Intraprocedural Residual Mitral Regurgitation and Survival After Transcatheter Edge-to-Edge Repair: Prospective German Multicenter Registry (MITRA-PRO).

BACKGROUND: Residual mitral regurgitation (MR) is thought to be an important predictor of long-term survival following transcatheter edge-to-edge repair (TEER). Intraprocedural MR assessment using transesophageal echocardiography could be limited by image quality, hemodynamics, and patient sedation. The MitraScore is a validated multimodal approach for intraprocedural MR assessment during TEER. OBJECTIVES: This study aimed to assess the impact of residual MR using the MitraScore on 1-year mortality. METHODS: Patients undergoing mitral TEER were eligible for inclusion in the prospective, multicenter MITRA-PRO registry (A Prospective Registry Study on 1-Year Mortality and the Prognostic Significance of MitraScore After MitraClip Implantation in Patients With Mitral Regurgitation). Patients with a MitraScore ≤3 were defined as patients with mild residual MR after mitral TEER, whereas a MitraScore ≥4 was considered as relevant residual MR. Mortality, rehospitalization, and major adverse events were assessed 1 year after TEER. RESULTS: A MitraScore ≤3 was found in 1,059 patients (71.0%), whereas 432 patients revealed a MitraScore ≥4 (29.0%). One-year mortality was significantly lower in patients with nonrelevant residual MR (MitraScore ≤3 14.6% vs MitraScore≥4 22.1%). An almost linear relationship between intraprocedural MitraScore after TEER and mortality was observed. The combined clinical endpoint of mortality and rehospitalization within the 1-year follow-up was also significantly lower in the MitraScore ≤3 group (31.5%) than in the MitraScore ≥4 group (40.8%). A subgroup analysis confirmed the predictive value of the MitraScore in patients with primary, secondary, or mixed MR etiologies. CONCLUSIONS: Residual MR assessed by intraprocedural MitraScore after TEER predicts 1-year mortality and rehospitalization. Therefore, the multimodal MitraScore improves MR assessment during mitral TEER and might improve patient survival.(A Prospective Registry Study on 1-Year Mortality and the Prognostic Significance of MitraScore After MitraClip Implantation in Patients With Mitral Regurgitation [MITRA-PRO]; DRKS00012288).

Continuous atrial pressure monitoring via steerable guide catheter in transcatheter mitral and tricuspid edge-to-edge repair.

Transcatheter edge-to-edge repair (TEER) has emerged to address severe mitral and tricuspid valve regurgitation in patients who are at high perioperative risk for open-heart surgery. No clinical data is available for continuous left and right atrial pressure monitoring using the steerable guiding catheter (SGC) during TEER. In a prospective single-center study, 40 patients with severe mitral (n = 20) or tricuspid (n = 20) regurgitation underwent TEER with the registration of atrial pressure via the SGC. All patients had successful TEER using the PASCAL Ace repair system, while atrial pressure was monitored continuously via the SGC. Simultaneous right or left atrial pressure monitoring via the SGC and a pigtail catheter during mitral and tricuspid TEER showed excellent reliability for SGC pressure registration. While for mitral TEER the beneficial effects of continuous atrial pressure monitoring are well known, we further evaluated the outcome of patients with tricuspid TEER. Echocardiographic and clinical results after tricuspid TEER showed a reduction of quantitative echocardiographic tricuspid regurgitation parameters and improved New York Heart Association classification after 3-month follow-up. Also, qualitative tricuspid valve assessment showed improved tricuspid regurgitation classification postimplantation and at 3-month follow-up. Furthermore, right atrial pressure was reduced by 37.6% and mean right atrial pressure by 30.6% after successful tricuspid TEER using the PASCAL Ace device. Continuous atrial pressure monitoring using the SGC of the PASCAL Ace repair system is reliable during mitral and tricuspid TEER. Furthermore, successful tricuspid TEER leads to reduced right atrial pressure.

Percutaneous double-valve interventions for aortic stenosis and pure mitral regurgitation.

Percutaneous interventions for valvular heart disease are rapidly gaining momentum. Transcatheter aortic valve implantation for aortic stenosis in patients with high surgical risk and percutaneous mitral valve repair with the MitraClip have been shown to be noninferior to surgery. Little is known about the combination of these interventions in patients with mixed valvular disease. The investigators present 2 patients, both with acute device successes but contrasting outcomes, and attempt to glean some insights from these patients.

