Transcatheter tricuspid valve intervention in the presence of a cardiac implantable electronic device; state of the art review.

A large proportion of patients referred for transcatheter tricuspid valve intervention (TTVI) will have the presence of a cardiac implantable electronic device (CIED). In such patients, surgical correction of tricuspid regurgitation (TR) is associated with high rates of morbidity and mortality. Transvenous lead extraction (TLE) could potentially ameliorate CIED-induced TR; however, it carries inherent risks and frequently does not result in TR improvement. As multiple TTVI devices are in trial to gain regulatory approval, understanding which therapy is most appropriate among patients with a CIED is essential. This review centers on the nonsurgical treatment, including TLE and transcatheter tricuspid valve repair and replacement options, aimed at enhancing outcomes in patients with TR who also have concurrent CIEDs.

Comparative analysis of MitraClip/TriClip and PASCAL in transcatheter tricuspid valve repair for tricuspid regurgitation: a systematic review and meta-analysis.

BACKGROUND: The edge-to-edge transcatheter tricuspid valve repair (TTVR) has emerged as a promising technique for the treatment of tricuspid regurgitation (TR). Despite its potential, comparative data on the performance of the novel edge-to-edge devices-MitraClip, PASCAL, and TriClip-remain controversial. In this study, we aim to evaluate the safety and efficacy of these devices in treating TR. METHODS: Five databases were systematically searched up to May 2023, with an updated search conducted in May 2024. Only original studies were included in the analysis and were critically evaluated using an adapted version of the Newcastle-Ottawa Scale (NOS) for observational cohort studies and the Cochrane Risk of Bias (ROB) tool for randomized controlled trials. RESULTS: The database search yielded 2239 studies, out of which 21 studies were included in the final analysis. These studies encompassed a total of 2178 patients who underwent TTVR using either the MitraClip, TriClip, or PASCAL devices. The risk of bias across these studies ranged from moderate to high. No significant differences were found among the three devices in terms of effective regurgitant orifice area (EROA) and tricuspid regurgitant volume. However, TriClip demonstrated statistically superior efficacy in reducing vena contracta compared to both MitraClip and PASCAL (P < 0.01) [TriClip: (MD = -7.4; 95% CI: -9.24, -5.56), MitraClip: (MD = -4.04; 95% CI: -5.03, -3.05), and PASCAL: (MD = -6.56; 95% CI: -7.76, -5.35)]. The procedural success rates and incidence of single leaflet device attachment (SLDA) were similar across all devices. Furthermore, there were no significant differences in mortality, stroke rates, or major bleeding events among the three devices. CONCLUSION: The TriClip outperforms the MitraClip and PASCAL in reducing vena contracta width, indicating greater effectiveness for severe tricuspid regurgitation. All devices show similar safety profiles and procedural success rates. Further research is needed to confirm these results.

Transcatheter valve repair of tricuspid regurgitation with the PASCAL system: TriCLASP study 30-day results.

BACKGROUND: Severe tricuspid regurgitation (TR) is independently associated with increased morbidity and mortality. Percutaneous transcatheter approaches may offer an alternative for patients not amenable to surgery. METHODS: TriCLASP is a prospective, single-arm, multicenter European post-market clinical follow-up study (NCT04614402) to evaluate the safety and performance of the PASCAL system (Edwards Lifesciences) in patients with severe or greater TR. At 30 days, a composite of major adverse events (MAEs) adjudicated by a clinical events committee, echocardiographic parameters adjudicated by core laboratory, and clinical, functional, and quality-of-life measures were evaluated. RESULTS: Mean age of the 74 enrolled patients was 80.3 years, with 58.1% female, 90.5% systemic hypertension, and 77.0% in New York Heart Association (NYHA) class III/IV. Mean Society for Thoracic Surgeons score (MV repair) was 9.0%. TR severity was significantly reduced at discharge (p < 0.001) and sustained at 30 days (p < 0.001), and 90.0% of patients achieved ≤moderate TR. The composite MAE rate at 30 days was 3.0%, including 4 events in 2 patients: cardiovascular mortality 1.5%, stroke 1.5%, renal complications requiring unplanned dialysis or renal replacement therapy 1.5%, and severe bleeding 1.5%. There were no nonelective tricuspid valve reinterventions, major access site and vascular complications, major cardiac structural complications, or device embolizations. NYHA class I/II was achieved in 55.8%, 6-minute walk distance improved by 38.2 m (p < 0.001), and Kansas City cardiomyopathy questionnaire scores improved by 13.4 points (p < 0.001). CONCLUSION: Experience with the PASCAL transcatheter valve repair system in a European post-market setting confirms favorable safety and effectiveness at 30 days. TR significantly reduced, and clinical, functional, and quality-of-life outcomes significantly improved. This study is ongoing. Clinical Trial Registration: The study is ongoing and registered on ClinicalTrials.gov as NCT04614402. The current analysis is an interim report.

