The effects of high quality team medicine on outcomes of chronic limb-threatening ischemia patients with infrapopliteal bypass

Abstract

Objectives

A team approach for treatment of patients with CLTI is used worldwide. However, the quality of team medicine is a concern. The Global Vascular Guidelines provide recommendations for high quality team medicine, but there is limited knowledge of the significance of team quality in CLTI treatment. The objective of this study is to evaluate the effects of team quality on clinical outcomes after infrapopliteal bypass.

Methods

A retrospective analysis was performed in 337 patients who underwent 414 infrapopliteal bypasses under a team medicine approach at a single center between 2009 and 2021. In 2017, team medicine was reorganized for improvement of quality. Comparisons were made between before (Group 1; 160 patients, 195 limbs) and after (Group 2; 177 patients, 219 limbs) reorganization. The primary endpoints were limb salvage and wound healing after infrapopliteal bypass.

Results

The patients included 227 males (67%) and had a median age of 76 [68-83] years. Diabetes mellitus was present in 67% and end-stage renal disease with hemodialysis in 37%. The follow-up rate was 96% in a mean follow-up period of 31±30 months. The 3-year limb salvage rate was significantly lower in Group 1 (before reorganization) than in Group 2 (after reorganization) (84% vs 95%, p = .001). The wound healing rates in the whole cohort were 72% at 6 months and 85% at 12 months, with no significant differences between the groups. In multivariate analysis, the risk factors for major amputation were treatment before reorganization (HR 2.68; p = .017), hemodialysis (HR 2.27; p = .017), and non-ambulatory status (HR 2.63; p = .005).

Conclusions

A reorganized team approach with the goal of higher quality was independently associated with reduced major amputation for patients with CLTI treated with infrapopliteal bypass. This result indicates the importance of a high quality team approach for success of this treatment.

Keywords

Team medicine infrapopliteal bypass chronic limb-threatening ischemia limb salvage wound healing

Introduction

The 2017 European Society of Cardiology guidelines recommend bypass using the great saphenous vein in patients with chronic limb-threatening ischemia (CLTI) with a long occlusive infrapopliteal lesion who have a suitable great saphenous vein and an adequate target for anastomosis/runoff without contraindication for surgery.¹ In the 2019 Global Vascular Guidelines (GVGs), the new Global Limb Anatomic Staging System (GLASS) was proposed.² The GVGs recommend the preferred method of initial revascularization (endovascular treatment (EVT) or bypass) for CLTI based on evaluation of anatomical complexity within TAP (GLASS stage) and limb severity (wound, ischemia, and foot infection (WIfI) stage).³ The GVGs recommend open bypass for patients with higher anatomical complexity (GLASS stage III) and higher limb severity (WIfI stage 3 or 4).

Bypass supplies more blood flow than EVT, but bypass revascularization alone cannot prevent major amputation in severe cases. The GVGs propose a multidisciplinary team approach for CLTI to prevent unnecessary amputation, with the statement that “teams can improve processes, time to intervention, and outcome.” A team approach for CLTI is now performed worldwide and quality has become the major concern in team medicine.

The GVGs suggests the need for a high quality team approach for these patients to prevent major amputation. The effectiveness of a team approach has been described for patients with foot ulcer,^4–17 but there is limited knowledge of the significance of team quality for CLTI, especially in severe cases requiring surgical reconstruction.¹⁴ Therefore, the aim of this study is to evaluate whether team quality can affect medium-term outcomes after infrapopliteal bypass in patients with CLTI.

Methods

A retrospective analysis was performed for 337 patients who underwent 414 infrapopliteal bypasses for CLTI under a team medicine approach at a single center in Japan between April 2009 and December 2021. Redo infrapopliteal bypass cases were excluded from the study. A team approach was started in 2009 for CLTI cases requiring surgical reconstruction. In 2017, inpatient team medicine was reorganized with the aim of improving quality. Baseline characteristics, procedural details, hospital outcomes, and medium-term outcomes (primary, assisted primary, and secondary patencies; limb salvage; survival; and wound healing) were collected from medical records at August 2022 and assessed before (Group 1; 160 patients, 195 limbs) and after (Group 2; 177 patients, 219 limbs) reorganization. The primary endpoints were limb salvage and wound healing after infrapopliteal bypass. The secondary endpoints were early outcomes (including hospital mortality within 30 days and major adverse cardiovascular events (MACE) within 30 days), survival, and graft patency. In the study period, a bypass-first strategy was selected for patients with CLTI. This strategy included preoperative cardiac evaluation and selection of bypass patients and the bypass method, as described in previous reports.^18,19

