Impact of Potentially Malignant Incidental Findings by Computed Tomographic Angiography on Long-Term Survival After Transcatheter Aortic Valve Implantation
2017; Elsevier BV; Volume: 120; Issue: 6 Linguagem: Inglês
10.1016/j.amjcard.2017.06.032
ISSN1879-1913
AutoresFloortje van Kesteren, Esther Wiegerinck, Martijn S. van Mourik, Marije M. Vis, Karel T. Koch, Jan J. Piek, Jaap Stoker, Jan G.P. Tijssen, Jan Baan, R. Nils Planken,
Tópico(s)Cardiac Imaging and Diagnostics
ResumoComputed tomography angiography (CTA) in workup for transcatheter aortic valve implantation (TAVI) frequently reveals potentially malignant incidental findings. Most incidental findings provoke discussions on their influence. We aimed to analyze if these findings were a predictor of long-term survival after TAVI. In a single-center retrospective analysis, all consecutive patients with pre-TAVI CTA were included (years 2009 to 2014). Patients were divided by presence or absence of incidental findings. We analyzed up to 5 years of all-cause, non-cardiovascular and cardiovascular mortality for all 553 patients who underwent TAVI; 113 had a potentially malignant incidental finding (20.4%). At 5 years, all-cause mortality risk was 64.5% in patients with versus 49.1% in patients without a finding (hazard ratio [HR] 1.70, 95% confidence interval [CI] 1.25 to 2.31). After adjustment, the findings remained an independent predictor of all-cause (adjusted HR 1.46, 95% CI 1.07 to 1.99) and non-cardiovascular mortality (adjusted subdistribution HR 1.84, 95% CI 1.06 to 3.20), but not of cardiovascular mortality. In conclusion, the presence of potentially malignant incidental findings on CTA is an independent predictor of long-term all-cause and noncardiovascular mortality but not of cardiovascular mortality. Computed tomography angiography (CTA) in workup for transcatheter aortic valve implantation (TAVI) frequently reveals potentially malignant incidental findings. Most incidental findings provoke discussions on their influence. We aimed to analyze if these findings were a predictor of long-term survival after TAVI. In a single-center retrospective analysis, all consecutive patients with pre-TAVI CTA were included (years 2009 to 2014). Patients were divided by presence or absence of incidental findings. We analyzed up to 5 years of all-cause, non-cardiovascular and cardiovascular mortality for all 553 patients who underwent TAVI; 113 had a potentially malignant incidental finding (20.4%). At 5 years, all-cause mortality risk was 64.5% in patients with versus 49.1% in patients without a finding (hazard ratio [HR] 1.70, 95% confidence interval [CI] 1.25 to 2.31). After adjustment, the findings remained an independent predictor of all-cause (adjusted HR 1.46, 95% CI 1.07 to 1.99) and non-cardiovascular mortality (adjusted subdistribution HR 1.84, 95% CI 1.06 to 3.20), but not of cardiovascular mortality. In conclusion, the presence of potentially malignant incidental findings on CTA is an independent predictor of long-term all-cause and noncardiovascular mortality but not of cardiovascular mortality. Transcatheter aortic valve implantation (TAVI) has evolved as a suitable treatment for patients with symptomatic aortic valve stenosis.1Leon M.B. Smith C.R. Mack M. Miller D.C. Moses J.W. 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A practical guide to multimodality imaging of transcatheter aortic valve replacement.JACC Cardiovasc Imaging. 2012; 5: 441-455Crossref PubMed Scopus (158) Google Scholar The CTA extends from the mandibula to the iliofemoral bifurcation and comprises a large number of noncardiac structures. Consequently, it frequently reveals pathology not directly relevant for the procedure; incidental findings. Especially in the old and frail TAVI population, potentially malignant incidental findings are common.8Stachon P. Kaier K. Milde S. Pache G. Sorg S. Siepe M. von zur Muhlen C. Zirlik A. Beyersdorf F. Langer M. Zehender M. Bode C. Reinohl J. Two-year survival of patients screened for transcatheter aortic valve replacement with potentially malignant incidental findings in initial body computed tomography.Eur Heart J Cardiovasc Imaging. 