Transesophageal Echocardiography For The Assessment of Left Atrial Pressure After Trans-Septal Mitral Valve Interventions.

The measure of left atrial pressure (LAP) is an ideal marker for the clinical efficacy of transcatheter mitral valve intervention. Currently, only the invasive measurement of LAP (i-LAP) is available and no echocardiographic methods are reliable in the setting of transcatheter mitral valve intervention. This study sought to validate a new echocardiographic method for the estimation of LAP (e-LAP) by comparing it with i-LAP. During percutaneous edge-to-edge procedure with MitraClip, the i-LAP was routinely monitored. Across the iatrogenic interatrial septum defect, the flow was sampled with continuous-wave Doppler echocardiography for deriving the mean pressure gradient between the left atrium and the right atrium, and the central venous pressure was added to obtain the e-LAP. The correlation between the measures derived from these 2 methods was explored. A total of 34 consecutive patients were included. Intraclass correlation coefficient between e-LAP and i-LAP was high (intraclass correlation coefficient [95% confidence interval] 0.809 [0.625 to 0.902], R Pearson 0.6, p <0.001); a bias of -1.3 mm Hg for e-LAP versus i-LAP was found (p = 0.32). The median follow-up was 108 days (interquartile range 40 to 264). No death occurred and 6 patients were rehospitalized for heart failure. Postimplant e-LAP was correlated with rehospitalization at follow-up (hazard ratio 1.46, 95% confidence interval 1.022 to 2.1, p = 0.038). A cut-off value of 9.5 mm Hg for the e-LAP was identified as predictor of rehospitalization for heart failure. The evaluation of e-LAP has optimal reliability compared with i-LAP; a value more than 9.5 mm Hg was found to be related to higher risk of events at short follow-up.

Synchronized diaphragmatic stimulation for heart failure using the VisONE system: a first-in-patient study.

AIMS: Synchronized diaphragmatic stimulation (SDS) modulates intrathoracic and intra-abdominal pressures with favourable effects on cardiac function for patients with a reduced left ventricular ejection fraction (LVEF) and heart failure (HFrEF). VisONE-HF is a first-in-patient, observational study assessing the feasibility and 1 year effects of a novel, minimally invasive SDS device. METHODS AND RESULTS: The SDS system comprises a pulse generator and two laparoscopically delivered, bipolar, active-fixation leads on the inferior diaphragmatic surface. Fifteen symptomatic men with HFrEF and ischaemic heart disease receiving guideline-recommended therapy were enrolled (age 60 [56, 67] years, New York Heart Association class II [53%] /III [47%], LVEF 27 [23, 33] %, QRSd 117 [100, 125] ms, & N terminal pro brain natriuretic peptide [NT-proBNP] 1779 [911, 2,072] pg/mL). Implant success was 100%. Patients were evaluated at 3, 6, and 12 months for device-related or lead-related complications, quality of life (SF-36 QOL), 6 min hall walk distance (6MHWd), and by echocardiography. No implant procedure or SDS-related adverse event occurred, and patients were unaware of diaphragmatic stimulation. By 12 months, left ventricular end-systolic volume decreased (136 [123, 170] mL to 98 [89, 106] mL; P = 0.05), 6MHWd increased (315 [300, 330] m to 340 [315, 368] m; P = 0.004), and SF-36 QOL improved (physical scale 0 [0, 0] to 25 [0, 50], P = 0.006; emotional scale 0 [0, 33] to 33 [33, 67], P = 0.001). Although neither reached statistical significance, LVEF decreased (28 [23, 40]% vs. 34 [29, 38]%; P = ns) and NT-proBNP was lower (1784 [920, 2540] pg/mL vs. 1492 [879, 2028] pg/mL; P = ns). CONCLUSIONS: These data demonstrate the feasibility of laparoscopic implantation and delivery of SDS without raising safety concerns. These encouraging findings should be investigated further in adequately powered randomized trials.

Synchronized diaphragmatic stimulation: a case report of a novel extra-cardiac intervention for chronic heart failure.

