Abstract
Aims
The number of transcatheter aortic valve implantation (TAVI) procedures is rapidly increasing. This has a major impact on health care resource planning. However, the annual numbers of ...TAVI candidates per country are unknown. The aim of this study was to estimate current and future number of annual TAVI candidates in 27 European countries, the USA and Canada.
Methods and results
Systematic literature searches and meta-analyses were performed on aortic stenosis (AS) epidemiology and decision-making in severe symptomatic AS. The incidence rate of severe AS was determined. Findings were combined with population statistics and integrated into a model employing Monte Carlo simulations to predict the annual number of TAVI candidates. Various future scenarios and sensitivity analyses were explored. Data from 37 studies (n = 26 402) informed the model. The calculated incidence rate of severe AS was 4.4‰/year 95% confidence interval (95% CI) 3.0–6.1‰ in patients ≥65 years. AS-related symptoms were present in 68.3% (95% CI 60.8–75.9%) of patients with severe AS. Despite having severe symptomatic AS, 41.6% (95% CI 36.9–46.3%) did not undergo surgical aortic valve replacement. Of the non-operated patients, 61.7% (95% CI 42.0–81.7%) received TAVI. The model predicted 114 757 (95% CI 69 380–172 799) European and 58 556 (95% CI 35 631–87 738) Northern-American TAVI candidates annually.
Conclusion
Currently, approximately 180 000 patients can be considered potential TAVI candidates in the European Union and in Northern-America annually. This number might increase up to 270 000 if indications for TAVI expand to low-risk patients. These findings have major implications for health care resource planning in the 29 individual countries.
Polymer-free drug-coated stents provide superior clinical outcomes to bare-metal stents in patients at high bleeding risk who undergo percutaneous coronary intervention (PCI) and are treated with 1 ...month of dual antiplatelet therapy. Data on the use of polymer-based drug-eluting stents, as compared with polymer-free drug-coated stents, in such patients are limited.
In an international, randomized, single-blind trial, we compared polymer-based zotarolimus-eluting stents with polymer-free umirolimus-coated stents in patients at high bleeding risk. After PCI, patients were treated with 1 month of dual antiplatelet therapy, followed by single antiplatelet therapy. The primary outcome was a safety composite of death from cardiac causes, myocardial infarction, or stent thrombosis at 1 year. The principal secondary outcome was target-lesion failure, an effectiveness composite of death from cardiac causes, target-vessel myocardial infarction, or clinically indicated target-lesion revascularization. Both outcomes were powered for noninferiority.
A total of 1996 patients at high bleeding risk were randomly assigned in a 1:1 ratio to receive zotarolimus-eluting stents (1003 patients) or polymer-free drug-coated stents (993 patients). At 1 year, the primary outcome was observed in 169 of 988 patients (17.1%) in the zotarolimus-eluting stent group and in 164 of 969 (16.9%) in the polymer-free drug-coated stent group (risk difference, 0.2 percentage points; upper boundary of the one-sided 97.5% confidence interval CI, 3.5; noninferiority margin, 4.1; P = 0.01 for noninferiority). The principal secondary outcome was observed in 174 patients (17.6%) in the zotarolimus-eluting stent group and in 169 (17.4%) in the polymer-free drug-coated stent group (risk difference, 0.2 percentage points; upper boundary of the one-sided 97.5% CI, 3.5; noninferiority margin, 4.4; P = 0.007 for noninferiority).
Among patients at high bleeding risk who received 1 month of dual antiplatelet therapy after PCI, use of polymer-based zotarolimus-eluting stents was noninferior to use of polymer-free drug-coated stents with regard to safety and effectiveness composite outcomes. (Funded by Medtronic; ONYX ONE ClinicalTrials.gov number, NCT03344653.).
Objective
This study reports the 1‐year clinical outcomes of the VitaFlow™ transcatheter aortic valve system in the treatment of severe aortic stenosis.
Background
The VitaFlow™ system (MicroPort®, ...Shanghai, China) was developed as a novel transcatheter aortic valve replacement system to mitigate or circumvent some of the challenges associated with heavily calcified valves and bicuspid valves.
Methods
From September 2014 to November 2017, a prospective, multicenter, single arm study was conducted in 11 centers in China. The primary end point was all cause mortality at 12 months.
Results
One hundred and ten symptomatic aortic stenosis patients (60 men, 50 women; mean age 77.73 ± 4.78 years) at prohibitive or high risk for surgery were enrolled. Mean society of thoracic surgeons score was 8.84 ± 5.58%. All‐cause mortality was 2.7% at 1‐year. Major stroke, major vascular complication, coronary artery obstruction, new pacemaker implantation occurred in 2.7, 2.7, 1.8, and 19.1% at 1‐year follow‐up, respectively. No patients had moderate or severe paravalvular leak at 1‐year. At 1 year follow‐up, 97% of patients had New York heart association ≤II. Patients with bicuspid valves had similar outcomes as those patients with tricuspid aortic valve stenosis.
