| 1. |
- Birkemeyer, Ralf, et al.
(författare)
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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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Ingår i: Cardiovascular Revascularization Medicine. - : Elsevier BV. - 1553-8389. ; 25, s. 20-26
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Tidskriftsartikel (refereegranskat)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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| 2. |
- Eppinger, S., et al.
(författare)
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Embolization of percutaneous left atrial appendage closure devices: timing, management and clinical outcomes
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Ingår i: Cardiovascular Revascularization Medicine. - 1553-8389.
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Tidskriftsartikel (refereegranskat)abstract
- Background: Left atrial appendage (LAA) occluder embolization is an infrequent but serious complication. Objectives: We aim to describe timing, management and clinical outcomes of device embolization in a multi-center registry. Methods: Patient characteristics, imaging findings and procedure and follow-up data were collected retrospectively. Device embolizations were categorized according to 1) timing 2) management and 3) clinical outcomes. Results: Sixty-seven centers contributed data. Device embolization occurred in 108 patients. In 70.4 % of cases, it happened within the first 24 h of the procedure. The device was purposefully left in the LA and the aorta in two (1.9 %) patients, an initial percutaneous retrieval was attempted in 81 (75.0 %) and surgery without prior percutaneous retrieval attempt was performed in 23 (21.3 %) patients. Two patients died before a retrieval attempt could be made. In 28/81 (34.6 %) patients with an initial percutaneous retrieval attempt a second, additional attempt was performed, which was associated with a high mortality (death in patients with one attempt: 2.9 % vs. second attempt: 21.4 %, p < 0.001). The primary outcome (bailout surgery, cardiogenic shock, stroke, TIA, and/or death) occurred in 47 (43.5 %) patients. Other major complications related to device embolization occurred in 21 (19.4 %) patients. Conclusions: The majority of device embolizations after LAA closure occurs early. A percutaneous approach is often the preferred method for a first rescue attempt. Major adverse event rates, including death, are high particularly if the first retrieval attempt was unsuccessful. Condensed abstract: This dedicated multicenter registry examined timing, management, and clinical outcome of device embolization. Early embolization (70.4 %) was most frequent. As a first rescue attempt, percutaneous retrieval was preferred in 75.0 %, followed by surgical removal (21.3 %). In patients with a second retrieval attempt a higher mortality (death first attempt: 2.9 % vs. death second attempt: 24.1 %, p < 0.001) was observed. Mortality (10.2 %) and the major complication rate after device embolization were high. © 2024
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| 3. |
- Jensen, Lisette Okkels, et al.
(författare)
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Intravascular ultrasound assessment of minimum lumen area and intimal hyperplasia in in-stent restenosis after drug-eluting or bare-metal stent implantation. The Nordic Intravascular Ultrasound Study (NIVUS)
- 2017
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Ingår i: Cardiovascular Revascularization Medicine. - : Elsevier BV. - 1553-8389. ; 18:8, s. 577-582
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Tidskriftsartikel (refereegranskat)abstract
- Introduction: Drug-eluting stents (DES) reduce the risk of restenosis after percutaneous coronary intervention. The aim of the study was to evaluate, by intravascular ultrasound (IVUS), the minimum lumen area site in the stented segment and the distribution of intimal hyperplasia in patients presenting with a DES or bare-metal stent (BMS) in-stent restenosis. Methods: The “Nordic Intravascular Ultrasound Study (NIVUS)” study was conducted in Nordic and Baltic countries as a prospective multicenter registry. Two hundred nine patients (DES n = 121 and BMS n = 88) with in-stent restenosis were enrolled. Results: At the minimum lumen area site in the stented segment, the stent area (5.8 ± 2.2 mm2 vs. 7.6 ± 2.4 mm2, p < 0.001) and intimal hyperplasia area (2.6 ± 2.0 mm2 vs. 5.0 ± 2.2 mm2, p < 0.001) were significantly lower in patients treated with DES compared to BMS. The percentage of stents that did not have a minimum stent area of at least 5.0 mm2 (under expansion) was higher in DES (58.7% vs. 37.7%, p = 0.008) compared to BMS. Intimal hyperplasia covered 55.4 ± 33.3% of the stent length in the DES compared to 90.7 ± 17.4% in the BMS group, p < 0.001. Focal in-stent restenosis was more often seen in DES treated patients compared to BMS treated patients (DES n = 84 (59.9%) vs. BMS n = 15 (17.0%), p < 0.001). Conclusion: Stent underexpansion was more often seen in DES than BMS in-stent restenosis. DES more often had focal in-stent restenosis with less intimal hyperplasia.
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| 4. |
- Keeble, Thomas R., et al.
