ABSTRACT
BACKGROUND: Transcatheter aortic valve implantation (TAVI) is an established therapy for the treatment of aortic valve disease in appropriately selected patients. Previous studies using the self-expanding Portico transcatheter heart valve (THV), (Abbott Structural Heart, St Paul, MN, USA) have demonstrated the technical feasibility of this system albeit in the hands of relatively inexperienced Portico users. The objective of this study was to assess the real-world safety and efficacy of the Portico THV (with and without the FlexNav delivery system, Abbott Structural Heart) at the 30-day timepoint in an Australian cohort. METHODS AND RESULTS: This study was a retrospective real-world cohort analysis of 269 consecutive patients with severe aortic valve disease who underwent TAVI at multiple centres within Australia between February 2015 and April 2021. Of the 269 patients, 51.7% were female, mean Society of Thoracic Surgeons (STS) score was 5.2 (±6.8) and 98.5% had successful implantations. Thirty (30)-day post-implantation all-cause mortality was observed in one (0.4%) patient, major vascular complications in two (0.7%) patients, more-than-mild paravalvular leak in six (2.2%) patients and requirement for new permanent pacemaker implantation in 27 (10.2%) patients. Haemodynamic parameters at 30 days included mean effective orifice area (EOA) of 2.3 (±0.9) cm2 and mean aortic valve gradient (AVG) of 9.6 (±6.2) mmHg. CONCLUSION: This analysis of the Portico THV in a real-world setting suggested that the system is associated with satisfactory safety and efficacy parameters. Previously published datasets may not have found similar findings owing to lower operator experience with the Portico THV system.
Subject(s)
Aortic Valve Disease , Aortic Valve Stenosis , Heart Valve Prosthesis , Transcatheter Aortic Valve Replacement , Humans , Female , Male , Aortic Valve/surgery , Aortic Valve Stenosis/diagnosis , Aortic Valve Stenosis/surgery , Retrospective Studies , Treatment Outcome , Australia/epidemiology , Transcatheter Aortic Valve Replacement/methods , Aortic Valve Disease/surgery , Prosthesis DesignABSTRACT
BACKGROUND: Thoracic surgery is associated with high levels of acute and chronic pain, which is associated with significant morbidity, reduced quality of life, and increased health care expenditure. This study aims to identify patient-care factors associated with higher levels of acute and chronic pain after thoracic surgery. METHODS: The acute pain component of this study retrospectively analysed 53 patients, surgical, anaesthetic, and postoperative factors against an average measure of acute pain during a patient's hospital admission, for 134 individual acute admission episodes. The chronic pain component analysed 58 care factors against a binary chronic pain outcome based on the Neuropathic Pain Scale and the Brief Pain Inventory, for 72 patients, at an average of 7 months postoperatively. RESULTS: Younger age, chronic opioid use, use of talc, and multi-port video-assisted thoracoscopic surgery (VATS) compared to uniport VATS, were all associated with higher levels of acute postoperative pain. Seven (7) months postoperatively, the rate of chronic sensation change or numbness was 31%. The rate of troublesome chronic pain was 8%. History of a mental health condition, chronic opioid use, urgent operation, and the use of tramadol postoperatively were independently associated with a higher risk of chronic pain. CONCLUSIONS: This study identifies several factors associated with higher rates of acute and chronic postoperative pain, and defines the rate of chronic pain in a large tertiary thoracic surgery centre. Consideration should be given to modifying those surgical practices which were identified as being associated with higher levels of pain, including multi-port VATS, and the use of talc. It is important that non-modifiable risk factors for pain, including history of mental health condition, opioid use, age, and urgency of operation, are taken into consideration when informing a patient of the risk of pain postoperatively.