Sanford Heart Hospital

The Oncotype DX colon cancer assay is a clinically validated predictor of recurrence risk in stage II colon cancer patients. This prospective study evaluated the impact of recurrence score (RS) results on physician recommendations regarding adjuvant chemotherapy in T3, mismatch repair-proficient (MMR-P) stage II colon cancer patients. Patients and Methods. Stage IIA colon cancer patients were enrolled in 17 centers. Patient tumor specimens were assessed by the RS test (quantitative reverse transcription-polymerase chain reaction) and mismatch repair (immunohistochemistry). For each patient, the physician's recommended postoperative treatment plan of observation, fluoropyrimidine monotherapy, or combination therapy with oxaliplatin was recorded before and after the RS and mismatch repair results were provided. Results. Of 221 enrolled patients, 141 patients had T3 MMR-P tumors and were eligible for the primary analysis. Treatment recommendations changed for 63 (45%; 95% confidence interval: 36%-53%) of these 141 T3 MMR-P patients, with intensity decreasing for 47 (33%) and increasing for 16 (11%). Recommendations for chemotherapy decreased from 73 patients (52%) to 42 (30%), following review of RS results by physician and patient. Increased treatment intensity was more often observed at higher RS values, and decreased intensity was observed at lower values (p = .011). Conclusion. Compared with traditional clinicopathological assessment, incorporation of the RS result into clinical decision making was associated with treatment recommendation changes for 45% of T3 MMR-P stage II colon cancer patients in this prospective multicenter study. Use of the RS assay may lead to overall reduction in adjuvant chemotherapy use in this subgroup of stage II colon cancer patients.

BACKGROUND: Monitoring supine pulmonary artery pressures to guide heart failure (HF) management has reduced HF hospitalizations in select patients. OBJECTIVES: The purpose of this study was to evaluate the effect of managing seated mean pulmonary artery pressure (mPAP) with the Cordella Pulmonary Artery sensor on outcomes in patients with HF. METHODS: Following GUIDE-HF (Hemodynamic-GUIDEd Management of Heart Failure Trial), with U.S. Food and Drug Administration input, PROACTIVE-HF (A Prospective, Multi-Center, Open Label, Single Arm Clinical Trial Evaluating the Safety and Efficacy of the Cordella Pulmonary Artery Sensor System in NYHA Class III Heart Failure Patients trial) was changed from a randomized to a single-arm, open label trial, conducted at 75 centers in the USA and Europe. Eligible patients had chronic HF with NYHA functional class III symptoms, irrespective of the ejection fraction, and recent HF hospitalization and/or elevated natriuretic peptides. The primary effectiveness endpoint at 6 months required the HF hospitalization or all-cause mortality rate to be lower than a performance goal of 0.43 events/patient, established from previous hemodynamic monitoring trials. Primary safety endpoints at 6 months were freedom from device- or system-related complications or pressure sensor failure. RESULTS: Between February 7, 2020, and March 31, 2023, 456 patients were successfully implanted in modified intent-to-treat cohort. The 6-month event rate was 0.15 (95% CI: 0.12-0.20) which was significantly lower than performance goal (0.15 vs 0.43; P < 0.0001). Freedom from device- or system-related complications was 99.2% and freedom from sensor failure was 99.8% through 6 months. CONCLUSIONS: Remote management of seated mPAP is safe and results in a low rate of HF hospitalizations and mortality. These results support the use of seated mPAP monitoring and extend the growing body of evidence that pulmonary artery pressure-guided management improves outcomes in heart failure. (Multi-Center, Open Label, Single Arm Clinical Trial Evaluating the Safety and Efficacy of the Cordella Pulmonary Artery Sensor System in NYHA Class III Heart Failure Patients trial [PROACTIVE-HF]; NCT04089059).

