Outcomes in Multivessel Coronary Disease Stratified by The Society of Thoracic Surgeons Risk.

BACKGROUND: Surgical risk stratified outcomes after contemporary revascularization strategies have not been well described. We report these outcomes in patients undergoing percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) for multivessel coronary disease. METHODS: A total of 5836 patients with multivessel disease who underwent CABG (n = 4420) or PCI (n = 1416) were included in this retrospective observational analysis. Data were stratified based on The Society of Thoracic Surgeons risk score. A score less than 4% was considered low risk and a score greater than or equal to 4% was considered intermediate-high risk. Outcomes included mortality, inpatient readmissions, and repeat revascularizations. RESULTS: In the CABG population, 3863 (87.3%) were low risk and 557 (12.6%) were intermediate-high risk. The 5-year mortality for the low-risk cohort was 10.9% (95% confidence interval [CI], 9.83%-12.05%), and for the intermediate-high-risk cohort it was 40.1% (95% CI, 35.76%-44.54%). Among those undergoing PCI, 1163 (82.1%) were low risk, while 249 (17.6%) were intermediate-high risk. The 5-year mortality for the low-risk cohort was 21.6% (95% CI, 19.10%-24.26%), and for the intermediate-high-risk cohort it was 61.8% (95% CI, 54.72%-68.70%). CONCLUSIONS: This study reports outcomes stratified by surgical risk after PCI or CABG in patients with multivessel coronary disease. These data can help guide the revascularization strategy choice for individual patients.

Long term mortality and readmissions after transcatheter aortic valve replacement.

BACKGROUND: Readmissions following transcatheter aortic valve replacement (TAVR) are common but detailed analysis of cardiac and non-cardiac inpatient readmissions beyond thirty days to different levels of care are limited. METHODS: Our study population was 1,037 consecutive patients who underwent TAVR between 2011-2017 within a multi-hospital quaternary health system. A retrospective chart review was performed and readmissions were adjudicated and classified based on primary readmission diagnosis (cardiac versus noncardiac) and level of care [intensive care unit (ICU) admission vs. non-ICU admission]. Incidence, causes, and outcomes of readmissions to up to three years post procedure were evaluated. RESULTS: Of the 1,017 patients who survived their index hospitalization, there were readmissions due to noncardiac causes in 350 (34.4%) and cardiac causes in 208 (20.5%) during a mean 1.96 years of follow-up. The most common non-cardiac causes of readmission were sepsis/infection (14.3%), gastrointestinal (8.3%), and respiratory (4.8%), whereas heart failure (14.0%) and arrhythmias (4.6%) were the most common cardiac causes of readmission. A total of 191 (18.8%) patients were readmitted to the ICU and 372 patients (36.6%) were non-ICU readmissions. The risk of a noncardiac readmission was highest in the period immediately following TAVR (~4.5% per month) with an early high hazard phase that gradually declined over months. However, the risk of cardiac readmission remained stable at ~1% per month throughout. TAVR patients that were readmitted for any cause had markedly increased mortality; this was especially true for patients readmitted to an ICU. CONCLUSIONS: In TAVR patients who survived their index hospitalization, non-cardiac readmissions were more prevalent than cardiac. The risk of readmission and subsequent mortality was highest immediately post-procedure and declined thereafter. Readmission to ICU portends the highest risk of subsequent death in this cohort. Patient baseline co-morbidities are an important consideration for TAVR patients and play a significant role in readmissions and outcomes.

Cardiovascular Disease Risk-Based Statin Utilization and Associated Outcomes in a Primary Prevention Cohort: Insights From a Large Health Care Network.

