- Email: [email protected]
Safety and efficacy of endovenous ablations in octogenarians, nonagenarians, and centenarians
Safety and efficacy of endovenous ablations in octogenarians, nonagenarians, and centenarians Pavel Kibrik, DO, Jesse Chait, BS, Michael Arustamyan, DO, Ahmad Alsheekh, MD, Sareh Rajaee, MD, Natalie Marks, MD, Anil Hingorani, MD, and Enrico Ascher, MD, Brooklyn, NY
ABSTRACT Objective: Endovenous ablation of the lower extremity veins has become the primary treatment of symptomatic venous reflux disease. Endovenous heat-induced thrombosis (EHIT) and recanalization are two well-known complications of these venous ablative procedures. Because the elderly represent the fastest growing demographic, our goal was to look at whether there is a difference of these complications and age distribution in octogenarians, nonagenarians, and centenarians vs the younger population. Methods: A retrospective study was conducted of 10,029 procedures that were performed from March 2012 to September 2018 on 8273 veins across 3218 patients who underwent endovenous ablation for lower extremity venous reflux; 6091 procedures were performed with radiofrequency ablation, and 3938 were performed with endovenous laser ablation. We reviewed charts of all patients who underwent radiofrequency ablation or endovenous laser treatment during this time. Postprocedural venous duplex ultrasound was performed at 3 to 7 days to check for EHIT and recanalization, every 3 months for the first year, and every 6 to 12 months thereafter. The c2 test and analysis of variance were used for statistical analysis. Results: Ages ranged from 15 years to 103 years. The average age of the patients was 61.9 6 15.2 years. Average overall followup for all age groups was 25.8 6 12.9 months. Of the 3218 patients, 2700 were younger than 80 years, 380 were between 80 and 89 years, 132 were between 90 and 99 years, and 6 were 100 years or older. Of the 10,029 procedures, 8730 were performed on patients younger than 80 years; 1124, on patients 80 to 89 years; 159, on patients 90 to 99 years; and 16, on patients 100 years or older. There were 111 patients who had bilateral procedures in the accessory saphenous vein, 1878 patients who had bilateral procedures in the great saphenous vein, 99 patients who had bilateral procedures in the perforator vein, and 760 patients who had bilateral procedures in the small saphenous vein. There were statistically significant increases in EHIT rates between octogenarians and those in the age group <80 years (P ¼ .047); between nonagenarians and those in the age group <80 years (P ¼ .04); and between the combined group of octogenarians, nonagenarians, and centenarians and the age group <80 years (P ¼ .012). No statistical difference was found in rates of EHIT between octogenarians and nonagenarians (P ¼ .5). Overall age is a risk factor for the development of EHIT (odds ratio, 1.03; 95% confidence interval, 1.02-1.04; P < .00001). There were statistically significant increases in recanalization rates between octogenarians and those in the age group <80 years (P ¼ .000013); between nonagenarians and those in the age group <80 years (P ¼ .00022); and between the combined group of octogenarians, nonagenarians, and centenarians and the age group <80 years (P < .00001). No statistical difference was found in rates of recanalization between octogenarians and nonagenarians (P ¼ .48). Statistical analysis of centenarians alone was not done because of zero patients available in the EHIT or recanalization category. Overall age was found to be a risk factor for recanalization (odds ratio, 1.03; 95% confidence interval, 1.01-1.04; P < .00002). Conclusions: Whereas there is a relatively higher chance of EHIT and recanalization in the age group >80 years, our study shows that the majority of EHITs were class 1 and class 2. According to our study, venous ablation is safe and effective across all age groups, and age alone should not be used to deny patients venous ablations. (J Vasc Surg: Venous and Lym Dis 2019;-:1-5.) Keywords: Endovenous heat-induced thrombosis; Ablations; Chronic venous insufficiency; Recanalization
Endovenous ablation is a treatment of choice for venous reflux in lower extremity veins.1,2 Laser ablation and radiofrequency ablation (RFA) have long-term efficacies that are comparable to those of other treatments.3,4 Regarding
From the Vascular Institute of New York. Author conflict of interest: none. Correspondence: Pavel Kibrik, DO, Vascular Institute of New York, 960 50th St, Brooklyn, NY 11219 (e-mail: [email protected]). The editors and reviewers of this article have no relevant financial relationships to disclose per the Journal policy that requires reviewers to decline review of any manuscript for which they may have a conflict of interest. 2213-333X Copyright Ó 2019 by the Society for Vascular Surgery. Published by Elsevier Inc. https://doi.org/10.1016/j.jvsv.2019.05.011
