First-in-human clinical series of a novel conformable large-lattice pulsed field ablation catheter for pulmonary vein isolation.

AIMS: Pulsed field ablation (PFA) has significant advantages over conventional thermal ablation of atrial fibrillation (AF). This first-in-human, single-arm trial to treat paroxysmal AF (PAF) assessed the efficiency, safety, pulmonary vein isolation (PVI) durability and one-year clinical effectiveness of an 8 Fr, large-lattice, conformable single-shot PFA catheter together with a dedicated electroanatomical mapping system. METHODS AND RESULTS: After rendering the PV anatomy, the PFA catheter delivered monopolar, biphasic pulse trains (5-6 s per application; ∼4 applications per PV). Three waveforms were tested: PULSE1, PULSE2, and PULSE3. Follow-up included ECGs, Holters at 6 and 12 months, and symptomatic and scheduled transtelephonic monitoring. The primary and secondary efficacy endpoints were acute PVI and post-blanking atrial arrhythmia recurrence, respectively. Invasive remapping was conducted ∼75 days post-ablation. At three centres, PVI was performed by five operators in 85 patients using PULSE1 (n = 30), PULSE2 (n = 20), and PULSE3 (n = 35). Acute PVI was achieved in 100% of PVs using 3.9 ± 1.4 PFA applications per PV. Overall procedure, transpired ablation, PFA catheter dwell and fluoroscopy times were 56.5 ± 21.6, 10.0 ± 6.0, 19.1 ± 9.3, and 5.7 ± 3.9 min, respectively. No pre-defined primary safety events occurred. Upon remapping, PVI durability was 90% and 99% on a per-vein basis for the total and PULSE3 cohort, respectively. The Kaplan-Meier estimate of one-year freedom from atrial arrhythmias was 81.8% (95% CI 70.2-89.2%) for the total, and 100% (95% CI 80.6-100%) for the PULSE3 cohort. CONCLUSION: Pulmonary vein isolation (PVI) utilizing a conformable single-shot PFA catheter to treat PAF was efficient, safe, and effective, with durable lesions demonstrated upon remapping.

Results of a 4-Year Follow Up of Patients with Paroxysmal and Persistent Atrial Fibrillation after Cryoablation.

Background and Objectives: Cryoablation is an established treatment method for atrial fibrillation (AF). We present the long-term results of cryoablation in 94 patients with paroxysmal and persistent AF treated in our center. Materials and Methods: This was an observational, retrospective study of 94 patients who underwent a cryoablation procedure for paroxysmal or persistent AF from 2015 to 2017. The follow up was 51 ± 3 months. The absence of arrhythmia was checked at 6, 12, 24, and 48 months after the procedure with 24 h Holter monitoring. We evaluated echocardiography parameters before and 48 months after cryoablation. The quality of life was assessed by calculating EHRA scores at each visit. Results: The mean history of pre-procedural AF duration was 55.3 ± 8.6 months. Paroxysmal AF was present in 42% of patients and persistent AF in 58%. Comparing the EHRA classes, a statistically significant difference was observed between the score assessed before the procedure and the score after one year, as well as when comparing the rates before the procedure and four years after the procedure (p < 0.000). The recurrence of AF was observed in 22.3% of patients 1 year after the procedure, in 26.6% of patients 2 years after the procedure, and in 34% of patients 4 years after the procedure; 9.3% of them were left in permanent AF. During the observation period, 28% of patients underwent a repeated pulmonary vein isolation procedure, and 6% of patients had a permanent pacemaker implanted. Five hematomas (5%) and one instance of phrenic nerve palsy (1%) were observed during the procedure. Conclusions: The rate of arrhythmia recurrence increased every year after cryoablation. Quality of life improved after the procedure, despite the recurrence of AF. A quarter of patients had to undergo a repeat pulmonary vein isolation procedure.

Aborted Cardiac Arrest in LQT2 Related to Novel KCNH2 (hERG) Variant Identified in One Lithuanian Family.

Congenital long QT syndrome (LQTS) is a hereditary ion channelopathy associated with ventricular arrhythmia and sudden cardiac death starting from young age due to prolonged cardiac repolarization, which is represented by QT interval changes in electrocardiogram (ECG). Mutations in human ether-à-go-go related gene (KCNH2 (7q36.1), formerly named hERG) are responsible for Long QT syndrome type 2 (LQT2). LQT2 is the second most common type of LQTS. A resuscitated 31-year-old male with the diagnosis of LQT2 and his family are described. Sequencing analysis of their genomic DNA was performed. Amino acid alteration p.(Ser631Pro) in KCNH2 gene was found. This variant had not been previously described in literature, and it was found in three nuclear family members with different clinical course of the disease. Better understanding of genetic alterations and genotype-phenotype correlations aids in risk stratification and more effective management of these patients, especially when employing a trigger-specific approach to risk-assessment and individually tailored therapy.

