Incidence of atrial fibrillation in cryptogenic stroke with patent foramen ovale closure: protocol for the prospective, observational PFO-AF study.

INTRODUCTION: After closure of patent foramen ovale (PFO) due to stroke, atrial fibrillation (AF) occurs in up to one in five patients. However, data are sparse regarding the possible pre-existence of AF in these patients prior to PFO closure, and about recurrence of AF in the long term after the procedure. No prospective study to date has investigated these topics in patients with implanted cardiac monitor (ICM). The PFO-AF study (registered with ClinicalTrials.gov under the number NCT04926142) will investigate the incidence of AF occurring within 2 months after percutaneous closure of PFO in patients with prior stroke. AF will be identified using systematic ICM. Secondary objectives are to assess incidence and burden of AF in the 2 months prior to, and up to 2 years after PFO closure. METHODS AND ANALYSIS: Prospective, multicentre, observational study including 250 patients with an indication for PFO closure after stroke, as decided by interdisciplinary meetings with cardiologists and neurologists. Patients will undergo implantation of a Reveal Linq device (Medtronic). Percutaneous PFO closure will be performed 2 months after device implantation. Follow-up will include consultation, ECG and reading of ICM data at 2, 12 and 24 months after PFO closure. The primary endpoint is occurrence of AF at 2 months, defined as an episode of AF or atrial tachycardia/flutter lasting at least 30 s, and recorded by the ICM and/or any AF or atrial tachycardia/flutter documented on ECG during the first 2 months of follow-up. ETHICS AND DISSEMINATION: The study was approved by the Ethics Committee 'Comité de Protection des Personnes (CPP) Sud-Méditerranéen III' on 2 June 2021 and registered with ClinicalTrials.gov (NCT04926142). Findings will be presented in national and international congresses and peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT04926142.

Cardiac implantable electronic device dysfunctions in patients undergoing radiotherapy: A prospective cohort study.

BACKGROUND: Increasing numbers of patients with cardiac implantable electronic devices (CIEDs) are undergoing radiotherapy (RT) for cancer. The aim of the study was to prospectively evaluate the incidence, characteristics, and associated factors of CIED dysfunctions related to RT. METHODS: Between April 2013 and March 2020, all patients with a CIED who underwent ≥1 RT session were enrolled. Patients were monitored according to a systematic protocol, including device interrogation before the first and after each RT session. The primary endpoint was CIED dysfunction, defined as oversensing, total or partial deprogramming, and/or unrecoverable reset. RESULTS: We included a total of 92 CIED RT courses: 77 (83.7%) in patients with a pacemaker and 15 (16.3%) in those with an implantable cardioverter-defibrillator. Overall, 13 dysfunctions (14.1%) were observed during 92 courses (1509 sessions), giving an incidence of 0.9 per 100 sessions. These included nine deprogramming (three total resets to back-up pacing mode and six partial deprogramming that were all successfully reprogrammed), three transient oversensing, and one unrecoverable oversensing requiring CIED and leads replacement. There were no adverse clinical events related to device dysfunction. In multivariable analysis, neutron-producing irradiation (odds ratio [OR], 5.59; 95% confidence interval [CI], 1.09-28.65; p = .039) and cumulative tumor dose (OR, 1.05; 95% CI, 1.01-1.10; p = .007) remained significantly associated with CIED dysfunction. CONCLUSION: In this prospective study, transient or permanent subclinical CIED dysfunction occurred in 14.1% of RT courses. Our findings emphasize the importance of high-energy beams and neutron-producing irradiation in risk assessment.

Evolution of high-grade atrioventricular conduction disorders after transcatheter aortic valve implantation in patients who underwent implantation of a pacemaker with specific mode-that minimizes ventricular pacing-activated.

