Integrated Stroke System Model Expands Availability of Endovascular Therapy While Maintaining Quality Outcomes.

BACKGROUND AND PURPOSE: The optimal endovascular stroke therapy (EVT) care delivery structure is unknown. Here, we present our experience in creating an integrated stroke system (ISS) to expand EVT availability throughout our region while maintaining hospital and physician quality standards. METHODS: We identified all consecutive patients with large vessel occlusion acute ischemic stroke treated with EVT from January 2014 to February 2019 in our health care system. In October 2017, we implemented the ISS, in which 3 additional hospitals (4 total) became EVT-performing hospitals (EPHs) and physicians were rotated between all centers. The cohort was divided by time into pre-ISS and post-ISS, and the primary outcome was time from stroke onset to EPH arrival. Secondary outcomes included hospital and procedural quality metrics. We performed an external validation using data from the Southeast Texas Regional Advisory Council. RESULTS: Among 513 patients with large vessel occlusion acute ischemic stroke treated with EVT, 58% were treated pre-ISS and 43% post-ISS. Over the study period, EVT procedural volume increased overall but remained relatively low at the 3 new EPHs (<70 EVT/y). After ISS, the proportion of patients who underwent interhospital transfer decreased (46% versus 37%; P<0.05). In adjusted quantile regression, ISS implementation resulted in a reduction of time from stroke onset to EPH arrival by 40 minutes (P<0.01) and onset to groin puncture by 29 minutes (P<0.05). Rates of postprocedural hemorrhage, modified Thrombolysis in Cerebral Infarction (TICI) 2b/3, and 90-day modified Rankin Scale were comparable at the higher and lower volume EPHs. The improvement in onset-to-arrival time was not reflective of overall improvement in secular trends in regional prehospital care. CONCLUSIONS: In our system, increasing EVT availability decreased time from stroke onset to EPH arrival. The ISS provides a framework to maintain quality in lower volume hospitals.

Quantification of Cerebral Edema After Subarachnoid Hemorrhage.

BACKGROUND: Global cerebral edema (GCE) is a manifestation of early brain injury (EBI) after subarachnoid hemorrhage (SAH) and is an independent risk factor for poor outcome. The lack of a quantitative method to measure GCE limits the study of its pathophysiology. The goal of this study is to develop a quantitative surrogate marker that represents GCE after SAH. METHODS: Patients with spontaneous SAH were enrolled into a prospective observational database. Initial CT scans were graded for GCE using established qualitative criteria. Selective sulcal volume (SSV) was defined as total mL of sulcal volumes on axial CT slices above the most cranial section of the lateral ventricles to the last visible section. Using a semiautomatic threshold approach, sulcal regions were traced out with manual adjustments when necessary. The volume of sulci in each slice was calculated and multiplied by the slice thickness and number of slices to calculate the SSV. All volumetric analysis was performed using Medical Image Processing, Analysis and Visualization Version 7.0.1 (MIPAV). RESULTS: A total of 109 subjects were included in our analysis. Mean selective sulcal volumes (SSV) differed between subjects with and without GCE 4.5 and 21.2 mL (P < 0.001). When separated into quartiles, the odds of qualitative GCE increases as SSV decreases. Compared to the highest SSV quartile, smaller SSV was associated with worse clinical outcomes. CONCLUSION: GCE can be quantified using volumetric analysis of SSV measurements on routine CT scans. Smaller SSV on admission is predictive of worse clinical outcomes. SSV may be an important marker of EBI after SAH.

A perforating pilomatricomal horn on the arm of an 11-year-old girl.

Cutaneous horns are uncommon in adults and rare in the pediatric population. Although verruca vulgaris, solar keratosis, and squamous cell carcinoma are more common entities that can present as cutaneous horns in the general population, conditions such as molluscum contagiosum, juvenile xanthgranuloma, and pyogenic granuloma have been reported causes in the pediatric population. We present a case of a perforating pilomatricoma presenting as a cutaneous horn in an 11 year old girl.

An Unusual Variant of Anomalous Pancreaticobiliary Junction.

