Role of contractile reserve as a predictor of mortality in low-flow, low-gradient severe aortic stenosis following transcatheter aortic valve replacement.

OBJECTIVES: The aim of this study was to determine the prognostic value of contractile reserve (CR) at baseline in patients with low-flow, low-gradient severe aortic stenosis (AS) undergoing transcatheter aortic valve replacement (TAVR). BACKGROUND: Patients with severe AS, left ventricular dysfunction, and low transaortic gradient are at high risk for mortality during surgical aortic valve replacement (SAVR). Furthermore, patients without CR have been shown to have perioperative mortality comparable to that of patients treated medically for severe AS. METHODS: We retrospectively analyzed patients who underwent TAVR with a diagnosis of low-gradient severe AS (mean transvalvular aortic gradient < 40 mmHg, LVEF < 50%, and AVA ≤ 1.0 cm2 or AVAi ≤ 0.6 cm2 ) and who had a pre-TAVR dobutamine stress echocardiogram (DSE). Patients were stratified by the presence or absence of CR, defined as an increase in stroke volume ≥ 20% during DSE. RESULTS: From 2008 to 2016, 61 patients with low-gradient severe AS underwent TAVR and had pre-TAVR DSE. CR was present in 31 patients (51%) and absent in 30 (49%). There was no significant difference between the two groups in baseline demographics, medical history, access site, or types of valves. All-cause mortality was similar in both groups at 30 days (13% with CR vs 10% without CR, P = 1.00) and 1 year (29% with CR vs 33% without CR, HR 1.20, 95% CI 0.49-2.96, P = 0.69). CONCLUSION: In patients with low-flow, low-gradient severe AS undergoing TAVR, the presence or absence of CR does not predict all-cause mortality at 30 days or 1 year.

Temporal trends in patient referral for Transcatheter aortic valve replacement and reasons for exclusion at a high-volume Center in the United States.

BACKGROUND: Clinical indications for transcatheter aortic valve replacement (TAVR) and elements of the implantation procedure, including delivery system miniaturization and novel access options, have evolved over time. The reasons patients are excluded from TAVR also have changed. The impact of these changes on patient referral for and exclusion from TAVR is unknown. METHODS: We retrospectively analyzed patients referred to our center for TAVR from January 2010 to August 2016 to evaluate reasons for patient exclusion. Patients were divided into three groups based on initial screening date for trends in demographics and exclusion: Group 1, 2010-2012; Group 2, 2012-2014; Group 3, 2014 to August 1, 2016. Annual trends for patient exclusion from TAVR were assessed. RESULTS: One thousand nine hundred fifty-three patients were referred and underwent screening for TAVR. The rates at which patients were referred for TAVR were 23.8, 25.9, and 24.5 per month in groups 1, 2, and 3, respectively. Rate of patient exclusion from TAVR decreased from 68% in Group 1 to 38% in Group 3 (P < .001). The largest percentage of patients (29.4%) were initially excluded from TAVR for cardiac reasons, but this trend has decreased over time. Twenty-five percent are excluded for lack of procedural indication. Exclusion from TAVR for vascular access reasons decreased from 7.9% in 2010 to 1.0% in 2016 (P = .017). CONCLUSIONS: Referral numbers have been robust since TAVR became available. The percentage of patients excluded from TAVR has decreased over time. Patients are most commonly excluded from TAVR for concomitant coronary artery disease (CAD), asymptomatic severe AS, moderate AS, or non-cardiac critical illness. Patients with CAD and those with asymptomatic severe AS or moderate AS should be a focus for continued research in TAVR.

Utility of an additive frailty tests index score for mortality risk assessment following transcatheter aortic valve replacement.

