Readability and reliability of online patient education materials about statins.

Objective: Statins are the cornerstone for the prevention and treatment of cardiovascular disease. Patients often consult online patient education materials (OPEMs) to inform medical decision-making. We therefore aimed to assess the readability and reliability of OPEMs related to statins. Methods: A total of 17 statin-related terms were queried using an online search engine to identify the top 20 search results for each statin-related term. Each OPEM was then grouped into the following categories based on 2 independent reviewers: government OPEMs (national, state, or local government agencies); healthcare/nonprofit OPEMs (major health systems and nonprofit organizations with a specific cardiovascular health focus); industry/commercial OPEMs (pharmaceutical manufacturers and online pharmacies); lay press OPEMs (healthcare-oriented news organizations); and dictionary/encyclopedia OPEMs. Grade-level readability for each OPEM was calculated using 5 standard readability metrics and compared with AMA-recommended readability recommendations. Reliability of each OPEM was evaluated using the JAMA benchmark criteria for online health information and certification from Health on the Net (HONCode). Results: A total of 340 websites were identified across the 17 statin search terms. There were 211 statin OPEMs after excluding non-OPEM results; 172 OPEMs had unique content. Statin OPEM readability exceeded the recommended 6th grade AMA reading level (average reading grade level of 10.9). The average JAMA benchmark criteria score was 2.13 (on a scale of 0-4, with higher scores indicating higher reliability), and only 60% of statin OPEMs were HONCode-certified. There was an inverse association between readability and reliability. The most readable results were from industry and commercial sources, while the most reliable sites were from lay press sources. Conclusions: Statin OPEMs are written at an overall averaging reading grade level of 10.9. There was an inverse association between readability and reliability. Lack of accessible, high-quality online health information may contribute to statin nonadherence.

Stellate ganglia stimulation counteracts vagal stimulation by significantly increasing heart rate and blood pressure.

BACKGROUND: Vasovagal syncope (VVS) is the leading cause of syncope. The most frequent mechanism is that of a cardioinhibitory response, vasodepressor response, or mixture of both. Neural stimulation that negates or overcomes the effects of vagal tone may be used as a treatment strategy for VVS. METHODS: Six male canines were studied. Stimulation (10-Hz, 2 ms pulse duration, 2 min duration) of the cervical vagus (CV), thoracic vagus (TV), and stellate ganglia (SG) was performed using needle electrodes at 3 V, 5 V, and 10 V output. SG stimulation at an output of 10 V overlaying TV stimulation at the same output was performed. Heart rate (HR), blood pressure (BP), and cardiac output (CO) were measured before, during, and after stimulation. RESULTS: Right cervical vagal stimulation was associated with significant hemodynamic changes. HR, SBP, and DBP were reduced (107 ± 16 vs. 78 ± 15 bpm [P < 0.0001], 116 ± 24 vs. 107 ± 28 mmHg [P = 0.002] and 71 ± 18 vs. 58 ± 20 mmHg [P < 0.0001]), respectively, while left cervical vagal stimulation had minimal changes. CV stimulation was associated with greater hemodynamic changes than TV stimulation. Left and right SG stimulation significantly increased systolic blood pressure (SBP), diastolic blood pressure (DBP), and HR at 5 V and 10 V, which could be observed within 30 s after stimulation. An output-dependent increase in hemodynamic parameters was seen with both left and right SG stimulation. No difference between left and right SG stimulation was seen. SG stimulation overlay significantly increased HR, BP, and CO from baseline vagal stimulation bilaterally. CONCLUSIONS: Stellate ganglia stimulation leads to increased HR and BP despite significant vagal stimulation. This may be exploited therapeutically in the management of vasovagal syncope.

Trends in Cardiovascular Implantable Electronic Device Insertion Between 1988 and 2018 in Olmsted County.

