text:
Acute and 30-Day Outcomes in Women After TAVRResults From the WIN-TAVI (Women's INternational Transcatheter Aortic Valve Implantation) Real-World Registry
Author + information
- Received May 9, 2016
- Accepted May 9, 2016
- Published online August 8, 2016.
Author Information
- Alaide Chieffo, MDa,
- Anna Sonia Petronio, MDb,
- Julinda Mehilli, MDc,
- Jaya Chandrasekhar, MBBSd,
- Samantha Sartori, PhDd,
- Thierry Lefèvre, MDe,
- Patrizia Presbitero, MDf,
- Piera Capranzano, MDg,
- Didier Tchetche, MDh,
- Alessandro Iadanza, MDi,
- Gennaro Sardella, MDj,
- Nicolas M. Van Mieghem, MD, PhDk,
- Emanuele Meliga, MDl,
- Nicholas Dumonteil, MDm,
- Chiara Fraccaro, MD, PhDn,
- Daniela Trabattoni, MDo,
- Ghada W. Mikhail, MDp,
- Samin Sharma, MDq,
- Maria Cruz Ferrer, MDr,
- Christoph Naber, MDs,
- Peter Kievit, MDt,
- Michela Faggioni, MDb,d,
- Clayton Snyder, BScd,
- Marie Claude Morice, MDe,
- Roxana Mehran, MDd,∗ (roxana.mehran{at}mountsinai.org),
- WIN-TAVI Investigators
- aDepartment of Cardiology, San Raffaele Scientific Institute, Milan, Italy
- bDepartment of Cardiology, AOUP Cisanello, University Hospital, Pisa, Italy
- cDepartment of Cardiology, Ludwig-Maximilians-University of Munich, Munich, Germany
- dThe Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York
- eDepartment of Cardiology, Institut Hospitalier Jacques Cartier, Ramsay Générale de Santé, Massy, France
- fDepartment of Cardiology, Istituto Clinico Humanitas; Milan, Italy
- gDepartment of Cardiology, University of Catania, Catania, Italy
- hDepartment of Cardiology, Clinique Pasteur, Toulouse, France
- iDepartment of Cardiology, Azienda Ospedaliera Universitaria Senese, Policlinico Le Scotte, Siena, Italy
- jDepartment of Cardiology, Policlinico "Umberto I", "Sapienza" University of Rome, Rome, Italy
- kDepartment of Cardiology, Erasmus Medical Center, Thoraxcenter, Rotterdam, the Netherlands
- lDepartment of Cardiology, Mauriziano Hospital, Turin, Italy
- mDepartment of Cardiology, Rangueil University Hospital, Toulouse, France
- nDepartment of Cardiology, University of Padova, Padova, Italy
- oDepartment of Cardiology, Centro Cardiologico Monzino, Milan, Italy
- pDepartment of Cardiology, Imperial College Healthcare NHS Trust, Hammersmith Hospital, London, United Kingdom
- qDepartment of Cardiology, Mount Sinai Hospital, New York, New York
- rDepartment of Cardiology, Hospital Universitario Miguel Servet, Zaragoza, Spain
- sDepartment of Cardiology, Contilia Heart and Vascular Centre, Elisabeth Krankenhaus, Essen, Germany
- tDepartment of Cardiology, Radboud University Nijmegen Medical Center, Nijmegen, the Netherlands
- ↵∗Reprint requests and correspondence:
Dr. Roxana Mehran, MD, Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Place, Box 1030, New York, NY 10029
Objectives The study sought to examine the safety and performance of transcatheter aortic valve replacement (TAVR) using an all-female registry and to further explore the potential impact of female sex-specific characteristics on clinical outcomes after TAVR.
Background Although women comprise 50% of patients with symptomatic severe aortic stenosis undergoing TAVR, the optimal treatment strategy remains undetermined.
Methods The WIN-TAVI (Women's INternational Transcatheter Aortic Valve Implantation) registry is a multinational, prospective, observational registry of women undergoing TAVR for aortic stenosis, conducted without any external funding. The primary endpoint was the Valve Academic Research Consortium (VARC)-2 early safety endpoint at 30 days (composite of mortality, stroke, major vascular complication, life-threatening bleeding, stage 2 or 3 acute kidney injury, coronary artery obstruction, or repeat procedure for valve-related dysfunction).
Results Between January 2013 and December 2015, 1,019 women were enrolled across 19 European and North American centers. The mean patient age was 82.5 ± 6.3 years, mean EuroSCORE I was 17.8 ± 11.7% and mean Society of Thoracic Surgeons score was 8.3 ± 7.4%. TAVR was performed via transfemoral access in 90.6% and new-generation devices were used in 42.1%. In more than two-thirds of cases, an Edwards SAPIEN 23 mm (Edwards Lifesciences, Irvine, California) or Medtronic CoreValve ≤26 mm (Medtronic Inc., Minneapolis, Minnesota) device was implanted. The 30-day VARC-2 composite endpoint occurred in 14.0% with 3.4% all-cause mortality, 1.3% stroke, 7.7% major vascular complications, and 4.4% VARC life-threatening bleeding. The independent predictors of the primary endpoint were age (odds ratio [OR]: 1.04; 95% confidence interval [CI]: 1.00 to 1.08), prior stroke (OR: 2.02; 95% CI: 1.07 to 3.80), left ventricular ejection fraction <30% (OR: 2.62; 95% CI: 1.07 to 6.40), new device generation (OR: 0.59; 95% CI: 0.38 to 0.91), and history of pregnancy (OR: 0.57; 95% CI: 0.37 to 0.85).
Conclusions Women enrolled in this first ever all-female TAVR registry with collection of female sex-specific baseline parameters, were at intermediate-high risk and experienced a 30-day VARC-2 composite safety endpoint of 14.0% with a low incidence of early mortality and stroke. Randomized assessment of TAVR versus surgical aortic valve replacement in intermediate risk women is warranted to determine the optimal strategy.
Transcatheter aortic valve replacement (TAVR) has been clearly demonstrated to be an alternative treatment for severe aortic stenosis (AS) in patients considered at high risk for surgical aortic valve replacement (SAVR) (1,2). In the PARTNER A (Placement of AoRTic TraNscathetER valve trial) trial, women (n = 300; 42.9%) treated with TAVR had lower 12-month mortality compared to men (18.4% vs. 28.0%) (1,3). Recently, in the PARTNER 2 cohort A randomized trial, evaluating intermediate-risk patients with severe AS, TAVR was found to be similar to SAVR with respect to the primary endpoint of 2-year death or disabling stroke (19.3% with TAVR vs. 21.1% with SAVR; hazard ratio: 0.89; 95% confidence interval [CI]: 0.73 to 1.09; p = 0.25; p = 0.001 for noninferiority) (4).
Prior studies have shown that women are better represented in TAVR studies compared with coronary artery disease (CAD) trials, where the inclusion of women has historically been low (3,5–7). The reasons for this may be different left ventricular adaptation to AS in women (8,9) with predominant hypertrophy rather than dilation and preserved systolic function, as well as a low prevalence of concurrent CAD, both of which may delay symptom onset. Consequently women with symptomatic AS are older with a lower body mass index (BMI), characteristics that can influence the therapeutic decision for TAVR (10). Female sex itself is an independent predictor of survival in older patients undergoing conventional SAVR and therefore has bearing on heart team decision for TAVR rather than SAVR (3,11). In addition, the influence of female-specific or female-predominant factors such as frailty, osteoporosis, history of pregnancy, and age of menopause on TAVR outcomes is unknown. While frailty and osteoporosis have been linked with poor post-operative recovery (12), osteoporosis and vertebral fractures may also influence cardiac rotation impacting on device positioning and implantation. Lifetime hormonal influences may have a role in arterial stiffness and diastolic dysfunction, consequently impacting on AS (13) and post-TAVR outcomes.
Recent data have shown female sex to be independently associated with better recovery of LV systolic function following aortic valve replacement (9,14,15) with lower 1-year mortality compared to men undergoing TAVR (16,17). Thus, women may be more suited to derive greater benefit from TAVR. Nevertheless, studies have also reported that women undergoing TAVR experience more major vascular and bleeding complications and in a recent meta-analysis women experienced a high 30-day stroke rate (6,16,17). Therefore, the optimal approach to definitive management in women with symptomatic AS is undetermined.
The purpose of this multicenter international registry dedicated to women was to investigate the safety and performance of contemporary TAVR and to further explore the influence of female sex-specific factors which have never previously been investigated but may be relevant in the management of women undergoing TAVR.
The WIN-TAVI (Women's INternational Transcatheter Aortic Valve Implantation) registry (NCT01819181) is an international, multicenter, prospective, observational registry of women undergoing TAVR at 19 European and North American centers treated with commercially available and approved TAVR devices and delivery systems for the treatment of severe symptomatic AS. The centers were selected on the basis of review of individual site survey responses to determine the total number of TAVR performed at each center (minimum of 50) and the planned number of TAVR to be performed in the following year.
