Chronic Wireless Communication Between Dual-Chamber Leadless Pacemaker Devices.

BACKGROUND: Aveir™ DR (Abbott) is a dual-chamber leadless pacemaker (LP) system with distinct atrial and ventricular LPs (ALP, VLP) that communicate wirelessly to deliver atrioventricular synchronous pacing. Success rates of these implant-to-implant (i2i™) transmissions have not been systematically evaluated. OBJECTIVE: To evaluate chronic i2i success rates in a clinical setting. METHODS: Patients meeting standard dual-chamber pacing indications were enrolled and implanted with dual-chamber LP systems as part of a prospective, international clinical trial ("Aveir DR i2i Study"). The percent of successful i2i transmissions from ALP-to-VLP (A-to-V) and VLP-to-ALP (V-to-A) were interrogated from LPs in de novo patients using the device programmer at implant, discharge, and at 1-, 3-, and 6-months post-implant (1M, 3M, 6M). RESULTS: 399 patients completed device implant and i2i diagnostic interrogation (62% male; age 69 years; 65% sinus node dysfunction, 32% AV block). Median A-to-V and V-to-A i2i success rates exceeded 90% of beats at all time-points from implant to 6M. The minority of patients with A-to-V or V-to-A i2i success in <70% of beats at implant (A-to-V: 19% of patients, V-to-A: 31% of patients) showed roughly 40% improvement by 1M, with this minority dropping to roughly 5% of patients by 6M. Improvement in i2i communication success may be attributed to reprogramming of i2i setting levels, natural changes in dominant posture, and device stabilization. CONCLUSION: Wireless implant-to-implant communication in the new dual-chamber leadless pacemaker system demonstrated successful transmissions in >90% of beats throughout the 6-month evaluation period. Communication success improved significantly over time post-implant for specific subgroups.

Atrial fibrillation ablation long-term ESC-EHRA EORP AFA LT registry: in-hospital and 1-year follow-up findings in Italy.

AIM: To report the Italian data deriving from the European Society of Cardiology-EURObservational Research Program atrial fibrillation ablation long-term registry. METHODS AND RESULTS: Ten Italian centers enrolled up to 50 consecutive patients undergoing atrial fibrillation ablation. Of the 318 patients included, 5 (1.6%) did not undergo catheter ablation, 1 had ablation partially done and 62 were lost at 1-year follow-up. Women were less represented (23.6%) and the median age was 60.0 years. A total of 195 patients (62.3%) suffered paroxysmal atrial fibrillation, whereas only 9 (2.9%) had long-standing persistent atrial fibrillation. Most Italian patients (92.3%) were symptomatic but suffering fewer symptomatic events than patients enrolled in other countries (median of two events in the month preceding the ablation vs. three, respectively; P < 0.0001). The main finding of the study is that the success rate at 1 year, with and without antiarrhythmic drugs, was 76.4%, consistently with other participating countries (73.4%). This result was obtained however, with a significantly lower prevalence of 1-year adverse events (7.3 vs. 16.6%, P < 0.0001). Procedure duration and fluoroscopy total time resulted as being shorter in Italy (145 vs. 160, P = 0.0005 and 16.9 vs. 20.0 min, P = 0.0018, respectively); however, the radiation dose per BSA was greater (37.5 vs. 26.0 mGy/cm, P = 0.0022). CONCLUSION: The demographic characteristics of patients undergoing atrial fibrillation ablation are similar to those reported in other countries. The success rate in Italy is consistent with those in other countries, whereas the complications rate is lower.

Leadless technology: a new paradigm for cardiac pacing?

