| 1. |
- Koutouzis, Michael, 1973, et al.
(author)
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Radial vs. femoral approach for primary percutaneous coronary intervention in octogenarians.
- 2010
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In: Cardiovascular revascularization medicine : including molecular interventions. - : Elsevier BV. - 1878-0938 .- 1553-8389. ; 11:2, s. 79-83
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Journal article (peer-reviewed)abstract
- BACKGROUND: The transradial approach is associated with fewer bleeding complications during percutaneous coronary interventions (PCIs) but is more technically challenging and associated with prolonged times during intervention. The aim of this study is to retrospectively compare the results of radial vs. femoral approach in patients >or=80 years old undergoing primary or rescue PCI. METHODS: Between January 2002 and December 2007, 354 interventions were performed in our institution with the indication of primary or rescue PCI in patients over 80 years old, without history of previous bypass operation or cardiogenic shock on presentation. Thirteen patients required a change of the approach during the procedure and were not enrolled in the final analysis. Forty (12%) interventions were performed through the transradial approach and 301 (88%) through the femoral approach. In-hospital major adverse cerebral and cardiac events and access site bleeding complications as well as 30- and 365-day mortality, procedural times, and contrast volume were evaluated. RESULTS: The two groups had similar clinical characteristics, with the exception of serum creatinine that was higher in the transfemoral approach group. There were no differences in procedural times and clinical outcomes, although the transfemoral group had numerically more access site bleeding complications (12/301 vs. 0/40, P=.41). The transradial approach had a higher conversion rate compared with the transfemoral approach (18.3% vs. 1.3%, P<.001). CONCLUSION: The transradial approach is feasible and safe in the octogenarians undergoing primary and rescue PCI, but it is associated with a high conversion rate to another approach.
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| 2. |
- Mohammad, Moman A., et al.
(author)
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On the Natural History of Coronary Artery Disease : A Longitudinal Nationwide Serial Angiography Study
- 2022
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In: Journal of the American Heart Association. - : John Wiley & Sons. - 2047-9980. ; 11:21
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Journal article (peer-reviewed)abstract
- Background: The long-term course of coronary atherosclerosis has not been studied in large nationwide cohorts. Understanding the natural history of coronary atherosclerosis could help identify patients at risk for future coronary events.Methods and Results: All coronary artery segments with <50% luminal stenosis in patients with a first-time coronary angiogram between 1989 and 2017 were identified (n=2 661 245 coronary artery segments in 248 736 patients) and followed until a clinically indicated angiography within 15 years was performed or until death or end of follow-up (April 2018) using SCAAR (Swedish Coronary Angiography and Angioplasty Registry). The stenosis progression and incidence rates were 2.6% and 1.45 (95% CI, 1.43-1.46) per 1000 segment-years, respectively. The greatest progression rate occurred in the proximal and middle segments of the left anterior descending artery. Male sex and diabetes were associated with a 2-fold increase in risk, and nearly 70% of new stenoses occurred in patients with baseline single-vessel disease (hazard ratio, 3.86 [95% CI, 3.69-4.04]). Coronary artery segments in patients with no baseline risk factors had a progression rate of 0.6% and incidence rate of 0.36 (95% CI, 0.34-0.39), increasing to 8.1% and 4.01 (95% CI, 3.89-4.14) per 1000 segment-years, respectively, in patients with ≥4 risk factors. The prognostic impact of risk factors on stenosis progression was greatest in younger patients and women.Conclusions: Coronary atherosclerosis progressed slowly but more frequently in the left coronary artery in men and in the presence of traditional risk factors. Coronary artery segments in patients without risk factors had little or no risk of stenosis progression, and the relative impact of risk factors appears to be of greater importance in younger patients and women. These findings help in the understanding the long-term course of coronary atherosclerosis.
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| 3. |
- Biasco, Luigi, et al.
