Performance of Transcatheter Direct Annuloplasty in Patients With Atrial and Nonatrial Functional Tricuspid Regurgitation.

BACKGROUND: A novel echocardiography-based definition of atrial functional tricuspid regurgitation (A-FTR) has shown superior outcomes in patients undergoing conservative treatment or tricuspid valve transcatheter edge-to-edge repair. Its prognostic significance for transcatheter tricuspid valve annuloplasty (TTVA) outcomes is unknown. OBJECTIVES: This study sought to investigate prognostic, clinical, and technical implications of A-FTR phenotype in patients undergoing TTVA. METHODS: This multicenter study investigated clinical and echocardiographic outcomes up to 1 year in 165 consecutive patients who underwent TTVA for A-FTR (characterized by the absence of tricuspid valve tenting, midventricular right ventricular [RV] dilatation, and impaired left ventricular ejection fraction) and nonatrial functional tricuspid regurgitation (NA-FTR). RESULTS: A total of 62 A-FTR and 103 NA-FTR patients were identified, with the latter exhibiting more pronounced RV remodeling. Compared to baseline, the tricuspid regurgitation (TR) grade at discharge was significantly reduced (P < 0.001 for both subtypes), and TR ≤II was achieved more frequently in A-FTR (85.2% vs 60.8%; P = 0.001). Baseline TR grade and A-FTR phenotype were independently associated with TR ≤II at discharge and 30 days. In multivariate analyses, A-FTR phenotype was a strong predictor (OR: 5.8; 95% CI: 2.1-16.1; P < 0.001) of TR ≤II at 30 days. At 1 year, functional class had significantly improved compared to baseline (both P < 0.001). One-year mortality was lower in A-FTR (6.5% vs 23.8%; P = 0.011) without significant differences in heart failure hospitalizations (13.3% vs 22.7%; P = 0.188). CONCLUSIONS: Direct TTVA effectively reduces TR in both A-FTR, which is a strong and independent predictor of achieving TR ≤II, and NA-FTR. Even though NA-FTR showed more RV remodeling at baseline, both phenotypes experienced similar symptomatic improvement, emphasizing the benefit of TTVA even in advanced disease stages. Additionally, phenotyping was of prognostic relevance in patients undergoing TTVA.

A 3D-Printed Externally Adjustable Symmetrically Extensible (EASE) Aortic Annuloplasty Ring for Root Repair and Aortic Valve Regurgitation.

PURPOSE: The valve-sparing aortic root replacement (VSARR) procedure was developed to preserve the aortic valve apparatus to replace aneurysmal aortic roots with synthetic grafts and to eliminate associated aortic regurgitation (AR). However, residual post-repair AR is not uncommon and has been found to be associated with recurrent AR and future reoperation. METHODS: We designed and manufactured a 3D-printed, external adjustable symmetrically extensible (EASE) aortic annuloplasty ring that can symmetrically reduce the aortic annulus diameter via a radial constriction, compliant mechanism. An ex vivo porcine VSARR model with annular dilation and AR was developed (n = 4) and used for hemodynamic, echocardiography, and high-speed videography data collection. RESULTS: After ring annuloplasty repair using the EASE aortic ring, the regurgitant fraction decreased from 23.6 ± 6.9% from the VSARR model to 7.4 ± 5.6% (p = 0.05), which was similar to that measured from baseline with a regurgitant fraction of 10.2 ± 3.9% (p = 0.34). The leaflet coaptation height after annuloplasty repair also significantly increased from that measured in VSARR model (0.4 ± 0.1 cm) to 0.9 ± 0.1 cm (p = 0.0004), a level similar to that measured in baseline (1.1 ± 0.1 cm, p = 0.28). CONCLUSION: Using an ex vivo VSARR model, the EASE ring successfully reduced AR by reducing the annular diameter and improving leaflet coaptation. With its broad applicability and ease of use, this device has the potential to have a significant impact on patients suffering worldwide from AR due to root aneurysms.

"Mind the Gap": An 85-Year-Old Man with Severe Tricuspid Valve Regurgitation Who Underwent Percutaneous Edge-to-Edge Valve Leaflet Plication Using the New and Advanced MitraClip XTR System.