OBJECTIVES: This study sought to describe trends in cardiovascular implantable electronic device (CIED) insertion over the past 3 decades in Olmsted County. BACKGROUND: Trends in CIED insertion in the United States have not been extensively studied. METHODS: The Rochester Epidemiology Project is a medical records linkage system comprising the records of all residents of Olmsted County from 1966 to the present. CIED insertion between 1988 and 2018 was determined using International Classification of Diseases-Ninth Revision, International Classification of Diseases-10th Revision, and Current Procedural Terminology codes. Age- and sex-adjusted incidence rates, adjusted to the 2010 US White population, were calculated. Trends in incidence over time, across age groups, and between sex are estimated using Poisson regression models. RESULTS: The age- and sex-adjusted incidence of device implants for the study period were as follows: overall CIED: 82.4 (95% CI: 79.2-85.6); permanent pacemaker (PPM): 62.9 (95% CI: 60.0-65.7); implantable cardioverter-defibrillator (ICD): 14.0 (95% CI: 12.6-15.3); and cardiac resynchronization therapy (CRT): 5.6 (95% CI: 4.7-6.4) per 100,000 per year. The overall incidence of CIED insertion increased between 1988 to 1993 and 2000 to 2005 and then decreased between 2000 to 2005 and 2012 to 218 (P < 0.0001). PPM and ICD insertion incidence followed these trends, whereas the incidence of CRT insertion increased between 2000 to 2005 and 2012 to 2018. CIED insertion incidence increased with age (P < 0.0001). CIED insertion incidence was greater in men (116.3 vs 57.3 per 100,000 per year in men vs women; P < 0.0001). The overall survival of CRT recipients improved (P = 0.0044). CONCLUSIONS: The incidence values for PPM and ICD implants are decreasing, while the incidence of CRT implants is increasing. CIEDs are increasingly inserted in the elderly, men, and patients with higher comorbidities.

Injectable Flexible Subcutaneous Electrode Array Technology for Electrocardiogram Monitoring Device.

Implantable cardiac monitors have undergone considerable miniaturization. However, they continue to be associated with complications such as infection, bleeding/bruising, and device extrusion or migration. In this paper, we demonstrate the feasibility of using a small, flexible, injectable, subcutaneous microelectrode-based device to record electrocardiograms (ECGs). We describe the fabrication process and demonstrate the ease of insertion of the injectable ECG device in vivo swine model. We also demonstrate our device's high-density channel microelectrode array's ability to detect the P, R, and T waves. The amplitude of these waves showed excellent correlation with distance of the bipolar electrodes used to detect them. Given the success of our initial studies, this device has the potential to improve the safety profile of implantable cardiac monitors and simplify the implantation procedure to allow for placement in a primary care setting.

Nanostim leadless pacemaker retrieval and simultaneous micra leadless pacemaker replacement: a single-center experience.

PURPOSE: The leadless pacemaker (LP) is a promising new technology in pacing therapy that avoids a generator pocket and transvenous lead-related complications. However, extraction experience with simultaneous re-implant of a leadless device remains limited. We sought to study the outcomes of Nanostim LP retrieval and simultaneous reimplantation of Micra LP. METHODS: Patients undergoing retrieval of the Nanostim LP and receiving a Micra LP implant between 2016 and 2018 at Mayo Clinic (Rochester, MN) were studied. The procedural and outcome data were collected from the electronic medical record. RESULTS: Nine patients underwent attempted Nanostim LP retrieval and 6 of these simultaneously received a Micra LP reimplant. All retrievals were considered chronic due to implant durations of > 1 year. Extraction procedures were completed with a success rate of 89% and simultaneous reimplantations were performed successfully in all cases with no major complications. Newly implanted Micra LP device function was normal at follow-up. Factors such as duration of device implant and device positioning appeared to impact ease of extraction. CONCLUSIONS: Retrieval of the Nanostim LP system and simultaneous replacement with an alternate Micra leadless device appears to be a feasible approach.

Trends of Cardiovascular Implantable Electronic Device Infection in 3 Decades: A Population-Based Study.

OBJECTIVES: This study assessed trends in the incidence of cardiovascular implantable electronic device (CIED) infection in the last 3 decades using a population-based records linkage study. BACKGROUND: Infection remains an important issue associated with increased implantation rate and dwell time of CIEDs. METHODS: We identified a cohort of all adults with CIEDs who resided in Olmsted County, Minnesota, from 1988 to 2015, using the medical linkage system of the Rochester Epidemiology Project. Standardized criteria were used to identify all CIED infection cases. The cumulative rate of CIED infection was estimated using the Kaplan-Meier method, and the trends of CIED infection incidence were calculated with person-years of follow-up after device implantation. RESULTS: The cumulative probabilities of overall CIED infection were 6.2% (95% confidence interval [CI]: 4.0% to 8.4%) at 15 years and 11.7% (95% CI: 6.8% to 17.3%) at 25 years of follow-up. The incidence of CIED infection every 7 years from 1988 to 2015 was 1.3, 5.7, 4.1, and 4.7 per 1,000-person years, respectively. The 15-year cumulative probabilities of CIED infection after the initial, second, and third procedures were 2.6% (95% CI: 1.4% to 3.8%), 2.7% (95% CI: 1.2% to 4.2%), and 24.1% (95% CI: 3.8% to 44.4%), respectively. Generator changes (hazard ratio [HR]: 3.91; 95% CI: 1.47 to 10.37; p = 0.006) and upgrades (HR: 3.08; 95% CI: 1.24 to 7.62; p = 0.02) were significantly associated with infection. CONCLUSIONS: The incidence of CIED infection had a trend of increasing in the past 2 decades. Contemporary implantable cardioverter-defibrillator and cardiac resynchronization therapies and repeated manipulation of device pockets introduced a greater risk of CIED infection.

