Left ventricular guidewire pacing for transcatheter aortic valve implantation.

Previous reports prove the safety and efficacy of cardiac pacing employing a guidewire in the left ventricle as unipolar pacing electrode. We describe the use of left ventricular guidewire pacing as an alternative to conventional transvenous temporary right ventricular pacing in the context of transcatheter aortic valve implantation.

Oclusão do apêndice atrial esquerdo com o Amplatzer Cardiac Plug em pacientes com fibrilação atrial / Left atrial appendage closure with the Amplatzer Cardiac Plug in patients with atrial fibrillation

FUNDAMENTO: A oclusão percutânea do apêndice atrial esquerdo (OAAE) surgiu como alternativa à anticoagulação oral (AO) para prevenção do acidente vascular cerebral (AVC) em pacientes com fibrilação atrial não-valvular (FANV). OBJETIVO: Relatar os resultados imediatos e o seguimento clínico de pacientes submetidos a OAAE com o Amplatzer Cardiac Plug (ACP) em um único centro de referência. MÉTODOS: Oitenta e seis pacientes consecutivos com FANV, contra-indicação à AO e escore CHADS2= 2,6±1,2 foram submetidos a OAAE com implante de ACP. Realizou-se seguimento clínico e ecocardiográfico no mínimo 4 meses após o implante. RESULTADOS: Todos os implantes foram guiados apenas por angiografia. O sucesso do procedimento foi de 99% (1 insucesso por tamponamento cardíaco e consequente suspensão da OAAE). Houve 4 complicações maiores (o tamponamento já referido, 2 AVCs transitórios e uma embolização com retirada percutânea da prótese) e duas menores (um derrame pericárdico sem tamponamento e uma pequena comunicação interatrial evidenciada no seguimento). Houve 1 óbito hospitalar após 6 dias, não relacionado à intervenção. Todos os outros pacientes receberam alta sem AO. Após seguimento de 25,9 pacientes-ano (69 pacientes) não houve AVCs nem embolizações tardias de próteses. O AAE estava completamente ocluído em 97% dos casos. Seis pacientes apresentaram evidência de trombo sobre a prótese, que desapareceram após reinstituição de AO por 3 meses. CONCLUSÃO: OAAE se associa a um alto índice de sucesso, um índice aceitável de complicações e resultados promissores a médio prazo, podendo ser considerada uma alternativa válida à OA na prevenção do AVC em pacientes com FANV.

BACKGROUND: Percutaneous left atrial appendage closure (LAAC) has emerged as an alternative to oral anticoagulation (OA) for prevention of thromboembolic stroke in patients with non-valvular atrial fibrillation (NVAF). OBJECTIVE: To describe the immediate results and short- to medium-term clinical follow-up (FU) of patients that underwent LAAC with Amplatzer Cardiac Plug (ACP) implantation in a single reference center. METHODS: Eighty-six consecutive patients with NVAF, contraindication to OA, and CHADS2 score=2.6±1.2 underwent LAAC with ACP implantation. Clinical and echocardiographic FU was performed at least four months after the procedure. RESULTS: All implants were guided by angiography alone. Procedural success was 99% (one patient suffered a cardiac tamponade requiring pericardiocentesis, and the procedure was waived). There were four major complications (the already mentioned cardiac tamponade, two transient ischemic attacks and one device embolization with percutaneous retrieval) and two minor complications (one pericardial effusion without clinical significance and one non-significant ASD evidenced at FU). There was one in-hospital death after six days, unrelated to the procedure. All other patients were discharged without OA. After 25.9 patient-years of FU (69 patients), there were no strokes and no late device embolization. The LAA was completely closed in 97% of the cases. Six patients showed evidence of thrombus formation on the device, which resolved after three months of OA. CONCLUSION: LAAC is associated with high success, acceptable complication rates, and promising FU results, and may be considered a valuable alternative or complement to OA for stroke prevention in patients with NVAF.

