BioMonitor 2 in-office setting insertion safety and feasibility evaluation with device functionality assessment: results from the prospective cohort BioInsight study.

BACKGROUND: Insertable cardiac monitors are utilized for the diagnosis of arrhythmias and traditionally have been inserted within hospitals. Recent code updates allow for reimbursement of office-based insertions; however, there is limited information regarding the resources and processes required to support in-office insertions. We sought to determine the safety and feasibility of in-office insertion of the BioMonitor 2 and better understand in-office procedures, including patient selection, pre-insertion protocols, resource availability, and staff support. METHODS: Patients meeting an indication for a rhythm monitor were prospectively enrolled into this single-arm, non-randomized trial. All patients underwent insertion in an office setting. Two follow-up visits at days 7 and 90 were required. Information on adverse events, device performance, office site preparations, and resource utilization were collected. RESULTS: Eighty-two patients were enrolled at six sites. Insertion was successful in all 77 patients with an attempt. Oral anticoagulation was stopped in 20.8% of patients and continued through insertion in 23.4%, while prophylactic antibiotics were infrequently utilized (37.7% of study participants). On average, the procedure required a surgeon plus two support staff and 35 min in an office room to complete the 8.4 min insertion procedure. The mean R-wave amplitude was 0.77 mV at insertion and 0.67 mV at 90-days with low noise burden (2.7%). There were no procedure related complications. Two adverse events were reported (event rate 2.7% [95% CI 0.3, 9.5%]). CONCLUSIONS: In-office insertion of the BioMonitor 2 is safe and feasible. Devices performed well with high R-wave amplitudes and low noise burden. These results further support shifting cardiac monitor insertions to office-based locations. TRIAL REGISTRATION: clinicaltrials.gov, NCT02756338. Registered 29 April 2016.

Anatomic Patterns of Renal Arterial Sympathetic Innervation: New Aspects for Renal Denervation.

AIMS: Initial studies of catheter-based renal arterial sympathetic denervation to lower blood pressure in resistant hypertensive patients renewed interest in the sympathetic nervous system's role in the pathogenesis of hypertension. However, the SYMPLICITY HTN-3 study failed to meet its prespecified blood pressure lowering efficacy endpoint. To date, only a limited number of studies have described the microanatomy of renal nerves, of which, only two involve humans. METHODS AND RESULTS: Renal arteries were harvested from 15 cadavers from the Klinikum Osnabruck and Schuchtermann Klinik, Bad Rothenfelde. Each artery was divided longitudinally in equal thirds (proximal, middle, and distal), with each section then divided into equal superior, inferior, anterior, and posterior quadrants, which were then stained. Segments containing no renal nerves were given a score value = 0, 1-2 nerves with diameter <300 µm a score = 1; 3-4 nerves or nerve diameter 300-599 µm a score = 2, and >4 nerves or nerve diameter ≥600 µm a score = 3. A total of 22 renal arteries (9 right-sided, 13 left-sided) were suitable for examination. Overall, 691 sections of 5 mm thickness were prepared. Right renal arteries had significantly higher mean innervation grade (1.56 ± 0.85) compared to left renal arteries (1.09 ± 0.87) (P < 0.001). Medial (1.30 ± 0.59) and distal (1.39 ± 0.62) innervation was higher than the proximal (1.17 ± 0.55) segments (p < 0.001). When divided in quadrants, the anterior (1.52 ± 0.96) and superior (1.71 ± 0.89) segments were more innervated compared to posterior (0.96 ± 0.72) and inferior (0.90 ± 0.68) segments (P < 0.001). CONCLUSIONS: That the right renal artery has significantly higher innervation scores than the left. The anterior and superior quadrants of the renal arteries scored higher in innervation than the posterior and inferior quadrants did. The distal third of the renal arteries are more innervated than the more proximal segments. These findings warrant further evaluation of the spatial innervation patterns of the renal artery in order to understand how it may enhance catheter-based renal arterial denervation procedural strategy and outcomes. CONDENSED ABSTRACT: The SYMPLICITY HTN-3 study dealt a blow to the idea of the catheter-based renal arterial sympathetic denervation. We investigated the location and patterns of periarterial renal nerves in cadaveric human renal arteries. To quantify the density of the renal nerves we created a novel innervation score. On average the right renal arteries were significantly more densely innervated than the left renal arteries, the anterior and superior segments were significantly more innervated compared to the posterior and inferior segments, absolute innervation scores in the proximal third of the left or right renal arteries were always lower when compared to distal segments. These findings may enhance catheter-based renal arterial denervation procedural strategy and outcomes.

