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1.  Repositionable Versus Balloon‐Expandable Devices for Transcatheter Aortic Valve Implantation in Patients With Aortic Stenosis 
Background
The safety and effectiveness of the fully repositionable LOTUS valve system as compared with the balloon‐expandable Edwards SAPIEN 3 prosthesis for the treatment of aortic stenosis has not been evaluated to date.
Methods and Results
All patients undergoing transcatheter aortic valve implantation with the Edwards SAPIEN 3 or the LOTUS valve system were included into the Swiss Transcatheter Aortic Valve Implantation Registry. An adjusted analysis was performed to compare the early clinical safety outcome according to the Valve Academic Research Consortium‐2 definition. Between February 2014 and September 2015, 140 and 815 patients were treated with the LOTUS and the Edwards SAPIEN 3 valve, respectively. There was no difference in crude and adjusted analyses of the early safety outcome between patients treated with LOTUS (14.3%) and those treated with Edwards SAPIEN 3 (14.6%) (crude hazard ratio, 0.97; 95% CI, 0.61–1.56 [P=0.915]; adjusted hazard ratio, 1.03; 95% CI, 0.64–1.67 [P=0.909]). More than mild aortic regurgitation was <2% for both devices. A total of 34.3% of patients treated with LOTUS and 14.1% of patients treated with Edwards SAPIEN 3 required a permanent pacemaker (HR, 2.76; 95% CI, 1.97–3.87 [P<0.001]).
Conclusions
The repositionable LOTUS valve system and the balloon‐expandable Edwards SAPIEN 3 prosthesis appeared comparable in regard to the Valve Academic Research Consortium‐2 early safety outcome, and the rates of more than mild aortic regurgitation were exceedingly low for both devices. The need for new permanent pacemaker implantation was more frequent among patients treated with the LOTUS valve.
doi:10.1161/JAHA.116.004088
PMCID: PMC5210340  PMID: 27856487
aortic valve regurgitation; newer‐generation devices; permanent pacemaker; transcatheter aortic valve replacement; Aortic Valve Replacement/Transcather Aortic Valve Implantation
2.  Ultrathin Strut Biodegradable Polymer Sirolimus‐Eluting Stent Versus Durable‐Polymer Everolimus‐Eluting Stent for Percutaneous Coronary Revascularization: 2‐Year Results of the BIOSCIENCE Trial 
Background
No data are available on the long‐term performance of ultrathin strut biodegradable polymer sirolimus‐eluting stents (BP‐SES). We reported 2‐year clinical outcomes of the BIOSCIENCE (Ultrathin Strut Biodegradable Polymer Sirolimus‐Eluting Stent Versus Durable Polymer Everolimus‐Eluting Stent for Percutaneous Coronary Revascularisation) trial, which compared BP‐SES with durable‐polymer everolimus‐eluting stents (DP‐EES) in patients undergoing percutaneous coronary intervention.
Methods and Results
A total of 2119 patients with minimal exclusion criteria were assigned to treatment with BP‐SES (n=1063) or DP‐EES (n=1056). Follow‐up at 2 years was available for 2048 patients (97%). The primary end point was target‐lesion failure, a composite of cardiac death, target‐vessel myocardial infarction, or clinically indicated target‐lesion revascularization. At 2 years, target‐lesion failure occurred in 107 patients (10.5%) in the BP‐SES arm and 107 patients (10.4%) in the DP‐EES arm (risk ratio [RR] 1.00, 95% CI 0.77–1.31, P=0.979). There were no significant differences between BP‐SES and DP‐EES with respect to cardiac death (RR 1.01, 95% CI 0.62–1.63, P=0.984), target‐vessel myocardial infarction (RR 0.91, 95% CI 0.60–1.39, P=0.669), target‐lesion revascularization (RR 1.17, 95% CI 0.81–1.71, P=0.403), and definite stent thrombosis (RR 1.38, 95% CI 0.56–3.44, P=0.485). There were 2 cases (0.2%) of definite very late stent thrombosis in the BP‐SES arm and 4 cases (0.4%) in the DP‐EES arm (P=0.423). In the prespecified subgroup of patients with ST‐segment elevation myocardial infarction, BP‐SES was associated with a lower risk of target‐lesion failure compared with DP‐EES (RR 0.48, 95% CI 0.23–0.99, P=0.043, P interaction=0.026).
