Integrative echocardiographic assessment of patients with secondary mitral regurgitation undergoing transcatheter edge-to-edge repair.

OBJECTIVES: To investigate whether the integrative echocardiographic criteria used in the cardiovascular outcomes assessment of the mitraclip percutaneous therapy (COAPT) for heart failure patients with functional mitral regurgitation study predict outcomes after edge-to-edge trancatheter mitral valve repair (TMVr) for the treatment of secondary mitral regurgitation (SMR). BACKGROUND: Two randomized controlled trials comparing TMVr to medical treatment reported conflicting findings. Differences in patient selection criteria may have contributed to these diverging results. METHODS: Patients undergoing TMVr were stratified following the integrative COAPT echocardiographic criteria in noneligible and eligible patients who were further classified into three tiers according to effective regurgitant orifice (EROA) (Tier 1: EROA ≥ 0.3cm2 ; Tier 2: EROA 0.2cm2 and 0.29cm2 ; Tier 3: EROA<0.2cm2 ) combined with several other severity criteria. We assessed between group differences in all-cause mortality, successful SMR reduction, and symptom relief from baseline to 2-year follow-up. RESULTS: Between March 2011 and March 2018, 138 patients (mean age 75 years) satisfying the inclusion criteria underwent TMVr for treatment of symptomatic SMR. The mean EROA area was 0.35 ± 0.17 mm2 . Ten patients (7%) died within 30 days, 29 (21%) within 12 months, and 41 (30%) within 2 years. After stratification according to the COAPT echocardiographic criteria that were fulfilled in 72% of the studied population, Tier 2 patients (45%), as well as noneligible patients (38%) had a higher mortality rate compared to those in Tier 1 (19%). CONCLUSIONS: SMR patients stratified into tiers according to the COAPT integrative echocardiographic criteria have diverging prognostic and symptomatic benefit after edge-to-edge TMVr.

An unusual cause of recurrent mitral regurgitation after percutaneous mitral valve repair.

Recurrent flail leaflet represents an infrequent cause of recurrent mitral regurgitation after MitraClip. This report presents a case of recurrent severe MR due to a ruptured chorda tendineae after edge-to-edge repair.

The PASCAL Device-Early Experience with a Leaflet Approximation Device: What Are the Benefits/Limitations Compared with the MitraClip?

PURPOSE OF REVIEW: This review article describes the technical features of the novel Edwards PASCAL transcatheter valve repair system as well as the evidence accumulated so far. RECENT FINDINGS: Transcatheter mitral and tricuspid valve leaflet approximation enable treatment of patients with mitral and tricuspid regurgitation who are not eligible for surgery. The PASCAL device offers an alternative that may allow to overcome some of the limitations of previous systems and open the path for an approach adapted to individual patient's anatomy. Early data show similar safety and efficacy compared with the Abbott MitraClip system. The PASCAL system is a valuable addition to the armamentarium of transcatheter mitral and tricuspid valve repair devices. Randomized head-to-head comparisons and long-term data are needed to confirm the promising results observed so far.

Management and Outcome of Failed Percutaneous Edge-to-Edge Mitral Valve Plasty: Insight From an International Registry.