Correlation of Device landing zone calcification and acute procedural success in patients undergoing transcatheter aortic valve implantations with the self-expanding CoreValve prosthesis.

OBJECTIVES: The aim of this study was to assess the influence of amount and distribution of calcifications of the aortic valve and the left ventricular outflow tract on the acute procedural outcome of patients undergoing transcatheter aortic valve implantation (TAVI). BACKGROUND: Transcatheter aortic valve implantation is a new percutaneous technique especially for elderly, high-risk patients with significant aortic valve stenosis (AS). After TAVI, post-interventional paravalvular aortic regurgitations (PAR) can occur, which is believed to be related partially to valve calcifications. METHODS: We prospectively analyzed 100 symptomatic patients with severe AS scheduled for TAVI with the CoreValve ReValving (Medtronic, Minneapolis, Minnesota) prosthesis. In all patients, a native and contrast-enhanced multislice cardiac computed tomography was performed pre-interventionally. Calcification load of the valve and the adjacent outflow tract was estimated by the Agatston Score (AgS), and the amount and distribution of calcification was semi-quantitatively assessed and graded on a 1 to 4 scale (device "landing zone" calcification score [DLZ-CS]). Aortography was performed to evaluate the PAR pre-interventionally, after initial device release (PAR0) and after termination of the procedure (PAR1). Transthoracic echocardiography was performed 2 weeks after implantation (PAR2). RESULTS: The AgS and DLZ-CS showed a significant correlation with the grade of PAR0 (AgS: r = 0.329, p = 0.001; DLZ-CS: r = 0.356, p < 0.001), PAR1 (AgS: r = 0.254, p = 0.011; DLZ-CS: r = 0.240, p = 0.016), and PAR2 (AgS: r = 0.341, p = 0.001; DLZ-CS: r = 0.300, p = 0.002). Both scores (AgS and DLZ-CS) showed a significant positive correlation (r = 0.858, p < 0.001). CONCLUSIONS: Calcification in the CoreValve device "landing zone" shows a significant positive correlation to PAR after TAVI. Furthermore, the need for "second maneuvers" (i.e., post-dilation after initial device release) can be predicted by these calcification scores (AgS and DLZ-CS).

Progress and current status of percutaneous aortic valve replacement: results of three device generations of the CoreValve Revalving system.

BACKGROUND: Percutaneous aortic valve replacement is a new emerging technology for interventional treatment of severe aortic valve stenosis in surgical high-risk patients. This study was intended to provide a summary of the development and current safety and efficacy status of the self-expanding CoreValve Revalving prosthesis. METHOD AND RESULTS: Between 2005 and 2008, we have enrolled 136 consecutive patients with percutaneous aortic valve replacement using the CoreValve prosthesis. In this prospective nonrandomized, single-center trial, we analyzed procedural outcome, complications and clinical status up to 1 year. First, second, and third generation of the CoreValve prosthesis were implanted in 10, 24, and 102 consecutive high-risk patients (logistic EuroScore: 23.1+/-15.0%) with severe symptomatic aortic valve stenosis. Mean transvalvular pressure gradient was 41.5+/-16.7 mm Hg. The procedural success rate increased from generation 1/2 to 3 from 70.0%/70.8% to 91.2% (P=0.003). The 30-day combined rate of death/stroke/myocardial infarction was 40.0%/20.8%/14.7% (P=0.11) for generation 1, 2, and 3, with no procedural death in generation 3. Pressure gradients improved significantly with a final mean gradient of 8.1+/-3.8 mm Hg. Overall functional status assessed by New York Heart Association class improved from 3.3+/-0.5 (pre) to 1.7+/-0.7 (post) (P<0.001) and remained stable in the follow-up. CONCLUSIONS: In experienced hands, percutaneous aortic valve replacement with the CoreValve system for selected patients with severe aortic valve stenosis has a high acute success rate associated with a low periprocedural mortality/stroke rate as well as remarkable clinical and hemodynamic improvements, which persist over time. Additional studies are now required to confirm these findings, particularly head-to-head comparisons with surgical valve replacement in different risk populations.