Continuous atrial pressure monitoring via steerable guide catheter in transcatheter mitral and tricuspid edge-to-edge repair.

Transcatheter edge-to-edge repair (TEER) has emerged to address severe mitral and tricuspid valve regurgitation in patients who are at high perioperative risk for open-heart surgery. No clinical data is available for continuous left and right atrial pressure monitoring using the steerable guiding catheter (SGC) during TEER. In a prospective single-center study, 40 patients with severe mitral (n = 20) or tricuspid (n = 20) regurgitation underwent TEER with the registration of atrial pressure via the SGC. All patients had successful TEER using the PASCAL Ace repair system, while atrial pressure was monitored continuously via the SGC. Simultaneous right or left atrial pressure monitoring via the SGC and a pigtail catheter during mitral and tricuspid TEER showed excellent reliability for SGC pressure registration. While for mitral TEER the beneficial effects of continuous atrial pressure monitoring are well known, we further evaluated the outcome of patients with tricuspid TEER. Echocardiographic and clinical results after tricuspid TEER showed a reduction of quantitative echocardiographic tricuspid regurgitation parameters and improved New York Heart Association classification after 3-month follow-up. Also, qualitative tricuspid valve assessment showed improved tricuspid regurgitation classification postimplantation and at 3-month follow-up. Furthermore, right atrial pressure was reduced by 37.6% and mean right atrial pressure by 30.6% after successful tricuspid TEER using the PASCAL Ace device. Continuous atrial pressure monitoring using the SGC of the PASCAL Ace repair system is reliable during mitral and tricuspid TEER. Furthermore, successful tricuspid TEER leads to reduced right atrial pressure.

Functional Tricuspid Regurgitation in Patients With Chronic Mitral Regurgitation: An Evidence-Based Narrative Review.

Chronic mitral regurgitation leads to a series of downstream pathologic changes, including pulmonary hypertension, right ventricular dilation, tricuspid leaflet tethering, and tricuspid annular dilation, which can result in functional tricuspid regurgitation (FTR). The five-year survival rate for patients with severe FTR is reported to be as low as 34%. While FTR was often left uncorrected during left-heart valvular surgery, under the assumption that correction of the left-sided lesion would reverse the right-heart changes that cause FTR, recent data largely have supported concomitant tricuspid valve repair at the time of mitral surgery. In this review, the authors discuss the potentially irreversible nature of the changes leading to FTR, the likelihood of progression of FTR after mitral surgery, and the evidence for and against concomitant tricuspid valve repair at the time of mitral valve intervention. Lastly, this narrative review also examines advances in transcatheter therapies for the tricuspid valve and the evidence behind concomitant transcatheter tricuspid repair at the time of transcatheter mitral repair.

Tricuspid Valve Percutaneous Therapies.

PURPOSE OF REVIEW: In this review, we have focused on the currently available transcatheter tricuspid valve therapies, device selection, as well as role and management of tricuspid regurgitation (TR) in the setting of other transcatheter valvular procedures. RECENT FINDINGS: In this review, we have enlisted the recently finished as well as ongoing trials in the percutaneous tricuspid valve therapies. TR is highly prevalent yet remains underrecognized and is often untreated. TR has traditionally been managed conservatively with medical therapies including diuretics for volume management, whereas surgical therapies are reserved for those undergoing left-sided valvular surgery. Although the transcatheter devices for tricuspid repair and replacement are in clinical trials, the experience to date for their effectiveness and safety has been reassuring.

Right ventricle dysfunction assessment for transcatheter tricuspid valve repair: A matter of debate.

Newer approaches in transcatheter tricuspid valve replacement (TTVR) have recently showed optimistic data of efficacy and safety in patients at high risk for surgery. However, the absence of residual regurgitation (and subsequently higher likelihood for developing afterload mismatch) with TTVR compared with transcatheter tricuspid valve intervention may become a critical concern if RV dysfunction is misdiagnosed. Indeed, such sudden increase in afterload on the right ventricle (RV) may not be tolerable, resulting in higher risk of acute right heart failure in the early postoperative period. In this context, strain imaging may find a further application to provide a more comprehensive stratification of the severity of RV dysfunction and thus help to better define the eligibility criteria and timing for TTVR. Meanwhile, it is of paramount importance to underline the contribution given by the Trivalve study on the understanding of the role of RV function in TTVI, that so far was largely undefined, being evaluated only in small noncontrolled cohorts.

