Routine revascularization with percutaneous coronary intervention in patients with coronary artery disease undergoing transcatheter aortic valve implantation - the third nordic aortic valve intervention trial - NOTION-3.

BACKGROUND: Coronary artery disease (CAD) frequently coexists with severe aortic valve stenosis (AS) in patients planned for transcatheter aortic valve implantation (TAVI). How to manage CAD in this patient population is still an unresolved question. In particular, it is still not known whether fractional flow reserve (FFR) guided revascularization with percutaneous coronary intervention (PCI) is superior to medical treatment for CAD in terms of clinical outcomes. STUDY DESIGN: The third Nordic Aortic Valve Intervention (NOTION-3) Trial is an open-label investigator-initiated, multicenter multinational trial planned to randomize 452 patients with severe AS and significant CAD to either FFR-guided PCI or medical treatment, in addition to TAVI. Patients are eligible for the study in the presence of at least 1 significant PCI-eligible coronary stenosis. A significant stenosis is defined as either FFR ≤0.80 and/or diameter stenosis >90%. The primary end point is a composite of first occurring all-cause mortality, myocardial infarction, or urgent revascularization (PCI or coronary artery bypass graft performed during unplanned hospital admission) until the last included patient have been followed for 1 year after the TAVI. SUMMARY: NOTION-3 is a multicenter, multinational randomized trial aiming at comparing FFR-guided revascularization vs medical treatment of CAD in patients with severe AS planned for TAVI.

HEART-score can be simplified without loss of discriminatory power in patients with chest pain - Introducing the HET-score.

BACKGROUND: The History, Electrocardiogram (ECG), Age, Risk factors and Troponin, (HEART) score is useful for early risk stratification in chest pain patients. The aim was to validate previous findings that a simplified score using history, ECG and troponin (HET-score) has similar ability to stratify risk. METHODS: Patients presenting with chest pain with duration of ≥10 min and an onset of last episode ≤12 h but without ST-segment elevation on ECG at 6 emergency departments were eligible for inclusion. The HEART-score and the simplified HET-score were calculated. The endpoint was a composite of myocardial infarction (MI) as index diagnosis, readmission due to new MI or death within 30 days. RESULTS: HEART-score identified 32% as low risk (0-2p), 47% as intermediate risk (3-5p), and 20% as high risk (6-10p) patients. The endpoint occurred in 0.5%, 7.3% and 35.7%, respectively. HET-score identified 39%, 42% and 19% as low- (0p), intermediate- (1-2p) and high-risk (3-6p) patients, with the endpoint occurring in 0.6%, 6.2% and 43.2%, respectively. When all variables included in the HEART-score were included in a multivariable logistic regression analysis, only History (OR, CI [95%]): 2.97(2.16-4.09), ECG (1.61[1.14-2.28]) and troponin level (5.21[3.91-6.95]) were significantly associated with cardiovascular events. When HEART- and HET-score were compared in a ROC-analysis, HET-score had a significantly larger AUC (0.887 vs 0.853, p < 0.001). CONCLUSIONS: Compared with HEART-score, HET-score is simpler and appears to have similar ability to discriminate between chest pain patients with and without cardiovascular event.

Oxygen Therapy in Suspected Acute Myocardial Infarction.

