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ORIGINAL ARTICLE
Year : 2021  |  Volume : 8  |  Issue : 5  |  Page : 36-40

Assessment of quality of life between patients undergoing pharmacomechanical catheter-directed thrombolysis versus conservative management with iliofemoro-popliteal deep-vein thrombosis


Department of Vascular and Endovascular Sciences, Medanta the Medicity, Gurgaon, Haryana, India

Date of Submission05-Nov-2020
Date of Decision04-Dec-2020
Date of Acceptance07-Dec-2020
Date of Web Publication30-Aug-2021

Correspondence Address:
S V R Krishna Yeramsetti
Department of Vascular and Endovascular Sciences, Medanta the Medicity, Gurgaon, Haryana
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/ijves.ijves_147_20

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  Abstract 


Background: Pharmacomechanical catheter-directed thrombolysis (PCDT) has revolutionized the treatment of acute deep-vein thrombosis (DVT). Assessment and comparison of quality of life (QOL) in patients treated with anticoagulation alone and PCDT need to be elaborated more in the context of better management of patients. The objective of this study was to compare and assess QOL using health-related QOL (HRQOL) which includes short form-36 (SF-36) and VIENES QOL/sym scoring systems in anticoagulation alone group and patients treated with PCDT. Methods: There were 130 consecutive patients presenting to our department with acute iliofemoro-popliteal DVT (IFPDVT) with <2 weeks duration treated between April 2018 and April 2019 were included in the study. Sixty-five patients received anticoagulation alone and the other 65 patients received PCDT along with anticoagulation. Patients were assessed at baseline, the 1st month, and the 6th month in terms of QOL, deep venous patency (DVP), and deep venous reflux (DVR). Results: There was a statistically significant difference between the two groups in terms of QOL at 1st and 6 months. Mean physical component score and mental component score were statistically significantly better in PCDT than the conservative group at 1 and 6 months, respectively (P = 0.001). Mean venous insufficiency epidemiological and economic study (VEINES) QOL and VEINES SYM scores were significantly better in PCDT group than conservative group at 1 and 6 months, respectively (P = 0.001). Conclusion: QOL, DVP, and DVR are significantly better when PCDT is offered as an initial option when compared to anticoagulation alone. HRQOL (SF 36 and VEINESQOL/SYM score) should be considered as an outcome measure in clinical studies on patients with IFPDVT along with other comparison parameters with respect to QOL. However, long-term follow-up is required to establish the superiority of PCDT in IFPDVT patients.

Keywords: Anticoagulation, deep-vein thrombosis, health-related quality of life, the 36-item short-form health survey and the venous insufficiency epidemiological and economic study – quality of life


How to cite this article:
Yeramsetti S V, Ghanwat SP, Sahu T, Sheorain V, Grover T, Parakh R. Assessment of quality of life between patients undergoing pharmacomechanical catheter-directed thrombolysis versus conservative management with iliofemoro-popliteal deep-vein thrombosis. Indian J Vasc Endovasc Surg 2021;8, Suppl S1:36-40

How to cite this URL:
Yeramsetti S V, Ghanwat SP, Sahu T, Sheorain V, Grover T, Parakh R. Assessment of quality of life between patients undergoing pharmacomechanical catheter-directed thrombolysis versus conservative management with iliofemoro-popliteal deep-vein thrombosis. Indian J Vasc Endovasc Surg [serial online] 2021 [cited 2021 Nov 28];8, Suppl S1:36-40. Available from: https://www.indjvascsurg.org/text.asp?2021/8/5/36/324934