BACKGROUND: The impact of frailty assessment on outcomes in patients undergoing transcatheter aortic valve replacement (TAVR) remains unclear. Our aim was to evaluate the individual effect of each frailty test and the utility of an additive frailty index score on short- and long-term survival following TAVR. METHODS: Retrospective analysis of consecutive TAVR patients for whom a complete set of frailty tests was obtained: algorithm defined grip strength and 5-m walking tests, body mass index <20 kg/m2, Katz activities of daily living ≤4/6, serum albumin <3.5 g/dL. Frailty status was defined as having 3 or more positive frailty tests. Included were 498 patients with a mean age of 82±8 years. RESULTS: Frailty status, observed in 266 (53%) patients, was associated with both 30-day and 1-year mortality (6% vs. 2%, P=.016; 20% vs. 9%, P<.001; within the respective frailty groups). As compared to 0-2 frailty criteria, a higher frailty index score was associated with increased risk of death at 1 year (OR 2.23; 95% CI 1.14-4.34; P=.019 and OR 3.30; 95% CI 1.36-8.00; P=.008 for 3 and 4-5 frailty criteria met, respectively). In Cox regression analysis, frailty status was correlated with 1-year mortality (HR=2.2; 95%CI 1.25-3.96; P=.007), and a higher frailty index was associated with increased mortality risk (HR=2.0; 95% CI 1.08-3.7; P=.027; and HR=3.07; 95% CI 1.4-6.7; P=.005; for any 3, and 4-5 frailty criteria, respectively). CONCLUSIONS: Frailty status and a higher frailty index score were associated with increased 1-year mortality risk following TAVR.

Predicted magnitude of alternate access in the contemporary transcatheter aortic valve replacement era.

OBJECTIVES: We aimed to evaluate the true extent of alternate access in a contemporary cohort of transcatheter aortic valve replacement (TAVR) patients. BACKGROUND: Appropriate access selection for TAVR impacts clinical outcomes. Despite device miniaturization, some patients remain ineligible for transfemoral arterial access. METHODS: Five hundred seventy-five consecutive TAVR patients were classified according to iliofemoral artery diameters measured by computed tomography (<5.0 mm, 5.0-5.4 mm, 5.5-5.9 mm, or ≥6 mm) and need for alternate access rate was estimated according to commercially available transcatheter heart valve Instructions For Use (IFU). RESULTS: Based on iliofemoral artery diameters alone, 11.5% of patients were predicted to require alternate access. After patient-level adjustment for the size of the planned THV and severe tortuosity or severe calcification, 14.9% and 20.8% of patients, respectively were predicted to require alternate access. Overall, 87.8% of patients underwent transfemoral TAVR and 12.3% underwent alternate access. There was no difference in the rate of major vascular complications and life threatening or major bleeding between groups, but transfusion rate was higher in smaller vessel groups. CONCLUSIONS: Despite device miniaturization, a substantial minority of contemporary TAVR patients still require alternate access. Most are eligible for newer extrathoracic approaches including transcaval, subclavian, and transcarotid that avoid the morbidity of transthoracic access.

Contemporary transcatheter aortic valve replacement with third-generation balloon-expandable versus self-expanding devices.

OBJECTIVES: To evaluate balloon-expandable and self-expanding third-generation transcatheter aortic valve replacement (TAVR) devices according to patient selection criteria and outcomes. BACKGROUND: Two competing third-generation TAVR technologies are currently commercially available in the US. There are no published head-to-head comparisons of the relative performance of these two devices. METHODS: 257 consecutive patients undergoing TAVR with a third-generation balloon-expandable (Edwards Sapien 3) or self-expanding device (Medtronic CoreValve Evolut R) at a single US medical center were included. Choice of TAVR device was at the discretion of the multidisciplinary Heart Team. Baseline clinical characteristics, echocardiographic and CT imaging, procedural and 30-day outcomes were prospectively collected. RESULTS: 74 patients received a self-expanding valve (SEV) and 183 received a balloon-expandable valve (BEV). Patients selected for SEV were more frequently women, with lower body surface area and smaller calcified iliofemoral arteries. Three SEV patients required implantation of a second valve to successfully treat paravalvular leak. Only one BEV patient had moderate paravalvular regurgitation. There was no difference in the rate of stroke, major vascular complication or bleeding. Permanent pacemaker implantation rate was significantly higher with SEV (12.7% vs 4.7%, P = 0.49) and hospital length of stay was longer (8.3% vs 6.5%, P = 0.043), but 30-day mortality was comparable (1.4% vs 1.6%, P = 1.00). CONCLUSIONS: Short-term outcomes were equivalent between the two technologies. Clinically significant paravalvular regurgitation was rare. SEV were more frequently selected in women and patients with challenging transfemoral access, but were associated with higher permanent pacemaker implantation rate and longer hospital length of stay.

