Transcatheter mitral valve repair for functional mitral regurgitation using the Cardioband system: 1 year outcomes.

Aims: The Cardioband™ (Edwards Lifesciences) is a transcatheter implant designed to reduce mitral annulus size and mitral regurgitation (MR) severity. We report the 1-year outcomes of consecutive patients who underwent the Cardioband procedure between 2013 and 2016. Methods and results: Sixty patients with moderate or severe secondary MR (72 ± 7 years, 60% ischaemic origin) on guideline-recommended medical therapy were treated and analyzed at 11 European institutions. There were two in-hospital deaths (none device-related), one stroke, two coronary artery complications, and one tamponade. Anchor disengagement, observed in 10 patients (all but one in the first half of the population), resulted in device inefficacy in five patients and led to device modification half way through the study to mitigate this issue. Technical, device, and procedural successes, assessed based on Mitral Valve Academic Research Consortium (MVARC) criteria, were 97% (58/60), 72% (43/60), and 68% (41/60), respectively. At 1-year, overall survival, survival free of readmission for heart failure, and survival free of reintervention (performed in seven patients) were 87%, 66%, and 78%, respectively. In the overall population, MR grade at 12 months was moderate or less 61% and moderate or less in 95% of the 39 patients who underwent a transthoracic echocardiography at 1-year [but worsened by at least one grade in 11 patients (22%)]. Functional status (79% vs. 14% in New York Heart Association Class I/II), quality of life (-19 points on the Minnesota Living with Heart Failure Questionnaire score), and exercise capacity (+58 m by 6MWT) improved significantly (all P < 0.01). Conclusion: In this multicentre trial, the Cardioband mitral system demonstrated reasonable performance and safety. At 1 year, most patients had moderate or less MR and experienced significant functional improvements. A randomized controlled trial is underway to demonstrate the impact of Cardioband in patients on guideline-directed medical therapy.

Effect of Bone Marrow-Derived Mononuclear Cell Treatment, Early or Late After Acute Myocardial Infarction: Twelve Months CMR and Long-Term Clinical Results.

RATIONALE: Intracoronary delivery of autologous bone marrow-derived mononuclear cells (BM-MNC) may improve remodeling of the left ventricle (LV) after acute myocardial infarction (AMI). OBJECTIVE: To demonstrate long-term efficacy of BM-MNC treatment after AMI. METHODS AND RESULTS: In a multicenter study, we randomized 200 patients with large AMI in a 1:1:1 pattern into an open-labeled control and 2 BM-MNC treatment groups. In the BM-MNC groups, cells were either administered 5 to 7 days (early) or 3 to 4 weeks (late) after AMI. Cardiac magnetic resonance imaging was performed at baseline and after 12 months. The current analysis investigates the change from baseline to 12 months in global LV ejection fraction, LV volumes, scar size, and N-terminal pro-brain natriuretic peptide values comparing the 2 treatment groups with control in a linear regression model. Besides the complete case analysis, multiple imputation analysis was performed to address for missing data. Furthermore, the long-term clinical event rate was computed. The absolute change in LV ejection fraction from baseline to 12 months was -1.9±9.8% for control (mean±SD), -0.9±10.5% for the early treatment group, and -0.7±10.1% for the late treatment group. The difference between the groups was not significant, both for complete case analysis and multiple imputation analysis. A combined clinical end point occurred equally in all the groups. Overall, 1-year mortality was low (2.25%). CONCLUSIONS: Among patients with AMI and LV dysfunction, treatment with BM-MNC either 5 to 7 days or 3 to 4 weeks after AMI did not improve LV function at 12 months, compared with control. The results are limited by an important drop out rate. CLINICAL TRIAL REGISTRATION INFORMATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00355186.

Cardioband, a transcatheter surgical-like direct mitral valve annuloplasty system: early results of the feasibility trial.

