Cardiac Rehabilitation After TAVI -A Systematic Review and Meta-Analysis.

Despite the increasing popularity of Transcatheter aortic valve implantation (TAVI) in patients with high surgical risk, there is no current guideline for the management of patients following the intervention. This systematic review and meta-analysis aims to summarize and analyse all clinical data and evidence regarding the effectiveness and outcomes of CR following TAVI. The first meta-analysis measured the walked distance in the Six-Minute Walk Test (6MWT) and the second meta-analysis included studies that showed the Barthel Index (BI) before and after CR. The mean distance walked prior to CR was 235.88 ± 69.36 m increased to 292.12 ± 54.92 m after rehabilitation, signifying a moderate clinically relevant effect size (0.593 (0.42, 0.76); P=0.00). The mean BI score before CR was 76.6 ± 11.5 which increased to 89.8 ± 5.5 after the programme and similarly demonstrated a significant standardized mean improvement (0.75 (0.57, 0.93); I= 0.00). Exercise-based CR in patients with aortic stenosis treated with TAVI demonstrated a significant improvement in exercise tolerance and functional independence shown by the 6MWT and BI.

Dose-related meta-analysis for Omega-3 fatty acids supplementation on major adverse cardiovascular events.

BACKGROUND & AIMS: Omega-3 supplements are widely used for cardiovascular (CV) protection. We performed an updated meta-analysis for omega-3 and CV outcomes. METHODS: Random-effects meta-analysis including double-blind RCTs with duration ≥1 year, evaluating omega-3 supplements in 4 a priori defined categories (<1, 1, 2, ≥3 of 1g capsules/day) on all-cause mortality, cardiac death, myocardial infarction and stroke, reporting the relative risk (RR) as the measure of interest. Complementary approaches were Trial Sequential Analysis (TSA) and sensitivity analyses for triglycerides, prevention setting, intention-to-treat analysis, eicosapentaenoic acid (EPA), sample size, statin use and study duration. RESULTS: Nineteen randomized controlled trials (RCTs) with 97,709 participants were included. Omega-3 supplements were not statistically significantly associated with reduced all-cause mortality, cardiac death, MI, or stroke, with the exception of reduced cardiac mortality only for the equivalent dose of 2 capsules/day (RR 0.55, 95%CI 0.33, 0.90, p = 0.0169, I2 = 0%). TSA reached the required information size only for the lower doses regarding all-cause and cardiac mortality, where they show no significant association. Meta-regression on EPA dose, as well as the majority of sensitivity analyses did not show any statistically significant association. CONCLUSION: Compared to the robust evidence for low doses, higher doses and particularly for the unique type of omega-3 icosapent ethyl ester should be further addressed.

STRIDE BP international initiative for accurate blood pressure measurement: Systematic review of published validation studies of blood pressure measuring devices.

Blood pressure (BP) is a vital sign, and its measurement is essential for diagnosing and treating hypertension. The accuracy of BP monitors is therefore essential, but unfortunately very few devices available on the market have been validated using an established protocol. STRIDE BP (www.stridebp.org) is an international nonprofit organization with the mission to improve the accuracy of BP measurement and the diagnosis of hypertension. It has a prestigious Scientific Advisory Board and operates in affiliation with the European Society of Hypertension, the International Society of Hypertension, and the World Hypertension League. STRIDE BP provides lists of accurate office, ambulatory, and home BP monitors. STRIDE BP performed a systematic review of 419 published validations (270 articles and 260 devices). In these publications, 50 (12%) of the validations were rejected compared with 129 (31%) rejected by STRIDE BP (P < .001). Of 79 validations approved in publications but rejected by STRIDE BP, 7 (9%) were rejected due to device inaccuracy and 72 (91%) due to inadequate study quality (execution, analysis, and reporting). Errors in conducting and reporting published validations must be avoided. Peer review must ascertain that a comprehensive checklist of all aspects of a validation study have been adhered to. The implementation of a Universal Standard for device validation and the global dissemination of information on accurate devices by STRIDE BP are expected to improve the quality and accuracy of BP measurement, which should have a positive impact on the diagnosis and management of hypertension globally.