Atrial arrhythmias in patients with arrhythmogenic right ventricular cardiomyopathy: Prevalence, echocardiographic predictors, and treatment.

INTRODUCTION: The clinical role of atrial arrhythmias (AA) in arrhythmogenic right ventricular cardiomyopathy (ARVC) and the echocardiographic variables that predict them are not well defined. We describe the prevalence, types, echocardiographic predictors, and management of AA in patients with ARVC. METHODS: We retrospectively evaluated medical records of 117 patients with definite ARVC (2010 Task Force Criteria) from two tertiary care centers. We identified those patients with sustained AA (>30 seconds), including atrial fibrillation (AF), atrial flutter (AFL), and atrial tachycardia (AT). We collected demographic, genetic, and clinical data. The median follow-up was 3.4 years (interquartile range = 2.0-5.7). RESULTS: Total 26 patients (22%) had one or more types of AA: AF (n = 19), AFL (n = 9), and AT (n = 8). We performed genetic testing on 84 patients with ARVC (71.8%). Two patients with AA (8%) had peripheral emboli, and one patient (4%) suffered inappropriate implantable cardioverter-defibrillator shock. We performed catheter ablation of AA in eight patients (31%), with no procedural complications. Right atrial area and left atrial volume index were independently associated with increased odds of AA; odds ratio (OR), 1.1 (95% confidence interval [CI]:1.02-1.16) (P = .01) and OR, 1.1 (95% CI:1.03-1.15) (P = .003), respectively. An increase in tricuspid annular plane peak systolic excursion was independently associated with reduced odds; OR, 0.3 (95% CI: 0.1-0.94) (P = .003). CONCLUSIONS: Atrial arrhythmias (AA) are common in patients with arrhythmogenic right ventricular cardiomyopathy (ARVC). Inappropriate shocks and systemic emboli may be associated with AA. Atrial size and right ventricular dysfunction may help identify patients with ARVC at increased odds of AA.

Comparative outcomes of subcutaneous and transvenous cardioverter-defibrillators.

BACKGROUND: The comparative outcomes of subcutaneous implantable cardioverter-defibrillator (S-ICD) and transvenous ICD (T-ICD) have not been well studied. The aim of this study was to evaluate the safety and efficacy of currently available S-ICD and T-ICD. METHODS: The study included 86 patients who received an S-ICD and 1:1 matched to those who received single-chamber T-ICD by gender, age, diagnosis, left ventricular ejection fraction (LVEF), and implant year. The clinical outcomes and implant complications were compared between the two groups. RESULTS: The mean age of the 172 patients was 45 years, and 129 (75%) were male. The most common cardiac condition was hypertrophic cardiomyopathy (HCM, 37.8%). The mean LVEF was 50%. At a mean follow-up of 23 months, the appropriate and inappropriate ICD therapy rate were 1.2% vs. 4.7% (χ = 1.854, P = 0.368) and 9.3% vs. 3.5% (χ = 2.428, P = 0.211) in S-ICD and T-ICD groups respectively. There were no significant differences in device-related major and minor complications between the two groups (7.0% vs. 3.5%, χ = 1.055, P = 0.496). The S-ICD group had higher T-wave oversensing than T-ICD group (9.3% vs. 0%, χ = 8.390, P = 0.007). Sixty-five patients had HCM (32 in S-ICD and 33 in T-ICD). The incidence of major complications was not significantly different between the two groups. CONCLUSIONS: The efficacy of an S-ICD is comparable to that of T-ICD, especially in a dominantly HCM patient population. The S-ICD is associated with fewer major complications demanding reoperation.

Outcomes of repeated transvenous lead extraction.

