Australian multi-centre experience with bioresorbable vascular scaffolds in “real-world” coronary disease - twelve-month outcomes (original) (raw)
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Catheterization and Cardiovascular Interventions, 2013
Objectives: We sought to characterize UK-wide balloon aortic valvuloplasty (BAV) experience in the TAVI era. Background: BAV for acquired calcific aortic stenosis is in a phase of renaissance, largely due to the development of transcatheter aortic valve implantation (TAVI). Methods: Data from 423 patients at 14 centers across the UK were analyzed. Results: Patients were aged 80.9 6 9.5 years; 52.5% were male. Mean logistic EuroScore was 27.3% 6 16.8%. Mean peak transaortic gradient fell from 62.0 6 26.3 to 28.3 6 16.2 mm Hg. Aortic valve area increased from 0.58 6 0.19 to 0.80 6 0.25 cm 2 echocardiographically. Procedural complication rate was 6.3%, comprising death (2.4%), blood transfusion !2 U (1.2%), cardiac tamponade (1.0%), stroke (1.0%), vascular surgical repair (1.0%), coronary embolism (0.5%), and permanent pacemaker (0.2%). Mortality was 13.8% at 30 days and 36.3% at 12 months. Subsequently, 18.3% of patients underwent TAVI and 7.0% sAVR, with improved survival compared to those who had no further intervention (logrank < 0.0001). Multivariate Cox proportional hazard analysis demonstrated that survival was adversely effected by the presence of coronary artery disease (HR 1.53, 95%CI 1.08-2.17, P 5 0.018), poor LV function (HR 1.54, 95%CI 1.09-2.16, P 5 0.014), and either urgent (HR 1.70, 95%CI 1.18-2.45; P 5 0.004) or emergent presentation (HR 3.72, 95%CI 2.27-6.08; P < 0.0001). Conclusion: Balloon aortic valvuloplasty offers good immediate hemodynamic efficacy at an acceptable risk of major complications. Medium-term prognosis is poor in the absence of definitive therapy. V C 2013 Wiley Periodicals, Inc.
EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology, 2015
Aims: Next to patient characteristics, the lack of a standardised approach for bioresorbable vascular scaffold (BVS) implantation is perceived as a potential explanation for the heterogeneous results reported so far. To provide some guidance, we sought to find a consensus on the best practices for BVS implantation and management across a broad array of patient and lesion scenarios. Methods and results: Fourteen European centres with a high volume of BVS procedures combined their efforts in an informal collaboration. To get the most objective snapshot of different practices among the participating centres, a survey with 45 multiple choice questions was prepared and conducted. The results of the survey represented a basis for the technical advice provided in the document, whereas areas of controversy are highlighted. Conclusions: Consensus criteria for patient and lesion selection, BVS implantation and optimisation, use of intravascular imaging guidance, approach to multiple patient a...
Journal of Interventional Cardiology, 2010
has been used as a bridge to surgical aortic valve replacement (SAVR) in high-risk patients with severe symptomatic aortic stenosis (AS). Such patients are now being referred for transcatheter aortic valve implantation (TAVI). We sought to study the indications and outcomes of BAV in patients with severe AS in the pre-TAVI era. Methods: We analyzed consecutive patients with severe AS undergoing BAV from 1990BAV from to 2005. In these patients with no immediate surgical option, BAV was attempted to temporarily improve hemodynamics, with a goal to improve general health of the patient, and ultimately AVR. Results: A total of 99 BAVs (eight repeats, one second repeat) were performed in 90 consecutive patients. Baseline ejection fraction was ≤25% in 36 (36%) patients. The 30-day mortality rate was 17% (n = 17). Of the 99 patients, 27 (30%) underwent AVR. Average follow-up of patients with and without AVR was 55 ± 57 months and 16 ± 23 months, respectively. The 6-month and 1-year survival rates in patients who underwent AVR were 81% and 78%, respectively, versus 57% and 44% in patients who did not undergo AVR (P = 0.024). Conclusion: BAV can be used successfully to clinically improve the health of some nonsurgical patients with severe symptomatic AS, and a proportion of these patients improve to a point where AVR can be performed. Bridging to TAVI will provide further options to high-risk patients who cannot be bridged to conventional AVR. The role of BAV in bridging to TAVI merits further study. (J Interven Cardiol 2010;23:499-508)
Advances in Interventional Cardiology, 2014
A b s t r a c t Despite significant advances in design and technology of drug eluting stents (DES) and improved long-term outcome of patients treated with percutaneous coronary intervention, the implantation of metallic stents is associated with some limitations. Multiple stents, covering long coronary segments substantially affect vasomotion, changing the vessel into a rigid tube. Bioresorbable vascular scaffolds (BVS) promise complete bioresorption after 2 to 3 years, vessel lumen enlargement, reduction of the plaque to media ratio, and restoration of vasomotion. Thus BVS seems to be a new, promising, and perhaps even a breakthrough invasive treatment for patients with coronary artery disease. The results of randomised trials and registries confirm the efficacy and safety of the BVS, provided the compliance with the technical aspects of implantation. A key role plays also the selection of patients who could potentially benefit most from the implantation of the BVS. The idea of "leaving nothing behind" after percutaneous coronary interventions is a very exiting concept in modern interventional cardiology. If current technology meets the challenge, major limitations will be overcome, and scaffolds prove to be at least as safe and effective as current DES, than in a long run we will be facing a real breakthrough not only in cardiology, but generally in medicine.
