In a trial, patients who had undergone successful TAVR were assigned to rivaroxaban or antiplatelet therapy. In this substudy in patients who underwent CT, leaflet thickening and reduced leaflet ...motion at 90 days were less common with rivaroxaban. However, in the main trial, rivaroxaban was associated with a higher risk of death or thromboembolic complications and a higher risk of bleeding.
Summary Background Patients with acute ST-segment elevation myocardial infarction (STEMI) and multivessel coronary disease have a worse prognosis compared with individuals with single-vessel disease. ...We aimed to study the clinical outcome of patients with STEMI treated with fractional flow reserve (FFR)-guided complete revascularisation versus treatment of the infarct-related artery only. Methods We undertook an open-label, randomised controlled trial at two university hospitals in Denmark. Patients presenting with STEMI who had one or more clinically significant coronary stenosis in addition to the lesion in the infarct-related artery were included. After successful percutaneous coronary intervention (PCI) of the infarct-related artery, patients were randomly allocated (in a 1:1 ratio) either no further invasive treatment or complete FFR-guided revascularisation before discharge. Randomisation was done electronically via a web-based system in permuted blocks of varying size by the clinician who did the primary PCI. All patients received best medical treatment. The primary endpoint was a composite of all-cause mortality, non-fatal reinfarction, and ischaemia-driven revascularisation of lesions in non-infarct-related arteries and was assessed when the last enrolled patient had been followed up for 1 year. Analysis was on an intention-to-treat basis. This trial is registered with ClinicalTrials.gov , number NCT01960933. Findings From March, 2011, to February, 2014, we enrolled 627 patients to the trial; 313 were allocated no further invasive treatment after primary PCI of the infarct-related artery only and 314 were assigned complete revascularisation guided by FFR values. Median follow-up was 27 months (range 12–44 months). Events comprising the primary endpoint were recorded in 68 (22%) patients who had PCI of the infarct-related artery only and in 40 (13%) patients who had complete revascularisation (hazard ratio 0·56, 95% CI 0·38–0·83; p=0·004). Interpretation In patients with STEMI and multivessel disease, complete revascularisation guided by FFR measurements significantly reduces the risk of future events compared with no further invasive intervention after primary PCI. This effect is driven by significantly fewer repeat revascularisations, because all-cause mortality and non-fatal reinfarction did not differ between groups. Thus, to avoid repeat revascularisation, patients can safely have all their lesions treated during the index admission. Future studies should clarify whether complete revascularisation should be done acutely during the index procedure or at later time and whether it has an effect on hard endpoints. Funding Danish Agency for Science, Technology and Innovation and Danish Council for Strategic Research.
We examined loop diuretic treatment before and 1-year after transcatheter aortic valve implantation (TAVI), as a proxy for changes in symptom severity and secondly assessed how changes in loop ...diuretics related to mortality risk.
Randomized clinical trials suggest that approximately one third of patients undergoing TAVI do not achieve symptom relief, but "all-comer" data are lacking.
Using Danish nationwide registries, we identified all citizens, who underwent TAVI from 2008 to 2019 and were alive at 1-year post-discharge. Loop diuretic treatment pre-TAVI and at 1-year post-TAVI were assessed and grouped as receiving 1) no-loop diuretics; 2) low: 1-40 mg of furosemide (or equivalent bumetanide) daily; 3) intermediate: 41-120 mg of furosemide daily; or 4) high: >120 mg furosemide daily.
Among the 4431 patients undergoing TAVI, 2173 (49%) patients were not treated with loop diuretics at the time of TAVI, 918 (21%) had low-loop diuretics, 881 (20%) had intermediate-loop diuretics, and 459 (10%) had high-loop diuretics. At 1-year post-TAVI, 893 (20%) patients had increased, 1010 (23%) had reduced, and 2528 (57%) had unchanged loop diuretic treatment. The cumulative 5-year risk of death in patients surviving one year, was 61% (95% CI: 56.4% to 65.3%) in patients with increased and 47% (95% CI: 44.9% to 49.9%) in patients with reduced/unchanged loop diuretic treatment, respectively. In multivariable Cox proportional hazard analysis, increased loop diuretic treatment was associated with a higher risk of death compared with reduced/unchanged loop diuretic treatment (Hazard ratio: 1.4; 95% CI: 1.22 to 1.52).
