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Background: Arctic Front™ and Thermocool® ablation catheters have proven to be safe in clinical trials; real-world data on modes of failure and the complications of these devices are limited. Objectives: To assess the reported mechanisms of failure, clinical consequences, and outcomes among the most frequently used ablation catheters in the United States. Methods: Retrospective analysis of data from the FDA Manufacturer and User Facility Device Experience (MAUDE) registry in the last decade. Results: A total of 2092 reports were found during the study period. 1588 reports were included in the final analysis (Thermocool n=1016, Arctic Front n=572). The most commonly reported mode of failure was fracture of catheter component (i.e., guidewire, pebax, Balloon connector, shaft, tip, or bowden) 20.0% overall (13.9% with Thermocool and 30.8% with Arctic Front). Cardiac tamponade was the most common reported complication 23.4% overall (23.4% with Thermocool and 0% with Arctic Front). The procedure was aborted in 11.3% of the reported cases (16.2% with Thermocool and 2.6% with Arctic Front) with the need for surgical conversion in 7.9% overall (12.3 % with Thermocool and 0% with Arctic Front). The death occurred in 2.4% overall (3.7% with Thermocool and 0% with Arctic Front). Conclusions: The most reported mode of failure is the fracture of the catheter component, followed by the Kink of the catheter. The mostreported complications were cardiac tamponade and hemodynamic compromise; however, Arctic Front seems to be safe. Future efforts should focus on an innovative guidewire structure. [ABSTRACT FROM AUTHOR]

Background: The modes of failure of coronary polymer-jacketed guidewires have received limited study.Methods: We queried the Manufacturer and User Facility Device Experience (MAUDE) database between January 2011 and December 2020 for reports on coronary polymer-jacketed guidewires and retrieved 254 reports.Results: The most common failure mode was failure of the guidewire to cross (36.2%), followed by guidewire fracture (35%), peeling of the polymer jacket (13.8%), failure to retrieve the guidewire (13.8%), and guidewire unraveling (4.7%). Guidewire fracture was more common with soft (37.3%) compared with stiff (23.8%) guidewires. Failure of retrieval was only reported with soft guidewires (9%). Coronary perforation and dissection occurred in 19.7% and 7.9% of the reports, with more reports with stiff as compared with soft guidewires (45.2% vs. 14.6% for perforation and 21.4% vs. 5.3% for dissection).Conclusions: The most common failure modes of polymer-jacketed guidewires during percutaneous coronary intervention are failure to cross the lesion, guidewire fracture, and peeling of the polymer jacket. Coronary perforations were more common with stiff whereas wire fracture was more common with soft polymer-jacketed guidewires. [ABSTRACT FROM AUTHOR]

The cardiovascular and renal systems share an intimate physiological relationship, wherein a perturbance in one system may have an adverse effect on the other. Since the burden of renal disease increases with age, there is a considerable interest in the pathophysiology of kidney disease in the geriatric patient population. This review will explore the physiological dynamics behind the increased susceptibility to kidney disease in this population. A better understanding of these pathophysiological changes may lead to improved prevention and management strategies. [ABSTRACT FROM AUTHOR]

Background: Post-operative atrial fibrillation (POAF) is common after aortic valve replacement (AVR) and is associated with worse outcomes. We performed a meta-analysis of randomized controlled trials comparing Surgical Aortic Valve Replacement (SAVR) and Transcatheter Aortic Valve Replacement (TAVR) for incidence of POAF at 30 days. Methods: We searched databases from 1/1/1990 to 1/1/2020 for randomized studies comparing TAVR and SAVR. POAF was defined as either worsening or new-onset atrial fibrillation. Random effects model was used to estimate the risk of POAF with TAVR vs SAVR in all trials, and in subgroups (low, intermediate, high risk, and in self-expandable vs balloon expandable valves). Sensitivity analysis was performed including only studies reporting new-onset atrial fibrillation Results: Seven RCTs were identified that enrolled 7,934 patients (3,999 to TAVR and 3,935 to SAVR). The overall incidence of POAF was 9.7% after TAVR and 33.3% after SAVR. TAVR was associated with a lower risk of POAF compared with SAVR (OR 0.21 [0.18-0.24]; P < 0.0001). Compared with SAVR, TAVR was associated with a significantly lower risk of POAF in the high-risk cohort (OR 0.37 [0.27-0.49]; P < 0.0001), in the intermediate-risk cohort (OR 0.23 [0.19-0.28]; P < 0.0001), low-risk cohort (OR 0.13 [0.10-0.16]; P < 0.0001). Sensitivity analysis of 4 trials including only new-onset POAF showed similar summary estimates (OR 0.21, 95% CI [0.18-0.25]; P< 0.0001). Conclusions: TAVR is associated with a significantly lower risk of post-operative atrial fibrillation compared with SAVR in all strata. Further studies are needed to identify the contribution of post-operative atrial fibrillation to the differences in clinical outcomes after TAVR and SAVR. [ABSTRACT FROM AUTHOR]

