Detailed analysis of a series of explanted Talent AAA stent-grafts: biofunctionality assessment.

Six Talent stent-grafts were harvested at reoperations (N=5) and autopsy (N=1). The explants were observed nondestructively, including gross morphology, X-rays, CT scans and closed pressure system analysis. The Nitinol frames in three devices harvested at reoperations and another harvested at autopsy were intact. One had a stent fracture of the proximal bare stent, and one had a wire fracture of a thin proximal external supporting stent as well as a hole in the fabric just above the bifurcation. For the three devices structurally intact, reoperations were performed for a type 1A endoleak (one patient) and aorto-enteric fistulas (two patients). The healing characteristics were poor or absent. The fabric in the main body of the grafts harvested after aorto-enteric fistula was devoid of biological deposits. Two of the grafts harvested at reoperation demonstrated fabric holes of up to 4 mm 2. The device obtained at autopsy showed an almost continuous internal capsule with variable thickness. The luminal surface was smooth, but the capsule detached easily. The devices explanted at reoperations showed various levels of impaired biofunctionality associated with adverse outcomes. The stent-graft retrieved from autopsy was intact.

Cardiovascular magnetic resonance in mild to moderate clozapine-induced myocarditis: is there a role in the absence of electrocardiographic and echocardiographic abnormalities?

Clozapine is an atypical, neuroleptic medication that can cause myocarditis. While the "gold standard" for diagnosis of myocarditis is perceived to be via myocardial biopsy, cardiovascular magnetic resonance (CMR) has also proven its utility in this respect, primarily through its ability to detect myocardial scar by late-gadolinium enhancement (LGE). Until recently, however, clozapine-induced myocarditis specifically has not been known to be associated with LGE on CMR. In that particular case, LGE was demonstrated in a patient with clozapine-induced myocarditis. However, quite important, that patient also had specific abnormalities on the electrocardiogram (ECG) and echocardiogram that corresponded to the area of LGE demonstrated by CMR. We highlight a case series of three patients with clozapine-induced myocarditis and provide a literature review to discuss and critically appraise the true incremental diagnostic value of CMR in such patients with normal ECG and echocardiography.

Analysis of explanted Latecba modular stent-grafts deployed transrenally to repair AAAs with short necks in 29 dogs.

Twenty-nine modular stent-grafts deployed transrenally to repair AAAs with short necks in dogs were harvested at autopsy of the animals after scheduled durations of implantations of 10 days, one month, three months, and six months. Analyses of the explanted devices included non-destructive techniques such as gross observations, X-rays CT scan, IVUS and angioscopy. Further to appropriate dissection, histological investigations were carried out by means of scanning electron microscopy (SEM) and light microscopy. All the 29 specimens were extensively encapsulated with fibrous tissues but the fibrous capsule was thin in six of them; four capsules were ulcerated. The X-rays confirmed the stability of the devices that were still straight (12), slightly bent (12) or bent (4). The modules were misaligned in only one case. IVUS and angioscopy confirmed the patency of all the stent-grafts with thin internal capsules both proximally and distally with variable capsulation in the mid-section of the grafts. The left renal artery orifices were found to be patent at dissection with no obstruction to flow. The luminal flow surface of the stent-grafts was smooth and glistening proximally and distally containing endothelial like cells and vasa-vasorum. Poor healing was noted in the aneurysm area. Transrenal deployment of this modular stent-graft is feasible and gave excellent results with regard to biofunctionality and biocompatibility. The device proved to be safe and efficient.

Late gadolinium enhancement cardiovascular magnetic resonance in genotyped hypertrophic cardiomyopathy with normal phenotype.

A 35 year-old asymptomatic Caucasian female with a family history of hypertrophic cardiomyopathy (HCM) was referred for cardiologic evaluation. The electrocardiogram and transthoracic echocardiogram were normal. Cardiovascular magnetic resonance (CMR) was performed for further assessment of myocardial function and presence of myocardial scar. CMR showed normal left ventricular systolic size, measurements and function. However, there was extensive, diffuse late gadolinium enhancement (LGE) throughout the left ventricle. This finding was consistent with extensive myocardial scarring and was highly suggestive of advanced, non-ischemic cardiomyopathy. Genotyping showed a heterozygous mis-sense mutation (275G>A) in the cardiac troponin T (TNNT2) gene, which is causally associated with HCM. There have been no previous reports of such extensive, atypical pattern of myocardial scarring despite an otherwise structurally and functionally normal left ventricle in an asymptomatic individual with HCM. This finding has important implications for phenotype screening in HCM.

