Gerhard Schuler

Intracoronary Compared With Intravenous Bolus Abciximab Application in Patients With ST-Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention. The Randomized Leipzig Immediate Percutaneous Coronary Intervention Abciximab IV Versus IC in ST-Elevation Myocardial Infarction Trial

Background— Abciximab reduces major adverse cardiac events in patients with ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention (PCI). Intracoronary abciximab bolus application results in high local drug concentrations and may be more effective than a standard intravenous bolus. Methods and Results— Patients undergoing primary PCI were randomized to either intracoronary (n=77) or intravenous (n=77) bolus abciximab administration with subsequent 12-hour intravenous infusion. The primary end point was infarct size and extent of microvascular obstruction as assessed by delayed enhancement magnetic resonance. Secondary end points were ST-segment resolution at 90 minutes, Thrombolysis in Myocardial Infarction flow and perfusion grades after PCI, and the occurrence of major adverse cardiac events within 30 days. The median infarct size was 15.1% (interquartile range, 6.1% to 25.2%) in the intracoronary versus 23.4% (interquartile range, 13.6% to 33.2%) in the intravenous group (P=0.01). Similarly, the extent of microvascular obstruction was significantly smaller in intracoronary compared with intravenous abciximab patients (P=0.01). Myocardial perfusion measured as early ST-segment resolution was significantly improved in intracoronary patients with an absolute ST-segment resolution of 77.8% (interquartile range, 66.7% to 100.0%) versus 70.0% (interquartile range, 45.2% to 83.5%; P=0.006). The Thrombolysis in Myocardial Infarction flow after PCI was not different between treatment groups (P=0.51), but there was a trend toward an improved perfusion grade (P=0.09). There also was a trend toward a lower major adverse cardiac event rate after intracoronary versus intravenous abciximab application (5.2% versus 15.6%; P=0.06; relative risk, 0.33; 95% CI, 0.09 to 1.05). Conclusions— Intracoronary bolus administration of abciximab in primary PCI is superior to standard intravenous treatment with respect to infarct size, extent of microvascular obstruction, and perfusion.

Transapikale minimal invasive Aortenklappen-Implantation

ZusammenfassungHintergrundZiel dieser Sudie war die Bewertungnder Machbarkeit der minimal invasiven transapikalen Aortenklappenimplantationn(TAP-AKI) am schlagenden Herzen bei Hochrisiko-Patientennmit Aortenstenose.Methodik:TAP-AKI wurde von Februar bis Septembern2006 bei 30 Patienten über eine anterolaterale Minithorakotomie amnschlagenden Herzen mit femoraler Kannülierung für die Herz-Lungen-Maschine (HLM) (n = 13) oder ohne HLM „off-pump“ (n = 17) durchgeführt.nEs wurde eine biologische Perikard-Klappenprothese (Edwards SAPIEN™nTHV, Edwards Lifesiences, Irvine, CA, USA), die innerhalb einesnStahl-Stents fixiert ist, über einen Ballon-Katheter implantiert. Die Patientennwaren 82 ± 5,1 Jahre alt und 21 (70%) waren weiblich. Die Positionierungnder Prothese erfolgte mittels Durchleuchtung und Echokardiographie.nDas Mortalitätsrisiko nach logistischem EuroSCORE betrugn27 ± 12%.ErgebnisseDie Klappenprothese konnte bei 29 Patienten erfolgreichnpositioniert werden – ein Patient musste bei proximalem Verrutschennder Prothese konventionell operiert werden. Die Implantationn(8-mal 23mm-, 22-mal 26mm-Prothese) wurde am schlagenden Herzennwährend kurzer Phasen tachykarder Ventrikelstimulation („rapid ventricularnpacing“) durchgeführt. Es wurden weder Verlegungen der Koronarostien,nnoch Dislokationen der Prothesen beobachtet. Alle Klappen zeigtenneine gute hämodynamische Funktion. In der Echokardiographie zeigtennsich geringradige paravalvuläre Insuffizienz bei 14 Patienten (3 minimal,n9 gering, 2 mittel). Drei Patienten verstarben (10%), einer am 3. postoperativennTag bei bereits präoperativ aufgetretenem globalem Herzversagennund zwei am Tag 18 und 86 aufgrund abdomineller, nicht klappenbezogenernKomplikationen.SchlussfolgerungDie minimal invasive transapikalenAortenklappenimplantation (TAP-AKI) am schlagenden Herzen ist machbar.nDie ersten Ergebnisse sind, unter Berücksichtigung des Risikoprofilsndieser Patienten, exzellent. Die Langzeitergebnisse bleiben abzuwarten.AbstractBackgroundThe aim of the present study was to evaluatenthe feasibility of minimally invasive transapical beating heart aorticnvalve implantation (TAP-AVI) for high-risk patients with aortic stenosis.MethodsTAP-AVI was performed via a small anterolateral minithoracotomynwith (n = 13) or without (n = 17) femoral cardiopulmonary bypassnon the beating heart. A pericardial xenograft fixed within a stainlessnsteel, balloon expandable stent (Cribier-Edwards, Edwards Lifesciences,nIrvine, CA, USA) was used. Thirty consecutive patients (82 ± 5.1 years,n21 (70%) female) were operated from February 2006 to September 2006nat one center using fluoroscopic and echocardiographic visualization.nAverage EuroSCORE predicted risk for mortality was 27 ± 12%.ResultsValve-positioning was successful in 29 patients and one required earlynconversion to full sternotomy. Implantation (8 × 23 mm and 22 × 26 mmnvalves) was performed on the beating heart during brief periods ofnrapid ventricular pacing. Neither coronary artery obstruction nornmigration of the prosthesis was observed and all valves displayed goodnhemodynamic function. Echocardiography revealed minor paravalvularnleakage in 14 patients (trace in 3, mild in 9 and moderate in 2). Threenpatients (10%) died, one on postoperative day (POD) 3 secondary tonpreoperative global myocardial failure, and two on POD 18 and 86 duento abdominal complications.ConclusionsMinimally invasive beatingnheart TAP-AVI is feasible. Initial results are excellent in view of thenhigh-risk profile of the patients. Longer-term studies as well as randomizednprotocols are required.