Jan Harnek

Thrombus Aspiration during ST-Segment Elevation Myocardial Infarction

BACKGROUND The clinical effect of routine intracoronary thrombus aspiration before primary percutaneous coronary intervention (PCI) in patients with ST-segment elevation myocardial infarction (STEMI) is uncertain. We aimed to evaluate whether thrombus aspiration reduces mortality. METHODS We conducted a multicenter, prospective, randomized, controlled, open-label clinical trial, with enrollment of patients from the national comprehensive Swedish Coronary Angiography and Angioplasty Registry (SCAAR) and end points evaluated through national registries. A total of 7244 patients with STEMI undergoing PCI were randomly assigned to manual thrombus aspiration followed by PCI or to PCI only. The primary end point was all-cause mortality at 30 days. RESULTS No patients were lost to follow-up. Death from any cause occurred in 2.8% of the patients in the thrombus-aspiration group (103 of 3621), as compared with 3.0% in the PCI-only group (110 of 3623) (hazard ratio, 0.94; 95% confidence interval [CI], 0.72 to 1.22; P=0.63). The rates of hospitalization for recurrent myocardial infarction at 30 days were 0.5% and 0.9% in the two groups, respectively (hazard ratio, 0.61; 95% CI, 0.34 to 1.07; P=0.09), and the rates of stent thrombosis were 0.2% and 0.5%, respectively (hazard ratio, 0.47; 95% CI, 0.20 to 1.02; P=0.06). There were no significant differences between the groups with respect to the rate of stroke or neurologic complications at the time of discharge (P=0.87). The results were consistent across all major prespecified subgroups, including subgroups defined according to thrombus burden and coronary flow before PCI. CONCLUSIONS Routine thrombus aspiration before PCI as compared with PCI alone did not reduce 30-day mortality among patients with STEMI. (Funded by the Swedish Research Council and others; ClinicalTrials.gov number, NCT01093404.).

Differential Response of Delayed Healing and Persistent Inflammation at Sites of Overlapping Sirolimus- or Paclitaxel-Eluting Stents

Background—Although effective coverage of challenging coronary lesions has warranted the use of overlapping drug-eluting stents, the histopathological response to stent overlap is unknown. Methods and Results—The arterial reaction to overlapping Cypher or Taxus drug-eluting stents was examined in rabbits with bare metal stents, BxVelocity or Express, serving as controls. Single iliac artery balloon injury was followed by placement of 2 overlapping 3.0-mm-diameter drug-eluting stents or bare metal stents in 60 animals (mean length of overlap, 9.8±3.6 mm). Stented arteries were harvested at 28 and 90 days for histology. Overlapped segments exhibited delayed healing compared with proximal and distal nonoverlapping sites at 28 days. Overlapped segments in Taxus stents induced significantly more luminal heterophils/eosinophils and fibrin deposition than Cypher; peristrut giant cell infiltration, however, was more frequent in the latter. Overlapping bare metal stents also showed mild delayed healing compared with nonoverlapped segments, but not to the same extent as drug-eluting stents. Although neointimal thickness within the overlap was similar in 28- and 90-day Cypher stents, there was a significant increase with Taxus (P=0.03). Conclusions—Compared with bare metal stents, drug-eluting stents further delay arterial healing and promote inflammation at sites of overlap. Taxus stents induced greater fibrin deposition, medial cell loss, heterophils/eosinophils, and late neointimal hyperplasia. Patients receiving overlapping drug-eluting stents need more frequent follow-up than patients with nonoverlapping stents.

Percutaneous Transvenous Mitral Annuloplasty Initial Human Experience With Device Implantation in the Coronary Sinus

Background— Mitral annuloplasty is the most common surgical procedure performed for ischemic mitral regurgitation (MR). Surgical mitral annuloplasty is limited by morbidity, mortality, and MR recurrence. We evaluated the safety and feasibility of a transvenous catheter-delivered implantable device to provide a percutaneous alternative to surgical mitral annuloplasty. Methods and Results— Five patients with chronic ischemic MR underwent percutaneous transvenous implantation of an annuloplasty device in the coronary sinus. Implantation was successful in 4 patients. Baseline MR in the entire group was grade 3.0±0.7 and was reduced to grade 1.6±1.1 at the last postimplantation visit when the device was intact or the last postprocedural visit in the patient in whom the device was not successfully implanted. Separation of the bridge section of the device occurred in 3 of 4 implanted devices and was detected at 28 to 81 days after implantation. There were no postprocedural device-related complications. Conclusions— Percutaneous implantation of a device intended to remodel the mitral annulus is feasible. Initial experience suggests a possible favorable effect on MR. Percutaneous transvenous mitral annuloplasty warrants further evaluation as a less invasive alternative to surgical annuloplasty.

Cardiac arrest in the catheterisation laboratory: a 5-year experience of using mechanical chest compressions to facilitate PCI during prolonged resuscitation efforts.

