Isolation precautions cause minor delays in diagnostics and treatment of non-COVID patients.

BACKGROUND: Isolation precautions are essential prevent spread of COVID-19 infection but may have a negative impact on inpatient care. The impact of these measures on non-COVID-19 patients remains largely unexplored. AIM: This study aimed to investigate diagnostic and treatment delays related to isolation precautions, the associated patient outcome, and the predisposing risk factors for delays. METHODS: This observational study was conducted in seven Helsinki region hospitals during the first wave of the COVID-19 pandemic in Finland. The study used data on all non-COVID-19 inpatients, who were initially isolated due to suspected COVID-19, to estimate whether isolation precautions resulted in diagnostic or treatment delays. RESULTS: Out of 683 non-COVID-19 patients, 33 (4.8%) had delays related to isolation precautions. Clinical condition deteriorated non-fatally in seven (1.0%) patients. The following events were associated with an increased risk of treatment or a diagnostic delay: more than three ward transfers (P = 0.025); referral to an incorrect speciality in the emergency department (P = 0.004); more than three SARS-CoV-2 RT-PCR tests performed (P = 0.022); and where cancer was the final diagnosis (P = 0.018). In contrast, lower respiratory tract symptoms (P = 0.013) decreased the risk. CONCLUSIONS: The use of isolation precautions for patients who did not have COVID-19 had minor negative effects on patient outcomes. The present study underlines the importance of targeting diagnostic efforts to patients with unspecified symptoms and to those with a negative SARS-CoV-2 test result. Thorough investigations to achieve an accurate diagnosis improves the prognosis of patients and facilitates appropriate targeting of hospital resources.

Outcome after Hybrid Outflow Interventions for Chronic Limb-threatening Ischemia.

BACKGROUND AND AIMS: Because chronic limb-threatening ischemia (CLTI) is often associated with multilevel arterial disease, it usually requires revascularization at different sites of the limb vasculature. We aim to assess the outcome of the hybrid interventions including open surgical revascularization together with outflow segment percutaneous transluminal angioplasty (PTA) in patients with chronic limb-threatening ischemia. MATERIAL AND METHODS: This study included all hybrid outflow-PTA interventions (n = 80) on patients suffering from CLTI performed in Helsinki University Hospital between 2003 and 2015. Follow-up ended on 31 December 2019. Patient data were prospectively collected into our vascular registry and scrutinized retrospectively. Thirty-one patients (39%) suffered from rest pain (Rutherford category IV) and 49 patients (61%) had ischemic ulcers (Rutherford category V-VI). The most common open surgical procedure was femoral endarterectomy (n = 63, 79%) and the most common endovascular procedure was superficial femoral artery percutaneous transluminal angioplasty (n = 65, 81%). Mean follow-up time was 56 months (range: 4 days-183 months). RESULTS: Limb salvage was at 30 days-92%, at 1 year-91%, and at 5 and 10 years-86%. Survival and amputation-free survival were at 30 days-93% and 86%, at 1 year-80% and 76%, at 5 years-51% and 48%, and at 10 years-21% and 21%. Wound healing at 3, 6, and 12 months was 48%, 71%, and 87%. Freedom from target lesion revascularization was at 30 days-97%, at 1 year-88%, at 5 years-72%, and at 10 years-66%. CONCLUSION: Hybrid outflow revascularization is an important tool in the vascular surgeon's armamentarium for treatment of patients with multilevel arterial disease causing chronic limb-threatening ischemia.

Randomized clinical trial of mechanochemical and endovenous thermal ablation of great saphenous varicose veins.