Correction to: Prevalence and prognostic value of late gadolinium enhancement on CMR in aortic stenosis: meta-analysis.

The original version of this article, published on 12 August 2019, unfortunately contained a mistake. The funding note was incorrect; the correct funding note is given below.

Prevalence and prognostic value of late gadolinium enhancement on CMR in aortic stenosis: meta-analysis.

OBJECTIVES: The aim of this study was to investigate the prevalence and prognostic value of late gadolinium enhancement (LGE), as assessed by cardiovascular magnetic resonance (CMR) imaging, in patients with aortic stenosis. METHODS AND RESULTS: A systematic search of PubMed and EMBASE was performed, and observational cohort studies that analysed the prevalence of LGE and its relation to clinical outcomes in patients with aortic stenosis were included. Odds ratios were used to measure an effect of the presence of LGE on both all-cause and cardiovascular mortality. Nineteen studies were retrieved, accounting for 2032 patients (mean age 69.8 years, mean follow-up 2.8 years). We found that LGE is highly prevalent in aortic stenosis, affecting half of all patients (49.6%), with a non-infarct pattern being the most frequent type (63.6%). The estimated extent of focal fibrosis, expressed in % of LV mass, was equal to 3.83 (95% CI [2.14, 5.52], p < 0.0001). The meta-analysis showed that the presence of LGE was associated with increased all-cause (pooled OR [95% CI] = 3.26 [1.72, 6.18], p = 0.0003) and cardiovascular mortality (pooled OR [95% CI] = 2.89 [1.90, 4.38], p < 0.0001). CONCLUSIONS: LGE by CMR is highly prevalent in aortic stenosis patients and exhibits a substantial value in all-cause and cardiovascular mortality prediction. These results suggest a potential role of LGE in aortic stenosis patient risk stratification. KEY POINTS: • Up to the half of aortic stenosis patients are affected by myocardial focal fibrosis. • Sixty-four percent of focal fibrosis detected by LGE-CMR is non-infarct type. • The presence of focal fibrosis triples all-cause and cardiovascular mortality.

Prognostic value of myocardial fibrosis in severe aortic stenosis: study protocol for a prospective observational multi-center study (FIB-AS).

BACKGROUND: Adverse cardiac remodeling with a myocardial fibrosis as a key pathophysiologic component may be associated to worse survival in aortic stenosis (AS) patients. Therefore, with the application of advanced cardiac imaging we aim to investigate left ventricular myocardial fibrosis in severe AS patients undergoing aortic valve replacement (AVR) and determine its impact with post-intervention clinical outcomes. METHODS: In a prospective, observational, cohort study patients with severe AS scheduled either for surgical or transcatheter AVR will be recruited from two tertiary heart centers in Denmark and Lithuania. All patients will receive standard of care in accordance with the current guidelines and will undergo additional imaging testing before and after AVR: echocardiography with deformation analysis and cardiovascular magnetic resonance (CMR) with T1 parametric mapping. Those undergoing surgical AVR will also have a myocardial biopsy sampled at the time of a surgery for histological validation. Patients will be recruited over a 2-year period and followed up to 2 years to ascertain clinical outcomes. Follow-up CMR will be performed 12 months following AVR, and echocardiography with deformation analysis will be performed 3, 12, and 24 months following AVR. The study primary outcome is a composite of all-cause mortality and major adverse cardiovascular events. DISCUSSION: Despite continuous effort of research community there is still a lack of early predictors of left ventricular decompensation in AS, which could improve patient risk stratification and guide the optimal timing for aortic valve intervention, before irreversible left ventricular damage occurs. Advanced cardiac imaging and CMR derived markers of diffuse myocardial fibrosis could be utilized for this purpose. FIB-AS study is intended to invasively and non-invasively assess diffuse myocardial fibrosis in AS patients and investigate its prognostic significance in post-interventional outcomes. The results of the study will expand the current knowledge of cardiac remodeling in AS and will bring additional data on myocardial fibrosis and its clinical implications following AVR. ETHICS/DISSEMINATION: The study has full ethical approval and is actively recruiting patients. The results will be disseminated through scientific journals and conference presentations. TRIAL REGISTRATION: ClinicalTrials.govNCT03585933. Registered on 02 July 2018.

Anesthetic Management and Procedural Outcomes of Patients Undergoing Off-Pump Transapical Implantation of Artificial Chordae to Correct Mitral Regurgitation: Case Series of 76 Patients.