All participating sites had institutional approval from the local ethical review board and the study was conducted according to the principles of the Declaration of Helsinki, International Organization for Standardization Guidelines, and Good Clinical Practice Guidelines. All patients who met the inclusion criteria and provided written informed consent were enrolled in the study. Of note, the study was conducted without any external funding and was driven by the scientific interest and collaboration of the investigators. The protocol and study endpoints were designed by the executive committee and principal investigators of the study (Online Appendix).
Eligibility criteria
The main inclusion criteria were women with: 1) severe AS determined by echocardiography and Doppler, defined as mean gradient >40 mm Hg or peak jet velocity >4.0 m/s and an aortic valve area ≤0.8 cm2 or aortic valve area index ≤0.5 cm2/m2; and 2) symptoms of angina, congestive heart failure, New York Heart Association functional class ≥II, or syncope.
Additional inclusion criteria were on the basis of high logistic EuroSCORE or presence of other comorbidities (e.g., severe airways disease, porcelain aorta, previous thoracic radiotherapy, Child-Pugh class B and C liver disease) leading to multidisciplinary heart team (interventional cardiologists, cardiothoracic surgeons and cardiac anesthesiologists) decision for TAVR rather than SAVR.
The exclusion criteria were female patients not eligible for TAVR, untreated clinically significant (>70% obstruction) proximal vessel CAD amenable to revascularization; echocardiographic evidence of intracardiac mass, thrombus, or vegetation; hemodynamic instability (e.g., requiring inotropic support), active endocarditis or sepsis within 6 months prior to the study procedure or use of an investigational device without Conformité Européene mark.
TAVR procedure and clinical follow-up
Pre-screening included evaluation of medical history and diagnostic imaging performed as per standard of care (transthoracic/transesophageal echocardiogram and/or multidetector computed tomography measurements) at the treating physician's discretion (18). We also collected information on female specific factors including menstrual history, use of hormone replacement therapy, history of pregnancy, osteoporosis, and gynecological or breast cancer.
Procedural selection of access, device type, use of pre- and post-dilation, and interventional therapies was at the discretion of the treating physicians.
Patient follow-up was conducted by phone contact or clinic visit at 1 month, 6 months, 12 months, and 24 months following TAVR to record clinical status and occurrence of adverse events. Of note, as per the standard of care at the participating sites not all the patients underwent a neurological evaluation after TAVR, unless clinically indicated. All events were reported by the sites in the electronic study database.
The Clinical and Data coordinating center for the study was at the Icahn School of Medicine at Mount Sinai (New York, New York), which was responsible for the monitoring of electronic data entry for accuracy of data, database and data management and statistical analyses. All events were adjudicated by an independent Clinical Event Committee using source documents provided by the sites. The study was endorsed by the SCAI-WIN (Society for Cardiovascular Angiography and Interventions - Women In Innovation) initiative.
Study endpoints and definitions
Primary endpoint
The primary study endpoint was the Valve Academic Research Consortium (VARC) 2 early safety endpoint at 30 days—a composite of all-cause mortality, all stroke, major vascular complication, life-threatening bleeding, stage 2 or 3 acute kidney injury (AKI), coronary artery obstruction requiring intervention, or repeat procedure for valve-related dysfunction (19).
Secondary endpoints
Individual safety endpoints included the following: all-cause mortality, cardiovascular mortality, all stroke, myocardial infarction, bleeding (VARC-2 life-threatening or disabling and major bleeding and Bleeding Academic Research Consortium bleeding 3 or 5) (20), stage 2 or 3 AKI, and vascular complications. Additional TAVR-related endpoints included the following: coronary artery obstruction, surgical conversion, unplanned use of cardiopulmonary bypass, ventricular septal perforation, mitral valve apparatus damage or dysfunction, and cardiac tamponade and cardiac arrhythmias or conduction disturbances.
Outcomes beyond 30 days
Both the clinical efficacy endpoint and prosthetic valve performance endpoints will be evaluated beyond 30 days.
Study definitions
History of pregnancy was defined as any history of pregnancy and not pregnancy resulting in a live birth. Frailty was defined as judged by the heart team and use of objective scales was recommended but not mandated. Old-generation devices comprised Edwards SAPIEN XT (Edwards Lifesciences, Irvine, California) and Medtronic CoreValve (Medtronic Inc., Minneapolis, Minnesota). All other prostheses types are considered new-generation devices.
Statistical approach
Categorical data are presented as frequencies and percentages and were compared using the chi-square or Fisher exact test. Continuous variables are presented as mean ± SD or medians and interquartile range and were compared using Student t test or Wilcoxon signed rank test. Time-to-event curves were represented using Kaplan-Meier methods. Using logistic regression methods, we generated a multivariable model for predictors of the 30-day primary VARC-2 safety endpoint. The following covariates were entered in the model on the basis of prior data or expected impact on the outcome: age, BMI, diabetes, chronic kidney disease, prior coronary revascularization, atrial fibrillation, prior stroke, EuroSCORE I, frailty, left ventricular ejection fraction (LVEF) <30%, transfemoral versus nontransfemoral access, new versus old generation TAVR device, TAVR device >26 mm versus ≤26 mm, and post-TAVR aortic incompetence grade 2 or 3. The incremental value of each female-specific characteristic on the 30-day primary endpoint was evaluated adjusted for this model. All analyses were performed using Stata version 14.0 (StataCorp., College Station, Texas) and p values <0.05 were considered significant.
Study population
From January 2013 to December 2015, 1019 women were enrolled across 19 centers in Europe and North America. Baseline characteristics are shown in Table 1. The study population included women with a mean age of 82.5 ± 6.3 years, with mean BMI 26.0 ± 5.5, mean EuroSCORE I 17.8 ± 11.7%, and mean Society of Thoracic Surgeons score 8.3 ± 7.4%. History of diabetes was present in 264 (26.1%), chronic kidney disease in 306 (30.8%), prior percutaneous coronary intervention in 233 (22.9%), and prior stroke in 76 (7.5%) of the patients. The most common reasons for TAVR were high surgical risk, >80 years of age, and frailty as per surgical evaluation; nearly three-quarters (71%) of patients had more than 3 high-risk reasons for TAVR (Figures 1A and 1B).
The mean aortic annulus diameter was 21.8 ± 2.04 mm on pre-screening echocardiography and mean LVEF was 55.7 ± 10.7%. On multidetector computed tomography, mean aortic annulus diameter was 22.7 ± 2.0 mm and mean femoral artery diameter was 7.9 ± 3.2 mm. Baseline coronary angiography showed no obstructive disease in 62.6%, triple vessel disease in 10.4%, and left main disease in 5.7% patients.
Female sex-specific baseline characteristics
A total of 738 (72.4%) patients had a history of pregnancy, and only 31 of them reported to have suffered from a pregnancy-induced complication, either gestational diabetes or hypertension. History of osteoporosis was reported in 178 (17.5%) women; 56 of whom received medications for osteoporosis. Frailty and osteoporosis were noted in 103 (10.1%) women. History of breast and gynecological cancer were present in 9.3% and 2.3% of patients, respectively. The mean age of menopause was 48.8 ± 5.1 years.
Discharge information
The mean length of stay in the intensive care unit was 2.9 ± 3.3 days and mean duration of total hospital stay was 11.8 ± 8.0 days. Most (75.3%) of the patients were discharged home. Approximately 89% of patients were discharged on aspirin or P2Y12 receptor inhibitor, 50% on dual antiplatelet therapy, and 27.1% on an oral anticoagulant.
Procedural characteristics and complications
Table 2 shows the procedural characteristics of the study population. Local anesthesia or conscious sedation was used in 64.2% patients. TAVR was mainly performed via transfemoral access (90%) using a percutaneous approach (87.0%). In 32% of patients the sheath size used was 16-F or smaller. The devices used most often were CoreValve (47.2%) and Edwards SAPIEN (41.7%). New-generation devices were used in 42.1% (Figures 2A and 2B). In particular, SAPIEN 3 was used in 229 (22.4%) and Evolute R (Medtronic Inc., Minneapolis, Minnesota) in 79 (8.1%) of the overall patients. In more than two-thirds of cases, an Edwards SAPIEN 23 mm device (68.4% of all Edwards SAPIEN devices) or a Medtronic CoreValve ≤26 mm (66.6% of all Medtronic devices) was implanted.
Site-reported procedural complications are shown in Table 3. Valve embolization occurred in 11 (1.1%) patients. A total of 12 (1.2%) patients had annulus or aortic rupture, whereas 14 (1.4%) patients had ventricular perforation. Procedure-related atrioventricular block was reported in 81 (8.1%) cases. Online Table 1 demonstrates the procedural complications by valve type.