patient safety, there is some evidence that the two endovenous ablation modalities produce less periprocedural disability and less pain and have a faster recovery time compared with more invasive treatments.2,5 They also pose a small risk of periprocedural adverse effects, such as deep venous thrombosis and pulmonary embolism.6 Indeed, two previous meta-analyses of short-term studies demonstrated good safety and efficacy profiles for the treatment of lower extremity veins.2,4 However, endovenous heat-induced thrombosis (EHIT) and recanalization are two well-known complications of both endovenous laser ablation (EVLA) and RFA procedures, with an incidence rate in the range of 0% to 6%.5,7 A single-center prospective RFA study of 224 legs in 185 patients with varicose 1
2
Kibrik et al
Journal of Vascular Surgery: Venous and Lymphatic Disorders ---
veins reported EHIT in 44 legs (27%; EHIT class 1, 21%; EHIT class $2, 6%), with the majority being detected on day 7 (21%) compared with day 30 (5.5%) and 3 months (0.6%).8 Thus, postoperative surveillance with duplex ultrasound imaging is important as it allows early intervention of thromboembolism in patients (male sex; multiple phlebectomies; large great saphenous vein [GSV] diameter; and clinical class $3 per the Clinical, Etiology, Anatomy, and Pathophysiology [CEAP] classification8,9). Some studies have noted that patients in whom EHIT developed were slightly older than those without EHIT,9,10 indicating that old age could be a risk factor for EHIT after endovenous ablation. Whereas Sufian et al9 and Rizvi et al10 found age to be associated with EHIT, they did not specifically look at patients older than 80 years. On the other hand, recanalization of isolated vein segments of the GSV is also an important complication of endothermal ablation.11 Predictors of GSV recanalization include clinical class and diameter, patient’s sex, device type, and length of vein, with clinical class and diameter being strong predictors.12 The aim of this study was to further delineate the risk of EHIT and recanalization among octogenarians (8089 years), nonagenarians (90-99 years), and centenarians ($100 years) and the younger population (<80 years).
METHODS A retrospective study was conducted of 10,029 procedures that were performed from March 2012 to September 2018 on 8273 veins that underwent endovenous ablation for lower extremity venous reflux. Once the diagnosis of chronic venous disease was acknowledged on the basis of history and physical examination findings along with duplex ultrasound demonstrating reflux of >500 milliseconds, the initial treatment protocol managed patients with conservative therapy (ie, compression therapy, leg elevation). If patients’ symptoms persisted or worsened during 3 months, causing alteration in daily living activities, or they were unable to use compression therapy because of discomfort, these patients were offered venous ablation therapy. There were 6091 procedures performed with RFA and 3938 with EVLA. Charts of the identified patients were reviewed to identify those who underwent RFA and EVLA treatment during this time. Follow-up data for postprocedural venous duplex ultrasound scan performed 3 to 7 days after treatment, after every 3 months in the first year, and every 6 to 12 months thereafter were analyzed to identify patients in whom EHIT and recanalization developed. First, the patients were age stratified into four groups: <80 years, 80 to 89 years (octogenarian), 90 to 99 years (nonagenarian) and $100 years (centenarian). Each group was subcategorized according to the post-treatment complications, particularly EHIT (classes 1-4) and total recanalization. One-way analysis of variance was used to test whether EHIT rates between groups and between EHIT classes (classes 1-4) differed
2019
ARTICLE HIGHLIGHTS d
d
d
Type of Research: Single-center retrospective review Key Findings: In 10,029 thermal ablation procedures performed on 8273 veins of 3218 patients, there were increased rates of endovenous heat-induced thrombosis (EHIT) and recanalization between octogenarians, nonagenarians, and centenarians vs the age group <80 years. There was no difference in EHIT and recanalization rates between octogenarians and nonagenarians. Overall age was a risk factor for EHIT and recanalization. Take Home Message: Venous ablation was safe and effective across all age groups, and age alone should not deny patients venous ablations.
significantly. Pearson c2 test was used to evaluate the correlation of the occurrence of EHIT and recanalization. The odds ratio (OR) with a 95% confidence interval (CI) was used to investigate the association between age and EHIT or recanalization. Statistics for Windows version 22.0 software (IBM Corp, Armonk, NY) was used for all statistical analyses. The protocol for the collection and interpretation of data conformed to the principles set by the Declaration of Helsinki. The protocol was approved by the Institutional Review Board, and because data are retrospective, low risk, and deidentified for analysis, informed consent was waived.
