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    Aging and cardiac implantable electronic device complications: is the procedure safe in older patients?
    (Springer, 2023) Guzel, Tuncay; Aktan, Adem; Kilic, Raif; Gunlu, Serhat; Arslan, Bayram; Arpa, Abdulkadir; Guzel, Hamdullah
    BackgroundIn this study, we investigated whether there is a higher incidence of cardiac implantable electronic devices (CIED) procedures related complications in older (& GE; 75 years) than in younger (< 75 years) patients.MethodsThis retrospective cohort study enrolled patients who had undergone CIED procedures (de novo implantation, system upgrade, generator substitution, pocket revision or lead replacement) at two heart centers in Turkey between January 2011 and May 2023. The primary composite endpoint included clinically significant hematoma (CSH), pericardial effusion or tamponade, pneumothorax, and infection related to the device system. Secondary outcomes included each component of the composite end point.ResultsThe overall sample included 1923 patients (1419 < 75 years and 504 aged & GE; 75 years). There was no difference between the groups in terms of cumulative events defined as primary outcome (3.5% vs. 4.4%, p = 0.393). Infection related to device system was significantly higher in the & GE; 75 age group (1.8% vs. 3.4%, p = 0.034). There was no significant difference between the groups in terms of clinically significant hematoma and pneumothorax (0.7% vs. 0.4%, p = 0.451, 1.4% vs. 1.0%, p = 0.477, respectively). In multivariate model analysis, no association was found between age & GE; 75 years and infection related to the device system.ConclusionInfection rates were relatively higher in the patient group aged & GE; 75 years. This patient group should be evaluated more carefully in terms of infection development before and after the procedure.
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    Comparison of Evolut-R 34 mm Valve and Smaller Evolut-R Valves in Patients Undergoing Transcatheter Aortic Valve Implantation and Determination of Mild Paravalvular Leak Predictors
    (Kare Publ, 2024) Kilic, Raif; Guzel, Tuncay; Aktan, Adem; Demir, Muhammed; Gunlu, Serhat; Arslan, Bayram; Ertas, Faruk
    Objective: The main purpose of this study was to evaluate and compare the in -hospital, 1 -month and 1 -year post -procedure outcomes of patients treated with Evolut-R 34 mm and Evolut-R 23/26/29 mm devices. Additionally, the study aimed to identify factors that could predict the occurrence of >= mild paravalvular leaks (PVL). Methods: Between April 2015 and May 2022, 269 consecutive patients who underwent transcatheter aortic valve implantation (TAVI) with Evolut-R 34 mm (n = 66, 24.5%) and Evolut-R 23/26/29 mm (n = 203, 75.5%) devices in a single center were retrospectively analyzed. Results: Patients in the Evolut-R 34 mm group had a lower female sex ratio (16.7% vs. 66.5%, P < .001, respectively), ejection fraction (50.7 +/- 10.1% vs. 54.5 +/- 9.3%, P = .016, respectively), and mean aortic gradient (7.4 +/- 3.3 vs. 9.2 +/- 5.0, P = .026, respectively) compared to the Evolut-R 23/26/29 mm group. The groups did not exhibit any statistically significant distinctions with regard to technical success, the need for a permanent pacemaker, occurrences of stroke, major vascular complications, PVL, major adverse cardiovascular and cerebrovascular events, or mortality. Peak velocity was confirmed as a significant pre- dictor of >= mild PVL in both patient groups in the receiver operating characteristic curve analysis. In logistic regression analysis; In patients with Evolut-R 34 mm valve, pre-TAVI aortic valve peak velocity (odds ratio (OR) = 23.202; P = .019) and calcium volume 800 Hounsfield Units (mm(3)) (OR = 1.017; P < .001) were independent predictors of >= mild PVL. Conclusion: The Evolut-R 34 mm valve has shown comparable in -hospital results with smaller valve sizes. Pre-TAVI aortic valve peak velocity and calcium volume predicted >= mild PVL in Evolut-R 34 mm patients.