AIMS: Cardioband system is a direct annuloplasty adjustable device that is implanted in the beating heart on the posterior annulus under fluoroscopic and transoesophageal echocardiographic (TEE) guidance. We report the early (1 month) outcomes of the first-in-man pre-CE-mark feasibility and safety trial. METHODS AND RESULTS: The study enrolled high-risk adult individuals at five institutions in Europe with symptomatic secondary mitral regurgitation (MR) despite optimal medical therapy. The primary efficacy endpoints included the technical success rate of implantation, feasibility of the Cardioband adjustment (technical performance), and ability to reduce the annular septolateral dimension and MR grade at hospital discharge and at 30 days. The study group included 31 consecutively enrolled high-risk patients with moderate-to-severe or severe secondary MR with at least 1 month of follow-up (mean age 71.8 ± 6.9 years). All patients received the full implant of a Cardioband. Adjustment of the Cardioband resulted in a significant reduction in the septolateral dimension in all but two patients (septolateral dimension from 36.8 ± 4.8 to 29 ± 5.5 mm after the procedure, P < 0.01). Following Cardioband adjustment (29 of 31 patients) MR was none or trace in 6 (21%), mild in 21 (72%), and moderate in 2 (7%). No patient had severe MR after adjustment. Procedural mortality was zero and in-hospital mortality was 6.5% (2 of 31 patients, neither procedure- nor device-related). At 30 days, 22 of the 25 patients (88%) had MR ≤2+. CONCLUSIONS: This study demonstrates the feasibility and safety of percutaneous direct mitral annuloplasty with the Cardioband device in high-risk patients with MR.

Intracoronary injection of bone marrow-derived mononuclear cells early or late after acute myocardial infarction: effects on global left ventricular function.

BACKGROUND: Intracoronary administration of autologous bone marrow-derived mononuclear cells (BM-MNC) may improve remodeling of the left ventricle (LV) after acute myocardial infarction. The optimal time point of administration of BM-MNC is still uncertain and has rarely been addressed prospectively in randomized clinical trials. METHODS AND RESULTS: In a multicenter study, we randomized 200 patients with large, successfully reperfused ST-segment elevation myocardial infarction in a 1:1:1 pattern into an open-labeled control and 2 BM-MNC treatment groups. In the BM-MNC groups, cells were administered either early (i.e., 5 to 7 days) or late (i.e., 3 to 4 weeks) after acute myocardial infarction. Cardiac magnetic resonance imaging was performed at baseline and after 4 months. The primary end point was the change from baseline to 4 months in global LV ejection fraction between the 2 treatment groups and the control group. The absolute change in LV ejection fraction from baseline to 4 months was -0.4±8.8% (mean±SD; P=0.74 versus baseline) in the control group, 1.8±8.4% (P=0.12 versus baseline) in the early group, and 0.8±7.6% (P=0.45 versus baseline) in the late group. The treatment effect of BM-MNC as estimated by ANCOVA was 1.25 (95% confidence interval, -1.83 to 4.32; P=0.42) for the early therapy group and 0.55 (95% confidence interval, -2.61 to 3.71; P=0.73) for the late therapy group. CONCLUSIONS: Among patients with ST-segment elevation myocardial infarction and LV dysfunction after successful reperfusion, intracoronary infusion of BM-MNC at either 5 to 7 days or 3 to 4 weeks after acute myocardial infarction did not improve LV function at 4-month follow-up. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00355186.

Impact of cardiac computed tomography of the interatrial septum before pulmonary vein isolation.

BACKGROUND: Multidetector computed tomography (MDCT) may be useful to identify patients with patent foramen ovale (PFO). The aim of this study was to analyze whether a MDCT performed before pulmonary vein isolation reliably detects a PFO that may be used for access to the left atrium. METHODS AND RESULTS: In 79 consecutive patients, who were referred for catheter ablation of symptomatic paroxysmal or persistent atrial fibrillation (AF), the presence of a PFO was explored by MDCT and transesophageal echocardiography (TEE). TEE was considered as the gold standard, and quality of TEE was good in all patients. In 16 patients (20.3%), MDCT could not be used for analysis because of artifacts, mainly because of AF. On TEE, a PFO was found in 15 (23.8%) of the 63 patients with usable MDCT. MDCT detected six PFO of which four were present on TEE. This corresponded to a sensitivity of 26.7%, a specificity of 95.8%, a negative predictive value of 80.7%, and a positive predictive value of 66.7%. The receiver operating characteristics curve of MDCT for the detection of PFO was 0.613 (95% confidence interval 0.493-0.732). CONCLUSIONS: MDCT may detect a PFO before pulmonary isolation. However, presence of AF may lead to artifacts on MDCT impeding a meaningful analysis. Furthermore, in this study sensitivity and positive predictive value of MDCT were low and therefore MDCT was not a reliable screening tool for detection of PFO.