Among patients undergoing TAVI, surviving one year, one fifth of patients had increased loop diuretic treatment, and a little over one fifth had reduced loop diuretic treatment 1-year post-procedure. In patients with increased diuretic treatment, the risk of death was higher compared to those with reduced/unchanged loop diuretic treatment.
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DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
Patients who had undergone successful TAVR were randomly assigned to receive either a rivaroxaban-based antithrombotic regimen or an antiplatelet-based antithrombotic regimen. At 17 months, the ...primary outcome of death or thromboembolic complications occurred more frequently with rivaroxaban.
No published studies have compared the outcome after transcatheter aortic valve implantation (TAVI) with the outcome in the general population. Thus, it is unknown whether TAVI restores normal life ...expectancy and stroke risk. Furthermore, despite the increasing use of TAVI, only little is known about the temporal trends for TAVI regarding patient characteristics and outcomes. We identified all Danish patients treated with TAVI from 2006 to 2014 (n = 1,631) and 9,737 general population controls matched by gender, age, and co-morbidity. The primary end point was a composite end point of all-cause mortality and stroke. During the first 90 days, the risk of the combined end point, the stroke risk, and mortality were significantly higher among TAVI patients compared with controls (9.4%, 7.5%, and 2.5%, respectively, in TAVI patients compared with 2.0%, 1.6%, and 0.5% in controls). After 90 days, there were no differences (adjusted mortality rate ratio, stroke rate ratio, and mortality or stroke rate ratio 0.92 0.79 to 1.06, 1.32 0.98 to 1.78, and 1.00 0.90 to 1.10, respectively). During the study period, there were small changes in the characteristics of patients treated with TAVI; however, more patients were treated by transfemoral access; fewer needed blood transfusions, hospital stays were shorter, and the overall mortality rate decreased. In conclusion, 90 days after TAVI, the stroke risk and mortality of the TAVI patients were comparable with the stroke risk and mortality of the general population. Over time, the patient risk profiles have remained largely unchanged; however, outcomes have improved substantially, including lower short- and long-term mortality.
Summary Background Subclinical leaflet thrombosis of bioprosthetic aortic valves after transcatheter valve replacement (TAVR) and surgical aortic valve replacement (SAVR) has been found with CT ...imaging. The objective of this study was to report the prevalence of subclinical leaflet thrombosis in surgical and transcatheter aortic valves and the effect of novel oral anticoagulants (NOACs) on the subclinical leaflet thrombosis and subsequent valve haemodynamics and clinical outcomes on the basis of two registries of patients who had CT imaging done after TAVR or SAVR. Methods Patients enrolled between Dec 22, 2014, and Jan 18, 2017, in the RESOLVE registry, and between June 2, 2014, and Sept 28, 2016, in the SAVORY registry, had CT imaging done with a dedicated four-dimensional volume-rendered imaging protocol at varying intervals after TAVR and SAVR. We defined subclinical leaflet thrombosis as the presence of reduced leaflet motion, along with corresponding hypoattenuating lesions shown with CT. We collected data for baseline demographics, antithrombotic therapy, and clinical outcomes. We analysed all CT scans, echocardiograms, and neurological events in a masked fashion. Findings Of the 931 patients who had CT imaging done (657 71% in the RESOLVE registry and 274 29% in the SAVORY registry), 890 96% had interpretable CT scans (626 70% in the RESOLVE registry and 264 30% in the SAVORY registry). 