Update device therapy

Disorders of the cardiac muscle or cardiomyopathies are a broad, yet collectively common, group of conditions. Despite the heterogeneous etiologies, mode of death from these conditions is remarkably similar - progressive decline in cardiac function leading to intractable heart failure (HF) and sustained ventricular arrhythmias resulting in sudden cardiac death (SCD). Nearly 50% of patients die within 5 years of a HF diagnosis.1 Indeed, in the United States, HF alone is thought to cause 55,000 deaths per year2 and further contribute to 1 in 9 deaths overall.1 However, while advanced HF and the risk of SCD were once thought to be untreatable, technological advances has seen the emergence of device therapies as viable treatment options. Specifically, implantable cardioverter-defibrillator (ICD) therapy for treatment of ventricular arrhythmias, cardiac resynchronization therapy (CRT) for restoring cardiac synchrony and mechanical efficiency, and ventricular assist device (VAD) therapy to temporarily or permanently replace the function of the failing heart, have all emerged as highly efficacious therapies. The expanding use of device therapies, however, poses many challenges. First, while the indications for these devices are well summarized in clinical guidelines,3,4 considerable hurdles remain in ensuring eligible patients receive these therapies.5 By the same token, establishing the safety and effectiveness of these therapies in populations that are found in clinical practice, yet commonly excluded from trials, such as the elderly6 and uncommon forms of cardiomyopathies,7 is a high priority. Second, rapid dissemination of technologies frequently results in disparities in care. Indeed, age, gender, and racial disparities, in both receipt of these devices and outcomes following implantation, have been well documented. Whether these disparities have persisted, and the potential causative mechanisms underlying these disparities, however, are uncertain.8,9 Third, these devices are not without significant untoward effects; understanding …

Patients with preexisting mild cognitive impairment or dementia may be at increased risk for developing cardiac device complications due to an impaired ability to follow postimplant care instructions. We sought to determine whether rates of infection, lead dislodgement, or appropriate or inappropriate implantable cardioverter defibrillator (ICD) shocks are increased in this population. Medical charts of 561 patients with mild cognitive impairment or dementia who underwent pacemaker (PM) or ICD implantation between January 2002 and October 2009 at Mayo Clinic were identified. A total of 134 patients who were diagnosed with cognitive impairment or dementia before device implantation or within 1 year of implantation were compared with 134 matched controls. Information was collected on patient characteristics, comorbid medical conditions, ejection fraction, complications, device type, device therapy, and mortality. Device information was prospectively entered into a database and retrospectively reviewed. Of the 134 patients with mild cognitive impairment and dementia, 99 underwent PM implantation and 35 underwent ICD implantation. Compared to controls, there was no difference in patient characteristics, ejection fraction, or comorbidities except for diabetes, which was more prevalent in the cognitively impaired and demented group (18.7% vs 30.6%, P = 0.02). There was no difference in device therapy and complications (14.4% vs 5.8%, P = 0.268). However, there was a decreased survival in patients with cognitive impairment and dementia when compared to the control group (42% vs 67% at 5 years, P = 0.007). Patients with cognitive impairment and standard device indications are not at increased risk for device complications and therapy but their survival is much lower than in matched controls. The cause of this lower survival is unknown but may be related to the underlying neurological disease. Presence of cognitive impairment should therefore be considered when contemplating implantation of a cardiac device.

Influence of Predictive Modeling in Implementing Optimal Heart Failure Therapy

ACC/AHA/HRS 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities

Invited Commentary

Introduction Hospital admissions of patients with cardiovascular disease were markedly reduced in the UK in 2020 during the Covid-19 pandemic. In many institutions, including ours, patient care was redistributed from a specialty-based approach to a ward-based system, meaning some patients being admitted and managed under the care of non-specialist teams. Purpose We wished to examine the impact of these changes on heart failure (HF) patients presenting during the pandemic and on appropriate delivery of complex device therapies. Methods The study was undertaken in a large UK teaching hospital. The institution audit programme includes cardiac device therapy provision, aiming to ensure that implantable cardioverter defibrillators and cardiac resynchronisation therapy are offered to the target population in accordance with NICE guidance [Technology Appraisal 314]. In accordance with the guidance, patients admitted to hospital with serious ventricular arrhythmia, familial cardiac condition with high risk of sudden cardiac death (SCD), surgical repair of congenital heart disease (CHD) and patients with HF and LVEF<36% were identified from hospital coding. Findings during the pandemic (March to August 2020) were compared with the same period in 2019. Fisher's exact test was used to compare proportions. Results Among non-HF patients, device therapy prescription was consistent in the two periods observed. Table 1 shows how many patients were eligible for device therapy and how many were offered it. Table 2 contains details of HF admissions, showing an 8% reduction in admissions during the pandemic. The proportion of patients eligible for device therapy did not change significantly. However, there was a significant reduction in the proportion of eligible patients who were offered device therapy (79% vs 94% p=0.03). In addition, during the pandemic there was a trend towards a greater chance of patients being considered too frail for device therapy (p=0.08). Among 12 patients overlooked for device therapy, 10 were not under the care of Cardiology. Among 31 patients considered too frail for device therapy, 26 were not under the care of Cardiology. Conclusion During the Covid-19 pandemic, a modest reduction in HF hospital admission was observed with a marked fall in identification of patients eligible for device therapy. Possible explanations include intense pressure to discharge patients quickly, an increased perception of patient frailty during a crisis and the lack of recognition of indications for device therapy when patients are under the care of non-specialists. These findings suggest that cardiac services should actively look for HF patients who may have missed out on life-saving device therapies during the pandemic. Funding Acknowledgement Type of funding sources: None.

