Sex differences in transradial access failure in ST segment elevation myocardial infarction.

BACKGROUND: Transradial access (TRA) is now the default access site for PPCI, but technically is a more challenging approach mostly due to anatomic challenges connected to the RA. AIMS: To assess the differences according to sex in radial artery (RA) access site characteristics during primary percutaneous coronary intervention (PPCI) for ST segment elevation myocardial infarction (STEMI). MATERIAL AND METHODS: All 5092 consecutive STEMI patients from our center in the period from March 2011 until December 2017 were examined. The right proximal radial was the "intention-to-treat" access in all patients. Preprocedural RA angiography was performed in all patients. Clinical and procedure characteristics, type of radial anatomy variants, need to use another arterial access sites (the primary endpoint for this study), and procedure time were analyzed by sex. Using logistic regression, we selected predictors of radial crossover. Access site bleeding complications and vascular complications were also recorded. RESULTS: The STEMI population in this period included 1326 females and 3766 male patients. Females were older (65 ± 11 years) than males (59 ± 11 years, p < 0.0001). Among standard risk factors, hypertension and diabetes mellitus were more common in women and smoking less common. RA anomalies were more frequent in the females (8.8% vs. 6.5%, p < 0.0001), with complex RA loop and tortuous RA twice as frequent in women. Failure of TRA access as the initially chosen site occurred in 4.6% (61) of females versus 2.5% (97) of male STEMI patients (p = 0.0003). The most common subsequent access site was right ulnar access in both groups (57 and 61% respectively). Access site bleeding complications were more common in women 4.4% versus 3.2%, mirrored in hematomas with EASY score III to V. Clinical RA spasm (RAS) was significantly more frequent in females (5.7% vs. 2.2%, p < 0.0001). Multiple regression analysis identified 5 independent predictors for TRA access crossover: previous TRA, anomalous RA, RAS, along with female sex and diabetes. CONCLUSION: Female sex is a significant predictor of more complex TRA in STEMI. Understanding sex differences and predictors for TRA crossover will strengthen the use of different procedural modalities that can help in preserving a successful wrist access in female STEMI patients.

Ipsilateral transulnar artery approach catheterizations after failure of the radial approach-Are two sheaths in the same arm safe?

AIMS: To assess the safety and feasibility of ipsilateral transulnar access (TUA) after failure of radial access (TRA), with two sheaths placed in the radial and ulnar arteries (RA and UA) in the same arm. MATERIALS AND METHODS: All consecutive patients with TUA due to inability to cross from ipsilateral TRA in the period from March 2011 until September 2020 were included in the study. We examined clinical and procedure characteristics, access site bleeding and ischemic complications and failure mode of initial TRA. Patients were assessed by duplex ultrasound post-procedure (at an average of 56 ± 31 months) and followed clinically (functional and pain assessment). RESULTS: In this period, out of 51,866 patients 112 (0.2%) had a transulnar artery approach due to inability to cross from ipsilateral radial approach. Mean age of patients was 65 ± 11 years with 44% females. Cause for crossover to ipsilateral TUA was inability to cross a RA anomaly in 107 (95%) patients, mostly due to the presence of a "360°" RA loop in 88 patients. Type 3 and 4 EASY Score hematoma was present in 3 patients (2.6%). Six (5.3%) of the patients had new ipsilateral radial artery occlusion noted on duplex on follow up. There were no ulnar artery occlusions detected. There were no clinical or ischemic hand complications seen during a median 4.3 years of follow up. CONCLUSION: Ipsilateral transulnar artery access following failed radial artery access crossing is safe and successful for coronary angiography and intervention with low rates of complications.

Reducing use of triple therapy after percutaneous coronary intervention: Results from a hospital-wide quality improvement initiative.