Conclusions
Comparable safety and efficacy profiles of BP‐SES and DP‐EES were maintained throughout 2 years of follow‐up.
Clinical Trial Registration
URL: https://www.clinicaltrials.gov. Unique identifier: NCT01443104.
doi:10.1161/JAHA.116.003255
PMCID: PMC4943287  PMID: 26979080
biodegradable polymer; drug‐eluting stent; everolimus‐eluting stent; percutaneous coronary intervention; sirolimus‐eluting stent; Percutaneous Coronary Intervention; Stent
3.  Post‐Procedural Troponin Elevation and Clinical Outcomes Following Transcatheter Aortic Valve Implantation 
Background
Biomarkers of myocardial injury increase frequently during transcatheter aortic valve implantation (TAVI). The impact of postprocedural cardiac troponin (cTn) elevation on short‐term outcomes remains controversial, and the association with long‐term prognosis is unknown.
Methods and Results
We evaluated 577 consecutive patients with severe aortic stenosis treated with TAVI between 2007 and 2012. Myocardial injury, defined according to the Valve Academic Research Consortium (VARC)‐2 as post‐TAVI cardiac troponin T (cTnT) >15× the upper limit of normal, occurred in 338 patients (58.1%). In multivariate analyses, myocardial injury was associated with higher risk of all‐cause mortality at 30 days (adjusted hazard ratio [HR], 8.77; 95% CI, 2.07–37.12; P=0.003) and remained a significant predictor at 2 years (adjusted HR, 1.98; 95% CI, 1.36–2.88; P<0.001). Higher cTnT cutoffs did not add incremental predictive value compared with the VARC‐2–defined cutoff. Whereas myocardial injury occurred more frequently in patients with versus without coronary artery disease (CAD), the relative impact of cTnT elevation on 2‐year mortality did not differ between patients without CAD (adjusted HR, 2.59; 95% CI, 1.27–5.26; P=0.009) and those with CAD (adjusted HR, 1.71; 95% CI, 1.10–2.65; P=0.018; P for interaction=0.24). Mortality rates at 2 years were lowest in patients without CAD and no myocardial injury (11.6%) and highest in patients with complex CAD (SYNTAX score >22) and myocardial injury (41.1%).
Conclusions
VARC‐2–defined cTnT elevation emerged as a strong, independent predictor of 30‐day mortality and remained a modest, but significant, predictor throughout 2 years post‐TAVI. The prognostic value of cTnT elevation was modified by the presence and complexity of underlying CAD with highest mortality risk observed in patients combining SYNTAX score >22 and evidence of myocardial injury.
doi:10.1161/JAHA.115.002430
PMCID: PMC4802442  PMID: 26896474
aortic stenosis; prognosis; transcatheter aortic valve implantation; troponin; Aortic Valve Replacement/Transcather Aortic Valve Implantation; Biomarkers; Catheter-Based Coronary and Valvular Interventions
4.  Validation of the Valve Academic Research Consortium Bleeding Definition in Patients With Severe Aortic Stenosis Undergoing Transcatheter Aortic Valve Implantation 
Background
The Valve Academic Research Consortium (VARC) has proposed a standardized definition of bleeding in patients undergoing transcatheter aortic valve interventions (TAVI). The VARC bleeding definition has not been validated or compared to other established bleeding definitions so far. Thus, we aimed to investigate the impact of bleeding and compare the predictivity of VARC bleeding events with established bleeding definitions.
Methods and Results
Between August 2007 and April 2012, 489 consecutive patients with severe aortic stenosis were included into the Bern‐TAVI‐Registry. Every bleeding complication was adjudicated according to the definitions of VARC, BARC, TIMI, and GUSTO. Periprocedural blood loss was added to the definition of VARC, providing a modified VARC definition. A total of 152 bleeding events were observed during the index hospitalization. Bleeding severity according to VARC was associated with a gradual increase in mortality, which was comparable to the BARC, TIMI, GUSTO, and the modified VARC classifications. The predictive precision of a multivariable model for mortality at 30 days was significantly improved by adding the most serious bleeding of VARC (area under the curve [AUC], 0.773; 95% confidence interval [CI], 0.706 to 0.839), BARC (AUC, 0.776; 95% CI, 0.694 to 0.857), TIMI (AUC, 0.768; 95% CI, 0.692 to 0.844), and GUSTO (AUC, 0.791; 95% CI, 0.714 to 0.869), with the modified VARC definition resulting in the best predictivity (AUC, 0.814; 95% CI, 0.759 to 0.870).
