Tricuspid Valve Reconstruction Research Articles

Surgical Treatment Methods for Tricuspid Valve Infective Endocarditis

Introduction: In recent years, there has been a significant increase in the incidence of tricuspid valve infective endocarditis (IE), which is associated with both the increased number of invasive examinations and procedures and the high rates of intravenous drug use. The initial treatment for tricuspid valve IE was surgical removal of the focus of infection and restoration of intracardiac hemodynamics.Reconstructive surgery aimed at preserving the valve is the preferred method of surgical treatment. If a valve-­preserving operation is not possible due to significant valvular apparatus destruction, implantation of artificial heart valves (both mechanical and biological) is the method of choice.Objective: To analyze the results of reconstructive valve-­preserving surgery and tricuspid valve replacement for tricuspid valve IE treatment.Materials and methods: In the Scientific Research Institute – Specialized Cardiac Surgery Clinical Hospital named after Academician B.A. Korolev (Nizhny Novgorod, Russian Federation) 110 patients underwent surgery for tricuspid valve IE. Primary surgery was performed in 97 patients, and 13 patients underwent repeated surgery. The patients were divided into 2 groups based on the chosen surgical method for correcting tricuspid valve disease. Group 1 included 62 patients who successfully underwent tricuspid valve replacement: mechanical prostheses in 10 patients and biological prostheses in 52 patients. Group 2 included 38 patients who underwent reconstructive valve­preserving surgery. All patients underwent De Vega annuloplasty. In 10 patients it was directly associated with bicuspidalization of the tricuspid valve and plastic surgery of intact leaflets. Two patients had suture annuloplasty of the tricuspid valve based on the modified technique. In 2 of 3 patients, an infected right atrial thrombus was removed. Three patients underwent removal of the left ventricular wall abscess and aortic valve replacement for critical stenosis. After translocation of the chords, triangular resection of the anterior leaflet was performed to separate the chord of the left side of the chest and the myxoma of the right and left chest.Results: In the early postoperative period, no valve­related complications were observed in group 1. The most common nonlethal complication was a third­-degree atrioventricular block. Multiple organ dysfunction syndrome occurred in 3 patients; cardiac tamponade was reported in 2 patients, and 1 patient had postoperative bleeding that required resternotomy for serous mediastinitis in the mid­term period and reosteosynthesis. At the hospital stage, 1 patient from group 1 died, whereas there were no deaths in group 2. In­-hospital mortality in the groups of operated patients was 0.9%.Functional ultrasound imaging findings in the postoperative period show that patients from group 1 had the peak gradient across the prosthetic tricuspid valve of 9.4 ± 1.8 mm Hg, while the mean gradient was 5.8 ± 1.75 mm Hg. There was a significant decrease in the estimated right ventricle pressure from 54.0 ± 16.2 to 35.0 ± 5.5 mm Hg. In group 2 tricuspid valve regurgitation was not observed in 27 patients, while mild and moderate regurgitation was reported in 8 and 3 patients, respectively. The peak gradient during the tricuspid valve reconstruction was 6.2 ± 1.7 mm Hg, while the mean gradient was 2.8 ± 0.75 mm Hg. The annulus fibrosus size during tricuspid valve annuloplasty averaged 30.8 ± 2.5 (28­33) mm. There was a decrease in the right ventricle pressure from 44.0 ± 18.4 to 32.0 ± 7.3 mm Hg. In the mid-­term follow­up, surviving patients were classified as NYHA classes I­-II. Of 110 patients discharged from the clinic, we were able to trace the fate of 69 patients, which accounted for 62.7%. In the long-­term period, 3 patients from group 1 died. Thus, long­term mortality in the general group was 2.72%.Conclusions: Reconstructive surgery has significant advantages over tricuspid valve replacement using various artificial heart valve models: lower rates of in-­hospital and long­-term mortality and specific complications, higher quality of life. Compliance with principles and methods of pathogenetic treatment of electrode­induced IE guarantees a success in the cohort of severe patients. The technique of reconstruction and restoration of tricuspid valve structures and functions in case of active tricuspid valve IE with detachment of the chords and destruction of the leaflets demonstrated high surgical efficiency.

Hedinger Syndrome-Lessons Learnt: A Single-Center Experience.

