Physicians performing interventional procedures are chronically exposed to ionizing radiation, which is known to pose increased cancer risks. We recently reported 9 cases of brain cancer in ...interventional cardiologists. Subsequently, we received 22 additional cases from around the world, comprising an expanded 31 case cohort. Data were transmitted to us during the past few months. For all cases, where possible, we endeavored to obtain the baseline data, including age, gender, tumor type, and side involved, specialty (cardiologist vs radiologist), and number of years in practice. These data were obtained from the medical records, interviews with patients, when possible, or with family members and/or colleagues. The present report documented brain and neck tumors occurring in 31 physicians: 23 interventional cardiologists, 2 electrophysiologists, and 6 interventional radiologists. All physicians had worked for prolonged periods (latency period 12 to 32 years, mean 23.5 ± 5.9) in active interventional practice with exposure to ionizing radiation in the catheterization laboratory. The tumors included 17 cases (55%) of glioblastoma multiforme (GBM), 2 astrocytomas (7%), and 5 meningiomas (16%). In 26 of 31 cases, data were available regarding the side of the brain involved. The malignancy was left sided in 22 (85%), midline in 1, and right sided in 3 operators. In conclusion, these results raise additional concerns regarding brain cancer developing in physicians performing interventional procedures. Given that the brain is relatively unprotected and the left side of the head is known to be more exposed to radiation than the right, these findings of disproportionate reports of left-sided tumors suggest the possibility of a causal relation to occupational radiation exposure.
Abstract Background Interventional cardiologists (ICs) are exposed to X-rays and may be at risk to develop cataract earlier than common senile cataract. Excess risk of posterior subcapsular cataract, ...known as radiation-induced, was previously observed in samples of ICs from Malaysia, and Latin America. The O'CLOC study (Occupational Cataracts and Lens Opacities in interventional Cardiology) was performed to quantify the risk at the scale of France. Methods This cross-sectional multicenter study included an exposed group of ICs from different French centers and an unexposed control group of non-medical workers. Individual information was collected about cataract risk factors and past and present workload in catheterization laboratory. All participants had a clinical eye examination to classify the lens opacities (nuclear, cortical, or posterior subcapsular) with the international standard classification LOCS III. Results The study included 106 ICs (mean age = 51 ± 7 years) and 99 unexposed control subjects (mean age = 50 ± 7 years). The groups did not differ significantly in the prevalence of either nuclear or cortical lens opacities (61% vs. 69% and 23% vs. 29%, respectively). However, posterior subcapsular lens opacities, were significantly more frequent among ICs (17% vs. 5%, p = 0.006), for an OR = 3.9 1.3–11.4. The risk increased with duration of activity but no clear relationship with workload was observed. However, the risk appeared lower for regular users of protective lead glasses (OR = 2.2 0.4–12.8). Conclusions ICs, in France as elsewhere, are at high risk of posterior subcapsular cataracts. Use of protective equipment against X-rays, in particular lead glasses, is strongly recommended to limit this risk.
The durability of transcatheter aortic bioprosthetic valves is a crucial issue, but data are scarce, especially beyond 5 years of follow-up. We aimed to assess long-term (7 years) structural valve ...deterioration (SVD) and bioprosthetic valve failure of transcatheter aortic bioprosthetic valves.
Consecutive patients with at least 5-year follow-up available undergoing transcatheter aortic valve implantation from April 2002 to December 2011 in 5 French centers were included. Incidence of SVD and bioprosthetic valve failure were defined according to newly standardized criteria of the European Association of Percutaneous Cardiovascular Interventions/European Society of Cardiology/European Association for Cardio-Thoracic Surgery and reported as cumulative incidence function to account for the competing risk of death. One thousand four hundred three consecutive patients were included with a mean age of 82.6±7.5 years and with a mean logistic EuroSCORE (European System for Cardiac Operative Risk Evaluation) of 21.3±7.5%. A balloon-expandable valve was used in 83.7% of cases. Survival rates were 83.5% (95% CI, 81.4%-85.5%) and 18.6% (95% CI, 15.3%-21.8%) at 1 and 7 years, respectively. Median duration of follow-up was 3.9 years. Bioprosthetic valve failure occurred in 19 patients with a 7-year cumulative incidence of 1.9% (95% CI, 1.4%-2.4%). SVD occurred in 49 patients (moderate, n=32; severe, n=17) with a 7-year cumulative incidence of moderate and severe SVD of 7.0% (95% CI, 5.6%-8.4%) and 4.2% (95% CI, 2.9%-5.5%), respectively. Five patients had aortic valve reintervention (1.0%; 95% CI, 0.4%-1.6%) including 1 case of surgical aortic valve replacement and 4 redo-transcatheter aortic valve implantation. The incidences of SVD and bioprosthetic valve failure were not significantly different between balloon and self-expandable prostheses.
