Intermediate and Late Outcomes With PCI vs CABG for Left Main Disease - Landmark Meta-Analysis of Randomized Trials.

PCI to improve survival is currently recommended as a reasonable alternative to CABG in patients with unprotected left main disease. However, RCTs to support this recommendation has generated mixed results and recently published EXCEL trial has sparked debate about differences in late mortality. To address this point, we performed landmark meta-analysis of 4 RCTs with 5 year follow up data - EXCEL, NOBLE, PRECOMBAT and SYNTAX LEFT MAIN. Overall, there was no significant difference in all-cause mortality between PCI and CABG at 5 years (RR = 1.03 [95% CI = 0.79-1.33]). However, there was apparent change in the direction of association before and after the 1 year landmark that underscores the need for long term follow up in these trials. In addition, we found that PCI was associated with significantly lower rate of intermediate stroke at 1 year (RR = 0.44 [0.24-0.82]) but higher rate of late MI after 1 year (3.31 [2.11-5.18]) compared to CABG.

Aortic Valve Replacement for Severe Aortic Stenosis Before and During the Era of Transcatheter Aortic Valve Implantation.

Recent positive results of transcatheter aortic valve replacement (TAVI) in clinical trials have sparked debate on whether TAVI should be first line for all patients with aortic stenosis. However, limited evidence exists on the clinical impact of TAVI on a national level. Using the national inpatient sample (NIS) of hospital discharges in the United States from 2001 to 2016, we evaluated the rate of AVR and associated in-hospital outcomes in pre-TAVI and TAVI era. Hierarchical mixed effect modeling was used to assess for trend and calculate risk adjusted estimates. Annual volume of AVR increased from 49,357 in 2001 to 100,050 in 2016 (103% increase). Compared with the pre-TAVI era, mean annual change in volume of AVR was higher in the TAVI era (+2.9% vs +9.4%, respectively, p <0.001). In contrast, rate of in-hospital mortality decreased from 5.4% in 2001 to 2.7% in 2016 (50% decrease). Compared with the pre-TAVI era, magnitude of mean annual change in mortality was higher in TAVI era (-4.0% vs -6.7%, respectively, p = 0.04). Unlike SAVR for which risk-adjusted rate for most outcomes seems to have plateaued, TAVI demonstrated significant improvement from 2012 to 2016 for mortality (4.6% to 1.8%), acute kidney injury (15.1% to 2.6%) and nonroutine home discharge (63.6% to 44.6%). However, no significant change in the rate of stroke (2.4% to 2.1%) and pacemaker implantation remained high (8.1% to 9.4%). Lastly, median length of stay was shorter for TAVI compared with isolated SAVR (3 vs 8 days, respectively). In conclusion, the adoption of TAVI has led to increase in volume of AVR for severe aortic stenosis in the United States with favorable short-term outcome.

Impact of Pre-Existing and New-Onset Atrial Fibrillation on Outcomes After Transcatheter Aortic Valve Replacement.

OBJECTIVES: This study sought to evaluate impact of new-onset and pre-existing atrial fibrillation (AF) on transcatheter aortic valve replacement (TAVR) long-term outcomes compared with patients without AF. BACKGROUND: Pre-existing and new-onset AF in patients undergoing TAVR are associated with poor outcomes. METHODS: The study identified 72,660 patients ≥65 years of age who underwent nonapical TAVR between 2014 and 2016 using Medicare inpatient claims. History of AF was defined by diagnoses on claims during the 3 years preceding the TAVR, and new-onset AF was defined as occurrence of AF during the TAVR admission or within 30 days after TAVR in a patient without prior history of AF. Outcomes included all-cause mortality, and readmission for bleeding, stroke, and heart failure (HF). RESULTS: Overall, 40.7% had pre-existing AF (n = 29,563) and 6.8% experienced new-onset AF (n = 2,948) after TAVR. Mean age was 81.3, 82.4, and 83.8 years in patients with no AF, pre-existing, and new-onset AF, respectively. Pre-existing AF patients had the highest burden of comorbidities. After follow-up of 73,732 person-years, mortality was higher with new-onset AF compared with pre-existing and no AF (29.7, 22.6, and 12.8 per 100 person-years, respectively; p < 0.001). After adjusting for patient characteristics and hospital TAVR volume, new-onset AF remained associated with higher mortality compared with no AF (adjusted hazard ratio: 2.068, 95% confidence interval [CI]: 1.92 to 2.20; p < 0.01) and pre-existing AF (adjusted hazard ratio: 1.35; 95% CI: 1.26 to 1.45; p < 0.01). In competing risk analysis, new-onset AF was associated with higher risk of bleeding (subdistribution hazard ratio [sHR]: 1.66; 95% CI: 1.48 to 1.86; p < 0.01), stroke (sHR: 1.92; 95% CI: 1.63 to 2.26; p < 0.01), and HF (sHR: 1.98; 95% CI: 1.81 to 2.16; p < 0.01) compared with pre-existing AF. CONCLUSIONS: In patients undergoing TAVR, new-onset AF is associated with increased risk of mortality and bleeding, stroke, and HF hospitalizations compared with pre-existing AF or no AF.