RESULTS A total of 10,029 procedures in 3218 patients who successfully underwent endovenous ablation for lower extremity venous reflux were included in the study. A total of 6091 procedures were performed using RFA; 3938 procedures were performed using EVLA. The age of the patients ranged from 15 years to 103 years (mean, 61.9 6 15.2 years). Average overall follow-up was 25.8 6 12.9 months. Of the 3218 patients, 2700 patients were aged <80 years, 380 patients were octogenarians, 132 patients were nonagenarians, and 6 patients were centenarians. There were 111 patients who had bilateral procedures in the accessory saphenous vein, 1878 patients who had bilateral procedures in the GSV, 99 patients who had bilateral procedures in the perforator vein, and 760 patients who had bilateral procedures in the small saphenous vein. A total of 286 procedures were redo procedures (35 accessory saphenous veins, 108 GSVs, 52 perforator veins, and 91 small saphenous veins); 1470 GSVs had procedures performed above and below the knee. Patients’ characteristics and outcomes can be seen in Table I. The rate of any EHIT was highest in the nonagenarian group (8.8%) and lower in the age stratum <80 years (1.7%). EHIT class 1 was the most common; EHIT class 3
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Number
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Table I. Characteristics and outcomes of vein ablations per age group <80 years Variables Male
80-89 years
90-99 years
>100 years
383
54
5
.995
P value
No. of procedures 2956
Female
5774
741
105
11
.995
Right leg
4262
553
86
8
.62
Left leg
4468
571
73
8
.62
GSV
5572
688
114
9
SSV
2247
284
32
6
ASV
535
67
8
1
Perforator
376
85
5
0
Vein treated
CEAP class
No. of limbs
1
17
0
0
0
2
106
5
4
0
3
1989
279
33
1
4
2703
565
73
2
5
87
39
12
1
6
639
236
53
2
Total No. of veins treated
8730
Mean follow-up, months
29.1 6 11.8
1124
159
26.2 6 11.3
24.1 6 13.9
16 23.6 6 14.7
EHIT classes 1-4, No. of veins
137
47
1
1
<.0001a
Recanalizations, No. of veins
144
47
16
0
<.0005a
ASV, Accessory saphenous vein; CEAP, Clinical, Etiology, Anatomy, and Pathophysiology; EHIT, endovenous heat-induced thrombosis; GSV, great saphenous vein; SSV, small saphenous vein. a The increase in EHIT and recanalization rates were both statistically significant in octogenarians and nonagenarians versus <80 years old age group.
and class 4 were the least common. No EHIT was recorded in the centenarian group. There were no deep venous thromboses associated with ablations in this database. The rate of limb recanalization was higher in the nonagenarian group (10%) and lowest in the age stratum <80 years. There was no recanalization in the centenarian group (Table II). However, there were statistically significant increases in EHIT rates between the age group <80 years and octogenarians (P ¼ .047), the age group <80 years and nonagenarians (P ¼ .04), and the age group <80 years and all other groups combined (P ¼ .012). No statistical difference was found in rates of EHIT between octogenarians and nonagenarians (P ¼ .5). Unadjusted relative risk for the development of EHIT was significantly associated with older age (OR, 1.03; 95% CI, 1.02-1.04; P < .00001) and RFA (OR, 1.52; 95% CI, 1.03-2.24; P ¼ .03). Multivariate analysis indicated that there was no significant difference between the development of EHIT and body mass index, CEAP class, or vein treated, but there was a significant difference found between the development of EHIT and treatment modality, showing that RFA increased the risk of an EHIT (P ¼ .03), and between older age and the development of EHIT (P < .0001). There were statistically significant increases in recanalization rates between the age group <80 years and octogenarians (P ¼ .000013), nonagenarians
(P ¼ .00022), and the combined group of octogenarians, nonagenarians, and centenarians (P < .00001). No statistical difference was found in rates of recanalization between octogenarians and nonagenarians (P ¼ .48). Overall age was found to be a significant risk factor for recanalization (OR, 1.03; 95% CI, 1.01-1.04; P < .00002). Multivariate analysis indicated that there was no significant difference between recanalization and CEAP class or vein treated. However, a difference was found between recanalization and treatment modality, showing that RFA increased the risk of recanalization (P < .0001); higher body mass index increased the risk of recanalization (P ¼ .004), and older age increased the risk of recanalization (P < .001).
DISCUSSION According to the World Health Organization, people are living longer worldwide. By 2050, the world’s population aged 60 years and older is expected to total 2 billion, up from 900 million in 2015. Currently, 125 million people are aged 80 years or older. By 2050, it is estimated that there will be 434 million people in this age group worldwide.13 It is known that the frequency of chronic venous insufficiency increases with age. Logically, as the number of people who are living to the age of 80 years and older grows, so will the prevalence of chronic venous
4
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Journal of Vascular Surgery: Venous and Lymphatic Disorders ---
Table II. Age-stratified and recanalization Age, years <80
complications
of
endovenous
ablation:
Endovenous
No.
