Cross-cultural adaptation of the Spanish MINICHAL instrument into English for use in the United Kingdom.

BACKGROUND: Hypertension is a highly prevalent condition, with optimal treatment to BP targets conferring significant gains in terms of cardiovascular outcomes. Understanding why some patients do not achieve BP targets would be enhanced through greater understanding of their health-related quality of life (HRQoL). However, the only English language disease-specific instruments for measurement of HRQoL in hypertension have not been validated in accordance with accepted standards. It is proposed that the Spanish MINICHAL instrument for the assessment of HRQoL in hypertension could be translated, adapted and validated for use in the United Kingdom. The aim of the study was therefore to complete this process. METHODS: The MINICHAL authors were contacted and the original instrument obtained. This was then translated into English by two independent English-speakers, with these versions then reconciled, before back-translation and subsequent production of a 2nd reconciled version. Thereafter, a final version was produced after cognitive debriefing, for administration and psychometric analysis in the target population of patients living in the Exeter area (Southwest UK) aged 18-80 years with treatment-naïve grade II-III hypertension, before, during and after 18 weeks' intensive treatment. RESULTS: The English-language instrument was administered to 30 individuals (median age: 58.5 years, 53% male). Psychometric analysis demonstrated a floor effect, though no ceiling effect. Internal consistency for both state of mind (StM) and somatic manifestations (SM) dimensions of the instrument were acceptable (Cronbach's alpha = 0.81 and 0.75), as was test-retest reliability (ICC = 0.717 and 0.961) and construct validity, which was measured through co-administration with the EQ-5D-5L and Bulpitt-Fletcher instruments. No significant associations were found between scores and patient characteristics known to affect HRQoL. The EQ-5D-5L instrument found an improvement in HRQoL following treatment, with the StM and SM dimensions of the English language MINICHAL trending to support this (d = 0.32 and 0.02 respectively). CONCLUSIONS: The present study details the successful English translation and validation of the MINICHAL instrument for use in individuals with hypertension. The data reported also supports an improvement in HRQoL with rapid treatment of grade II-III hypertension, a strategy which has been recommended by contemporaneous European guidelines. Trial registration ISRCTN registry number: 57475376 (assigned 25/06/2015).

Morphological and functional cardiac consequences of rapid hypertension treatment: a cohort study.

BACKGROUND: Left ventricular (LV) hypertrophy (LVH) in uncontrolled hypertension is an independent predictor of mortality, though its regression with treatment improves outcomes. Retrospective data suggest that early control of hypertension provides a prognostic advantage and this strategy is included in the 2018 European guidelines, which recommend treating grade II/III hypertension to target blood pressure (BP) within 3 months. The earliest LVH regression to date was demonstrated by echocardiography at 24 weeks. The effect of a rapid guideline-based treatment protocol on LV remodelling, with very early BP control by 18 weeks remains controversial and previously unreported. We aimed to determine whether such rapid hypertension treatment is associated with improvements in LV structure and function through paired cardiovascular magnetic resonance (CMR) scanning at baseline and 18 weeks, utilising CMR mass and feature tracking analysis. METHODS: We recruited participants with never-treated grade II/III hypertension, initiating a guideline-based treatment protocol which aimed to achieve BP control within 18 weeks. CMR and feature tracking were used to assess myocardial morphology and function immediately before and after treatment. RESULTS: We acquired complete pre- and 18-week post-treatment data for 41 participants. During the interval, LV mass index reduced significantly (43.5 ± 9.8 to 37.6 ± 8.3 g/m2, p < 0.001) following treatment, accompanied by reductions in LV ejection fraction (65.6 ± 6.8 to 63.4 ± 7.1%, p = 0.03), global radial strain (46.1 ± 9.7 to 39.1 ± 10.9, p < 0.001), mid-circumferential strain (- 20.8 ± 4.9 to - 19.1 ± 3.7, p = 0.02), apical circumferential strain (- 26.0 ± 5.3 to - 23.4 ± 4.2, p = 0.003) and apical rotation (9.8 ± 5.0 to 7.5 ± 4.5, p = 0.003). CONCLUSIONS: LVH regresses following just 18 weeks of intensive antihypertensive treatment in subjects with newly-diagnosed grade II/III hypertension. This is accompanied by potentially advantageous functional changes within the myocardium and supports the hypothesis that rapid treatment of hypertension could improve clinical outcomes. TRIAL REGISTRATION: ISRCTN registry number: 57475376 (assigned 25/06/2015).

Rapid treatment of moderate to severe hypertension using a novel protocol in a single-centre, before and after interventional study.

