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��ࡱ�>��	������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������������	���bjbj$$	4�F|F|UR+���������33333����GGG8��G�"j�222"""""""$&%��'Z="9322222="33v"���2�33"�2"��i � �����wɒ�u�G�B� "�"0�"� ,"(2T"(� � &"(3� (22�22222="="�222�"2222��������������������������������������������������������������������"(222222222�	�:	@Acute Pulmonary Embolism In Young: A Prospective Observational Study On Clinical Implication Of Age On The Presentation And Management Of Patients With Acute Pulmonary Embolism.
Soumya Patra, MD; Nagamani AC, DM; Manjunath CN, DM; Ravindranath KS, DM; Ramesh B, DM; Navin Agrawal, DM; from the Department of Cardiology, Sri Jayadeva Institute of Cardiovascular Sciences & Research, Bangalore, Karnataka, India.
Address of correspondence: Dr. Soumya Patra, Post Doctoral Trainee in Cardiology, Department of Cardiology, Sri Jayadeva Institute of Cardiovascular Sciences & Research, Bangalore, Karnataka, India. Pin: 560069. E-mail- HYPERLINK "mailto:dr_soumyapatra@rediffmail.com"dr_soumyapatra@rediffmail.com.
Running head: Pulmonary embolism in young:-prevalence and practice
Funding and conflict of interest: None.

Acknowledgement:-None

Contributors: SP, NAC, CNM, KSR, BR & NA were involved in the management of the patients. SP planned the study, designed the protocol, collected & analyzed the data, reviewed the literatures & drafted the manuscript. Navin Agrawal revised and modified the drafting of the manuscript. All authors approved the final version of the manuscript.
Word count: Abstract: 250; Manuscript: 2717.

Abstract
Background: Prevalence of acute pulmonary embolism is increasing in general population especially in old population. Prevalence of acute pulmonary embolism in young adults is unknown. Rationale: The objective of this study was to assess the prevalence of acute pulmonary embolism in young (<40 years) population and to compare the clinical presentation and the therapeutic benefit in regards to age at presentation. Settings: A single tertiary cardiac care centre. Methods: In this study, among 202 patients enrolled, 97 & 105 patients were admitted as young & old patient, respectively. The clinical presentation and course after therapy among them were observed and compared. Results: forty-eight percent of our study population belongs to <40 years of age. There were no significant differences seen in functional class, hypotension, electrocardiographic & echocardiographic features based on age difference. Clinical improvement after treatment (68% vs 78%, p=0.42) and in hospital death (10% vs 16%, p=0.36) was non-significantly more in older than in young patients. Though the incidence of minor bleeding (14% vs 11%, p=0.68) was non-significantly higher in older group of patients but two patients in this group had intra-cerebral bleed following thrombolytic therapy. Conclusion: As there were no significant differences in the clinical presentation, therapeutic benefit, and course after therapy and complication, therefore, age should not influence the decision to treat pulmonary embolism patients especially with thrombolytic agents though caution should be taken while treating older patients.  
Key-words: Acute; age; pulmonary embolism; thrombolytic therapy; young.

Introduction
Acute pulmonary embolism (PE) is the third most common acute cardiovascular cause for hospital admission after myocardial infarction and stroke. The incidence of acute PE is increasing in the general population.1 More recent epidemiological data revealed the attack rate of acute PE of 98 cases per 100,000 person-years.2 The case fatality rate may vary and 1% of all patients admitted to hospitals die of acute PE, and 10% of all hospital deaths are PE related.3-5 There is increasing prevalence of acute coronary syndrome seen in young adults in both developing and developed countries.6-7 Likewise, prevalence of PE also seems to be increasing in young adults though so far no study demonstrated this data. We conducted this prospective observational study to assess the relative prevalence of acute PE in young (<40 years) and old (>40 years) population and to compare the clinical presentation, therapeutic benefit of treatment, course after treatment and complication in women and men with acute pulmonary embolism.