2015; 16: 731-737Crossref PubMed Scopus (30) Google Scholar, 9Orme N.M. Wright T.C. Harmon G.E. Nkomo V.T. Williamson E.E. Sorajja P. Foley T.A. Greason K.L. 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Prevalence of noncardiac findings in computed tomography angiography before transcatheter aortic valve replacement.J Cardiovasc Comput Tomogr. 2014; 8: 222-229Abstract Full Text Full Text PDF PubMed Scopus (19) Google Scholar, 13Apfaltrer P. Schymik G. Reimer P. Schroefel H. Sueselbeck T. Henzler T. Krissak R. Nance Jr, J.W. Schoepf U.J. Wollschlaeger D. Schoenberg S.O. Fink C. Aortoiliac CT angiography for planning transcutaneous aortic valve implantation: aortic root anatomy and frequency of clinically significant incidental findings.AJR Am J Roentgenol. 2012; 198: 939-945Crossref PubMed Scopus (39) Google Scholar Following CTA, a dedicated team considers the patients' suitability for the procedure. Guidelines recommend denying TAVI if the estimated survival is <1 year.3Nishimura R.A. Otto C.M. Bonow R.O. Carabello B.A. Erwin 3rd, J.P. Guyton R.A. O'Gara P.T. Ruiz C.E. Skubas N.J. Sorajja P. Sundt 3rd, T.M. Thomas J.D. Anderson J.L. Halperin J.L. Albert N.M. Bozkurt B. Brindis R.G. 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Smith C.R. 5-year outcomes of transcatheter aortic valve replacement compared with standard treatment for patients with inoperable aortic stenosis (PARTNER 1): a randomised controlled trial.Lancet. 2015; 385: 2485-2491Abstract Full Text Full Text PDF PubMed Scopus (618) Google Scholar, 15Mack M.J. Leon M.B. Smith C.R. Miller D.C. Moses J.W. Tuzcu E.M. Webb J.G. Douglas P.S. Anderson W.N. Blackstone E.H. Kodali S.K. Makkar R.R. Fontana G.P. Kapadia S. Bavaria J. Hahn R.T. Thourani V.H. Babaliaros V. Pichard A. Herrmann H.C. Brown D.L. Williams M. Akin J. Davidson M.J. Svensson L.G. 5-year outcomes of transcatheter aortic valve replacement or surgical aortic valve replacement for high surgical risk patients with aortic stenosis (PARTNER 1): a randomised controlled trial.Lancet. 2015; 385: 2477-2484Abstract Full Text Full Text PDF PubMed Scopus (1179) Google Scholar Consequently, even if the findings do not influence 1-year survival, they still might be of concern. Until now the only follow-up studies of incidental findings in TAVI work-up include a small number of patients who eventually underwent TAVI.8Stachon P. Kaier K. Milde S. Pache G. Sorg S. Siepe M. von zur Muhlen C. Zirlik A. Beyersdorf F. Langer M. Zehender M. Bode C. Reinohl J. Two-year survival of patients screened for transcatheter aortic valve replacement with potentially malignant incidental findings in initial body computed tomography.Eur Heart J Cardiovasc Imaging. 2015; 16: 731-737Crossref PubMed Scopus (30) Google Scholar, 9Orme N.M. Wright T.C. Harmon G.E. Nkomo V.T. Williamson E.E. Sorajja P. Foley T.A. Greason K.L. Suri R.M. Rihal C.S. Young P.M. Imaging Pandora's Box: incidental findings in elderly patients evaluated for transcatheter aortic valve replacement.Mayo Clin Proc. 2014; 89: 747-753Abstract Full Text Full Text PDF PubMed Scopus (14) Google Scholar, 10Lindsay A.C. Sriharan M. Lazoura O. Sau A. Roughton M. Jabbour R.J. Di Mario C. Davies S.W. Moat N.E. Padley S.P. Rubens M.B. Nicol E.D. Clinical and economic consequences of non-cardiac incidental findings detected on cardiovascular computed tomography performed prior to transcatheter aortic valve implantation (TAVI).Int J Cardiovasc Imaging. 2015; 31: 1435-1446Crossref PubMed Scopus (21) Google Scholar, 11Showkathali R. Sen A. Brickham B. Dworakowski R. Wendler O. MacCarthy P. "Incidental findings" during TAVI work-up: more than just an inconvenience.EuroIntervention. 