BACKGROUND: The clinical effect of routine oxygen therapy in patients with suspected acute myocardial infarction who do not have hypoxemia at baseline is uncertain. METHODS: In this registry-based randomized clinical trial, we used nationwide Swedish registries for patient enrollment and data collection. Patients with suspected myocardial infarction and an oxygen saturation of 90% or higher were randomly assigned to receive either supplemental oxygen (6 liters per minute for 6 to 12 hours, delivered through an open face mask) or ambient air. RESULTS: A total of 6629 patients were enrolled. The median duration of oxygen therapy was 11.6 hours, and the median oxygen saturation at the end of the treatment period was 99% among patients assigned to oxygen and 97% among patients assigned to ambient air. Hypoxemia developed in 62 patients (1.9%) in the oxygen group, as compared with 254 patients (7.7%) in the ambient-air group. The median of the highest troponin level during hospitalization was 946.5 ng per liter in the oxygen group and 983.0 ng per liter in the ambient-air group. The primary end point of death from any cause within 1 year after randomization occurred in 5.0% of patients (166 of 3311) assigned to oxygen and in 5.1% of patients (168 of 3318) assigned to ambient air (hazard ratio, 0.97; 95% confidence interval [CI], 0.79 to 1.21; P=0.80). Rehospitalization with myocardial infarction within 1 year occurred in 126 patients (3.8%) assigned to oxygen and in 111 patients (3.3%) assigned to ambient air (hazard ratio, 1.13; 95% CI, 0.88 to 1.46; P=0.33). The results were consistent across all predefined subgroups. CONCLUSIONS: Routine use of supplemental oxygen in patients with suspected myocardial infarction who did not have hypoxemia was not found to reduce 1-year all-cause mortality. (Funded by the Swedish Heart-Lung Foundation and others; DETO2X-AMI ClinicalTrials.gov number, NCT01787110 .).

Outcomes 1 year after thrombus aspiration for myocardial infarction.

BACKGROUND: Routine intracoronary thrombus aspiration before primary percutaneous coronary intervention (PCI) in patients with ST-segment elevation myocardial infarction (STEMI) has not been proved to reduce short-term mortality. We evaluated clinical outcomes at 1 year after thrombus aspiration. METHODS: We randomly assigned 7244 patients with STEMI to undergo manual thrombus aspiration followed by PCI or to undergo PCI alone, in a registry-based, randomized clinical trial. The primary end point of all-cause mortality at 30 days has been reported previously. Death from any cause at 1 year was a prespecified secondary end point of the trial. RESULTS: No patients were lost to follow-up. Death from any cause occurred in 5.3% of the patients (191 of 3621 patients) in the thrombus-aspiration group, as compared with 5.6% (202 of 3623) in the PCI-only group (hazard ratio, 0.94; 95% confidence interval [CI], 0.78 to 1.15; P=0.57). Rehospitalization for myocardial infarction at 1 year occurred in 2.7% and 2.7% of the patients, respectively (hazard ratio, 0.97; 95% CI, 0.73 to 1.28; P=0.81), and stent thrombosis in 0.7% and 0.9%, respectively (hazard ratio, 0.84; 95% CI, 0.50 to 1.40; P=0.51). The composite of death from any cause, rehospitalization for myocardial infarction, or stent thrombosis occurred in 8.0% and 8.5% of the patients, respectively (hazard ratio, 0.94; 95% CI, 0.80 to 1.11; P=0.48). The results were consistent across all the major subgroups, including grade of thrombus burden and coronary flow before PCI. CONCLUSIONS: Routine thrombus aspiration before PCI in patients with STEMI did not reduce the rate of death from any cause or the composite of death from any cause, rehospitalization for myocardial infarction, or stent thrombosis at 1 year. (Funded by the Swedish Research Council and others; TASTE ClinicalTrials.gov number, NCT01093404.).

Mind the Gap in TAVR: Recognizing and Managing Misloaded Self-Expanding TAVR Devices.

Misloading during transcatheter aortic valve replacement (TAVR) is rare but can cause unpredictable valve release if unrecognized. We describe how to identify a misloaded ACURATE neo2 device, and 3 methods to solve this by using a modified technique of valve deployment, ipsilateral extraction, and contralateral valve externalization with extracorporeal valve release.

Implementation of an extracorporeal resuscitation (ECPR) program for out-of-hospital cardiac arrest in Stockholm, Sweden: Feasibility, safety, and outcome.