Netherlands Heart Journal, 2017
Background To eliminate some of the potential late limitations of permanent metallic stents, the bioresorbable coronary stents or 'bioresorbable vascular scaffolds' (BVS) have been developed. Methods We reviewed all currently available clinical data on BVS implantation. Results Since the 2015 position statement on the appropriateness of BVS in percutaneous coronary interventions, several large randomised trials have been presented. These have demonstrated that achieving adequate 1 and 2 year outcomes with these first-generation BVS is not straightforward. These first adequately powered studies in noncomplex lesions showed worse results if standard implan-R. J. van Geuns
Balloon Aortic Valvuloplasty for Severe Aortic Stenosis as Rescue or Bridge Therapy
Journal of Clinical Medicine
The study aimed to assess procedural complications, patient flow and clinical outcomes after balloon aortic valvuloplasty (BAV) as rescue or bridge therapy, based on data from our registry. A total of 382 BAVs in 374 patients was performed. The main primary indication for BAV was a bridge for TAVI (n = 185, 49.4%). Other indications included a bridge for AVR (n = 26, 6.9%) and rescue procedure in hemodynamically unstable patients (n = 139, 37.2%). The mortality rate at 30 days, 6 and 12 months was 10.4%, 21.6%, 28.3%, respectively. In rescue patients, the death rate raised to 66.9% at 12 months. A significant improvement in symptoms was confirmed after BAV, after 30 days, 6 months, and in survivors after 1 year (p < 0.05 for all). Independent predictors of 12-month mortality were baseline STS score [HR (95% CI) 1.42 (1.34 to 2.88), p < 0.0001], baseline LVEF <20% [HR (95% CI) 1.89 (1.55–2.83), p < 0.0001] and LVEF <30% at 1 month [HR (95% CI) 1.97 (1.62–3.67), p < ...
Vessel Plus, 2017
Aim: Bioresorbable vascular scaffolds (BVS) have recently been introduced to minimise the long-term complications of metallic stents in acute coronary syndrome (ACS), but their benefits have not been well analysed. Methods: The authors studied all ACS patients treated with any kind of stent at a single centre between March 2013 (when the first BVS was implanted) and June 2016. Results: The study included 951 subjects, mean age 67.9 ± 13.3 years, mean Global Registry of Acute Coronary Events (GRACE) score 148.5 ± 44.8, 75.2% men and 38.2% with an ST-segment elevation myocardial infarction. The mean number of stents implanted was 1.3 ± 1.0 and 54 subjects (5.7%) received at least 1 BVS. Drug-eluting stents were implanted in 57.3% subjects, followed by bare-metal stents (19.0%). The subjects treated with BVS were younger and had lower GRACE scores compared to the rest. Inhospital mortality was 4.8% and no subject treated with BVS died before discharge. BVStreated patients received dual antiplatelet therapy or new antiplatelet agents more frequently. During a median follow-up of 13 months, all-cause mortality was 7.8%, cardiovascular mortality was 6.1%, and at least 1 major cardiovascular event occurred in 26.4% of the subjects. Stent type did not affect prognosis. Conclusion: Coronary revascularisation using BVS in selected ACS patients is safe and effective.
Advances in Interventional Cardiology, 2018
Introduction: Randomized trials have proven the feasibility and safety of the bioresorbable vascular scaffold (BVS) in selected populations of patients. Data concerning the results of BVS in "real-world" registries with an appropriate sample size are limited. Aim: Assessment of early-and long-term outcomes of patients undergoing bioresorbable scaffold implantation in an all-comers population of the ZABRZE-BVS registry. Material and methods: The ZABRZE-BVS registry is a prospective registry including consecutive patients treated in the period 2013-2016 with the intention to implant a BVS (ABSORB, Abbott Vascular, Santa Clara, California). The primary endpoint was occurrence of the 12-and 24-month device-oriented composite endpoint (DoCE) defined as cardiac death, target-vessel myocardial infarction (TV-MI) or target lesion revascularization (TLR). The secondary endpoint includes occurrence of patient-oriented composite endpoint (PoCE) at 12 and 24 months, device (lesion basis) and procedural success (patient basis). Results: A total of 456 patients during 467 procedures received 588 scaffolds in 563 lesions. Of note, 25.4% of patients presented with diabetes mellitus and 62.3% had an acute coronary syndrome. In QCA analysis, 78.7% of patients had type B2/C lesions, minimal lumen diameter was 0.78 ±0.54 mm, whereas post-procedural acute lumen gain was 1.61 ±0.61 mm. Median follow-up was 781 days. The cumulative rate of DoCE was 6.7% at 12 months and 12.2% at 24 months. Rates of 12-and 24-month PoCE were 12.4% and 20.1%, respectively. The percentage of device success was 98.7%, while the procedural success rate was 96.9%. Conclusions: The Absorb BVS was successfully and safely implanted in an unselected group of patients. Scaffold thrombosis developed predominantly in patients with acute coronary syndrome (ACS).