2015; 11: 465-469Crossref PubMed Google Scholar The long-term impact of potentially malignant incidental finding after the procedure remains unknown. We aimed to gain insight in the influence of potentially malignant incidental findings on long-term survival after TAVI and evaluate if the findings are an independent predictor of mortality. The population comprised all consecutive patients with CTA in TAVI work-up (January 2009 to December 2014) in the Academic Medical Center Amsterdam, the Netherlands. During work-up, all imaging data, including the incidental findings, were discussed in a multidisciplinary TAVI team. CTAs were performed on a 64-slice CT scanner (Brilliance 64, Philips Medical Systems, Cleveland, OH). A standardized TAVI protocol was used, consisting of a scout view of the thorax and abdomen. After contrast injection (100 ml iomeprol, Iomeron 400 mg/ml, Bracco, Milan, Italy), a retrospective electrocardiogram (ECG)-gated helical acquisition of the heart, aortic annulus, and proximal ascending aorta was acquired, immediately followed by a helical scan from the mandibula to the iliofemoral bifurcation. All CTA scans were assessed by a cardiovascular radiologist with either 15 or 5 years' experience. In addition to standard TAVI measurements, assessment included detailed reporting of incidental findings. All radiology reports were searched for potentially malignant incidental findings (subsequently named: incidental findings) by 1 observer (FvK). A finding on CTA was considered "incidental" if it was not previously described in the patients' history. Vascular findings (including stenosis, aneurysm, and dissection) were not considered incidental findings because one of the reasons to perform a CTA is detection of these findings for access route assessment. Next, 2 observers (FvK and RNP) classified the incidental findings of all patients discussed in the TAVI team who were not immediately denied for reasons not concerning the incidental finding, as (1) patients with a reported incidental finding requiring action, including additional diagnostic testing, treatment, or follow-up before or after TAVI, or (2) patients with no reported incidental finding. If the reports did not give a clear description of the (severity) of the incidental findings, the images were reviewed once more. Pulmonary nodules were categorized depending on the Fleischner criteria based on size and risk profile.16MacMahon H. Austin J.H. Gamsu G. Herold C.J. Jett J.R. Naidich D.P. Patz Jr, E.F. Swensen S.J. Guidelines for management of small pulmonary nodules detected on CT scans: a statement from the Fleischner Society.Radiology. 2005; 237: 395-400Crossref PubMed Scopus (1318) Google Scholar, 17Naidich D.P. Bankier A.A. MacMahon H. Schaefer-Prokop C.M. Pistolesi M. Goo J.M. Macchiarini P. Crapo J.D. Herold C.J. Austin J.H. Travis W.D. Recommendations for the management of subsolid pulmonary nodules detected at CT: a statement from the Fleischner Society.Radiology. 2013; 266: 304-317Crossref PubMed Scopus (766) Google Scholar Pleural effusion without other pulmonary findings was not considered incidental because its appearance was most likely related to congestive heart failure. Lymph nodes were categorized as incidental findings if follow-up was required because of malignant features, size, location, or number of nodes.18Heller M.T. Harisinghani M. Neitlich J.D. Yeghiayan P. Berland L.L. Managing incidental findings on abdominal and pelvic CT and MRI, part 3: white paper of the ACR Incidental Findings Committee II on splenic and nodal findings.J Am Coll Radiol. 2013; 10: 833-839Abstract Full Text Full Text PDF PubMed Scopus (85) Google Scholar Because enlarged mediastinal lymph nodes are common in patients with congestive heart failure, they were categorized as findings without consequences, unless the patient or finding showed other malignant features.19Frank L. Quint L.E. Chest CT incidentalomas: thyroid lesions, enlarged mediastinal lymph nodes, and lung nodules.Cancer Imaging. 2012; 12: 41-48Crossref PubMed Scopus (26) Google Scholar For renal cysts, the Bosniak classification was used.20Bosniak M.A. The current radiological approach to renal cysts.Radiology. 1986; 158: 1-10Crossref PubMed Scopus (810) Google Scholar, 21Israel G.M. Bosniak M.A. How I do it: evaluating renal masses.Radiology. 