Impact of baseline mitral regurgitation on short- and long-term outcomes following transcatheter aortic valve replacement.

BACKGROUND: The prevalence of concomitant significant mitral regurgitation (MR) in patients with severe aortic stenosis (AS) undergoing transcatheter aortic valve replacement (TAVR) ranges from 2% to 33%. The impact of significant MR on post-TAVR outcomes remains controversial. METHODS: The data from a cohort of patients with symptomatic severe AS undergoing TAVR at out institution were retrospectively analyzed. The last transthoracic echocardiogram (TTE) before the index TAVR procedure was selected as the baseline assessment of the degree of MR. The total study cohort (N = 589) was divided into 2 groups: significant ≥moderate MR (n = 68) versus nonsignificant

Body mass index association with survival in severe aortic stenosis patients undergoing transcatheter aortic valve replacement.

BACKGROUND: Conflicting results have been reported regarding impact of body mass index (BMI) on outcome of transcatheter aortic valve replacement (TAVR) patients. This study evaluates the impact of BMI on 1 year mortality in patients undergoing TAVR via the transfemoral (TF) access. METHODS: Aortic stenosis (AS) patients undergoing TAVR via a TF access between May 2007 and December 2014 were categorized to 4 groups by BMI: low (<20), normal (20-24.9), overweight (25-30), and obese (>30). Baseline parameters were compared, and multivariate Cox proportional hazard regression models were generated to assess outcome differences. RESULTS: Among 491 severe AS TAVR patients, 43 had low BMI, 148 had normal BMI, 162 were overweight, and 138 were obese. Obese patients were younger with lower Society of Thoracic Surgeons scores and higher rates of preserved ejection fraction and diabetes. There was a higher rate of women in the BMI extremes. Aortic valve area was higher among obese patients; however, the indexed area was inversely correlated with BMI. Vascular complications and transfusions were more common in the low-BMI group, while acute kidney injury was more common in obese patients. All-cause mortality at 1 year was higher in the low-BMI group (log-rank p = 0.003) with no significant difference among normal and above-normal BMI patients. In a multivariate model, BMI <20 kg/m(2) was an independent predictor of mortality (HR = 2.45, p = 0.01). CONCLUSIONS: BMI <20 kg/m(2) should be considered a frailty marker during the screening process of severe AS TAVR patients as it is associated with higher mortality, while obesity confers similar mortality risk as normal weight. © 2015 Wiley Periodicals, Inc.

Outcome comparison of African-American and Caucasian patients with severe aortic stenosis subjected to transcatheter aortic valve replacement: a single-center experience.

OBJECTIVE: This study aimed to report the outcomes of African Americans (AAs) in the US undergoing transcatheter aortic valve replacement (TAVR) for severe aortic stenosis (AS). BACKGROUND: Compared to Caucasians, AAs are reported to have poorer outcomes from most cardiovascular diseases, including high complication rates after surgical aortic valve replacement. The outcomes of AAs undergoing TAVR are not well established. METHODS: Consecutive patients who underwent TAVR were included in this analysis. Patients' baseline characteristics, procedural data, in-hospital- and long-term outcomes were recorded and a comparison was performed between the AA and Caucasian cohorts. RESULTS: In a cohort of 469 consecutive patients, 51 (10.8%) were AA and 345 (74.5%) were Caucasian. The remaining patients (n = 73; 15.3%) self-reported their race as "unknown" or were from other races. Most baseline characteristics were similar between the two groups except for less men (33.3 vs. 50.1%; P = 0.016), a lower mean left ventricular ejection fraction (48.85 ± 16.35 vs. 53.24 ± 13.41%; P = 0.04) and lower rates of atrial fibrillation in AAs (15.7 vs.45.4%; P < 0.001). TAVR procedures in AAs were less frequently performed as part of a clinical trial (60.8 vs. 76.8%; P = 0.014). Most procedural and periprocedural outcome parameters were similar save for a higher rate of hemodynamic instability and postoperative need for intubation in AAs (10.4 vs. 2.5%; P = 0.018 and 29.4 vs. 16.9%; P = 0.03, respectively). This did not translate into a difference in mortality between AAs and Caucasians (30-day mortality 9.8 vs. 9.9%; P = 0.99; 1-year mortality 19.6 vs. 24.3%; P = 0.458, respectively). CONCLUSION: Unlike with other cardiovascular interventions, this study demonstrates that AA patients referred for TAVR shared similar risks and outcomes when compared to a Caucasian population.

