Leadless Pacemakers: State of the Art and Selection of the Ideal Candidate.

The field of cardiac pacing has been defined by constant development to provide efficacious, safe, and reliable therapy. Traditional pacing utilizes transvenous leads, which dwell in the venous system and place patients at risk for complications, including pneumothorax, bleeding, infection, vascular obstruction, and valvular compromise. Leadless pacemakers have been developed to overcome many of the challenges of transvenous pacing while providing safe and effective pacing therapy for an increasing population of patients. The Medtronic Micra transcatheter pacing system was approved by the FDA in April of 2016 and the Abbott Aveir pacemaker was approved in April of 2022. Several additional leadless pacemakers are in various stages of development and testing. There exists limited guidance on the selection of the ideal candidate for leadless pacemakers. Advantages of leadless pacemakers include decreased infection risk, overcoming limited vascular access, and avoidance of interaction with the tricuspid valve apparatus. Disadvantages of leadless pacemakers include right ventricular-only pacing, unclear lifecycle management, cost, perforation risk, and lack of integration with defibrillator systems. This review aims to provide an overview of the current state of the art of leadless pacemakers, currently approved systems, clinical trials and real-world evidence, considerations for patient selection, and future directions of this promising technology.

Ventricular arrhythmia burden and implantable cardioverter-defibrillator outcomes in transthyretin cardiac amyloidosis.

BACKGROUND: As targeted treatments for amyloid transthyretin cardiomyopathy (ATTR-CM) are becoming available, we aim to characterize the rates of ventricular arrhythmias (VAs), implantable cardioverter-defibrillator (ICD) utilization, and their impact on survival. METHODS: This is a retrospective cohort study of 130 patients with ATTR-CM diagnosed at Emory University's Cardiac Amyloidosis Center between April 2012 and September 2020. VAs were defined as nonsustained or sustained ventricular tachycardia and ventricular fibrillation. RESULTS: Of 130 patients, 42 had wild-type disease (wtATTR) and 88 had hereditary variants (hATTR), most commonly Val122Ile (89%). At ATTR-CM diagnosis, 80 (62%) patients had EF ≤ 40% consistent with systolic heart failure. Of the 69 (53%) patients with documented VAs significantly higher rates occurred among those with EF ≤ 40% compared with EF > 40% (67% vs. 28%, p = .001). Thirty-two patients (25 hATTR, 7 wtATTR) had primary prevention ICDs implanted. Eight (25%) of these patients received appropriate ICD therapy while two (6%) experienced inappropriate therapy. Comparing patients with EF ≤ 35% with and without ICDs did not reveal any survival difference (3.3 ± 0.5 vs. 2.8 ± 0.4 years, p = .699). CONCLUSIONS: High rates of VAs and appropriate ICD therapy were found among a unique cohort of largely hereditary ATTR-CM patients with a high rate of systolic heart failure.

Modernizing the World Health Organization List of Essential Medicines for Preventing and Controlling Cardiovascular Diseases.

The World Health Organization (WHO) Model List of Essential Medicines (EML) is a key tool for improving global access to medicines for all conditions, including cardiovascular diseases (CVDs). The WHO EML is used by member states to determine their national essential medicine lists and policies and to guide procurement of medicines in the public sector. Here, we describe our efforts to modernize the EML for global CVD prevention and control. We review the recent history of applications to add, delete, and change indications for CVD medicines, with the aim of aligning the list with contemporary clinical practice guidelines. We have identified 4 issues that affect decisions for the EML and may strengthen future applications: 1) cost and cost-effectiveness; 2) presence in clinical practice guidelines; 3) feedback loops; and 4) community engagement. We share our lessons to stimulate others in the global CVD community to embark on similar efforts.

Barriers and Facilitators to Nurse Management of Hypertension: A Qualitative Analysis from Western Kenya.

