Long-term follow-up of a patient undergoing interatrial shunt device implantation for treatment of heart failure with a preserved ejection fraction.

We herein present a case study of a patient with heart failure with a preserved ejection fraction and severe symptoms who underwent interatrial shunt device implantation and follow-up at a tertiary care heart failure clinic. The interatrial shunt device implantation was successful. No adverse events occurred, and the device prevented hospitalization for heart failure during long-term follow-up.

Intracardiac Echocardiography-Guided Left Atrial Appendage Closure With a Novel Foam-Based Conformable Device: Safety and 1-Year Outcomes.

OBJECTIVES: This is a first report of the safety and 1-year outcomes of left atrial appendage closure (LAAC) using a novel foam-based conformable device, guided by intracardiac echocardiography (ICE). BACKGROUND: Limitations of current transcatheter LAAC devices include the need for precise coaxial delivery into the left atrial appendage (LAA), potential for traumatic implantation, incomplete LAA seal, and device-related thrombus. METHODS: The device (Conformal Left Atrial Appendage Seal, Conformal Medical Inc) is a self-expanding occluder consisting of a cylindrical nitinol endoskeleton with low-profile anchor barbs around the midpoint, covered with a porous foam cup. In a prospective single-center series, under conscious sedation, the device was delivered under fluoroscopic and ICE guidance. After positioning, a transesophageal echocardiography probe was placed to confirm ICE findings before device release. After closure, dual antiplatelet therapy was administered for 6 months. Follow-up imaging was planned for 45 days and 6 and 12 months. RESULTS: A total of 15 patients (age 71.3 ± 10.8 years, 33% men, CHA2DS2-VASc 4.1 ± 1.7, HAS-BLED 3.4 ± 1.4) underwent LAAC, 100% successfully. There were no procedure/device-related complications requiring intervention. Asymptomatic pericardial effusion occurred in 2 patients. The 45-day, 6-month, and 12-month follow-up imaging in 11, 9, and 13 patients, respectively, revealed adequate LAA seal (leak ≤5 mm) in all patients; device-related thrombus was detected in 1 patient at 6 months. Over 1-year follow-up, there were no ischemic strokes and 1 minor bleed. Nonprocedure-/device-related death occurred in 2 patients. CONCLUSIONS: This first report indicates that LAAC with the conformable implant guided by ICE imaging is feasible with encouraging 1-year clinical outcomes. (The Conformal Prague Study; NCT04193826).

Long-Term Results of Hybrid Left Ventricular Reconstruction in the Treatment of Ischemic Cardiomyopathy.

The evidence supporting surgical aneurysmectomy in ischemic heart failure is inconsistent. The aim of the study was to describe long-term effect of minimally invasive hybrid transcatheter and minithoracotomy left ventricular (LV) reconstruction in patients with ischemic cardiomyopathy. Twenty-three subjects with transmural anterior wall scarring, LV ejection fraction 15-45%, and New York Heart Association class ≥ II were intervened using Revivent TC anchoring system. LV end-systolic volume index was reduced from 73.2 ± 27 ml at baseline to 51.5 ± 22 ml after 6 months (p < 0.001), 49.9 ± 20 ml after 2 years (p < 0.001), and 56.1 ± 16 ml after 5 years (p = 0.047). NYHA class improved significantly at 5 years compared to baseline. Six-min walk test distance increased at 2 years compared to the 6-month visit. Hybrid LV reconstruction using the anchoring system provides significant and durable LV volume reduction during 5-year follow-up in preselected patients with ischemic heart failure. Legend: Hybrid left ventricular reconstruction using the anchoring system provides significant and durable LV volume reduction throughout 5-year follow-up in preselected patients with ischemic heart failure.

Intracardiac echocardiography-guided implantation of the Watchman FLX left atrial appendage closure device.

BACKGROUND: The next-generation Watchman FLX left atrial appendage closure (LAAC) device has: (1) an atraumatic closed distal end, (2) reduced height, (3) a recessed screw hub to decrease device-related thrombus (DRT), (4) two rows of J-shape anchors so redeployment is possible after full recapture, and (5) ability to treat a greater size range of LAA ostia. OBJECTIVE: To report, for the first time, the feasibility and safety of intracardiac echocardiography (ICE)-guided Watchman FLX implantation. METHODS: A single-center prospective registry of atrial fibrillation patients planned for LAAC with the FLX device underwent ICE-guided implantation with conscious sedation. Transesophageal echocardiography (TEE) imaging was done preprocedure (to assess LAA size and exclude thrombus) and at clinical follow-up at 6-12 weeks. Clinical outcomes were LAA closure success, complications, leak, or DRT on follow-up TEE and major safety events. RESULTS: The study included 30 patients: age 75 ± 8 years, 53% men, CHA2 DS2 -VASc 4.6 ± 1.6, and HAS-BLED 3.4 ± 1.1. The primary indication was prior bleeding in 60% (72% GI bleeding). The LAA orifice width and length were 22.7 ± 3.1 and 25.7 ± 5.7 mm, respectively. Technical success was 100% (the first-choice device was used in 28 of 30). Procedure time was less than 30 min in 27 of 30 cases, with 36 ± 15 ml contrast used. The final device size was 29.2 ± 4.7 mm with 21.6 ± 4.5% compression. There were no procedure-related complications. Follow-up TEE at a median 47 days follow-up showed 100% device success with no DRT or peridevice leak ≥5 mm. Major safety events occurred in 6.6% (2/30). CONCLUSION: The Watchman FLX device can be safely implanted with intraprocedural ICE imaging instead of TEE.

