Introduction
In 2010, estimates suggested that over 200 million people worldwide were living with PAD. This represented a 23.5% increase since 2000, which is largely attributed to aging populations and the growing prevalence of risk factors, particularly diabetes mellitus [1]. While CLTI is widely recognized as a significant global healthcare issue, reliable epidemiological data on CLTI are scarce [1]. CLTI likely accounts for less than 10% of all PAD cases, and individuals undergoing amputation due to CLTI face a significantly higher risk of premature death [1]. Without treatment, the risk of lower limb loss in CLTI patients is approximately 25% within one year [2]. CLTI represents the advanced stage of atherosclerosis and is often accompanied by significant cardiovascular morbidity, resulting in high mortality rates due to stroke and myocardial infarction [2]. Without timely identification of risk factors and effective management of comorbidities, the prognosis for CLTI patients is generally unfavorable, with a mortality rate ranging from 20% to 26% within one year of diagnosis [2, 3]. A study conducted on 574 CLTI patients who did not undergo limb revascularizations revealed that 31.6% of patients died from cardiovascular causes, while 23% required major amputations [2, 4]. Hence, the objective of this study is to analyze the impact of hybrid revascularizations on the length of hospital stay for patients with CLTI, multilevel atherosclerosis, and a high anesthesiological risk.
Materials and methods
This study utilized a prospective, superiority design, comprising a study group (N = 48) and a historical control group (N = 50) from the period of 2010-2015. The primary objective of the study was to compare the efficacy of the hybrid vascular approach with the classical vascular surgical treatment for patients with multilevel atherosclerosis and CLTI. The ultimate endpoint of the study was to assess the impact of the hybrid approach on reducing morbidity and mortality within the study group. The sample size for the study group was determined using the "Mureșanu formula." The study was conducted at the Republican Clinical Hospital, while the control group was formed by selecting every 5th patient file from the anonymized and codified records of 250 patients in the hospital archive from the 2010-2015 period. Inclusion criteria for the study were as follows: (1) men and women aged over 50 years old; (2) presence of multilevel atherosclerotic lesions; (3) diagnosis of CLTI based on Fontaine grades III and IV or Rutherford 4-6 classification. Exclusion criteria for the study were: (1) presence of an aortic infrarenal aneurysm greater than 5.5cm; (2) inoperable patients; (3) patients in terminal stages; (4) allergic to iodinated contrast material; (5) presence of isolated atherosclerotic lesions; (6) absence of CLTI; (7) refusal to sign the informed consent; (8) non-compliant patients.
The study group consisted of all consecutive patients meeting the inclusion criteria, with a total of N = 50. These patients underwent hybrid interventions, which involved a combination of one open surgical reconstruction and another endovascular procedure. Two patients were excluded from the analysis due to their failure to attend the follow-up visits. The follow-up assessments were conducted at one month and three months post-treatment. Additionally, two subgroups were formed based on the severity of ischemia, categorized as Fontaine grade III and IV. The study analyzed both the total length of hospital stay and the postoperative length of hospital stay for the patients. A database was created to store the collected data, which was subsequently subjected to statistical analysis using the "SPSS" software. The statistical tests employed in the analysis included chi-square, p-value calculations, and frequency analysis. The scientific research project was favorably approved by the Research Ethics Committee of Nicolae Testemitanu SUMPh (minutes no.17 from 14.11.2016).
Results
Demographic data analysis revealed an equal distribution between men and women in the study population, with no significant statistical difference observed (χ2 = 0.004, df = 1, p = 0.952). In both the study group and the control group, the majority of patients were men: 44 patients (91.7%; 95% CI [84.0-98.0]) in the study group and 46 patients (92.0%; 95% CI [84.0-98.0]) in the control group. The most common age group among the patients was 60-69 years, comprising 21 patients (43.8%; 95% CI [29.4-57.8]) in the study group and 28 patients (56.0%; 95% CI [40.1-70.0]) in the control group. The next most prevalent age group was 50-59 years, with 17 patients (35.4%; 95% CI [22.2-50.0]) in the study group and 13 patients (26.0%; 95% CI [14.0-38.0]) in the control group. However, the data did not reveal any significant statistical difference between the two groups in terms of age distribution (χ2 = 1.979, df = 3, p = 0.577).