Leadless pacemaker (LP) technology was recently developed and introduced for clinical purpose as an alternative to traditional systems in order to reduce leads and pocket-related complications. Currently, two self-contained right ventricular pacemakers implanted by using a femoral percutaneous approach have been developed and initial results seem promising. Although the clinical use is still limited to the right ventricular pacing, the LP currently represents a valid and alternative solution in several settings, when the standard pacemaker cannot be used or its use is associated with higher risk of complications. Implementation of particular pacing algorithms in the near future will allow for a VDD pacing mode with only a single ventricular component, whereas the next evolution of technology will lead to develop multicomponent, communicating leadless systems capable to perform a dual-chamber pacing or even a cardiac resynchronization. The management after battery depletion is still controversial and experience on retrievability is anecdotic. Long term data from registry are necessary to reinforce the reliability of these systems in the real life and randomized trials comparing LPs with traditional pacemaker will be essential to better understand if the LP can become a new paradigm in cardiac pacing.

Prevention of sudden cardiac death: from wearable to subcutaneous cardioverter defibrillator.

The implantable cardioverter defibrillator (ICD) is today an indisputable evidence-based treatment for cardiac sudden death both in primary and secondary prevention. However many clinical conditions that would represent an indication to ICD implantation, according to guidelines, may be potentially reversible or may be accompanied by temporary contraindications to the implant. Moreover transvenous cardioverter defibrillator implantation still carries a not negligible risk of complications both acutely and at follow-up. The Wearable Cardioverter Defibrillator and the Subcutaneous Defibrillator are two recently developed technologies that can potentially overcome the aforementioned limitations of traditional transvenous ICDs. This review will discuss the main aspects of these 2 technologies, the data coming from clinical experiences and future perspectives.

Perioperative management of antithrombotic treatment during implantation or revision of cardiac implantable electronic devices: the European Snapshot Survey on Procedural Routines for Electronic Device Implantation (ESS-PREDI).

The European Snapshot Survey on Procedural Routines for Electronic Device Implantation (ESS-PREDI) was a prospective European survey of consecutive adults who had undergone implantation/surgical revision of a cardiac implantable electronic device (CIED) on chronic antithrombotic therapy (enrolment March-June 2015). The aim of the survey was to investigate perioperative treatment with oral anticoagulants and antiplatelets in CIED implantation or surgical revision and to determine the incidence of complications, including clinically significant pocket haematomas. Information on antithrombotic therapy before and after surgery and bleeding and thromboembolic complications occurring after the intervention was collected at first follow-up. The study population comprised 723 patients (66.7% men, 76.9% aged ≥66 years). Antithrombotic treatment was continued during surgery in 489 (67.6%) patients; 6 (0.8%) had their treatment definitively stopped; 46 (6.4%) were switched to another antithrombotic therapy. Heparin bridging was used in 55 out of 154 (35.8%) patients when interrupting vitamin K antagonist (VKA) treatment. Non-vitamin K oral anticoagulant (NOAC) treatment was interrupted in 88.7% of patients, with heparin bridging in 25.6%, but accounted for only 25.3% of the oral anticoagulants used. A total of 108 complications were observed in 98 patients. No intracranial haemorrhage or embolic events were observed. Chronic NOAC treatment before surgery was associated with lower rates of minor pocket haematoma (1.4%; P= 0.042) vs. dual antiplatelet therapy (13.0%), VKA (11.4%), VKA + antiplatelet (9.2%), or NOAC + antiplatelet (7.7%). Similar results were observed for bleeding complications (P= 0.028). Perioperative management of patients undergoing CIED implantation/surgical revision while on chronic antithrombotic therapy varies, with evidence of a disparity between guideline recommendations and practice patterns in Europe. Haemorrhagic complications were significantly less frequent in patients treated with NOACs. Despite this, the incidence of severe pocket haematomas was low.

Differences in attitude, education, and knowledge about oral anticoagulation therapy among patients with atrial fibrillation in Europe: result of a self-assessment patient survey conducted by the European Heart Rhythm Association.