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    Comparison of tenecteplase versus alteplase in STEMI patients treated with ticagrelor: A cross-sectional study
    (W B Saunders Co-Elsevier Inc, 2022) Gunlu, Serhat; Demir, Muhammed
    Background: The effectiveness and safety of administration of ticagrelor simultaneously with fibrinolytic agents in STEMI patients remain unclear.Objective: This study aimed to investigate the effectiveness and safety of tenecteplase against alteplase in patients with STEMI receiving a loading dose of ticagrelor.Methods: We conducted a cross-sectional study in patients with STEMI who were reperfused with fibrinolytic. The study included 150 patients (ages 18 to 75 years) administered tenecteplase or alteplase and concomitantly given ticagrelor [180 mg loading dose, 90 mg bid (bis in die)]. Patients who had active major bleeding, died, and who were decided to have a CABG surgery as a result of coronary angiography were excluded. Patients who underwent facilitated-PCI with fibrinolysis continued to receive ticagrelor without switching to clopidogrel. The MACE (in-hospital death, TIMI flow grade, major bleeding) rates of the two groups were compared.Results: The study consisted of 150 patients, comprising 99 (66%) men and 51 women (34%) with a mean age of 60,33 +/- 13,83 years. Patients were divided into two groups according to the thrombolytic therapy: alteplase (n = 60) and tenecteplase (n = 90). The major adverse cardiac events (MACE) (45% vs 22.2%), bleeding (11.7% vs 2.2%), hypertension (51.7% vs 30%), atrial fibrillation (26.7% vs 12.2%), left ventricular hypertrophy (26.7% vs 10%), CRP (p < 0.001) were significantly higher and the recanalization (66.7% vs 85.4%), hematocrit (p = 0.03) were significantly lower in the alteplase group compared to the tenecteplase group. No significant differences were found between the two groups about in-hospital mortality (p = 0.151). Kaplan Meier analysis was performed in terms of MACE (TIMI flow grade 1, major bleeding, in-hospital mortality) rates during the followup period (Log-rank test, p = 0.032). Patients who received tenecteplase treatment had a lower MACE, according to a Kaplan-Meier analysis.Conclusions: The administration of tenecteplase in STEMI patients who received a loading dose with ticagrelor resulted in a significant reduction in MACE compared to alteplase. Larger multi-center studies are warranted to investigate the effect of tenecteplase treatment on clinical results.(c) 2022 Elsevier Inc. All rights reserved.
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    Comparison of the real-life clinical outcomes of warfarin with effective time in therapeutic range and non-vitamin K antagonist oral anticoagulants: Insight from the AFTER-2 trial
    (Polish Cardiac Soc, 2023) Aktan, Adem; Guzel, Tuncay; Aslan, Burhan; Kilic, Raif; Gunlu, Serhat; Ozbek, Mehmet; Arslan, Bayram
    Background: It is unclear whether warfarin treatment with high time in therapeutic range (TTR) is as effective and safe as non-vitamin K antagonist oral anticoagulants (NOACs). It is crucial to compare warfarin with effective TTR and NOACs to predict long-term adverse events in patients with atrial fibrillation. Aims: We aimed to compare the long-term follow-up results of patients with atrial fibrillation (AF) who use vitamin K antagonists (VKAs) with effective TTR and NOACs. Methods: A total of 1140 patients were followed at 35 different centers for five years. During the follow-up period, the international normalized ratio (INR) values were studied at least 4 times a year, and the TTR values were calculated according to the Roosendaal method. The effective TTR level was accepted as >60% as recommended by the guidelines. There were 254 patients in the effective TTR group and 886 patients in the NOAC group. Ischemic cerebrovascular disease/transient ischemic attack (CVD/TIA), intracranial bleeding, and mortality were considered primary endpoints based on one-year and five-year follow-ups. Results: Ischemic CVD/TIA (3.9% vs. 6.2%; P = 0.17) and intracranial bleeding (0.4% vs. 0.5%; P = 0.69), the one-year mortality rate (7.1% vs. 8.1%; P = 0.59), the five-year mortality rate (24% vs. 26.3%; P = 0.46) were not different between the effective TTR and NOACs groups during the follow-up, respectively. The CHA2DS2-VASC score was similar between the warfarin with effective TTR group and the NOAC group (3 [2-4] vs. 3 [2-4]; P = 0.17, respectively). Additionally, survival free-time did not differ between the warfarin with effective TTR group and each NOAC in the Kaplan-Meier analysis (dabigatran; P = 0.59, rivaroxaban; P = 0.34, apixaban; P = 0.26, and edoxaban; P = 0.14). Conclusion: There was no significant difference in primary outcomes between the effective TTR and NOAC groups in AF patients.