BACKGROUND Severe tricuspid valve regurgitation (TR) is associated with high cardiovascular mortality. Safe and feasible interventional approaches to treat severe TR are of clinical relevance. The MitraClip is a device that has been approved by the US Food and Drug Administration (FDA) for the repair of mitral valve lesions. Percutaneous femoral venous access with fluoroscopic and echocardiographic guidance is used to deliver a cobalt-chromium clip to secure the mitral valve leaflets. We report on an 85-year-old man with tricuspid valve regurgitation who underwent percutaneous edge-to-edge tricuspid valve leaflet plication with the new, advanced MitraClip XTR System. CASE REPORT An 85-year-old man with severe TR due to annulus dilation of the right ventricle and short septal leaflet presented repeatedly at our hospital with severe right heart failure symptoms. Transesophageal echocardiography revealed severe TR with a large coaptation gap size of 10.6 mm. Percutaneous edge-to-edge valve repair with the new-generation MitraClip System XTR with wider clip arms could overcome the large coaptation gap. We achieved a strong reduction of TR after deploying 2 MitraClips XTR. The patient recovered quickly and has not been admitted to hospital due to heart failure symptoms since the intervention for more than 6 months. CONCLUSIONS Previous studies have shown the safety and effectiveness of the MitraClip device and supported FDA approval for tricuspid valve repair. This report of a patient with complex tricuspid regurgitation demonstrated the feasible use of the new MitraClip XTR System, which improved edge-to-edge tricuspid valve repair due to its increased span and improved grip.

Feasibility Study of the Transcatheter Valve Repair System for Severe Tricuspid Regurgitation.

BACKGROUND: Tricuspid regurgitation (TR) is a prevalent disease with limited treatment options. OBJECTIVES: This is the first 30-day report of the U.S. single-arm, multicenter, prospective CLASP TR early feasibility study of the PASCAL transcatheter valve repair system in the treatment of TR. METHODS: Patients with symptomatic TR despite optimal medical therapy, reviewed by the local heart team and central screening committee, were eligible for the study. Data were collected at baseline, discharge, and the 30-day follow-up and were reviewed by an independent clinical events committee and echocardiographic core laboratory. Feasibility endpoints included safety (composite major adverse event [MAE] rate), echocardiographic, clinical, and functional endpoints. RESULTS: Of the 34 patients enrolled in the study, the mean age was 76 years, 53% were women, the mean Society of Thoracic Surgeons score was 7.3%, 88% had atrial fibrillation/flutter, 97% had severe or greater TR, and 79% had New York Heart Association (NYHA) functional class III/IV symptoms. Twenty-nine patients (85%) received implants; at 30 days, 85% of them achieved a TR severity reduction of at least 1 grade, with 52% with moderate or less TR (p < 0.001). The MAE rate was 5.9%, and none of the patients experienced cardiovascular mortality, stroke, myocardial infarction, renal complication, or reintervention. Eighty-nine percent of the patients improved to NYHA functional class I/II (p < 0.001), the mean 6-min walk distance improved by 71 m (p < 0.001), and the mean Kansas City Cardiomyopathy Questionnaire score improved by 15 points (p < 0.001). CONCLUSIONS: In this early experience, the repair system performed as intended, with substantial TR reduction, favorable safety results with a low MAE rate, no mortality or reintervention, and significant improvements in functional status, exercise capacity, and quality of life. (Edwards CLASP TR EFS [CLASP TR EFS]; NCT03745313).

Choosing the Ideal Candidate for a Robotic Valve Intervention.

Robotic cardiac surgery addressing the mitral and tricuspid valves is a highly developed field offering multiple potential advantages regarding postoperative complications, valve repair rates, hospital length of stay, and rapid functional recovery compared with the conventional sternotomy approach for select patients. The unparalleled stereoscopic view within the heart and precision of robotic arms make robotic surgery a highly attractive minimally invasive approach, facilitating repair of even the most complex valvular pathology. Careful candidate selection and surgical planning are paramount to optimising the outcomes of those who undergo robotic valve surgery. As a team's experience grows, the technique can be applied to a wider range of patients that may derive even greater benefit, such as those with significant comorbid conditions, ventricular dysfunction, and previous sternotomy. The goal of this review is to provide clinicians with a practical overview of the factors influencing a patient's candidacy for robotic valve surgery. We discuss key issues such as preoperative diagnostic assessment, concerns regarding demographics and surgical pathology, and additional considerations relating to surgical exposure, cardiopulmonary bypass, and myocardial protection. Diligent patient assessment and a strong team-based approach are paramount to developing and maintaining a successful robotic valve surgery program, with the most seasoned teams being able to safely offer the technique to the vast majority of patients referred for mitral or tricuspid valve repair or replacement.

Risk factors for recurrence of aortic regurgitation after aortic valve repair.