BACKGROUND: Trials have shown that for patients on oral anticoagulants (OAC), a short course of dual antiplatelet therapy (DAPT) with OAC reduces post-percutaneous coronary intervention (PCI) bleeding without increasing ischemic events. Adoption of this strategy has been variable. We evaluated the impact of an institutional quality improvement (QI) initiative to reduce the use of triple therapy (TT, OAC + DAPT) and improve discharge communication post-PCI. METHODS: A hospital-wide QI initiative was developed to minimize time on TT post-PCI. Interventions included institutional guidelines emphasizing discharge on OAC with a P2Y12 inhibitor or reducing TT duration to ≤30 days, changes to the computerized decision-support system, and an educational curriculum for house staff. PCI patients 18 months before and after the initiative (2017-2020) were reviewed along with a faculty survey assessing prescribing practices to evaluate the efficacy of the interventions. RESULTS: Among 2797 PCIs reviewed, 431 were included based on OAC at discharge: 24.9% female, 80.1% White, and the mean age was 74 years. The most common indications for OAC were atrial fibrillation (70.1%) and left ventricular dysfunction (11.4%). Mean duration of TT decreased (58.7-37.8 days, p = 0.02) and patients discharged on TT ≤ 30 days increased (24%-37%, p = 0.019) after intervention. Of surveyed faculty (n = 20), 75.0% reported familiarity with the guidelines and 57.9% reported using them to make therapy decisions. CONCLUSIONS: Following the implementation of a QI initiative, fewer patients were discharged on TT and shorter durations of TT were used. Similar initiatives should be considered at institutions with the prevalent use of TT post-PCI.

Expanding opportunities to understand quality and outcomes of peripheral vascular interventions: The ACC NCDR PVI Registry.

Lower extremity peripheral artery disease (PAD) and cerebrovascular disease (CeVD) are prevalent conditions in the United States, and both are associated with significant morbidity (eg, stroke, myocardial infarction, and limb loss) and increased mortality. With a growth in invasive procedures for PAD and CeVD, this demands a more clear responsibility and introduces an opportunity to study how patients are treated and evaluate associated outcomes. The American College of Cardiology (ACC) National Cardiovascular Data Registry (NCDR) Peripheral Vascular Intervention (PVI) Registry is a prospective, independent collection of data elements from individual patients at participating centers, and it is a natural extension of the already robust NCDR infrastructure. As of September 20, 2018, data have been collected on 45,316 lower extremity PVIs, 12,417 carotid artery stenting procedures, and 11,027 carotid endarterectomy procedures at 208 centers in the United States. The purpose of the present report is to describe the patient and procedural characteristics of the overall cohort and the methods used to design and implement the registry. In collecting these data, ACC and ACC PVI Registry have the opportunity to play a pivotal role in scientific evidence generation, medical device surveillance, and creation of best practices for PVI and carotid artery revascularization.

Identifying Complications and Optimizing Consultations following Transradial Arterial Access for Cardiac Procedures.

BACKGROUND: The radial approach to cardiac procedures has become increasingly common. Although previous studies have suggested a favorable risk profile, serious complications can occur. The purpose of this study is to examine the incidence, subsequent treatment, and outcome of all suspected significant neurovascular complications following transradial cardiac procedures at a large US hospital. METHODS: We reviewed all patients who underwent a left heart catheterization, coronary angiogram, or percutaneous coronary intervention via the transradial approach at a single large academic medical center in the United States between 2010 and 2016. Consultations to the vascular and hand surgery services were examined to assess demographic variables, risk factors, presenting symptoms, subsequent treatment, and outcome of all serious complications. RESULTS: A total of 9,681 radial access cardiac procedures were performed during the study period. Twenty-four cases (0.25%) were suspected to have major complications and subsequently received consults. A total of 18 complications were diagnosed, including 8 vascular injuries or perforations, 4 hematomas, 4 radial artery occlusions, 1 case of compartment syndrome, and 1 severe radial artery spasm. Of the complications noted, 3 (16.7%) required operative interventions, but all recovered neurovascular function. CONCLUSIONS: Radial artery access for cardiac procedures has become increasingly common and has been associated with a low rate of major peripheral neurovascular complications. The majority (83.3%) of complications were successfully treated with a nonoperative management algorithm.