INTRODUCTION: The outcomes of repeated cardiovascular implantable electronic device (CIED) lead extraction have not been well studied. We sought to determine the indications, outcomes, and safety of repeated lead extraction procedures. METHODS: This retrospective study was conducted using data from two medical centers, including 38 patients who had undergone two or more lead extraction procedures compared to 439 patients who had a single procedure. The electronic medical records and procedural databases were reviewed to determine the indications, procedural characteristics, and outcomes. The outcomes of the first procedure were compared to the outcomes of subsequent procedures. RESULTS: The 5-year cumulative probability of a repeated extraction procedure was 11% (95% confidence interval, 7%-15%). In 439 patients who underwent single lead extractions, 72% had device and lead related infections as the procedure indication compared to 39% for 38 patients who underwent repeated extraction (P < 0.001). The mean duration from device reimplant to repeated extraction procedures was 63 ± 48 months. Ninety-eight percent of the leads were removed completely in repeated procedures, similar to the 95% success rate of the first procedure (P = 0.51). There was no significant difference in major complication rate in the first or repeated extractions (2.6% vs 5.2%, P = 0.79). CONCLUSIONS: Repeated transvenous lead extraction is not uncommon. It had a high success rate comparable to that of the initial procedure and was not associated with an increased incidence of adverse events.

Intramural conduction system gradients and electrogram regularity during ventricular fibrillation.

INTRODUCTION: The His-Purkinje system has been shown to harbor triggers for ventricular fibrillation (VF) initiation. However, the substrate responsible for VF maintenance remains elusive. We hypothesized that standard, electrode-based, point-to-point mapping would yield meaningful insight into site-specific patterns and organization which may shed light on the critical substrate for maintenance of VF. METHODS: VF was induced under general anesthesia by direct current (DC) application to the right ventricle in 7 acute canines. A standard EPT Blazer mapping catheter (Boston Scientific, Natuck, MA) was used for mapping in conjunction with a Prucka recording system. We collected 30 consecutive electrograms at 24 distinct sites, confirmed by fluoroscopy and intracardiac echo. These sites included both endocardial and epicardial locations throughout the ventricles and conduction system. RESULTS: A total of 5040 individual data points were collected in 7 separate canine studies. During VF mapping, a transmural disparity was found between the epicardium (average cycle length [CL] of 1136 m s) and the endocardium (average CL of 123 m s) with a p value of <0.01. An additional, intramural gradient was found when comparing the proximal, insulated conduction system to the distal, non-insulated conduction system (average CL 218 versus 111 m s [p = 0.03]). CONCLUSION: Our data are supportive of a novel observation of intramural difference between insulated and non-insulated regions of the His-Purkinje network in canines. In addition, certain areas exhibited periods of regular electrogram characteristics; this was despite the heart remaining in terminal VF. These early canine data merit further study to investigate if specific ablation of the distal conduction system can perturb or extinguish VF.

Ventricular dyssynchrony assessment using ultra-high frequency ECG technique.

PURPOSE: The aim of this proof-of-concept study is to introduce new high-dynamic ECG technique with potential to detect temporal-spatial distribution of ventricular electrical depolarization and to assess the level of ventricular dyssynchrony. METHODS: 5-kHz 12-lead ECG data was collected. The amplitude envelopes of the QRS were computed in an ultra-high frequency band of 500-1000 Hz and were averaged (UHFQRS). UHFQRS V lead maps were compiled, and numerical descriptor identifying ventricular dyssynchrony (UHFDYS) was detected. RESULTS: An electrical UHFQRS maps describe the ventricular dyssynchrony distribution in resolution of milliseconds and correlate with strain rate results obtained by speckle tracking echocardiography. The effect of biventricular stimulation is demonstrated by the UHFQRS morphology and by the UHFDYS descriptor in selected examples. CONCLUSIONS: UHFQRS offers a new and simple technique for assessing electrical activation patterns in ventricular dyssynchrony with a temporal-spatial resolution that cannot be obtained by processing standard surface ECG. The main clinical potential of UHFQRS lies in the identification of differences in electrical activation among CRT candidates and detection of improvements in electrical synchrony in patients with biventricular pacing.

Evaluation of a Unique Defibrillation Unit with Dual-Vector Biphasic Waveform Capabilities: Towards a Miniaturized Defibrillator.