  Introduction Top


After acute myocardial infarction, stroke and venous thromboembolism (VTE),[1] which encompasses deep-vein thrombosis (DVT) and pulmonary embolism (PE), is the third leading vascular disease and contributes to a yearly economic burden of $7–10 billion in the USA.[2] It was earlier thought that the incidence and prevalence of lower limb DVT in India is lower than that of the Western population, but recent studies,[3],[4] however, have adequately dispelled this myth and have estimated that the burden of DVT in Indian patients is comparable to (if not greater than) their Western counterparts. Iliofemoro-popliteal DVT (IFPDVT) is associated with the greater incidence of post-thrombotic syndrome (PTS) which significantly impairs the quality of life (QOL) which occurs in a relative young/economically productive population. Anticoagulation is the mainstay for the treatment of patients with VTE.[5] The largest trial till date comparing the two methods of the treatment have focussed on bleeding, recanalization, PTS, and other clinical parameters. No large scale studies till date compared QOL in patients undergoing pharmacomechanical catheter-directed thrombolysis (PCDT). Catheter-directed interventions for acute IFPDVT are used to prevent or reduce the likelihood of developing PTS, thereby improving the QOL. PCDT actively removes thrombus burden thus attempting to regain patency of the occluded veins, thereby also preventing resulting valvular damage and reflux. QOL, by defining health in broader terms than morbidity and mortality, yields valuable information on burden of illness and is an important end point to consider when studying patients with DVT.[6],[7],[8],[9] Impairment in QOL has been studied and well described by researchers. There are few studies in the literature, assessing QOL between anticoagulation alone and PCDT group with HRQOL scoring systems. Standardized self-administered questionnaires are used to measure generic and venous disease-specific QOL. These include the 36-item short-form health survey (SF-36) and the venous insufficiency epidemiological and economic study (VEINES) – QOL. The objective of this study is to assess and compare HRQOL between anticoagulation alone group and PCDT group.


  Methods Top


In this prospective, observational study, after fulfilling the inclusion and exclusion criteria and approval from the Institutional Ethics Committee, 130 patients who were diagnosed with acute IFPDVT from April 2019 to April 2020 were enrolled into the study. Sixty-five patients were allocated for PCDT + standard DVT therapy (test arm) and another 65 patients were allocated for standard DVT therapy (anticoagulation alone-control arm). Once the diagnosis of acute DVT was confirmed by duplex ultrasound and then computed tomography (CT) pulmonary angiography with DVT protocol was performed to ascertain level of proximal thrombus extension and pulmonary involvement. Patients in both groups were given self-administered questionnaires in the form of SF-36 (physical component score [PCS] and mental component score [MCS] SCORE) and VEINES QOL/SYM scoring systems, which were filled by patients themselves after explaining in detail. Initially both arm received IV unfractionated heparin: initial bolus of 80 units/kg. All participants who were allocated in control arm received anticoagulation therapy for at least 5 days by subcutaneous enoxaparin injection twice-daily at 1 mg/kg. Test arm was subjected to PCDT which was performed by our technique as elucidated below. This procedure was performed under local anesthesia in our Cath laboratory. The thrombolytic agent used was recombinant tissue plasminogen activator (rT-PA) (Actliyse). Preoperative selective inferior vena cava (IVC) filter placement was done in PCDT group as per CT venography findings. After confirmation of the position and extent of the thrombus, a 7 Fr-guiding catheter (Cordis) was advanced into the thrombus and exchanged with infusion catheter (multiside hole catheter), then thrombolysis was initiated with rT-PA at 0.01 mg/kg/h (maximum = 1 mg/h) with a maximum dose <35 mg. Check venogram with pharmaco-mechanical thrombolysis was performed using a PENUMBRA cat 8 indigo aspiration catheter system/AngioJet Rheolytic Thrombectomy device. Treatment is discontinued when (a) adequate thrombus removal was achieved with restoration of flow; (b) the 35 mg rT-PA maximum dose was reached; or (c) the patient suffers clinically overt bleeding or low fibrinogen levels or another complication that mandates cessation of therapy. Balloon angioplasty and stent placement were performed to treat the residual areas of venous stenosis or obstruction that persist after PCDT since these lesions, when not treated, were associated with high rates of immediate re-thrombosis. As per the recommendation, self-expandable bare stents with radial flexibility, sized to the veins expected diameter (usually 10–16 mm) were used.[10] HRQOL assessment (SF-36, VEINES-QOL/SYM scores), deep venous patency (DVP), and deep venous reflux (DVR) at baseline, 1 month and 6 months were evaluated in both groups. Major and minor complications were noted.

