Browsing by Subject "REVASCULARIZATION"

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  • Virtanen, Marko P. O.; Eskola, Markku; Jalava, Maina P.; Husso, Annastiina; Laakso, Teemu; Niemelä, Matti; Ahvenvaara, Tuomas; Tauriainen, Tuomas; Maaranen, Pasi; Kinnunen, Eeva-Maija; Dahlbacka, Sebastian; Jaakkola, Jussi; Vasankari, Tuija; Airaksinen, Juhani; Anttila, Vesa; Rosato, Stefano; D'Errigo, Paola; Savontaus, Mikko; Juvonen, Tatu; Laine, Mika; Mäkikallio, Timo; Valtola, Antti; Raivio, Peter; Biancari, Fausto (2019)
    IMPORTANCE Transcatheter aortic valve replacement (TAVR) has been shown to be a valid alternative to surgical aortic valve replacement (SAVR) in patients at high operative risk with severe aortic stenosis (AS). However, the evidence of the benefits and harms of TAVR in patients at low operative risk is still scarce. OBJECTIVE To compare the short-term and midterm outcomes after TAVR and SAVR in low-risk patients with AS. DESIGN, SETTING, AND PARTICIPANTS This retrospective comparative effectiveness cohort study used data from the Nationwide Finnish Registry of Transcatheter and Surgical Aortic Valve Replacement for Aortic Valve Stenosis of patients at low operative risk who underwent TAVR or SAVR with a bioprosthesis for severe AS from January 1, 2008, to November 30, 2017. Low operative risk was defined as a Society of Thoracic Surgeons Predicted Risk of Mortality score less than 3% without other comorbidities of clinical relevance. One-to-one propensity score matching was performed to adjust for baseline covariates between the TAVR and SAVR cohorts. EXPOSURES Primary TAVR or SAVR with a bioprosthesis for AS with or without associated coronary revascularization. MAIN OUTCOMES AND MEASURES The primary outcomes were 30-day and 3-year survival. RESULTS Overall, 2841 patients (mean [SD] age, 74.0 [6.2] years; 1560 [54.9%] men) fulfilled the inclusion criteria and were included in the analysis; TAVR was performed in 325 patients and SAVR in 2516 patients. Propensity score matching produced 304 pairs with similar baseline characteristics. Third-generation devices were used in 263 patients (86.5%) who underwent TAVR. Among these matched pairs, 30-day mortality was 1.3% after TAVR and 3.6% after SAVR (P=.12). Three-year survival was similar in the study cohorts (TAVR, 85.7%; SAVR, 87.7%; P=.45). Interaction tests found no differences in terms of 3-year survival between the study cohorts in patients younger than vs older than 80 years or in patients who received recent aortic valve prostheses vs those who did not. CONCLUSIONS AND RELEVANCE Transcatheter aortic valve replacement using mostly third-generation devices achieved similar short- and mid-term survival compared with SAVR in low-risk patients. Further studies are needed to assess the long-term durability of TAVR prostheses before extending their use to low-risk patients.
  • Wickstrom, Jan-Erik; Jalkanen, Juho M.; Venermo, Maarit; Hakovirta, Harri H. (2017)
    Background and aims: Limited data exist on the association of the anatomical distribution of atherosclerotic lesions and the extent of atherosclerosis at defined arterial segments with life expectancy. We recently presented a new classification of the extent of atherosclerosis in crural vessels and showed that Crural Index (CIx) was associated with mid-term survival of symptomatic peripheral artery disease (PAD) patients. This study evaluates the significance of the extent of crural atherosclerosis on long-term cardiovascular mortality. Methods: 887 consecutive patients with PAD, admitted for digital subtraction angiography (DSA) at Turku University Hospital Department of Vascular Surgery (Turku, Finland) between January 1st, 2009 and July 30th, 2011, were retrospectively analysed. Each crural angiographic image was graded according to CIx criteria. Aorto-iliac and femoro-popliteal arterial segments were similarly graded according to modified TASC II criteria. CIx was used as the categorical variable for the extent of atherosclerosis in crural vessels for survival analysis. Survival was also evaluated with respect to which arterial segment was most severely affected. Causes of death were provided by the Cause of Death Registry of Statistics Finland, updated on January 23rd, 2017. Results: Altogether, 408 (46%) patients died during follow-up. The majority of deaths were due to cardiovascular causes (n = 246, 60%). Cardiovascular mortality was strongly associated with a high CIx (CIx III (Hazard ratio (HR) 2.16, Confidence interval (CI) 95% 1.23-3.80, p = 0.007)) and CIx IV (HR 3.513, 95% CI 1.93-4.565, p <0.001), as compared to CIx 0. In patients having the crural segment as the most severely affected arterial segment, cardiovascular mortality was significantly increased (HR 2.321, 95% CI 1.45-3.73, p <0.001), as was overall mortality (HR 2.177, 95% CI 1.53-3.10, p <0.001). Conclusions: High Crural Index and extensive crural vessel atherosclerosis are associated with long-term cardiovascular mortality, and both may serve as useful indicators of survival among patients with symptomatic PAD. (c) 2017 Elsevier B.V. All rights reserved.
