Critical limb-threatening ischaemia and microvascular transformation: clinical implications.

BACKGROUND AND AIMS: Clinical management of critical limb-threatening ischaemia (CLTI) is focused on prevention and treatment of atherosclerotic arterial occlusions. The role of microvascular pathology in disease progression is still largely unspecified and more importantly not utilized for treatment. The aim of this explorative study was to characterize the role of the microvasculature in CLTI pathology. METHODS: Clinical high-resolution imaging of CLTI patients (n = 50) and muscle samples from amputated CLTI limbs (n = 40) were used to describe microvascular pathology of CLTI at the level of resting muscle blood flow and microvascular structure, respectively. Furthermore, a chronic, low arterial driving pressure-simulating ischaemia model in rabbits (n = 24) was used together with adenoviral vascular endothelial growth factor A gene transfers to study the effect of microvascular alterations on muscle outcome. RESULTS: Resting microvascular blood flow was not depleted but displayed decreased capillary transit time (P < .01) in CLTI muscles. Critical limb-threatening ischaemia muscle microvasculature also exhibited capillary enlargement (P < .001) and further arterialization along worsening of myofibre atrophy and detaching of capillaries from myofibres. Furthermore, CLTI-like capillary transformation was shown to worsen calf muscle force production (P < .05) and tissue outcome (P < .01) under chronic ischaemia in rabbits and in healthy, normal rabbit muscle. CONCLUSIONS: These findings depict a progressive, hypoxia-driven transformation of the microvasculature in CLTI muscles, which pathologically alters blood flow dynamics and aggravates tissue damage under low arterial driving pressure. Hypoxia-driven capillary enlargement can be highly important for CLTI outcomes and should therefore be considered in further development of diagnostics and treatment of CLTI.

Compensated and non-compensated patient injury claims in internal carotid artery interventions in Finland, 2004-2017.

OBJECTIVES: Analysis of patient injuries offers possibilities for improving quality in patient care. The aim of this study was to identify errors and adverse events leading to patient injuries in the treatment of internal carotid artery stenosis (ICAS). METHODS: A retrospective analysis was performed on data from Finnish patient injury claims and patient insurance center decisions in the treatment of ICAS, 2004-2017. Contributing factors to injury were identified and evaluated. RESULTS: During the 14-year study period, 42 patient injury claims involving ICAS treatment were closed in Finland. One claim involved carotid artery stenting, and the other operations were carotid artery endarterectomies. Nine of the claims were compensated (seven for operations and two for evaluations). Fully trained vascular surgeons had carried out all the operations and evaluations. Stroke was the most common complaint in the claims (n = 12). Six of the compensated patients were symptomatic prior to the interventions. Injuries were related to errors in decision-making and patient selection in two cases. Four patients received compensation for nerve injury and three for stroke. No deaths were compensated as patient injuries. Most negative claim decisions were related to the injury having been unavoidable. CONCLUSION: Compensated patient injuries involving the treatment of ICAS are rare but often serious and mostly involve open surgery. Patient injury claims provide a valuable source of information for recognizing errors in care and offer possibilities to improve patient safety.

Aortic calcification index predicts mortality and cardiovascular events in operatively treated patients with peripheral artery disease: A prospective PURE ASO cohort follow-up study.

OBJECTIVE: The present study evaluates the association of aortic calcification with mortality and major adverse cardiovascular and leg events (MACEs and MALEs) in patients with peripheral artery disease (PAD). The risk for mortality and MACEs and MALEs is considered in clinical decision-making. METHODS: This cohort found in 2012-2013 consists of 226 patients with symptomatic PAD referred to Turku University Hospital for invasive treatment. Follow-up data about mortality and survival without MACEs and MALEs were collected up to 5 years from the inclusion date, and aortic calcification index (ACI) was measured from patients with available imaging studies (164 of 226). ACIs' association with events and mortality was evaluated in Cox regression, Kaplan-Meier, and classification and regression tree analysis. RESULTS: All-cause mortality at 1, 3, and 5 years was 13.7% (31), 26.1% (59), and 46.9% (106), respectively. In multivariable Cox regression analysis, ACI and ACI > 43 were independent risk factors for all-cause mortality (hazard ratio [HR]: 1.13 per 10 units, 95% confidence interval [CI]: 1.00-1.22 and HR: 1.83, 95% CI: 1.01-3.32, respectively) and for MACEs (HR: 1.10 per 10 units, 95% CI: 1.00-1.22 and HR: 3.14, 95% CI: 1.67-5.91, respectively), but not for MALEs. Classification and regression tree analysis showed that ACI = 43 best divides cohort in relation to mortality. Kaplan-Meier analyses showed that ACI > 43 is associated with greater mortality and occurrence of MACEs compared with those who have ACI ≤ 43 (log-rank P value .005 and .0012, respectively). CONCLUSIONS: Risk for mortality and MACEs is associated with high ACI. ACI can expose the risk in patients with PAD for further cardiovascular events and mortality.

