Rainer Schräder

Immediate sealing of arterial puncture sites after cardiac catheterization and coronary angioplasty using a biodegradable collagen plug: results of an international registry.

OBJECTIVES The aim of this study was to evaluate the safety and efficacy of a biodegradable collagen plug that has been developed to reduce the arterial compression time required to achieve hemostasis at the arterial puncture site after diagnostic and interventional coronary procedures. BACKGROUND After diagnostic and interventional coronary catheterization procedures, local arterial compression is required to achieve hemostasis and complications may ensue, especially in patients on full anticoagulation. METHODS Between March 1991 and July 1991, 252 patients admitted for routine coronary angiography or angioplasty to four large hospitals received such a hemostatic device immediately after the procedure. Hemostasis was achieved with collagen in 87% of patients after a mean compression time of 4.8 min. Time to hemostasis was independent of the heparin load. A total of 54 hematomas (21%) was reported; all but 2 resolved without additional treatment. Two patients had a severe hematoma, requiring blood transfusion, and two patients required surgery to repair a pseudoaneurysm. During a follow-up period of 4 weeks no severe late complications were reported. CONCLUSIONS We conclude that the collagen plug appears to be a safe device to achieve hemostasis at the arterial puncture site, independent of anticoagulation.

Incidence of Atrial Fibrillation Following Transcatheter Closure of Atrial Septal Defects in Adults

Transcatheter closure of secundum atrial septal defect (ASD) and patent foramen ovale (PFO) has become a routine procedure. Little is known about the effect of atrial septal device implantation on the occurrence of atrial fibrillation (AF). We evaluated the frequency of AF occurring after transcatheter PFO and ASD closure in a large population. From 1994 until 2007 a total of 1,062 patients underwent transcatheter closure of an interatrial communication. New-onset AF was defined by 12-lead electrocardiogram or Holter monitoring in patients without a history of AF at baseline. Of the 1,062 patients, 822 had a PFO and 240 had an ASD. During a median follow up of 20 months, new-onset AF was documented in 8% of patients. New-onset AF occurred in 7% of patients after PFO closure and in 12% of patients with underlying ASD. The annual incidence of new-onset AF was 2.5% and 4.1% in patients with PFO and ASD, respectively. Generally, patients with new-onset AF were older than those without AF. Device type or size did not influence the occurrence of AF. In the group of patients with PFO, residual shunt was more common in patients with AF compared with the non-AF group. In conclusion, AF is more common after PFO and ASD closure compared with the general population; although device type or size did not impact the occurrence of AF, residual shunt may influence the occurrence of AF after intervention in patients with underlying PFO.

Transcatheter closure of secundum atrial septal defects in adults with the Amplatzer septal occluder: Intermediate and long-term results

AimsTranscatheter closure of secundum atrial septal defects (ASD) with the Amplatzer septal occluder (ASO) has become a standard procedure in most pediatric and adult patients. However, data addressing success rates and outcome in adults is limited. We sought to define the safety profile of the ASO in the community setting and identify the percentage of adults with ASD amenable to percutaneous closure with the ASO.MethodsWe performed a retrospective analysis of patients’ records referred for transcatheter ASD closure from 1999 through 2005 at a single institution. Patients were evaluated with right heart catheterization and underwent closure of the ASD according to standard indications under transesophageal and fluoroscopic guidance.ResultsTwo hundred and seven consecutive patients were taken to the catheterization laboratory for hemodynamic evaluation and possible interventional closure of an ASD. Of those patients, 18 were excluded because the defect and the left-to-right shunt were hemodynamically insignificant (n = 7) or because there was no distinct defect, but instead a multi-perforated septum (n = 11). Nineteen cases were excluded for anatomic reasons. Of the remaining 170 patients, ASO implantation was attempted and successfully performed in 166 (83% of 200 patients with hemodynamically significant ASD). Complications occurred in 11 cases (6.5%) (device dislocation = 4, transient ST-segment elevation = 4, TIA = 1, hemoptysis = 1, pericardial effusion = 1); none of these events were associated with long-term sequelae. During a median follow-up period of 13 months (range 6–0) there were no major clinical events.ConclusionsMore than 80% of adults with a distinct, hemodynamically significant secundum ASD can be successfully treated with the ASO. The immediate success rates are excellent and follow-up data suggest that the ASO is a safe device well suited for transcatheter ASD closure.

