Mitral Valve Academic Research Consortium Research Articles

Cerebrovascular events after transcatheter mitral valve interventions: a systematic review and meta-analysis

ObjectiveCurrent guidelines support the use of transcatheter mitral valve interventions to treat some selected high-risk patients with significant mitral valvulopathy. As with any other interventional cardiac procedure, concerns have been...

Real-World Safety and Efficacy of Transcatheter Mitral Valve Repair With MitraClip: Thirty-Day Results From the Italian Society of Interventional Cardiology (GIse) Registry Of Transcatheter Treatment of Mitral Valve RegurgitaTiOn (GIOTTO)

BackgroundAvailable scientific evidence of transcatheter mitral valve repair with the MitraClip comes from randomized controlled trials, which showed controversial results that hardly translate into real-world practice, and from registries of relatively small sample size. AimTo collect real-world data in a multicenter, prospective, country-level registry. Methods and resultThe Italian Society of Interventional Cardiology (GIse) Registry Of Transcatheter Treatment of Mitral Valve RegurgitaTiOn (GIOTTO) is an ongoing single-arm, multicenter, prospective registry that started enrollment in February 2016. Clinical end points were defined according to the Mitral Valve Academic Research Consortium (MVARC) criteria. From February 2016 to December 2018, 1189 patients (mean age 76 ± 9.1 years) were enrolled. The main MR etiology was functional (64.9%). MVARC technical success was 96.6%. At 30-day follow-up (n = 1131), MVARC device and procedural success were 92.5% and 87% respectively, and all-cause death was 3%. The majority of patients who died at 30-day had functional MR (69.7%). Mixed etiology (OR 0.94, 95% CI 0.02–0.61) and prolonged length of stay in ICU (OR 0.97, 95% CI 0.95–0.99) were found to be negative independent predictors of device success at 30-day. The EuroSCORE II (OR 0.96, 95% CI 0.93–0.99), LVEDV-I (OR 0.99, 95% CI 0.98–0.99) and prolonged length of stay in ICU (OR 0.98, 95% CI 0.97–0.99) were negative independent factors of MVARC procedural success at 30-day. ConclusionsThe GIOTTO registry is one of the largest prospective registries available on MitraClip and shows favorable acute and 30-day safety and efficacy.

Percutaneous Transcatheter MitralValveReplacement: First-in-Human Experience With a New Transseptal System.

Severe mitral regurgitation (MR) conveys significant morbidity and mortality, and surgical repair or replacement may not be a desirable option. The purpose of this study was to evaluate the feasibility of a percutaneous transseptal transcatheter mitral valve replacement (TMVR) system. This first-in-human study was conducted between August 2017 and August 2018. The system comprises a nitinol dock, which encircles the chordae tendineae, and a balloon-expandable transcatheter heart valve. The dock and transcatheter heart valve form an ensemble, with the native mitral valve leaflets secured in between, thereby abolishing MR. Key inclusion criteria were severe symptomatic MR and high surgical risk; exclusion criteria included left ventricular ejection fraction<30% or screening suggesting unfavorable anatomy. The primary endpoint was technical success as defined by Mitral Valve Academic Research Consortium (MVARC) criteria at completion of the index procedure. The secondary endpoint was freedom from mortality, stroke, and device dysfunction (MR grade >1, mitral gradient >6mmHg, left ventricular outflow tract gradient >20mmHg) at 30days. Ten patients with severe MR of various etiologies (4 degenerative, 4 functional, and 2 mixed) were treated. The device was successfully implanted and the primary endpoint was achieved in 9 of 10 patients (90%). By transesophageal echocardiography, total MR was reduced to≤ trivial in all implanted patients, and mean transmitral gradient was 2.3 ± 1.4mmHg. A pericardial effusion occurred in 1 patient: pericardiocentesis was performed, and the device was not implanted. Median length of hospital stay was 1.5days. At 30days, there was no stroke, myocardial infarction, rehospitalization, left ventricular outflow tract obstruction, device migration, embolization, or conversion to mitral surgery. One patient had recurrent regurgitation due to a paravalvular leak, treated with a closure device. All other treated patients had≤1+ MR. No patients died. Percutaneous transvenous transseptal TMVR is feasible and safe in patients with severe MR who are at high risk for mitral valve surgery. Further evaluation is warranted.