BACKGROUND: Hypertension is the leading global risk for mortality. Poor treatment and control of hypertension in low- and middle-income countries is due to several reasons, including insufficient human resources. Nurse management of hypertension is a novel approach to address the human resource challenge. However, specific barriers and facilitators to this strategy are not known. OBJECTIVE: To evaluate barriers and facilitators to nurse management of hypertensive patients in rural western Kenya, using a qualitative research approach. METHODS: Six key informant interviews (five men, one woman) and seven focus group discussions (24 men, 33 women) were conducted among physicians, clinical officers, nurses, support staff, patients, and community leaders. Content analysis was performed using Atlas.ti 7.0, using deductive and inductive codes that were then grouped into themes representing barriers and facilitators. Ranking of barriers and facilitators was performed using triangulation of density of participant responses from the focus group discussions and key informant interviews, as well as investigator assessments using a two-round Delphi exercise. RESULTS: We identified a total of 23 barriers and nine facilitators to nurse management of hypertension, spanning the following categories of factors: health systems, environmental, nurse-specific, patient-specific, emotional, and community. The Delphi results were generally consistent with the findings from the content analysis. CONCLUSION: Nurse management of hypertension is a potentially feasible strategy to address the human resource challenge of hypertension control in low-resource settings. However, successful implementation will be contingent upon addressing barriers such as access to medications, quality of care, training of nurses, health education, and stigma.

Usability and feasibility of a tablet-based Decision-Support and Integrated Record-keeping (DESIRE) tool in the nurse management of hypertension in rural western Kenya.

BACKGROUND: Mobile health (mHealth) applications have recently proliferated, especially in low- and middle-income countries, complementing task-redistribution strategies with clinical decision support. Relatively few studies address usability and feasibility issues that may impact success or failure of implementation, and few have been conducted for non-communicable diseases such as hypertension. OBJECTIVE: To conduct iterative usability and feasibility testing of a tablet-based Decision Support and Integrated Record-keeping (DESIRE) tool, a technology intended to assist rural clinicians taking care of hypertension patients at the community level in a resource-limited setting in western Kenya. METHODS: Usability testing consisted of "think aloud" exercises and "mock patient encounters" with five nurses, as well as one focus group discussion. Feasibility testing consisted of semi-structured interviews of five nurses and two members of the implementation team, and one focus group discussion with nurses. Content analysis was performed using both deductive codes and significant inductive codes. Critical incidents were identified and ranked according to severity. A cause-of-error analysis was used to develop corresponding design change suggestions. RESULTS: Fifty-seven critical incidents were identified in usability testing, 21 of which were unique. The cause-of-error analysis yielded 23 design change suggestions. Feasibility themes included barriers to implementation along both human and technical axes, facilitators to implementation, provider issues, patient issues and feature requests. CONCLUSIONS: This participatory, iterative human-centered design process revealed previously unaddressed usability and feasibility issues affecting the implementation of the DESIRE tool in western Kenya. In addition to well-known technical issues, we highlight the importance of human factors that can impact implementation of mHealth interventions.

Usability of implementing a tablet-based decision support and integrated record- keeping (DESIRE) tool in the nurse management of hypertension in rural Kenya.

In sub-Saharan Africa (SSA), cardiovascular disease (CVD) is the leading cause of death among individuals over the age of 30. Hypertension, a major risk factor for CVD, contributes significantly to the CVD burden in SSA. In order to address the human resource challenge of managing hypertension in low- and middle-income countries (LMICs), task-shifting hypertension care from physicians to nurses has been proposed. To support this task-shifting strategy, the Academic Partnership Providing Access to Healthcare (AMPATH) has developed an Android tablet-based electronic Decision Support and Integrated Record-Keeping (DESIRE) tool to record patient data and assist with clinical decision-making. We investigated the usability of the DESIRE tool in the setting of nurse management of hypertension in rural western Kenya through the use of "mock patient" encounters and "think aloud" exercises. Fiftyseven critical incidents were identified and twenty-three design changes were suggested. Optimization of the tool has the potential to broadly impact treatment of non-communicable diseases in LMICs by providing a model of electronic decision-support in task shifting.