BACKGROUND: Transapical implantation of artificial chordae using the NeoChord system (NeoChord Inc, Minneapolis, MN) is an emerging beating-heart technique for correction of mitral regurgitation (MR) through a minimally invasive left minithoracotomy. The purpose of the study was to describe the anesthetic management and procedural success of patients undergoing this procedure. METHODS: All patients (n = 76) who underwent mitral valve repair with the NeoChord system in our institution from December 2011 to December 2016 were included in this observational prospective study. Balanced anesthesia with a combination of fentanyl, propofol, and sevoflurane was used in all patients. Each patient's core temperature was maintained at >36°C whenever possible. Two- and 3-dimensional transesophageal echocardiography was used in all patients to navigate the device to the posterior mitral valve leaflet (68 of 76 patients), anterior mitral valve leaflet (3 of 76 patients), or both leaflets (5 of 76 patients). After effective leaflet capture, the artificial chordae were deployed. Position and function of the artificial chordae were assessed by evaluating the degree of MR when the neochordae were tensed. After surgery, all patients were transferred to the intensive care unit. RESULTS: The mean age of the patients was 60 ± 13 years (range, 33-87 years), and the male/female ratio was 52/24. Most patients had severe MR (grade 4+ in 25 [33%] patients, grade 3+ in 51 [67%] patients). The average preoperative EuroSCORE II was 1.23% ± 1.16% (range, 0.46%-4.23%). The median duration of the procedure was 120 minutes (interquartile range [IQR] 115-145 minutes). After the procedure, 42 (56%) patients had trivial MR, 27 (36%) had grade 1+ MR, 4 (5%) had grade 2+ MR, and 2 (3%) had >2+ MR. One patient underwent conversion to conventional mitral valve repair due to perforation of the posterior mitral valve leaflet. The whole procedure was well tolerated by the patients, with hemodynamics remaining stable in the majority of the cases. Only 20 (26%) patients needed low-dose inotropic support perioperatively. All patients had an uneventful postoperative course. The median time to extubation was 4 hours (IQR, 2.6-6), and the length of intensive care unit stay was 22 hours (IQR, 21-24). Five (6.6%) patients required allogeneic blood products. CONCLUSIONS: Anesthesia for transapical NeoChord implantation can be safely performed under beating-heart conditions, with low perioperative morbidity and rare blood transfusions. Transesophageal echocardiography is crucial for the guidance, safety, and effectiveness of the procedure.

Left atrial strain - an early marker of left ventricular diastolic dysfunction in patients with hypertension and paroxysmal atrial fibrillation.

BACKGROUND: 2D strain imaging of the left atrium (LA) is a new echocardiographic method which allows us to determine contractile, conduit and reservoir functions separately. This method is particularly useful when changes are subtle and not easily determined by traditional parameters, as it is in arterial hypertension and atrial fibrillation (AF). THE AIMS OF OUR STUDY WERE: to determine LA contractile, conduit and reservoir function by 2D strain imaging in patients with mild arterial hypertension and paroxysmal AF; to assess LA contractile, conduit and reservoir functions' relation with LV diastolic dysfunction (DD) parameters. METHODS: LA contractile, conduit and reservoir functions together with echocardiographic signs of LV DD were assessed in 63 patients with arterial hypertension and paroxysmal AF. Patients were grouped according to number of signs showing LV DD (annular e' velocity: septal e' < 7 cm/s, lateral e' < 10 cm/s, average E/e' ratio > 14, LA volume index > 34 ml/m2, peak tricuspid regurgitation velocity > 2.8 m/s) present. Number of patients with 0 signs - 17, 1 sign - 26, 2 signs - 19. Contractile, conduit and reservoir functions were compared between the groups. RESULTS: Mean contractile, conduit and reservoir strains in all the patients were - 14.14 (± 5.83) %, 15.98 (± 4.85) % and 31.03 (± 7.64) % respectively. Contractile strain did not differ between the groups. Conduit strain was higher in patients with 0 signs compared with other groups (p = 0.016 vs 1 sign of LV DD and p = 0.001 vs 2 signs of LV DD). Reservoir strain was higher in patients with 0 signs compared with other groups (p = 0.014 vs 1 sign of LV DD and p < 0.001 vs 2 signs of LV DD). CONCLUSIONS: The patients with paroxysmal AF and primary arterial hypertension have decreased reservoir, conduit and pump LA functions even in the absence of echocardiographic signs of LV DD. With increasing number of parameters showing LV DD, LA conduit and reservoir functions decrease while contractile does not change. LA conduit and reservoir functions decrease earlier than the diagnosis of LV DD can be established according to the guidelines in patients with primary arterial hypertension and AF.

Findings of transoesophageal echocardiogram in appropriately anticoagulated patients with persistent atrial fibrillation prior to planned cardioversion.