Primary and secondary study endpoints
Follow-up at 30 days was completed in 99.8% of the patients. The clinical outcomes at 30 days are shown in Table 4 and the Central Illustration. The composite safety primary endpoint occurred in 147 patients (14.0%). All cause death occurred in 40 (3.4%) patients, of these 38 (3.3%) were cardiac deaths. Stroke occurred in 13 (1.3%) patients and death or stroke occurred in 50 (4.9%) patients. Major vascular complications were observed in 80 (7.7%), VARC life-threatening bleeding in 45 (4.4%), and Bleeding Academic Research Consortium 3 or 5 bleeding in 123 (12%) patients. Coronary artery obstruction occurred in 7 (0.7%), TAV-in-TAV in 17 (1.7%), and surgical conversion in 7 (0.7%) of the patients. The incidence of stage 2 or 3 AKI was 1.3%.
Any arrhythmia or conduction disturbance was reported in 21.9% of the patients after TAVR, however new permanent pacemaker implantation occurred in 123 (12.1%) patients. AI grade ≥2 was reported in 14.1% and ≥3 in 1.9% on angiography post-TAVR implantation.
Figure 3 shows the prevalence of female-specific characteristics and the incidence of the VARC-2 safety endpoint in patients with versus without history of pregnancy (12.7% vs. 18.9%; p = 0.013). Patients without history of pregnancy were more likely to be considered frail on surgical assessment (70.0% vs. 61.3%; p = 0.01), were more often current smokers (5.4% vs. 2.5%; p =0.02), had left main disease ≥ 50% (8.7% vs. 4.6%; p = 0.06), or had severe aortic valve calcification (39.4% vs. 30.7%; p = 0.04).
Predictors of the 30-day primary safety endpoint
The baseline characteristics of women with and without the 30-day primary safety endpoint are shown in Online Table 2. On univariable analysis, patients with a prior stroke, higher Society of Thoracic Surgeons score, and LVEF <30% had a higher occurrence of the primary safety endpoint. Moreover, patients with a history of pregnancy had a lower occurrence of the primary safety endpoint. On multivariable logistic regression (Table 5⇓), age (OR: 1.04; 95% CI: 1.00 to 1.08; p = 0.028), prior stroke (OR: 2.02; 95% CI: 1.07 to 3.80; p = 0.029), LVEF <30% (OR: 2.62; 95% CI: 1.07 to 6.40; p = 0.035), and TAVR device generation (OR: 0.59; 95% CI: 0.38 to 0.91; p = 0.018) were independent predictors of the 30 day primary safety endpoint. History of pregnancy was an incremental predictor and was associated with lower rate of the 30-day primary safety endpoint (crude OR: 0.63; 95% CI: 0.43 to 0.91; p = 0.013; adjusted OR: 0.57, 95% CI: 0.37 to 0.85; p = 0.007) (Table 6).
The 30-day clinical outcomes in patients with and without history of pregnancy are shown in Online Table 3. Women with a history of pregnancy had lower rate of stroke, death or stroke and AKI but no difference in 30-day death or vascular or bleeding complications post-TAVR compared with women without history of pregnancy.
The WIN-TAVI registry is the first ever all-female single-arm study to evaluate the safety and performance of TAVR in women and to further explore the influence of other female sex-specific characteristics that have never been collected in prior TAVR studies. The study received no external funding and was entirely driven by site principal investigators who conducted enrollment, data collection and follow-up. This was made possible by the leadership of primarily female interventional cardiologists, with scientific collaboration from academic centers in Europe and North America.
The main findings of this report are: 1) nearly three-quarters of women undergoing TAVR for symptomatic AS were >80 years of age, almost 90% were considered high risk, and two-thirds were considered frail on surgical assessment; 2) the incidence of the 30-day VARC-2 composite safety endpoint was 14.0%, and all-cause mortality occurred in 3.4% and stroke in 1.3%; 3) although the primary endpoint was driven largely by vascular or bleeding events, the observed rate of these events was lower than previously reported; 4) the independent predictors of the 30-day VARC-2 composite safety endpoint were increasing age, history of prior stroke, LVEF <30%, and TAVR device generation; 5) remote history of pregnancy was found to be associated with lower rate of the 30-day VARC-2 composite endpoint; and 6) only 12.1% patients received a permanent pacemaker within 30 days.
Prevalence and characteristics of women undergoing TAVR
Despite the high prevalence of significant AS in women, the most optimal approach for definitive management remains undetermined. Compared with prior TAVR reports from sex-based subgroup analyses, our study population had lower calculated risk scores, identifying a predominantly intermediate-high risk population (5,6,15). Although the prevalence of baseline comorbidities was in keeping with prior studies, the key reasons for TAVR indicated by local heart teams included high surgical risk, >80 years of age and frailty with 3 or more high-risk reasons influencing decision making in the majority of the patients. This underlines the discrepancy between historical surgical scores and physician assessment of all individual patient comorbidities for selection of the appropriate treatment strategy. With respect to female sex-specific characteristics, most women (72%) had at least 1 pregnancy in their lifetime. The mean reported age of menopause and prevalence of osteoporosis was consistent with published literature (21). Conversely, the low prevalence of pregnancy-induced complications and female cancers may be subject to recall bias and under-reporting. Interestingly, only one-fifth of women with osteoporosis in our study were on treatment for it, a factor that may affect future rehabilitation and functional recovery (16).
With respect to procedural characteristics, this analysis represents current TAVR practice including mainly percutaneous transfemoral approach, low use of general anesthesia, 32% use of sheath sizes ≤16-F, and 42.1% use of new-generation devices (22–25).
30-day clinical endpoints
Aligned with prior literature, the most frequent events observed in our population were vascular and bleeding complications whereas the rate of death, stroke, and other endpoints was low. However, the observed rate of vascular and bleeding complications in the current study was lower than prior studies, which have reported an incidence upward of 7% to 10% (5,14,15). Several factors may have contributed to these results, including the lower risk profile of our population as compared with women in prior TAVR reports (5,6,15), the use of new-generation devices compatible with smaller sheaths, completely or partially retrievable, the expertise of our operators and centers and prescribed discharge antithrombotic regimens. We selected the study centers on the basis of the number of TAVR procedures performed prior to study commencement, reflecting that sites were not in an early learning curve. Moreover, we found that 50% of our study population was discharged on dual antiplatelet therapy whereas 27% of patients were prescribed an oral anticoagulant. Although the ideal antithrombotic regimen in TAVR is currently undetermined, discharge therapies may influence both early and long-term bleeding outcomes.
Notably, our 30-day incidence of all-cause mortality (3.4%) and stroke (1.3%) were low as compared to the recent meta-analysis by O'Connor et al. (15), who reported a mortality rate of 6.5% and a stroke rate of 4.4%. However, this meta-analysis included older TAVR studies and patients with higher EuroSCORE and/or Society of Thoracic Surgeons score. Conversely, as post-TAVR neurological evaluation was only performed at the clinical discretion of the centers, neurological events may be under-reported in our study. Certainly, a randomized comparison of SAVR versus TAVR in women is needed to establish the optimal approach. In fact, the findings of the current registry underscore the importance and safety of moving to a lower risk population of women with TAVR. Indeed, the potential superiority of transfemoral TAVR over SAVR in the PARTNER 2A trial may have been driven by better outcomes in women (4).
Predictors of 30-day VARC-2 safety endpoint
We observed that the independent predictors of the 30-day VARC-2 composite safety end point were age, prior stroke, LVEF <30%, and TAVR device generation. Although other studies have shown age to be a predictor of TAVR mortality, LVEF and prior stroke have been shown to be associated with early events in men but not in women (6,26). No study has shown TAVR device generation to be a predictor of early outcomes, however this is consistent with the reduction in outcomes shown in these device trials (22–25,27). Indeed, as the indication for TAVR continues to expand in intermediate-risk patients, the protective influence of new-generation TAVR devices is encouraging and may be due to the lower incidence of vascular and bleeding complications with smaller sheath sizes, more precise and accurate positioning with retrievable or partially retrievable devices, and lower paravalvular leak.
Of note, history of pregnancy and the number of prior pregnancies were incremental predictors of the 30-day primary safety endpoint, which remained significant despite adjusting for baseline risks expected to be correlated with adverse early outcomes. We found that patients without history of pregnancy were more frequently active smokers, with significant left main disease or severely calcified aortic valves, and were more often considered to be frail on surgical assessment. Furthermore, history of pregnancy was not observed to influence 30-day mortality, vascular or bleeding endpoints but impacted the incidence of 30-day composite death or stroke. This effect of prior pregnancy will need to be confirmed at longer-term follow up, however, this study remains novel for the evaluation of female sex-specific baseline characteristics in the context of TAVR. Additionally, further study on the hormonal influence and effect of pregnancy on cardiovascular outcomes in TAVR is needed.