The prognostic value of the relationship between right atrial and pulmonary capillary wedge pressure in diverse cardiovascular conditions.

BACKGROUND: Physical examination of jugular venous pressure is used to estimate right atrial (RA) pressure and infer left-sided filling pressure to assist volume management. Previous studies in advanced heart failure patients showed about 75% concordance between RA and pulmonary capillary wedge (PCW) pressures. We sought to determine the relationship between mean RA and mean PCW pressure and assess the clinical significance in a broad population of patients undergoing invasive right heart catheterization (RHC). METHODS: We examined 4135 RHC cases at a single academic medical center from February 2007 to December 2014, analyzing baseline variables, hemodynamic data, and in-hospital mortality. RESULTS: The overall Pearson correlation for mean RA and PCW pressures was 0.68 with 70% concordance between dichotomized pressures (RA ≥10 and PCW ≥22 mmHg). Results were similar in subgroups with heart failure (r=0.67, 72%), STEMI/NSTEMI (r=0.60, 69%), unstable angina (r=0.78, 69%), stable/no angina (r=0.72, 67%), and valvular disease (r=0.61, 72%; Chi-square P=.15). Mean RA pressure was independently associated with in-hospital mortality in multivariate analysis (OR 1.12 [95% CI 1.081-1.157] per 1 mmHg increase, P<.001). The RA/PCW ratio was not independently associated with in-hospital mortality. Mean RA pressure was also weakly associated with worse renal function (rho=-0.16, P<.001). CONCLUSION: In patients undergoing right catheterization for diverse indications, the mean RA and PCW pressures correlated moderately well, but there was discordance in a sizable minority, in whom assessment of left-sided filling pressures using estimated jugular venous pressure may be misleading. Elevated right atrial pressure is a marker for in-hospital mortality.

Time-Course of Cause-Specific Hospital Admissions During Snowstorms: An Analysis of Electronic Medical Records From Major Hospitals in Boston, Massachusetts.

With global climate change, more frequent severe snowstorms are expected; however, evidence regarding their health effects is very limited. We gathered detailed medical records on hospital admissions (n = 433,037 admissions) from the 4 largest hospitals in Boston, Massachusetts, during the winters of 2010-2015. We estimated the percentage increase in hospitalizations for cardiovascular and cold-related diseases, falls, and injuries on the day of and for 6 days after a day with low (0.05-5.0 inches), moderate (5.1-10.0 inches), or high (>10.0 inches) snowfall using distributed lag regression models. We found that cardiovascular disease admissions decreased by 32% on high snowfall days (relative risk (RR) = 0.68, 95% confidence interval (CI): 0.54, 0.85) but increased by 23% 2 days after (RR = 1.23, 95% CI: 1.01, 1.49); cold-related admissions increased by 3.7% on high snowfall days (RR = 3.7, 95% CI: 1.6, 8.6) and remained high for 5 days after; and admissions for falls increased by 18% on average in the 6 days after a moderate snowfall day (RR = 1.18, 95% CI: 1.09, 1.27). We did not find a higher risk of hospitalizations for injuries. To our knowledge, this is the first study in which the time course of hospitalizations during and immediately after snowfall days has been examined. These findings can be translated into interventions that prevent hospitalizations and protect public health during harsh winter conditions.

Type 4a myocardial infarction: Incidence, risk factors, and long-term outcomes.