Acquired thrombocytopenia after transcatheter aortic valve replacement: clinical correlates and association with outcomes.

AIMS: This study aimed to evaluate incidence and correlates for low platelet count after transcatheter aortic valve replacement (TAVR) and to determine a possible association between acquired thrombocytopenia and clinical outcomes. METHODS AND RESULTS: Patients undergoing TAVR from two medical centres were included in the study. They were stratified according to nadir platelet count post procedure: no/mild thrombocytopenia, ≥100 × 10(9)/L; moderate, 50-99 × 10(9)/L; and severe, <50 × 10(9)/L. A total of 488 patients composed of the study population (age 84.7 ± 7.5 years). At a median time of 2 days after TAVR, 176 patients (36.1%) developed significant thrombocytopenia: 149 (30.5%) moderate; 27 patients (5.5%) severe. Upon discharge, the vast majority of patients (90.2%) had no/mild thrombocytopenia. Nadir platelet count <50 × 10(9)/L was highly specific (96.3%), and a count <150 × 10(9)/L highly sensitive (91.2%), for predicting 30-day death (C-statistic 0.76). Patients with severe acquired thrombocytopenia had a significantly higher mortality rate at 1 year (66.7% for severe vs. 16.0% for no/mild vs. 20.1% for moderate; P < 0.001). In multivariate logistic regression, severe thrombocytopenia was independently associated with 1-year mortality (hazard ratio 3.44, CI: 1.02-11.6; P = 0.046). CONCLUSIONS: Acquired thrombocytopenia was common after TAVR and was mostly resolved at patient discharge. The severity of thrombocytopenia after TAVR could be used as an excellent, easily obtainable, marker for worse short- and long-term outcomes after the procedure.

Balloon aortic valvuloplasty for severe aortic stenosis as a bridge to transcatheter/surgical aortic valve replacement.

OBJECTIVES: This study aimed to determine success- and complication rates after balloon aortic valvuloplasty (BAV) and the outcome of BAV as a standalone therapy versus BAV as a bridge to transcatheter/surgical aortic valve replacement (T/SAVR). BACKGROUND: The introduction of transcatheter aortic valve replacement (TAVR) has led to a revival in BAV as treatment for patients with severe aortic stenosis. METHODS: A cohort of 472 patients underwent 538 BAV procedures. The cohort was divided into two groups: BAV alone 387 (81.9%) and BAV as a bridge 85 (18.1%) to (n = 65, TAVR; n = 20, surgery). Clinical, hemodynamic, and follow-up mortality data were collected. RESULTS: There was no significant difference between the two groups in mean age (81.7 ± 8.3 vs. 83.2 ± 10.9 years, P = 0.18), society of thoracic surgeons score (13.1 ± 6.2 and 12.4 ± 6.4, P = 0.4), logistic EuroSCORE (45.4 ± 22.3 vs. 46.9 ± 21.8, P = 0.43), and other comorbidities. The mean increase in aortic valve area was 0.39 ± 0.25 in the BAV alone group and 0.42 ± 0.26 in the BAV as a bridge group, P = 0.33. The decrease in mean gradient was 24.1 ± 13.1 in the BAV alone group vs. 27.1 ± 13.8 in the BAV as a bridge group, P = 0.06. During a median follow up of 183 days [54-409], the mortality rate was 55.2% (n = 214) in the BAV alone group vs. 22.3% (n = 19) in the BAV as a bridge group during a median follow-up of 378 days [177-690], P < 0.001. CONCLUSION: In high-risk patients with aortic stenosis and temporary contraindications to SAVR/TAVR, BAV may be used as a bridge to intervention with good mid-term outcomes.

