Percutaneous balloon mitral valvuloplasty with shockwave lithotripsy for the treatment of calcific mitral valve stenosis.

BACKGROUND: Calcific mitral stenosis (calcific MS) presents a challenge for surgical treatment and is a contraindication for most contemporary transcatheter mitral valve replacement devices (TMVR), rendering patients with very limited therapeutic options. AIMS: This study aims to assess the clinical and hemodynamic follow-up after mitral valve lithotripsy (MVL). METHODS: All consecutive patients who underwent MVL to treat symptomatic calcific MS at St Michael's Hospital, Toronto, Canada, were included. Patients were deemed unsuitable for mitral surgery or TMVR after heart team assessment. Patients with rheumatic MS or ≥moderate mitral regurgitation (MR) were excluded. The primary endpoint was a reduction in the invasive mitral gradient by ≥50% without significant (≥moderate) MR. RESULTS: Fifteen patients underwent MVL between 2021 and 2023 with a mean age of 74 ± 9 years; 53% were female, with a mean STS score of 10% ± 0.1%. Following MVL, there was a reduction in the invasively measured mean trans-mitral gradient compared to baseline (14 mmHg vs. 6 mmHg; p < 0.05). The primary endpoint was achieved in 8 patients (53%) with no major procedural complications. At follow-up (median 90 days, IQR 58-115 days), 14 (93%) patients reported improved symptoms from New York Heart Association (NYHA) Class III-IV to NYHA Class I-II (p < 0.01) with stable echo-derived mean gradient (7.7 mmHg ± 2 mmHg vs. 8.4 mmHg ± 2.9 mmHg (p = 0.7). CONCLUSIONS: In selected patients with symptomatic inoperable calcific MS, MVL was safe and associated with significant short-term clinical and hemodynamic improvement. MVL may represent a new compassionate therapy for this challenging cohort. Further studies are needed to determine the long-term outcomes and help define the role of IVL technology in treating calcific valvular conditions.

Clinical Characteristics and Outcomes of Patients Screened for Transcatheter Tricuspid Valve Replacement: The TriACT Registry.

BACKGROUND: Transcatheter tricuspid valve replacement (TTVR) abolishes tricuspid regurgitation (TR) and has emerged as a definitive treatment for TR. OBJECTIVES: The purpose of this multicenter, observational study was to determine the clinical characteristics and short-term outcomes of patients with TR screened for TTVR. METHODS: Patients underwent TTVR screening at 7 centers on a compassionate-use basis. The primary endpoints were NYHA functional class and TR grade at 30-day follow-up. Secondary endpoints included all-cause mortality, heart failure hospitalization, technical success, and reasons for TTVR screening failure. RESULTS: A total of 149 patients (median age 79 years [Q1-Q3: 72-84 years], 54% women) underwent TTVR screening. The TTVR screening failure rate was 74%, mainly related to large tricuspid annular diameter. Patients undergoing TTVR (n = 38) had significant functional improvements (NYHA functional class I or II from 21% to 68%; P < 0.001), with TR ≤1+ in 97% at 30-day follow-up (P < 0.001 from baseline). Technical success was achieved in 91%, with no intraprocedural mortality or conversion to surgery. At 30-day follow-up, mortality was 8%, heart failure hospitalization 5%, major bleeding 18%, and reintervention 9%. Patients who failed screening for TTVR and subsequently underwent "bailout" transcatheter edge-to-edge repair (n = 26) had favorable outcomes (NYHA functional class I or II from 27% to 58%; P < 0.001), with TR ≤1+ in 43% at 30-day follow-up (P < 0.001 from baseline). CONCLUSIONS: This first real-world report of TTVR screening demonstrated a high screening failure rate, mainly related to large tricuspid annular diameter. Patients undergoing TTVR had superior TR reduction and symptom alleviation compared with bailout tricuspid transcatheter edge-to-edge repair, at the cost of greater procedural complications.

Echocardiographic Outcomes With Transcatheter Edge-to-Edge Repair for Degenerative Mitral Regurgitation in Prohibitive Surgical Risk Patients.

