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Transcatheter heart valve technology has rapidly progressed since initial approval in the United States. There are currently two widely available transcatheter heart valve delivery systems approved in the US; however limited data exist on optimal device selection for various patient populations. This review explores the characteristics of currently approved transcatheter heart valve systems and scenarios where one valve system may be favored over others. We provide a simplified decision tree for selecting the optimal transcatheter valve system for specific patient-centered characteristics.

Objective Bioprosthetic heart valves (BHVs) are commonly used in surgical and percutaneous valve replacement. The durability of percutaneous valve replacement is unknown, but surgical valves have been shown to require reintervention after 10 to 15 years. Further, smaller-diameter surgical BHVs generally experience higher rates of prosthesis–patient mismatch, which leads to higher rates of failure. Bioprosthetic aortic valves can flutter in systole, and fluttering is associated with fatigue and failure in flexible structures. The determinants of flutter in BHVs have not been well characterized, despite their potential to influence durability. Methods We use an experimental pulse duplicator and a computational fluid-structure interaction model of this system to study the role of device geometry on BHV dynamics. The experimental system mimics physiological conditions, and the computational model enables precise control of leaflet biomechanics and flow conditions to isolate the effects of variations in BHV geometry on leaflet dynamics. Results Both experimental and computational models demonstrate that smaller-diameter BHVs yield markedly higher leaflet fluttering frequencies across a range of conditions. The computational model also predicts that fluttering frequency is directly related to leaflet thickness. A scaling model is introduced that rationalizes these findings. Conclusions We systematically characterize the influence of BHV diameter and leaflet thickness on fluttering dynamics. Although this study does not determine how flutter influences device durability, increased flutter in smaller-diameter BHVs may explain how prosthesis–patient mismatch could induce BHV leaflet fatigue and failure. Ultimately, understanding the effects of device geometry on leaflet kinematics may lead to more durable valve replacements.

Objectives This study investigates the prevalence and prognostic significance of mitral regurgitation (MR) in acute decompensated heart failure (ADHF) patients. Background Few studies characterize the burden of MR in heart failure. Methods The ARIC (Atherosclerosis Risk In Communities) study surveilled ADHF hospitalizations for residents ≥55 years of age in 4 U.S. communities. ADHF cases were stratified by left ventricular ejection fraction (LVEF): Results From 2005 to 2014, there were 17,931 weighted ADHF hospitalizations of which 49.2% had an LVEF Conclusions Patients with ADHF have a significant MR burden that varies with sex and race. In ADHF patients with an LVEF

Objectives The aim of this study was to compare 1-year outcomes following transcatheter mitral valve (MV) repair in patients with and without atrial fibrillation (AF). Background The development of AF in degenerative mitral regurgitation (MR) is considered a sign of MR progression and is associated with adverse clinical events. However, the impact of AF in patients undergoing transcatheter MV repair remains uncertain. Methods The TVT (Transcatheter Valve Therapy) Registry was used to identify patients undergoing transcatheter MV repair with the MitraClip between November 2013 and June 2016. Using Centers for Medicare and Medicaid Services–linked data, the 1-year rate of death, heart failure hospitalization, stroke, and bleeding following transcatheter MV repair was compared in patients with and without AF. Outcomes were analyzed using multivariate Cox regression modeling. Results A total of 5,613 patients underwent commercial transcatheter MV repair in the United States during the study period, including 3,555 (63%) with pre-existing AF. Compared with patients without AF, patients with AF were older, were more likely to be male and Caucasian, had more comorbidities, and had higher Society of Thoracic Surgeons Predicted Risk of Mortality scores (median 7% vs. 5%; p Conclusions In patients undergoing transcatheter MV repair, AF is common and is associated with worse clinical outcomes at 1 year despite similar acute procedural success. Further study is needed to investigate if early treatment of MR reduces the future risk for developing AF and to identify therapies that improve outcomes in these patients.

