Six-month and one-year outcomes with the PASCAL transcatheter valve repair system for patients with mitral regurgitation from the multicentre, prospective CLASP study

Abstract Background Transcatheter mitral valve repair has emerged as a viable option for treating mitral regurgitation (MR). We report results from the multicentre, prospective, single arm CLASP study with the PASCAL transcatheter valve repair system. Methods 109 patients with clinically significant MR deemed candidates for transcatheter repair by the local heart team were treated in the CLASP study. The study evaluated safety, performance, clinical and echocardiographic outcomes and included an independent clinical events committee and echocardiographic core lab. The primary safety endpoint was a composite MAE rate at 30 days of cardiovascular mortality, stroke, MI, new need for renal replacement therapy, severe bleeding, and re-intervention for study device-related complications. Results Mean age was 76 years, 54% male, 57% NYHA Class III/IV, 100% MR grade ≥3+ with 62% functional, 31% degenerative, 7% mixed etiology. Successful implantation was achieved in 95% of patients. At 30 days, the MAE rate was 8.3% including one cardiovascular mortality due to cardiogenic shock as a result of severe bleeding at the contralateral arterial access site for hemodynamic monitoring further complicated by disseminated intravascular coagulation, one stroke, and one conversion to mitral valve replacement surgery. In paired analysis, 88% of patients were in NYHA Class I/II (p<0.001), MR grade was ≤1+ in 79% of patients and ≤2+ in 96% of patients. Significant improvements in 6MWD (+27 m, p<0.001) and KCCQ (+16 points, p<0.001) were observed. The six-month data will be available for presentation. In addition, we report one-year follow up of the first 62 patients (ITT): 93% one-year survival rate (Kaplan-Meier estimate), no stroke, no late reintervention, one late MI. In paired analysis, MR grade was ≤1+ in 82% of patients and ≤2+ in 100% of patients. 88% of patients were in NYHA Class I/II (p<0.001), 6MWD improved by 21 m (p=0.124) and KCCQ improved by 13 points (p<0.001). Conclusions This study demonstrates the PASCAL transcatheter valve repair system is safe and resulted in robust MR reduction with 100% of patients achieving MR ≤2+, and ∼ 80% MR ≤1+, sustained at one year. Results show high survival and low complication rates, and sustained improvements in functional status, exercise capacity, and quality of life at one year in patients with clinically significant, symptomatic MR. The CLASP IID/IIF pivotal trial is underway. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Edwards Lifesciences (Irvine, CA)

Download Full-text

4291Six-month outcomes from the multicenter, prospective study with the novel PASCAL transcatheter valve repair system for patients with mitral regurgitation in the CLASP study

European Heart Journal ◽

10.1093/eurheartj/ehz745.0144 ◽

2019 ◽

Vol 40 (Supplement_1) ◽

Author(s):

S Kar ◽

S Lim ◽

K Spargias ◽

R Kipperman ◽

W O Neill ◽

...

Keyword(s):

Mitral Regurgitation ◽

Medical Therapy ◽

Cardiovascular Mortality ◽

Nyha Class ◽

Severe Bleeding ◽

Repair System ◽

Heart Team ◽

Valve Repair ◽

Transcatheter Valve

Abstract Background Severe mitral regurgitation may lead to an impaired prognosis if left untreated. Transcatheter treatment options have emerged as an alternative to surgery and an adjunct to medical therapy. We report the six-month results of the PASCAL transcatheter valve repair system in treating patients with mitral regurgitation enrolled in the multicenter, prospective, single arm CLASP study. Methods The PASCAL Transcatheter Valve Repair System is a leaflet repair therapy that uses clasps and paddles to place a woven Nitinol spacer between the native valve leaflets to fill the regurgitant orifice via a transseptal approach. Eligible patients had clinically significant MR despite optimal medical therapy and were deemed candidates for transcatheter mitral repair by the local Heart Team. Safety, performance, and clinical outcomes were prospectively assessed at baseline, discharge, 30 days, and 6 months post-procedure. All major adverse events (MAE) were adjudicated by an independent clinical events committee and echocardiographic images were assessed by a core lab. The MAE rate was the primary safety endpoint, defined as the composite of cardiovascular mortality, stroke, MI, new need for renal replacement therapy, severe bleeding, and re-intervention for study device-related complications. Results Between June 2017 and September 2018, 62 patients were enrolled at 14 sites worldwide for transcatheter mitral valve reconstruction using the PASCAL system. The mean age was 76.5 years (62.9% male). All patients had MR grade ≥3+, with 59% functional, 34% degenerative, and 7% mixed etiology, and 51.6% of patients were in NYHA Class III/IV. Successful implantation of the PASCAL device was achieved in 95% of patients. At discharge, 95% of patients had MR grade ≤2+ with 81% grade ≤1+. There was one cardiovascular mortality and the MAE rate was 4.8%. At 30-day follow-up, paired analyses shows that 98% of patients had MR grade ≤2+ with 81% grade ≤1+ and 88% were in NYHA Class I/II (p<0.0001). The 6MWD improved by 38.9 m (p=0.0015) and was accompanied by average improvements in KCCQ and EQ5D scores by 14.1 points (p<0.0001) and 8.3 points (p=0.0028), respectively. The six-month data will be available for presentation. Conclusions In this early device experience, the PASCAL transcatheter valve repair system showed an acceptable safety profile and performed as intended in treating patients with mitral regurgitation. The PASCAL device resulted in significant MR grade reduction, which was associated with clinically and statistically significant improvements in functional status, exercise capacity, and quality of life. Continued follow-up is warranted to validate these initial promising results. Acknowledgement/Funding Edwards Lifesciences

