Implantation of one versus two MitraClips in the German TRAMI registry: Is more always better?

OBJECTIVES: To compare baseline characteristics and outcomes in patients treated with either 1 or 2 MitraClips in the German TRAMI (Transcatheter Mitral Valve Interventions) registry. BACKGROUND: The MitraClip community seems to silently assume that results should intrinsically be better after implantation of more than one clip, although data is still sparse. METHODS: In 2010-2013, 803 patients were enrolled prospectively into TRAMI (461 one-clip and 312 two-clip procedures). Follow-up was performed centrally at 30 days and 1 year. RESULTS: Baseline characteristics of TRAMI-patients with two clips differed significantly from single-clip patients regarding constitutional (more men, taller body height) and heart failure-related factors (larger left ventricular dimensions, reduced left ventricular ejection fraction, more severe heart failure). Also, a significant increase in two-clip procedures over time was present. After propensity score matching for differing baseline characteristics, residual moderate mitral regurgitation (MR) occurred more frequently after implantation of two clips, whereas residual severe MR could more frequently be observed after one-clip procedures. However, no or mild residual MR at discharge was present in 71.6% after single-clip and in 70.1% after two-clips implantation (p = .81). After 1 year, no significant differences regarding mortality or New York Heart Association status could be detected in the propensity matched cohorts. However, TRAMI-patients treated with two clips had a significantly higher incidence of cerebral-vascular events (p = .02). CONCLUSIONS: TRAMI data cannot support the theory that implantation of more than one clip is associated with better clinical outcomes. The finding of more cerebral-vascular events after two-clip procedures might be hypothesis-generating.

Long-term outcomes after TAVI in patients with different types of aortic stenosis: the conundrum of low flow, low gradient and low ejection fraction.

AIMS: The objective of this study was to examine the impact of guideline-defined subtypes of severe aortic stenosis (AS) on long-term outcomes after TAVI. METHODS AND RESULTS: Four hundred (400) consecutive patients who underwent TAVI (203 transapical, 197 transfemoral) at our institution 8/2008-3/2013 were followed systematically (for up to seven years). One hundred and forty-seven (147) individuals suffered from NEF-HG AS (LV-EF ≥50%, high Pmean ≥40 mmHg), 63 from LEF-HG AS (LV-EF <50%, high gradient), 77 from PLF-LG AS (LV-EF ≥50%, low gradient, stroke volume index [SVI] <35 ml/m²), and 81 from LEF-LG AS (LV-EF <50%, low gradient). LEF-LG status was associated with the highest all-cause and cardiovascular mortality and MACCE rate, whereas NEF-HG patients exhibited the best outcome (i.e., median survival 5.1 years in NEF-HG vs. 1.3 years in LEF-LG, p=0.0006; or vs. 3.3 years in PLF-LG, p=0.02). In multivariate analysis, LEF-LG status emerged as the outcome predictor with the highest hazard ratio for all-cause mortality (HR 2.86, p=0.003), cardiovascular mortality (HR 6.53, p<0.0001), and MACCE (HR 2.44, p=0.007), whereas neither baseline EF nor SVI <35 ml/m² independently predicted these endpoints. CONCLUSIONS: These findings suggest that an assessment of LV-EF alone for outcome prediction after TAVI is inadequate; it is the guideline-defined subtype of AS that determines outcome.