RF87 TRANSAPICAL OFF-PUMP MITRAL VALVE REPAIR WITH PTFE CHORD IMPLANTATION

Background: NeoChord DS-1000 system (NeoChord,Inc,Minneapolis, Minnesota)is a novel minimally invasive technique of mitral valve repair (MVR)consisting in off-pump beating heart transapical implantation of artificial neo-chordae under TEE guide. Aim: To evaluate the feasibility,safety and up to 12 months outcome of the NeoChord DS-1000 system in patients with primary mitral regurgitation (MR),due to leaflet(s) prolapse or flail. Methods: From July 2015 to November 2016,34 patients with severe primary MR were selected for transapical Neochordae implantation at 3 centers in Italy. Mitral Valve Academic Research Consortium (MVARC) procedural success criteria were evaluated in all patients at 30 days,6 and 12 months. Results: Mean age was 64.7 ± 11 years,mean STS repair score was 1.06%(IQR 0.46-1.12).25 patients had isolated P2 disease and 9 patients had other or multisegment disease involvement. MR ≤moderate at 30 days was achieved in 91%of patients. In hospital mortality was 2.9% for respiratory failure,and 2 patients had undergone conversion to traditional valve surgery for functional failure and residual significant MR. At discharge 80.6% patients had MR ≤mild and 17% patients had moderate MR.2 patients experienced early device failure with recurrent sever MR and had undergone additional valve surgery (at 61 and 129 days after implantation).22 patients reached 6 month follow up,all had MR ≤moderate and showed significant improvement in NYHA functional class (P &lt; 0.005).10 patients reached 12 month follow up,all had MR ≤moderate and 90% had NYHA class I. Conclusion: Mitral valve repair with the NeoChord DS-1000 system for primary MR due to leaflet(s) prolapse or flail is feasible and safe.Its efficacy is maintained up to 1 year showing significant clinical benefit and functional class improvement.

Open atrial transcatheter mitral valve replacement in patients with mitral annular calcification

BackgroundMitral valve replacement in the setting of severe mitral annular calcification remains a surgical challenge. Transcatheter mitral valve replacement (TMVR) using an aortic balloon-expandable transcatheter heart valve is emerging as a potential treatment option for high surgical risk patients. Transseptal, transapical, or transatrial access is not always feasible, so an understanding of alternative implantation techniques is important. ObjectivesThe authors sought to present a step-by-step description of a contemporary transatrial TMVR technique using balloon-expandable aortic transcatheter heart valves. This procedure has evolved over time to address valve migration, left ventricular outflow tract obstruction, and paravalvular leak. The authors present a refined technique that has been associated with the most reproducible outcomes. MethodsA step-by-step description of the TMVR technique and outcomes of 8 patients treated using this technique are described. Baseline patient clinical and echocardiographic characteristics and 30-day post-TMVR outcomes are presented. ResultsEight patients underwent transatrial TMVR at a single institution. Five had previous cardiac surgery. Mean STS score was 8%. Technical success by MVARC (Mitral Valve Academic Research Consortium) criteria was 100%. There was zero in-hospital and 30-day mortality. Procedural success by MVARC criteria at 30 days was 100%. Paravalvular leak immediately post-implant was none or trace in 6 and mild in 1. ConclusionsThe technique described is reproducible and was associated with favorable outcomes in this early experience. It represents a useful technique for the treatment of mitral valve disease in the setting of severe annular calcification. A structured and defined implantation technique is critical to investigators as this field evolves.