A 27-year-old previously healthy African American female presented to the Emergency Department with an acute onset of epigastric abdominal pain and nausea. Laboratory studies proved unremarkable. CT scan demonstrated intrahepatic and extrahepatic biliary ductal dilation with possible stones within the common bile duct. The patient was discharged with a surgery follow-up appointment. Laparoscopic cholecystectomy with intraoperative cholangiography was performed 3 weeks later due to concern for choledocholithiasis. The intraoperative cholangiogram showed multiple abnormalities, concerning for an infectious or inflammatory process. Magnetic resonance cholangiopancreatography (MRCP) demonstrated a suspected anomalous pancreaticobiliary junction and cystic lesion near the pancreatic head. Endoscopic retrograde cholangiopancreatography (ERCP) for cholangioscopy showed normal-appearing pancreaticobiliary mucosa with 3 tributaries directly from the pancreas entering the bile duct and an ansa orientation to the pancreatic duct. Biopsies of the mucosa were benign. Annual MRCP and MRI to assess for findings concerning for neoplasm given the anomalous pancreaticobiliary junction were recommended.

A multi-firearm, multi-orientation audio dataset of gunshots.

Early detection of firearm discharge has become increasingly critical for situational awareness in both civilian and military domains. The ability to determine the location and model of a discharged firearm is vital, as this can inform effective response plans. To this end, several gunshot audio datasets have been released that aim to facilitate gunshot detection and classification of a discharged firearm based on acoustic signatures. However, these datasets often suffer from a lack of variety in the orientations of recording devices around the source of the gunshot. Additionally, these datasets often suffer from the absence of proper time synchronization, which prevents the usage of these datasets for determining the Direction of Arrival (DoA) of the sound. In this paper, we present a multi-firearm, multi-orientation time-synchronized audio dataset collected in a semi-controlled real-world setting - providing us a degree of supervision - using several edge devices positioned in and around an outdoor firing range.

Reconstitution studies of pesticides and surfactants exploring the cause of estrogenic activity observed in surface waters of the San Francisco Bay Delta.

To evaluate the potential role of endocrine disruption in the decline of pelagic fishes in the San Francisco Bay Delta of California, various surface water samples were collected, extracted, and found to elicit estrogenic activity in laboratory fish. Chemical analysis of the estrogenic samples indicated 2 pesticides (bifenthrin, diuron), 2 alkyphenols (AP), and mixtures of 2 types of alkyphenol polyethoxylates (APEOs). Evaluation of estrogenic activity was further characterized by in vitro bioassays using rainbow trout hepatocytes (Oncorhynchus mykiss) and in vivo studies with Japanese medaka (Oryzias latipes). In the in vitro bioassays, hepatocytes exposed to the pesticides alone or in combination with the AP/APEO mixtures at concentrations observed in surface waters failed to show estrogenic activity (induction of vitelloginin mRNA). In the in vivo bioassays, medaka exposed to individual pesticides or to AP/APEO alone did not have elevated VTG at ambient concentrations. However, when the pesticides were combined with AP/APEOs in the 7-day exposure a significant increase in VTG was observed. Exposure to a 5-fold higher concentration of the AP/APEO mixture alone also significantly induced VTG. In contrast to earlier studies with permethrin, biotransformation of bifenthrin to estrogenic metabolites was not observed in medaka liver microsomes and cytochrome P450 was not induced with AP/APEO treatment. These results showed that mixtures of pesticides with significantly different modes of action and AP/APEOs at environmentally relevant concentrations may be associated with estrogenic activity measured in water extracts and feral fish that have been shown to be in population decline in the San Francisco Bay Delta.

Thyroid Steal Syndrome Secondary to Active Hyperthyroid State.

Thyroid steal syndrome (TSS) is a rare condition characterized by recurrent transient ischemic attack (TIA) that is found to be due to a large thyroid goiter or thyroid hormone derangement causing a diversion of blood flow from the cerebral circulation. Here we report a patient with a history of multiple TIAs thought initially to be due to intracranial arterial stenosis based on CT angiography (CTA) findings, but later found to be secondary to hyperthyroid state causing TSS. To our knowledge, this is the first-ever reported case of TSS secondary to hyperthyroidism and only the second case of TSS secondary to any thyroid hormone derangement.

Reducing risks associated with medicines and lifestyle in a residential care population with intellectual disabilities: evaluation of a pharmacy review initiative in England.

