Comparison of plug-based versus suture-based vascular closure for large-bore arterial access: a collaborative meta-analysis of observational and randomized studies.

BACKGROUND: Large-bore arteriotomies can be percutaneously closed with suture-based or plug-based vascular closure device (VCD) strategies. The efficacy of both techniques remains controversial. AIMS: We conducted a meta-analysis of comparative studies between both VCD strategies, focusing on the most commonly applied VCDs (MANTA and ProGlide). METHODS: We searched MEDLINE, the Cochrane Central Register of Controlled Trials and Google scholar for observational studies (OS) and randomized controlled trials (RCT) comparing vascular closure with the MANTA-based and the ProGlide-based technique. The principal endpoint of this analysis was access-site related vascular complications. Both study types were analyzed separately. RESULTS: Access-site related vascular complications were less frequent after vascular closure with the MANTA technique in the analysis of OS (RR 0.61 [95%CI 0.43-0.89], p = 0.01, I2 = 0%), but more frequent in the analysis of RCT data (RR 1.70 [95%CI 1.16-2.51], p = 0.01, I2 = 0%). Both data sets provided no significant difference between the VCD techniques in terms of overall bleeding events (OS: RR 0.57 [95%CI 0.32-1.02], p = 0.06, I2 = 70%; and RCT: RR 1.37 [95%CI 0.82-2.28], p = 0.23, I2 = 30%). RCT data showed that endovascular stenting or vascular surgery due to VCD failure occurred more often after MANTA application (RR 3.53 [95%CI 1.07-11.33], p = 0.04, I2 = 0%). CONCLUSIONS: While OS point to favorable outcomes for large-bore vascular closure with the MANTA-based technique, RCT data show that this strategy is associated with more access-site related vascular complications as well as endovascular stenting or vascular surgery due to device failure compared with the ProGlide-based technique.

Clinical Characteristics, Histopathological Features, and Clinical Outcome of Methamphetamine-Associated Cardiomyopathy.

OBJECTIVES: This study aimed to assess characteristics including endomyocardial biopsy and outcome of patients with methamphetamine (MA)-associated cardiomyopathy in a series of patients treated in Germany. BACKGROUND: MA abuse is an increasing problem worldwide. METHODS: The cases of 30 consecutive MA-abusing patients with a left ventricular (LV) ejection fraction of <40% and endomyocardial biopsy performed at initial diagnosis were analyzed. Baseline characteristics were collected retrospectively, whereas follow-up was prospective. The primary endpoint was a composite of death, nonfatal stroke, and rehospitalization for heart failure. RESULTS: Patients were 30.3 ± 1.9 years of age, predominantly male (93.3%), and highly symptomatic; 83.3% had New York Heart Association functional class III or IV dyspnea. Echocardiography revealed marked LV dilatation (mean LV end-diastolic diameter 67.1 ± 7.4 mm) and impaired LV ejection fraction (mean 19 ± 6%). One-third of the patients had intraventricular thrombi. Endomyocardial biopsy revealed markers of inflammation and fibrosis; the fibrosis correlated with the duration of MA abuse. At follow-up, discontinuation of MA abuse together with medical therapy partially improved cardiac function (LV ejection fraction, 19 ± 6 vs. 43 ± 13; p < 0.001) and symptoms (p = 0.056), whereas patients with continued abuse did not show any improvement. The improvement in cardiac function was independently associated with the extent of fibrosis. The primary endpoint occurred more often in patients with continued MA abuse (57.1% vs. 13.0%; p = 0.037). CONCLUSIONS: MA-associated cardiomyopathy is characterized by severe heart failure and depressed cardiac function. The extent of myocardial fibrosis seems to predict the recoverability of LV function. Cessation of MA abuse is associated with improvement in cardiac function and symptoms, whereas continued MA abuse leads to ongoing heart failure and worse outcome.

Comparison of Percutaneous Closure Versus Surgical Femoral Cutdown for Decannulation of Large-Sized Arterial and Venous Access Sites in Adults After Successful Weaning of Veno-Arterial Extracorporeal Membrane Oxygenation.