Patients with calcific aortic stenosis (AS) often have diffuse cardiac calcification involving the mitral valve apparatus and coronary arteries. We examined the association between global cardiac calcification quantified by a previously validated echocardiographic calcium score (eCS) with the severity of mitral stenosis (MS) and coronary artery disease (CAD) in patients with a clinical diagnosis of severe calcific AS. In this sample of 147 patients (mean age 81 ± 9 years, 50% male), 81 patients (55%) were determined by echocardiography to have some degree of MS. Higher mean eCS was observed in patients with more severe MS (r = 0.54, p 0.0001). Higher eCS was also inversely associated with mitral valve area (r = -0.31, p = 0.001) and positively associated with mitral valve mean pressure gradient (r = 0.46, p 0.0001) and mitral valve peak flow velocity (r = 0.55, p 0.0001). The area under the receiver operating characteristic curve for using eCS to predict the presence of MS was 0.76. An eCS ≥ 8 predicted MS with a sensitivity of 68%, specificity of 76%, positive predictive value of 77%, and negative predictive value of 66%. High eCS, relative to low eCS, was associated with 2.70 times the adjusted odds of CAD (odds ratio = 2.70, 95% confidence interval 1.02 to 7.17). In conclusion, global cardiac calcification is associated with MS and CAD in patients with severe calcific AS, and eCS shows ability to predict the presence of MS. This study suggests that a simple eCS may be used as part of a risk-stratification tool in patients with severe calcific aortic valve stenosis.

Background The results from the PARTNER 2 trial showed the feasibility of transcatheter aortic valve replacement (TAVR) in intermediate surgical risk patients. Although low risk clinical trials will take time to conclude, some data has emerged comparing TAVR with surgical aortic valve replacement (SAVR) in lower risk patients. Methods A Medline search was conducted using standard methodology to search for studies reporting results comparing TAVR and SAVR. Studies were included if the overall mean Society of Thoracic Surgeons Score was less than 4% (or equivalent Euroscore). A meta-analysis comparing the 30-day risk of clinical outcomes between TAVR and SAVR in the lower surgical risk population was conducted. Results A total of four studies, including one clinical trial and three propensity-matched cohort studies met the inclusion criteria. Compared to SAVR, TAVR had a lower risk of 30-day mortality (RR 0.67, 95% CI 0.41, 1.10), stroke (RR 0.60, 95% CI 0.30, 1.22), bleeding complications (RR 0.51, 95% CI 0.40, 0.67) and acute kidney injury (RR 0.66, 95% CI 0.47, 0.94). However, a higher risk of vascular complications (RR 11.72, 95% CI 3.75, 36.64), moderate or severe paravalvular leak (RR 5.04, 95% CI 3.01, 8.43), and permanent pacemaker implantations (RR 4.62, 95% CI 2.63, 8.12) was noted for TAVR. Conclusion Among lower risk patients, TAVR and SAVR appear to be comparable in short term outcomes. Additional high quality studies among patients classified as low risk are needed to further explore the feasibility of TAVR in all surgical risk patients.

Highlights • Acute cardiovascular hospitalizations in NC declined after the state of emergency order. • Declines in rates were similar in both urban and rural counties, and older individuals experienced the most substantial declines. • After reopening measures, there was an abrupt rebound in acute cardiovascular hospitalizations. • Government orders closely correlate with health care seeking behavior in acute cardiovascular events., Objective Little is known about the effect of government-issued State of Emergency (SOE) and Reopening orders on health care behaviors. We aimed to determine the effect of SOE and Phase 1 of Reopening orders on hospitalizations for acute myocardial infarction (AMI) or acute decompensated heart failure (ADHF). Methods Hospitalizations for AMI and ADHF in the UNC Health system, which includes 10 hospitals in both urban and rural counties, were identified. An interrupted time series design was used to compare weekly hospitalization rates for eight weeks before the March 10th SOE declaration, eight weeks between the SOE order and Phase 1 of Reopening order, and the subsequent eight weeks. Results Overall, 3,792 hospitalizations for AMI and 7,223 for ADHF were identified. Rates before March 10th were stable. AMI/ADHF hospitalizations declined about 6% per week in both urban and rural hospitals from March 11th to May 5th. Larger declines in hospitalizations were seen in adults ≥65 years old (-8% per week), women (-7% per week), and White individuals (-6% per week). After the Reopening order, AMI/ADHF hospitalizations increased by 8% per week in urban centers and 9% per week in rural centers, including a significant increase in each demographic group. The decline and rebound in acute CV hospitalizations were most pronounced in the two weeks following the government orders. Conclusions AMI and ADHF hospitalization rates closely correlated to SOE and Reopening orders. These data highlight the impact of public health measures on individuals seeking care for essential services; future policies may benefit from clarity regarding when individuals should present for care., Graphical abstract Image, graphical abstract