Fungal Keratitis: Diagnosis, Management, and Recent Advances.

Fungal keratitis is one of the major causes of microbial keratitis that may lead to corneal blindness. Many problems related to diagnosis and therapy are encountered in fungal keratitis, including difficulty in obtaining laboratory diagnoses and the availability and efficacy of antifungal medications. Intensive and prolonged use of antifungal topical preparations may not be enough. The use of antifungal medications is considered the main treatment for fungal keratitis. It is recommended to start antifungal therapy after confirmation of the clinical diagnosis with a smear or positive cultures. Topical application of antifungal medications is a mainstay for the treatment of fungal keratitis; however, systemic, intra-stromal, or intra-cameral routes may be used. Therapeutic keratoplasty is the main surgical procedure approved for the management of fungal keratitis with good success rate. Intrastromal corneal injection of antifungal medications may result in steady-state drug levels within the corneal tissue and prevent intervals of decreased antifungal drug concentration below its therapeutic level. In cases of severe fungal keratitis with deep stromal infiltration not responding to treatment, intracameral injection of antifungal agents may be effective. Collagen cross-linking has been proposed to be beneficial for cases of fungal keratitis as a stand-alone therapy or as an adjunct to antifungal medications. Although collagen cross-linking has been extensively studied in the past few years, its protocol still needs many modifications to optimize UV fluence levels, irradiation time, and concentration of riboflavin to achieve 100% microbial killing.

Femto-SMILE after photo-therapeutic keratectomy in an eye with failed LASIK flap: A case report.

Purpose: The aim of the study is to describe a case where Femtosecond Intrastromal Lenticule Extraction was used to address the refractive defect following topography-guided phototherapeutic keratectomy (topo-PTK) to regularise a scarred corneal surface after an initial LASIK flap formation attempt failed. Observations: A 23-year-old female experienced a thin and irregular corneal flap, during a microkeratome LASIK surgery of the right eye. Subsequently, she experienced epithelial ingrowth. Three months postoperatively the cornea showed scarring and partial flap melting. Topo-PTK was employed to ablate the scarred surface rendering it regular. Treatment with Femtosecond Intrastromal Lenticule Extraction was performed to correct the final refractive error of Sph -5.50 Cyl -2.00 Axis 180° with a happy end of uncorrected visual acuity (UCVA) of 20/20. Conclusions and Importance: Femtosecond Intrastromal Lenticule Extraction can be used for retreatment after surface ablation. Topo-PTK can be used to ablate post-operative LASIK-induced irregularities with a successful outcome.

An analysis of implantable cardiac device reliability. The case for improved postmarketing risk assessment and surveillance.

