Long-term outcome of percutaneous closure of secundum-type atrial septal defects in adults.

AIMS: Transcatheter closure of the secundum-type atrial septal defect (ASD) is widely practised. We report complications and efficacy of percutaneous ASD closure in adults using the Amplatzer ASD occluder and the Cardioseal/Starflex device during long-term follow-up. METHODS AND RESULTS: Between 1996 and 2008 percutaneous ASD closure was performed in 133 patients (mean age 46.8 ± 16.9 years; 36 men) by using the Amplatzer(r) device in 104 patients and the Cardioseal/Starflex device in 29. During a mean follow-up of 3.4 ± 2.8 years the occurrence of major complications was higher in patients with the Cardioseal/Starflex compared to patients with the Amplatzer(r) devices (17.2 vs. 2.9%, log rank, P=0.005), due to a higher embolisation rate (13.8 vs. 1.0%, log rank, P=0.002). In univariable analysis, the implantation of a Cardioseal/Starflex device (OR 6.0 (CI 1.4-25.2); P=0.01) and a larger device diameter (OR 1.1 (CI 1.0-1.2); P=0.04) were found to be predictors of the occurrence of major complications. Minor complications occurred in 10.5%, recurrent thrombo-embolism in 2.3% and residual shunting at six months was 13.9% without differences between devices. NYHA class improved from 1.8 ± 0.6 before to 1.2 ± 0.4 after closure (P<0.001) without differences between devices. CONCLUSIONS: During long-term follow-up, percutaneous ASD closure in adults is safe and effective when using the Amplatzer(r) device. Larger Cardioseal/Starflex devices are related to a higher embolisation rate. Randomised trials are needed.

Advanced glycation end-products, anti-hypertensive treatment and diastolic function in patients with hypertension and diastolic dysfunction.

AIMS: To investigate the relationship between advanced glycation end-products (AGEs) and diastolic function and the response to blood pressure treatment in patients with hypertension and diastolic dysfunction. METHODS AND RESULTS: Data were analysed from 97 patients (aged 65 +/- 10 years, 36% male) who were randomly assigned to 6 months open-label treatment with either eprosartan on top of other anti-hypertensive drugs (n = 47) or other anti-hypertensive drugs alone (n = 50). Tissue AGE accumulation was measured using a validated skin-autofluorescence (skin-AF) reader (n = 26). Plasma N(epsilon)-(carboxymethyl)lysine (CML), N(epsilon)-(carboxyethyl)lysine (CEL), and pentosidine were measured by LC-MS/MS and HPLC. Diastolic function was assessed using echocardiography. Blood pressure was reduced from 157/91 to 145/84 mmHg (P < 0.001) in the eprosartan group and from 158/91 to 141/83 mmHg (P < 0.001) in the control group. No effect of eprosartan was found on AGE levels. In patients with baseline skin-AF < median, E/A ratio (P = 0.04) and the mean peak early-diastolic filling velocity (E') improved (P = 0.001). In contrast, in patients with skin-AF levels > median, E/A ratio (P = 0.84) and mean E' (P = 0.32) remained unchanged. CONCLUSION: Although eprosartan did not decrease levels of AGEs, patients with lower skin-AF at baseline showed a larger improvement in diastolic function in response to either anti-hypertensive treatment compared with patients with higher skin-AF.

Is a predominant left-to-right shunt associated with migraine?: A prospective atrial septal defect closure study.

BACKGROUND: A right-to-left shunt, as seen in patients with a patent foramen ovale, seems to be associated with migraine. An atrial septal defect (ASD), however, is characterized by a predominant left-to-right shunt (LRS). We prospectively evaluated the effect of percutaneous ASD closure on migraine METHODS: All 70 consecutive patients (>16 years) who underwent a percutaneous ASD closure between November 2003 and December 2005 in one of the two participating centers were included in the study. On the basis of standardized headache questionnaire, two independent neurologists diagnosed migraine with or without aura (MA+ and MA-, respectively) according to the International Headache Society criteria, before, 6 and 12 months after closure. RESULTS: Sixty-eight patients (97%; mean age 47.3 + or - 16.4 years; 22% men) agreed to participate in the study and completed the questionnaire. Before ASD closure, the overall prevalence of migraine was 34%, MA+ 22% and MA- 12%. At 6 months follow-up, the headache questionnaire was completed by 63 patients (93%) and the prevalence of overall migraine decreased to 19%, MA+ to 8% and MA- to 11% (Mc Nemar test, P = 0.08, P = 0.07, and P = 1.0, respectively). At 12 months, the prevalence of migraine decreased further to 12%, MA+ to 5% and MA- to 7% (McNemar test, P = 0.003, P = 0.04, and P = 0.29 versus at inclusion, respectively) based on a completed headache questionnaire of 57 patients (84%). CONCLUSION: We found a high prevalence of migraine in patients with an ASD, and observed prospectively a reduction in the occurrence of migraine, especially migraine with aura, 1 year after percutaneous closure.

