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.

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.

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.

Accuracy of predicted orthogonal projection angles for valve deployment during transcatheter aortic valve replacement.

BACKGROUND: Multi-detector computed tomography (MDCT) predicted orthogonal projection angles have been introduced to guide valve deployment during transcatheter aortic valve replacement (TAVR). Our aim was to investigate the accuracy of MDCT prediction methods versus actual angiographic deployment angles. METHODS: Retrospective analysis of 2 currently used MDCT methods: manual multiplanar reformations (MR) and the semiautomatic optimal angle graph (OAG). Paired analysis was used to compare the 2-dimensional distributions and means. RESULTS: We included 101 patients with a mean (±SD) age of 81 ±â€¯9 years. The MR and OAG methods were used in 46 and 55 patients, respectively. A ≥5% change from the predicted MDCT range in left anterior oblique/right anterior oblique (LAO/RAO) and the cranial/caudal (CRA/CAU) angle occurred in 42% and 58% of patients, respectively. The mean predicted versus actual deployment angles were significantly different (CRA/CAU: -2.6 ±â€¯11.5 vs. -7.6 ±â€¯10.7, p < 0.001; RAO/LAO 8.1 ±â€¯10.9 vs. 9.5 ±â€¯10.6, p = 0.048; respectively). The MR method resulted in a more accurate CRA/CAU angle (CRA/CAU: -4.6 ±â€¯11.1 vs. -6.5 ±â€¯11.8, p = 0.139; RAO/LAO 7.4 ±â€¯11.2 vs. 10.4 ±â€¯11.2, p = 0.008; respectively), whereas the use of the OAG resulted in a more accurate RAO/LAO angle (CRA/CAU: -0.9 ±â€¯10.8 vs. -9±11.2, p < 0.001; RAO/LAO 9.05 ±â€¯10.6 vs. 8.5 ±â€¯9.9, p = 0.458; respectively). For the entire cohort, the 2-dimensional distributions and means of the predicted versus the actual angles were significantly different from each other (p < 0.001). We repeated our analysis using both MDCT methods and demonstrated similar results with each method. CONCLUSIONS: Currently used MDCT methods for TAVR implantation angles are significantly modified before actual valve deployment. Thus, further refinement of these prediction methods is required.

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.

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.

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.

Utility of Invasive Electrophysiology Studies in Patients With Severe Aortic Stenosis Undergoing Transcatheter Aortic Valve Implantation.

Permanent pacemaker (PPM) implantation remains common after transcatheter aortic valve implantation (TAVI). Invasive electrophysiology studies (EPSs) may reduce PPM implantation rates by identifying patients who do not require long-term pacing. At our institution, a new strategy in which patients with equivocal indications for pacing underwent EPSs to determine the need for PPM implantation was adopted. We compared baseline demographics, TAVI procedural details, and outcomes in patients without any conduction disturbance after TAVI, patients with new PPM implantation, and patients with EPS ± new PPM implantation. After exclusion for preexisting PPMs, of a total of 614 consecutive TAVI patients, 117 (19.1%) required new PPM implantation for unequivocal pacing indications, and 95 (15.5%) underwent EPSs. Of those patients who underwent EPSs, 28 (29.5%) required PPM implantation and 67 (70.5%) did not. The overall rate of new PPM implantation was higher for self-expanding versus balloon-expandable valves (34.0% vs 19.9%, p = 0.0011). PPM implantation increased intensive care and hospital length of stay compared with patients without any conduction disturbance (10.7 ± 8.3 vs 8.5 ± 6.4 days, p = 0.003). A negative EPS did not prolong length of stay. There were no significant differences in 30-day and 1-year mortality between groups. In conclusion, among TAVI patients with new-onset conduction disturbance, EPS is a safe strategy to identify those who require PPM implantation and those in whom PPMs can be avoided.

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.

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.

Choice of Balloon-Expandable Versus Self-Expanding Transcatheter Aortic Valve Impacts Hemodynamics Differently According to Aortic Annular Size.

We sought to determine whether balloon-expandable valve (BEV) and self-expanding valve (SEV) affect valve hemodynamics differently according to native aortic annulus size. Transcatheter aortic valve replacement can achieve superior prosthetic valve hemodynamics compared with surgical aortic valve replacement, particularly in patients with small aortic annulus. One hundred ninety-three consecutive transcatheter aortic valve replacement patients were grouped into tertiles defined by computed tomography derived aortic annulus systolic perimeter. The predischarge echocardiogram was analyzed for prosthetic valve hemodynamics. Tertile perimeter cutoffs were 73 and 80 mm. STS score decreased as annulus size increased (7.8% vs 7.6% vs 6.0%, p ≤0.05 for small, medium, and large annulus, respectively). In patients with small aortic annulus, SEV was associated with significantly higher dimensionless index (0.64 vs 0.53, p = 0.02) and lower peak velocity (1.8 vs 2.4 m/sec, p <0.001) and a trend toward lower mean gradient (7.5 vs 10.0 mm Hg, p = 0.07) compared with BEV. These differences were attenuated and absent in patients with medium and large annulus, respectively. Few patients had moderate/severe paravalvular leak, with no association with valve type or annulus size. There was no difference in mortality between tertiles or valve type at 30 days or 1 year. There was no association between aortic annulus perimeter and 1-year mortality by univariate analysis (hazard ratio 1.00, 95% CI 0.95 to 1.05, p = 0.86) or multivariate analysis (hazard ratio 1.02, 95% CI 0.95 to 1.09, p = 0.60). In conclusion, SEV hemodynamics was superior to BEV in patients with small aortic annulus. This difference was diminished in patients with larger aortic annulus. This study highlights the importance of valve selection in patients with small aortic annulus.