  • Wessels, Lars; Fekonja, Lucius Samo; Achberger, Johannes; Dengler, Julius; Czabanka, Marcus; Hecht, Nils; Schneider, Ulf; Tkatschenko, Dimitri; Schebesch, Karl-Michael; Schmidt, Nils Ole; Mielke, Dorothee; Hosch, Henning; Ganslandt, Oliver; Gräwe, Alexander; Hong, Bujung; Walter, Jan; Güresir, Erdem; Bijlenga, Philippe; Haemmerli, Julien; Maldaner, Nicolai; Marbacher, Serge; Nurminen, Ville; Zitek, Hynek; Dammers, Ruben; Kato, Naoki; Linfante, Italo; Pedro, Maria-Teresa; Wrede, Karsten; Wang, Wei-Te; Wostrack, Maria; Vajkoczy, Peter (2020)
    Background and objective The main challenge of bypass surgery of complex MCA aneurysms is not the selection of the bypass type but the initial decision-making of how to exclude the affected vessel segment from circulation. To this end, we have previously proposed a classification for complex MCA aneurysms based on the preoperative angiography. The current study aimed to validate this new classification and assess its diagnostic reliability using the giant aneurysm registry as an independent data set. Methods We reviewed the pretreatment neuroimaging of 51 patients with giant (> 2.5 cm) MCA aneurysms from 18 centers, prospectively entered into the international giant aneurysm registry. We classified the aneurysms according to our previously proposed Berlin classification for complex MCA aneurysms. To test for interrater diagnostic reliability, the data set was reviewed by four independent observers. Results We were able to classify all 51 aneurysms according to the Berlin classification for complex MCA aneurysms. Eight percent of the aneurysm were classified as type 1a, 14% as type 1b, 14% as type 2a, 24% as type 2b, 33% as type 2c, and 8% as type 3. The interrater reliability was moderate with Fleiss's Kappa of 0.419. Conclusion The recently published Berlin classification for complex MCA aneurysms showed diagnostic reliability, independent of the observer when applied to the MCA aneurysms of the international giant aneurysm registry.
  • IN.PACT Global Study Investigators; Venermo, Maarit (2018)
    OBJECTIVES The IN. PACT Global Study is the largest prospective, multicenter, independently adjudicated trial to evaluate a paclitaxel drug-coated balloon in patients with lifestyle-limiting claudication and/or ischemic rest pain due to atherosclerotic disease of the femoropopliteal artery and includes complex lesions beyond what are typically included in randomized controlled trials. BACKGROUND Randomized controlled trials have demonstrated the safety and efficacy of drug-coated balloons for the treatment of Trans-Atlantic Inter-Society Consensus Document II A and B lesions, but there is a need for large-scale prospective studies to evaluate a broader range of lesions. METHODS The IN. PACT Global Study enrolled 1,535 subjects, and 1,406 (1,773 lesions) were included in the pre-defined clinical cohort analysis. Freedom from clinically driven target lesion revascularization was evaluated at 24 months. The safety composite endpoint was freedom from device-and procedure-related death through 30 days and freedom from target limb major amputation and clinically driven target vessel revascularization within 24 months. RESULTS Mean lesion length was 12.1 cm, 35.5% were total occlusions, and 18.0% had in-stent restenosis. Freedom from clinically driven target lesion revascularization at 24 months was 83.3%, the composite safety endpoint was met in 81.7%, the 2-year all-cause mortality rate was 7.0%, and the major target limb amputation rate was 0.7%. Increased lesion length and the presence of de novo in-stent restenosis or coronary artery disease were associated with increased risk for clinically driven target lesion revascularization by 24 months. CONCLUSIONS This real-world study of femoropopliteal artery disease treatment with drug-coated balloons confirmed positive findings reported from more strictly designed randomized controlled trials and showed that outcomes are durable in this population up to 2 years after treatment. (c) 2018 The Authors. Published by Elsevier on behalf of the American College of Cardiology Foundation. This is an open access article under the CC BY-NC-ND license (