Hedinger syndrome (HS) or carcinoid heart disease (CD) is a rare and challenging manifestation of malignant neuroendocrine tumours (NETs) involving the heart. We aimed to report our experience with surgical strategies and midterm results in HS patients. Eleven patients (58 ± 11 (range 41 to 79 years); 5 females) with HS who underwent cardiac surgery in our department between 07/2005 and 05/2023 were analysed. All patients showed a New York Heart Association (NYHA) class III-IV and in all the tricuspid valve (TV) was involved. Four patients received a TV replacement, and three TV reconstruction. Recently, to preserve the geometry and function of the compromised right ventricle (RV), we have applied the TV "bio-prosthesis in native-valve" implantation technique with the preservation of the valve apparatus (tricuspid valve implantation: TVI) in four cases. Concomitant procedures included pulmonary valve replacement in four, pulmonary implantation in one, and aortic valve replacement in three cases. To treat RV failure, we adapted a combined TandemHeart®-CytoSorb® haemoperfusion strategy in Patient #10 and venoarterial extracorporeal membrane oxygenation (V-A ECMO) support avoidance, after experiencing an ECMO-induced carcinoid-storm-related death in Patient #8. Mortality at 30 days was 18% (2/11). The median follow up was 2 ± 2.1 years (range 1 month to 6 years) with an overall mortality during the follow-up period of 72.7% (8/11). HS surgery, despite being a high-risk procedure, can efficiently prolong survival, and represents a safe and feasible procedure. However, patient selection seems to be crucial. Further follow up and larger cohorts are needed.

Cardiac remodeling after tricuspid valve repair in Ebstein's anomaly: a magnetic resonance study.

We aimed to evaluate immediate and midterm cardiac remodeling after surgery by cardiac magnetic resonance (CMR) in Ebstein's anomaly (EA), and also to investigate preoperative predictors of right ventricular (RV) normalization. We retrospectively analyzed CMR parameters of the whole heart in adult patients with EA before surgery, at discharge and follow-up. A total of 26 patients were included and performed CMR at 7 days (interquartile range, 3-13 days) before surgery. Immediate postoperative CMR was finished at discharge (median: 8 [7-9] days; n = 18) and follow-up CMR at 187 days (interquartile range, 167-356 days; n = 17). RV and right atrial (RA) volumes promptly decreased immediately after surgery and at follow-up (all p < 0.05). RV ejection fraction decreased significantly at discharge (p < 0.05) but recovered at follow-up (p = 0.18). However, RV global longitudinal strain and RA reservoir strain were significantly impaired immediately and midterm after surgery (all p < 0.05). Indexed left ventricular (LV) end-diastolic volume, stroke volume, as well as global longitudinal strain increased from preoperative to follow-up (all p < 0.05). Patients who achieved normalization of RV volumes after surgery had smaller severity index and RV and RA volumes and higher LV ejection fraction and RA reservoir strain at baseline than patients without RV normalization (all p < 0.05). Reverse biventricular remodeling took place in EA after tricuspid valve surgery. Tricuspid valve reconstruction should be performed before deterioration of RV volume overload and LV function to achieve reverse RV remodeling. Key Points • After removing the volume load of tricuspid regurgitation in Ebstein's anomaly, reverse remodeling was detected by CMR in both left and right heart at midterm follow-up. • Tricuspid valve reconstruction should be performed before deterioration of RV volume overload and LV function to achieve reverse RV remodeling.

1-Year Outcomes of Cardioband Tricuspid Valve Reconstruction System Early Feasibility Study.

Tricuspid regurgitation (TR) is prevalent and undertreated, with mortality and morbidity increasing with TR severity. Given poor outcomes with medical therapy and high in-hospital mortality for isolated tricuspid valve surgery, emerging transcatheter repair devices offer a promising alternative. The Edwards Cardioband Tricuspid Valve Reconstruction System Early Feasibility study (NCT03382457) evaluates the treatment of functional TR via annular reduction with the Cardioband Tricuspid Valve Reconstruction System (Edwards Lifesciences). Patients with≥ moderate functional TR were eligible for this prospective, single-arm multicenter study. At 1year, patients were evaluated for echocardiographic parameters, clinical and quality-of-life measures, and major adverse events. The 37 patients enrolled had a mean age of 78 years; 76% were female; and they had≥ severe functional (97.3%) or mixed (2.7%) TR, atrial flutter/fibrillation (97%), and New York Heart Association functional class III/IV (65%). At 1 year, 73.0% achieved≤ moderate TR (P< 0.0001), and 73.1% had≥2 grade reductions. Echocardiography showedsignificant reductions in the tricuspid annulus diameter (P< 0.0001), mean vena contracta (P< 0.0001), proximal isovelocity surface area effective regurgitant orifice area (P< 0.0001), right ventricular end-diastolic diameter (P< 0.0001), and inferior vena contracta (P = 0.0006). New York Heart Association functional class improved significantly (P< 0.0001), with 92.3% achieving class I/II, and Kansas City Cardiomyopathy Questionnaire scores improved by 19.0 points (P< 0.0001). One-year cardiovascular mortality was 8.1%, reinterventions were necessary in 5.4%, major access site complications occurred in 8.1%, and severe bleeding was noted in 35.1% of patients. Kaplan-Meier estimates of survival and freedom from heart failure rehospitalization were 85.9% and 88.7%, respectively. One-year experience using the Cardioband system for tricuspid valve repair shows high survival and low rehospitalization rates with durable outcomes in TR reduction and echocardiographic, clinical, and quality-of-life outcomes.

