ABSTRACT Aims: To assess procedural feasibility and early safety of hybrid coronary revasculariza... more ABSTRACT Aims: To assess procedural feasibility and early safety of hybrid coronary revascularization, combining off-pump left internal mammary artery grafting to the left descendent coronary artery (LAD) through an inferior J-hemisternotomy (JOPCAB) and percutaneous coronary intervention (PCI) of non-LAD lesions. Methods and Results: A total of 100 consecutive patients with multivessel coronary artery disease involving LAD were included in this prospective registry. JOPCAB was performed prior to PCI in 89 (89%) patients, and PCI was scheduled prior to surgery in 11 (11%) patients with total occlusion of a non-LAD artery. Two of these patients were treated by CABG, as revascularization by PCI failed. We chose to re-operate one patient with LIMA graft thrombosis by conventional CABG, as the LAD had shown diffuse arteriosclerotic disease at JOPCAB. Thus, the procedural success rate was 97%. One month after completed hybrid intervention, we observed no deaths. There was one stroke on the fourth postoperative day and two procedure-related, but no spontaneous myocardial infarctions. Conclusion: Our prospective registry documented excellent procedural feasibility and one-month safety of coronary hybrid revascularization combining JOPCAB with PCI.
Catheterization and Cardiovascular Interventions, 2013
In transcatheter aortic valve replacement (TAVR), the influence of aortic annular assessment with... more In transcatheter aortic valve replacement (TAVR), the influence of aortic annular assessment with either multidetector computed tomography (MDCT) or conventional transesophageal echocardiography (TEE) on the incidence of postprocedural paravalvular aortic regurgitation (PAR) was evaluated. PAR remains a major limitation in TAVR. Appropriate selection of transcatheter heart valve (THV) size is crucial to prevent PAR. Outcomes following TAVR with a balloon-expandable THV were compared in two retrospective cohorts identified according to whether THV size selection was based on TEE (study group 1, n = 80) or MDCT (study group 2, n = 58). The two study groups were comparable with regard to baseline clinical, risk score, and echocardiographic characteristics. The incidence of moderate/severe PAR was lower in study group 2 than in group 1, 8.6% versus 28.8% (P < 0.01). The difference between the THV nominal diameter and MDCT annular diameter was predictive of moderate/severe PAR (AUC 0.84; 95% CI: 0.72-0.92). Neither age, gender, body mass index, annular eccentricity index, aortic valve calcification nor the difference between the THV diameter and the TEE annular diameter predicted postprocedural PAR. Increased THV oversizing relative to the MDCT mean annular diameter was associated with reduced severity of PAR. No difference in perprocedural complications between two study groups was observed. MDCT-based annular sizing in TAVR significantly reduces postprocedural PAR, and THV oversizing appears pivotal in this aspect. Further delineation of the optimal degree of THV oversizing is needed.
Primary percutaneous coronary intervention (PCI) is the treatment of choice for patients presenti... more Primary percutaneous coronary intervention (PCI) is the treatment of choice for patients presenting with acute ST-segment elevation myocardial infarction (STEMI). However, if catheterization facilities are not immediately available, the effectiveness of PCI can be affected by delays in transfer. Evidence suggests that antiplatelet therapy administered early, preferably in the ambulance during transfer, may provide better and earlier perfusion. Ticagrelor, a direct platelet P2Y12 receptor inhibitor, is indicated for the management of patients with acute coronary syndromes. The ATLANTIC study (NCT01347580; EudraCT 2011-000214-19) is a 30-day international, randomized, parallel-group, placebo-controlled study in male and female patients (aged ≥18 years) who are diagnosed as having STEMI, with intended primary PCI. In total, 1770 patients will be randomized immediately after diagnosis to prehospital administration of ticagrelor 180 mg followed by matching placebo administered in hospital, or prehospital administration of placebo followed by ticagrelor 180 mg administered in hospital. All patients will then receive ticagrelor 90 mg twice daily for 30 days. The coprimary end point is the percentage of patients reaching thrombolysis in myocardial infarction flow grade 3 in the infarct-related artery at initial angiography or achieving ≥70% ST-segment elevation resolution pre-PCI. The primary safety end point is major, life-threatening, or minor bleeding after ticagrelor administration. The results of this study may have an impact on future recommendations for treatment for patients with STEMI.
Hypersensitivity reaction towards the stent polymer resulting in formation of evaginations has be... more Hypersensitivity reaction towards the stent polymer resulting in formation of evaginations has been detected predominantly after treatment by the first generation drug eluting stents. This case shows that despite the use of more biocompatible polymers in second generation drug eluting stents there will still be patients developing adverse vessel wall reactions consistent with a hypersensitivity reaction towards the implanted stent.
