Advances in Clinical Cardiology 2021: A Summary of Key Clinical Trials.

INTRODUCTION: Over the course of 2021, numerous key clinical trials with valuable contributions to clinical cardiology were published or presented at major international conferences. This review seeks to summarise these trials and reflect on their clinical context. METHODS: The authors reviewed clinical trials presented at major cardiology conferences during 2021 including the American College of Cardiology (ACC), European Association for Percutaneous Cardiovascular Interventions (EuroPCR), European Society of Cardiology (ESC), Transcatheter Cardiovascular Therapeutics (TCT), American Heart Association (AHA), European Heart Rhythm Association (EHRA), Society for Cardiovascular Angiography and Interventions (SCAI), TVT-The Heart Summit (TVT) and Cardiovascular Research Technologies (CRT). Trials with a broad relevance to the cardiology community and those with potential to change current practice were included. RESULTS: A total of 150 key cardiology clinical trials were identified for inclusion. Interventional cardiology data included trials evaluating the use of new generation novel stent technology and new intravascular physiology strategies such as quantitative flow ratio (QFR) to guide revascularisation in stable and unstable coronary artery disease. New trials in acute coronary syndromes focused on shock, out of hospital cardiac arrest (OOHCA), the impact of COVID-19 on ST-elevation myocardial infarction (STEMI) networks and optimal duration/type of antiplatelet treatment. Structural intervention trials included latest data on transcatheter aortic valve replacement (TAVR) and mitral, tricuspid and pulmonary valve interventions. Heart failure data included trials with sodium-glucose cotransporter 2 (SGLT2) inhibitors, sacubitril/valsartan and novel drugs such as mavacamten for hypertrophic cardiomyopathy (HCM). Prevention trials included new data on proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors. In electrophysiology, new data regarding atrial fibrillation (AF) screening and new evidence for rhythm vs. rate control strategies were evaluated. CONCLUSION: This article presents a summary of key clinical cardiology trials published and presented during the past year and should be of interest to both practising clinicians and researchers.

Official Information Act investigation of the Ministry of Health's process to assess the Southern District Health Board's readiness to join the National Bowel Screening Programme in 2018

We examined the documentation underlying the decision to permit the Southern District Health Board (SDHB) to join the National Bowel Screening Programme (NBSP) at a time when it was not providing an adequate colonoscopy service for symptomatic patients. A coordinated sequence of relevant Official Information Act 1982 (OIA) requests was lodged with the New Zealand Ministry of Health (MoH), which is responsible for determining the readiness of district health boards (DHBs) to join the NBSP. However, the MoH OIA process was obfuscating, unduly long and responded only after they anticipated imminent intervention by the Office of the Ombudsman. The amount of information provided was massive, partly irrelevant and presented in an inconvenient format. It revealed that the MoH readiness process was incomplete, and permission for the SDHB to join the NBSP was given prematurely without following due process and despite concerns expressed by some MoH staff. Subsequently, the MoH has failed to admit that they made errors in this case or have any weaknesses in their readiness assessment process. The MoH readiness process failed to determine that the SDHB was not ready to join the NBSP in 2018. Concerns have been expressed in the public media that such failures have occurred with the assessment of other DHBs. The process needs to be overhauled or replaced before further permissions are granted to DHBs. Requests for information under the OIA from the MoH, and similar public entities and agencies subject to the OIA, are too easily deferred, derailed or declined. The OIA is in need of revision.

Adequacy of publicly funded colonoscopy services in New Zealand

In order to improve clinical referral for the relatively scarce and costly resource of colonoscopy, national clinical guidelines for its use in the diagnosis of symptomatic cases and for those at increased risk of colorectal cancer (CRC) were introduced in 2011.3 The guidelines were listed as clinical practice recommendations for patients presenting with symptoms of CRC and were specified to only apply to patients referred by GPs and non-gastrointestinal specialists.3 A fundamental feature of clinical guidelines is that they should be evidence-based indicators of medical practice to assist clinical decision-making. In response to the deficiency, and to avoid costly outsourcing to the private sector, most DHBs started using the national clinical guidelines as necessary requirements, or access protocols, (with and without local modifications) for colonoscopy from all sources, including those from physicians and surgeons with specialist gastrointestinal training and interests.7 This development raises three concerns: (i) the clinical guidelines were largely based on overseas data about the positive predictive value for the detection of CRC;they did not take account of the likelihood of the presence of other serious colorectal diseases: (ii) in spite of their widespread use, their effectiveness has only been quantified in terms of DHB compliance rates with clinical categories of urgency of need;they have not been formally assessed in relation to clinical or economic outcomes: (iii) local modification can produce inequitable regional variability in access to colonoscopy and the impact on CRC mortality from restricted access has not been sufficiently evaluated. [...]the use of the clinical guidelines to restrict access to colonoscopy was applied inappropriately and not adequately monitored for efficacy or harm. Emerging evidence increasingly indicates that the predicted conflicts16 have occurred in some regions between access to colonoscopy for symptomatic cases versus access for screening purposes, as happened for example at the Southern DHB.717 Underlying causes for this conflict might include failure of the DHB 'readiness assessment', adjudged by the Ministry of Health,18 to adequately predict the requirements of the complex additional burden of screening, insufficient funding for screening to prevent interference with other clinical care, or failure of the Ministry of Health to implement the guidelines of the Health Quality and Safety Commission.16 Efforts have been applied by the New Zealand Society of Gastroenterology, among others, to attract the additional resources needed to expand workforce numbers, and in advocating for more financial and infra-structural support from government. [...]competition for colonoscopy access between symptomatic and screening cases is occurring in some DHBs.