[Robot-assisted surgery on a broad front--without evidence for being cost-effective]. / Robotkirurgi på bred front ­ utan evidensbaserad grund - Tekniken används allt mer, trots att den är dyr och att vetenskapliga bevis för patientnytta saknas.

Robot-assisted surgery on a broad front - without evidence for being cost-effective Robot-assisted surgery is currently heavily marketed. The HTA centre in Region Västra Götaland has produced five HTA reports regarding use of robot-assisted surgery in different clinical situations (prostatic cancer, benign gynaecological surgery, pediatric pyeloplasty and fundoplication, and rectal cancer), finding weak evidence for a patient value. The current report by Per Carlsson et al confirms that robot-assisted surgery indeed leads to increased costs that are not balanced by augmented patient value, i.e. robot-assisted surgery cannot be regarded as cost efficient. We comment critically on the capricious introduction of new techniques/devices, a procedure that stands in sharp contrast to the strictly formalized system for approval of new drugs.

[Better regulatory framework needed for medical devices]. / Bättre regelverk behövs för medicintekniska produkter - HTA-utredning av läkemedelsavgivande stentar och ballonger vid benartärsjukdom visar på bristerna.

We summarize an HTA report regarding patient values of drug-eluting stents and balloons for treatment of atherosclerotic disease in the lower extremities. We found 17 randomized controlled trials, 4 cohort studies and 13 case series. The total number of studied patients was substantial (about 3,000) but there was a strong heterogeneity regarding site of lesion, symptom pattern, device, drug used and outcome measures, making the analysis difficult and based on relatively small subgroups. We found low certainty of evidence (GRADE ++) for a reduced risk of restenosis in patients with critical ischemia and lesions below the knee, and also a modest beneficial effect on ischemic symptoms in a mixed patient population. However, we also identified a worrying safety signal, with increased risk for amputation in a group of patients with below-the-knee disease and critical ischemia. The results highlight the need for a structured system for validation of medical devices, a system analogous to that currently used for evaluation of new pharmacological products.