Outcomes of concomitant percutaneous coronary intervention and balloon aortic valvuloplasty.

BACKGROUND: Coronary artery disease often coexists with severe aortic stenosis. The feasibility and safety of combined balloon aortic valvuloplasty (BAV) and percutaneous coronary intervention (PCI) are unknown. AIM: To compare outcomes and complications of combined BAV and PCI with BAV alone. METHODS: The study cohort consisted of 409 patients with severe aortic stenosis undergoing BAV from 1/2007 to 12/2010. Overall, 329 patients underwent BAV alone and 80 underwent concomitant PCI. Clinical and hemodynamic data, as well as acute and intermediate-term outcomes, were collected. RESULTS: At the operator's discretion PCI was done before BAV in 66 (82.5%) and after in 14 (17.5%). Patients who underwent concomitant procedures had a higher incidence of prior stroke and a lower incidence of atrial fibrillation. Procedure time and fluoroscopic time were significantly greater in the BAV/PCI group, (90.0 ± 36.6 vs. 72.8 ± 39.8, P = 0.002 and 20.5 ± 10.9 vs. 12.9 ± 7.0, P < 0.001). Significantly more radiographic contrast was used in the BAV/PCI group (95.1 ± 45.5 vs. 36.7 ± 38.4 cm(3) , P < 0.001. Serious adverse events occurred with equal frequency 13.7 and 17.3%, P = 0.44). Transfusion requirement was also similar (21.2% vs. 20.0%, P = 0.81). The frequency of a periprocedural increase in troponin or creatinine was also similar. In the BAV alone group the mortality rate was 48.6% (n = 160) during a mean follow-up of 191 days, and in the BAV/PCI group the mortality rate was 40% (n = 32) during mean follow-up of 175.5 day, P = 0.34. CONCLUSION: Combined BAV and PCI are safe and are associated with similar complications as BAV alone and may offer protection against myocardial ischemia during BAV.

Correlates and causes of death in patients with severe symptomatic aortic stenosis who are not eligible to participate in a clinical trial of transcatheter aortic valve implantation.

BACKGROUND: Transcatheter aortic valve implantation is currently being evaluated in patients with severe aortic stenosis who are considered high-risk surgical candidates. This study aimed to detect incidences, causes, and correlates of mortality in patients ineligible to participate in transcatheter aortic valve implantation studies. METHODS AND RESULTS: From April 2007 to July 2009, a cohort of 362 patients with severe aortic stenosis were screened and did not meet the inclusion/exclusion criteria necessary to participate in a transcatheter aortic valve implantation trial. These patients were classified into 2 groups: group 1 (medical): 274 (75.7%): 97 (35.4%) treated medically and 177 (64.6%) treated with balloon aortic valvuloplasty; and group 2 (surgical): 88 (24.3%). The medical/balloon aortic valvuloplasty group had significantly higher clinical risk compared with the surgical group, with significantly higher Society of Thoracic Surgeons score (12.8±7.0 versus 8.5±5.1; P<0.001) and logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE) (42.4±22.8 versus 24.4±18.1; P<0.001). The medical/balloon aortic valvuloplasty group had a higher New York Heart Association functional class, incidence of renal failure, and lower ejection fraction. During median follow-up of 377.5 days, mortality in the medical/balloon aortic valvuloplasty group was 102 (37.2%), and during median follow-up of 386 days, mortality in the surgical group was 19 (21.5%). Multivariable adjustment analysis identified renal failure (hazard ratio [HR]: 5.60), New York Heart Association class IV (HR: 5.88), and aortic systolic pressure (HR: 0.99) as independent correlates for mortality in the medical group, whereas renal failure (HR: 7.45), Society of Thoracic Surgeons score (STS; HR: 1.09) and logistic EuroSCORE (HR: 1.45) were correlates of mortality in the in the surgical group. CONCLUSIONS: Patients with severe symptomatic aortic stenosis not included in transcatheter aortic valve implantation trials do poorly and have extremely high mortality rates, especially in nonsurgical groups, and loss of quality of life in surgical groups.

