Device-less patent foramen ovale closure by radiofrequency thermal energy.

UNLABELLED: The goal of this study was to assess the feasibility, safety and success of a system which uses radiofrequency energy (RFE) rather than a device for percutaneous closure of patent foramen ovale (PFO). METHODS: Sixteen patients (10 men, 6 women, mean age 50 years) were included in the study. All of them had a proven PFO with documented right-to-left shunt (RLS) after Valsalva manoeuvre (VM) during transoesophageal echocardiography (TEE). The patients had an average PFO diameter of 6 +/- 2 mm at TEE and an average of 23 +/- 4 microembolic signals (MES) in power M-mode transcranial Doppler sonography (pm-TCD), measured over the middle cerebral artery. An atrial septal aneurysm (ASA) was present in 7 patients (44%). Balloon measurement, performed in all patients, revealed a stretched PFO diameter of 8 +/- 3 mm. In 2 patients (stretched diameter 11 and 14 mm respectively, both with ASA >10 mm), radiofrequency was not applied (PFO too large) and the PFO was closed with an Amplatzer PFO occluder instead. A 6-month follow-up TEE was performed in all patients. RESULTS: There were no serious adverse events during the procedure or at follow-up (12 months average). TEE 6 months after the first RFE procedure showed complete closure of the PFO in 50% of the patients (7/14). Closure appeared to be influenced by PFO diameter, complete closure being achieved in 89% (7/8) with a balloon-stretched diameter < or =7 mm but in none of the patients >7 mm. Only one of the complete closure patients had an ASA. Of the remainder, 4 (29%) had an ASA. Although the PFO was not completely closed in this group, some reduction in the diameter of the PFO and in MES was documented by TEE and pm-TCD with VM. Five of the 7 residual shunt patients received an Amplatzer PFO occluder. Except for one patient with a minimal residual shunt, all showed complete closure of PFO at 6-month follow-up TEE and pm-TCD with VM. The other two refused a closure device. CONCLUSIONS: The results confirm that radiofrequency closure of the PFO is safe albeit less efficacious and more complex than device closure. The technique in its current state should not be attempted in patients with a balloon-stretched PFO diameter >7 mm and an ASA.

Is alcohol ablation of the septum associated with recurrent tachyarrhythmias?

QUESTIONS UNDER STUDY: Alcohol ablation (AA) of the septum has been introduced as new therapy in hypertrophic cardiomyopathy (HCM). It was feared that iatrogenic myocardial infarction due to AA may induce re-entry tachyarrhythmias and increase sudden cardiac death. METHODS AND RESULTS: Twenty-four patients (mean age 52 years) underwent successful AA. Clinical follow-up (FU) ranged from 0.3 to 0.7 years (mean 2.8). One patient died (suicide) 4 years after AA. Left ventricular (LV) outflow gradient (peak-to-peak) decreased (median) after AA from 43 (IQR 25 to 4) mmHg to 1 (IQR 0 to 12) mmHg (rest) (p <0.001) and from 130 (IQR 75 to 165) mmHg to 13 (IQR 0 to 31) mmHg (postextrasystolic) (p <0.001). Transient AV block occurred in 22% (5/24) necessitating temporary pacing. A permanent pacemaker was implanted in 4% (1/24). NYHA-class was 2.5 (IQR 2.0 to 3.0) before and 1.5 (IQR 1.3 to 2.0) (p <0.001) after AA. During FU, 2 pacemakers were implanted due to bradycardia (no AV block). A right bundle branch block was found in 13% (2/24) before and 46 % (11/24) after AA (p = 0.003). Non-sustained ventricular tachycardia (NSVT) was observed in 13% (2/16) before and 22% (5/23) (p = 0.46) after AA. Two patients required ICD implantation. CONCLUSIONS: Long-term FU is excellent in HCM after AA. The pressure gradient drops below 25 mm Hg in 95% (23/24) of all patients. Transient AV block occurs in 22% (5/24), but permanent pacemaker implantation is rarely needed (13%, 2/24). Severe NSVT occurs in 13% (2/16) before and 22% (5/23) after AA but ICD implantation is only occasionally required.