OBJECTIVES: A collaborative service initiative involving community pharmacists and a specialist mental health pharmacist was developed to provide pharmacist reviews for care home residents with intellectual disabilities (IDs). This study aimed to characterise the medicines and lifestyle risk outcomes of the service and determine how these align with national priority issues in ID. DESIGN: Descriptive statistical analysis of routinely collected service delivery data. SETTING: Residential care homes in the Wirral, England for people with ID. PARTICIPANTS: 160 residents. INTERVENTIONS: Pharmacist review of residents' medicines and lifestyle risk factors between November 2019 and May 2020. PRIMARY AND SECONDARY OUTCOME MEASURES: Numbers of medicines prescribed, the nature of pharmacists' interventions/recommendations and general practitioner (GP)/psychiatrist acceptance. RESULTS: The 160 residents were prescribed 1207 medicines, 74% were prescribed ≥5 medicines and 507 interventions/recommendations were made, averaging 3.3 per resident. The highest proportion (30.4%) were lifestyle risk related, while changing and stopping medicines accounted for 17.9% and 12.8%, respectively. Of the recommendations discussed with GPs/psychiatrists, 86% were accepted. Medicines with anticholinergic properties were prescribed for 115 (72%) residents, of whom 43 (37%) had a high anticholinergic burden score. Pharmacists recommended anticholinergic discontinuation or dose reduction for 28 (24%) residents. The pharmacists made interventions/recommendations about constipation management for 10% of residents and about respiratory medicines for 17 (81%) of the 21 residents with respiratory diagnoses. CONCLUSIONS: The findings indicate considerable polypharmacy among the residents and a high level of pharmacists' interventions/recommendations about medicines and lifestyle risk, most of which were accepted by GPs/psychiatrists. This included anticholinergic burden reduction and improving respiratory disease and constipation management, which are national priority issues. Wider adoption of collaborative pharmacist review models could have similar benefits for residential populations with ID and potentially reduce pressure on other health services.

[Neurostimulation by music - an overview]. / Neurostimulation durch Musik.

What is music and how does it affect the human body? Historically, music is considered something divine because it has a huge impact on human emotions. This effect also has a psychosomatic effect and can influence and control the thoughts and actions of the listener. For example, purchasing behavior can be severely manipulated by musical accompaniment alone. Even the motivation can be either increased or reduced with the appropriate setting. In today's civilization, music accompanies people every day and is used for many different purposes. Thus, the musical stimulation is to be evaluated as a kind of psychotherapy, which is often used purposefully, but subconsciously takes place in the influenced. Of course, as there are still unanswered questions about the exact effect of music on the brain, many studies are currently being conducted in the field of neuroscience to fully understand this phenomenon.

Endoscopic retrograde cholangiopancreatography in general surgery: how much are we outsourcing?

Although surgeons can safely perform endoscopic retrograde cholangiopancreatography (ERCP), it has fallen within the domain of gastroenterologists. We sought to quantify the role of ERCP in a tertiary-care surgery department. The hospital discharge database was queried for all ERCPs performed from January 2007 to December 2007. Gastroenterologists performed all ERCPs in our query. Surgical patients were admitted and/or under the care of a surgeon; whereas nonsurgical patients had no surgeon involvement. Patient characteristics and diagnoses were compared between groups. ERCP procedural details were recorded. Surgical patients comprised 48 per cent (n = 151) of the total 311 ERCPs performed. The mean time interval from a surgeon's request for ERCP to actual procedure was 2.43 days (standard deviation [SD] 2.55; range, 0-13 days). The surgical group had significantly different diagnoses and underwent less diagnostic (22% vs 56%) and more therapeutic ERCPs (72% vs 38%). Surgical patients were more likely inpatients (82.1% vs 16.8%) with a longer length of stay (6.7 vs 3.9 days; P = 0.0029) compared with nonsurgical patients. We found surgical patients requiring ERCP differ significantly from nonsurgical patients, with a significant number of technical interventions being outsourced. Given the benefits of a surgical ERCP program and the potential volume of these unique patients, this procedure should be performed by appropriately trained surgeons.

Treatment outcomes, 30-day readmission and healthcare resource utilization after pancreatoduodenectomy for pancreatic malignancies.