Modified cone procedure along with bidirectional cavopulmonary shunt for Ebstein anomaly in adult patients

Ebstein anomaly is an uncommon congenital cardiac disease affecting the tricuspid valve and right ventricle. Da silva pioneered the cone reconstruction of tricuspid valve for surgical repair of this anomaly in 2007. We describe our experience of 5 adult patients who underwent cone repair along with a bidirectional cavopulmonary shunt and tricuspid annuloplasty ring placement at our institute. Five adult patients with Ebstein anomaly with progressive disease and symptoms were taken up cone reconstruction from 2019 to 2021. Along with cone reconstruction of tricuspid valve, we routinely added an end to side superior vena cava to right pulmonary artery shunt and a tricuspid annuloplasty ring in the newly formed tricuspid annulus in all cases. All patients tolerated the procedure well and easily weaned off cardiopulmonary bypass. There were no complications regarding bidirectional cavopulmonary shunt and only one patient had a temporary heart block which was managed conservatively. This series shows routine addition of a cavopulmonary shunt and an annuloplasty ring improves outcomes and can be performed at other experienced cardiac surgery centres.

Risk of Permanent Pacemaker Implantation Following Bentall Operation

Conduction disorders following cardiac surgery are common complications with incidences of permanent pacemaker dependency up to 5%. However, data on pacemaker implantation rates in the long-term follow-up after Bentall operations are scarce. In a retrospective study, a mixed cohort of 260 patients including endocarditis and aortic dissection undergoing Bentall operation between March 1996 and December 2015 was analyzed. Median follow-up time was 60 (12-107) months. Early and late rates of permanent pacemaker implantation and associated risk factors were investigated. In the postoperative course 31 (11.9%) permanent pacemakers were implanted. The 30-day incidence of pacemaker implantations was 7.7% with operations performed after a median of 6 (3-12) days after the Bentall operation. After ten years, 21% of the Bentall patients were permanent pacemaker dependent. The risk factors for permanent pacemaker dependency included age above 75 years (16.1% vs 5.7%; P < 0.001), preoperative cardiac conduction disturbance (32.3% vs 22.7%, P = 0.018), aortic valve stenosis (38.7% vs 23.1, P = 0.008), infective endocarditis (19.4% vs 7.4%, P = 0.004), tricuspid valve reconstruction (6.5% vs 0.9%, P = 0.033), sepsis (12.9% vs 4.4%, P < 0.001) and non-cardiac reoperation (19.4% vs 8.7%, P = 0.004). Pacemaker implantation significantly increased the length of initial hospitalization (13 [8-26] days vs 8 [7-13] days; P = 0.003). In the long-term follow-up, mortality was not different between the groups. Permanent pacemaker dependency is a frequent complication in the short- and long-term follow-up after Bentall operations. Screening for cardiac conduction disturbances in the short- and long-term follow-up is recommended.

Tricuspid valve repair concomitant with the Norwood operation among babies with hypoplastic left heart syndrome.