Compensated Patient Injuries in the Treatment of Abdominal Aortic and Iliac Artery Aneurysms in Finland: A Nationwide Patient Insurance Registry Study.

OBJECTIVES: Patient injury claims data and insurance records provide detailed information on patient injuries. This study aimed to identify the errors and adverse events that led to patient injuries in vascular surgery for the treatments of abdominal aortic aneurysms (AAA) and iliac artery aneurysms (IAA) in Finland. The study also assessed the severity and preventability of the injuries. MATERIALS AND METHODS: A retrospective analysis of Finnish Patient Insurance Centre's insurance charts of compensated patient injuries in the treatment of AAA and IAA. Records of all compensated patient injury claims involving AAA and IAA between 2004 and 2017 inclusive were reviewed. Contributing factors to injury were identified and classified. The injuries were assessed for their preventability by using the WHO Surgical Safety Checklist correctly. The degree of harm was graded by Clavien-Dindo classification. RESULTS: Twenty-six patient injury incidents were identified in the treatment of 23 patients. Typical injuries involved delays in diagnosis or treatment, errors in surgical technique or injuries to adjacent anatomic organs. Three (13.0%) patients died due to patient injury. Two deaths were caused by delays in diagnosis of ruptured abdominal aortic aneurysm (RAAA) and the third death was due to missed diagnosis of post-operative myocardial infarction. Retained foreign material caused injuries to two (8.7%) patients. One (4.3%) patient had a severe postoperative infection. Three (13.0%) patients experienced an injury to an adjacent organ. One patient had a bilateral and another a unilateral above-the-knee amputation due to patient injury. Three injuries were considered preventable. Most harms were grade IIIb Clavien-Dindo classification in which injured patients required a surgical intervention under general anesthesia. CONCLUSIONS: Compensated patient injuries involving the treatment of AAA and IAA are rare, but are often serious. Injuries were identified during all stages of care. Most injuries involved open surgical procedures.

Vein Harvest Wound Healing after Bypass Surgery for Critical Limb Ischemia.

BACKGROUND: Lower-limb revascularization surgery, especially when performed using the great saphenous vein, predisposes patients to major surgical trauma on initially ischemic tissue. Vein harvest wounds (VHWs) after infrainguinal revascularization heal slowly. This study's aim was to assess the factors associated with VHW healing after infrainquinal bypass surgery for critical limb ischemia (CLI). METHODS: A retrospective patient record study was conducted. All patients with CLI who underwent infrainguinal bypass surgery with autologous vein graft between January 1, 2015, and December 31, 2017, in the Turku University Hospital, were included. Follow-up data were collected until February 28, 2018. The following data was collected from the patient files; risk factors, ankle-brachial indices (ABIs), systolic toe pressures (STPs), the presence of an ischemic ulcer, VHW dehiscence, and the time when the VHW was completely healed. Procedures with outflow vessels at either popliteal or tibial artery were analyzed separately. Descriptive and univariate statistical analyses were performed. RESULTS: Altogether, 195 patients were operated on for CLI, of whom 133 (68.2%) patients had ischemic ulcers. The mean follow-up time was 535.0 days (range 3.0-1143.0 days). The mean ABI improvement was 0.49 (P = 0.00), and STP improvement, 39.9 mm Hg (P = 0.00). The median time taken when VHW was healed was 48.0 days (95% confidence interval [CI], 39.4-56.6) in patients without ischemic ulcers and 82.0 days (95% CI, 59.7-104.3) in patients with ischemic ulcers, P = 0.03. VHW in patients who underwent popliteal artery bypass (62 days, 95% CI, 12.9-93.0) healed faster than VHW in those who underwent tibial artery bypass (132 days, 95% CI, 48.0-93.0), P = 0.02. Risk factors and the preoperative or postoperative ABIs or STPs had no effect on VHW healing time. CONCLUSIONS: VHW healing was remarkably slower after revascularization surgery in patients with an ischemic foot ulcer than in those without ischemic ulcers.