Download Full-text

Favorable course of tricuspid regurgitation after percutaneous mitral valve repair is associated with improved survival and clinical outcome

European Heart Journal ◽

10.1093/ehjci/ehaa946.1945 ◽

2020 ◽

Vol 41 (Supplement_2) ◽

Author(s):

F Meijerink ◽

J Baan ◽

B.J Bouma

Keyword(s):

Mitral Valve ◽

Clinical Outcome ◽

Mitral Valve Repair ◽

Tricuspid Regurgitation ◽

Nyha Class ◽

Funding Source ◽

Valve Repair ◽

Percutaneous Mitral Valve Repair ◽

All Cause Mortality

Abstract Background Tricuspid Regurgitation (TR) is often present in patients with mitral regurgitation (MR) and is associated with increased mortality and morbidity after percutaneous mitral valve repair (PMVR) using the MitraClip (Abbott Vascular). It is unclear to what extent TR is reduced after PMVR and whether the reduction of TR is related to survival and functional outcome. Purpose The aim of this study was to determine (1) the TR course after PMVR and (2) if this was related to survival and clinical outcome. Methods Patients who underwent PMVR and had complete echocardiographic data at baseline and follow-up were included. TR severity was graded as none, mild, moderate or severe (according to current guidelines) and was determined before treatment and at 6-months of follow up. Favorable TR course was defined as improvement of ≥1 grade or ≤ mild TR at 6-months. Clinical endpoints were all-cause mortality during 1-year of follow-up and improvement in New York Heart Association (NYHA) functional class after 6 months. Results A total of 67 patients were included (mean age 76 years, 57% male, 81% NYHA class ≥3 and 69% baseline TR ≥ moderate). Favorable TR course was achieved in 31 patients (46%) (figure 1A). All-cause mortality at 1 year was 7.5%, and was lower in the favorable TR course group (0% vs. 13.9%, p=0.057) (figure 1B). Improvement in NYHA class at 6-months was seen in 45% of patients without vs. 81% of patients with favorable TR course (p=0.01) (figure 1C). Conclusion A favorable TR course is achieved in 46% of PMVR patients and is associated with improved survival and improvement of NYHA class. The relatively high rate of an unfavorable TR course at 6-months, indicates that interventional treatment of the tricuspid valve might benefit these patients. TR course (A) and NYHA improvement (B) Funding Acknowledgement Type of funding source: Other. Main funding source(s): Abbott

Download Full-text

P1758 Global left ventricular myocardial work efficiency as a prognostic marker for clinical responders one year after edge-to-edge mitral valve repair in patients with functional mitral regurgitation

European Heart Journal - Cardiovascular Imaging ◽

10.1093/ehjci/jez319.1117 ◽

2020 ◽

Vol 21 (Supplement_1) ◽

Author(s):

K Papadopoulos ◽

I Ikonomidis ◽

M Chrissoheris ◽

A Chalapas ◽

P Kourkoveli ◽

...