Among patients with hypoplastic left heart syndrome (HLHS), tricuspid valve regurgitation (TR) portends a poor prognosis. Our goal was to describe the outcomes of tricuspid valve reconstruction (TVR) concomitant with the Norwood operation and using two-dimensional echocardiography and evaluate the structural factors associated with successful functional correction. We performed a retrospective, single-centre study of patients with HLHS undergoing TVR at the time of the Norwood operation. Structural echocardiographic parameters were compared between patients with successful correction (≤ mild TR) and those with ≥ moderate regurgitation at discharge. Preoperative dimensions of matched HLHS controls with ≤ trivial TR were used as a reference. Of 205 patients with HLHS undergoing the Norwood operation, 18 patients had a concomitant TVR. Ten (56%) patients had an improved TR grade postoperatively, 8 (44%) of whom had ≤ mild TR at discharge. Improvement in TR grade (P = 0.001) and having ≤ mild TR at discharge (P = 0.011) were associated with an improved reintervention and TR-free survival. Patients with successful functional correction had smaller preoperative tricuspid annulus lateral dimensions (P = 0.023), tricuspid valve area (P = 0.007) and right ventricle mid-width (P = 0.064). Preoperatively, the successful TVR cases tended to have had higher anterior leaflet excursion (80 ± 20 vs 55 ± 11, P = 0.010), and a higher proportion of anterior leaflet prolapse (63% vs 10%, P = 0.043) compared to cases where TVR was not successful. Patients with HLHS with significant tricuspid regurgitation undergoing the stage 1 operation were more likely to have successful concomitant tricuspid valve repair if they had less tricuspid annular dilation, less-severe RV enlargement and predominantly anterior leaflet prolapse. Successful tricuspid valve repair was associated with improved mid- and long-term outcomes.

Thirty-day outcomes of the Cardioband tricuspid system for patients with symptomatic functional tricuspid regurgitation: The TriBAND study.

Severe tricuspid regurgitation (TR) has limited treatment options and is associated with high morbidity and mortality. We evaluated the safety and effectiveness of the Cardioband tricuspid valve reconstruction system from the ongoing European single-arm, multicentre, prospective TriBAND post-market clinical follow-up study. Eligible patients had chronic symptomatic functional TR despite diuretic therapy and were deemed candidates for transcatheter tricuspid repair by the local Heart Team. Sixty-one patients had ≥severe functional TR. At baseline, 85% of patients were in NYHA Class III-IV, 94% had ≥severe TR (core laboratory-assessed) with 6.8% EuroSCORE II and 53% LVEF. Device success was 96.7%. At discharge, 59% (p<0.001) of patients achieved ≤moderate TR and 78% had at least one grade TR reduction. At 30 days, all-cause mortality and composite MAE rates were 1.6% and 19.7%, respectively; septolateral annular diameter was reduced by 20%, where 69% of patients achieved ≤moderate TR and 85% of patients had at least one grade TR reduction (all p<0.001). Mid-RVEDD, RA volume, and IVC diameter decreased by 10% (p=0.005), 21% (p<0.001), and 11% (p=0.022), respectively; 74% were in NYHA Class I-II (p<0.001) with improvements in overall KCCQ score by 17 points (p<0.001). In the TriBAND study, the Cardioband tricuspid system demonstrated favourable outcomes at discharge and 30 days in a challenging patient population with symptomatic ≥severe functional TR. Results showed significant reductions in annular diameter and TR severity, accompanied by early evidence of right heart remodelling and improvements in functional status and quality of life.

Early Feasibility Study of Cardioband Tricuspid System for Functional Tricuspid Regurgitation: 30-Day Outcomes.

The study reports for the first time the 30-day outcomes of the first U.S. study with the Cardioband tricuspid valve reconstruction system for the treatment of functional tricuspid regurgitation (TR). Increasing severity of TR is associated with progressively higher morbidity and mortality; however, treatment options for isolated significant disease are limited. In this single-arm, multicenter, prospective Food and Drug Administration-approved early feasibility study (EFS), 30 patients with severe or greater symptomatic functional TR were enrolled who were deemed candidates for transcatheter tricuspid repair with the Cardioband tricuspid system by the local heart team and multidisciplinary screening committee. The mean patient age was 77 years, 80% were women, 97% had atrial fibrillation, 70% were in New York Heart Association functional class III to IV with mean left ventricular ejection fraction of 58%, and 27% had severe, 20% massive, and 53% torrential TR. Device success was 93% and all patients were alive at 30days. Between baseline and 30days, septolateral tricuspid annular diameter was reduced by 13% (p<0.001), 85% of patients had≥1 grade TR reduction and 44% had≤moderate TR, 75% were in New York Heart Association functional class I to II (p<0.001), and overall Kansas City Cardiomyopathy Questionnaire score improved by 16 points (p<0.001). In patients with severe symptomatic functional TR, this is the first study in the United States with the Cardioband tricuspid system for direct transcatheter annular reduction. This early feasibility study demonstrates high procedural feasibility with no 30-day mortality. There is significant reduction of functional TR with clinically significant improvements in functional status and quality of life. (Edwards Cardioband Tricuspid Valve Reconstruction System Early Feasibility Study; NCT03382457).