OBJECTIVES: This study evaluated the incidence, management, and outcome of patients who experienced MitraClip (Abbott Vascular) failure secondary to loss of leaflet insertion (LLI), single leaflet detachment (SLD), or embolization. BACKGROUND: Transcatheter edge-to-edge repair with MitraClip is an established therapy for the treatment of mitral regurgitation (MR), but no data exist regarding the prevalence and outcome according to the mode of clip failure. METHODS: Between January 2009 and December 2020, we retrospectively screened 4,294 procedures of MitraClip performed in 19 centers. LLI was defined as damage to the leaflet where the MitraClip was attached, SLD as demonstration of complete separation between the device and a single leaflet tissue, and clip embolization as loss of contact between MitraClip and both leaflets. RESULTS: A total of 147 cases of MitraClip failure were detected (overall incidence = 3.5%), and these were secondary to LLI or SLD in 47 (31.9%) and 99 (67.3%) cases, respectively, whereas in 1 (0.8%) case clip embolization was observed. MitraClip failure occurred in 67 (45.5%) patients with functional MR, in 64 (43.5%) patients with degenerative MR, and 16 (10.8%) with mixed etiology. Although the majority of MitraClip failures were detected before discharge (47 intraprocedural and 42 in the hospital), up to 39.5% of cases were diagnosed at follow-up. In total, 80 (54.4%) subjects underwent a redo procedure, either percutaneously with MitraClip (n = 51, 34.7%) or surgically (n = 36, 24.5%) including 4 cases of surgical conversion of the index procedure and 7 cases of bailout surgery after unsuccessful redo MitraClip. After a median follow-up of 163 days (IQR: 22-720 days), 50 (43.9%) subjects presented moderate to severe MR, and 43 (29.3%) patients died. An up-front redo MitraClip strategy was associated with a trend toward a reduced rate of death at follow-up vs surgical or conservative management (P = 0.067), whereas postprocedural acute kidney injury, age, and moderate to severe tricuspid regurgitation were independent predictors of death. CONCLUSIONS: MitraClip failure secondary to LLI and SLD is not a rare phenomenon and may occur during and also beyond hospitalization. Redo MitraClip strategy demonstrates a trend toward a reduced risk of death compared with bailout surgery and conservative management. A third of those patients remained with more than moderate MR and had substantial mortality at the intermediate-term follow-up.

Clinical impact of mitral calcium volume in patients undergoing transcatheter aortic valve implantation.

BACKGROUND: Mitral annular calcification (MAC) has been associated with mitral valve (MV) disease and cardiovascular events in patients undergoing transcatheter aortic valve implantation (TAVI). We aimed to investigate the incidence and impact of mitral calcium volume (MCV) quantified by multidetector computed tomography (MDCT) on MV function and clinical outcomes after TAVI. METHODS: Consecutive patients with exploitable echocardiography and MDCT performed during TAVI screening were enrolled in this retrospective analysis. Mitral calcium was assessed visually and measured using a semi-automatic tool developed for the aortic valve in an off-label fashion. RESULTS: MCV >0 mm3 was found in 65% of the 875 included patients. Patients with calcification were older (82 ± 6 versus 81 ± 7; P = 0.002) and had high prevalence of renal dysfunction (69% versus 61%; P = 0.017) and mitral stenosis (25% versus 4%, P < 0.001). MCV correlated well with visual MAC severity (r = 0.94; P < 0.001), but showed a greater predictive value for mitral stenosis (AUC = 0.804 vs. 0.780, P = 0.012) , while it was not a predictor of mitral regurgitation (AUC = 0.514). Correlations were found between MCV and echocardiographic parameters including MV area, mean transmitral gradient, and pressure half-time (P < 0.001 for all). MCV did not impact on cardiovascular mortality or new permanent pacemaker implantation after TAVI. CONCLUSIONS: Calcification of the mitral apparatus is common in TAVI candidates and results in mitral stenosis in 25% of the patients. Increasing MCV predicts mitral stenosis, but had no impact on clinical outcomes following TAVI. CLINICAL TRIAL REGISTRATION: NCT01368250.

Mitral and Tricuspid Transcatheter Interventions Current Indications and Future Directions.

Valvular heart disease is responsible for a high rate of morbidity and mortality, especially in the elderly population. With the emergence of new transcatheter treatment options, the therapeutic spectrum for patients with valvular heart disease has considerably expanded during the past years. Interventional treatment of the mitral and tricuspid valve requires an individualized and versatile approach owing to the different etiologies of valvular dysfunction and the complex anatomy of the atrioventricular valves. This article aims to review recent developments, summarize the evidence, indications and limitations of the available systems, and provide a glimpse into the future of transcatheter interventions for the treatment of mitral and tricuspid valve disease.

[Transcatheter Treatment of Severe Tricuspid Regurgitation]. / Transkatheter-Verfahren bei schwerer Trikuspidalklappeninsuffizienz.

Transcatheter Treatment of Severe Tricuspid Regurgitation Abstract. Severe tricuspid regurgitation can lead to increased morbidity and mortality due to clinical symptoms and impairment of organ function. With the emergence of new interventional treatment options, the once neglected tricuspid valve is receiving increased attention. The following article intends to provide an overview of the causes, diagnostic modalities, and therapeutic options of severe tricuspid regurgitation.