Closure of a patent foramen ovale is associated with a decrease in prevalence of migraine: a prospective observational study.

BACKGROUND: A causal relationship between migraine and a right-to-left shunt, due to a patent foramen ovale (PFO), has been suggested. In mainly retrospective studies, percutaneous closure of a PFO has been associated with a decrease in the prevalence of migraine. OBJECTIVE: In this prospective observational study we evaluated whether percutaneous closure of a PFO is associated with a decrease in the prevalence of migraine. METHODS: Between November 2003 and August 2005, we included 92 patients (age >16 years) who underwent a percutaneous closure of a symptomatic PFO, which was considered to be related to a paradoxical embolism.They received a headache questionnaire before and six months after closure.Two neurologists diagnosed migraine, according to the International Headache Criteria. RESULTS: Eighty-nine of 92 patients (97%, mean age 51.6 +/- 12.3 years, 63 men) completed the questionnaire immediately before PFO closure.The overall prevalence of migraine was 27.0%, for migraine without aura (MA-) 15.7%, and for migraine with aura (MA+) 11.2%. After more than six months of follow-up 84 of 89 patients (94%, mean age 52.1 +/- 12.0 years, 60 men) returned the questionnaire. The overall prevalence of migraine in this group decreased from 28.6% to 10.7% (P = 0.001), for MA-from 16.7% to 8.3% (P = 0.07), and for MA+ from 11.9% to 2.4% (P = 0.02). CONCLUSIONS: Percutaneous PFO closure is related to a decrease in the prevalence of migraine in this prospective observational study. However, randomized placebo controlled trials have to confirm these findings.

Myocardial infarction with ventricular septal rupture complicating elective aortic valve replacement.

Herein is described the case of a 79-year-old woman who underwent elective aortic valve replacement. The procedure was complicated by a particulate embolism into the left anterior descending artery leading to a myocardial infarction, complicated by ventricular septal rupture. Subsequently, the patient was reoperated on and the septal defect closed successfully, with an uneventful recovery.

Comparison of outcome and complications using different types of devices for percutaneous closure of a secundum atrial septal defect in adults: a single-center experience.

The objective of this study was to find differences in outcome and complications using three different types of devices for percutaneous atrial septal defect (ASD) closure in adults. Percutaneous closure of a secundum-type ASD is increasingly performed in adult patients. All adult patients who underwent a percutaneous closure of a secundum-type ASD in our center between November 1996 and November 2004 were included. Failure was defined as dislocation or embolization of the device, which required surgical intervention. Periprocedural and mid-term complications were registered. Sixty-five patients, mean age 45.7+/-18.1 years (18 men, 47 women), underwent a percutaneous closure of an ASD with an ASDOS in 3, an Amplatzer in 36, and a Cardioseal/Starflex closure device in 26 patients. During an overall median follow-up of 1.2 years (range, 0.1-6.7 years), the failure occurred in four patients, all Cardioseal/Starflex (P=0.04). Within the Cardioseal/Starflex subgroup, the ASD and device diameters were significantly higher in those patients in whom the primary endpoint occurred compared to the others, 18.8+/-3.8 vs. 13.0+/-3.8 mm for ASD diameter (P=0.01) and 40 (range, 40-43) vs. 33 mm (range, 20-40) for device diameter (P=0.008). Overall complications were transient arrhythmias in 15.4%, pericardial effusion in 1.5%, and transient ischemic attack in 1.5%. Complete closure 6 months after the procedure occurred in 79.6%, without difference between the devices. Percutaneous ASD closure seems to be a relatively safe and effective procedure. However, using the larger Cardioseal/Starflex devices for closure seems to be related to a higher rate of device dislocation and embolization.

Effect of intensive versus moderate lipid lowering on endothelial function and vascular responsiveness to angiotensin II in stable coronary artery disease.