Use of an ePTFE-covered nitinol self-expanding stent graft for the treatment off pre-closure device failure during transcatheter aortic valve replacement.

OBJECTIVES: Our aim was to describe our experience with the use of an ePTFE-covered nitinol self-expanding stent graft (GORE® VIABAHN® Endoprosthesis, Gore Medical, USA) placed in the common femoral artery for the treatment of suture-mediated pre-closure device failure following transcatheter aortic valve replacement (TAVR). BACKGROUND: Access site-related vascular complications (VC) following sheath removal related to pre-closure device failure during TAVR are common and treatment options may vary. METHODS: We performed an observational study on a series of consecutive patients who underwent TAVR between 2013 and 2015. RESULTS: Included were 25 patients at a mean (±SD) age of 82±9. Failure of the closure device resulted in overt bleeding in 19 patients, dissection or no flow in 5 patients, and angiographic pseudoaneurysm in 1. Overall 29 stents were deployed with diameters ranging from 8 to 11mm and a length of 50mm (26, 90%). All stent-graft deployments achieved complete hemostasis of the arteriotomy site and resulted in normal flow to the distal vessels. None of the patients required open surgical repair. The mean hemoglobin drop was 2.6±1.3g/dl. Blood transfusions were used in 15 (60%) patients. Acute kidney injury occurred in 4 (16%) patients, none of whom was treated with dialysis. Length of hospital stay was 9±5days. All patients survived during a 30-day follow-up period, and none had VC related to the stented site. CONCLUSIONS: The use of an ePTFE-covered Nitinol self-expanding stent graft is a feasible, safe, and effective treatment modality for access site-related VC following TAVR. SUMMARY: The use of an ePTFE-covered nitinol self-expanding stent graft placed in the common femoral artery for the treatment of suture-mediated pre-closure device failure following transcatheter aortic valve replacement (TAVR) is described in 25 patients. Its use was found to be feasible, safe, and an effective treatment modality for access site-related vascular complications following TAVR.

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

Comparison of clinical outcomes with the utilization of monitored anesthesia care vs. general anesthesia in patients undergoing transcatheter aortic valve replacement.

BACKGROUND: There is no clear consensus in regard to the optimal anesthesia utilization during transcatheter aortic valve replacement (TAVR). The aim was to compare outcomes of transfemoral (TF) TAVR under monitored anesthesia care (MAC) vs. general anesthesia (GA) and evaluate the rates and causes of intra-procedural MAC failure. METHODS: All consecutive patients who underwent TF TAVR from April 2007 through March 2015 were retrospectively analyzed and dichotomized into two groups: TAVR under MAC vs. GA. The main endpoints of the study included 30-day and 1-year mortality, the rates and reasons for failure of MAC, in-hospital clinical safety outcomes, and post-procedural hospital and intensive care unit length-of-stays. RESULTS: A total of 533 patients (51% male, mean-age 83years) underwent TF TAVR under MAC (n=467) or GA (n=66). Fifty-six patients (12%) in the MAC group required conversion to GA. The MAC group had significantly shorter post-procedural hospital (6.0 vs. 7.9, p=0.023) and numerically shorter ICU (2.4 vs. 2.8, p=0.355) mean length-of-stays in days. The clinical safety outcomes were similar in both groups. Kaplan-Meier unadjusted cumulative in-hospital and 30-day mortality rates were higher in the GA group but similar in both groups at 1-year. CONCLUSIONS: TF TAVR under MAC is feasible and safe, results in shorter hospital stays, can be performed in the majority of cases, and should be utilized as the default strategy. Trans-esophageal echocardiography utilization during TAVR with MAC is safe and feasible. The most common cause for conversion of MAC to GA is cardiac instability and hypotension. The complete heart team should be available at all times in case the need arises for a rapid conversion to GA.

The adjunctive use of Angio-Seal in femoral vascular closure following percutaneous transcatheter aortic valve replacement.

AIMS: The objective of this study was to describe and evaluate the adjunctive technique of Angio-Seal (AS) use to augment the dual Perclose ProGlide (PP) in achieving haemostasis in patients undergoing transfemoral percutaneous transcatheter aortic valve replacement (TAVR). METHODS AND RESULTS: All patients who underwent TAVR from May 2007 to January 2015 via a planned transfemoral percutaneous approach with a dual PP pre-close strategy were retrospectively analysed. This cohort was divided into two groups: dual PP versus dual PP with adjunctive AS (PP+AS) use based on the specific status of intraprocedural haemostasis. The baseline and procedural characteristics and in-hospital outcomes were prospectively collected and retrospectively compared. Overall, a total of 387 consecutive patients (55% male, mean age 83 years) with dual PP (n=179) vs. dual PP+AS (n=208) were evaluated. There were no statistically significant differences between the dual PP vs. dual PP+AS groups with regard to the in-hospital Valve Academic Research Consortium-2 (VARC-2) primary endpoints of major vascular complications (8.0% vs. 6.6%, p=0.592), minor vascular complications (18.4% vs. 13.7%, p=0.218), life-threatening or disabling bleeding (5.1% vs. 3.0%, p=0.291), major bleeding (1.7% vs. 1.5%, p=1.000), and minor bleeding (14.4% vs. 10.6%, p=0.271). CONCLUSIONS: The adjunctive Angio-Seal technique to augment the dual PP pre-close strategy for patients undergoing percutaneous femoral closure following TAVR is feasible and safe and may be considered as a bail-out or an alternative strategy when the dual PP closure technique fails to obtain complete haemostasis.