The long-term assessment of transcatheter aortic bioprosthetic valves durability is limited by the poor survival of our population beyond 5 years. Further studies are warranted, particularly in younger and lower-risk patients.
Interventional cardiologists who work in cardiac catheterisation laboratories are exposed to low doses of ionising radiation that could pose a health hazard. DNA damage is considered to be the main ...initiating event by which radiation damage to cells results in development of cancer.
We report on four interventional cardiologists, all with brain malignancies in the left hemisphere. In a literature search, we found five additional cases and thus present data on six interventional cardiologist and three interventional radiologists who were diagnosed with brain tumours. All worked for prolonged periods with exposure to ionising radiation in the catheterisation laboratory.
In interventional cardiologists and radiologists, the left side of the head is known to be more exposed to radiation than the right. A connection to occupational radiation exposure is biologically plausible, but risk assessment is difficult due to the small population of interventional cardiologists and the low incidence of these tumours. This may be a chance occurrence, but the cause may also be radiation exposure. Scientific study further delineating occupational risks is essential. Since interventional cardiologists have the highest radiation exposure among health professionals, major awareness of radiation safety and training in radiological protection are essential and imperative, and should be used in every procedure.
Transcatheter aortic valve replacement (TAVR) is standard therapy for patients with severe aortic stenosis who are at high surgical risk. However, national data regarding procedural characteristics ...and clinical outcomes over time are limited.
The aim of this study was to assess nationwide performance trends and clinical outcomes of TAVR during a 6-year period.
TAVRs performed in 48 centers across France between January 2013 and December 2015 were prospectively included in the FRANCE TAVI (French Transcatheter Aortic Valve Implantation) registry. Findings were further compared with those reported from the FRANCE 2 (French Aortic National CoreValve and Edwards 2) registry, which captured all TAVRs performed from January 2010 to January 2012 across 34 centers.
A total of 12,804 patients from FRANCE TAVI and 4,165 patients from FRANCE 2 were included in this analysis. The median age of patients was 84.6 years, and 49.7% were men. FRANCE TAVI participants were older but at lower surgical risk (median logistic European System for Cardiac Operative Risk Evaluation EuroSCORE: 15.0% vs. 18.4%; p < 0.001). More than 80% of patients in FRANCE TAVI underwent transfemoral TAVR. Transesophageal echocardiography guidance decreased from 60.7% to 32.3% of cases, whereas more recent procedures were increasingly performed in hybrid operating rooms (15.8% vs. 35.7%). Rates of Valve Academic Research Consortium-defined device success increased from 95.3% in FRANCE 2 to 96.8% in FRANCE TAVI (p < 0.001). In-hospital and 30-day mortality rates were 4.4% and 5.4%, respectively, in FRANCE TAVI compared with 8.2% and 10.1%, respectively, in FRANCE 2 (p < 0.001 for both). Stroke and potentially life-threatening complications, such as annulus rupture or aortic dissection, remained stable over time, whereas rates of cardiac tamponade and pacemaker implantation significantly increased.
The FRANCE TAVI registry provided reassuring data regarding trends in TAVR performance in an all-comers population on a national scale. Nonetheless, given that TAVR indications are likely to expand to patients at lower surgical risk, concerns remain regarding potentially life-threatening complications and pacemaker implantation. (Registry of Aortic Valve Bioprostheses Established by Catheter FRANCE TAVI; NCT01777828).