BACKGROUND: A variety of minimally invasive techniques are available for the treatment of varicose great saphenous vein (GSVs). Non-tumescent, non-thermal ablation methods have been developed. This study compared mechanochemical ablation (MOCA), a non-tumescent, non-thermal ablation technique, with two endovenous thermal ablation methods requiring tumescence in an RCT. METHODS: Patients with GSV reflux were randomized to undergo MOCA, or thermal ablation with endovenous laser (EVLA) or radiofrequency (RFA). The primary outcome measure was the occlusion rate of the GSV at 1 year. RESULTS: The study finally included 125 patients, of whom 117 (93·6 per cent) attended 1-year follow-up. At 1 year, the treated part of the GSV was fully occluded in all patients in the EVLA and RFA groups, and in 45 of 55 in the MOCA group (occlusion rates 100, 100 and 82 per cent respectively; P = 0·002). The preoperative GSV diameter was associated with the recanalization rate of the proximal GSV in the MOCA group. At 1 year after treatment, disease-specific life quality was similar in the three groups. CONCLUSION: The GSV occlusion rate 1 year after treatment was significantly higher after EVLA and RFA than after MOCA. Quality of life was similar between interventions. Registration number: NCT03722134 (http://www.clinicaltrials.gov).

Five-year follow-up of a randomized clinical trial comparing open surgery, foam sclerotherapy and endovenous laser ablation for great saphenous varicose veins.

BACKGROUND: New treatment methods have challenged open surgery as a treatment for great saphenous vein (GSV) insufficiency, the most common being ultrasound-guided foam sclerotherapy (UGFS) and endovenous laser ablation (EVLA). This study evaluated the long-term results of surgery, EVLA and UGFS in the treatment of GSV reflux. METHODS: Patients with symptomatic GSV reflux were randomized to undergo either open surgery, EVLA or UGFS. The main outcome measure was the occlusion rate of the GSV at 5 years after operation. RESULTS: The study included 196 patients treated during 2008-2010; of these, 166 (84·7 per cent) participated in the 5-year follow-up. At 5 years, the GSV occlusion rate was 96 (95 per cent c.i. 91 to 100) per cent in the open surgery group, 89 (82 to 98) per cent after EVLA and 51 (38 to 64) per cent after UGFS (P < 0·001). For patients who had received no additional treatment during follow-up, the occlusion rates were 96 per cent (46 of 48), 89 per cent (51 of 57) and 41 per cent (16 of 39) respectively. UGFS without further GSV treatment was successful in only 16 of 59 patients (27 per cent) at 5 years. CONCLUSION: UGFS has significantly inferior occlusion rates compared with open surgery or EVLA, and results in additional treatments.

Rupture of Abdominal Aortic Aneurysms in Patients Under Screening Age and Elective Repair Threshold.

OBJECTIVES: The objective of this study was to identify the proportion of abdominal aortic aneurysm ruptures that occur before the screening age or threshold diameter for operative repair is reached. METHODS: The study was a retrospective analysis of RAAA patients including all RAAA patients admitted to Helsinki (HUH) and Tampere University Hospitals (TaUH) during 2002-2013. The data for age, gender, and comorbidities were collected from vascular registry and patient records. Computed tomography images taken at the time of admission were used for the measurement of maximum anteroposterior (AP) aneurysm diameter at the time of rupture. Age and diameter data were compared with risk factors. RESULTS: A total of 585 patients diagnosed with RAAA were admitted to the two hospitals during the 12 year period. The mean age at the time of rupture was 73.6 years (SD 9.5, range 42-96 years). 18.3% of patients were under 65: 21.4% of men and 3.0% of women. Men were on average 8 years younger than women. The odds ratio (OR) for rupture before 65 years of age for smokers was 2.1 compared with non-smokers, and 28.4% of smokers were under 65 at the time of rupture. Of all RAAA patients, 327 had a computed tomography scan confirming rupture. The mean AP diameter of the aneurysm was 75.6 mm (SD 15.8, range 32-155 mm). The mean size was significantly lower in women than in men (70.5 vs. 76.8, p = .005). CONCLUSIONS: The data from this study show that a fifth of men would not make it to the screening age of 65 before AAA rupture, the proportion being even larger in active smokers. The data from this study also supports the previous finding that aneurysm size at the time of rupture is significantly smaller in women.

Predictors of failure of endovascular revascularization for critical limb ischemia.