Imaging and Patient Selection for Transcatheter Tricuspid Valve Interventions.

With the emergence of transcatheter solutions for the treatment of tricuspid regurgitation (TR) increased attention has been directed to the once neglected tricuspid valve (TV) complex. Recent studies have highlighted new aspects of valve anatomy and TR etiology. The assessment of valve morphology along with quantification of regurgitation severity and RV function pose several challenges to cardiac imagers guiding transcatheter valve procedures. This review article aims to give an overview over the role of modern imaging modalities during assessment and treatment of the TV.

Impact of Massive or Torrential Tricuspid Regurgitation in Patients Undergoing Transcatheter Tricuspid Valve Intervention.

OBJECTIVES: The aim of this study was to assess the clinical outcome of baseline massive or torrential tricuspid regurgitation (TR) after transcatheter tricuspid valve intervention (TTVI). BACKGROUND: The use of TTVI to treat symptomatic severe TR has been increasing rapidly, but little is known regarding the impact of massive or torrential TR beyond severe TR. METHODS: The study population comprised 333 patients with significant symptomatic TR from the TriValve Registry who underwent TTVI. Mid-term outcomes after TTVI were assessed according to the presence of massive or torrential TR, defined as vena contracta width ≥14 mm. Procedural success was defined as patient survival after successful device implantation and delivery system retrieval, with residual TR ≤2+. The primary endpoint comprised survival rate and freedom from rehospitalization for heart failure, survival rate, and rehospitalization at 1 year. RESULTS: Baseline massive or torrential TR and severe TR were observed in 154 patients (46.2%) and 179 patients (53.8%), respectively. Patients with massive or torrential TR had a higher prevalence of ascites than those with severe TR (27.3% vs. 20.4%, respectively; p = 0.15) and demonstrated a similar procedural success rate (83.2% vs. 77.3%, respectively; p = 0.21). The incidence of peri-procedural adverse events was low, with no significant between-group differences. Freedom from the composite endpoint was significantly lower in patients with massive or torrential TR than in those with severe TR, which was significantly associated with an increased risk for 1-year death of any cause or rehospitalization for heart failure (adjusted hazard ratio: 1.91; 95% confidence interval: 1.10 to 3.34; p = 0.022). Freedom from the composite endpoint was significantly higher in patients with massive or torrential TR when procedural success was achieved (69.9% vs. 54.2%, p = 0.048). CONCLUSIONS: Baseline massive or torrential TR is associated with an increased risk for all-cause mortality and rehospitalization for heart failure 1 year after TTVI. Procedural success is related to better outcomes, even in the presence of baseline massive or torrential TR. (International Multisite Transcatheter Tricuspid Valve Therapies Registry [TriValve]; NCT03416166).

Outcomes of TTVI in Patients With Pacemaker or Defibrillator Leads: Data From the TriValve Registry.

OBJECTIVES: The interference of a transtricuspid cardiac implantable electronic device (CIED) lead with tricuspid valve function may contribute to the mechanism of tricuspid regurgitation (TR) and poses specific therapeutic challenges during transcatheter tricuspid valve intervention (TTVI). Feasibility and efficacy of TTVI in presence of a CIED is unclear. BACKGROUND: Feasibility of TTVI in presence of a CIED lead has never been proven on a large basis. METHODS: The study population consisted of 470 patients with severe symptomatic TR from the TriValve (Transcatheter Tricuspid Valve Therapies) registry who underwent TTVI at 21 centers between 2015 and 2018. The association of CIED and outcomes were assessed. RESULTS: Pre-procedural CIED was present in 121 of 470 (25.7%) patients. The most frequent location of the CIED lead was the posteroseptal commissure (44.0%). As compared with patients without a transvalvular lead (no-CIED group), patients having a tricuspid lead (CIED group) were more symptomatic (New York Heart Association functional class III to IV in 95.9% vs. 92.3%; p = 0.02) and more frequently had previous episodes of right heart failure (87.8% vs. 69.0%; p = 0.002). No-CIED patients had more severe TR (effective regurgitant orifice area 0.7 ± 0.6 cm2 vs. 0.6 ± 0.3 cm2; p = 0.02), but significantly better right ventricular function (tricuspid annular plane systolic excursion = 16.7 ± 5.0 mm vs. 15.9 ± 4.0 mm; p = 0.04). Overall, 373 patients (79%) were treated with the MitraClip (Abbott Vascular, Santa Clara, California) (106 [87.0%] in the CIED group). Among them, 154 (33%) patients had concomitant transcatheter mitral repair (55 [46.0%] in the CIED group, all MitraClip). Procedural success was achieved in 80.0% of no-CIED patients and in 78.6% of CIED patients (p = 0.74), with an in-hospital mortality of 2.9% and 3.7%, respectively (p = 0.70). At 30 days, residual TR ≤2+ was observed in 70.8% of no-CIED and in 73.7% of CIED patients (p = 0.6). Symptomatic improvement was observed in both groups (NYHA functional class I to II at 30 days: 66.0% vs. 65.0%; p = 0.30). Survival at 12 months was 80.7 ± 3.0% in the no-CIED patients and 73.6 ± 5.0% in the CIED patients (p = 0.30). CONCLUSIONS: TTVI is feasible in selected patients with CIED leads and acute procedural success and short-term clinical outcomes are comparable to those observed in patients without a transtricuspid lead.