OBJECTIVES: To assess the incidence of and outcomes related to periprocedural (Type 4a) myocardial infarction (MI) in a cohort of patients undergoing percutaneous coronary intervention (PCI) for stable coronary disease or non ST-elevation acute coronary syndrome with stable or falling cardiac troponin levels. BACKGROUND: The 2012 Third Universal Definition for Type 4a MI has not been prospectively studied in routine clinical practice. METHODS: The study included 516 patients undergoing eligible PCI at a single institution. Data were extracted from the National Cardiovascular Data Registry, review of electronic medical records, and telephone interviews. Clinical outcomes assessed at one year included all-cause mortality, recurrent MI, or any repeat coronary revascularization. RESULTS: Based on the Third Universal Definition of MI, 53 (10.3%) patients met criteria for Type 4a MI and 116 (22.5%) had myocardial injury. The Type 4a MI and myocardial injury groups each had significantly higher numbers of stents, longer stent lengths, and more use of rotational atherectomy than the control group. Type 4a MI was not associated with one-year mortality. The composite endpoint of death or recurrent MI at one year was similar between the Type 4a MI and myocardial injury groups (12 vs. 11%; P > 0.05), which were both higher compared with the control group (3%; P = 0.02, 0.03). CONCLUSIONS: Type 4a MI and myocardial injury were frequent, and were associated with more complicated index PCI and more frequent death or recurrent MI at one year as compared with the control group. © 2016 Wiley Periodicals, Inc.

Utility of a real-time appropriate use criteria decision support application for percutaneous coronary interventions in non-acute coronary syndrome.

OBJECTIVES: The aim of this study was to test the feasibility and value of a real-time online appropriate use criteria (AUC) application for percutaneous coronary intervention (PCI) in patients without acute coronary syndrome. BACKGROUND: High rates of non-appropriate elective PCI in the National Cardiovascular Data Registry (NCDR) CathPCI Registry have created interest in integrating decision support tools into routine clinical care to improve the frequency of appropriate PCIs. METHODS: Patients undergoing diagnostic coronary angiography and subsequent PCI for non-ACS indications at a single center were scored using a real-time AUC application pre-procedure. Blinded angiographic review was performed subsequently for each case. Rates of appropriate, inappropriate, uncertain and not rated PCIs were tabulated according to specific clinical scenarios using information available both before and after the angiographic audit. RESULTS: Of 308 PCIs in 272 patients, 196 (63.6%) were deemed appropriate, 79 (25.6%) uncertain, and two (0.6%) inappropriate; 31 (10.1%) scenarios could not be rated. With angiographic audit, inappropriate PCIs increased to 9.7%. There was a significant improvement in the rate of appropriate PCI using the real-time AUC application compared with retrospective data collection for NCDR reporting (64% vs. 53%, P = 0.01). CONCLUSIONS: Use of a real-time AUC application together with angiographic audit may improve the accuracy of reporting PCI appropriateness. © 2015 Wiley Periodicals, Inc.

Cardiac biomarker measurement after elective percutaneous coronary interventions in older patients: insights from the National Cardiovascular Data Registry.

BACKGROUND: Guidelines recommend consideration of cardiac biomarker measurement after elective percutaneous coronary intervention (PCI), especially with complex cases or complicated procedures. However, the long-term prognostic implications of biomarker measurement after elective PCI have not been well characterized in older patients. METHODS: We examined 157,825 Medicare patients undergoing elective PCI in the United States from 2004 to 2008 at 711 hospitals in the CathPCI Registry. Clinical characteristics and 1-year mortality risk were studied, stratified by creatine kinase-muscle band measurement. RESULTS: Overall, 26% of patients on elective PCI had postprocedure biomarkers measured. These patients had more complex coronary anatomy and procedures but had similar rates of PCI success and inhospital mortality when compared with patients without biomarker measurement. The treating hospital was a significant factor associated with the likelihood of postprocedure biomarker surveillance. Hospitals that measured creatine kinase-muscle band in ≥ 90% of patients on elective PCI had lower associated 1-year mortality rates (adjusted hazard ratio 0.84, 95% CI 0.75-0.94) compared with hospitals that measured in < 10% of patients. CONCLUSIONS: Among older patients undergoing elective PCI, postprocedure cardiac biomarker measurement occurred infrequently and was concentrated at certain hospitals. Hospitals that routinely measured post-PCI biomarkers were associated with lower long-term mortality compared with hospitals without routine measurement.