Rapid treatment to target in hypertension may have beneficial effects on long-term outcomes. This has led to a new recommendation in the 2018 European hypertension guidelines for patients with grade II/III hypertension to be treated to target within three months. However, whether it is feasible and safe to quickly manage treatment-naïve grade II/III hypertension to target was unclear. We examined this using a single-centre before and after interventional study, treating newly diagnosed, never-treated, grade II/III hypertensive patients with a daytime average systolic ABP ≥ 150 mmHg to target within 18 weeks. The proportion at office target BP at 18 weeks was determined, together with office and ambulatory BP change from baseline to after the intervention. The protocol was designed to maximise medication adherence, including a low threshold for treatment adaptation. Safety was evaluated through close monitoring of adverse events and protocol discontinuation. Fifty-five participants were enrolled with 54 completing the protocol. 69 ± 12.3% were at office target BP at their final visit, despite a high average starting BP of 175/103 mmHg, as a consequence of significant reductions in both office and ambulatory BP. Of those at office target BP, 51% were above target on ambulatory measurement. Adherence testing demonstrated that 92% of participants were adherent to treatment at their final visit. Therefore we conclude that the accelerated management of treatment-naïve grade II/III hypertension is feasible and safe to implement in routine practice and there is no evidence to suggest it causes harm. Further large-scale randomised studies of rapid, adaptive treatment, including a cost-effectiveness analysis, are required.

Cardiac magnetic resonance imaging in Alström syndrome.

BACKGROUND: A case series of the cardiac magnetic resonance imaging findings in seven adult Alström patients. METHODS: Seven patients from the National Specialist Commissioning Group Centre for Alström Disease, Torbay, England, UK, completed the cardiac magnetic resonance imaging protocol to assess cardiac structure and function in Alström cardiomyopathy. RESULTS: All patients had some degree of left and right ventricular dysfunction. Patchy mid wall gadolinium delayed enhancement was demonstrated, suggesting an underlying fibrotic process. Some degree of cardiomyopathy was universal. No evidence of myocardial infarction or fatty infiltration was demonstrated, but coronary artery disease cannot be completely excluded. Repeat scanning after 18 months in one subject showed progression of fibrosis and decreased left ventricular function. CONCLUSION: Adult Alström cardiomyopathy appears to be a fibrotic process causing impairment of both ventricles. Serial cardiac magnetic resonance scanning has helped clarify the underlying disease progression and responses to treatment. Confirmation of significant mutations in the ALMS1 gene should lead to advice to screen the subject for cardiomyopathy, and metabolic disorders.

Interstudy reproducibility of right ventricular volumes, function, and mass with cardiovascular magnetic resonance.

BACKGROUND: Cardiovascular magnetic resonance (CMR) has shown excellent results for interstudy reproducibility in the assessment of left ventricular (LV) parameters. However, interstudy reproducibility data for the more complex-shaped right ventricle in a large study group have not yet been reported. We sought to determine the interstudy reproducibility of measurements of right ventricular (RV) volumes, function, and mass with CMR and compare it with correspondent LV values. METHODS: Sixty subjects (47 men; 20 healthy volunteers, 20 patients with heart failure, 20 patients with ventricular hypertrophy) underwent 2 CMR studies for assessment of RV measurements with a minimum time interval between each study. RESULTS: The overall interstudy reproducibility (range between groups) for the RV was 6.2% (4.2%-7.8%) for end-diastolic volume, 14.1% (8.1%-18.1%) for end-systolic volume, 8.3% (4.3%-10.4%) for ejection fraction (EF), and 8.7% (7.8%-9.4%) for RV mass. RV reproducibility was not as good as for the LV for all measures in all 3 groups, but this was only statistically significant for EF (P <.01). CONCLUSIONS: CMR showed good interstudy reproducibility for RV function parameters in healthy subjects, patients with heart failure, and patients with hypertrophy, which suggests that CMR is reliable for serial RV assessment. These data can be used to power sample sizes for longitudinal research studies of RV volume and function. The reproducibility values were similar to, but generally lower than, the reproducibility values for the LV in the same study population, which indicates that sample sizes for RV studies are in general larger than those for LV studies.

Assessment of left ventricular mass regression after aortic valve replacement--cardiovascular magnetic resonance versus M-mode echocardiography.