Learning from patient and site perspectives to develop better digital health trials: Recommendations from the Clinical Trials Transformation Initiative.

In order to harness the potential of digital health technologies to enhance the quality of clinical research, it is critical to first understand how to engage patients and research sites when planning and conducting digital health trials. To pave the way for the more effective use of digital health technologies in trials, the Clinical Trials Transformation Initiative has developed the first comprehensive, evidence-based set of recommendations for incorporating patient and site perspectives in digital health trials. While directed primarily at sponsors, these recommendations are expected to be valuable for all stakeholders including investigators.

Impact of Transcatheter Aortic Valve Replacement on Risk Profiles of Surgical Aortic Valve Replacement Patients.

BACKGROUND: The advent of transcatheter aortic valve replacement (TAVR) has changed which patients undergo surgical aortic valve replacement (SAVR). We sought to understand the impact of TAVR on the characteristics of SAVR patients in the United States. METHODS: A cohort of 2959 patients who underwent isolated SAVR at 11 US hospitals that perform both TAVR and SAVR from 2013 through 2017 were grouped by the Society of Thoracic Surgeons (STS) Adult Cardiac Surgery Database version (v)2.73 (2011-2014), v2.81 (2014-2017), and v2.9 (2017) to assess temporal trends in patient characteristics. RESULTS: Over time, SAVR patients were younger with fewer preoperative comorbidities. There was a significant decrease in median STS predicted risk of mortality (PROM) score (2.0 vs. 1.8 vs. 1.3, p < 0.001, in v2.73 vs. v2.81 vs. v2.9). Specifically, there were fewer high-risk (STS PROM > 8%: 4.3% vs. 4.7% vs. 1.2%, p = 0.03) and intermediate-risk (STS PROM 4% to 8%: 16.3% vs. 11.7% vs. 4.3%, p < 0.001) patients. The proportion of patients with bicuspid aortic valve disease increased significantly (11.2% vs. 26.9% vs. 36.6%, p < 0.001). There were no differences in operative mortality (1.9% vs. 2.1% vs. 1.4%, p = 0.75). CONCLUSIONS: The introduction of TAVR has already impacted the demographics, clinical characteristics and risk profiles of patients undergoing SAVR in the US. Now that TAVR is approved for low-risk patients, SAVR is likely to be reserved for younger patients who are willing to receive a mechanical valve and for patients with aortopathy, coronary artery disease, or concomitant mitral or tricuspid pathology.

Feasibility of Coronary Access and Aortic Valve Reintervention in Low-Risk TAVR Patients.

OBJECTIVES: The aim of this study was to evaluate the feasibility of coronary access and aortic valve reintervention in low-risk patients undergoing transcatheter aortic valve replacement (TAVR) with a balloon-expandable transcatheter heart valve (THV). BACKGROUND: Younger, low-risk TAVR patients are more likely than older, higher risk patients to require coronary angiography, percutaneous coronary intervention, or aortic valve reintervention, but their THVs may impede coronary access and cause coronary obstruction during TAVR-in-TAVR. METHODS: The LRT (Low Risk TAVR) trial (NCT02628899) enrolled 200 subjects with symptomatic severe aortic stenosis to undergo TAVR using commercially available THVs. Subjects who received balloon-expandable THVs and who had 30-day cardiac computed tomographic scans were included in this study. In a subgroup, the feasibility of intentional THV crimping on the delivery catheter to pre-determine commissural alignment was tested. RESULTS: In the LRT trial, 168 subjects received balloon-expandable THVs and had 30-day cardiac computed tomographic scans, of which 137 were of adequate image quality for analysis. The most challenging anatomy for coronary access (THV frame above and commissural suture post in front of a coronary ostium) was observed in 9% to 13% of subjects. Intentional THV crimping did not appear to meaningfully affect commissural alignment. The THV frame extended above the sinotubular junction in 21% of subjects, and in 13%, the distance between the THV and the sinotubular junction was <2 mm, signifying that TAVR-in-TAVR may not be feasible without causing coronary obstruction. CONCLUSIONS: TAVR may present challenges to future coronary access and aortic valve reintervention in a substantial number of low-risk patients.

