{"title":"Response to: Correspondence on 'Cost-effectiveness of transcatheter edge-to-edge repair in secondary mitral regurgitation does need confirmation' by Armoiry and Connock","authors":"M. Garbi, Alfredo Mariani","doi":"10.1136/heartjnl-2022-321181","DOIUrl":"https://doi.org/10.1136/heartjnl-2022-321181","url":null,"abstract":"We read with interest the response of Armoiry and Connock to our editorial and to the Cohen et al paper it referred to. This response demonstrates the wide interest on costeffectiveness of transcatheter edgetoedge repair (TEER) in secondary mitral regurgitation. Armoiry and Connock generously conclude that the paper by Cohen et al ‘represents a valuable contribution’, although criticising it throughout the text. Regarding our editorial, we are sorry that Armoiry and Connock disagree with our statement that costeffectiveness of TEER in secondary mitral regurgitation does not need confirmation. Yet, our statement refers strictly to the UK NHS and is underpinned by the costeffectiveness analyses that informed the National Institute for Health and Care Excellence (NICE) guidelines recommendation: the NICE MitraClip model and Shore 2020. Although Armoiry and Connock state that in the UK ‘costeffectiveness is a key criterion to judge recommendation’ and although at current device cost, in the UK NHS, the incremental cost per qualityadjusted lifeyear (QALY) gained for TEER in secondary mitral regurgitation was significantly above the £20 000 threshold in both NICE analysis and Shore 2020, the NICE guidelines do recommend TEER in secondary mitral regurgitation; the recommendation (‘consider TEER’) is of similar strength with the European and American guidelines recommendation (class II). The NICE incremental cost per QALY gained threshold refers to a strong recommendation (‘offer TEER’), equivalent with a European and American recommendation class I. However, the existent clinical effectiveness evidence prevents all guidelines from making a strong recommendation. Further costeffectiveness confirmation would only be needed in case of new clinical effectiveness evidence supportive of a strong recommendation and of reduction of device cost in the UK NHS.","PeriodicalId":9311,"journal":{"name":"British Heart Journal","volume":"108 1","pages":"1073 - 1073"},"PeriodicalIF":0.0,"publicationDate":"2022-05-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"45624687","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Correspondence on 'Cost-effectiveness of transcatheter edge-to-edge repair in secondary mitral regurgitation does need confirmation' by Cohen et al","authors":"X. Armoiry, M. Connock","doi":"10.1136/heartjnl-2022-321179","DOIUrl":"https://doi.org/10.1136/heartjnl-2022-321179","url":null,"abstract":"To the Editor: we have read with considerable interest the paper by Cohen et al estimating the costeffectiveness of the Mitraclip system in patients with secondary mitral regurgitation (SMR). Like other published works that adopted different healthcare perspectives, including the one by Baron et al, the costeffectiveness analysis conducted by Cohen et al was based on 2year data from the Coapt randomised controlled trial (RCT). Generating lifetime estimates of survival gain (1.57 years here) from the 2year data of Coapt requires extensive extrapolation of about 13 years beyond observed data and >95% of benefit reported in the percutaneous repair (PR) arm accrues in the extrapolation phase rather than the observation phase. The observed source data used for extrapolation can therefore exert a profound influence on estimation of gained benefit from PR. We were surprised that Cohen et al chose not to consider in their economic model the 3year data from Coapt which were released as oral presentation in 2019 and fully published in late 2020. Indeed, the 3year allcause mortality curve for the Mitraclip arm of Coapt reported by Mack et al 5 indicates a doubling in mean mortality rate in years 2–3 relative to years 1–2 (estimated using area under the curve as is done in costeffectiveness analysis). The upturn in mortality during years 2–3 in the PR arm is similarly reflected in the cumulative percentage mortality reported at years 1, 2 and 3 of 19%, 28.2% and 42.8%, respectively, that translates to a crude estimate of annual mortality rates of 19% over the first year, 9.2% over years 1–2, and 14.6% over years 2–3; an increase of 59% in rate for years 2–3 relative to years 1–2. It is therefore evident that using 3year mortality data instead of 2year will considerably influence estimated survival gains accrued