BACKGROUND AND AIMS: To characterize predictors of failure when treating critical limb ischemia (CLI) patients with an endovascular intervention as the first-line strategy. PATIENTS AND METHODS: This retrospective, registry-based study included 217 consecutive patients with 240 chronic critically ischemic limbs treated with infrainguinal percutaneous trans-luminal angioplasty (PTA) during 2006-2007 at Helsinki University Central Hospital, Finland. The primary outcome measures were death, major (above-ankle) amputation, and the need for surgical re-intervention within 6 months after the primary procedure. The secondary out-come measures were overall major amputation and survival rates as well as the overall need for surgical or any other (surgical or endovascular) type of re-intervention. Predictors of outcome endpoints were identified with a univariate screen, and a Cox regression model was used in the multivariate analysis. RESULTS: Compared to ulcer, gangrene was significantly more strongly associated with amputation within 6 months post-procedurally as well as during the whole follow-up period (p ≤ 0.028). The patient's inability to walk upon hospital arrival was a significant predictor of death, amputation and surgical re-intervention. Mediasclerotic ankle-brachial index (ABI) was an independent predictor of amputation as well as endovascular re-interventions. CONCLUSIONS: The strong predictors of poor outcome after endovascular revascularization for patients with CLI are cardiac morbidity, the inability to ambulate upon hospital arrival, and gangrene as a manifestation of CLI. The risk of amputation seems to be significantly higher for gangrene than for ulcer and this matter should be taken into account in the clinical classifications for CLI.

End-stage renal disease and critical limb ischemia: a deadly combination?

OBJECTIVES: This study was planned to evaluate the prognostic impact of end-stage renal disease (ESRD) in patients with critical leg ischemia (CLI) undergoing infrainguinal revascularization. MATERIALS AND METHODS: 1425 patients who underwent infrainguinal revascularization for CLI were the subjects of the present analysis. Ninety-five patients had ESRD (eGFR < 15 ml/min/m²), and of them 66 (70%) underwent percutaneous transluminal angioplasty and 29 (30%) underwent bypass surgery. RESULTS: ESRD patients had significantly lower overall survival (at 3-year, 27.1% vs. 59.7%, p < 0.0001), leg salvage (at 3-year, 57.7% vs. 83.0%, p < 0.0001), and amputation free survival (at 3-year, 16.2% vs. 52.9%, p < 0.0001) than patients with no or less severe renal failure. The difference in survival was even greater between 86 one-to-one propensity matched pairs (at 3-year, 23.1% vs. 67.3%, p < 0.0001). ESRD was an independent predictor of all-cause mortality (RR 2.46, 95%CI 1.85-3.26). Logistic regression showed that age ≥ 75 years was the only independent predictor of 1-year all-cause mortality (OR 4.92, 95%CI 1.32-18.36). Classification and regression tree analysis showed that age ≥ 75 years and, among younger patients, bypass surgery for leg ulcer and gangrene were associated with significantly higher 1-year mortality CONCLUSIONS: Lower limb revascularization in patients with CLI and end-stage renal failure is associated with favourable leg salvage. However, these patients have a very poor survival and this may jeopardize any attempt of revascularization. Further studies are needed to identify ESRD patients with acceptable life expectancy and who may benefit from lower limb revascularization.

The role of chronic kidney disease as a predictor of outcome after revascularisation of the ulcerated diabetic foot.

AIMS/HYPOTHESIS: The aim of the study was to stratify the risk of diabetic patients with leg ulcer or gangrene undergoing infrainguinal revascularisation for critical limb ischaemia. METHODS: The study cohort included 732 revascularisation procedures performed in 597 diabetic patients with ulcer or gangrene. Logistic regression and CART analysis were used for identification of predictors of 1-year outcome. RESULTS: Logistic regression showed that chronic kidney disease (CKD) class (OR 1.38, 95% CI 1.16, 1.65) was an independent predictor of 1-year leg salvage (area under the receiver operating characteristic [ROC] curve 0.60, 95% CI 0.54, 0.65). The terminal nodes of the CART for 1-year leg salvage were CKD classes 4-5, the level (infrapopliteal vs femoropopliteal revascularisation), type of revascularisation (bypass surgery vs percutaneous transluminal angioplasty) and gangrene (area under the ROC curve 0.62, 95% CI 0.57, 0.68). Logistic regression showed that pulmonary disease (OR 1.76, 95% CI 1.11, 2.78), CKD class (OR 1.43, 95% CI 1.24, 1.65), foot gangrene (OR 1.76, 95% CI 1.21, 2.60) and patient age (OR 1.02, 95% CI 1.01, 1.04) were independent predictors of 1-year amputation-free survival (area under the ROC curve 0.65, 95% CI 0.60, 0.69). The terminal nodes of the CART for 1-year amputation-free survival were CKD classes 3-5, patient's age of ≥ 75 years and foot gangrene (area under the ROC curve 0.64, 95% CI 0.60, 0.68). CONCLUSIONS/INTERPRETATION: CKD is a formidable risk factor for poor intermediate outcome after infrainguinal revascularisation in diabetic patients with foot ulcer or gangrene. CART analysis indicates that foot gangrene is also a significant risk factor for adverse outcome.