Purpose: Our objective was to determine significant predictors of spinal cord ischemia (SCI) following Thoracic Endovascular Aortic Repair (TEVAR) and to further develop a simple and clinically orientated risk score model. Methods: A retrospective review of data from the Society of Vascular Surgery/Vascular Quality Initiative national data set was performed for all patients undergoing TEVAR from January, 2014 to June 2018. Preoperative demographics, procedure-related variables, and clinical details related to SCI were examined. A SCI risk score was developed utilizing a multivariable logistic regression model. Results: For the 7889 patients in the final analysis who underwent TEVAR during the study period, the mean age was 67.6 ± 13.9, range 18 to 90 years, and the majority was male (65%). Postoperative outcomes included stroke (3.0%), myocardial infarction (2.9%), inhospital mortality (5.4%), transient SCI (1.5%), and permanent SCI (2.1%). Nearly half of the overall cases were performed in high volume centers. Predictors of increased risk for SCI included age by decade (odds ratio [OR]: 1.2), celiac coverage (OR: 1.5), current smoker (OR: 1.6), dialysis (OR: 1.9), 3 or more aortic implanted devices (OR: 1.7), emergent or urgent surgery (OR: 1.5), adjunct aorta-related procedure (OR: 2.5), adjunct not related (OR: 2.6), total estimated length of aortic device (19-31 cm, OR: 1.9 and ≥32 cm, OR: 3.0), ASA class 4 or 5 (OR: 1.6), and procedure time ≥154 minutes (OR: 1.8). Two predictors decreased the risk of SCI, cases from high-volume centers (OR: 0.6) and eGFR ≥ 60 (OR: 0.6). To evaluate the risk score model, probabilities of SCI from the original regression, raw score, and raw score categories resulted in area under the curve statistics of 0.792, 0.786, and 0.738, respectively. Conclusions: Spinal cord ischemia remains one of the most feared complications of TEVAR. Incidence of SCI in this large series of patients with TEVAR was 3.6% with nearly 60% being permanent. The proposed model provides an assessment tool to guide clinical decisions, patient consent process, risk-assessment, and procedural strategy. [ABSTRACT FROM AUTHOR]

Peripheral arterial disease (PAD) refers to partial or complete occlusion of one or more non-coronary arteries that leads to compromised blood flow and ischemia. Numerous processes are involved in arterial stenosis, however, atherosclerosis remains the most common etiology. PAD constitutes a major health economic problem, and it is estimated that over 200 million people around the world suffer from PAD, with at least 20% having some degree of claudication. The purpose of this review is to compare and contrast the guidelines on PAD published in 2005, 2011 and 2016 in terms of new recommendations and level of evidence for practicing clinicians. [ABSTRACT FROM AUTHOR]

Contrast-induced acute kidney injury (CI-AKI) is an important consideration in patients undergoing cardiac catheterization. There has been a continuous strive to decrease morbidity and improve procedural safety. This review will address the pathophysiology, predictors, and clinical management of CI-AKI with a concise overview of the pathophysiology and a suggested association with left atrial appendage closure. Minimizing contrast administration and intravenous fluid hydration are the cornerstones of an effective preventive strategy. A few adjunctive pharmacotherapies hold promise, but there are no consensus recommendations on prophylactic therapies. [ABSTRACT FROM AUTHOR]

Periprocedural imaging assessment for percutaneous Left Atrial Appendage (LAA) transcatheter occlusion can be obtained by utilizing different imaging modalities including fluoroscopy, magnetic resonance imaging (MRI), computed tomography (CT), and ultrasound imaging. Given the complex and variable morphology of the left atrial appendage, it is crucial to obtain the most accurate LAA dimensions to prevent intra-procedural device changes, recapture maneuvers, and prolonged procedure time. We therefore sought to examine the accuracy of the most commonly utilized imaging modalities in LAA occlusion. Institutional Review Board (IRB) approval was waived as we only reviewed published data. By utilizing PUBMED which is an integrated online website to list the published literature based on its relevance, we retrieved thirty-two articles on the accuracy of most commonly used imaging modalities for pre-procedural assessment of the left atrial appendage morphology, namely, two-dimensional transesophageal echocardiography, three-dimensional transesophageal echocardiography, computed tomography, and three-dimensional printing. There is strong evidence that real-time three-dimensional transesophageal echocardiography is more accurate than two-dimensional transesophageal echocardiography. Three-dimensional computed tomography has recently emerged as an imaging modality and it showed exceptional accuracy when merged with three-dimensional printing technology. However, real time three-dimensional transesophageal echocardiography may be considered the preferred imaging modality as it can provide accurate measurements without requiring radiation exposure or contrast administration. We will present the most common imaging modality used for LAA assessment and will provide an algorithmic approach including preprocedural, periprocedural, intraprocedural, and postprocedural. [ABSTRACT FROM AUTHOR]