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1.
Arch Cardiovasc Dis ; 2019 Aug 27.
Artigo em Inglês | MEDLINE | ID: mdl-31471226

RESUMO

This review summarizes the main findings of the French multicentre DAI-PP pilot programme, and discusses the related clinical and research perspectives. This project included retrospectively (2002-2012 period) more than 5000 subjects with structural heart disease who received an implantable cardioverter defibrillator (ICD) for primary prevention of sudden cardiac death, and were followed for a mean period of 3 years. The pilot phase of the DAI-PP programme has provided valuable information on several practical and clinically relevant aspects of primary prevention ICD implantation in the real-world population, which are summarized in this review. This pilot has led to a prospective evaluation that started in May 2018, assessing ICD therapy in primary and secondary prevention in patients with structural and electrical heart diseases, with remote monitoring follow-up using a dedicated platform. This should further enhance our understanding of sudden cardiac death, to eventually optimize the field of preventative actions.

2.
Heart Rhythm ; 2019 Jun 27.
Artigo em Inglês | MEDLINE | ID: mdl-31255846

RESUMO

BACKGROUND: Ventricular arrhythmias (VAs) can occur after continuous flow left ventricular assist device (LVAD) implantation as a single arrhythmic event or as electrical storm (ES) with multiple repetitive VA episodes. OBJECTIVE: We aimed at analyzing the incidence, predictors, and clinical impact of ES in LVAD recipients. METHODS: Patients analyzed were those included in the multicenter ASSIST-ICD observational study. ES was consensually defined as occurrence of ≥3 separate episodes of sustained VAs within a 24-hour interval. RESULTS: Of 652 patients with an LVAD, 61 (9.4%) presented ES during a median follow-up period of 9.1 (interquartile range [IQR] 2.5-22.1) months. The first ES occurred after 17 (IQR 4.0-56.2) days post LVAD implantation, most of them during the first month after the device implantation (62.9%). The incidence then tended to decrease during the initial years of follow-up and increased again after the third year post LVAD implantation. History of VAs before LVAD implantation and heart failure duration > 84 months were independent predictors of ES. The occurrence of ES was associated with an increased early mortality since 20 patients (32.8%) died within the first 2 weeks of ES. Twenty-two patients (36.1%) presented at least 1 recurrence of ES, occurring 43.0 (IQR 8.0-69.0) days after the initial ES. Patients experiencing ES had a significantly lower 1-year survival rate than did those free from ES (log-rank, P = .039). CONCLUSION: There is a significant incidence of ES in patients with an LVAD. The short-term mortality after ES is high, and one-third of patients will die within 15 days. Whether radiofrequency ablation of arrhythmias improves outcomes would require further studies.

3.
Int J Cardiol ; 2019 Jun 26.
Artigo em Inglês | MEDLINE | ID: mdl-31281047

RESUMO

INTRODUCTION: Chest X-ray (CXR) widely used, but the prognostic value of congestion quantification using CXR remains uncertain. The main objective of the present study was to assess whether initial quantification of lung congestion evaluated by CXR [and its interplay with estimated plasma volume status (ePVS)] in patients with worsening heart failure (WHF) is associated with in-hospital and short-term clinical outcome. METHODS: We studied 117 patients hospitalized for WHF in the ICALOR HF disease management program. Pulmonary congestion was estimated using congestion score index (CSI, range 0 to 3) evaluated from 6 lung areas on CXR. Systemic congestion was assessed by ePVS. Logistic regression analysis was used to assess length of stay and the composite of all-cause death or HF re-hospitalization at 90 days. RESULTS: Patients were divided according to the median of admission CSI (median = 2.20) and ePVS (median = 5.38). Higher CSI was significantly associated with higher pulmonary arterial systolic pressure in multivariable models. Multivariable models showed patients with high CSI/high ePVS had a 6-day longer length of stay [OR (95% CI) = 6.78 (1.82-29.79), p < 0.01] and 5-fold higher risk of 90-day composite outcome [OR (95% CI) = 5.13 (1.26-25.11) p = 0.03] compared to patients with low CSI/low ePVS, while other configurations (either isolated high CSI or high ePVS) yielded neutral associations. Furthermore, CSI and ePVS significantly improved reclassification on top of clinical covariates for the composite outcome [Net reclassification index = 37.3% (0.52-87.0), p = 0.046]. CONCLUSION: An admission assessment of pulmonary and systemic congestion in WHF patients using CSI and ePVS can identify a cluster of high-risk patients at short-term outcomes.

