Journal and News Scan

This editorial summarizes the landscape that led to the founding of the Thoracic Surgical Oncology Group in 2017, in an era when, due to various oncology group reorganizations, a need developed for a focused committee to conduct thoracic surgery oncology-based clinical trials. The group has expanded over the years to include 32 hospitals. It has completed two clinical trials, with three more actively recruiting patients, and four new studies planned in the near future. There remain multiple challenges, however, with increasing interest, there are more opportunities going forward.

In an analysis of 1,826 patients randomized to surgical aortic valve replacement in the three Placement of Aortic Transcatheter Valves (PARTNER) trials, patient-prosthesis mismatch was assessed using transthoracic echocardiography and by the normal reference value for each size and model of implanted valve. Compared with transthoracic echocardiography (21.6 percent), reference values underestimated the incidence of severe patient-prosthesis mismatch (2.1 percent), which was associated with worse all-cause mortality and heart failure rehospitalizations at the two year follow-up.

This report comprises the contents of the presentations and following discussions of a workshop of the German Heart Transplant Centers in Martinsried, Germany on cardiac xenotransplantation. Summary: This report comprises the contents of the presentations and following discussions of a workshop of the German Heart Transplant Centers in Martinsried, Germany, on cardiac xenotransplantation. The production and current availability of genetically modified donor pigs, preservation techniques during organ harvesting, and immunosuppressive regimens in the recipient are described. Selection criteria for suitable patients and possible solutions to the problem of overgrowth of the xenotransplant are also discussed. Obviously, microbiological safety for the recipient and close contacts is essential, and ethical considerations to gain public acceptance for clinical applications are addressed. The first clinical trial will be regulated and supervised by the Paul Ehrlich Institute as the National Competent Authority for Germany, and the German Heart Transplant Centers agreed to cooperatively select the first patients for cardiac xenotransplantation.

The DEDICATE-DZHK6 is a non-industry sponsored randomized noninferiority trial conducted at 38 sites in Germany, where patients with severe aortic stenosis who were at low or intermediate surgical risk were randomly assigned to undergo either transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (SAVR). TAVI and SAVR prostheses were selected at the operator's discretion. The primary outcome was a composite of death from any cause or fatal or nonfatal stroke at one year. A total of 1,414 patients underwent randomization, 701 to the TAVI group and 713 to the SAVR group). The mean age was 74±4 years, 57 percent were men, and the median Society of Thoracic Surgeons risk score was 1.8 percent. The Kaplan–Meier estimate of the primary outcome at one year was 5.4 percent in the TAVI group and 10 percent in the SAVR group (hazard ratio (HR) for death or stroke, 0.53; 95 percent confidence interval [CI], 0.35 to 0.79; P <0.001 for noninferiority). The incidence of death from any cause was 2.6 percent in the TAVI group and 6.2 percent in the SAVR group (HR 0.43; 95 percent CI, 0.24 to 0.73). The incidence of stroke was 2.9 percent and 4.7 percent in the TAVI and SAVR groups, respectively (HR 0.61; 95 percent CI, 0.35 to 1.06). The authors concluded that among patients with severe aortic stenosis at low or intermediate surgical risk, TAVI was noninferior to SAVR with respect to death from any cause or stroke at one year.