Etiology, epidemiology, pathophysiology and management of tricuspid regurgitation: an overview.

Significant tricuspid regurgitation (TR) is a common finding, affecting about one in twenty-five subjects among the elderly and presenting more frequently in women than in men. This review summarizes data concerning etiology, epidemiology, pathophysiology and management strategies of TR. The tricuspid valve (TV) has a broad anatomical variability. Classically, TR has been distinguished as primary and secondary or functional TR (FTR), with the latter being the most prevalent. FTR is a multifactorial disorder, resulting from maladaptive right ventricular remodeling secondary to pulmonary hypertension or from atrial fibrillation leading to dilation of the right atrium, tricuspid annulus and base of the right ventricle, with pathological TV coaptation. Thus two main types of FTR can be identified: pulmonary hypertension-FTR and idiopathic-FTR, depending on which factor, ventricular or atrial respectively, is the primum movens of the disease. Appreciable evidence suggests that significant TR leads to worsening prognosis regardless of the underlying etiology and should be addressed as a separate therapeutic target. The treatment of TR in patients undergoing left-sided cardiac surgery is well established. Isolated surgical repair of TR is instead rarely performed because patients are often deemed inoperable due to prohibitive risk. Besides, perioperative mortality remains higher than for any other valve. Several transcatheter TV replacement and repair systems, the latter mostly borrowed from percutaneous treatment systems of mitral regurgitation or from TV repair surgical techniques, have shown efficacy and safety when used on the TV. These could provide an effective treatment option for patients not eligible for surgery.

Tricuspid clip implantation using the MitraClip system-A step-by-step guide.

Many novel percutaneous interventions are being developed for application in the tricuspid valve position. At the present time, there are no commercially available devices for this application. There has been mounting evidence supporting the safety and efficacy of using the MitraClip system on the tricuspid valve. This review summarizes the peer reviewed data available to date supporting this procedure, outlines the step-by-step maneuvers using the MitraClip system for this application, and imaging techniques used prior to and during the procedure.

Diagnosis and Management of Failed Surgical Tricuspid Valve Annuloplasty.

PURPOSE OF THE REVIEW: Annular-based strategies for treating tricuspid valve (TV) regurgitation do not always have satisfactory long-term outcomes. Management of failed TV annuloplasty can be challenging and requires a dedicated heart team approach. This review explores the treatment options available for failed TV annuloplasty. RECENT FINDINGS: Recent developments and novel percutaneous treatment options have emerged as promising alternatives for patients with failed TV annuloplasty. Leaflet-based interventions, valve-in-valve procedures, transcatheter tricuspid valves and new-generation trans-caval valves are all feasible options, which can assure good results whilst minimizing risks for the patient. Failure of tricuspid annuloplasty is not uncommon amongst patients treated with either a tricuspid ring or suture-based device. The complex anatomy, physiology and clinical risk profile should be carefully evaluated on an individual patient-by-patient basis in order to select the most appropriate clinical and percutaneous treatment strategy. Different transcatheter tricuspid valve repair or replacement techniques may provide an attractive alternative treatment option for managing this challenging patient cohort.

Mitral and Tricuspid Valves Percutaneous Repair in Patients with Advanced Heart Failure: Panacea, or Pandora's Box?

In heart failure with reduced ejection fraction, the interventional landscape has recently expanded. New transcatheter approaches are emerging for both mitral and tricuspid secondary (functional) regurgitation. Transcatheter therapies for mitral and tricuspid valve require a more tailored approach than for the aortic valve, because of more heterogeneous clinical scenarios, anatomic features, and mechanisms of valvular lesions.

Anesthetic Considerations for Transcatheter Tricuspid Valve Repair.

The development of transcatheter approaches for heart valve repair and replacement procedures have revolutionized the field of structural cardiology and cardiac anesthesiology. With the recently reported benefits of transcatheter mitral repair procedures, there has been increasing focus on transcatheter tricuspid repair technologies. Currently, there are multiple transcatheter tricuspid repair devices that are undergoing feasibility testing, and each device has its own unique procedural considerations. This review discusses the anesthetic management of transcatheter tricuspid repair by describing the causes of tricuspid regurgitation, the currently available transcatheter tricuspid repair devices, the procedural considerations relevant to the cardiac anesthesiologist, and pearls for proper intraprocedural image guidance via transesophageal echocardiography.