The effect of hysterectomy or levonorgestrel-releasing intrauterine system on cardiovascular disease risk factors in menorrhagia patients: a 10-year follow-up of a randomised trial.

OBJECTIVE: To compare, whether women with menorrhagia, treated with either hysterectomy or LNG-IUS, differ in their cardiovascular risk profile during 10-year follow-up. STUDY DESIGN: A total of 236 women were randomized to treatment by hysterectomy (n=117) or LNG-IUS (n=119). Their cardiovascular risk factors were analyzed at baseline, at 5 years, and at 10 years. As 55 originally randomized to the LNG-IUS group had hysterectomy during the follow-up, all analyzes were performed by actual treatment modality. MAIN OUTCOME MEASURES: Waist circumference, body-mass index (BMI), blood pressure, and the levels of blood lipids, serum high-sensitivity CRP (hsCRP) and tumor necrosis factor alpha (TNF-α) were measured, and the use of medication for hypertension, diabetes, hypercholesterolemia, and ischemic heart disease was analyzed. RESULTS: After 5 years, an increase in the use of diabetes medication during the follow-up was only detected in the hysterectomy group (from 1.7% to 6.7%, P=0.008 vs from 5.1% to 8.4%, P=0.08), as well as they had significantly higher serum levels of TNF-α (108.59 pg/ml vs 49.02 pg/ml, P=0.001) and hsCRP (1.55 µg/ml vs 0.78 µg/ml, P=0.038) at 5- and 10-years. There was no difference between the groups in the use of cardiovascular medication, neither was there difference in blood pressure, waist circumference, BMI, or concentrations of blood lipids. CONCLUSIONS: Hysterectomy seems to be associated with increased levels of serum inflammatory markers and increased diabetes medication, which in turn, may predispose individual to future cardiovascular events.

Infrainguinal percutaneous transluminal angioplasty or bypass surgery in patients aged 80 years and older with critical leg ischaemia.

BACKGROUND: Infrainguinal revascularization for critical leg ischaemia (CLI) in patients aged 80 years and over is associated with increased operative risk. The aim was to compare the results of percutaneous transluminal angioplasty (PTA) and bypass surgery in these patients. METHODS: Some 584 consecutive patients aged at least 80 years treated with either PTA (277) or bypass surgery (307) for CLI between 2000 and 2007 were included in this study. RESULTS: After 2 years PTA achieved better results than bypass surgery (leg salvage: 85.4 versus 78.7 per cent, P = 0.039; survival: 57.7 versus 52.3 per cent, P = 0.014; amputation-free survival (AFS): 53.0 versus 44.9 per cent, P = 0.005). Cox regression analysis showed that increased age (relative risk (RR) 1.05, 95 per cent confidence interval 1.02 to 1.08), decreased estimated glomerular filtration rate (RR 0.99, 0.99 to 1.00), diabetes (RR 1.30, 1.04 to 1.62), coronary artery disease (RR 1.36, 1.05 to 1.75) and bypass surgery (RR 1.55, 1.24 to 1.93) were associated with decreased AFS. In 95 propensity score-matched pairs, leg salvage at 2 years (88 versus 75 per cent; P = 0.010) and AFS (53 versus 45 per cent; P = 0.033) were significantly better after PTA. Classification and regression tree analysis suggested that PTA was associated with better 1-year AFS, especially in patients with coronary artery disease (63.8 versus 48.9 per cent; P = 0.008). CONCLUSION: When feasible, a strategy of PTA first appears to achieve better results than infrainguinal bypass surgery in patients aged 80 years and older.