Open Atrial Transcatheter Mitral Valve Replacement in Patients With Mitral Annular Calcification

BackgroundMitral valve replacement in the setting of severe mitral annular calcification remains a surgical challenge. Transcatheter mitral valve replacement (TMVR) using an aortic balloon-expandable transcatheter heart valve is emerging as a potential treatment option for high surgical risk patients. Transseptal, transapical, or transatrial access is not always feasible, so an understanding of alternative implantation techniques is important. ObjectivesThe authors sought to present a step-by-step description of a contemporary transatrial TMVR technique using balloon-expandable aortic transcatheter heart valves. This procedure has evolved over time to address valve migration, left ventricular outflow tract obstruction, and paravalvular leak. The authors present a refined technique that has been associated with the most reproducible outcomes. MethodsA step-by-step description of the TMVR technique and outcomes of 8 patients treated using this technique are described. Baseline patient clinical and echocardiographic characteristics and 30-day post-TMVR outcomes are presented. ResultsEight patients underwent transatrial TMVR at a single institution. Five had previous cardiac surgery. Mean STS score was 8%. Technical success by MVARC (Mitral Valve Academic Research Consortium) criteria was 100%. There was zero in-hospital and 30-day mortality. Procedural success by MVARC criteria at 30 days was 100%. Paravalvular leak immediately post-implant was none or trace in 6 and mild in 1. ConclusionsThe technique described is reproducible and was associated with favorable outcomes in this early experience. It represents a useful technique for the treatment of mitral valve disease in the setting of severe annular calcification. A structured and defined implantation technique is critical to investigators as this field evolves.

Transatrial implantation of a transcatheter heart valve for severe mitral annular calcification

ObjectiveTo assess the outcomes of transatrial implantation of a transcatheter heart valve (THV) for the treatment of mitral valve disease with severe mitral annular calcification (MAC). MethodsImplantation of a balloon-expandable THV was performed on cardiopulmonary bypass via left atrial exposure in patients considered at risk for left ventricular outflow tract obstruction. The anterior mitral valve leaflet was systematically resected and pledgeted sutures were placed to enhance stability and reduce paravalvular leak. ResultsTwenty-six consecutive symptomatic patients with severe MAC (mean age, 78 ± 7 years; 92% female; mean Society of Thoracic Surgeons score, 9.4 ± 4.8) were included at 6 different centers. Two patients (8%) received an Edwards Sapien XT (Edwards Lifesciences, Irvine, Calif), and 24 (92%) an Edwards Sapien 3 bioprosthesis (Edwards Lifesciences). Concomitant aortic valve replacement was performed in 11 patients. Technical success according to the criteria of the Mitral Valve Academic Research Consortium was achieved in all patients. The mean transmitral gradient decreased from 10 ± 5 to 4 ± 2 mm Hg (P < .001) with trace or mild regurgitation in all patients. An elevated mean transaortic gradient (30 mm Hg) was observed in 1 patient (4%). Five patients died during hospital stay (19%) and 2 additional between discharge and 30 days (30-day mortality: 27%). Sustained functional improvement was observed in the remaining patients. ConclusionsTransatrial implantation of a THV for the treatment of MAC is associated with high technical success despite unfavorable anatomy. In this early experience of very high surgical risk patients, 30-day all-cause mortality was high. Patients at particular risk appear to be those with chronic kidney disease requiring multiple valve surgery.

Learning curve analysis of transapical NeoChord mitral valve repair.

Transapical off-pump mitral valve intervention with neochordae implantation is a novel, minimally invasive procedure for treatment of degenerative mitral valve regurgitation. The aim of this study was to apply control charts (CUSUM curves) to monitor the performance of NeoChord repair during the initial phase of its adoption. The first 112 consecutive patients who underwent NeoChord repair at our institution between November 2013 and March 2016 were included in the analysis. Mitral Valve Academic Research Consortium criteria for 1-year patient success was utilized to determine failed procedures. Control charts had predetermined acceptable and unacceptable failure rates of 5% and 15%, respectively. The actual incidence of 1-year-patient failure was 11% (12 of 112 cases), with a cluster of failures within the first 20 cases. The CUSUM analysis demonstrated an initial learning curve; however, the upper boundary (alarm line) was never crossed. The reassurance line was first crossed after 40 procedures and performance remained stable after 49 procedures. NeoChord repair is a safe procedure, and the results are maintained through the 1-year follow-up. A relative high number of implants were required to overcome the learning curve at our institution due to the concurrent development of patient selection criteria and the technical refinement of the procedure. Future studies are needed to assess the evolution of the learning curve after the wide adoption of the procedure across European and North American centres.