The role of cardiac surgery in transvenous lead extraction (TLE) – experience from high volume center and 3207 procedures

Abstract Background The guidelines suggest close co-operation between TLE operating team and cardiac surgery and its key role in the management of life-threatening complications remains unquestionable. But the role of cardiac surgeon seems to be much more extended. Purpose We have analysed the role of cardiac surgery in treatment of patients undergoing TLE procedures. Methods Using standard non-powered mechanical systems we have extracted ingrown PM/ICD leads from 3207 pts (38,7% female, average age 65,7-y) during the last 14 years. Non-infectious TLE indications were in 66,4% of patients. 46% had PM DDD system, 19% PM SSI, 22% ICD, 9% CRT, 4% other systems. In 12% of patients abandoned leads were found. 8% of patients had one lead, 54% - two, 15% - three and 4% - 4–6 leads in the heart. An average dwell time of all leads was 91,5 mth. The lead entry side was left in 96% of patients, right in 3% and both – 4%. Results Procedural success 96,1%, clinical success - 97,8%, procedure-related death 0,2%. Major complications appeared in 1,9% (cardiac tamponade 1,2%, haemothorax 0,2%, tricuspid valve damage 0,3%, stroke, pulmonary embolism &amp;lt;1%). Conclusions Rescue cardiac surgery (for severe haemorrhagic complications) is still the most frequent reason of surgical intervention (1,1%). The second area of co-operation includes supplementary cardiac surgery after (incomplete) TLE (0,8%). The third one is connected with reconstruction or replacement of tricuspid valve, which can be affected by ingrown lead or damaged during TLE procedure (0,5%). Implantation of the complete epicardial system during any surgical intervention (rescue or delayed) should be considered as a supplementation of the operation (0,65%). Some of patients after TLE need implantation of epicardial leads for permanent epicardial pacing (0,6%) and some only left ventricular lead to rebuild permanent cardiac resynchronisation (0,5%). The single experience of large TLE centre indicates the necessity of close co-operation with cardiac surgeon, whose role seems to be more comprehensive than a surgical stand-by itself. Table 1 Funding Acknowledgement Type of funding source: None

Transient acute right coronary artery deformation during transcatheter interventional tricuspid repair with the Cardioband tricuspid system.

The Cardioband tricuspid valve reconstruction system is a size-adjustable tricuspid reconstruction device for interventional treatment of tricuspid regurgitation (TR). Contraction of the device after successful implantation can be associated with an acute deformation of the right coronary artery (RCA). The aim of this study was to provide data on the persistence and clinical significance of acute RCA deformation following Cardioband implant procedures. Data from all patients with intraprocedural RCA deformation during Cardioband implantation were collected from four centres between October 2018 and January 2020. Control angiographies were performed in all of these patients before discharge. RCA deformation occurred in 14 out of 51 patients. Follow-up coronary angiography showed a complete resolution of deformation in all cases while patients remained clinically asymptomatic and had an uneventful post-interventional course. Intraprocedural coronary stent implantation was performed in two of the earlier cases according to the personal assessment of the implanters. RCA deformation is relatively frequent following interventional tricuspid annuloplasty but appears to be completely reversible in the absence of flow impairment or vascular damage. Based on our early experience watchful waiting is the most appropriate strategy to avoid unnecessary coronary interventions.

Aortic Valve Replacement with Bovine Pericardium in Patients with Aortic Valve Regurgitation.