European heart journal. Acute cardiovascular care, 2015
The impact of angiographically visible distal embolization (DE) and distal protection occurring d... more The impact of angiographically visible distal embolization (DE) and distal protection occurring during primary percutaneous coronary intervention (PCI) on long-term outcome has not been studied in a contemporary ST-segment elevation myocardial infarction (STEMI) cohort. To evaluate the association between DE and long-term outcome in STEMI patients treated with primary PCI with or without distal protection. In this post-hoc analysis of a randomized study, 591 STEMI patients were randomized to conventional primary PCI or primary PCI with distal protection and followed for 5 years. There was no statistically significant difference in MACE rate between patients treated with or wthout distal protection (19% versus 25%; p=0.10). There seemed to be interaction between distal protection and DE in major adverse cardiac events (MACE) (p=0.08), mortality (p=0.02) and reinfarction (p=0.06), but not admission for heart failure (p=0.40). DE was related to increased risk of admission for heart fai...
In 1998, the sale of vitamin K antagonists (VKA) in Denmark corresponded to the amount used for t... more In 1998, the sale of vitamin K antagonists (VKA) in Denmark corresponded to the amount used for treatment of more than 20,000 patients for one year. This is more than three times more than ten years earlier. The reasons for the increasing use of VKA are new indications for permanent anticoagulant treatment, especially chronic atrial fibrillation and venous thromboembolism associated with permanent thromboembolic risk factors. The risk of bleeding is higher in the introductory phase of anticoagulant treatment than later on. It is now recommended to commence anticoagulant therapy without a loading dose. This seems to hasten a good estimate of the maintenance dose. The metabolism of VKA depends on a number of genetic and acquired factors. Knowledge of these factors is crucial for optimal regulation of the treatment, and it is important that patients at start of treatment are thoroughly informed about these factors in order to minimize the risk of complications.
The use of drug-eluting stents (DESs) versus bare metal stents (BMSs) in primary percutaneous cor... more The use of drug-eluting stents (DESs) versus bare metal stents (BMSs) in primary percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction is a matter of debate. Therefore, we examined the risk of target lesion revascularization (TLR), stent thrombosis, myocardial infarction, and death after the implantation of DES or BMS in primary PCI patients in Western Denmark. A total of 3756 consecutive patients with ST-segment elevation myocardial infarction treated with primary PCI and stent implantation, recorded in the Western Denmark Heart Registry from January 2002 through June 2005, were followed up for 2 years. We used Cox regression analysis to control for confounding. The 2-year incidence of definite stent thrombosis was 1.9% in the DES group and 1.1% in the BMS group (adjusted relative risk [RR]=1.53; 95% CI=0.84 to 2.78; P=0.17). Very late definite stent thrombosis (> or =12 months) was seen in 0.4% in the DES group and 0.06% in the BMS group (adjus...
We compared 5-year clinical outcomes in diabetic and nondiabetic patients treated with Endeavor z... more We compared 5-year clinical outcomes in diabetic and nondiabetic patients treated with Endeavor zotarolimus-eluting stents (ZESs; Endeavor Sprint, Medtronic, Santa Rosa, California) or Cypher sirolimus-eluting stents (SESs; Cordis, Johnson & Johnson, Warren, New Jersey) coronary implantation. We randomized 2,332 patients to either ZESs (n = 1,162, n = 169 diabetic patients) or SESs (n = 1,170, n = 168 diabetic patients) stratified according to presence or absence of diabetes mellitus. End points included major adverse cardiac event (MACE), a composite of cardiac death, myocardial infarction, target vessel revascularization (TVR), and definite stent thrombosis. Among diabetic patients, MACE occurred more frequently in patients treated with ZESs than SESs (48 [28.4%] vs 31 [18.5%]; odds ratio [OR] 1.75, 95% confidence interval [CI] 1.05 to 2.93, p = 0.032) because of a higher rate of TVR (32 [18.9%] vs 14 [8.3%]; OR 2.57, 95% CI 1.32 to 5.02, p = 0.006). Among nondiabetic patients, ZE...