Risk factors for nosocomial gastrointestinal bleeding and use of acid-suppressive medication in non-critically ill patients.

BACKGROUND: It is unknown whether there exist certain subsets of patients outside of the intensive care unit in whom the risk of nosocomial gastrointestinal bleeding is high enough that prophylactic use of acid-suppressive medication may be warranted. OBJECTIVE: To identify risk factors for nosocomial gastrointestinal bleeding in a cohort of non-critically ill hospitalized patients, develop a risk scoring system, and use this system to identify patients most likely to benefit from acid suppression. DESIGN: Cohort study. PATIENTS: Adult patients admitted to an academic medical center from 2004 through 2007. Admissions with a principal diagnosis of gastrointestinal bleeding or a principal procedure code for cardiac catheterization were excluded. MAIN MEASURES: Medication, laboratory, and other clinical data were obtained through electronic data repositories maintained at the medical center. The main outcome measure-nosocomial gastrointestinal bleeding occurring outside of the intensive care unit-was ascertained via ICD-9-CM coding and confirmed by chart review. KEY RESULTS: Of 75,723 admissions (median age = 56 years; 40 % men), nosocomial gastrointestinal bleeding occurred in 203 (0.27 %). Independent risk factors for bleeding included age > 60 years, male sex, liver disease, acute renal failure, sepsis, being on a medicine service, prophylactic anticoagulants, and coagulopathy. Risk of bleeding increased as clinical risk score derived from these factors increased. Acid-suppressive medication was utilized in > 50 % of patients in each risk stratum. Our risk scoring system identified a high risk group in whom the number-needed-to-treat with acid-suppressive medication to prevent one bleeding event was < 100. CONCLUSIONS: In this large cohort of non-critically ill hospitalized patients, we identified several independent risk factors for nosocomial gastrointestinal bleeding. With further validation at other medical centers, the risk model derived from these factors may help clinicians to direct acid-suppressive medication to those most likely to benefit.

Predicting the restenosis benefit of drug-eluting versus bare metal stents in percutaneous coronary intervention.

BACKGROUND: Drug-eluting stents (DES) for percutaneous coronary intervention decrease the risk of restenosis compared with bare metal stents. However, they are costlier, require prolonged dual antiplatelet therapy, and provide the most benefit in patients at highest risk for restenosis. To assist physicians in targeting DES use in patients at the highest risk for target vessel revascularization (TVR), we developed and validated a model to predict TVR. METHODS AND RESULTS: Preprocedural clinical and angiographic data from 27 107 percutaneous coronary intervention hospitalizations between October 1, 2004, and September 30, 2007, in Massachusetts were used to develop prediction models for TVR at 1 year. Models were developed from a two-thirds random sample and validated in the remaining third. The overall rate of TVR was 7.6% (6.7% with DES, 11% with bare metal stents). Significant predictors of TVR included prior percutaneous coronary intervention, emergency or salvage percutaneous coronary intervention, prior coronary bypass surgery, peripheral vascular disease, diabetes mellitus, and angiographic characteristics. The model was superior to a 3-variable model of diabetes mellitus, stent diameter, and stent length (c statistic, 0.66 versus 0.60; P<0.001) and was well calibrated. The predicted number needed to treat with DES to prevent 1 TVR compared with bare metal stents ranged from 6 (95% confidence interval, 5.4-7.6) to 80 (95% confidence interval, 62.7-116.3), depending on patients' clinical and angiographic factors. CONCLUSIONS: A predictive model using commonly collected variables can identify patients who may derive the greatest benefit in TVR reduction from DES. Whether use of the model improves the safety and cost-effectiveness of DES use should be tested prospectively.

