Implementation of a randomized mobile-technology lifestyle program in individuals with nonalcoholic fatty liver disease.

Identifying effective, feasible, low-cost interventions that promote sustainable lifestyle changes in nonalcoholic fatty liver disease (NAFLD) is a key unmet need. The aim of this study was to assess predictors of lifestyle practice patterns of NAFLD patients and evaluate the implementation of a mobile technology-based intervention. We prospectively enrolled adults with NAFLD (diagnosed by imaging or biopsy). Individuals with additional liver diseases or decompensated cirrhosis were excluded. Patient were randomized to usual care or a FitBit based program for 6-months. We obtained anthropometrics, labs, vibration controlled transient elastography (VCTE), health-related quality of life (HRQOL), physical activity, diet and motivation to change data. 70 patients were enrolled, 33% with cirrhosis. Median age was 52.1 years, 47% males, 83% white, body mass index 32.3, liver stiffness 7.6 kPa, controlled attenuation parameter 319 db/m, and 50% had diabetes. Baseline HRQOL was 5.4/7 and independently negatively correlated with level of concern about their disease and positively with physical function. Younger age was independently associated with unhealthy diets whereas diabetes was independently associated with unhealthy diets and higher VCTE kPa. 6-month follow-up data available on 31 patients showed trends in improvement in weight. In a cohort of NAFLD patients, we identified independent correlates of lifestyle behaviors and HRQOL. Implementation of interventions that improve physical function may improve HRQOL in NAFLD. Younger patients and those with diabetes appeared to have the greatest need for dietary interventions. Structured mobile technology lifestyle interventions using Fitbit and personalized coaching showed promise but require further validation with a focus on sustainability of intervention and improvement in outcomes.

Short-Term Changes in Vasectomy Consults and Procedures Following Dobbs v Jackson Women's Health Organization.

INTRODUCTION: On June 24, 2022, the US Supreme Court issued its decision on Dobbs v Jackson Women's Health Organization (Dobbs). This decision had major implications on female reproductive choices, but also had potential implications on their male counterparts. We sought to determine the association of Dobbs with the number and characteristics of men seeking vasectomy. METHODS: A retrospective review was performed to determine the number of vasectomy consults and procedures completed at a single Michigan health system in the 6 months following Dobbs (June 24, 2022-December 24, 2022) vs the same 6-month time frame between 2019 and 2021. Another retrospective review was conducted in the 3 months following Dobbs (June 24, 2022-September 24, 2022) vs the same days in 2021 to determine the number of vasectomy consults completed and to evaluate for differences in the characteristics of these men. RESULTS: In the 6 months after Dobbs, there was a 150% and 160% increase in vasectomy consults and procedures completed, respectively, compared to a similar time frame in 2019 to 2021. In the 3 months after Dobbs, there was a 225% increase in new vasectomy consults compared to a similar time frame in 2021. There were no differences in the age, race, religion, median household income, or insurance type of men seeking vasectomy consult pre- vs post-Dobbs. Partnerless men (odds ratio 3.66) and those without children (odds ratio 2.85) were more likely than married men and those with 3 or more children, respectively, to seek vasectomy consult post-Dobbs. CONCLUSIONS: Dobbs was associated with a marked increase in vasectomy consultations and procedures at our institution in the state of Michigan. Future studies are needed to determine the long-term implications of Dobbs on vasectomy practices and determine if vasectomy practices differ by states and their respective abortion laws.

Predictors and outcomes of patients requiring repeat transvenous lead extraction of pacemaker and defibrillator leads.

BACKGROUND: A proportion of patients who undergo an initial lead extraction procedure will require a second, repeat extraction. Data regarding this clinical entity are scarce and neither the predisposing risk factors for, nor outcomes from, these procedures have been described previously. We sought to determine the incidence, risk factors, and outcomes of repeat lead extraction. METHODS: A database of extraction procedures from 2001 to 2015 was analyzed. Repeat extraction procedures were identified and the indication for extraction was dichotomized into infection and lead-related problems. Univariate and multivariate analyses were performed to identify predictors of repeat extraction. RESULTS: 807 extraction procedures were identified in 755 patients of whom 6% required a repeat extraction. At multivariate analysis, only suffering a major complication at the initial extraction procedure (odds ratio [OR] 21.5, 95% confidence interval [CI] 2.69-171.92; P < 0.01), complexity of device (cardiac resynchronization devices/implantable cardioverter defibrillators) (OR 2.58, 95% CI 1.2-5.2; P = 0.01), and age (OR 1.02 per year, 95% CI 1.0-1.4; P  =  0.03) were significant predictors of repeat extraction. When repeat extraction was required for infection there was a significant increase in mortality compared with those who did not require a second procedure (36% vs 23%; P  =  0.02). CONCLUSIONS: Repeat lead extraction is required in 6% of cases. Complexity of device, age at extraction, and a major complication at the first extraction were predictors of repeat extraction. Mortality is significantly increased where the repeat procedure is for infection. Clinicians should alert patients to the potential need for further extraction and the increased risks of repeat procedures when indicated for infection.