BACKGROUND: Current American College of Cardiology/American Heart Association guidelines recommend using the 10-year atherosclerotic cardiovascular disease (ASCVD) risk to guide statin therapy for primary prevention. Real-world data on adherence and consequences of nonadherence to the guidelines in primary are limited. We investigated the guideline-directed statin intensity (GDSI) and associated outcomes in a large health care system, stratified by ASCVD risk. METHODS: Statin prescription in patients without coronary artery disease, peripheral vascular disease, or ischemic stroke were evaluated within a large health care network (2013-2017) using electronic medical health records. Patient categories constructed by the 10-year ASCVD risk were borderline (5%-7.4%), intermediate (7.5%-19.9%), or high (≥20%). The GDSI (before time of first event) was defined as none or any intensity for borderline, and at least moderate for intermediate and high-risk groups. Mean (±SD) time to start/change to GDSI from first interaction in health care and incident rates (per 1000 person-years) for each outcome were calculated. Cox regression models were used to calculate hazard ratios for incident ASCVD and mortality across risk categories stratified by statin utilization. RESULTS: Among 282 298 patients (mean age ≈50 years), 29 134 (10.3%), 63 299 (22.4%), and 26 687 (9.5%) were categorized as borderline, intermediate, and high risk, respectively. Among intermediate and high-risk categories, 27 358 (43%) and 8300 (31%) patients did not receive any statin, respectively. Only 17 519 (65.6%) high-risk patients who were prescribed a statin received GDSI. The mean time to GDSI was ≈2 years among the intermediate and high-risk groups. At a median follow-up of 6 years, there was a graded increase in risk of ASCVD events in intermediate risk (hazard ratio=1.15 [1.07-1.24]) and high risk (hazard ratio=1.27 [1.17-1.37]) when comparing no statin use with GDSI therapy. Similarly, mortality risk among intermediate and high-risk groups was higher in no statin use versus GDSI. CONCLUSIONS: In a real-world primary prevention cohort, over one-third of statin-eligible patients were not prescribed statin therapy. Among those receiving a statin, mean time to GDSI was ≈2 years. The consequences of nonadherence to guidelines are illustrated by greater incident ASCVD and mortality events. Further research can develop and optimize health care system strategies for primary prevention.

Impact of Combined Pre and Postcapillary Pulmonary Hypertension on Survival after Transcatheter Aortic Valve Implantation.

We aimed to evaluate the association between pulmonary hypertension (PH) hemodynamic classification and all-cause mortality in patients with symptomatic severe aortic stenosis (AS) undergoing transcatheter aortic valve implantation (TAVI). PH is common and associated with post-TAVI outcomes in patients with severe AS. Although PH in these patients is primarily driven by elevated left-sided pressures (postcapillary PH), some patients develop increased pulmonary vascular resistance (PVR) configuring the combined pre- and postcapillary PH (CpcPH). We analyzed severe AS patients with mean pulmonary artery pressure (mPAP) measured by right heart catheterization (RHC) before TAVI between 2011 and 2017. PH hemodynamic classification was defined as: No PH (mPAP < 25 mm Hg); precapillary PH (mPAP ≥ 25 mm Hg, pulmonary capillary wedge pressure (PCWP) ≤15 mm Hg); isolated postcapillary PH (IpcPH; mPAP ≥ 25 mm Hg, PCWP > 15 mm Hg, PVR ≤ 3 Wood units (WU); CpcPH (mPAP ≥ 25 mm Hg, PCWP > 15 mm Hg, PVR > 3 WU). Kaplan-Meier and Cox regression analyses were used to test the association of PH hemodynamic classification with post-TAVI all-cause mortality. We examined 561 patients (mean age 82 ± 8 years, 51% men, mean LVEF 54 ± 14%). The prevalence of no PH was 201 (36%); precapillary PH, 59 (10%); IpcPH, 189 (34%); and CpcPH, 112 (20%). During a median follow-up of 30 months, 240 all-cause deaths occurred. Patients with CpcPH had higher mortality than those with no-PH even after adjustment for baseline characteristics (Hazard ratio 1.56, 95% confidence interval 1.06 to 2.29, p = 0.025). There was no survival difference among patients with non-PH, precapillary PH and IpcPH. In conclusion, for patients with symptomatic severe AS treated with TAVI, CcpPH is independently associated with long-term all-cause mortality despite successful TAVI.

Surgical versus percutaneous multivessel coronary revascularization in patients with chronic kidney disease.