2005; 236: 441-450Crossref PubMed Scopus (362) Google Scholar In addition, all findings that were not captured in these guidelines but were clearly considered potentially malignant were classified as incidental findings as well. To evaluate the impact of incidental findings on survival after TAVI, our analysis cohort comprised all patients with and without incidental findings requiring (further) action at time of TAVI. The cohort with an incidental finding requiring (further) action included patients who underwent TAVI with an incidental finding that was identified as a new malignancy before the procedure (anticipated life expectancy ≥1 year) as well as patients who required follow-up of the finding after TAVI. The cohort of patients with no incidental finding requiring action also comprised all patients in whom additional diagnostic testing was performed before the procedure, which demonstrated a benign finding. All patients who were denied for TAVI as a consequence of the finding (anticipated life expectancy <1 year) were excluded from the main analysis. Procedural and clinical characteristics were documented including traditional risk scores and co-morbidities not captured by these scores.22Kappetein A.P. Head S.J. Genereux P. Piazza N. van Mieghem N.M. Blackstone E.H. Brott T.G. Cohen D.J. Cutlip D.E. van Es G.A. Hahn R.T. Kirtane A.J. Krucoff M.W. Kodali S. Mack M.J. Mehran R. Rodes-Cabau J. Vranckx P. Webb J.G. Windecker S. Serruys P.W. Leon M.B. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document.J Thorac Cardiovasc Surg. 2013; 145: 6-23Abstract Full Text Full Text PDF PubMed Scopus (703) Google Scholar In compliance with national legislation, the Ethics Committee approved this research with a waiver. Patient survival was calculated as from TAVI and was obtained as mortality data via the centralized Dutch national population register at 1.5 years after the latest TAVI (October 2016) to complete follow-up of at minimum 18 months up to 5 years. Additional information on causes of death was obtained from the hospitals' medical records or primary care physicians. Causes of death were divided as suggested by the valve academic research criteria 2 (VARC-2 criteria) in non-cardiovascular and cardiovascular mortality, the latter including patients with unwitnessed death and death of unknown cause.22Kappetein A.P. Head S.J. Genereux P. Piazza N. van Mieghem N.M. Blackstone E.H. Brott T.G. Cohen D.J. Cutlip D.E. van Es G.A. Hahn R.T. Kirtane A.J. Krucoff M.W. Kodali S. Mack M.J. Mehran R. Rodes-Cabau J. Vranckx P. Webb J.G. Windecker S. Serruys P.W. Leon M.B. Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document.J Thorac Cardiovasc Surg. 2013; 145: 6-23Abstract Full Text Full Text PDF PubMed Scopus (703) Google Scholar A directed acyclic graph was used to determine covariates that should be included in the multivariate analysis of mortality.23Textor J. Hardt J. Knuppel S. DAGitty: a graphical tool for analyzing causal diagrams.Epidemiology. 2011; 22: 745Crossref PubMed Scopus (767) Google Scholar We selected age, gender, body mass index, society of thoracic surgery predicted risk of mortality (STS-PROM), second European system for cardiac operative risk evaluation (EuroSCORE II), impaired right ventricular function, porcelain aorta, liver disease, hostile chest, previous malignancy, and smoking in the last 10 years. Categorical variables were presented as numbers with percentages and compared using the Fisher's exact test. Continuous variables were presented as means with standard deviations or medians with interquartile ranges (IQR) and were compared using Student t test or Mann Whitney U test as appropriate. Distributions for 5-year mortality were plotted and calculated using cumulative incidence according to Kaplan-Meier for all-cause mortality and cause-specific cumulative incidence for cardiovascular and non-cardiovascular mortality. Univariate and multivariate Cox proportional hazard models were used to calculate the hazard ratios (HR) for all-cause mortality. We analyzed the unadjusted HRs for all covariates. For multivariate analysis, we used all covariates in a multivariate model (model 1) and with manual backward elimination of all parameters, retaining values with a p value <0.20 (Model 2). If necessary, the factor incidental finding would be forced into the models. In the presence of competing risks, we repeated the analyses with the use of subdistribution hazard ratios (SHR) to interpret if incidental findings were an independent predictor of cardiovascular and noncardiovascular mortality.24Fine J.P. Gray R.J. A proportional hazards model for the subdistribution of a competing risk.J Am Stat Assoc. 