Transcatheter Aortic Valve Replacement in Patients With Symptomatic Severe Aortic Stenosis and Prior External Chest Radiation.

BACKGROUND/PURPOSE: Surgical aortic valve replacement (SAVR) in patients with symptomatic severe aortic stenosis (AS) and prior chest radiation is associated with poor outcomes in comparison with patients without prior radiation. Our objective was to compare clinical outcomes of patients with and without prior chest radiation undergoing transcatheter aortic valve replacement (TAVR) for symptomatic severe AS. METHODS/MATERIALS: Between January 2003 and January 2017, 1150 patients underwent TAVR at our institution. Of these, 44 had prior chest radiation. Baseline demographic and clinical characteristics, procedural details, and clinical outcomes were prospectively collected. RESULTS: Patients with prior chest radiation were younger, 76 ±â€¯13 years, compared with those without prior chest radiation, 82 ±â€¯8 years (p = 0.002). Median Society of Thoracic Surgeons score for chest radiation patients was 7 ±â€¯4, compared to 8 ±â€¯5 in those without prior radiation. Despite higher prevalence of complete heart block, there was no significant difference between the 2 groups with regard to the need for permanent pacemaker implantation. There was a trend toward longer length of intensive care unit stay in chest radiation patients, but there was no significant difference in 30-day or 1-year mortality. CONCLUSIONS: Thus, TAVR appears to be a safe treatment option in the short and medium term for patients with symptomatic severe AS and prior chest radiation.

Antiplatelet and anticoagulation regimen in patients with mechanical valve undergoing PCI - State-of-the-art review.

A common clinical dilemma regarding treatment of patients with a mechanical valve is the need for concomitant antiplatelet therapy for a variety of reasons, referred to as triple therapy. Triple therapy is when a patient is prescribed aspirin, a P2Y12 antagonist, and an oral anticoagulant. Based on the totality of the available evidence, best practice in 2017 for patients with mechanical valves undergoing percutaneous coronary intervention (PCI) is unclear. Furthermore, the optimal duration of dual antiplatelet therapy after PCI is evolving. With better valve designs that are less thrombogenic, the thromboembolic risks can be reduced at a lower international normalized ratio target, thus decreasing the bleeding risk. This review will offer an in-depth survey of current guidelines, current evidence, suggested approach for PCI in this cohort, and future studies regarding mechanical valve patients undergoing PCI.

MynxGrip® vascular closure device versus manual compression for hemostasis of percutaneous transfemoral venous access closure: Results from a prospective multicenter randomized study.

PURPOSE: Evaluate the safety of MynxGrip® for common femoral vein closure. METHODS AND MATERIALS: This is a multicenter, randomized, prospective study of 208 patients who were slated to undergo diagnostic/interventional procedures via femoral venous access. Patients were randomized 1:1 to receive venous hemostasis via MynxGrip® (n = 104) or manual compression (n = 104) utilizing 5, 6, and 7 Fr sheaths. Bilateral calf and thigh circumferences were measured serially. Patients were followed up through hospital discharge. There were no differences in the baseline characteristics between the two groups. RESULTS: There was no difference between the groups for venous thrombosis, (0%, p = 1). Overall, there was no significant change in access site calf (-0.18 ±â€¯1.38 cm, p = 0.18) or thigh diameter (0.33 ±â€¯2.86, p = 0.81). In both groups, none of the patients had major or minor vascular complications, access site infection, nerve injury, or access site bleeding requiring transfusion. The pre- to post-procedure hemoglobin drop was -0.51 ±â€¯1.1 vs. -0.64 ±â€¯1.3 g/dL, p = 0.59 in the manual compression group and MynxGrip® group, respectively. Time to hemostasis, was significantly lower in the MynxGrip® group compared to the manual compression group with 0.12 ±â€¯0.89 vs. 7.6 ±â€¯5.7 min, respectively (p < 0.001). CONCLUSIONS: The MynxGrip® extravascular sealant is safe and effective for femoral venous access site closure.