Predicting Malignant Ventricular Arrhythmias Using Real-Time Remote Monitoring

Muscle activity of leg muscles during unipedal stance on therapy devices with different stability properties

Evidence regarding the efficacy and safety of DeVIC (dexamethasone, etoposide, ifosfamide, and carboplatin) therapy for relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL) is critically lacking. This retrospective study analyzed 78 patients with r/r DLBCL who received DeVIC therapy at a single institution. The overall response rate was 37.2%, comprising 21.8% complete and 15.4% partial responses. A total of 15 (19.2%) patients proceeded to transplantation or cellular therapy. The 3-year overall survival and progression-free survival were 28.2 and 18.0%, respectively. Multivariable analyses identified refractoriness to prior therapy and elevated serum lactate dehydrogenase (LDH) levels as significant predictors of poor response and survival. Decision tree models confirmed these findings, revealing that relapsed cases with low LDH had the most favorable outcomes. Hematological toxicities were frequent, with febrile neutropenia in 52.6% and infection-related mortality in 3.8% of patients. Those with central nervous system involvement had a dismal prognosis, underscoring the need for novel therapeutic approaches. These findings highlight the potential role of DeVIC therapy in selected patients with r/r DLBCL and provide insights into optimizing bridging strategies and subsequent immunocellular therapies.

This study aimed to assess the clinical benefit of device therapy on controlling the symptoms of Meniere's disease (MD). We searched PubMed, Embase, the Cochrane Library, China National Knowledge Internet, and Wanfang Data before January 13, 2018. We selected randomized controlled clinical trials, case-controlled studies, and cohort studies that dealt with outcomes of device therapy for the treatment of MD. Sixteen trials met our inclusion criteria. The use of device therapy resulted in improved vertigo control, which was described as a reduction in the number of vertigo days by month (weighted mean difference [WMD]: 3.15, 95% confidence interval [CI]: 2.00-4.31), in the number of vertigo episodes by month (WMD: 7.37, 95% CI: 2.40-12.35), and in the vertigo visual analog score (WMD: 41.51, 95% CI: 34.68-48.34). In addition, the overall complete vertigo control (class A) rate was 50% (95% CI: 37%-64%). The device therapy also reduced the number of sick days by month (WMD: 4.56, 95% CI: 2.15-6.97), and the functional level improved (WMD: 2.66, 95% CI: 2.15-3.17). The electrocochleographic parameters decreased. The device therapy proved beneficial for hearing changes (WMD: 3.19, 95% CI: 0.66-5.71). No publication bias was found in the funnel plot and the results of Egger's test. This study showed that the device therapy might reduce vertigo attacks and sick days in patients with MD. Additionally, the function level and hearing level may improve after the device therapy. In addition, the decrease in electrocochleographic parameters showed that inner ear electrophysiology improved after device therapy.

Tissue Doppler-Derived Left Ventricular Systolic Velocity Is Associated with Lethal Arrhythmias in Cardiac Device Recipients Irrespective of Left Ventricular Ejection Fraction

Recent studies showed that J waves were associated with higher incidence of ventricular tachyarrhythmia (VT/VF) in patients with idiopathic ventricular fibrillation (VF) and myocardial infarction. We sought to assess the association between J waves and VT/VF in patients with nonischemic cardiomyopathy (NICM). We retrospectively enrolled 109 patients (79 men; mean age, 60 ± 15 years) with NICM who underwent implantable cardioverter defibrillator (ICD) implantation. The primary endpoint of this study was the occurrence of appropriate device therapy due to sustained VT/VF. The J wave was electrocardiographically defined as an elevation of the terminal portion of the QRS complex of >0.1 mV in at least 2 contiguous inferior or lateral leads. Among the 109 patients, 37 (34%) experienced an episode of appropriate device therapy during a median follow-up period of 25.9 (IQR 11.5-54.3) months. Kaplan-Meier curves showed that the presence of J waves on the 12-lead ECG obtained before device implantation was associated with an increased occurrence of appropriate device therapy (P < 0.001). Multivariate Cox proportional regression analysis revealed that the presence of J waves (HR 2.95; 95% CI 1.31-6.64; P = 0.009) was an independent predictor for the occurrence of appropriate device therapy. In the subgroup analysis of the patients with dilated or hypertrophic cardiomyopathy, J wave tended to increase the occurrence of appropriate device therapy (P = 0.056 and P = 0.092, respectively). The presence of J waves was an independent predictor for the occurrence of appropriate device therapy in patients with NICM who underwent ICD implantation.