Blood pressure measurement in atrial fibrillation: review and meta-analysis of evidence on accuracy and clinical relevance.

: Atrial fibrillation (AF) often coexists with hypertension in the elderly and multiplies the risk of stroke and death. Blood pressure (BP) measurement in patients with AF is difficult and uncertain and has been a classic exclusion criterion in hypertension clinical trials leading to limited research data. This article reviews the evidence on the accuracy of BP measurement in AF performed using different methods (office, ambulatory, home) and devices (auscultatory, oscillometric) and its clinical relevance in predicting cardiovascular damage. The current evidence suggests the following: (i) Interobserver and intra-observer variation in auscultatory BP measurement is increased in AF because of increased beat-to-beat BP variability and triplicate measurement is required; (ii) Data from validation studies of automated electronic BP monitors in AF are limited and methodologically heterogeneous and suggest reasonable accuracy in measuring SBP and a small yet consistent overestimation of DBP; (iii) 24-h ambulatory BP monitoring is feasible in AF, with similar proportion of errors as in individuals without AF; (iv) both auscultatory and automated oscillometric BP measurements appear to be clinically relevant in AF, providing similar associations with intra-arterial BP measurements and with indices of preclinical cardiac damage as in patients without AF, and predict cardiovascular events and death; (v) Screening for AF in the elderly using an AF-specific algorithm during routine automated office, home or ambulatory BP measurement has high diagnostic accuracy. In conclusion, in AF patients, BP measurement is important, reliable, and clinically relevant and should not be neglected in clinical research and in practice.

High-fidelity digital recording and playback sphygmomanometry system: device description and proof of concept.

OBJECTIVES: This study describes the development of a new digital sphygmocorder (DS-II), which allows the digital recording and playback of the Korotkoff sounds, together with cuff pressure waveform, and its performance in a pilot validation study. MATERIALS AND METHODS: A condenser microphone and stethoscope head detect Korotkoff sounds and an electronic chip, dedicated to audio-signal processing, is used to record high-quality sounds. Systolic and diastolic blood pressure (SBP/DBP) are determined from the recorded signals with an automatic beat detection algorithm that displays the cuff pressure at each beat on the monitor. Recordings of Korotkoff sounds, with the cuff pressure waveforms, and the simultaneous on-site assessments of SBP/DBP were performed during 100 measurements in 10 individuals. The observers reassessed the recorded signals to verify their accuracy and differences were calculated. RESULTS: The features of the high-fidelity DS-II, the technical specifications and the assessment procedures utilizing the playback software are described. Interobserver absolute differences (mean±SD) in measurements were 0.7±1.1/1.3±1.3 mmHg (SBP/DBP) with a mercury sphygmomanometer and 0.3±0.9/0.8±1.2 mmHg with the DS-II. The absolute DS-II mercury sphygmomanometer differences were 1.3±1.9/1.5±1.3 mmHg (SBP/DBP). CONCLUSION: The high-fidelity DS-II device presents satisfactory agreement with simultaneous measurements of blood pressure with a mercury sphygmomanometer. The device will be a valuable methodology for validating new blood pressure measurement technologies and devices.

The Mystery of High-density Lipoprotein: Quantity or Quality? Update on Therapeutic Strategies.

This review summarizes the data challenging the concept that cardiovascular protection through high-density lipoprotein (HDL) is only associated with its serum concentration. This conventional impression about its protective role now appears obsolete. New aspects of its mechanisms are revealed and novel therapeutic strategies are based on them. However, data from long-term cost-effectiveness studies of treating HDL are still needed. There is a need for biomarkers that represent the functional characteristics of HDL in order to better quantify the total cardiovascular risk.

Treatment-induced changes in ambulatory arterial stiffness index: one-year prospective study and meta-analysis of evidence.