Transcatheter Aortic Valve Implantation Current Indications and Future Directions.

Degenerative heart valve disease is associated with significant morbidity and mortality and healthcare expenditures. Transcatheter heart valve repair and replacement has introduced a fundamental change in the therapeutic management and transcatheter aortic valve replacement (TAVR) has gained substantial popularity. Favorable results from randomized trials and large real world registries lead to TAVR being considered a standard procedure with high rates of procedural success and low rates of peri-procedural complications. This article aims to review the past evolution, summarize the available evidence, discuss current indications and limitations and venture a glimpse into the future of percutaneous interventions for aortic valve disease.

Percutaneous Mitral Edge-to-Edge Repair: State of the Art and a Glimpse to the Future.

Patients with severe symptomatic mitral regurgitation have a poor prognosis if left untreated. In those patients who are not eligible for mitral valve surgery, percutaneous edge-to-edge repair may improve clinical outcomes. Recent clinical trials have added to our knowledge and provide interesting insights into the management of such patients. With an increasingly aging global population, these technologies are likely to represent an important treatment option. This mini-review will examine the technology, the evidence and the latest developments in percutaneous mitral edge-to-edge repair.

Prosthesis-Patient Mismatch Following Transcatheter Aortic Valve Replacement With Supra-Annular and Intra-Annular Prostheses.

OBJECTIVES: This study sought to compare the frequency of prosthesis-patient mismatch (PPM) with self-expandable valves (SEV) to balloon-expandable valves (BEV). BACKGROUND: PPM has been associated with increased mortality after transcatheter aortic valve replacement. Data on the frequency of PPM as a function of supra-annular or intra-annular position of transcatheter heart valves are insufficient. METHODS: A total of 757 patients treated with SEV (CoreValve, Evolut R) and BEV (SAPIEN THV/XT/3) were enrolled in the present analysis between August 2007 and June 2017. PPM was classified based on discharge prosthetic effective orifice area indexed to body surface area (BSA) as severe (<0.65 cm2/m2) or moderate (0.65 to 0.85 cm2/m2) in the general population, and as severe (<0.60 cm2/m2) or moderate (0.60 to 0.90 cm2/m2) in the obese population (body mass index ≥30 kg/m2). RESULTS: Propensity score matching resulted in 224 matched pairs. At discharge, SEV were associated with a lower incidence of PPM compared with BEV (PPM, 33.5% vs. 46.9%; p = 0.004; severe PPM, 6.7% vs. 15.6%; p = 0.003). The lower frequency of severe PPM in SEV was observed even in patients with larger annulus. Although patients with BSA >1.83 m2 had a significantly lower incidence of PPM with SEV compared with BEV, there was no significant difference in patients with BSA ≤1.83 m2. We found no impact of PPM on cardiovascular mortality or New York Heart Association functional class at 1 year. CONCLUSIONS: SEV were associated with a lower frequency of PPM compared with BEV irrespective of annulus area. The difference was mainly driven by larger patients with BSA >1.83 m2.