Background: The aim of this study was to evaluate the implementation of a novel extra corporeal cardiopulmonary (ECPR) program in the greater Stockholm area with focus on feasibility, safety aspects and clinical outcomes. Methods: Prospective observational study of ECPR program including patients with OHCA from January 2020 to December 2022, fulfilling ECPR criteria: age 18-65 years, initial shockable rhythm or pulseless electrical activity, witnessed arrest, bystander cardiopulmonary resuscitation and refractory arrest after three cycles of advance cardiac life support. The predefined time threshold from collapse to extracorporeal membrane oxygenation (ECMO) initiation was set at 60 min. Results: We included 95 patients. Of these, 22/95 (23%) had return of spontaneous circulation before ECMO initiation, 39/95 (41%) were excluded for ECMO and 34/95 (36%) had ECMO initiated out of which 23 patients were admitted alive to the ICU. ECMO-initiation within 60 min was met in 9%. In 6 patients vascular access was complicated, 2 patients had severe bleeding at access site requiring intervention. Survival to discharge among all cases was 25% (24/95). Among patients admitted to ICU on ECMO 39% (9/23) survived to discharge, of these 78% had cerebral performance category scale score 1-2 within 12 months. 8 out of 9 survivors had time from OHCA to ECMO-initiation >60 min. Conclusion: The implementation of an ECPR protocol was feasible without any major, unexpected safety aspects but did not meet the intended target time intervals. Despite this, survival rates were similar to previous studies although most survivors had >60 min to ECMO-initiation.

[More coronary computed tomography angiographies and less exercise electrocardiograms in patients under investigation for coronary artery disease?] / DT kranskärl bör användas oftare vid misstänkt kranskärlssjukdom.

Chronic coronary syndrome is a clinical diagnosis based on medical history and risk factors. To confirm diagnosis, an anatomical or functional assessment is recommended. Selection of diagnostic test is guided by clinical likelihood, patient characteristics, local expertise and availability. If the likelihood is low to intermediate, coronary computed tomography angiography (CCTA) is recommended; if intermediate to high, a functional non-invasive test, such as stress echocardiography, is recommended. As compared with other non-invasive diagnostic tests, exercise electrocardiogram has the lowest sensitivity and is only recommended when other imaging diagnostic tests are unavailable. The availability of CCTA is unequal and inadequate in most parts of Sweden. Efforts to increase the availability are called for.

BASILICA Procedure Prior to Valve-in-Valve TAVR in a Supra-Annular TAV Prosthesis.

An 80-year-old man with a supra-annular transcatheter aortic valve (TAV) prosthesis presented with severe transvalvular aortic regurgitation 18 months after the TAV replacement procedure. The authors report the first ever valve-in-valve procedure using BASILICA (bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction) in such a supra-annular TAV prosthesis. Minimal paravalvular leakage, normal coronary artery flow, and easy coronary access were seen postimplantation. (Level of Difficulty: Advanced.).

Reducing cardiac tamponade caused by temporary pacemaker perforation in transcatheter aortic valve replacement.

BACKGROUND: Cardiac tamponade caused by temporary right ventricular (RV) pacemaker perforation is a rare but serious complication in transcatheter aortic valve replacement (TAVR). AIMS: To study the incidence of temporary pacemaker related cardiac tamponade in TAVR, and the relation to the type of pacemaker lead used in periprocedural temporary transvenous pacing. METHODS: A single center registry of transfemoral TAVRs in 2014-2020. Main inclusion criterion was peri-operative use of a temporary RV pacing lead. Main exclusion criteria were a preoperatively implanted permanent pacemaker or the exclusive use of left ventricular guidewire pacing. Incident cardiac tamponade was classified as pacemaker lead related, or other. Patients were grouped according to type of temporary RV pacing wire. RESULTS: 810 patients were included (age 80.5 ± 7.3 [mean ± standard deviation], female 319, 39.4%). Of these, 566 (69.9%) received a standard RV temporary pacing wire (RV-TPW), and 244 (30.1%) received temporary RV pacing through a permanent, passive pacemaker lead (RV-TPPL). In total, 18 (2.2%) events of cardiac tamponade occurred, 12 (67%) were pacemaker lead related. All pacemaker lead-related cardiac tamponades occurred in the group who received a standard RV-TPW and none in the group who received RV-TPPL (n = 12 [2.1%] vs. n = 0 [0%], p = 0.022). No difference in cardiac tamponade due to other causes was seen between the groups (p = 0.82). CONCLUSIONS: The use of soft-tip RV-TPPL was associated with a lower risk of pacemaker related cardiac tamponade in TAVR. When perioperative pacing is indicated, temporary RV-TPPL may contribute to a significant reduction of cardiac tamponade in TAVR.

