Safety, effectiveness and costs of percutaneous mitral valve repair: A real-world prospective study.

AIMS: Percutaneous mitral valve leaflet repair is a treatment option for some people with severe mitral valve regurgitation for whom conventional mitral valve surgery is clinically inappropriate. This study aimed to determine the safety, efficacy, and costs of percutaneous mitral valve leaflet repair, using the MitraClip device in a UK setting. METHODS AND RESULTS: This was a prospective, single-armed registry with a follow-up of 2 years that reported a range of procedural, clinical and patient-orientated outcomes. Registry data were linked to routine data sources to allow for more comprehensive follow up concerning mortality and healthcare resource use. The registry received data for 199 mainly elective patients with mixed mitral regurgitation aetiology. A MitraClip device was implanted in 187 patients (94%), with a procedural success rate of 86%, with 8% of patients having a serious in-hospital adverse event (including 5% mortality). Percutaneous mitral valve leaflet repair reduced mitral regurgitation from 100% MR grade ≥ 3+ to 7% at discharge. There were corresponding improvements in New York Heart Association functional class, reducing from 92% (class ≥ 3) at baseline to 18% at 6 weeks. There were significant improvements in generic and disease specific quality of life indicators up to 2 years. The all-cause mortality rate was estimated to be 12.7% (95% CI 7.5 to 17.7%) at 1 year. Percutaneous mitral valve leaflet repair was associated with reduced hospital readmissions and potential cost-savings in post-procedural care. CONCLUSION: This study shows that percutaneous mitral valve leaflet repair using MitraClip is a relatively safe and effective treatment in patients unable to tolerate surgery and has the potential to reduce ongoing healthcare costs in the UK.

Comparison of identifiable and non-identifiable data linkage: health technology assessment of MitraClip using registry, administrative and mortality datasets.

OBJECTIVES: The UK MitraClip registry was commissioned by National Health Service (NHS) England to assess real-world outcomes from percutaneous mitral valve repair for mitral regurgitation using a new technology, MitraClip. This study aimed to determine longitudinal patient outcomes by linking to routine datasets: Hospital Episode Statistics (HES) Admitted Patient Care (APC) and Office of National Statistics. METHODS: Two methods of linkage were compared, using identifiable (NHS number, date of birth, postcode, gender) and non-identifiable data (hospital trust, age in years, admission, discharge and operation dates, operation and diagnosis codes). Outcome measures included: matching success, patient demographics, all-cause mortality and subsequent cardiac intervention. RESULTS: A total of 197 registry patients were eligible for matching with routine administrative data. Using identifiable linkage, a total of 187 patients (94.9%) were matched with the HES APC dataset. However, 21 matched individuals (11.2%) had inconsistencies across the datasets (eg, different gender) and were subsequently removed, leaving 166 (84.3%) for analysis. Using non-identifiable data linkage, a total of 170 patients (86.3%) were uniquely matched with the HES APC dataset.Baseline patient characteristics were not significantly different between the two methods of data linkage. The total number of deaths (all causes) identified from identifiable and non-identifiable linkage methods was 37 and 40, respectively, and the difference in subsequent cardiac interventions identified between the two methods was negligible. CONCLUSIONS: Patients from a bespoke clinical procedural registry were matched to routine administrative data using identifiable and non-identifiable methods with equivalent matching success rates, similar baseline characteristics and similar 2-year outcomes.

Realities of environmental toxicity and their ramifications for community engagement.

Research on community responses to environmental toxicity has richly described the struggles of citizens to identify unrecognized toxins, collect their own environmental health facts, and use them to lobby authorities for recognition and remediation. Much of this literature is based on an empiricist premise: it is concerned with exploring differences in how laypeople and experts perceive what is presumed to be a singular toxic reality that preexists these varying perspectives. Here, we seek to reexamine this topic by shifting the focus from facts to facticity-that is, by exploring the many types of knowledge that communities develop about toxicity and how these knowledges articulate with the ideas of scientific and governmental authorities about what kinds of information are valid bases for policymaking. In making this shift, we are influenced by work in semiotic anthropology and science and technology studies (STS), which emphasizes that lived experience generates distinct realities rather than different perceptions of the same underlying state. Using this framework, we present an analysis of oral history interviews conducted in 2013-14 in the small American town of Ambler, Pennsylvania. Part of Ambler's legacy as a nineteenth- and twentieth-century center of asbestos manufacture is that it is home to two massive asbestos-containing waste sites, one of which was being remediated by the Environmental Protection Agency (EPA) at the time of this study. Our interviews demonstrate that even asbestos, a toxin with a well-established public narrative, is a fundamentally different object for different members of the Ambler community. For many of these individuals, the epistemology and practices of the EPA are incongruent with or tangential to their toxicity-related experiences and their consequent concerns for the future. As such, our findings suggest caution in framing the community engagement efforts of environmental health agencies primarily as facilitations of citizen science; this approach does not acknowledge the multiplicity of toxic realities.