Conclusions
The VARC bleeding definition offers a severity stratification that is associated with a gradual increase in mortality and prognostic information comparable to established bleeding definitions. Adding the information of periprocedural blood loss to VARC may increase the sensitivity and the predictive power of this classification.
doi:10.1161/JAHA.115.002135
PMCID: PMC4845126  PMID: 26408014
bleeding; complication; TAVI; transcatheter aortic valve implantation; transcatheter aortic valve intervention; Valve Academic Research Consortium
5.  Everolimus-eluting bioresorbable stent vs. durable polymer everolimus-eluting metallic stent in patients with ST-segment elevation myocardial infarction: results of the randomized ABSORB ST-segment elevation myocardial infarction—TROFI II trial 
European Heart Journal  2015;37(3):229-240.
Aims
Patients with ST-segment elevation myocardial infarction (STEMI) feature thrombus-rich lesions with large necrotic core, which are usually associated with delayed arterial healing and impaired stent-related outcomes. The use of bioresorbable vascular scaffolds (Absorb) has the potential to overcome these limitations owing to restoration of native vessel lumen and physiology at long term. The purpose of this randomized trial was to compare the arterial healing response at short term, as a surrogate for safety and efficacy, between the Absorb and the metallic everolimus-eluting stent (EES) in patients with STEMI.
Methods and results
ABSORB-STEMI TROFI II was a multicentre, single-blind, non-inferiority, randomized controlled trial. Patients with STEMI who underwent primary percutaneous coronary intervention were randomly allocated 1:1 to treatment with the Absorb or EES. The primary endpoint was the 6-month optical frequency domain imaging healing score (HS) based on the presence of uncovered and/or malapposed stent struts and intraluminal filling defects. Main secondary endpoint included the device-oriented composite endpoint (DOCE) according to the Academic Research Consortium definition. Between 06 January 2014 and 21 September 2014, 191 patients (Absorb [n = 95] or EES [n = 96]; mean age 58.6 years old; 17.8% females) were enrolled at eight centres. At 6 months, HS was lower in the Absorb arm when compared with EES arm [1.74 (2.39) vs. 2.80 (4.44); difference (90% CI) −1.06 (−1.96, −0.16); Pnon-inferiority <0.001]. Device-oriented composite endpoint was also comparably low between groups (1.1% Absorb vs. 0% EES). One case of definite subacute stent thrombosis occurred in the Absorb arm (1.1% vs. 0% EES; P = ns).
Conclusion
Stenting of culprit lesions with Absorb in the setting of STEMI resulted in a nearly complete arterial healing which was comparable with that of metallic EES at 6 months. These findings provide the basis for further exploration in clinically oriented outcome trials.
doi:10.1093/eurheartj/ehv500
PMCID: PMC4712350  PMID: 26405232
ST elevation myocardial infarction; Bioresorbable scaffold; Optical coherence tomography; Randomized control study
6.  Age- and Gender-related Disparities in Primary Percutaneous Coronary Interventions for Acute ST-segment elevation Myocardial Infarction 
PLoS ONE  2015;10(9):e0137047.
Background
Previous analyses reported age- and gender-related differences in the provision of cardiac care. The objective of the study was to compare circadian disparities in the delivery of primary percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI) according to the patient’s age and gender.
Methods
We investigated patients included into the Acute Myocardial Infarction in Switzerland (AMIS) registry presenting to one of 11 centers in Switzerland providing primary PCI around the clock, and stratified patients according to gender and age.