4.
Circulation ; 140(4): 293-302, 2019 Jul 23.
Artigo em Inglês | MEDLINE | ID: mdl-31155932

RESUMO

BACKGROUND: An accurate estimation of the risk of life-threatening (LT) ventricular tachyarrhythmia (VTA) in patients with LMNA mutations is crucial to select candidates for implantable cardioverter-defibrillator implantation. METHODS: We included 839 adult patients with LMNA mutations, including 660 from a French nationwide registry in the development sample, and 179 from other countries, referred to 5 tertiary centers for cardiomyopathies, in the validation sample. LTVTA was defined as (1) sudden cardiac death or (2) implantable cardioverter defibrillator-treated or hemodynamically unstable VTA. The prognostic model was derived using the Fine-Gray regression model. The net reclassification was compared with current clinical practice guidelines. The results are presented as means (SD) or medians [interquartile range]. RESULTS: We included 444 patients, 40.6 (14.1) years of age, in the derivation sample and 145 patients, 38.2 (15.0) years, in the validation sample, of whom 86 (19.3%) and 34 (23.4%) experienced LTVTA over 3.6 [1.0-7.2] and 5.1 [2.0-9.3] years of follow-up, respectively. Predictors of LTVTA in the derivation sample were: male sex, nonmissense LMNA mutation, first degree and higher atrioventricular block, nonsustained ventricular tachycardia, and left ventricular ejection fraction (https://lmna-risk-vta.fr). In the derivation sample, C-index (95% CI) of the model was 0.776 (0.711-0.842), and the calibration slope 0.827. In the external validation sample, the C-index was 0.800 (0.642-0.959), and the calibration slope was 1.082 (95% CI, 0.643-1.522). A 5-year estimated risk threshold ≥7% predicted 96.2% of LTVTA and net reclassified 28.8% of patients with LTVTA in comparison with the guidelines-based approach. CONCLUSIONS: In comparison with the current standard of care, this risk prediction model for LTVTA in laminopathies significantly facilitated the choice of candidates for implantable cardioverter defibrillators. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT03058185.

5.
Eur Heart J ; 40(26): 2121-2127, 2019 Jul 01.
Artigo em Inglês | MEDLINE | ID: mdl-31046090

RESUMO

AIMS: The very long-term outcome of patients who survive the first few years after receiving cardiac resynchronization therapy (CRT) has not been well described thus far. We aimed to provide long-term outcomes, especially with regard to the occurrence of sudden cardiac death (SCD), in CRT patients without (CRT-P) and with defibrillator (CRT-D). METHODS AND RESULTS: A total of 1775 patients, with ischaemic or non-ischaemic dilated cardiomyopathy, who were alive 5 years after CRT implantation, were enrolled in this multicentre European observational cohort study. Overall long-term mortality rates and specific causes of death were assessed, with a focus on late SCD. Over a mean follow-up of 30 months (interquartile range 10-42 months) beyond the first 5 years, we observed 473 deaths. The annual age-standardized mortality rates of CRT-D and CRT-P patients were 40.4 [95% confidence interval (CI) 35.3-45.5] and 97.2 (95% CI 85.5-109.9) per 1000 patient-years, respectively. The adjusted hazard ratio (HR) for all-cause mortality was 0.99 (95% CI 0.79-1.22). Twenty-nine patients in total died of late SCD (14 with CRT-P, 15 with CRT-D), corresponding to 6.1% of all causes of death in both device groups. Specific annual SCD rates were 8.5 and 5.8 per 1000 patient-years in CRT-P and CRT-D patients, respectively, with no significant difference between groups (adjusted HR 1.0, 95% CI 0.45-2.44). Death due to progressive heart failure represented the principal cause of death (42.8% in CRT-P patients and 52.6% among CRT-D recipients), whereas approximately one-third of deaths in both device groups were due to non-cardiovascular death. CONCLUSION: In this first description of very long-term outcomes among CRT recipients, progressive heart failure death still represented the most frequent cause of death in patients surviving the first 5 years after CRT implant. In contrast, SCD represents a very low proportion of late mortality irrespective of the presence of a defibrillator.