Patient Injuries in Treatment of Peripheral Arterial Disease in Finland: Review of National Patient Insurance Charts.

BACKGROUND: Patient injury claim data and insurance records constitute detailed sources of information on patient injuries and their contributing or causal factors. This study aimed to identify the unintended incidents that lead to patient injuries in vascular surgery in the treatment of peripheral arterial disease (PAD) in Finland. METHODS: The records of all accepted patient injury claims involving PAD between 2004 and 2017 inclusive were obtained from the nationwide Finnish Patient Insurance Centre registry and were reviewed. Factors contributing to injury were classified by patient careflow. RESULTS: Sixty-nine patient injury incidents were identified in 60 treated patients with PAD. Sixteen injuries (23.2%) were related to outpatient or preoperative care. Twenty-seven injuries (39.1%) were caused by incidents in performing open or endovascular procedures, and 26 injuries (37.7%) were related to postoperative care. Delay in treatment affected 11 (18.3%) patients. Incidents involving surgical technique were identified in the treatment of 13 (21.7%) patients. Retained foreign material caused injuries to four (6.7%) patients. Five (8.3%) patients suffered from postoperative hemorrhage and eleven (18.3%) from infection damage. Delay in treatment resulted in two major amputations. Technical problems in bypass operations led to the loss of the bypass graft and to reoperation. Three nerve injuries led to permanent disability. One (1.7%) patient died because of fatal postoperative bleeding after being discharged from the hospital. CONCLUSIONS: Compensated patient injuries in the treatment of PAD are rare. Injuries occur during all stages of care and are caused by both surgical system procedural failures and common complications.

Major Lower Limb Amputations and Amputees in an Aging Population in Southwest Finland 2007-2017.

Purpose: The aim of the present study was to describe and analyze changes in the incidences of lower extremity amputations (LEAs), patient characteristics, vascular history of amputees and survival in Southwest Finland. Patients and Methods: This is a retrospective patient study in the Hospital District of Southwest Finland. All consecutive patients with atherosclerosis and diabetes-caused LEA, between 1st January 2007 and 31st December 2017, were included. The annual incidences of major LEA patients were statistically standardized. Patients' diagnoses, functional status, previous revascularizations and minor amputations were recorded, and survival was analyzed. Results: During the 11-year-period major LEAs were performed on 891 patients, 118 (13.2%) were urgent operations. The overall incidence of major LEA was 17.2/100 000 and was age-dependent (3.1 for ≤64 years, 34.3 for 65-74 years, 81.5 for 75-84 years, 216 for ≥85 years). A decrease in incidence was detected in the <65 year-age-group (incidence 4.98 in 2007 and 1.88 in 2017; p = 0.0018). Among older age groups, there was no significant change. Half (50.6%) of all amputees were diabetics. Altogether, 472 patients (53.0%) had a history of revascularization before LEA. 80.1% of index amputations were transfemoral and 19.9% transtibial. Re-surgery was performed on 94 (10.5%) patients. The 1-, 3- and 5-year overall survival were 56%, 30%, and 18%, respectively. Conclusion: Our results suggest that in an aging population, despite good availability of vascular services, a significant number of patients are not fit for active revascularization, and LEA is the only feasible treatment for critical limb ischemia.

Patient injuries in the treatment of superficial venous insufficiency registered in Finland between 2004 and 2017.

OBJECTIVES: This study aimed to identify the unintended incidents that led to patient injuries (PIs) in the treatment of superficial venous insufficiency (SVI). METHODS: PI claims filed with the Finnish Patient Insurance Centre between 2004 and 2017 involving SVI were reviewed. Factors contributing to PI were identified and classified. RESULTS: Eighteen (13.2%) of 136 compensated PIs in the specialty of vascular surgery were related to SVI. Only 4.7% of 383 SVI claims were compensated. The incidence of PIs was 9.9 per 100 000 patients. Fifteen patients had open surgery (83.3%) and three (16.7%) endovenous treatment. Two (11.1%) patients had necrotising fasciitis, four (22.1%) had deep vein injuries and two (11.1%) had a permanent nerve injury. Two (11.1%) patients had retained endovenous material that required surgical removal. CONCLUSIONS: PIs were identifiable during all stages of care, perioperative injuries related to open surgery being the most common.