Incidence of Myopericarditis and Myocardial Injury in Coronavirus Disease 2019 Vaccinated Subjects.

Several recent publications have described myopericarditis cases after the coronavirus disease 2019 (COVID-19) vaccination. However, it is uncertain if these cases occurred secondary to the vaccination or more common etiologies of myopericarditis. To help determine whether a correlation exists between COVID-19 vaccination and myopericarditis, the present study compared the gender-specific cumulative incidence of myopericarditis and myocardial injury in a cohort of COVID-19 vaccinated patients at a tertiary care center in 2021 with the cumulative incidence of these conditions in the same subjects exactly 2 years earlier. We found that the age-adjusted incidence rate of myopericarditis in men was higher in the vaccinated than the control population, rate ratio 9.7 (p = 0.04). However, the age-adjusted incidence rate of myopericarditis in women was no different between the vaccinated and control populations, rate ratio 1.28 (p = 0.71). We further found that the rate of myocardial injury was higher in both men and women in 2021 than in 2019 both before and after vaccination, suggesting that some of the apparent increase in the diagnosis of myopericarditis after vaccination may be attributable to factors unrelated to the COVID-19 vaccinations. In conclusion, our study reaffirms the apparent increase in the diagnosis of myopericarditis after COVID-19 vaccination in men but not in women, although this finding may be confounded by increased rates of myocardial injury in 2021. The benefits of COVID-19 vaccination to individual and public health clearly outweigh the small potential increased risk of myopericarditis after vaccination.

Prevalence and Risk Factors for Preprocedural Medication Errors in Patients With Atrial Fibrillation and Atrial Flutter.

Perfect adherence to anticoagulant medications is an important aspect of care for patients with atrial fibrillation undergoing cardiac electrophysiology procedures to minimize the risk of stroke. Despite this, adherence remains imperfect as is associated with added cost of additional procedures (e.g., transesophageal echocardiography) and administrative burden. We sought to identify characteristics of such patients and predictors of medication errors at Beth Israel Deaconess Medical Center.

Relation of the Number of Cardiovascular Conditions and Short-term Symptom Improvement After Percutaneous Coronary Intervention for Stable Angina Pectoris.

With aging of the population, cardiovascular conditions (CC) are increasingly common in individuals undergoing PCI for stable angina pectoris (AP). It is unknown if the overall burden of CCs associates with diminished symptom improvement after PCI for stable AP. We prospectively administered validated surveys assessing AP, dyspnea, and depression to patients undergoing PCI for stable AP at our institution, 2016-2018. The association of CC burden and symptoms at 30-days post-PCI was assessed via linear mixed effects models. Included individuals (N = 121; mean age 68 ± 10 years; response rate = 42%) were similar to non-included individuals. At baseline, greater CC burden was associated with worse dyspnea, depression, and physical limitations due to AP, but not AP frequency or quality of life. PCI was associated with small improvements in AP and dyspnea (p ≤ 0.001 for both), but not depression (p = 0.15). After multivariable adjustment, including for baseline symptoms, CC burden was associated with a greater improvement in AP physical limitations (p = 0.01) and depression (p = 0.002), albeit small, but not other symptom domains (all p ≥ 0.05). In patients undergoing PCI for stable AP, increasing CC burden was associated with worse dyspnea, depression, and AP physical limitations at baseline. An increasing number of CCs was associated with greater improvements, though small, in AP physical limitations and depression. In conclusion, the overall number of cardiovascular conditions should not be used to exclude patients from PCI for stable AP on the basis of an expectation of less symptom improvement.

Lessons for Treating Structural Heart Patients during the COVID-19 Pandemic and Beyond.