6.
Europace ; 21(7): 1063-1069, 2019 Jul 01.
Artigo em Inglês | MEDLINE | ID: mdl-30891608

RESUMO

AIMS: Current guidelines do not propose any age cut-off for the primary prevention implantable cardioverter-defibrillator (ICD). However, the risk/benefit balance in the very elderly population has not been well studied. METHODS AND RESULTS: In a multicentre French study assessing patients implanted with an ICD for primary prevention, outcomes among patients aged ≥80 years were compared with <80 years old controls matched for sex and underlying heart disease (ischaemic and dilated cardiomyopathy). A total of 300 ICD recipients were enrolled in this specific analysis, including 150 patients ≥80 years (mean age 81.9 ± 2.0 years; 86.7% males) and 150 controls (mean age 61.8 ± 10.8 years). Among older patients, 92 (75.6%) had no more than one associated comorbidity. Most subjects in the elderly group got an ICD as part of a cardiac resynchronization therapy procedure (74% vs. 46%, P < 0.0001). After a mean follow-up of 3.0 ± 2 years, 53 patients (35%) in the elderly group died, including 38.2% from non cardiovascular causes of death. Similar proportion of patients received ≥1 appropriate therapy (19.4% vs. 21.6%; P = 0.65) in the elderly group and controls, respectively. There was a trend towards more early perioperative events (P = 0.10) in the elderly, with no significant increase in late complications (P = 0.73). CONCLUSION: Primary prevention ICD recipients ≥80 years in the real world had relatively low associated comorbidity. Rates of appropriate therapies and device-related complications were similar, compared with younger subjects. Nevertheless, the inherent limitations in interpreting observational data on this particular competing risk situation call for randomized controlled trials to provide definitive answers. Meanwhile, a careful multidisciplinary evaluation is needed to guide patient selection for ICD implantation in the elderly population.

8.
Europace ; 21(4): 607-615, 2019 Apr 01.
Artigo em Inglês | MEDLINE | ID: mdl-30605510

RESUMO

AIMS: Implantable cardioverter-defibrillators (ICDs) reduce sudden cardiac death in selected patients but inappropriate ICD shocks have been associated with increased mortality. The THORN registry aims to describe the rate of inappropriate ventricular arrhythmia diagnoses and therapies in patients followed by remote monitoring, as well as the following delay to next patient contact (DNPC). METHODS AND RESULTS: One thousand eight hundred and eighty-two patients issued from a large remote monitoring database first implanted with an ICD for primary or secondary prevention in 110 French hospitals from 2007 to 2014 constitute the THORN population. Among them, 504 patients were additionally followed prospectively for evaluation of the DNPC. Eight hundred and ninety-five out of 1551 (58%) patients had ischaemic heart disease and 358/771 (46%) were implanted for secondary prevention. During 13.7 ± 3.4 months of follow-up, the prevalence of first inappropriate diagnosis in a ventricular arrhythmia zone with enabled therapy was 162/1882 (9%). Among those patients, 122/162 (75%) suffered at least one inappropriate therapy and 58/162 (36%) at least one inappropriate shock. Eighty-three out of 162 (51%) of first inappropriate diagnosis occurred during the first 4 months following implantation. The median DNPC was 8 days (interquartile range 1-26). At least one other day with recording of an inappropriate diagnosis of the same cause occurred in 13/43 (30%) of available DNPC periods, with an inappropriate therapy in 7/13 (54%). CONCLUSION: Inappropriate diagnoses occurred in 9% of patients implanted with an ICD during the first 14 months. The DNPC after inadequate ventricular arrhythmia diagnoses remains long in daily practice and should be optimized. CLINICALTRIALS.GOV IDENTIFIER: NCT01594112.

