Effect of Transcatheter Aortic Valve Implantation vs Surgical Aortic Valve Replacement on All-Cause Mortality in Patients With Aortic Stenosis: A Randomized Clinical Trial.

Importance: Transcatheter aortic valve implantation (TAVI) is a less invasive alternative to surgical aortic valve replacement and is the treatment of choice for patients at high operative risk. The role of TAVI in patients at lower risk is unclear. Objective: To determine whether TAVI is noninferior to surgery in patients at moderately increased operative risk. Design, Setting, and Participants: In this randomized clinical trial conducted at 34 UK centers, 913 patients aged 70 years or older with severe, symptomatic aortic stenosis and moderately increased operative risk due to age or comorbidity were enrolled between April 2014 and April 2018 and followed up through April 2019. Interventions: TAVI using any valve with a CE mark (indicating conformity of the valve with all legal and safety requirements for sale throughout the European Economic Area) and any access route (n = 458) or surgical aortic valve replacement (surgery; n = 455). Main Outcomes and Measures: The primary outcome was all-cause mortality at 1 year. The primary hypothesis was that TAVI was noninferior to surgery, with a noninferiority margin of 5% for the upper limit of the 1-sided 97.5% CI for the absolute between-group difference in mortality. There were 36 secondary outcomes (30 reported herein), including duration of hospital stay, major bleeding events, vascular complications, conduction disturbance requiring pacemaker implantation, and aortic regurgitation. Results: Among 913 patients randomized (median age, 81 years [IQR, 78 to 84 years]; 424 [46%] were female; median Society of Thoracic Surgeons mortality risk score, 2.6% [IQR, 2.0% to 3.4%]), 912 (99.9%) completed follow-up and were included in the noninferiority analysis. At 1 year, there were 21 deaths (4.6%) in the TAVI group and 30 deaths (6.6%) in the surgery group, with an adjusted absolute risk difference of -2.0% (1-sided 97.5% CI, -∞ to 1.2%; P < .001 for noninferiority). Of 30 prespecified secondary outcomes reported herein, 24 showed no significant difference at 1 year. TAVI was associated with significantly shorter postprocedural hospitalization (median of 3 days [IQR, 2 to 5 days] vs 8 days [IQR, 6 to 13 days] in the surgery group). At 1 year, there were significantly fewer major bleeding events after TAVI compared with surgery (7.2% vs 20.2%, respectively; adjusted hazard ratio [HR], 0.33 [95% CI, 0.24 to 0.45]) but significantly more vascular complications (10.3% vs 2.4%; adjusted HR, 4.42 [95% CI, 2.54 to 7.71]), conduction disturbances requiring pacemaker implantation (14.2% vs 7.3%; adjusted HR, 2.05 [95% CI, 1.43 to 2.94]), and mild (38.3% vs 11.7%) or moderate (2.3% vs 0.6%) aortic regurgitation (adjusted odds ratio for mild, moderate, or severe [no instance of severe reported] aortic regurgitation combined vs none, 4.89 [95% CI, 3.08 to 7.75]). Conclusions and Relevance: Among patients aged 70 years or older with severe, symptomatic aortic stenosis and moderately increased operative risk, TAVI was noninferior to surgery with respect to all-cause mortality at 1 year. Trial Registration: isrctn.com Identifier: ISRCTN57819173.

A feasibility study of transaxillary TAVI with the lotus valve.

OBJECTIVES: To assess the feasibility of axillary transcatheter aortic valve implantation (TAVI) using the Lotus valve. BACKGROUND: TAVI is used to treat patients with severe aortic stenosis, with transfemoral (TF) access being the safest and most widely used route. In patients unsuitable for this, there are reports that the axillary artery may be safest alternative access route. The Lotus device is a fully retrievable 2nd generation transcatheter heart valve which is licensed for femoral and transaortic access. There are limited data on the suitability of this valve for axillary access. METHODS: We assessed the feasibility of transaxillary TAVI with the Lotus valve in patients unsuitable for TF TAVI. Between January and October 2016, we identified 10 patients who underwent transaxillary TAVI with the Lotus valve. This cohort was compared with 347 (85%) patients who underwent TF TAVI, 45 (11%) patients who underwent and trans-apical or direct-aortic TAVI and the total group of 16 (4%) patients who underwent axillary TAVI. RESULTS: Ten patients aged 75 years (69-83) underwent attempted TAVI with the Lotus via axillary access. Device success was 100%. In-hospital and 30-day mortality was zero. There were no neurological events, no major vascular complications and no myocardial infarctions. Four of 10 patients required a pacemaker post-TAVI. No patient was left with moderate or greater aortic regurgitation. Median length of stay was 3 days CONCLUSIONS: TAVI with the Lotus valve is feasible via the axillary artery and appears safe in our small cohort of patients.