Left atrial appendage closure with the Amplatzer cardiac plug in patients with atrial fibrillation.

BACKGROUND: Percutaneous left atrial appendage closure (LAAC) has emerged as an alternative to oral anticoagulation (OA) for prevention of thromboembolic stroke in patients with non-valvular atrial fibrillation (NVAF). OBJECTIVE: To describe the immediate results and short- to medium-term clinical follow-up (FU) of patients that underwent LAAC with Amplatzer Cardiac Plug (ACP) implantation in a single reference center. METHODS: Eighty-six consecutive patients with NVAF, contraindication to OA, and CHADS2 score=2.6 ± 1.2 underwent LAAC with ACP implantation. Clinical and echocardiographic FU was performed at least four months after the procedure. RESULTS: All implants were guided by angiography alone. Procedural success was 99% (one patient suffered a cardiac tamponade requiring pericardiocentesis, and the procedure was waived). There were four major complications (the already mentioned cardiac tamponade, two transient ischemic attacks and one device embolization with percutaneous retrieval) and two minor complications (one pericardial effusion without clinical significance and one non-significant ASD evidenced at FU). There was one in-hospital death after six days, unrelated to the procedure. All other patients were discharged without OA. After 25.9 patient-years of FU (69 patients), there were no strokes and no late device embolization. The LAA was completely closed in 97% of the cases. Six patients showed evidence of thrombus formation on the device, which resolved after three months of OA. CONCLUSION: LAAC is associated with high success, acceptable complication rates, and promising FU results, and may be considered a valuable alternative or complement to OA for stroke prevention in patients with NVAF.

Sirolimus-eluting coronary stents in small vessels

Background This prospective multicenter study compared angiographic in-lesion late lumen loss in de novo native coronary artery lesions (vessel diameter range 2.25-2.75 mm, length range z15 to V30 mm) 8 months after the implantation of a sirolimus-eluting stent with that of similar vessels with the same drug-eluting stent or a bare stent of the SIRIUS study (historical controls). Methods and Results One hundred one patients (study group) were matched and compared with 323 patients receiving the bare stent (bare control group) and with 350 receiving the Cypher stent (Cypher control group) in the SIRIUS trial. Mean in-lesion late loss in the study group was lower than that in the bare control group (0.20 versus 0.76 mm, P b .0001) and not inferior to that in the Cypher control group (0.27 mm, P = .3). Adverse event rates (death and myocardial infarction) were similar between groups. At 8 months, target lesion revascularization rates were 0% in the study group, 13.2% in the bare control group ( P b .001), and 4.6% in the Cypher control group ( P = .03). Conclusions The Cypher Bx Velocity stent was confirmed to be superior to the bare Bx Velocity stent in small coronary vessels in terms of in-lesion late loss 8 months after implantation. (Am Heart J 2006;151:1019.e121019.e7.) Rates of angiographic restenosis and target lesion revascularization (TLR) were found to be higher in small vessels (b2.5 mm in diameter) than in larger vessels 6 months after percutaneous transluminal coronary angioplasty or stenting1,2 and 1 year after stenting.3 Predictors of small vessel restenosis are diabetes, complex lesions, and long lesions.1,4,5 Although estenosis has not been conclusively linked to mortality, it can adversely affect quality of life.6 tents reduce restenosis by preventing recoil, but tissue growth renarrows the lumen significantly in approximately 20% of patients.7-12 Small vessel stenting has shown some advantages over balloon angioplasty randomized and nonrandomized trials but a higher risk for restenosis as compared with larger vessels.13-17 In recent years, stents eluting sirolimus or taxol have attenuated vascular hyperproliferation.18-25 Sirolimus prevents neointimal proliferation.26,27 The Cypher (sirolimus-eluting Bx Velocity) stent was compared with the bare Bx Velocity stent in the SIRIUS study...