Definition

Major amputation was defined as limb loss above ankle level, and limb salvage as freedom from major amputation. Anatomical severity was diagnosed by the GLASS stage, and limb severity by the WIfI stage. Malnutrition was defined as a Controlling Nutritional Status (CONUT) score ≥5 points.²⁰ MACE was defined as cardiovascular death, nonfatal myocardial infarction, unstable angina, congestive heart failure, stroke, or another cardiovascular event requiring hospitalization.

Reorganization of the team approach to prevent amputation

The nine essential skills to prevent amputation and the specialty responsible recommended in the GVGs are summarized in Table 1. A preoperative team conference was conducted once each week after reorganization. In the team reorganization, a vascular surgeon, plastic surgeon, wound nurse, nutritionist, physical therapist, and pharmacist were added to this conference. The conference was used to discuss the operation, perioperative medication, perioperative wound management, perioperative nutritional management, and postoperative rehabilitation program, based on preoperative evaluation of anatomical complexity, limb severity, functional status, drug adherence, and nutritional status. Anatomical complexity (GLASS stage or Trans-Atlantic Inter-Society Consensus (TASC) II classification) was diagnosed by a vascular surgeon based on high quality angiography and/or computed tomography.²¹ Limb severity (WIfI classification) was assessed by a vascular surgeon or plastic surgeon. Drug adherence was monitored by a pharmacist and nutritional assessments (CONUT) were performed preoperatively by a nutritionist. CONUT was calculated using albumin (ALB), total cholesterol (TC), and total lymphocyte count (TLC).

Table 1.

Nine essential skills recommended in the global vascular guidelines (GVGs) for prevention of amputation.

Essential skills	Team members	Methods
The ability to perform hemodynamic and anatomic vascular assessment	Vascular surgeon cardiologist	Hemodynamic assessment
		Ankle-brachial index (ABI) and skin perfusion pressure (SPP)
		Anatomic vascular assessment
		Global limb anatomic staging system (GLASS) femoropoplitela (FP) grading, infrapopliteal (IP) grading, inframallealor (IM) grading, and GLASS stage, based on preoperative high quality angiography and/or computed tomography (CT)
The ability to perform a peripheral neurologic workup	Endocrinologist	Current perception threshold (CPT), touch test, achilles tendon reflex test, and vibration sense test
The ability to perform a peripheral neurologic workup	Medical technologist
The ability to perform site appropriate culture technique	Vascular surgeon	Preoperative wound culture
The ability to perform site appropriate culture technique	Plastic surgeon	Preoperative wound culture
The ability to perform wound assessment and staging or grading of infection and ischemia	Vascular surgeon	Wound, ischemia, and foot infection (WIfI) classification
	Plastic surgeon	Laboratory data (white blood cell count, C-reactive protein)
	Wound nurse	Ankle-brachial index (ABI) and skin perfusion pressure (SPP)
The ability to perform site-specific bedside and intraoperative incision and drainage or débridement	Vascular surgeon	Drainage or debridement, based on below the ankle X-ray imaging and laboratory data (white blood cell count, C-reactive protein)
	Plastic surgeon
The ability to initiate and to modify culture-specific and patient-appropriate antibiotic therapy	Vascular surgeon	Reference to Sanford guide, based on preoperative wound culture and glomerular filtration rate (GFR) Sanford guide. [Mobile app]. https://www.sanfordguide.com
	Plastic surgeon
	Pharmacist
The ability to perform revascularization	Vascular surgeon cardiologist	Reference to global vascular guidelines (GVGs) and vascular quality initiative (VQI) chronic limb-threatening ischemia (CLTI) mortality prediction model
The ability to perform soft tissue or osseous reconstruction of deformities and defects	Plastic surgeons	Reconstruction about 3-4 weeks after revascularization with reference to wound status and SPP
The ability to perform appropriate postoperative monitoring to reduce risks of reulceration and infection	Wound nurse	Wound check and treatment, hemodynamic assessment based on audible Doppler signals in pedal arteries
	Nutritionist ultrasound technicians	Nutritional evaluation (CONUT) and nutritional intervention graft surveillance using diplex ultrasound (DUS)