Procedural and Clinical Results of the New MitraClip® NT after Percutaneous Edge to Edge Repair of Mitral Valve Regurgitation

Objective: The MitraClip® NT (MC-NT) as an updated version aim to facilitate improved maneuvering of the guide catheter and more efficient leaflet capture due to technical improvements of the delivery system and clip material. We evaluate procedural results and 12-month clinical outcomes of the new MC-NT device and compare them with the previous MitraClip® MC. Methods: We analyzed a total population of 231 patients from our Ulm - Transcatheter Mitral Valve Repair registry. To adjust for differences of baseline characteristics a propensity-score matching was performed (N=142). 30-day endpoints were analyzed in accordance with the Mitral Valve Academic Research Consortium (MVARC). For both devices 12-month clinical results (MACCE, mortality, and heart failure rehospitalization) were evaluated. Results: Acute technical success was achieved in 100% with both device groups. Device, procedure and fluoroscopy time were comparable in both treatment groups. In-hospital mortality was 2.8% in the MC-NT group and 4.2% in the MC group (p=0.65). After 30 days single-leaflet clip detachment was observed in 2.8% in the MC-NT group compared to 1.4% (p=0.56). Mitral regurgitation was reduced to the same extent in both treatment groups (1.6 ± 0.6 vs. 1.6 ± 0.5 in MC-NT group, p=0.57) with comparable rates of recurrent moderate to severe mitral regurgitation after 30 days and during 12-month follow-up. Clinical results up to 12 months and improvement of New York Heart Association functional class were comparable in both device groups (3.1 ± 0.7 to 2.1 ± 0.9 vs. 3.2 ± 0.6 to 2.1 ± 0.9, p=0.75). Conclusion: The new MitraClip® NT as an updated version presents itself as an efficacious and safe device, but all in all failed to prove superiority compared to the original MitraClip® in terms of procedural and clinical results.

Bleeding Complications After Percutaneous Mitral Valve Repair With the MitraClip

Bleeding after cardiac surgery or cardiovascular interventions is associated with worse patient outcome. Only very limited data are available on the subject of bleeding after percutaneous edge-to-edge mitral valve repair (PMVR). We performed a single center analysis including 347 consecutive patients who underwent PMVR. Bleeding was defined according to the Mitral Valve Academic Research Consortium (MVARC) end point definition. The incidence of MVARC bleeding was 21.6% (n = 75), whereas major MVARC bleeding (hemoglobin decrease ≥3 g/dl) occurred in 7.4% (n = 26). Only 33.3% of all bleeding cases were access site-related. In multivariate regression analyses, independent predictors of MVARC bleeding were the presence of coronary artery disease (2.809, 95% CI 1.123 to 7.022, p = 0.027) and intervention duration (1.010, 95% CI 1.002 to 1.018, p = 0.010). Patients experiencing MVARC bleeding had longer hospital stays (p = 0.026); however, neither major nor extensive MVARC bleeding was associated with increased 30-day or 1-year mortality. A decrease in hemoglobin levels ≥3 g/dl without clinically visible bleeding sign-not considered in the MVARC bleeding definition-occurred in 9.5% of patients. A hemoglobin decrease of ≥4 g/dl had a strong association with worse survival in those patients with obscure bleeding. In conclusion, these data show a relevant incidence of bleeding after PMVR. In contrast to other cardiovascular interventions, the majority of bleedings were not access site-related. Particularly, patients with obscure bleeding, which are not included in the MVARC end point definitions, had worse outcomes and should therefore be considered for a more intensive workup.