Findings
A total of 4723 patients presented with AMI between 2005 and 2010; 1319 (28%) were women and 2172 (54%) were ≥65 years of age. More than 90% of patients <65 years of age underwent primary PCI without differences between gender. Elderly patients and particularly women were at increased risk of being withheld primary PCI (males adj. HR 4.91, 95% CI 3.93–6.13; females adj. HR 9.31, 95% CI 7.37–11.75) as compared to males <65 years of age. An increased risk of a delay in door-to-balloon time >90 minutes was found in elderly males (adj HR 1.66 (95% CI 1.40–1.95), p<0.001) and females (adj HR 1.57 (95% CI 1.27–1.93), p<0.001), as well as in females <65 years (adj HR 1.47 (95% CI 1.13–1.91), p = 0.004) as compared to males <65 years of age, with significant differences in circadian patterns during on- and off-duty hours.
Conclusions
In a cohort of patients with AMI in Switzerland, we observed discrimination of elderly patients and females in the circadian provision of primary PCI.
doi:10.1371/journal.pone.0137047
PMCID: PMC4564139  PMID: 26352574
7.  Screening for Rheumatic Heart Disease among Peruvian Children: A Two-Stage Sampling Observational Study 
PLoS ONE  2015;10(7):e0133004.
Background
The objective of the study was to evaluate the implications of different classifications of rheumatic heart disease on estimated prevalence, and to systematically assess the importance of incidental findings from echocardiographic screening among schoolchildren in Peru.
Methods
We performed a cluster randomized observational survey using portable echocardiography among schoolchildren aged 5 to 16 years from randomly selected public and private schools in Arequipa, Peru. Rheumatic heart disease was defined according to the modified World Health Organization (WHO) criteria and the World Heart Federation (WHF) criteria.
Findings
Among 1395 eligible students from 40 classes and 20 schools, 1023 (73%) participated in the present survey. The median age of the children was 11 years (interquartile range [IQR] 8–13 years) and 50% were girls. Prevalence of possible, probable and definite rheumatic heart disease according to the modified WHO criteria amounted to 19.7/1000 children and ranged from 10.2/1000 among children 5 to 8 years of age to 39.8/1000 among children 13 to 16 years of age; the prevalence of borderline/definite rheumatic heart disease according to the WHF criteria was 3.9/1000 children. 21 children (2.1%) were found to have congenital heart disease, 8 of which were referred for percutaneous or surgical intervention.
Conclusions
Prevalence of RHD in Peru was considerably lower compared to endemic regions in sub-Saharan Africa, southeast Asia, and Oceania; and paralleled by a comparable number of undetected congenital heart disease. Strategies to address collateral findings from echocardiographic screening are necessary in the setup of active surveillance programs for RHD.
Trial Registration
ClinicalTrials.gov identifier: NCT02353663
doi:10.1371/journal.pone.0133004
PMCID: PMC4514892  PMID: 26208006
8.  Additive Effect of Anemia and Renal Impairment on Long-Term Outcome after Percutaneous Coronary Intervention 
PLoS ONE  2014;9(12):e114846.
Introduction
Anemia and renal impairment are important co-morbidities among patients with coronary artery disease undergoing Percutaneous Coronary Intervention (PCI). Disease progression to eventual death can be understood as the combined effect of baseline characteristics and intermediate outcomes.
Methods
Using data from a prospective cohort study, we investigated clinical pathways reflecting the transitions from PCI through intermediate ischemic or hemorrhagic events to all-cause mortality in a multi-state analysis as a function of anemia (hemoglobin concentration <120 g/l and <130 g/l, for women and men, respectively) and renal impairment (creatinine clearance <60 ml/min) at baseline.
Results
Among 6029 patients undergoing PCI, anemia and renal impairment were observed isolated or in combination in 990 (16.4%), 384 (6.4%), and 309 (5.1%) patients, respectively. The most frequent transition was from PCI to death (6.7%, 95% CI 6.1–7.3), followed by ischemic events (4.8%, 95 CI 4.3–5.4) and bleeding (3.4%, 95% CI 3.0–3.9). Among patients with both anemia and renal impairment, the risk of death was increased 4-fold as compared to the reference group (HR 3.9, 95% CI 2.9–5.4) and roughly doubled as compared to patients with either anemia (HR 1.7, 95% CI 1.3–2.2) or renal impairment (HR 2.1, 95% CI 1.5–2.9) alone. Hazard ratios indicated an increased risk of bleeding in all three groups compared to patients with neither anemia nor renal impairment.