Synchronized diaphragmatic stimulation (SDS) is a novel extra-cardiac device-based therapy for symptomatic heart failure with reduced ejection fraction. SDS provides imperceptible chronic stimulation of the diaphragm through a laparoscopically implanted system consisting of an implantable pulse generator and two sensing/stimulating leads affixed to the inferior surface of the diaphragm delivering imperceptible R-wave gaited pulses that alter intrathoracic pressure improving ventricular filling and cardiac output. We describe, in a man with a history of myocardial infarctions resulting in heart failure and persistent New York Heart Association Class III symptoms despite standard therapies, the successful implantation of SDS resulting in improved quality of life, N-terminal pro brain natriuretic peptide, cardiac function, and exercise tolerance through 12 months of follow-up. Randomized trials are now required to validate these findings.

Synchronized Diaphragmatic Stimulation for Heart Failure With a Reduced Left Ventricular Ejection Fraction Using the VisONE System: A First-in-Patient Study With Extended Population.

Background: Synchronized diaphragmatic stimulation (SDS) produces localized contractions of the diaphragm gated to the cardiac cycle to transiently modulate intrathoracic pressures, thereby impacting cardiac function for heart failure patients with reduced ejection fraction (HFrEF). This study prospectively evaluated the safety and 1-year effectiveness of SDS in an expanded first-in-patient cohort using multiple implant methods. Methods: Symptomatic patients with HFrEF despite guideline-directed therapy were enrolled. Patients were evaluated at 3, 6 and 12 months for adverse events, quality of life (SF-36 QOL), echocardiography and 6-minute hall walk distance. The SDS system consists of 2 bipolar, active-fixation leads, and an implantable pulse generator. Results: Nineteen men were enrolled (age 63 [57, 67] years, New York Heart Association class II [53%]/III [47%], N-terminal pro B-type natriuretic peptide 1779 [886, 2309] pg/mL, left ventricular ejection fraction 27 [23, 33] %). Three implant techniques (abdominal laparoscopy: sensing and stimulating leads on the inferior diaphragm (n = 15); subxiphoid access for an epicardial sensing lead and abdominal laparoscopy for stimulation on the inferior diaphragm (n = 2); thoracoscopy to place an epicardial sensing lead and a stimulating lead on the superior diaphragm (n = 2)) were employed with 100% success. Patients were unaware of diaphragmatic stimulation. From discharge to 12 months, 6-minute hall walk distance increased (315 [296, 332]m to 340 [319, 384]m; p = 0.002), left ventricular end-systolic volume decreased (135 [114, 140]mL to 99 [90, 105]mL; p = 0.04), and SF-36 QOL improved (physical scale 0 [0, 0] to 25 [0, 50], p = 0.004; emotional scale 0 [0, 33] to 67 [33, 67], p = 0.001). N-terminal pro B-type natriuretic peptide was lower (1784 [944, 2659]pg/mL vs. 962 [671, 1960]pg/mL; p = ns) and left ventricular ejection fraction increased (28 [23, 38]% vs. 35 [31, 40]%; p = ns) although neither reached statistical significance. There were no procedure- or SDS-related adverse events. Conclusions: These data demonstrate that SDS can be delivered using alternative implantation methods without raising safety concerns and suggest improved outcomes over 1 â€‹year of follow-up. Adequately powered randomized trials are now needed to confirm these findings.

TrueVue transillumination volume rendering for three-dimensional transoesophageal echocardiography in interventional imaging.