Commissural Alignment With ACURATE neo2 Valve in an Unselected Population.

BACKGROUND: Commissural alignment has become an important topic in transcatheter aortic valve replacement (TAVR) because it may improve coronary access, facilitate future valve procedures, and possibly improve valve durability. The efficacy of commissural alignment with ACURATE neo2 has not yet been shown in a large population. OBJECTIVES: The authors sought to determine the feasibility and success of attempting commissural alignment in an unselected TAVR population treated with the ACURATE neo2 prosthetic heart valve. METHODS: A total of 170 consecutive patients underwent TAVR with a dedicated implantation technique to align the TAVR valve to the native valve. Using right-left overlap and 3-cusp views, valve orientation was adjusted by rotation of the unexpanded valve at the level of the aortic root. Effectiveness was assessed postprocedure as the degree of misalignment determined by analyzing fluoroscopic valve orientation to corresponding cusp orientation on preprocedural computed tomography. Safety endpoints included mortality, stroke/transient ischemic attack, and additional complications through 30 days. RESULTS: Of 170 patients, 167 (98.2%) could be analyzed for alignment, and all 170, for safety outcomes. Most patients (97%) had successful alignment (≤ mild misalignment), with 80% with commissural alignment, while the degrees of misalignment were 17% mild, 1.2% moderate, 1.8% severe. CONCLUSIONS: In this large evaluation of a commissural alignment technique, alignment was achieved in nearly all patients without safety concerns or impact to procedure duration. Commissural alignment appears effective and safe across all patients with this novel technique.

Percutaneous plug-based vascular closure device in 1000 consecutive transfemoral transcatheter aortic valve implantations.

BACKGROUND: Arterial access-site related complications constitute a large proportion of adverse events related to cardiac interventions requiring large-bore devices and have significant implications on morbidity, mortality and hospital cost. AIMS: To evaluate the safety and effectiveness of a novel percutaneous plug-based vascular closure device (VCD) in 1000 consecutive patients undergoing transfemoral transcatheter aortic valve implantation (TAVI). METHODS: A single-center observational study evaluating a plug-based VCD (MANTA, Teleflex/Essential Medical Inc., Malvern, Pennsylvania, USA) in patients undergoing TAVI at the Karolinska University Hospital, Stockholm, Sweden. The primary outcome was VCD-related major vascular complication according to the criteria of the Valve Academic Research Consortium (VARC)-2. RESULTS: From May 2017 to September 2020 a total of 1000 consecutive patients underwent transfemoral TAVI with arterial access-site management using the MANTA VCD. VARC-2 major vascular complications occurred in 42 (4.2%) patients: 17 (1.7%) patients intraoperatively received a covered stent, 17 (1.7%) patients underwent surgical repair during hospital stay, 3 (0.3%) patients underwent vascular surgery after discharge, 3 (0.3%) patients had major bleeding and 2 (0.2%) patients had symptoms of claudication with conservative treatment. No significant differences in major complications were seen between individual interventionists irrespective of experience with the device. A larger sheath outer diameter to femoral artery inner diameter ratio was the only factor associated with a significant increase of VCD-related major vascular complications. CONCLUSION: This largest ever real-world evaluation of MANTA for large-bore arteriotomy closure in transfemoral TAVI patients indicates effective and safe arterial access-site management with low complication rates and short learning curve. CLINICAL TRIAL REGISTRATION: http://www. CLINICALTRIALS: gov. Unique identifier: NCT04392492.

Transcatheter aortic valve replacement using the iSleeve expandable sheath in small femoral arteries.