Femoropopliteal balloon angioplasty vs. bypass surgery for CLI: a propensity score analysis.

OBJECTIVES: To compare the outcomes of femoropopliteal percutaneous transluminal angioplasty (PTA) and bypass surgery for critical limb ischaemia (CLI). DESIGN: The study is retrospective in nature. MATERIALS AND METHODS: This study included 858 consecutive patients, who underwent femoropopliteal revascularisation for CLI at Helsinki University Central Hospital during 2000-2007. As many as 517 patients (60%) underwent PTA and 341 (40%) bypass surgery. Propensity score analysis was used for risk adjustment in multivariable analysis and for one-to-one matching. RESULTS: In the overall series, PTA had poorer long-term results than bypass (5-year leg salvage, 78.2% vs. 91.8%, p < 0.0001; survival 49.2% vs. 57.1%, p = 0.048; amputation-free survival, 42.0% vs. 53.7%, p = 0.003; freedom from surgical re-intervention 86.2% vs. 94.3%, p < 0.0001). When treatment method was adjusted for propensity score as well as in the propensity score-matched pairs, leg salvage and freedom from surgical re-intervention were worse after PTA than after bypass (among the 241 propensity score-matched pairs, 74.3% vs. 88.2%, p = 0.031, and 86.1% vs. 89.8%, p = 0.025, respectively). Differences in survival, amputation-free survival and freedom from any re-intervention were not observed. CONCLUSIONS: In CLI patients, femoropopliteal PTA seems to be associated with poorer long-term leg salvage and freedom from surgical re-intervention than bypass surgery. However, the treatment method did not affect long-term amputation-free survival.

The effect of hysterectomy or levonorgestrel-releasing intrauterine system on lower urinary tract symptoms: a 10-year follow-up study of a randomised trial.

OBJECTIVE: To evaluate the effect of hysterectomy and levonorgestrel-releasing intrauterine system (LNG-IUS) on lower urinary tract symptoms (LUTS) among women treated for menorrhagia. DESIGN: Randomised controlled trial analysed by actual treatment. SETTING: Five university hospitals in Finland. SAMPLE: A cohort of 236 women, aged 35-49 years, referred for menorrhagia between 1994 and 1997. METHODS: Women were randomly assigned to treatment by hysterectomy (n = 117) or LNG-IUS (n = 119). MAIN OUTCOME MEASURES: Lower urinary tract symptoms were evaluated by questionnaires at baseline, and after 6, 12 months, 5, and 10 years. Medications and operations for urinary incontinence were confirmed from medical records and national registries. RESULTS: Overall, 221 (94%) women took part in the 10-year follow-up evaluation. As 55 (46%) women originally randomised to the LNG-IUS group underwent hysterectomy, the results were analysed by actual treatment. Women treated by hysterectomy used more medication for urinary incontinence than LNG-IUS users (12% versus 1%) (OR 9.45, 95% CI 1.24-71.87, P = 0.006). Three hysterectomised women and one LNG-IUS user underwent surgery for stress urinary incontinence (SUI). Women treated by hysterectomy had more urinary tract infections (UTIs) than LNG-IUS users (OR 3.20, 95% CI 1.47-6.96, P = 0.002). Feeling of incomplete emptying (OR 3.00, 95% CI 1.00-9.05, P = 0.04) and SUI (OR 1.83, 95% CI 1.01-3.32, P = 0.04) were more common among women treated by hysterectomy. No differences between the study arms were noted in urge urinary incontinence or by the Urinary Incontinence Severity Score. A multivariate model showed that UTIs were associated with hysterectomy (P = 0.004). CONCLUSIONS: Hysterectomy increases the risks for incomplete emptying, lower UTIs and SUI.

Poor inter-observer agreement on the TASC II classification of femoropopliteal lesions.