Any EHIT, No. of veins (%)
EHIT class 1
EHIT class 2
EHIT class 3
heat-induced
thrombosis
2019
(EHIT)
EHIT class 4
Total recanalizations, No. of veins (%)
2700
127/8730 (1.45)
108
30
1
0
144/8730 (1.65)
80-89 (octogenarian)
380
33/1124 (2.94)
19
14
0
0
47/1124 (4.2)
90-99 (nonagenarian)
132
14/159 (8.81)
10
3
0
1
16/159 (10)
0/16 (0)
0
0
0
0
137
47
1
1
$100 (centenarian) Total
6 3218
174/10,029 (1.73)
insufficiency. This population of patients will therefore see a rise in treatments such as EVLA and RFA and thus a rise in possible side effects, especially EHIT and recanalization. Because of these reasons, it becomes important to evaluate whether ablations are safe and efficacious in the age group >80 years. Sutzko et al found that patients older than 65 years seem to benefit from varicose vein procedures and should not be denied interventions on the basis of their age alone. In addition, Sutzko et al found that octogenarians have a low risk of complications despite more advanced venous disease at presentation. Although endovenous ablation modalities for the treatment of symptomatic venous reflux disease are considered safe, they also present the risk of EHIT and recanalization complications.5,7 Significant increases in both EHIT and recanalization rates were observed in octogenarians and nonagenarians compared with the age group <80 years (P < .05). EHIT rates appeared comparable between octogenarians and nonagenarians. This study demonstrated older age to be a significant risk factor for recanalization (OR, 1.03; 95% CI, 1.01-1.04; P < .00002). Overall, older age was a risk factor for EHIT and recanalization. Although there is a relatively higher chance of EHIT and recanalization in the age group >80 years, our study shows that the majority of EHITs were EHIT class 1 (73.7%), followed by 25.3% for EHIT class 2 and 0.5% for both EHIT class 3 and class 4. According to our study, venous ablation is safe and effective across all age groups, and age alone should not be used to deny patients venous ablations. Limitations of the study are that it is a single-center retrospective study, performed with four interventionalists following a standardized preoperative, intraoperative, and postoperative protocol. There may have been a selection bias, as the patients were chosen for the procedures performed at the interventionalist’s discretion, and the patients chosen were high functioning and had severe symptoms. We do not have the data on patient-reported outcomes in this particular data set, and we do not have the Venous Clinical Severity Scores retrospectively, although we are currently collecting them for new patients. In addition, other complications besides EHIT and recanalization, such as infections, numbness, and neurapraxia, were not examined.
0/16 (0) 207/10,029 (2.1)
CONCLUSIONS Whereas there is a relatively higher chance of EHIT and recanalization in the age group >80 years, our study shows that the majority of EHITs were class 1 and class 2. According to our study, venous ablation is safe and effective across all age groups, and age alone should not be used to deny patients venous ablations.
AUTHOR CONTRIBUTIONS Conception and design: PK, AH, EA Analysis and interpretation: AA, SR, NM Data collection: PK, JC, MA Writing the article: PK Critical revision of the article: PK, JC, MA, AA, SR, NM, AH, EA Final approval of the article: PK, JC, MA, AA, SR, NM, AH, EA Statistical analysis: PK, JC, SR Obtained funding: Not applicable Overall responsibility: PK
REFERENCES 1. Atasoy MM. Efficacy and safety of endovenous laser ablation in very large and tortuous great saphenous veins. J Vasc Interv Radiol 2015;26:1347-52. 2. Murad MH, Coto-Yglesias F, Zumaeta-Garcia M, Elamin MB, Duggirala MK, Erwin PJ, et al. A systematic review and metaanalysis of the treatments of varicose veins. J Vasc Surg 2011;53(Suppl):49S-65S. 3. Oliveira RA, Mazzucca AC, Pachito DV, Riera R, BaptistaSilva J. Evidence for varicose vein treatment: an overview of systematic reviews. Sao Paulo Med J 2018;136:324-32. 4. Xenos ES, Bietz G, Minion DJ, Abedi NN, Sorial EE, Karagiorgos N, et al. Endoluminal thermal ablation versus stripping of the saphenous vein: meta-analysis of recurrence of reflux. Int J Angiol 2009;18:75-8. 5. Kwak JH, Min SI, Kim SY, Han A, Choi C, Ahn S, et al. Delayed presentation of endovenous heat-induced thrombosis treated by thrombolysis and subsequent open thrombectomy. Vasc Specialist Int 2016;32:72-6. 6. Kurihara N, Hirokawa M, Yamamoto T. Postoperative venous thromboembolism in patients undergoing endovenous laser and radiofrequency ablation of the saphenous vein. Ann Vasc Dis 2016;9:259-66. 7. Harlander-Locke M, Jimenez JC, Lawrence PF, Derubertis BG, Rigberg DA, Gelabert HA, et al. Management of endovenous heat-induced thrombus using a classification system and treatment algorithm following segmental thermal ablation of the small saphenous vein. J Vasc Surg 2013;58:427-32.