BACKGROUND: Automated external defibrillators can provide life-saving therapies to treat ventricular fibrillation. We developed a prototype unit that can deliver a unique shock waveform produced by four independent capacitors that is delivered through two shock vectors, with the rationale of providing more robust shock pathways during emergent defibrillation. We describe the initial testing and feasibility of this unique defibrillation unit, features of which may enable downsizing of current defibrillator devices. METHODS: We tested our defibrillation unit in four large animal models (two canine and two swine) under general anesthesia. Experimental defibrillation thresholds (DFT) were obtained by delivery of a unique waveform shock pulse via a dual-vector pathway with four defibrillation pads (placed across the chest). DFTs were measured and compared with those of a commercially available biphasic defibrillator (Zoll M series, Zoll Medical, Chelmsford, MA, USA) tested in two different vectors. Shocks were delivered after 10 seconds of stable ventricular fibrillation and the output characteristics and shock outcome recorded. Each defibrillation series used a step-down to failure protocol to define the defibrillation threshold. RESULTS: A total of 96 shocks were delivered during ventricular fibrillation in four large animals. In comparison to the Zoll M series, which delivered a single-vector, biphasic shock, the energy required for successful defibrillation using the unique dual-vector biphasic waveform did not differ significantly (P = 0.65). CONCLUSIONS: Our early findings support the feasibility of a unique external defibrillation unit using a dual-vector biphasic waveform approach. This warrants further study to leverage this unique concept and work toward a miniaturized, portable shock delivery system.

Effects of stepwise denervation of the stellate ganglion: Novel insights from an acute canine study.

BACKGROUND: The stellate ganglion (SG) is important for cardiac autonomic control. SG modification is an option for treating refractory ventricular tachyarrhythmias. The optimal extent of left- and right-sided SG denervation necessary for antiarrhythmic effect, however, remains to be learned. OBJECTIVE: The purpose of this study was to evaluate the effects of stepwise SG denervation on hemodynamic and electrophysiological parameters in dogs. METHODS: After sequential left and right thoracotomy in 8 healthy dogs, the SG was exposed by dissection. Two pacing wires were placed in the upper SG to deliver high-frequency stimulation. The lower SG, ansae subclaviae, and upper SG were removed in a stepwise manner. The same protocol was performed on the right side. Blood pressure (BP), heart rate, and electrophysiological parameters were recorded at baseline and after 5 minutes of stimulation. RESULTS: Systolic and diastolic BP significantly increased during stimulation of the upper left SG. The mean increase in systolic BP from baseline was 49.4 ± 26.6 mm Hg (P = .007), 25.5 ± 14.1 mm Hg after the lower SG was removed (P = .02), and 8.6 ± 3.4 mm Hg after resection of the ipsilateral ansae subclaviae (P = .048). Heart rate and other electrophysiological parameters did not change significantly. After the complete removal of the left SG, systolic BP increased by 34.0 ± 17.6 mm Hg (P = .005) after stimulation of the right SG. CONCLUSION: Sympathetic output remains after the lower SG is removed, and sympathetic output from the right SG remains after the complete resection of the left SG and ansae subclaviae. Thus, some patients who undergo left SG denervation can still have significant sympathetic response via right SG regulation.

Electroporation ablation of bronchial smooth muscle cells: A novel non-thermal asthma therapy.

OBJECTIVE: Asthma is a common disease which places significant burden on the US healthcare system and which can be associated with significant patient morbidity and mortality. Current medical therapies are costly and not curative. A new approach for a more permanent asthma treatment is the use of radiofrequency ablation. However, this radiofrequency approach is thermal-based and can result in deleterious effects to the airways, such as stenosis or ulceration. We describe a novel, improved therapeutic approach for smooth muscle ablation using non-thermal DC electroporation ablation. METHODS: We developed and tested prototype electroporation ablation devices that access the airways both endoscopically and via a bronchoscope. We tested the feasibility of this approach and demonstrated proof-of-concept in 2 mongrel dogs. In order to assess for smooth muscle function, we performed functional studies pre and post ablation with methacholine challenge to assess for airway reversibility. We also evaluated bronchial lesions via direct vision with bronchoscopy. RESULTS: We developed novel electroporation catheters to delivery energy to the bronchial smooth muscle through an endoscopic approach. We tested these catheters in 2 acute canine studies and successfully demonstrated the ability to destroy smooth muscle tissue via novel prototypes and saline irrigation for widespread non-thermal electroporation ablation. Our functional studies demonstrate the efficacy of this approach. CONCLUSION: We report a novel method for non-thermal bronchial smooth muscle ablation using novel prototypes and electroporation with normal saline. These early findings require further evaluation in larger, chronic canine studies to assess for use as a potential curative therapy.