The ambulatory arterial stiffness index (AASI) has been introduced as an index of arterial function, predicting cardiovascular events. However, treatment-induced changes in AASI are rather equivocal. This study aims to: (i) present the results of treatment-induced changes in AASI in untreated subjects with elevated blood pressure (BP), subjected to antihypertensive treatment for 1 year and (ii) perform a meta-analysis of studies reporting on treatment-induced change in AASI. A total of 104 subjects (mean age 51.4±10.3 years, 62% males, mean follow-up: 13.6±2.4 months) were analyzed. Despite significant reductions in 24-h ambulatory systolic/diastolic BP, pulse pressure and pulse wave velocity (mean change: -15.9±12/-10.4±7.6 mm Hg, -5.4±6.8 mm Hg, -0.7±1.9 m s(-1), respectively, all P<0.05), there was no significant change (Follow up-Baseline) in AASI values (mean change: 0.01±0.17, P=not significant). The treatment-induced change in AASI was correlated with baseline AASI (r=-0.61), baseline 24-h pulse pressure (-0.26), treatment-induced change in 24-h pulse pressure (0.26) and in systolic/diastolic nocturnal dipping (-0.25/-0.40, respectively). Meta-analysis of eight trials (n=990) revealed a marginal decrease in AASI with antihypertensive treatment (pooled change: -0.018 (95% confidence interval (CI): -0.033,-0.003)). When the analysis was restricted to data with renin-angiotensin system blockers (n=755, 76% of total), the results did not significantly change (pooled change -0.028 (95% CI -0.048, -0.007)). In conclusion, although AASI is an independent predictor of cardiovascular events, its response to antihypertensive treatment is only marginal and clinically uncertain, which may render its use as a therapeutic target in clinical practice questionable.

How should I treat dislocation of a TAVI SAPIEN prosthesis into the left ventricle?

BACKGROUND: Despite the technical advancements of the transcatheter aortic valve implantation (TAVI) procedure, valve embolisation into the left ventricle remains a challenging situation requiring expedited management through the Heart Team. INVESTIGATION: The advantages and pitfalls of an interventional transfemoral approach, a transapical extraction of the dislocated prosthesis or the conversion to open heart surgery have to be balanced depending on the overall situation and the specific characteristics of the patient. DIAGNOSIS: A transfemoral approach would be the first choice for most TAVI implanters. We discuss the different options and present an elegant solution solving this challenging situation, leading to a good immediate and long-term outcome. MANAGEMENT: Attempts at pulling the prosthesis out of the ventricle using a balloon remained unsuccessful. After grasping of the prosthesis with a goose-neck snare, the valve was pulled into the annulus. A second SAPIEN XT prosthesis was implanted and fixed the first prosthesis within the annulus. After post-dilatation, there was a good result without relevant gradient and minimal aortic regurgitation.

Cost estimation of hypertension management based on home blood pressure monitoring alone or combined office and ambulatory blood pressure measurements.

This study aims at estimating the resources consumed and subsequent costs for hypertension management, using home blood pressure (BP) monitoring (HBPM) alone versus combined clinic measurements and ambulatory blood pressure monitoring (C/ABPM). One hundred sixteen untreated hypertensive subjects were randomized to use HBPM or C/ABPM for antihypertensive treatment initiation and titration. Health resources utilized within 12-months follow-up, their respective costs, and hypertension control were assessed. The total cost of the first year of hypertension management was lower in HBPM than C/ABPM arm (€1336.0 vs. €1473.5 per subject, respectively; P < .001). Laboratory tests' cost was identical in both arms. There was no difference in achieved BP control and drug expenditure (HBPM: €233.1 per subject; C/ABPM: €247.6 per subject; P = not significant), whereas the cost of BP measurements and/or visits was higher in C/ABPM arm (€393.9 vs. €516.9, per patient, respectively P < .001). The cost for subsequent years (>1) was €348.9 and €440.2 per subject, respectively for HBPM and C/ABPM arm and €2731.4 versus €3234.3 per subject, respectively (P < .001) for a 5-year projection. HBPM used alone for the first year of hypertension management presents lower cost than C/ABPM, and the same trend is observed in 5-year projection. The results on the resources consumption can be used to make cost estimates for other health-care systems.

Home blood pressure monitoring: primary role in hypertension management.