This study aimed to analyze the early and mid-term outcomes of aortic valve replacement with bovine pericardium in the treatment of aortic valve regurgitation.From January 2015 to March 2018, 36 patients (19 men; mean ± standard deviation [SD] age, 46.70 ± 16.60 years) underwent aortic valve replacement with bovine pericardium. The bovine pericardium was intraoperatively measured and shaped using an Ozaki template, according to the shape and size of the individual patient's aortic valve leaflets. Additional procedures were performed, including ventricular septal defect repair in 5 cases, mitral valve reconstruction in 6 cases, tricuspid valve reconstruction in 6 cases, and coronary artery bypass grafting in 3 cases.There were no perioperative deaths. One elderly patient with postoperative respiratory failure recovered after symptomatic treatment. One patient with frequent ventricular tachycardia after intraoperative cardiac re-jump underwent intra-aortic balloon counterpulsation (IABP), and the IABP device was successfully removed on the second postoperative day. Within the first 6 months of follow-up, there were no death events, no reoperation events, and no additional thromboembolic events. Follow-up echocardiography was performed for 6 months, with average left ventricular ejection fraction of 62.01 ± 3.21%, mean transvalvular pressure gradient of 11.17 ± 4.90 mmHg, and mean aortic valve velocity of 1.60 ± 0.58 m/s. Compared with the preoperative transthoracic echocardiography findings, the results at the six-month follow-up were statistically significant (P < 0.05). Mild aortic valve regurgitation occurred in 2 patients (5.56%), whereas other patients had no or only minimal aortic valve regurgitation (n = 34, 94.44%). Moderate aortic valve regurgitation occurred in one patient at 9 months after the initial operation. This was found to be due to infective endocarditis, and a biological valve was finally implanted.Aortic valve replacement with bovine pericardium in the treatment of aortic valve regurgitation is feasible, and good early and mid-term results are achieved. Long-term results need to be followed up in the future.

P4716One-year outcomes of the tri-repair study assessing cardioband tricuspid valve reconstruction system for patients with severe tricuspid regurgitation

Abstract Background Severe tricuspid regurgitation (TR) is associated with high morbidity and mortality rates with limited treatment options. Objectives We report the one-year outcomes of the Cardioband™ Tricuspid Valve Reconstruction System in the treatment of severe functional TR in 30 patients enrolled in the TRI-REPAIR study. Methods Between October 2016 and July 2017, 30 patients were enrolled in this single-arm, multicenter, prospective study. Patients were diagnosed with severe, symptomatic TR in the absence of untreated left-heart disease and deemed inoperable because of unacceptable risk for open-heart surgery by the local heart team. Clinical, functional, and echocardiographic data were prospectively collected before and up to one year post-procedure. An independent core lab assessed all echocardiographic data and an independent clinical event committee adjudicated the safety events. Results Mean patient age was 75 years, 73% were females, 23% had ischemic heart disease, and 93% had atrial fibrillation. At baseline, 83% were in NYHA Class III-IV, 63% had edema, and LVEF was 58%. Technical success was 100%. Through one year, one patient had a reintervention and exited the study. Five patients died of which one was device-related. Between baseline and one year (paired analyses), echocardiography showed average reductions of annular septolateral diameter of 16% (44mm vs. 37mm; p&lt;0.0001), PISA EROA of 49% (0.73cm2 vs. 0.37cm2, p=0.0037), and mean vena contracta of 30% (1.2cm vs. 0.9cm, p=0.0046). Clinical assessment showed that at one year 78% of patients were in NYHA Class I-II (p=0.0003). Six minute walk distance improved by 42m (p=0.0525). Kansas City Cardiomyopathy Questionnaire score improved by 19 points (p=0.0009). Edema was absent in 70% of the patients. Conclusions These results show that the Cardioband tricuspid system performs as intended and appears to be safe in patients with symptomatic and severe functional TR. At one year significant reduction of TR through a sustained decrease of annular dimensions, improvements in heart failure symptoms, quality of life, and exercise capacity were observed. Further studies are warranted to validate these initial promising results. Acknowledgement/Funding Edwards Lifescieinces

TCT-93 Results From the Early Feasibility Study of Cardioband Tricuspid System for Functional Tricuspid Regurgitation

Severe tricuspid regurgitation (TR) is associated with high morbidity and mortality rates with limited treatment options. We report the 30-day outcomes of the Cardioband Tricuspid Valve Reconstruction System in the treatment of moderate and severe functional TR in the first 15 patients enrolled in

One-Year Outcomes of the TRI-REPAIR Study Assessing Cardioband Tricuspid Valve Reconstruction System for Patients with Functional Tricuspid Regurgitation

