Journal and News Scan

This is a letter in response to the article by Chang and colleagues. The authors begin by stating that the data from this study should be graded according to an internationally accepted system, GRADE. In terms of overall mortality, the study should be downgraded by two points to low quality, because the two trials had different results and the pooled estimate is inaccurate. Moreover, given the small sample size, it is likely that the two groups differed with regards to risk of mortality, perhaps with higher risk patients randomised to the surgical arm as evidenced by the unacceptably high mortality rate in that group. They also point out that only 27% of patients in the SABR arm of the ROSEL trial had biopsy proven NSCLC. In addition, Figure 2, A (overall survival) has a hazard ratio of 0.14 in favor of SABR, but the 95% CI (0.017-1.190) is discrepant with the p-value of 0.037. Lastly, the original article concluded that the two treatments were equally effective although the two trials were not designed as equivalence trials. The authors state that no conclusions can be drawn from the data of these trials. 

This is the authors' reply to the letters submitted to The Lancet Oncology. They begin by stating that the strength of their analysis was that patients were randomised, thereby avoiding selection bias. With regards to low accrual, one major factor was failure of thoracic surgeons to participate. In addition, stage I NSCLC is relatively uncommon. They state that the median follow-up was long enough to discover recurrences and that there were enough patients to accurately analyze the data from a statistical standpoint. For patients in the ROSEL trial who did not undergo biopsy, clinical staging via PET scan has been shown to have a low false positive rate in the Netherlands. When considering VATS versus thoracotomy, cancer outcomes are not improved by VATS, readmission for complications of VATS is similar to thoracotomy, and nodal upstaging for clinical stage I NSCLC is more common after thoracotomy, although extent of lymph node dissection does not affect outcomes. Therefore the possible superiority of VATS may not lead to a clinically significant improvement in the surgical treatment of these patients. With regards to comorbidities, all patients underwent cardiopulmonary testing to determine their surgical candidacy. Zhang and colleagues had disagreed with the use of SABR and EBUS for concern that lymph node involvement would be understaged and those patients would miss out on adjuvant therapy. The original article showed no difference in regional recurrence between the two groups. Opitz and colleagues graded the original article, but Chang and colleagues replied that the randomised design of the two trials translates to a higher level of evidence than prior studies. Chang clarifies that the 30-day surgical mortality was 0%, but the 90-day mortality was 3.7% which is less than recent published literature. The authors respond to Dearman and colleagues' suggestion regarding NHS England and CtE by stating that there is already a considerable amount of data comparing SABR versus surgery. The authors finish by stating that they continue to support their conclusion that SABR is a non-invasive standard treatment alternative to surgery for patients unable to undergo surgery and should also be considered a viable treatment option for patients who are surgical candidates.

The authors investigate the safety of minimally invasive Transcatheter Aortic Valve Replacement (MA-TAVR) and its learning curve.  MA-TAVR was performed by a team consisting of a cardiologist and cardiac surgeon. The patient was teated in a catheterization laboratory under conscious sedation. During the series the routine changed from transferring patients to the ICU to transferring patients to a regular telemetry room.  The authors found in 151 consecutive cases that the majority of patients were high surgical risk (STS-PROM of 10.0%). The rates of major stroke (3.3%), major vascular complications (3%) and paravalvular leak (7%) did not change over time.  The authors conclude that in a high-volume TAVR center, MA-TAVR is feasible. Moreover, they conclude that the learning curve for moving from regular TAVR to MA-TAVR is small and that TAVR centers actively pursue the minimalist technique.

The Texas Heart Institute reports its experience with 27 patients with prior continuous flow LVADs who had undergone varying degrees of device explantation.  Although the numbers are small, the explantation methods ranged from near-complete device removal to driveline transection and removal.  In general, the device explantation technique has evolved over time to a progressively less invasive option.  This experience provides justification for a tailored approach, but lesser degrees of device removal appear to be well tolerated.  The exception may be patients with chronic device infection:  6 of 10 patients with superficial driveline infection required further procedures for either debridement or removal of infected device material.  More radical explantation of device material is recommended in these patients.