According to the Sanford Guide, perioperative antibiotic therapy was conducted with reference to the wound culture and glomerular filtration rate (GFR).²² Daily treatment for ulcer or gangrene was performed by a wound nurse. A plastic surgeon checked the wound status twice a week with a wound nurse and/or vascular surgeon until discharge. If needed, bedside drainage was performed by a plastic surgeon or vascular surgeon, based on evaluations of inflammatory reactions (i.e., white blood cell count, C-reactive protein) and wound status. Also if needed, intraoperative debridement was performed by a plastic surgeon under nerve block, with reference to the wound status, below the ankle X-ray imaging, and/or inflammatory reactions. Based on wound status and skin perfusion pressure (SPP), minor amputation and reconstruction were performed by a plastic surgeon about 3-4 weeks after revascularization. Nutritional interventions such as protein and energy supplementation were provided perioperatively (within 1 week postoperatively) for patients with malnutrition and sustained dietary decline.

Rehabilitation after reorganization

Postoperative rehabilitation was performed with assistance of physical therapists. Patients without plantar ulcer started sitting without assistance on postoperative day (POM) 1, standing training on POM 2, and walking training on POM 4, with the aim of walking 200 m without stopping by POM 14. Patients with plantar ulcer started walking training on POM 7 using plantar decompression shoes, with the aim of walking 200 m by POM 21. If a wound nurse or plastic surgeon pointed out exacerbation of ulcer, walking training was suspended for four to 7 days. Home exercise guidance was provided before discharge.

Medication after reorganization

Inpatients with diabetes were tested for blood glucose three or four times a day and were treated with oral hypoglycemic agents or insulin injection, with a target hemoglobin A1c level of <7% and fasting blood glucose level of <150 mg/dL. Diabetes management was conducted by endocrinologists. Details of other medications have been documented elsewhere.¹⁸ During the hospital stay, prescription of potentially inappropriate medication was corrected by pharmacists, based on Screening Tool of Older Person’s Potentially Inappropriate Prescriptions (STOPP) criteria and Screening Tool to Alert to Right Treatment (START) criteria.²³

Follow-up program

After distal bypass, all patients were enrolled in a follow-up program that involved DUS graft surveillance, measurement of the ankle-brachial index (ABI), and attendance at a wound clinic at 1, 2, 3, 4, and 6 months after the procedure and every 3 months thereafter lifelong. DUS was performed by vascular surgeons and ultrasound technicians. Details of the follow-up program have been described elsewhere.¹⁹

Ethics

This study was conducted in accordance with the Declaration of Helsinki and was approved by the ethics committee of JA Hiroshima General Hospital (Hiroshima, Japan; approval number: 22-26). The analysis is observational without intervention or invasiveness, and thus, the IRB waived the need for informed consent from patients. The opt-out method was alternatively utilized.

Statistical analysis

Continuous variables are expressed as medians [25th-75th percentile]. Categorical variables are presented as absolute values and percentages. Differences in background factors, operative details, and hospital outcomes between groups (before vs after reorganization) were compared by Fisher exact test for categorical data and by Mann–Whitney U test for continuous variables. Primary, assisted primary, and secondary patencies, limb salvage, survival and wound healing rates were evaluated by Kaplan–Meier analyses with a log-rank test.²⁴ Univariate Kaplan–Meier analysis was used to select potential risk factors for major amputation. Variables with p < .05 in univariate analysis were defined as potential risk factors for major amputation and used in multivariate Cox proportional hazard analysis. A p value <.05 was defined as significant. All statistical analyses were conducted with EZR (Saitama Medical Center, Jichi Medical University, Saitama, Japan), a graphical user interface for R (The R Foundation for Statistical Computing, Vienna, Austria).²⁵

Results

The patients included 227 men (67%) and had a median age of 76 [68–83] years. Diabetes mellitus was present in 67% of the patients and end-stage renal disease with hemodialysis in 37%. Patient characteristics and clinical data are summarized in Table 2. Malnutrition was more common in Group 2 (after reorganization) than in Group 1 (before reorganization). Of all the patients, 87% were ambulatory or ambulatory with assistance, with no significant difference between the groups. The predicted 30-day and 2-year survival rates using the Vascular Quality Initiative (VQI) CLTI risk model were 98 [95–99]% and 80 [68–88]%, respectively, again with no significant difference between the groups.²⁶

Table 2.