Real-Time X-MRI-Guided Left Ventricular Lead Implantation for Targeted Delivery of Cardiac Resynchronization Therapy.

OBJECTIVES: This study sought to test the feasibility of a purpose-built, integrated software platform to process, analyze, and overlay cardiac magnetic resonance (CMR) data in real time within a combined cardiac catheter laboratory and magnetic resonance imaging scanner suite (X-MRI) to guide left ventricular (LV) lead implantation. BACKGROUND: Suboptimal LV lead position is a major determinant of poor cardiac resynchronization therapy (CRT) response, and the optimal site is highly patient specific. Pacing myocardial scar is associated with poorer outcomes; conversely, targeting latest mechanical activation (LMA) may improve them. METHODS: Fourteen patients (age 74 ± 5.1 years; New York Heart Association functional class: 2.7 ± 0.4; 86% ischemic with ejection fraction 27 ± 7.6%; QRSd: 157 ± 19 ms) underwent CMR followed by immediate CRT implantation using derived scar and dyssynchrony data, overlaid onto fluoroscopy in an X-MRI suite. Rapid LV segmentation enabled detailed scar quantification, identification of LMA segments, and selection of myocardial targets. At coronary venography, the CMR-derived 3-dimensional shell was fused, enabling identification of viable venous targets subtended by target segments for LV lead placement. RESULTS: The platform was successful in all 14 patients, of whom 10 (71%) were paced in pre-procedurally defined target segments. Pacing in CMR-defined target segments (out of scar) showed a significant decrease in the LV capture threshold (mean difference: 2.4 [1.5 to 3.2]; p < 0.001) and shorter paced QRS duration (mean difference: 25 [15 to 34]; p < 0.001) compared with pacing in areas of CMR determined scar. In 5 (36%) patients with extensive scar in the posterolateral wall, CMR guidance enabled successful lead delivery in an alternative anatomically favorable site. Radiation dose and implant times were similar to historical controls (p = NS). CONCLUSIONS: Real-time CMR-guided LV lead placement is feasible and achievable in a single clinical setting and may prove helpful to preferentially select sites for LV lead placement.

The benefit of a remotely monitored implantable loop recorder as a first line investigation in unexplained syncope: the EaSyAS II trial.

AIMS: This prospective randomized controlled study evaluated the first-line use of a novel remotely monitored implantable loop recorder (ILR) in the initial investigation of unexplained syncope, and compared this to conventional therapy and a dedicated Syncope Clinic (SC). METHODS AND RESULTS: A total of 246 patients (mean age 70.3 years) were randomly allocated to conventional management, SC alone, ILR alone, or SC + ILR. Median follow-up was 20 months (IQR 15-25 months). Time to electrocardiogram (ECG) diagnosis was significantly shorter with ILR alone vs. conventional [hazard ratio (HR) 35.5, P = 0.0004] and with SC vs. conventional (HR 25.6, P = 0.002). Seventy-four per cent of first syncopal events documented in the SC groups occurred during provocative tilt testing. Twenty-two per cent of patients who received an ILR were found to have a bradycardia indication for permanent pacing, compared with 3% of patients who did not. Overall, more investigative tests were undertaken in the conventional group than in any other. Only patients who received an ILR had a significant increase in time to second syncope (P = 0.02), suggesting successful diagnosis and management of treatable causes of syncope. CONCLUSIONS: Implantable loop recorder monitoring achieved a more rapid diagnosis in unexplained syncope than usual care. Conventional management of syncope failed to achieve an ECG diagnosis despite a large number of investigative tests. Syncope Clinic and provocative tilt testing delivered a rapid ECG diagnosis, but did not prevent recurrent syncope. Implantable loop recorders offered rapid diagnosis, increased the likelihood of syncope being reported, demonstrated a high rate of intermittent bradycardia requiring pacing, and reduced recurrent syncope.

Laser lead extraction to facilitate cardiac implantable electronic device upgrade and revision in the presence of central venous obstruction.