Among patients presenting with ST-segment elevation myocardial infarction (STEMI) for primary percutaneous coronary intervention (PCI), the associations between clinical outcomes and both baseline renal function and the development of acute kidney injury (AKI) have not been reported in a trial population with unselected baseline renal function.Patients enrolled in the APEX-AMI trial who underwent primary PCI for the treatment of STEMI were categorized according to (a) baseline renal function and (b) the development of AKI. Patient characteristics, clinical outcomes, and treatment patterns were analyzed according to baseline renal function and the development of AKI. A prediction model for AKI after primary PCI for STEMI was also developed.A total of 5,244 patients were included in this analysis and stratified according to baseline estimated glomerular filtration rate (eGFR) (milliliters per minute per 1.73 m(2)) of90, 60 to 90, 30 to 59, or30 or as dialysis dependent. Patients with lower eGFR were older, more often female, and less often treated with evidence-based medicines and had worse angiographic outcomes and higher mortality. The rates of AKI for patients with a baseline eGFR of90, 60 to 90, 30 to 59, and30 were 2.5%, 4.1%, 8.1%, and 1.6%, respectively (P.0001). The strongest predictors of AKI were age and presenting in Killip class III or IV.Among patients undergoing primary PCI for STEMI, impaired renal function at presentation and development of post-PCI AKI were highly associated with worse clinical and angiographic outcomes, including death. The risk of developing AKI was low and only modestly associated with baseline renal function.

We read with interest the paper by Kundi et al. [(1)][1] that assessed trends in transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) volume, and the effect of TAVR volume on SAVR mortality. Although this question is an important one, there are concerns

Conduction defects after transcatheter aortic valve replacement (TAVR) occasionally require permanent pacemaker (PPM) implantation. Data on timing of PPM post-TAVR are lacking, particularly in patients who re-present after discharge with new high degree AV block (HAVB). We performed a single-center

Degenerative mitral valves, associated with mitral valve prolapse, are more frequent in those with low body weight. However, the association of body mass index (BMI) and outcomes after transcatheter mitral valve repair has not been studied. Patients who underwent commercial MitraClip from November

BackgroundPatients with thoracic aortic disease undergoing thoracic endovascular aortic repair (TEVAR) often have concomitant coronary artery disease and are at risk for perioperative adverse cardiac events. Despite this risk, the need for and extent of preoperative cardiac workup before TEVAR remain undefined. This study seeks to assess the adequacy of a limited cardiac evaluation before TEVAR, including assessment of cardiac symptoms, resting electrocardiography (ECG), and transthoracic echocardiography (TTE), as well as to estimate the incidence of perioperative cardiac events in patients undergoing TEVAR.MethodsRetrospective analysis of a prospectively maintained Institutional Review Board-approved database was performed for all patients undergoing TEVAR at a single referral institution between May 2002 and June 2013. The analysis identified 463 TEVAR procedures. All procedures involving median sternotomy were excluded, and 380 procedures (343 patients) were included in the final analysis. Degree of cardiac workup was classified on the basis of the highest level of preoperative testing: no workup, resting ECG only, resting TTE, exercise/pharmacologic stress testing, or coronary angiography. Standard workup consisted of cardiac symptom assessment along with resting ECG or TTE, with further workup indicated for unstable symptoms, significantly abnormal findings on ECG or TTE, or multiple cardiac risk factors. Categorical and continuous variables were compared by Fisher's exact test and analysis of variance, respectively.ResultsNo preoperative cardiac workup was performed for 28 patients (7.4%); 127 patients (33.4%) had resting ECG only, 208 patients (54.7%) had resting echocardiography, 12 patients (3.2%) underwent stress testing, and five patients (1.3%) had coronary angiography. Patients undergoing stress testing or coronary angiography were older and had a higher incidence of known coronary artery disease (P < .01) and prior myocardial infarction (P = .01). Complex hybrid aortic repairs and TEVAR for aneurysmal disease were more likely to have an extensive workup, whereas nonelective procedures more commonly had no workup. A total of nine patients (2.4%) experienced a perioperative cardiac event (myocardial infarction or cardiac arrest), with no significant difference noted among all groups (P = .45), suggesting that the extent of cardiac workup was appropriate. The incidence of 30-day/in-hospital mortality (5.5%) and cardiac-specific mortality (0.8%) was similar among all groups.ConclusionsThe risk of a postoperative cardiac event after TEVAR is low (2.4%), and initial screening with either resting TTE or ECG, in addition to assessment of cardiac symptom status, appears adequate for most TEVAR patients. As such, we recommend resting TTE or ECG as the initial cardiovascular screening mechanism in patients undergoing TEVAR, with subsequent more invasive studies if initial screening reveals cardiovascular abnormalities.