(författare)
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Effect of intravascular cooling on microvascular obstruction (MVO) in conscious patients with ST-elevation myocardial infarction undergoing primary PCI : Results from the COOL AMI EU pilot study
- 2019
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Ingår i: Cardiovascular Revascularization Medicine. - : Elsevier BV. - 1553-8389. ; 20:9, s. 799-804
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Tidskriftsartikel (refereegranskat)abstract
- Objective: COOL AMI EU pilot was a multi-center, randomized controlled trial to assess feasibility and safety of rapid intravascular therapeutic hypothermia (TH) in conscious patients with anterior ST-elevation myocardial infarction (STEMI) undergoing primary PCI (PPCI). We report the effect of hypothermia upon microvascular obstruction (MVO). Methods: Conscious patients with anterior STEMI and symptom duration <6 h were recruited and randomized to PPCI + TH or PPCI alone. TH was induced using the ZOLL® Proteus™ intravascular temperature management system and rapid infusion of 1 L of cold normal saline, with a target temperature of 32 °C. MVO was measured by cardiac magnetic resonance (CMR) at 4 to 6 days post-MI. MVO larger than 3.9% of LV was considered as extensive MVO. Results: 50 patients were randomized; mean age was 58 years, and 86% were men. At reperfusion, mean intravascular temperature for the TH group was 33.6 ± 1 °C. The presence of MVO was high and not different in both groups (74% vs. 77%, p = 0.79). The proportion of patients with extensive MVO was 11% in the TH group and 23% in the control group (OR 0.4 95%CI 0.07–2.35, p = 0.30). Patients with extensive MVO showed reduced EF at 4–6 days (34% versus 43%, p = 0.01). The percentage of patients with EF <35% at 30 days was 6% in the TH group versus 24% in the control group (p = 0.19). Conclusion: In the COOL-AMI Pilot Trial, the presence of MVO in both test groups was high and extensive MVO was related with reduced LVEF. The efficacy of therapeutic hypothermia (TH) in MVO reduction should be tested in a pivotal trial.
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| 5. |
- Koutouzis, Michael, 1973, et al.
(författare)
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Radial vs. femoral approach for primary percutaneous coronary intervention in octogenarians.
- 2010
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Ingår i: Cardiovascular revascularization medicine : including molecular interventions. - : Elsevier BV. - 1878-0938 .- 1553-8389. ; 11:2, s. 79-83
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Tidskriftsartikel (refereegranskat)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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| 6. |
- Lindstedt Ingemansson, Sandra, et al.
(författare)
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Impact of different topical negative pressure levels on myocardial microvascular blood flow.
- 2008
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Ingår i: Cardiovascular Revascularization Medicine. - : Elsevier BV. - 1878-0938 .- 1553-8389. ; 9:1, s. 29-35
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: We have previously shown that a myocardial topical negative pressure (TNP) of -50 mmHg significantly increases microvascular blood flow in the underlying myocardium in normal, ischemic, and reperfused porcine myocardium. The present study was designed to elucidate the effect of different TNP levels between -50 and -150 mmHg on microvascular flow in normal and ischemic myocardium. MATERIALS AND METHODS: Seven pigs underwent median sternotomy. The microvascular blood flow in the myocardium was recorded, before and after the application of TNP, using laser Doppler velocimetry. Analyses were performed before left anterior descending artery (LAD) occlusion (normal myocardium) and after 20 min of LAD occlusion (ischemic myocardium). RESULTS: A TNP of -50 mmHg significantly increased microvascular blood flow in both normal (from 320.0+/-56.1 PU before TNP application to 435.7+/-65.5 PU after TNP application, P=.028) and ischemic myocardium (from 110.0+/-36.7 PU before TNP application to 194.3+/-56.2 PU after TNP application, P=.012). TNP between -75 and -150 mmHg showed no significant increase in microvascular blood flow in normal or ischemic myocardium. CONCLUSIONS: Of pressures between -50 and -150 mmHg, a TNP of -50 mmHg seems to be the most effective negative pressure concerning significant increase in microvascular blood flow in both normal and ischemic myocardium.
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| 7. |
- Nilsson, Konrad, et al.