Methods 
Study Design: It was a prospective observational study. This study was conducted in a tertiary cardiac care institution in the last two years.
Eligibility criteria:
Inclusion criteria: Patients of any age who presented with Acute PE (first symptoms 15 d or less before presentation) and confirmed by a positive findings in CT pulmonary angiogram (CTPA) or through echocardiography were included.
Exclusion criteria: Patients were excluded from the study those who have the following criteria 
Symptoms started more than 15 days.
Administration of a thrombolytic agent in the previous 4 d or glycoprotein IIb/IIIa antagonists within the preceding 7 days
Vena cava filter insertion or pulmonary thrombectomy in the previous 4 d
Uncontrolled hypertension (systolic BP >180 mm Hg and/or diastolic BP >110 mm Hg at presentation)
Known hypersensitivity to STK, TNK or heparin.
Known coagulation disorder (including use of vitamin K antagonists and platelet count <100,000/mm3)
Clinically relevant bleeding within the last 6 months or if they had a hemorrhagic diathesis, active peptic ulcer, arterial aneurysm or arterial/venous malformation, cancer at increased risk for bleeding, history of stroke, intracranial or spinal surgery
Major surgery, biopsy or trauma in the 2 months preceding the admission 
Had prolonged cardiopulmonary resuscitation (>10 minutes) in the last two weeks
Ethics: The study protocol was approved by the Ethics Committee of the respective authority of our institution. Written informed consent was obtained from all patients, before inclusion in the study. 
Methods: Written proformas will be filled up during inclusion of patients which will contain epidemiological information (age, sex, occupation, and place), questionnaires for risk factor evaluation (smoking, drug history, malignancy, comorbid condition, hypercoagulable state), information of clinical presentation (dyspnea, chest pain, syncope, cardiac arrest, etc.) and clinical signs. Those patients had diagnosed acute PE, was treated as per unit protocol with either thrombolytic agent tenecteplase or streptokinase followed by unfractionated heparin (UFH) injection or UFH alone. The patients were divided in two groups according to their age at admission and were called as young group who were arbitrarily less than 40 years old and old group who were more than 40 years old.  All the patients were prospectively studied; data was collected, compiled and analysed.  
Investigations: All patients will be investigated with the following tests;
1. Chest X-ray 
2. Electrocardiogram: For all patients, standard 12-lead ECG was recorded on admission with a paper speed of 25 mm/s. The first available ECG was used for analysis. 
3. Echocardiography: Baseline echocardiography was to be done within 24 hours from the diagnosis of PE. For the purpose of this study, right ventricular dysfunction (RVD) was defined as the right/left ventricle end-diastolic dimension ratio >1 in the apical 4-chamber view and/or >0.7 in parasternal long axis, both in the absence of right ventricle hypertrophy. Echocardiography was scheduled to be repeated 24 hours and at discharge or 7 days after study treatment administration. The pulmonary artery systolic pressure (PASP) was calculated by using tricuspid valve regurgitation jet & inferior vena cava dimension.8
4. d-Dimer test/ Troponin T assay
5. CTPA
6. Complete Hemogram, Bleeding time (BT), Clotting time (CT), Prothrombin time (PT) & activated plasma thromboplastin time (aPTT), Renal function test, Liver function test.
7. Doppler Venography/ ultrasound abdomen if necessary
Outcomes: First we have assessed the prevalence of acute PE in our young and old population. Then, patients were evaluated on the day of discharge and the outcome in this study was to determine the clinical improvement following thrombolysis which was defined as improvement in the New York Heart Association (NYHA) functional class, dyspnoea, tachycardia, hypoxemia, and improvement in general well being along with reduction of RVD and/ or PASP seen at echocardiography. 
Complication: This was as follows: (1) composite of death from any cause, (2) Hemodynamic collapse is defined as at least 1 of the following: (i) the need for cardiopulmonary resuscitation; (ii) systolic blood pressure <90 mm Hg for at least 15 minutes, or drop of systolic blood pressure by at least 40 mm Hg for at least 15 minutes, with signs of end-organ hypoperfusion (cold extremities, or urinary output <30 mL/h, or mental confusion); (iii) the need for catecholamines (except for dopamine at a rate of <5 �g kg"1 min"1) to maintain adequate organ perfusion and a systolic blood pressure of >90 mm Hg, (3) ischemic or hemorrhagic stroke within 7 days, and (4) bleeding (ie, minor or severe) within 7 days. Minor bleeding defined as a bleeding not requiring blood transfusion. Severe bleeding is defined as an episode that leads to hemodynamic compromise requiring emergency intervention (as administration of fluids and/or blood products, inotropic support, or surgical treatment), or is life threatening, or fatal. 
Statistics: All the data was compiled at the end of the study and the sample was analyzed with Chi-square. The p value of <0.05 will be considered as statistically significant.