A multi-center, comparative, phase 3 study to determine the efficacy of gadofosveset-enhanced magnetic resonance angiography for evaluation of renal artery disease.

PURPOSE: To determine prospectively the safety and efficacy of the blood-pool contrast agent gadofosveset trisodium in renal artery magnetic resonance angiography (MRA). MATERIALS AND METHODS: Gadofosveset (0.03 mmol/kg) was administered to adult patients with known or suspected renal arterial disease in a multi-center phase 3 single dose study. The drug binds reversibly to albumin, prolonging the blood residence time, and allowing collection of images in the first-pass and steady-state phases. The combination of these images was compared to non-contrast MRA, using catheter X-ray angiography (XRA) as the standard of reference (SOR). All MRA images were collected at 1.5 T in one imaging session for direct comparison, and XRA within 30 days. Sensitivity, specificity, and accuracy for diagnosing significant disease (stenosis > or =50%) were calculated for MRA using three independent blinded readers. Patient safety was monitored for 72-96 h. RESULTS: A total of 145 patients at 18 centers were enrolled and received gadofosveset; the 127 with complete efficacy data entered the primary efficacy analysis. Gadofosveset-enhanced MRA led to significant improvement (p<0.01) in sensitivity (+25%, +26%, +42%), specificity (+23%, +25%, +29%), and accuracy (+23%, +28%, +29%) over non-enhanced MRA for the three readers. The rate of uninterpretable examinations decreased from 30% to less than 2%. There were no serious adverse events, and the most common adverse events were nausea, pruritus, and headache (8% each). No significant trends in clinical chemistry parameters, nor significant changes in serum creatinine, were found following administration of gadofosveset. CONCLUSION: In patients with known or suspected renal arterial disease, multi-phase gadofosveset-enhanced MRA significantly improves sensitivity, specificity, and accuracy versus non-enhanced MRA. Gadofosveset was safe and well tolerated in this patient population.

Transrenal deployment of a modular stent graft to repair AAAs with short necks: experiments in dogs.

Severely angulated (> 60 degrees ) or short (< 15 mm) proximal necks remain significant anatomical limitations for endovascular stent-graft repairs for abdominal aortic aneurysms. Ensuring proper proximal fixation of the stent-graft to the host artery without the short-or long-term risks of endoleak or migration represents a particular technical challenge for these anatomical circumstances. An innovative balloon expandable stent combined with a weft-knitted prosthesis was specifically designed for these situations by modelling the stent to the neck anatomy without overdistension or potential barotrauma allowing better incorporation of the device. The Latecba stent-graft consists of a 2 parts modular design. The first one, Module A, is deployed at the transrenal level and consists of a Palmaz type stent whose first half is bare and second half is sutured to a crimped weft-knitted polyester graft whose distal end holds a constriction. The second Module B is a non-crimped weft-knitted graft attached to 2 stainless steel stents. The first stent is entirely contained in the proximal textile tube, allowing fixation to module A. The second stent, which is left uncovered over the distal third, ensures proper fixation of the stent-graft distally. Following the creation of a prosthetic aneurysm in the infrarenal aorta in 32 dogs, 29 received the Latecba stent-graft for scheduled durations of 10 days, 1 month, 3 months and 6 months. Proper deployment of the stent-grafts was achieved without difficulty. All 29 animals survived and the devices were all patent at sacrifice. No device defects or migrations were observed and the stent-grafts proved to be efficient in this setting to exclude the aneurysm. Analyses of the explanted devices (gross observations, RX, CT scan, IVUS, angioscopy) confirmed the stability of this modular stent-graft. Further on-going clinical investigations are warranted to validate this concept before this stent-graft becomes commercially available without any restriction.

Specific shortcomings of endograft design.

Further to the rapid enlargement of an aneurysm to 5.6 cm in diameter after 3 years of surveillance, a 79-year-old patient was fitted with a Vanguard modular stent graft and monitored on a regular basis for 6 years. Two years later, the aneurysmal sac ruptured. The patient died 1 month after an open surgery. The device was devoid of any encapsulation and the ipsilateral limb was detached from the body. The Nitinol skeleton was mostly maintained, however, some polypropylene sutures were broken. The resulting motion of the sharp-angled Nitinol wires caused abrasion and resulted in a few localized holes that were sufficient to permit blood to percolate through the textile wall. Some polyester yarns in the warp direction were ruptured. The Nitinol wire used in this device was shown to be corrosion resistant but the selection of the polypropylene suture was inappropriate. Because this technology is maturing rapidly, these weaknesses can be avoided in the future generations of endovascular devices. It is recommended that these Nitinol wires be sutured to the fabric and that polyester yarns stronger than 68 decitex in tubes 8 mm in diameter are selected.