(author)
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First-in-Man Experience with the ClearLumen Thrombectomy System as an Adjunctive Therapy in Primary Percutaneous Coronary Interventions
- 2016
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In: Journal of Interventional Cardiology. - : Wiley. - 0896-4327. ; 29:2, s. 155-161
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Journal article (peer-reviewed)abstract
- Objectives To describe the first-in-man experience with the ClearLumen Thrombectomy System (Walk Vascular, Irvine, CA) and report on its safety, feasibility and efficacy when used as an adjunctive therapy during primary PCI. Background Thrombus aspiration (TA) aims to improve microvascular perfusion but currently available devices are not optimal. Methods Prospective, single-centre, non-randomized, safety, and efficacy trial. Patients with acute STEMI were enrolled and the investigational device was used for thrombus aspiration. Safety was evaluated as the overall rate of device related complications while efficacy as the rate of successful device deployment and culprit vessel reperfusion. The composite endpoint based on the achievement of at least two of the following three criteria - TIMI flow 3 and/or myocardial blush grade ≥2 at completion of the case and ST-resolution >70% at 90 minutes after vessel reperfusion - was also evaluated. Results Over a 3 months period 20 patients were enrolled in the study. Culprit lesion was successfully reached with the investigational device in 19 patients (95%). The pre-specified combined endpoint was met in 16 out of 19 patients (84.2%). Three patients not meeting the combined end point had procedure related, non TA associated, adverse event. Only 2 minor procedural adverse event occurred after thrombus aspiration. Conclusions This first-in-man experience with the ClearLumen Thrombectomy System demonstrates initial promising results on safety and efficacy when used as an adjunctive therapy during primary PCI. (J Interven Cardiol 2016;29:155-161)
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| 4. |
- Birkemeyer, Ralf, et al.
(author)
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Sealing of coronary perforations with a second-generation covered stent graft - Results from the PAST-PERF registry
- 2021
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In: Cardiovascular Revascularization Medicine. - : Elsevier BV. - 1553-8389. ; 25, s. 20-26
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Journal article (peer-reviewed)abstract
- Background: The PAST-PERF registry was initiated to collect data on the PK Papyrus covered stent, a second-generation device for the treatment of coronary artery perforations with enhanced mechanical properties, but with limited available data. Methods: Patients treated for coronary artery perforations with the PK Papyrus stent at 14 international centers were retrospectively identified. The primary effectiveness outcome was successful sealing of the perforation. The primary safety outcome was a composite of all-cause mortality, definite or probable stent thrombosis, myocardial infarction and target lesion revascularization. Results: Among the 94 included patients, 72.3% (68/94) had Ellis type III and cavity spilling perforations. Complete sealing was achieved in 93.6% (n = 88), and no sealing could be achieved in 3.2% (n = 3, including one patient with a geographical miss and one patient in whom the device could not be implanted). Pericardiocentesis was required in 25.0% (n = 23), emergency cardiac surgery was needed in 7.6% (n = 7), acute stent thrombosis was observed in 1.1% (n = 1), and in-hospital mortality occurred in 11.7% (n = 11). The median follow-up duration was 283 (IQR:40;670) days. At 6 and 12 months, the incidence of the primary safety endpoint was 26.6% [95%CI:18.6;37.1] and 32.0% [95%CI:22.8;43.4], mortality 15.0% [95%CI:9.0;24.6] and 19.0% [95%CI:11.3;30.0], and target lesion revascularization 5.5% [95%CI:2.0;14.6] and 7.7% [95%CI:3.1;18.2]. Two definite stent thrombosis occurred, one during the procedure and one on post-procedure day 233. Conclusions: The registry demonstrates favorably high rates of successful stent delivery and sealing of coronary perforations using a second-generation covered stent with low target lesion revascularization and stent thrombosis rates. Annotated table of content: The PAST-PERF registry demonstrates favorably high rates of successful stent delivery and sealing of coronary perforations using a second-generation covered stent with low target lesion revascularization and stent thrombosis rates. Specifically, complete sealing was achieved in 93.6% of patients (n = 88/94), and no sealing could be achieved in 3.2% (n = 3, including one patient with a geographical miss and one patient in whom the device could not be implanted). The 12-month mortality was 19.0% [95%CI:11.3;30.0], the rate of target lesion revascularization was 7.7% [95%CI:3.1;18.2], and two definite stent thromboses occurred (one during procedure and one on post-procedure day 233).
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| 5. |
- Bjursten, Henrik, et al.
(author)
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The safety of introducing a new generation TAVR device : One departments experience from introducing a second generation repositionable TAVR
- 2017
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In: BMC Cardiovascular Disorders. - : Springer Science and Business Media LLC. - 1471-2261. ; 17:1
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Journal article (peer-reviewed)abstract
- Background: In the evolving field of transcatheter aortic valve replacements a new generation of valves have been introduced to clinical practice. With the complexity of the TAVR procedure and the unique aspects of each TAVR device, there is a perceived risk that changing or adding a new valve in a department could lead to a worse outcome for patients, especially during the learning phase. The objective was to study the safety aspect of introducing a second generation repositionable transcatheter valve (Boston Scientific Lotus valve besides Edwards Sapien valve) in a department. Methods: In a retrospective study, 53 patients receiving the Lotus system, and 47 patients receiving the Sapien system over a period of three years were compared for short-term outcome according to VARC-2 definitions and 1-year survival. Results: Outcome in terms VARC-2 criteria for early safety and clinical efficacy, stroke rate, and survival at 30 days and at 1 year were similar. The Lotus valve had less paravalvular leakage, where 90% had none or trace aortic insufficiency as compared to only 48% for the Sapien system. Conclusions: Introduction of a new generation valve can be done with early device success and safety, and without jeopardizing the outcome for patients up to one year. We found no adverse effects by changing valve type and observed improved outcome in terms of lower PVL-rates. Both existing and new centers starting a TAVR program can benefit from the use of a new generation device.