Background Severe tricuspid regurgitation (TR) is associated with high morbidity and mortality rates with limited treatment options. Objectives We report the one-year outcomes of the Cardioband™ Tricuspid Valve Reconstruction System in the treatment of severe functional TR in 30 patients enrolled in the TRI-REPAIR study. Methods Between October 2016 and July 2017, 30 patients were enrolled in this single-arm, multicenter, prospective study. Patients were diagnosed with severe, symptomatic TR in the absence of untreated left-heart disease and deemed inoperable because of unacceptable risk for open-heart surgery by the local heart team. Clinical, functional, and echocardiographic data were prospectively collected before and up to one year post-procedure. An independent core lab assessed all echocardiographic data and an independent clinical event committee adjudicated the safety events. Results Mean patient age was 75 years, 73% were females, 23% had ischemic heart disease, and 93% had atrial fibrillation. At baseline, 83% were in NYHA Class III-IV, 63% had edema, and LVEF was 58%. Technical success was 100%. Through one year, one patient had a reintervention and exited the study. Five patients died of which one was device-related. Between baseline and one year (paired analyses), echocardiography showed average reductions of annular septolateral diameter of 16% (44mm vs. 37mm; p Conclusions These results show that the Cardioband tricuspid system performs as intended and appears to be safe in patients with symptomatic and severe functional TR. At one year, significant reduction of TR through a sustained decrease of annular dimensions, improvements in heart failure symptoms, quality of life, and exercise capacity were observed. Further studies are warranted to validate these initial promising results.

Left ventricular assist device implantation with concomitant tricuspid valve repair: is there really a benefit?

The objectives of this study was to investigate if concomitant tricuspid valve repair in patients undergoing continuous flow left ventricular assist device (LVAD) implantation has an impact on the outcome regarding survival and adverse events. Between June 2007 and February 2018, 124 consecutive patients received HeartMate II (HMII) [74 (59.7%)] HeartWare (HVAD) [16 (12.9%)], or HeartMate III (HM III) [34 (27.4%)] for end-stage heart failure. Mean age was 63.5±10.9 years. Two 18-patient groups were identified; with [tricuspid valve reconstruction (TVR)] group and without (non-TVR group) accompanying TVR. The primary endpoint was overall survival after device implantation. Secondary endpoints were adverse events during the follow-up period. Survival was not significantly different between the groups (P>0.05). In TVR group, there was a higher need for open chest after surgery and a prolonged inotrope use because of right heart failure (RHF), a higher incidence of acute kidney dysfunction requiring dialysis, as well as a higher need for packed red blood cells due to postoperative bleeding (P<0.05). In this cohort of patients, LVAD implantation with a concurrent tricuspid valve repair appears to have a worse outcome regarding RHF, bleeding tendency and renal dysfunction (P<0.05). However, the survival was comparable in both TVR and Non-TVR groups (P>0.05).

6-Month Outcomes of Tricuspid Valve Reconstruction for Patients With Severe Tricuspid Regurgitation

BackgroundSevere tricuspid regurgitation (TR) is associated with high morbidity and mortality rates with limited treatment options. ObjectivesThe authors report the 6-month safety and performance of a transcatheter tricuspid valve reconstruction system in the treatment of moderate to severe functional TR in 30 patients enrolled in the TRI-REPAIR (TrIcuspid Regurgitation RePAIr With CaRdioband Transcatheter System) study. MethodsBetween October 2016 and July 2017, 30 patients were enrolled in this single-arm, multicenter, prospective trial. Patients were diagnosed with moderate to severe, symptomatic TR in the absence of untreated left-heart disease and deemed inoperable because of unacceptable risk for open-heart surgery by the local heart team. Clinical, functional, and echocardiographic data were prospectively collected before and up to 6 months post-procedure. An independent core lab assessed all echocardiographic data, and an independent clinical event committee adjudicated the safety events. ResultsMean patient age was 75 years, 73% were female, and 23% had ischemic heart disease. At baseline, 83% were in New York Heart Association (NYHA) functional class III to IV, and mean left ventricular ejection fraction was 58%. Technical success was 100%. Through 6 months, 3 patients died. Between 6 months and baseline, echocardiography showed average reductions of annular septolateral diameter of 9% (42 mm vs. 38 mm; p < 0.01), proximal isovelocity surface area effective regurgitant orifice area of 50% (0.8 cm2 vs. 0.4 cm2; p < 0.01), and mean vena contracta width of 28% (1.2 cm vs. 0.9 cm; p < 0.01). Clinical assessment showed that 76% of patients improved by at least 1 NYHA functional class with 88% in NYHA functional class I or II. Six-minute walk distance improved by 60 m (p < 0.01), and Kansas City Cardiomyopathy Questionnaire score improved by 24 points (p < 0.01). ConclusionsSix-month outcomes show that the system performs as intended and appears to be safe in patients with symptomatic and moderate to severe functional TR. Significant reduction of TR through decrease of annular dimensions, improvements in heart failure symptoms, quality of life, and exercise capacity were observed. Further studies are warranted to validate these initial promising results. (TrIcuspid Regurgitation RePAIr With CaRdioband Transcatheter System [TRI-REPAIR]; NCT02981953)