Statistical methods

Quantitative data were presented in terms of mean and standard deviation. HRQOL scoring at baseline, 1st month and 6th month were assessed. Demographic, preoperative, and postoperative data were compared using the Student's t-test. All reported P values were based on two-sided tests, and P < 0.05 was considered statistically significant. All statistical calculations were performed using the SPSS software version 24.0 (SPSS Inc., Chicago, IL, USA).


  Results Top


In our study, the mean age in PCDT group was 49.03 years ± 16.51 standard deviation (SD), whereas in the conservative group, the mean age was 54.45 years ± 12.85 SD in PCDT and conservative group; male-to-female ratio of population was 66:34 and 58:42, respectively. Left lower limb was involved in 66% and right lower limbs in 34% in the PCDT group. Predisposing factors in PCDT group were history of DVT (17%) and immobilization (18%). In PCDT group, thrombolysis was discontinued in one patient due to bleeding complication. Venoplasty was done in 43%; stenting was done in 17%; and IVC filter placement was done in 28%. Significantly better DVR and DVP were seen in PCDT group than conservative group at 1 and 6 months (P = 0.001) [Figure 1] and [Figure 2]. In our PCDT group and conservative group, overall complications were 8% and 6%, respectively. In PCDT group and conservative group, minor bleeding complications were seen in 3% and 6%, respectively. Major bleeding complications were seen in 5% of PCDT group and none in conservative group. Mean PCS and MCS scores were significantly better in PCDT than in the conservative group at 1 month and 6 months (P = 0.001) [Figure 3] and [Figure 4]. Mean VEINESQOL and VEINES SYM scores were statistically significantly better in PCDT than in the conservative group at 1 month and 6 months (P = 0.001) [Figure 5] and [Figure 6].
Figure 1: Deep venous reflux in both groups

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Figure 2: Deep venous patency in both groups

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Figure 3: Physical component score in catheter-directed thrombolysis group

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Figure 4: Mental component score in catheter-directed thrombolysis group

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Figure 5: VEINES quality of life in both groups

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Figure 6: VEINES sym score in both groups