In the last two decades, considerable evidence on home blood pressure monitoring has accumulated and current guidelines recommend its wide application in clinical practice. First, several outcome studies have shown that the ability of home blood pressure measurements in predicting preclinical target organ damage and cardiovascular events is superior to that of the conventional office blood pressure measurements and similar to that of 24-hour ambulatory monitoring. Second, cross-sectional studies showed considerable agreement of home blood pressure measurements with ambulatory monitoring in detecting the white-coat and masked hypertension phenomena, in both untreated and treated subjects. Third, studies have shown larger blood pressure decline by using home blood pressure monitoring instead of office measurements for treatment adjustment. Fourth, in treated hypertensives, home blood pressure monitoring has been shown to improve long-term adherence to antihypertensive drug treatment and thus, has improved hypertension control rates. These data suggest that home blood pressure should no longer be regarded as only a screening tool that requires confirmation by ambulatory monitoring. Provided that an unbiased assessment is obtained according to current recommendations, home blood pressure monitoring should have primary role in diagnosis, treatment adjustment, and long-term follow-up of most cases with hypertension.

Prediction of treatment-induced changes in target-organ damage using changes in clinic, home and ambulatory blood pressure.

Cross-sectional studies have shown that ambulatory and home blood pressure (ABP and HBP, respectively) measurements are more closely associated with preclinical organ damage than are office measurements. This study investigated the association between treatment-induced changes in BP assessed by the three methods and the corresponding changes in organ damage. Untreated hypertensives were evaluated with office, ABP and HBP measurements and indices of organ damage (echocardiographic left-ventricular mass index (LVMI), pulse wave velocity (PWV), albuminuria) before and after 12 months of treatment. A total of 116 subjects completed the study (mean age 50.7±10.5 years, 69 men (59%), mean follow-up 13.4±1.4 months). The treatment-induced change in the LVMI was correlated with changes in BP and pulse pressure (PP) assessed by all methods. The change in PWV was correlated with changes in home systolic and ABP and PP and with the change in home diastolic BP. Albuminuria showed no correlations. In linear regression models, changes in home BP and PP had the strongest predictive ability for the change in the LVMI, whereas the change in ABP was the strongest predictor of the change in PWV. The change in office BP had no predictive value. HBP and ABP measurements appear to be superior to office BP measurements and should be considered complementary rather than interchangeable methods for monitoring the effects of antihypertensive treatment on target-organ damage.

Home blood pressure monitoring alone vs. combined clinic and ambulatory measurements in following treatment-induced changes in blood pressure and organ damage.

BACKGROUND: Out-of-office blood pressure (BP) measurement using home BP (HBP) or ambulatory BP (ABP) monitoring is often necessary for the accurate evaluation of hypertension. These methods have several similarities but also have major differences. Therefore, they are regarded as complementary, and there is uncertainty on how they should be applied in clinical practice. This study compared hypertension management based on clinic and ABP measurements or on HBP measurements alone. METHODS: Untreated subjects with elevated BP were randomized to treatment initiation and titration based on clinic and ABP measurements or on HBP measurements alone. Target organ damage was assessed at baseline and after 1 year of treatment with echocardiographic left ventricular mass index (primary endpoint), pulse wave velocity, and urinary albumin excretion. RESULTS: A total of 145 subjects were randomized, and 116 completed the study (mean age = 50.7±10.5 years; 69 men (59%); mean follow-up = 13.4±1.4 months). There was no difference between the 2 arms in treatment-induced change in left ventricular mass index (mean difference = 0.50±1.11 g/m2; 95% confidence interval (CI) = -1.70 to 2.70). Moreover, there was no difference between the 2 arms in treatment-induced changes in pulse wave velocity (mean difference = -0.16±0.42 m/s; 95% CI = -0.99 to 0.66), urinary albumin excretion (mean difference = -0.85±4.28 mg/dl; 95% CI = -9.37 to 7.66), HBP and ABP levels, and hypertension control rates. CONCLUSIONS: These data suggest that HBP monitoring alone is as reliable as combined clinic and ABP measurements in monitoring the effects of antihypertensive drug treatment on BP and preclinical target organ damage.

