Experience of Combined Procedure during Percutaneous LAA Closure

Introduction: Percutaneous left atrial appendage closure (LAAC) is an alternative to oral anticoagulants (OAC) in patients with non-valvular atrial fibrillation (AF) and contraindication to long-term OAC. Combined strategy with percutaneous LAAC at the same time of other cardiac structural or electrophysiological procedures has emerged as an alternative to a staged strategy. Aim: To describe our experience with combined LAAC procedures using Watchman™ devices. Methods: All patients with combined LAAC procedures using Watchman™ (WN) devices performed from 2016 to 2021 were included. The primary safety endpoint was a composite of periprocedural complications and adverse events during the follow-up. The primary efficacy endpoint included strokes, systemic embolisms, major bleeding and cardiovascular death. Results: From 2016, among 160 patients who underwent LAAC using WN devices, 19 underwent a combined strategy: 7 transcatheter edge-to-edge mitral valve repair (TEMVR) (37%), 6 typical atrial flutter ablation (31%), 2 leadless pacemaker (LP) implantation (10%) and 4 AF ablation (22%). The WN device was successfully implanted in 98% and 100% of cases for single and combined LAAC procedures, respectively (p = 0.63). Median follow-up was 13 months (IQR 25/75 3/24). Device-related complications occurred in 6 out of 141 patients (4%) who underwent single LAAC and in no (0/19) patient in the combined LAAC procedure (p = ns). The procedural-related complications did not differ significantly between groups (5% vs. 10%, respectively, in the single and combined group, p = 0.1). Conclusion: Combined procedure using the Watchman™ devices and one other structural or electrophysiological procedure appears safe and effective. Larger series are needed to confirm these results.</jats:p

Experience of Combined Procedure during Percutaneous LAA Closure

Introduction: Percutaneous left atrial appendage closure (LAAC) is an alternative to oral anticoagulants (OAC) in patients with non-valvular atrial fibrillation (AF) and contraindication to long-term OAC. Combined strategy with percutaneous LAAC at the same time of other cardiac structural or electrophysiological procedures has emerged as an alternative to a staged strategy. Aim: To describe our experience with combined LAAC procedures using Watchman&trade; devices. Methods: All patients with combined LAAC procedures using Watchman&trade; (WN) devices performed from 2016 to 2021 were included. The primary safety endpoint was a composite of periprocedural complications and adverse events during the follow-up. The primary efficacy endpoint included strokes, systemic embolisms, major bleeding and cardiovascular death. Results: From 2016, among 160 patients who underwent LAAC using WN devices, 19 underwent a combined strategy: 7 transcatheter edge-to-edge mitral valve repair (TEMVR) (37%), 6 typical atrial flutter ablation (31%), 2 leadless pacemaker (LP) implantation (10%) and 4 AF ablation (22%). The WN device was successfully implanted in 98% and 100% of cases for single and combined LAAC procedures, respectively (p = 0.63). Median follow-up was 13 months (IQR 25/75 3/24). Device-related complications occurred in 6 out of 141 patients (4%) who underwent single LAAC and in no (0/19) patient in the combined LAAC procedure (p = ns). The procedural-related complications did not differ significantly between groups (5% vs. 10%, respectively, in the single and combined group, p = 0.1). Conclusion: Combined procedure using the Watchman&trade; devices and one other structural or electrophysiological procedure appears safe and effective. Larger series are needed to confirm these results

Abstract 360: How Should We Measure Quality of Care for Transcatheter Aortic Valve Implantation (TAVI)? Results for 6 Quebec TAVI Programs Compared with International Registries