The most prevalent comorbidity among the patients was arterial hypertension, with a higher rate observed in the study group (44 patients; 91.7%; 95% CI [83.3-98.1]) compared to the control group (36 patients; 72.0%; 95% CI [59.1-85.1]). This difference between the two groups was statistically significant (χ2 = 6.317, df = 1, p = 0.012). Ischemic heart disease was the second most frequent comorbidity, with similar rates observed in both the study group (30 patients; 62.5%; 95% CI [49.0-77.8]) and the control group (32 patients; 64.0%; 95% CI [51.0-77.8]), showing no significant statistical difference (χ2 = 0.024, df = 1, p = 0.878). Chronic obstructive pulmonary disease was the third most common comorbidity, being more prevalent in the control group (32 patients; 64.0%; 95% CI [51.0-77.8]) compared to the study group (23 patients; 47.9%; 95% CI [32.6-62.7]), but this difference did not reach statistical significance (χ2 = 2.573, df = 1, p = 0.109). Cerebrovascular disease, the fourth comorbidity analyzed, was identified at similar rates in both the study group and the control group. In the study group, 20 patients (41.7%; 95% CI [27.7-56.5]) had cerebrovascular disease, while in the control group, 16 patients (32.0%; 95% CI [19.6-44.7]) had the same condition. However, there was no significant statistical difference between the two groups (χ2 = 0.985, df = 1, p = 0.321). The prevalence of DM was relatively equal in both groups. In the study group, 17 patients (35.4%; 95% CI [21.2-50.0]) had DM, while in the control group, 13 patients (26.0%; 95% CI [13.7-37.5]) had DM. The statistical analysis showed no significant difference between the two groups (χ2 = 1.022, df = 1, p = 0.312). The majority of patients in both the study group (42 patients; 87.5%; 95% CI [76.5-95.9]) and the control group (41 patients; 82.0%; 95% CI [72.0-92.0]) had an anesthesiological risk score of ASA 3 (Severe systemic disease that is not incapacitating, mortality 1.8%) based on the ASA grading scale. However, there was no significant statistical difference observed between the groups (χ2 = 0.571, df = 1, p = 0.450).
Analyzing the total length of hospital stay in the two groups in relation to the grade of limb ischemia, it was found that the highest frequency for Fontaine grade III consisted of lengths of stay within the period of 9-12 days. Out of 32 cases in the study group, 11 cases fell within this period, compared to the control group where the period with the highest frequency was more than 14 days. Out of 22 cases in the control group, 11 cases had a length of hospital stay exceeding 14 days (Table 1). Thus, there was a significant statistical difference between the groups (χ2 = 10.53; df = 4; p = 0.03). Furthermore, a moderately significant statistical difference was observed (χ2 = 15.53; df = 4; p = 0.004; V. Cramer = 0.536).
Table 1. Overall length of hospital stay in groups for Fontaine grade III limb ischemia. | |||
Length of hospital stay periods | Study group (N = 32) | Control group (N = 22) | p |
3-5 days | 3 | – | χ2 = 15.53 df = 4 p = 0.004 |
6-8 days | 8 | – | |
9-11 days | 11 | 4 | |
12-14 days | 5 | 7 | |
> 14 days | 5 | 11 | |
Note: p – significance level; χ2 – Pearson test; df – degrees of freedom. | |||
Regarding the length of hospital stay after the intervention, it was found that patients with Fontaine grade III limb ischemia from the study group required a period of 3-5 days in 17 out of 32 cases. In contrast, patients from the control group required 6-8 days in 7 out of 22 cases and 9-11 days in 7 out of 22 cases (Table 2). A moderately significant statistical difference was observed between the groups (χ2 = 12.73; df = 4; p = 0.013; V. Cramer = 0.486).
Table 2. Postoperative length of hospital stay in groups for Fontaine grade III limb ischemia. | |||
Length of hospital stay periods | Study group (N = 32) | Control group (N = 22) | p |
3-5 days | 17 | 4 | χ2 = 12.73 df = 4 p = 0.013 |
6-8 days | 12 | 7 | |
9-11 days | 2 | 7 | |
12-14 days | 1 | 3 | |
> 14 days | – | 1 | |
Note: p – significance level; χ2 – Pearson test; df – degrees of freedom. | |||
When comparing the length of hospital stay of patients with Fontaine grade IV limb ischemia, it was discovered that the study group had the highest frequency for the period of 6-8 days, with 5 out of 16 cases falling within this range. Conversely, in the control group, the majority of patients required more than 14 days, specifically 18 out of 28 cases (Table 3). This difference between the groups was found to be statistically significant with a moderate level of significance (χ2 = 10.93; df = 4; p = 0.027; V. Cramer = 0.498).