Clinical data for 337 patients who underwent infrapopliteal bypass for chronic limb-threatening ischemia before and after reorganization of multidisciplinary team care.

Demographics	Cohort	Before	After	p value
Patients	337	160	177
Age, years				.32
<60	23 (7)	15 (9)	8 (5)
60–70	88 (26)	43 (27)	45 (25)
71–80	110 (33)	49 (31)	61 (35)
>80	116 (34)	53 (33)	63 (36)
Nonwhite	337 (100)	160 (100)	177 (100)	1.0
Male	227 (67)	108 (68)	119 (67)	1.0
Indication
Rest pain	54 (16)	23 (14)	31 (18)	0.46
Tissue loss	283 (84)	137 (86)	146 (82)
Diabetes	227 (67)	103 (64)	124 (70)	0.30
Hypertension	289 (86)	146 (91)	143 (81)	0.008
Smoking history				0.56
Never	103 (31)	47 (29)	56 (32)
Prior history	206 (61)	97 (61)	109 (62)
Current	28 (8)	16 (10)	12 (7)
Coronary artery disease				0.10
None	199 (59)	90 (56)	109 (62)
History of myocardial infarction, asymptomatic or stable angina	131 (39)	64 (40)	67 (38)
Unstable angina/myocardial infarction within 6 months	7 (2)	6 (4)	1 (1)
Cerebrovascular disease	81 (24)	42 (26)	39 (22)	0.38
Chronic heart failure	62 (18)	27 (17)	35 (20)	0.57
COPD				0.26
Not treated or on medication	26 (8)	16 (10)	10 (6)
Home oxygen	2 (2)	1 (1)	1 (1)
Chronic kidney disease stage				0.74
1 (GFR >90 mL/min/1.73 m²)	8 (2)	4 (2)	4 (2)
2 (GFR 60–89 mL/min/1.73 m²)	58 (17)	23 (14)	35 (20)
3 (GFR 30–59 mL/min/1.73 m²)	110 (33)	56 (35)	54 (31)
4 (GFR 15–29 mL/min/1.73 m²)	35 (11)	17 (10)	18 (11)
5 (GFR <15 mL/min/1.73 m²)	126 (38)	60 (38)	66 (37)
Hemodialysis	124 (37)	60 (37)	64 (36)	0.82
Malnutrition	135 (40)	55 (34)	80 (45)	0.046
Preoperative medication
Beta blocker	60 (18)	22 (14)	38 (21)	0.087
Antiplatelet	253 (75)	125 (78)	128 (72)	0.21
Statin	111 (33)	56 (35)	55 (31)	0.49
Ambulation status				0.24
Independent	211 (63)	95 (59)	116 (66)
With assistance	79 (34)	44 (28)	35 (20)
Wheelchair bound	29 (9)	11 (7)	18 (10)
Bedbound	18 (5)	10 (6)	8 (5)
Predict 30-day mortality base on VQI CLTI risk model	98 [95–99]	98 [96–99]	98 [96–99]	0.61
Predict 2-year mortality base on VQI CLTI risk model	80 [68–88]	78 [70–88]	81 [68–88]	0.75

COPD: chronic obstructive pulmonary disease; GFR: glomerular filtration rate; VQI: Vascular Quality Initiative; CLTI: chronic limb-threatening ischemia.

Data are presented as n (%) or median values [interquartile range].

Malnutrition was defined as a Controlling Nutritional Status (CONUT) score ≥5 points.

Operative details are shown in Table 3. Prior infrapopliteal EVT was more frequently performed in Group 2 (p = .022). The WIfI stage in the study cohort was 2 in 80 (19%), 3 in 141 (34%), and 4 in 193 (46%) cases, and the GLASS stage was Ⅰ in 6 (1%), Ⅱ in 29 (7%), and Ⅲ in 379 (92%), both with no significant difference between the groups. Most bypasses used a single-segment saphenous vein graft. Bypass originating from the popliteal artery was more common in Group 2 (p < .001), and bypasses were more frequently performed in a non-reversed fashion in Group 2 than in Group 1 (p < .001). The median operation time was shorter in Group 2 than in Group 1 (p < .001).