Background: Our publicly funded cardiology evaluation unit examined quality indicators relating to the use and outcomes of transcatheter aortic valve implantation (TAVI). We compared results in Québec hospitals with registries around the world. Methods: We abstracted data on all TAVI cases (n=294) in 6 hospitals in 2013-14. Variables, outcomes and definitions were chosen to facilitate comparisons with registries. Results were presented to TAVI teams with the goal of choosing quality indicators and improving performance. Results: Annual TAVI center volume ranged from 30 to 115 and rate of TAVI varied widely across Quebec’s 16 health regions, as did rates around the world. Median patient age was 83 years (interquartile range [IQR]: 78-86) with little variation across centers and international registries. Documented proportion of patients with NYHA class III/IV was 64% (188/294) for Quebec and varied from 75 to 86% across registries. A surgical risk score (STS) was recorded in only 53% (156/294) of Quebec patients but was often obligatory in registries. The median STS score for Quebec was very similar to that reported in the USA [6% (IQR: 4-10) vs 7% (IQR: 5-11), respectively] but was much lower than in France, Austria and Brazil. Frequency of in-hospital adverse events varied widely across Québec centers: stroke (0-7.5%), bleeding (16.7-26.7%) and transfusion (16.7-43.3%). Overall incidence of in-hospital stroke was 2.3% (7/294) and varied from 1.8 to 5.3% across registries. Bleeding and transfusion were rarely reported in registries. Conversion to surgery was 3% (9/294) in Quebec, and 0.4-4.3% in registries. In Quebec, 15% of patients required a new pacemaker, with wide variation across centers (0-21%) and registries (6.6-25%). Rates of procedural success varied widely across Quebec, largely due to non-standardized classification of post-TAVI aortic regurgitation. Such classification also varied across registries. Overall procedural success for Quebec (73%; 215/294) was lower than in registries but in the latter, the definition of success was often unclear. In-hospital mortality in Quebec was 6.5% (19/294) versus 5.5% in USA and a reported 5.1% for transvascular and 7.7% for transapical TAVI in Germany. Other registries only reported 30-day mortality, varying from 4.1 to 9.1%. Discharge home was more likely in Quebec (80%) than the USA (63%); this outcome was not reported elsewhere. Conclusions: Practice and outcomes in TAVI vary widely across Quebec hospitals and internationally. Despite publication of recommended endpoints (VARC and BARC), there is a lack of standardized reported outcomes and patient populations. While quality benchmarks for patient selection and outcomes remain unclear, continued monitoring with timely feedback to TAVI teams and decision-makers is essential for this new and costly intervention that is predominantly being performed in the very elderly. </jats:p

Abstract 364: Results of a Province-wide Field Evaluation of the Use and Outcomes of Transcatheter Aortic Valve Implantation (TAVI) in Quebec Compared With the STS/ACC Registry

Background: After a review of the evidence, our cardiology evaluation unit recommended to the Quebec Ministry of Health that transcatheter aortic valve implantation (TAVI) should be used in carefully selected patients and that use and outcomes be independently monitored. Herein, we describe the first results of our province-wide field evaluation of patient and procedural characteristics and clinical outcomes and compare them with the STS/ACC TVT registry. Methods: Our trained data abstractors conducted a retrospective review of medical charts of all TAVI cases (n=96) in 6 hospitals during April-July 2013. Variables, outcomes and definitions were chosen to enable valid comparison with other registries in Canada and the USA. The evaluation protocol was created in collaboration with a scientific committee of representative interventionists and surgeons. Results: During the 4-month period, the number of TAVI patients varied from 4 to 37 across the 6 centers. Median age was 83 years (interquartile range [IQR]: 78-86) vs 84 years (IQR: 78-88) in the TVT registry. Half of Quebec TAVI patients were women, as in TVT. Documentation of an evaluation by a surgeon was found for only 58% of patients and the STS predicted risk of operative mortality was documented for only 54%. Of these, the median STS score was 6% (IQR: 4-10) compared to 7% (IQR: 5-11) in TVT where 91% of patients were evaluated by 2 surgeons. The most common vascular access approach in Quebec was transfemoral (70% vs. 64% in TVT); the transapical approach was used less in Quebec than in TVT (16% vs. 29%). While all TAVI in the TVT registry used Edwards SAPIEN XT valves, in Quebec 71% of TAVI used Edwards SAPIEN XT valves, 26% were Medtronic Corevalve and 3% were Portico valves. In-hospital mortality in Quebec was 6.3% (95% CI: 1.3-11.2) compared with 5.5% (95% CI: 5.0-6.1) in TVT. Conversion to surgery (3% vs 1%) and insertion of a new permanent pacemaker (13% vs 7%) were higher in Quebec than in TVT. TAVI patients in Quebec spent less time in intensive care (median 31 hours (IQR: 23-70) vs 46 hours (IQR: 25-77) and in hospital after TAVI (median 5 days (IQR: 3-8) vs 6 (IQR: 4-10). They were also more likely to be discharged home than patients in the TVT registry (80% vs 63%). Conclusions: Preliminary results from a province-wide TAVI registry in Quebec suggest that practice and outcomes are similar to those observed in the TVT registry. Compared with TVT, notable differences in practice were less documentation of surgical evaluation and of STS predicted mortality, less use of the transapical approach and more frequent need for a permanent pacemaker. Some differences may relate to use of a greater variety of valve types in Quebec. In-hospital mortality was similar. These results will be discussed with each TAVI team. Continued monitoring and long-term follow-up in collaboration with clinical experts are essential to promote an optimal quality of care. </jats:p