AIMS: The aim of the present article is to address the advantages of real-time TrueVue transillumination rendering for three-dimensional transoesophageal echocardiography in the context of echocardiographic procedural guidance for structural interventions for several procedural concerns. METHODS: Procedures in which transillumination imaging was used during at least one step of the whole intervention were retrospectively collected; the loops were reviewed by an experienced imaging specialist and the most important concerns imaged in the loops were listed. The apparent added value of transillumination for each of these concerns was scored independently by two imager specialists, and their agreement was derived. RESULTS: Between January and June 2019, 50 procedures were performed in our centre. Transillumination imaging was used in 64% of these cases. Considering all the loops the added value of transillumination compared with the conventional rendering was scored greater than 3 in a Likert scale in 87% of analysed loops by both the operators with a good agreement (κ  = 0.47, P  = 0.001). A different level of perceived advantage and agreement was observed between three image features that improved: substantial agreement (κ  = 0.652, P  = 0.001) for enhancing the contrast between structures and cavities (n  = 24 loops); good agreement for the contrast between different structures (κ  = 0.588, P  = 0.002) (n  = 37 loops); moderate agreement for the perception of interaction between the device and structures (κ  = 0.3, P  = 0.027) (n  = 7 loops). CONCLUSION: The use of new volume-rendering techniques in interventional imaging may be useful especially for solving the concerns regarding the cavity-structure contrast.

Outcomes of transcatheter tricuspid valve intervention by right ventricular function: a multicentre propensity-matched analysis.

BACKGROUND: Tricuspid regurgitation (TR) has a poor prognosis and limited treatment options and is frequently accompanied by right ventricular (RV) dysfunction. Transcatheter tricuspid valve interventions (TTVI) to reduce TR have been shown to be safe and feasible with encouraging early results. Patient selection for TTVI remains challenging, with the role of right ventricular (RV) function being unknown. AIMS: The aims of this study were 1) to investigate survival in a TTVI-treated patient population and a conservatively treated TR population, and 2) to evaluate the outcome of TTVI as compared to conservative treatment stratified according to the degree of RV function. METHODS: We studied 684 patients from the multicentre TriValve cohort (TTVI cohort) and compared them to 914 conservatively treated patients from two tertiary care centres. Propensity matching identified 213 pairs of patients with severe TR. As we observed a non-linear relationship of RV function and TTVI outcome, we stratified patients according to tricuspid annular plane systolic excursion (TAPSE) to preserved (TAPSE >17 mm), mid-range (TAPSE 13-17 mm) and reduced (TAPSE <13 mm) RV function. The primary outcome was one-year all-cause mortality. RESULTS: TTVI was associated with a survival benefit in patients with severe TR when compared to matched controls (one-year mortality rate: 13.1% vs 25.8%; p=0.031). Of the three RV subgroups, only in patients with mid-range RV function was TTVI associated with an improved survival (p log-rank 0.004). In these patients, procedural success was associated with a reduced hazard ratio for all-cause mortality (HR 0.22; 95% CI: 0.09, 0.57). CONCLUSIONS: TTVI is associated with reduced mortality compared to conservative therapy and might exert its highest treatment effect in patients with mid-range reduced RV function.

Exercise intolerance - from spiroergometry to transdiaphragmatic myocardial punch biopsy: a case report of isolated cardiac sarcoidosis.

BACKGROUND: Several aetiologies account for exercise intolerance, with cardiac sarcoidosis (CS) constituting a rare cause thereof. The pathogenesis of CS is still unresolved and its diagnosis still difficult to establish, in the absence of any extracardiac manifestations in particular. CASE SUMMARY: A 49-year-old amateur athlete presented with exercise intolerance during running over a 3-week period. Coronary artery and structural lung disease were excluded by coronary angiography and computer tomography. The symptoms could be reproduced during spiroergometry during which an exercise-induced high-degree atrioventricular (AV) block was documented. During electrocardiographic monitoring, a 2:1 AV block was observed. Different imaging modalities showed inferobasal septal inflammation and fibrosis. Transthoracic and transoesophageal echocardiography-guided endomyocardial biopsies were inconclusive and only subsequent epicardial biopsy performed by transdiaphragmatic minimally invasive surgery lead to the histological diagnosis of non-caseating granuloma, confirming CS. The patient was treated with high-dose steroids 1 week after implantation of a primary prevention dual-chamber implantable cardioverter-defibrillator (ICD). While tapering steroids, recurrence of myocardial inflammation occurred. However, no tachytherapies and <0.1% right ventricular pacing were needed after 2 years of follow-up. DISCUSSION: Differential diagnoses were either an infiltrative disease, a tumour, or an infectious disease. Due to the different treatment options, we had to establish definite diagnosis by myocardial biopsy. Retrospectively, the implantation of the ICD can be discussed. However, cardiac magnetic resonance imaging showed fibrosis which is usually irreversible and substrate for potentially lethal ventricular arrhythmia. Confirming the diagnosis of isolated CS is challenging. Long-term management should be guided individually based on clinical and imaging findings.

Bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction technique in transcatheter aortic valve-in-valve procedures: a single-center initial experience.

AIM: To describe six cases using the bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction technique to prevent coronary artery obstruction during transcatheter aortic valve-in-valve procedures. METHODS: All patients presented degeneration of a bovine pericardium bioprosthesis [four Trifecta (19, 21, 23, and 25 mm); two Mitroflow (25 and 27 mm)] resulting in severe aortic stenosis (n = 5) or severe aortic regurgitation (n = 1). Procedures were performed under fluoroscopic and echocardiography guidance, and the transfemoral access was used to deliver a self-expanding valve. Data are expressed as frequency or median (Q1-Q3). RESULTS: Age, EuroScore II, and Society of Thoracic Surgeons score were 81 years (75-83.2), 2.9% (2.6-10.7), and 2.7% (2.3-3.2), respectively. Median left and right coronary heights were 9.1 mm (6.2-10.3) and 12.4 mm (10-13.5), respectively, with a median virtual transcatheter heart valve-to-coronary distance of 2.9 mm on the left and 4.6 mm on the right side. Isolated left leaflet laceration was planned in four patients, and bileaflet in two. One unsuccessful right leaflet laceration was reported, corresponding to the first patient (success rate 87.5%). All other seven leaflets lacerations were successfully performed, with no intraprocedure complications. No coronary obstruction, in-hospital death, valve complication, cardiovascular event, or pacemaker implantation were reported. All patients are being followed in routine outpatient visits, and no adverse events were registered. CONCLUSION: The high procedural success and low complication rate reported in this initial experience, demonstrates that the bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction technique can be a viable solution to prevent coronary obstruction in selected patients undergoing valve-in-valve procedures. Operator experience, periprocedural imaging and teamwork are essential to enable an accurate and successful procedure.

Impact of Coronavirus Disease 2019 (COVID-19) Outbreak on Acute Admissions at the Emergency and Cardiology Departments Across Europe.

PURPOSE: We evaluated whether the severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) pandemic was associated with changes in the pattern of acute cardiovascular admissions across European centers. METHODS: We set-up a multicenter, multinational, pan-European observational registry in 15 centers from 12 countries. All consecutive acute admissions to emergency departments and cardiology departments throughout a 1-month period during the COVID-19 outbreak were compared with an equivalent 1-month period in 2019. The acute admissions to cardiology departments were classified into 5 major categories: acute coronary syndrome, acute heart failure, arrhythmia, pulmonary embolism, and other. RESULTS: Data from 54,331 patients were collected and analyzed. Nine centers provided data on acute admissions to emergency departments comprising 50,384 patients: 20,226 in 2020 compared with 30,158 in 2019 (incidence rate ratio [IRR] with 95% confidence interval [95%CI]: 0.66 [0.58-0.76]). The risk of death at the emergency departments was higher in 2020 compared to 2019 (odds ratio [OR] with 95% CI: 4.1 [3.0-5.8], P < 0.0001). All 15 centers provided data on acute cardiology departments admissions: 3007 patients in 2020 and 4452 in 2019; IRR (95% CI): 0.68 (0.64-0.71). In 2020, there were fewer admissions with IRR (95% CI): acute coronary syndrome: 0.68 (0.63-0.73); acute heart failure: 0.65 (0.58-0.74); arrhythmia: 0.66 (0.60-0.72); and other: 0.68(0.62-0.76). We found a relatively higher percentage of pulmonary embolism admissions in 2020: odds ratio (95% CI): 1.5 (1.1-2.1), P = 0.02. Among patients with acute coronary syndrome, there were fewer admissions with unstable angina: 0.79 (0.66-0.94); non-ST segment elevation myocardial infarction: 0.56 (0.50-0.64); and ST-segment elevation myocardial infarction: 0.78 (0.68-0.89). CONCLUSION: In the European centers during the COVID-19 outbreak, there were fewer acute cardiovascular admissions. Also, fewer patients were admitted to the emergency departments with 4 times higher death risk at the emergency departments.