Inadequacy of existing clinical prediction models for predicting mortality after transcatheter aortic valve implantation.

BACKGROUND: The performance of emerging transcatheter aortic valve implantation (TAVI) clinical prediction models (CPMs) in national TAVI cohorts distinct from those where they have been derived is unknown. This study aimed to investigate the performance of the German Aortic Valve, FRANCE-2, OBSERVANT and American College of Cardiology (ACC) TAVI CPMs compared with the performance of historic cardiac CPMs such as the EuroSCORE and STS-PROM, in a large national TAVI registry. METHODS: The calibration and discrimination of each CPM were analyzed in 6676 patients from the UK TAVI registry, as a whole cohort and across several subgroups. Strata included gender, diabetes status, access route, and valve type. Furthermore, the amount of agreement in risk classification between each of the considered CPMs was analyzed at an individual patient level. RESULTS: The observed 30-day mortality rate was 5.4%. In the whole cohort, the majority of CPMs over-estimated the risk of 30-day mortality, although the mean ACC score (5.2%) approximately matched the observed mortality rate. The areas under ROC curve were between 0.57 for OBSERVANT and 0.64 for ACC. Risk classification agreement was low across all models, with Fleiss's kappa values between 0.17 and 0.50. CONCLUSIONS: Although the FRANCE-2 and ACC models outperformed all other CPMs, the performance of current TAVI-CPMs was low when applied to an independent cohort of TAVI patients. Hence, TAVI specific CPMs need to be derived outside populations previously used for model derivation, either by adapting existing CPMs or developing new risk scores in large national registries.

Transcatheter aortic valve implantation in the United Kingdom: temporal trends, predictors of outcome, and 6-year follow-up: a report from the UK Transcatheter Aortic Valve Implantation (TAVI) Registry, 2007 to 2012.

BACKGROUND: We assessed trends in the performance of transcatheter aortic valve implantation in the United Kingdom from the first case in 2007 to the end of 2012. We analyzed changes in case mix, complications, outcomes to 6 years, and predictors of mortality. METHODS AND RESULTS: Annual cohorts were examined. Mortality outcomes were analyzed in the 92% of patients from England and Wales for whom independent mortality tracking was available. A total of 3980 transcatheter aortic valve implantation procedures were performed. In successive years, there was an increase in frequency of impaired left ventricular function, but there was no change in Logistic EuroSCORE. Overall 30-day mortality was 6.3%; it was highest in the first cohort (2007-2008), after which there were no further significant changes. One-year survival was 81.7%, falling to 37.3% at 6 years. Discharge by day 5 rose from 16.7% in 2007 and 2008 to 28% in 2012. The only multivariate preprocedural predictor of 30-day mortality was Logistic EuroSCORE ≥40. During long-term follow-up, multivariate predictors of mortality were preprocedural atrial fibrillation, chronic obstructive pulmonary disease, creatinine >200 µmol/L, diabetes mellitus, and coronary artery disease. The strongest independent procedural predictor of long-term mortality was periprocedural stroke (hazard ratio=3.00; P<0.0001). Nonfemoral access and postprocedural aortic regurgitation were also significant predictors of adverse outcome. CONCLUSIONS: We analyzed transcatheter aortic valve implantation in an entire country, with follow-up over 6 years. Although clinical profiles of enrolled patients remained unchanged, longer-term outcomes improved, and patients were discharged earlier. Periprocedural stroke, nonfemoral access, and postprocedural aortic regurgitation are predictors of adverse outcome, along with intrinsic patient risk factors.