The purpose of this patient survey was to analyse the knowledge about blood thinning medications relative to gender, age, education, and region of residence in patients with atrial fibrillation (AF). A total of 1147 patients with AF [mean age 66 ± 13 years, 529 (45%) women] from eight European countries responded to this survey. Most patients understood that the indication for anticoagulation therapy was to 'thin the blood', but 8.1% responded that the purpose of the medication was to treat the arrhythmia. Patients with college or university grades reported less frequent deviations from their target INR range compared with those without schooling (2.8% vs. 5.1%, P < 0.05). The awareness of anticoagulation-related risk of bleedings was lowest in patients without schooling (38.5%) and highest in those with college and university education (57.0%), P < 0.05. The same pattern was also observed regarding patient's awareness of non-vitamin K antagonist oral anticoagulants (NOACs): 56.5% of the patients with university education and only 20.5% of those without schooling (P < 0.05) knew about NOACs, indicating that information about new anticoagulation therapies remains well below the target. Bleeding events were statistically less frequent in patients on NOACs compared with vitamin K antagonists. The education level and patients' knowledge have a direct influence on the global management of the anticoagulation.

Right heart failure due to a fistula between a giant aortic pseudoaneurysm and the left atrium: a late complication after cardiovascular surgery.

: A 69-year-old woman, treated 5 years before with mechanical aortic valve and vascular prosthesis of ascending aorta implantation for severe aortic regurgitation and dilation of ascending aorta, was referred to our center for dyspnea and peripheral edema. The transthoracic echocardiography showed a giant pseudoaneurysm incorporating the vascular prosthesis and a fistula of it with the left atrium. These findings were confirmed using the transesophageal echocardiogram, cardiac computed tomography, and during cardiac surgery, which was performed 5 days later. The reparative intervention consisted of suturing of both the connections; the patient survived the surgery, but she died 6 weeks later due to infectious complications.

Patients' attitude and knowledge about oral anticoagulation therapy: results of a self-assessment survey in patients with atrial fibrillation conducted by the European Heart Rhythm Association.

The purpose of this European Heart Rhythm Association survey was to assess the attitude, level of education, and knowledge concerning oral anticoagulants (OACs) among patients with atrial fibrillation (AF) taking vitamin K antagonists (VKAs), non-VKA oral anticoagulants (NOACs) or antiplatelets. A total of 1147 patients with AF [mean age 66 ± 13 years, 529 (45%) women] from 8 selected European countries responded to this survey. The overall use of OACs and antiplatelets was 77 and 15.3%, respectively. Of the patients taking OACs, 67% were on VKAs, 33% on NOACs, and 17.9% on a combination of OACs and antiplatelets. Among patients on VKAs, 91% correctly stated the target international normalized ratio (INR) level. The proportion of patients on VKA medication who were aware that monthly INR monitoring was required for this treatment and the proportion of patients on NOAC who knew that renal function monitoring at least annually was mandatory for NOACs was 76 and 21%, respectively. An indirect estimation of compliance indicated that 14.5% of patients temporarily discontinued the treatment, and 26.5% of patients reported having missed at least one dose. The survey shows that there is room for improvement regarding education and adherence of patients taking OACs, particularly regarding monitoring requirements for NOACs.

EHRA(European Heart Rhythm Association) EP-Wires Surveys: What Is Common Practice In Device Management?

Guidelines and recommendations within the field of electrophysiological (EP) practice are usually drawn from the results of multicentre trials, often conducted in selected centers and under special circumstances. In contrast, daily practice is generally influenced by many factors, which may be different from those that are considered in strictly controlled scientific conditions. Even though patient registries may mirror daily practice, the enrollment of consecutive patients for longer periods of time for such purpose within the health care community is costly and time consuming. A short form of survey directed to physicians, could within a reasonable time frame highlight areas where the evidence base for clinical practice and implementation of guidelines needs to be augmented. Such short form of surveys, called EP Wires, are on-line surveys carefully constructed to give a picture of daily cardiac EP practice in Europe without burdening the responders with extensive data collection. The network of centers formed, are contacted on a regular basis every month. It is the purpose of this summary to present the result of four such EP wires, all of which concern devices, with special emphasis on centre differences and adherence to guidelines.

Port-a-Cath complicated by infection or migration not removed by manual traction: usefulness of cardiac pacing leads extraction techniques.