BACKGROUND: To evaluate a diagnostic value of transoesophageal echocardiogram (TEE) in appropriately anticoagulated patients with a non-valvular atrial fibrillation (AF) and to establish possible additional indications for TEE; to evaluate the incidence of left atrial (LA) thrombi in appropriately anticoagulated patients in daily clinical practice. METHODS: This retrospective study analyses data of 432 patients who had been anticoagulated by means of oral anticoagulants (OACs) prior to planned cardioversion during the period from 2012 to 2015. Thromboembolic (TE) and bleeding risks were assessed using CHA2DS2-VASc and HAS-BLED scores. Transthoracic and transoesophageal echocardiograms were evaluated. TE complications during 30 days after discharge were assessed. RESULTS: 432 patients were selected, aged from 22 to 89 years (mean 65.0 ±11.5), 277 (64.1%) males and 155 (35.9%) females, 306 (70.8%) on warfarin and 126 (29.2%) on non-vitamin K antagonist oral anticoagulants (NOAC). Mean CHA2DS2-VASc score was 3.5 ±1.5. TEE was performed for 120 (27.8%) patients, more frequently for patients on NOACs and for ones with III° LA enlargement. TEE revealed LA thrombi in seven (5.8%) of the patients. In warfarin and NOACs groups thrombi were revealed in five (7.0%) and two (4.1%) patients, respectively. TEE did not reveal any thrombi in patients with normal left ventricular (LV) function; however, thrombi were found in two (6.1%) patients with slightly decreased LV function, and in five (17.9%) patients with markedly decreased LV function. In patients with decreased left ventricular ejection fraction (LVEF) thrombi in LA were found more frequently than in patients with normal and slightly decreased LVEF (17.9% vs 2.2%, p=0.008). CHA2DS2-VASc score of all 7 patients was ≥5. None of the patients after cardioversion had TE complications 30 days after discharge. CONCLUSIONS: The risk of LA thrombi in patients prepared for scheduled cardioversion in line with the guidelines is low. Higher risk of thrombi was present in patients with decreased LVEF (≤40%), CHA2DS2-VASc ≥5. In order to assess more accurately indications to perform TEE for appropriately anticoagulated patients prior to scheduled cardioversion a study with larger number of patients is required.

Auscultatory versus oscillometric blood pressure measurement in patients with atrial fibrillation and arterial hypertension.

BACKGROUND: The aim of our study was to investigate the reliability of automated oscillometric blood pressure (BP) monitoring in the presence and absence of atrial fibrillation (AF) in hypertensive patients. METHODS: BP was measured and compared in 71 randomly selected patients with AF and arterial hypertension diagnosis, 4 times each by auscultatory and oscillometric (Microlife BP A6 PC with AF detection system) methods. RESULTS: Study included 71 patients: 36 males (mean age 67.4 years) and 35 females (70.2 years). At the time of BP measuring procedure, 36 patients were in sinus rhythm (SR) and 35 in AF. In SR patients mean systolic blood pressure (SBP) was 132 ± 17.9 mmHg with auscultatory method (AM), 137.4 ± 19.4 mmHg with oscillometric method (OM); mean diastolic BP was 77.1 ± 10.9 mmHg (AM), 78.5 ± 12.2 mmHg (OM), in AF patients mean SBP was 127.5 ± 15.1 mmHg (AM), 133.6 ± 17.4 mmHg (OM); mean diastolic BP was 81.4 ± 9.9 mmHg (AM), 83.5 ± 11.8 mmHg (OM), p = 0.037. The averages of differences for SBP and DBP in sinus rhythm group were (-5.3 mmHg (95% limits of agreement -27.2 - 16.6)) and (-1.4 mmHg (95% limits of agreement -12.8 - 10.0)), respectively. In patients with AF the averages of differences for SBP and DBP were (-6.1 mmHg (95% limits of agreement -23.9 - 11.7)) and (-2.1 mmHg (95% limits of agreement -12.9 - 8.7)), respectively. CONCLUSIONS: The oscillometric device validated for patients with AF on average gives 5.3 mmHg higher systolic BP values for patients with SR and 6.3 mmHg higher BP values for patients with AF. However, the limits of agreement between two methods reveal wide range of random error rates which is a questionable topic in clinical practice, as it could possibly affect the treatment of arterial hypertension in patients with AF.

Evaluation of atrial fibrillation management and cardiovascular risk profile in atrial fibrillation patients: A cross-sectional survey.

