Clinical Characteristics and Outcomes of Patients Screened for but Deemed Clinically Not Suitable for Transcatheter Mitral Valve Replacement: DECLINE-TMVR Registry.

BACKGROUND: Transcatheter therapies are a recognized alternative intervention in patients with severe mitral regurgitation who are at high surgical risk. The purpose of this study was to characterize patients screened for transcatheter mitral valve replacement (TMVR), establish the clinical and anatomic reasons for unsuitability, and determine clinical course and early outcomes. METHODS: International multicentre registry was conducted of consecutive patients screened for TMVR at 12 centres in Europe, the United States, and Canada between April 2015 and September 2018. Patient-level retrospective data were collected for all patients screened. RESULTS: From a total of 294 patients, 87 (30%) patients were suitable for and underwent TMVR, whereas 207 (70%) patients were unsuitable for TMVR. There was no difference in Society of Thoracic Surgeons predicted risk of mortality (6.3% ± 4.3% vs 6.7 ± 6.1%, P = 0.52) for mitral valve replacement between the groups. The most common reasons for TMVR unsuitability were mitral annular size outside therapeutic range (28%) and small predicted neo-LVOT (25%). Preprocedural multidetector computed tomographic demonstrated that patients unsuitable for TMVR had smaller predicted neo-left ventricular outflow tract (LVOT) area (318 ±192 mm2 vs 495 ± 202 mm2, P = 0.04). At 30 days, there was no difference in rates of rehospitalization (8% vs 8%, P = 0.21), stroke (1% vs 2%, P = 0.42), or mortality (4% vs 10%, P = 0.10), unadjusted for procedural risk, between unsuitable for TMVR and TMVR groups, respectively. CONCLUSIONS: Two-thirds of patients failed screening as anatomically unsuitable for TMVR. The findings of this study have important clinical implications, highlighting an unmet clinical need and provide a target for design innovation in future iterations of TMVR devices.

Effect of Aortic Regurgitation by Cardiovascular Magnetic Resonance After Transcatheter Aortic Valve Implantation.

Cardiovascular magnetic resonance (CMR) has demonstrated a high accuracy for evaluating the severity of aortic regurgitation (AR). However, scarce data exist on the impact of AR as evaluated by CMR on clinical outcomes following transcatheter aortic valve implantation (TAVI). The objective of this study was to evaluate the impact of AR as determined by CMR on clinical outcomes (mortality, heart failure [HF] hospitalization) post-TAVI. A total of 448 TAVI recipients from 2 centers (mean age: 80 ± 7 years, mean STS: 5.8 ± 5.4%) who survived the periprocedural period with no pacemaker implantation were included. A newer generation transcatheter valve system was used in 213 patients (48%). The CMR examination was performed at a median of 12 (IQR: 7 to 21) days post-TAVI. After a mean follow-up of 24 ± 19 months, a total of 94 patients (21%) had died and 72 patients (16%) had at least 1 hospitalization because of decompensated HF. The aortic regurgitation fraction (RF) as determined by CMR was an independent predictor of mortality (hazard ratio[HR]:1.06 for each increase of 10%, 95% confidence interval [CI]: 1.01 to 1.12, p = 0.03) and HF hospitalization (HR:1.15 for each increase of 10%, 95% CI:1.02 to 1.30, p = 0.02). The rate of moderate-severe CMR-AR defined as a RF ≥30% was 3%, and this was associated with an increased risk of mortality (HR: 2.63, 95% CI: 2.30 to 2.99, p <0.001) and HF hospitalization (HR: 2.96, 95% CI: 1.62 to 5.42, p ˂0.001). A stepwise increase in the risk of mortality and HF hospitalization was observed with an increase in AR severity, with a peak increase among patients with RF ≥30%. In conclusion, our results showed the clinical usefulness of evaluating AR severity by CMR post-TAVI. CMR would be particularly helpful in doubtful cases or those with discordances between echocardiography and clinical data.

Very Long Term Follow-Up After Percutaneous Balloon Mitral Valvuloplasty.

OBJECTIVES: The aim of this study was to assess very long term outcomes after successful percutaneous balloon mitral valvuloplasty (PBMV). BACKGROUND: PBMV remains the preferred treatment for patients with severe symptomatic rheumatic mitral stenosis and suitable anatomy. METHODS: All consecutive patients who underwent successful PBMV between 1987 and 2010 were included. The primary endpoint was the composite of all-cause mortality, need for mitral surgery, or repeat PBMV up to 23 years. RESULTS: Among all 1,582 consecutive patients undergoing PBMV, acute success was achieved in 90.9% (n = 1,438). Independent predictors of acute success included left atrial size (odds ratio: 0.96; 95% confidence interval [CI]: 0.93 to 0.99; p = 0.045), Wilkins score ≤8 (odds ratio: 1.66; 95% CI: 0.48 to 0.93; p = 0.02) and age (odds ratio: 0.97; 95% CI: 0.96 to 0.99; p = 0.006). Very long term follow-up (median 8.3 years, mean 15.6 years) was obtained in 79.1% of successful cases. The incidence of the primary endpoint was 19.1% (95% CI: 17.0% to 21.1%). The rates of overall mortality, need for mitral valve surgery, or repeat PBMV were 0.6% (95% CI: 0.3% to 1.2%), 8.3% (95% CI: 7.0% to 9.9%), and 10.0% (95% CI: 8.5% to 11.7%), respectively. On multivariate analysis, New York Heart Association functional class III or IV (hazard ratio: 1.62; 95% CI: 1.26 to 2.09; p < 0.001), higher age (hazard ratio: 0.97; 95% CI: 0.96 to 0.98; p = 0.028), and mitral valve area ≤1.75 cm2 after the procedure (hazard ratio: 1.67; 95% CI: 1.28 to 2.11; p = 0.028) were independent predictors of the primary endpoint. CONCLUSIONS: In very long term follow-up, more than 75% of patients exhibited sustained results. Prediction of late favorable results is multifactorial and strongly determined by age, previous symptoms and post-procedural mitral valve area.