Conclusions
Applying a multi-state model we found evidence for a gradient of risk for the composite of bleeding, ischemic events, or death as a function of hemoglobin value and estimated glomerular filtration rate at baseline.
doi:10.1371/journal.pone.0114846
PMCID: PMC4260949  PMID: 25489846
9.  The Impact of Renal Impairment on Long-Term Safety and Effectiveness of Drug-Eluting Stents 
PLoS ONE  2014;9(9):e106450.
Background
Renal impairment (RI) is associated with impaired prognosis in patients with coronary artery disease. Clinical and angiographic outcomes of patients undergoing percutaneous coronary intervention (PCI) with the use of drug-eluting stents (DES) in this patient population are not well established.
Methods
We pooled individual data for 5,011 patients from 3 trials with the exclusive and unrestricted use of DES (SIRTAX - N = 1,012, LEADERS - N = 1,707, RESOLUTE AC - N = 2,292). Angiographic follow-up was available for 1,544 lesions. Outcomes through 2 years were stratified according to glomerular filtration rate (normal renal function: GFR≥90 ml/min; mild RI: 90
Results
Patients with moderate/severe RI had an increased risk of cardiac death or myocardial infarction ([MI], OR 2.14, 95%CI 1.36–3.36), cardiac death (OR 2.21, 95%CI 1.10–4.46), and MI (OR 2.02, 95%CI 1.19–3.43) compared with patients with normal renal function at 2 years follow-up. There was no difference in cardiac death or MI between patients with mild RI compared to those with normal renal function (OR 1.10, 95%CI 0.75–1.61). The risk of target-lesion revascularization was similar for patients with moderate/severe RI (OR 1.17, 95%CI 0.70–1.95) and mild RI (OR 1.16, 95%CI 0.81–1.64) compared with patients with normal renal function. In-stent late loss and in-segment restenosis were not different for patients with moderate/severe RI, mild RI, and normal renal function.
Conclusions
Renal function does not affect clinical and angiographic effectiveness of DES. However, prognosis remains impaired among patients with moderate/severe RI.
doi:10.1371/journal.pone.0106450
PMCID: PMC4153613  PMID: 25184244
Open Heart  2014;1(1):e000014.
Background
Concurrent cardiac diseases are frequent among elderly patients and invite simultaneous treatment to ensure an overall favourable patient outcome.
Aim
To investigate the feasibility of combined single-session percutaneous cardiac interventions in the era of transcatheter aortic valve implantation (TAVI).
Methods
This prospective, case–control study included 10 consecutive patients treated with TAVI, left atrial appendage occlusion and percutaneous coronary interventions. Some in addition had patent foramen ovale or atrial septal defect closure in the same session. The patients were matched in a 1:10 manner with TAVI-only cases treated within the same time period at the same institution regarding their baseline factors. The outcome was validated according to the Valve Academic Research Consortium (VARC) criteria.
Results
Procedural time (126±42 vs 83±40 min, p=0.0016), radiation time (34±8 vs 22±12 min, p=0.0001) and contrast dye (397±89 vs 250±105 mL, p<0.0001) were higher in the combined intervention group than in the TAVI-only group. Despite these drawbacks, no difference in the VARC endpoints was evident during the in-hospital period and after 30 days (VARC combined safety endpoint 32% for TAVI only and 20% for combined intervention, p=1.0).
Conclusions
Transcatheter treatment of combined cardiac diseases is feasible even in a single session in a high-volume centre with experienced operators.
doi:10.1136/openhrt-2013-000014
PMCID: PMC4195934  PMID: 25332781
Heart Asia  2014;6(1):26-29.
Objective
To investigate the prevalence, characteristics and maternal and perinatal outcomes of pregnancies complicated by heart disease.
Design
Prospective single-centre registry.
Setting
Tertiary care teaching hospital in eastern Nepal.
Patients
Pregnant women presenting to the antenatal clinic and/or labour room between 1 March 2012 and 31 March 2013.
Main outcome measures
Prevalence, characteristics, and maternal and perinatal outcomes of pregnancies complicated by heart disease.