OBJECTIVE: Surgical femoral cutdown for decannulation after veno-arterial extracorporeal membrane oxygenation (VA-ECMO) is considered standard practice. However, access-site complications with this technique are not rare. The objective of this study is to evaluate feasibility, safety, and efficacy of a complete percutaneous decannulation procedure after VA-ECMO compared with the conventional surgical cutdown approach. METHODS: In 35 patients who were successfully weaned from VA-ECMO support, femoral artery and vein access sites were closed using a completely percutaneous approach in 15 patients, whereas 20 patients had conventional surgical cutdown for access-site closure. Data concerning all 35 patients were collected retrospectively and analyzed regarding immediate vascular closure success, associated complications, and clinical outcomes. RESULTS: Technical deployment success of the percutaneous vascular closure devices was achieved in all patients. Immediate success of closure was achieved more frequently in the surgical group (29% vs 100%; P<.05). Severe wound complications requiring surgery occurred only in the surgical group (0% vs 35%; P=NS). Surgical cutdown was associated with a significantly greater need for transfusion of packed red blood cells (1.6 ± 1.4 vs 2.2 ± 1.2; P<.05). Mean hospital stay was shorter in the percutaneous group (32 ± 18 days vs 36 ± 12 days; P=NS). One patient in the surgical group complained about sustained paresthesia after discharge. CONCLUSIONS: Complete percutaneous closure of the femoral access site after VA-ECMO is feasible, effective, and safe when compared with conventional surgical closure and performed by experienced operators.

Device closure of residual shunt after percutaneous closure of patent foramen ovale.

AIMS: To summarise our experiences of device closure of residual shunt after transcatheter closure of patent foramen ovale (PFO). METHODS AND RESULTS: Since October 1997 implantation of a second closure device was attempted in 40 patients with a moderate or large residual shunt after implantation of a PFO closure device. The mean age of the patients was 51 years. Implantation of a second closure device was technically successful in 39/40 patients (98 %). The following devices were implanted: Premere (n=20), Amplatzer PFO (n=13), STARFlex (n=4), Helex (n=1), Angelwings (n=1). During a mean follow-up of 36+/-29 months complete closure was achieved in 27 patients (69 %). The remaining shunt was small in nine patients, moderate in one and large in two. One patient with a moderate and one patient with a large residual shunt received a third device. The third patient was sent to surgery. One patient died 21 days after implantation of a third closure device due to acute pericardial tamponade. No other complications occurred. CONCLUSIONS: Transcatheter implantation of a second closure device after PFO closure is feasible. Complete closure can be achieved in the majority of patients.

Closure of atrial septal defect with the Amplatzer septal occluder in adults.

Transcatheter closure of atrial septal defects (ASDs) was performed mainly in children and adolescents. Information about outcome and complications in adults was limited. From November 1997 to November 2005, percutaneous closure of ASDs using the Amplatzer septal occluder was attempted in 650 consecutive adult patients. Median patient age was 45.8 +/- 16.2 years (range 18 to 90), mean systolic artery pressure was 33.3 +/- 10.6 mm Hg (range 11 to 85), and mean pulmonary and systemic blood flow (Qp/Qs) ratio was 1.9 +/- 0.7 (range 0.8 to 6.6). Mean stretched diameter of the ASD was 21.2 +/- 5.1 mm (range 3.1 to 43). Seventy-eight patients (12%) had multiple defects. Of 572 patients with a single ASD, device implantation was successful in 563 patients (98%). During follow-up, complete closure could be achieved in 96% of patients with a single ASD and 71% of patients with multiple defects. Mean systolic artery pressure decreased to 28.3 +/- 10.1 mm Hg and mean Qp/Qs ratio decreased to 1 +/- 0.3. The 3 complications that occurred during the procedure were device embolization (2 patients; 0.3%) and transient ST depression (1 patient; 0.2%). The most common complication immediately after the procedure and during follow-up was new-onset atrial fibrillation (28 patients; 4.3%). Electrical cardioversion was successfully in most. Complications requiring emergency or elective surgery occurred in 6 patients (0.9%; hemopericardium, 2 patients, 0.3%; device embolization, 3 patients, 0.5%, and pericardial tamponade, 1 patient, 0.2%). In conclusion, closure of ASDs using the Amplatzer septal occluder in adults was efficient and safe, with excellent long-term success rates. Serious complications were rare.