in economic models. Consequently, we believe that the lifetime extrapolation beyond the observed 2year data is highly optimistic in the work by Cohen et al, particularly for the intervention arm, and that this has potential to impact the costeffectiveness in favour of the intervention. As a general principle, it would be expected that using longer rather than shorter followup results from trials is likely to reduce uncertainty in costeffectiveness estimates. This can optimise decisionmaking in territories such as the UK where costeffectiveness is a key criterion to judge recommendation of new technologies. In consequence, in our opinion, the 2year mortality data from Stone et al are likely to be unsuitable for reliable costeffectiveness analysis. Further prespecified analyses from Coapt at 4 and 5 years are eagerly awaited. Additionally, the generalisability of Cohen et al findings using US Coapt population as source of clinical inputs may be questionable since, as acknowledged by authors in the Limitation section, the inputs from the MitraFr RCT (undertaken in a French population and showing no advantage of PR relative to medical treatment alone) wer","PeriodicalId":9311,"journal":{"name":"British Heart Journal","volume":"108 1","pages":"1071 - 1071"},"PeriodicalIF":0.0,"publicationDate":"2022-05-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44480985","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Juan A Quintero-Martinez, Joya-Rita Hindy, Said El Zein, Hector I Michelena, Vuyisile T Nkomo, Daniel C DeSimone, Larry M Baddour
{"title":"Contemporary demographics, diagnostics and outcomes in non-bacterial thrombotic endocarditis.","authors":"Juan A Quintero-Martinez, Joya-Rita Hindy, Said El Zein, Hector I Michelena, Vuyisile T Nkomo, Daniel C DeSimone, Larry M Baddour","doi":"10.1136/heartjnl-2022-320970","DOIUrl":"10.1136/heartjnl-2022-320970","url":null,"abstract":"<p><strong>Objective: </strong>Non-bacterial thrombotic endocarditis (NBTE) is a syndrome characterised by cardiac valve vegetations and/or thickening due to non-infective mechanisms. Nowadays, a premortem diagnosis of NBTE is possible based on echocardiographic findings. Therefore, to better characterise this disease, we performed a contemporary review of the epidemiology, demographics, diagnosis and clinical outcomes of these patients.</p><p><strong>Methods: </strong>Adults with a diagnosis of NBTE seen within the Mayo Clinic Enterprise from December 2014 to December 2021 were included. NBTE diagnosis was identified by clinicians representing at least two specialties including cardiology, infectious diseases, rheumatology and oncology. Patients with positive blood cultures, infective endocarditis, culture-negative endocarditis and denial of research authorisation were excluded. All patients had a 1-year follow-up.</p><p><strong>Results: </strong>Forty-eight cases were identified; mean age was 60.0±13.8 years, 75% were female. The most prevalent comorbidities were malignancy (52.1%) and connective tissue disease (37.5%). Valvular abnormalities included 41 (85.4%) patients with vegetations, 43 (89.6%) patients with thickening and 26 (54.2%) with moderate to severe regurgitation. Thirty-eight (79.2%) patients had an embolic event (stroke in 26 (54.2%) patients) within 1 month of NBTE diagnosis and 16 (33.3%) patients died within 1 year of NBTE diagnosis. Metastatic tumours and lung cancer were associated with 1-year all-cause mortality (p=0.0017 and p=0.0004, respectively).</p><p><strong>Conclusions: </strong>NBTE was more prevalent in females and embolic complications were the most frequent clinical finding. Overall, patients with NBTE had a poor prognosis, particularly in those with lung cancer or metastatic tumours. Further studies in patients with NBTE are needed given its morbidity and mortality.</p>","PeriodicalId":9311,"journal":{"name":"British Heart Journal","volume":"108 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-05-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48960331","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Response to: Correspondence on 'Cost-effectiveness of transcatheter edge-to-edge repair in secondary mitral regurgitation does need confirmation' by Armoiry and Connock","authors":"D. Cohen, E. Magnuson, G. Stone, J. Cleland","doi":"10.1136/heartjnl-2022-321180","DOIUrl":"https://doi.org/10.1136/heartjnl-2022-321180","url":null,"abstract":"","PeriodicalId":9311,"journal":{"name":"British Heart Journal","volume":"108 1","pages":"1072 - 1072"},"PeriodicalIF":0.0,"publicationDate":"2022-05-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48364165","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