Implantable cardiac devices have become the mainstay of the treatment of patients with heart disease. However, data regarding their reliability and, inferentially, safety have been called into question. We reviewed annual reports submitted to the Food and Drug Administration Office of Device Evaluation by device manufacturers from 2003 to 2007. The annual number of implantable cardiac defibrillators (ICDs) and cardiac resynchronization therapy defibrillator (CRT-D) implants, explants, and returned devices were tabulated along with the cumulative (Cum) number of implants for each device. We derived an annual explantation rate (AER) defined as the ratio of the annual number of explants less the number of normal battery depletions/Cum (×1000). From 2003 to 2007, 256,392 CRT-D and 459,300 ICD devices were implanted in the United States. The overall mean (±SD) AERs for ICD and CRT-D devices were, respectively, 49.5 (15.6) per 1000 ICD devices and 82.6 (35.5) per 1000 CRT-D devices. The AER for each device type significantly decreased over the study period (P for trend <0.001) although the AER for CRT-D devices was 38% higher than that for ICD devices (P < 0.001). On average, 20.3% of CRT-D devices and 22.6% of ICD devices were returned to the manufacturer for analysis after explantation. The rates of explanted CRT-D and ICD devices decreased from 2003 to 2007. Notwithstanding this favorable trend, the AER for CRT-D devices was higher than that for ICD devices. Improved methods for tracking individual device histories are needed for more precise estimates of the risk of device explantation for suspected malfunction. The proportion of devices returned to the manufacturer is suboptimal and needs to be improved to better understand the mechanisms of device malfunction.

Comparison between three different high fluence UVA levels in corneal collagen cross-linking for treatment of experimentally induced fungal keratitis in rabbits.

INTRODUCTION: The aim of this study was to compare the efficacy of Photo-Activated Chromophore for Keratitis - Corneal Collagen Cross-linking (PACK-CXL) of three different total UVA fluence levels and topical voriconazole in treatment of fungal keratitis experimentally induced in rabbits. METHODS: This is an interventional experimental study including both eyes of 16 rabbits (32 eyes). Fungal keratitis was induced by intrastromal injection of Fusarium Solani into the cornea. The rabbits were then divided into four groups (8 eyes for each) from which group A received Voriconazole eye drops and considered as control group. Group B, C, D received single PACK-CXL session with total fluence levels of 7.2, 10.0 and 15.0 J/cm2 for each respectively. Daily clinical examination was recorded and all corneas were removed for microbiology and histopathology on day ten. RESULTS: The mean clinical signs score eyes treated with high fluence PACK-CXL showed evident clinical improvement from fourth to tenth day of treatment. This improvement was equivalent to that of Voriconazole treatment. The results showed better improvement with increasing the UVA total fluence levels but this difference was not statistically significant (P < 0.05). Similarly, the median CFU/ml declined on increasing UVA fluence but with no statistically significant values. Histopathological examination revealed better improvement of inflammatory signs on higher fluence levels compared to lower ones. CONCLUSIONS: High intensity PACK-CXL (30 mW/cm2) was as effective as Voriconazole in the treatment of fungal keratitis in rabbits. Increasing the fluence of UVA was associated with slightly better clinical outcomes with no added risks. More clinical studies are needed to confirm these results.

Modified Pull-Through Technique for Cardiac Resynchronization Therapy Upgrades in Patients with Occluded Access Veins.

The number of procedures for upgrading implantable devices for cardiac resynchronization therapy has increased considerably during the last decade. A major challenge that operators face in these circumstances is occlusion of the access vein. We have modified a pull-through method to overcome this obstacle. Six consecutive patients with occluded access veins and well-developed collateral networks underwent a procedure in which the occluded vein was recanalized by snaring the existing atrial lead via transfemoral access. Upgrading the device was successful in all patients; none had intraprocedural complications. Our experience shows that our modified pull-through technique may be a feasible alternative for upgrading cardiac resynchronization therapy in patients with venous occlusion.

Transesophageal Versus Transthoracic Echocardiography for Assessment of Left Ventricular Diastolic Function.