Persistent type II endoleak unrelated to an Anaconda aortic stent graft fulfilling the 3Bs requirements of biofunctionality, biodurability, and biocompatibility.

A patient was fitted with an Anaconda stent graft for which there was a persistent type II endoleak. Two subsequent attempts at embolization were unable to resolve the endoleak. The diameter of the aneurysm varied initially from 5.5 cm in diameter down to 4.8 cm but then later re-dilated to 6.1 cm, with evidence of persistent flow into the aneurysmal sac from the inferior mesenteric artery. Results from serial computed tomography scans demonstrated clear evidence of a type II endoleak that originated from the inferior mesenteric artery with outflow to a distal lumbar artery. The harvested stent graft did not show evidence of a device-related failure. The stent graft and its modular segments were found to have been properly deployed. Only a thin external capsule was evident at explantation. The internal wall of the device showed irregular and thin encapsulation with scattered mural thrombi, which were more prominent at the bifurcation of the main body of the device. Blood deposits and tissue development were sufficient to prevent blood oozing through the wall. The explanted Anaconda stent graft was devoid of any construction flaws or damage (fatigue of the textile or corrosion of the Nitinol wires) after implantation.

Characterization of an endovascular prosthesis using the 3Bs rule (biocompatibility, biofunctionality and biodurability): a recommended protocol to investigate a device harvested at necropsy.

Numerous endovascular stent grafts to treat intrarenal aortic aneurysms are now commercially available, and many new concepts are currently in development worldwide. In order to objectively quantify their outcomes, we propose a detailed protocol to examine a reference device that was harvested from a patient who died a few hours after endovascular stent-graft deployment for an abdominal aortic aneurysm according to the 3Bs rule (biocompatibility, biofunctionality, and biodurability). Relevant patient history of this 63-year-old man included radiotherapy treatment for lung cancer. Following the patient's death, the device was harvested en bloc together with the aneurysmal sac. The analysis of the device was conducted using nondestructive testing (X-rays, CT scan, magnetic resonance imaging [MRI], and endoscopy) and destructive testing (dissection, histology, and fabric and wire component analyses). Results from the gross examination demonstrated that the outer layer of the aneurysm sac was white, stiff, and continuous without any disruption. The Xray analysis, CT scan, and MRI confirmed that the device together with its modular segments was properly deployed at implantation. Endoscopy showed that the device was deployed securely immediately distal to the renal arteries. As anticipated, thin scattered mural thrombi at the blood/foreign material interface were observed on the blood tight flow surface. There were no tears in the fabric, and the dimensions and textile structure were well preserved. The metallic wires were intact. This fatality had no association with the stent graft as the patient's death was caused by the rupture of the pulmonary artery following intensive radiotherapy. In conclusion, autopsy, nondestructive testing, and destructive testing are therefore the necessary steps to validate any explanted endovascular stent graft in terms of biocompatibility, biofunctionality, and biodurability. In this specific case, the endovascular device fulfills the 3Bs rule. The authors recommend this protocol to investigate explanted endovascular devices.

Differential diagnosis of chest symptoms in the athlete.

Chest pain is a common complaint of athletes in all age groups. In athletes, chest pain is often attributed to "chest tightness," and treatment for bronchospasm is considered. However, the causes of the pain are wide and varied, and the pain is referable to the many organ systems that localize to the thorax. Therefore, when treatment with bronchodilators fails, it becomes important to consider other nonasthmatic causes of the pain. These causes can be organized by system and are explained in this article. Cardiac causes are the most feared and, fortunately, are very rare in the adolescent setting. With a thorough knowledge of etiologies of chest pain, the physician can often make a diagnosis with only a history and a physical exam.

New professionalism challenges in medical training: an exploration of social networking.