AIMS: The number of procedures involving upgrade or revision of cardiac implantable electronic devices (CIEDs) is increasing and the risks of adding additional leads are significant. Central venous occlusion in patients with pre-existing devices is often asymptomatic and optimal management of such patients in need of device revision/upgrade is not clear. We sought to assess our use of laser lead extraction in overcoming venous obstruction. METHODS AND RESULTS: Patients in need of device upgrade/revision underwent pre-procedure venography to assess venous patency. In patients with venous occlusion or stenosis severe enough to preclude passage of a hydrophilic guide wire, laser lead extraction with retention of the outer sheath in the vasculature was performed with the aim of maintaining a patent channel through which new leads could be implanted. Data were recorded on a dedicated database and patient outcomes were assessed. Between July 2004 and April 2012, laser lead extractions were performed in 71 patients scheduled for device upgrade/revision who had occluded or functionally obstructed venous anatomy. New leads were successfully implanted across the obstruction in 67 (94%) cases. There were two major complications (infection) and four minor complications with no peri-procedural mortality. Device follow-up was satisfactory in 65 (92%) cases with mean follow-up up to 26 ± 19 months. CONCLUSION: Laser lead extraction is a safe and effective option when managing patients with central venous obstruction in need of CIED revision or upgrade.

Prospective peer review of regional percutaneous interventional procedures: a tool for quality control and revalidation.

AIMS: Current quality measures of percutaneous coronary intervention (PCI) procedures are based on the incidence of major adverse cardiac events (MACE). This crude marker ignores the many clinical nuances that make for sound decision making in PCI. We have established a prospective peer review audit tool to determine the quality of PCI within our cardiac network, which consists of five PCI hospitals serving a population of 1.4 million people in Sussex, UK. METHODS AND RESULTS: Analysis of 10% of all PCI cases selected at random each month by a non-clinical audit manager is made by a rotating panel of two PCI operators and one cardiac surgeon. Each PCI case is assessed for anatomical suitability, lesion severity, strategic appropriateness and final outcome. Panel findings were reported back to the operator and the audit manager. A total of 326 cases were assessed by the review committee. Results were disseminated to individual operators. Coronary anatomy and lesion severity were considered appropriate for PCI in 94.2% and 96.0% of cases, respectively. Appropriateness of strategy was confirmed in 86.2% and the outcome considered satisfactory in 90.8%. A total of 242 subsequent cases were analysed to assess practice trends. This analysis demonstrated a statistically significant improvement in clinical decision making with respect to appropriateness of strategy (from 86.2% to 92.6%; p=0.004). CONCLUSIONS: Prospective peer review of percutaneous coronary intervention cases by a rotating regional committee is valuable in ensuring procedural quality.

Extraction of chronic pacemaker and defibrillator leads from the coronary sinus: laser infrequently used but required.

AIMS: Cardiac resynchronization therapy is an accepted treatment for heart failure but it may be necessary to explant these systems along with their leads. The evidence base for coronary sinus (CS) lead extractions is limited. We aimed to evaluate the percutaneous removal of these leads and the utility of laser extraction when necessary. METHODS AND RESULTS: Of 265 patients referred for lead extraction between January 2004 and June 2008, 32 (12.1%) involved CS leads (30 males, mean age 67 years). Mean implantation time was 26.5 +/- 28.7 months (range 1-116 months). Indications for extraction were pocket infection (34.4%), lead malfunction (43.8%), skin erosion (15.6%), and endocarditis (6.2%). Twenty-eight (87.5%) CS leads were removed with manual traction, with laser utilized in four cases (12.5%). No major complications of CS laceration, pericardial effusion, emergency surgery, or death occurred. CONCLUSION: Our experience supports the percutaneous extraction of CS leads as a safe and effective procedure including the utility of laser when necessary.

Randomized controlled trial of intraputamenal glial cell line-derived neurotrophic factor infusion in Parkinson disease.

OBJECTIVE: Glial cell line-derived neurotrophic factor (GDNF) exerts potent trophic influence on midbrain dopaminergic neurons. This randomized controlled clinical trial was designed to confirm initial clinical benefits observed in a small, open-label trial using intraputamenal (Ipu) infusion of recombinant human GDNF (liatermin). METHODS: Thirty-four PD patients were randomized 1 to 1 to receive bilateral continuous Ipu infusion of liatermin 15 microg/putamen/day or placebo. The primary end point was the change in Unified Parkinson Disease Rating Scale (UPDRS) motor score in the practically defined off condition at 6 months. Secondary end points included other UPDRS scores, motor tests, dyskinesia ratings, patient diaries, and (18)F-dopa uptake. RESULTS: At 6 months, mean percentage changes in "off" UPDRS motor score were -10.0% and -4.5% in the liatermin and placebo groups, respectively. This treatment difference was not significant (95% confidence interval, -23.0 to 12.0, p = 0.53). Secondary end point results were similar between the groups. A 32.5% treatment difference favoring liatermin in mean (18)F-dopa influx constant (p = 0.019) was observed. Serious, device-related adverse events required surgical repositioning of catheters in two patients and removal of devices in another. Neutralizing antiliatermin antibodies were detected in three patients (one on-study and two in the open-label extension). INTERPRETATION: Liatermin did not confer the predetermined level of clinical benefit to patients with PD despite increased (18)F-dopa uptake. It is uncertain whether technical differences between this trial and positive open-label studies contributed in any way this negative outcome.