Showing 6 ideas for tag "valvular"

Goal 2: Reduce Human Disease

Detection of rupture prone small aortic aneurysms

Critical challenges in the assessment of aortic aneurysms are: (1) Availability of reliable animal models that simulate the human pathology, (2) Availability of molecular imaging resources – identification of biomarkers, development of targeted imaging probes and pre-clinical imaging methods, and plasma markers that predict whether an aneurysm is prone to rupture or dissection, (3) Bringing together a wide array of multi-disciplinary... more »

Is this idea a Compelling Question (CQ) or Critical Challenge (CC)? Critical Challenge (CC)

Details on the impact of addressing this CQ or CC

Developing clinically viable methods to detect rupture prone aneurysms can lead to better methods of diagnosis and intervention and avoid preventable fatalities

Feasibility and challenges of addressing this CQ or CC

Several other disease areas including oncological that had similar gap was filled by NIH (NCI) and the challenges were overcome in less than 10 years. The scientific expertise to fill the gap exists, however they work in silos, which need to be brought together to fulfil this gap and is achievable in less than 10 years
Assessment of aortic aneurysms that are prone to rupture or dissection has been an elusive target. Current clinical practice measures the aortic diameter and fails to relate to the pathophysiology and biomechanical properties of the aneurysm in deciding preventive surgery. Critical gap exists in the diagnosis of aneurysm especially with small aneurysms (3 - 5 cm in diameter) that are rupture prone. Based on autopsy about 10 percent of individuals with small abdominal aneurysms had undergone fatal rupture, while 40 percent with diameters of 7-10 cm had intact aneurysm and died from other causes. International Registry of Aortic Dissection found that 40% of thoracic aneurysms dissected at diameters smaller than 5 cm.

Name of idea submitter and other team members who worked on this idea NHLBI Staff

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Goal 2: Reduce Human Disease

Management strategies for severe, asymptomatic aortic stenosis

What is the optimal management approach to severe asymptomatic calcific aortic stenosis (surgical aortic valve replacement (AVR) or deferred surgical AVR until development of symptoms (watchful waiting))?

Is this idea a Compelling Question (CQ) or Critical Challenge (CC)? Compelling Question (CQ)

Details on the impact of addressing this CQ or CC

Several non-randomized, retrospective analyses suggest early surgery results in improved survival but significant controversy remains. Answering this compelling question will clear up this conundrum of clinical management in this prevalent disease.

Feasibility and challenges of addressing this CQ or CC

It is feasible to answer this question over the next 5-10 years because the disease is prevalent and growing with the aging population and there is equipoise within the medical community about current management options.

Name of idea submitter and other team members who worked on this idea NHLBI Staff

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6 net votes
14 up votes
8 down votes
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Goal 3: Advance Translational Research

Safety and effectiveness of new direct oral anticoagulants

What is the optimal use of new direct oral anticoagulants?

Is this idea a Compelling Question (CQ) or Critical Challenge (CC)? Compelling Question (CQ)

Details on the impact of addressing this CQ or CC

Vitamin K antagonist, warfarin, has traditionally been the mainstay of anticoagulation therapy. It requires frequent monitoring to maintain safe and effective dose and is associated with many food and drug interactions. A new generation of direct oral anticoagulants has been developed to overcome such shortcomings.
Two main classes of new direct oral anticoagulants are available: factor Xa inhibitors and factor IIa (thrombin) inhibitors. Their mechanism of action involves direct inhibition of a single factor within the coagulation cascade to exert an anticoagulant effect. The industry is positioning them as monitoring-free universal warfarin replacement products. However, use of new direct oral anticoagulants introduces two major clinical issues: majority of new generation anticoagulants do not have developed dose-monitoring assay and do not have antidotes to rapidly restore blood coagulation properties in patients with trauma, emergent surgery, or anticoagulation overdose. Addressing these issues would positively impact cardiovascular, pulmonary, benign hematology, and orthopedic services worldwide.
While the idea of a universal, low-maintenance, “one dose fits all” anticoagulant is highly appealing to both patients and physicians, it may be feasible to consider more targeted approach, where each new anticoagulant would be assessed for most plausible effect in the specific patient population with consideration to genetic s, sex, race, age, thrombosis history, and obesity