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  Discussion Top


IFPDVT with PTS significantly affects the QOL. There is a significant evolution in the management of DVT over the last few decades. Conventional anticoagulation has been replaced with PCDT to a larger extent. Study to address the issue of PTS earlier was done by Srinivas and Soumya Patra,[11] which showed an incidence of 20% PTS among the PCDT patients and 77% among those on anticoagulation. There has been a change in the treatment paradigm since the publication of the two landmark trials (ATTRACT and CaVenT). In a study by Srinivas and Soumya Patra,[11] the mean age ± SD was 39 ± 16 years and 53 ± 17 years in the PCDT group and anticoagulation group, respectively. In Sebastian et al.'s[12] study, the mean age was 42.5 years in both groups. They included 18–75 years of age group with <14 days duration. In our study, the mean age in PCDT group was 49.03 ± 16.51 years, whereas in conservative group, the mean age was 54.45 ± 12.85 years. Increase in the mean age in our study is probably due to slightly larger sample size groups in our study. In studies by Enden et al.[13] and Utne et al.,[14] the mean age was 53.3 and 60 years, respectively, while in our study, it was 51.74 which was comparable. No PE was noted in our study, which may be due to selective preoperative IVC filter insertion. In Sebastian et al.'s[12] study, the need for stenting was 22%. According to Srinivas and Soumya Patra[11] study, the need for venoplasty, stenting, and IVC filter placement were 11%, 6%, and 5%, and in our study, it was 43%, 17%, and 28%, respectively. Higher rates were also seen in other studies. The ATTRACT trial series[15] had an 88% need for additional endovascular procedures (stenting/venoplasty). This high percentage of need for venoplasty/stenting underscores a hitherto unexplored aspect of PCDT as it unmasks obstructive venous lesions which were possibly precursors for the acute DVT itself and that their venoplastic correction is also possible in the same/eventual sessions further leading to reduction in the rates of recurrent thrombotic events in the predisposed group. This advantage of PCDT is unmatched by the use of anticoagulation alone. In our study, the rates of overall bleeding were 8%, and major bleeding was 5% in the PCDT group, which was higher compared to conservative group, but the difference was not statistically significant (P = 1.00). Kim et al.'s study had 4% major bleeding where Angiojet was used for PCDT.[16] In Srinivas and Soumya Patra,[11] study, the rate of major bleeding was 15% and minor complications were 23%. Reports from the trials and registries utilizing various devices to perform PCDT show reduced rates of bleeding (0%–11%) compared with standard CDT at 22% in the CAVENT trial. The lower incidence of bleeding is possibly due to reduced dosage of rT-PA afforded by the use of mechanical aspiration. Lin et al.[17] reported a 10% incidence of minor and 2% incidence of major bleeding with the use of PCDT. The ATTRACT trial reported a 4% rate of major bleeding. Overall, lower rates of bleeding are seen in patients in the PCDT group and even the slightly higher rates (as compared to anticoagulation) are not significant. There were no cases of PE in our study. One possible reason for the absence of PE could be the selective use of IVC filters in our study. The symptomatic/clinical success rate was gauged by increase in PCS, MCS, VEINES QOL, and VEINES SYM scores at 1 and 6 months in PCDT group. PCS, MCS, VEINES QOL, and VEINES SYM scores were significantly better at 1 and 6 months of follow up (P = 0.001). In conservative group at 6 months, mean SF-36 PCS and MCS scores improved by 7.32 and 5.6 points respectively; VEINES-QOL and VEINES-Sym scores improved by 5.93 and 5.72 points respectively. In PCDT group at 6 months, mean SF-36 PCS and MCS scores improved by 19.09 and 18.27 points respectively; VEINESQOL and VEINES-Sym scores improved by 17.07 and 16.72 points respectively (P = 0.001 for time trend for all measures). QOL was significantly better at 6 months in PCDT group following DVT. Laiho et al.[18] showed deep vein reflux in 44% of catheter-directed lysis treated patients compared with 81% of the systemically treated patients in their study (P = 0.03). Our study showed that DVR and DVP in conservative group and PCDT group was not significant at 1 month but was significantly better (42% vs. 18%) at 6 months (P = 0.004) in the PCDT group.

To our knowledge, the burden of DVT from the patient's perspective has not been quantified, and relatively less studies are available in the literature. We evaluated HRQOL after DVT and compared results with PCDT group. Our study has several strengths. We evaluated QOL prospectively starting from the time of DVT diagnosis using measures that have been shown to be reliable, valid, and responsive to change. To ensure comprehensive assessment of QOL, we used generic and diseases-specific measures, because generic measures allow comparisons with the general population norms or with groups of patients with other medical conditions, while disease-specific measures permit assessment of health outcomes and patient satisfaction for a particular disease with a focus on measuring changes over time. Our study outcomes indicate that good QOL can be provided to the patients who were given an initial option of PCDT rather than anticoagulation alone. PCDT can be considered as a primary option in acute IFP DVT for improving the QOL (both immediate and persisting till 6 months) in patients suffering from acute ileo-femoral DVT.


  Conclusion Top


QOL is significantly better when PCDT is used as an initial option when compared to anticoagulation alone in acute IFPDVT patients. DVP and DVR were significantly much better in PCDT group than anticoagulation alone group. HRQOL (SF 36 and VEINESQOL/SYM score) should be considered as an outcome measure in clinical studies on patients with IFPDVT along with other questionnaires.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
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  [Figure 1], [Figure 2], [Figure 3], [Figure 4], [Figure 5], [Figure 6]



 

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