Title: Percutaneous Mitral Valve Repair With the MitraClip System: Acute Results From a Real World Setting
Topic: Interventional Cardiology
Date Posted: 3/23/2010
Author(s): Tamburino C, Ussia GP, Maisano F, et al.
Citation: Eur Heart J 2010;Mar 18:[Epub ahead of print].
Clinical Trial: No
Study Question: What is the short-term safety and efficacy of the percutaneous edge-to-edge repair approach for mitral regurgitation (MR) with the MitraClip system?
Methods: The authors reported their experience with the MitraClip system at two Italian hospitals. The primary efficacy endpoint was acute device success, defined as clip placement with reduction of MR to ≤2 +. The primary acute safety endpoint was 30-day freedom from major adverse events, defined as the composite of death, myocardial infarction, nonelective cardiac surgery for adverse events, renal failure, transfusion of more than 2 units of blood, ventilation for >48 hours, deep wound infection, septicemia, and new onset of atrial fibrillation.
Results: A total of 31 patients were treated between August 2008 and July 2009. The median age of the cohort was 71 years and 25 (81%) were men. The etiology of the MR was functional in 18 patients and degenerative disease in 13. A single clip was successfully implanted in 19 patients and two clips in 12 patients. The median device implantation time was 80 minutes, with procedure duration decreasing with increasing operator experience. At 30 days, there was one intraprocedural cardiac tamponade and one noncardiac death (from a gastrointestinal bleed), resulting in a primary safety endpoint of 93.6%. Acute device success was achieved in 96.8% of patients. There was a reduction in left ventricular diameters, diastolic left ventricular volume, diastolic annular septal–lateral dimension, and mitral valve area from baseline to 30 days.
Conclusions: Percutaneous MR repair using the MitraClip device can be accomplished with favorable short-term safety and efficacy.
Perspective: The results of this study support good short-term safety and efficacy of the MitraClip system. The results of the recently presented EVEREST II trial suggest a lower complication rate with MitraClip compared with open surgical repair and a noninferior clinical success at 1 year. While larger studies are required to assess the long-term safety and efficacy of this device, percutaneous mitral valve repair is likely to emerge as a viable option for many patients in the near future. Hitinder S. Gurm, M.B.B.S., F.A.C.C.
Title: 5-Year Clinical Outcomes in the ICTUS (Invasive versus Conservative Treatment in Unstable coronary Syndromes) Trial: A Randomized Comparison of an Early Invasive Versus Selective Invasive Management in Patients With Non–ST-Segment Elevation Acute Coronary Syndrome
Topic: Interventional Cardiology
Date Posted: 3/24/2010
Author(s): Damman P, Hirsch A, Windhausen F, Tijssen JG, de Winter RJ, on behalf of the ICTUS Investigators.
Citation: J Am Coll Cardiol 2010;55:858-864.
Clinical Trial: yes
Related Resources
JACC Article: 5-Year Clinical Outcomes in the ICTUS Trial: A Randomized Comparison of an Early Invasive Versus Selective Invasive Management in Patients With Non–ST-Segment Elevation Acute Coronary Syndrome
Trial: Invasive Versus Conservative Treatment in Unstable Coronary Syndromes (ICTUS)
Study Question: What is the long-term outcome of patients with non–ST-elevation acute coronary syndromes (ACS) treated with an early invasive versus an ischemia-guided therapy?
Methods: The authors reported the 5-year outcome of patients enrolled in the Invasive versus Conservative Treatment in Unstable coronary Syndromes (ICTUS) trial. This trial randomized 1,200 patients to an early invasive or selective invasive therapy. During the initial hospitalization, 76% of patients in the invasive arm and 40% of patients in the selective invasive therapy arm were revascularized.
Results: The 5-year revascularization rate was 81% in the invasive arm and 60% in the selective invasive arm. The cumulative rate of death or myocardial infarction was higher in the early invasive therapy arm (22.3% vs. 18.1%, hazard ratio, 1.29; 95% confidence interval, 1.00-1.66; p = 0.053). There was no difference in 5-year mortality (11.1% vs. 9.9%; p = 0.49). After risk stratification using the FRISC score, no benefit of an early invasive strategy was observed in reducing death or myocardial infarction in any of the risk groups.
Conclusions: There was no advantage of an early invasive therapy over selectively invasive therapy in patients with ACS.
Perspective: Current guidelines support an early invasive approach to treatment of patients with ACS. Prior studies had suggested better long-term survival with such an approach, but the results of the ICTUS trial suggest that either approach provides a similar outcome. This difference is largely due to the more liberal use of an invasive strategy in patients randomized to the selectively invasive arm such that over 54% of patients in this arm had undergone revascularization (54%) by 1 year. These results suggest that either an early invasive strategy or a selective (albeit liberally) invasive strategy can be used to treat patients with ACS based on patient and physician preference. Hitinder S. Gurm, M.B.B.S., F.A.C.C.
|