OBJECTIVES: This study compared contemporary outcomes following surgical versus percutaneous coronary revascularization for multivessel coronary artery disease (MVCAD) in patients with chronic kidney disease. METHODS: Patients with MVCAD and a reduced glomerular filtration rate (<60 ml/min) undergoing coronary bypass surgery (CABG) or percutaneous coronary intervention (PCI) at a single institution between 2010 and 2017 were included. The primary outcome was major adverse cardiac and cerebrovascular events (MACCE) defined as a composite outcome of death, stroke, myocardial infarction or repeat revascularization. Multivariable Cox regression models were used for risk-adjustment and propensity matching was also performed. RESULTS: A total of 1853 patients were included in the study (1269 CABG, 584 PCI). CABG was associated with greater 5-year freedom from MACCE (70.1% vs 47.3%, P < 0.0001), a finding that persisted after risk-adjustment. The rates of early and late mortality and readmission were also lower with CABG as were individual rates of myocardial infarction and repeat revascularization. A propensity-matched analysis generated 704 well-matched patients (352 in each arm) with similar results, including greater 5-year freedom from MACCE (72.8% vs 45.8%, P < 0.0001), improved 5-year survival (73.9% vs 52.3%, P < 0.0001), lower readmission (cause-specific hazard ratio 0.68, 95% confidence interval 0.58-0.80; P < 0.0001), lower individual rates of myocardial infarction (2.6% vs 9.7%, P < 0.0001) and repeat revascularization (1.1% vs 7.4%, P < 0.0001). CONCLUSIONS: CABG is associated with a lower MACCE rate than that of PCI in patients with MVCAD and chronic kidney disease. Multidisciplinary discussions regarding the optimal revascularization strategy are important in MVCAD, particularly in more complex scenarios such as chronic kidney disease.

Baseline global longitudinal strain by computed tomography is associated with post transcatheter aortic valve replacement outcomes.

BACKGROUNDS: Subclinical myocardial dysfunction detected by global longitudinal strain (GLS) using echocardiography is associated with poor outcomes in patients with severe aortic stenosis (AS) despite normal left ventricular ejection fraction (LVEF). Computed tomography angiography derived GLS (CTA-GLS) has recently shown to be feasible, however the prognostic value remains unclear in severe AS patients treated with transcatheter aortic valve replacement (TAVR). METHODS: We analyzed consecutive patients who underwent TAVR with pre-TAVR retrospective gated acquisition CTA study with adequate image quality covering the entire left ventricle. CTA-GLS analysis was performed using 2D CT-Cardiac Performance Analysis prototype software (TomTec GmbH). Kaplan-Meier and Cox regression analyses were performed to evaluate the association of baseline CTA-GLS with all-cause mortality and a composite outcome of all-cause death and hospitalization for heart failure after TAVR. RESULTS: A total of 223 patients were included (mean age 83.5 ± 6.8 years, 45.7% female, mean CTA-LVEF 50.7 ± 14.5%). During a median follow-up of 32 months, 81 all-cause deaths and 134 composite outcomes occurred. When compared to patients with normal LVEF (≥50%) and preserved CTA-GLS (≤-20.5%), patients with normal LVEF but reduced CTA-GLS (>-20.5%) had higher all-cause mortality (Chi-square 6.89, p = 0.032) and the risk of composite outcome (Chi-square 7.80, p = 0.020) which was no different than those with impaired LVEF. Reduced CTA-GLS was independently associated with all-cause mortality (HR 1.71, 95% CI 1.01-2.90, p = 0.049) and the risk of composite outcome (HR 1.51, 95% CI 1.01-2.25, p = 0.044) on multivariable Cox regression analysis. CONCLUSIONS: Reduced CTA-GLS provides independent prognostic value above multiple clinical and echocardiographic characteristics.

Safety and Efficacy of Direct Oral Anticoagulants Versus Warfarin in Patients With Chronic Kidney Disease and Atrial Fibrillation.