INTRODUCTION: The evolution of atrioventricular conduction disorders after transcatheter aortic valve implantation (TAVI) remains poorly understood. We sought to identify factors associated with late (occurring ≥7 days after the procedure) high-grade atrioventricular blocks after TAVI, based on specific pacemaker memory data. METHODS AND RESULTS: STIM-TAVI (NCT03338582) was a prospective, multicentre, observational study that enrolled all patients (from November 2015 to January 2017) implanted with a specific dual chamber pacemaker after TAVI, with the SafeR algorithm activated, allowing continuous monitoring of atrioventricular conduction. The primary endpoint was the occurrence of centrally adjudicated late high-grade atrioventricular blocks during the year after TAVI. Among 197 patients, 138 (70.1%) had ≥1 late high-grade atrioventricular block. Whereas oversizing (p = .005), high-grade atrioventricular block during TAVI (p < .001), and early (within 6 days) high-grade atrioventricular block (p < .001) were associated with occurrence of late high-grade atrioventricular block, self-expanding prothesis (p = .88), prior right bundle branch block (p = .45), low implantation (p = .06), and new or wider left bundle branch block and lengthening of PR interval (p = .24) were not. In multivariable analysis, only post-TAVI early high-grade atrioventricular block remained associated with late high-grade atrioventricular blocks (Days 0-1: odds ratio [OR], 3.25; 95% confidence interval [CI], 1.57-6.74; p = .001; Days 2-6: OR, 4.13; 95% CI, 2.06-8.31; p < .001), whereas other conventionally used predictors were not. CONCLUSION: One-third of pacemaker-implanted patients do not experience late high-grade atrioventricular block. Our findings suggest that post-TAVI early high-grade atrioventricular block is the main factor associated with occurrence of late high-grade atrioventricular blocks.

Radiotherapy in Patients With a Cardiac Implantable Electronic Device.

Recently, the Heart Rhythm Society published recommendations on management of patients with cardiac implantable electronic device (CIED) who require radiotherapy (RT). We aimed to report the experience of a teaching hospital, and discuss our practice in the context of recently published guidelines. We identified all consecutive CIED recipients (12,736 patients) who underwent RT between March 2006 and June 2017. Among them, 90 (1%) patients (78.2 ± 10 years, 73% male) had a CIED: 82 pacemakers and 8 implantable cardioverter-defibrillators. Two patients required CIED extraction prior to RT for ipsilateral breast cancer (no device replacement in 1 patient). Four patients (5%) were considered at high-risk, 35 (39%) at intermediate-risk, and the remaining 50 (56%) at low-risk for CIED dysfunction. Overall, only a minority of patients followed recommended local protocol during RT delivery (31%) and during follow-up (56%). CIED malfunction was detected in 5 patients (6%), mainly back-up mode resetting (80%), with 4 (including 3 pelvic cancer location) patients initially classified as being at intermediate-risk and 1 at low-risk. Four out of the 5 patients with CEID malfunction had received neutron producing beams. In conclusion, our findings underline the lack of rigorous monitoring of patients undergoing RT (though CIED malfunction appears to be rare and relatively benign in nature), and emphasize the interest of considering neutron producing beam for risk stratification as recommended in recent guidelines. Optimization of patient's management requires a close collaboration between both CIED clinicians and radiation oncologists, and more systematic remote CIED monitoring may be helpful.

Effects of Obesity on Postoperative Complications and Graft Survival After Kidney Transplantation.

OBJECTIVE: The objective of this study was to analyze the effects of obesity on postoperative complications and patient and graft survival after kidney transplantation. METHODS: We retrospectively included 506 patients who received a kidney transplant in our center during eleven years. Obesity was defined by a body mass index ≥ 30 kg/m2 based on World Health Organization criteria. Using univariate and multivariate analyses, we evaluated the impact of obesity on surgical complications according to the Clavien-Dindo classification up to 30 days after surgery. The impact of obesity on graft and patient survival was assessed using a Cox proportional regression model. RESULTS: Seventy-one patients were obese (14%), and mean follow-up was 63.1 months (59.7-66.5). By multivariable analysis, obesity was associated with delayed graft function (hazard ratio [HR] = 2.60 [1.31-5.02], P = .004). Obesity was not associated with surgical complications, but cardiovascular history was (HR = 1.68 [1.09-2.99], P = .048). By Cox regression analysis, obesity was significantly associated with a higher risk of graft loss (HR = 1.55 [1.06-2.99], P = .042) but not with patient survival (HR = 1.82 [0.88-3.79], P = .106). CONCLUSION: Obesity was associated with delayed graft function and graft loss. However, it was not associated with surgical complications. Kidney transplantation remains the best therapy for obese patients suffering from end-stage renal disease, despite shorter graft survival.