OBJECTIVE: The aim of this study to investigate the most frequent risk factors of atrial fibrillation (AF), co-morbidities, complications associated with AF and the use of anticoagulants and other medications in patients who were referred to university hospitals in Lithuania. MATERIALS AND METHODS: This cross-sectional study enrolled consecutive inpatients and outpatients with AF presenting to cardiologists in the two biggest Lithuanian university hospitals from November 2013 to May 2014. AF diagnosis was confirmed by a 12-lead ECG or 24-h Holter with an episode duration of >30s. RESULTS: A total number of 575 patients were recruited, and complete data on clinical subtype were available for 515 patients (mean age of 70.7 years; 48.5% of women). Permanent AF was the most frequent type of AF (46.6%). Common comorbidities were hypertension (85.8%), heart failure (77.9%) and coronary artery disease (51.8%). Amiodarone was the most common antiarrhythmic agent used in 14.6% of the patients, while beta-blockers and digoxin were the most often used rate control drugs (59.6% and 10.7%, respectively). Oral anticoagulants were used by 53.3% of the patients; of them, 95.6% used vitamin K antagonists, while non-vitamin K antagonist were used by only 4.4%. The INR within a therapeutic range (2.0-3.0) was documented in 19.2% of the patients. Other antithrombotic drugs such as aspirin and clopidogrel were used in 13.7% and 2.0% of the patients, respectively; dual antiplatelet treatment was administered in 6.2% of the patients. Of the entire cohort, the mean CHA2DS2-VASc score was 3.97±1.6 and the mean HAS-BLED score was 2.25±1.0. CONCLUSIONS: Compliance with the treatment guidelines remains suboptimal and further patient education is needed.

Long-Term Results of the Mini Maze Standalone Bi-Atrial Surgical Ablation: A 10-Year Follow-Up.

Background: One way to treat atrial fibrillation is through surgical ablation. However, the literature only provides information on patient follow-up results for up to 5 years. Methods: In order to assess long-term monitoring data over ten years, this retrospective study included 58 patients with paroxysmal or persistent atrial fibrillation who underwent Mini Maze surgical ablation at Santaros Clinics between 1 February 2009 and 1 June 2014. The follow-up time after surgery was 144 ± 48 months. We evaluated the absence of atrial fibrillation, echocardiographic and clinical parameters, and EHRA score. Results: Sinus rhythm remained in 69.4%, 75.5%, 55.6%, and 44.1% of patients with paroxysmal AF, and 68,2%, 59.1%, 50%, and 41.9% of patients with persistent AF (p = 0.681). In the post-operative period, one patient (1.7%) had a transient ischemic attack, and another patient (1.7%) had a thoracotomy for post-operative bleeding. A total of 20% of patients were diagnosed with a post-operative respiratory tract infection. EHRA scores showed that patients' quality of life improved after they underwent Mini Maze surgical ablation. Conclusions: Despite AF recurrences after surgery, quality of life remains better than before surgery, showing that Mini Maze surgery is an effective and safe second-line treatment method for atrial fibrillation.

Reversible Pulsed Electrical Fields as an In Vivo Tool to Study Cardiac Electrophysiology: The Advent of Pulsed Field Mapping.

BACKGROUND: During electrophysiological mapping of tachycardias, putative target sites are often only truly confirmed to be vital after observing the effect of ablation. This lack of mapping specificity potentiates inadvertent ablation of innocent cardiac tissue not relevant to the arrhythmia. But if myocardial excitability could be transiently suppressed at critical regions, their suitability as targets could be conclusively determined before delivering tissue-destructive ablation lesions. We studied whether reversible pulsed electric fields (PFREV) could transiently suppress electrical conduction, thereby providing a means to dissect tachycardia circuits in vivo. METHODS: PFREV energy was delivered from a 9-mm lattice-tip catheter to the atria of 12 swine and 9 patients, followed by serial electrogram assessments. The effects on electrical conduction were explored in 5 additional animals by applying PFREV to the atrioventricular node: 17 low-dose (PFREV-LOW) and 10 high-dose (PFREV-HIGH) applications. Finally, in 3 patients manifesting spontaneous tachycardias, PFREV was applied at putative critical sites. RESULTS: In animals, the immediate post-PFREV electrogram amplitudes diminished by 74%, followed by 78% recovery by 5 minutes. Similarly, in patients, a 69.9% amplitude reduction was followed by 84% recovery by 3 minutes. Histology revealed only minimal to no focal, superficial fibrosis. PFREV-LOW at the atrioventricular node resulted in transient PR prolongation and transient AV block in 59% and 6%, while PFREV-HIGH caused transient PR prolongation and transient AV block in 30% and 50%, respectively. The 3 tachycardia patients had atypical atrial flutters (n=2) and atrioventricular nodal reentrant tachycardia. PFREV at putative critical sites reproducibly terminated the tachycardias; ablation rendered the tachycardias noninducible and without recurrence during 1-year follow-up. CONCLUSIONS: Reversible electroporation pulses can be applied to myocardial tissue to transiently block electrical conduction. This technique of pulsed field mapping may represent a novel electrophysiological tool to help identify the critical isthmus of tachycardia circuits.