Several studies, including the DANAMI-2 trial, have shown that primary percutanous intervention (... more Several studies, including the DANAMI-2 trial, have shown that primary percutanous intervention (PCI) results in better survival, fewer reinfarctions and fewer cerebrovascular incidents than thrombolysis in the treatment of acute ST-elevation myocardial infarction (STEMI). The aim of this study was to follow the implementation of primary PCI as a routine treatment for patients with STEMI and to compare the results with those of DANAMI-2. We performed a prospective analysis of 212 patients admitted to our department from 1 April 2002 to 31 December 2002 with STEMI. Acute coronary angiography and, if indicated, primary PCI were performed. At 30 days, the mortality rate was 6.6%, the reinfarction rate 1.4% and the rate of disabling stroke 1.4%. Combined endpoints were present in 8% of the patients. The results are in agreement with those from the DANAMI-2 trial. Primary PCI can be performed in daily clinical practice in accordance with the DANAMI-2 protocol. The results are in agreemen...
Journal of Cardiovascular Computed Tomography, 2014
Fractional flow reserve (FFR) is the standard of reference for assessing the hemodynamic signific... more Fractional flow reserve (FFR) is the standard of reference for assessing the hemodynamic significance of coronary stenoses in patients with stable coronary artery disease. Noninvasive FFR derived from coronary CT angiography (FFRCT) is a promising new noninvasive method for assessing the physiologic significance of epicardial stenoses. The reproducibility of FFRCT has not yet been established. The aim of this study was to evaluate the variation of repeated analyses of FFRCT per se and in the context of the reproducibility of repeated FFR measurements. Coronary CT angiography and invasive coronary angiography with repeated FFR measurements were performed in 28 patients (58 vessels) with suspected stable coronary artery disease. Based on the coronary CT angiography data set, FFRCT analyses were performed twice by 2 independent blinded analysts. In 12 of 58 (21%) vessels FFR was ≤ 0.80. The standard deviation for the difference between first and second FFRCT analyses was 0.034 vs 0.033 for FFR repeated measurements (P = .722). Limits of agreement were -0.06 to 0.08 for FFRCT and -0.07 to 0.06 for FFR. The coefficient of variation of FFRCT (CVFFRct) was 3.4% (95% confidence interval [CI], 1.4%-4.6%) vs 2.7% (95% CI, 1.8%-3.3%) for FFR. In vessels with mean FFR ranging between 0.70 and 0.90 (n = 25), the difference between the first and second FFRCT analyses was 0.035 and FFR repeated measurements was 0.043 (P = .357), whereas CVFFRct was 3.3% (95% CI, 1.5%-4.3%) and coefficient of variation for FFR was 3.6% (95% CI, 2.3%-4.6%). The reproducibility of both repeated FFRCT analyses and repeated FFR measurements is high.
ABSTRACT Aims: To assess procedural feasibility and early safety of hybrid coronary revasculariza... more ABSTRACT Aims: To assess procedural feasibility and early safety of hybrid coronary revascularization, combining off-pump left internal mammary artery grafting to the left descendent coronary artery (LAD) through an inferior J-hemisternotomy (JOPCAB) and percutaneous coronary intervention (PCI) of non-LAD lesions. Methods and Results: A total of 100 consecutive patients with multivessel coronary artery disease involving LAD were included in this prospective registry. JOPCAB was performed prior to PCI in 89 (89%) patients, and PCI was scheduled prior to surgery in 11 (11%) patients with total occlusion of a non-LAD artery. Two of these patients were treated by CABG, as revascularization by PCI failed. We chose to re-operate one patient with LIMA graft thrombosis by conventional CABG, as the LAD had shown diffuse arteriosclerotic disease at JOPCAB. Thus, the procedural success rate was 97%. One month after completed hybrid intervention, we observed no deaths. There was one stroke on the fourth postoperative day and two procedure-related, but no spontaneous myocardial infarctions. Conclusion: Our prospective registry documented excellent procedural feasibility and one-month safety of coronary hybrid revascularization combining JOPCAB with PCI.
Catheterization and Cardiovascular Interventions, 2013
In transcatheter aortic valve replacement (TAVR), the influence of aortic annular assessment with... more In transcatheter aortic valve replacement (TAVR), the influence of aortic annular assessment with either multidetector computed tomography (MDCT) or conventional transesophageal echocardiography (TEE) on the incidence of postprocedural paravalvular aortic regurgitation (PAR) was evaluated. PAR remains a major limitation in TAVR. Appropriate selection of transcatheter heart valve (THV) size is crucial to prevent PAR. Outcomes following TAVR with a balloon-expandable THV were compared in two retrospective cohorts identified according to whether THV size selection was based on TEE (study group 1, n = 80) or MDCT (study group 2, n = 58). The two study groups were comparable with regard to baseline clinical, risk score, and echocardiographic characteristics. The incidence of moderate/severe PAR was lower in study group 2 than in group 1, 8.6% versus 28.8% (P < 0.01). The difference between the THV nominal diameter and MDCT annular diameter was predictive of moderate/severe PAR (AUC 0.84; 95% CI: 0.72-0.92). Neither age, gender, body mass index, annular eccentricity index, aortic valve calcification nor the difference between the THV diameter and the TEE annular diameter predicted postprocedural PAR. Increased THV oversizing relative to the MDCT mean annular diameter was associated with reduced severity of PAR. No difference in perprocedural complications between two study groups was observed. MDCT-based annular sizing in TAVR significantly reduces postprocedural PAR, and THV oversizing appears pivotal in this aspect. Further delineation of the optimal degree of THV oversizing is needed.