Transcatheter Mitral Valve Replacement for Degenerated Bioprosthetic Valves and Failed Annuloplasty Rings

BackgroundLimited data exist regarding transcatheter mitral valve replacement (TMVR) for patients with failed mitral valve replacement and repair. ObjectivesThis study sought to evaluate the outcomes of TMVR in patients with failed mitral bioprosthetic valves (valve-in-valve [ViV]) and annuloplasty rings (valve-in-ring [ViR]). MethodsFrom the TMVR multicenter registry, procedural and clinical outcomes of mitral ViV and ViR were compared according to Mitral Valve Academic Research Consortium criteria. ResultsA total of 248 patients with mean Society of Thoracic Surgeons score of 8.9 ± 6.8% underwent TMVR. Transseptal access and the balloon-expandable valve were used in 33.1% and 89.9%, respectively. Compared with 176 patients undergoing ViV, 72 patients undergoing ViR had lower left ventricular ejection fraction (45.6 ± 17.4% vs. 55.3 ± 11.1%; p < 0.001). Overall technical and device success rates were acceptable, at 92.3% and 85.5%, respectively. However, compared with the ViV group, the ViR group had lower technical success (83.3% vs. 96.0%; p = 0.001) due to more frequent second valve implantation (11.1% vs. 2.8%; p = 0.008), and lower device success (76.4% vs. 89.2%; p = 0.009) due to more frequent reintervention (16.7% vs. 7.4%; p = 0.03). Mean mitral valve gradients were similar between groups (6.4 ± 2.3 mm Hg vs. 5.8 ± 2.7 mm Hg; p = 0.17), whereas the ViR group had more frequent post-procedural mitral regurgitation moderate or higher (19.4% vs. 6.8%; p = 0.003). Furthermore, the ViR group had more frequent life-threatening bleeding (8.3% vs. 2.3%; p = 0.03), acute kidney injury (11.1% vs. 4.0%; p = 0.03), and subsequent lower procedural success (58.3% vs. 79.5%; p = 0.001). The 1-year all-cause mortality rate was significantly higher in the ViR group compared with the ViV group (28.7% vs. 12.6%; log-rank test, p = 0.01). On multivariable analysis, failed annuloplasty ring was independently associated with all-cause mortality (hazard ratio: 2.70; 95% confidence interval: 1.34 to 5.43; p = 0.005). ConclusionsThe TMVR procedure provided acceptable outcomes in high-risk patients with degenerated bioprostheses or failed annuloplasty rings, but mitral ViR was associated with higher rates of procedural complications and mid-term mortality compared with mitral ViV.

Compassionate use of the PASCAL transcatheter mitral valve repair system for patients with severe mitral regurgitation: a multicentre, prospective, observational, first-in-man study

Severe mitral regurgitation is associated with impaired prognosis if left untreated. Using the devices currently available, transcatheter mitral valve repair (TMVr) remains challenging in complex anatomical situations. We report the procedural and 30-day results of the first-in-man study of the Edwards PASCAL TMVr system. In this multicentre, prospective, observational, first-in-man study, we collected data from seven tertiary care hospitals in five countries that had a compassionate use programme in which patients underwent transcatheter mitral valve repair using the Edwards PASCAL TMVr system. Eligible patients were those with symptomatic, severe functional, degenerative, or mixed mitral regurgitation deemed at high risk or inoperable. Safety and efficacy of the procedure were prospectively assessed at device implantation, discharge, and 30 days after device implantation. The key study endpoints were technical success assessed at the end of the procedure and device success 30 days after implantation using the Mitral Valve Academic Research Consortium definitions. Between Sept 1, 2016, and March 31, 2017, 23 patients (median age 75 years [IQR 61-82]) had treatment for moderate-to-severe (grade 3+) or severe (grade 4+) mitral regurgitation using the Edwards PASCAL TMVr system. At baseline, the median EuroScore II score was 7·1% (IQR 3·6-12·8) and the median Society of Thoracic Surgeons predicted risk of mortality for mitral valve repair was 4·8% (2·1-9·0) and 6·8% (2·9-10·1) for mitral valve replacement. 22 (96%) of 23 patients were New York Heart Association (NYHA) class III or IV at baseline. The implantation of at least one device was successful in all patients, resulting in procedural residual mitral regurgitation of grade 2+ or less in 22 (96%) patients. Six (26%) of 23 patients had two implants. Periprocedural complications occurred in two (9%) of 23 patients (one minor bleeding event and one transient ischaemic attack). Despite the anatomical complexity of mitral regurgitation in the patients in this compassionate use cohort, technical success was achieved in 22 (96%) of 23 patients, and device success at 30 days was achieved in 18 (78%) patients. Three patients (13%) died during the 30 day follow-up. 19 (95%) of 20 patients alive 30 days after implantation were NYHA class I or II. This study establishes feasibility of the Edwards PASCAL TMVr system with a high rate of technical success and reduction of mitral regurgitation severity. Further research is needed on procedural and long-term clinical outcomes. None.