Fluoroquinolones and the risk of aortopathy: A systematic review and meta-analysis.

OBJECTIVE: To investigate the association between fluoroquinolones use and development of aortopathy. METHODS: A systematic review and meta-analysis was conducted following PRISMA and MOOSE guidelines for reporting systematic reviews of observational studies. Multiple databases were searched and two authors independently screened studies for eligibility. Newcastle Ottawa scale was used to assessed the quality of included studies. Primary outcome of interest was development of aortic aneurysm or dissection among fluoroquinolones users in comparison to non-users. An inverse variance model meta-analysis was used to pool odds ratio or hazards ratio from included studies to calculate the overall effect estimate. Pre specified subgroups analyses were also conducted to explore sources of heterogeneity. RESULTS: Three observational studies that enrolled 941,639 subjects met the inclusion criteria and were included in the final analysis. All studies were of a good methodological quality. Current use of fluoroquinolones, defined as within 60 days from development of the primary outcome, was associated with significantly elevated risk of developing aortic aneurysm and/or dissection in comparison to controls, (OR = 2.04; 95% CI [1.67, 2.48]). There was only a mild degree of between study heterogeneity, I2 = 33%. The association remains robust among all subgroups analyses. CONCLUSION: Our findings indicate that current fluoroquinolone use was significantly associated with increased risk of aortic aneurysm and dissection. Health care providers need to be aware of this serious association and use fluoroquinolones judiciously in order to minimize the risk of the serious sequela of aortopathy.

Comparison of Radial Artery Occlusion Following Transradial Access for Percutaneous Coronary Intervention Using Sheath-based versus Sheathless Technique.

We compared the risk of radial artery occlusion (RAO) in patients undergoing coronary intervention with introducer sheath (SG) or without introducer sheath (SLG). 1251 consecutive patients, from 2 tertiary care center in Pennsylvania, USA, undergoing percutaneous coronary interventions (PCI) between 2008-2013 formed the study cohort (SLG: 161 patients, SG: 1090 patients). Radial artery patency was assessed using plethysmography. The association between sheath use and RAO was assessed using unadjusted, adjusted and propensity macthed logistic regression analyses. Mean age: 65 years, men: 63%, diabetics: 37%. SG was associated with lower RAO at band removal [unadjusted (OR: 0.31, 95% CI: 0.21-0.46), adjusted (OR: 0.10, 95% CI: 0.05-0.20) and propensity matched (OR: 0.20, 95% CI: 0.13-0.32)], at 24 hours [unadjusted (OR: 0.20, 95% CI: 0.12-0.34), adjusted (OR: 0.12, 95% CI: 0.06-0.24) and propensity matched (OR: 0.13, 95% CI: 0.07-0.25)] and 30 days [unadjusted (OR: 0.28, 95% CI: 0.14-0.54), adjusted (OR: 0.22, 95% CI: 0.10-0.50) and propensity matched (OR: 0.18, 95% CI: 0.10-0.40)], compared to SLG. Sheath use during radial access for PCI is associated with less RAO. It is unclear if use of introducer sheath during radial access for PCI reduces incidence of RAO. In this prospective cohort study involving 1251 concecutive patients undergoing PCI via radial access between 2008-2013, we assessed the difference in incidence of RAO between the SG (n = 1090) and the SLG (n = 161 patients) groups. SG group experienced lower incidence of RAO at band removal, 24 hours and 30 days post PCI in the unadjusted, adjusted, and propensity matched analyses compared to the SLG group. In conclusion sheath use during radial access for PCI is associated with less RAO.

Diagnostic Accuracy of Coronary Computed Tomography Before Aortic Valve Replacement: Systematic Review and Meta-Analysis.