Determinants and Outcomes of Stroke Following Percutaneous Coronary Intervention by Indication.

BACKGROUND AND PURPOSE: Stroke after percutaneous coronary intervention (PCI) is a serious complication, but its determinants and outcomes after PCI in different clinical settings are poorly documented. METHODS: The British Cardiovascular Intervention Society (BCIS) database was used to study 560 439 patients who underwent PCI in England and Wales between 2006 and 2013. We examined procedural-type specific determinants of ischemic and hemorrhagic stroke and the likelihood of subsequent 30-day mortality and in-hospital major adverse cardiovascular events (a composite of in-hospital mortality, myocardial infarction or reinfarction, and repeat revascularization). RESULTS: A total of 705 stroke cases were recorded (80% ischemic). Stroke after an elective PCI or PCI for acute coronary syndrome indications was associated with a higher risk of adverse outcomes compared with those without stroke; 30-day mortality and major adverse cardiovascular events outcomes in fully adjusted model were odds ratios 37.90 (21.43-67.05) and 21.05 (13.25-33.44) for elective and 5.00 (3.96-6.31) and 6.25 (5.03-7.77) for acute coronary syndrome, respectively. Comparison of odds of these outcomes between these 2 settings showed no differences; corresponding odds ratios were 1.24 (0.64-2.43) and 0.63 (0.35-1.15), respectively. CONCLUSIONS: Hemorrhagic and ischemic stroke complications are uncommon, but serious complications can occur after PCI and are independently associated with worse mortality and major adverse cardiovascular events outcomes in both the elective and acute coronary syndrome setting irrespective of stroke type. Our study provides a better understanding of the risk factors and prognosis of stroke after PCI by procedure type, allowing physicians to provide more informed advice around stroke risk after PCI and counsel patients and their families around outcomes if such neurological complications occur.

Stroke following percutaneous coronary intervention: type-specific incidence, outcomes and determinants seen by the British Cardiovascular Intervention Society 2007-12.

AIMS: This study aims to evaluate temporal changes in stroke complications and their association with mortality and MACE outcomes in a national cohort of patients undergoing percutaneous coronary interventions (PCIs) in England and Wales. METHODS AND RESULTS: A total of 426 046 patients who underwent PCI in England and Wales between 2007 and 2012 in the British Cardiovascular Intervention Society (BCIS) database were analysed. Statistical analyses were performed evaluating the rates of stroke complications according to the year of PCI and multiple logistic regressions were used to evaluate the odds of 30-day mortality and in-hospital major adverse cardiovascular events (MACE; a composite of in-hospital mortality, myocardial infarction or re-infarction, and revascularization) with stroke complications. Four hundred and thirty-six patients (0.1%) sustained an ischaemic stroke/TIA complication and 107 patients (0.03%) sustained a haemorrhagic stroke complication. Ischaemic stroke/TIA complications increased non-linearly from 0.67 (95% CI 0.47-0.87) to 1.14 (0.94-1.34) per 1000 patients between 2007 and 2012 (P = 0.006), whilst haemorrhagic stroke rates decreased non-linearly from 0.29 (0.19-0.39) to 0.15 (0.05-0.25) per 1000 patients in 2012 (P = 0.009). Following adjustment for baseline clinical and procedural demographics, ischaemic stroke was independently associated with both 30-day mortality (OR 4.92, 3.06-7.92) and in-hospital MACE (OR 3.11, 1.83-5.27). An even greater impact on prognosis was observed with haemorrhagic complications (30-day mortality: OR 13.87, 6.37-30.21), in-hospital MACE (OR 13.50, 6.30-28.92). CONCLUSIONS: Incident ischaemic stroke complications have increased over time, whilst haemorrhagic stroke complications have decreased, driven through changes in clinical, procedural, drug-treatment, and demographic factors. Both ischaemic and haemorrhagic strokes are rare but devastating complications with high 30-day mortality and in-hospital MACE rates.

Effect of access site, gender, and indication on clinical outcomes after percutaneous coronary intervention: Insights from the British Cardiovascular Intervention Society (BCIS).