10.
Arch Cardiovasc Dis ; 2018 Aug 27.
Artigo em Inglês | MEDLINE | ID: mdl-30166064

RESUMO

The introduction of catheter ablation techniques has vastly improved the treatment of cardiac arrhythmias. However, as complex ablations are technically demanding and can cause various complications, they require a high level of expertise to maximize success rates and minimize complication rates. As French recommendations regarding the required technical competence and equipment are not yet available, this position paper has been compiled by the Working Group of Pacing and Electrophysiology of the French Society of Cardiology, detailing the required features of an interventional cardiac electrophysiological centre for complex ablation procedures: (1) sufficient institutional volume; (2) physician training, qualifications and experience; (3) paramedical staff training and attendance; and (4) institutional facilities and technical equipment. The importance of being able to diagnose, monitor and manage complications associated with complex ablations is highlighted. Supplemental hospital-based resources are also discussed, such as anaesthesia, surgical back-up, intensive care, haemodynamic assistance and imaging. Further, the ideal features of an interventional cardiac electrophysiology training centre are considered. Lastly, the need for quality evaluations and national registries for complex ablations is discussed.

11.
Arch Cardiovasc Dis ; 2018 Aug 02.
Artigo em Inglês | MEDLINE | ID: mdl-30078651

RESUMO

BACKGROUND: The frequency, characteristics and outcomes of primary prevention implantable cardioverter defibrillator (ICD) recipients who eventually undergo heart transplantation (HT) during follow-up have not been well described. AIMS: In a cohort of patients with heart failure implanted with an ICD for primary prevention of sudden cardiac death, to identify those at high risk of subsequent HT and evaluate ICD usefulness. METHODS: Between 2002 and 2012, 5539 patients received a primary prevention ICD across 12 centers, and were enrolled in the DAI-PP programme, including 5427 with full HT information available. RESULTS: During a median follow-up of 1024 days (interquartile range 484-1702 days), 176 (3.2%) patients underwent HT. Median duration between ICD implantation and HT was 484 days (IQR 169-1117 days). Among those aged≤65 years (theoretical age limit for HT registration in France), the overall incidence per 1000 person-years was 18.03 (95% confidence interval [CI]: 15.32-20.74). Left ventricular ejection fraction<25% (hazard ratio [HR]: 3.43, 95% CI: 2.34-5.04; P<0.0001), younger age (HR: 0.95, 95% CI: 0.93-0.96; P<0.0001), New York Heart Association (NYHA) class III-IV (HR: 2.67, 95% CI: 1.79-4.00; P<0.0001) and no cardiac resynchronization therapy (HR: 2.09, 95% CI: 1.39-3.14; P=0.0004) were independently associated with HT. Patients with these three characteristics (excluding age) had a 1-year HT rate of 15.2%. Incidence of appropriate ICD therapies was 92.7 per 1000 person-years for patients who underwent HT versus 76.1 for those who did not (P=0.64). CONCLUSIONS: The overall incidence of HT in this primary prevention population was relatively high, especially among young patients with a very low ejection fraction, an advanced NYHA class and were unsuitable for cardiac resynchronization therapy (up to 15% annually). Patients awaiting HT experienced a significant rate of appropriate ICD therapies, reinforcing the importance of specific cardiac rhythm management in these patients.

12.
Europace ; 20(7): 1218-1224, 2018 Jul 01.
Artigo em Inglês | MEDLINE | ID: mdl-29762683

RESUMO

The aim of this European Heart Rhythm Association (EHRA) prospective snapshot survey is to assess peri-procedural practices, implantation techniques, and short-term procedure-related complications associated with implantation of subcutaneous implantable cardioverter-defibrillator (S-ICD) or transvenous implantable cardioverter-defibrillator (TV-ICD), across tertiary European electrophysiology centres. An internet-based electronic questionnaire concerning implantation settings, peri-procedural routines, techniques, personnel, complications, and patient outcomes was sent to the centres routinely implanting both TV-ICDs and S-ICDs. The centres were requested to prospectively include consecutive patients implanted with either TV-ICD or S-ICD during the 8-week enrolment period. Overall, 20 centres from 6 countries enrolled 429 consecutive patients. Subcutaneous implantable cardioverter-defibrillators (20%) compared with TV-ICD were implanted mainly under general anaesthesia (72% vs. 14%), in the surgical operation room settings (69% vs. 43%), with more frequent prophylactic antibiotic administration (82% vs. 91%), and post-implant defibrillation testing (85% vs. 7%, all P < 0.05). Feasibility (implantation duration of 45 min) and short-term complication rates (4%) were comparable for S-ICDs and TV-ICDs, but the spectrum of complications varied, despite different baseline characteristics of patients undergoing the S-ICD vs. TV-ICD implantation. This EHRA snapshot survey provides important insights into the implantable cardioverter-defibrillator implantation routines and patient outcomes. Our study showed differences between the S-ICD and TV-ICD implantation routines with respect to implantation settings, peri-procedural management, and pre-defined procedural endpoints. However, the comparable duration of S-ICD or TV-ICD implantation and similar rates of peri-procedural complications indicate that both devices can be routinely used in clinical practice.