BACKGROUND: We sought to determine treatment outcomes after pancreatoduodenectomy for pancreatic head and uncinate process malignancy and its impact on mortality, morbidity, and resource utilization. METHODS: This was a retrospective cohort study using the 2014 Nationwide Readmissions Database. Discharges were included if they had an ICD-9 CM procedure code for pancreatoduodenectomy and any code for malignancy of the pancreas head and uncinate process. Independent predictors of readmission were identified using multivariable Cox regression analysis. RESULTS: A total of 4,445 patients were included. The surgical complication rate was 17.3%, and in-hospital mortality rate was 3%. The 30-day readmission rate was 19.7% with an in-hospital mortality rate of 3.9%. The most common reason for readmission was postoperative infection. The mean length of stay during readmission was 6.50 days, while the mean total hospitalization costs and charges were $15,589 and $52,922, respectively. The number of hospital days associated with readmission was 5,548, with an in-hospital economic burden of $12.9 million (costs) and $43.7 million (charges). Hospital volume and discharge disposition were independent predictors of 30-day readmission. CONCLUSIONS: Pancreatoduodenectomy for pancreatic malignancies is still associated with significant morbidity, mortality and 30-day readmission. Reducing readmission can impact mortality, quality of life, and healthcare economic burden in this setting.

Clinical results using bioabsorbable staple line reinforcement for circular staplers.

Although linear surgical staple line reinforcement has been shown to increase anastomotic tensile strength in animal models and reduce the incidence of staple line bleeding and anastomotic leaks in colorectal surgery, the benefits of staple line reinforcement on circular stapled anastomoses in bariatric surgery remain unreported in the literature. The purpose if this study was to compare the incidence of anastomotic bleeding, leak, and stricture in patients undergoing laparoscopic gastric bypass with circular staple line reinforcements with those with no circular staple line reinforcements. Since May 2006, 138 consecutive patients (Group B) have undergone laparoscopic Roux-en-Y divided gastric bypass with a 25-mm circular stapled gastrojejunal anastomosis using GORE SEAMGUARD bioabsorbable circular staple line reinforcement (CBSG) with a mean follow up of 9 months. The incidence of anastomotic bleeding, leak, and stricture was compared with 255 similar patients (Group A) who underwent surgery before May 2006 without gastrojejunal reinforcement with a mean follow up of 22 months. The rates of anastomotic bleeding, leak, and stricture for Group B versus Group A were 0.7 per cent versus 1.1 per cent (P = 0.64); 0.7 per cent versus 1.9 per cent (P = 0.34); and 0.7 per cent versus 9.3 per cent (P = 0.0005), respectively. The use of CBSG reduced the incidence of anastomotic stricture by 93 per cent and the incidence of a composite end point of all anastomotic complications by 85 per cent. Our results indicate that the use of circular staple line reinforcement at the gastrojejunal anastomosis in patients undergoing laparoscopic gastric bypass significantly decreases the incidence of anastomotic stricture and a composite end point of all anastomotic complications. On this basis, strong consideration should be given to the routine use of CBSG staple line reinforcement in patients undergoing laparoscopic divided gastric bypass with a circular stapled gastrojejunal anastomosis.

Spontaneous Healing of a Ruptured Blood Blister-Like Aneurysm.

BACKGROUND: Blood blister-like aneurysms (BBAs) are an uncommon group of arterial aneurysms with a high risk of rupture, progression, and repeat rupture. The best intervention is unclear; however, their clinical behavior typically requires urgent intervention. We describe a BBA managed conservatively with complete resolution found at follow-up. CASE DESCRIPTION: A 50-year-old woman presented with a Hunt-Hess grade 2, Fisher grade 3 subarachnoid hemorrhage (SAH). Computed tomography (CT) revealed mild hydrocephalus with a thick basal SAH that was eccentric to the left. The findings from CT angiography were negative. Digital subtraction arteriography (DSA) revealed a focal protuberance along the dorsal surface of the left ophthalmic segment that was concerning for a dorsal variant BBA. Repeat angiography 48 hours later demonstrated receding of the ectasia, with replacement by a <1-mm defect resembling a dorsal vessel surface fenestration. DSA 7 days after her presentation showed further healing. At 6 weeks, DSA showed no residual abnormality. CONCLUSIONS: DSA remains an important imaging study for the detection of small aneurysms, because CT angiography might not have sufficient resolution. Our unique case provides strong evidence that BBAs represent a parent artery focal dissection. BBAs can remodel over time, usually with enlargement and repeat rupture if untreated. It is possible, as we have demonstrated, that some small lesions presenting with SAH might spontaneously heal without intervention.