In the past decade, the treatment of aortic regurgitation has evolved from a strategy focused mainly on valve replacement to one of valve repair (AVr). Nevertheless, AVr has yet to gain broad acceptance within the surgical community despite excellent reported results in selected centers. In fact, AVr failure due to recurrence of regurgitation remains a challenge. Thanks to sustained research efforts, the mechanisms underlying aortic valve repair failure are now better understood. The aim of this article is to discuss the risk factors for recurrent AR after valve repair, the technical strategies that can mitigate this risk and highlight the contemporary results associated with AVr.

Long-term outcomes of rigid ring versus De Vega annuloplasty for functional tricuspid regurgitation: A propensity score-matching analysis.

OBJECTIVE: This study was conducted to compare the outcomes of rigid ring versus De Vega annuloplasty for the treatment of functional tricuspid regurgitation (TR). METHODS: From 2003 to 2017, De Vega annuloplasty (group D) was used in 231 patients, and rigid ring annuloplasty (group R) was used in 204 patients for the treatment of functional TR during left-sided valve surgery. A propensity score-matching analysis was used to pair group D (n = 109) with group R (n = 109). The primary outcomes were long-term overall survival and cardiac death, and the secondary outcomes were tricuspid valve-related events and TR recurrence (TR moderate or severe). The follow-up data were complete in 99.6% (447 out of 449) of the patients with a follow-up duration of 102 months. RESULTS: There were no differences in the overall survival and cardiac death between the propensity score-matched groups (P = .793 and P = .175, respectively) up to 14 years after surgery. Tricuspid valve-related events, including cardiac death, permanent pacemaker implantation, thromboembolism, bleeding and tricuspid valve reoperation were also similar between the 2 matched groups during the follow-up (P > .999). However, cumulative incidence of TR recurrence was significantly higher in group R than in group D (P = .007). Multivariate analysis indicated the annuloplasty method (De Vega) and preoperative TR grade as risk factors for late TR recurrence. CONCLUSIONS: In functional TR, annuloplasty methods did not influence long-term overall survival, cardiac mortality, and tricuspid valve-related events. However, rigid ring annuloplasty showed less late TR recurrence. Rigid ring annuloplasty can be considered for the treatment of functional TR in terms of its better durability.

Root repair with aortic ring annuloplasty using the standard approach.

Standardization of aortic valve repair techniques with use of a calibrated annuloplasty have led to improved long-term outcomes in dystrophic aortic insufficiency. It can also improve dissemination of techniques and rates of aortic valve repair. Dystrophic aortic insufficiency can be found in three aortic phenotypes: dilated aortic root, dilated ascending aorta and isolated aortic insufficiency. The aortic annulus is invariably dilated above 25 mm in the vast majority of cases of aortic insufficiency, regardless of whether the aorta is dilated or not. A dilated annulus is a risk factor for late failure of aortic valve repair if not addressed at the time of surgery. We perform a calibrated annuloplasty at both sub- and supra-valvular levels in order to restore the ratio of sinotubular junction and annulus. Current evidence shows aortic valve repair reduces valve-related mortality compared to prosthetic valve replacement, with an improved quality of life.

Cusp-based geometric height-oriented repair of a pediatric aortic valve.

Progressive aortic regurgitation can occur in pediatric patients due to root dilation with conotruncal anomalies or cusp prolapse associated with a ventricular septal defect. It is treated using various approaches influenced by personal preferences and institutional experience. We applied geometrical concepts developed for adult aortic valve repair to pediatric valves. The basal ring and sinotubular junction are downsized in relation to the geometric height of the cusp by external suture annuloplasty. The length of the cusp free margin is then adjusted with central plication, guided by measuring the effective height of the cusp. This approach facilitates the reproducibility and predictability of pediatric aortic valve repair.

Leadless pacemaker for patients following cardiac valve intervention.

BACKGROUND: Permanent pacing is common after valve intervention. The presence of a conventional pacemaker in this population is recognized as a risk factor for infectious events. Therefore, a leadless pacing system could be the preferred strategy when permanent pacing is required after valve intervention. AIM: To report periprocedural outcomes and follow-up of patients undergoing implantation of a leadless pacing system after valve intervention. METHODS: Patients with previous valve intervention at the time of attempted implantation of a leadless pacemaker (Micra™, Medtronic, Minneapolis, MN, USA) were included, and were compared with a control group (patients also implanted with Micra™ without valve intervention). RESULTS: Among a total of 170 Micra™ implantation procedures, 54 patients (31.8%) had a history of valve intervention: 28 after aortic valve replacement; 10 after mitral valve replacement; one after single tricuspid valvuloplasty; and 15 after multiple valve surgery. Median age of the patients was 82.5 (77.0-86.0) years and 53.7% were male. Patients with previous valve intervention had a higher incidence of arterial hypertension (P=0.014) and ischaemic heart disease (P=0.040). The primary indications for permanent pacing after valve intervention were high-degree atrioventricular block (59.3%) and atrial fibrillation with bradycardia (27.8%). Micra™ was successfully implanted in all patients (n=170) without any procedure-related major complications. During a median follow-up of 12 months, electrical performance was excellent and similar in both groups. Also, a similar reduction in left ventricular ejection fraction was observed at 12 months in both groups, which was correlated with the percentage of right ventricular pacing. CONCLUSION: A leadless pacemaker is safe and efficient after valve intervention, and therefore represents an effective pacing option in patients after valve intervention.