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| 6. |
- Bondesson, Per, et al.
(author)
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Comparison of two drug-eluting balloons : a report from the SCAAR registry
- 2012
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In: EuroIntervention. - : Europa Edition. - 1774-024X .- 1969-6213. ; 8:4, s. 444-449
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Journal article (peer-reviewed)abstract
- Aims: Recently, drug-eluting balloons have received a guideline class IIa recommendation in the treatment of in-stent restenosis after bare metal stent implantation. It is not known if different balloons perform equally. Using a large real world registry, restenosis frequency was reported for two drug-eluting balloons. less thanbrgreater than less thanbrgreater thanMethods and results: From April 2009 until September 2011, 1,129 patients were treated with paclitaxel-eluting balloons in Sweden. Mean follow-up was 328 +/- 210 days. Nine hundred and nineteen patients were treated with a balloon using a contrast agent as a drug-carrier and 217 with a balloon without a contrast agent as a drug-carrier. The indications were predominantly de novo (45.4%) or in-stent restenotic (51.8%) lesions. The overall incidence of restenosis at six months was 3.4% with the paclitaxel balloon using a contrast agent as carrier, compared with 12.5% with the paclitaxel-eluting balloon without a carrier (risk ratio: 0.42; 95% confidence interval [CI] [0.26-0.68]). After adjusting for indications, lesion types and procedural factors, the risk ratio was 0.39; 95% CI (0.24-0.65). less thanbrgreater than less thanbrgreater thanConclusions: This observational study from a large real world population shows a major difference between two paclitaxel-eluting balloons. The findings suggest that there are no class effects for drug-eluting balloons and factors other than the drug may be important for the clinical effect.
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| 7. |
- Bonnemeier, Hendrik, et al.
(author)
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Automated continuous chest compression for in-hospital cardiopulmonary resuscitation of patients with pulseless electrical activity: A report of five cases
- 2009
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In: International Journal of Cardiology. - : Elsevier BV. - 0167-5273. ; 136:2, s. 39-50
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Journal article (peer-reviewed)abstract
- Of patients with in-hospital cardiac arrest, those with pulseless electrical activity ( PEA) have the worst outcome. Especially in these patients effective chest compressions according to the guidelines may be the key strategy to improve survival. Recently, a novel automatic mechanical chest compression device (LUCAS-CPR) has been shown to ensure effective continuous compressions without interruption during transport, diagnostic procedures and in the catheter laboratory, and may thus significantly improve outcome after resuscitation of in-hospital cardiac arrest. We report here on the first five well documented cases of in-hospital resuscitation of PEA using the LUCAS-CPR compression device. (C) 2008 Elsevier Ireland Ltd. All rights reserved.
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| 8. |
- Bonnemeier, Hendrik, et al.
(author)
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Continuous mechanical chest compression during in-hospital cardiopulmonary resuscitation of patients with pulseless electrical activity
- 2011
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In: Resuscitation. - : Elsevier BV. - 1873-1570 .- 0300-9572. ; 82:2, s. 155-159
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Journal article (peer-reviewed)abstract
- Survival after in-hospital pulseless electrical activity (PEA) cardiac arrest is poor and has not changed during the last 10 years. Effective chest compressions may improve survival after PEA. We investigated whether a mechanical device (LUCAS (TM)-CPR) can ensure chest compressions during cardiac arrest according to guidelines and without interruption during transport, diagnostic procedures and in the catheter laboratory. Methods: We studied mechanical chest compression in 28 patients with PEA (pulmonary embolism (PE) n = 14; cardiogenic shock/acute myocardial infarction; n=9; severe hyperkalemia; n=2; sustained ventricular arrhythmias/electrical storm; n=3) in a university hospital setting. Results: During or immediately after CPR, 21 patients underwent coronary angiography and or pulmonary angiography. Successful return of a spontaneous circulation (ROSC) was achieved in 27 out of the 28 patients. Ten patients died within the first hour and three patients died within 2411 after CPR. A total of 14 patients survived and were discharged from hospital (13 without significant neurological deficit). Interestingly, six patients with PE did not have thrombolytic therapy due to contraindications. CT-angiography findings in these patients showed fragmentation of the thrombus suggesting thrombus breakdown as an additional effect of mechanical chest compressions. No patients exhibited any life-threatening device-related complications. Conclusion: Continuous chest compression with an automatic mechanical device is feasible, safe, and might improve outcomes after in-hospital-resuscitation of PEA. Patients with PE may benefit from effective continuous chest compression, probably due to thrombus fragmentation and increased pulmonary artery blood flow. (C) 2010 Elsevier Ireland Ltd. All rights reserved.