BACKGROUND: Powassan virus is a flavivirus related to eastern hemisphere's tick-borne encephalitis viruses. It can cause a rare but potentially life-threatening disease including encephalitis. CASE PRESENTATION: We report four cases of POWV infection in Minnesota and North Dakota with known exposure to tick bites in 2011. Our first case was an 18-year-old male who dramatically presented with seizure and headache with positive serum analysis for Powassan virus immunoglobulin M. The second case was a 60 year old gentleman with intraparenchymal hemorrhage and was diagnosed via cerebrospinal fluid analysis. Thirdly, a 61 year old male developed altered mental status and encephalitis. Our fourth patient was a 69 year old male who had headache and non-focal weakness who was diagnosed with serum analysis. CONCLUSION: Symptoms of Powassan virus infection ranged from headaches to seizures and severe neurological symptoms. This study serves to highlight the increased detection of Powassan virus infection in the central north United States. This report focuses on the increasing incidence that can lead to increasing efforts for raising awareness regarding this infection. There is a need for clinician vigilance and public attention due to its increasing detection, westward progression and varied clinical presentations.

PURPOSE: Sacral neuromodulation is a guideline recommended treatment of urinary dysfunction and fecal incontinence in patients in whom conservative treatments have failed. Historically sacral neuromodulation has been delivered using a nonrechargeable device with an average life span of 4.4 years. Surgery is required to replace the implanted neurostimulator due to battery depletion. Implantation of a long-lived implanted neurostimulator can eliminate the need for replacement surgeries, potentially reducing patient surgical risks and health care costs. The Axonics r-SNM System™ is a miniaturized, rechargeable sacral neuromodulation system designed to deliver therapy for at least 15 years. The ARTISAN-SNM (Axonics® Sacral Neuromodulation System for Urinary Urgency Incontinence Treatment) study is a pivotal study using rechargeable sacral neuromodulation therapy to treat urinary urgency incontinence. Six-month results are presented. MATERIALS AND METHODS: A total of 129 eligible patients with urinary urgency incontinence were treated. All participants were implanted with a tined lead and the rechargeable sacral neuromodulation system in a nonstaged procedure. Efficacy data were collected using a 3-day bladder diary, the validated ICIQ-OABqol (International Consultation on Incontinence Questionnaire Overactive Bladder quality of life) questionnaire and a participant satisfaction questionnaire. Therapy responders were identified as participants with a 50% or greater reduction in urinary urgency incontinence episodes compared to baseline. We performed an as-treated analysis in all implanted participants. RESULTS: At 6 months 90% of participants were therapy responders. The mean ± SE number of urinary urgency incontinence episodes per day was reduced from 5.6 ± 0.3 at baseline to 1.3 ± 0.2. Participants experienced a clinically meaningful 34-point improvement on the ICIQ-OABqol questionnaire. There were no serious device related adverse events. CONCLUSIONS: The Axonics r-SNM System is safe and effective with 90% of participants experiencing clinically and statistically significant improvements in urinary urgency incontinence symptoms.

AIMS: Sacral neuromodulation (SNM) is a guideline-recommended treatment with proven therapeutic benefit for urinary urgency incontinence (UUI) patients. The Axonics® System is the first Food and Drug Administration-approved rechargeable SNM system and is designed to deliver therapy for a minimum of 15 years. The ARTISAN-SNM study was designed to evaluate UUI participants treated with the Axonics System. Two-year follow-up results are presented. METHODS: One hundred and twenty-nine UUI participants underwent implantation with the Axonics System. Therapeutic response rate, participant quality of life (QoL), and satisfaction were determined using 3-day voiding diaries, ICIQ-OABqol, and satisfaction questionnaires. Participants were considered responders if they had a 50% or greater reduction in UUI episodes post-treatment. As-treated and Completers analyses are presented. RESULTS: At 2 years, 93% of the participants (n = 121 Completers at 2 years) were therapy responders, of which 82% achieved ≥ 75% reduction in UUI episodes and 37% were dry (100% reduction). Daily UUI episodes reduced from 5.6 ± 0.3 at baseline to 1.0 ± 0.2 at 2 years. Statistically significant improvements in ICIQ-OABqol were reported. All participants were able to recharge their device and 94% of participants reported that the recharging frequency and duration were acceptable. Participant demographics nor condition severity were correlated with clinical outcomes or recharging experience. No unanticipated or serious device-related adverse events occurred. CONCLUSIONS: At 2 years, participants treated with the Axonics System demonstrated sustained safety and efficacy, high levels of satisfaction with therapy and recharging. Participant-related factors were not associated with efficacy or recharging outcomes, indicating the reported results are applicable to a diverse population.