PURPOSE Lengthy resuscitations in the catheterisation laboratory carry extremely high rates of mortality because it is essentially impossible to perform effective chest compressions during percutaneous coronary intervention (PCI). The purpose of this study was to evaluate the use of a mechanical chest compression device, LUCAS, in the catheterisation laboratory, in patients who suffered circulatory arrest requiring prolonged resuscitation. MATERIALS AND METHODS The study population was comprised of patients who arrived alive to the catheterisation laboratory and then required mechanical chest compression at some time during the angiogram, PCI or pericardiocentesis between 2004 and 2008 at the Lund University Hospital. This is a retrospective registry analysis. RESULTS During the study period, a total of 3058 patients were treated with PCI for ST-elevation myocardial infarction (STEMI) of whom 118 were in cardiogenic shock and 81 required defibrillations. LUCAS was used in 43 patients (33 STEMI, 7 non-ST-elevation myocardial infarction (NSTEMI), 2 elective PCIs and 1 patient with tamponade). Five patients had tamponade due to myocardial rupture prior to PCI that was revealed at the start of the PCI, and all five died. Of the remaining 38 patients, 1 patient underwent a successful pericardiocentesis and 36 were treated with PCI. Eleven of these patients were discharged alive in good neurological condition. CONCLUSION The use of mechanical chest compressions in the catheterisation laboratory allows for continued PCI or pericardiocentesis despite ongoing cardiac or circulatory arrest with artificially sustained circulation. It is unlikely that few, if any, of the patients would have survived without the use of mechanical chest compressions in the catheterisation laboratory.

Transcatheter Implantation of the MONARC Coronary Sinus Device for Mitral Regurgitation 1-Year Results From the EVOLUTION Phase I Study (Clinical Evaluation of the Edwards Lifesciences Percutaneous Mitral Annuloplasty System for The Treatment of Mitral Regurgitation)

OBJECTIVES This study sought to assess the safety and efficacy of transcatheter valve annuloplasty in patients with mitral regurgitation (MR). BACKGROUND Mitral regurgitation is associated with a worsened prognosis in patients with dilated cardiomyopathy. Surgical mitral annuloplasty reduces the septal-lateral dimension of the mitral annulus resulting in improved leaflet coaptation with a reduction in regurgitation. Percutaneous annuloplasty with the MONARC device (Edwards Lifesciences, Irvine, California) implanted within the coronary sinus is designed to reduce mitral regurgitation through a similar mechanism. METHODS A total of 72 patients with MR grade ≥ 2 were enrolled at 8 participating centers in 4 countries. Clinical evaluation and transthoracic echocardiography were performed at baseline and at 3, 6, and 12 months. Multislice cardiac computed tomography and coronary angiography were performed at baseline and 3 months. RESULTS The MONARC device was implanted in 59 of 72 patients (82%). The primary safety end point (freedom from death, tamponade, or myocardial infarction at 30 days) was met in 91% of patients at 30 days and in 82% at 1 year. Computed tomography imaging documented passage of the great cardiac vein over an obtuse marginal artery in 55% of patients and was associated with angiographic coronary artery compression in 15 patients and myocardial infarction in 2 patients (3.4%). At 12 months, a reduction in MR by ≥ 1 grade was observed in 50.0% of 22 implanted patients with matched echocardiograms and in 85.7% of 7 patients with baseline MR grade ≥ 3. CONCLUSIONS Implantation of the MONARC device in the coronary sinus is feasible and may reduce MR. However, coronary artery compression may occur in patients in whom the great cardiac vein passes over a coronary artery, necessitating strategies in future studies to avoid this occurrence.

Transapical Versus Transfemoral Aortic Valve Implantation: A Comparison of Survival and Safety

BACKGROUND Transcatheter aortic valve implantation (TAVI) is a therapeutic option for high-risk patients with aortic stenosis. Procedural mortality remains high in comparison with conventional aortic valve replacement (AVR) because patients determined for TAVI are commonly denied conventional surgery. We aimed to evaluate access-related complications between the transfemoral (TF) and the transapical (TA) approach and to compare survival between TAVI and conventional AVR in propensity-score-matched patients. METHODS Between January 2008 and November 2009, 40 patients underwent TAVI (TF, n=10; TA, n=30) with the Edwards Sapien bioprosthesis (Edwards Lifesciences, Irvine, CA). Survival and postoperative complications were evaluated between the TF and the TA approach. A comparison of survival was made between the TAVI patients and propensity-score-matched patients undergoing conventional AVR. RESULTS Successful implantation rate was 92.5% (37 of 40). Thirty-day mortality was 5.0% (2 of 40), and the overall in-hospital mortality was 10.0% (4 of 40). Survival after TAVI was 77% at both 6 months and 1 year. Major vascular complications occurred in 3 of 10 patients (all in the TF group), and 3 of 40 patients (7.5%) suffered cerebrovascular events. A comparison of survival between TAVI and propensity score-matched conventional AVR patients showed no significant difference in either the TA group (p=0.73) or the TF group (p=0.59). CONCLUSIONS The vascular complications occurring when using the TF approach were probably related to a combination of a wide introducer sheath and heavily calcified femoral arteries in a high-risk population. No serious complications were encountered when using the TA approach. After propensity-score matching, survival with both the TA and TF approaches is similar to that after AVR.