Pacemaker-Mediated Programmable Hypertension Control Therapy.

BACKGROUND: Many patients requiring a pacemaker have persistent hypertension with systolic blood pressures above recommended levels. We evaluated a pacemaker-based Programmable Hypertension Control (PHC) therapy that uses a sequence of variably timed shorter and longer atrioventricular intervals. METHODS AND RESULTS: Patients indicated for dual-chamber pacing with office systolic blood pressure (oSBP) >150 mm Hg despite stable medical therapy were implanted with a Moderato™ pulse generator that delivers PHC therapy. Patients were followed for 1 month (Run-In period) with conventional pacing; those with persistent oSBP >140 mm Hg were included in the study and had PHC therapy activated. The co-primary efficacy end points were changes in 24-hour ambulatory systolic blood pressure and oSBP between baseline and 3 months. Safety was assessed by tracking adverse events. Thirty-five patients met the initial inclusion criteria and underwent Moderato implantation. At 1 month, oSBP was <140 mm Hg in 7 patients who were excluded. PHC was activated in the remaining 27 patients with baseline office blood pressure 166±11/80±10 mm Hg despite an average of 3.2 antihypertensive medications. During the Run-In period, oSBP and 24-hour ambulatory systolic blood pressure decreased by 8±13 and 5±12 mm Hg (P<0.002), respectively. Compared with pre-PHC activation measurements, oSBP decreased by another 16±15 mm Hg and 24-hour ambulatory systolic blood pressure decreased by an additional 10±13 mm Hg (both P<0.01) at 3 months. No device-related serious adverse effects were noted. CONCLUSIONS: In pacemaker patients with persistent hypertension despite medical therapy, oSBP and 24-hour ambulatory systolic blood pressure are decreased by PHC therapy. Initial indications are that this therapy is a safe and promising therapy for such patients. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT02282033.

Assessment of left ventricular diastolic function by radionuclide ventriculography in patients with chronic heart failure and reduced ejection fraction.

STUDY OBJECTIVE: To compare parameters of diastolic function as assessed by radionuclide ventriculography (RNVG) and Doppler echocardiography (ECHO) in the patients with chronic heart failure and reduced ejection fraction (HF REF). PATIENTS AND METHODS: RNVG and ECHO were performed on the same day in 40 patients with systolic chronic HF, NYHA II and III, with LV EF < 50 % and sinus rhythm, followed at tertiary HF clinic. Diastolic function was assessed by RNVG using parameters: PFR (peak filling rate [% SV/sec]), TFR - time to peak filling rate (ms), and by ECHO using pulse Doppler parameters: the peak Doppler velocities of early (E) and late diastolic flow (A), the E/A ratio, the calculated mean of the early (E´) diastolic velocity of septal and lateral mitral annulus measured by tissue Doppler imaging, and the E/E´ ratio. RESULTS: The mean PFR was 421.7 (median 371.0) % SV/sec and TPF was 198.7 ms (median 169.5), the mean E/A ratio was 1.21 (median 0.85) and the E/E´ ratio was 9.0 (median 8.40). TPF correlated significantly (inverse correlation) with the E/A ratio (r = -0.34, p = 0.030), and not significantly with E´ (r = -0.27, p = 0.082), the PFR/age ratio correlated with the E/E´ ratio (r = -0.31, p = 0.05). CONCLUSION: Significant correlations of parame-ters of diastolic function as assessed by radionuclide and Doppler studies were identified in the HF REF patients.

Incomplete occlusion of the left atrial appendage with the percutaneous left atrial appendage transcatheter occlusion device is not associated with increased risk of stroke.

