Objective
Approximately 50% of patients with severe symptomatic mitral regurgitation
are deemed too high risk for surgery. The MitraClip procedure is a viable
option for this population. Our goal was ...to assess outcomes and survival of
patients who underwent the MitraClip procedure at an institution where
mitral valve surgery is routinely performed.
Methods
A retrospective study of patients undergoing the MitraClip procedure was
performed. Baseline characteristics, perioperative outcomes, and follow-up
echocardiographic and clinical outcomes were examined. Primary end point was
survival. Secondary end points included technical failure (residual 3/4+
mitral regurgitation), reoperation, New York Heart Association symptoms,
30-day mortality, and other clinical outcomes. Predictors of mortality were
determined using multivariable regression analysis.
Results
Fifty consecutive patients underwent the MitraClip procedure during the
4-year period. The average age was 83, the Society of Thoracic Surgeons
predicted risk of mortality mean was 9.4%, 88% (44/50) had New York Heart
Association III/IV symptoms, 86% (43/50) had 4+ mitral regurgitation, and
72% (36/50) had degenerative mitral disease etiology. Echocardiographic data
(median interquartile range follow-up = 43 26–392) showed that 86%
(43/50) of patients had 2+ or less mitral regurgitation. Sixty percent
(24/40) had New York Heart Association I/II symptoms at last follow-up.
Predictors of mortality were higher Society of Thoracic Surgeons predicted
risk of mortality (P = 0.042, hazard ratio = 1.098) and
previous cardiac surgery (P = 0.013, hazard ratio = 3.848).
Survival at 1 and 2 years was 75% and 63%, respectively.
Conclusions
Many patients with mitral valve regurgitation who are high risk for open
surgery can be treated with the MitraClip procedure. In our study, most
patients (86%) had a technically successful operation and postoperative
outcomes including survival were acceptable.
Abstract Background Neurological events and brain infarction after transcatheter aortic valve replacement (TAVR) are concerns which may be reduced with transcatheter embolic protection (TEP). ...Objective Evaluate the safety and efficacy of TEP during TAVR. Methods Nineteen centers randomized 363 patients undergoing TAVR to safety (n=123), device imaging (n=121), and control imaging (n=119). The primary safety endpoint was major adverse cardiac and cerebrovascular events (MACCE) at 30 days and the primary efficacy endpoint was reduction in new lesion volume in protected brain territories on MRI scans at 2-7 days. Patients underwent neurocognitive assessments and the debris captured was analyzed. Results MACCE (7.3%) was non-inferior to the performance goal (18.3%, pnoninferior <0.001) and not statistically different from control (9.9%, p=0.41). New lesion volume was 178.0 mm3 in controls and 102.8 mm3 in the device arm (p=0.33). A post hoc multivariable analysis identified preexisting lesion volume and valve type to be predictors of new lesion volume. Strokes at 30d were 9.1% in controls and 5.6% in device patients (p=0.25). Although neurocognitive function was similar in control and device patients, there was correlation between lesion volume and neurocognitive decline (p=0.0022). Histopathologic debris, found within filters in 99% of patients, included thrombus, calcification, valve tissue, artery wall and foreign material. Conclusions TEP was safe, captured embolic debris 99% patients, and did not change neurocognitive function. Reduction in new lesion volume on MR scans was not statistically significant.
At 2-year follow-up, SAVR patients with moderate or severe MR had a higher mortality than those with <=mild MR (49.8% vs 28.1%; adjusted hazard ratio (HR): 1.73; 95% confidence interval ...(CI)1.01-2.96, p=0.04).
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