A Focal Ablation Catheter Toggling Between Radiofrequency and Pulsed Field Energy to Treat Atrial Fibrillation.

BACKGROUND: Because of its safety, "single-shot" pulsed field ablation (PFA) catheters have been developed for pulmonary vein isolation (PVI). However, most atrial fibrillation (AF) ablation procedures are performed with focal catheters to permit flexibility of lesion sets beyond PVI. OBJECTIVES: This study sought to determine the safety and efficacy of a focal ablation catheter able to toggle between radiofrequency ablation (RFA) or PFA to treat paroxysmal or persistent AF. METHODS: In a first-in-human study, a focal 9-mm lattice tip catheter was used for PFA posteriorly and either irrigated RFA (RF/PF) or PFA (PF/PF) anteriorly. Protocol-driven remapping was at ∼3 months postablation. The remapping data prompted PFA waveform evolution: PULSE1 (n = 76), PULSE2 (n = 47), and the optimized PULSE3 (n = 55). RESULTS: The study included 178 patients (paroxysmal/persistent AF = 70/108). Linear lesions, either PFA or RFA, included 78 mitral, 121 cavotricuspid isthmus, and 130 left atrial roof lines. All lesion sets (100%) were acutely successful. Invasive remapping of 122 patients revealed improvement of PVI durability with waveform evolution: PULSE1: 51%; PULSE2: 87%; and PULSE3: 97%. After 348 ± 652 days of follow-up, the 1-year Kaplan-Meier estimates for freedom from atrial arrhythmias were 78.3% ± 5.0% and 77.9% ± 4.1% for paroxysmal and persistent AF, respectively, and 84.8% ± 4.9% for the subset of persistent AF patients receiving the PULSE3 waveform. There was 1 primary adverse event-inflammatory pericardial effusion not requiring intervention. CONCLUSIONS: AF ablation with a focal RF/PF catheter allows efficient procedures, chronic lesion durability, and good freedom from atrial arrhythmias-for both paroxysmal and persistent AF. (Safety and Performance Assessment of the Sphere-9 Catheter and the Affera Mapping and RF/PF Ablation System to Treat Atrial Fibrillation; NCT04141007 and NCT04194307).

Six-lead electrocardiography compared to single-lead electrocardiography and photoplethysmography of a wrist-worn device for atrial fibrillation detection controlled by premature atrial or ventricular contractions: six is smarter than one.

Background: Smartwatches are commonly capable to record a lead-I-like electrocardiogram (ECG) and perform a photoplethysmography (PPG)-based atrial fibrillation (AF) detection. Wearable technologies repeatedly face the challenge of frequent premature beats, particularly in target populations for screening of AF. Objective: To investigate the potential diagnostic benefit of six-lead ECG compared to single-lead ECG and PPG-based algorithm for AF detection of the wrist-worn device. Methods and results: From the database of DoubleCheck-AF 249 adults were enrolled in AF group (n = 121) or control group of SR with frequent premature ventricular (PVCs) or atrial (PACs) contractions (n = 128). Cardiac rhythm was monitored using a wrist-worn device capable of recording continuous PPG and simultaneous intermittent six-lead standard-limb-like ECG. To display a single-lead ECG, the six-lead ECGs were trimmed to lead-I-like ECGs. Two diagnosis-blinded cardiologists evaluated reference, six-lead and single-lead ECGs as "AF", "SR", or "Cannot be concluded". AF detection based on six-lead ECG, single-lead ECG, and PPG yielded a sensitivity of 99.2%, 95.7%, and 94.2%, respectively. The higher number of premature beats per minute was associated with false positive outcomes of single-lead ECG (18.80 vs. 5.40 beats/min, P < 0.01), six-lead ECG (64.3 vs. 5.8 beats/min, P = 0.018), and PPG-based detector (13.20 vs. 5.60 beats/min, P = 0.05). Single-lead ECG required 3.4 times fewer extrasystoles than six-lead ECG to result in a false positive outcome. In a control subgroup of PACs, the specificity of six-lead ECG, single-lead ECG, and PPG dropped to 95%, 83.8%, and 90%, respectively. The diagnostic value of single-lead ECG (AUC 0.898) was inferior to six-lead ECG (AUC 0.971) and PPG-based detector (AUC 0.921). In a control subgroup of PVCs, the specificity of six-lead ECG, single-lead ECG, and PPG was 100%, 96.4%, and 96.6%, respectively. The diagnostic value of single-lead ECG (AUC 0.961) was inferior to six-lead ECG (AUC 0.996) and non-inferior to PPG-based detector (AUC 0.954). Conclusions: A six-lead wearable-recorded ECG demonstrated the superior diagnostic value of AF detection compared to a single-lead ECG and PPG-based AF detection. The risk of type I error due to the widespread use of smartwatch-enabled single-lead ECGs in populations with frequent premature beats is significant.