Abstract An 83-year-old patient, with prior history of coronary artery disease treated by coronary-artery bypass graft with left internal mammary artery (LIMA) to the left anterior descending artery ...(2001) and angioplasty of the right coronary artery (2012) and prior pacemaker through left subclavian vein (2014), was referred to coronary angiography for an anterior silent ischemia. It found no evolving lesion on the native coronary artery network (compared with 2012 review) but revealed an external compression of the LIMA bridge by the pacemaker lead. Conservative treatment was chosen rather than explantation and reimplantation of stimulus material or LIMA angioplasty. < Learning objective: This case highlights the interest for preferential use of the cephalic pathway in patients with left internal mammary bypass graft undergoing cardiac pacing.>
Hakki's formula (simplified Gorlin formula) can be used during cardiac catheterization to calculate the stenosed cardiac valve areas and can also be adapted to magnetic resonance imaging (MRI) to ...measure the stenosed cardiac valve areas. We evaluated the reliability of this approach to determine the severity of aortic stenosis compared to the continuity equation using transthoracic echocardiography and planimetry using MRI. We included all eligible symptomatic patients with known aortic stenosis referred to our department during a 1-year period. The aortic valve area (AVA) was estimated using Hakki's formula (MRI), planimetry (MRI), and the continuity equation (transthoracic echocardiography). The agreement among the measurement methods was analyzed using the Bland-Altman method. A total of 63 patients were included (mean age 72 ± 10 years, 35 men 56%). The mean AVA was 0.70 ± 0.21 cm2 using the continuity equation (transthoracic echocardiography), 0.67 ± 0.18 cm2 using planimetry (MRI), and 0.64 ± 0.21 cm2 using Hakki's formula (MRI). The mean difference was 0.03 cm2 (95% limits of agreement −0.32 to 0.25) between planimetry and the continuity equation, 0.05 cm2 (95% limits of agreement −0.40 to 0.29) between Hakki's formula and the continuity equation, 0.02 cm2 (95% limits of agreement −0.20 to 0.25) between Hakki's formula and planimetry. The inter- and intraobserver reproducibility using Hakki's formula was excellent. In conclusion, measurement of the AVA using Hakki's formula yielded similar results to those obtained using planimetry and slightly different ones from those obtained using the continuity equation. However, Hakki's formula has the advantage of being easy to use, fast, and reproducible and can be used regardless of the status of the valve (in contrast to planimetry).
No randomized study powered to compare balloon expandable (BE) with self expanding (SE) transcatheter heart valves (THVs) on individual end points after transcatheter aortic valve replacement has ...been conducted to date.
From January 2013 to December 2015, the FRANCE-TAVI nationwide registry (Registry of Aortic Valve Bioprostheses Established by Catheter) included 12 141 patients undergoing BE-THV (Edwards, n=8038) or SE-THV (Medtronic, n=4103) for treatment of native aortic stenosis. Long term mortality status was available in all patients (median 20 months; interquartile range, 14 to 30). Patients treated with BE-THV (n=3910) were successfully matched 1:1 with 3910 patients treated with SE-THV by using propensity score (25 clinical, anatomical, and procedural variables) and by date of the procedure (within 3 months). The first coprimary outcome was ≥ moderate occurrence of paravalvular regurgitation or in-hospital mortality, or both. The second coprimary outcome was 2-year all-cause mortality.
In propensity-matched analyses, the incidence of the first coprimary outcome was higher with SE-THV (19.8%) compared with BE-THV (11.9%; relative risk, 1.68 95% CI, 1.46-1.91;
<0.0001). Each component of the outcome was also higher in patients receiving SE-THV: ≥ moderate paravalvular regurgitation (15.5% versus 8.3%; relative risk, 1.90 95% CI, 1.63-2.22;
<0.0001) and in hospital mortality (5.6% versus 4.2%; relative risk, 1.34 95% CI, 1.07-1.66;
=0.01). During follow up, all cause mortality occurred in 899 patients treated with SE-THV (2-year mortality, 29.8%) and in 801 patients treated with BE-THV (2-year mortality, 26.6%; hazard ratio, 1.17 95% CI, 1.06-1.29;
=0.003). Similar results were found using inverse probability of treatment weighting using propensity score analysis.
The present study suggests that use of SE-THV was associated with a higher risk of paravalvular regurgitation and higher in-hospital and 2-year mortality compared with use of BE-THV. These data strongly support the need for a randomized trial sufficiently powered to compare the latest generation of SE-THV and BE-THV.
https://www.clinicaltrials.gov. Unique identifier: NCT01777828.