scholarly journals Prognostic value of cardiovascular magnetic resonance left ventricular volumetry and geometry in patients receiving an implantable cardioverter defibrillator

2021 ◽  
Vol 23 (1) ◽  
Author(s):  
Camila M. Urzua Fresno ◽  
Luciano Folador ◽  
Tamar Shalmon ◽  
Faisal Mhd. Dib Hamad ◽  
Sheldon M. Singh ◽  
...  
Keyword(s):  
Cardiovascular Magnetic Resonance ◽  
Magnetic Resonance ◽  
Implantable Cardioverter Defibrillator ◽  
Prognostic Value ◽  
Outcome Data ◽  
Left Ventricular ◽  
Icd Implantation ◽  
Cardioverter Defibrillator ◽  
Lv Mass ◽  
Icd Shock

Abstract Background Current indications for implantable cardioverter defibrillator (ICD) implantation for sudden cardiac death prevention rely primarily on left ventricular (LV) ejection fraction (LVEF). Currently, two different contouring methods by cardiovascular magnetic resonance (CMR) are used for LVEF calculation. We evaluated the comparative prognostic value of these two methods in the ICD population, and if measures of LV geometry added predictive value. Methods In this retrospective, 2-center observational cohort study, patients underwent CMR prior to ICD implantation for primary or secondary prevention from January 2005 to December 2018. Two readers, blinded to all clinical and outcome data assessed CMR studies by: (a) including the LV trabeculae and papillary muscles (TPM) (trabeculated endocardial contours), and (b) excluding LV TPM (rounded endocardial contours) from the total LV mass for calculation of LVEF, LV volumes and mass. LV sphericity and sphere-volume indices were also calculated. The primary outcome was a composite of appropriate ICD shocks or death. Results Of the 372 consecutive eligible patients, 129 patients (34.7%) had appropriate ICD shock, and 65 (17.5%) died over a median duration follow-up of 61 months (IQR 38–103). LVEF was higher when including TPM versus excluding TPM (36% vs. 31%, p < 0.001). The rate of appropriate ICD shock or all-cause death was higher among patients with lower LVEF both including and excluding TPM (p for trend = 0.019 and 0.004, respectively). In multivariable models adjusting for age, primary prevention, ischemic heart disease and late gadolinium enhancement, both LVEF (HR per 10% including TPM 0.814 [95%CI 0.688–0.962] p = 0.016, vs. HR per 10% excluding TPM 0.780 [95%CI 0.639–0.951] p = 0.014) and LV mass index (HR per 10 g/m2 including TPM 1.099 [95%CI 1.027–1.175] p = 0.006; HR per 10 g/m2 excluding TPM 1.126 [95%CI 1.032–1.228] p = 0.008) had independent prognostic value. Higher LV end-systolic volumes and LV sphericity were significantly associated with increased mortality but showed no added prognostic value. Conclusion Both CMR post-processing methods showed similar prognostic value and can be used for LVEF assessment. LVEF and indexed LV mass are independent predictors for appropriate ICD shocks and all-cause mortality in the ICD population.

Abstract 2037: Renal Dysfunction and Appropriate Shock Therapy in Implantable Cardioverter Defibrillator Patients with Nonischemic Heart Failure

Circulation ◽  
2007 ◽  
Vol 116 (suppl_16) ◽  
Author(s):  
Atsushi Takahashi ◽  
Tsuyoshi Shiga ◽  
Keisuke Futagawa ◽  
Ryusuke Kimura ◽  
Koichiro Ejima ◽  
...  
Keyword(s):  
Heart Failure ◽  
Renal Insufficiency ◽  
Renal Dysfunction ◽  
Implantable Cardioverter Defibrillator ◽  
Shock Therapy ◽  
Left Ventricular ◽  
Left Ventricular Ejection ◽  
Icd Implantation ◽  
Cardioverter Defibrillator ◽  
Icd Shock