BACKGROUND: The CLASP IID randomized trial (Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial) demonstrated the safety and effectiveness of the PASCAL system for mitral transcatheter edge-to-edge repair (M-TEER) in patients at prohibitive surgical risk with significant symptomatic degenerative mitral regurgitation (DMR). OBJECTIVES: This study describes the echocardiographic methods and outcomes from the CLASP IID trial and analyzes baseline variables associated with residual mitral regurgitation (MR) ≤1+. METHODS: An independent echocardiographic core laboratory assessed echocardiographic parameters based on American Society of Echocardiography guidelines focusing on MR mechanism, severity, and feasibility of M-TEER. Factors associated with residual MR ≤1+ were identified using logistic regression. RESULTS: In 180 randomized patients, baseline echocardiographic parameters were well matched between the PASCAL (n = 117) and MitraClip (n = 63) groups, with flail leaflets present in 79.2% of patients. Baseline MR was 4+ in 76.4% and 3+ in 23.6% of patients. All patients achieved MR ≤2+ at discharge. The proportion of patients with MR ≤1+ was similar in both groups at discharge but diverged at 6 months, favoring PASCAL (83.7% vs 71.2%). Overall, patients with a smaller flail gap were significantly more likely to achieve MR ≤1+ at discharge (adjusted OR: 0.70; 95% CI: 0.50-0.99). Patients treated with PASCAL and those with a smaller flail gap were significantly more likely to sustain MR ≤1+ to 6 months (adjusted OR: 2.72 and 0.76; 95% CI: 1.08-6.89 and 0.60-0.98, respectively). CONCLUSIONS: The study used DMR-specific echocardiographic methodology for M-TEER reflecting current guidelines and advances in 3-dimensional echocardiography. Treatment with PASCAL and a smaller flail gap were significant factors in sustaining MR ≤1+ to 6 months. Results demonstrate that MR ≤1+ is an achievable benchmark for successful M-TEER. (Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial [CLASP IID]; NCT03706833).

Transfemoral tricuspid valve replacement and one-year outcomes: the TRISCEND study.

BACKGROUND AND AIMS: For patients with symptomatic, severe tricuspid regurgitation (TR), early results of transcatheter tricuspid valve (TV) intervention studies have shown significant improvements in functional status and quality of life associated with right-heart reverse remodelling. Longer-term follow-up is needed to confirm sustained improvements in these outcomes. METHODS: The prospective, single-arm, multicentre TRISCEND study enrolled 176 patients to evaluate the safety and performance of transcatheter TV replacement in patients with ≥moderate, symptomatic TR despite medical therapy. Major adverse events, reduction in TR grade and haemodynamic outcomes by echocardiography, and clinical, functional, and quality-of-life parameters are reported to one year. RESULTS: Enrolled patients were 71.0% female, mean age 78.7 years, 88.0% ≥ severe TR, and 75.4% New York Heart Association classes III-IV. Tricuspid regurgitation was reduced to ≤mild in 97.6% (P < .001), with increases in stroke volume (10.5 ± 16.8 mL, P < .001) and cardiac output (0.6 ± 1.2 L/min, P < .001). New York Heart Association class I or II was achieved in 93.3% (P < .001), Kansas City Cardiomyopathy Questionnaire score increased by 25.7 points (P < .001), and six-minute walk distance increased by 56.2 m (P < .001). All-cause mortality was 9.1%, and 10.2% of patients were hospitalized for heart failure. CONCLUSIONS: In an elderly, highly comorbid population with ≥moderate TR, patients receiving transfemoral EVOQUE transcatheter TV replacement had sustained TR reduction, significant increases in stroke volume and cardiac output, and high survival and low hospitalization rates with improved clinical, functional, and quality-of-life outcomes to one year. Funded by Edwards Lifesciences, TRISCEND ClinicalTrials.gov number, NCT04221490.

Is there a role for biomarkers in asymptomatic severe chronic primary mitral regurgitation?

PURPOSE OF REVIEW: Chronic primary mitral regurgitation (MR) is a common heart valve disease with a rising prevalence with the aging populations worldwide. The timing of surgical intervention in patients who have severe MR but remain asymptomatic is often debated. Herein we synthesize the latest American College of Cardiology/American Heart Association (ACC/AHA) and European Society of Cardiology/ European Association for Cardio-Thoracic Surgery (ESC/EACTS) heart valve guidelines in such patients and illustrate how circulating and/or imaging biomarkers can be used to help refine decision making algorithms. RECENT FINDINGS: The approach to decision making and strength of guideline recommendations in patients with asymptomatic stage C1 (left ventricular ejection fraction [LVEF] > 60% and left ventricular end systolic dimension [LVESD] < 40 mm) and stage C2 disease (LVEF ≤ 60% and/or LVESD ≥ 40 mm) are reviewed. While surgical intervention is clearly indicated in patients with stage C2 disease, a multifaceted approach that integrates repairability, expertise, sub-clinical evidence of left ventricular (LV) dysfunction, and patient preferences is required to identify the optimal approach to surveillance vs. surgery. The role of imaging (3D echocardiography, contrast echocardiography, left ventricular global longitudinal strain, and cardiovascular magnetic resonance imaging [CMR]) and circulating (natriuretic peptides) biomarkers in decision making is also reviewed. SUMMARY: The decision making around timing of intervention in chronic primary MR requires a personalized approach that is based on accurate assessments of severity of MR, LV dimensions, LV function, valve morphology/repairability, surgeon and center expertise, and patient wishes. Biomarkers hold promise in refining decision making.