Ambulatory and home blood pressure monitoring in children and adolescents: diagnosis of hypertension and assessment of target-organ damage.

The prevalence of elevated blood pressure in children and adolescents is more common than previously believed and often represents the early onset of essential hypertension, particularly in adolescents. The definition of hypertension in children is based on distribution criteria and normalcy tables that provide blood pressure percentiles for each measurement method (office, ambulatory and home) according to the individual's age, gender and body size. Owing to the white coat and masked hypertension phenomena, ambulatory blood pressure monitoring is indispensable for the diagnosis of hypertension in children. Home blood pressure monitoring in children has been less well studied, and at present, treatment decisions should not be based solely on such measurements. Hypertension-induced preclinical target-organ damage (mainly echocardiographic left ventricular hypertrophy) is not uncommon in children and should be evaluated in all hypertensive children. Other indices of target-organ damage, such as carotid intima-media thickness, pulse wave velocity and microalbuminuria, remain under investigation in pediatric hypertension.

Automatic office blood pressure measured without doctors or nurses present.

BACKGROUND: We evaluated the agreement between office blood pressure (OBP) measured by a mercury sphygmomanometer (Sphyg) and an automatic (Auto) device without any observers, and compared Auto and Sphyg OBP with ambulatory blood pressure (ABP) and home blood pressure (HBP). METHODS: OBP was measured in 75 hypertensive patients at two sites using an automatic monitor without a doctor or a nurse present and by Sphyg during three clinic visits. Between visits, monitoring of ABP and HBP was also performed. RESULTS: The mean Auto OBP was similar to that of Sphyg OBP and the values were closely correlated (intraclass correlation coefficient=0.84 for systolic OBP and 0.91 for diastolic OBP); however, the difference between Auto and Sphyg systolic OBP (1.6 ± 8.2 mmHg) varied by the first office visit, sex, and the site. Auto systolic OBP was lower than both systolic awake ABP (137.1 ± 14.7 mmHg) and HBP (139.2 ± 15.6 mmHg). Auto systolic OBP and Sphyg OBP were similarly correlated with systolic awake ABP (both r=0.59, P<0.001). The mean Auto diastolic OBP was similar to that of Sphyg OBP (81.1 ± 11.3 vs. 80.3 ± 13.3 mmHg, P=0.20, intraclass correlation coefficient=0.91), and diastolic awake ABP and HBP. Auto diastolic OBP and Sphyg OBP were related to diastolic awake ABP (both r>0.68, P<0.001). In multivariable analyses, neither OBP measure was a significantly stronger predictor of out-of-office blood pressure than the other. CONCLUSION: Auto systolic OBP measured without a doctor or a nurse present was lower than systolic awake ABP and HBP. Auto and rigorously assessed Sphyg OBP had similar means and were similarly related to awake ABP. Auto OBP might be an advantageous alternative to Sphyg measurements in the usual clinic setting.

Impact of applying the more stringent validation criteria of the revised European Society of Hypertension International Protocol 2010 on earlier validation studies.

OBJECTIVE: Since 2002 when the European Society of Hypertension International Protocol (ESH-IP) was published it has become the preferred protocol for validating blood pressure monitors worldwide. In 2010, a revised version of the ESH-IP with more stringent criteria was published. This study assesses the impact of applying the revised ESH-IP criteria. METHODS: A systematic literature review of ESH-IP studies reported between 2002 and 2010 was conducted. The impact of applying the ESH-IP 2010 criteria retrospectively on the data reported in these studies was investigated. The performance of the oscillometric devices in the last decade was also investigated on the basis of the ESH-IP criteria. RESULTS: Among 119 published studies, 112 with sufficient data were analyzed. According to ESH-IP 2002, the test device failed in 19 studies, whereas by applying the ESH-IP 2010 criteria in 28 additional studies increased the failure rate from 17 to 42%. Of these 28 studies, in 20 (71%) the test device failed at part 1 (accuracy per measurement) and in 22 (79%) at part 2 (accuracy per subject). Most of the failures involved the '5 mmHg or less' criterion. In the last decade there has been a consistent trend toward improved performance of oscillometric devices assessed on the basis of the ESH-IP criteria. CONCLUSION: This retrospective analysis shows that the stricter revised ESH-IP 2010 criteria will noticeably increase the failure rate of devices being validated. Oscillometric devices are becoming more accurate, and the revised ESH-IP by acknowledging this trend will allow more accurate devices to enter the market.