  • Leopold, Valentine; Gayat, Etienne; Pirracchio, Romain; Spinar, Jindrich; Parenica, Jiri; Tarvasmäki, Tuukka; Lassus, Johan; Harjola, Veli-Pekka; Champion, Sebastien; Zannad, Faiez; Valente, Serafina; Urban, Philip; Chua, Horng-Ruey; Bellomo, Rinaldo; Popovic, Batric; Ouweneel, Dagmar M.; Henriques, Jose P. S.; Simonis, Gregor; Levy, Bruno; Kimmoun, Antoine; Gaudard, Philippe; Basir, Mir Babar; Markota, Andrej; Adler, Christoph; Reuter, Hannes; Mebazaa, Alexandre; Chouihed, Tahar (2018)
    Catecholamines have been the mainstay of pharmacological treatment of cardiogenic shock (CS). Recently, use of epinephrine has been associated with detrimental outcomes. In the present study we aimed to evaluate the association between epinephrine use and short-term mortality in all-cause CS patients. We performed a meta-analysis of individual data with prespecified inclusion criteria: (1) patients in non-surgical CS treated with inotropes and/or vasopressors and (2) at least 15% of patients treated with epinephrine administrated alone or in association with other inotropes/vasopressors. The primary outcome was short-term mortality. Fourteen published cohorts and two unpublished data sets were included. We studied 2583 patients. Across all cohorts of patients, the incidence of epinephrine use was 37% (17-76%) and short-term mortality rate was 49% (21-69%). A positive correlation was found between percentages of epinephrine use and short-term mortality in the CS cohort. The risk of death was higher in epinephrine-treated CS patients (OR [CI] = 3.3 [2.8-3.9]) compared to patients treated with other drug regimens. Adjusted mortality risk remained striking in epinephrine-treated patients (n = 1227) (adjusted OR = 4.7 [3.4-6.4]). After propensity score matching, two sets of 338 matched patients were identified and epinephrine use remained associated with a strong detrimental impact on short-term mortality (OR = 4.2 [3.0-6.0]). In this very large cohort, epinephrine use for hemodynamic management of CS patients is associated with a threefold increase of risk of death.
  • Kallio, Mika; Korkeila, Jyrki; Malmberg, Markus; Gunn, Jarmo; Rautava, Päivi; Korhonen, Paivi; Kytö, Ville (2022)
    Background Patients with schizophrenia spectrum disorder have increased risk of coronary artery disease. Aims To investigate long-term outcomes of patients with schizophrenia spectrum disorder and coronary artery disease after coronary artery bypass grafting surgery (CABG). Method Data from patients with schizophrenia spectrum disorder (n = 126) were retrospectively compared with propensity-matched (1:20) control patients without schizophrenia spectrum disorder (n = 2520) in a multicentre study in Finland. All patients were treated with CABG. The median follow-up was 7.1 years. The primary outcome was all-cause mortality. Results Patients with diagnosed schizophrenia spectrum disorder had an elevated risk of 10-year mortality after CABG, compared with control patients (42.7 v. 30.3%; hazard ratio 1.56; 95% CI 1.13-2.17; P = 0.008). Schizophrenia spectrum diagnosis was associated with a higher risk of major adverse cardiovascular events during follow-up (49.9 v. 32.6%, subdistribution hazard ratio 1.59; 95% CI 1.18-2.15; P = 0.003). Myocardial infarction (subdistribution hazard ratio 1.86; P = 0.003) and cardiovascular mortality (subdistribution hazard ratio 1.65; P = 0.017) were more frequent in patients with versus those without schizophrenia spectrum disorder, but there was no difference for stroke. Psychiatric ward admission, antipsychotic medication, antidepressant use and benzodiazepine use before CABG were not associated with outcome differences. After CABG, patients with schizophrenia spectrum disorder received statin therapy less often and had lower doses; the use of other cardiovascular medications was similar between schizophrenia spectrum and control groups. Conclusions Patients with schizophrenia spectrum disorder have higher long-term risks of death and major adverse cardiovascular events after CABG. The results underline the vulnerability of these patients and highlight the importance of intensive secondary prevention and risk factor optimisation.