M. Imazio, Gabriele Barberi Squarotti, A. Andreis, A. Agosti, M. Millesimo, S. Frea, C. Giustetto, G. Deferrari
{"title":"Diagnostic and prognostic role of the electrocardiogram in patients with pericarditis","authors":"M. Imazio, Gabriele Barberi Squarotti, A. Andreis, A. Agosti, M. Millesimo, S. Frea, C. Giustetto, G. Deferrari","doi":"10.1136/heartjnl-2021-320443","DOIUrl":"https://doi.org/10.1136/heartjnl-2021-320443","url":null,"abstract":"Objective The ECG has been traditionally used to support the diagnosis of pericarditis. However, the pericardium is electrically silent and ECG changes may imply concurrent myocardial involvement rather than simple pericarditis. The aim of the present paper is to analyse the frequency, type and clinical implication of ECG changes in patients with pericarditis compared with those with myocarditis. Methods Consecutive patients with pericarditis and/or myocarditis were included in a prospective cohort study from January 2017 to December 2020. A clinical and echocardiographic follow-up was performed at 1, 3, 6 months and then every 6 months. Cardiac magnetic resonance was used to diagnose concurrent myocarditis. Results 166 patients (median age 47 years, 95% CI 44 to 51) with 66 men (39.8%) were included: 110 cases with pericarditis (mean age 47.7 years, 29.1% male) and 56 cases with myocarditis (mean age 44.8, 60.7% male). ECG changes were reported in 61 of 166 (36.7%) patients: 27 of 110 (24.5%) among those with pericarditis and 34 of 56 (60.7%) among those with myocarditis (p<0.0001). In multivariate logistic regression analysis, ECG changes were associated with troponin elevation (risk ratio 1.97; 95% CI 1.13 to 3.43), suggesting myocardial involvement. ECG changes were not associated with increased risk of adverse events. Conclusions ECG changes, mainly widespread ST-segment elevation, can be recorded in about one-quarter of patients with pericarditis, and were not associated with a worse prognosis. These changes may reflect concurrent myocarditis that should be ruled out.","PeriodicalId":9311,"journal":{"name":"British Heart Journal","volume":"108 1","pages":"1474 - 1478"},"PeriodicalIF":0.0,"publicationDate":"2022-05-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44411703","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Christine Mansour, Nooshin Beygui, M. Mamas, P. Parwani
{"title":"Utilizing social media for cardiovascular education","authors":"Christine Mansour, Nooshin Beygui, M. Mamas, P. Parwani","doi":"10.1136/heartjnl-2021-320483","DOIUrl":"https://doi.org/10.1136/heartjnl-2021-320483","url":null,"abstract":"","PeriodicalId":9311,"journal":{"name":"British Heart Journal","volume":"108 1","pages":"1240 - 1241"},"PeriodicalIF":0.0,"publicationDate":"2022-05-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43181076","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Correction: Heart failure medication dosage and survival in women and men seen at outpatient clinics","authors":"","doi":"10.1136/heartjnl-2021-319229corr1","DOIUrl":"https://doi.org/10.1136/heartjnl-2021-319229corr1","url":null,"abstract":"","PeriodicalId":9311,"journal":{"name":"British Heart Journal","volume":"108 1","pages":"e4 - e4"},"PeriodicalIF":0.0,"publicationDate":"2022-05-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46807324","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Jing Li, Heyue Du, Yang Wang, B. Aertgeerts, G. Guyatt, Q. Hao, Yanjiao Shen, Ling Li, N. Su, N. Delvaux, G. Bekkering, Safi U. Khan, I. Riaz, P. Vandvik, Baihai Su, H. Tian, Sheyu Li
{"title":"Safety of proprotein convertase subtilisin/kexin 9 inhibitors: a systematic review and meta-analysis","authors":"Jing Li, Heyue Du, Yang Wang, B. Aertgeerts, G. Guyatt, Q. Hao, Yanjiao Shen, Ling Li, N. Su, N. Delvaux, G. Bekkering, Safi U. Khan, I. Riaz, P. Vandvik, Baihai Su, H. Tian, Sheyu Li","doi":"10.1136/heartjnl-2021-320556","DOIUrl":"https://doi.org/10.1136/heartjnl-2021-320556","url":null,"abstract":"Objective To determine the harms of proprotein convertase subtilisin/kexin 9 (PCSK9) inhibitors in people who need lipid-lowering therapy. Methods This systematic review included randomised controlled trials that compared PCSK9 inhibitors with placebo, standard care or active lipid-lowering comparators in people who need lipid-lowering therapy with the follow-up duration of at least 24 weeks. We summarised the relative effects for potential harms from PCSK9 inhibitors using random-effect pairwise meta-analyses