Office, ambulatory and home blood pressure measurement in children and adolescents.

There is an increasing interest in pediatric hypertension, the prevalence of which is rising in parallel with the obesity epidemic. Traditionally the assessment of hypertension in children has relied on office blood pressure (BP) measurements by the physician. However, as in adults, office BP might be misleading in children mainly due to the white coat and masked hypertension phenomena. Thus, out-of-office BP assessment, using ambulatory or home monitoring, has gained ground for the accurate diagnosis of hypertension and decision-making. Ambulatory monitoring is regarded as indispensable for the evaluation of pediatric hypertension. Preliminary data support the usefulness of home monitoring, yet more evidence is needed. Office, ambulatory and home BP normalcy tables providing thresholds for diagnosis have been published and should be used for the assessment of elevated BP in children.

European Society of Hypertension International Protocol for the validation of blood pressure monitors: a critical review of its application and rationale for revision.

OBJECTIVE: To perform a systematic review of validation studies of blood pressure measuring devices done using the European Society of Hypertension International Protocol (ESH-IP) since its publication in 2002. METHODS: Major aspects of ESH-IP studies are described. A review of the ESH-IP performance, problems and violations in its application, and the effect of applying several more stringent validation criteria in an ESH-IP revision is carried out. RESULTS: From January 2002 to June 2009, 104 validation studies had been conducted using the ESH-IP, 36 using the British Hypertension Society protocol and 28 using the US Association for the Advancement of Medical Instrumentation protocol. Among 78 studies reported up to June 2008, in 66 (85%) the tested device has passed the ESH-IP. In 19 validations a modification of the ESH-IP was performed to adapt for specific study needs (population or device). Protocol violations of the ESH-IP were identified in 23 studies (eight major violations). A test of several arbitrarily chosen changes in the ESH-IP validation criteria applied in the published studies showed the phase 2.1 criterion (BP differences < or =15 mmHg) and the phase 2.2 criteria to be the more stringent. CONCLUSION: The ESH-IP has succeeded in expanding the validation procedure worldwide by three to four-fold compared with the period before its publication. There is a need for protocol revision aiming to address issues that appeared in published studies, prevent protocol violations, and ensure complete data reporting. Standardization of the ESH-IP validation studies' report and application of more stringent criteria should be considered.

Home blood pressure monitoring in children and adolescents: a systematic review.

OBJECTIVE: As in the adults, in children and adolescents with elevated blood pressure (BP), the conventional office BP measurements might lead to incorrect diagnosis. Therefore, out-of-office BP measurements are often needed. Several studies have demonstrated the value of ambulatory BP (ABP) monitoring in pediatric hypertension, whereas home BP (HBP) monitoring has only recently been evaluated. METHODS: A systematic review of the evidence on HBP monitoring in children and adolescents has been performed (Medline/PubMed, Embase and Cochrane Library). RESULTS: A total of 27 studies (19 original study reports, two surveys, three guidelines documents, two reviews and one letter) were identified. These data suggest that by using electronic arm devices, reliable HBP readings are obtained. Unfortunately, very few electronic devices have been successfully validated in children. The reproducibility of HBP in children appears to be superior to office and similar to ABP measurements. Three-day-HBP monitoring with duplicate morning and evening measurements is the minimum schedule required, yet 6-7-day monitoring is recommended. HBP in children and adolescents is lower than daytime ABP, whereas no such difference exists in the adults. A school-based study in 778 children and adolescents provided the first HBP normalcy data. HBP has similar diagnostic value in children as in the adults and appears to be a reliable alternative to ABP monitoring in the detection of white-coat hypertension. CONCLUSION: HBP monitoring appears to have considerable potential in pediatric hypertension. More research is needed on the clinical application of this method in children and adolescents.