Current MitraClip experience, safety and feasibility in the Netherlands.

PurposeData on MitraClip procedural safety and efficacy in the Netherlands are scarce. We aim to provide an overview of the Dutch MitraClip experience.MethodsWe pooled anonymised demographic and procedural data of 1151 consecutive MitraClip patients, from 13 Dutch hospitals. Data was collected by product specialists in collaboration with local operators. Effect on mitral regurgitation was intra-procedurally assessed by transoesophageal echocardiography. Technical success and device success were defined according to modified definitions of the Mitral Valve Academic Research Consortium (MVARC).ResultsMedian age was 76 (interquartile range 69–82) years and 59% were males. Patients presented with ≥moderate mitral regurgitation and a predominance of functional mitral regurgitation (72%). Overall, 611 (53%) patients were treated with one Clip, 486 (42%) with ≥2 Clips and 54 (5%) received no Clip. The number of patients with ≥2 Clips increased from 22% in 2009 to 52% in 2016. Device success and technical success were 91 and 95%, respectively, and were consistent over the years. Significant reduction of mitral regurgitation by MitraClip was achieved in 94% of patients and was observed more often in patients with functional mitral regurgitation (95% vs. 91%, p = 0.025). Device time declined from 145 min in 2009 to 55 min in 2016.ConclusionMitraClip experience in the Netherlands is growing with excellent technical success and device success. Over the years, device time decreased and more patients were treated with ≥2 Clips.

Feasibility and predictors of early discharge after percutaneous edge-to-edge mitral valve repair

BackgroundPercutaneous edge-to-edge mitral valve repair (PMVR) recently emerged as an effective treatment modality for patients with severe mitral regurgitation (MR). Length of postprocedural hospital stay may represent a modifiable cost...

Transcatheter implantation of aortic valve prostheses into degenerated mitral valve bioprostheses and failed annuloplasty rings: outcomes according to access route and Mitral Valve Academic Research Consortium (MVARC) criteria.

The study sought to assess outcomes of transcatheter mitral valve-in-valve implantation (TMVIV) for degenerated bioprostheses and transcatheter mitral valve-in-ring implantation (TMVIR) for failed annuloplasty rings according to access route and the Mitral Valve Academic Research Consortium (MVARC) criteria. Twenty-four patients (72±13 years; eight men [33%]) underwent TMVIV (n=14) or TMVIR (n=10) for mitral regurgitation (MR; n=17) or stenosis (n=7) using balloon-expandable bioprostheses. Transapical (TA) access was chosen in 13, and transseptal (TS) access in 11 patients. MVARC technical success, device success and procedural success were 95.8%, 41.7% and 33.3%, respectively, with no differences between access routes. Cardiac output (CO) increased significantly by 1.1±0.8 l/min in TS patients, but not in TA patients (ΔCO=0.0±0.5 l/min; p=0.0051). Overall three-year survival was estimated at 57.6% (95% confidence interval: 33.9-81.3; TA 35.5% [5.2-65.9]; TS 90.9% [73.9-100]). Survival up to four years according to vascular access showed a clear benefit in patients treated transseptally (p=0.045). Regardless of the access route, TMVIV/TMVIR was associated with high technical success yet impaired device success. In the long term, TA access had a significant adverse impact on survival.