Study limitations
First, the study was observational in nature without a randomized control arm (men) to provide definitive conclusions with respect to sex differences. However, the main aim of the study was to provide real-world data in women and as such a control arm was not essential by design. Second, as majority of patients in the registry were Caucasian, the results cannot be extrapolated to other populations. However, the patients in this registry had a comparable prevalence of cardiovascular risk factors to multiple other registries and therefore accurately reflect real world practice. Third, our registry included all-comer TAVR patients who were treated with different TAVR valve types per operator discretion, thus analyses for valve type are subject to selection bias and will be underpowered to draw reliable conclusions. Fourth, the lack of systematic neurological evaluation after TAVR may have underestimated the true incidence of 30-day stroke. Similarly, the low rate of AKI may be related to under-reporting from sites, but is consistent with recent data (4). Fifth, information on remote female sex-specific characteristics is subject to recall bias.
Women enrolled in this first ever all-female TAVR registry were at intermediate to high risk compared to women in prior TAVR studies, and experienced a 30-day VARC-2 composite safety endpoint of 14.0%, with a low incidence of early mortality and stroke. Age, prior stroke, LVEF <30%, TAVR device generation, and history of pregnancy were independent predictors of the 30 day composite safety endpoint. Randomized assessment of TAVR versus SAVR in intermediate-risk women with severe AS is warranted to determine the optimal treatment strategy.
WHAT IS KNOWN? Women undergoing TAVR have been reported to have more favorable outcomes as compared with their male counterparts, as well as lower 1-year mortality compared to women undergoing SAVR.
WHAT IS NEW? The WIN-TAVI registry is the first ever all-female single-arm study to evaluate the safety and performance of TAVR in women and to further explore the influence of other female sex-specific characteristics that have never been collected in prior TAVR studies. Women enrolled in this registry were at intermediate to high risk compared to women in prior TAVR studies, and experienced a 30-day VARC-2 composite safety endpoint of 14.0%, with a low incidence of early mortality and stroke.
WHAT IS NEXT? Randomized assessment of TAVR versus SAVR in intermediate-risk women with severe AS is warranted to determine the optimal treatment strategy.
The authors would like to thank the Society for Cardiovascular Angiography and Interventions for supporting the launch of this study. The authors also thank Usman Baber, MD, MS for his statistical expertise; Melissa Aquino, MS, for providing analytical assistance; Theresa Franklin-Bond, PA, MS, and Jin-Young Cha, BS, for providing CEC support; and Lauren Lopez, BA, Linsey Walker, BA, and Vered Weisz, BA, for providing project support.
For an expanded Methods section as well as supplemental tables, please see the online version of this article.
Dr. Petronio has received proctorship fees from Boston Scientific Corporation and Medtronic; and has served as a consultant for Abbott Vascular. Dr. Mehilli has received lecture fees and institutional research grant from Edwards Lifesciences. Other disclosures include lecture fees and institutional grant from Abbott Vascular; lecture fees from Lilly/Daiichi Sankyo, Terumo, Bristol-Myers Squibb. Dr. Lefevre has received proctorship fees from Edwards Lifesciences.
Dr. Sardella has received proctorship fees for Edwards Lifesciences and speaking fees for Direct Flow. Dr. Van Mieghem has received research grant support from Boston Scientific, Edwards Lifesciences, Medtronic, St. Jude Medical, Abbott Vascular, and Claret Medical.
Dr. Naber has received speakers fees from Edwards Lifesciences, Direct Flow, Medtronic, and Claret Medical; is a minor shareholder with Claret Medical; and is an advisor to Direct Flow, Medtronic, and Claret Medical. Dr. Sharma has served as a member of the Speakers Bureau for Abbott Vascular, Angioscore, Boston Scientific Corporation, Cardiovascular System Inc., TriReme, and The Medicines Company. Dr. Mehran has received research grant support from Eli Lilly/Daiichi-Sankyo, AstraZeneca, The Medicines Company, Bristol-Myers Squibb, and OrbusNeich; consulting fees from Janssen Pharmaceuticals Inc., Medscape, Osprey Medical Inc., Watermark Research Partners (modest <$5,000/year), AstraZeneca, Bayer, CSL Behring, Merck & Co., Regado Biosciences, and The Medicines Company. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Abbreviations and Acronyms
- acute kidney injury
- aortic stenosis
- body mass index
- coronary artery disease
- confidence interval
- left ventricular ejection fraction
- odds ratio
- surgical aortic valve replacement
- transcatheter aortic valve replacement
- Valve Academic Research Consortium
- Received May 9, 2016.
- Accepted May 9, 2016.
- American College of Cardiology Foundation
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- et al.
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- Petrov G.,
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- Lehmkuhl E.,
- et al.
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- et al.
- O'Connor S.A.,
- Morice M.C.,
- Gilard M.,
- et al.
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- Buchanan G.L.,
- Van Mieghem N.M.,
- et al.
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- Mehran R.,
- Rao S.V.,
- Bhatt D.L.,
- et al.
- ↵
- ↵
- Meredith I.T.,
- Walters D.L.,
- Dumonteil N.,
- et al.
- Lefevre T.,
- Colombo A.,
- Tchetche D.,
- et al.
- Manoharan G.,
- Walton A.S.,
- Brecker S.J.,
- et al.
- Thourani V.H.,
- Kodali S.,
- Makkar R.R.,
- et al.
- Meredith Am I.T.,
- Walters D.L.,
- Dumonteil N.,
- et al.


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Blood Channel
Related Channels
People who have peripheral T-cell lymphoma may receive pralatrexate if their cancer has come back or has not responded to other treatments. This prescription medicine works by disrupting the multiplication process of the cancer cells. Side effects may include abnormal bruising, mouth sores, and nausea. This product is given as an intravenous injection once a week for six weeks, followed by a one-week break.
What Is Pralatrexate?Pralatrexate (Folotyn®) is a prescription medication approved to treat peripheral T-cell lymphoma, a cancer that begins in the cells of the immune system. It is for use in people whose disease has not improved, or has returned after other treatment.
(Click What Is Pralatrexate Used For? for more information on this topic, including possible off-label uses.)
Are There Side Effects?Just like any chemotherapy medicine, pralatrexate can cause side effects, some of which can be quite significant. Talk with your healthcare provider about ways to prevent or lessen side effects.
Common reactions to this chemotherapy drug include but are not limited to:
- Mouth sores
- Low platelet counts, which could cause abnormal bruising or bleeding
- Nausea
- Fatigue.
(Click Pralatrexate Side Effects to learn more, including potentially serious side effects you should report immediately to your healthcare provider.)
Pralatrexate Drug Information
List of references (click here)
Folotyn [package insert]. Westminster, CO: Allos Therapeutics, Inc.;2011 January.
Folotyn Web site. Available at: http://www.folotyn.com. Accessed February 9, 2012.
Food and Drug Administration, Center for Drug Evaluation and Research. FDA approved drug products. FDA Web site. Available at: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/. Accessed February 9, 2012.
National Library of Medicine (US). Hazardous Substances Data Bank (HSDB). NLM Web site. Available at: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?HSDB. Accessed February 8, 2012.
Written by/reviewed by: Susan Lakey, PharmD, MPH, BCPP
Last reviewed by: Kristi Monson, PharmD

subset: commoncrawl


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Landscape and Visual
Modern CCGT power stations are substantially smaller in size, require less space and have less of a visual impact than traditional fossil fuel power plants. As landscape and visual impact is often a key concern for local communities and stakeholders, the proposed CCGT power station will be designed to minimise the visual impact on its surroundings.
The main power station building will be approximately 40m high and the chimney stacks will be approximately 75m high. In collaboration with Wakefield Metropolitan District Council, Selby District Council and North Yorkshire County Council we have selected 11 viewpoints taken from local residential areas, recreational locations and sites of a special local interest.
For each viewpoint we have created a photomontage showing how the station would look. The photomontages will inform the assessment of the project to ensure all significant effects are taken into account. So far we have completed four photomontages which are shown below. Click on the images to enlarge.


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Spiced chicken broth flavoured with cinnamon and star anise, with chicken, rice noodles and green beans.
This is a recipe from Rick Steins Far Eastern Odyssey Cookbook, which I tried out for dinner one night this week. It was absolutely delicious, and made a really simple and healthy weekday dinner!
Ingredients: Serves Two
- 2 chicken legs, skin removed.
- 15g ginger – sliced into rings
- 2 cloves of garlic, finely chopped
- 2 star anise
- 1 cinnamon stick
- 1/2 tsp black peppercorns
- 200g chopped green veg -I used sugar snap peas.
