|Year : 2020 | Volume
| Issue : 1 | Page : 54-57
Perioperative complications after revascularization in diabetic and nondiabetic chronic limb-threatening ischemia patients and its relation with preoperative hemoglobin A1c
S Roshan Rodney, Vivekanand, M Vishnu, KB Sumanthraj, Hemant Chaudhari, Dharmesh Davra, Piyushkumar Jain, C P S Sravan, Vaibhav Lende, Hudgi Vishal, K Sivakrishna, B Nishan
Jain Institute of Vascular Sciences, A Unit of Bhagwan Mahaveer Jain Hospital, Bengaluru, Karnataka, India
|Date of Submission||22-Jul-2019|
|Date of Decision||23-Jul-2019|
|Date of Acceptance||30-Oct-2019|
|Date of Web Publication||16-Mar-2020|
Dr. S Roshan Rodney
Jain Institute of Vascular Sciences, A Unit of Bhagwan Mahaveer Jain Hospital, Bengaluru, Karnataka
Source of Support: None, Conflict of Interest: None
Background: Hemoglobin A1c (HbA1c) reflects average blood glucose over a 2–3 month period. Patients with an elevated HbA1c with and without diabetes have an increased risk of adverse outcomes following surgical intervention. Our aim is to determine whether elevated plasma HbA1c level is associated with high perioperative morbidity and mortality in chronic limb-threatening ischemia (CLTI) patients undergoing peripheral revascularization. Materials and Methods: This is a single center, retrospective analysis of 307 CLTI patients who underwent lower limb revascularization (open/endovascular/hybrid) at Jain Institute of Vascular Sciences over a 1-year period from January 2018 to December 2018. Patients were categorized into two groups as either diabetic or nondiabetic based on their history and preoperative plasma HbA1c level ≥6.5% or <6.5%, respectively. Diabetics were stratified into four subgroups (HbA1c ≥6.5%–7.4%, HbA1c 7.4%–8.9%, and HbA1c ≥9%) and controlled diabetes mellitus (HbA1c <6.5%) and nondiabetics into two subgroups (HbA1c <6.0 and HbA1c ≥6%–6.5%. The primary endpoints include perioperative major adverse cardiac event (MACE), major adverse limb event (MALE), and mortality. Results: Of 307 patients, 253 (82.4%) were diabetics and the rest 54 (17.6%) were nondiabetics. On comparison with other HbA1C groups, among diabetics those with HbA1c >9% had a significantly higher incidence of perioperative MACE 7 (12.07%), MALE 3 (5.17%), and death 6 (10.34%), and among nondiabetics, those with HbA1c levels (6%–6.5%) had a higher incidence of perioperative MACE 3 (9.68%), MALE 1 (3.23%), and death 1 (3.23%), but the difference was not statistically significant. Conclusion: HbA1c levels serve as an independent predictor of untoward events in CLTI patients with or without diabetes undergoing revascularization.
Keywords: Endovascular, ischemia, mortality, perioperative, revascularization
|How to cite this article:|
Rodney S R, Vivekanand, Vishnu M, Sumanthraj K B, Chaudhari H, Davra D, Jain P, Sravan C P, Lende V, Vishal H, Sivakrishna K, Nishan B. Perioperative complications after revascularization in diabetic and nondiabetic chronic limb-threatening ischemia patients and its relation with preoperative hemoglobin A1c. Indian J Vasc Endovasc Surg 2020;7:54-7
|How to cite this URL:|
Rodney S R, Vivekanand, Vishnu M, Sumanthraj K B, Chaudhari H, Davra D, Jain P, Sravan C P, Lende V, Vishal H, Sivakrishna K, Nishan B. Perioperative complications after revascularization in diabetic and nondiabetic chronic limb-threatening ischemia patients and its relation with preoperative hemoglobin A1c. Indian J Vasc Endovasc Surg [serial online] 2020 [cited 2020 Apr 5];7:54-7. Available from: http://www.indjvascsurg.org/text.asp?2020/7/1/54/280670
| Introduction|| |
Diabetes is a common aggravating comorbidity in patients with peripheral artery disease (PAD). Chronic limb-threatening ischemia (CLTI) patients with diabetes are at average 3 years younger as compared to nondiabetic patients at the same Rutherford grade. This trend likely reflects the progressing effect of diabetes on the arterial calcification and clinical severity of PAD. Hemoglobin A1c (HbA1c) reflects average blood glucose over a 2–3 month period. Patients with an elevated HbA1c with and without diabetes have an increased risk of adverse outcomes following surgical intervention. Glycemic control is of importance, and in the UK Prospective Diabetic Study, an increase in HbA1c by 1% increased the risk of lower extremity arterial disease by 28%.