  • Katsanos, Konstantinos; Spiliopoulos, Stavros; Teichgraeber, Ulf; Kitrou, Panagiotis; Del Giudice, Costantino; Björkman, Patrick; Bisdas, Theodosios; de Boer, Sanne; Krokidis, Miltiadis; Karnabatidis, Dimitrios (2022)
    Objective: There have been concerns about the long term safety of paclitaxel coated devices in the lower limbs. A formal systematic review and meta-analysis of randomised controlled trials (RCTs) was performed to examine the long term risk of major amputation using paclitaxel coated balloons in peripheral arterial disease (PAD). Method: This systematic review was registered with PROSPERO (ID 227761). A broad bibliographic search was performed for RCTs investigating paclitaxel coated balloons in the peripheral arteries (femoropopliteal and infrapopliteal) for treatment of intermittent claudication or critical limb ischaemia (CLI). The literature search was last updated on 20 February 2021 without any restrictions on publication language, date, or status. Major amputations were analysed with time to event methods employing one and two stage models. Sensitivity and subgroup analyses, combinatorial meta-analysis, and a multivariable dose response meta-analysis to examine presence of a biological gradient were also performed. Results: In all, 21 RCTs with 3 760 lower limbs were analysed (52% intermittent claudication and 48% CLI; median follow up two years). There were 87 major amputations of 2 216 limbs in the paclitaxel arms (4.0% crude risk) compared with 41 major amputations in 1 544 limbs in the control arms (2.7% crude risk). The risk of major amputation was significantly higher for paclitaxel coated balloons with a hazard ratio (HR) of 1.66 (95% CI 1.14 - 2.42; p = .008, one stage stratified Cox model). The prediction interval was 95% CI 1.10 - 2.46 (two stage model). The observed amputation risk was consistent for both femoropopliteal (p = .055) and infrapopliteal (p = .055) vessels. Number needed to harm was 35 for CLI. There was good evidence of a significant non-linear dose response relationship with accelerated risk per cumulative paclitaxel dose (chi square model p = .007). There was no evidence of publication bias (p = .80) and no significant statistical heterogeneity between studies (I-2 = 0%, p = .77). Results were stable across sensitivity analyses (different models and subgroups based on anatomy and clinical indication and excluding unpublished trials). There were no influential single trials. Level of certainty in evidence was downrated from high to moderate because of sparse events in some studies. Conclusion: There appears to be heightened risk of major amputation after use of paclitaxel coated balloons in the peripheral arteries. Further investigations are warranted urgently.
  • Aro, Ellinoora; Ijas, Petra; Vikatmaa, Leena; Soinne, Lauri; Sund, Reijo; Venermo, Maarit; Vikatmaa, Pirkka (2019)
    Objective: Considering carotid endarterectomy (CEA), reporting treatment delay, symptom status, and surgical complication rates separately gives an incomplete picture of efficacy; therefore, the aim was to combine these factors and develop a reporting standard that better describes the number of potentially prevented strokes. With a real life cohort and theoretical inclusion scenarios, the aim was to explore the stroke prevention potential of different carotid practices. Methods: Landmark studies for symptomatic and asymptomatic patients were revisited. By using published estimates of treatment effect, a simplified calculator was designed to assess the five year stroke prevention rate per 1000 CEAs (stroke prevention potential [SPP], range 0-478), including the presence and recentness of symptoms, sex, increasing stenosis severity, and complication rates. Patients operated on for carotid stenosis at Helsinki University Hospital (HUH) between 2008 and 2016 were collected from a vascular registry (HUSVASC) and categorised according to the model. The local annual complication rate was re-evaluated and added to the model. The HUH patient cohort was incorporated into the SPP model, and changes over time analysed. Finally, theoretical changes in patient selection were compared in order to explore the theoretical impact of patient selection and shortening of the delay. Results: Fifteen hundred and five symptomatic and 356 asymptomatic carotid stenoses were operated on with stroke plus death rates of 3.6% and 0.3%, respectively. The proportion of CEAs performed within two weeks of the index event increased over the follow up period, being 77% in 2016. The SPP increased from 123 in 2008 to 229 in 2016. Theoretically, 350 ischaemic strokes were prevented in the period 2008-16, with 1861 CEAs. Conclusions: National and international comparison of different CEA series is irrelevant if the inclusion criteria are not considered. A calculator that is easy to apply to large scale high quality registered data was developed and tested. SPP was found to increase over time, which is a probable sign of improved patient selection and an increased number of strokes prevented by the CEAs performed.