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Journal of Vascular Surgery: Venous and Lymphatic Disorders Volume
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8. Kitagawa A, Nagao T. FT22. Endovenous heat-induced thrombosis after radiofrequency ablation for varicose veinsdwhen and why it happened? J Vasc Surg 2017;65: 25S-6S. 9. Sufian S, Arnez A, Labropoulos N, Lakhanpal S. Incidence, progression, and risk factors for endovenous heat-induced thrombosis after radiofrequency ablation. J Vasc Surg Venous Lymphat Disord 2013;1:159-64. 10. Rizvi SA, Hingorani A, Kibrik P, Patel R, Victory J, Rybitskiy D, et al. Is endovenous heat-induced thrombosis bilateral? J Vasc Surg 2016;64:839. 11. Bunnell AP, Zaidi S, Eidson JL 3rd, Bohannon WT, Atkins MD Jr, Bush RL. Factors associated with saphenous
vein recanalization after endothermal ablation. Ann Vasc Surg 2015;29:322-7. 12. Van der Velden SK, Lawaetz M, De Maeseneer MG, Hollestein L, Nijsten T, van den Bos RR, et al. Predictors of recanalization of the great saphenous vein in randomized controlled trials 1 year after endovenous thermal ablation. Eur J Vasc Endovasc Surg 2016;52:234-41. 13. World Health Organization. Ageing and health. Available at: www.who.int/news-room/fact-sheets/detail/ageing-andhealth. Accessed April 1, 2019.
Submitted Mar 7, 2019; accepted May 19, 2019.
ABSTRACT Objective: Endovenous ablation of the lower extremity veins has become the primary treatment of symptomatic venous reflux disease. Endovenous heat-induced thrombosis (EHIT) and recanalization are two well-known complications of these venous ablative procedures. Because the elderly represent the fastest growing demographic, our goal was to look at whether there is a difference of these complications and age distribution in octogenarians, nonagenarians, and centenarians vs the younger population. Methods: A retrospective study was conducted of 10,029 procedures that were performed from March 2012 to September 2018 on 8273 veins across 3218 patients who underwent endovenous ablation for lower extremity venous reflux; 6091 procedures were performed with radiofrequency ablation, and 3938 were performed with endovenous laser ablation. We reviewed charts of all patients who underwent radiofrequency ablation or endovenous laser treatment during this time. Postprocedural venous duplex ultrasound was performed at 3 to 7 days to check for EHIT and recanalization, every 3 months for the first year, and every 6 to 12 months thereafter. The c2 test and analysis of variance were used for statistical analysis. Results: Ages ranged from 15 years to 103 years. The average age of the patients was 61.9 6 15.2 years. Average overall followup for all age groups was 25.8 6 12.9 months. Of the 3218 patients, 2700 were younger than 80 years, 380 were between 80 and 89 years, 132 were between 90 and 99 years, and 6 were 100 years or older. Of the 10,029 procedures, 8730 were performed on patients younger than 80 years; 1124, on patients 80 to 89 years; 159, on patients 90 to 99 years; and 16, on patients 100 years or older. There were 111 patients who had bilateral procedures in the accessory saphenous vein, 1878 patients who had bilateral procedures in the great saphenous vein, 99 patients who had bilateral procedures in the perforator vein, and 760 patients who had bilateral procedures in the small saphenous vein. There were statistically significant increases in EHIT rates between octogenarians and those in the age group <80 years (P ¼ .047); between nonagenarians and those in the age group <80 years (P ¼ .04); and between the combined group of octogenarians, nonagenarians, and centenarians and the age group <80 years (P ¼ .012). No statistical difference was found in rates of EHIT between octogenarians and nonagenarians (P ¼ .5). Overall age is a risk factor for the development of EHIT (odds ratio, 1.03; 95% confidence interval, 1.02-1.04; P < .00001). There were statistically significant increases in recanalization rates between octogenarians and those in the age group <80 years (P ¼ .000013); between nonagenarians and those in the age group <80 years (P ¼ .00022); and between the combined group of octogenarians, nonagenarians, and centenarians and the age group <80 years (P < .00001). No statistical difference was found in rates of recanalization between octogenarians and nonagenarians (P ¼ .48). Statistical analysis of centenarians alone was not done because of zero patients available in the EHIT or recanalization category. Overall age was found to be a risk factor for recanalization (odds ratio, 1.03; 95% confidence interval, 1.01-1.04; P < .00002). Conclusions: Whereas there is a relatively higher chance of EHIT and recanalization in the age group >80 years, our study shows that the majority of EHITs were class 1 and class 2. According to our study, venous ablation is safe and effective across all age groups, and age alone should not be used to deny patients venous ablations. (J Vasc Surg: Venous and Lym Dis 2019;-:1-5.) Keywords: Endovenous heat-induced thrombosis; Ablations; Chronic venous insufficiency; Recanalization