Patients with atrial fibrillation (AF) commonly have impaired renal function. The safety and efficacy of direct oral anticoagulants (DOACs) in patients with chronic kidney disease (CKD) and end-stage renal disease has not been fully elucidated. This study evaluated and compared the safety outcomes of DOACs versus warfarin in patients with nonvalvular AF and concomitant CKD. Patients in our health system with AF prescribed oral anticoagulants during 2010 to 2017 were identified. All-cause mortality, bleeding and hemorrhagic, and ischemic stroke were evaluated based on degree of renal impairment and method of anticoagulation. There were 21,733 patients with a CHA2DS2-VASc score of ≥2 included in this analysis. Compared with warfarin, DOAC use in patients with impaired renal function was associated with lower risk of mortality with a hazard ratio (HR): 0.76 (95% confidence interval [CI] 0.70 to 0.84, p value <0.001) in patients with eGFR >60, HR 0.74 (95% CI 0.68 to 0.81, p value <0.001) in patients with eGFR >30 to 60, and HR 0.76 (95% CI 0.63 to 0.92, p value <0.001) in patients with eGFR ≤30 or on dialysis. Bleeding requiring hospitalization was also less in the DOAC group with a HR 0.93 (95% CI 0.82 to 1.04, p value 0.209) in patients with eGFR >60, HR 0.83 (95% CI 0.74 to 0.94, p value 0.003) in patients with eGFR >30 to 60, and HR 0.69 (95% CI 0.50 to 0.93, p value 0.017) in patients with eGFR ≤30 or on dialysis. In conclusion, in comparison to warfarin, DOACs appear to be safe and effective with a lower risk of all-cause mortality and lower bleeding across all levels of CKD.

Coronary Bypass Versus Percutaneous Revascularization in Multivessel Coronary Artery Disease.

BACKGROUND: This study focused on contemporary outcomes after coronary artery bypass graft (CABG) surgery versus percutaneous coronary intervention (PCI) in patients with multivessel coronary artery disease (MVCAD). METHODS: This was a propensity-matched retrospective, observational analysis. Patients with MVCAD who underwent CABG or PCI between 2010 and 2018 and for whom data were available through the National Cardiovascular Data Registry or The Society of Thoracic Surgeons Adult Cardiac Surgery Database were included. The primary outcome was overall survival. Secondary outcomes included freedom from inpatient readmission and freedom from repeat revascularization. RESULTS: Of the initial 6,163 patients with MVCAD, the propensity-matched cohort included 844 in each group. The estimated 1-year mortality was 11.5% and 7.2% (p < 0.001) in the PCI and CABG groups, respectively, with an overall hazard ratio for mortality of PCI versus CABG of 1.64 (95% confidence interval [CI], 1.29 to 2.10; p < 0.001). The overall hazard ratio for readmission for PCI versus CABG was 1.42 (95% CI, 1.23 to 1.64; p < 0.001). The overall hazard ratio for repeat revascularization for PCI versus CABG was 4.06 (95% CI, 2.39 to 6.91; p < 0.001). Overall major adverse cardiovascular events and individual outcomes of mortality, readmission, and repeat revascularization all favored CABG across virtually all major clinical subgroups. CONCLUSIONS: This contemporary propensity-matched analysis of patients undergoing coronary revascularization for MVCAD demonstrates a significant mortality benefit with CABG over PCI, and this benefit is consistent across virtually all major patient subgroups. Futures studies are needed reflecting routine practice to assess how best to approach shared decision making and informed consent when it comes to revascularization decisions in any patient with MVCAD.

Longitudinal Outcomes of Women Undergoing Transcatheter Aortic Valve Replacement.

OBJECTIVE: Recent data have suggested that women have a survival benefit at 1-year follow-up. However, long-term gender-based TAVR outcomes are lacking. METHODS: All patients undergoing isolated TAVR from 2011 to 2017 were included. Patients were stratified by gender. The primary outcomes of the study were 3-year mortality and 3-year hospital readmissions. Multivariable logistic regression analysis was used to evaluate the risk-adjusted impact of gender on TAVR outcomes. RESULTS: A total of 1,036 patients were divided into male (n = 518) and female (n = 518) cohorts. Women had a borderline significantly increased STS PROM (8.3% ± 5 vs. 7.7% ± 4.4; P = 0.05). The majority of procedures were performed under conscious sedation (male: 89% vs. female: 88%; P = 0.62) and via transfemoral access (male: 81.8% vs. female: 81.4%; P = 0.46). There was no difference in operative (30-day) mortality (male: 15 [3.3%] vs. female: 17 [3.7%]; P = 0.77) or 30-day readmissions (male: 40 [10.8%] vs. female: 44 [12.2%]; P = 0.56). Perioperative blood product usage was higher for women (male: 8.1% vs. female: 14.1%; P = 0.002). There was no significant difference in major vascular complications (male: 0.4% vs. female: 1.0%; P = 0.26) or major bleeding (male: 0.2% vs. female: 0.4%; P = 0.56). Permanent pacemaker placement was higher for males (11.6% vs. 7.0%; P = 0.01). On risk-adjusted multivariable analysis, gender was not a factor associated with mortality (HR 0.99 [0.76 to 1.30]; P = 0.99) or readmission (HR 0.90 [0.72 to 1.14]; P = 0.42) at 5 years. CONCLUSIONS: There was no difference in survival or readmissions on multivariable analysis for women undergoing TAVR at 3 years. Longitudinal multi-institutional data will be important to validate these findings.