Management and Outcomes of Transvenous Pacing Leads in Patients Undergoing Transcatheter Tricuspid Valve Replacement.

OBJECTIVES: The aim of this study was to determine the prevalence of pacemaker lead-related complications following transcatheter tricuspid valve replacement (TTVR). BACKGROUND: The rate of permanent pacemaker implantation following tricuspid valve (TV) surgery is high, and many patients have transvenous leads. The feasibility, safety, and outcomes of subsequently performing TTVR in the setting of transvenous pacemaker leads have not been established. METHODS: The VIVID (Valve-in-Valve International Database) registry was used to review 329 patients who underwent TTVR following TV repair or replacement. Patients were subdivided into 3 cohorts for intergroup comparisons: no lead, epicardial lead, and transvenous lead (entrapped or not entrapped during the TTVR procedure). RESULTS: Of 329 patients who underwent TTVR, 128 (39%) had prior pacing systems in place, 70 with epicardial and 58 with transvenous leads. A total of 31 patients had leads passing through the TV. Three patients had the right ventricular (RV) lead extracted prior to TTVR. The remaining 28 patients had the RV lead entrapped between the transcatheter TV implant and the surgical valve (n = 22) or the repaired TV (n = 6). One patient had displacement of the RV lead during the procedure, and 2 experienced lead failure during follow-up. Overall, there was no significant difference in the cumulative incidences of competing outcomes (death, TV reintervention, TV dysfunction) between patients with and those without pacing leads or entrapped RV leads. CONCLUSIONS: TTVR in the setting of trans-TV pacemaker leads without lead extraction or re-replacement can be performed safely with a low risk for complications, offering an alternative to surgical TV replacement.

Transcatheter therapies for tricuspid valve regurgitation.

: Tricuspid regurgitation, either isolated or associated with left-valve disease, has a strong impact on outcome. Surgical treatment of tricuspid regurgitation has increased in recent years, but in-hospital mortality remains high probably due to the risk profile of the recipients. As a consequence, most of the patients with severe tricuspid regurgitation, especially if isolated, remain untreated. Transcatheter tricuspid valve interventions are rapidly spreading as alternative options to open-heart procedures fulfilling this important unmet need. Although patient selection and timing of intervention are unclear, many devices have been developed in recent years for both repair and replacement of tricuspid valve. Repair tools can be targeted to leaflets or annulus. Replacement devices include heterotopic and orthotropic systems. The aim of this review is to report possible indications and summarize current data about the different devices available for transcatheter tricuspid valve interventions.

Isolated tricuspid valve regurgitation: old concepts, new insights and innovation.

: Tricuspid valve regurgitation is usually progressive and associated with reduced long-term survival. International guidelines recommend surgery in cases of isolated severe regurgitation associated with symptoms or progressive worsening of right ventricular function. In addition, several percutaneous strategies have been reported with promising results in the last decade. The aim of the present review is to summarize the current state of the art in the management of isolated functional or degenerative tricuspid valve insufficiency, from the preoperative assessment to the results of both surgical and transcatheter approaches and explore future directions.

Early exercise training feasibility after aortic valve repair: A multicentre prospective French survey on behalf of the Aortic Valve repair International Registry (AVIATOR).