Primary percutaneous coronary intervention (PCI) is the treatment of choice for patients presenti... more Primary percutaneous coronary intervention (PCI) is the treatment of choice for patients presenting with acute ST-segment elevation myocardial infarction (STEMI). However, if catheterization facilities are not immediately available, the effectiveness of PCI can be affected by delays in transfer. Evidence suggests that antiplatelet therapy administered early, preferably in the ambulance during transfer, may provide better and earlier perfusion. Ticagrelor, a direct platelet P2Y12 receptor inhibitor, is indicated for the management of patients with acute coronary syndromes. The ATLANTIC study (NCT01347580; EudraCT 2011-000214-19) is a 30-day international, randomized, parallel-group, placebo-controlled study in male and female patients (aged ≥18 years) who are diagnosed as having STEMI, with intended primary PCI. In total, 1770 patients will be randomized immediately after diagnosis to prehospital administration of ticagrelor 180 mg followed by matching placebo administered in hospital, or prehospital administration of placebo followed by ticagrelor 180 mg administered in hospital. All patients will then receive ticagrelor 90 mg twice daily for 30 days. The coprimary end point is the percentage of patients reaching thrombolysis in myocardial infarction flow grade 3 in the infarct-related artery at initial angiography or achieving ≥70% ST-segment elevation resolution pre-PCI. The primary safety end point is major, life-threatening, or minor bleeding after ticagrelor administration. The results of this study may have an impact on future recommendations for treatment for patients with STEMI.
Hypersensitivity reaction towards the stent polymer resulting in formation of evaginations has be... more Hypersensitivity reaction towards the stent polymer resulting in formation of evaginations has been detected predominantly after treatment by the first generation drug eluting stents. This case shows that despite the use of more biocompatible polymers in second generation drug eluting stents there will still be patients developing adverse vessel wall reactions consistent with a hypersensitivity reaction towards the implanted stent.
European heart journal. Acute cardiovascular care, 2015
The impact of angiographically visible distal embolization (DE) and distal protection occurring d... more The impact of angiographically visible distal embolization (DE) and distal protection occurring during primary percutaneous coronary intervention (PCI) on long-term outcome has not been studied in a contemporary ST-segment elevation myocardial infarction (STEMI) cohort. To evaluate the association between DE and long-term outcome in STEMI patients treated with primary PCI with or without distal protection. In this post-hoc analysis of a randomized study, 591 STEMI patients were randomized to conventional primary PCI or primary PCI with distal protection and followed for 5 years. There was no statistically significant difference in MACE rate between patients treated with or wthout distal protection (19% versus 25%; p=0.10). There seemed to be interaction between distal protection and DE in major adverse cardiac events (MACE) (p=0.08), mortality (p=0.02) and reinfarction (p=0.06), but not admission for heart failure (p=0.40). DE was related to increased risk of admission for heart fai...
In 1998, the sale of vitamin K antagonists (VKA) in Denmark corresponded to the amount used for t... more In 1998, the sale of vitamin K antagonists (VKA) in Denmark corresponded to the amount used for treatment of more than 20,000 patients for one year. This is more than three times more than ten years earlier. The reasons for the increasing use of VKA are new indications for permanent anticoagulant treatment, especially chronic atrial fibrillation and venous thromboembolism associated with permanent thromboembolic risk factors. The risk of bleeding is higher in the introductory phase of anticoagulant treatment than later on. It is now recommended to commence anticoagulant therapy without a loading dose. This seems to hasten a good estimate of the maintenance dose. The metabolism of VKA depends on a number of genetic and acquired factors. Knowledge of these factors is crucial for optimal regulation of the treatment, and it is important that patients at start of treatment are thoroughly informed about these factors in order to minimize the risk of complications.
