Assessment of Long-Term Structural Deterioration of Transcatheter Aortic Bioprosthetic Valves Using the New European Definition.

BACKGROUND: 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. METHODS AND RESULTS: 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. CONCLUSIONS: 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.

The appropriate and justified use of medical radiation in cardiovascular imaging: a position document of the ESC Associations of Cardiovascular Imaging, Percutaneous Cardiovascular Interventions and Electrophysiology.

The benefits of cardiac imaging are immense, and modern medicine requires the extensive and versatile use of a variety of cardiac imaging techniques. Cardiologists are responsible for a large part of the radiation exposures every person gets per year from all medical sources. Therefore, they have a particular responsibility to avoid unjustified and non-optimized use of radiation, but sometimes are imperfectly aware of the radiological dose of the examination they prescribe or practice. This position paper aims to summarize the current knowledge on radiation effective doses (and risks) related to cardiac imaging procedures. We have reviewed the literature on radiation doses, which can range from the equivalent of 1-60 milliSievert (mSv) around a reference dose average of 15 mSv (corresponding to 750 chest X-rays) for a percutaneous coronary intervention, a cardiac radiofrequency ablation, a multidetector coronary angiography, or a myocardial perfusion imaging scintigraphy. We provide a European perspective on the best way to play an active role in implementing into clinical practice the key principle of radiation protection that: 'each patient should get the right imaging exam, at the right time, with the right radiation dose'.

Brain and neck tumors among physicians performing interventional procedures.

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.

Interventional cardiologists and risk of radiation-induced cataract: results of a French multicenter observational study.

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.

Eye lens radiation exposure to interventional cardiologists: a retrospective assessment of cumulative doses.

Radiation dose to the eye lens is a crucial issue for interventional cardiologists (ICs) who are exposed during the procedures they perform. This paper presents a retrospective assessment of the cumulative eye lens doses of ICs enrolled in the O'CLOC study for Occupational Cataracts and Lens Opacities in interventional Cardiology. Information on the workload in the catheterisation laboratory, radiation protection equipment, eye lens dose per procedure and dose reduction factors associated with eye-protective equipment were considered. For the 129 ICs at an average age of 51 who had worked for an average period of 22 years, the estimated cumulative eye lens dose ranged from 25 mSv to more than 1600 mSv; the mean ± SD was 423 ± 359 mSv. After several years of practice, without eye protection, ICs may exceed the new ICRP lifetime eye dose threshold of 500 mSv and be at high risk of developing early radiation-induced cataracts. Radiation protection equipment can reduce these doses and should be used routinely.

Understanding and Minimising Occupational Radiation in the Catheterisation Laboratory with PISAX and the ACIST CVi® Contrast Delivery System.

This paper provides an overview of radiation exposure and its associated risks in the cardiac catheterisation laboratory (cath lab), as well as strategies to minimise radiation exposure for operators, cath lab staff and patients. The benefits of using a mobile 2 mm lead equivalent radiation shield (PISAX) and adoption of an automated contrast injection system (the ACIST CVi® Contrast Delivery System) are discussed, and the potential advantages of their combination are reviewed.

Brain tumours among interventional cardiologists: a cause for alarm? Report of four new cases from two cities and a review of the literature.

AIMS: 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. METHODS AND RESULTS: 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. CONCLUSIONS: 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.

Occupational cataracts and lens opacities in interventional cardiology (O'CLOC study): are X-Rays involved? Radiation-induced cataracts and lens opacities.