The AF-FICIENT magnetic resonance imaging and endoscopy safety substudy: A visually guided radiofrequency balloon ablation catheter for pulmonary vein isolation.

BACKGROUND: Early experience with a novel multielectrode saline-irrigated radiofrequency balloon (RFB) catheter with an integrated camera system found that it was safe and effective in performing single-shot pulmonary vein isolation (PVI) for atrial fibrillation. OBJECTIVE: The purpose of this study was to further assess potential treatment risks by looking for subclinical events. METHODS: The study was performed at 2 sites. Patients underwent PVI by RFB. A control group underwent conventional point-by-point radiofrequency ablation. Stroke scale questionnaire and brain magnetic resonance imaging (MRI) were performed before and after the ablation procedure, and esophageal endoscopy was performed after the procedure in RFB patients only. RESULTS: We enrolled 27 patients in the RFB group and 15 patients in the control group. The RFB and control groups were well matched [predominantly male: 62% vs 53%; CHA2DS2-VASc score: 1.9 ± 1.3 vs 1.5 ± 1.6; mean age 60 years in both groups]. All patients underwent successful ablation and completed study assessments. Clinically silent, new MRI diffusion weighted imaging cerebral lesions were observed in 8 patients (30%) in the RFB group and 1 patient (7%) in the control group, and 11 susceptibility weighted imaging lesions in the RFB group and 1 in the control group. Endoscopy showed a minor thermal injury in 1 patient in the RFB group. CONCLUSION: An increased rate of clinically silent cerebral events was seen in the RFB group. A low rate of esophageal thermal injury was observed.

Exploring myocardial fibrosis in severe aortic stenosis: echo, CMR and histology data from FIB-AS study.

Myocardial fibrosis in aortic stenosis is associated with worse survival following aortic valve replacement. We assessed myocardial fibrosis in severe AS patients, integrating echocardiographic, cardiovascular magnetic resonance (CMR) and histological data. A total of 83 severe AS patients (age 66.4 ± 8.3, 42% male) who were scheduled for surgical AVR underwent CMR with late gadolinium enhancement and T1 mapping and global longitudinal strain analysis. Collagen volume fraction was measured in myocardial biopsies (71) that were sampled at the time of AVR. Results. CVF correlated with imaging and serum biomarkers of LV systolic dysfunction and left side chamber enlargement and was higher in the sub-endocardium compared with midmyocardium (p<0.001). CVF median values were higher in LGE-positive versus LGE-negative patients [28.7% (19-33) vs 20.7% (15-30), respectively, p=0.040]. GLS was associated with invasively (CVF; r=-0.303, p=0.013) and non-invasively (native T1; r=-0.321, p<0.05) measured myocardial fibrosis. GLS and native T1 correlated with parameters of adverse LV remodelling, systolic and diastolic dysfunction and serum biomarkers of heart failure and myocardial injury. Conclusion. Our data highlight the role of myocardial fibrosis in adverse cardiac remodelling in AS. GLS has potential as a surrogate marker of myocardial fibrosis, and high native T1 and low GLS values differentiated patients with more advanced cardiac remodelling.

High Specificity Wearable Device With Photoplethysmography and Six-Lead Electrocardiography for Atrial Fibrillation Detection Challenged by Frequent Premature Contractions: DoubleCheck-AF.

Background: Consumer smartwatches have gained attention as mobile health (mHealth) tools able to detect atrial fibrillation (AF) using photoplethysmography (PPG) or a short strip of electrocardiogram (ECG). PPG has limited accuracy due to the movement artifacts, whereas ECG cannot be used continuously, is usually displayed as a single-lead signal and is limited in asymptomatic cases. Objective: DoubleCheck-AF is a validation study of a wrist-worn device dedicated to providing both continuous PPG-based rhythm monitoring and instant 6-lead ECG with no wires. We evaluated its ability to differentiate between AF and sinus rhythm (SR) with particular emphasis on the challenge of frequent premature beats. Methods and Results: We performed a prospective, non-randomized study of 344 participants including 121 patients in AF. To challenge the specificity of the device two control groups were selected: 95 patients in stable SR and 128 patients in SR with frequent premature ventricular or atrial contractions (PVCs/PACs). All ECG tracings were labeled by two independent diagnosis-blinded cardiologists as "AF," "SR" or "Cannot be concluded." In case of disagreement, a third cardiologist was consulted. A simultaneously recorded ECG of Holter monitor served as a reference. It revealed a high burden of ectopy in the corresponding control group: 6.2 PVCs/PACs per minute, bigeminy/trigeminy episodes in 24.2% (31/128) and runs of ≥3 beats in 9.4% (12/128) of patients. AF detection with PPG-based algorithm, ECG of the wearable and combination of both yielded sensitivity and specificity of 94.2 and 96.9%; 99.2 and 99.1%; 94.2 and 99.6%, respectively. All seven false-positive PPG-based cases were from the frequent PVCs/PACs group compared to none from the stable SR group (P < 0.001). In the majority of these cases (6/7) cardiologists were able to correct the diagnosis to SR with the help of the ECG of the device (P = 0.012). Conclusions: This is the first wearable combining PPG-based AF detection algorithm for screening of AF together with an instant 6-lead ECG with no wires for manual rhythm confirmation. The system maintained high specificity despite a remarkable amount of frequent single or multiple premature contractions.