The use of drug-eluting stents (DESs) versus bare metal stents (BMSs) in primary percutaneous cor... more The use of drug-eluting stents (DESs) versus bare metal stents (BMSs) in primary percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction is a matter of debate. Therefore, we examined the risk of target lesion revascularization (TLR), stent thrombosis, myocardial infarction, and death after the implantation of DES or BMS in primary PCI patients in Western Denmark. A total of 3756 consecutive patients with ST-segment elevation myocardial infarction treated with primary PCI and stent implantation, recorded in the Western Denmark Heart Registry from January 2002 through June 2005, were followed up for 2 years. We used Cox regression analysis to control for confounding. The 2-year incidence of definite stent thrombosis was 1.9% in the DES group and 1.1% in the BMS group (adjusted relative risk [RR]=1.53; 95% CI=0.84 to 2.78; P=0.17). Very late definite stent thrombosis (> or =12 months) was seen in 0.4% in the DES group and 0.06% in the BMS group (adjus...
We compared 5-year clinical outcomes in diabetic and nondiabetic patients treated with Endeavor z... more We compared 5-year clinical outcomes in diabetic and nondiabetic patients treated with Endeavor zotarolimus-eluting stents (ZESs; Endeavor Sprint, Medtronic, Santa Rosa, California) or Cypher sirolimus-eluting stents (SESs; Cordis, Johnson & Johnson, Warren, New Jersey) coronary implantation. We randomized 2,332 patients to either ZESs (n = 1,162, n = 169 diabetic patients) or SESs (n = 1,170, n = 168 diabetic patients) stratified according to presence or absence of diabetes mellitus. End points included major adverse cardiac event (MACE), a composite of cardiac death, myocardial infarction, target vessel revascularization (TVR), and definite stent thrombosis. Among diabetic patients, MACE occurred more frequently in patients treated with ZESs than SESs (48 [28.4%] vs 31 [18.5%]; odds ratio [OR] 1.75, 95% confidence interval [CI] 1.05 to 2.93, p = 0.032) because of a higher rate of TVR (32 [18.9%] vs 14 [8.3%]; OR 2.57, 95% CI 1.32 to 5.02, p = 0.006). Among nondiabetic patients, ZE...
Several studies, including the DANAMI-2 trial, have shown that primary percutanous intervention (... more Several studies, including the DANAMI-2 trial, have shown that primary percutanous intervention (PCI) results in better survival, fewer reinfarctions and fewer cerebrovascular incidents than thrombolysis in the treatment of acute ST-elevation myocardial infarction (STEMI). The aim of this study was to follow the implementation of primary PCI as a routine treatment for patients with STEMI and to compare the results with those of DANAMI-2. We performed a prospective analysis of 212 patients admitted to our department from 1 April 2002 to 31 December 2002 with STEMI. Acute coronary angiography and, if indicated, primary PCI were performed. At 30 days, the mortality rate was 6.6%, the reinfarction rate 1.4% and the rate of disabling stroke 1.4%. Combined endpoints were present in 8% of the patients. The results are in agreement with those from the DANAMI-2 trial. Primary PCI can be performed in daily clinical practice in accordance with the DANAMI-2 protocol. The results are in agreemen...
Journal of Cardiovascular Computed Tomography, 2014
Fractional flow reserve (FFR) is the standard of reference for assessing the hemodynamic signific... more Fractional flow reserve (FFR) is the standard of reference for assessing the hemodynamic significance of coronary stenoses in patients with stable coronary artery disease. Noninvasive FFR derived from coronary CT angiography (FFRCT) is a promising new noninvasive method for assessing the physiologic significance of epicardial stenoses. The reproducibility of FFRCT has not yet been established. The aim of this study was to evaluate the variation of repeated analyses of FFRCT per se and in the context of the reproducibility of repeated FFR measurements. Coronary CT angiography and invasive coronary angiography with repeated FFR measurements were performed in 28 patients (58 vessels) with suspected stable coronary artery disease. Based on the coronary CT angiography data set, FFRCT analyses were performed twice by 2 independent blinded analysts. In 12 of 58 (21%) vessels FFR was ≤ 0.80. The standard deviation for the difference between first and second FFRCT analyses was 0.034 vs 0.033 for FFR repeated measurements (P = .722). Limits of agreement were -0.06 to 0.08 for FFRCT and -0.07 to 0.06 for FFR. The coefficient of variation of FFRCT (CVFFRct) was 3.4% (95% confidence interval [CI], 1.4%-4.6%) vs 2.7% (95% CI, 1.8%-3.3%) for FFR. In vessels with mean FFR ranging between 0.70 and 0.90 (n = 25), the difference between the first and second FFRCT analyses was 0.035 and FFR repeated measurements was 0.043 (P = .357), whereas CVFFRct was 3.3% (95% CI, 1.5%-4.3%) and coefficient of variation for FFR was 3.6% (95% CI, 2.3%-4.6%). The reproducibility of both repeated FFRCT analyses and repeated FFR measurements is high.
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