Sirolimus- vs paclitaxel-eluting stents in de novo coronary artery lesions

Context Compared with bare metal stents, sirolimus-eluting and paclitaxel-eluting stents have been shown to markedly improve angiographic and clinical outcomes after percutaneous coronary revascularization, but their performance in the treatment of de novo coronary lesions has not been compared in a prospective multicenter study. Objective To compare the safety and efficacy of sirolimus-eluting vs paclitaxeleluting coronary stents. Design Prospective, randomized comparative trial (the REALITY trial) conducted between August 2003 and February 2004, with angiographic follow-up at 8 months and clinical follow-up at 12 months. Setting Ninety hospitals in Europe, Latin America, and Asia. Patients A total of 1386 patients (mean age, 62.6 years; 73.1% men; 28.0% with diabetes) with angina pectoris and 1 or 2 de novo lesions (2.25-3.00 mm in diameter) in native coronary arteries. Intervention Patients were randomly assigned in a 1:1 ratio to receive a sirolimuseluting stent (n=701) or a paclitaxel-eluting stent (n=685). Main Outcome Measures The primary end point was in-lesion binary restenosis (presence of a more than 50% luminal-diameter stenosis) at 8 months. Secondary end points included 1-year rates of target lesion and vessel revascularization and a composite end point of cardiac death, Q-wave or non–Q-wave myocardial infarction, coronary artery bypass graft surgery, or repeat target lesion revascularization. Results In-lesion binary restenosis at 8 months occurred in 86 patients (9.6%) with sirolimus-eluting stent vs 95 (11.1%) with a paclitaxel-eluting stent (relative risk [RR], 0.84; 95% confidence interval [CI], 0.61-1.17; P=.31). For sirolimus- vs paclitaxeleluting stents, respectively, the mean (SD) in-stent late loss was 0.09 (0.43) mm vs 0.31 (0.44) mm (difference, −0.22 mm; 95% CI, −0.26 to −0.18 mm; P .001), mean (SD) in-stent diameter stenosis was 23.1% (16.6%) vs 26.7% (15.8%) (difference, −3.60%; 95% CI, −5.12% to −2.08%; P .001), and the number of major adverse cardiac events at 1 year was 73 (10.7%) vs 76 (11.4%) (RR, 0.94; 95% CI, 0.69- 1.27; P=.73). Conclusion In this trial comparing sirolimus- and paclitaxel-eluting coronary stents, there were no differences in the rates of binary restenosis or major adverse cardiac events.

Fluvastatin for prevention of cardiac events following successful first percutaneous coronary intervention

Context Percutaneous coronary intervention (PCI) is associated with excellent short-term improvements in ischemic symptoms, yet only three fifths of PCI patients at 5 years and one third of patients at 10 years remain free of major adverse cardiac events (MACE).Objective To determine whether treatment with fluvastatin reduces MACE in patients who have undergone PCI.Design and Setting Randomized, double-blind, placebo-controlled trial conductedat 77 referral centers in Europe, Canada, and Brazil. Patients A total of 1677 patients (aged 18-80 years) recruited between April 1996 and October 1998 with stable or unstable angina or silent ischemia following successful completion of their first PCI who had baseline total cholesterol levels between 135 and 270 mg/dL (3.5-7.0 mmol/L), with fasting triglyceride levels of less than 400 mg/dL (4.5 mmol/L).Interventions Patients were randomly assigned to receive treatment with fluvastatin, 80 mg/d (n = 844), or matching placebo (n = 833) at hospital discharge for 3 to 4 years. Main Outcome Measure Survival time free of MACE, defined as cardiac death,nonfatal myocardial infarction, or reintervention procedure, compared between the treatment and placebo groups. Results Median time between PCI and first dose of study medication was 2.0 days, and median follow-up was 3.9 years. MACE-free survival time was significantly longer in the fluvastatin group (P = .01). One hundred eighty-one (21.4%) of 844 patients in the fluvastatin group and 222 (26.7%) of 833 patients in the placebo group had at least 1 MACE (relative risk [RR], 0.78; 95% confidence interval [CI], 0.64-0.95; P = .01)...