Background: Implantable Cardioverter Defibrillator (ICD) prevent sudden cardiac death in high risk patients with heart failure. The presence of coexisting conditions has a substantial effect on the rate of arrhythmic events in heart failure patients. Renal dysfunction is associated with mortality in patients with myocardial infarction or heart failure, but the influence of degrees of renal impairment is less well defined. Methods: A total of 221 patients who underwent ICD implantation were included between 1990 and 2006. Gromerular Filteration Rate (GFR) was estimated using the Modification of Diet in Renal Disease (MDRD) and renal insufficiency was defined as MDRD GFR<60mL/min/1.73m 2 . Differences in arrhythmia recurrences according to the MDRD GFR were compared by Kaplan-Meier survival curves. Results: During a mean follow-up time of 3.7±2.8 years, 82 (37%) of 221 patients (mean age; 4.7±1.3 years, 71% male) experienced appropriate ICD shock therapy. There was a trend of higher cumulative rate of appropriate ICD shock therapies in patients with renal insufficiency than other patients (p<0.10). The result of subgroup analysis of 94 patients with low LVEF (LVEF<35%) indicated that the patients with renal insufficiency experienced electrical storms more frequently (p<0.05). After correcting for age, sex, left ventricular ejection fraction (LVEF), indication for ICD implantation, and use of beta-blockers in a Cox regression model, low MDRD GFR was still an independent predictor of the time to first appropriate ICD shock (hazard ratio [HR] 2.30, 95% confidence interval [CI] 1.13–4.69, p<0.05). Below 60mL/min/1.73m 2 , each reduction of the MDRD GFR by 10 units was associated with a HR for appropriate shock of 1.40 (95% CI, 1.00 to 1.95). Conclusion: Renal insufficiency is associated with increased rate of arrhythmic event in nonischemic HF patients. Especially, those patients with low LVEF and renal dysfunction experience more frequent ICD shocks.

Abstract 5700: Worsening Renal Function and Arrhythmic Event in Implantable Cardioverter Defibrillator Patients with Nonischemic Heart Failure

Circulation ◽  
2008 ◽  
Vol 118 (suppl_18) ◽  
Author(s):  
Atsushi Takahashi ◽  
Tsuyoshi Shiga ◽  
Daigo Yagishita ◽  
Keisuke Futagawa ◽  
Naoki Serizawa ◽  
...  
Keyword(s):  
Heart Failure ◽  
Renal Function ◽  
Renal Dysfunction ◽  
Implantable Cardioverter Defibrillator ◽  
Shock Therapy ◽  
Electrical Storm ◽  
Icd Implantation ◽  
Cardioverter Defibrillator ◽  
Arrhythmic Event ◽  
Icd Shock

Purpose: Implantable Cardioverter Defibrillator (ICD) prevents sudden cardiac death in high risk patients with heart failure (HF). Worsening renal function (WRF) is associated with mortality in patients with myocardial infarction or HF, but its effect on lethal arrhythmia is unknown. We evaluated the influence of WRF on the occurrence of arrhythmic events in patients with nonischemic HF and ICD. Methods: A total of 286 nonischemic HF patients who underwent ICD implantation between 1990 and 2007 were studied. Estimated Glomerular Filtration Rate (eGFR) was calculated using the Modification of Diet in Renal Disease. Renal dysfunction was defined as eGFR <60mL/min/1.73m 2 and WRF was defined as 15mL/min/1.73m 2 per year. Differences in arrhythmia recurrences according to the eGFR and WRF were compared by Kaplan-Meier survival curves. Results: During a mean follow-up time of 2.2+/−1.0 years, 94 (33%) of 286 patients (mean age; 57+/−15 years, 72% male) experienced appropriate ICD shock therapy. There was a significantly higher cumulative rate of appropriate ICD shock therapy (p<0.05) and electrical storm (p<0.05) in patients with renal dysfunction than others. The patients with renal dysfunction at baseline experience WRF more frequently than other patients (53% vs. 23%, respectively, p<0.01). After correcting for age, sex, left ventricular ejection fraction (LVEF), indication for ICD implantation, and use of beta-blockers in a Cox regression model, WRF was still an independent predictor of the time to first appropriate shock (HR 2.21, 95% CI 1.32–3.69, p<0.05) and electrical storm (HR 2.22, 95% CI 1.19 – 4.13, p<0.05). The result of subgroup analysis of 147 patients with low LVEF (LVEF<35%) indicated that the patients with WRF experienced electrical storms more frequently (p<0.05). Conclusion: WRF is associated with increased rate of arrhythmic event in nonischemic HF patients. Especially, those patients with low LVEF and WRF experience more frequent ICD shocks.