BACKGROUND: Standardization of aortic valve repair by the external ring annuloplasty approach is an alternative to valve replacement to avoid prosthetic valve-related events. Although the benefit of exercise training to improve postoperative exercise tolerance has been demonstrated in many conditions after cardiac surgery, it has never been described after aortic valve repair. OBJECTIVES: To evaluate the feasibility of an early exercise training programme after aortic valve repair. METHODS: Consecutive patients were prospectively included in 13 postoperative centres. Patients underwent an exercise training programme for approximately 3-5 weeks. Transthoracic echocardiography and a cardiopulmonary exercise test were performed before and after the exercise training programme. RESULTS: Fifty patients (mean±standard deviation [SD] age: 50±13 years) were included a mean of 13.6±12.0 days after aortic valve repair. The preoperative degree of aortic insufficiency was moderate to severe in 35 patients (70%) and the aortic valve was bicuspid in 24 patients (48%). Valve-sparing root replacement and isolated aortic valve repair (including 10% supracoronary aorta replacement) were performed in 64% and 36% of patients, respectively. We found no aortic insufficiency occurrence or worsening and no adverse clinical events after the exercise training programme. Mean left ventricular ejection fraction increased significantly (from 54%±8% to 57%±9%; P=0.0007). Mean peak oxygen consumption and first ventilatory threshold increased from 17.0±5.3 to 22.5±7.8mL/kg/min (32% increase) and from 12.0±3.9 to 14.3±5.2mL/kg/min (19% increase), respectively (both P<0.05). CONCLUSION: Exercise training early after aortic valve repair is safe and seems to significantly improve exercise capacity.

Functional tricuspid regurgitation in rheumatic mitral valve disease patients with and without tricuspid annuloplasty: a three-dimensional echocardiography study with one year follow up.

The aim of this study is to analyze the clinical and echocardiographic determinants of functional tricuspid regurgitation (TR) before and after surgical intervention of rheumatic mitral valve disease, with focus on effectiveness of different methods of tricuspid valve annuloplasty (TAP). Three-dimensional echocardiographic images were obtained in 170 patients with mitral valve rheumatic disease before and 1 year after mitral valve replacement, with and without concomitant TAP. Together with standard cardiac chamber quantification, multiplanar reconstruction images of the tricuspid valve (TV) apparatus were analyzed in the septal-lateral and antero-posterior directions, end-diastolic TV annular diameter, TV tenting height and tenting area were measured. By multivariate logistic regression, septal-lateral TV tenting area (p < 0.001) were independently correlated with preoperative FTR severity while postoperative septal-lateral TV annular diameter (p < 0.001) independently determined residual TR at 1-year follow-up. Both ring and suture TAP groups had postoperative reduction of S-L TV diameters, but isolated MVR group had an 11% increase in S-L TV diameters. Compared with TAP of size 26 mm and 28 mm rings group, suture TAP group had more common significant residual TR (29% vs. 3%, p = 0.001). Our study demonstrated that ring annuloplasty could provide effective reduction of the TV annulus and prevent postoperative TR progression, and for rheumatic mitral valve disease patients with mild functional TR, prophylactic TAP concomitant with MVR might be considered to address the postoperative TV annulus dilation.

Off-Pump Tricuspid Annuloplasty through a Direct Transatrial Approach: Early Results.

Severe tricuspid regurgitation constitutes a growing disease burden. Conventional surgery for tricuspid valve disease has an increased risk while several interventional procedures are currently under clinical investigation, yet do not offer comprehensive solutions. We investigated a novel surgical approach for off-pump beating-heart tricuspid annuloplasty in circulating blood through a single port in the right atrium. Early feasibility results in preclinical porcine in vivo studies encourage further development of this approach, combining the proven concept of surgical annuloplasty with the benefits of minimally invasive off-pump procedures in a hybrid setting.

In Vivo Biocompatibility of a Novel Expanded Polytetrafluoroethylene Suture for Annuloplasty.

BACKGROUND: Expanded polytetrafluoroethylene (ePTFE) is a suture material for annuloplasty in aortic valve repair. For this particular application, it should induce minimal local stress and promote rapid tissue incorporation. To achieve this, a novel ePTFE suture with a larger diameter and high porosity in its midsection has been developed. Herein, we analyzed the acute and chronic tissue reaction to this suture material compared with a commercially available control ePTFE suture. METHODS: Novel and control suture samples were implanted into dorsal skinfold chambers of BALB/c mice to analyze the early inflammatory response using intravital fluorescence microscopy over 14 days. Additional suture samples were implanted for 4 and 12 weeks in the flank musculature of mice and analyzed by histology and immunohistochemistry. RESULTS: The implantation of novel and control ePTFE suture into the dorsal skinfold chamber did not induce an acute inflammation, as indicated by physiological numbers of rolling and adherent leukocytes in all analyzed venules. Chronic implantation into the flank musculature showed a better tissue incorporation of the novel ePTFE suture with more infiltrating cells and a higher content of Sirius red+ collagen fibers when compared with controls. Cell proliferation and viability as well as numbers of recruited CD68+ macrophages, myeloperoxidase+ neutrophilic granulocytes and CD3+ lymphocytes did not significantly differ between the groups. CONCLUSION: The novel ePTFE suture exhibits a good in vivo biocompatibility which is comparable to that of the control suture. Due to its improved tissue incorporation, it may provide a better long-term stability during annuloplasty.