Endovenous ablation is a treatment of choice for venous reflux in lower extremity veins.1,2 Laser ablation and radiofrequency ablation (RFA) have long-term efficacies that are comparable to those of other treatments.3,4 Regarding
From the Vascular Institute of New York. Author conflict of interest: none. Correspondence: Pavel Kibrik, DO, Vascular Institute of New York, 960 50th St, Brooklyn, NY 11219 (e-mail: [email protected]). The editors and reviewers of this article have no relevant financial relationships to disclose per the Journal policy that requires reviewers to decline review of any manuscript for which they may have a conflict of interest. 2213-333X Copyright Ó 2019 by the Society for Vascular Surgery. Published by Elsevier Inc. https://doi.org/10.1016/j.jvsv.2019.05.011
patient safety, there is some evidence that the two endovenous ablation modalities produce less periprocedural disability and less pain and have a faster recovery time compared with more invasive treatments.2,5 They also pose a small risk of periprocedural adverse effects, such as deep venous thrombosis and pulmonary embolism.6 Indeed, two previous meta-analyses of short-term studies demonstrated good safety and efficacy profiles for the treatment of lower extremity veins.2,4 However, endovenous heat-induced thrombosis (EHIT) and recanalization are two well-known complications of both endovenous laser ablation (EVLA) and RFA procedures, with an incidence rate in the range of 0% to 6%.5,7 A single-center prospective RFA study of 224 legs in 185 patients with varicose 1
2
Kibrik et al
Journal of Vascular Surgery: Venous and Lymphatic Disorders ---
veins reported EHIT in 44 legs (27%; EHIT class 1, 21%; EHIT class $2, 6%), with the majority being detected on day 7 (21%) compared with day 30 (5.5%) and 3 months (0.6%).8 Thus, postoperative surveillance with duplex ultrasound imaging is important as it allows early intervention of thromboembolism in patients (male sex; multiple phlebectomies; large great saphenous vein [GSV] diameter; and clinical class $3 per the Clinical, Etiology, Anatomy, and Pathophysiology [CEAP] classification8,9). Some studies have noted that patients in whom EHIT developed were slightly older than those without EHIT,9,10 indicating that old age could be a risk factor for EHIT after endovenous ablation. Whereas Sufian et al9 and Rizvi et al10 found age to be associated with EHIT, they did not specifically look at patients older than 80 years. On the other hand, recanalization of isolated vein segments of the GSV is also an important complication of endothermal ablation.11 Predictors of GSV recanalization include clinical class and diameter, patient’s sex, device type, and length of vein, with clinical class and diameter being strong predictors.12 The aim of this study was to further delineate the risk of EHIT and recanalization among octogenarians (8089 years), nonagenarians (90-99 years), and centenarians ($100 years) and the younger population (<80 years).
METHODS A retrospective study was conducted of 10,029 procedures that were performed from March 2012 to September 2018 on 8273 veins that underwent endovenous ablation for lower extremity venous reflux. Once the diagnosis of chronic venous disease was acknowledged on the basis of history and physical examination findings along with duplex ultrasound demonstrating reflux of >500 milliseconds, the initial treatment protocol managed patients with conservative therapy (ie, compression therapy, leg elevation). If patients’ symptoms persisted or worsened during 3 months, causing alteration in daily living activities, or they were unable to use compression therapy because of discomfort, these patients were offered venous ablation therapy. There were 6091 procedures performed with RFA and 3938 with EVLA. Charts of the identified patients were reviewed to identify those who underwent RFA and EVLA treatment during this time. Follow-up data for postprocedural venous duplex ultrasound scan performed 3 to 7 days after treatment, after every 3 months in the first year, and every 6 to 12 months thereafter were analyzed to identify patients in whom EHIT and recanalization developed. First, the patients were age stratified into four groups: <80 years, 80 to 89 years (octogenarian), 90 to 99 years (nonagenarian) and $100 years (centenarian). Each group was subcategorized according to the post-treatment complications, particularly EHIT (classes 1-4) and total recanalization. One-way analysis of variance was used to test whether EHIT rates between groups and between EHIT classes (classes 1-4) differed
2019
ARTICLE HIGHLIGHTS d
d
d
Type of Research: Single-center retrospective review Key Findings: In 10,029 thermal ablation procedures performed on 8273 veins of 3218 patients, there were increased rates of endovenous heat-induced thrombosis (EHIT) and recanalization between octogenarians, nonagenarians, and centenarians vs the age group <80 years. There was no difference in EHIT and recanalization rates between octogenarians and nonagenarians. Overall age was a risk factor for EHIT and recanalization. Take Home Message: Venous ablation was safe and effective across all age groups, and age alone should not deny patients venous ablations.