scholarly journals LEFT VENTRICULAR LEAD IMPLANTATION FOR DETECTION OF VENTRICULAR ARRHYTHMIAS IN PATIENT WITH IMPLANTABLE CARDIOVERTER DEFIBRILLATOR AND LOW R WAVE IN RIGHT VENTRICLE

2021 ◽  
pp. 17
Author(s):  
Keyword(s):  
Sudden Cardiac Death ◽  
Right Ventricle ◽  
Implantable Cardioverter Defibrillator ◽  
Cardiac Death ◽  
Ventricular Arrhythmias ◽  
Systolic Function ◽  
Left Ventricular ◽  
Icd Implantation ◽  
Cardioverter Defibrillator ◽  
Ventricular Lead

Dilated cardiomyopathy (DCM) is a disease characterised as left ventricular (LV) or biventricular dilatation with impaired systolic function. Regardless of underlying cause patients with DCM have a propensity to ventricular arrhythmias and sudden cardiac death. Implantable Cardioverter Defibrillator (ICD) implantation for these patients results in significant reduction of sudden cardiac death [1-3]. ICD devices may be limited by right ventricle (RV) sensing dysfunction with low RV sensing amplitude. We present a clinical case of patient with DCM, implanted ICD and low R wave sensing on RV lead.

5968Adherence to driving restrictions among patients with an implantable cardioverter defibrillator: insights from a nationwide register-linked survey study

2019 ◽  
Vol 40 (Supplement_1) ◽  
Author(s):  
J Bjerre ◽  
S M Rosenkranz ◽  
M Schou ◽  
C Jons ◽  
B T Philbert ◽  
...  
Keyword(s):  
Logistic Regression ◽  
Primary Prevention ◽  
Secondary Prevention ◽  
Implantable Cardioverter Defibrillator ◽  
Survey Study ◽  
Icd Implantation ◽  
Cardioverter Defibrillator ◽  
Driving Restrictions ◽  
Driver's License ◽  
Icd Shock

Abstract Background Patients with an implantable cardioverter defibrillator (ICD) are restricted from driving following initial implantation or ICD shock. It is unclear how many patients are aware of, and adhere to, these restrictions. Purpose To investigate knowledge of, and adherence to, private and professional driving restrictions in a nationwide cohort of ICD patients. Methods A questionnaire was distributed to all living Danish residents ≥18 years who received a first-time ICD between 2013 and 2016 (n=3,913). During this period, Danish guidelines recommended 1 week driving restriction following ICD implantation for primary prevention, and 3 months following either ICD implantation for secondary prevention or appropriate ICD shock, and permanent restriction of professional driving and driving of large vehicles (>3.5 metric tons). Questionnaires were linked with relevant nationwide registries. Logistic regression was applied to identify factors associated with non-adherence. Results Of 2,741 questionnaire respondents, 92% (n=2,513) held a valid private driver's license at time of ICD implantation (85% male; 46% primary prevention indication; median age: 67 years (IQR: 59–73)). Of these, 7% (n=175) were actively using a professional driver's license for truck driving (n=73), bus driving (n=45), taxi driving (n=22), large vehicle driving for private use (n=54), or other purposes (n=32) (multiple purposes allowed). Only 42% of primary prevention patients, 63% of secondary prevention patients, and 72% of patients who experienced an appropriate ICD shock, recalled being informed of any driving restrictions. Only 45% of professional drivers recalled being informed about specific professional driving restrictions (Figure). Most patients (93%, n=2,344) resumed private driving after ICD implantation, more than 30% during the driving restriction period: 34% of primary prevention patients resumed driving within 1 week, 43% of secondary prevention patients resumed driving within 3 months, and 30% of patients who experienced an appropriate ICD shock resumed driving within 3 months. Professional driving was resumed by 35%. Patients who resumed driving within the restricted periods were less likely to report having received information about driving restrictions (all p<0.001) (Figure). In a multiple logistic regression model, non-adherence was predicted by reporting non-receipt of information about driving restrictions (OR: 3.34, CI: 2.27–4.03), as well as male sex (OR: 1.53, CI: 1.17–2.01), age ≥60 years (OR: 1.20, CI: 1.02–1.64), receipt of a secondary prevention ICD (OR: 2.2, CI: 1.80–2.62), and being the only driver in the household (OR: 1.29, CI: 1.05–1.57). Conclusion In this nationwide survey study, many ICD patients were unaware of the driving restrictions, and many ICD patients, including professional drivers, resumed driving within the restricted periods. More focus on communicating driving restrictions might improve adherence. Acknowledgement/Funding Danish Heart Foundation, Arvid Nilsson Foundation, Fraenkels Mindefond