Corrigendum to: Management of Tricuspid Regurgitation: The Role of Transcatheter Therapies.

[This corrects the article DOI: 10.15420/icr.2017:3:2.].

Functional mitral regurgitation and cardiac resynchronization therapy in the "era" of trans-catheter interventions: Is it time to move from a staged strategy to a tailored therapy?

Cardiac resynchronization therapy (CRT) has been associated to left ventricle (LV) remodelling, reduction of functional mitral regurgitation (FMR) and clinical improvement in patients with heart failure and reduced ejection fraction (HFrEF). The prevalence of significant FMR in patients with LV dyssynchrony that are candidate to CRT is up to 40%. Current approach in patients with FMR undergoing CRT consists of re-evaluation of the amount of FMR following a waiting period of at least 3 months after the implant. In case of persistent significant FMR despite CRT and guideline directed medical therapy, trancatheter Mitral Valve repair (TMVR) is an important option to improve quality of life and prognosis. This stepwise approach does not take into account the probability of the individual response to CRT and the availability of TMVR solutions that are safe and effective in high risk patients. We reviewed the effects of CRT on FMR, the prognostic role of persistence of FMR after CRT treatment and the impact of treatment of FMR in patients CRT non responders. We aimed to point out the limits of current step-wised approach in light on more recent evidence regarding FMR treatment. A new, "tailored" approached is proposed.

Conceiving MitraClip as a tool: percutaneous edge-to-edge repair in complex mitral valve anatomies.

Improvements in procedural technique and intra-procedural imaging have progressively expanded the indications of percutaneous edge-to-edge technique. To date in higher volume centres and by experienced operators MitraClip is used for the treatment of complex anatomies and challenging cases in high risk-inoperable patients. This progressive step is superimposable to what observed in surgery for edge-to-edge surgery (Alfieri's technique). Moreover, the results of clinical studies on the treatment of patients with high surgical risk and functional mitral insufficiency have confirmed that the main goal to be achieved for improving clinical outcomes of patients with severe mitral regurgitation (MR) is the reduction of MR itself. The MitraClip should therefore be considered as a tool to achieve this goal in addition to medical therapy. Nowadays, evaluation of patient's candidacy to MitraClip procedure, discussed in local Heart Team, must take into account not only the clinical features of patients but even the experience of the operators and the volume of the centre, which are mostly related to the probability to achieve good procedural results. This 'relative feasibility' of challenges cases by experienced operators should always been taken into account in selecting patients for MitraClip. Here, we present a review of the literature available on the treatment of complex and challenging lesions.

Impact of disproportionate secondary mitral regurgitation in patients undergoing edge-to-edge percutaneous mitral valve repair.

AIMS: The aim of this study was to evaluate the prognostic role of echocardiographic parameters assessing secondary mitral regurgitation (SMR) severity and left ventricular dimension, including proportionate versus disproportionate SMR, in MitraClip recipients. METHODS AND RESULTS: We analysed 137 patients undergoing MitraClip implantation for SMR at three centres. SMR was classified as proportionate or disproportionate based on the median value of the ratio between effective regurgitant orifice area (EROA) and left ventricular end-diastolic volume (LVEDV). The primary endpoint was a composite of cardiovascular mortality and heart failure hospitalisation at two-year follow-up. Mean age was 70±10 years, 80% were male, and median EuroSCORE II was 5.7%. No differences were observed in the disproportionate compared to the proportionate group except for a more severe NYHA class and their expected higher EROA and lower LVEDV. Number of clips deployed, device success and procedural success were similar between the two groups. Residual mitral regurgitation (MR) >1+ at 30 days was more common among patients with an EROA >0.42 cm2 compared to those with an EROA ≤0.42 cm2 (81.3% vs 58%; p=0.004). The relative risk of the primary endpoint was independent from any echocardiographic parameter, including the presence of disproportionate SMR. The only independent predictors of clinical events were EuroSCORE II >8%, NYHA class and residual MR >1+ at 30 days. CONCLUSIONS: Echocardiographic parameters, including the EROA/LVEDV ratio, do not have independent prognostic value in patients undergoing MitraClip implantation. High surgical risk, advanced symptoms and non-optimal MR reduction increase the relative risk of two-year clinical events.