Mitral repair with leaflet preservation versus leaflet resection and ventricular reverse remodeling from a randomized trial.

OBJECTIVES: In the Canadian Mitral Research Alliance (CAMRA) Trial CardioLink-2 leaflet resection versus preservation techniques for posterior leaflet prolapse was investigated and no difference was shown in their effect on mean mitral gradient at peak exercise at 12 months postoperatively. The purpose of this subanalysis was to evaluate the effect of the 2 strategies on left ventricular (LV) reverse remodeling after repair. METHODS: A total of 104 patients were randomized to either a leaflet resection or leaflet preservation strategy. Echocardiograms, performed at baseline (preoperative), predischarge, and 12 months postoperatively, were analyzed in a blinded fashion at a core laboratory. RESULTS: All patients underwent successful mitral repair. At discharge, 3 patients showed moderate mitral regurgitation, whereas the remainder showed mild or less regurgitation. Compared with the baseline echocardiogram, the indexed end diastolic volume was reduced at the discharge echocardiogram (P < .0001) and was further reduced at the 12-month echocardiogram (P = .01). In contrast, the indexed end systolic volume did not significantly change from baseline assessed at the predischarge echocardiogram (P = .32) but improved at 12 months postoperatively (P < .0001), resulting in a corresponding improvement in ejection fraction at 12 months (P < .0001). The type of mitral repair strategy had no significant effect on LV reverse remodeling trends. CONCLUSIONS: The mitral repair strategies used did not influence postoperative LV reverse remodeling, which occurred in stages. Although LV end diastolic dimensions recovered before discharge, improvements in LV end systolic dimension were evident 12 months after repair.

Transcatheter tricuspid valve intervention: to repair or to replace?

PURPOSE OF REVIEW: The burden of tricuspid regurgitation (TR) is high in the aging population, almost 4% in the age group over 75 have moderate or more TR. This carries a poor prognosis and an increased incidence of mortality, prolonged hospitalization, and rehospitalization in symptomatic patients with severe TR is observed. Percutaneous tricuspid valve intervention has emerged as a viable therapeutic option, with an increasingly large toolbox of both tricuspid repair and replacement devices. The optimal strategy, timing and patient selection for transcatheter intervention are yet to be determined. This review focuses on the current strengths and limitations of transcatheter tricuspid repair vs. replacement, drawing on lessons learned from surgery. RECENT FINDINGS: Early outcome studies have been published in the last 2 years for many of the new percutaneous tricuspid valve devices. We have summarized these results and compared them to surgical tricuspid valve repair and replacement. We found that surgical data shows a tendency to better outcome with tricuspid valve repair compared to replacement. For transcatheter interventions studies comparing repair and replacement are lacking but both interventions show good procedural success rates and are efficient in reducing the grade of tricuspid regurgitation. SUMMARY: Transcatheter tricuspid valve interventions offer a safe and effective alternative to tricuspid surgery or medical therapy. The decision between valve replacement and repair should be based on patient anatomy, operator experience and device availability until head-to-head comparison of different devices are available.

Transcatheter Aortic Valve Implantation for Severe Pure Aortic Regurgitation With Dedicated Devices.

Aortic regurgitation (AR) is not the most common valvular disease; however, its prevalence increases with age, with more than 2% of those aged >70 years having at least moderate AR. Once symptoms related to AR develop, the prognosis becomes poor. Transcatheter aortic valve implantation for patients with pure severe AR and at prohibitive surgical risk is occasionally performed, but remains a clinical challenge due to absence of valvular calcium, large aortic root and increased stroke volume. These issues make the positioning and deployment of transcatheter aortic valve implantation devices unpredictable, with a tendency to prosthesis embolisation or malposition. To date, the only two dedicated transcatheter valves for AR are the J-Valve (JC Medical) and the JenaValve (JenaValve Technology). Both devices have been used successfully via the transapical approach. The transfemoral experience is limited to first-in-human publications and to a clinical trial dedicated to AR, for which the completion date is still pending.