Effects of implantable cardioverter defibrillator implantation and shock application on serum endothelin-1 and big-endothelin levels

2002 ◽  
Vol 103 (s2002) ◽  
pp. 233S-236S ◽  
Author(s):  
Andrea SZÜCS ◽  
Katalin KELTAI ◽  
Endre ZIMA ◽  
Hajnalka VÁGÓ ◽  
Pál SOÓS ◽  
...  
Keyword(s):  
Implantable Cardioverter Defibrillator ◽  
Heart Diseases ◽  
Shock Therapy ◽  
Left Ventricular ◽  
Left Ventricular Ejection ◽  
Icd Implantation ◽  
Shock Delivery ◽  
Ventricular Ejection Fraction ◽  
Cardioverter Defibrillator ◽  
Endothelin 1

The incidence of ventricular tachyarrhythmias in the early post-operative period following implantable cardioverter-defibrillator (ICD) implantation is relatively high compared with that in control periods. Since endothelin-1 (ET-1) has been proven to be an endogenous arrhythmogenic substance, we investigated the changes in serum ET-1 and big-ET levels in patients undergoing ICD implantation. Serum concentrations of ET-1 and big-ET were measured in 14 patients with various heart diseases before the operation, as well as 1min and 1h after the last shock therapy. Big-ET levels and the sum of ET-1 and big-ET levels were unchanged immediately after the operation, but had increased significantly by 1h after implantation (before, 1.57±0.61pmol/l; 1min, 1.86±0.87pmol/l; 1h, 4.29±1.65pmol/l for big-ET; before, 3.44±1.07pmol/l; 1min, 3.79±1.29pmol/l; 1h, 6.36±2.03pmol/l for big-ET+ET-1). There was a significant correlation between left ventricular ejection fraction and big-ET level measured 1h after the last shock delivery (r =-0.542, P<0.05). We conclude that the increased big-ET level observed 1h after the last induction and shock therapy of ventricular fibrillation might have a pathophysiological role in the increased incidence of post-operative spontaneous ventricular arrhythmias.

scholarly journals Predictors of Mortality in Patients With Biopsy‐Proven Viral Myocarditis: 10‐Year Outcome Data

2020 ◽  
Vol 9 (16) ◽  
Author(s):  
Simon Greulich ◽  
Andreas Seitz ◽  
Karin A. L. Müller ◽  
Stefan Grün ◽  
Peter Ong ◽  
...  
Keyword(s):  
Cardiovascular Magnetic Resonance ◽  
Magnetic Resonance ◽  
Cardiac Death ◽  
Prognostic Value ◽  
Viral Myocarditis ◽  
Outcome Data ◽  
Risk Of Death ◽  
Long Term Mortality

Background There is scarce data about the long‐term mortality as well as the prognostic value of cardiovascular magnetic resonance and late gadolinium enhancement (LGE) in patients with biopsy‐proven viral myocarditis. We sought to investigate: (1) mortality and (2) prognostic value of LGEcardiovascular magnetic resonance (location, pattern, extent, and distribution) in a >10‐year follow‐up in patients with biopsy‐proven myocarditis. Methods and Results Two‐hundred three consecutive patients with biopsy‐proven viral myocarditis and cardiovascular magnetic resonance were enrolled; 183 patients were eligible for standardized follow‐up. The median follow‐up was 10.1 years. End points were all‐cause death, cardiac death, and sudden cardiac death (SCD). We found substantial long‐term mortality in patients with biopsy‐proven myocarditis (39.3% all cause, 27.3% cardiac, and 10.9% SCD); 101 patients (55.2%) demonstrated LGE. The presence of LGE was associated with a more than a doubled risk of death (hazard ratio [HR], 2.40; 95% CI], 1.30–4.43), escalating to a HR of 3.00 (95% CI, 1.41–6.42) for cardiac death, and a HR of 14.79 (95% CI, 1.95–112.00) for SCD; all P ≤0.009. Specifically, midwall, (antero‐) septal LGE, and extent of LGE were highly associated with death, all P <0.001. Septal LGE was the best independent predictor for SCD (HR, 4.59; 95% CI, 1.38–15.24; P =0.01). Conclusions In patients with biopsy‐proven viral myocarditis, the presence of midwall LGE in the (antero‐) septal segments is associated with a higher rate of mortality (including SCD) compared with absent LGE or other LGE patterns, underlining the prognostic benefit of a distinct LGE analysis in these patients.

