Percutaneous Coronary Intervention Outcomes Based on Decision‐Making Capacity

Background Long‐term outcomes of percutaneous coronary intervention (PCI) based on patients’ decision‐making ability have not been studied. Our objective was to assess long‐term outcomes after PCI in patients who provided individual versus surrogate consent. Methods and Results Data were collected retrospectively for patients who underwent PCI at Cleveland Clinic between January 1, 2015 and December 31, 2016. Inclusion criteria consisted of hospitalized patients aged ≥20 years who had PCI. Patients with outpatient PCI, or major surgery 30 days before or 90 days after PCI, were excluded. Patients who underwent PCI with surrogate consent versus individual consent were matched using the propensity analysis. Kaplan–Meier, log rank, t ‐statistic, and χ 2 tests were used for statistical analysis. The study was approved by the Institutional Review Board at Cleveland Clinic, Ohio. Of 3136 patients who underwent PCI during the study period, 183 had surrogate consent. Propensity matching yielded 149 patients from each group. Two‐year all‐cause mortality was significantly higher in the surrogate consent group (38 [25.5%] versus 16 [10.7%] deaths, log‐rank χ 2 =10.16, P <0.001). The 2‐year major adverse cardiac events rate was also significantly higher in the surrogate consent group (60 versus 36 events, log‐rank χ 2 =8.36, P =0.003). Conclusions Patients with surrogate consent had significantly higher all‐cause mortality and higher major adverse cardiac events when compared with patients with individual consent. This study emphasizes the fact that patients with an inability to give consent are at high risk and may need special attention in postprocedural and postdischarge care.

Research in Adults with Diminished Capacity

Informed consent is often identified as a condition of ethical research. Therefore, ethical challenges arise when conducting research with adults who lack the capacity to provide informed consent. In this chapter, the authors consider these challenges using two principal cases: adults with dementia and adults with acute, emergent health conditions. As this pair of cases shows, decisional capacity can be “diminished” in many ways, and a number of strategies are available to address diminished capacity. In this chapter, the authors highlight surrogate consent and the partial-involvement strategies of assent and dissent and note additional protections afforded to these vulnerable populations.

Healthcare Provider Limitation of Life-Sustaining Treatment without Patient or Surrogate Consent

In June 2015, the major North American and European critical care societies released new joint guidelines that delineate a process-based approach to resolving intractable conflicts over the appropriateness of providing or continuing LST.2 This article frames the new guidelines within the history, ethical arguments, legal landscape, and empirical evidence regarding limitation of LST without surrogate consent in cases of intractable conflict.