Acute Afterload Mismatch After Transcatheter Tricuspid Valve Repair.

Acute afterload mismatch and left ventricular dysfunction after mitral valve repair are well established. The impact of transcatheter tricuspid valve repair (TTVr) on right ventricular (RV) function is less clearly defined. To our knowledge, there are no reports of acute RV dysfunction after TTVr. Here we report a case of acute afterload mismatch after successful TTVr. (Level of Difficulty: Advanced.).

Transcatheter Tricuspid Valve Replacement With the EVOQUE System: 1-Year Outcomes of a Multicenter, First-in-Human Experience.

OBJECTIVES: The aim of this study was to report the midterm outcomes at 1 year in the expanded first-in-human experience with the transfemoral EVOQUE system (Edwards Lifesciences) for tricuspid regurgitation (TR). BACKGROUND: Untreated TR is associated with excess mortality and morbidity. The first-in-human experience with the EVOQUE tricuspid valve replacement system reported favorable 30-day outcomes with no mortality in a compassionate use population. METHODS: Twenty-seven patients with severe TR were treated with the EVOQUE system in a compassionate use experience at 7 centers between May 2019 and July 2020. All patients had clinical right-sided heart failure (HF) and were deemed inoperable and unsuitable for transcatheter edge-to-edge repair by the institutional heart teams. The clinical outcomes collected included all-cause mortality, symptom status, TR severity, HF hospitalization, and major adverse cardiovascular events. RESULTS: At baseline, all patients (age: 77 ± 8 years, 89% female) were at high surgical risk (mean Society of Thoracic Surgeons score: 8.6% ± 5.5%), with 89% New York Heart Association functional class III/IV. TR was predominantly functional in etiology (19/27, 70%). At 1 year, mortality was 7% (2/27), 70% of patients were New York Heart Association functional class I/II, and 96% and 87% of patients had a TR grade ≤2+ and ≤1+, respectively. Between 30 days and 1 year, 2 patients experienced HF hospitalizations, and 1 patient required a new pacemaker implantation. CONCLUSIONS: In this early, compassionate use experience, the transfemoral transcatheter EVOQUE tricuspid valve replacement system demonstrated durable efficacy, persistent improvement in symptom status, and low rates of mortality and HF hospitalizations at a 1-year follow-up. Further studies are underway to validate its efficacy.

The impact of transcatheter edge-to-edge repair on mitral valve annular geometry.

PURPOSE OF REVIEW: Mitral valve transcatheter edge-to-edge repair (TEER) is becoming increasingly common to treat severe mitral regurgitation. However, the lack of concomitant annuloplasty raises concerns regarding its durability. As a result, there is an emerging body of literature evaluating the impacts of TEER on mitral annular geometry. In this review, we summarize the most recent literature evaluating the impacts of TEER on annular geometry in the acute, intermediate and long-term. We also review the relationship between changes in annular geometry and clinical endpoints. RECENT FINDINGS: Current evidence suggests that TEER acutely induces favourable changes in mitral annular size and shape, which may persist for at least up to 1 year. Few studies suggest that TEER-induced annular remodelling is associated with positive clinical outcomes. SUMMARY: The current body of literature is sparse and limited to primarily small case series. Data from the surgical literature suggest that ringless edge-to-edge repair is associated with eventual failure. Unfortunately, few studies evaluate TEER-induced annular changes beyond the acute postprocedural phase. Future research needs to focus on and evaluate the significance of TEER-induced changes in annular dimensions in the long-term.

The Role of Intracardiac Echocardiography in Percutaneous Tricuspid Intervention: A New ICE Age.

The prevalence of severe tricuspid regurgitation in older patients is high, and the clinical relevance is perceived more and more in recent years. Many of these patients are not suitable for surgery because of their age and comorbidities. Therefore, a variety of percutaneous interventions have been developed to address this unmet need. Procedural success strongly depends on adequate imaging during the intervention. Although transesophageal echocardiography is the standard of care, imaging may be limited due to anatomic factors and adverse acoustic shadowing. In this review, we discuss the current and future role of intracardiac echocardiography in tricuspid valve interventions.