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.
Abstract Background Few studies have evaluated the clinical outcomes of transcatheter aortic valve replacement (TAVR) in patients with bicuspid aortic valve stenosis (AS). Particularly, limited data ...exist comparing the results of TAVR with new-generation devices versus early-generation devices. Objectives This study sought to evaluate the clinical outcomes of TAVR for bicuspid AS with early- and new-generation devices. Methods The Bicuspid TAVR Registry is an international multicenter study enrolling consecutive patients with bicuspid AS undergoing TAVR between April 2005 and May 2015. Results Of 301 patients, 199 patients (71.1%) were treated with early-generation devices (Sapien XT Edwards Lifesciences Corporation, Irvine, California: n = 87; CoreValve Medtronic, Minneapolis, Minnesota: n = 112) and 102 with new-generation devices (Sapien 3 Edwards Lifesciences Corporation: n = 91; Lotus Boston Scientific Corporation, Marlborough, Massachusetts: n = 11). The mean Society of Thoracic Surgeons score was 4.7 ± 5.2 without significant differences between groups (4.6 ± 5.1 vs. 4.9 ± 5.4; p = 0.57). Overall, all-cause mortality rates were 4.3% at 30 days and 14.4% at 1 year. Moderate or severe paravalvular leak was absent and significantly less frequent with new-generation compared to early-generation devices (0.0% vs. 8.5%; p = 0.002), which resulted in a higher device success rate (92.2% vs. 80.9%; p = 0.01). There were no differences between early- and new-generation devices in stroke (2.5% vs. 2.0%; p > 0.99), life-threatening bleeding (3.5% vs. 2.9%; p > 0.99), major vascular complication (4.5% vs. 2.9%; p = 0.76), stage 2 to 3 acute kidney injury (2.5% vs. 2.9%; p > 0.99), early safety endpoints (15.1% vs. 10.8%; p = 0.30), and 30-day all-cause mortality (4.5% vs. 3.9%; p > 0.99). Conclusions The clinical outcomes of TAVR in patients with bicuspid AS were favorable. New-generation devices were associated with less paravalvular leak and, hence, a higher device success rate than early-generation devices. (The Bicuspid Aortic Stenosis Following Transcatheter Aortic Valve Replacement Registry Bicuspid TAVR; NCT02394184 )
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.
Abstract Vascular access and closure remains a challenge in transcatheter aortic valve replacement (TAVR). This single-center study aimed to report the incidence, predictive factors and clinical ...outcomes of access-related vascular injury and subsequent vascular intervention. During a 30 month-period, 365 patients underwent TAVR and 333 patients (94%) were treated by true percutaneous transfemoral (TF) approach. Of this latter group, 83 patients (25%) had an access-related vascular injury that was managed by use of a covered self-expanding stent (n=49), balloon angioplasty (n=33), or by surgical intervention (n=1). In 16 patients (5%), the vascular injury was classified as a major vascular complication. Absence of a pre-procedural computed tomography angiography (CTA) of the iliofemoral arteries (OR 2.04, p=0.007) and female sex (OR 2.18, p=0.004) were independent predictors of the need for access-related vascular intervention. In addition, a high sheath/common femoral artery (CFA) ratio as measured on preoperative CTA was associated with a higher rate of post-TAVR vascular intervention. The radiation dose, iodine contrast volume, transfusion need, length of hospitalization and 30-day mortality were not significantly different between patients with versus without access-related vascular intervention. In conclusion, access-related vascular intervention in patients undergoing TF-TAVR is not uncommon. Female sex and a high sheath/CFA ratio are risk factors for access-related vascular injury, whereas pre-procedural planning with CTA of the access vessels may reduce the risk of vascular injury. Importantly, most access-related vascular injuries may be treated by percutaneous techniques with similar clinical outcomes to patients without vascular injuries.
Abstract Objectives The aim of this study was to evaluate the choice of treatment for severe aortic valve stenosis in the era of transcatheter aortic valve replacement (TAVR) in eastern Denmark. ...Background Until the early 21st century, the only therapeutic option for aortic valve stenosis was surgical aortic valve replacement (SAVR), but this has changed with the introduction of TAVR. Methods Using the East Denmark Heart Registry, the evolution of AVR over time was studied for the period 2005 to 2015. Results TAVR has since its introduction in 2007 seen steady growth, with currently more than 35% of AVR procedures - and 45% of isolated AVR procedures - being performed by transcatheter-based technology. The number of SAVR procedures remained rather stable over the study period and even saw a slight decline since 2012 - there was a marked decrease in the age at which surgical bioprostheses are considered appropriate. The age profile of TAVR patients remained unchanged over the study period, with a recent trend toward more low- and intermediate-risk patients. Currently, patients aged ≥80 years and/or with a Society of Thoracic Surgeons (STS) surgical risk score >6 are automatically referred for TAVR, and half of patients aged 70 to 80 years with an STS risk score of 4 to 6 are treated with TAVR. Conclusions The number of TAVR procedures has increased steadily in recent years, with a TAVR penetration rate of 35% in 2015 and close to 45% when considering isolated AVR. The number of SAVR procedures remained stable over the study period, and surgical bioprostheses are currently used at a much younger age than in 2005.