Despite the growing acceptance of left ventricular assist device (LVAD) therapy to improve survival and quality of life in heart failure (HF) patients, uncertainties persist regarding the definition of a successful implant. We sought to define an innovative approach to assess success and subsequently compare preoperative variables affecting outcomes. From January 2007 to 2015, 278 patients underwent LVAD implantation. Median age at implant was 62 years and 81% patients were males. Indication for support was bridge-to-transplantation in 36% patients and the etiology of HF was ischemic in 49% patients. Based on clinically relevant and accepted standards, we defined successful LVAD implant as someone who was alive or transplanted at 2 years, had two or less readmissions in the first year, had no major adverse events in the first year, and had a New York Heart Association class of ≤ II at 6 months. Follow-up was obtained for a median of 1.7 years for a total of 605 patient-years-of-support. Based on our criteria, 81/278 (29%) patients were defined as having a successful implant. Univariate predictors of LVAD failure included destination therapy indication (hazard ratio [HR] = 2.11 [1.24, 3.58]), ischemic cardiomyopathy (HR = 1.73 [1.02, 2.94]), and a higher left ventricular ejection fraction (HR = 1.54 [1.07, 2.22]). After multivariable analysis, only destination therapy indication (HR = 2.2 [1.28, 3.78]) was found to be independently predictive of success failure. Despite an overall trend toward improved outcomes on device therapy, our criteria classified only one-third of patients as successful. Continued improvements in adverse event profiles, appropriate patient selection, and optimal time of implantation, together hold the key to improve outcomes after LVAD therapy.

Background: Collateral circulation may enhance recanalization in acute ischemic stroke. Augmentation of collaterals with partial aortic occlusion may promote recanalization and thereby influence outcomes in the SENTIS randomized controlled trial of the NeuroFlo device. We conducted a post hoc analysis of angiography acquired in SENTIS to evaluate potential differences in recanalization rates between NeuroFlo-treated and non-treated arms, accounting for site of arterial occlusion. Methods: Blinded imaging expert review of baseline and 6-hour follow-up angiography (CTA, MRA, or DSA) from the core lab was conducted for evaluation of recanalization. Recanalization was defined as TIMI 2-3 in the arterial segment distal to baseline occlusion. Baseline demographics, stroke presentation characteristics, and medical history variables were analyzed with respect to recanalization in univariate and subsequent multivariable logistic regression models after adjusting by treatment arm. Results: Serial angiography was available in 109/515 SENTIS subjects, including 56 in the treatment arm and 53 in the non-treated arm. Baseline demographics, stroke presentation characteristics, and medical history variables did not differ statistically between arms. Across all sites of arterial occlusion, recanalization occurred in 25.7% of cases, with similar rates between device (25.0%) and medical therapy (26.4%) arms. Age and baseline stroke severity (NIHSS score) were significant predictors of recanalization in univariate analyses. Multivariable logistic regression analyses confirmed that baseline NIHSS score was the sole predictor of recanalization (OR 0.90, p=0.0458) per one unit increase, with decreased recanalization in more severe strokes. Device treatment was not associated with significant increases in recanalization rates (p=NS). Recanalization of terminal internal carotid artery (12.5%), proximal MCA or M1 (17.9%) and M2 (46.7%) occlusions was not different between arms (all p=NS). Recanalization of proximal arterial occlusion in acute ischemic stroke cases enrolled in SENTIS was more frequent in M2 occlusions. Conclusions: More severe strokes at baseline were less likely to recanalize and device therapy did not increase recanalization rates. Treatment with the NeuroFlo device may invoke mechanisms of collateral perfusion distinct from direct arterial recanalization.

Heart failure (HF) is prevalent among women and remains a leading cause of morbidity and mortality in the United States. Currently, 3million women live with HF and the prevalence is projected to continue to increase. The purpose of this review is to highlight sex differences in the use and response to evidence-based pharmacological, device, and advanced HF therapies, as well as explore emerging areas of research in sex differences in the treatment of HF. Under-representation of women in clinical HF trials has limited our understanding of sex-related differences in the treatment and outcomes of HF. Important sex differences exist in the use of evidence-based HF therapies and clinical response among women with HF. In general, women tend to obtain the same clinical benefit from evidence-based HF drug and device therapies, but the utilization rates of guideline-directed medical therapies remain poor compared to men. Future research efforts should focus on increasing the enrollment of women in HF trials to help gain helpful insight into sex-specific differences in treatment effects and subsequent clinical outcomes.