BACKGROUND: Innovative online technology can enhance the practice of medicine, yet it also may be a forum for unprofessional behavior. OBJECTIVE: We surveyed program directors regarding their perceptions and experiences with residents' use of social networking sites (SNS). METHODS: In September 2011, we sent an online survey to program directors and associate program directors of pediatrics residency programs within the United States who are members of the Association of Pediatric Program Directors. RESULTS: A total of 162 program directors or associate program directors (representing 50% of residency programs) responded to the survey. One-third of respondents are "very familiar" with SNS and 23% use them "daily or often." Most respondents (70%) rated "friending" peers as "completely appropriate," whereas only 1% of respondents rated "friending" current or past patients as "completely appropriate." More than one half of respondents believe inappropriate behavior on SNS is "somewhat" or "very" prevalent, and 91% are "somewhat" or "very" concerned that the prevalence of inappropriate behavior on SNS may increase. The most commonly reported problematic online activity was posting inappropriate comments about the workplace. Posting of inappropriate comments about self, patients, and staff also was observed. Residency programs commonly educate trainees about SNS during intern orientation (45%), or using written guidelines (29%) and ad hoc remediation (16%). CONCLUSIONS: As educators teach trainees principles of online professionalism, appropriate use of SNS needs to be included in the training process. Curricular efforts may be hindered by some program directors' lack of familiarity with SNS.

Patient-specific simulations and measurements of the magneto-hemodynamic effect in human primary vessels.

This paper investigates the main characteristics of the magneto-hemodynamic (MHD) response for application as a biomarker of vascular blood flow. The induced surface potential changes of a volunteer exposed to a 3 T static B0 field of a magnetic resonance imaging (MRI) magnet were measured over time at multiple locations by an electrocardiogram device and compared to simulation results. The flow simulations were based on boundary conditions derived from MRI flow measurements restricted to the aorta and vena cava. A dedicated and validated low-frequency electromagnetic solver was applied to determine the induced temporal surface potential change from the obtained 4D flow distribution using a detailed whole-body model of the volunteer. The simulated MHD signal agreed with major characteristics of the measured signal (temporal location of main peak, magnitude, variation across chest and along torso) except in the vicinity of the heart. The MHD signal is mostly influenced by the aorta; however, more vessels and better boundary conditions are needed to analyze the finer details of the response. The results show that the MHD signal is strongly position dependent with highly variable but reproducibly measurable distinguished characteristics. Additional investigations are necessary before determining whether the MHD effect is a reliable reference for location-specific information on blood flow.

A collaborative model for inpatient training in a small pediatric residency program.

BACKGROUND: The nationwide decline in pediatric admissions to community hospitals threatens the sustainability of small pediatric residency programs. Little is known about the response of small programs to this challenge. OBJECTIVES: We report on the design and evaluation of an innovative, collaborative model for pediatric inpatient training between an academic community medical center and a children's hospital. METHODS: We describe the operational, academic, and financial features of the model. Outcome measures include patient volume and subspecialty mix, resident and faculty perceptions as reported in an anonymous survey, and Accreditation Council for Graduate Medical Education Residency Review Committee (RRC) review. RESULTS: In 2003, Albert Einstein Medical Center (Einstein) closed its pediatric inpatient unit and established an independent teaching service at St Christopher's Hospital for Children (St Christopher's) in Philadelphia, Pennsylvania. Under the new model, patient volume and subspecialty mix more than tripled. Einstein residents and faculty identified 5 major strengths: level of responsibility and decision making, caring for medically complex children, quality of teaching, teamwork, and opportunity to participate in academic activities at a children's hospital. St Christopher's leadership reported increased volume, no disruption of their residency program, and no dilution of clinical teaching material. The Einstein program was reaccredited by the RRC in 2006 for 2 years and in 2009 for 4 years. CONCLUSION: A collaborative model for inpatient training was successful in maintaining a community hospital-based pediatric residency program. Positive outcomes were documented for the residency program, the parent community hospital, and the collaborating children's hospital.

Progression of low-pressure to acute classic cardiac tamponade-a diagnostic dilemma in the setting of spontaneous left ventricular rupture.

Cardiac tamponade (CT) is a pathophysiologic continuum where hemodynamic embarrassment occurs as a result of progressive, decreased venous return that impairs diastolic ventricular filling, which in turn, when uncorrected, severely compromises cardiac output. While CT is classically associated with high intrapericardial pressures due to rapidly accumulating large pericardial effusions, low-pressure CT is a recognized entity in which a comparatively low intrapericardial pressure could result in cardiac chamber compression and subsequent cardiovascular collapse. In this article, we highlight a previously unreported scenario of rapidly re-accumulating, acute CT in the setting of left ventricular rupture in a patient who had presumably presented with low-pressure CT due to hemoperiardium.