PURPOSE: In aortic stenosis patients referred for surgical and transcatheter aortic valve replacement (AVR), the evidence of diagnostic accuracy of coronary computed tomography angiography (CCTA) has been limited. The objective of this study was to investigate the diagnostic accuracy of CCTA for significant coronary artery disease (CAD) in patients referred for AVR using invasive coronary angiography (ICA) as the gold standard. MATERIALS AND METHODS: We searched databases for all diagnostic studies of CCTA in patients referred for AVR, which reported diagnostic testing characteristics on patient-based analysis required to pool summary sensitivity, specificity, positive-likelihood ratio, and negative-likelihood ratio. Significant CAD in both CCTA and ICA was defined by >50% stenosis in any coronary artery, coronary stent, or bypass graft. RESULTS: Thirteen studies evaluated 1498 patients (mean age, 74 y; 47% men; 76% transcatheter AVR). The pooled prevalence of significant stenosis determined by ICA was 43%. Hierarchical summary receiver-operating characteristic analysis demonstrated a summary area under curve of 0.96. The pooled sensitivity, specificity, and positive-likelihood and negative-likelihood ratios of CCTA in identifying significant stenosis determined by ICA were 95%, 79%, 4.48, and 0.06, respectively. In subgroup analysis, the diagnostic profiles of CCTA were comparable between surgical and transcatheter AVR. CONCLUSIONS: Despite the higher prevalence of significant CAD in patients with aortic stenosis than with other valvular heart diseases, our meta-analysis has shown that CCTA has a suitable diagnostic accuracy profile as a gatekeeper test for ICA. Our study illustrates a need for further study of the potential role of CCTA in preoperative planning for AVR.

Trends in the rates of hospitalizations for acute stroke among patients over 90 years of age with atrial fibrillation in the United States: from 2005 to 2014.

BACKGROUND: Acute stroke (AS) rates in patients over 90 years of age (very elderly) with atrial fibrillation (AF) in the United States (US) are not known. We assessed trends in hospitalizations for AS among very elderly with AF in the US from 2005 to 2014. METHODS: We used the nationwide inpatient sample (NIS) from the USA; 2005-2014. AF and AS diagnoses were abstracted using international classification of diseases, 9th Revision, clinical modification (ICD-9-CM) codes. RESULTS: From 2005 to 2014, 3,606,073 hospitalizations of very elderly with AF were reported. Of these, 188,948 hospitalizations (141,822 hospitalizations in women and 47,126 hospitalizations in men) had AS as the primary diagnosis. Age adjusted AS hospitalizations increased in the total cohort (3217/million in 2005 to 3871/million in 2014), in women (3540/million in 2005 to 4487/million in 2014) and in men (2490/million in 2005 to 3173/million in 2014) (P < 0.001). Anticoagulation rates increased in women (8% in 2005 to 19.9% in 2014) and in men (8.9% in 2005 to 21.6% in 2014). AS rates, though numerically lower than the total cohort, showed an increasing trend in anticoagulated patients as well (all anticoagulated patients: 212/million in 2005 to 513/million in 2014; anticoagulated women: 224/million in 2005 to 529/million in 2014, anticoagulated men: 184/million in 2005 to 518/million in 2014). CONCLUSIONS: There is an increasing trend in AS hospitalizations among nonagenarians with AF in the US despite improving utilization of anticoagulants in this patient population. The etiologies driving this alarming trend are unclear and require further study.

Gender Differences in the Trends of Hospitalizations for Acute Stroke Among Patients With Atrial Fibrillation in the United States: 2005 to 2014.

Female gender was included in stroke prediction algorithms in an attempt to improve anticoagulation rates in women with atrial fibrillation (AF). It is unclear if these efforts reduced stroke burden in women with AF. To bridge this literature gap, using the Nationwide Inpatient Sample, we assessed gender differences in the trends of hospitalizations for stroke among patients with AF in the United States in 2005 to 2014. International classification of diseases, 9th revision, clinical modification codes were used to abstract AF and stroke diagnoses. From 2005 to 2014, 18,413,291 hospitalizations of women with AF and 18,035,866 hospitalizations of men with AF were reported. Of these, 740,635 hospitalizations in women and 595,730 hospitalizations in men had stroke as the primary diagnosis. Age-adjusted stroke hospitalizations increased in women (443 per million in 2005 to 495 per million in 2014) as well as in men (351 per million in 2005 to 453 per million in 2014) (p trend < 0.001). Further, anticoagulation rates increased in women (11.5% in 2005 to 24.0% in 2014) as well as in men (11.7% in 2005 to 24.9% in 2014). Stroke hospitalizations involving anticoagulated patients with AF decreased in women (411 per million in 2005 to 347 per million in 2014) as well as in men (402 per million in 2005 to 311 per million in 2014) (p trend < 0.001). In conclusion, although we noted an increasing trend of stroke hospitalizations in both genders, it is reassuring to note that stroke hospitalizations involving anticoagulated patients with AF is decreasing in both genders and in particular among women.

