Detailed thrombogenicity phenotyping and 1 year outcomes in patients undergoing WATCHMAN implantation: (TARGET-WATCHMAN) a case-control study.

The relation of device related thrombosis (DRT) and major bleeding after left atrial appendage closure (LAAC) to laboratory thrombosis and hemostasis markers has not been studied. We performed a prospective case control study to identify clinical characteristics and laboratory markers in patients who developed DRT and major bleeding following WATCHMAN LAAC. Thromboelastography, platelet aggregation (PA), urinary 11-dehydrothromboxane B2 (UTX), fibrinogen, D-dimer, thrombin time and von Willebrand factor activity were determined at baseline, immediately following, and at 45 and 180 days post-LAAC (n = 32) and outcomes were followed for 1 year. Baseline characteristics and thrombogenic profiles of patients with and without DRT and/or BARC bleeding were compared. Mean age was 76 ± 8 years and CHADS2 VASc score was 4.4 ± 1.4. There were 3 DRTs (2 within 6 months, and 1 at 12 months), 4 Type 3A BARC bleeds, and 2 non-cardiac deaths. Patients with DRT had higher baseline thrombin-induced platelet-fibrin clot strength (68.0 ± 1.8 vs. 62.7 ± 4.7 mm, p = 0.06); FCS (35.6 ± 6.0 vs. 24.4 ± 6.6 mm, p = 0.009); and D-dimer (1712 ± 2330 vs. 283 ± 213 ng/mL, p = 0.001). At baseline, 5 patients had all 3 factors associated with high thrombotic risk and 2 experienced a DRT within 6 months. Patients with Type 3A BARC bleeding had lower baseline collagen-induced and 45-day ADP-induced PA (p < 0.01 for both). DRT following LAAC was associated with a baseline prothrombogenic profile whereas bleeding was associated with low platelet reactivity. These preliminary findings warrant further validation and have future implications on patient selection and adjunctive antithrombotic therapy following LAAC.Clinical Trial Registration: https://clinicaltrials.gov/ct2/show/NCT03040622 .

A randomized comparison of manual pressure versus figure-of-eight suture for hemostasis after cryoballoon ablation for atrial fibrillation.

INTRODUCTION: Cryoballoon ablation is commonly used to treat atrial fibrillation (AF). Femoral vein hemostasis after cryoballoon ablation for AF is routinely achieved with manual pressure (MP) after reversal of heparin and reassessment of the activated clotting time, or with a figure-of-eight suture (F8). The purpose of this randomized trial was to compare these two techniques for femoral vein hemostasis after cryoballoon ablation for AF in a patient population predominantly on novel anticoagulants (NOAC). METHODS AND RESULTS: Seventy consecutive patients who underwent cryoballoon ablation were randomized to either the MP or F8 for femoral vein hemostasis. Clinical and procedural characteristics were similar between the groups with the majority of patients treated with a NOAC. The total time in the electrophysiology laboratory for the MP group and the F8 group (197 ± 37 minutes vs 167 ± 36 minutes, respectively; P = .02), and the time from sheath removal until the patient left the laboratory (28 ± 9 minutes vs 20 ± 5 minutes, respectively; P < .0001) were significantly less in the F8 group. Additional pressure for hemostasis in the recovery suite was required more often in the MP Group, as opposed to the F8 group (29% vs 3%; P = .003). No major bleeding occurred and the rate of minor hematomas was statistically similar. CONCLUSIONS: Hemostasis obtained with a F8 suture after cryoballoon ablation for AF is associated with significantly less patient time in the electrophysiology laboratory, and an improved safety profile, compared with manual hemostasis, even amongst patients treated with a NOAC.

Comparison of ICD implantation in obese and nonobese patients.

BACKGROUND: Implantable defibrillator (ICD) therapy improves mortality in patients at risk for sudden cardiac death. Obese patients pose challenges during ICD implantation and may have an increased risk of procedure-related complications. The comparison of acute procedural success and safety of ICD implantation in obese and nonobese patients has not been previously reported. METHODS: A total of 181 patients underwent ICD implantation at a single institution. Obesity was defined as a body mass index (BMI) greater than or equal to 30 kg/m(2) . Acute safety and efficacy data were collected and analyzed from a prospectively maintained database, with retrospective chart review, as required. RESULTS: Among the 181 patients, 58 (32.0%) were obese. Mean BMI was 36.7 ± 6.3 kg/m(2) among obese patients and was 24.6 ± 3.1 kg/m(2) among nonobese patients (P < 0.001). Successful ICD implantation occurred in 58 of 58 (100%) obese patients and 122 of 123 (99.2%) nonobese patients (P = 1.0). A complication was observed in three of 58 (5.2%) obese patients and in seven of 123 (5.7%) nonobese patients (P = 1.0). Similarly, there was no difference in acute procedural success and safety in patients receiving a cardiac resynchronization therapy (CRT)-ICD. CONCLUSIONS: Acute success and safety of ICD implantation is similar in both obese and nonobese patients. This finding extended to patients treated with a CRT-ICD and among patients with extreme obesity. Obesity should probably not be a factor in determining whether a patient is a candidate for ICD implantation.