BACKGROUND: Long-term use of Port-a-Caths (PACs) is related to device-related delayed complications. The aim of this study is to describe the high success rate and safety of cardiac pacing lead extraction techniques used for PACs complicated by infection or migration and not removed by manual traction. METHODS: During a 13-year period (1997-2010), 19 consecutive PAC recipients (54.1±13 years, 11 females) were referred to our hospital for PAC-related delayed complications and PACs not removable by manual traction (mean dwelling time 29.3±31 months). RESULTS: PAC implantation indications included gastrointestinal cancer (21%), breast cancer (15.7%), other malignant diseases (52.6%), and nonmalignant diseases (10.5%). PAC removal indications were breakdown due to subclavian crush (63.1%), breakdown due to unsuccessful previous removal attempt (21%), sepsis (10.5%), or malfunction (5.3%). Removal of fractured free-floating catheters (16) migrated toward the venous blood course was attempted by tool-guided traction in all cases except 1 in whom mechanical dilation was necessary. For the 3 intact ones (2 infected and one malfunctioning) we used tool-guided traction and single-sheath mechanical dilation, depending on the vascular/cardiac-catheter setting. By using multiple venous approaches we removed 18 catheters completely and 1 partially, achieving clinical success in all of the patients. The most commonly used venous approach was transfemoral (TFA; 73.6%), followed by the original venous entry site approach (VEA; 15.7%) and internal transjugular approach (ITA; 10.5%). No major or minor complications were observed. CONCLUSIONS: In experienced centers, cardiac pacing lead extraction techniques may be considered as an additional, efficacious, safe option for extraction of otherwise nonremovable entrapped PACs before surgery.

Multicenter experience with transvenous lead extraction of active fixation coronary sinus leads.

BACKGROUND/OBJECTIVE: Active fixation coronary sinus (CS) leads limit dislodgement and represent an attractive option to the implanter. Although extraction of passive fixation CS leads is a common and frequently uncomplicated procedure, data regarding extraction of chronically implanted active fixation CS leads are limited. METHODS: We performed a retrospective cohort study of patients undergoing active fixation CS lead extraction at six centers. Patient and procedural characteristics, indications for extraction, use of extraction sheath (ES) assistance, and outcomes are reported. RESULTS: Between January 2009 and February 2011, 12 patients underwent transvenous lead extraction (TLE) of Medtronic StarFix® lead (Medtronic Inc., Minneapolis, MN, USA). The cohort was 83% male with mean age 71 ± 14 years. Average implant duration was 14.2 ± 5.7 months (2.3-23.6). All leads but one were removed for infectious indications (67% systemic infection). At the time of explant, the fixation lobes were completely retracted in only one of the 12 cases and ES assistance was required for lead removal in all cases (58% laser, 25% cutting, 25% mechanical, and 25% femoral). The majority of cases required advancement of the sheath into the CS (75.0%) and often into a branch vessel (41.7%). One lead could not be removed transvenously and required surgical lead extraction. There were no major complications. Examination of the leads after extraction frequently revealed significant tissue growth into the fixation lobes. CONCLUSIONS: Although TLE of active fixation CS leads can be a safe procedure in select patients and experienced hands, powered sheaths and aggressive techniques are frequently required for successful removal despite relatively short implant durations. This raises significant concern regarding future TLE of active fixation CS leads with longer implant durations.

Cardiac resynchronization after left ventricular lead extraction: usefulness of angioplasty in coronary sinus stenosis.

A 68-year-old man, 54 months after having been implanted with a biventricular device, underwent successful extraction of the malfunctioning left ventricular (LV) lead using mechanical dilation. During LV lead reimplantation, venography documented stenosis of the coronary sinus (CS). To overcome the obstacle, balloon angioplasty was performed and a LV lead was then inserted into a lateral tributary of the CS. The procedure was complicated by local infection and, after 2 months, removal of the entire unit became necessary. During controlateral device implantation, a second angioplasty was carried before insertion of the new LV lead because, in the meantime, restenosis had developed in the CS.