Stent or angioplasty after recanalization of chronic coronary occlusions? (the SARECCO trial)

This study tests whether stent implantation without anticoagulation after catheter recanalization of coronary occlusions can improve outcome compared with balloon angioplasty alone. One hundred ten patients were randomly assigned to angioplasty alone (no stent group) or stent implantation (stent group) after successful recanalization and balloon angioplasty. The type of stent and angioplasty technique utilized were decided by the operator. The acute procedural success in both groups was 100%. The acute minimal lumen diameter (MLD) was 1.85 +/- 0.44 mm in the no stent group versus 2.54 +/- 0.53 mm in the stent group (p <0.01). The diameter stenosis was 21 +/- 13% versus 3 +/- 14% (p <0.01). This was achieved not only by the stent implantation itself but primarily by a larger maximum balloon diameter in the stent group after stent implantation (3.32 +/- 0.55 mm vs 2.86 +/- 0.4 mm, p <0.05). After 4 months, the MLD was 1.15 +/- 0.73 mm in the no stent group versus 1.81 +/- 0.9 mm in the stent group (p <0.01). The diameter stenosis was 56 +/- 29% versus 34 +/- 28% (p <0.01). After 2 years, event-free survival was 26% in the no stent group and 52% in the stent group (p <0.05). Thus, acute and long-term procedural and angiographic success of stent implantation without anticoagulation after recanalization of total coronary occlusions is superior to that of balloon angioplasty alone. This beneficial effect is mainly the result of the larger balloon diameters, which may be used after stent implantation.

Outcome after percutaneous closure of a patent foramen ovale using the Intrasept device: a multi-centre study.

Objectives: This multi‐centre study reports safety and efficacy of percutaneous patent foramen ovale (PFO) closure, using the fourth generation Intrasept™ device. Background: PFO has been associated with paradoxical embolism and cryptogenic stroke. Percutaneous PFO closure seems to reduce the risk for recurrent paradoxical thrombo‐embolism. Currently, different devices are used for PFO closure. Methods: Patients, who underwent a PFO closure with the Intrasept device (Cardia, Eagan, MN) between July 2002 and September 2006, were included in the study. The primary endpoint was defined as reoccurrence of stroke, transient ischemic attack (TIA), or peripheral thrombo‐embolism. Peri‐procedural and mid‐term complications were reported. Results: Four‐hundred thirty patients (mean age 50.7 ± 13.0 years, 231 men) underwent closure. The indications were cryptogenic stroke (69.8%), TIA (23.5%), peripheral embolism (3.3%), and other (3.5%). The median follow‐up time was 0.8 years, range 3.9 years. The primary endpoint occurred in 0.5% for stroke, in 2.5% for TIA, and in none for peripheral embolism. Peri‐procedural complications were reported in 11.5% of cases, from which 0.2% was defined as major. No severe complications occurred during mid‐term follow‐up. A residual shunt was present in 12.5% of patients who did not suffer from a recurrent event, compared to 36.4% of patients who reached the primary endpoint (P = 0.04). Conclusion: This multi‐centre study suggests that percutaneous closure of a symptomatic PFO with the fourth generation Intrasept device is safe and might be effective to prevent the recurrence of paradoxical thrombo‐embolic events.

Late (Five to Nine Years) Follow-Up After Balloon Dilation of Valvular Pulmonary Stenosis in Adults

The transvalvular gradient was investigated in 14 patients with pulmonary stenosis 5 to 9 years after balloon valvuloplasty. None of the patients had developed restenosis, and in those who had a peak gradient >100 mm Hg before valvuloplasty, the gradient decreased further due to resolution of subvalvular muscular hypertrophy within 3 months after intervention.

Left main coronary artery stenosis after aortic valve replacement: genetic disposition for accelerated arteriosclerosis after injury of the intact human coronary artery?

Background:Left main coronary artery stenosis is a rare but life-threatening complication after aortic valve replacement because of coronary perfusion-related trauma to the vessel wall with cannulation of the coronary ostia. We investigated whether this complication still occurs in the 1990s despite the use of more advanced catheter materials and modern surgical preservation techniques. MethodsFour years after identification of the first two cases in 1987, five further patients had developed left main coronary artery stenosis after aortic valve replacement (incidence, 0.9%) at the cardiothroacic clinic of the J.W Goethe University and were studied for contributing factors. Results:Severe coronary ostial stenosis developed within 1 to 6 months after aortic valve replacement. In one such case, intimal proliferation was seen in a biopsy specimen that was comparable to the restenosis induced by coronary angioplasty. The clinical characteristics of the patients developing the complication, the surgical technique, and the intraoperative course did not differ from the other patients. However, five of the seven patients (71 %) had a common genetic trait concerning their apolipoprotein E genotype (the e4 allele) that is normally present in only 10% to 15% of patients screened (P<0.01). Conclusions:These lesions seem to result from a uniform response of the vessel wall to injury. Their incidence is probably related in part to the degree of injury after trauma to the coronary ostia during cannulation for myocardial protection. Patients with the

Right ventricular function before and after percutaneous balloon mitral valvuloplasty

4 allele might be genetically predisposed for a pathologically increased response of proliferative repair mechanisms after arterial injury. The complication can be avoided by not instrumenting the coronary ostia for direct antegrade cardioplegia but using retrograde delivery as an alternative method of myocardial protection.

Effect of balloon valvuloplasty for mitral stenosis on right ventricular function.

We report our experience of transcatheter patent foramen ovale (PFO) closure with the new Intrasept occluder.