BACKGROUND: Percutaneous approaches to left atrial appendage (LAA) closure are being developed for stroke prophylaxis in atrial fibrillation patients as an alternative to warfarin. Non-randomized clinical trials suggested that the first of these devices, the percutaneous left atrial appendage transcatheter occlusion (PLAATO) device, is safe and reduces stroke risk. Percutaneous closure has the potential limitation of incomplete exclusion of LAA from the systemic circulation, which could potentially lead to thrombus formation and stroke. This study investigated the interaction between residual blood flow in the LAA after percutaneous closure with PLAATO and risk of stroke. METHODS AND RESULTS: Data from the PLAATO trial current as of July 2010 was used for this analysis (n = 22). Mechanical occlusion using the PLAATO device was used in 22 patients (age 68 ± 5, CHADS(2) score = 3.03 ± 0.6). Warfarin and clopidogrel were stopped during follow-up in all but one patient due to development of pulmonary emboli. After an average follow-up of 58 ± 9 months, four out of 22 patients (16.7%) developed a new ischemic stroke/TIA, translating to an annualized embolic rate of 3.63%. There were no differences in the demographics (age, sex, and CHADS(2) score) among patients with and without stroke. Cardiac CT documented peri-device leak in three out of four patients with stroke and in seven out of nine (75% vs. 77%, p = 0.706) patients without stroke that agreed to have a follow-up cardiac CT (Chi squared with Yates correction for this interaction = 0.012, p = 0.912). TEE corroborated these results but failed to identify peri-device leak in three patients without stroke. CONCLUSIONS: The main finding of our analysis suggests that in long-term follow-up, residual flow after LAA occlusion with the PLAATO device, as documented by cardiac CT, is ubiquitous but is not associated with an increased risk of stroke.

Reproducibility of tissue Doppler parameters of asynchrony in patients with advanced LV dysfunction.

AIMS: To assess the reproducibility of tissue Doppler myocardial velocities in patients with dilated ventricles and markedly reduced systolic function (ejection fraction <35%). METHODS AND RESULTS: Forty-one patients referred for cardiac resynchronization therapy (CRT) were evaluated using tissue Doppler echocardiography. The inter and intra-individual reproducibility of peak systolic myocardial velocities and the intra-ventricular delay in three apical projections was assessed by repeated evaluation of each registered data set. Variability (measured by the coefficient of variation) ranged between 18 and 56% for the peak systolic velocities and between 32 and 117% for the time intervals. CONCLUSION: The reproducibility of the tissue Doppler echocardiography parameters (peak systolic myocardial velocity and intra-ventricular delay) was poor in our set of patients with dilated left ventricles and low ejection fraction. The most probable causes of our poor results are discussed including the missing standardization of the TDI measurements.

Use of intracardiac echocardiography to guide implantation of a left atrial appendage occlusion device (PLAATO).

BACKGROUND: Over 90% of thrombi in atrial fibrillation (AF) originate from the left atrial appendage (LAA). Patients with contraindications to anticoagulation are potential candidates for LAA occlusion using the Percutaneous Left Atrial Appendage Transcatheter Occlusion system (PLAATO, ev3 Inc., Plymouth, MN). Transesophageal echocardiography (TEE) is typically used to guide implantation. OBJECTIVE: This study sought to examine the utility of intracardiac echocardiography (ICE) in providing adequate imaging guidance as an alternative to TEE during PLAATO implantation. METHODS: The study group consisted of 10 patients who underwent PLAATO implantation with simultaneous TEE and ICE imaging guidance. ICE was used to perform the following tasks typically fulfilled by TEE: (1) verification of the absence of LAA thrombus, (2) identification of the LAA ostial dimension for device sizing, (3) guidance of transseptal puncture, (4) verification of the delivery sheath position, and (5) confirmation of location and stability of device before its irrecoverable release. The ability of ICE to perform these tasks was assessed from three separate positions: the standard right atrial (RA) position, within the coronary sinus (CS), and the right ventricular outflow tract. RESULTS: ICE imaging of the LAA was optimal from within the CS, although imaging from the proximal pulmonary artery provided better visualization of the distal LAA in cross-section. The LAA dimensions, confirmation of the absence of LAA thrombus, proper positioning of the delivery sheath, verification of location and stability of the device obtained by ICE were consistent with findings from TEE. CONCLUSION: Using nonconventional imaging planes, ICE imaging was able to perform the intraprocedural functions provided by TEE during implantation of the PLAATO left atrial appendage occlusion device.

Role of echocardiography in percutaneous occlusion of the left atrial appendage.

UNLABELLED: Percutaneous occlusion of the left atrial appendage (LAA) is a modern alternative for the treatment of patients with atrial fibrillation (AF) and with a high risk of stroke who are not eligible for long-term anticoagulation therapy. Echocardiography plays a significant role in selecting patients, guiding the procedure, and in the post-procedural follow-up. OBJECTIVES AND METHODS: To test the role of transesophageal echocardiography (TEE) and intracardiac echocardiography (ICE) in facilitating and shortening the procedure. RESULTS: ICE represents a more convenient approach in patients who are not under generally anesthesia and helps to facilitate transseptal puncture. On the other hand, TEE, having the ability to rotate the image plane, helps to better determine the position of the occluder. CONCLUSIONS: Echocardiographic guidance of this procedure is essential. Which approach will be preferred will depend on the development of these two methods.