Cardiovascular magnetic resonance imaging for diagnosis and clinical management of suspected cardiac masses and tumours.

AIMS: To evaluate the diagnostic accuracy of cardiovascular magnetic resonance (CMR) imaging from a risk-stratification and therapeutic-management perspective in patients with suspected cardiac tumours. METHODS AND RESULTS: Cardiovascular magnetic resonance exams of 41 consecutive patients (aged 61 ± 14 years, 21 men) referred for evaluation of a suspected cardiac mass were reviewed for tumour morphology and signal characteristics in various unenhanced and contrast-enhanced sequences. Cardiovascular magnetic resonance-derived diagnosis and treatment were compared with clinical outcome and histology in patients undergoing surgery or autopsy (n = 20). In 18 of 41 patients, CMR excluded masses or reclassified them as normal variants; all were treated conservatively. In 23 of 41 patients, CMR diagnosed a neoplasm (14 'benign', 8 'malignant', and 1 'equivocal'); 18 of these patients were operated on, 2 managed conservatively, and 3 by palliation. During follow-up of 705 (inter-quartile range 303-1472) days, 13 patients died. No tumour-related deaths occurred in conservatively managed patients. Patients with a CMR-based diagnosis and treatment of benign tumour had a similar survival as patients without detectable tumour. Compared with histology, CMR correctly classified masses as 'benign or malignant' in 95% of the cases. Tumour perfusion, invasiveness, localization, and pericardial fluid were valuable to distinguish between malignant and benign tumours. Soft tissue contrast and signal intensity patterns in various sequences were valuable for excluding neoplastic lesions and helped to obtain tissue characterization at the histological level in selected tumour cases, respectively. CONCLUSION: Comprehensive CMR provides a confident risk-stratification and clinical-management tool in patients with suspected tumours. Patients where CMR excludes tumours can be managed conservatively.

Impact of preload changes on positive and negative left ventricular dP/dt and systolic time intervals: preload changes on left ventricular function.

AIM/OBJECTIVES: Previous work has shown that the electromechanical activation time (EMAT) is prolonged in patients with abnormally low left ventricular (LV) dP/dt. In the present study, we investigated whether EMAT was responsive to rapid changes in LV systolic function induced by abrupt increases in LV preload. METHODS AND RESULTS: A total of 116 patients were assessed before and after LV angiography with a bolus injection of 40 mL of non-ionic contrast dye. Left ventricular end-diastolic pressure (LVEDP) increased from 18 ± 7 mmHg to 20 ± 8 mmHg (P < 0.01). In patients with a baseline dP/dt < 1500 mmHg/sec, dP/dt increased from 1098 ± 213 mmHg/sec to 1146 ±306 mmHg/sec (P=0.02) and EMAT decreased from 106 ± 29 ms to 103 ±18 ms (P=0.02). In patients with a baseline dP/dt > 1500 mmHg/sec, dP/dt decreased from 1894 ± 368 mmHg/sec to 1762 ± 403 mmHg/sec (P=0.01) and EMAT increased from 88 ± 13 ms to 93 ± 16 ms (P=0.02). Changes in negative dP/dt were similar to changes in dP/dt. CONCLUSION: Electromechanical activation time is a non-invasively measured parameter that allows accurate and rapid detection of changes in LV contractility.

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 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.

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.

Thromboembolic acute myocardial infarction in a congenital double chambered left ventricle.

A 61-year-old woman with a congenital double-chamber left ventricle (DCLV) was admitted because of an anterior ST-elevation myocardial infarction (STEMI). Urgent coronary angiography showed a thrombotic occlusion of the distal part of the left anterior descending artery (LAD). The left ventricular injection revealed a slightly reduced ejection fraction, antero-apical akinesia and an accessory chamber. Two dimensional and three dimensional echocardiography showed anterior akinesia with an accessory chamber at the apex which was separated by a fibromuscular ridge distal to the papillary muscles. The DCLV with myocardial contraction in the additional chamber was originally diagnosed seven years ago during a routine follow-up echocardiography in the course of management for thyroid cancer and at that time left ventricular function was described to be normal. Thromboembolism was assumed to have originated from the hypocontractile left accessory chamber and the patient was set on oral anticoagulation. During follow-up global left ventricular function normalized.

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.