106 (12%) of 890 patients had subclinical leaflet thrombosis, including five (4%) of 138 with thrombosis of surgical valves versus 101 (13%) of 752 with thrombosis of transcatheter valves (p=0·001). The median time from aortic valve replacement to CT for the entire cohort was 83 days (IQR 33–281). Subclinical leaflet thrombosis was less frequent among patients receiving anticoagulants (eight 4% of 224) than among those receiving dual antiplatelet therapy (31 15% of 208; p<0·0001); NOACs were equally as effective as warfarin (three 3% of 107 vs five 4% of 117; p=0·72). Subclinical leaflet thrombosis resolved in 36 (100%) of 36 patients (warfarin 24 67%; NOACs 12 33%) receiving anticoagulants, whereas it persisted in 20 (91%) of 22 patients not receiving anticoagulants (p<0·0001). A greater proportion of patients with subclinical leaflet thrombosis had aortic valve gradients of more than 20 mm Hg and increases in aortic valve gradients of more than 10 mm Hg (12 14% of 88) than did those with normal leaflet motion (seven 1% of 632; p<0·0001). Although stroke rates were not different between those with (4·12 strokes per 100 person-years) or without (1·92 strokes per 100 person-years) reduced leaflet motion (p=0·10), subclinical leaflet thrombosis was associated with increased rates of transient ischaemic attacks (TIAs; 4·18 TIAs per 100 person-years vs 0·60 TIAs per 100 person-years; p=0·0005) and all strokes or TIAs (7·85 vs 2·36 per 100 person-years; p=0·001). Interpretation Subclinical leaflet thrombosis occurred frequently in bioprosthetic aortic valves, more commonly in transcatheter than in surgical valves. Anticoagulation (both NOACs and warfarin), but not dual antiplatelet therapy, was effective in prevention or treatment of subclinical leaflet thrombosis. Subclinical leaflet thrombosis was associated with increased rates of TIAs and strokes or TIAs. Despite excellent outcomes after TAVR with the new-generation valves, prevention and treatment of subclinical leaflet thrombosis might offer a potential opportunity for further improvement in valve haemodynamics and clinical outcomes. Funding RESOLVE (Cedars-Sinai Heart Institute) and SAVORY (Rigshospitalet).
Patients undergoing surgical aortic valve replacement (SAVR) are considered at high risk of infective endocarditis (IE). However, data on the risk of IE following transcatheter aortic valve ...replacement (TAVR) are sparse and limited by the lack of long-term follow-up as well as a direct comparison with patients undergoing SAVR.
This study sought to investigate the long-term incidence of IE in patients undergoing TAVR and to compare the long-term risk of IE with patients undergoing isolated SAVR.
In this nationwide observational cohort study, all patients undergoing TAVR and isolated SAVR from January 1, 2008, to December 31, 2016, with no history of IE and alive at discharge were identified using data from Danish nationwide registries.
A total of 2,632 patients undergoing TAVR and 3,777 patients undergoing isolated SAVR were identified. During a mean follow-up of 3.6 years, 115 patients (4.4%) with TAVR and 186 patients (4.9%) with SAVR were admitted with IE. The median time from procedure to IE hospitalization was 352 days (25th to 75th percentile: 133 to 778 days) in the TAVR group and 625 days (25th to 75th percentile: 209 to 1,385 days) in the SAVR group. The crude incidence rates of IE were 1.6 (95% confidence interval CI: 1.4 to 1.9) and 1.2 (95% CI: 1.0 to 1.4) events per 100 person-years in TAVR and SAVR patients, respectively. The cumulative 1-year risk of IE was 2.3% (95% CI: 1.8% to 2.9%) and 1.8% (95% CI: 1.4% to 2.3%) in TAVR and SAVR patients, respectively. Correspondingly, the cumulative 5-year risk of IE was 5.8% (95% CI: 4.7% to 7.0%) and 5.1% (95% CI: 4.4% to 6.0%), respectively. In multivariable Cox proportional hazard analysis, TAVR was not associated with a statistically significant different risk of IE compared with SAVR (hazard ratio: 1.12; 95% CI: 0.84 to 1.49).
The 5-year incidence of IE following TAVR was 5.8% and not significantly different than the incidence following SAVR.