Table 3.

Operative and postoperative data for 414 infrapopliteal bypasses for chronic limb-threatening ischemia in 337 patients before and after reorganization of multidisciplinary team care.

Demographics	Cohort (%)	Before (%)	After (%)	p value
Limbs/Patients	414/337	195/160	219/177
Contralateral CLTI	116 (28)	51 (26)	65 (30)	0.44
Prior infrapopliteal EVT	16 (4)	3 (2)	13 (6)	0.022
GLASS stage Ⅰ/Ⅱ/Ⅲ	6(1)/29(7)/379(92)	1(1)/12(6)/172(93)	5(2)/17(8)/197(90)	0.29
WIfI stage 1/2/3/4	0(0)/80(19)/141(34)/193(46)	0(0)/34(17)/68(35)/93(48)	0(0)/46(21)/73(33)/100(46)	0.67
Proximal anastomotic site
Femoral artery	181 (44)	105 (54)	76 (35)	<0.001
Popliteal artery	233 (56)	90 (46)	143 (65)
Distal anastomotic site
Below knee popliteal artery	31 (7)	16 (8)	15 (7)
Posterior tibial artery	146 (35)	75 (39)	71 (32)
Anterior tibial artery	34 (8)	11 (6)	23 (11)
Peroneal artery	41 (10)	19 (10)	22 (10)
Dorsalis pedis artery	117	46 (24)	71 (32)
Plantar artery	42	25 (13)	17 (8)
Sural artery	3	3 (2)	0 (0)
Conduit				.54
Saphenous vein graft	373	176 (90)	197 (90)
Other vein graft	37	16 (8)	21 (10)
Artificial graft	4	3 (2)	1 (1)
Single use vein graft	374	175 (90)	203 (93)	0.30
Spliced vein graft	36	20 (10)	16 (7)
Bypass fashion				<0.001
Non-reversed	361	153 (80)	208 (95)
Insitu	22	15 (8)	7 (3)
Reversed	27	24 (13)	3 (1)
Operation time (min)	172 [134-210]	197 [168-232]	143 [121-180]	<0.001
Hospital death (within 30 days)	2 (1)	1 (1)	1 (1)	1.0
Major adverse cardiovascular event (within 30 days)	6 (2)	3 (2)	3 (2)	1.0
Surgical site infection	49 (15)	22 (14)	27 (15)	0.76
Perioperative blood fusion	79 (23)	45 (28)	34 (19)	0.005
Hospital stay (days)	42 [28 - 63]	44 [28 - 73]	40 [29 - 55]	0.12
Postoperative medication
Single antiplatelet therapy (SAPT)	242 (73)	105 (66)	137 (77)	0.021
Double antiplatelet therapy (DAPT)	78 (23)	45 (28)	33 (19)	.052
Warfarin	202 (60)	131 (82)	71 (40)	<0.001
Direct oral anticoagulants (DOAC)	22 (7)	2 (1)	20 (11)	<0.001

CLTI: chronic limb-threatening ischemia; EVT: endovascular treatment; GLASS: Global Limb Anatomic Staging System; WIfI: Wound, Ischemia, and Foot infection; SAPT: single antiplatelet therapy; DAPT: double antiplatelet therapy; DOAC: direct oral anticoagulants.

Data are presented as n (%) or median values [interquartile range].

Postoperative outcomes are summarized in Table 3. There were four hospital deaths (1%) within 30 days due to sepsis (n = 2), acute myocardial infarction (AMI) (n = 1), and graft rupture with surgical site infection (SSI) (n = 1); MACE within 30 days occurred in 6 patients (2%): stroke (n = 3), AMI (n = 2), and graft rapture (n = 1, the same case as above); and SSI occurred in 49 cases (15%). None of these variables differed significantly between the groups. Transfusion was required less in Group 2 compared with Group 1 (p = .005), and single antiplatelet agents and direct oral anticoagulants (DOACs) were more frequently used in Group 2 (p = .021, p < .001).