and assessed the certainty of evidence using GRADE (Grading of Recommendation Assessment, Development and Evaluation) for each outcome. Results We included 32 trials with 65 861 participants (with the median follow-up duration of 40 weeks, ranging from 24 to 146 weeks). The meta-analysis showed an incidence of injection-site reaction leading to discontinuation (absolute incidence of 15 events (95% CI 11 to 20) per 1000 persons in a 5-year time frame, high certainty evidence). PCSK9 inhibitors do not increase the risk of new-onset diabetes mellitus, neurocognitive events, cataracts or gastrointestinal haemorrhage with high certainty evidence. PCSK9 inhibitors probably do not increase the risks of myalgia or muscular pain leading to discontinuation or any adverse events leading to discontinuation with moderate evidence certainty. Given very limited evidence, PCSK9 inhibitors might not increase influenza-like symptoms leading to discontinuation (risk ratio 1.5; 95% CI 0.06 to 36.58). We did not identify credible subgroup analyses results, including shorter versus longer follow-up duration of trials. Conclusions PCSK9 inhibitors slightly increase the risk of severe injection-site reaction but not cataracts, gastrointestinal haemorrhage, neurocognitive events, new-onset diabetes or severe myalgia or muscular pain.","PeriodicalId":9311,"journal":{"name":"British Heart Journal","volume":"108 1","pages":"1296 - 1302"},"PeriodicalIF":0.0,"publicationDate":"2022-05-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48391593","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"BMJ Rapid Recommendations on use of proprotein convertase subtilisin/kexin 9 inhibitors and ezetimibe to reduce cardiovascular risk","authors":"H. White","doi":"10.1136/heartjnl-2022-321063","DOIUrl":"https://doi.org/10.1136/heartjnl-2022-321063","url":null,"abstract":"The new BMJ Rapid Recommendations addressed the following question: should we add another lipidlowering drug in adults with lowdensity lipoproteincholesterol (LDLC) over 1.8 mmol/L using a maximal dose of statins or intolerant to statins? Why is this question important? Both proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors and ezetimibe have been shown to reduce LDLC by approximately 60% and approximately 20%, respectively, and correspondingly may reduce major adverse cardiovascular events (MACE), including allcause death, cardiovascular death, myocardial infarction (MI) and stroke. However, the benefit of ezetimibe is small and PCSK9 inhibitors are very costly. Both drugs have adverse effects which must be considered when balancing recommendations to achieve maximal benefit and minimal harm. Current guidelines recommend differing LDLC treatment targets. Examples of thresholds include the European Society of Cardiology (ESC) guidelines, which recommend an LDLC target of 1.4 mmol/L for patients at very high cardiovascular risk, and the American College of Cardiology/American Heart Association (AHA/ACC) guidelines, which set a less aggressive LDLC target of 1.8 mmol/L. The new guideline is a collaborative initiative from the MAGIC Evidence Ecosystem Foundation (www.magicproject. org) and the BMJ. The authors performed a systematic review and network metaanalysis of 14 trials, with 83 660 participants, to define the absolute incremental beneficial effects of ezetimibe and PCSK9 inhibitors to statins, and this is published simultaneously in the BMJ. The guideline represents a shift from the traditional focus on lipid level goals to a focus on reducing an individual’s absolute cardiovascular risk. Few other guidelines specifically do this. To apply these recommendations, clinicians need to calculate patients’ individual absolute cardiovascular risks using risk calculators applicable to specific geographical regions.","PeriodicalId":9311,"journal":{"name":"British Heart Journal","volume":"108 1","pages":"1250 - 1252"},"PeriodicalIF":0.0,"publicationDate":"2022-05-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48649189","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Women in cardiology: narrowing the gender gap.","authors":"Rebecca Dobson, Sarah C Clarke","doi":"10.1136/heartjnl-2021-320144","DOIUrl":"10.1136/heartjnl-2021-320144","url":null,"abstract":"","PeriodicalId":9311,"journal":{"name":"British Heart Journal","volume":"108 1","pages":"757-759"},"PeriodicalIF":0.0,"publicationDate":"2022-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9046733/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"43485917","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}