Long-term prognostic value of ischaemia and cardiovascular magnetic resonance-related revascularization for stable coronary disease, irrespective of patient’s sex: a large retrospective study

2021 ◽  
Author(s):  
Théo Pezel ◽  
Philippe Garot ◽  
Marine Kinnel ◽  
Thomas Hovasse ◽  
Stéphane Champagne ◽  
...  
Keyword(s):  
Cardiovascular Magnetic Resonance ◽  
Magnetic Resonance ◽  
Prognostic Value ◽  
Cox Regression ◽  
Left Ventricular ◽  
Left Ventricular Ejection ◽  
Major Adverse Cardiovascular Events ◽  
Ventricular Ejection Fraction ◽  
Inducible Ischaemia

Abstract Aims To assess the sex-specific, long-term prognostic value of myocardial ischaemia induced by stress cardiovascular magnetic resonance (CMR) and early CMR-related revascularization in consecutive patients from a large registry. Methods and results Between 2008 and 2010, all consecutive patients referred for stress CMR were followed for the occurrence of major adverse cardiovascular events (MACE), defined by cardiovascular mortality or recurrent non-fatal myocardial infarction (MI). Early CMR-related revascularization was defined as any revascularization within 90 days after CMR. Among 3664 patients (56.9% male, mean age 69.9 ± 11.8 years), 472 (12.9%) had MACE (163 women and 309 men) after a median follow-up of 8.8 (IQR 6.9-9.5) years. Inducible ischaemia and late gadolinium enhancement (LGE) by CMR were associated with MACE in women and men (all P &lt; 0.001). In multivariable Cox regression, inducible ischaemia, LGE, and CMR-related revascularization were independent predictors of MACE both in women [heart rate (HR) 4.79, 95% confidence interval (CI) 2.17–9.10; HR 1.82, 95% CI 1.22–2.71; HR 0.71, 95% CI 0.54–0.92, respectively; all P &lt; 0.001] and men (HR 3.88, 95% CI 2.33–5.98; HR 1.48, 95% CI 1.16–1.89; HR 0.78, 95% CI 0.65–0.97, respectively; all P &lt; 0.001). The addition of CMR-parameters led to improved model discrimination for MACE (C-statistic 0.61 vs. 0.71; NRI = 0.212; IDI = 0.032) for both women and men. CMR-related revascularization was associated with a lower incidence of MACE in patients with left ventricular ejection fraction (LVEF)&lt;50%. Conclusion Inducible ischaemia and early CMR-related revascularization were good long-term predictors of MACE irrespective of sex. CMR-related revascularization was associated with a lower MACE incidence in the sole sub-set of patients with LVEF &lt; 50%.

Cardioverter-related complications: observations from an institutional implantable cardioverter defibrillator registry

EP Europace ◽  
2021 ◽  
Vol 23 (Supplement_3) ◽  
Author(s):  
I Prepolec ◽  
V Pasara ◽  
E Ciglenecki ◽  
J Putric Posavec ◽  
JE Bogdanic ◽  
...  
Keyword(s):  
Antibiotic Prophylaxis ◽  
Implantable Cardioverter Defibrillator ◽  
Needle Aspiration ◽  
Left Ventricular ◽  
Icd Implantation ◽  
Cardioverter Defibrillator ◽  
Vein Thrombosis ◽  
Funding Sources ◽  
Major Complications