MRI Safety for Patients Implanted With the MRI Ready ICD System: MRI Ready Study Results.

OBJECTIVES: A prospective, multicenter study was performed to assess the safety and efficacy of the Durata and Optisure HV leads and the Ellipse VR implantable cardioverter-defibrillator (ICD) (St. Jude Medical, Sylmar, California) in a 1.5-T magnetic resonance imaging (MRI) environment. The primary safety objective was >90% freedom from MRI scan-related complications. The primary efficacy objectives were absence of change in capture threshold and absence of decrease of sensing amplitude from pre-MRI examination to 1 month after MRI. BACKGROUND: MRI scanning of patients has been shown to be safe in patients with magnetic resonance-conditional implantable cardioverter-defibrillators (ICD) systems. METHODS: Patients with a previously implanted magnetic resonance-conditional system underwent a nondiagnostic MRI scan. After the scan, a questionnaire was given to investigators and patients who returned for 1-month follow-up examination. A subset of patients underwent ventricular tachyarrhythmia or ventricular fibrillation (VT/VF) induction testing after the MRI to evaluate defibrillation function. RESULTS: There were 220 patients (81% male; 62.1 ± 11.2 years of age) enrolled who received an MRI scans from 29 centers. All primary safety and efficacy endpoints were met (p < 0.0001). No significant detection delays were found in 34 patients who had VT/VF episodes after the MRI scan was performed. Most physicians reported easy and acceptable programming and ease of MRI scheduling. CONCLUSIONS: The MRI Ready MRI-conditional ICD system is safe, and electrical performance was not affected in patients receiving a 1.5-T whole-body MRI scan. Investigators reported favorable collaboration between cardiologists and radiologists in the MRI Ready IDE clinical trial. (A Clinical Evaluation of the Durata or Optisure High Voltage Leads and Ellipse VR ICD Undergoing MRI, an IDE Study [MRI Ready IDE]; NCT02787291).

Retrieval of the Leadless Cardiac Pacemaker: A Multicenter Experience.

BACKGROUND: Leadless cardiac pacemakers have emerged as a safe and effective alternative to conventional transvenous single-chamber ventricular pacemakers. Herein, we report a multicenter experience on the feasibility and safety of acute retrieval (<6 weeks) and chronic retrieval (>6 weeks) of the leadless cardiac pacemaker in humans. METHODS AND RESULTS: This study included patients enrolled in 3 multicenter trials, who received a leadless cardiac pacemaker implant and who subsequently underwent a device removal attempt. The overall leadless pacemaker retrieval success rate was 94%: for patients whose leadless cardiac pacemaker had been implanted for <6 weeks (acute retrieval cohort), complete retrieval was achieved in 100% (n=5/5); for those implanted for ≥ 6 weeks (chronic retrieval cohort), retrieval was achieved in 91% (n=10/11) of patients. The mean duration of time from implant to retrieval attempt was 346 days (range, 88-1188 days) in the chronic retrieval cohort, and nearly two thirds (n=7; 63%) had been implanted for >6 months before the retrieval attempt. There were no procedure-related adverse events at 30 days post retrieval procedure. CONCLUSIONS: This multicenter experience demonstrated the feasibility and safety of retrieving a chronically implanted single-chamber (right ventricle) active fixation leadless pacemaker. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifiers: NCT02051972, NCT02030418, and NCT01700244.

Patients with an ICD can safely resume work in industrial facilities following simple screening for electromagnetic interference.

Patients with ICDs are commonly advised to quit industrial jobs because of concerns that strong electromagnetic fields operating in the industrial environment might interfere with ICD functions. This study was done to assess interactions between industrial equipment and ICDs, and to devise a simple low risk screening protocol. We studied 18 patients carrying nine different ICD models who were met at their workplace by a clinical technician and were asked to walk through their workplace and perform typical duties while sensing status was monitored by listening to the ICD's beeper. All devices were interrogated at the completion of testing. At follow-up, patients were contacted by phone and were asked about employment status and history of ICD discharges or syncope. One hundred eighty-four contacts with 114 types of industrial equipment in 13 different industrial facilities (including 31 contacts with arc welding machines) were monitored. Interference with ICD's function occurred in only one contact (0.5%), when ICD therapy was temporarily suspended while a worker was attaching a huge electromagnet to a crane. At follow-up 46.0 +/- 6.0 months after testing, 7 patients (41%) are still holding the same job, 7 have retired because of reasons unrelated to their ICD, and 3 patients were transferred to a nonindustrial job. None of the patients had either an ICD shock or syncope during work. The use of a simple screening procedure can safely identify sources of electromagnetic interference that may affect ICD operation, and can predict long-term safety of working in an industrial workplace for ICD patients.