Significance of the learning curve in left atrial appendage occlusion with two different devices.

OBJECTIVE: To evaluate the impact of learning on outcome with use of two different left atrial appendage (LAA) occlusion devices. BACKGROUND: Two self-expanding devices, the Watchman and the Amplatzer Cardiac Plug (ACP), have been used for LAA occlusion in the last few years. It has been demonstrated that complications associated with implantation decrease in frequency with operator experience. However, the role of operator experience has not been compared across the two device types. METHODS: The study comprises 31 consecutive patients who underwent LAA occlusion. We compare the first 10 patients in whom an ACP was implanted with the subsequent eleven patients who underwent ACP implantation and with 10 cases where a Watcthman device was implanted. The composite safety end point comprised procedure-related events and excessive bleeding events. We also performed 3 months echocardiographic and clinical follow-up. RESULTS: There were not significant differences in the basal clinical and echocardiographical characteristics across the three groups. Cardiac complications only occurred in the ACP initial experience group (9% vs. 0% vs. 0% P = 0.04). Echocardiographic and clinical follow-up at 3 months was completed in all patients. No significant residual leak was detected. One patient in the ACP initial experience group developed a thrombus on the device. One patient in ACP late experience presented an ischemic stroke. CONCLUSIONS: Complications associated with LAA occlusion cluster early in the peri-procedural period and significantly decrease in frequency with operator experience. Initial experience gained with one of device may improve outcome with use of alternative LAA occlusion devices.

Relation of circulating C-reactive protein to progression of aortic valve stenosis.

C-reactive protein (CRP) is a marker of inflammation and predicts outcome in apparently healthy subjects and patients with coronary artery disease. Systemic inflammation is present in patients with aortic valve stenosis (AS). The aim of this prospective study was to assess whether CRP levels predict the progression of AS severity. Blood samples for high-sensitivity CRP measurements and echocardiographic data were obtained in 43 patients (70% men; mean age 73 +/- 8 years) with asymptomatic degenerative AS at study entry. On the basis of repeat echocardiographic assessment at 6 months, patients were grouped as (1) slow progressors (a decrease in aortic valve area [AVA] <0.05 cm2 and/or an increase in aortic peak velocity <0.15 m/s) and (2) rapid progressors (a decrease in AVA > or =0.05 cm2 and/or an increase in aortic peak velocity > or =0.15 m/s). Plasma CRP levels were significantly higher in rapid progressors than slow progressors (median 5.1 [range 2.3 to 11.3] vs 2.1 [range 1.0 to 3.1] mg/L, p = 0.007). In multivariate analysis, CRP levels >3 mg/L were independently associated with rapid AS progression (odds ratio 9.1, 95% confidence interval 2.2 to 37.3). In conclusion, CRP levels are higher in patients with degenerative AS who show rapid valve disease progression. These findings suggest that inflammation may have a pathogenic role in degenerative AS.

[Clinical safety and efficacy of single-chamber atrial pacing in sick sinus syndrome: long-term follow-up]. / Seguridad y eficacia clínica de la estimulación con el modo AAI en la disfunción del nodo sinusal: seguimiento a largo plazo.

INTRODUCTION AND OBJECTIVES: Although atrial pacing is a more physiological mode of stimulation in sinus node dysfunction, the pacing modes most often are used DDD and VVI. The aim of our study was to demonstrate that AAI/AAIR pacing is effective and safe by analyzing the complications and mortality of this pacing mode in a long-term follow-up study. PATIENTS AND METHOD: Between 1982 and 2000 definitive AAI-mode pacemakers were implanted for sinus node dysfunction in mode AAI in 160 patients. We analyzed the clinical characteristics, evolution, and complications of the AAI pacing mode during a follow-up of 5.4 4.5 years. RESULTS: The sample was made up of 104 women and 56 men with an average age of 72 12 years. During follow-up, it was necessary to change the pacing mode for symptomatic bradycardia in 11 patients (annual incidence 1.2%), which was caused by second or third-degree atrioventricular block in 7 patients (annual incidence 0.8%), and chronic atrial fibrillation with bradycardia in 4 patients (annual incidence 0.4%). During follow-up, atrial arrhythmias occurred in 32 patients (annual incidence 3.7%), stroke in 4 patients (annual incidence 0.4%), and 27 patients (annual incidence 3.1%) died. CONCLUSIONS: The AAI/AAIR pacing mode was safe and effective in sinus node dysfunction, with a low percentage of pacing changes required for progression to atrioventricular block, low incidence of atrial arrhythmias, stroke and low mortality during long term follow-up.