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| 9. |
- Buccheri, Sergio, et al.
(author)
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Assessing the Nationwide Impact of a Registry-Based Randomized Clinical Trial on Cardiovascular Practice The TASTE Trial in Perspective
- 2019
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In: Circulation. Cardiovascular Interventions. - : Lippincott Williams & Wilkins. - 1941-7640 .- 1941-7632. ; 12:3
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Journal article (peer-reviewed)abstract
- BACKGROUND: Registry-based randomized clinical trials have emerged as useful tools to provide evidence on the comparative efficacy and safety of different therapeutic strategies. However, it remains unknown whether the results of registry-based randomized clinical trials have a sizable impact on daily clinical practice. We sought, therefore, to describe the temporal trends in thrombus aspiration (TA) use in Sweden before, during, and after dissemination of the TASTE trial (Thrombus Aspiration in ST-Elevation Myocardial Infarction in Scandinavia) results.METHODS AND RESULTS: From January 1, 2006, to December 31, 2017, we included all consecutive patients with ST-segment-elevation myocardial infarction undergoing percutaneous revascularization in Sweden. All patients were registered in the Swedish Coronary Angiography and Angioplasty Registry. A total of 55 809 ST-segment-elevation myocardial infarction patients were included. TA use in Sweden substantially decreased after dissemination of TASTE results (from 39.8% to 11.8% during and after TASTE, respectively). Substantial variability in TA use across treating centers was observed before TASTE (TA use ranging from 0% to 70%), but after TASTE both the interhospital variability and the frequency of TA use were markedly reduced. A constant shift in medical practice was seen about 4 months after dissemination of the TASTE trial results. Time trends for all-cause mortality and definite stent thrombosis at 30 days were not associated with variations in TA use (P values >0.05 using the Granger test).CONCLUSIONS: In Sweden, the results of the TASTE trial were impactful in daily clinical practice and led to a relevant decrease in TA use in ST-segment-elevation myocardial infarction patients undergoing percutaneous revascularization.
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| 10. |
- Buccheri, Sergio, et al.
(author)
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Bioabsorbable polymer everolimus-eluting stents in patients with acute myocardial infarction : A report from the Swedish Coronary Angiography and Angioplasty Registry
- 2018
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In: EuroIntervention. - 1774-024X .- 1969-6213. ; 14:5, s. 562-569
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Journal article (peer-reviewed)abstract
- Aims: The clinical performance of the SYNERGY drug-eluting stent (DES) in patients with acute myocardial infarction (MI) has not been investigated in detail. We sought to report on the outcomes after SYNERGY DES (Boston Scientific, Marlborough, MA, USA) implantation in patients with MI undergoing percutaneous revascularisation (PCI). Methods and results: We included all consecutive patients with MI undergoing PCI with the SYNERGY DES and newer-generation DES (n-DES group) in Sweden. From March 2013 to September 2016, a total of 36,292 patients, of whom 39.7% presented with ST-elevation MI, were included. As compared to patients in the n-DES group (n=31,403), patients in the SYNERGY group (n=4,889) were older and presented more often with left main or three-vessel disease involvement, as well as with restenotic lesions (p<0.001 for all parameters). The Kaplan-Meier estimates of ST at two years in the SYNERGY and n-DES groups were 0.69% and 0.81%, respectively (adjusted HR 1.00, 95% CI: 0.69-1.46; p=0.99). Clinically relevant restenosis was encountered in 1.48% and 1.25% of patients in the SYNERGY and n-DES groups, respectively (adjusted HR 1.05, 95% CI: 0.81-1.37; p=0.72). No differences in the risk of all-cause death and recurrent MI were found between the two groups after adjustment (adjusted HR 1.12, 95% CI: 0.98-1.28; p=0.10, and adjusted HR 0.95, 95% CI: 0.82-1.10; p=0.49, respectively). Conclusions: In a large and unselected cohort of patients with MI undergoing percutaneous revascularisation with the SYNERGY DES, stent performance and clinical outcomes did not differ compared with other n-DES up to two years.
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