Feasibility and challenges of addressing this CQ or CC

Rapid advancement in the field of new generation direct oral anticoagulants and multiplicity of new drugs introduce opportunity to conduct comparative effectiveness research and assess how different characteristics of new products may be appropriate for different patients. Increased use of new direct oral anticoagulants requires expedited development of assays and antidotes for safe and efficient therapy of millions of Americans.

 

A challenge is that the majority of the clinical trials for new direct oral anticoagulants were conducted by the industry with the main goal of demonstrating superiority, or non-inferiority to warfarin. Secondary analyses of these trials’ data for efficacy in specific patient population may be difficult. Prospective clinical studies in this area may require large sample size and establishing collaboration between hematologists and other involved clinicians.

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4 net votes
31 up votes
27 down votes
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Goal 2: Reduce Human Disease

Risk scores for valvular heart disease

What is an appropriate risk score for intervention in valvular heart disease?

Is this idea a Compelling Question (CQ) or Critical Challenge (CC)? Compelling Question (CQ)

Details on the impact of addressing this CQ or CC

More accurate risk estimates would provide clinicians with clearer guidance in selecting how and when to intervene in valvular heart disease.

Feasibility and challenges of addressing this CQ or CC

The advent and rapid advance of transcatheter therapy for valvular heart disease makes this an opportune time to develop metrics to determine whether transcatheter or surgical intervention is most appropriate and when.
The decision to intervene, as well as the type of intervention, is based on individual risk scores such as the STS risk estimate or the Euroscore. However, these scores are derived only from surgical patients and do not take into account procedure-specific impediments, major organ system compromise, comorbidities, or the frailty of the patient.

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5 up votes
10 down votes
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Goal 2: Reduce Human Disease

Prevention of rheumatic heart disease

Global health system outcomes studies are needed to identify impediments to successful primary and secondary prevention of rheumatic heart disease.

Other approaches, such as development of a vaccine for group A streptococcus and delaying disease progression once valve damage is present, could also be explored.

Is this idea a Compelling Question (CQ) or Critical Challenge (CC)? Critical Challenge (CC)

Details on the impact of addressing this CQ or CC

On a global basis, rheumatic fever remains the primary cause of valvular heart disease. Although the prevalence is much less in developed countries, pockets remain among groups with less access to healthcare.

Feasibility and challenges of addressing this CQ or CC

Global health outcome studies could be performed over the next 5-10 years. The use of recently-developed point-of-care diagnostic tests could support these studies.

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Goal 2: Reduce Human Disease

Antibiotic prophylaxis of infective endocarditis

What is the optimal use of antibiotics for prophylaxis of infective endocarditis?

Is this idea a Compelling Question (CQ) or Critical Challenge (CC)? Compelling Question (CQ)

Details on the impact of addressing this CQ or CC

Answering this question would provide an evidence base for the use of antibiotics for prophylaxis of infective endocarditis (IE). Clinicians in the US remain skeptical of the 2007 AHA guidelines reducing the use of antibiotics, and the guidelines, themselves, cited the need for additional prospective studies. In addition, a recent study by Dayer et al reports an increase in the incidence of IE in the UK following adoption of similar guidelines.

Feasibility and challenges of addressing this CQ or CC

The question is actually overdue to be addressed following adoption of the 2007 guidelines.
Challenge: Considering the severe consequences of infective endocarditis, it may be difficult to design a definitive placebo-controlled clinical trial.

Name of idea submitter and other team members who worked on this idea NHLBI Staff

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3 up votes
9 down votes
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