The Subarachnoid Hemorrhage Early Brain Edema Score Predicts Delayed Cerebral Ischemia and Clinical Outcomes.

BACKGROUND: Early brain injury (EBI) after subarachnoid hemorrhage (SAH) is an important determinant of clinical outcomes. However, a major hindrance to studies of EBI is the lack of radiographic surrogate marker. OBJECTIVE: To propose a scoring system based on early changes in clinically obtained computed tomography (CT), called the Subarachnoid hemorrhage Early Brain Edema Score (SEBES). METHODS: Patients with spontaneous aneurysmal SAH and a CT within 24 h of ictus were included. We defined SEBES as a scale of 0 to 4 points according to the (1) absence of visible sulci caused by effacement of sulci or (2) absence of visible sulci with disruption of the gray-white matter junction at 2 predetermined levels in each hemisphere. Prognostic value of the SEBES grade for the prediction of delayed cerebral ischemia (DCI) and unfavorable outcomes was assessed. A separate cohort of patients was used as a validation cohort. RESULTS: Of the 164 subjects in our study, high-grade SEBES (3 or 4 points) was identified in 48 patients (29.3%). CT interobserver reliability of SEBES grades was high with a Kappa value of 0.89. After adjusting for covariables, SEBES was identified as an independent predictor of DCI (OR = 2.24, 95% CI: 1.58-3.17) and unfavorable outcome (OR = 3.45, 95% CI: 1.95-6.07). In our validation cohort, 84 subjects showed similar predictive power of SEBES for a prediction of DCI and unfavorable long-term outcome. CONCLUSION: SEBES may be a surrogate marker of EBI and predicts DCI and clinical outcomes after SAH.

Surgical revascularization in patients with end-stage renal disease: results using a new paradigm in outcomes assessment.

Studies evaluating the outcome of surgical revascularization (SR) for critical limb ischemia in patients who have end-stage renal disease (ESRD) have differed widely in their findings and conclusions. Differences in definitions of success are largely responsible for the varying outcomes. We developed a method of outcomes assessment that incorporates four all-inclusive endpoints to define success. These include primary graft patency to the point of wound healing, postoperative survival of at least 6 months, limb salvage of at least 1 year, and maintenance of ambulatory status of at least 6 months. The purpose of this study was to use this novel method of defining success to determine the outcome of SR in patients with ESRD. From 1998 to 2004, 40 patients (52 limbs) with ESRD and tissue loss underwent SR for limb salvage. Secondary graft patency and limb salvage rates at 36 months were 54.7 per cent and 53 per cent, respectively. When considering each of the four components used to define success separately, success encouragingly ranged between 60 per cent (patent graft until wound healing) and 87.5 per cent (survival for 6 months). However, if all parameters were combined, clinical success was achieved in only 40 per cent (16/40) of patients. Coronary artery disease was the only factor found to significantly reduce success (P = 0.04). In conclusion, using this multiparameter definition of success, which combines four rather modest outcome milestones, favorable outcome occurred in the minority of cases. This study challenges our current method of analyzing success and questions our therapeutic approach to patients with critical limb ischemia and ESRD.

Antiplatelet therapy for the prevention of peri-coiling thromboembolism in high-risk patients with ruptured intracranial aneurysms.