BACKGROUND: Small femoral arteries have been associated with a higher risk of vascular complications in transfemoral transcatheter aortic valve replacement (TAVR). We investigated the feasibility and safety of TAVR in patients with small femoral arteries. METHODS: In this observational study, we included 82 patients who underwent transfemoral TAVR with the ACURATE neo system using the expandable 14F iSleeve sheath between 2018 and 2019 at Karolinska University Hospital, Sweden. Of these, 41 patients had a minimal femoral artery diameter of ≥5.5 mm (mean 6.5, range 5.5-9.2), and 41 patients had a minimal femoral artery diameter <5.5 mm (mean 4.9, range 3.9-5.4). RESULTS: There was no significant difference in major vascular and bleeding complications between the small femoral artery group (7%) and the normal femoral artery group (2%) (p=0.62). The total of major and minor vascular complications did not differ significantly according to femoral artery size (17% vs 5%) (p=0.16). The iSleeve sheath was not correlated with any of the complications. The use of the iSleeve sheath was unsuccessful in four patients (5%), of which one patient had a small femoral artery diameter. CONCLUSION: Transfemoral TAVR with the ACURATE neo system using the iSleeve sheath is a promising method for patients with small femoral arteries even though we found a trend towards higher rates of complications in these patients. The use of expandable sheaths may expand the spectrum of patients that can be treated with transfemoral TAVR, and thus may improve the prognosis in patients with severe aortic valve stenosis.

Transradial simultaneous kissing stenting (SKS) with SheathLess access.

Transradial coronary intervention is usually performed via a 5 or 6 Fr sheath due to the small calibre of radial arteries. Simultaneous kissing stenting (SKS) technique requires a guiding catheter 7 Fr or larger and is therefore difficult to perform via transradial approach. Conversion to femoral approach or additional arterial access is usually required to achieve this goal. To overcome this limitation, a hydrophilic 7.5 Fr SheathLess guiding catheter can be exploited. This catheter possesses approximately the same size outer diameter as a 6 Fr sheath and an internal diameter of a 7.5 Fr catheter. A smooth and successful performance of SKS through transradial approach is described using this catheter.

Is rheumatoid arthritis a risk factor for acute coronary syndrome also among individuals at elevated risk, such as individuals presenting with acute chest pain?

BACKGROUND: Patients with rheumatoid arthritis (RA) are, on average, at increased risk of acute coronary syndrome (ACS) compared to the general population, but it remains unknown whether RA remains an ACS risk factor also in settings where the ACS risk is already high elevated, such as among individuals presenting to the emergency department (ED) with chest pain. METHODS AND RESULTS: We included 49 283 individuals (514 (1.0%) had RA) presenting with chest pain at the four hospital EDs in Stockholm, Sweden, 2013-2016 in a cohort study. Information on exposure (RA), outcome (ACS) and comorbidities was provided through national registers. The association between RA and ACS was assessed, overall and by levels of high-sensitivity cardiac troponin T (hs-cTnT) and number of ACS risk factors, using logistic regression models adjusted for age, sex, hospital, calendar year and cardiovascular risk factors. ACS was more common in patients with (8.2%) than without (4.6%) RA, adjusted OR =1.4, 95% CI 1.0 to 2.0. This association was particularly strong in individuals with initial hs-cTnT levels between 5 and 14 ng/L, or no additional ACS risk factors (adjusted ORs above 2), but no longer detectable in those with hs-cTnT >14 ng/L or with three or more additional ACS risk factors. CONCLUSION: RA is a risk factor for ACS also among patients at the ED with chest pain. This association is not explained by traditional ACS risk factors, and most pronounced in patients with normal hs-cTnT and few other ACS risk factors, prompting particular ACS vigilance in this RA patient group.

Family history of coronary artery disease is associated with acute coronary syndrome in 28,188 chest pain patients.