Keyword(s):

Mitral Valve ◽

Mitral Regurgitation ◽

Nyha Class ◽

The Other ◽

Work Efficiency ◽

Valve Repair ◽

Work Index ◽

Class Status ◽

Global Work ◽

One Year

Abstract Background Percutaneous edge-to-edge mitral valve repair (PMVR) has been proven to be effective for treating patients with functional MR (FMR). However it remains to be answered which patients will benefit more from this method. Novel echocardiographic markers like myocardial work efficiency can be quantified non-invasively and have never been analyzed in this subgroup of patients before. Purpose The purpose of this study is to analyze the myocardial work efficiency in patients treated with PMVR for FMR and identify predictors of clinical response. Methods We retrospectively analyzed 22 high surgical risk (logistic EuroSCORE 28.9 ± 18.2%) consecutive patients (aged 72 ± 8yrs) with functional moderate-to-severe and severe mitral regurgitation (EROA 28.6 ± 14.6mm2, RV 41.7 ± 15.8ml) and reduced LV contractility (EF 32.7 ± 7.5%, GLS -8.8 ± 3.4%). At baseline and 1-year after PMVR or optimal medical treatment (OMT) we assessed echocardiographic parameters such as MR severity, Global Work Index (GWI), Global Constructive Work (GCW), Global Wasted Work (GWW) and Global Work Efficiency (GWE), along with BNP levels and NYHA class status. Results One year after PMVR there was a significant reduction of MR (3.6 ± 0.5 vs 1.8 ± 0.8, p = 0.009) and BNP levels (901 ± 610pg/ml vs 479 ± 385pg/ml, p < 0.001) and significant improvement of NYHA class status (3.0 ± 0.6 to 2.2 ± 0.4, p < 0.001). On the other hand, patients treated with OMT didn’t have any significant change of their MR (3.6 ± 0.5 vs 3.3 ± 1.0), BNP levels (296 ± 114 vs 241 ± 183pg/ml) or NYHA class status (2.6 ± 0.5 vs 2.4 ± 0.5). In device group, there was a preservation of GWI (572 ± 290 vs 609 ± 299mmHg%) and GCW (757 ± 310 vs 789 ± 316mmHg%) and non significant change of GWW and GWE (140 ± 70 vs 150 ± 73mmHg% and 79 ± 9 vs 79 ± 10% respectively, p < 0.05 for all comparisons). On the other hand in medical treatment group there was a significant impairment of GWI (635 ± 263 vs 564 ± 267mmHg%, p = 0.08) and GWE (83 ± 9 vs 76 ± 11%, p = 0.03) and significant increase of GWW (123 ± 90 vs 162 ± 74mmHg%, p < 0.001). Further, baseline GCW was reversely associated with the difference in BNP (r=-0.559, p = 0.038), NYHA class (r=-0.501, p = 0.06) and 6MWT (r=-0.577, p = 0.08) after PMVR, meaning that patients with worse energetics will respond better. Conclusions PMVR is an effective method for treating patients with FMR and preserves myocardial work index after one year of FU in contrast to medically treated patients in whom deterioration is observed.

Download Full-text

P301Preserved global longitudinal strain predicts left ventricular reverse remodeling one year after edge-to-edge mitral valve repair in functional mitral regurgitation

European Heart Journal ◽

10.1093/eurheartj/ehz747.0136 ◽

2019 ◽

Vol 40 (Supplement_1) ◽

Author(s):

K Papadopoulos ◽

I Ikonomidis ◽

M Chrissoheris ◽

A Chalapas ◽

P Kourkoveli ◽

...

Keyword(s):