30-Day and 1-Year Outcomes With HYDRA Self-Expanding Transcatheter Aortic Valve: The Hydra CE Study.

OBJECTIVES: This study sought to evaluate the 30-day and 1-year safety and performance of the Hydra transcatheter aortic valve (THV) (in the treatment of symptomatic severe aortic stenosis in patients at high or extreme surgical risk. BACKGROUND: The Hydra THV is a novel repositionable self-expanding system with supra-annular bovine pericardial leaflets. METHODS: The Hydra CE study was a premarket, prospective, multicenter, single-arm study conducted across 18 study centers in Europe and Asia-Pacific countries. The primary endpoint was all-cause mortality at 30 days. All endpoints were adjudicated by an independent clinical events committee. RESULTS: A total of 157 patients (79.2 ± 7.1 years of age, 58.6% female; Society of Thoracic Surgeons score 4.7 ± 3.4%) were enrolled. Successful implantation was achieved in 94.3% cases. At 30 days, there were 11 (7.0%) deaths, including 9 (5.7%) cardiovascular deaths, of which 5 (3.2%) were device related. At 1 year, there were 23 (14.6%) deaths, including 13 (8.3%) cardiovascular deaths. At 30 days, there were significant improvement of effective orifice area (from 0.7 ± 0.2 cm2 to 1.9 ± 0.6 cm2) and mean aortic valve gradient (from 49.5 ± 18.5 mm Hg to 8.1 ± 3.7 mm Hg), which were sustained up to 1 year. Moderate or severe paravalvular leak was observed in 6.3% of patients at 30 days and 6.9% of patients at 1 year. The rate of new permanent pacemaker implantation was 11.7% at 30 days and 12.4% at 1 year. CONCLUSIONS: The Hydra CE study demonstrated that transcatheter aortic valve replacement with Hydra THV offered favorable efficacy at 1 year, providing large effective orifice area and low transvalvular gradient as well as acceptable complication rates with regard to new permanent pacemaker and paravalvular leak. (A Clinical Evaluation of the HYDRA Self Expanding Transcatheter Aortic Valve; NCT02434263).

Rescue transventricular off-pump mitral valve repair with artificial neochords for acute mitral regurgitation due to postinfarction papillary muscle rupture.

BACKGROUND: We report 3 cases of rescue transventricular off-pump mitral valve (MV) repair in high-risk patients with acute mitral regurgitation (MR) due to post-myocardial infarction (MI) papillary muscle rupture (PMR). METHODS: The 3 patients presented with acute inferior ST elevation myocardial infarction, cardiogenic shock, and pulmonary edema. Their preoperative peak troponin I levels were 1909 ng/L, 16,963 ng/L, and 8299 ng/L. All 3 patients underwent successful percutaneous intervention to the culprit coronary artery, and antiplatelet therapy was initiated. All patients required inotropic support and had an intra-aortic balloon pump inserted preoperatively. Transesophageal echocardiography (TEE) demonstrated severe eccentric MR due to the leaflet prolapse secondary to PMR. The patients' estimated EuroSCORE II scores were 16.03%, 16.68%, and 7.81%, and their Society of Thoracic Surgeons scores were 14.77%, 18.24%, and 9.8%, respectively. All 3 patients underwent urgent transventricular off-pump MV repair using artificial chords, with 2 or 3 three neochords implanted. The duration of operation was <2 hours, and intraoperative and postoperative drainage was minimal in all cases. MV function was assessed by qualitative and semiquantitative TEE. RESULTS: Intraoperative MR reduction to a mild level was achieved in all 3 patients. All patients had moderate MR at discharge, likely due to left ventricular remodeling. Severe MR recurred in all patients, at 5, 4, and 2 months of follow-up, respectively. All 3 patients underwent an elective MV reoperation via conventional approach. CONCLUSIONS: Off-pump transventricular MV repair may offer a safe and feasible alternative to stabilize high-risk patients with acute MR due to post-MI PMR. Although early MR recurrence is concerning, urgent transventricular MV repair may serve as a bridge to conventional surgery in such unstable patients.