BACKGROUND: The value of family history of coronary artery disease (CAD) in diagnosing acute coronary syndrome (ACS) in chest pain patients is uncertain, especially in relation to high-sensitivity assays for cardiac troponin T (hs-cTnT), which have improved ACS diagnostics. Our objective was to investigate the association between verified family history of CAD and ACS in chest pain patients, overall and in different strata of initial hs-cTnT. METHODS: Data on chest pain patients visiting four emergency departments in Sweden during 2013-2016 were cross-referenced with national registers of kinship, diseases and prescriptions. Family history of early CAD was defined as the occurrence of myocardial infarction or coronary revascularization before the age of 55 years in male and 65 years in female first-degree relatives. The outcome was combined including ACS and cardiovascular death within 30 days of presentation. RESULTS: Of 28,188 patients, 4.7% of patients had ACS. In total, 8.2% and 32.4% had a family history of early and ever-occurring CAD, respectively. Family history of CAD was positively associated with the outcome, independently of age, gender, cardiovascular risk factors and electrocardiogram findings. The strongest association was observed for family history of early CAD (odds ratio 1.62, 95% confidence interval 1.35-1.94). Stronger associations were observed in young patients (e.g. <65 years) and in patients with non-elevated initial hs-cTnT levels (p-value for interaction = 0.004 and 0.001, respectively). CONCLUSIONS: Family history of CAD is associated with ACS in chest pain patients, especially in patients of young age or with non-elevated initial hs-cTnT levels.

Radial artery access is associated with lower mortality in patients undergoing primary PCI: a report from the SWEDEHEART registry.

OBJECTIVES: The purpose of this observational study was to evaluate the effects of radial artery access versus femoral artery access on the risk of 30-day mortality, inhospital bleeding and cardiogenic shock in patients with ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention. METHODS: We used data from the SWEDEHEART registry and included all patients who were treated with primary percutaneous coronary intervention in Sweden between 2005 and 2016. We compared patients who had percutaneous coronary intervention by radial access versus femoral access with regard to the primary endpoint of all-cause death within 30 days, using a multilevel propensity score adjusted logistic regression which included hospital as a random effect. RESULTS: During the study period, 44,804 patients underwent primary percutaneous coronary intervention of whom 24,299 (54.2%) had radial access and 20,505 (45.8%) femoral access. There were 2487 (5.5%) deaths within 30 days, of which 920 (3.8%) occurred in the radial access and 1567 (7.6%) in the femoral access group. After propensity score adjustment, radial access was associated with a lower risk of death (adjusted odds ratio (OR) 0.70, 95% confidence interval (CI) 0.55-0.88, P = 0.025). We found no interaction between access site and age, gender and cardiogenic shock regarding 30-day mortality. Radial access was also associated with a lower adjusted risk of bleeding (adjusted OR 0.45, 95% CI 0.25-0.79, P = 0.006) and cardiogenic shock (adjusted OR 0.41, 95% CI 0.24-0.73, P = 0.002). CONCLUSIONS: In patients with ST-elevation myocardial infarction, primary percutaneous coronary intervention by radial access rather than femoral access was associated with an adjusted lower risk of death, bleeding and cardiogenic shock. Our findings are consistent with, and add external validity to, recent randomised trials.

Survival of Patients With Angina Pectoris Undergoing Percutaneous Coronary Intervention With Intracoronary Pressure Wire Guidance.

BACKGROUND: Intracoronary pressure wire measurement of fractional flow reserve (FFR) provides decision-making guidance during percutaneous coronary intervention (PCI). However, limited data exist on the effect of FFR on long-term clinical outcomes in patients with stable angina pectoris. OBJECTIVES: The purpose of this study was to determine the association between the usage of FFR and all-cause mortality in patients with stable angina undergoing PCI. METHODS: Data was used from the SCAAR (Swedish Coronary Angiography and Angioplasty Registry) on all patients undergoing PCI (with or without FFR guidance) for stable angina pectoris in Sweden between January 2005 and March 2016. The primary endpoint was all-cause mortality, and the secondary endpoints were stent thrombosis (ST) or restenosis and peri-procedural complications. The primary model was multilevel Cox proportional hazards regression adjusted with Kernel-based propensity score matching. RESULTS: In total, 23,860 patients underwent PCI for stable angina pectoris; of these, FFR guidance was used in 3,367. After a median follow-up of 4.7 years (range 0 to 11.2 years), the FFR group had lower adjusted risk estimates for all-cause mortality (hazard ratio: 0.81; 95% confidence interval [CI]: 0.73 to 0.89; p < 0.001), and ST and restenosis (hazard ratio: 0.74; 95% CI: 0.57 to 0.96; p = 0.022). The number of peri-procedural complications did not differ between the groups (adjusted odds ratio: 0.96; 95% CI: 0.77 to 1.19; p = 0.697). CONCLUSIONS: In this observational study, the use of FFR was associated with a lower risk of long-term mortality, ST, and restenosis in patients undergoing PCI for stable angina pectoris. This study supports the current European and American guidelines for the use of FFR during PCI and shows that intracoronary pressure wire guidance confers prognostic benefit in patients with stable angina pectoris.