14.
Int J Cardiol ; 260: 82-87, 2018 06 01.
Artigo em Inglês | MEDLINE | ID: mdl-29622458

RESUMO

BACKGROUND: Almost 1/3 of heart failure patients fail to respond to cardiac resynchronization therapy (CRT). A simple clinical score to predict who these patients are at the moment of referral or at time of implant may be of importance for early optimization of their management. METHODS: Observational study. A risk score was derived from factors associated to CRT response. The derivation cohort was composed of 1301 patients implanted with a CRT defibrillator in a multi-center French cohort-study. External validation of this score and assessment of its association with CRT response and all-cause mortality and/or heart transplant was performed in 1959 CRT patients implanted in 4 high-volume European centers. RESULTS: Independent predictors of CRT response in the derivation cohort were: female gender (OR = 2.08, 95% CI 1.26-3.45), NYHA class ≤ III (OR = 2.71, 95% CI 1.63-4.52), left ventricular ejection fraction ≥ 25% (OR = 1.75, 95% CI 1.27-2.41), QRS duration ≥ 150 ms (OR = 1.70, 95% CI 1.25-2.30) and estimated glomerular filtration rate ≥ 60 mL/min (OR = 2.01, 95% CI 1.48-2.72). Each was assigned 1 point. External validation showed good calibration (Hosmer-Lemeshow test-P = 0.95), accuracy (Brier score = 0.19) and discrimination (c-statistic = 0.67), with CRT response increasing progressively from 37.5% in patients with a score of 0 to 91.9% among those with score of 5 (Gamma for trend = 0.44, P < 0.001). Similar results were observed regarding all-cause mortality or heart transplant. CONCLUSION: The ScREEN score (Sex category, Renal function, ECG/QRS width, Ejection fraction and NYHA class) is composed of widely validated, easy to obtain predictors of CRT response, and predicts CRT response and overall mortality. It should be helpful in facilitating early consideration of alternative therapies for predicted non-responders to CRT therapy.


Assuntos
Terapia de Ressincronização Cardíaca/tendências , Insuficiência Cardíaca/fisiopatologia , Insuficiência Cardíaca/terapia , Idoso , Feminino , Seguimentos , Taxa de Filtração Glomerular/fisiologia , Insuficiência Cardíaca/diagnóstico , Humanos , Masculino , Pessoa de Meia-Idade , Valor Preditivo dos Testes , Fatores de Risco , Resultado do Tratamento
16.
Heart ; 104(18): 1529-1535, 2018 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-29540431

RESUMO

OBJECTIVE: In patients indicated for cardiac resynchronisation therapy (CRT), the choice between a CRT-pacemaker (CRT-P) versus defibrillator (CRT-D) remains controversial and indications in this setting have not been well delineated. Apart from inappropriate therapies, which are inherent to the presence of a defibrillator, whether adding defibrillator to CRT in the primary prevention setting impacts risk of other acute and late device-related complications has not been well studied and may bear relevance for device selection. METHODS: Observational multicentre European cohort study of 3008 consecutive patients with ischaemic or non-ischaemic dilated cardiomyopathy and no history of sustained ventricular arrhythmias, undergoing CRT implantation with (CRT-D, n=1785) or without (CRT-P, n=1223) defibrillator. Using propensity score and competing risk analyses, we assessed the risk of significant device-related complications requiring surgical reintervention. Inappropriate shocks were not considered except those due to lead malfunction requiring lead revision. RESULTS: Acute complications occurred in 148 patients (4.9%), without significant difference between groups, even after considering potential confounders (OR=1.20, 95% CI 0.72 to 2.00, p=0.47). During a mean follow-up of 41.4±29 months, late complications occurred in 475 patients, giving an annual incidence rate of 26 (95% CI 9 to 43) and 15 (95% CI 6 to 24) per 1000 patient-years in CRT-D and CRT-P patients, respectively. CRT-D was independently associated with increased occurrence of late complications (HR=1.68, 95% CI 1.27 to 2.23, p=0.001). In particular, when compared with CRT-P, CRT-D was associated with an increased risk of device-related infection (HR 2.10, 95% CI 1.18 to 3.45, p=0.004). Acute complications did not predict overall late complications, but predicted device-related infection (HR 2.85, 95% CI 1.71 to 4.56, p<0.001). CONCLUSIONS: Compared with CRT-P, CRT-D is associated with a similar risk of periprocedural complications but increased risk of long-term complications, mainly infection. This needs to be considered in the decision of implanting CRT with or without a defibrillator.