significantly. Pearson c2 test was used to evaluate the correlation of the occurrence of EHIT and recanalization. The odds ratio (OR) with a 95% confidence interval (CI) was used to investigate the association between age and EHIT or recanalization. Statistics for Windows version 22.0 software (IBM Corp, Armonk, NY) was used for all statistical analyses. The protocol for the collection and interpretation of data conformed to the principles set by the Declaration of Helsinki. The protocol was approved by the Institutional Review Board, and because data are retrospective, low risk, and deidentified for analysis, informed consent was waived.
RESULTS A total of 10,029 procedures in 3218 patients who successfully underwent endovenous ablation for lower extremity venous reflux were included in the study. A total of 6091 procedures were performed using RFA; 3938 procedures were performed using EVLA. The age of the patients ranged from 15 years to 103 years (mean, 61.9 6 15.2 years). Average overall follow-up was 25.8 6 12.9 months. Of the 3218 patients, 2700 patients were aged <80 years, 380 patients were octogenarians, 132 patients were nonagenarians, and 6 patients were centenarians. There were 111 patients who had bilateral procedures in the accessory saphenous vein, 1878 patients who had bilateral procedures in the GSV, 99 patients who had bilateral procedures in the perforator vein, and 760 patients who had bilateral procedures in the small saphenous vein. A total of 286 procedures were redo procedures (35 accessory saphenous veins, 108 GSVs, 52 perforator veins, and 91 small saphenous veins); 1470 GSVs had procedures performed above and below the knee. Patients’ characteristics and outcomes can be seen in Table I. The rate of any EHIT was highest in the nonagenarian group (8.8%) and lower in the age stratum <80 years (1.7%). EHIT class 1 was the most common; EHIT class 3
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Table I. Characteristics and outcomes of vein ablations per age group <80 years Variables Male
80-89 years
90-99 years
>100 years
383
54
5
.995
P value
No. of procedures 2956
Female
5774
741
105
11
.995
Right leg
4262
553
86
8
.62
Left leg
4468
571
73
8
.62
GSV
5572
688
114
9
SSV
2247
284
32
6
ASV
535
67
8
1
Perforator
376
85
5
0
Vein treated
CEAP class
No. of limbs
1
17
0
0
0
2
106
5
4
0
3
1989
279
33
1
4
2703
565
73
2
5
87
39
12
1
6
639
236
53
2
Total No. of veins treated
8730
Mean follow-up, months
29.1 6 11.8
1124
159
26.2 6 11.3
24.1 6 13.9
16 23.6 6 14.7
EHIT classes 1-4, No. of veins
137
47
1
1
<.0001a
Recanalizations, No. of veins
144
47
16
0
<.0005a
ASV, Accessory saphenous vein; CEAP, Clinical, Etiology, Anatomy, and Pathophysiology; EHIT, endovenous heat-induced thrombosis; GSV, great saphenous vein; SSV, small saphenous vein. a The increase in EHIT and recanalization rates were both statistically significant in octogenarians and nonagenarians versus <80 years old age group.
and class 4 were the least common. No EHIT was recorded in the centenarian group. There were no deep venous thromboses associated with ablations in this database. The rate of limb recanalization was higher in the nonagenarian group (10%) and lowest in the age stratum <80 years. There was no recanalization in the centenarian group (Table II). However, there were statistically significant increases in EHIT rates between the age group <80 years and octogenarians (P ¼ .047), the age group <80 years and nonagenarians (P ¼ .04), and the age group <80 years and all other groups combined (P ¼ .012). No statistical difference was found in rates of EHIT between octogenarians and nonagenarians (P ¼ .5). Unadjusted relative risk for the development of EHIT was significantly associated with older age (OR, 1.03; 95% CI, 1.02-1.04; P < .00001) and RFA (OR, 1.52; 95% CI, 1.03-2.24; P ¼ .03). Multivariate analysis indicated that there was no significant difference between the development of EHIT and body mass index, CEAP class, or vein treated, but there was a significant difference found between the development of EHIT and treatment modality, showing that RFA increased the risk of an EHIT (P ¼ .03), and between older age and the development of EHIT (P < .0001). There were statistically significant increases in recanalization rates between the age group <80 years and octogenarians (P ¼ .000013), nonagenarians
(P ¼ .00022), and the combined group of octogenarians, nonagenarians, and centenarians (P < .00001). No statistical difference was found in rates of recanalization between octogenarians and nonagenarians (P ¼ .48). Overall age was found to be a significant risk factor for recanalization (OR, 1.03; 95% CI, 1.01-1.04; P < .00002). Multivariate analysis indicated that there was no significant difference between recanalization and CEAP class or vein treated. However, a difference was found between recanalization and treatment modality, showing that RFA increased the risk of recanalization (P < .0001); higher body mass index increased the risk of recanalization (P ¼ .004), and older age increased the risk of recanalization (P < .001).