We retrospectively reviewed the patients admitted in Jain Institute of Vascular Sciences (JIVAS), Bengaluru, India, with the diagnosis of CLTI who underwent revascularization whether preoperative plasma HbA1c level is associated with high perioperative morbidity and mortality.
| Materials and Methods|| |
We reviewed 307 CLTI patients who underwent lower limb revascularization (open/endovascular/hybrid) at JIVAS, Bengaluru, over a 1-year period from January 2018 to December 2018. Clinical data were collected from our institute database. Prior ethics committee approval was not required as this is an observational, single-center, retrospective study, and patient's identities were not revealed in the study. The clinical data included in the study were a history of diabetes mellitus (DM), plasma HbA1c % on admission, demographics (age/sex), and perioperative complications (major adverse cardiac event [MACE], major adverse limb event [MALE], and death). Samples for plasma HbA1c were collected preoperatively from all patients admitted with the diagnosis of CLTI irrespective of their preoperative diabetic status along with the other routine preoperative blood.
Patients were categorized into two groups as either diabetic or nondiabetic based on their history and preoperative plasma HbA1c level ≥6.5% or <6.5%, respectively. Diabetics were stratified into four subgroups (HbA1c ≥6.5-7.4%, HbA1c 7.4%–8.9%, and HbA1c ≥9%) and controlled DM (HbA1c <6.5%) and nondiabetics into two subgroups (HbA1c <6.0 and HbA1c ≥6%–6.5%).
All patients with diabetes were reviewed by a consultant diabetologist both preoperatively and postoperatively. Preoperatively, blood sugars were measured routinely by nursing staff using a glucometer, and the appropriate dose of insulin was given according to the sliding scale. Postoperatively, blood glucose levels were monitored 2–4 times daily on all patients with diabetes by nursing staff using a glucometer. These blood sugar levels were monitored daily by a diabetologist, and appropriate measures were taken to maintain blood sugars in the normal range. Those newly diagnosed with diabetes underwent a comprehensive assessment.
The primary endpoints for the study were patients who developed perioperative complications (MACE, MALE, and death). All outcomes were within 30 days of the index procedure. MACE was defined as cerebrovascular accident, myocardial infarction, or death. A MALE was defined as either major amputation of the revascularized limb or reintervention on the revascularized segment. In our study, death was separately taken into consideration and not included in MACE.
The Chi-square test was used to analyze the effect of HbA1c and perioperative complications. P < 0.05 was considered statistically significant.
| Results|| |
From January 2018 to December 2018, 307 patients were admitted for elective vascular surgical procedures. No patients met the exclusion criteria. Of the 307 patients, 54 (17.6%) were nondiabetic and 253 (82.4%) were diabetic. The distribution of various HbA1c groups in diabetics and nondiabetics is shown in [Figure 1].
|Figure 1: Hemoglobin A1c group distribution for all patients, diabetics and nondiabetics|
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Among the patients without diabetes, those with HbA1c levels of 6%–6.5% had a higher incidence of perioperative morbidity and mortality compared to patients with HbA1c levels <6.0, but the difference is not statistically significant [Table 1], [Table 2], [Table 3]. Perioperative morbidity and mortality rates in diabetics were more significant in HbA1C >9.0% as compared to other HbA1c groups in diabetics [Table 1], [Table 2], [Table 3].
|Table 1: Perioperative major adverse cardiac event among various hemoglobin A1c groups|
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|Table 2: Perioperative major adverse limb event among various hemoglobin A1c groups|
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On comparing the perioperative complication rates for patients with and without diabetes, even though diabetics with HbA1c <7.4 had lesser complications than nondiabetics, but the observed difference is not statistically significant. These results would appear to suggest that an adverse outcome is more dependent on the preoperative plasma HbA1c level than on the diabetes status of the patient.
| Discussion|| |
HbA1c (A1C), a measure of long-term glycemic control, is used to monitor and guide clinical treatment in persons with diabetes. Studies have also suggested that HbA1C may be associated with incident large-vessel disease (coronary heart disease, stroke, and PAD) in persons with diabetes., The association between DM and postoperative mortality and cardiac morbidity is strong, but the role of DM as an independent risk factor has been unclear.,,
This retrospective study included 253 diabetics and 54 nondiabetics set out to determine the correlation between preoperative HbA1c levels and perioperative complications in patients with CLTI.