Abstract Funding Acknowledgements Type of funding sources: None. Introduction Implantable cardioverter defibrillator (ICD) is gold standard therapy for primary and secondary prevention of sudden cardiac death (SCD) and ventricular tachyarrhythmias. While reducing arrhythmic mortality in patients with left ventricular dysfunction of various causes, inherited primary arrhythmia syndromes and after aborted SCD, these devices can have serious adverse effects including inappropriate shocks and device-related infection. Purpose The aim of this study was to create an institutional ICD registry and to examine the major complications after ICD implantation. Methods We analysed the data concerning all newly implanted ICDs in our institution from 2011 to 2017. All patients received periprocedural antibiotic prophylaxis according to relevant guidelines. Follow-up data was collected from hospital electronic medical records. Results Total number of implanted ICDs was 507 (85.4% male, 57.6 ± 14.0 years-old) and mean follow-up was 34.3 ± 23.8 months. Major complications (infection, large haematoma/hemorrhage, lead displacement/dysfunction) occurred in 18 (3.6%) patients. In 9 (1.8%) cases patients were diagnosed with ICD infection (8 surgical wound/pocket infections and 1 confirmed endocarditis of the lead). Device was explanted in 5 cases (1.0%) while the rest were treated only with antibiotic therapy (empirically or according to swab/blood culture results). All of the infections were successfully resolved and no relapses were noted. Eventually, 3 of 5 devices were reimplanted. One death was recorded 5 month after the explanation. Second most common complication was lead displacement/dysfunction which occurred in 5 (1.0%) patients and was successfully repaired in all cases. Large haematoma and/or hemorrhage at the implantation site were present in 5 (0.8%) patients (2 required surgical revision and transfusion while 2 were managed by needle aspiration). Pneumothorax (2 cases, 0.4%) had to be drained in one patient. There was one case of subclavian vein thrombosis which was treated by anticoagulation. Conclusion Despite appropriate antibiotic prophylaxis, the rate of ICD infections in our institution was relatively higher than the one reported in similar registries. The prevalence of other major complications, including lead dysfunction was quite low. Institutional registries could help monitor and plan actions to resolve ICD-related complications to improve patient outcomes.

Fast manual long-axis strain assessment provides optimized cardiovascular event prediction following myocardial infarction

2019 ◽  
Vol 20 (11) ◽  
pp. 1262-1270 ◽  
Author(s):  
Andreas Schuster ◽  
Sören J Backhaus ◽  
Thomas Stiermaier ◽  
Johannes T Kowallick ◽  
Alina Stulle ◽  
...  
Keyword(s):  
Myocardial Infarction ◽  
Cardiovascular Magnetic Resonance ◽  
Magnetic Resonance ◽  
Prognostic Value ◽  
Left Ventricular ◽  
St Elevation Myocardial Infarction ◽  
Event Prediction ◽  
St Elevation ◽  
Incremental Prognostic Value ◽  
Long Axis Strain

Abstract Aims Cardiovascular magnetic resonance feature tracking (CMR-FT) global longitudinal strain (GLS) provides incremental prognostic value following acute myocardial infarction (AMI) but requires substantial post-processing. Alternatively, manual global long-axis strain (LAS) can be easily assessed from standard steady state free precession images. We aimed to define the prognostic value of LAS in a large multicentre study in patients following AMI. Methods and results A total of 1235 patients with myocardial infarction [n = 795 with ST-elevation myocardial infarction (STEMI) and 440 with non-ST-elevation myocardial infarction (NSTEMI)] underwent cardiovascular magnetic resonance imaging after primary percutaneous coronary intervention in eight centres across Germany. Assessment of LAS was performed in a blinded core-laboratory measuring the systolic shortening between the epicardial apical border and the middle of a line connecting the origins of the mitral leaflets. Primary clinical endpoint was the occurrence of major adverse clinical events (MACE) including death, reinfarction, and congestive heart failure within 1 year after AMI. During 1-year follow-up, 76 patients suffered from MACE. Impaired LAS was associated with higher MACE occurrence both in STEMI (P < 0.001) and NSTEMI (P = 0.001) patients. Association of LAS remained significant (P = 0.017) after correction for univariate significant parameters for MACE prediction. C-statistics revealed incremental value of additional LAS assessment for optimized event prediction compared with left ventricular ejection fraction (MACE P = 0.044; mortality P = 0.013) and a combination of established clinical and imaging parameters (MACE P = 0.084; mortality P = 0.027), but not CMR-FT GLS (MACE P = 0.075; mortality P = 0.380). Conclusion LAS provides software independent, widely available, easy and fast approximation of longitudinal left ventricular shortening early after reperfused AMI with incremental prognostic value beyond established risk stratification parameters. Clinical Trials.gov NCT00712101 and NCT01612312.

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