Mitral Valve ◽

Mitral Regurgitation ◽

Longitudinal Strain ◽

Nyha Class ◽

Walking Distance ◽

Functional Mitral Regurgitation ◽

Valve Repair ◽

Post Intervention ◽

Echocardiographic Parameters ◽

One Year

Abstract Background Percutaneous edge-to-edge mitral valve repair (PMVR) has emerged as an effective treatment modality for high surgical risk patients with severe functional mitral regurgitation (FMR). Novel echocardiographic parameters, such as deformation imaging and their predictive significance have not been analyzed in this group of patients. Purpose The purpose of this study is to identify echocardiographic predictors of response in patients with FMR undergoing PMVR. Methods We retrospectively analyzed 44 consecutive patients with ischemic or dilated cardiomyopathy, reduced ejection fraction and severe functional MR (FMR), aged 71±9 years, 71% males, LVEF 30.9±8.7%, mitral valve effective regurgitant orifice area (EROA)>20mm2, regurgitant volume (RV) >30ml and logistic EuroSCORE 22±14.7%. At baseline and 1-year after PMVR we assessed echocardiographic parameters such as LV longitudinal strain (LVGLS) and peak left atrial longitudinal strain (PALS) using speckle tracking echocardiography, LV end-systolic and end-diastolic volumes (LVESV, LVEDV), LA volume, MR severity by Doppler echocardiography along with BNP levels, NYHA class and 6 minute walking distance. Results One year after edge-to-edge repair there was a significant reduction of MR (74.2% had mild to moderate MR, 22.6% moderate-to-severe MR and 3.2% severe MR) and BNP levels (933±943pg/ml to 669±824pg/ml), improvement of NYHA class (3.11±0.55 to 2.0±0.6, P<0.05) and increase of the 6 minute walking distance (251±141 to 296±148m, P<0.05). LA volume was reduced (132.5±62.1ml to 115.2±57.7ml) and PALS was improved (6.89±3.47 to 7.94±5.27) (P<0.05 for all comparisons). Baseline LVGLS did not change significantly post intervention (−8.8±4.1 vs. −8.8±3.9, P=0.7) but the baseline value predicted the percentage difference in LVEDV (r=−0.61, P<0.01), LVESV (r=−0.47, P=0.03), BNP (r=0.45, P=0.04) and NYHA class (r=0.63, P<0.01). The best reverse LV remodeling was found in patients with GLS better than −10% and the trend was that the better the GLS the greater the LVEDV and LVESV reduction post-intervention. Additionally, patients with GLS between −10% and −5% had the largest improvement in BNP (P<0.05) and NYHA class (P=0.005). Conclusions Edge-to-edge repair is effective in reducing MR in patients with severe functional MR and has a positive impact in patients' clinical status at one year follow up. A preserved LVGLS seems to be a good predictor of reverse modeling and clinical improvement post intervention.

Download Full-text

Transapical Transcatheter Valve-in-Ring Implantation for Failed Mitral Valve Repair Solely Guided by 3D-Echocardiography

The Thoracic and Cardiovascular Surgeon ◽

10.1055/s-0035-1544576 ◽

2015 ◽

Vol 63 (S 01) ◽

Author(s):

M. Wilbring ◽

K. Alexiou ◽

S. Arzt ◽

U. Kappert ◽

K. Matschke

Keyword(s):

Mitral Valve ◽

Mitral Valve Repair ◽

3D Echocardiography ◽

Valve Repair ◽

Transcatheter Valve

Download Full-text

Ventricular arrhythmias in patients with functional mitral regurgitation and implantable cardiac devices: implications of mitral valve repair with Mitraclip

European Heart Journal ◽

10.1093/ehjci/ehaa946.2636 ◽

2020 ◽

Vol 41 (Supplement_2) ◽

Author(s):

T Benito Gonzalez ◽

X Freixa ◽

C Godino ◽

M Taramasso ◽

R Estevez-Loureiro ◽

...

Keyword(s):

Mitral Valve ◽

Mitral Regurgitation ◽

Mitral Valve Repair ◽

Left Ventricular ◽

Left Ventricular Ejection ◽

Functional Mitral Regurgitation ◽

Valve Repair ◽

One Year ◽

The Impact

Abstract Background Limited information has been reported regarding the impact of percutaneous mitral valve repair (PMVR) on ventricular arrhythmic (VA) burden. The aim of this study was to address the incidence of VA and appropriate antitachycardia implantable cardiac defibrillator (ICD) therapies before and after PMVR. Methods We retrospectively analyzed all consecutive patients with heart failure with reduce left ventricular ejection fraction, functional mitral regurgitation grade 3+ or 4+ and an active ICD or cardiac resynchronizer who underwent PMVR in any of the eleven recruiting centers. Only patients with complete available device VA monitoring from one-year before to one year after PMVR were included. Baseline clinical and echocardiographic characteristics were collected before PMVR and at 12-months follow-up. Results 93 patients (68.2±10.9 years old, male 88.2%) were enrolled. PMVR was successfully performed in all patients and device success at discharge was 91.4%. At 12-months follow-up, we observed a significant reduction in mitral regurgitation severity, NT-proBNP and prevalence of severe pulmonary hypertension and severe kidney disease. Patients also referred a significant improvement in NYHA functional class and showed a non-significant trend to reserve left ventricular remodeling. After PMVR a significant decrease in the incidence of non-sustained ventricular tachycardia (VT) (5.0–17.8 vs 2.7–13.5, p=0.002), sustained VT or ventricular fibrillation (0.9–2.5 vs 0.5–2.9, p=0.012) and ICD antitachycardia therapies (2.5–12.0 vs 0.9–5.0, p=0.033) were observed. Conclusion PMVR was related to a reduction in arrhythmic burden and ICD therapies in our cohort. Proportion of patients who presented ven Funding Acknowledgement Type of funding source: None

Download Full-text