Pyoderma gangrenosum complicating a permanent pacemaker implantation: a case report and literature review.

BACKGROUND: Pocket complications are common after cardiac implantable electronic device implantation. We report a rare case of pyoderma gangrenosum (PG) complicating a permanent pacemaker implantation, and the first literature review of 10 published cases. CASE SUMMARY: Five days after pacemaker implantation for heart failure and 2:1 atrioventricular block, a 93-year-old man had pain in the scar and bleeding on contact. Two days later, he had fever, inflammatory syndrome, and a necrotic 7-cm wound. The pacemaker was removed and he was started on antibiotics. Due to a lack of bacterial growth in samples, PG (a rare aseptic, destructive inflammatory cutaneous condition) was suspected, and histology was compatible with this diagnosis. High-dose corticosteroids vastly improved his condition within 1 week, and after 2 months of decreasing-dose corticosteroid therapy, complete healing and normalization of the inflammatory syndrome were observed. DISCUSSION: Pyoderma gangrenosum should be considered if there is aseptic skin ulceration that is not controlled by antibiotic treatment. The first-line treatment for PG is high-dose systemic corticosteroids.

Incidence, Predictors, and Impact on Six-Month Mortality of Three Different Definitions of Contrast-Induced Acute Kidney Injury After Coronary Angiography.

We assessed incidence, predictors, and impact on 6-month mortality of contrast-induced acute kidney injury (CI-AKI) after coronary angiography with or without percutaneous coronary intervention in patients with acute coronary syndrome (ACS), according to 3 different CI-AKI definitions. Serum creatinine (sCr) was assessed at baseline and 48 to 72 hours after procedure to classify patients into 3 CI-AKI groups: Group 1: increase in sCR ≥25% over baseline but absolute increase <0.5 mg/dl; Group 2: absolute increase ≥0.5 mg/dl; Group 3: absolute increase ≥0.3 mg/dl or ≥50% over baseline. The association between CI-AKI and all-cause 6-month mortality was assessed using multivariate Cox regression. Among 1,002 patients included, median age was 68 [57 to 79] years. The sample had the following characteristics: 70% men, 25% diabetics, 22% had a history of myocardial infarction, 21% had baseline estimated glomerular filtration rate (as calculated by the Modification of Diet in Renal Disease) <60 ml/min/1.72 m2, 34% had ST-segment elevation myocardial infarction, 61% underwent percutaneous coronary intervention, and 43% had multivessel disease. Based on changes in sCr, 89 patients (8.9%) were classified in Group 1; 69 (6.9%) in Group 2; and 157 (15.7%) in Group 3, whereas sCr did not increase >25% in the remaining 844 (84.2%). CI-AKI was significantly associated with 6-month all-cause mortality using the definitions for Group 2 (hazard ratio 3.1, 95% confidence interval [CI] 1.5 to 6.6, p = 0.002) and Group 3 (hazard ratio 2.03, 95% CI 1.03 to 4.0, p = 0.04), but not Group 1. In conclusion, based on the definition used for CI-AKI, CI-AKI is observed in 6% to 15.7% of patients. An increase of 25% over baseline sCr does not identify high-risk patients. CI-AKI defined as an increase in sCr >0.3 mg/dl identifies 15.7% of the population at 2-fold higher risk of mortality.