Background: Transesophageal echocardiography (TEE) has not been compared to transthoracic echocardiography (TTE) for assessment of left ventricular diastolic function (LVDF). Left ventricular diastolic dysfunction is common in systemic lupus erythematosus (SLE), a disease model of premature myocardial disease. Methods: 66 patients with SLE (mean age 36±12 years, 91% women) and 26 age-and-sex matched healthy volunteers (mean age 34±11 years, 85% women) underwent TEE immediately followed by TTE. From basal four-chamber views, mitral inflow E and A velocities, E/A ratio, E deceleration time, isovolumic relaxation time, septal and lateral mitral E' and A' velocities, septal E'/A' ratio, mitral E to septal and lateral E' ratios, and pulmonary veins systolic to diastolic peak velocities ratio were measured. Measurements were averaged over 3 cardiac cycles and performed by 2 independent observers. Results: LVDF parameters were worse in patients than in controls by TEE and TTE (all p≤0.03). Most LVDF parameters were similar within each group by TEE and TTE (all p≥0.17). By both techniques, mitral E and A, mitral and septal E/A ratios, septal and lateral E', septal and lateral E/E' ratios, and average E/E' ratio were highly correlated (r=0.64-0.96, all p≤0.003); E deceleration time, isovolumic relaxation time, and septal A' velocities were moderately correlated (r=0.43-0.54, all p≤0.03); and pulmonary veins systolic to diastolic ratio showed the lowest correlation (r=0.27, p=0.04). Conclusion: By TEE and TTE, LVDF parameters were worse in SLE patients than in controls; and in both groups, LVDF parameters assessed by TEE and TTE were similar and significantly correlated.

Hybrid salvage of thrombosed dialysis access grafts.

BACKGROUND: To report our experience and evaluate the results of a hybrid procedure comprising of surgical thrombectomy and adjuvant high pressure balloon angioplasty for management of thrombosed arteriovenous grafts (AVGs) with underlying venous anastomotic stenosis. METHODS: Between January 2015 and June 2017, 148 patients with first-time thrombosis of AVGs were considered for treatment with surgical thrombectomy followed by high pressure balloon angioplasty of the underlying venous anastomotic lesions. Monitoring and surveillance was subsequently performed using clinical and hemodialysis criteria to detect a failing/failed access. Primary, assisted primary, and secondary patency rates were calculated using Kaplan-Meier analysis. RESULTS: This hybrid procedure was technically successful in 135 cases (91.2%) and clinically successful in 131 cases (88.5%). The postintervention primary patency rate of the target lesions was 68.2%, 52.4%, and 44.2% at 3, 6, and 12 months, respectively. Endovascular re-interventions increased significantly the postintervention assisted primary patency to 79.1%, 71.9%, and 66.8% (P=0.0004), and the postintervention secondary patency to 86.5%, 82.2%, and 78.6% (P<0.0001) at the same time points, respectively. CONCLUSIONS: Hybrid salvage of thrombosed AVGs using high pressure balloon angioplasty of the venous anastomotic stenosis following surgical thrombectomy by Fogarty catheter is a highly successful and safe procedure, with acceptable short-term primary patency. The need for repeated interventions demonstrates the necessity of continuous graft monitoring and surveillance to improve both assisted primary, and secondary patency rates.

Takotsubo cardiomyopathy: pathogenetic insights and myocardial perfusion kinetics using myocardial contrast echocardiography.

Transient apical ballooning syndrome or Takotsubo cardiomyopathy (TC) is a novel acute cardiac syndrome, characterized by regional systolic dysfunction involving the apex and mid-ventricular segments, with hyperkinesis of the basal segments. Mid-ventricular ballooning cardiomyopathy (MVBC) is a recently recognized variant of TC. Both disorders share the same precipitating factors, clinical features and course; however, unlike TC, MVBC is characterized by ballooning and akinesis of the mid-ventricular segments with hypercontractility of the basal and apical segments. While the precise pathogenetic mechanism of this disorder remains elusive, microvascular dysfunction from excessive catecholamine release has been implicated. We report findings on regional contractile dysfunction (strain imaging), myocardial blood flow (semi-quantitative), and perfusion kinetics using myocardial contrast echocardiography in a series of three illustrative cases of TC.

Aldosterone antagonists: the most underutilized class of heart failure medications.