Table 3. Overall length of hospital stay in groups for Fontaine grade IV limb ischemia. | |||
Length of hospital stay periods | Study group (N = 16) | Control group (N = 28) | p |
3-5 days | 1 | – | χ2 = 10.93 df = 4 p = 0.027 |
6-8 days | 5 | 1 | |
9-11 days | 2 | 2 | |
12-14 days | 4 | 7 | |
> 14 days | 4 | 18 | |
Note: p – significance level; χ2 – Pearson test; df – degrees of freedom. | |||
Regarding the postoperative length of hospital stay in patients with Fontaine grade IV limb ischemia, a significant statistical difference was observed between the study and control groups (χ2 = 10.53; df = 4; p = 0.032; V. Cramer = 0.489). Among patients with Fontaine grade IV limb ischemia, the highest frequency was found in the 3-5 day period, with 6 out of 16 cases in the study group. In the control group, the majority of cases were in the 9-11 day period, with 10 out of 28 cases (Table 4).
Table 4. Postoperative length of hospital stay in groups for Fontaine grade IV limb ischemia. | |||
Length of hospital stay periods | Study group (N = 16) | Control group (N = 28) | p |
3-5 days | 6 | 1 | χ2 = 10.53 df = 4 p = 0.032 |
6-8 days | 5 | 7 | |
9-11 days | 2 | 10 | |
12-14 days | 2 | 7 | |
> 14 days | 1 | 3 | |
Note: p – significance level; χ2 – Pearson test; df – degrees of freedom. | |||
Discussions
Hybrid interventions have become an integral part of the strategy for limb salvage in patients with multilevel arterial occlusive disease. Technical success, early results, as well as long-term results, have shown to be at least comparable to conventional endovascular and open vascular procedures. Hybrid revascularization offers the efficiency and convenience of a single-stage revascularization [5]. Currently, most of the combined procedures are performed by vascular surgeons trained in both open and endovascular surgery. Simultaneous hybrid interventions are associated with potential benefits such as decreasing the length of stay, the absence of the need to delay complete revascularization of the ischemic limb, avoidance of puncture site complications due to direct surgical access, and the possibility of open surgical correction of inadequate endovascular revascularization sites [6, 7]. In a study by Peter L. Faries et al., all the combined interventions were performed in a staged manner, with an interval of 3.1 days between the open and endovascular stages. When comparing simultaneous and staged hybrid procedures, factors such as patient comfort and convenience, length of stay, procedure costs, and the possibility of staging the procedure were taken into consideration. These factors demonstrate the advantages of choosing the simultaneous hybrid procedure over the staged approach [8]. Elbadawy A. et al., in their study, recommend decision-making based on the patient's risk and the severity of limb ischemia when determining the appropriate strategy [9]. In a review conducted by Christos D. Liapis and Elias A. Tzortzis, it was concluded that combining open vascular and endovascular techniques yields greater benefits compared to using each technique alone [10]. James L. Ebaugh et al., in their study, identified 5 variables as confounders in the relationship between staged and same-day procedures. Patients with the following conditions were excluded from the final subgroup analysis: (1) gangrene; (2) ischemic rest pain; (3) non-elective admission; (4) chronic heart failure; and (5) renal failure. After excluding patients with these confounders, hospital charges and length of hospital stay were compared once again. The results indicate that when performing elective hybrid procedures in patients without gangrene, ischemic rest pain, chronic heart failure, or renal failure, conducting both the endovascular and open portions on the same day significantly reduces total hospital charges by 78% and length of hospital stay by 133% [11]. Therefore, compared to the staged hybrid procedure, the simultaneous procedure may lead to a shorter length of stay, reduced procedural costs, and a broader range of revascularization options by combining open and endovascular techniques [12, 13, 14].
Conclusions
The length of hospital stay for patients with CLTI and multilevel atherosclerotic lesions is significantly reduced when hybrid revascularizations are used compared to conventional revascularizations.