Results
Fifty-three out of 9463 pregnancies (0.6%) were complicated by cardiac disease. Proportions of acquired, congenital and arrhythmic heart disease amounted to 89%, 9% and 2%, respectively. Rheumatic heart disease (RHD) was the most frequent cardiac disease complicating pregnancy (n=47). Among 45 women with RHD continuing pregnancy until delivery, 30 (67%) were primigravidae. The predominant valvular pathology was mitral stenosis (62%), followed by mitral regurgitation (21%) and aortic regurgitation (13%). Twenty women (44%) underwent elective or emergency caesarean section. Maternal and fetal/perinatal mortality of pregnancies complicated by RHD amounted to 4% and 16%, respectively. New York Heart Association (NYHA) functional class III or class IV (HR 6.0, 95% CI 1.2 to 29.1, p=0.026), pulmonary hypertension (HR 9.1, 95% CI 1.6 to 51.5, p=0.012) and severe mitral stenosis (HR 7.0, 95% CI 1.4 to 34.4, p=0.017) were identified as predictors of maternal or fetal/perinatal mortality in an univariate analysis.
Conclusions
Rheumatic mitral stenosis was the most frequent heart disease complicating pregnancy in a consecutive cohort from a teaching hospital in Nepal. Exercise intolerance, pulmonary hypertension and severe mitral stenosis were identified as predictors of maternal or fetal/perinatal mortality.
doi:10.1136/heartasia-2013-010396
PMCID: PMC4832684  PMID: 27326158
BMJ Open  2012;2(5):e001616.
Objectives
To evaluate a protocol for a population-based programme targeting the prevention of rheumatic heart disease (RHD) progression by early echocardiographic diagnosis of valvular lesions and timely implementation of secondary prevention.
Design
Observational survey with a subsequent prospective cohort study.
Setting
Private boarding school in the urban area of the Sunsari district situated on the foothills of the Lower Himalayan Range in Eastern Nepal.
Participants
Fifty-four unselected school-going children 5–15 years of age, 24 girls and 30 boys.
Primary outcome measure
Logistic feasibility of a large-scale population-based screening study using the echocardiographic criteria formulated by the World Heart Federation, with longitudinal follow-up of children with definite or borderline RHD in a prospective cohort study.
Results
Standardised interview, physical examination and screening echocardiography were performed in a three-staged process and took approximately 6 min per child. Socio-economic status was assessed using surrogate markers such as the occupation of the primary caregiver, numbers of rooms at home, car, television, cell phone and internet connection. Physical examination was focused on cardiac auscultation and signs of acute rheumatic fever and targeted echocardiography was performed by an independent examiner without knowledge of the clinical findings. Two children with evidence of borderline RHD were re-examined at B.P. Koirala Institute of Health Sciences and the indication for secondary antibiotic prevention was discussed with the parents and the children. At 6 months of follow-up, echocardiographic findings were stable in both children. Implementation of secondary antibiotic prevention was challenged by impaired awareness of subclinical RHD among parents and inadequate cooperation with family physicians.
Conclusions
This pilot study shows that the methods outlined in the protocol can be translated into a large-scale population-based study. We learned that education and collaboration with teachers, parents and family physicians/paediatricians will be of key importance in order to establish a sustainable programme.
doi:10.1136/bmjopen-2012-001616
PMCID: PMC3488717  PMID: 23087010
Cardiology
BMJ Open  2012;2(3):e001320.
Introduction
Rheumatic heart disease (RHD) remains a major contributor to morbidity and mortality in developing countries. The reported prevalence rates of RHD are highly variable and mainly attributable to differences in the sensitivity of either clinical screening to detect advanced heart disease or echocardiographic evaluation where disease is diagnosed earlier across a continuous spectrum. The clinical significance of diagnosis of subclinical RHD by echocardiographic screening and early implementation of secondary prevention has not been clearly established.