BACKGROUND: Aldosterone antagonists have been proven to be beneficial in severe heart failure (HF) as a result of systolic dysfunction. We sought to determine if there is a disparity in their utilization compared with ACE inhibitors and beta-adrenoceptor antagonists (beta-blockers). METHODS: In the first part of the study, we asked physicians to answer a questionnaire presenting a hypothetical HF patient. In the second part, we reviewed hospital charts of patients with HF exacerbation. RESULTS: Spironolactone was used less frequently than other drugs. At home, 75.0% of patients were receiving ACE inhibitors, 66.7% received beta-blockers, and 38.2% received spironolactone (p < 0.001). During the admission, 93.1% of patients received ACE inhibitors and 58.3% received spironolactone (p < 0.001). CONCLUSIONS: Despite good evidence, underutilization of aldosterone antagonists in patients matching the population of the RALES (Randomized Aldactone Evaluation Study) trial persists in both outpatient and inpatient settings. The difference between the usage of ACE inhibitors and spironolactone is significant in patients with systolic dysfunction equally qualifying for both medications.

A Novel Method of Axillary Venipuncture Using the Cephalic Vein as a Sole Anatomic Landmark.

The use of axillary venipuncture for pacemaker lead implantation has become a common technique. However, because of its relatively high complexity, it is still not the method of choice in most hospitals. As such, we propose an effective, simple, and safe technique for axillary venipuncture using only the cephalic vein as an anatomic landmark, with the possibility of selective cephalic contrast venography as a backup. A total of 108 patients were examined. After preparation of the cephalic vein, the puncture needle was inserted into the superficial pectoral muscle 1.5-2 cm medial to the cephalic vein and advanced in the direction parallel to the course of the cephalic vein. The needle was advanced up to 3-4 cm at an angle of 30° relative to the body surface, applying gentle suction during advancement. If after 3 attempts the axillary vein was not accessed, the same process was repeated 3-4 cm medial to the cephalic vein. If this was not effective, contrast venography of the axillary vein through the cephalic vein was performed. In 92.6% of all cases, the axillary vein was cannulated without fluoroscopic control, and in 7.4% of cases, fluoroscopic control and selective contrast venography were needed. A novel technique for axillary venipuncture using the cephalic vein as a single landmark is a simple, effective, and safe tool for pacemaker lead implantation. In some cases, selective cephalic contrast venography is an elegant and effective addition.

Clinical safety of the Iforia implantable cardioverter-defibrillator system in patients subjected to thoracic spine and cardiac 1.5-T magnetic resonance imaging scanning conditions.

BACKGROUND: Implantable cardioverter-defibrillators (ICDs) are generally considered a contraindication to magnetic resonance imaging (MRI). OBJECTIVE: The purpose of the ProMRI Phase C study, a multicenter, prospective, single-arm, nonrandomized study, was to evaluate the clinical safety of the Biotronik ProMRI Iforia ICD system during MRI. METHODS: Patients were enrolled after ICD implantation, with either a dual-chamber DR-T or single-lead VR-T DX system. Study-defined, nondiagnostic cardiac or thoracic spine MRI was performed at least 1 week after enrollment. ICDs were placed into MRI mode with ventricular fibrillation (VF) detection/therapy programmed "off" before scan and restored to non-MRI mode after scan. Interrogation was performed before, immediately after, and 1 month post-MRI. The primary end-points were (1) ventricular pacing threshold increase >0.5 V from pre-MRI to 1 month post-MRI; (2) R-wave amplitude decrease >50% from pre-MRI to 1 month post-MRI or R-wave amplitude <5 mV at 1 month post-MRI; and (3) MRI and ICD system-related serious adverse device effects. RESULTS: One hundred seventy patients were enrolled at 39 US centers. One hundred fifty-three patients underwent MRI (25.7% cardiac, 74.3% thoracic spine) and completed follow-up. Freedom from the primary end-points was met in all but 1 subject, in whom reduced R-wave amplitude was detected 1 month post-MRI. No serious adverse device effects occurred during the course of the study. CONCLUSION: These results demonstrate the clinical safety and efficacy of the ProMRI ICD system in patients subjected to thoracic spine and cardiac MRI imaging in 1.5-T scanners.

