In Reply: Dr Miller and Dr Sims and colleagues highlight an inherent challenge of studying long-term outcomes associated with evolving technologies like ventricular assist devices. By the time long-term outcome data become available, a new generation of devices has entered the market. This challenge is not unique to ventricular assist devices, and experience with other devices indicates that postmarketing surveillance is important.1,2 Although the most recent generation of assist devices represents an important advance, only time will tell how well the devices work in patients who receive them outside of clinical trials. When sufficient long-term data on the current generation of continuous-flow devices are available, another generation will have emerged. Once again, there will be a new technology but no relevant long-term data.
Hernandez AF, Hammill BG, Curtis LH. Outcomes of Medicare Beneficiaries With Ventricular Assist Devices—Reply. JAMA. 2009;301(16):1656-1658. doi:10.1001/jama.2009.527