Background: We sought to compare characteristics and outcomes of structural heart disease (SHD) patients treated during the regional peak of the Coronavirus Disease 2019 (COVID-19) pandemic ("COVID era") compared with historical controls. During the COVID era, elective SHD procedures at Beth Israel Deaconess Medical Center were canceled but urgent cases were still performed. We enacted several practice changes in an effort to minimize complications, prevent COVID transmission, and decrease hospital stay during the pandemic. Methods: Baseline characteristics and outcomes were collected on all patients who underwent SHD procedures during the COVID era and compared with patients treated during the same time period in 2019. Results: Compared with SHD patients treated during 2019 (N = 259), those treated during the COVID era (N = 26) had higher left ventricular end diastolic pressure (LVEDP; 28 vs. 21 mmHg, p = 0.001), and were more likely New York Heart Association class IV (26.9% vs. 10.0%, p = 0.019), but had a lower rate of bleeding/vascular complications (0% vs. 16.2%, p = 0.013), a lower rate of permanent pacemaker implantation (0% vs. 17.4%, p = 0.019), and a greater proportion of patients were discharged on post-operative day 1 (POD#1; 68.2% vs. 22.2%, p < 0.001). Conclusion: Practice changes employed for patients treated during the COVID era were associated with fewer vascular complications, a greater proportion of patients discharged on POD#1, and a lower rate of pacemaker implantation despite more severe illness. As a result, we plan to continue these practices in the post-COVID era.

Stent thrombosis in randomized clinical trials of drug-eluting stents.

BACKGROUND: Definitions of stent thrombosis that have been used in clinical trials of drug-eluting stents have been restrictive and have not been used in a uniform manner. METHODS: We applied a hierarchical classification of stent thrombosis set by the Academic Research Consortium (ARC) across randomized trials involving 878 patients treated with sirolimus-eluting stents, 1400 treated with paclitaxel-eluting stents, and 2267 treated with bare-metal stents. We then pooled 4 years of follow-up data. All events were adjudicated by an independent clinical-events committee. RESULTS: The cumulative incidence of stent thrombosis according to the original protocol definitions was 1.2% in the sirolimus-stent group versus 0.6% in the bare-metal-stent group (P=0.20; 95% confidence interval [CI], -0.4 to 1.5) and 1.3% in the paclitaxel-stent group versus 0.8% in the bare-metal-stent group (P=0.24; 95% CI, -0.3 to 1.4). The incidence of definite or probable stent thrombosis as defined by the ARC was 1.5% in the sirolimus-stent group versus 1.7% in the bare-metal-stent group (P=0.70; 95% CI, -1.5 to 1.0) and 1.8% in the paclitaxel-stent group versus 1.4% in the bare-metal-stent group (P=0.52; 95% CI, -0.7 to 1.4). The incidence of definite or probable events occurring 1 to 4 years after implantation was 0.9% in the sirolimus-stent group versus 0.4% in the bare-metal-stent group and 0.9% in the paclitaxel-stent group versus 0.6% in the bare-metal-stent group. CONCLUSIONS: The incidence of stent thrombosis did not differ significantly between patients with drug-eluting stents and those with bare-metal stents in randomized clinical trials, although the power to detect small differences in rates was limited.

Clinical features and outcomes of carotid artery stenting by clinical expert consensus criteria: a report from the CARE registry.

BACKGROUND: In 2007, a multispecialty society task force published a clinical expert consensus document (CECD) on carotid stenting (CAS), containing recommendations for appropriate patient selection and quality of care. The CECD also inspired creation of a large, national registry of carotid revascularization, the Carotid Artery Revascularization and Endarterectomy (CARE) registry. Our goal here was to investigate whether initial CAS procedures submitted to CARE conformed to CECD recommendations, and examine their clinical outcomes. METHODS: We analyzed CAS procedures for the period January 1, 2005 through December 31, 2008. These were grouped into those that conformed to CECD recommendations [CECD(+), n = 4,636, 79.8%] and those that did not [CECD(-), n = 1,168, 20.2%]. RESULTS: The CECD(+) patients were older than CECD(-) patients (71.5 +/- 10.3 vs. 67.6 +/- 10.3 years, P = 0.001, respectively), and more frequently had chronic kidney disease (46.9% vs. 17.8%, P = 0.001), chronic lung disease (33.0% vs. 12.4%, P = 0.001), ejection fraction

Transradial vs transfemoral secondary access outcomes in transcatheter aortic valve implantation: A systematic review and meta-analysis.