Conclusions
The 12‐month clinical results support the safety and efficacy of VitaFlow™ in the treatment of patients with severe aortic stenosis, including patients with bicuspid aortic valve.
SUMMARY
The primary hypothesis of the ROMA trial is that in patients undergoing primary isolated non-emergent coronary artery bypass grafting, the use of 2 or more arterial grafts compared with a ...single arterial graft (SAG) is associated with a reduction in the composite outcome of death from any cause, any stroke, post-discharge myocardial infarction and/or repeat revascularization.
The secondary hypothesis is that in these patients, the use of 2 or more arterial grafts compared with a SAG is associated with improved survival. The ROMA trial is a prospective, unblinded, randomized event-driven multicentre trial comprising at least 4300 subjects. Patients younger than 70 years with left main and/or multivessel disease will be randomized to a SAG or multiple arterial grafts to the left coronary system in a 1:1 fashion. Permuted block randomization stratified by the centre and the type of second arterial graft will be used. The primary outcome will be a composite of death from any cause, any stroke, post-discharge myocardial infarction and/or repeat revascularization. The secondary outcome will be all-cause mortality. The primary safety outcome will be a composite of death from any cause, any stroke and any myocardial infarction. In all patients, 1 internal thoracic artery will be anastomosed to the left anterior descending coronary artery. For patients randomized to the SAG group, saphenous vein grafts will be used for all non-left anterior descending target vessels. For patients randomized to the multiple arterial graft group, the main target vessel of the lateral wall will be grafted with either a radial artery or a second internal thoracic artery. Additional grafts for the multiple arterial graft group can be saphenous veins or supplemental arterial conduits. To detect a 20% relative reduction in the primary outcome, with 90% power at 5% alpha and assuming a time-to-event analysis, the sample size must include 845 events (and 3650 patients). To detect a 20% relative reduction in the secondary outcome, with 80% power at 5% alpha, the sample size must include 631 events (and 3650 patients). To be conservative, the sample size will be set at 4300 patients. The primary outcome will be tested according to the intention-to-treat principle. The primary analysis will be a Cox proportional hazards regression model, with the treatment arm included as a covariate. If non-proportional hazards are observed, alternatives to Cox proportional hazards regression will be explored.
Abstract Background Limited information exists describing the results of transcatheter aortic valve (TAV) replacement in patients with bicuspid aortic valve (BAV) disease (TAV-in-BAV). Objectives ...This study sought to evaluate clinical outcomes of a large cohort of patients undergoing TAV-in-BAV. Methods We retrospectively collected baseline characteristics, procedural data, and clinical follow-up findings from 12 centers in Europe and Canada that had performed TAV-in-BAV. Results A total of 139 patients underwent TAV-in-BAV with the balloon-expandable transcatheter heart valve (THV) (n = 48) or self-expandable THV (n = 91) systems. Patient mean age and Society of Thoracic Surgeons predicted risk of mortality scores were 78.0 ± 8.9 years and 4.9 ± 3.4%, respectively. BAV stenosis occurred in 65.5%, regurgitation in 0.7%, and mixed disease in 33.8% of patients. Incidence of type 0 BAV was 26.7%; type 1 BAV was 68.3%; and type 2 BAV was 5.0%. Multislice computed tomography (MSCT)-based TAV sizing was used in 63.5% of patients (77.1% balloon-expandable THV vs. 56.0% self-expandable THV, p = 0.02). Procedural mortality was 3.6%, with TAV embolization in 2.2% and conversion to surgery in 2.2%. The mean aortic gradient decreased from 48.7 ± 16.5 mm Hg to 11.4 ± 9.9 mm Hg (p < 0.0001). Post-implantation aortic regurgitation (AR) grade ≥2 occurred in 28.4% (19.6% balloon-expandable THV vs. 32.2% self-expandable THV, p = 0.11) but was prevalent in only 17.4% when MSCT-based TAV sizing was performed (16.7% balloon-expandable THV vs. 17.6% self-expandable THV, p = 0.99). MSCT sizing was associated with reduced AR on multivariate analysis (odds ratio OR: 0.19, 95% confidence intervals CI: 0.08 to 0.45; p < 0.0001). Thirty-day device safety, success, and efficacy were noted in 79.1%, 89.9%, and 84.9% of patients, respectively. One-year mortality was 17.5%. Major vascular complications were associated with increased 1-year mortality (OR: 5.66, 95% CI: 1.21 to 26.43; p = 0.03). Conclusions TAV-in-BAV is feasible with encouraging short- and intermediate-term clinical outcomes. Importantly, a high incidence of post-implantation AR is observed, which appears to be mitigated by MSCT-based TAV sizing. Given the suboptimal echocardiographic results, further study is required to evaluate long-term efficacy.