Results
Within last two years, 202 patients were admitted in our hospital with the clinical diagnosis of acute PE. Among them, 97 (forty-eight percent) patients were belonged to young age and 105 (fifty-two percent) patients were belonged to old age. 
Baseline characteristics of patients at presentation: Table 1 demonstrated the baseline characteristics of our study patients. There was almost similar distribution of sex ratio in these two study group. Among the risk factors, history of deep vein thrombosis (DVT) was the most common risk factor (41%) in young patients and was followed by smoking (33%) and obesity/ dyslipidemia (27%), whereas smoking was the most common risk factor (36%) in older patients which was followed by DVT (33%). Interestingly, about one-third of patients in the both the groups had no apparent risk factors for PE. There were no statistically significant differences seen in the distribution of risk factors in both the groups. The mean duration of symptoms before admission was also similar in both the groups. Dyspnoea & tachypnoea were the most common clinical features of PE in both groups. We couldn�t find any significant differences as per the clinical features, investigation and treatment in young and old patients. Sinus tachycardia was the most common ECG findings in both the groups. Classical S1Q3T3 pattern was seen in 52% of young age and 45% of old age patients. The mean PASP (66 +/- 22.4 vs. 63.7 +/- 17.9 mm of Hg) was more and RVD (77% vs 81%) was less in young patients than the old patients without any statistical significance. Seventy-one percent of young age patients were treated with streptokinase infusion. 
Clinical course after therapy: Table 2 demonstrated the results of clinical course after therapy. Persistently elevated PASP of > 30 mm of Hg was less frequent (22% vs. 26%) and clinical improvement (78% vs. 68%) was more frequent in young age than in old age patients. But both these results were statistically insignificant. 
Complications after therapy: Table 3 showed the results of complication after receiving treatment in both young age & old age patients. Ten percent of young age patients had in hospital death while on treatment and 22% patients had clinical deterioration even after starting treatment, whereas 16% of old age patients had in hospital death and 32% had clinical deterioration. Only 11% of young age patients had minor bleeding following treatment with thrombolytic agent or anticoagulant but none of them had major bleeding, while 14% of old age patients had minor bleeding. Though all these adverse events following therapy like death, minor bleeding, and clinical deterioration were statistically insignificant in both the study groups of patients, but two patients in old age groups had inra-cerebral bleed following treatment with thrombolytic agent. Duration of stay in intensive care unit (ICU) was insignificantly less in young age than the old age patients. 