Very Long Term Follow-Up After Percutaneous Balloon Mitral Valvuloplasty

OBJECTIVES: The aim of this study was to assess very long term outcomes after successful percutaneous balloon mitral valvuloplasty (PBMV).BACKGROUND: PBMV remains the preferred treatment for patients with severe symptomatic rheumatic mitral stenosis and suitable anatomy.METHODS: All consecutive patients who underwent successful PBMV between 1987 and 2010 were included. The primary endpoint was the composite of all-cause mortality, need for mitral surgery, or repeat PBMV up to 23 years.RESULTS: Among all 1,582 consecutive patients undergoing PBMV, acute success was achieved in 90.9% (n»1,438).Independent predictors of acute success included left atrial size (odds ratio: 0.96; 95% confidence interval [CI]: 0.93 to0.99; p»0.045), Wilkins score#8 (odds ratio: 1.66; 95% CI: 0.48 to 0.93; p»0.02) and age (odds ratio: 0.97; 95% CI:0.96 to 0.99; p»0.006). Very long-term follow-up (median 8.3 years, mean 15.6 years) was obtained in 79.1% of successful cases. The incidence of the primary endpoint was 19.1% (95% CI: 17.0% to 21.1%). The rates of overall lmortality, need for mitral valve surgery, or repeat PBMV were 0.6% (95% CI: 0.3% to 1.2%), 8.3% (95% CI: 7.0% to9.9%), and 10.0% (95% CI: 8.5% to 11.7%), respectively. On multivariate analysis, New York Heart Association functional class III or IV (hazard ratio: 1.62; 95% CI: 1.26 to 2.09; p<0.001), higher age (hazard ratio: 0.97; 95% CI: 0.96 to0.98; p»0.028), and mitral valve area#1.75 cm2after the procedure (hazard ratio: 1.67; 95% CI: 1.28 to 2.11;p»0.028) were independent predictors of the primary endpoint. CONCLUSIONS: In very long term follow-up, more than 75% of patients exhibited sustained results. Prediction of late favorable results is multifactorial and strongly determined by age, previous symptoms and post-procedural mitral valve area.(J Am Coll Cardiol Intv 2018;11:1945­52) © 2018 by the American College of Cardiology Foundation.

Long-term follow-up in patients with rheumatic mitral stenosis and severe pulmonary artery hypertension submitted to percutaneous mitral balloon commissurotomy

BACKGROUND: Percutaneous balloon mitral commissurotomy (PMBC) is an attractive therapeutic approach in patients with mitral stenosis. The aim of this study was to assess the immediate and long-term clinical, echocardiographic and haemodynamic outcomes of PMBC in patients with severe pulmonary hypertension (PH). METHODS: Among all procedures (in more than two decades of experience), PMBC was performed from 1987 until 2011 at a single-center in 147 patients who had significant PH defined as baseline pulmonary artery mean pressure (PAMP) (systolic pulmonary pressure > 75 mmHg). All-cause mortality, need for mitral valve replacement (MVR) or new PMBC, and valve restenosis were evaluated during follow-up yearly. RESULTS: Mean age was 33.8 ± 12.8 years and 83.6% (123 patients) were women. Primary success was achieved in 89.8% of the patients (132 patients). Mitral valve area (MVA) increased from 0.83 ± 0.17 cm2 to 2.03± 0.35 cm2 (p<0.001), and at 20-years, mitral valve area was 1.46± 0.34 cm2 (p=0.235). Systolic pulmonary artery pressure decreased from 87.0 ± 6.0 mmHg to 60.0 ± 0.9 mmHg (p<0.001) The rates of all-cause mortality, need for MVR, new PMV, and valve restenosis were 0.67%, 20.0%, 8.78% and 30.4%, respectively, in long-term follow- up (mean 15.6 ± 4.9 years). CONCLUSIONS: PMBC is a safe and effective technique for the treatment of patients with mitral stenosis and PH. A significant decrease in pulmonary pressure was observed after commissurotomy. Although there was a gradual decrease of MVA at long-term follow-up, most patients remained asymptomatic and without major adverse events.