OBJECTIVE The most frequent procedural complication of the endovascular treatment of intracranial aneurysms is a thromboembolic event (TEE); in a subset of patients, such events will cause permanent neurological disability. In patients with unruptured aneurysms, increasing evidence supports the use of periprocedural antiplatelet therapy to prevent TEEs. The object of this study was to evaluate whether patients with ruptured aneurysms and subarachnoid hemorrhage would also benefit from periprocedural antiplatelet therapy. METHODS The authors reviewed a prospective registry of 169 patients with endovascularly treated intracranial aneurysms to delineate angiographic features associated with periprocedural TEEs. They then performed a controlled before-and-after study in 79 patients with ruptured aneurysms who were deemed to be at high risk for TEEs (for example, patients with at least 1 angiographic feature associated with TEEs) to evaluate whether selective aspirin administration would reduce the rate of periprocedural thromboembolism without increasing major hemorrhagic complications. RESULTS Six angiographic features were associated with periprocedural TEEs in the study cohort: wide aneurysm neck, coil or loop protrusion, small parent artery diameter, an incorporated branch, intraprocedural thrombus formation, and intracranial parent vessel atherosclerosis. Aspirin administration to high-risk patients significantly decreased the rate of periprocedural TEEs, from 53.8% in the control group to 10.6% in the aspirin-treated group (p = 0.001). The reduction in TEEs in the aspirin-treated group continued to be statistically significant even when adjusted for age, sex, cardiovascular risk factors (smoking, diabetes, hypertension, dyslipidemia, coronary artery disease), and factors associated with TEEs in other large studies (wide aneurysm neck, aneurysm size ≥ 10 mm), with an adjusted OR of 0.16 (95% CI 0.03-0.8). There were no major systemic hemorrhagic complications, and aspirin did not increase the risk of aneurysm rebleeding, symptomatic intracranial hemorrhage, or major external ventricular drain (EVD)-associated hemorrhage (p = 0.3), though there was an increase in asymptomatic, minor (< 1 cm) EVD-associated hemorrhage in the aspirin-treated group (p = 0.02). CONCLUSIONS The study findings suggest that for ruptured aneurysm patients with high-risk features, antiplatelet therapy can significantly reduce the rate of periprocedural TEE without increasing major systemic or intracranial hemorrhages.

Outcomes of Endoscopic Stenting for Traumatic Biliary and Pancreatic Fistulae.

The role of endoscopic retrograde cholangiopancreatography (ERCP) in the trauma patient is limited. Therefore, reporting of outcomes is sparse in the literature. The purpose of this study was to review outcomes of patients who underwent ERCP for traumatic biliopancreatic injury. We retrospectively reviewed 1550 ERCPs, from a prospectively maintained database, performed by a single surgical endoscopist consulted by the trauma surgical service for the management of traumatic fistulae. Referral was made for patients with high output (greater than 200 mL/d) and/or persistent (failure to resolve within 30 days) fistulae and traumatic biliary stricture. Primary end point was postprocedural complications. Secondary end points included patient characteristics, stents placed, and duration of stenting. Seventeen patients underwent a total of 31 ERCPs for biliary and/or pancreatic injury resulting from abdominal trauma (eight penetrating, nine blunt). Fourteen patients had ERCP after laparotomy, with a mean interval to ERCP of 74 days. In three patients, ERCP was the only intervention required. Fourteen biliary stents were placed, seven of which were metallic. Ten pancreatic stents were placed; one proximally migrated but was successfully retrieved. Four patients had both ducts simultaneously stented. The mean duration of stenting was 158 days. All fistulae resolved after stenting. There were no serious complications.

Transcatheter versus surgical aortic valve replacement in intermediate risk patients: a meta-analysis.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) has been approved in patients with high or prohibited surgical risk for surgery for treatment of severe symptomatic aortic stenosis. Prospective studies examining the benefits of TAVR in intermediate risk patients are ongoing. Other smaller studies including lower risk patients have been conducted, but further meta-analysis of these studies is required to draw more broad comparisons. METHODS: A Medline search was conducted using standard methodology to search for clinical trials and observational studies including intermediate risk patients. We limited our meta-analysis to studies matching patient populations by propensity scores or randomization and examined clinical outcomes between TAVR and surgical aortic valve replacement (SAVR). RESULTS: Analysis of the TAVR and SAVR cohorts revealed no significant differences in the outcomes of 30-day [OR (95% CI): 0.85 (0.57, 1.26)] or 1-year mortality [OR (95% CI): 0.96 (0.75, 1.23)]. A trend towards benefit with TAVR was noted in terms of neurological events and myocardial infarction (MI) without statistical significance. A statistically significant decrease in risk of post-procedural acute renal failure in the TAVR group [OR (95% CI): 0.52 (0.27, 0.99)] was observed, but so was a significantly higher rate of pacemaker implantations for the TAVR group [OR (95% CI): 6.51 (3.23, 13.12)]. CONCLUSIONS: We conclude that in intermediate risk patients undergoing aortic valve replacement, the risk of mortality, neurological outcomes, and MI do not appear to be significantly different between TAVR and SAVR. However, there appears to be a significant reduction in risk of acute renal failure at the expense of an increased risk of requiring a permanent pacemaker in low and intermediate risk patients undergoing TAVR compared to SAVR.