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    The Effect of Aortic Angulation on Clinical Outcomes of Patients Undergoing Transcatheter Aortic Valve Replacement
    (Soc Brasil Cirurgia Cardiovasc, 2024) Aktan, Adem; Demir, Muhammed; Guzel, Tuncay; Karahan, Mehmet Zulkuf; Aslan, Burhan; Kilic, Raif; Gunlu, Serhat
    Introduction: The aim of this study was to assess the impact of aortic angulation (AA) on periprocedural and in -hospital complications as well as mortality of patients undergoing Evolut (TM) R valve implantation. Methods: A retrospective study was conducted on 264 patients who underwent transfemoral-approach transcatheter aortic valve replacement with self-expandable valve at our hospital between August 2015 and August 2022. These patients underwent multislice computer tomography scans to evaluate AA. Transcatheter aortic valve replacement endpoints, device success, and clinical events were assessed according to the definitions provided by the Valve Academic Research Consortium -3. Cumulative events included paravalvular leak, permanent pacemaker implantation, new-onset stroke, and in -hospital mortality. Patients were divided into two groups, AA <= 48(degrees) and AA > 48(degrees), based on the mean AA measurement (48.3 +/- 8.8) on multislice computer tomography. Results: Multivariable logistic regression analysis was performed to identify predictors of cumulative events, utilizing variables with a P-value < 0.2 obtained from univariable logistic regression analysis, including AA, age, hypertension, chronic renal failure, and heart failure. AA (odds ratio [OR]: 1.73, 95% confidence interval [CI]: 0.89-3.38, P=0.104), age (OR: 1.04, 95% CI: 0.99-1.10, P=0.099), hypertension (OR: 1.66, 95% CI: 0.82-3.33, P=0.155), chronic renal failure (OR: 1.82, 95% CI: 0.92-3.61, P=0.084), and heart failure (OR: 0.57, 95% CI: 0.27-1.21, P=0.145) were not found to be significantly associated with cumulative events in the multivariable logistic regression analysis. Conclusion: This study demonstrated that increased AA does not have a significant impact on intraprocedural and periprocedural complications of patients with new generation self-expandable valves implanted.
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    The effect of body mass index on complications in cardiac implantable electronic device surgery
    (Wiley, 2024) Guzel, Tuncay; Demir, Muhammed; Aktan, Adem; Kilic, Raif; Arslan, Bayram; Gunlu, Serhat; Altintas, Bernas
    Background Cardiac implantable electronic device (CIED) procedures are prone to complications. In our study, we investigated the effect of body mass index (BMI) on CIED-related complications.Methods1676 patients who had undergone CIED surgery (de novo implantation, system upgrade, generator change, pocket revision or lead replacement) at two heart centers in Turkey and met the study criteria were included in our study. For analysis of primary and secondary endpoints, patients were classified as non-obese (BMI < 25 kg/m(2)), overweight (25 <= BMI < 30 kg/m(2)), and obese (BMI >= 30 kg/m(2)). The primary endpoint was accepted as cumulative events, including the composite of clinically significant hematoma (CSH), pericardial effusion or tamponade, pneumothorax, and infection related to the device system. Secondary outcomes included each component of cumulative events.Results The rate of cumulative events, defined as primary outcome, was higher in the obese patient group, and we found a significant difference between the groups (3.0%, 4.3%, 8.9%, p = .001). CSH and pneumothorax rates were significantly higher in the obese patient group (0.3%, 0.9%, 1.9%, p = .04; 1.0%, 1.4%, 3.3%, p = .04, respectively). According to our multivariate model analysis; gender (OR:1.882, 95%CI:1.156-3.064, p = .01), hypertension (OR:4.768, 95%CI:2.470-9.204, p < .001), BMI (OR:1.069, 95%CI:1.012-1.129, p = .01) were independent predictors of cumulative events rates.Conclusions Periprocedural complications associated with CIED (especially hematoma and pneumothorax) are more common in the group with high BMI.
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    Evaluation of Hematological Parameters After Transcatheter Aortic Valve Replacement
    (Sage Publications Inc, 2023) Karahan, Mehmet Zulkuf; Aktan, Adem; Guzel, Tuncay; Kilic, Raif; Gunlu, Serhat; Demir, Muhammed; Ertas, Faruk
    Although transcatheter aortic valve replacement (TAVR) is safe and effective, mortality and bleeding events post procedure are important. The present study investigated the changes in hematologic parameters to evaluate whether they predict mortality or major bleeding. We enrolled 248 consecutive patients (44.8% male; mean age 79.0 +/- 6.4 years) undergoing TAVR. In addition to demographic and clinical examination, blood parameters were recorded before TAVR, at discharge, 1 month and 1 year. Hemoglobin levels before TAVR 12.1 +/- 1.8 g/dL, 10.8 +/- 1.7 g/dL at discharge, 11.7 +/- 1.7 g/dL at first month, 11.8 +/- 1.4 g/dL at first year (Hemoglobin values compared with pre-TAVR, P < .001, P = .019, P = .047, respectively). Mean platelet volume (MPV) before TAVR 8.72 +/- 1.71 fL, 8.16 +/- 1.46 fL at discharge, 8.09 +/- 1.44 fL at first month, 7.94 +/- 1.18 fL at first year (MPV values compared with pre-TAVR, P < .001, P < .001, P < .001, respectively). Other hematologic parameters were also evaluated. Hemoglobin, platelet count, MPV, and red cell distribution width before the procedure, at discharge, and at the first year did not predict mortality and major bleeding in receiver operating characteristic analysis. After multivariate Cox regression analysis, hematologic parameters were not independent predictors of in-hospital mortality, major bleeding, and death at 1 year after TAVR.