BACKGROUND: Gender is a strong predictor of periprocedural major bleeding complications after percutaneous coronary intervention (PCI). The access site represents an important site of such bleeding complications, which has driven adoption of the transradial access (TRA) use during PCI, although female gender is an independent predictor of transradial PCI failure. This study sought to define gender differences in access site practice and study associations between access site choice and clinical outcomes for PCI over a 6-year period, through the analysis of the British Cardiovascular Intervention Society observational database. METHODS AND RESULTS: In-hospital major adverse cardiovascular events (a composite of in-hospital mortality and in-hospital myocardial reinfarction and target vessel revascularization), in-hospital bleeding complications, and 30-day mortality were studied based on gender and access site choice (transfemoral access, TRA) in 412,122 patients who underwent PCI between 2007 and 2012 in the United Kingdom. Use of TRA increased in both genders over time, although this lagged behind in women (21% in 2007 to 58% in 2012) compared with men (24% in 2007 to 64% in 2012). In both men and women, TRA was independently associated with a lower in-hospital major adverse cardiovascular event (odds ratio [OR] 0.82, 95% CI 0.76-0.90; OR 0.75, 95% CI 0.66-0.84), in-hospital major bleeding (OR 0.54, 95% CI 0.44-0.66; OR 0.26, 95% CI 0.20-0.33), and 30-day mortality (OR 0.80, 95% CI 0.73-0.89; OR 0.82, 95% CI 0.71-0.94), respectively. CONCLUSIONS: Where possible, TRA should be considered as the preferred access site choice for PCI, particularly in women in whom the greatest reductions bleeding end points were observed across all indications.

Feasibility and efficacy of the 2.5 L and 3.8 L impella percutaneous left ventricular support device during high-risk, percutaneous coronary intervention in patients with severe aortic stenosis.

OBJECTIVE: Assessment of the feasibility and outcomes of the 2.5 L and 3.8 L Impella cardiac pump in patients with severe aortic stenosis (AS) and left ventricular impairment undergoing percutaneous revascularization (PCI) with or without balloon aortic valvuloplasty (BAV). METHODS: We reviewed the clinical and procedural findings from a consecutive series of unselected patients with severe AS who underwent PCI during Impella support. In addition, we describe novel "balloon-assist" techniques that allowed implantation of Impella into the left ventricle (LV) when initial unassisted attempts failed. RESULTS: Five patients with severe AS were identified (four males, age 78.2 years, aortic valve area (AVA) 0.6 cm(2) , left ventricular ejection fraction (LVEF) 24 ± 5%, mean Society of Thoracic Surgeons (STS) mortality 11% (range 3-17%)). The Impella catheter traversed the aortic valve (AV) unassisted in only one patient, with four cases requiring balloon-assist techniques. All patients underwent planned revascularisation; mean procedure time 177 min (range 135-252 min), mean number of stents 3.4 (range 1-8), with three patients requiring rotational atherectomy. All procedures were well tolerated, with absence of arrhythmia, hypotension, pulmonary edema, stroke, or myocardial infarction. One patient died 48 hr post-PCI of multi-organ failure. The four remaining patients were well at 30 days. CONCLUSION: Implantation of the 2.5 and 3.8 L Impella appears feasible in patients with severe AS and left ventricle (LV) impairment. A balloon-assist technique may be used to facilitate device implantation when initial unassisted attempts fail. Improved hemodynamic stability may enhance the tolerability of lengthy and complex procedures.

Impact of age on the prognostic value of left ventricular function in relation to procedural outcomes following percutaneous coronary intervention: insights from the British Cardiovascular Intervention Society.