AIMS: Sacral neuromodulation (SNM) is a guideline-recommended treatment for voiding dysfunction including urgency, urge incontinence, and nonobstructive retention as well as fecal incontinence. The Axonics® System is a miniaturized, rechargeable SNM system designed to provide therapy for at least 15 years, which is expected to significantly reduce revision surgeries as it will not require replacement as frequently as the non-rechargeable SNM system. The ARTISAN-SNM study is a pivotal study designed to treat patients with urinary urgency incontinence (UUI). Clinical results at 1-year are presented. METHODS: A total of 129 eligible UUI patients were treated. All participants were implanted with a quadripolar tined lead and neurostimulator in a single procedure. Efficacy data were collected using a 3-day bladder diary, a validated quality of life questionnaire (ICIQ-OABqol), and a participant satisfaction questionnaire. Therapy responders were defined as participants with ≥50% reduction in UUI episodes compared to baseline. Data were analyzed on all 129 participants. RESULTS: At 1 year, 89% of the participants were therapy responders. The average UUI episodes per day reduced from 5.6 ± 0.3 at baseline to 1.4 ± 0.2. Participants experienced an overall clinically meaningful improvement of 34 points on the ICIQ-OABqol questionnaire. All study participants (100%) were able to recharge their device at 1 year, and 96% of participants reported that the frequency and duration of recharging was acceptable. There were no serious device-related adverse events. CONCLUSIONS: The Axonics System is safe and effective at 1 year, with 89% of participants experiencing clinically and statistically significant improvements in UUI symptoms.

INTRODUCTION: Cerebral venous thrombosis is a rare initial presentation of polycythemia. If diagnosed early, treatment can reduce mortality and morbidity significantly. Often it may present with headache as the only complaint, and thus the diagnosis is likely to be missed. CASE PRESENTATION: A medically stable 31-year-old male, a chronic smoker with a ∼17 pack-year history of smoking, was admitted to the emergency room with a 2-week history of gradually worsening, severe, throbbing headache in the occipital region sensitive to light. Initial neurological examination was positive only for some involuntary motor tics of the left leg. Initial laboratory workup showed hemoglobin of 20 g/dl and hematocrit of 56.5%. The carboxyhemoglobin level was normal, but the oxygen dissociation curve was shifted to the left. Further evaluation by MRI and MRA of the brain suggested extensive and complete thrombosis of the superior sagittal sinus, right transverse sinus and right sigmoid sinus with a small venous infarct in the right parafrontal region. Given that the patient first presented with a thrombotic event, workup for primary polycythemia and hypercoagulable disorders was carried out, including JAK2 mutation evaluation, which was negative. This left us with smoking as the only risk factor and possible cause for secondary polycythemia. He improved significantly with phlebotomy and anticoagulation treatment. CONCLUSION: This case illustrates a rare but severe complication of secondary polycythemia stressing the importance of being aware of the risk of developing cerebral thrombosis in patients with chronic smoking exposure.

Angiographically visible thrombus and distal embolization are relatively common during percutaneous coronary intervention (PCI) in myocardial infarction (MI) and correspond to worse outcomes. Several aspiration and thrombectomy devices have been shown to be effective for prevention of distal embolization. We present a technique with successful use of the GuideLiner catheter (Vascular Solutions) for thrombus aspiration after dedicated manual aspiration thrombectomy devices have failed. Our case series includes large thrombus burden in clinical scenarios of ST-elevation MI in a native vessel, non-ST elevation MI in a vein graft, and ST-elevation MI due to native vessel in stent thrombosis.