TCT-636 Percutaneous mitral valve repair in primary compared with secondary mitral valve regurgitation using the Mitral Valve Academic Research Consortium criteria

TCT-636 Percutaneous mitral valve repair in primary compared with secondary mitral valve regurgitation using the Mitral Valve Academic Research Consortium criteria

Transcatheter Mitral Valve Replacement inNativeMitral Valve Disease With SevereMitralAnnular Calcification: Results From the First Multicenter Global Registry.

This study sought to evaluate the outcomes of the early experience of transcatheter mitral valve replacement (TMVR) with balloon-expandable valves in patients with severe mitral annular calcification (MAC) and reports the first large series from a multicenter global registry. The risk of surgical mitral valve replacement in patients with severe MAC is high. There are isolated reports of successful TMVR with balloon-expandable valves in this patient population. We performed a multicenter retrospective review of clinical outcomes of patients with severe MAC undergoing TMVR. From September 2012 to July of 2015, 64 patients in 32 centers underwent TMVR with compassionate use of balloon-expandable valves. Mean age was 73 ± 13 years, 66% were female, and mean Society of Thoracic Surgeons score was 14.4 ± 9.5%. The mean mitral gradient was 11.45 ± 4.4 mmHg and the mean mitral area was 1.18 ± 0.5 cm(2). SAPIEN valves (Edwards Lifesciences, Irvine, California) were used in 7.8%, SAPIEN XT in 59.4%, SAPIEN 3 in 28.1%, and Inovare (Braile Biomedica, Brazil) in 4.7%. Access was transatrial in 15.6%, transapical in 43.8%, and transseptal in 40.6%. Technical success according to Mitral Valve Academic Research Consortium criteria was achieved in 46 (72%) patients, primarily limited by the need for a second valve in 11 (17.2%). Six (9.3%) had left ventricular tract obstruction with hemodynamic compromise. Mean mitral gradient post-procedure was 4 ± 2.2 mmHg, paravalvular regurgitation was mild or absent in all. Thirty-day all-cause mortality was 29.7% (cardiovascular= 12.5% and noncardiac= 17.2%); 84% of the survivors with follow-up data available were in New York Heart Association functional class I or II at 30 days (n= 25). TMVR with balloon-expandable valves in patients with severe MAC is feasible but may be associated with significant adverse events. This strategy might be an alternative for selected high-risk patients with limited treatment options.

Mitraclip therapy in patients with functional mitral regurgitation and missing leaflet coaptation: is it still an exclusion criterion?

The aim of this study was to investigate the feasibility, safety, and efficacy of Mitraclip therapy in patients with functional mitral regurgitation (MR) and missing leaflet coaptation (MLC). Out of 62 consecutive patients with functional MR undergoing Mitraclip implantation, 22 had MLC defined as the presence of a 'gap' between two mitral leaflets or insufficient coaptation length (<2 mm), according to the EVEREST II criterion. Compared with the control group, the MLC population had a significantly higher effective regurgitant orifice area (0.67 ± 0.31 vs. 0.41 ± 0.13 cm2 ; P = 0.019) and sphericity index (0.80 ± 0.11 vs. 0.71 ± 0.10; P = 0.003). MLC patients were treated with pharmacological/mechanical support in order to improve leaflet coaptation and to prepare the mitral valve apparatus for grasping. Implantation of >1 clip and device time were comparable in patients with and without MLC (61.9% vs. 47.5%; P = 0.284 and 101 ± 39 vs. 108 ± 69 min; P = 0.646, respectively). No significant differences were observed between the two cohorts in technical success (95.5% vs. 97.5%, P = 0.667), 30-day device success (85.7% vs. 78.9%; P = 0.525), procedural success (81.8% vs. 75%; P = 0.842), and 1-year patient success (52.9% vs. 44.1%; P = 0.261), defined according to the MVARC (Mitral Valve Academic Research Consortium) criteria. The long-term composite endpoint of cardiovascular death and heart failure hospitalization was similar in the two groups (49.9% vs. 44.4%; P = 0.348). A significant improvement of MR and NYHA functional class and a lack of reverse remodelling were observed up to 2 years in both arms. The Mitraclip procedure could be extended to patients with functional MR who do not fulfil the coaptation length EVEREST II criterion and who would otherwise be excluded from this treatment.