- 1 large carrot, sliced
- 150g dried rice noodles
- 1 chicken stock cube
- light soy sauce
- sesame oil
- 5 spring onions, finely chopped
- handful of mint leaves
- handful of coriander leaves
- red chilli
To Make:
Place the chicken legs in a large wok, along with the ginger, garlic cloves, chilli, star anise, cinnamon, black peppercorns, spring onions and stock cube. Cover with water and simmer for 30-45 minutes until the chicken is completely cooked through and beginning to fall off the bone.
Soak the rice noodles in hot water, according to the packet instructions.
Remove the chicken legs from the broth and shred the meat off the bone, return the meat to the pan, along with the chopped green vegetables. cook for a further 2-3 minutes until the green veg is cooked.
Taste the broth and season with soy sauce. Then add the mint and coriander.
Strain the noodles and divide between two bowls. Ladle over big spoonfuls of the soup mixture. Finish off with a drizzle of sesame oil and a few extra slices of spring onion and red chilli.
Serve and enjoy!


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All about cycling in the Netherlands
Rain! We almost need to apologize when we draw attention to it nowadays, because, as you know, It Almost Never Rains! But… as will become clear from this post, it does rain sometimes! The past week was a week with some very wet days. It also rained during the morning rush hours. But everybody still had to get to work and school and so I pointed my camera at all those brave people who just kept on cycling as they always do. Perhaps they dressed up a little different than they usually do and perhaps they also looked a little less happy than they usually do on their bicycles, but at least they were still there.
It is winter now, so we would have liked it to look a bit more like winter, I certainly would, but there was nothing like winter so far. After last December was the first ever December on record without temperatures dropping under the freezing point, January hasn't been very winterlike either. There was some snow and ice in the north of The Netherlands in the first month of this year, but nothing like that where I live and work. Winter isn't over though, we could still get something. Last winter, first snow was on the 27th of December 2014, but that can sometimes also only be on the 3rd of February, such as in 2012.
Back to that wet morning rush hour. I filmed it on the five new bridges over the also new city moat of Utrecht. The bridges may be ready for the most part. The traffic situation in the area is far from finished. That means the flows of people cycling are still not where they will be in the end-situation, leading to very crowded areas that will be less crowed in future and areas with a lot less cycling that will see more cycling in future. Even without the proposed solution for such busy cycleways which I showed you last week. The signals are also still in temporary traffic light installations. Most of the poles are in concrete filled old oil drums. It will take a lot of time before the bus lanes will be in their final location, and finishing the new buildings here will also take a few years more, so the people of Utrecht need to have a lot more patience before everything is finalised here. Some finishing touches are ready now: the city was busy putting in stairs to the waterside path. I hope the last of the five bridges, which is a bridge for cycling, could be opened soon too. It would disperse the flows of cycling a bit more and it would give you more options to go around the flow of buses at this location.
Cycling in the morning rush hour in the rain, this week's video.
The latest aerial picture from just one month ago shows the actual situation is still far away from the renderings of how everything will be. The five bridges are there but only one of the three water branches is really finished. Especially in the foreground, what should become a small park with a bus lane, it is still a mess. The bus lane makes an extra curve where the water should be. There are thousands of bicycles parked in what should become green. It will take years before that can be changed. The city is building the largest bicycle parking garage in the world for those bicycles. That will take another two years to be finished. Only when those bicycles are gone the bus lane can be relocated and the last branch of the water can be dug. The water at the top right of the picture is almost finished. The people of Utrecht hope to sit on a terrace under the parasols (that can be seen on the rendering) this coming summer!
Pingback: Cycling the San Diego River Trail | On The Road With "Olivia"
I actually love riding in the rain, although it would probably be a different story during rush hour. Courtesy during these times will definitely go a long way.
Not as controversial a subject as last week. 🙂
Riding practically every day I encounter all types of weather. The rain like the one in your video is not so bad. If you're already riding and warmed up it can be invigorating. It's not so fun to start out in it cold though. In Atlanta, we have hard downpours. You have to take your glasses off in order to see. The bicycle can hydroplane just like a car.
Riding while it's sleeting is not so bad, although it can sting a little. Hail, on the other hand, hurts! You have to seek shelter from the hail. And of course lightning is too dangerous to ride in. In hot weather, thunderheads here can boil up quickly and produce hail and lightning. Time to get out of the elements. I don't know if that's much of an issue there or not.
Very nice video. Good to see the Dutch going about life as usual!
When I get caught in the rain, I optimistically tell people that I won't have to take a shower this week. 🙂
Keep in mind that they don't have thunderstorms in the Netherlands.
Why no one is carrying a baby/toddler? What would one do if you have to carry your baby to the kindergarten and then head to work, but it's raining?
Also, it's interesting that there isn't an "standard" solution to riding with rain, but a wide array of arrangements (an umbrella, a coat, a water cape, just get wet, etc).
Kindergartens and schools in a Dutch city like this one tend to be close to home in residential areas. This video consists of mostly students and people going to work or uni. You're probably just not likely to find them in this area at rush hour, even more so because this is filmed near the train station. Having grown up in a densely populated city in NL myself, my school and kindergarten were no more than 500 meters from my house.
You mentioned a couple times that bus routes have moved away from some locations and onto others. What process was that? My city is doing a transit system reorganization and it might involve not using a "bus stop at most 400 metres from every home and business" ideology. I know that buses do not belong in most residential areas, and if they run along straighter arteries, they are much better bus routes. So if someone can explain the process, that would be awesome.
I know you Mark don't like the idea of helmets, except on brommers and maybe used when racing, and the handlebar cam doesn't provide for a very stable video, but how about attaching a sweatband around your forhead or wrist, and fastening a camera to that? Or you could use the handlebar attachment and use a spring to act like a shock absorber. That could work quite nicely.


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The Minnesota Hosta Society is a great place to meet fellow Hosta enthusiast at our local events.
• Annually MHS hosts three regular meeting per year: February, April, and October, and an informal gathering in March.
• The Hosta Potting Party: Digging, Potting, and Labeling Hosta for Sale.
• The Hosta Sale: Open to members and the public one Saturday in June.
Check calendar for date; hundreds of varieties at reasonable prices.
• Member Garden Tour: June or July, we tour member and friends' gardens
• Hosta Show: Each year we hold an educational hosta show. Many varieties of hosta leaves, and container grown hosta
are on display for viewing by the public.
• Members enjoy the "Hostaphile" our informative newsletter with event and meeting information four times a year.
• Minnesota State Fair: MHS hosts a booth as the State Fair every other year with the Rochester Hosta Society
"Shades of Green" https://www.soghs.org/
• Awards recognition: "AHS President's Wall of Honor" is recognition for outstanding members, participation, and service.
• The National Display Garden: See Display garden
Copyright Minnesota Hosta Society.
All rights reserved.


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InfiniGlobe Achieves ISO/IEC 27001 Certification
NEWPORT BEACH, CA – InfiniGlobe, announced today that it has obtained ISO/IEC 27001:2013 certification. Schellman & Company, an ANAB and UKAS Accredited Certification Body, certified InfiniGlobe LLC as compliant with all of the ISO/IEC 27001:2013 certification requirements – an information security standard from the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC). The scope of ...Read more


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My goal for 2012 was to read 52 books. These are the books I have read to help me reach my goal.