Aortic stiffness is associated with left ventricular diastolic dysfunction in systemic lupus erythematosus: a controlled transesophageal echocardiographic study.

BACKGROUND: Aortic stiffness and left ventricular (LV) diastolic dysfunction are common and associated with increased morbidity and mortality in systemic lupus erythematosus (SLE). HYPOTHESIS: In SLE, aortic stiffness and LV diastolic dysfunction may be associated. METHODS: This 6-year-duration, cross-sectional, and controlled study was conducted in 76 SLE patients (69 women; mean age, 37 ± 12 years) and 26 age- and sex-matched healthy controls. All subjects underwent clinical and laboratory evaluations and transesophageal echocardiography (TEE) to assess LV diastolic function and stiffness of the descending thoracic aorta using the pressure-strain elastic modulus (PSEM). To validate results using PSEM, aortic strain, stiffness, and distensibility were assessed. RESULTS: Patients as compared with controls had higher PSEM (8.14 ± 4.25 vs 5.97 ± 2.31 U, P < 0.001) and had lower mitral inflow E/A and septal and lateral mitral annulus tissue Doppler E'/A' velocity ratios, longer isovolumic relaxation time, lower septal and lateral mitral annulus E' velocities, and higher mitral E/septal E' and mitral E/lateral E' velocity ratios (all P ≤ 0.03), all indicative of LV diastolic dysfunction. In patients, PSEM was correlated with parameters of LV diastolic dysfunction (all P < 0.05), was independently negatively associated with E/A and E'/A' ratios and E' velocities, and was positively associated with E/E' ratios (P ≤ 0.02 for each parameter and P < 0.001 for all parameters as a profile). Aortic strain, stiffness, and distensibility were also worse in patients than in controls (all P < 0.05) and were correlated with parameters of LV diastolic dysfunction (all P ≤ 0.03). CONCLUSIONS: Aortic stiffness is independently associated with LV diastolic dysfunction in young adult patients with SLE.

Valvular perforation in left-sided native valve infective endocarditis.

BACKGROUND: Left-sided native valve infective endocarditis (LNVIE) can result in mitral (MP) and aortic (AP) valve perforation, the prognostic significance of which remains poorly defined. HYPOTHESIS: Valvular perforation is associated with worse outcomes. METHODS: Retrospective review of patients with LNVIE during 1998-2005 was performed to examine characteristics and outcome predictors of LNVIE complicated by valve perforation. Patients were stratified as: group A: MP or AP detected by transesophageal echocardiography (TEE) or surgery; group B: no TEE evidence of MP or AP. RESULTS: A total of 123 patients were included (group A = 47, group B = 76). In group A, 35 patients (74.5%) had MP alone, 11 (23.4%) had AP alone, and 1 patient had both. Severe valvular insufficiency was encountered more in group A (85.1% versus 59.2%, p = 0.003), so was hemodialysis (40.4% versus 17.1%, p = 0.004) and indications for valvular surgery (93.6% versus 77.6%, p = 0.02). Group A had a higher rate of in-hospital death (31.9% versus 15.8%, p = 0.04). Among patients who had an indication for valvular surgery, the in-hospital mortality rate for those who underwent valvular surgery was 16.7% in group A, and 7.9% in group B (p = 0.4), compared to those who did not undergo surgery (71.4% versus 33.3%, p = 0.04). Amongst survivors, hospital stay was on average 9.2 d longer in group A (38.9 versus 29.7 d, p = 0.05). Univariate analysis revealed association between lower survival and valvular perforation (odds ratio [OR]: 0.4, 95% confidence interval [CI]: 0.17-0.95), that was lost after adjusting for hemodialysis. CONCLUSIONS: Valve perforation complicating LNVIE is associated with hemodialysis, severe valvular insufficiency, and significant morbidity and mortality. Compared to conservative management, early surgical intervention is associated with improved survival.