Long-term Hospital Readmissions After Surgical Vs Transcatheter Aortic Valve Replacement.

BACKGROUND: Limited data exist for rates and causes of readmission beyond short-term follow-up for patients undergoing surgical and transcatheter aortic valve replacement (SAVR and TAVR) METHODS: Patients undergoing isolated SAVR and TAVR between 2011 and 2017 at our institution were included in this study. The primary outcome was 5-year hospital readmission. The readmission cohort was identified from index readmission. Multivariable logistic regression analysis was used to evaluate the risk-adjusted impact of TAVR vs SAVR on outcomes. RESULTS: A total of 2379 patients were included: 1034 TAVR (43.5%) and 1345 SAVR (56.5%). Patients undergoing TAVR were on average older (81.8 ± 7.8 years vs 69.1 ± 11.85 years, P < .0001) and had more comorbidities than SAVR patients as represented by a greater Society of Thoracic Surgeons Predicted Risk of Mortality (7.96% ± 4.71% vs 2.73% ± 2.93%, P < .0001). Operative mortality was higher in the TAVR cohort (3.19% vs 1.12%, P < .004) and remained high at 5 years despite risk adjustment. Significantly more cardiac readmissions were found at 5-year follow-up in the TAVR group (73.3% vs 60.0%, P < .0001). Heart failure was the most common cause of cardiac readmission in the TAVR cohort (58.7% vs 42.1%, P = .0001). No difference was found in overall readmission risk at 30 days (hazard ratio [HR] 1.23, 95% confidence interval [CI]: 0.94 to 1.61, P = .12), 1 year (HR 0.93, 95% CI: 0.77 to 1.16, P = .52), and 5 years (HR 0.99, 95% CI: 0.83 to 1.18, P = .89). CONCLUSIONS: There is a disproportionately high rate of long-term hospital readmissions for cardiac causes, including heart failure, in patients who underwent TAVR. These data may support aggressive medical management of patients with careful follow-up in patients undergoing TAVR.

Association of Structural and Functional Cardiac Changes With Transcatheter Aortic Valve Replacement Outcomes in Patients With Aortic Stenosis.

Importance: Severe aortic stenosis causes pressure overload of the left ventricle, resulting in progressive cardiac dysfunction that can extend beyond the left ventricle. A staging system for aortic stenosis has been recently proposed that quantifies the extent of structural and functional cardiac changes in aortic stenosis. Objectives: To confirm the reproducibility of a proposed staging system and expand the study findings by performing a survival analysis and to evaluate the association of aortic stenosis staging with both cardiac and noncardiac post-transcatheter aortic valve replacement (TAVR) readmissions. Design, Setting, and Participants: A cohort analysis was conducted involving patients with severe aortic stenosis who underwent TAVR at the University of Pittsburgh Medical Center between July 1, 2011, and January 31, 2017. Patients who had undergone TAVR for valve-in-valve procedures and had an incomplete or unavailable baseline echocardiogram study for review were excluded. Clinical, laboratorial, and procedural data were collected from the Society of Thoracic Surgeons database and augmented by electronic medical record review. Exposures: The aortic stenosis staging system is based on echocardiographic markers of abnormal cardiac function. The stages are as follows: stage 1 (left ventricle changes - increased left ventricular mass index; early mitral inflow to early diastolic mitral annulus velocity (E/e') >14; and left ventricular ejection fraction <50%), stage 2 (left atrial or mitral changes - left atrial volume index >34 mL/m2; moderate to severe mitral regurgitation; and atrial fibrillation), stage 3 (pulmonary artery or tricuspid changes - pulmonary artery systolic pressure ≥60 mm Hg; moderate to severe tricuspid regurgitation), and stage 4 (right ventricle changes - moderate to severe right ventricle dysfunction). Main Outcomes and Measures: Primary outcome was post-TAVR all-cause mortality. Secondary outcomes were composite outcomes of all-cause mortality and post-TAVR all-cause and cardiac-cause readmissions. Results: A total of 689 consecutive patients (351 [50.9%] were male, with a mean [SD] age of 82.4 [7.6] years) were included. The prevalence of stage 1 was 13%; stage 2, 62%; stage 3, 21%; and stage 4, 4%. Patients with higher staging had a greater burden of comorbidities as captured by the Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM). Despite adjustment for STS-PROM, a graded association was found between aortic stenosis staging and all-cause mortality (hazard ratio [HR] stage 2 vs stage 1: 1.37 [95% CI, 0.81-2.31; P = .25]; stage 3 vs stage 1: 2.24 [95% CI, 1.28-3.92; P = .005]; and stage 4 vs stage 1: 2.83 [95% CI, 1.39-5.76; P = .004]). Stage 3 patients had higher post-TAVR readmission rates for both cardiac (HR, 1.84; 95% CI, 1.13-3.00; P = .01) and noncardiac causes. Conclusions and Relevance: Aortic stenosis staging appears to show a strong graded association between the extent of cardiac changes and post-TAVR all-cause mortality; such staging may improve patient care, risk stratification, assessment of prognosis, and shared decision making for patients undergoing TAVR.