Abbreviations
CLTI – chronic limb-threatening ischemia; PAD – peripheral arterial disease; DM – diabetes mellitus.
Competing interests
None declared.
Authors’ ORCID IDs
Sorin Barat – https://orcid.org/0000-0001-7253-822X
References
Conte MS, Bradbury AW, Kolh P, White JV, Dick F, Fitridge R, Mills JL, Ricco JB, Suresh KR, Murad MH; GVG Writing Group. Global vascular guidelines on the management of chronic limb-threatening ischemia. J Vasc Surg. 2019 Jun;69(6S):3S-125S.e40. doi: 10.1016/j.jvs.2019.02.016.
Barat S. [Hybrid approach in treatment of patients with multilevel peripheral artery disease and chronically threatened limb ischemia]. Arta Medica (Chisinau). 2020;(3):92-99. doi: 10.5281/zenodo.4070076. Romanian.
Abu Dabrh AM, Steffen MW, Undavalli C, Asi N, Wang Z, Elamin MB, Conte MS, Murad MH. The natural history of untreated severe or critical limb ischemia. J Vasc Surg. 2015 Dec;62(6):1642-51.e3. doi: 10.1016/j.jvs.2015.07.065.
Marston WA, Davies SW, Armstrong B, Farber MA, Mendes RC, Fulton JJ, Keagy BA. Natural history of limbs with arterial insufficiency and chronic ulceration treated without revascularization. J Vasc Surg. 2006 Jul;44(1):108-114. doi: 10.1016/j.jvs.2006.03.026.
Huynh TT, Bechara CF. Hybrid interventions in limb salvage. Methodist Debakey Cardiovasc J. 2013 Apr;9(2):90-4. doi: 10.14797/mdcj-9-2-90.
Balaz P, Rokosny S, Wohlfahrt P, Adamec M, Janousek L, Björck M. Early and late outcomes of hybrid endovascular and open repair procedures in patients with peripheral arterial disease. Vasa. 2013 Jul;42(4):292-300. doi: 10.1024/0301-1526/a000290.
Joh JH, Joo SH, Park HC. Simultaneous hybrid revascularization for symptomatic lower extremity arterial occlusive disease. Exp Ther Med. 2014 Apr;7(4):804-810. doi: 10.3892/etm.2014.1513.
Faries PL, Brophy D, LoGerfo FW, Akbari CM, Campbell DR, Spence LD, Hook SC, Pomposelli FB Jr. Combined iliac angioplasty and infrainguinal revascularization surgery are effective in diabetic patients with multilevel arterial disease. Ann Vasc Surg. 2001 Jan;15(1):67-72. doi: 10.1007/s100160010012.
Elbadawy A, Ali H, Saleh M. Midterm outcomes of common femoral endarterectomy combined with inflow and outflow endovascular treatment for chronic limb threatening ischaemia. Eur J Vasc Endovasc Surg. 2020 Jun;59(6):947-955. doi: 10.1016/j.ejvs.2020.02.028.
Liapis CD, Tzortzis EA. Advances in the management of iliac artery occlusive disease: a short review. Vasc Endovascular Surg. 2004 Nov-Dec;38(6):541-5. doi: 10.1177/153857440403800608.
Ebaugh JL, Gagnon D, Owens CD, Conte MS, Raffetto JD. Comparison of costs of staged versus simultaneous lower extremity arterial hybrid procedures. Am J Surg. 2008 Nov;196(5):634-40. doi: 10.1016/j.amjsurg.2008.08.003.
Jung HJ, Lee SC, Kim KY, Lee SS. Simultaneous hybrid operation common femoral endarterectomy and endovascular treatment in multilevel peripheral arterial disease with critical limb ischemia. Indian J Surg. 2018 Apr;80(2):140-145. doi: 10.1007/s12262-016-1570-2.
Schneider PA. Iliac angioplasty and stenting in association with infrainguinal bypasses: timing and techniques. Semin Vasc Surg. 2003 Dec;16(4):291-9. doi: 10.1053/j.semvascsurg.2003.08.007.
Balaz P, Rokosny S, Bafrnec J, Björck M. The role of hybrid procedures in the management of peripheral vascular disease. Scand J Surg. 2012;101(4):232-7. doi: 10.1177/145749691210100402.