Giant coronary artery fistula complicated by cardiac tamponade.

A 30 year old female was admitted to the hospital with cardiogenic shock due to cardiac tamponade. A ruptured giant coronary artery fistula (CAF) originating from the left main coronary artery draining into the right atrium was identified as the cause. In this case report we describe the clinical course with emphasis on diagnostic work-up and imaging.

Clinical experience with the second-generation 3f Enable sutureless aortic valve prosthesis.

OBJECTIVE: The 3f Enable aortic bioprosthesis (ATS Medical, Inc, Minneapolis, Minn) represents a new generation of equine pericardial self-expanding valve designed for sutureless implantation. This study evaluated technical aspects of implantation and safety and effectiveness of the valve in the short term. METHODS: In an outcome analysis of a consecutive series of 28 patients who underwent aortic valve replacement for aortic stenosis with the 3f Enable during an 18-month period, mean age was 75.7 +/- 6.6 years, 18 patients were female (64.2%), and mean EuroSCORE was 7.1% +/- 1.7%. RESULTS: Most implanted valves were 23 mm in diameter (19-27 mm). Mean aortic crossclamp time was 39 +/- 15 minutes (29-103 minutes), mean cardiopulmonary bypass time was 58 +/- 20 minutes (41-127 minutes), mean hospital stay was 11 days (7-22 days), and 30-day mortality was 3.5%. Mean and peak intraoperative transvalvular pressure gradients were 6.1 +/- 2.6 and 18 +/- 5 mm Hg, respectively. Trivial and mild paravalvular leaks were observed in 1 patient each. One patient underwent reoperative aortic valve replacement 4 months after initial surgery for severe valve-unrelated paravalvular leakage. Five patients (18.5%) required permanent pacemakers. No patients were unavailable for follow-up. One-year survival was 86.2%. CONCLUSIONS: The 3-f Enable aortic bioprosthesis can be implanted safely with favorable early hemodynamics. The self-expanding stent allows sutureless implantation with a large valve area. The procedure was fast, although not as fast as expected. This experience has led to continued design and procedural enhancements to facilitate and accelerate future implantation.

Improvement of migraine headaches after percutaneous closure of patent foramen ovale for secondary prevention of paradoxical embolism.

OBJECTIVES: Patent foramen ovale (PFO) has been linked to migraine, and an improvement in migraine prevalence or frequency has been reported after PFO closure for other reasons. We sought to identify whether there is a specific patient population of migraineurs which may be more susceptible to benefiting from PFO closure. DESIGN: Retrospective cohort study. SETTING: Tertiary care centre. Participants 603 consecutive patients undergoing percutaneous PFO closure for secondary prevention of paradoxical embolism. INTERVENTIONS: PFO closure using the Amplatzer PFO occluder. MAIN OUTCOME MEASURES: Improvement of migraine symptoms. RESULTS: 150 patients (25%; aged 51+/-11 years) suffered from migraine, including 96 patients with migraine with aura. All implantation procedures were successful, without procedural complications. Contrast transoesophageal echocardiography at 6 months showed complete PFO closure in 136 patients (91%), whereas a minimal, moderate or large residual shunt persisted in 11 (7%), 2 (1%) or 1 (1%) patients, respectively. During 5.0+/-1.9 years of follow-up, one TIA and one ischaemic stroke occurred. Migraine headaches disappeared in 51 patients (34%) and improved in 72 additional patients (48%). Mean subjective improvement was 69+/-35%. Overall, mean headache frequency (from 2-3x/month to 1x/month; p<0.001), duration (from 4-72 to <4 h; p<0.001) and intensity (from 7+/-2 to 3+/-3; p<0.001) improved significantly. The prevalence of any migraine headaches (from 100% to 66%; p<0.001), migraine with aura (from 64% to 19%; p<0.001) and the number of patients taking any migraine medication (from 90% to 50%; p<0.001) decreased significantly. Both the presence of aura (OR 3.2; 95%CI 1.3 to 8.2; p=0.014) and high pain intensity at baseline (pain scale >5; OR 3.3; 95%CI 1.3 to 8.4; p=0.013) were independent predictors of response to PFO closure. A residual shunt had no influence on migraine improvement (OR 0.6; 95%CI 0.1 to 2.3; p=0.42). CONCLUSIONS: These results suggest that percutaneous PFO closure durably alters the spontaneous course of shunt-associated migraine, especially but not exclusively in case of migraine with aura.