1999; 94: 496-509Crossref Scopus (9173) Google Scholar A p value <0.050 was considered statistically significant. Statistical analyses were performed on SPSS Statistics version 22.0 (IBM Corp, Chicago, IL), and the survival and cmprsk packages in R statistical software version 3.3.1.25R Development Core Team R: A Language and Environment for Statistical Computing. R Foundation for Statistical Computing, Vienna, Austria2016Google Scholar CTA in TAVI work-up was performed in 616 patients. After review of all examinations, 564 patients were considered a possible TAVI candidate (Figure 1). In 535 of the 564 patients, ≥1 incidental finding was identified at CTA (95%). These findings were considered potentially malignant in 139 of the 564 patients (25%). Five patients were denied for TAVI as a consequence of a reported incidental finding (anticipated life expectancy <1 year): 0.9% of all TAVI candidates (Figure 1). In 19 patients, preprocedural analysis revealed that the finding was benign (14%). For all further analyses, these patients were considered in the cohort without incidental findings (Figure 1). Six patients died between CTA and TAVI as a consequence of heart failure: 2 patients with an incidental finding and 4 without. TAVI was performed in 553 patients of whom 113 still had an incidental finding requiring (further) action after TAVI, including treatment, additional diagnostic testing, or follow-up (20%). In 11 of these 113 patients, preprocedural analysis already revealed a new malignancy; in the others, the finding required follow-up after TAVI. Most incidental findings were located in the lung (n = 56), followed by renal (n = 15) and pancreatic lesions (n = 14) (Table 1).Table 1Incidental findings requiring treatment or follow-up in patients who underwent transcatheter aortic valve implantationLocationNumberIdentified as new-malignancy pre-TAVI11 (2.0%) Lung 4 (0.7%) Renal 3 (0.5%) Breast 2 (0.4%) Urothelial 1 (0.2%) Metastasis (known cancer) 1 (0.2%)Requiring (further) follow-up post-TAVI102 (18.4%)*8 patients had 2 findings requiring follow-up. Lung 52 (9.4%) Kidney 12 (2.2%) Pancreas14 (2.5%) Ovarian 9 (1.6%) Lymph node(s) 5 (0.9%) Adrenal gland 4 (0.7%) Liver 3 (0.5%) Prostate 2 (0.4%) Thyroid 2 (0.4%) Gallbladder 2 (0.4%) Mediastinal 1 (0.2%) Breast 1 (0.2%) Colorectal 1 (0.2%) Parotid gland 1 (0.2%) Chondroid 1 (0.2%)TAVI = transcatheter aortic valve implantation.Data are presented as n (% of all patients who underwent TAVI).* 8 patients had 2 findings requiring follow-up. Open table in a new tab TAVI = transcatheter aortic valve implantation. Data are presented as n (% of all patients who underwent TAVI). The median age of patients who underwent TAVI was 82 years (IQR 77 to 85); 42% were men. Patients with incidental findings more frequently had a malignancy described in their medical history as compared with patients without incidental findings (33% vs 23%, p = 0.052). Other demographic and clinical characteristics did not differ substantially (Table 2). Median time from CTA to TAVI was 29 days (IQR 15 to 65) and did not differ between patients with and patients without incidental findings. Other procedural characteristics and complications did not differ significantly as well (Table 3).Table 2Clinical characteristics of patients who underwent transcatheter aortic valve implantationVariableIncidental FindingYes (n = 113)No (n = 440)p valueAge (years)82 (78–85)82 (77–85)0.44Men50 (44.2%)182 (41.4%)0.59Body mass index (kg/m2)26.9 ± 4.327.7 ± 5.30.13Body