Mitral Valve Surgery in a Patient 50 Years after a Pneumonectomy

Background Patients who survive long after pneumonectomy may develop heart valve disease. The consecutive operations can be complex because of the challenging anatomical conditions and the limited physiologic reserves of the patient. Case Presentation The subject is a 78-year-old patient who underwent a left-sided pneumonectomy for a metastasized testicular tumor 50 years ago. At 32 and 37 years postpneumonectomy, mitral regurgitation was manifested, and valve repair was performed. Bioprosthetic mitral valve replacement and tricuspid valve reconstruction became necessary 44 years postpneumonectomy. The patient was fully recovered. Conclusion In case of relevant heart valve disease after pneumonectomies, heart valve surgeries are feasible.

Среднеотдаленные результаты реконструкции створок трикус- пидального клапана с использованием перикарда и неохорд при инфекционном эндокардите у кандидатов на протезирование клапана

Введение. Выбор метода хирургического лечения инфекционного эндокардита трикуспидального клапана (ИЭ ТК) остается открытым вопросом для обсуждения. Данное исследование обобщает наш опыт восстановления створок ТК при обширном поражении створок инфекционным процессом.

Six-Month Outcomes of the Tri-Repair Study Assessing the Cardioband Tricuspid Valve Reconstruction System for Patients with Severe Tricuspid Regurgitation

Background: Severe tricuspid regurgitation (TR) is associated with high morbidity and mortality rates with limited treatment options. We report the six-month safety and performance of the Cardioband™ Tricuspid Valve Reconstruction System in the treatment of severe functional TR in 30 patients enrolled in the TRI-REPAIR study. Methods: Between October 2016 and July 2017, 30 patients were enrolled in this single-arm, multicenter, prospective trial. Patients were diagnosed with severe, symptomatic TR in the absence of untreated left-heart disease and deemed inoperable because of unacceptable risk for open-heart surgery by the local heart team. Clinical, functional, and echocardiographic data were prospectively collected before and up to six months post-procedure. An independent core lab assessed all echocardiographic data and an independent Clinical Event Committee adjudicated the safety events. Findings: Mean patient age was 75 years and all patients presented with functional TR. At baseline, 25 (83%) patients were in NYHA Class III-IV and LVEF was 58%. Technical success was 100%. Through six months, three (10%) patients died. Between baseline and 6 months, echocardiography showed average reductions of annular septolateral diameter of 10% (41·9mm vs. 37·9mm; p=0·0014), PISA EROA of 48% (0·78cm2 vs. 0·41cm2, p=0·0004), and mean vena contracta of 28% (1·2cm vs. 0·9cm, p<0·0001). Clinical assessment showed that 19 (76%) of 25 patients improved by at least one NYHA Class with 22 (88%) in NYHA Class I-II (p<0·0001). Six minute walk distance improved by 78m (p=0.0035) and Kansas City Cardiomyopathy Questionnaire score improved by 25 points (p<0·0001). Interpretation: Six-month outcomes show that the Cardioband system performs as intended and appears to be safe in patients with symptomatic and severe functional TR. Significant reduction of TR through decrease of annular dimensions, improvements in heart failure symptoms, quality of life, and exercise capacity were observed. Further studies are warranted to validate these initial promising results. Clinical Trial Number: The study is registered in clinicaltrials.gov (NCT02981953). Funding Statement: Edwards Lifesciences. Declaration of Interests: GN, US, SB, and FD have received speakers’ honoraria as well as travel and grant support from Edwards Lifesciences. EA and RS have received speakers’ honoraria from Edwards Lifesciences. PV and PV are employees of Edwards Lifesciences. Ethics Approval Statement: The TRI-REPAIR study was conducted in conformity with the ethical principles set forth by the Declaration of Helsinki, Good Clinical Practice principles, and in accordance with ISO 14155:2011. The study was approved by local ethics committees and respective health authorities of the participating countries.