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.

Assessment of tricuspid valve by two- and three-dimensional echocardiography with special reference to percutaneous repair and prosthetic valve implantation procedures.

Moderate-to-severe tricuspid regurgitation affects approximately 1.6 million people in the United States. An estimated 8000 patients will undergo tricuspid surgery annually, leaving a large number of patients with this condition untreated. Many of these individuals who are not referred for surgery engender a large unmet clinical need; this may be primarily due to the surgical risk involved. In persons who are categorized as high-risk surgical candidates, percutaneous procedures present a viable alternative. The majority of developmental attention as regards percutaneous approaches has been focused on the aortic and mitral valves recently, but few data are available about the feasibility and efficacy of minimally invasive tricuspid valve treatment. We review the usefulness of two- and three-dimensional echocardiography in the assessment of the tricuspid valve with special reference to recent interest in percutaneous repair and prosthetic valve implantation procedures for severe functional tricuspid regurgitation.

Role of Echocardiography in Transcatheter Valvular Heart Disease Interventions.

PURPOSE OF REVIEW: Transcatheter valvular interventions have increased in importance and utility for surgical valve repair and replacement. Cardiac imaging is the most crucial aspect of procedural planning and guidance. Echocardiography is a widely used, portable, and dynamic imaging modality used for many of these interventions. This review will summarize the role echocardiography in structural heart valvular interventions. RECENT FINDINGS: Intraprocedural echocardiographic guidance has been a mainstay of structural heart interventions. Over the years, the use of 3-dimensional echocardiography has increased, and studies have shown utility in paravalvular leak prediction in the setting of transcatheter aortic valve replacement, procedural guidance in MitraClip repair, and in mitral and tricuspid valve therapies. Intraprocedural echocardiography is of paramount important for procedural success during all structural heart valvular interventions. Continued use of 2 and 3-dimensional echocardiography will be a major factor in driving the innovative field of structural heart interventions forward.

Role of preexisting right ventricular remodeling in symptoms and prognosis after transcatheter tricuspid valve repair.

BACKGROUND: Severe tricuspid regurgitation (TR) is associated with chronic volume overload and right ventricular remodeling (RVR). Transcatheter tricuspid valve repair (TTVr) reduces TR and can improve quality of life (QoL), but the role of preprocedural RVR on TTVr outcomes remains unclear. AIMS: To investigate the role of RVR on outcomes after TTVr for severe TR. METHODS: Consecutive patients undergoing TTVr (61% edge-to-edge vs. 39% direct annuloplasty) for severe TR were retrospectively compared by preexisting RVR which was defined as dilation of RV mid-level diameter (> 35 mm) according to guidelines. QoL was evaluated using NYHA class, Minnesota Living with Heart Failure Questionnaire (MLHFQ), 36-Item Short Form Health Survey (SF-36), and 6-min walking distance (6MWD) 1-month after TTVr. Mid-term mortality and heart failure (HF) hospitalization were assessed through 1 year. RESULTS: RVR was present in 137 of 223 patients (61%). Symptoms and QoL improved equally in both groups: ≥ 1 NYHA class (57% vs. 65% of patients with vs. without RVR, respectively), 6MWD (36% vs. 34%), MLHFQ (81% vs. 69%), and SF-36 (68% vs. 65%) improvement. One-year mortality and HF hospitalization were significantly higher in patients with RVR (24% and 30%, respectively) than in patients without (8% and 13%, both p < 0.05). In multivariable analysis, RVR was independently associated with mortality (HR 2.3, 95%CI (1.0-5.0), p = 0.04) and the combined endpoint of mortality or rehospitalization (HR 2.0, 95%CI (1.1-3.8), p = 0.03). CONCLUSIONS: TTVr was associated with significant QoL improvement after 1 month, irrespective of RVR. Despite increased mortality and rehospitalization for heart failure, TTVr in the presence of RVR still provides substantial symptomatic benefit for patients with severe TR.

Transcatheter tricuspid valve interventions: Current devices and clinical evidence.