OBJECTIVES: This study aims to evaluate the reproducibility of femoropopliteal TASC II classification and to analyse the influence of an educational intervention on inter-observer agreement. DESIGN: This is a validation study. MATERIALS: This study included 200 consecutive angiograms of femoropopliteal arterial lesions. METHODS: Seven investigators evaluated the first 100 angiograms, independently aided by the available TASC guide. Thereafter, the intervention included a discussion of the 25 most problematic cases, initially by a panel of 22 vascular surgeons, and later by the seven investigators to clarify grading principles. In the second stage, the 100 remaining cases were evaluated independently. A multi-rater variation of Brennan and Prediger's free-marginal kappa (kappa(free)) was used to calculate inter-observer agreement. RESULTS: There were lesions not fitting any of the TASC classes. Total agreement among all seven investigators was reached in 7% and 19% of the cases before and after the intervention, respectively. In the first stage, kappa(free) was 0.32 between all observers (range between two observers kappa(free)=0.11-0.54). The intervention increased the agreement to kappa(free)=0.49 (range: 0.20-0.56). Agreement between the two observers was 38-69% (mean 49%) before the intervention and 51-73% (mean 61%) thereafter. CONCLUSIONS: TASC II classification for femoropopliteal lesions allows individual interpretations, and the common use of this classification as a basis for decision making and reporting outcomes could therefore be questioned.

The effect of hysterectomy or levonorgestrel-releasing intrauterine system on sexual functioning among women with menorrhagia: a 5-year randomised controlled trial.

OBJECTIVE: To compare among women with menorrhagia the effect of hysterectomy or levonorgestrel-releasing intrauterine system (LNG-IUS) on sexual functioning. DESIGN: A randomised controlled trial. SETTING: Five university hospitals in Finland. SAMPLE: A total of 236 women, aged 35-49 years. METHODS: Of the women, 117 were treated by hysterectomy and 119 by LNG-IUS. MAIN OUTCOME MEASURES: Sexual functioning was evaluated by modified McCoy sexual scale at baseline and at 6 months, 12 months, and 5 years after initiation of treatment (hysterectomy or application of LNG-IUS). RESULTS: Among women treated by hysterectomy, sexual satisfaction increased and sexual problems decreased. Among LNG-IUS users, satisfaction with partner decreased. In addition to treatment modality (P = 0.02), estrogen therapy (P = 0.01), smoking (P = 0.001), night sweats (P = 0.03), vaginal dryness (P = 0.04), hot flushes (P = 0.01), and having someone to ask for advice (P = 0.03) and to share worries (P = 0.01) explained changes in sexual functioning. CONCLUSIONS: Among women with menorrhagia, hysterectomy improves sexual functioning, whereas LNG-IUS does not have such a positive effect.

A randomized controlled trial of hysterectomy or levonorgestrel-releasing intrauterine system in the treatment of menorrhagia-effect on FSH levels and menopausal symptoms.

BACKGROUND: The purpose of this study was to compare the effects of hysterectomy and a levonorgestrel-releasing intrauterine system (LNG-IUS) on serum FSH levels and menopausal symptoms. METHODS: A total of 236 women referred for menorrhagia to five university hospitals were randomly assigned to treatment with hysterectomy (n = 117) or LNG-IUS (n = 119). Menopausal symptoms were characterized by the Kupperman menopausal distress test. Serum FSH and estradiol levels were measured at baseline and 6 and 12 months after hysterectomy or application of LNG-IUS. Analyses were by intention to treat. RESULTS: After 6 months, there was no difference between the groups, but 12 months after follow-up hysterectomized women had higher FSH levels than women with LNG-IUS (P = 0.005). There was a significant association between FSH levels and treatment modality (P = 0.020). Hot flushes increased significantly in the hysterectomy group (P = 0.02). There was a significant association between hot flushes and both treatment modality and age (P = 0.02 and P = 0.01, respectively). CONCLUSION: Hysterectomy may impair ovarian function shown by rising serum FSH levels and hot flushes. However, these results should be interpreted with caution, and longer follow-up is needed.