BACKGROUND: Complications of transcatheter aortic valve implantation (TAVI) procedures include bleeding, vascular complications, and strokes. These complications are often associated with the type of access used. The two types of access in TAVI procedures are primary and secondary. The main use of the primary access is for valve delivery, while secondary access is used for angiography and hemodynamic monitoring. While there are many options for primary access, those for secondary access are transfemoral and transradial. AIM: To compare outcomes between transradial vs transfemoral secondary access (TFSA). METHODS: A systematic search was conducted using major databases (EMBASE, PubMed, Cochrane Central, Google Scholar), which resulted in 5 studies that met the criteria for study selection. Outcomes of interest were 30-d rates each of major/life-threatening bleeding, vascular complications, strokes, and mortality. All 5 studies were observational. Only adjusted or matched data were used when available in this meta-analysis. RESULTS: A total of 5065 patients underwent TAVI, with 1453 patients (28.7%) having undergone transradial secondary access (TRSA) and 3612 patients (71.3%) TFSA. Irrespective of the site of primary access, the odds of having major or life-threatening bleeding were 60% lower in the TRSA group than the TFSA group (P < 0.00001). The odds of having major vascular complications were 52% lower in the TRSA group (P < 0.0001) with no difference in minor vascular complications between the 2 groups. Similarly, the odds of mortality in 30-d after the procedure were 41% lower (P = 0.006) and the odds of stroke were 54% lower (P = 0.001) in the TRSA group than the TFSA group. CONCLUSION: The transradial secondary approach appears to be a safer alternative to the transfemoral secondary approach in TAVI procedures.

Association between procedure appropriateness and patient-reported outcomes after percutaneous coronary intervention.

OBJECTIVE: The Appropriate Use Criteria (AUC) has been used to identify individuals who are likely to benefit from percutaneous coronary intervention (PCI) for stable ischaemic heart disease. However, whether physicians reliably grade PCI appropriateness and whether AUC categories stratify symptomatic improvement in real-world practice are unclear. METHODS: Patient-reported outcomes measures (PROMs) for angina (Seattle Angina Questionnaire (SAQ-7)), dyspnoea (Rose Dyspnea Scale (RDS)) and depression (Patient Health Questionnaire-2 (PHQ-2)) were collected on patients undergoing elective coronary angiography at an academic medical centre. Retrospectively, two physicians independently determined PCI appropriateness by the AUC criteria. RESULTS: Inter-rater agreement on appropriateness was moderate (κ=0.48, 95% CI 0.32 to 0.63). Of PCI procedures evaluated, 57 (47.1%) were appropriate (A-PCI), 62 (51.2%) were maybe appropriate (MA-PCI) and 2 (1.6%) were rarely appropriate. At baseline, A-PCI compared with MA-PCI patients had worse RDS scores (2.0 vs 1.2, p=0.01). At 30 days, the change in SAQ-7 summary score was similar between groups (A-PCI vs MA-PCI, +27.1 vs +20.7, p=0.11). The mean change in RDS score was greater in A-PCI than MA-PCI (-1.0 vs -0.5, p for group by time interaction=0.03). PHQ-2 scores were similar and did not improve at 30 days. CONCLUSION: In patients undergoing PCI with PROMs collected before and 30 days after PCI, similar improvements in angina were observed regardless of appropriateness. Inter-rater agreement on PCI appropriateness was only moderate. Use of PROMs may improve reliability of physician assessments of PCI appropriateness.