A Bloody Storm (Derrick Storm #3) by Richard Castle Review
A Raging Storm (Derrick Storm #2) by Richard Castle Review
Every Day by David Levithan Review
Over You by Emma McLaughlin, Nicola Kraus Review
Dirty Little Secrets by C.J. Omololu Review
Puck Bunny by Joelle McClure Review
The Time of My Life by Cecelia Ahern
Cold Kiss (Cold Kiss #1) by Amy Garvey
The Making of Us by Lisa Jewell
Shatter Me (Shatter Me #1) by Tahereh Mafi
Married by Monday (The Weekday Brides #2) by Catherine Bybee Review
Wife by Wednesday (The Weekday Brides #1) by Catherine Bybee Review
The Girl Who Was on Fire: Your Favorite Authors on Suzanne Collins' Hunger Games Trilogy (The Hunger Games Companions) by Leah Wilson, Diana Peterfreund, Brent Hartinger, Jackson Pearce, Jennifer Lynn Barne, Mary Borsellino, Sarah Rees Brennan, Terri Clark, Bree Despain, Adrienne Kress, Cara Lockwood, Elizabeth M. Rees, Carrie Ryan, Ned Vizzini, Lili Wilkinson, Blythe Woolston, Sarah Darer Review
Where She Went (If I Stay #2) by Gayle Forman Review
If I Stay (If I Stay, #1) by Gayle Forman Review
Why We Broke Up by Daniel Handler Review
Rebellion Quest (Quest #11) by Lisa Wright DeGroodt
Where We Belong by Emily Giffin
The Witch of Duva (The Grisha) by Leigh Bardugo
Shadow and Bone (The Grisha #1) by Leigh Bardugo
Size 12 and Ready to Rock (Heather Wells #4) by Meg Cabot
When in Doubt, Add Butter by Beth Harbison
Good Enough to Eat by Stacey Ballis
Off the Menu by Stacey Ballis Review
Roadside Assistance by Amy Clipston
The Sweet Far Thing (Gemma Doyle #3) by Libba Bray Review
Hana (Delirium #1.5) by Lauren Oliver
Rebel Angels (Gemma Doyle #2) by Libba Bray Review
A Great and Terrible Beauty (Gemma Doyle #1) by Libba Bray
Team Human by Justine Larbalestier, Sarah Rees Brennan Review
The Next Best Thing by Jennifer Weiner
Jeneration X: One Reluctant Adult's Attempt to Unarrest Her Arrested Development; Or, Why It's Never Too Late for Her Dumb Ass to Learn Why Froot Loops Are Not for Dinner by Jen Lancaster
Accidental It Girl by Libby Street Review
Room For Improvement by Stacey Ballis
The Diary of Darcy J. Rhone by Emily Giffin Review
A Farewell to Charms (Princess for Hire #3) by Lindsey Leavitt Review
Legend (Legend #1) by Marie Lu
Between You and Me by Emma McLaughlin, Nicola Kraus
See Jane Date by Melissa Senate
The Traitor in the Tunnel (The Agency #3) by Y.S. Lee
The Body at the Tower (The Agency #2) by Y.S. Lee
A Spy in the House (The Agency #1) by Y.S. Lee
Underworld (Abandon Trilogy #2) by Meg Cabot
Another Piece of My Heart by Jane Green
City of Lost Souls (The Mortal Instruments #5) by Cassandra Clare
Skinnydipping by Bethenny Frankel
The Battle Hymn Blues by Baker Lawley
Always the Last to Know by Crystal Bowling
Code Name Verity by Elizabeth Wein
The Lucky Dog Matchmaking Service by Beth Kendrick
Epic Fail by Claire LaZebnik Review
The Return of Sherlock Holmes (Sherlock Holmes #6) by Arthur Conan Doyle
A Brewing Storm (Derrick Storm #1) by Richard Castle Review
Swim: An eShort Story by Jennifer Weiner Review
Insurgent (Divergent #2) by Veronica Roth
The Book of Blood and Shadow by Robin Wasserman
Walt Disney Imagineering: A Behind the Dreams Look at Making More Magic Real by Imagineers,
Spell Bound (Hex Hall #3) by Rachel Hawkins
Demonglass (Hex Hall #2) by Rachel Hawkins
Hex Hall (Hex Hall #1) by Rachel Hawkins
Black Heart (Curse Workers #3) by Holly Black
The Lady of Bolton Hill by Elizabeth Camden Review
London Falling by Emma Carr Review
Out of Sight, Out of Time (Gallagher Girls #5) by Ally Carter Review
Jackpot! by Jackie Pilossoph
Uglies: Shay's Story (Uglies) by Scott Westerfeld, Devin Grayson, Steven Cummings Review
Pandemonium (Delirium #2) by Lauren Oliver
Baby Be-Bop (Weetzie Bat #5) by Francesca Lia Block
I've Got Your Number by Sophie Kinsella
The Accidental Bride by Denise Hunter Review
The Real Real by Emma McLaughlin, Nicola Kraus Review
Missing Angel Juan (Weetzie Bat #4) by Francesca Lia Block
Red Glove (Curse Workers #2) by Holly Black
White Cat (Curse Workers #1) by Holly Black Review
A Million Suns (Across the Universe #2) by Beth Revis Review
Cherokee Bat and the Goat Guys (Weetzie Bat #3) by Francesca Lia Block
Witch Baby (Weetzie Bat #2) by Francesca Lia Block
Across the Universe (Across the Universe #1) by Beth Revis
Weetzie Bat (Weetzie Bat #1) by Francesca Lia Block
Daughter of Smoke and Bone (Daughter of Smoke and Bone #1) by Laini Taylor
The Fault in Our Stars by John Green
Divergent (Divergent #1) by Veronica Roth Review
North by Northwestern: A Seafaring Family on Deadly Alaskan Waters by Sig Hansen, Mark Sundeen
The Statistical Probability of Love at First Sight by Jennifer E. Smith
* Please note that ARC stands for advance reading copy. For more information about what an ARC is or how to get your hands on one feel free to check out wikipedia.org


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Our family travels a lot. You have to when you live quite literally in the middle of nowhere. We travel mostly to the same place which is where we are originally from. That's where the big grocery store is, the one-stop store to pick up stuff that the grocery store doesn't have, and of course the other stores that support our "hobbies" like crafting or thrifting. People keep asking why I travel the 3.5 hours instead of the 2.5 hours it takes to get to an out-of-state town that has the same stuff, but that place doesn't have our friends and family to visit with. So we suck up the extra hour and make a weekend out of the trip.
During our drive, we begin to make a mental inventory of what we brought and what we may have forgotten. If by chance we forget something pretty important before the 10 mile mark out-of-town, then we may turn around to get it. After that mile marker we are plain out of luck unless it's a very important medication and even then, it's a toss-up if we turn around. If it's okay to skip a few days of the meds. then there is no turning around. The drive is too long to mess with turning around.
So the last time we went to town (that's what we call it… it sounds so archaic, but that's the way it is) it was well past the 20 mile marker, and we were in an entirely different county when Roger discovered that he had forgotten his phone. Those of you who don't know him, his phone is his life. He is always on his phone. Those who do know him accuse him of being like a teenage girl, talking and texting and talking some more. We both secretly thought that this trip was going to be doomed without that phone. We did agree out loud that there was no chance of going back home just to get it. He was just going to have to suck it in and live without it for a couple of days.
After 70 miles, we arrived to the first fairly big city and we stopped at the Safeway for a potty break and some lunch. Then we were off again to the next stop which was again the Safeway at our destination city for a potty break and a get-well flower arrangement.
As I walked up to the vehicle after the last stop, I noticed something amazing. There, sitting on the outside vents at the base of the windshield and wipers was Roger's phone! It had traveled the entire 190 miles there and two stops in busy parking lots. It also survived an abrupt, sharp turn at a garage sale sign, which I never found by the way.
I can't even explain how relieved we felt that we found it, and can only explain the whole situation as being phenomenal.


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Businesses of
all sizes have become increasingly aware of how important contact centers are in
retaining customers, helping to generate lasting loyalty, and ultimately
building the bottom line This has created an urgent need for technologies and
strategies to improve customer and employee engagement, increase satisfaction, and
ensure more effective use of data.
Companies are
looking to not only make immediate progress in operating more efficiently and
raising the bar on service on all touch points but to also find the right tools
and resources to be prepared to meet the evolving challenges of the next 5-10
years. The ICMI Contact Center Demo-Conference, held at the Mandalay Bay Hotel
from September 25-27, 2017, addressed the needs of both today and tomorrow with
a Demo hall that provided an opportunity to explore emerging trends and updated
solutions in a relaxed atmosphere. Attendees were able to evaluate the latest products
and services and get detailed answers to questions on how they would make a
difference for their organization. The event also offered a multi-faceted
education program including tracks on Boosting Contact Center Culture,
Maximizing Productivity, Elevating Leadership, Optimizing Technology, Driving
Customer Success and Achieving Metrics Nirvana.
CRMXchange reached
out to a number of exhibitors to gain insights on the high-interest offerings
they were demonstrating and how they might help companies plan for a more
productive present and be ready to meet the needs of the future.
AcuCall(Stephen Ward, CEO)
Why is it important for companies to
implement versatile, affordable contact center software that provide
scalability and make it easy to integrate at-home and offsite agents into the
AcuCall offers
a truly comprehensive suite of products with customized CRM, Reports, Scripting
and Integrations for each customer. Since the entire solution is developed
using proprietary code, AcuCall does not have to depend on 3rd party software
and can rapidly deploy to meet customer requirements, and often without added
cost! Remote Agents can easily log in to the web application to take Inbound
and Outbound calls just like agents in call centers.
The key cost
reduction benefits are in the significant reduction, and in some cases, elimination
of IT costs, equipment and infrastructure costs.
have unlimited oversight from their desktops over on site and at home agents –
they can listen-in, coach, join, take over calls, monitor agent desktop screen
– all as if they were in same offices.
This provides
businesses with the ability to manage and allocate their workforce from their
desktop – add or remove agents (home or office), rapidly create one-to-many
IVR's, campaigns, associated CRM's, start/stop campaigns, move agents around in
queues and campaigns, pause agents, etc., all on the fly in real-time.