BACKGROUND: Around one third of patients undergoing percutaneous coronary intervention (PCI) have left ventricular (LV) dysfunction. Whilst the prevalence of LV dysfunction is known to increase with age, the prevalence of LV dysfunction in different age groups in the PCI setting is not known and the effect of age on the prognostic value of LV function in the PCI setting has not been examined. METHODS: The relationship between LV function and 30-day mortality in patients undergoing PCI in different age groups (<60 years, 60 to <70 years, 70 to <80 years and ≥80 years) was studied in 246,840 patients in the UK between 2006 and 2011. RESULTS: Prevalent LV dysfunction in patients undergoing PCI increased with age; 25,106/83,161 (30.2%: <60 years), 24,114/76,895 (31.4%: 60 to <70 years), 23,580/64,711 36.4% (70 to <80 years) and 9,851/22,073 (44.6%) in patients aged 80 or over (P < 0.0001). Poor LV function was independently associated with increased risk of 30-day mortality outcomes in all age groups (OR 5.65:95% CI 4.21-7.58, age <60 years; OR 5.07: 95% CI 3.91-6.57, age 60 to <70 years; OR 4.50: 95% CI 3.64-5.57, 70 to <80 years and OR 4.83:95% CI 3.79-6.15, age ≥80 years). CONCLUSIONS: Our analysis suggests that worsening LV function is an important independent predictor of worse 30-day mortality outcomes across all age groups and underscores the need for a measure of LV function in all patients for accurate risk stratification prior to PCI.

Impact of age on access site-related outcomes in 469,983 percutaneous coronary intervention procedures: Insights from the British Cardiovascular Intervention Society.

We investigate adoption of the TRA in different age groups and study the relationship between age and access site related outcomes in a national cohort of patients undergoing PCI in the UK. Previous studies have reported conflicting data on radial access site adoption between different age groups, with age an independent predictor of failure of procedures undertaken through the radial approach. Age and access site related outcomes (based on transradial (TRA) and transfemoral (TFA) access) were studied in 469,983 PCI procedures undertaken in the UK from 2006 to 2012 in the age groups; <60, 60-<70, 70-<80, and ≥80 in the British Cardiovascular Intervention Society database. We studied access site practice in 469,983 patients who underwent PCI procedures in the United Kingdom. TRA utilization increased from 17.5% to 65.6% in the age group <60, and 16.6% to 54.5% in the age group ≥80 between 2006 and 2012. TRA was independently associated with decreased 30-day mortality in all age groups (<60: OR 0.64; 95% CI 0.54-0.74, P < 0.0001; 60-<70: OR 0.65; 95% CI 0.57-75, P < 0.0001, 70-<80: OR 0.58 (0.52-0.65, P < 0.0001 and ≥80: OR 0.65 (0.57-0.73, P < 0.0001). Adoption of the TRA for PCI has occurred least in older patients in the UK despite similar associations between TRA use and decreased 30-day mortality observed in all age groups.

Impact of left ventricular function in relation to procedural outcomes following percutaneous coronary intervention: insights from the British Cardiovascular Intervention Society.

AIM: Between 10 and 30% of patients undergoing percutaneous coronary intervention (PCI) have left ventricular (LV) dysfunction. We investigate the association between LV function on early and late mortality outcomes in a national 'real-world' cohort undergoing PCI in the elective and acute coronary syndrome setting through analysis of the British Cardiovascular Intervention Society (BCIS) data set. METHODS AND RESULTS: The relationship between LV function and 30-day mortality in patients undergoing PCI for elective, ST-elevation myocardial infarction (STEMI) and non-ST elevation myocardial infarction (NSTEMI) indications was studied in 230 464 patients in the UK between 2006 and 2011. Abnormal LV function was an independent predictor of 30-day mortality outcomes: 30-day mortality risk for patients with moderate LV function (EF: 30-49%) (HR: 2.91; 95% CI: 2.43-3.49, P < 0.0001) and poor LV function (EF <30%) (HR: 7.25; 95% CI: 5.87-8.96, P < 0.0001) was compared with patients with good LV function (EF >50%). The independent prognostic impact of poor LV function on 30-day mortality increased from elective PCI (HR: 3.72: 95% CI: 2.21-6.25, P < 0.0001) through to the NSTEMI (HR: 5.03: 95% CI: 3.64-6.93, P < 0.0001) and STEMI (HR: 8.18: 95% CI: 5.62-11.92, P < 0.0001). CONCLUSIONS: Our data suggest a strong relationship between LV function and mortality outcomes following PCI, with worsening LV function independently predicting 30-day and longer-term mortality outcomes across all indications for PCI. We report a differential impact of LV function on mortality outcomes across different indications for PCI, with the greatest adverse prognostic association between worsening LV function and mortality outcomes observed in patients undergoing PCI in the STEMI setting.