Comparison of two drug-eluting balloons: a report from the SCAAR registry.

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. METHODS 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). CONCLUSIONS 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.

SWEDEHEART Annual Report 2012

Abstract The Swedish Web-system for Enhancement and Development of Evidence-based care in Heart disease Evaluated According to Recommended Therapies (SWEDEHEART) supports continuous monitoring and improvement of care for coronary artery disease, catheter-based and surgical coronary interventions, secondary prevention as well as catheter based and surgical valve intervention, by providing extensive data on base-line, diagnostic, procedural and outcome variables. Design. This national quality registry collects information from all Swedish hospitals treating patients with acute coronary artery disease and all patients undergoing coronary angiography, catheter-based interventions or heart surgery. Combination with other national mandatory official registries enables complete follow-up of all individuals regarding myocardial infarction, new interventional procedures, death and all-cause hospitalizations. The registry is governed by an independent steering committee and funded by the Swedish National Health care provider. The software is developed by Uppsala Clinical Research Center. Results. The SWEDEHEART Quality Index reflects overall quality of care for coronary artery disease including secondary prevention. In comparison with 2011, an improvement of the index occurred in 2012 overall. There was however, still a wide range in performance between individual centers, emphasizing the need for continuous monitoring of quality of care at a national as well as on a center level.

Clinical impact of second-generation everolimus-eluting stent compared with first-generation drug-eluting stents in diabetes mellitus patients: insights from a nationwide coronary intervention register.

OBJECTIVES This study sought to study the second-generation everolimus-eluting stent (EES) as compared with first-generation sirolimus-eluting (SES) and paclitaxel-eluting stents (PES) in diabetes mellitus (DM) patients. BACKGROUND There are limited data available comparing clinical outcomes in this setting with EES and SES, whereas studies comparing EES with PES are not powered for low-frequency endpoints. METHODS All DM patients treated with EES, PES, or SES from January 18, 2007, to July 29, 2011, from the SCAAR (Swedish Coronary Angiography and Angioplasty Registery) were included. The EES was compared with SES or PES for the primary composite endpoint of clinically driven detected restenosis, definite stent thrombosis (ST), and all-cause mortality. RESULTS In 4,751 percutaneous coronary intervention-treated DM patients, 8,134 stents were implanted (EES = 3,928, PES = 2,836, SES = 1,370). The EES was associated with significantly lower event rates compared with SES (SES vs. EES hazard ratio [HR]: 1.99; 95% confidence interval (CI): 1.19 to 3.08). The same was observed when compared with PES (PES vs. EES HR: 1.33; 95% CI: 0.93 to 1.91) but did not reach statistical significance. These results were mainly driven by lower incidence of ST (SES vs. EES HR: 2.87; 95% CI: 1.08 to 7.61; PES vs. EES HR: 1.74, 95% CI: 0.82 to 3.71) and mortality (SES vs. EES HR: 2.02; 95% CI: 1.03 to 3.98; PES vs. EES HR: 1.69; 95% CI: 1.06 to 2.72). No significant differences in restenosis rates were observed between EES and SES or PES (SES vs. EES HR: 1.26; 95% CI: 0.77 to 2.08; PES vs. EES HR: 1.05; 95% CI: 0.71 to 1.55). CONCLUSIONS In all-comer DM patients the use of EES was associated with improved outcomes compared with SES and PES mainly driven by lower rates of ST and mortality. These results suggest better safety rather than efficacy with EES when compared with SES or PES.

Chronic Total Occlusions in Sweden - A Report from the Swedish Coronary Angiography and Angioplasty Registry (SCAAR)

Introduction Evidence for the current guidelines for the treatment of patients with chronic total occlusions (CTO) in coronary arteries is limited. In this study we identified all CTO patients registered in the Swedish Coronary Angiography and Angioplasty Registry (SCAAR) and studied the prevalence, patient characteristics and treatment decisions for CTO in Sweden. Methods and Results Between January 2005 and January 2012, 276,931 procedures (coronary angiography or percutaneous coronary intervention) were performed in 215,836 patients registered in SCAAR. We identified all patients who had 100% luminal diameter stenosis known or assumed to be ≥3 months old. After exclusion of patients with previous coronary artery bypass graft (CABG) surgery or coronary occlusions due to acute coronary syndrome, we identified 16,818 CTO patients. A CTO was present in 10.9% of all coronary angiographies and in 16.0% of patients with coronary artery disease. The majority of CTO patients were treated conservatively and PCI of CTO accounted for only 5.8% of all PCI procedures. CTO patients with diabetes and multivessel disease were more likely to be referred to CABG. Conclusion CTO is a common finding in Swedish patients undergoing coronary angiography but the number of CTO procedures in Sweden is low. Patients with CTO are a high-risk subgroup of patients with coronary artery disease. SCAAR has the largest register of CTO patients and therefore may be valuable for studies of clinical importance of CTO and optimal treatment for CTO patients.