19.
Heart Rhythm ; 15(6): 870-876, 2018 06.
Artigo em Inglês | MEDLINE | ID: mdl-29288035

RESUMO

BACKGROUND: Cardiac resynchronization therapy (CRT) is an effective treatment of heart failure (HF), but is limited by a substantial proportion of nonresponders. We hypothesized that adding a second left ventricular (LV) lead to deliver a triple-site CRT (V3 CRT) may improve clinical status of CRT nonresponders. OBJECTIVE: We assessed the feasibility and safety of adding a second LV lead to CRT nonresponders and its clinical impact. METHODS: Eighty-four recipients of a CRT system and considered as nonresponders as per clinical composite score (CCS) were enrolled in this multicenter study. They were randomized to the V3 arm (implantation of an additional LV lead; n = 43) or control arm (no change; n = 41). Implant success rate, incidence of severe adverse events, CCS, and secondary clinical and echocardiographic end points were evaluated at 12 and 24 months. RESULTS: Positioning of a second LV lead was successful at first (40 of 44 - 90.9%) or second (4 of 44 - 9.09%) attempt. The perioperative complication rate (infection, system explant, pneumothorax, and hematoma) was high (procedures or system-related complications for 9 patients- 20.4%). After 24 months, 35 systems (79.5%) were working properly. The multinomial logistic regression model showed that V3 treatment had no significant influence (P = .27) on the CCS, number of HF hospitalizations, time to first HF hospitalization, New York Heart Association class, and LV ejection fraction at 12 and 24 months. CONCLUSION: Although addition of a second LV lead in CRT nonresponders is feasible with a high success rate, this approach is associated with a significant rate of severe adverse events and does not provide significant long-term clinical benefits (ClinicalTrials.gov Identifier No. NCT01059175).

20.
Circ Res ; 122(4): 616-623, 2018 Feb 16.
Artigo em Inglês | MEDLINE | ID: mdl-29242238

RESUMO

RATIONALE: Short telomere length (TL) in leukocytes is associated with atherosclerotic cardiovascular disease (ASCVD). It is unknown whether this relationship stems from having inherently short leukocyte TL (LTL) at birth or a faster LTL attrition thereafter. LTL represents TL in the highly proliferative hematopoietic system, whereas TL in skeletal muscle represents a minimally replicative tissue. OBJECTIVE: We measured LTL and muscle TL (MTL) in the same individuals with a view to obtain comparative metrics for lifelong LTL attrition and learn about the temporal association of LTL with ASCVD. METHODS AND RESULTS: Our Discovery Cohort comprised 259 individuals aged 63±14 years (mean±SD), undergoing surgery with (n=131) or without (n=128) clinical manifestation of ASCVD. In all subjects, MTL adjusted for muscle biopsy site (MTLA) was longer than LTL and the LTL-MTLA gap similarly widened with age in ASCVD patients and controls. Age- and sex-adjusted LTL (P=0.005), but not MTLA (P=0.90), was shorter in patients with ASCVD than controls. The TL gap between leukocytes and muscle (LTL-MTLA) was wider (P=0.0003), and the TL ratio between leukocytes and muscle (LTL/MTLA) was smaller (P=0.0001) in ASCVD than in controls. Findings were replicated in a cohort comprising 143 individuals. CONCLUSIONS: This first study to apply the blood-and-muscle TL model shows more pronounced LTL attrition in ASCVD patients than controls. The difference in LTL attrition was not associated with age during adulthood suggesting that increased attrition in early life is more likely to be a major explanation of the shorter LTL in ASCVD patients. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT02176941.

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