"Two for the Price of One": A Single-Lead Implantable Cardioverter-Defibrillator System with a Floating Atrial Dipole.

In patients known to be a high risk for sudden cardiac arrest, implantable cardioverter defibrillators (ICD) are a proven therapy to reduce risk of death. However, in patients without conventional indications for pacing, the optimal strategy for type of device, dual- versus single-chamber, remains debatable. The benefit of prophylactic pacing in this category of patients has never been documented. Although available atrial electrograms in a dual chamber system improve interpretation of stored arrhythmia events, allow monitoring of atrial fibrillation and may potentially reduce the risk of inappropriate shocks by enhancing automated arrhythmia discrimination, the use of dual-chamber ICDs has a number of disadvantages. The addition of an atrial lead adds complexity to implantation and extraction procedures, increases procedural cost and is associated with a higher risk of periprocedural complications. The single lead pacing system with ability to sense atrial signals via floating atrial electrodes (VDD) clinically became available in early 1980's but did not gain much popularity due to inconsistent atrial sensing and concerns about the potential need for an atrial lead if sinus node fails. Most ICD patients do not have indications for pacing at implantation and subsequent risk of symptomatic bradycardia seems to be low. The concept of atrial sensing via floating electrodes has recently been revitalized in the Biotronik DX ICD system (Biotronik, SE & Co., Berlin, Germany) aiming to provide all of the potential advantages of available atrial electrograms without the risks and incremental cost of an additional atrial lead. Compared to a traditional VDD pacing system, the DX ICD system uses an optimized (15 mm) atrial dipole spacing and improved atrial signal processing to offer more reliable atrial sensing. The initial experience with the DX system indicates that the clinically useful atrial signal amplitude in sinus rhythm remains stable over time. Future studies are needed to determine reliability of atrial sensing during tachyarrhythmias, particularly atrial fibrillation as well as clinical utility and cost-effectiveness of this technology in different populations of patients.

Long-Term Stability and Clinical Utility of Amplified Atrial Electrograms in a Single-Lead ICD System with Floating Atrial Electrodes.

BACKGROUND: Available atrial electrograms in implantable cardioverter defibrillators (ICDs) improve arrhythmia diagnosis, allow monitoring for atrial fibrillation, and may reduce the risk of inappropriate therapies. A recently introduced ICD system using a single-lead with floating atrial electrodes provides diagnostic capability of a dual-chamber system without placing an additional lead. Data on long-term clinical performance of this system are limited. METHODS: We retrospectively analyzed data from 35 consecutive patients implanted with Biotronik VR-T DX devices and LinoxSmart DX leads. (Biotronik, SE & Co., Berlin, Germany) RESULTS: Of 35 patients (77% male, age 52 ± 11.28 years), 32 were followed for a mean of 432 ± 197 days (range 56-765). During implantation, average preamplified and amplified sinus P-wave amplitudes were 2.61 ± 1.39 mV (range 0.9-6.8 mV) and 8.7 ± 4.51 mV (range 1.4-18 mV), respectively. Despite statistically significant variations, the amplified P-wave amplitude measurements (calculated mean values over 3 months) remained within a clinically acceptable range during follow-up (5.4-8.7 mV). R-wave amplitude and ventricular pacing threshold measurements were stable over time. A total of 13 stored arrhythmia events (three ventricular tachycardia, eight supraventricular tachycardia, two atrial fibrillation) were reviewed. All of them showed readily interpretable atrial electrograms. Eight out of 10 (80%) supraventricular events were correctly classified by the device. Three patients received inappropriate ICD therapies. CONCLUSION: The single-lead ICD system using a floating atrial dipole provides reliable recording of atrial signals during sinus rhythm and arrhythmias. Our data suggest that the system may offer diagnostic advantages of a dual-chamber device without potential risks of an additional atrial lead.