Recent evidence has demonstrated that intensive lipid-lowering therapy with a high-dose statin provides significant clinical benefit beyond moderate lipid-lowering therapy. However, dose-dependent effects of short-term statin therapy on vascular function have not been demonstrated. We studied endothelial function and vascular responsiveness to angiotensin II in patients who had coronary artery diseased and were randomized to receive low- or high-dose atorvastatin (10 or 80 mg, respectively) or placebo. Internal thoracic artery segments were obtained during coronary bypass surgery and studied in vitro. Endothelium-dependent vasodilation was increased with atorvastatin therapy (p = 0.035) but was significantly increased further in patients who received 80 mg compared with those who received 10 mg of atorvastatin (p = 0.05). Endothelium improvement was accompanied by decreased vascular response to angiotensin II (p = 0.039). These findings suggest a mechanism for the clinical benefit of intensive lipid-lowering treatment in coronary heart disease.

High prevalence of microalbuminuria in chronic heart failure patients.

BACKGROUND: Microalbuminuria is associated with increased risk for cardiovascular morbidity and mortality. However, the relation between microalbuminuria and chronic heart failure has not been well described yet. In this cross-sectional study, we aim to evaluate the prevalence of microalbuminuria and the association with neurohormonal parameters in severe chronic heart failure patients. METHODS AND RESULTS: We studied 94 stable chronic heart failure patients (New York Heart Association class III/IV) receiving therapy with angiotensin-converting enzyme (ACE) inhibitors for over three months. In all patients, renal function and neurohormonal status were evaluated and correlated with urinary albumin/creatinine ratio. The studied population consisted of 70 men and 21 women (mean age 69 +/- 12 years). Ischemia was the underlying cause of heart failure in 61 patients. Overall, 100% of the patients were treated with an ACE inhibitor, 72% with a beta-blocker, and 47% with spironolactone. In 32% (95% confidence interval 22-42) of the patients, microalbuminuria was present, which is significantly higher than in the general population. However, we found no significant association between the presence of microalbuminuria and renal function. Plasma NT-proBNP, active renin protein, angiotensin I, angiotensin II, and aldosterone did not differ significantly between groups with and without microalbuminuria. CONCLUSION: In 32% of the patients, microalbuminuria was present. No association was found with either renal or neurohormonal parameters.

Mild preoperative renal dysfunction as a predictor of long-term clinical outcome after coronary bypass surgery.

BACKGROUND: Renal dysfunction is a prognostic marker in patients with cardiovascular disease. However, no long-term follow-up studies on the influence of mild renal dysfunction on mortality in patients undergoing coronary bypass grafting have been reported. Therefore, we aimed to identify the significance of preoperative (mild) renal dysfunction as a long-term predictor of clinical outcome after coronary bypass surgery. METHODS: In 358 patients who underwent isolated saphenous vein aorta-coronary artery bypass grafting, estimated glomerular filtration rates were calculated with the Cockroft-Gault equation (GFRc). Patients were categorized into 2 groups (group 1, GFRc >71.1 mL x min (-1) x 1.73 m (-2) ; group 2, GFRc <71.1 mL x min (-1) x 1.73 m (-2) ). Multivariate Cox proportional hazard analyses were performed to determine the independent prognostic value of GFRc. RESULTS: During a median follow-up of 18.2 years, 233 patients (65.1%) died. Patients who died had lower GFRc and were older. Multivariate analysis demonstrated that total mortality in patients with lower GFRc was significantly increased (lower GFRc group vs normal GFRc group: hazard ratio, 1.44; P = .019). Lower GFRc was also an independent predictor of cardiac mortality (hazard ratio, 1.51; P = .032). No significant differences were observed between groups in the occurrence of myocardial infarction and the need for reintervention. CONCLUSIONS: Our study demonstrates that after long-term follow-up, preoperative mild renal dysfunction is an independent predictor of long-term (cardiac) mortality in patients who undergo coronary artery bypass grafting.

Cutting balloon for in-stent restenosis: acute and long-term results.

INTRODUCTION: Conventional percutaneous coronary intervention for the treatment of in-stent restenosis (ISR) has shown a high rate of ISR (30-55%). Considering the need for both extrusion of hyperplastic intima and additional stent expansion, a cutting balloon might be more effective for the treatment of ISR. METHODS: We prospectively assessed the immediate and 8-month outcome of balloon angioplasty using the Barath Cutting Balloon in 100 consecutive patients (mean age: 60.5 +/- 10.8 years, 71% male). RESULTS: In 73 lesions (73%), a good result was reached with the cutting balloon only. In 21 lesions (21%) postdilatation and in 6 lesions (6%) predilatation with a conventional balloon was necessary. The mean inflation pressure was 8.7 +/- 2.0 (range: 6.0-18.0) atm. Before the procedure the mean minimal luminal diameter (MLD) was 0.95 +/- 0.45 mm. Quantitative coronary analysis showed a mean diameter stenosis of 65%+/- 16%. Immediately after the procedure the mean MLD was 2.42 +/- 0.54 mm with a mean diameter stenosis of 19%+/- 13%. Two patients died during the follow-up period (1 stroke, 1 nonvascular). At 8-month follow-up 26 patients (26%) reported to have anginal complaints CCS class II-IV of whom 16 (16%) needed target lesion revascularization. CONCLUSION: Treatment of ISR using the Barath Cutting Balloon can be performed safely with good immediate results and a relatively low need for repeated target lesion revascularization at 8-month follow-up.