  • Jalkanen, Juho M.; Wickstrom, Jan-Erik; Venermo, Maarit; Hakovirta, Harri H. (2016)
    Background and aims: Several studies report correlation of ankle brachial index (ABI) values and mortality. However, no studies exist on the predictive value of anatomical distribution of atherosclerotic lesions and the extent of atherosclerosis at defined arterial segments on life expectancy. The aim of the present study was to evaluate the significance of both extent and localisation of atherosclerotic lesions to mid-term patient survival. Methods: Digital subtraction angiography (DSA) images of 887 consecutive patients admitted to the Department of Vascular Surgery at Turku University Hospital (Turku, Finland) were retrospectively analysed. Each angiography was classified according to the TASC II classification for aorto-iliac and femoro-popliteal segments, and a similar four-grade index was created for crural arteries. Patients were followed until 36-months post DSA. Results: During 36-month follow-up 295 (33%) deaths occurred. Death during follow-up was strongly associated with extensive crural disease, but not with extensive proximal disease (Crural Index p = 0.044 and <0.001, respectively). In a Cox regression analysis incorporating baseline variables, Crural Index IV and most severe atherosclerosis on crural vessels were the strongest predictors of poor prognosis (HR 2.20 95% CI 1.3-3.7, p = 0.003 and HR 2.45 95% CI 1.5-4.0, p <0.001 respectively). Conclusions: The extent of crural atherosclerosis is independently associated with poor mid term life expectancy. Therefore, a classification of the extent of crural atherosclerosis could serve as an indicator of mortality among PAD patients and aid in clinical decision making. (C) 2016 Elsevier Ireland Ltd. All rights reserved.
  • Helve, Salla; Nieminen, Tuomo; Helanterä, Ilkka; Finne, Patrik; Rajala, Helena; Sinisalo, Juha; Laine, Mika (2020)
    Abstract The value of myocardial single-photon emission computed tomography (SPECT) in pre-transplant evaluation of kidney transplant recipients is controversial. We assessed whether myocardial SPECT predicts major adverse cardiac events (MACE) and determined whether SPECT findings affected transplant recipients? medical and invasive treatment. We analyzed 301 patients referred for myocardial SPECT before kidney transplantation and combined the results with information from patient files and the Transplantation registry. During the median follow-up time of 96 months (IQR 70.75-118.25 months), the incidence of MACE was higher in patients (n=37) with severely abnormal SPECT (>10 % reversible perfusion defect) than in patients (n=35) with mildly abnormal or normal SPECT (51.4%, 29.4% and 27.0%, respectively, p=0.011). Severely abnormal SPECT findings predicted long-term MACE in a univariable analysis but not after adjusting for other risk factors. Following SPECT, 29 patients (9.6%) underwent coronary angiography and 14 (4.6%) were revascularized. New antithrombotic or statin medication was prescribed to 7.3% of patients with ischemia in SPECT. Kidney transplantation patients are at high long-term risk of MACE even with normal preoperative myocardial SPECT. Abnormal SPECT did not predict MACE when adjusted for other risk factors. Minority of the patients underwent coronary revascularization or had changes in preventive medication before transplantation.
  • Wickstrom, J. -E.; Laivuori, Mirjami; Aro, E.; Sund, R. T.; Hautero, O.; Venermo, Maarit; Jalkanen, J.; Hakovirta, H. (2017)
    Objective/Background: Peripheral haemodynamic parameters are used to assess the presence and severity of peripheral artery disease (PAD). The prognostic value of ankle brachial index (ABI) has been thoroughly delineated. Nonetheless, the relative usefulness of ankle pressure (AP), ABI, toe pressure (TP), and toe brachial index (TBI) in assessing patient outcome has not been investigated in a concurrent study setting. This study aimed to resolve the association of all four non-invasive haemodynamic parameters in clinically symptomatic patients with PAD with cardiovascular mortality, overall mortality, and amputation free survival (AFS). Methods: In total, 732 symptomatic patients with PAD admitted to the Department of Vascular Surgery for conventional angiography at Turku University Hospital, Turku, Finland, between January 2009 and August 2011 were reviewed retrospectively. Demographic factors, cardiovascular mortality, all-cause mortality, and above foot level amputations were obtained and assessed in relation to AP, ABI, TP, and TBI by means of Kaplan-Meier life tables and a multivariate Cox regression model. Results: The haemodynamic parameter that was associated with poor 36 month general outcome was TP <30 mmHg. Univariate Cox regression analysis of stratified values showed that TP and TBI associated significantly with mortality. In multivariate analysis both TP and TBI were associated with a significant risk of death. For TP <30 mmHg and TBI <0.25 the risk of cardiovascular mortality was hazard ratio [HR] 2.84, 95% confidence interval [CI] 1.75-4.61 [p Conclusion: Among non-invasive haemodynamic measurements and pressure indices both TP and TBI appear to be associated with cardiovascular and overall mortality and AFS for patients with PAD presenting symptoms of the disease. (C) 2017 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.