Clinical trial design principles and endpoint definitions for transcatheter mitral valve repair and replacement: part 1: clinical trial design principles: A consensus document from the mitral valve academic research consortium.

Mitral regurgitation (MR) is one of the most prevalent valve disorders and has numerous aetiologies, including primary (organic) MR, due to underlying degenerative/structural mitral valve (MV) pathology, and secondary (functional) MR, which is principally caused by global or regional left ventricular remodelling and/or severe left atrial dilation. Diagnosis and optimal management of MR requires integration of valve disease and heart failure specialists, MV cardiac surgeons, interventional cardiologists with expertise in structural heart disease, and imaging experts. The introduction of transcatheter MV therapies has highlighted the need for a consensus approach to pragmatic clinical trial design and uniform endpoint definitions to evaluate outcomes in patients with MR. The Mitral Valve Academic Research Consortium is a collaboration between leading academic research organizations and physician-scientists specializing in MV disease from the United States and Europe. Three in-person meetings were held in Virginia and New York during which 44 heart failure, valve, and imaging experts, MV surgeons and interventional cardiologists, clinical trial specialists and statisticians, and representatives from the U.S. Food and Drug Administration considered all aspects of MV pathophysiology, prognosis, and therapies, culminating in a 2-part document describing consensus recommendations for clinical trial design (Part 1) and endpoint definitions (Part 2) to guide evaluation of transcatheter and surgical therapies for MR. The adoption of these recommendations will afford robustness and consistency in the comparative effectiveness evaluation of new devices and approaches to treat MR. These principles may be useful for regulatory assessment of new transcatheter MV devices, as well as for monitoring local and regional outcomes to guide quality improvement initiatives.

Clinical trial design principles and endpoint definitions for transcatheter mitral valve repair and replacement: part 2: endpoint definitions: A consensus document from the Mitral Valve Academic Research Consortium.

Mitral regurgitation (MR) is one of the most prevalent valve disorders and has numerous aetiologies, including primary (organic) MR, due to underlying degenerative/structural mitral valve (MV) pathology, and secondary (functional) MR, which is principally caused by global or regional left ventricular remodelling and/or severe left atrial dilation. Diagnosis and optimal management of MR requires integration of valve disease and heart failure specialists, MV cardiac surgeons, interventional cardiologists with expertise in structural heart disease, and imaging experts. The introduction of trans- catheter MV therapies has highlighted the need for a consensus approach to pragmatic clinical trial design and uniform endpoint definitions to evaluate outcomes in patients with MR. The Mitral Valve Academic Research Consortium is a collaboration between leading academic research organizations and physician-scientists specializing in MV disease from the United States and Europe. Three in-person meetings were held in Virginia and New York during which 44 heart failure, valve, and imaging experts, MV surgeons and interventional cardiologists, clinical trial specialists and statisticians, and representatives from the U.S. Food and Drug Administration considered all aspects of MV pathophysiology, prognosis, and therapies, culminating in a 2-part document describing consensus recommendations for clinical trial design (Part 1) and endpoint definitions (Part 2) to guide evaluation of transcatheter and surgical therapies for MR. The adoption of these recommendations will afford robustness and consistency in the comparative effectiveness evaluation of new devices and approaches to treat MR. These principles may be useful for regulatory assessment of new transcatheter MV devices, as well as for monitoring local and regional outcomes to guide quality improvement initiatives.