(författare)
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Fully independent external validation of the Transcatheter Aortic Valve Replacement 30-day (TAVR-30) hospital readmission model
- 2023
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Ingår i: Cardiovascular Revascularization Medicine. - : Elsevier. - 1553-8389 .- 1878-0938. ; 56, s. 9-15
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Tidskriftsartikel (refereegranskat)abstract
- Background: Early and late readmissions after Transcatheter Aortic Valve Replacement (TAVR) are common and associated with worse outcome. A risk prediction model (TAVR-30) was recently developed using readily available clinical variables to identify patients at risk for hospital readmission within 30 days after TAVR. We performed an independent external validation of the TAVR-30 model.Methods: The Swedish TAVR-registry, linked together with other mandatory national registries was used to identify all TAVR procedures, variables from the original model, hospitalizations and deaths between the years 2008 to 2021.Results: A total of 8459 patients underwent TAVR, 7693 patients had complete data and were included in the analysis. Out of these, 928 patients experienced a readmission within 30 days. Using the estimates from the original model, a concordance (c)-index of 0.51, a calibration slope of 0.07 and intercept of −0.62 were obtained respectively, overall implying poor model performance.Conclusions: This independent external validation indicates poor performance of the TAVR-30 model in a Swedish setting. Further research is needed to develop more reliable tools for predicting the risk of early hospital readmission after TAVR, as well as, for providing a deeper understanding of how to develop risk models that performs well in patients with multiple underlying comorbidities.
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| 8. |
- Omerovic, Elmir, et al.
(författare)
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Bivalirudin versus heparin in ST and non-ST-segment elevation myocardial infarction-Outcomes at two years
- 2024
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Ingår i: Cardiovascular Revascularization Medicine. - : Elsevier. - 1553-8389 .- 1878-0938.
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: The registry-based randomized VALIDATE-SWEDEHEART trial (NCT02311231) compared bivalirudin vs. heparin in patients undergoing percutaneous coronary intervention (PCI) for myocardial infarction (MI). It showed no difference in the composite primary endpoint of death, MI, or major bleeding at 180 days. Here, we report outcomes at two years.METHODS: Analysis of primary and secondary endpoints at two years of follow-up was prespecified in the study protocol. We report the study results for the extended follow-up time here.RESULTS: In total, 6006 patients were enrolled, 3005 with ST-segment elevation MI (STEMI) and 3001 with Non-STEMI (NSTEMI), representing 70 % of all eligible patients with these diagnoses during the study. The primary endpoint occurred in 14.0 % (421 of 3004) in the bivalirudin group compared with 14.3 % (429 of 3002) in the heparin group (hazard ratio [HR] 0.97; 95 % confidence interval [CI], 0.85-1.11; P = 0.70) at one year and in 16.7 % (503 of 3004) compared with 17.1 % (514 of 3002), (HR 0.97; 95 % CI, 0.96-1.10; P = 0.66) at two years. The results were consistent in patients with STEMI and NSTEMI and across major subgroups.CONCLUSIONS: Until the two-year follow-up, there were no differences in endpoints between patients with MI undergoing PCI and allocated to bivalirudin compared with those allocated to heparin.REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT02311231.
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| 9. |
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| 10. |
- Waltenberger, Johannes, et al.
(författare)
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Five-Year Results of the Bioflow-III Registry : Real-World Experience with a Biodegradable Polymer Sirolimus-Eluting Stent
- 2020
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Ingår i: Cardiovascular Revascularization Medicine. - : Elsevier. - 1553-8389 .- 1878-0938. ; 21:1, s. 63-69
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Tidskriftsartikel (refereegranskat)abstract
- Purpose: We aimed to assess long-term safety and performance of the Orsiro sirolimus-eluting coronary stent with biodegradable polymer in a large unselected population and in pre-specified subgroups.Methods: BIOFLOW-III is a prospective, multicenter, international, observational registry with follow-up visits scheduled at 6 and 12 months, and at 3 and 5 years (NCT01553526).Results: 1356 patients with 1738 lesions were enrolled. Of those, 392 (28.9%) declined to participate in the study extension from 18 months to 5 years, 37 (2.7%) withdrew consent, and 89 (6.6%) were lost to follow-up. At 5-years, Kaplan-Meier estimates of target lesion failure, defined as a composite of cardiac death, target-vessel myocardial infarction, coronary artery bypass grafting and clinically driven target lesion revascularization was 10.0% [95% confidence interval (CI): 8.4; 12.0] in the overall population, and 14.0% [95% CI: 10.5; 18.6], 10.3% [95% CI: 7.8; 13.5], 1.8% [95% CI: 0.3; 12.0], and 11.3% [95% CI: 8.5; 15.1] in the pre-defined risk groups of patients with diabetes mellitus, small vessels <= 2.75 mm, chronic total occlusion, and acute myocardial infarction. Definite stent thrombosis was observed in 0.3% [95% CI: 0.1; 0.9] of patients.Conclusion: These long-term outcomes provide further evidence on the safety and performance of a sirolimus-eluting biodegradable polymer stent within daily clinical practice. The very lowdefinite stent thrombosis rate affirms biodegradable polymer safety and performance.
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