[Hypoxemia and stroke in a patient with a pacemaker]. / Cianosis y accidente cerebrovascular en una paciente con marcapasos.

We report a woman with a VVI pacemaker and a history of stroke and severe hypoxemia due to a right-to-left shunt. Anomalous blood flow was through a patent foramen oval, and was related directly with severe tricuspid regurgitation because the ventricular pacemaker electro de was adhered to the tricuspid valve. She was treated successfully with surgery. We review the role of patent foramen ovale from a clinical point of view, and current therapeutic options.

[Long-term prognostic value of troponin I in patients admitted to a coronary unit for unstable angina]. / Valor pronóstico de la troponina I en los pacientes ingresados en una unidad coronaria por angina inestable.

INTRODUCTION AND OBJECTIVES: Troponin I (TnI) is a useful marker of myocardial damage for the diagnosis and prognosis of acute coronary syndrome. The purpose of this study was to analyze the long-term prognostic value of the peak TnI concentration obtained within 48 h of admission to the coronary unit for unstable angina. METHODS: The study included 149 consecutive patients. Serial determinations were made of the MB fraction of creatine kinase (CK-MB) and TnI. Patients without CK-MB elevation were classified into two groups depending on the presence of high (n = 58) or normal (n = 91) troponin I values. We prospectively analyzed the clinical and evolutive factors related to the probability of death, new acute coronary event, or coronary revascularization at one-year of follow-up. RESULTS: There were no differences in the clinical characteristics between groups, except that patients in the group with high TnI values were older (69 vs. 64 years, p = 0.01). At one year of follow-up there were no differences in the incidence of new acute coronary events or coronary revascularization procedures; however there was a higher mortality in the group with high TnI (13 vs. 4%; p = 0.01). The independent predictors of mortality were prior myocardial infarction (RR = 3), elevated troponin I (RR = 3.2), left ventricular ejection fraction < 35% (RR = 10), and age > 70 years (RR = 15). CONCLUSIONS: In patients with unstable angina a high troponin I value in the first 48 h of admission was associated with a higher mortality rate at one-year of follow-up.

Hemodynamic performance of the Medtronic Mosaic and Perimount Magna aortic bioprostheses: five-year results of a prospectively randomized study.

OBJECTIVE: Clinical outcomes of patients undergoing aortic valve replacement may be influenced by the presence of residual gradients and patient-prosthesis mismatch. The aim of this study was to compare hemodynamic performance and clinical outcomes at 5 years after prospectively randomized porcine versus bovine aortic valve replacement. We also aimed to determine the effects of valve hemodynamics on left ventricular (LV) mass regression. METHODS: A total of 108 patients undergoing aortic valve replacement were randomized to receive either the Medtronic Mosaic (MM) porcine (n=54) or the Edwards Perimount Magna (EPM) bovine pericardial prosthesis (n=54). Clinical outcomes, mean gradients, effective orifice area and LV mass regression were evaluated at 1 and 5 years after surgery. Follow-up echocardiograms were performed on 106 (98%) and 87 (92%) patients, respectively. RESULTS: Preoperative characteristics were similar between groups. Mean aortic annulus diameter and mean implant size were comparable in both groups. At 1 and 5 years, mean transprosthetic gradients were lower in the EPM group: EPM 10.3±3.4mmHg versus MM 16.3 ± 7.6 mmHg (p<0.0001) and EPM 9.6 ± 3.5 mmHg versus MM 16.8 ± 8.7 mmHg (p<0.0001), respectively. Similarly, indexed effective orifice areas (IEOA) at 1 and 5 years were significantly greater in the EPM group: EPM 1.10 ± 0.22 cm(2)m(-2) versus MM 0.96 ± 0.22 cm(2)m(-2) (p<0.004) and EPM 1.02 ± 0.25 cm(2)m(-2) versus MM 0.76 ± 0.19 cm(2)m(-2) (p<0.0001), respectively. At 5 years, the incidence of patient-prosthesis mismatch (IEOA ≤0.85 cm(2)m(-2)) was significantly lower in the EPM group: EPM 22.9% vs MM 73.9% (p<0.0001). Such differences were similar when analysis was stratified by surgically measured annular size and implant valve size. During the first year after surgery, both groups demonstrated similar regression of LV mass index (MM -26.3 ± 43 gm(2) vs EPM -30.1 ± 36 gm(-2); p=0.8); however, at 5 years, regression of LV mass index was significantly greater in the EPM group: (EPM -47.4 ± 35 gm(-2) vs -4.4 ± 36 gm(-2); p<0.0001). Five-year survival was 79.6 ± 4.1% in the MM group and 94.4 ± 2.2% in the EPM group (p=0.03). CONCLUSIONS: At 5 years, the EPM valve was significantly superior to the MM prosthesis with regard to hemodynamic performance, incidence of patient-prosthesis mismatch and regression of LV mass index. The hemodynamic superiority of the EPM prostheses in comparison to MM-prostheses demonstrated at 1 year, increased significantly over time.