Changes in rates of vascular procedure types and lower extremity amputations in Finland for 2007-2017 inclusive, a population cohort study of 69,523 revascularizations.

INTRODUCTION: Since 2000 the numbers of both open and endovascular revascularization procedures have increased. Despite these increases, the number of major lower extremity amputations (LEAs) has remained relatively constant. The aim of the present study was to assess the number of vascular procedures in relation to the frequency of major LEAs in Finland. METHODS: The Finnish National Institute for Health and Welfare (THL) administers a national registry of all procedures conducted by official healthcare providers in Finland. Data regarding all revascularization procedures and major LEAs between 2007 and 2017 inclusive, were collected from the THL registry. The rates of both open and endovascular procedures were analyzed. RESULTS: A total of 69,523 revascularization procedures were registered over the 11-year period. Of all revascularizations, 22.6% were endovascular in 2007, which rose to 60.5% in 2017. The annual rates of vascular procedures per 100,000 inhabitants increased from 66 in 2007 to 172 in 2017 (increase 10 procedures per year, 95% CI 8.6-12.3, P < 0.01) There was a significant increase (by 141 per year, 95% CI 110-174, P < 0.01) for open revascularizations (2705 operations in 2007, 3992 operations in 2017) and (by 491 per year, 95% CI 433-550, P < 0.01) for endovascular revascularizations (791 in 2007-5514 in 2017). Open aorto-iliac segment revascularization decreased, whereas the numbers of procedures increased for all other arterial segments. The overall frequency of amputations was 18-20 per 100,000. The frequency of amputations in the subpopulation over 65 years old decreased from 93 in 2007 to 72 in 2017 (P < 0.01). CONCLUSION: The present study demonstrated increases in vascular surgery procedures over the 11-year study-period. The increase was greatest for endovascular procedures. During the same period, there was a significant decrease in the frequency of major LEAs in the >65-year-old subpopulation.

Intra-Dermal Absorbable Suture in the Groin Incision Associated with Less Groin Surgical Site Infections than Trans-Dermal Sutures in Vascular Surgical Patients.

BACKGROUND: The groin surgical site is frequently infected in vascular surgical procedures. Our aim was to evaluate the relation of skin closure methods and groin incision infection after vascular operations involving femoral artery exposure. METHODS: In this retrospective patient record study, patient files of all consecutive patients admitted for a vascular procedure to the Turku University Hospital Department of Vascular Surgery during 2015-2016 were evaluated. Patients with an isolated groin surgical site because of femoral artery exposure (256) were included in the study. Patient demographics, details of the operations, and follow-up data were collected from the electronic patient data record. Statistical analyses were performed using a multi-variable model. RESULTS: Altogether, 330 groin incisions were performed for 256 patients. Of all incisions, 262 (79.4%) were closed using intra-dermal absorbable suture; trans-dermal sutures were used in 68 (20.6%) incisions. Groin infections occurred in 24 (9.2%) patients after skin closure with intra-dermal absorbable suture and in 17 (25.0%) cases after trans-dermal sutures. Incisions that were closed using trans-dermal sutures were 3.5 times as likely to have an infection as those closed using intra-dermal sutures (odds ratio 3.5, confidence interval 95% 1.6 to 7.6, p = 0.002). CONCLUSION: Present data suggest that groin incision closure with intra-dermal absorbable suture is associated with groin incision infections compared with those incisions closed with trans-dermal sutures.

Endoscopic treatment of internal gastrointestinal fistulas with fibrin glue.

OBJECTIVE: Gastrointestinal fistulae are a heterogenous entity originating from various etiologies. When occurring, these fistulae are associated with considerable morbidity and even mortality. One third of the fistulae heal spontaneously and the rest have traditionally required major revisional surgery at a later stage. Even after surgery, the healing rate remains at a level of 75% to 90%. During the last years, gastrointestinal fistulae have been successfully treated endoscopically with fibrin glue. METHODS: All (n = 8) consecutive patients with diagnosed internal upper or lower gastrointestinal fistula treated endoscopically with fibrin glue. RESULTS: During the minimum follow-up of 11 months, 7 of 8 patients (87.5%) were successfully treated endoscopically, and in only 1 case (12.5%) with a major diagnostic delay, a reoperation was required. CONCLUSIONS: Our results support the view that endoscopic treatment with fibrin glue may be considered as a first-line therapy to treat small caliber gastrointestinal fistulas.