OBJECTIVES: In patients with symptomatic aortic valve disease who are at intermediate to high risk for open surgical aortic valve replacement, transcatheter aortic valve replacement (TAVR) decreases overall mortality and improves quality of life. Hypertension (HTN) after TAVR has been associated with improved cardiac function and short-term survival but its effect on survival over 1 year is unclear. Our study aims to evaluate the effect of HTN following TAVR on short-term and long-term clinical and echocardiographic outcomes. METHODS: A retrospective chart review case-control study of 343 consecutive patients who underwent TAVR between August 2012 and November 2016 was performed to elucidate the relationship between HTN and post-TAVR outcomes. RESULTS: 193 patients who underwent TAVR (56.2%) developed or had a worsening of their HTN after TAVR. The development of post-TAVR HTN was associated with a significantly better overall survival at 1 year (89% vs 67%, p<0.001) and 2 years (72% vs 46%, p=0.002). Patients with increased blood pressure also had a significant lower in hospital cardiovascular mortality (1% vs 12%, p<0.001). However, the development or worsening of their HTN after TAVR was associated with an increase in heart failure (HF) exacerbations and diuretic use. CONCLUSIONS: The development or worsening of HTN after TAVR is associated with improved overall survival despite an increase in postprocedural HF exacerbations and antihypertensive medication utilisation. The outcomes of this study could be important in postoperative management of patients who underwent TAVR.

BACKGROUND: A causal genetic mutation is found in 40% of families with dilated cardiomyopathy (DCM), leaving a large percentage of families genetically unsolved. This prevents adequate counseling and clear recommendations in these families. We aim to identify novel genes or modifiers associated with DCM. METHODS: We performed computational ranking of human genes based on coexpression with a predefined set of genes known to be associated with DCM, which allowed us to prioritize gene candidates for their likelihood of being involved in DCM. Top candidates will be checked for variants in the available whole-exome sequencing data of 142 DCM patients. RNA was isolated from cardiac biopsies to investigate gene expression. RESULTS: PDLIM5 was classified as the top candidate. An interesting heterozygous variant (189_190delinsGG) was found in a DCM patient with a known pathogenic truncating TTN-variant. The PDLIM5 loss-of-function (LoF) variant affected all cardiac-specific isoforms of PDLIM5 and no LoF variants were detected in the same region in a control cohort of 26,000 individuals. RNA expression of PDLIM5 and its direct interactors (MYOT, LDB3, and MYOZ2) was increased in cardiac tissue of this patient, indicating a possible compensatory mechanism. The PDLIM5 variant cosegregated with the TTN-variant and the phenotype, leading to a high disease penetrance in this family. A second patient was an infant with a homozygous 10 kb-deletion of exon 2 in PDLIM5 resulting in early-onset cardiac disease, showing the importance of PDLIM5 in cardiac function. CONCLUSIONS: Heterozygous PDLIM5 variants are rare and therefore will not have a major contribution in DCM. Although they likely play a role in disease development as this gene plays a major role in contracting cardiomyocytes and homozygous variants lead to early-onset cardiac disease. Other environmental and/or genetic factors are probably necessary to unveil the cardiac phenotype in PDLIM5 mutation carriers.

BACKGROUND: Cryoballoon ablation of atrial fibrillation (AF) involves successful electrical pulmonary vein isolation (PVI). Pulmonary vein (PV) ostial occlusion with cryoballoon is classically assessed using PV angiography. A pressure-guided technique to assess ostial occlusion has been evaluated in small cohorts with mixed results. We evaluated the efficacy of this pressure-guided PVI technique and its impact on reducing contrast and fluoroscopy time as compared to the traditional approach. METHODS: We evaluated patients with paroxysmal AF, who underwent cryoballoon PVI. Patients prior to January 20th, 2013 underwent confirmation of PV occlusion by angiography only. Patients ablated after this time had PV occlusion initially determined by pressure monitoring and further confirmed by contrast injection into the PV in most cases (Pressure-guided PVI). Differences in the volume of contrast used and fluoroscopy time were evaluated. RESULTS: 46 patients had pressure-guided PVI and29 patients had occlusion of PV confirmed by angiography alone. Pressure-guided PVI was 99.5% successful in ablating AF, which was non-inferior to traditional method of PV isolation. This technique used an average of 8 cc of contrast and 21.5 min of fluoroscopy time, which was significantly less than the contrast amount used, and fluoroscopy time with angiographic isolation of PV. CONCLUSION: Pressure-guided PVI is an effective method for cryoablation of AF. This method not only significantly reduces the volume of contrast used but also decreases the fluoroscopy without compromising the success of PVI.