Primary stenting of occluded native coronary arteries: final results of the Primary Stenting of Occluded Native Coronary Arteries (PRISON) study.

BACKGROUND: Primary intracoronary stent placement after successfully crossing chronic total coronary occlusions may decrease the high restenosis rate at long-term follow-up compared with conventional balloon angioplasty. METHODS: In a prospective, randomized trial, balloon angioplasty was compared with stent implantation for the treatment of chronic total occlusions. Patients were followed for 12 months with angiographic follow-up at 6 months. Quantitative coronary analysis was performed by an independent core lab. RESULTS: A total of 200 patients were enrolled. Baseline characteristics were evenly distributed. After the procedure the mean minimal luminal diameter in the conventional group was 2.34 +/- 0.46 mm versus 2.90 +/- 0.41 mm in the stented group (P <.0001). The 6-month angiographic follow-up showed a mean minimal luminal diameter of 1.57 +/- 0.74 mm in the conventional group versus 1.93 +/- 0.85 mm in the stented group (P =.009) and a mean diameter stenosis of 44.7% +/- 25.0% versus 35.5% +/- 26.5% (P =.036). Binary angiographic restenosis (>50% diameter stenosis) was seen in 33% in the conventional group versus 22% in the stented group (P =.137). The reocclusion rates were 7.3% and 8.2%, respectively (P = 1.00). At 12 month follow-up, the rate of target lesion revascularization was significantly higher in the conventional group (29% versus 13%, P <.0001). CONCLUSION: These data demonstrate that stenting of chronic total occlusions is superior to balloon angioplasty alone with a statistically significant reduction in the need for target lesion revascularization and a lower, but not significant, restenosis rate.

Additional value of three-dimensional transesophageal echocardiography for patients with mitral valve stenosis undergoing balloon valvuloplasty.

The objective of this study was to validate the additional value of 3-dimensional (3D) transesophageal echocardiography (TEE) for patients with mitral valve stenosis undergoing percutaneous mitral balloon valvotomy (PTMV). Therefore, in a series of 21 patients with severe mitral valve stenosis selected for PTMV, 3D TEE was performed before and after PTMV. The mitral valve area was assessed by planimetry pre- and post-PTMV; the mitral valve volume was assessed and attention was paid to the amount of fusion of the commissures. These results were compared with findings by 2-dimensional transthoracic echocardiography using pressure half-time method for assessment of mitral valve area, and were analyzed for the prediction of successful outcome. Pre-PTMV the mitral valve area assessed by 3D TEE was 1.0 +/- 0.3 cm(2) vs 1.2 +/- 0.4 cm(2) assessed by 2-dimensional transthoracic echocardiography (P =.03) and post-PTMV it was 1.8 +/- 0.5 cm(2) vs 1.9 +/- 0.6 cm(2) (not significant), respectively. The mitral valve volume could be assessed by 3D TEE (mean 2.4 +/- 2.5 cm(3)) and was inversely correlated to a successful PTMV procedure (P <.001). The 3D TEE method enabled a better description of the mitral valvular anatomy, especially post-PTMV. We conclude that 3D TEE will have additional value over 2-dimensional echocardiography in this group of patients, for selection of patients pre-PTMV, and for analyzing pathology of the mitral valve afterward.

Stenting for restenotic lesions with the BARD XT stent.

BACKGROUND: Conventional PTCA for the treatment of restenotic lesions is associated with a high rate of recurrence (30-50%). Primary stenting decreases the restenosis rate at long-term follow-up. METHODS: One-hundred consecutive patients with restenosis received a Bard XT stent. Follow-up angiography was performed after 6 months. Angiograms were compared by means of computed quantitative analysis. RESULTS: The mean pretreatment reference diameter was 2.88 +/- 0.51 mm. The mean minimal luminal diameter (MLD) increased from 1.09 +/- 0.57 mm to 2.70 +/- 0.44 mm. The percent diameter stenosis decreased from 66 +/- 13% to 15 +/- 10%. The procedural success rate was 99%. At 6 month follow-up repeat angiography was performed in 86 patients. The mean MLD was 1.74 +/- 0.67 mm with a mean diameter stenosis of 41 +/- 20%. Residual anginal complaints were reported in 29% of patients. In-stent restenosis (defined as diameter stenosis of more than 50%) occurred in 18% of the patients. CONCLUSION: Placement of the Bard XT stent in restenotic lesions is feasible, has an excellent short term outcome and yields a favorable result at 6 month follow-up angiography.