The impact of in-hospital P2Y12 inhibitor switch in patients with acute coronary syndrome.

BACKGROUND/PURPOSE: Dual antiplatelet therapy (DAPT) varies after placement of drug-eluting stents (DES) in patients presenting with acute coronary syndromes (ACS). Our aim was to study patient characteristics and predictors of switching, in-hospital or at discharge, from clopidogrel (CLO) to ticagrelor (TIC) or vice versa. METHODS/MATERIALS: The study population included patients with ACS who had DES and initially received either CLO or TIC between January 2011 and December 2017. Patients were divided into 4 groups based on initial DAPT choice and whether DAPT was switched in-hospital or during discharge. Clinical outcomes of interest were bleeding events, need for anticoagulation, and need for in-hospital coronary artery bypass graft (CABG). RESULTS: We identified 2837 patients who received DES and started on DAPT. DAPT switch from 1 P2Y12 inhibitor to another occurred in 9%, either in-hospital or at discharge. Of 1834 patients started on CLO, 112 were switched to TIC. Of 1003 patients started on TIC, 142 were switched to CLO. The need for in-hospital CABG was 7.8% in the TIC-CLO group compared to none in the CLO-TIC group (p = 0.002). Adjusted for covariates, the TIC-CLO group was 3 times more likely to need anticoagulation with warfarin than the CLO-CLO group (p < 0.001) and over 5 times more likely than the CLO-TIC group and the TIC-TIC group (p < 0.005 for both). CONCLUSIONS: Switching from 1 generation P2Y12 inhibitor to another does occur in ACS patients. Clinical needs such as in-hospital CABG or oral anticoagulation upon discharge are real and dictate the switch from TIC to CLO. SUMMARY: A single-center observational study of 2837 patients with acute coronary syndromes treated with drug-eluting stents found that some do get switched from one generation P2Y12 inhibitor to another. The switch from clopidogrel to ticagrelor is driven by clinical needs such as in-hospital coronary artery bypass grafting or the need for oral anticoagulation upon discharge.

Clinical Characteristics, Procedural Factors, and Outcomes of Percutaneous Coronary Intervention in Patients With Mechanical and Bioprosthetic Heart Valves.

There is scarcity of evidence regarding antiplatelet and anticoagulant therapy in patients with prosthetic valves undergoing percutaneous coronary intervention (PCI). Our goal was to compare clinical outcomes between patients with mechanical or bioprosthetic valves undergoing PCI. The study population comprised patients with either a bioprosthetic or mechanical heart valve in the aortic and/or mitral position undergoing PCI between January 2003 and July 2017. Demographics, admission, and discharge medications as well as procedural details were documented. Outcomes were postprocedural bleeding, length of stay, and in-hospital deaths. Of 211 patients, we identified 119 and 92 patients with a bioprosthetic or mechanical valve, respectively. Mean age was 75 ± 9 years and 66 ± 12 years in bioprosthetic and mechanical valve patients, respectively. Bare-metal stents were used in 18.2% and 30.1% of bioprosthetic and mechanical valve patients, respectively. Major bleeding was documented in 0.8% and 6.5% of bioprosthetic and mechanical valve patients, respectively (p = 0.04). Use of triple therapy (aspirin AND clopidogrel AND oral vitamin K antagonist) was significantly lower in bioprosthetic valve patients compared with mechanical valve patients (12% vs 68%, p <0.001). Our study shows variation in periprocedural anticoagulation and/or antiplatelet choice exists in this population. Patients with mechanical valves experienced higher rates of major bleeding compared with patients with bioprosthetic valves, which could be due to concomitant anticoagulation and dual antiplatelet therapy.