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Vascular access complications (VACs) remain one of the biggest challenges when performing transcatheter aortic valve implantation (TAVI). This study aimed to investigate the short- and medium-term ...safety and efficacy of the Viabahn endoprosthesis (Gore, Flagstaff, AZ) when used to treat TAVI-induced vascular injury. Over a 40-month period, 354 patients underwent true percutaneous transfemoral (TF)-TAVI using a CoreValve and Prostar-XL closure system; this was our study population. A VAC leading to acute intervention occurred in 72 patients (20.3%) - of these, 18 were managed by balloon angioplasty, 48 were treated by Viabahn stenting (technical success rate 98%), and 6 needed surgical intervention. Overall, this approach resulted in a major VAC rate of 3.1% (n = 11) in our study cohort. Length of hospitalization and 30-day mortality rates were comparable in patients with a VAC treated by Viabahn stenting versus patients without vascular complications. Two patients (4.5%) presented with new-onset claudication; one of them had the stent implanted covering the deep femoral artery (DFA). At medium-term follow-up (median 372 days; range 55 to 978 days) duplex ultrasound showed 100% patency of the Viabahn endoprostheses with no signs of stent fracture or in-stent stenosis/occlusion. In conclusion, the use of self-expanding covered stents is safe and effective in case of TF-TAVI–induced vascular injury, with good short- and medium-term outcomes. Importantly, coverage of the DFA should be avoided. If confirmed by long-term (>5 years) follow-up studies, this strategy for treating TAVI-induced VAC may be used routinely in high-risk patients.
Delayed coronary obstruction (DCO) is an uncommon and barely reported complication following transcatheter aortic valve replacement (TAVR).
The aim of this study was to describe the incidence and ...pathophysiological features of DCO after TAVR, obtained from a large international multicenter registry.
Data were retrospectively collected from an international multicenter registry consisting of 18 centers between November 2005 and December 2016.
During the study period, 38 DCO (incidence 0.22%) cases were identified from a total of 17,092 TAVR procedures. DCO occurred more commonly after valve-in-valve procedures (0.89% vs. 0.18%; p < 0.001) and if self-expandable valves were used during the index procedure (0.36% vs. 0.11% balloon expandable; p < 0.01). DCO was most likely to occur ≤24 h after the TAVR procedure (47.4%; n = 18); 6 (15.8%) cases occurred between 24 h and ≤7 days, with the remaining 14 (36.8%) at ≥60 days. The most frequent presentation was cardiac arrest (31.6%; n = 12), followed by ST-segment elevation myocardial infarction (23.7%; n = 9). The left coronary artery was obstructed in most cases (92.1%; n = 35). Percutaneous coronary intervention was attempted in the majority of cases (74.3% left main; 60% right coronary), and stent implantation was successful in 68.8%. The overall in-hospital death rate was 50% (n = 19), and was higher if DCO occurred ≤7 days from the index procedure (62.5% vs. 28.6%; p = 0.09).
DCO following TAVR is a rare phenomenon that is associated with a high in-hospital mortality rate. Clinicians should be aware that coronary obstruction can occur after the original TAVR procedure and have a low threshold for performing coronary angiography when clinically suspected.
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Background ACURATE
is a transcatheter aortic valve implantation system consisting of a self-expanding bioprosthetic valve with supra-annular leaflet position and featuring innovations to facilitate ...placement accuracy and reduce paravalvular regurgitation. Methods and Results The goal of the Early neo2 (Early neo2 Registry of the ACURATE neo2 TAVI Prosthesis) was to gather real-life data on safety and efficacy in a European transcatheter aortic valve implantation population treated with ACURATE
. Data were collected from 554 consecutive patients treated with ACURATE
at 12 European sites (mean age, 82 years; 66% women; mean European System for Cardiac Operative Risk Evaluation II, 4.5%±3.8%) between September 2020 and March 2021. The composite primary end point was the occurrence of any of the following: postoperative (in-hospital) paravalvular regurgitation grade ≥2, in-hospital acute kidney injury stage 3, postoperative pacemaker implantation, 30-day death, and 30-day stroke. The primary end point occurred in 12.6% of patients. The 30-day rates for all-cause death and all stroke were 1.3% and 2.7%, respectively, and 1.5% of patients exhibited stage 3 acute kidney injury. A total of 34 patients (6.2%) received a postoperative permanent pacemaker. Per core laboratory-adjudicated echocardiographic analysis, mean postoperative aortic valve gradient was 7.6±3.3 mm Hg, and 2.8% of patients exhibited paravalvular regurgitation grade ≥2. Conclusions In this report of postmarket use of the ACURATE
valve in a real-world transcatheter aortic valve implantation population, patients exhibited favorable postoperative hemodynamics and clinical outcomes and a low rate of postoperative pacemaker implantation.
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