Despite accumulating evidence that culture shapes the symptoms of autism spectrum disorder (ASD), no studies have yet applied the Self-Construal Scale to individuals with ASD. We compared the self-construals (measured using the Self-Construal Scale) of 31 high-functioning Japanese individuals with ASD with those of 60 typically developing (TD) individuals. We also examined how the self-construals of individuals with ASD related to their intelligence quotient, adverse childhood experiences, attention deficit hyperactivity disorder, ASD symptoms during adulthood and preschool years, and subjective well-being. Individuals with ASD were more likely to display independent self-construals than were TD individuals; unexpectedly, however, a substantial proportion of individuals with ASD (43.8%) displayed relatively interdependent self-construals. Among individuals with ASD, self-construals were significantly associated with ASD symptoms during preschool years, and with satisfaction of the need for autonomy and frustration of the need for relatedness. Evaluating self-construals can help predict the subjective well-being of high-functioning individuals with ASD. Moreover, the Self-Construal Scale may be useful for understanding the heterogeneous phenotypes of ASD, based on its association with autistic symptoms during preschool years, suggesting that the scale is a potential tool to develop efficient interventions for high-functioning individuals with ASD. Autism Res 2020, 13: 947-958. © 2019 International Society for Autism Research, Wiley Periodicals, Inc. LAY SUMMARY: Autism Spectrum Disorders (ASD) are a group of disorders presenting a variety of symptoms and biological origins that can complicate choosing an intervention best suited for improving well-being. Results indicate that a self-construal scale could help understand individuals with high-functioning ASD by independent and interdependent self-construals that are associated with ASD symptoms during preschool years and adult subjective well-being. Our findings suggest that this scale can help understand ASD and select appropriate interventions.

Coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has become a pandemic that impacted the lives of billions of people worldwide. Angiotensin-converting enzyme 2 (ACE2) receptor act as a gate for viral cell entry through binding to virus S-protein. Cardiovascular patients are thought to be more susceptible to severe COVID-19 infection due to overexpression of ACE2 receptors in these patients. There is a growing body of evidence suggesting worse outcomes and increased mortality among COVID-19 patients with preexisting cardiovascular diseases. SARS-CoV-2 is capable of causing a wide range of cardiovascular diseases including myocarditis, heart failure, arrhythmia, myocardial ischemia and venous thromboembolism. Drug-disease interaction in COVID-19 patients with preexisting cardiovascular conditions has become a major concern. In this review, we discuss different aspects of the relationship between COVID-19 and the cardiovascular system along with a brief pharmacological overview.

Background Optical coherence tomography (OCT) is currently mostly performed using 6-Fr coronary guide catheters via femoral access. Catheters with such large internal diameters are necessary to deliver viscous contrast media and achieve sufficient red blood cell washout. Currently, undiluted iodinated contrast media (15 mL/injection) is used to clear the coronary arteries of red blood cells (RBCs). This leads to an increase in the total amount of contrast used and often the need for femoral artery access. Our objective is to assess the feasibility of performance of OCT using a 5-Fr guide catheter via radial access using diluted iodinated contrast. Methods We present a case series of 11 patients where second-generation frequency domain (FD)-OCT was used to assess the coronary arteries using a novel 70:30 dilution mixture of iodinated contrast medium with heparinized normal saline. All procedures were performed with a 5-Fr coronary guide catheter via the radial artery approach. Results All procedures were successfully performed vial radial access with good quality imaging obtained. The target vessel was the left anterior descending artery in eight patients, the right coronary artery in two patients, and the left main coronary artery in one patient. OCT resulted in a change in management in 7/11 (64%) patients; no complications were reported with OCT. On average, 10 mL of contrast was used per injection. Conclusions The current study demonstrates the feasibility of FD-OCT using 5-Fr guide catheters and diluted iodinated contrast media. This approach lowers contrast exposure and potentially decreases vascular complications without sacrificing image quality.

