomes are presented for a representative 3133 cases (40.6%) at 114 centers with at least 80% complete follow-up reporting. RESULTS The 7710 patients who underwent TAVR included 1559 (20%) cases that were inoperable and 6151 (80%) cases that were high-risk but operable. The median age was 84 years (interquartile range [IQR], 78-88 years); 3783 patients (49%) were women and the median STS predicted risk of mortality was 7% (IQR, 5%-11%). At baseline, 2176 patients (75%) were either not at all satisfied (1297 patients [45%]) or mostly dissatisfied (879 patients [30%]) with their symptom status; 2198 (72%) had a 5-m walk time longer than 6 seconds (slow gait speed). The most common vascular access approach was transfemoral (4972 patients [64%]), followed by transapical (2197 patients [29%]) and other alternative approaches (536 patients [7%]); successful device implantation occurred in 7069 patients (92%; 95% CI, 91%-92%). The observed incidence of in-hospital mortality was 5.5% (95% CI, 5.0%-6.1%). Other major complications included stroke (2.0%; 95% CI, 1.7%-2.4%), dialysis-dependent renal failure (1.9%; 95% CI, 1.6%-2.2%), and major vascular injury (6.4%; 95% CI, 5.8%-6.9%). Median hospital stay was 6 days (IQR, 4-10 days), with 4613 (63%) discharged home. Among patients with available follow-up at 30 days (n=3133), the incidence of mortality was 7.6% (95% CI, 6.7%-8.6%) (noncardiovascular cause, 52%); a stroke had occurred in 2.8% (95% CI, 2.3%-3.5%), new dialysis in 2.5% (95% CI, 2.0%-3.1%), and reintervention in 0.5% (95% CI, 0.3%-0.8%). CONCLUSIONS AND RELEVANCE Among patients undergoing TAVR at US centers in the STS/ACC TVT Registry, device implantation success was achieved in 92% of cases, the overall in-hospital mortality rate was 5.5%, and the stroke rate was 2.0%. Although these postmarket US approval findings are comparable with prior published trial data and international experience, long-term follow-up is essential to assess continued efficacy and safety. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT01737528.

Concepts: Dialysis, Medical terms, Medical statistics, Interquartile range, Aortic valve, Aortic valve replacement, Aortic insufficiency, 22nd century