Innovation in Medical Devices-Lessons from the Past, Planning for the Future: Hastings Lecture 2019.

The development of devices for cardiac and pulmonary support is an example of innovation that opened important therapeutic options for patients with life-limiting diseases. The history of this important advance provides guidance for future developments in the field. Integrity is fundamental to maintaining the trust necessary for success.

Assessment and management of right ventricular failure in left ventricular assist device patients.

Mechanical circulatory support devices, including ventricular assist devices (VADs) and the total artificial heart, have evolved to become accepted therapeutic options for patients with severe congestive heart failure. Continuous-flow left VADs are the most prevalent option for mechanical circulatory assistance and reliably provide years of support. However, problems related to acute and chronic right heart failure in patients with left VADs continue to cause important mortality and morbidity. This review discusses the assessment and management of right ventricular failure in left VAD patients. The goal is to summarize current knowledge and suggest new approaches to managing this problem.

Incremental value of live/real time three-dimensional transesophageal echocardiography over the two-dimensional technique in the assessment of sinus of valsalva aneurysm rupture.

We present an adult patient with rupture of the right sinus of Valsalva aneurysm in whom the two-dimensional transesophageal echocardiogram failed to show the rupture. On the other hand, live/real time three-dimensional transesophageal echocardiography clearly delineated the site of rupture into the pericardium and mediastinum.

Use of gated cardiac computed tomography angiography in the assessment of left ventricular assist device dysfunction.

The purpose of this study is to describe the utility and limitations of gated contrast-enhanced cardiac computed tomography angiography in assessing left ventricular assist device function. Computed tomography angiography (CTA) was used in 14 patients with left ventricular assist devices (LVADs) who had persistent heart failure symptoms, hemodynamic instability, or potential problems with LVAD flows. Retrospectively gated contrast-enhanced CTA was performed on 64-detector scanner, and the CTA images were postprocessed in multiple curved projections on TeraRecon workstation. This study describes the use of CTA to identify LVAD-related issues that altered clinical management and explores the role of CTA and other techniques in evaluating LVAD function. Six of 14 LVAD patients who demonstrated no abnormality on CTA remained stable with medical management. In the remaining eight patients, CTA was abnormal, including abnormalities specifically related to the LVAD cannula. As a result of findings detected by CTA, six patients underwent surgical intervention, including device exchange and heart transplant. Computed tomography angiography is a noninvasive method that enhances diagnostic evaluation of patients with suspected LVAD dysfunction and can lead to changes in patient management.

Is early too early? Effect of shorter stays after bypass surgery.

BACKGROUND: Postoperative stays after coronary artery bypass graft surgery (CABG) decreased substantially in the 1990s. Although shorter stays offer clinical benefits, premature discharge could increase adverse events and offset initial savings. This study examined the effect of early discharge after CABG on readmission/death and cost within 60 days of discharge home. Variability in hospitals' tendencies for early discharge and adverse outcomes was also explored. METHODS: Analyses were based on clinical and claims data for 55,889 New York CABG patients discharged home 1995 to 1998. Early discharge was defined as a postoperative stay below the 15th percentile for patients with similar risk. The likelihood of early discharge and its effect on readmission/death were examined using hierarchical logistic regression, accounting for patient risk and within-hospital correlation. The correlation between early discharge and adverse outcomes at the hospital level was assessed. The effect of early discharge on subsequent inpatient, outpatient, skilled nursing, and home health costs was examined in the Medicare subset. RESULTS: Overall, 17% of patients were discharged early, with increasing prevalence over time. The tendency to discharge early varied widely among hospitals (2% to 42% of patients). We found no association between hospitals' tendencies for early discharge and adverse outcomes. Lower postdischarge costs among patients discharged early (mean = 3,491 dollars versus 5,246 dollars for typical stays) resulted in average cumulative savings of 6,309 dollars. CONCLUSIONS: Patients selected for earlier discharge after CABG did not have increased adverse event rates or higher costs. Variation among hospitals in early discharge suggests that more efficient patient management could be achieved at some hospitals.

Left ventricular assist device performance with long-term circulatory support: lessons from the REMATCH trial.

BACKGROUND: Left ventricular assist device (LVAD) failure and malfunction rates are critical gauges for establishing LVADs as a long-term therapy for end-stage heart failure patients. These device performance measures, however, have been inadequately characterized in the bridge-to-transplantation literature. METHODS: REMATCH is a randomized trial that compares optimal medical management with LVAD implantation for patients with end-stage heart failure. An independent committee adjudicated patient outcomes. The primary endpoint--survival--was analyzed by intention to treat using the log-rank statistic. Frequency of event occurrence was analyzed by Poisson regression. The time to first event was analyzed by the product limit method. Device performance was disaggregated into confirmed malfunctions and system failures. The latter were events in which patients could not be rescued with backup circulatory support measures. RESULTS: The 1-year survival rate was 52% (95% confidence limit [CL]; 40%-63%) for LVAD patients versus 28% (95% CL; 17%-39%) for medical patients and the 2-year survival rate was 29% (95% CL; 19%-40%) for LVAD patients versus 13% (95% CL; 5%-22%) for medical patients. System failure was 0.13 per patient per year and the confirmed LVAD malfunction rate was 0.90. Freedom from device replacement was 87% at 1 year and 37% at 2 years. CONCLUSIONS: Despite the observed rates of device malfunction and replacement, LVAD implantation confers clinically significant improvement with regard to survival as compared with medical management. Device modifications and innovations for infection management exhibit great promise of improving device performance in the near future.