OBJECTIVE: In patients with aortic valve disease, the presence of left ventricular hypertrophy (LVH) carries a significant risk of adverse cardiovascular events. Regression of hypertrophy after aortic valve replacement (AVR) is associated with a reduction in risk. In general, M-mode echocardiography has been used for quantitative assessment of left ventricular mass (LVM) and regression, but this technique is believed to have limitations from which cardiovascular magnetic resonance (CMR) does not suffer. The objective of this study therefore was to determine whether quantitative assessment of LVM and regression after AVR using the two techniques was comparable. METHODS: Thirty-nine patients with aortic valve disease were studied before and 1 year after AVR. Transthoracic M-mode echocardiography and four different formulae were used to calculate left ventricular mass index (LVMI), and then compared with CMR measurements. RESULTS: Overall, correlation between the techniques for single measurement of LVMI was moderate (r-values from 0.64 to 0.69), with a tendency for overestimation by echocardiography; there was no agreement in degree of regression (r-values from 0.004 to 0.18). The Bland-Altman limits of agreement ranged from 85 to 131% for single measurement of LVMI, and 328-470% for regression. The change in LVMI with CMR was 43+/-28 g/m2, vs. 27 to 54+/-19 to 41 g/m2 using echocardiography. CONCLUSIONS: M-mode echocardiography does not provide reliable quantification of regression of LVH in individuals, and for accurate measurement CMR is superior. The use of CMR in future studies may reduce costs since fewer subjects are needed to accurately detect significant changes in LVMI after AVR.

Functional changes in coronary microcirculation after valve replacement in patients with aortic stenosis.

BACKGROUND: Increased extravascular compression and reduced diastolic perfusion time (DPT), rather than vascular remodeling, influence coronary microcirculatory dysfunction in aortic stenosis (AS). However, alterations after aortic valve replacement (AVR) remain unclear. The aim of the present study was to quantify changes in transmural perfusion and coronary vasodilator reserve (CVR), a measure of microcirculatory function, after AVR and determine the relative contribution of left ventricular mass (LVM) regression, change in aortic valve area (AVA), and DPT. METHODS AND RESULTS: Twenty-two patients with AS were studied before and 1 year after AVR using echocardiography to measure AVA, cardiovascular magnetic resonance to assess LVM, and positron emission tomography to quantify resting and hyperemic myocardial blood flow (MBF) and CVR. Regression of LVM occurred in all patients (from 129+/-30 to 94+/-24 g/m2; P<0.0001), and there was a significant reduction in resting MBF and increase in CVR corrected for rate-pressure product after AVR, although these changes displayed marked heterogeneity. Regression of LVM was linearly related to change in resting total LV blood flow but not CVR. Increase in hyperemic MBF and CVR transmurally was directly related to the increase in AVA after AVR. A significant relationship existed between the change in hyperemic DPT (1.0+/-4.7 s/min [range, 6.8 to 9.6]) and change in transmural CVR (y=0.08x+0.18; r=0.44; P=0.04). CONCLUSIONS: Changes in coronary microcirculatory function in patients with AS after AVR are not directly dependent on regression of LVM. Reduced extravascular compression and increased DPT are proposed as the main mechanisms for improvement in MBF and CVR after AVR.

Comparison of techniques for the measurement of left ventricular function following cardiac transplantation.

BACKGROUND: Assessment of graft function after cardiac transplantation is essential for patient management and clinical research. Previous studies have found that the left ventricular (LV) ejection fraction (EF) by echocardiography (echo), radionuclide ventriculography (RNV), and cardiovascular magnetic resonance (CMR) is discrepant in patients with heart failure. METHOD: Twelve patients underwent LV EF assessment by echo, angiography (angio), RNV, and CMR one year following heart transplantation. The scans were analyzed independently in blinded fashion. RESULTS: The mean EF was 63 +/- 6% by RNV, 66 +/- 6% by CMR, 70 +/- 12% by angio, and 74 +/- 4% by echo. Significant differences were found between CMR and echo (p < 0.001), RNV and echo (p < 0.001), and RNV and angio (p < 0.05). The correlation between the techniques was poor (r = 0.3-0.6), and the scatter plots also suggested considerable variations between techniques. This was confirmed by the wide Bland-Altman limits of agreement (ranging from 22 to 45%). These were particularly wide for comparisons with angiography (43-45%). CONCLUSION: The EF measurement by echo, angio, RNV, and CMR are not interchangeable in patients following heart transplantation. The CMR and RNV provided the best agreement in EF and appear preferable for research studies. Echocardiography systematically overestimated LV EF and showed poor agreement with other techniques. Angiography overestimated LV function, and its routine use did not add to information gained from noninvasive studies.

Comparison of interstudy reproducibility of cardiovascular magnetic resonance with two-dimensional echocardiography in normal subjects and in patients with heart failure or left ventricular hypertrophy.