Radial versus femoral access in patients with acute coronary syndrome undergoing invasive management: A prespecified subgroup analysis from VALIDATE-SWEDEHEART.

AIMS: In the Bivalirudin versus Heparin in ST-Segment and Non-ST-Segment Elevation Myocardial Infarction in Patients on Modern Antiplatelet Therapy in the Swedish Web System for Enhancement and Development of Evidence-based Care in Heart Disease Evaluated according to Recommended Therapies Registry Trial (VALIDATE-SWEDEHEART), bivalirudin was not superior to unfractionated heparin in patients with acute coronary syndrome undergoing invasive management. We assessed whether the access site had an impact on the primary endpoint of death, myocardial infarction or major bleeding at 180 days and whether it interacted with bivalirudin/unfractionated heparin. METHODS AND RESULTS: A total of 6006 patients with acute coronary syndrome planned for percutaneous coronary intervention were randomised to either bivalirudin or unfractionated heparin. Arterial access was left to the operator discretion. Overall, 90.5% of patients underwent transradial access and 9.5% transfemoral access. Baseline risk was higher in transfemoral access. The unadjusted hazard ratio for the primary outcome was lower with transradial access (hazard ratio 0.53, 95% confidence interval 0.43-0.67, p<0.001) and remained lower after multivariable adjustment (hazard ratio 0.56, 95% confidence interval 0.52-0.84, p<0.001). Transradial access was associated with lower risk of death (hazard ratio 0.41, 95% confidence interval 0.28-0.60, p<0.001) and major bleeding (hazard ratio 0.57, 95% confidence interval 0.44-0.75, p<0.001). There was no interaction between treatment with bivalirudin and access site for the primary endpoint (p=0.976) or major bleeding (p=0.801). CONCLUSIONS: Transradial access was associated with lower risk of death, myocardial infarction or major bleeding at 180 days. Bivalirudin was not associated with less bleeding, irrespective of access site.

Transcatheter aortic valve implantation using the ACURATE neo in bicuspid and tricuspid aortic valve stenosis: a propensity-matched analysis of a European experience.

AIMS: The aim of this study was to assess the performance of a self-expanding valve in bicuspid aortic valve (BAV) stenosis. METHODS AND RESULTS: An international registry included a total of 712 patients with aortic stenosis treated with the ACURATE neo in bicuspid (n=54; 7.5%) or tricuspid (n=658; 92.4%) anatomy. The overall mean age was 81±5.6 years. At baseline, no significant differences were found between the two groups. BAV more frequently required both predilatation (94.4% vs. 78.1%, p=0.004) and post-dilation (57.4% vs. 38.7%, p=0.007). Moderate perivalvular regurgitation was more frequently found in patients with BAV (7.4% vs. 3.18%, p=0.0001). After propensity score matching (PSM), the rate of predilation and post-dilation was confirmed to be higher in the BAV group (94.4% vs. 66.6%, p=0.001, and 57.4% vs. 37.1%, p=0.034, respectively), while the incidence of moderate perivalvular regurgitation was similar between the two groups (BAV 3.1% vs. 5.5% in tricuspid anatomy, p=0.734). In unmatched cohorts, the 30-day outcome showed a higher rate of stroke in the BAV group (7.4% vs. 1.8%, p=0.001). After adjustment for PSM quintiles, the rate of stroke resulted in being similar (odds ratioadj 1.20, 95% confidence interval [CI]: 0.81-1.76, p=0.819). The other 30-day clinical endpoints were similar between the two populations. CONCLUSIONS: This preliminary analysis shows that the use of the ACURATE neo in bicuspid aortic valves is feasible and has acceptable 30-day outcomes. Larger studies are needed to confirm our preliminary findings.