Transcatheter Edge-to-Edge Tricuspid Repair for Severe Tricuspid Regurgitation Reduces Hospitalizations for Heart Failure.

OBJECTIVES: The goal of this study was to evaluate the effect of transcatheter edge-to-edge tricuspid valve repair (TTVR) for severe tricuspid regurgitation (TR) on hospitalization for heart failure (HHF) and HF-related endpoints. BACKGROUND: Patients with severe TR need effective therapies beyond conservative treatment. The impact of TTVR on HHF and HF-related endpoints is unknown. METHODS: Isolated TTVR was performed in 119 patients. Assessments were conducted of New York Heart Association functional class, 6-min walk distance, Minnesota Living with Heart Failure Questionnaire scores, N-terminal pro-B-type natriuretic peptide level, and medication. HHFs were analyzed in the preceding 12 months before and until the longest available follow-up after TTVR. Results were compared with those of 114 patients who underwent combined mitral and tricuspid valve repair. RESULTS: Procedural success with a reduction to moderate or less TR and no in-hospital death was achieved in 82% of patients. With a median follow-up of 360 days (interquartile range: 187 to 408 days), a durable TR reduction to moderate or less was achieved in 72% of patients (p < 0.001). TTVR reduced the annual rate of HHF by 22% (1.21 to 0.95 HHF/patient-year; p = 0.02), with concomitant clinical improvement in New York Heart Association functional class (patients in class II or lower: 9% to 67%; p < 0.001), 6-min walk distance (+39 m; p = 0.001), and Minnesota Living with Heart Failure Questionnaire score (-6 points; p = 0.02). N-terminal pro-B-type natriuretic peptide level decreased numerically by 783 pg/ml. Diuretic dose before TTVR was increased, but HF medication did not change after TTVR. Procedural success was associated with improved 1-year survival (79% vs. 60%; p = 0.04) and event-free-survival (death + first HHF: 67% vs. 40%; p = 0.001). Transcatheter mitral and tricuspid valve repair-treated patients had comparable outcomes. CONCLUSIONS: TTVR for severe TR is associated with a reduction of HHF and improved clinical outcomes.

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

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

Automated Implantation of Artificial Mitral Chords: Preliminary Results From the Feasibility Trial.

PURPOSE: A novel chordal system enables automated implantation of artificial mitral chords to treat mitral regurgitation (MR). This article summarizes the first-in-man initial clinical results. DESCRIPTION: The CHAGALL (CHordArt system study for the treatment of mitral ReGurgitAtion due to leaflet proLapse or fLail) trial is a single arm, multicenter, prospective study to test the feasibility of this system for mitral repair. The interim clinical and echocardiographic results of the first 5 patients with a 12-month follow-up are presented. EVALUATION: Five patients (mean age, 64 years) with severe MR received implantation of neochords with this device under cardiopulmonary bypass. Technical success was obtained in all patients. Transesophageal echocardiogram showed either no or trace residual MR (<1+/4+) after repair. Survival at 30 days was 100%, and no device-related complication occurred. Reduction of MR was sustained up to 12 months. CONCLUSIONS: This novel chordal system is promising because it greatly facilitates the deployment of neochords to repair the mitral valve. Results at 12 months are encouraging. The device is currently under development for transcatheter approach.