We found that patients with diabetes with HbA1c >9% were found to be a significant independent predictor of perioperative morbidity and mortality with a higher incidence of perioperative MACE 7 (12.07%), MALE 3 (5.17%), and death 6 (10.34%) compared with the other HbA1c groups. Patients without diabetes with HbA1c levels (6%–6.5%) had a higher incidence of perioperative MACE 3 (9.68%), MALE 1 (3.23%), and death 1 (3.23%) compared to patients with HbA1c <6%, but the difference is not statistically significant. A similar study by Arya et al. found that patients with the poorest glycemic control (HbA1c >8.0%) are at twice the long-term risk of amputation and 33% higher risk for MALE compared with those with a normal HbA1c level, and patients without recognized diabetes in the preoperative setting and elevated HbA1c (>7.0%) are associated with the worst risk of amputation and MALE. Our study confirmed that the presence of diabetes does have an impact on perioperative outcomes and adverse limb events, but the level of glycemic control has a stronger association with these outcomes.
Our results also suggest possible usefulness of HbA1c to identify undiagnosed DM and also as a predictor of adverse events in PAD patients scheduled for revascularization.
Our study has several limitations. We only assessed the impact of preoperative HbA1c level on perioperative complications of MACE, MALE, and death. Our study is a retrospective observational, using our institute database, and the analysis may be susceptible to residual confounding. Technical details such as runoff vessels or patency and preoperative and postoperative ankle-brachial index were not included during the analysis. Even though the Wound, Ischemia, and foot infection classification was used to classify all CLTI patients, it was not included in our analysis for estimating the risk of MALE.
Higher rates of MALE and mortality in diabetic patients with CLTI can be attributed to other comorbidities such as ischemic heart disease and renal failure that reduce blood flow to the microvascular bed.
| Conclusion|| |
CLTI patients with DM and high preoperative HbA1c levels have significantly more prevalent cardiovascular comorbidity and are at a substantially higher risk of major amputation compared with patients with CLTI without DM. Thereby, HbA1c levels serve as an additional tool in predicting untoward events in CLTI patients with or without diabetes undergoing revascularization. This may suggest the need for screening for diabetes before a major revascularization procedure and perhaps using HbA1c as a screening tool.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
| References|| |
O'Sullivan CJ, Hynes N, Mahendran B, Andrews EJ, Avalos G, Tawfik S, et al
. Haemoglobin A1c (HbA1C) in non-diabetic and diabetic vascular patients. Is HbA1C an independent risk factor and predictor of adverse outcome? Eur J Vasc Endovasc Surg 2006;32:188-97.
American Diabetes Association. Diagnosis and classification of diabetes mellitus. Diabetes Care 2010;33 Suppl 1:S62-9.
Khaw KT, Wareham N, Bingham S, Luben R, Welch A, Day N. Association of hemoglobin A1c with cardiovascular disease and mortality in adults: The European prospective investigation into cancer in Norfolk. Ann Intern Med 2004;141:413-20.
Adler AI, Stevens RJ, Neil A, Stratton IM, Boulton AJ, Holman RR. UKPDS 59: Hyperglycemia and other potentially modifiable risk factors for peripheral vascular disease in type 2 diabetes. Diabetes Care 2002;25:894-9.
Fashandi AZ, Mehaffey JH, Hawkins RB, Kron IL, Upchurch GR Jr, Robinson WP. Major adverse limb events and major adverse cardiac events after contemporary lower extremity bypass and infrainguinal endovascular intervention in patients with claudication. J Vasc Surg 2018;68:1817-23.
Kuo-Chun L, Shih-Feng W, Chung-Hsi H, Cheng L, Jhi-Joung W, Kuo-Feng H, et al
. The amputation and mortality rates of diabetic patients with critical limb ischemia: A nationwide population-based follow-up study in Taiwan. Formos J Surg 2013;46:79-86.
Virkkunen J, Heikkinen M, Lepäntalo M, Metsänoja R, Salenius JP, Finnvasc Study Group. Diabetes as an independent risk factor for early postoperative complications in critical limb ischemia. J Vasc Surg 2004;40:761-7.
Freisinger E, Malyar NM, Reinecke H, Lawall H. Impact of diabetes on outcome in critical limb ischemia with tissue loss: A large-scaled routine data analysis. Cardiovasc Diabetol 2017;16:41.
Selvin E, Wattanakit K, Steffes MW, Coresh J, Sharrett AR. HbA1c and peripheral arterial disease in diabetes: The atherosclerosis risk in communities study. Diabetes Care 2006;29:877-82.
Arya S, Binney ZO, Khakharia A, Long CA, Brewster LP, Wilson PW, et al
. High hemoglobin associated with increased adverse limb events in peripheral arterial disease patients undergoing revascularization. J Vasc Surg 2018;67:217-280.
Liang P, Soden PA, Zettervall SL, Shean KE, Deery SE, Guzman RJ, et al
. Treatment outcomes in diabetic patients with chronic limb-threatening ischemia. J Vasc Surg 2018;68:487-94.
[Table 1], [Table 2], [Table 3]