Discussion
Our study was a prospective observational study from a single centre with adequate number of patients with acute PE. Here, in this study, we have assessed the relative prevalence of acute PE in both young and older age population. We also observed any difference in the clinical presentation, investigations along with response, course & complication after treatment among these groups of patients. So far no study have tried to find out the prevalence of acute PE in young adults of <40 years of age still PE is regarding a disease of mostly older age and thus no study has compared the differences in clinical presentation, investigations along with response, course & complication after treatment among these groups of patients. In our study, a significant number of patients (48%) were less than 40 years of age. This finding correlates the increasing prevalence of acute coronary syndrome (ACS) in younger population in both developing and developed world.4-5 Like ACS, prevalence of acute PE and DVT are also increasing in young adults in our country, and this result was not in agreement with the study from western countries where prevalence of acute PE is still more in older population. We didn�t observe any significant differences between young and old age patients in regards to clinical features, blood investigations, radiological investigations and echocardiographic parameters. In this study, we have included all patients with acute PE without differentiating whether they had massive or submassive PE. There was almost similar distribution of patients according to their treatment received. In our study, we had taken short term observation up to day of discharge of our patients than up to 30 days which was done in previous studies. The duration of hospital stay was insignificantly more in older age patient. The clinical improvement were more commonly seen in young age patients The death rate and clinical deterioration following treatment was insignificantly more in  old age population than in young age patients. There were insignificantly more cases with minor bleeding manifestation seen following thrombolytic therapy in old age patients. Though two patients in older age group had major intra cerebral bleeding but overall the adverse events were similar in both the study groups following treatment. As this was an observational study so this result shouldn�t be generalized and we have treated both massive & sub massive PE with thrombolytic therapy which is according to the few recent trials9-11 though treatment of sub massive PE with thrombolytic therapy is so far not indicated in the guidelines.12-13  
With keeping all these limitations in mind, our observations suggest that there is increasing prevalence of acute PE in young population what we have already observed in case ACS, so limitation of risk factors and life style modifications are also applicable in this disorder also. Beside this, there should not be any age related bias while managing a patient with acute PE especially with thrombolytic agents as we didn�t observe any significant differences in complication following therapy though we need to be more cautious while treating a old age patient, though further large randomized trial is needed to resolve this debate in future.

Funding and conflict of interest: None.
Contributors: Soumya Patra, Navin Agrawal & Manjunath C N planned the study. Soumya Patra designed the protocol, collected & analyzed the data, reviewed the literatures & drafted the manuscript. All authors approved the final version of the manuscript.

References
1. Penaloza A, Kline J, Verschuren F, et al. European and American suspected and confirmed pulmonary embolism populations: comparison and analysis. J Thromb Haemost 2012;10: 375�81.
2. Cohen AT, Agnelli G, Anderson FA, et al. Venous thromboembolism (VTE) in Europe. The number of VTE events and associated morbidity and mortality. Thromb Haemost 2007;98:756-64.
3. Goldhaber SZ, Visani L, De Rosa M. Acute pulmonary embolism: clinical outcomes in the International Cooperative Pulmonary Embolism Registry (ICOPER). Lancet 1999;353:1386-9.
4. Cohen AT, Edmondson RA, Phillips MJ, et al. The changing pattern of venous thromboembolic disease. Haemostasis 1996;26:65-71.
5. Lindblad B, Sternby NH, Bergqvist D. Incidence of venous thromboembolism verified by necropsy over 30 years. BMJ 1991;302:709-11.
6. Chen TS, Incani A, Butler TC, et al. The Demographic Profile of Young Patients (<45 years-old) with Acute Coronary Syndromes in Queensland. Heart Lung Circ. 2013 Jun 20. pii: S1443-9506(13)01021-4.
7. Jinnouchi H, Sakakura K, Wada H, et al. Clinical features of myocardial infarction in young Japanese patients. Int Heart J. 2013;54(3):123-8.
8. Konstantinides SV, Meyer G, Lang I, et al. Single-bolus tenecteplase plus heparin compared with heparin alone for normotensive patients with acute pulmonary embolism who have evidence of right ventricular dysfunction and myocardial injury: Rationale and design of the Pulmonary Embolism Thrombolysis (PEITHO) trial. Am Heart J. 2012;163:33-38.e1.
9. Bandyopadhyay T, Martin I, Lahiri B. Combined thrombolysis and inferior vena caval interruption as a therapeutic approach to massive and submassive pulmonary embolism. Conn Med. 2006;70(6):367-70.
10. Zamanian RT, Gould MK. Effectiveness and cost effectiveness of thrombolysis in patients with acute pulmonary embolism. Curr Opin Pulm Med. 2008;14(5):422-6.
11. Lankeit M, Konstantinides S. Thrombolytic therapy for submassive pulmonary embolism. Best Pract Res Clin Haematol. 2012;25(3):379-89.
12. Kearon C, Akl EA, Comerota AJ,et al. Antithrombotic therapy for VTE disease: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012;141(2 Suppl):e419S-94S.
13. Jaff MR, McMurtry MS, Archer SL, et al. Management of massive and submassive pulmonary embolism, iliofemoral deep vein thrombosis, and chronic thromboembolic pulmonary hypertension: a scientific statement from the American Heart Association. Circulation. 2011;123(16):1788-830.