Reperfusion therapy for ST elevation acute myocardial infarction 2010/2011: current status in 37 ESC countries.

AIMS: Primary percutaneous coronary intervention (PPCI) is the preferred reperfusion therapy in ST-elevation myocardial infarction (STEMI). We conducted this study to evaluate the contemporary status on the use and type of reperfusion therapy in patients admitted with STEMI in the European Society of Cardiology (ESC) member countries. METHODS AND RESULTS: A cross-sectional descriptive study based on aggregated country-level data on the use of reperfusion therapy in patients admitted with STEMI during 2010 or 2011. Thirty-seven ESC countries were able to provide data from existing national or regional registries. In countries where no such registries exist, data were based on best expert estimates. Data were collected on the use of STEMI reperfusion treatment and mortality, the numbers of cardiologists, and the availability of PPCI facilities in each country. Our survey provides a brief data summary of the degree of variation in reperfusion therapy across Europe. The number of PPCI procedures varied between countries, ranging from 23 to 884 per million inhabitants. Primary percutaneous coronary intervention and thrombolysis were the dominant reperfusion strategy in 33 and 4 countries, respectively. The mean population served by a single PPCI centre with a 24-h service 7 days a week ranged from 31 300 inhabitants per centre to 6 533 000 inhabitants per centre. Twenty-seven of the total 37 countries participated in a former survey from 2007, and major increases in PPCI utilization were observed in 13 of these countries. CONCLUSION: Large variations in reperfusion treatment are still present across Europe. Countries in Eastern and Southern Europe reported that a substantial number of STEMI patients are not receiving any reperfusion therapy. Implementation of the best reperfusion therapy as recommended in the guidelines should be encouraged.

Do outcomes from transcatheter aortic valve implantation vary according to access route and valve type? The UK TAVI Registry.

OBJECTIVES: To determine whether outcomes from transcatheter aortic valve implantation (TAVI) vary according to access route and valve type in a real-world population. BACKGROUND: Registry and uncontrolled trial data have found that patients undergoing nonfemoral TAVI have higher early and late mortality. It is not clear whether worse outcomes relate directly to access route. There have been no direct comparisons of outcomes according to valve type. METHODS: Data were collected prospectively on 1,620 patients undergoing TAVI in the UK and compared in 4 groups: SAPIEN transfemoral (TF); SAPIEN transapical (TA); CoreValve TF, CoreValve subclavian. Univariable and multivariable regression analysis was performed to identify independent predictors of mortality. RESULTS: Mortality in patients undergoing SAPIEN TAVI via a TA approach was higher than with TF at 30 days (11.2% vs. 4.4%, P < 0.01), 1 year (28.7% vs. 18.1%, P = 0.01), and 2 years (56.0% vs. 43.5%, P = 0.01). Logistic EuroSCORE was higher in TA patients (22.5 ± 12.9% vs. 17.7 ± 11.1%, P < 0.0001). After multivariable analysis TA access was associated with increased mortality at 30 days (OR 2.56, 95% CI 1.46-4.48, P < 0.01) and 2 years (OR 1.75, 1.08-2.74, P = 0.02). There was no significant difference in mortality at any time-point between patients treated with SAPIEN (n = 812) and CoreValve (n = 808) prostheses. CoreValve-treated patients had a higher rate of permanent pacemaker implantation (23.1% vs. 7.2%, P < 0.0001), and grade ≥2 aortic regurgitation on postprocedure echocardiography (13.0% vs. 7.3%, P < 0.01). CONCLUSIONS: Patients undergoing TA TAVI experienced increased early and late mortality compared to a TF approach. Survival was not influenced by valve type.

Prevalence and Impact of Concomitant Atrial Fibrillation in Patients Undergoing Percutaneous Coronary Intervention for Acute Myocardial Infarction.