DISCUSSION According to the World Health Organization, people are living longer worldwide. By 2050, the world’s population aged 60 years and older is expected to total 2 billion, up from 900 million in 2015. Currently, 125 million people are aged 80 years or older. By 2050, it is estimated that there will be 434 million people in this age group worldwide.13 It is known that the frequency of chronic venous insufficiency increases with age. Logically, as the number of people who are living to the age of 80 years and older grows, so will the prevalence of chronic venous
4
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Table II. Age-stratified and recanalization Age, years <80
complications
of
endovenous
ablation:
Endovenous
No.
Any EHIT, No. of veins (%)
EHIT class 1
EHIT class 2
EHIT class 3
heat-induced
thrombosis
2019
(EHIT)
EHIT class 4
Total recanalizations, No. of veins (%)
2700
127/8730 (1.45)
108
30
1
0
144/8730 (1.65)
80-89 (octogenarian)
380
33/1124 (2.94)
19
14
0
0
47/1124 (4.2)
90-99 (nonagenarian)
132
14/159 (8.81)
10
3
0
1
16/159 (10)
0/16 (0)
0
0
0
0
137
47
1
1
$100 (centenarian) Total
6 3218
174/10,029 (1.73)
insufficiency. This population of patients will therefore see a rise in treatments such as EVLA and RFA and thus a rise in possible side effects, especially EHIT and recanalization. Because of these reasons, it becomes important to evaluate whether ablations are safe and efficacious in the age group >80 years. Sutzko et al found that patients older than 65 years seem to benefit from varicose vein procedures and should not be denied interventions on the basis of their age alone. In addition, Sutzko et al found that octogenarians have a low risk of complications despite more advanced venous disease at presentation. Although endovenous ablation modalities for the treatment of symptomatic venous reflux disease are considered safe, they also present the risk of EHIT and recanalization complications.5,7 Significant increases in both EHIT and recanalization rates were observed in octogenarians and nonagenarians compared with the age group <80 years (P < .05). EHIT rates appeared comparable between octogenarians and nonagenarians. This study demonstrated older age to be a significant risk factor for recanalization (OR, 1.03; 95% CI, 1.01-1.04; P < .00002). Overall, older age was a risk factor for EHIT and recanalization. Although there is a relatively higher chance of EHIT and recanalization in the age group >80 years, our study shows that the majority of EHITs were EHIT class 1 (73.7%), followed by 25.3% for EHIT class 2 and 0.5% for both EHIT class 3 and class 4. According to our study, venous ablation is safe and effective across all age groups, and age alone should not be used to deny patients venous ablations. Limitations of the study are that it is a single-center retrospective study, performed with four interventionalists following a standardized preoperative, intraoperative, and postoperative protocol. There may have been a selection bias, as the patients were chosen for the procedures performed at the interventionalist’s discretion, and the patients chosen were high functioning and had severe symptoms. We do not have the data on patient-reported outcomes in this particular data set, and we do not have the Venous Clinical Severity Scores retrospectively, although we are currently collecting them for new patients. In addition, other complications besides EHIT and recanalization, such as infections, numbness, and neurapraxia, were not examined.
0/16 (0) 207/10,029 (2.1)
CONCLUSIONS Whereas there is a relatively higher chance of EHIT and recanalization in the age group >80 years, our study shows that the majority of EHITs were class 1 and class 2. According to our study, venous ablation is safe and effective across all age groups, and age alone should not be used to deny patients venous ablations.
AUTHOR CONTRIBUTIONS Conception and design: PK, AH, EA Analysis and interpretation: AA, SR, NM Data collection: PK, JC, MA Writing the article: PK Critical revision of the article: PK, JC, MA, AA, SR, NM, AH, EA Final approval of the article: PK, JC, MA, AA, SR, NM, AH, EA Statistical analysis: PK, JC, SR Obtained funding: Not applicable Overall responsibility: PK
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Submitted Mar 7, 2019; accepted May 19, 2019.