Shared Decision Making for an Implantable Pulmonary Artery Monitoring Device in Heart Failure: A Pilot Study

Heart Failure (HF) is a major societal concern. HF is projected to impact over 8.5 million adults in the United States by 2030 [1]. The diagnosis of HF indicates impaired health and well-being and has a poor prognosis. This is exemplified in the 5-year mortality rate for patients with chronic HF and many cancers, which is similar [2]. This creates a significant burden for patients, and also for our health care system. The cost is approximately $160 billion dollars total for cardiovascular care alone [3]. Quality, patient-centered care and accountability are crucial for complex chronic conditions, such as HF. Advances in technology and state-of-the-science treatment options for HF necessitate patient-centered care management with evidence-based strategies and treatments. Shared Decision Making (SDM) is essential to navigate the complexities of care for patients with complex chronic conditions, such as HF. SDM occurs when a patient and provider exchange information, deliberate, and make decisions in accordance with patient preferences. Notably, the SDM process incorporates patients’ beliefs, health-related fears, and what matters most to patients in selecting treatment options [4]. Novel advances in technology capable of minimizing the likelihood of hospital readmission can also minimize patient and caregiver burden and cost [5]. The primary cause of HF-related hospitalizations is fluid volume overload [2], which occurs in patients in the advanced stages HF. The characteristics of advanced stage of HF include multiple symptoms and marked limitation of functional ability. Ordinary activity often causes symptoms of fatigue, palpitations, shortness of breath, and/or chest pain in individuals with HF. The current standard of care is guideline-directed recommendations, including pharmacologic quadruple therapy consisting of four classes of medication supported by robust clinical trial evidence to reduce hospitalizations and mortality. Also included are devices, such as the implantable pulmonary artery pressure sensor that allows earlier intervention for fluid overload. The standard of care for patients with advanced stage HF includes monitoring patient daily weights, early consultation with a cardiologist HF specialist, and prompt follow-up after hospital discharge for HF exacerbation [6]. Despite these conventional methods to monitor fluid overload, symptoms often become apparent only after the patient’s condition has decompensated and hospitalization and/or diuresis are required [2]. One of the first miniature mechanical and electronic devices to monitor pulmonary artery pressures and fluid status was the Cardio-microelectromechanical system (CardioMEMS). This device received approval from the Food and Drug Administration (FDA) in May 2014 [7]. Currently, there are 12 pulmonary artery monitoring devices available on the market that have received FDA approval. A wireless sensor approximately the size of a grain of rice is permanently implanted in the pulmonary artery (PA) to measure pressures [2]. An external antenna is situated under the patient briefly to power the device, monitor the sensor, and measure PA pressures [8]. The information can then be transmitted to a secure online site for analysis. These devices are amenable to individualization to give alerts for pressure readings outside specified intervals and reported by text message to care providers. CardioMEMS is the PA pressure monitoring device used at the health system where this investigation was conducted. Research showed a correlation between pulmonary artery pressure and worsening HF [2]. The CHAMPION clinical trial [9] enrolled symptomatic NYHA functional class III patients across the US. All participants received the CardioMEMS system. Treatment decisions were made by providers based on the PA waveforms to optimize fluid status on an outpatient basis. The safety and clinical efficacy of the CardioMEMS monitoring system were demonstrated and established a new paradigm for medical management using implanted sensors [10,11]. While patients provided informed consent for implantation, there is a lack of reporting of the patient’s perspective regarding this device. Patients with HF experience many symptoms that threaten their functionality, impair decisional capacity, and reduce survival [12]. Patients, caregivers, and providers must be aware of patient-centered communication and SDM as an essential component of quality care for patients with complex chronic conditions. The decision that a PA pressure monitoring device is the optimal choice is presented by the provider to the patient with the flow of communication in that direction. This is generally a one-way process. Engaging the patient in SDM for CardioMEMS is an important aspect of patient-informed care. SDM is recommended by the Institute of Medicine and the U.S. Preventative Services Task Force for clinicians when treatment options are presented [13]. The purpose of this pilot study was to investigate patient and provider perceptions of shared decision making for the CardioMEMS implantation procedure. SDM is considered an optimal approach to making complex health care decisions since the early 1980’s, although the use as a specific technique has not often been reported [13]. SDM is a necessity for any patient faced with difficult decisions regarding their health. Complex chronic conditions, such as HF, often require patients to make many decisions guided by their healthcare provider along the trajectory of their illness. HF can lead to frequent hospital admissions for management of symptoms related to fluid volume overload. CardioMEMS is a recent advancement in treatment that serves to keep patients out of the hospital and manage HF symptoms before they escalate. The objectives of this investigation were to (1) test the methods and measures used to explore perceptions of patients and providers of SDM for the CardioMEMS procedure using the Shared Decision Making Questionnaires (SDM-Q-9, SDM-Q-Doc), and to (2) identify concordance between patient and provider survey responses and perceptions of the process. The theoretical framework guiding this project was the Collaborative Deliberation Model by Elwyn and Fisher [14]. This model served as the guiding framework for investigating SDM for the PA pressure monitoring procedure. The factors that are essential to deliberation among the patient and provider for the CardioMEMS device, included, interpersonal engagement, recognition of alternatives, information comparing options, preference determination, and preference integration [15]. This framework also considers the context that mediates patient and provider interactions. Various contexts are of interest with the procedure to implant a PA pressure monitor, including the emotional state of those involved, resources available, and the advantages and disadvantages of this advanced technology for monitoring fluid volume. The alternatives, along with norms, such as social and healthcare cultural norms shape patient and provider preferences for this state-of-the-science intervention. In this theoretical model, the key to patient engagement is a respectful and empathetic communication approach [16]. An interdependence occurs when recognizing and deliberating about alternatives to a PA pressure monitoring device. Deliberation includes learning about patient preferences and integrating these factors to reach an agreement. Implementation of collaborative deliberation in the HF setting as shown below in Figure 1, includes a series of strategies and the proximal, distal, and distant effects, and feedback that serve to strengthen ongoing use and mastery of collaborative deliberation strategies in the HF clinic setting [16].