Previous studies have shown a poor correlation between angiographic assessment of stenosis grade (%) and its functional assessment by fractional flow reserve (FFR). This study aimed to investigate ...whether a more comprehensive evaluation of the coronary angiogram may contribute to a better identification of flow-limiting stenoses. Coronary angiograms of 1,350 patients (1,883 lesions) were retrospectively analyzed for stenosis grade (eyeballing, %) and matched with FFR values. Angiography-derived optimal cut-off values and intervals delineating the 90% sensitivity–90% specificity range were 50.8% 42.5–65.0% for the left main (LM), 62.2% 50.0–72.5% for the proximal (prox)/mid left anterior descending (LAD) artery, 66.3% 57.5–77.5% for the prox/mid right coronary artery (RCA), 70.5% 60.0–80.0% for the prox left circumflex/first obtuse marginal (LCX/OM1), and 71.4% 62.5–82.5% for the more distal segments. In patients with intermediate LAD lesions, 5 angiographic parameters were identified as independent predictors of flow limitation: (1) a 30–50% lesion prox to the lesion of interest, (2) lesion length >20 mm, (3) distal take-off of all diagonal branches ≥2 mm diameter, (4) “apical wrap” of LAD, and (5) collaterals to an occluded LCX/RCA. Based on these results, a risk score (P20-DAC2 ) for prediction of flow limitation in intermediate LAD lesions was derived. In conclusion, a comprehensive evaluation of the coronary angiogram–in which besides stenosis grade also other lesion/vessel characteristics are evaluated–can lead to a more accurate identification of functionally significant coronary stenoses.
Myocardial Damage in Patients With Deferred Stenting After STEMI Lønborg, Jacob, MD, PhD, DMSc; Engstrøm, Thomas, MD, PhD, DMSc; Ahtarovski, Kiril Aleksov, MD, PhD ...
Journal of the American College of Cardiology,
06/2017, Letnik:
69, Številka:
23
Journal Article
Recenzirano
Odprti dostop
Abstract Background Although some studies found improved coronary flow and myocardial salvage when stent implantation was deferred, the DANAMI-3–DEFER (Third DANish Study of Optimal Acute Treatment ...of Patients With ST-elevation Myocardial Infarction) did not show any improvement in clinical outcome in patients with ST-segment elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention (PCI) and deferred stenting. Objectives This study sought to evaluate the effect of deferred stent implantation on infarct size, myocardial salvage, and microvascular obstruction (MVO) in patients with STEMI. Methods In the present DANAMI-3 substudy, a total of 510 patients with STEMI were randomized to PCI with deferred versus immediate stent implantation. The patients underwent a cardiac magnetic resonance examination before discharge after the index procedure and again 3 months later. The primary endpoint was final infarct size. Results Deferred stenting did not reduce final infarct size (9% left ventricle LV; interquartile range IQR: 3% to 18% vs. 10% LV; IQR: 3% to 18%; p = 0.67). Similarly, deferred stenting was not associated with myocardial salvage index (66%; IQR: 50% to 89% vs. 67%; IQR: 49% to 88%; p = 0.80) or presence of MVO (43% vs. 42%; p = 0.78). In a post hoc analysis, stent length was the only subgroup of 7 that had an effect on outcome. In patients with a stent length ≥24 mm, deferred stenting reduced the final infarct size (6% LV; IQR: 2% to 18% vs. 13% LV; IQR: 7% to 23%; p = 0.006; and p for interaction = 0.005). Conclusions In the DANAMI-3–DEFER cardiac magnetic resonance substudy, routine deferred stenting did not reduce infarct size or MVO and did not increase myocardial salvage. These results do not support the use of routine deferred stenting in STEMI patients treated with primary PCI. (DANish Study of Optimal Acute Treatment of Patients With ST-elevation Myocardial Infarction DANAMI-3; NCT01435408 )
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