Percutaneous coronary intervention in complex bifurcation lesions is prone to suboptimal implantation results and is associated with increased risk of subsequent clinical events. Angiographic ...ambiguity is high during bifurcation stenting, but it is unknown if procedural guidance by intravascular optical coherence tomography (OCT) improves clinical outcome.
OCTOBER is a randomized, investigator-initiated, multicenter trial aimed to show superiority of OCT-guided stent implantation compared to standard angiographic-guided implantation in bifurcation lesions. The primary outcome measure is a 2-year composite end point of cardiac death, target lesion myocardial infarction, and ischemia-driven target lesion revascularization. The calculated sample size is 1,200 patients in total, and allocation is 1:1. Eligible patients have stable or unstable angina pectoris or stabilized non–ST elevation myocardial infarction, and a coronary bifurcation lesion with significant main vessel stenosis and more than 50 % stenosis in a side branch with a reference diameter ≥2.5mm. Treatment is performed by the provisional side branch stenting technique or 2-stent techniques, and the systematic OCT guiding protocol is aimed to evaluate (1) plaque preparation, (2) lesion length, (3) segmental reference sizes, (4) lesion coverage, (5) stent expansion, (6) malapposition, (7) wire positions, and (8) ostial results.
A positive outcome of the OCTOBER trial may establish OCT as a routine tool for optimization of complex percutaneous coronary intervention, whereas a negative result would indicate that OCT remains a tool for ad hoc evaluation in selected cases.
Abstract Patients with advanced chronic renal dysfunction were excluded from randomized trials of transcatheter aortic valve replacement (TAVR). The potential impact of chronic renal disease on TAVR ...prognosis is not fully understood. We aim to evaluate outcomes within a large cohort of patients undergoing TAVR distinguished by renal function. Baseline characteristics, procedural data and clinical follow-up findings were collected from 10 high-volume TAVR centers in Europe, Israel and Japan. Data was analyzed according to renal function. Patients (n=1204) were divided into 4 groups according to pre-TAVR estimated glomerular filtration rate (eGFR): group I (eGFR >60) n=288 (female 45%), group II (eGFR 31-60) n=452 (female 61%), group III (eGFR ≤30) n=398 (female 61%) and group IV (dialysis) n=66 (female 31%). Mean Society of Thoracic Surgeons (STS) score was higher in patients with lower pre-procedural eGFR. All-cause mortality at 1-year was higher in patients with lower eGFR (9.0%, 12.1%, 24.3%, 24.2% for group I, II, III and IV; respectively, p <0.001). Multivariate analysis demonstrated that eGFR ≤30, but not eGFR 31-60, was associated with increased risk of death (OR 3), bleeding (OR 5.2) and device implantation failure (HR 2.28). For each 10-mL/min decrease in eGFR, there was an associated relative increase in the risk of death (35%; p<0.001), cardiovascular death (14%; p=0.018), major bleeding 35% (p<0.001), and transcatheter valve failure (16%; p=0.007). Renal dysfunction was not associated with stroke or need for pacemaker implantation. In conclusion among patients undergoing TAVR, baseline renal dysfunction is an important independent predictor of morbidity and mortality.
Objectives
We sought to identify the impact of transcatheter aortic valve implantation (TAVI) on changes of fractional flow reserve computed tomography (FFR
CT
) values and the associated clinical ...impact.
Methods
A retrospective analysis was done with CT obtained pre-TAVI, prior to hospital discharge and at 1-year follow-up, which provided imaging sources for the calculation of FFR
CT
values based on an online platform.
Results
A total of 190 patients were enrolled. Patients with pre-procedural FFR
CT
value > 0.80 (i.e., negative) and ≤ 0.80 (i.e., positive) demonstrated a significantly opposite change in the value after TAVI (0.8798 vs. 0.8718,
p
< 0.001 and 0.7634 vs. 0.8222,
p
< 0.001, respectively). The history of coronary artery disease (CAD) was identified as an independent predictor for FFR
CT
changing from negative to positive after TAVI (odds ratio OR 2.927, 95% confidence interval CI 1.130–7.587,
p
= 0.027), with lesions more severely stenosed (OR 1.039, 95% CI 1.003–1.076,
p
= 0.034) and in left anterior descending coronary artery (LAD) (OR 3.939, 95% CI 1.060–14.637,
p
= 0.041) being prone to change.
Conclusions
TAVI directly brings improvement in FFR
CT
values in patients with compromised coronary flow. Patients with a history of CAD, especially with lesions more severely stenosed and in LAD, were under risk of FFR
CT
changing from negative to positive after TAVI.
Key Points
•
The effect of TAVI on coronary hemodynamics might be influenced by different ischemic severity and coronary territories reflected by FFR
CT
values.
•
As different FFR
CT
variations did not impact outcomes of TAVI patients, AS, but not coronary issues, may be the primary problem to affect, which needs further validation.
PDF
