Clinical outcomes following implantation of the ION™ paclitaxel-eluting platinum chromium coronary stent in routine clinical practice: Results of the ION U.S. post-approval study.

BACKGROUND: The ION Study assessed clinical outcomes for the thin-strut, ION™ (TAXUS Element) Paclitaxel-Eluting Platinum Chromium Coronary Stent System (Boston Scientific, Marlborough, MA) in unselected patients. METHODS: This prospective, open-label registry enrolled the first 1,120 consenting patients treated with the ION stent without clinical or angiographic inclusion criteria at 40 clinical sites. Follow-up was at discharge, 30 days, 180 days, 1 and 2 years. The primary endpoint, the 1-year rate of cardiac death or MI (CD/MI) in PERSEUS-like patients (i.e., patients similar to those enrolled in PERSEUS, the pivotal approval trial), was tested in patients pooled from the ION study (N = 316), the European TAXUS Element post-approval registry (TE-PROVE; N = 306 PERSEUS-like patients), and the PERSEUS WH/SV populations (N = 1,166); and then compared with a prespecified performance goal. Additional outcomes were examined in the overall ION patient population. RESULTS: A total of 1,111 (out of 1,120) enrolled patients received a study stent. Most patients were male (70%) and mean age was 64 years. At 1 year, the primary endpoint of CD/MI occurred in 2.1% (6/292) of PERSEUS-like patients in ION, and 2.3% (40/1,729) of patients in the combined analysis. The upper one-sided 95% confidence interval for the combined analysis was 2.9%, which was significantly less than the performance goal of 7.6% (P < 0.001). Within patients enrolled in the ION study (N = 1,111), the rate of CD/MI was 4.5% at 1 year and 7.5% at 2 years. Definite/probable stent thrombosis occurred in 2.1% of patients at 1 year and 2.5% at 2 years. CONCLUSIONS: The results of the ION Study confirm the mid-term safety and effectiveness of the ION stent for the treatment of coronary artery disease in everyday clinical practice.

Trends in mitral valve surgery: a single practice experience.

BACKGROUND AND AIM OF THE STUDY: Mitral repair has evolved to a point where three methods can be used to address most pathologies: full ring annuloplasty (RA) for annular disease; Gore-Tex artificial chordal replacement (ACR) for chordal disease; and autologous pericardial augmentation (PA) for leaflet disease. The study aim was to assess the impact of the increasing application of these methods on operative results over time. METHODS: Of 328 consecutive mitral valve procedures, 34% involved myxomatous prolapse, 23% rheumatic, 13% ischemic, 12% pure annular dilatation, 7% prosthetic dysfunction, 6% endocarditis, 3% hypertrophic obstructive cardiomyopathy (HOCM), and 2% 'other'. All patients underwent RA. Myxomatous prolapse was repaired with ACR, and ischemic and annular dilatation with RA alone. Rheumatic, endocarditis, and HOCM etiologies were repaired with all three methods. Patients were allocated to two-year increments, and also to repair versus replacement groups. Operative outcomes over time were assessed with linear and binomial regression. RESULTS: Overall, 66% of mitral valves were repaired; the average operative mortality was 6% (2% for repair, 7% for replacement), and 18% involved multiple valve procedures (mortality 16%). The extent of repair increased over time, from 55% to 100% of all etiologies. Over the same period, operative mortality fell from 6% in 1994 to 0% over the past six years. Other variables, such as age, presentation status, left ventricular dysfunction and etiology were relatively constant over the period. Reoperation rates after repair have been only 2% over the past 10 years of follow up. CONCLUSION: With recent innovations, most mitral disease can be repaired with combinations of RA, ACR and PA. Today, operative mortality is approaching zero, and one factor may be the increasing application of repair to all mitral pathologies. These data support the trend of expanding valve repair across most mitral disorders.

Efficacy of a novel procedure sheath and closure device during diagnostic catheterization: the multicenter randomized clinical trial of the FISH device.

BACKGROUND: The aim of vascular closure devices is to safely secure the arterial access site at the conclusion of catheterization procedures, thereby increasing patient comfort and decreasing time to hemostasis and ambulation. The FISH (femoral introducer sheath and hemostasis) device is novel in that the access sheath and closure component are incorporated onto the same system. METHODS: The FISH pivotal investigation was conducted at 8 catheterization laboratories throughout the United States. Eligible diagnostic patients were randomized (2 to 1) to the FISH device versus manual compression and assessed for time to hemostasis and time to ambulation. Half of the participants underwent ultrasonographic evaluation at 30-day follow up. Enrollment for an interventional cohort is ongoing and will be reported at a later date; however, the interventional patients enrolled to date were combined with the diagnostic patients to comprise the safety data of the trial. RESULTS: Overall, 191 patients were randomized to the FISH device and 106 patients to manual compression. Most patients received a 6 Fr sheath (approximately 70%), while the remaining patients received a 5 or 8 Fr sheath. Twenty-seven patients who received the FISH device were converted to manual compression due to anticipated suboptimal hemostasis. Among the diagnostic patients, the mean time to hemostasis was 8.9 minutes for the FISH device, compared to 17.2 minutes for manual compression (p < 0.0001). Similarly, the mean time to ambulation was 2.4 hours for the FISH device, compared to 4.3 hours for manual compression (p < 0.0001). Among the total cohort, there was 1 death and 1 episode of major access-site-related bleeding that required transfusion occurred in the FISH group (1.1%), compared to no serious adverse safety events in the manual compression group (p = 1.0). For the FISH group, there were 5 minor adverse safety events; 3 access-site hematomas and 2 pseudoaneurysms treated with thrombin injection, and in the manual compression group, there was 2 access-site hematomas and 1 pseudoaneurysm treated with thrombin injection (p = 1.0). CONCLUSION: Among diagnostic patients with good sheath placement and favorable femoral anatomy, the FISH device is superior in achieving time to hemostasis and ambulation compared to manual compression. At 30 days, there is no apparent difference in serious or minor adverse vascular events with the use of the FISH device.