ABSTRACT
BACKGROUND: ProGlide is a percutaneous suture-mediated closure device used in arterial and venous closure following percutaneous intervention. Risk of vascular complications from use, particularly related to failure in hemostasis, or acute vessel closure, remains significant and often related to improper suture deployment. We describe a technique of ultrasound-guided ProGlide deployment in transfemoral transcatheter aortic valve implantation (TF-TAVI). AIMS: The aim of this study is to assess vascular outcomes for ultrasound-guided deployment of ProGlide vascular closure devices in patients undergoing TF-TAVI. METHODS: We collected relevant clinical data of patients undergoing TAVI in a large volume centre. PRIMARY OUTCOME: main access Valve Academic Research Consortium 3 (VARC-3) major vascular complication. SECONDARY OUTCOME: any major/minor VARC-3 vascular complication, its type (bleed or ischemia), and treatment required (medical, percutaneous, or surgical). We performed inverse weighting propensity score analysis to compare the population undergoing ultrasound-guided versus conventional ProGlide deployment for main TAVI access. Ultrasound technique for ProGlide insertion was performed as described below. RESULTS: Five hundred and seventeen patients undergoing TF-TAVI were included. PRIMARY OUTCOME: In 126 (ultrasound-guided) and 391 (conventional ProGlide insertion), 0% versus 1.8% (p < 0.001) had a major VARC-3 vascular complication, respectively. SECONDARY OUTCOME: 0.8% (one minor VARC-3 bleed) vs 4.1% (13 bleeds and three occlusions) had any VARC-3 vascular complication (major and minor) (p < 0.001). Surgical treatment of vascular complication was required in 0.8% versus 1.3% (p = NS). CONCLUSIONS: Ultrasound-guided deployment of ProGlide for vascular closure reduced the risk of major vascular complications in a large population undergoing TAVI.
Subject(s)
Aortic Valve Stenosis , Transcatheter Aortic Valve Replacement , Vascular Closure Devices , Humans , Aortic Valve Stenosis/diagnostic imaging , Aortic Valve Stenosis/surgery , Aortic Valve Stenosis/complications , Cohort Studies , Femoral Artery/diagnostic imaging , Femoral Artery/surgery , Treatment Outcome , Hemorrhage/etiology , Risk Reduction Behavior , Ultrasonography, Interventional/adverse effects , Aortic Valve/diagnostic imaging , Aortic Valve/surgeryABSTRACT
Increasingly, bioethicists have been exploring the possibility of making phase I clinical trials available to hospice patients. Phase I clinical trials are designed to test a drug's safety and dosage, not its effectiveness. Participants in these studies generally do not understand that the purpose of the investigation is not to benefit them, thus challenging the notion of informed consent. But furthermore, the idea that patients believe experimental drugs will help them is contrary to the principles of hospice. Also, the very nature of the research in phase I conflicts with hospice's methods. For these reasons, this paper finds that the two models must remain distinct.