One year hemodynamic performance of the Perimount Magna pericardial xenograft and the Medtronic Mosaic bioprosthesis in the aortic position: a prospective randomized study.

We compared the hemodynamic performance of the Edwards Perimount Magna (EPM) and the Medtronic Mosaic (MM) bioprostheses according to the patient aortic annulus diameter (AAD). Eighty-six patients undergoing aortic valve replacement were prospectively assigned to receive either an EPM-valve (n=43) or an MM-bioprosthesis (n=43). Randomization was performed after measuring the AAD and patients were grouped according to their AAD: <22 mm (n=12), 22-23 mm (n=31) and >23 mm (n=43). Echocardiographic assessment was performed one year postoperatively. The mean AAD (EPM 23.9+/-2.1 mm vs. MM 23.6+/-2.3 mm) and mean valve size implanted (EPM 22.6+/-2.1 mm vs. MM 23.3+/-2.1 mm) were comparable in both groups. The EPM-group showed significantly lower mean gradient (EPM 10.2+/-3.2 mmHg vs. MM 17.1+/-8.2 mmHg) and larger effective orifice area (EOA) (EPM 1.99+/-0.4 cm(2) vs. MM 1.69+/-0.4 cm(2), P<0.0001). The EPM-valve was superior with respect to mean pressure gradient and EOA in all AAD. This difference was statistically significant in AAD of 22-23 mm (EPM 9.6+/-3.0 mmHg vs. MM 18.2+/-8.6 mmHg; EPM 1.82+/-0.3 cm (2) vs. MM 1.51+/-0.2 cm (2)) and >23 mm (EPM 9.9+/-3.1 mmHg vs. MM 14.2+/-5.6 mmHg; EPM 2.18+/-0.4 cm(2) vs. MM 1.94+/-0.5 cm(2)). Patient-prosthesis mismatch was present in 26.8% (MM) vs. 6.9% (EPM) of the patients (P=0.01). When the same AAD is taken as a reference, the EPM-valve was hemodynamically superior to the MM-bioprosthesis. The EPM-prosthesis significantly reduced the incidence of PPM.

The Carpentier-Edwards Perimount Magna aortic xenograft: a new design with an improved hemodynamic performance.

This study compares the implantation characteristics and the hemodynamic performance of the new Carpentier-Edwards Perimount Magna (CEPM) xenograft with those of the standard Perimount (CEPS) valve in the aortic position. Eighty consecutive patients surviving an aortic valve replacement with either the CEPS valve (n=40) or the CEPM prosthesis (n=40) in the supra-annular position were retrospectively reviewed. One year follow-up was complete and hemodynamic performance assessed by Doppler echocardiography. The mean valve size implanted was 21.3+/-1.7 mm (CEPS) vs. 22.2+/-1.8 mm (CEPM). The average mean pressure gradient was 13.6+/-5.1 mmHg in the CEPS group and 9.6+/-3.3 mmHg in the CEPM group (P<0.0001). Mean and peak gradients were slightly lower and the effective orifice areas (EOA) were larger for the Magna prosthesis than for the comparable standard valves: 19 mm (1.58+/-0.2 vs. 1.28+/-0.1 cm(2)), 21 mm (1.90+/-0.4 vs. 1.69+/-0.4 cm(2)), 23 mm (2.07+/-0.3 vs. 1.86+/-0.3 cm(2)), 25 mm (2.30+/-0.1 vs. 1.89+/-0.5 cm(2)). The average indexed EOA was statistically different between groups (CEPS 0.98+/-0.21 cm(2)/m(2) vs. CEPM 1.20+/-0.25 cm(2)/m(2)). Patient-prosthesis mismatch (indexed EOA