Sunflower pan-genome analysis shows that hybridization altered gene content and disease resistance.

Domesticated plants and animals often display dramatic responses to selection, but the origins of the genetic diversity underlying these responses remain poorly understood. Despite domestication and improvement bottlenecks, the cultivated sunflower remains highly variable genetically, possibly due to hybridization with wild relatives. To characterize genetic diversity in the sunflower and to quantify contributions from wild relatives, we sequenced 287 cultivated lines, 17 Native American landraces and 189 wild accessions representing 11 compatible wild species. Cultivar sequences failing to map to the sunflower reference were assembled de novo for each genotype to determine the gene repertoire, or 'pan-genome', of the cultivated sunflower. Assembled genes were then compared to the wild species to estimate origins. Results indicate that the cultivated sunflower pan-genome comprises 61,205 genes, of which 27% vary across genotypes. Approximately 10% of the cultivated sunflower pan-genome is derived through introgression from wild sunflower species, and 1.5% of genes originated solely through introgression. Gene ontology functional analyses further indicate that genes associated with biotic resistance are over-represented among introgressed regions, an observation consistent with breeding records. Analyses of allelic variation associated with downy mildew resistance provide an example in which such introgressions have contributed to resistance to a globally challenging disease.

Right ventricle to pulmonary artery coupling in patients undergoing transcatheter aortic valve implantation.

OBJECTIVES: To evaluate the prognostic value of the ratio between tricuspid annular plane systolic excursion (TAPSE)-pulmonary artery systolic pressure (PASP) as a determinant of right ventricular to pulmonary artery (RV-PA) coupling in patients undergoing transcatheter aortic valve replacement (TAVI). BACKGROUND: RV function and pulmonary hypertension (PH) are both prognostically important in patients receiving TAVI. RV-PA coupling has been shown to be prognostic important in patients with heart failure but not previously evaluated in TAVI patients. METHODS: Consecutive patients with severe aortic stenosis who received TAVI from July 2011 through January 2016 and with comprehensive baseline echocardiogram were included. All individual echocardiographic images and Doppler data were independently reviewed and blinded to the clinical information and outcomes. Cox models quantified the effect of TAPSE/PASP quartiles on subsequent all-cause mortality while adjusting for confounders. RESULTS: A total of 457 patients were included with mean age of 82.8±7.2 years, left ventricular ejection fraction (LVEF) 54%±13%, PASP 44±17 mm Hg. TAPSE/PASP quartiles showed a dose-response relationship with survival. This remained significant (HR for lowest quartile vs highest quartile=2.21, 95% CI 1.07 to 4.57, p=0.03) after adjusting for age, atrial fibrillation, LVEF, stroke volume index, Society of Thoracic Surgeons Predicted Risk of Mortality. CONCLUSION: Baseline TAPSE/PASP ratio is associated with all-cause mortality in TAVI patients as it evaluates RV systolic performance at a given degree of afterload. Incorporation of right-side unit into the risk stratification may improve optimal selection of patients for TAVI.