Methods and analysis
The authors designed a cross-sectional survey to determine the prevalence of RHD in children from private and public schools between the age of 5 and 15 years in urban and rural areas of Eastern Nepal using both cardiac auscultation and echocardiographic evaluation. Children with RHD will be treated with secondary prevention and enrolled in a prospective cohort study. The authors will compare the prevalence rates by cardiac auscultation and echocardiography, determine risk factors associated with diagnosis and progression of RHD, investigate social and economic barriers for receiving adequate cardiac care and assess clinical outcomes with regular medical surveillance as a function of stage of disease at the time of diagnosis. Prospective clinical studies investigating the impact of secondary prevention for subclinical RHD on long-term clinical outcome will be of central relevance for future health resource utilisation in developing countries.
Ethics and dissemination
The study was considered ethically uncritical and was given an exempt status by the ethics committee at University of Bern, Switzerland. The study has been submitted to the National Nepal Health Research Council and was registered with http://www.ClinicalTrials.gov (NCT01550068). The study findings will be reported in peer-reviewed publications.
ClinicalTrials.gov Identifier
NCT01550068.
Article summary
Article focus
Study protocol of a population-based evaluation of the prevalence rate of RHD among schoolchildren in Eastern Nepal, with a subsequent prospective longitudinal cohort study assessing long-term clinical outcome of children undergoing secondary prevention for borderline and definite RHD according to the World Heart Federation criteria.
Key messages
RHD remains a major contributor to morbidity and mortality in developing countries.
Echocardiographic screening allows diagnosis of RHD at an earlier stage across a continuous spectrum as compared with cardiac auscultation.
The clinical significance of diagnosis of subclinical RHD by echocardiographic screening and early implementation of secondary prevention has not been clearly established.
Strengths and limitations of this study
The protocol describes a comprehensive approach to implement echocardiographic screening in a high prevalence region as recommended by the WHO and outlines a robust analysis plan to investigate clinical outcome with secondary prevention for subclinical RHD.
Since access to education is a marker of socioeconomic status, restriction of screening to school going children is subjected to selection bias likely to underestimate the real disease burden related to RHD in Eastern Nepal.
Cultural sensitivity with education programmes and focus group discussions will anticipate the potential social stigma of a diagnosis with a heart condition during childhood and increase public awareness.
doi:10.1136/bmjopen-2012-001320
PMCID: PMC3371575  PMID: 22685225
PLoS ONE  2011;6(11):e27556.
Introduction
Reduced left ventricular function in patients with severe symptomatic valvular aortic stenosis is associated with impaired clinical outcome in patients undergoing surgical aortic valve replacement (SAVR). Transcatheter Aortic Valve Implantation (TAVI) has been shown non-inferior to SAVR in high-risk patients with respect to mortality and may result in faster left ventricular recovery.
Methods
We investigated clinical outcomes of high-risk patients with severe aortic stenosis undergoing medical treatment (n = 71) or TAVI (n = 256) stratified by left ventricular ejection fraction (LVEF) in a prospective single center registry.
Results
Twenty-five patients (35%) among the medical cohort were found to have an LVEF≤30% (mean 26.7±4.1%) and 37 patients (14%) among the TAVI patients (mean 25.2±4.4%). Estimated peri-interventional risk as assessed by logistic EuroSCORE was significantly higher in patients with severely impaired LVEF as compared to patients with LVEF>30% (medical/TAVI 38.5±13.8%/40.6±16.4% versus medical/TAVI 22.5±10.8%/22.1±12.8%, p <0.001). In patients undergoing TAVI, there was no significant difference in the combined endpoint of death, myocardial infarction, major stroke, life-threatening bleeding, major access-site complications, valvular re-intervention, or renal failure at 30 days between the two groups (21.0% versus 27.0%, p = 0.40). After TAVI, patients with LVEF≤30% experienced a rapid improvement in LVEF (from 25±4% to 34±10% at discharge, p = 0.002) associated with improved NYHA functional class at 30 days (decrease ≥1 NYHA class in 95%). During long-term follow-up no difference in survival was observed in patients undergoing TAVI irrespective of baseline LVEF (p = 0.29), whereas there was a significantly higher mortality in medically treated patients with severely reduced LVEF (log rank p = 0.001).
Conclusion
TAVI in patients with severely reduced left ventricular function may be performed safely and is associated with rapid recovery of systolic left ventricular function and heart failure symptoms.
doi:10.1371/journal.pone.0027556
PMCID: PMC3213147  PMID: 22102909

Results 1-14 (14)