BACKGROUND: The eye is well known to be sensitive to clearly high doses (>2 Gy) of ionizing radiation. In recent years, however, cataracts have been observed in populations exposed to lower doses. Interventional cardiologists are repeatedly and acutely exposed to scattered ionizing radiation (X-rays) during the diagnostic and therapeutic procedures they perform. These "low" exposures may cause damage to the lens of the eye and induce early cataracts, known as radiation-induced cataracts. The O'CLOC study (Occupational Cataracts and Lens Opacities in interventional Cardiology) was designed to test the hypothesis that interventional cardiologists, compared with an unexposed reference group of non-interventional cardiologists, have an increased risk of cataracts. METHOD/DESIGN: The O'CLOC study is a cross-sectional study that will include a total of 300 cardiologists aged at least 40 years: one group of exposed interventional cardiologists and another of non-interventional cardiologists. The groups will be matched for age and sex. Individual information, including risk factors for cataracts (age, diabetes, myopia, etc.), will be collected during a telephone interview. A specific section of the questionnaire for the exposed group focuses on occupational history, including a description of the procedures (type, frequency, radiation protection tool) used. These data will be used to classify subjects into "exposure level" groups according to cumulative dose estimates. Eye examinations for all participants will be performed to detect cataracts, even in the early stages (lens opacities, according to LOCS III, the international standard classification). The analysis will provide an estimation of the cataract risk in interventional cardiology compared with the unexposed reference group, while taking other risk factors into account. An analysis comparing the risks according to level of exposure is also planned. DISCUSSION: This epidemiological study will provide further evidence about the potential risk of radiation-induced cataracts at low doses and contribute to cardiologists' awareness of the importance of radiation protection. TRIAL REGISTRATION: NCT01061463.

Impact of purely internal thoracic artery T-graft technique on the mode and quality of surgical myocardial revascularization evaluated by early postoperative coronary angiography.

BACKGROUND: The use of the internal thoracic artery for coronary artery bypass has improved the results of such surgery. However, bypass using only the internal thoracic arteries sometimes requires a T-graft. This purely internal thoracic artery T-graft technique has progressively become part of our surgical protocol for coronary artery bypass surgery. AIMS: The aim of the study was to analyse the impact of this surgical technique on the degree and quality of coronary revascularization using early postoperative angiography. METHODS: Between January 2004 and December 2006, 148 patients underwent coronary artery bypass surgery exclusively using both internal thoracic arteries in a T-graft configuration. Systematic postoperative angiography was offered to all 148 patients; it was accepted by 108 patients and refused by 40 patients. RESULTS: There were no statistically significant differences between the two groups. In-patient mortality was 2.02% (n=3) for the whole population studied, and 1.49% (n=2) for the 134 patients who received only coronary artery bypass grafts. The revascularization rate was 89% and 3.46 coronary anastomoses were constructed per patient (range 2-6). Angiography was performed on 108 right internal thoracic artery to left internal thoracic artery anastomoses, 374 anastomoses of internal thoracic arteries to coronary arteries and 382 inter-anastomosis segments: 98% of the anastomoses and segments were patent. CONCLUSION: The exclusive recourse to the purely internal thoracic artery T-graft technique meant that it has been possible to dispense with other types of graft while achieving complete and effective revascularization of the coronary artery.

A multicentre survey of patient exposure to ionising radiation during interventional cardiology procedures in France.

AIMS: A tentative evaluation of doses received by patients undergoing international cardiolfgy (IC) procedures was carried out in France in June 2006 by the GACI. A pilot survey was performed aiming at: a) demonstrating the feasibility of the adopted approach towards estimating patient exposure; b) getting a first estimate of national diagnostic reference level (DRL) values; c) gathering experience on data collection in view of nationwide future studies. METHODS AND RESULTS: Nineteen catheterisation laboratories provided data on 813 IC procedures (496 coronarography (CA) and 317 PTCA) performed by 60 cardiologists on 29 different installations. Data gathered for each procedure were: patient characteristics, dosimetry indicators (DosexArea Product, fluoroscopy time, number of frames) and examination details (number of severe lesions, number of stents, etc.). In spite of their overall compliance with international DRL values, dosimetric indicators showed large variations. Maximum to minimum ratios ranged from 60 to 160 for the DAP, from 80 to 60 for the fluoroscopy time and from 25 to 30 for the number of images for CA and PTCA respectively. CONCLUSION: Findings highlighted key aspects of IC practice which should be improved from the radiation protection point of view: training of cardiologists, awareness of equipment performance and optimisation of procedures.