Background: Concomitant atrial fibrillation (AF) is associated with an adverse prognosis in patients with acute myocardial infarction (MI). However, it remains unclear whether this is due to a causal effect of AF or whether AF acts as a surrogate marker for comorbidities in this population. Furthermore, there are limited data on whether coronary artery disease distribution impacts the risk of developing AF. Methods: Consecutive patients admitted with acute MI and treated using percutaneous coronary intervention (PCI) at a single centre were retrospectively identified. Associations between AF and major adverse cardiac and cerebrovascular events (MACCEs) over a median of five years of follow-up were assessed using Cox regression, with adjustment for confounding factors performed using both multivariable modelling and a propensity-score-matched analysis. Results: AF was identified in N = 65/1000 (6.5%) of cases; these patients were significantly older (mean: 73 vs. 65 years, p < 0.001), with lower creatinine clearance (p < 0.001), and were more likely to have a history of cerebrovascular disease (p = 0.011) than those without AF. In addition, patients with AF had a greater propensity for left main stem (p = 0.001) or left circumflex artery (p = 0.004) involvement. Long-term MACCE rates were significantly higher in the AF group than in the non-AF group (50.8% vs. 34.2% at five years), yielding an unadjusted hazard ratio (HR) of 1.86 (95% CI: 1.32-2.64, p < 0.001). However, after adjustment for confounding factors, AF was no longer independently associated with MACCEs, either on multivariable (adjusted HR: 1.25, 95% CI: 0.81-1.92, p = 0.319) or propensity-score-matched (HR: 1.04, 95% CI: 0.59-1.82, p = 0.886) analyses. Conclusions: AF is observed in 6.5% of patients admitted with acute MI, and those with AF are more likely to have significant diseases involving left main or circumflex arteries. Although unadjusted MACCE rates were significantly higher in patients with AF, this effect was not found to remain significant after adjustment for comorbidities. As such, this study provided no evidence to suggest that AF is independently associated with MACCEs.

Influence of access site choice on incidence of neurologic complications after percutaneous coronary intervention.

BACKGROUND: Neurologic complications (NCs) are a rare but potentially devastating complication that may follow percutaneous coronary intervention (PCI). In recent years, there has been an increase in use of transradial access, driven by a developing body of evidence that favors its use over femoral access. Concerns have been raised, however, that transradial access may increase the risk of NC compared with transfemoral access. We aimed to investigate the influence of access site selection on the occurrence of NCs through a period of transition during which transradial access became the dominant route for PCI procedures performed in the United Kingdom. METHODS: We performed a retrospective analysis of the British Cardiovascular Intervention Society database between January 2006 and December 2010. The data were split into 2 cohorts based on access site. An NC was defined as a periprocedural ischemic stroke, hemorrhagic stroke, or transient ischemic attack occurring before hospital discharge. Binary logistic multivariate analysis was used to investigate the influence of access site utilization on NCs and adjust for measured confounding factors. RESULTS: Between 2006 and 2010, the use of radial access increased from 17.2% to 50.8% of all PCI procedures. A total of 124,616 radial procedures and 223,476 femoral procedures were studied with a NC rate of 0.11% in each cohort. In univariate (odds ratio 1.01, 95% CI 0.82-1.24, P = .93) and multivariate analysis (odds ratio 0.99, 95% CI 0.79-1.23, P = .91), there was no significant association between the use of radial access and the occurrence of NCs. CONCLUSION: These results suggest that radial access is not associated with an increased risk of clinically detected NCs, even during a period when there was a rapid evolution in the preferred access site for PCI in the United Kingdom. These are reassuring results, particularly for operators embarking on a change to radial access for PCI.

Bleeding outcomes after routine transradial primary angioplasty for acute myocardial infarction using eptifibatide and unfractionated heparin: a single-center experience following the HORIZONS-AMI trial.