How does an agent desktop that provides
a single view for information both front-line personnel and managers contribute
to consistently delivering a superior customer experience?
The AcuView
Dashboard reporting tool provides consistent information across all Enterprise
locations and aggregates data from unlimited data feeds. As such, management
always has real-time location, campaign and agent information needed for
workforce and telephony resource deployments.
Can you elaborate on the broad variety
of capabilities included with your solution and discuss the importance of also
providing SMS text messaging?
The AcuCall
CenterMaster platform is HIPAA/PCI Compliant and includes native CRM, IP PBX,
Screen Monitoring as well as standard CTI features such as: Dialer, IVR, ACD,
Scripting Tool and Recording. It is also localized for Spanish or English with
White Label branding available. SMS, Chat, Email and Social Media have long
been available in CenterMaster to help customers communicate with businesses as
"they" desire and still receive consistent responses, regardless of media.
SMS in
particular helps clients in a variety of ways, sending blast notifications to
1-to-many of their customers, reminder notifications of appointments, payments
due with links to drive that business. SMS is only limited by the
imagination. This is a true Unified
Communications platform.
What pricing advantages does your
CenterMaster customer interaction platform offer to businesses of all sizes?
customers enjoy what we believe to be the most economical pricing available,
and are only billed for the actual number of licenses used each month. This way,
they can scale up or reduce license-count as their business dictates, and
without penalty. We feel that this should be the essence of software as a
service where the customer can focus on their business requirements, and not
getting charged for licenses that they do not need. This affords both smaller
start-up companies and Enterprise customers the freedom to deploy their agent
workforce as they see fit.
GamEffective (Roni Floman, VP Marketing)
As gamification technology has
advanced and implementation has widened over the past few years, can you
elaborate on the tangible benefits now being derived by organizations that have
adopted gamification?
has certainly evolved over the last couple of years. In the past, it
involved a simple toolset: slapping some points and badges over an existing
system, creating solutions that didn't add much to the employee experience.
Today, gamification involves a larger and wider toolset that impacts more
behaviors and more activities in the contact center. Adding to points, badges
and leaderboards, it is also adding automated messages to employees, dynamic
goals, deep gamification challenges (such as betting on yourself), a virtual
store and most importantly – microlearning that is injected daily into the
employee experience.
Additionally, gamification can drive employees to focus on a daily or
weekly timeframe, as opposed to monthly reports or call sampling. Done right,
it can drive daily engagement with short term goals, which increases
productivity and focus. Most importantly, since gamification typically serves
microlearning, it saves on in-class training as well as grows knowledge levels
and therefore, improves performance.
In what
ways does providing real-time feedback on specific KPIs contribute to employees
delivering consistently superior customer experiences?
Real-time feedback
is just like a fitness tracker. When you know you have a goal, like taking
10,000 steps daily, you tend to focus on it. A daily goal will drive you more
than a monthly goal – and this is what gamification does in the contact center.
What real-time feedback also does is give employees an opportunity to
self-correct. For instance, if I see I'm below my benchmark for the day/week, I
can focus on correcting this. Additionally, since gamification can identify
underperforming KPIs and suggest content to correct them, it can teach
employees by recommending the right actions.
does your solution enable businesses to create personalized scorecards that set
specific goals for individual agents?
serves more than scorecards since it uses learning feeds, and many game
elements on top of the KPIs. We do recommend setting personalized goals to
employees, so that lower performing ones can meet their goals and evolve over
time. This can be done by segmenting employee "audiences" and setting different
goals for them.
How does gamification make
onboarding easier and provide for a more comprehensive learning process?
Gamification and
eLearning work well together. We typically see very high engagement rates with
learning in gamified systems. In the on-boarding and in an in-class training
situation we can use gamified eLearning segments to drive personal
self-learning throughout the day. But this really gets interesting when
gamified eLearning is used for daily microlearning for agent off time. This
means that less hours are lost to pulling employees into classrooms. Employees
like learning in that way since they can control their time, get learning that
is relevant to their KPIs and only take several minutes daily.
NexInteractive (Rudy Salazar, Managing Partner &
Senior Sales Engineer)
Why is it important for companies to
adopt contact center software that can be rapidly deployed easily customized
and be instantly accessed by agents anywhere around the globe?
It's important because any company with a customer base requires a
customer support center either for handling Inbound calls with questions and
concerns or outbound calling for follow ups and quality surveys.
How does an agent desktop
that provides front-line personnel with added flexibility in how they handle
both inbound and outbound calls contribute to delivering a superior customer
The desktop Omnichannel offers an array of dynamic page scripting and
IVRs that give customers the best interactions for customer engagement.
Can you elaborate on the omnichannel
capabilities of your solution and discuss the importance of providing SMS text
messaging which is available via 800 numbers?
Multitasking is crucial in today's high demand for quick, reliable
support. SMS offers an agent to engage in chat sessions while on a customer
support call.
What pricing advantages does your INexus
platform offer businesses of all sizes?
Flexible pricing models are available to fit any organization's
budgets. iNexus offers what we believe to be the most competitive prices
in the industry.
Revation Systems
(Perry Price,
In what ways does a virtual contact
center allow businesses to lower operating expenses and improve communications
without burdening them with capital expenditures?
One of the
primary benefits of a virtual contact center in terms of its ability to lower
operating expenses is the ease and speed of deployment. Because virtual contact
center solutions eliminate the need for on-premise telephony equipment or other
hardware, they can drastically cut down on both the cost of equipment and the
time required to install, implement and deploy.
Virtual contact
centers enable organizations to invest in a single application for
communication, thereby empowering supervisors and managers to focus on what
matters most: improving the quality of communication with consumers.
How does your LinkLive solution enable
companies to route interactions on multiple channels to service, support and
sales groups?
provides a variety of options for routing interactions — including
skills-based, data-sourced (obtaining data from another system and analyzing it
to determine how to best route the call) and front end formed questions or
single sign on information to route, assign and distribute calls.
In an environment of ever-changing
regulations, how do you help ensure compliance across a broad spectrum of
One of the
qualities of Revation that sets us apart from other vendors is that we have
achieved HITRUST CSF Certification.
certification means that our solution, LinkLive, was born from a security-first
approach and demonstrates our commitment to securing confidential information,
particularly within the healthcare industry. LinkLive's unique architecture was
designed specifically to provide secure, encrypted communications across all
mediums to a variety of industries. LinkLive products are also compliant with
GLBA, SEC, Sarbanes-Oxley and HIPAA requirements for logging, privacy and
How does integrating an IVR help to
improve a business' omnichannel service?
Integrating an
IVR helps to enhance the speed with which contact center agents can respond to
customers through any mode of communication — whether it be phone, chat, SMS or
text. Since IVRs can be implemented across a variety of multimedia channels and
can help filter customer calls to the appropriate agent, they are a great
integration solution to improve agent productivity and efficiency.
What differentiates your platform from
other offerings on the marketplace?
LinkLive platform is unique in that it provides organizations with a true
unified communications suite without sacrificing a high level of security.
multimedia recording and encryption of all data (both in transit and at rest)
paired with our HITRUST CSF Certification makes the LinkLive solution
unparalleled in security by other offerings in the marketplace today. With
robust, powerful features that enhance agent-consumer communications, LinkLive
can help organizations across a variety of industries digitally transform to
keep up with the demands of consumers today.
LinkLive also offers
a few key features that differentiate it from other virtual contact centers;
the first of which is its Measuring, Monitoring & Planning Tool (MMP).
MMP is a unique
application for contact center agents and supervisors that utilizes a variety
of tools to measure contact center statistics, monitor agent performance in
real time and plan scheduling for peak call times. Contact center efficiency is
enhanced through MMP with the Workforce Management (WFM), Tiles, Reporting,
Quality Assurance (QA), Monitoring & Scoring, Call Detail Records (CDR)
& Audit Trails, Agent Dashboard and Surveys.
Softcom (Justin Fava, Director of Marketing)
While contact centers are diverse
operations with a variety of different purposes, what is the one common factor
that impacts the cost of running them and how can companies gain the insights
they need to control expenses?
The most
significant common factor that impacts contact center costs is the labor
component. Labor typically contributes up to 70% or more of the cost to run a
contact center. As such, it is imperative that you know and understand the
metrics that drive a successful operation, whatever type of contact center it
may be.
InsideEdge Enterprise suite of contact center solutions is a full suite of
tools that bring critical CC information to the forefront- helping agents,
supervisors, managers and directors discover, analyze and correct areas of
concern. InsideEdge provides analysis either manually or through automation,
utilizing advanced machine-learning techniques to highlight critical areas
while reducing false positives.