Open Surgical Access for Transfemoral TAVR Should Not Be a Contraindication for Conscious Sedation.

OBJECTIVES: The use of monitored anesthesia care (MAC) for transcatheter aortic valve replacement (TAVR) is gaining favor in the United States, although general anesthesia (GA) continues to be common for these procedures. Open surgical cutdown for transfemoral TAVR has been a relative contraindication for TAVR with MAC at most centers. The objective of this study was to review the authors' results of transfemoral TAVR performed in patients with open surgical cutdown with the use of MAC. DESIGN: Retrospective study design from a prospectively recorded database. SETTING: Tertiary academic (teaching) hospital. PARTICIPANTS: Two hundred eighty-two patients undergoing transfemoral TAVR with open surgical cutdown under MAC from 2015 to 2017. INTERVENTIONS: Transfemoral TAVR under MAC with surgical cutdown for femoral vascular access. MEASUREMENTS AND MAIN RESULTS: The study cohort consisted of 282 patients with severe aortic stenosis (mean area 0.65 [± 0.16] cm2, mean gradient of 48.9 [±13.3] mmHg, and mean age of 82.7 [± 7.31] years). Eleven (3.9%) patients required conversion to GA. First postoperative pain score (0-10) was 2.9 and highest postoperative pain score was 4.6. Major and minor vascular complications occurred in 2 (0.7%) and 6 (2.1%) patients, respectively. Twenty-nine (10.3%) patients were readmitted within 30 days, and 6 (2.1%) patients had in-hospital mortality. CONCLUSIONS: Open surgical cutdown for transfemoral TAVR can be performed safely using MAC and ilioinguinal block with low rates of conversion to general anesthesia and acceptable postoperative outcomes and pain scores.

Impact of cigarette taxes on smoking prevalence from 2001-2015: A report using the Behavioral and Risk Factor Surveillance Survey (BRFSS).

OBJECTIVES: To provide an up-to-date analysis on the relationship between excise taxes and the prevalence of cigarette smoking in the United States. METHODS: Linear mixed-effects models were used to model the relationship between excise taxes and prevalence of cigarette smoking in each state from 2001 through 2015. RESULTS: From 2001 through 2015, increases in state-level excise taxes were associated with declines in prevalence of cigarette smoking. The effect was strongest in young adults (age 18-24) and weakest in low-income individuals (<$25,000). CONCLUSIONS: Despite the shrinking pool of current smokers, excise taxes remain a valuable tool in public-health efforts to reduce the prevalence of cigarette smoking. POLICY IMPLICATIONS: States with high smoking prevalence may find increased excise taxes an effective measure to reduce population smoking prevalence. Since the effect is greatest in young adults, benefits of increased tax would likely accumulate over time by preventing new smokers in the pivotal young-adult years.

5-Year Outcomes of Self-Expanding Transcatheter Versus Surgical Aortic Valve Replacement in High-Risk Patients.

BACKGROUND: The CoreValve U.S. Pivotal High Risk Trial was the first randomized trial to show superior 1-year mortality of transcatheter aortic valve replacement (TAVR) compared with surgical aortic valve replacement (SAVR) among high operative mortality-risk patients. OBJECTIVES: The authors sought to compare TAVR to SAVR for mid-term 5-year outcomes of safety, performance, and durability. METHODS: Surgical high-risk patients were randomized (1:1) to TAVR with the self-expanding bioprosthesis or SAVR. VARC-1 (Valve Academic Research Consortium I) definitions were applied. Severe hemodynamic structural valve deterioration was defined as a mean gradient ≥40 mm Hg or a change in gradient ≥20 mm Hg or new severe aortic regurgitation. Five-year follow-up was planned. RESULTS: A total of 797 patients were randomized at 45 U.S. centers, of whom 750 underwent an attempted implant (TAVR = 391, SAVR = 359). The overall mean age was 83 years, and the STS score was 7.4%. All-cause mortality rates at 5 years were 55.3% for TAVR and 55.4% for SAVR. Subgroup analysis showed no differences in mortality. Major stroke rates were 12.3% for TAVR and 13.2% for SAVR. Mean aortic valve gradients were 7.1 ± 3.6 mm Hg for TAVR and 10.9 ± 5.7 mm Hg for SAVR. No clinically significant valve thrombosis was observed. Freedom from severe SVD was 99.2% for TAVR and 98.3% for SAVR (p = 0.32), and freedom from valve reintervention was 97.0% for TAVR and 98.9% for SAVR (p = 0.04). A permanent pacemaker was implanted in 33.0% of TAVR and 19.8% of SAVR patients at 5 years. CONCLUSIONS: This study shows similar mid-term survival and stroke rates in high-risk patients following TAVR or SAVR. Severe structural valve deterioration and valve reinterventions were uncommon. (Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement; NCT01240902).