A randomized trial assessing the effect of coumarins started before coronary angioplasty on restenosis: results of the 6-month angiographic substudy of the Balloon Angioplasty and Anticoagulation Study (BAAS).

BACKGROUND: Thrombus formation during coronary angioplasty may play a role in the restenosis process. METHODS: The effect of pretreatment with coumarins on 6-month angiographic outcome was studied. In addition, the effect of "optimal" anticoagulation, defined as an international normalized ratio >70% of the follow-up time in the target range, was studied. A total of 261 patients were assigned to aspirin alone (ASA group) and 270 patients to aspirin plus coumarins started 1 week before the procedure (coumarin group). RESULTS: The mean international normalized ratio was 2.7 +/- 1.2 at the start of the procedure and 3.1 +/- 0.5 during follow up. Quantitative coronary analysis was performed on 301 lesions in the ASA group and of 297 lesions in the coumarin group. At 6 months, the minimal luminal diameter was similar in the ASA and coumarin groups. Optimal anticoagulation, however, was an independent predictor of a larger minimal luminal diameter at follow up (P =.01). CONCLUSION: Overall, coumarins do not improve angiographic outcome 6 months after coronary angioplasty.

Is direct stent implantation without predilatation safe? Acute and long-term outcome.

Direct stenting could potentially lead to a reduction in dissections, time, and restenosis at 6-month follow-up. Using the premounted Palmaz-Schatz Crown stent elective stenting was performed without predilatation in 61 consecutive patients who were compared with a control group of provisional stenting. All patients underwent clinical and angiographic follow-up at 6 months. Direct stenting was successful in 81% of patients. In 16% of the patients predilatation was needed. In 3% the stent could not be implanted despite predilatation. Stent dislodgment occurred in 2% of patients, without embolization. Six-month angiographic follow-up was performed in 51 (84%) of 61 patients. In the direct stenting group the mean preprocedural minimal luminal diameter (MLD) increased from 0.96 +/- 0.47 to 3.09 +/- 0.54 mm directly after the procedure. At 6-month follow-up the MLD measured 2.32 +/- 0.79 mm. In the provisional stenting group the mean MLD increased from 0.92 +/- 0.51 to 2.44 +/- 0.58 mm and was 1.84 +/- 0.70 mm at 6-month follow-up. Restenosis, defined as a diameter stenosis > 50%, occurred in 8% of the direct stenting group compared with 28% in the provisional stenting group (P < 0.001). Direct coronary stent implantation can be attempted safely and efficaciously. The risk of stent loss is low. The initial and long-term angiographic results are significantly better as compared with provisional stenting. The risk of restenosis is significantly lower.

High-dose aspirin in addition to daily low-dose aspirin decreases platelet activation in patients before and after percutaneous coronary intervention.

BACKGROUND: Activated platelets play a major role in acute vessel closure after coronary angioplasty. Although aspirin is the routine therapy during angioplasty, it only incompletely prevents acute closure. This might be due to suboptimal dosing. OBJECTIVE: First, to study the effect of additional high-dose aspirin on platelet activation during coronary angioplasty. Second, to assess the potential of the new PFA-100 analyzer to evaluate the effect of different doses of aspirin in patients undergoing angioplasty. METHODS: Fifty-one patients on 100 mg aspirin/day for at least 1 month were randomized to continuation of 100 mg aspirin/day only (Group A=24 patients), or to this regime plus a bolus of 1000 mg of aspirin given 1 day before angioplasty (Group B=27 patients). Results were compared with 15 controls. Platelet function was measured before angioplasty by the PFA-100 analyzer; platelet activation was measured by flow cytometry just before and 1 h after angioplasty. RESULTS: At baseline, Group A had significantly more activated platelets than the control group (P<.001). High-dose aspirin in Group B resulted in significantly lower platelet activation as compared with both controls (P<.001) and Group A (P<.001). During angioplasty, the number of activated platelets decreased significantly in Group A (P<.001), while there was no change in Group B (P=.6). The PFA-100 analyzer was unable to detect differences between the two treatment groups. CONCLUSIONS: The addition of high-dose aspirin to daily low-dose aspirin, 1 day before coronary angioplasty, significantly reduced the platelet activation state before and after intervention. The PFA-100 analyzer did not detect differences in the effect of low- versus high-dose aspirin on platelet function.