Why is it important to examine both
real-time and historical metrics to improve contact center productivity?
metrics are a very good gauge of past performance to examine patterns,
standards and averages of contact center activities. Real-time metrics let
supervisors catch deviations at the moment they occur, speeding up correction
time and bringing productivity back in line within minutes.
How do companies benefit from having
separate applications for both agents and supervisors?
has been focused on giving supervisors information to manage their agents,
which is great. However, in many cases agents have no visibility into their own
performance or relative performance to the rest of their team. InsideEdge Agent
Dashboard gives agents real information and the tools they need, making them
feel more engaged, more competitive and more motivated.
In addition,
both supervisors and agents can collaborate with each other using built-in chat
and messaging features within InsideEdge.
What differentiates your analytics solutions
from other offerings in the marketplace??
value starts with our fully vetted turn-key Data Hub. We believe that other
analytics solutions in the marketplace simply cannot provide the depth of
technology and functionality of InsideEdge, such as Cradle-to-Grave Reporting
and Machine-Learning Contact Center Optimization. They also lack InsideEdge's
powerful Data Hub for data integration and modeling, which is the key to
building the foundation for reliable data delivery.
In general,
through the InsideEdge Data Hub, Softcom can integrate numerous unrelated data
sources to be managed and funneled through one central repository. Any data
that travels through the data hub is tested and validated so that users can
trust that data 100%.
regards to the IVR, users can examine the IVR component of a call within the
InsideEdge Life-of-Call module, using filters and trends. For example:
Finding that the IVR is causing a high number of hang-ups once a caller reaches
a certain option selection
Callers are consistently selecting the "0" option (speak to an operator) very
early in the call, which defeats the purpose of having an IVR in the first
Some IVR partners license it on a usage basis and an inefficient IVR can be a
significant cost to a company- one that many contact centers don't realize can
be corrected.
What specific benefits does your
solution deliver that differentiates it from other offerings in the marketplace?
reliable and validated data through the InsideEdge Data Hub
Cradle-to-Grave Analytics, including each and every segment of all calls
of contact center-focused domain expertise, and modular product design, allowing
us to provide you with a turn-key solution.
UJET (Anand Janefalkar, Founder & CEO)
Why is it important for a support
solution to provide frictionless conversational capabilities and more
productive interactions by making sure account and customer insights are at the
fingertips of the agents involved?
A customer
support call or chat – whether it's from an existing customer or a new prospect
– is a time-sensitive interaction with direct implication to a business' bottom
line. Having a support platform that covers all modern entry points such as web,
app, and phone eliminates piecemeal solutions that can delay resolution or
worse, confuse the end-user and agent. Cutting-edge technology that aims
to reduce the cognitive distance between the agent and the issue facilitates informed troubleshooting versus having an agent with scripts hoping to
resolve a problem.
How does native integration across every
channel enable companies to merge applications seamlessly with existing CRM
integration for both the agent and end-user is imperative to a great user
experience. Customer support today still largely requires the end-user to spell
out their name or even email to verify an identity. UJET bypasses all of this
by deeply integrating into a company's login at both the app and web level. By
linking this to the backend details in the CRM automatically, it saves about
30-40% of the call or chat duration. Agents can then attack the problem
immediately, maintaining a high level of customer satisfaction.
In what ways can a business benefit from
a holistic voice/chat platform that works out of the box with no installation
fees or professional service charges?
support should not be viewed as a channel function. Different queries merit
different channels, and companies are staffed in a variety of ways. Having a
holistic voice and chat platform that covers web, app, and phone routes enables
support teams to truly craft the best end-user experience.
For example, a
company could invest a lot of time in comprehensive FAQs that allow end-users
to self-serve without the need to change platforms. Another company may want to
have agents answering calls to close a sale or upsell. All in all, companies
should be able to do both: switching seamlessly from voice or chat or FAQs
depending on A/B testing. Here at UJET, we provide an instant and effective
control panel to enable such customer journeys.
How does the platform enable companies
to effortlessly modify IVR systems?
IVR systems have legacy or analog baggage associated with them. They require
outdated tools that need to be programmed and commissioned, with the ACD having
to be reset in order to see changes. By the time these changes are up and
running, the peak hour has already passed. That's why at UJET, we provide an
instant configuration tool to update IVR routing and skilling assignments.
This, in turn, enables admins and supervisors alike to react to traffic surges.
the UI for these legacy systems requires professional services for setup and
training, making for a poor and expensive experience. We recognize this and do
not charge for professional service, setup, recording, or markup per-minute
charges. We also have no charges for geographical redundancy or even CRM adapters. Couple
this newfound experience with a great UX and admins/supervisors can focus on
optimizing agent efficiency regardless of traffic variations.
As noted,
having a holistic experience for both the end-user and agent helps to provide
overall seamless support. Supplying a human-to-human connection to upsell,
close a deal, or walk through a more complex issue is invaluable for a majority
of company operations.
We've crafted a
modern, smartphone-centric experience that challenges outdated technology and
brings both customers and contact centers into the 21st century. With no hidden
fees and the fastest first-touch resolution, we're changing an antiquated
industry. The ability to send photos, videos, screenshots, error logs, and
verify through fingerprint/pin code while on a call or chat completely and
dramatically changes support experiences. Thanks to these unique Smart Actions,
customer support can finally become a competitive advantage.


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Critical Incident Stress Management
Critical Incident Stress Management, Relational Psychotherapy
Relational Psychotherapy assesses a client's psychic formation, which is the source of a person's interpersonal relationships and conflicts. A common therapy, Relational Psychotherapy focuses on the client's connection to other people.
When clients present with interpersonal relational distress, emotional or psychological issues, or chronic suffering, Relational Psychotherapy can be applied to help a person build and maintain emotionally satisfying relationships. An atmosphere that provides attentiveness and empathy will help the client commit to full disclosure of events and experiences.
A stronger sense of self confidence will arm the client with the tools and skills needed to create healthy, productive relationships with other people.
If you are looking for a therapist who offers Relational Psychotherapy, please browse our list of practitioners below..
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Chew On This: Why Natural Chewing Gum Is a Better Choice
Many people are surprised to learn that chewing gum can be good for your teeth. Chewing on a stick of gum can promote the development of saliva, which keeps food particles away from your teeth and limits tooth decay. Unfortunately, a lot of popular gum brands fill these products with cheap, synthetic alternatives and refined, artificial sweeteners that aren't good for your overall health, let alone your teeth. Choose your gum brands carefully to enjoy refreshed breath, better oral health and keep other toxins out of your body. Visit your family dentist in Edmonton for more diet and lifestyle tips to keep your teeth and gums in great condition. Joly Dental Care can answer your questions and offer advice for you and your family.
Choosing Healthier Chewing Gum
Those sweet, tasty and brightly packaged chewing gum packs by the checkout aisles seem harmless. They are sold everywhere and have been around for years. Reading the list of ingredients tells a different story, though. Here are some of the not-so-friendly ingredients in most of these popular chewing gums:
- Aspartame – Aspartame is metabolized by your body into formaldehyde, a carcinogen that is not filtered through the liver and kidneys. It also turns into wood alcohol, a poison.
- BHT – This preservative has been linked to toxicity in organ systems, kidney and liver damage and hyperactivity in children. It elongates the shelf-life of gums and other processed foods despite being banned in many other countries.
- Gum Base – It is hard to even determine what the gum base is made from. Studies have shown it is usually a combination of elastomers, resins, plasticizers and fillers if it isn't made from petroleum-derived paraffin wax, polyvinyl acetate (also known as carpenter's glue) and talc. Many of these ingredients have been linked to cancer and most people wouldn't want to have much contact with them, let alone chew on them for an extended period of time.
Gum can still be great to chew on and refresh your breath. Responsible companies are catching on and offering more health-conscious and natural alternatives. Here are some brands you can feel good about chewing on:
- Simply Gum – Clean ingredients and natural flavours, just like the name states: it's simple!
- Glee Gum – No genetically-modified ingredients, no synthetic plastics in the gum base, and Fair Trade cane sugar and brown rice syrup make this a pack of gum you can feel good about buying.
- Pur Gum – This brand is a good option for allergy sufferers as it does not contain any nuts, dairy, soy or gluten. It may not be as natural as the options listed above, but it does not contain aspartame.
Joly Dental Care is here to guide you towards products, habits and tools that can improve your lifestyle, oral health and support your overall well-being. Ask us any questions you have about improving your oral hygiene. We are currently accepting new patients and would be happy to offer dental services for your entire family. If you are looking for a comprehensive, professional and friendly dental clinic in downtown Edmonton, contact Joly Dental Care today.
Contact the team at Joly Dental Care for your dental healthcare needs in downtown Edmonton. Call us at 780-428-3281 or fill out an online contact form with any questions.