The Efficacy of Ketogenic Diet for Specific Genetic Mutation in Developmental and Epileptic Encephalopathy.

Objectives: Pathogenic mutations in developmental and epileptic encephalopathy (DEE) are increasingly being discovered. However, little has been known about effective targeted treatments for this rare disorder. Here, we assessed the efficacy of ketogenic diet (KD) according to the genes responsible for DEE. Methods: We retrospectively evaluated the data from 333 patients who underwent a targeted next-generation sequencing panel for DEE, 155 of whom had tried KD. Patients showing ≥90% seizure reduction from baseline were considered responders. The KD efficacy was examined at 3, 6, and 12 months after initiation. Patients were divided into those with an identified pathogenic mutation (n = 73) and those without (n = 82). The KD efficacy in patients with each identified pathogenic mutation was compared with that in patients without identified genetic mutations. Results: The responder rate to KD in the patients with identified pathogenic mutations (n = 73) was 52.1, 49.3, and 43.8% at 3, 6, and 12 months after initiation, respectively. Patients with mutations in SCN1A (n = 18, responder rate = 77.8%, p = 0.001), KCNQ2 (n = 6, responder rate = 83.3%, p = 0.022), STXBP1 (n = 4, responder rate = 100.0%, p = 0.015), and SCN2A (n = 3, responder rate = 100.0%, p = 0.041) showed significantly better responses to KD than patients without identified genetic mutations. Patients with CDKL5 encephalopathy (n = 10, responder rate = 0.0%, p = 0.031) showed significantly less-favorable responses to KD. Conclusions: The responder rate to KD remained consistent after KD in DEE patients with specific pathogenic mutations. KD is effective in patients with DEE with genetic etiology, especially in patients with SCN1A, KCNQ2, STXBP1, and SCN2A mutations, but is less effective in patients with CDKL5 mutations. Therefore, identifying the causative gene can help predict the efficacy of KD in patients with DEE.

Surgical cut down for vascular access with conscious sedation for transcatheter aortic valve replacement: the best of both worlds?

OBJECTIVES: Despite the established efficacy of transcatheter aortic valve replacement for aortic valve replacement, vascular complications remain a major cause of procedural morbidity and mortality. In this study, we evaluate the use of femoral artery cut down with conscious sedation and report outcomes and complications associated with this approach. METHODS: Our study included 282 patients undergoing transcatheter aortic valve replacement with conscious sedation and surgical cut down for femoral access between 2015 and 2017. Data were prospectively recorded in the local institutional database and were retrospectively accessed. Descriptive statistics are presented, and a Kaplan-Meier time-to-event plot was used to estimate 1-year survival. RESULTS: The mean age of the patients was 82.7 ± 7.31 years and consisted of 146 (52%) women. Echocardiographic data demonstrated a severe aortic stenosis with a mean area of 0.65 ± 0.16 cm2 and a mean gradient of 48.9 ± 13.3 mmHg. STS-PROM for the cohort was 7.2%, representing an intermediate risk group. Six (2.2%) patients died within 30 days after transcatheter aortic valve replacement. Major vascular complications occurred in 2 (0.7%) patients and minor vascular complications occurred in 6 (2.2%) patients in our cohort. Wound complications were observed in 2 (0.7%) patients. CONCLUSIONS: We demonstrate that the use of conscious sedation and surgical cut down for femoral arterial access resulted in a major vascular complication rate of less than 1% and low in-hospital mortality rates without any significant increase in wound complications.