Instant percutaneous closure of patent foramen ovale in patients with acute myocardial infarction and normal coronary arteries.

Two young women with angiographically normal coronary arteries suffered an acute myocardial infarction. Both were found to have a patent foramen ovale (PFO), the likely pathway of a paradoxical embolus causing the infarction. The PFOs were diagnosed and closed percutaneously with an Amplatzer PFO Occluder during the emergency coronary angiography.

Percutaneous coronary interventions in Europe 1992-2003.

AIMS: The purpose of this registry is to collect data on trends in interventional cardiology within Europe. Special interest focuses on relative increases and ratios in newer revascularization approaches and its distribution in different regions in Europe. We report the data of the year 2003 and give an overview of the development of coronary interventions since 1992, when the first data collection was performed. METHODS AND RESULTS: Questionnaires were distributed yearly to delegates of all national societies of cardiology represented in the European Society of Cardiology to collect the case numbers of all local institutions and operators. The overall numbers of coronary angiographies increased from 1992 to 2003 from 684,000 to 1,993,000 (from 1,250 to 3,500 per million inhabitants). The respective numbers for percutaneous coronary interventions (PCI-coronary angioplasty) and coronary stenting procedures increased from 184,000 to 733,000 (from 335 to 1,300) and from 3,000 to 610,000 (from 5 to 1,100), respectively. Germany has been the most active country for the past years with 653,000 angiographies (7,800), 222,000 angioplasties (2,500), and 180,000 stenting procedures (2,200) in 2003. The indication has shifted towards acute coronary syndromes, as demonstrated by raising rates of interventions for acute myocardial infarction over the last decade. The procedures are more readily performed and safer, as shown by increasing rate of "ad hoc" PCI and decreasing need for emergency coronary artery bypass surgery (CABG). In 2003, use of drug-eluting stents had further increased. However, an enormous variability is reported with the highest rate in Portugal (55%). CONCLUSION: Interventional cardiology in Europe is still expanding, mainly but not exclusively due to rapid growth in the eastern European countries. A number of new coronary revascularization procedures introduced over the years have all but disappeared. Only stenting has experienced an exponential growth. The same can be forecast for drug-eluting stenting.

QR in V1--an ECG sign associated with right ventricular strain and adverse clinical outcome in pulmonary embolism.

AIMS: To test the hypothesis that Qr in V(1)is a predictor of pulmonary embolism, right ventricular strain, and adverse clinical outcome. METHODS AND RESULTS: ECG's from 151 patients with suspected pulmonary embolism were blindly interpreted by two observers. Echocardiography, troponin I, and pro-brain natriuretic peptide levels were obtained in 75 patients with pulmonary embolism. Qr in V(1)(14 vs 0 in controls; p<0.0001) and ST elevation in V(1)> or =1 mV (15 vs 1 in controls; p=0.0002) were more frequently present in patients with pulmonary embolism. Sensitivity and specificity of Qr in V(1)and T wave inversion in V(2)for predicting right ventricular dysfunction were 31/97% and 45/94%, respectively. Three of five patients who died in-hospital and 11 of 20 patients with a complicated course, presented with Qr in V(1). After adjustment for right ventricular strain including ECG, echocardiography, pro-brain natriuretic peptide and troponin I levels, Qr in V(1)(OR 8.7, 95%CI 1.4-56.7; p=0.02) remained an independent predictor of adverse outcome. CONCLUSIONS: Among the ECG signs seen in patients with acute pulmonary embolism, Qr in V(1)is closely related to the presence of right ventricular dysfunction, and is an independent predictor of adverse clinical outcome.