The tricuspid valve is known as "the forgotten valve". Tricuspid regurgitation (TR) is a highly prevalent valvular heart disease. TR is often late in the course of the disease when it becomes symptomatic, often being a marker of late-stage chronic heart failure with a poor prognosis and high mortality rate at long-term follow-up. Despite the clear correlation between TR and mortality, most TR patients are under-treated. Neither pharmacologic nor surgical treatment demonstrates a significant survival benefit. Isolated tricuspid valve surgery has the highest mortality rate of all valve surgeries. Therefore, there is an urgent clinical need for minimally invasive therapies to meet the needs of patients with TR. In recent years, a variety of transcatheter tricuspid valve interventions representing less invasive alternatives to surgery have shown promising results, which bring hope to patients with severe TR. The purpose of this review is to provide a complete and updated overview on current transcatheter tricuspid valve interventions and clinical evidence.

Changes in right ventricular function and clinical outcomes following tricuspid transcatheter edge-to-edge repair.

AIMS: Prognostic impact of post-procedural changes in right ventricular (RV) function after tricuspid transcatheter edge-to-edge repair (T-TEER) is still unclear. We investigated association of RV function and its post-procedural changes with clinical outcomes in patients undergoing T-TEER. METHODS AND RESULTS: We retrospectively analysed 204 patients who underwent T-TEER and echocardiographic follow-up at 3 months after T-TEER. RV function was assessed by RV fractional area change (RVFAC), and RV dysfunction was defined as RVFAC <35%. Patients with an increase in RVFAC from baseline to the follow-up were considered as RV responders. Patients were divided into four groups according to baseline RVFAC and the RV responder. The primary outcome was a composite of mortality and hospitalization due to heart failure within 1 year. Forty-five of 204 patients (22.1%) had RVFAC <35% at baseline, and 71 (34.8%) were RV responders. The association between the RV responder and the composite outcome had a significant interaction with RVFAC at baseline. Among patients with baseline RVFAC <35%, RV responders had a lower risk of the composite outcome than RV non-responders, while this association was not significant in those with baseline RVFAC ≥35%. Among patients with baseline RVFAC <35%, a smaller RV diameter and a greater reduction of tricuspid regurgitation were predictors for the RV responder. CONCLUSION: Post-procedural increase in RVFAC after T-TEER is associated with improved outcomes in patients with RV dysfunction. The factors related to the increase in RVFAC may support patient selection for T-TEER in patients with RV dysfunction.

Personalized Guidance of Edge-to-Edge Transcatheter Tricuspid Valve Repair by Multimodality Imaging.

Background: Transcatheter edge-to-edge tricuspid valve repair (T-TEER) for tricuspid regurgitation (TR) is always guided by transesophageal echocardiography (TEE). As each patient has unique anatomy and acoustic window, adding transthoracic echocardiography (TTE) and cardiac CT could improve procedural planning and guidance. Objectives: We aimed to assess T-TEER success and outcomes of a personalized guidance approach, based on multimodality imaging (MMI) of patient-tailored four right-sided chamber views (four-right-ch), as depicted by CT, TTE, TEE and fluoroscopy. Methods: Patients were assigned to MMI or classical TEE guidance, depending on TTE acoustic window. In MMI patients, planning included cardiac CT, which determined the fluoroscopic angulations of the specific four-right-ch, while guidance relied heavily on TTE, with minimal intermittent TEE for leaflet grasping and result confirmation. Both TTE and TEE were matched to respective CT and fluoroscopy four-right-ch. TR severity and quality of life (QoL) parameters were assessed from baseline to 12 months. Results: A total of 40 T-TEER patients were included, with 17 procedures guided by MMI and 23 solely by TEE. Baseline characteristics were similar between groups, e.g., age (83.1 ± 4.1 vs. 81 ± 5.3, p = 0.182) or STS-Score (11.1 ± 7.4% vs. 10.6 ± 5.9%, p = 0.813). The primary efficacy endpoint of ≥one-grade TR reduction at 30 days was 94% (16/17) in MMI vs. 91% (21/23) in TEE patients, with two or more TR grade reduction in 65% vs. 52% (p = 0.793). Device success was overall 100%, with no device-related complications, but three TEE-associated cases of gastrointestinal bleeding in the TEE-only group. By 12 months, all 15 MMI and 19 TEE survivors improved NYHA functional class and QoL, e.g., Kansas City Cardiomyopathy Questionnaire Score Δ29.6 ± 6.7 vs. 21.9 ± 5.8 (p = 0.441) pts., 6-min walk distance Δ101.5 ± 36.4 vs. 85.7 ± 32.1 (p = 0.541) meters. Conclusions: In a subset of patients with good TTE acoustic window, MMI guidance of T-TEER is effective and seems to avoid gastroesophageal injuries caused by TEE probe manipulation. TR reduction, irrespective of guidance method, impacts long-term QoL.