Table 1: Baseline characteristics of patients according to their age
Variable Age <40 years (n=97)Age >40 (n=105)P valueAge (mean)31.2 +/- 6.1 years55.3 +/- 10.7 yearsP<0.01Sex (M:F)60:3764:41NSRisk factors
Smoking 
DVT
Obesity/ dyslipidemia
H/O recent surgery/ Bedridden 
No apparent risk factors                                       
32 (33%)
40 (41%)
26 (27%)
18 (19%)
32 (33%) 
                                       
38 (36%)
35 (33%)
35 (33%)
23(22%)
35 (33%)
                                 NS
NS
NS
NS
NS
Duration of symptoms  at presentation (mean)5.1+/- 4.09 days5.2 +/- 4.2 daysNSPresenting complaints
Dyspnoea
Chest pain
Syncope 
                                       
93 (96%)
29 (30%)
12 (12%)
                                       
96 (91%)
27 (26%)
15 (14%)
                                 NS
NS
NS
Clinical features
Hypotension 
Tachycardia 
Hypoxia
Sign of RV failure                                       
15 (15%)
76 (78%)
43 (44%)
16 (16%)                                       
25 (24%)
86 (85%)
46 (44%)
14 (13%)                                    
NS
NS
NS
NSInvestigations
d-Dimer
Toponin T/ CKMB
                                     
61 (63%)
65 (67%)
                                       
82 (78%)
72 (68%)
                                 NS
NSElectrocardiogram (ECG) features
Sinus tachycardia
RBBB
S1Q3T3
�T� inversion mid chest leads
Right axis deviation/ 
RVH with strain                                   

76 (78%)
22 (23%)
51 (52%)
49 (50%)
50 (51%)                                     

86 (85%)
18 (17%)
47 (45%)
51 (48%)
36 (34%)
                                 

NS
NS
NS
NS
NSBaseline Echocardiography
PASP (mean)
RVD                                  
66 +/- 22.4 mm of Hg
75 (77%)                                     
63.7 +/- 17.9 mm of Hg
85 (81%)                                 NS
NSTreatment
Streptokinase
Tenecteplase
Inj. UFH only
69 (71%)
10 (10%)
18 (19%)
70 (67%)
14 (13%)
21 (20%)
NS
NS
NS

Table 2: Clinical course after therapy
Variable Age <40 years (n=97)Age >40 (n=105)P valueAbnormal PASP (>30 mm of Hg) 21 (22%)27 (26%)NSClinical Improvement76 (78%)71 (68%)NS

Table 3: Complication after therapy & duration of ICU stay  
Variables Age <40 years (n=97)Age >40 (n=105)P valueAdverse events
In hospital death
Clinical deterioration
Development of Hypotension
Mild bleeding
Major bleeding (including Stroke)
                                     
10 (10%)
21 (22%)
8 (8%)
11 (11%)
0 
                                        
17 (16%)
34 (32%)
15 (14%)
15 (14%)
2 (2%)
                        NS
NS
NS
NS
NS
Duration of ICU stay (mean)2 +/- 0.5 days3 +/- 0.8 daysNS








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