14 patients (4%) were lost to follow up in a mean overall follow-up period of 31±30 months. The 3-year primary, assisted primary, and secondary patencies in the cohort were 51%, 72%, and 73%, respectively, with no significant differences between the groups (Figure 1(a)–(c)). During the follow-up period, 40 limbs (9%) required major amputation. The limb salvage rates in Groups 1 and 2 were 89% and 97% at 1 year, 86% and 95% at 2 years, and 84% and 95% at 3 years, with significantly higher rates in Group 2 (p = .001) (Figure 2(a)). During the follow-up period, 142 patients (42%) died. The survival rates in the cohort were 82% at 1 year, 70% at 2 years, and 58% at 3 years, with no significant difference between the groups (Figure 2(b)). Of 351 limbs with ulcer or gangrene, complete wound healing was achieved in 270 limbs (77%). The wound healing rates in the cohort were 56% at 3 months, 72% at 6 months, and 85% at 12 months, again with no significant differences between the groups (Figure 2(c)).

In multivariate analysis, the risk factors for major amputation were treatment before reorganization of team medicine (HR 2.68; 95%CI, 1.19–6.04; p = .017), hemodialysis (HR 2.27; 95%CI, 1.16–4.29; p = .017), and non-ambulatory status (HR 2.63; 95%CI, 1.33–5.00; p = .005) (Table 4).

Table 4.

Univariate and multivariate analysis of risk factors for major amputation after 414 infrapopliteal bypasses for chronic limb-threatening ischemia in 337 patients.

Variables	Univariate		Multivariate
Variables	R (95%HCI)	p Value	HR (95%CI)	p Value
Treatment before reorganization	3.27 (1.54–6.94)	.002	2.68 (1.19–6.04)	.017
Age ≥80 years	0.71 (0.35–1.45)	.34
Male	1.24 (0.60–2.53)	.56
Tissue loss	4.23 (1.02–17.6)	.047	1.91 (0.41–8.76)	.41
Diabetes	2.14 (0.95–4.84)	.068
Hypertension	2.38 (0.57–9.86)	.23
Smoking history (including past)	1.73 (0.77–3.92)	.19
Coronary artery disease	1.08 (0.58–2.01)	.82
Cerebrovascular disease	2.16 (1.12–4.14)	.021	1.36 (0.68–2.71)	.39
Chronic heart failure	0.86 (0.38–1.94)	.71
COPD	0.79 (0.24–2.57)	.70
Chronic kidney disease stage	2.83 (0.87–9.18)	.083
Hemodialysis	2.45 (1.30–4.62)	.006	2.27 (1.16–4.29)	.017
Malnutrition	1.39 (0.74–2.63)	.31
Beta blocker	0.70 (0.28–1.79)	.46
Antiplatelet	1.51 (0.67–3.43)	.32
Statin	0.72 (0.36–1.44)	.35
Non-ambulatory status	3.03 (1.61–5.55)	<.001	2.63 (1.33–5.00)	.005
Contralateral chronic limb-threatening ischemia	1.63 (0.86–3.09)	.14
Prior infrapopliteal endovascular treatment	0.78 (0.11–5.67)	.80
GLASS stage III	1.00 (0.36–2.82)	1.00
WIfI stage 4	2.58 (1.33–4.99)	.005	1.79 (.87–4.29)	.12
Proximal anastomosis to popliteal artery	1.15 (0.61–2.16)	.68
Distal anastomosis to pedal artery	1.11 (0.59–2.08)	.75
Saphenous vein use	0.80 (0.31–2.03)	.63
Spliced vein graft	1.19 (0.43–3.35)	.74
Bypass in a non-reversed fashion	1.24 (0.48–3.20)	.66
Operation time ≥180 min	2.04 (1.07–3.88)	.029	1.17 (0.58–2.37)	.66
SAPT	0.96 (0.49–1.90)	.92
DAPT	1.03 (0.50–2.10)	.94
Warfarin	1.19 (0.59–2.42)	.62

COPD: chronic obstructive pulmonary disease; GLASS: Global Limb Anatomic Staging System; WIfI: Wound, Ischemia, and Foot infection; SAPT: single antiplatelet therapy; DAPT: double antiplatelet therapy; HR: hazard ratio; CI: confidence interval.

Discussion

This study had three main findings. First, the 3-year limb salvage rate of 95% after reorganization of team medicine was significantly higher than that before reorganization, and reorganization was independently associated with reduced major amputation. Second, the median operation time of 143 [121–180] min after reorganization was shorter than that before reorganization, and transfusion was required less after reorganization. Third, the hospital mortality and postoperative MACE rates of 1% and 2% in the cohort were both favorable.