OBJECTIVES: We sought to (1) determine the bleeding rates after primary percutaneous coronary intervention (PPCI) in our institution, where the default strategy has been transradial (TR) access in combination with unfractionated heparin (UFH) plus eptifibatide, and (2) compare these with the outcomes of patients treated with bivalirudin in HORIZONS-AMI. BACKGROUND: HORIZONS-AMI demonstrated that in PPCI undertaken via the transfemoral route, routine use of bivalirudin was associated with lower bleeding rates and improved mortality compared to routine use of UFH plus glycoprotein IIb/IIIa inhibitor (GPI). METHODS: This was a single-center prospective registry of consecutive patients undergoing PPCI from January 2009 to August 2011 at the Queen Elizabeth Hospital Birmingham, UK. Thirty-day major bleeding was defined as per the HORIZONS-AMI criteria and also according to TIMI and GUSTO scales. RESULTS: Of the 432 consecutive patients, 350 fulfilled entry criteria for HORIZONS-AMI. In contrast with HORIZONS-AMI, these subjects were older (62.5 ± 13.7 yr vs. 59.8 ± 11.1 yr, P < 0.05) with a higher rate of cardiogenic shock (6.3% vs. 0.8%, P < 0.0001). Despite this higher risk population, the rate of major bleeding was favorable (3.7% [95% CI: 2.0-6.3%] vs. 4.9% [4.0-6.1%], P = 0.32). Similarly, TIMI major bleeding (2.0% [0.8-4.1%] vs. 3.1% [2.3-3.4%], P = 0.10) and GUSTO severe or life-threatening bleeding (0.6% [0.1-2.5%] vs. 0.4% [0.2-0.9%], P = 0.75) were comparable. CONCLUSIONS: Routine TR access for PPCI using UFH plus GPI is associated with a low 30-day rate of major bleeding equivalent to the bivalirudin arm of HORIZONS-AMI. Default transradial access for PPCI permits routine use of a GPI without the penalty of high bleeding rates.

Isoprenaline induced myocardial infarction in a patient with high-grade atrioventricular block: a case report.

Background: Isoprenaline is widely used in the treatment of symptomatic bradycardia. Myocardial infarction precipitated by the therapeutic use of isoprenaline has not been reported in the literature. Case summary: We describe the case of a 67-year-old male patient who presented to our institution with symptomatic Mobitz type II 2:1 atrioventricular block. He had a several-month history of unexplained syncope. He had several cardiovascular risk factors but did not have a diagnosis of coronary artery disease. On admission, he was symptomatic with dizziness but had no chest pain. High-sensitivity troponin I was normal. After initiation of an isoprenaline infusion, he developed cardiac-sounding chest pain and an ischaemic electrocardiogram. Emergency coronary angiography was performed that demonstrated a severe mid-vessel stenosis in his right coronary artery that was treated with percutaneous coronary intervention and the deployment of one drug-eluting stent. He remained in Mobitz type II 2:1 atrioventricular block 48 hours after the procedure, and a dual-chamber permanent pacemaker was implanted. He was discharged in a stable condition with no further chest pain or bradyarrhythmia. Discussion: To our knowledge, this is the first reported case of myocardial infarction precipitated by the therapeutic use of isoprenaline. Our hypothesis is that isoprenaline increased myocardial oxygen demand and induced a type 2 myocardial infarction in this patient with occult coronary artery disease. Isoprenaline should be used with caution in patients with confirmed or suspected coronary artery disease.

Intraprocedural versus next day transthoracic echocardiography following minimalist transfemoral TAVI.

BACKGROUND: Routine pre-discharge echocardiography (ECHO) is recommended post transcatheter aortic valve implantation (TAVI) as a baseline for future comparison. However, there is no clear guidance on the optimal timing of this study. AIM: The purpose of this retrospective study was to investigate the safety and work-force efficiency of intraprocedural same-day ECHO versus next-day ECHO, following transfemoral TAVI. METHODS AND RESULTS: In this retrospective study 100 consecutive patients who underwent intraprocedural ECHO only were compared with 100 consecutive patients undergoing both intraprocedural and routine next-day ECHO following elective transfemoral TAVI. All patients received the Sapien 3/Ultra transcatheter heart valve and were treated with a minimalist procedure with conscious sedation. The composite of in-hospital mortality, urgent ECHO and new tamponade after leaving the cath lab and before discharge was not different between the two groups (4 vs. 4%, P = 1). There was no paravalvular leak more than mild in any of the cases. Length of stay was similar (1 day). CONCLUSIONS: Intraprocedural post-TAVI ECHO appears as safe as next day pre-discharge ECHO and obviates the need for a routine next day study, thereby reducing burden on echocardiography services and allows better utilisation of resources.