A novel system for transcatheter closure of patent foramen ovale: clinical and echocardiographic outcome comparison with other contemporary devices.

BACKGROUND: Effective closure performance for patent foramen ovale (PFO) has been suggested to be one of the factors that plays a relevant role in future clinical outcomes after stroke or transient ischemic attack. METHODS: Between January 2009 and June 2012, all consecutive patients undergoing transcatheter PFO closure in our institution using the Amplatzer PFO Occluder (APO) (St Jude Medical, St Paul, MN), BioSTAR (NMT Medical Inc, Boston, MA), GORE HELEX (HELEX) (W.L. Gore & Associates, Newark, DE), and GORE Septal Occluder (GSO) (W.L. Gore & Associates) were included. Closure performance was assessed using transesophageal echocardiography 4 months after the index procedure. RESULTS: One hundred ninety-three patients were included in the study. Patient distribution was as follows: (1) 48 GSO (24.8%); (2) 34 HELEX (17.6%); (3) 74 APO (38.3%); and (4) 37 BioSTAR (19.1%). No complications occurred during device implantation. During clinical follow-up (20.8 ± 13.2 months), 2 (1.1%) patients had a stroke, 3 (1.7%) patients had a peripheral embolism, and 8 (4.7%) patients presented with a documented atrial arrhythmia. There were no significant differences in clinical outcomes among the devices. Transesophageal echocardiography follow-up revealed higher closure rates with GSO (92.6%) and BioSTAR (93.7%) compared with HELEX (74.2%; P = 0.031 and P = 0.034, respectively) and APO (76.4%; P = 0.036 and P = 0.041, respectively). CONCLUSIONS: The GSO and BioSTAR showed better closure rates than HELEX and APO at 4 months. PFO closure is a safe procedure with a low rate of clinical events at follow-up.

Effect on bleeding, time to revascularization, and one-year clinical outcomes of the radial approach during primary percutaneous coronary intervention in patients with ST-segment elevation myocardial infarction.

The radial approach during percutaneous coronary intervention (PCI) has been reported to reduce the incidence of bleeding complications. However, the radial approach still accounts for <10% of procedures worldwide and only 1% in the United States. Our objective was to compare the effect of radial versus femoral vascular access on the time to reperfusion, incidence of bleeding complications, and overall clinical outcomes in the setting of primary PCI. We prospectively collected data on all patients undergoing primary PCI at the Montreal Heart Institute from April 1, 2007 to March 30, 2008. The time to revascularization and major bleeding were prespecified as a co-primary end point, and major adverse cardiac events, including death, myocardial infarction, and target vessel revascularization within 12 months, were considered a secondary end point. A total of 489 patients were included in the present longitudinal cohort study, 234 in the femoral group and 254 in the radial group. In the propensity-adjusted model, the use of the femoral approach was a strong independent predictor of bleeding (odds ratio 4.22, 95% confidence interval 3.17 to 10.60). No significant difference between the radial and femoral groups was observed relative to the time to revascularization (21.4 +/- 11.8 minutes vs 22.8 +/- 10.3 minutes, respectively; p = 0.68). Moreover, the radial approach was associated with a decreased risk of major adverse cardiac events (odds ratio 0.31, 95% confidence interval 0.10 to 0.94). In conclusion, primary PCI using the radial approach was associated with a fourfold reduction in major bleeding, without compromising the time to revascularization. Moreover, the radial approach was associated with a significant reduction in major adverse cardiac events at 12 months.

Role of rheolytic thrombectomy in massive pulmonary embolism with contraindication to systemic thrombolytic therapy.

AIMS: Mortality of massive pulmonary embolism remains exceedingly high despite thrombolytic therapy. Despite initial encouraging results, rheolytic thrombectomy has not been considered the first choice of treatment in the current European Guidelines for massive pulmonary embolism, even in cases of major contraindication to thrombolysis. Our objective was to assess the efficacy of rheolytic thrombectomy in the specific treatment of massive pulmonary embolism with contraindication to systemic thrombolytic therapy. METHODS AND RESULTS: Between January 2003 and April 2008 a total of 10 patients with massive pulmonary embolism referred for rheolytic thrombectomy were included. Clinical data including medical history, haemodynamic status, procedural characteristic, in-hospital complications and survival were collected. Seven patients survived after undergoing the procedure, three patients died in during their initial hospitalisation however, two of these deaths were not attributable to the pulmonary embolism or the procedure. Rheolytic thrombectomy resulted in reduction of mean pulmonary artery pressures from 34.6+/-13.1 mmHg to 26.9+/-8.2 mmHg immediately following the procedure. Additionally, the Miller index improved from 22.4+/-2.8 to 9.8+/-2.7. There were no periprocedural bleeding complications associated with the procedure. CONCLUSIONS: Rheolytic thrombectomy might be an effective and safe treatment for massive pulmonary embolism when systemic thrombolytic therapy is contraindicated. These data form the basis for further clinical investigation of this novel therapy among patients with massive pulmonary embolism.