The effectiveness of team medicine for patients with foot ulcer is well documented and multidisciplinary team approaches for these patients are increasingly used worldwide to prevent unnecessary amputation.^4–14 However, the main issue is the quality of team medicine and the GVGs make proposals for the team setting, nine essential skills, and team protocols. In 2017, we reorganized our multidisciplinary team with the goal of improved treatment quality. In a series of 272 patients treated for diabetic foot infections, Laakso et al. found a significantly reduced below-the-knee amputation rate after team reorganization (25.8% vs 9.5%, p < .001).¹⁴ Similarly, in the current study, major amputation in the long-term was significantly reduced after reorganization (p = .001), and reorganization was independently associated with reduced major amputation (p = .017). These results suggest that reorganization aimed at improved quality of treatment can prevent unnecessary amputation for patients with CLTI.

In the current study, operation time was shorter and blood fusion was less frequently required after reorganization. These results may have been influenced by the learning curve for vascular surgeons and operative staff and by the more common performance of bypass originating from the popliteal artery after reorganization. A preoperative team conference was held after reorganization, at which the revascularization strategy (i.e., inflow, outflow, conduit, and bypass method) was determined based on evaluation of anatomical complexity, limb severity, functional status, drug adherence, and nutritional status. The collective decision making in the team conference may have resulted in performance of less invasive surgery, leading to a shorter operation time and less transfusion.

Patients with CLTI who undergo surgical revascularization have high postoperative mortality and morbidity compared with those after EVT. In a meta-analysis of CLTI cases with popliteal-to-distal vein bypass, Albers et al. found early mortality rates in 30 articles of 0% to 11.5%, with a weighted average of 2.3%.²⁷ In the current study, the hospital mortality of 1.0% was lower than this average. In a meta-analysis of 8602 CLTI cases with endovascular or surgical intervention for infrapopliteal lesions, Almasri et al. found an early major adverse cardiac event rate after bypass of 1% to 14%,²⁸ which is comparable to the 30-day MACE rate of 2.0% in the current study. Many factors affect early mortality and morbidity, but high quality team medicine may reduce these rates due to the comprehensive and multidisciplinary perioperative approach. Further studies are needed to determine the detailed impact of a high quality team approach on hospital outcomes for CLTI patients after bypass surgery.

We started team medicine for CLTI from 2009, and initially made minor changes through trial and error, followed by a major change in 2017. Implementation of all of these changes reflects the time required for maturation of the team approach: the team was not built in a day. The Japanese proverb “continuation is power” is a message we would like to send to medical teams worldwide.

Limitations

This study has several limitations. The first of these is the single center, retrospective design. However, team medicine is generally performed in hospital units, and multicenter studies are difficult to perform. Second, there is no formal qualification as a podiatrist in Japan, and so plastic surgeons and vascular surgeons served in this role. Third, it was not possible to evaluate graft length and the diameter of the target below the knee artery, which might influence graft patency or limb salvage. Fourth, 14 patients who were lost to follow-up might have been treated at other hospitals, and we were unable to assess the reasons for loss in follow-up. Fifth, we were unable to perform sensitivity analyses and the learning curve of team skills might have influenced the outcomes. Finally, the team reorganization in 2017 involved changes in ulcer management, medication correction, rehabilitation programs, and nutritional management. Especially, changes in postoperative medications, such as high-dose statins, cilostazol, and many others could be part of the improvement. Reorganization was an independent factor associated with limb salvage, but we were unable to determine the specific change that affected limb salvage.

Conclusion

A reorganized multidisciplinary team approach for patients with CLTI after infrapopliteal bypass was independently associated with reduced major amputation. This suggests that a high quality team approach is important for treatment of CLTI with infrapopliteal surgical revascularization.

Footnotes

Acknowledgments

We gratefully acknowledge the work of past and present members of the vascular team (i.e., physical therapists, wound nurses, certified diabetes educators, pharmacists, nutritionists, clinical engineers, ultrasound technicians, medical technologists, radiological technologists, medical secretaries, and prosthetists).

Declaration of conflicting interests

The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Funding

The author(s) received no financial support for the research, authorship, and/or publication of this article.

ORCID iD

Taira Kobayashi

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