mass index<20.0 kg/m24 (3.5%)18 (4.1%)1.00Society of Thoracic Surgeons score5.210 (3.351–7.634)4.714 (3.367–6.472)0.22Logistic Euroscore I16.25 (10.44–24.84)14.59 (10.11–23.22)0.20Euroscore II4.92 (2.79–7.99)4.25 (2.70–7.25)0.25Impaired right ventricular function21 (18.6%)69 (15.7%)0.27Hostile chest**Hostile chest was defined as any reason to make redo operation through sternotomy hazardous: chest wall abnormalities, previous chest radiation, complications from previous surgery, and evidence of pleural effusion causing adhesions.8 (7.1%)24 (5.5%)0.50Porcelain aorta5 (4.4%)26 (5.9%)0.65Liver disease3 (2.7%)14 (3.2%)1.00New York Heart Association class III/IV79 (69.9%)314 (71.4%)0.82Left ventricular ejection fraction 60 mmHg†Data were missing in 169.8 (10.7%)20 (6.5%)0.22Renal clearance <50 ml/min§Renal clearance was calculated using Cockcroft-Gault formula.47 (41.6%)170 (38.6%)0.59Albumin<3.5 g/dL‡Data were missing in 133.7 (8.0%)11 (3.3%)0.070Anemia¶Anemia was defined as preprocedural hemoglobin levels for men <8.5 mmol/L and women <7.5 mmol/L.54 (47.8%)207 (47.0%)0.92Valvular surgery3 (2.7%)14 (3.2%)1.00Coronary bypass surgery20 (17.7%)63 (14.3%)0.38Chronic obstructive pulmonary disease48 (42.5%)159 (36.1%)0.23Atrial fibrillation42 (37.2%)187 (42.5%)0.34Diabetes mellitus31 (27.4%)132 (30.0%)0.65Peripheral artery disease30 (26.5%)117 (26.6%)1.00Cerebral vascular accident14 (12.4%)44 (10.0%)0.49Smoker ≤ 10 years18 (15.9%)90 (20.5%)0.17Previous malignancy38 (32.7%)103 (23.4%)0.052Data are presented as median (IQR), mean ± SD, or n (%).* Data were missing in 1.† Data were missing in 169.‡ Data were missing in 133.§ Renal clearance was calculated using Cockcroft-Gault formula.¶ Anemia was defined as preprocedural hemoglobin levels for men <8.5 mmol/L and women <7.5 mmol/L.** Hostile chest was defined as any reason to make redo operation through sternotomy hazardous: chest wall abnormalities, previous chest radiation, complications from previous surgery, and evidence of pleural effusion causing adhesions. Open table in a new tab Table 3Procedural characteristics of patients who underwent transcatheter aortic valve implantationVariableIncidental FindingYes (n = 113)No (n = 440)p valueTime CTA-TAVI (days)30 (14–65)29 (15–65)0.90Procedure year 2009–201242 (37.2%)172 (39.1%)0.75Elective procedure88 (77.9%)344 (78.2%)1.00Transthoracic access40 (35.4%)126 (28.6%)0.17Post-TAVI moderate/severe paravalvular leakage*Data were missing in 15 patients.7 (6.6%)34 (7.9%)0.84Vascular complication with intervention11 (9.7%)38 (8.6%)0.42Stroke ≤ 72h†Data were missing in 10.2 (1.8%)14 (3.2%)0.75Pacemaker ≤ 30 days‡Data were missing in 34.6 (5.8%)35 (8.4%)0.42CTA = computed tomography angiography; TAVI = transcatheter aortic valve implantation.Data are presented as median (IQR) or n (%).* Data were missing in 15 patients.† Data were missing in 10.‡ Data were missing in 34. Open table in a new tab Data are presented as median (IQR), mean ± SD, or n (%). CTA = computed tomography angiography; TAVI = transcatheter aortic valve implantation. Data are presented as median (IQR) or n (%). The median follow-up after TAVI was 39 months (IQR 29 to 57). At 5 years, the risk of death from any cause was 65% in patients with incidental findings versus 49% in patients without findings (HR 1.70, 95% CI 1.25 to 2.31, p = 0.00070) (Figure 2, Table 4). After adjustment for other covariates, incidental findings remained an independent predictor of all-cause mortality (adjusted HR 1.46, 95% CI 1.07 to 1.99, p = 0.018). Other factors significantly associated with mortality were male gender and higher STS-PROM score (Table 4). Death was of cardiovascular origin in 68% of the patients with incidental findings and in 75% of the patients without (p = 0.38). Heart failure was described most frequently; 10% of all patients died as a consequence of end-stage heart failure. The presence of an incidental finding was no significant predictor of cardiovascular mortality (SHR 1.42, 95% CI 0.98 to 2.07, p = 0.064) (Figure 3,
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