Fast breath-hold cardiovascular magnetic resonance (CMR) shows excellent results for interstudy reproducibility of left ventricular (LV) volumes, ejection fraction, and mass, which are thought to be superior to results of 2-dimensional echocardiography. However, there is no direct comparison of the interstudy reproducibility of both methods in the same subjects. A total of 60 subjects (normal volunteers [n = 20], or patients with heart failure [n = 20] or LV hypertrophy [n = 20]) underwent 2 CMRs and 2 echocardiographic studies for assessment of LV volumes, function, and mass. The interstudy reproducibility coefficient of variability was superior for CMR in all groups for all parameters. Statistical significance was reached for end-systolic volume (4.4% to 9.2% vs 13.7% to 20.3%, p <0.001), ejection fraction (2.4% to 7.3% vs 8.6% to 19.4%, p <0.001), and mass (2.8% to 4.8% vs 11.6% to 15.7% p <0.001), with a trend for end-diastolic volume (2.9% to 4.9% vs 5.5% to 10.5%, p = 0.17). The superior interstudy reproducibility resulted in considerably lower calculated sample sizes (reductions of 55% to 93%) required by CMR compared with echocardiography to show clinically relevant changes in LV dimensions and function. Thus, CMR has excellent interstudy reproducibility in normal, dilated, and hypertrophic hearts, and is superior to 2-dimensional echocardiography.

Cardiac remodelling in the era of aggressive medical therapy: does it still exist?

AIM: To delineate the natural history of left ventricular remodelling following large anterior myocardial infarction (MI), in the era of aggressive medical therapy. METHODS: Seventeen selected patients underwent cardiovascular magnetic resonance (CMR) at 2 weeks and 1, 3, 6 and 12 months post infarction. RESULTS: There was a significant increase in left ventricular (LV) end-diastolic volume index (EDVI) and LV ESVI from 2 weeks to 1 month (P<0.05) but no significant change thereafter. The LV ejection fraction (EF) decreased from 2 weeks to 1 month (P<0.05) and then increased over the year (P=0.02). Throughout the study period the sphericity index increased. There was a significant and progressive decrease in LV mass index over the year, which was associated with a decrease in wall thickness at both the infarct and non-infarct sites. Independent predictors of an early increase in LVESVI were increasing age, increasing CK-MB and not receiving treatment with a statin. CONCLUSION: This study delineates the natural history of left ventricular remodelling in the modern medical era in those patients who have suffered a large anterior MI. Classical remodelling occurred up to 1 month, but thereafter was attenuated. These findings would suggest that remodelling is not as prevalent in the modern era, and that combined medical management with thrombolysis, ACEi, beta-blockers and statins may strongly influence the development of this remodelling.

Assessment of left ventricular mass by cardiovascular magnetic resonance.

Left ventricular hypertrophy is associated with significant excess mortality and morbidity. The study and treatment of this condition, in particular the prognostic implications of changes in left ventricular mass, require an accurate, safe, and reproducible method of measurement. Cardiovascular magnetic resonance is a suitable tool for this purpose, and this review assesses the technique in comparison with others and examines the clinical and research implications of the improved reproducibility.

Evaluation of left ventricular function and mass after Medtronic Freestyle versus homograft aortic root replacement using cardiovascular magnetic resonance.

BACKGROUND AND AIM OF THE STUDY: Regression of left ventricular hypertrophy (LVH) after aortic valve replacement has traditionally been measured by echocardiography. However, cardiovascular magnetic resonance (CMR) can be used to measure left ventricular function and mass more accurately and reproducibly. This translates into fewer patients being needed to demonstrate significant changes. The study aim was to demonstrate the feasibility of using CMR to measure left ventricular mass index (LVMI) and function in patients from a prospective randomized trial, and to compare homografts with the Medtronic Freestyle root replacement. METHODS: Among 23 patients recruited, 17 had LVMI and function (end-diastolic volume (EDV), end-systolic volume (ESV), stroke volume (SV) and ejection fraction (EF)) measured pre- and postoperatively using CMR (eight homograft, nine Freestyle). RESULTS: Significant regression of LVH was seen in both groups one year postoperatively (homograft LVMI 145+/-44 g/m2 preoperative versus 83+/-23 g/m2 one year postoperatively; Freestyle LVMI 140+/-28 g/m2 versus 93+/-21 g/m2, respectively). At six months there was significant regression in the xenograft group (from 140+/-28 to 106+/-22 g/m2; p <0.05) and a trend towards regression in the homograft group (from 145+/-44 to 103+/-25 g/m2; p = NS). There was also a trend towards a reduction in EDV, ESV and SV, and an increase in EF over one year in both groups. CONCLUSION: Regression of LVH was measured using CMR in patients after aortic root replacement and coronary implantation with the homograft and Medtronic Freestyle root replacement. Despite the small number of patients studied, it was possible to demonstrate the extent and pattern of regression of left ventricular mass in the two groups.