AIM: Adverse effects (ADRs) of non-steroidal anti-inflammatory drugs (NSAIDs) represent a public health problem. To decrease the negative effect on the population, an improvement of risk awareness is crucial. We aimed to evaluate the risk perception and the use of NSAIDs in South Dakota in comparison with Slovakia and Greece. METHOD: A structured questionnaire evaluating NSAID use in 185 patients in a hospital in South Dakota. RESULTS: 95.7 % of respondents reported the use of analgesics. On 1-10 visual analogue scale, perceived risk of NSAIDs was 4.27±2.46, similar to Greece (4.36±2.41, p=0.360), but significantly higher than in Slovakia (3.8±1.9, p=0.038). Only 12.4 % were familiar with gastrointestinal ADRs and only 1.1 % were aware of cardiovascular risk. Although 57.8 % were informed about ADRs by their doctor or pharmacist, only 33.0 % were informed spontaneously, without actively asking. Providers in South Dakota were informing patients spontaneously more often than in Slovakia (15.9 %, p≤0.001) and on par with Greece (36.3 %, p=0.631). CONCLUSIONS: Public awareness about NSAID risk is dangerously low. Only a third of providers are informing patients about possible risks spontaneously (Tab. 6, Ref. 15) Keywords: non-steroidal anti-inflammatory drugs, risk perception, adverse effects, cardiovascular risk, gastrointestinal risk.

Percutaneous coronary intervention in the diseased saphenous vein graft differs significantly from that in the diseased native coronary artery. After being exposed to arterial pressures over time, vein grafts have substantially different plaque characteristics, with more inflammatory cells, more diffuse disease, and less calcification. Severe calcification of saphenous vein grafts, although uncommon, poses a high risk of stent underexpansion. Orbital atherectomy for treatment of de novo calcified coronary lesions has been associated with better outcomes at 5-year follow-up. However, there are no published data on the use of orbital atherectomy to treat severely calcified saphenous vein graft lesions. We present the case of a 77-year-old woman with non-ST-segment-elevation myocardial infarction who underwent successful orbital atherectomy to prepare a severely calcified saphenous vein graft lesion for stent implantation.

Hyperdominant left anterior descending artery (LAD) is a rare anomaly in which the LAD gives rise to the posterior descending artery. Our case report describes an extreme case of hyperdominant LAD supplying the anterior, inferior, and partially the lateral walls of the left ventricle. It is crucial that physicians be aware of the possibility of extreme LAD dominance. A proximal occlusion of such a vessel might have catastrophic consequences with atypical presentation on electrocardiogram.

The association of complete atrioventricular (AV) block with Takotsubo syndrome (TTS) is well known, but the cause-and-effect relationship has not been determined. We present the case of a 91-year-old female with complete AV block who went untreated for over a year and later developed Takotsubo syndrome. Reversal of wall movement defects was seen after a permanent pacemaker was implanted, and routine follow-up showed that the implanted pacemaker worked normally.

BACKGROUND: Coronavirus disease 2019 (COVID-19) has become a leading cause of morbidity and mortality worldwide. One of the major complications of COVID-19 infection is the hypercoagulability state. Cardiac thrombi and venous thromboembolism (VTE) have been documented with severe COVID-19 infection. We present a case of large right atrial (RA) thrombus in transit incidentally diagnosed following a mild COVID-19 in a previously vaccinated patient. CASE SUMMARY: An 85-year-old male presented to the emergency department two weeks following resolution of a mild COVID-19 infection due to an incidentally discovered large RA thrombus. Computed tomography with angiography of the chest was positive for acute pulmonary thromboembolic disease with large clot burden and findings consistent with right heart strain. The patient remained hemodynamically stable and was successfully managed with anticoagulation. CONCLUSION: RA thrombi and VTE can occur in patients with mild COVID-19 infection and in the setting of full COVID-19 vaccination. Echocardiography is a useful imaging modality in this patient population.

Stent underexpansion, a potential complication of percutaneous coronary intervention in severely calcified and stenotic coronary arteries, may result in in-stent thrombosis and restenosis. Different balloon-based and atheroablative techniques have been proposed to reduce the risk of these complications. We describe a simple triple-guidewire technique that we used to treat stent underexpansion in 2 elderly men.