Despite advances in the treatment of aortic stenosis (AS), many patients with AS remain untreated. Barriers to accessing cardiovascular surgical care may play a role in this undertreatment. We sought to examine whether there are geographic variations in the treatment of AS within North Carolina that may reflect differential access to care. Hospital discharge data from North Carolina hospitals during federal fiscal year 2010 were analyzed from the Thomson Reuters database. Patients hospitalized with AS were identified using International Classification of Diseases, ninth revision (ICD-9) diagnosis codes. ICD-9 procedure codes were used to identify patients who had aortic valve replacement and other cardiac procedures. The rates of hospitalizations for AS and aortic valve replacement were calculated per county in North Carolina. In fiscal year 2010, there were 12,111 patients who were discharged from a North Carolina hospital with AS listed as one of the ICD-9 discharge diagnosis codes. The median age for this population was 79 (twenty-fifth to seventy-fifth), with approximately 1/3 patients (28.9%) being at least 85 years of age and >1/2 being female (53.8%). Of them, 1,608 patients underwent valvular surgery with an in-hospital mortality rate of 3.3%. The highest rates, corrected for county population, of hospitalizations where AS was listed as the primary diagnosis were in the most rural segments of North Carolina while those same areas had the lowest rates of valvular surgery. In conclusion, there are significant geographic variations in the rates of hospitalization for AS and for valvular surgery within North Carolina. The most rural segments of the state have the highest rates of hospitalization while also having the lowest rates of surgery. This suggests geographic treatment disparities as a result of access to surgical care that must be considered as new therapies for AS, such as transcatheter aortic valve replacement, are deployed.

The Centers for Medicare Services (CMS) has imposed restrictions on which cardiac surgery programs can offer TAVR. This is now likely impacting patient selection for SAVR based on whether a program can offer TAVR. Therefore, it is paramount to investigate if outcomes for SAVR differ at TAVR

Atrial fibrillation (AF) is the most common arrythmia and is often seen in patients presenting with acute myocardial infarction (MI). AF is also an established indicator of adverse prognosis in patients with MI. However, the impact of AF on revascularization strategies (percutaneous coronary

Over the last decade, transcatheter aortic valve replacement (TAVR) has emerged as an effective treatment for inoperable and selected high surgical-risk patients with aortic stenosis. However, management of procedural complications with TAVR represents a major challenge as most TAVR patients carry prohibitive or high-risk of mortality with open surgical conversion. Here we present a case of TAVR complicated by aortic annulus rupture that was successfully managed nonoperatively by pericardial drainage, blood product transfusion, and adjunctive administration of recombinant activated factor VIIa.

Numerous challenges-financial, regulatory, and cultural-are hindering US participation and performance in multinational clinical trials. Consequently, it is increasingly unclear how the results of these trials should be applied to American patients, practice patterns, and systems of care. Both incremental and transformative changes are needed to revitalize US participation as well as the broader clinical trial enterprise. To promote consensus around the solutions needed to address the adverse trends in clinical research, the Duke Clinical Research Institute convenedstakeholders from academia, industry, and government. article summarizes the proceedings of this meeting and addresses: (1) adverse trends in the United States and multinational clinical trials, (2) the key issues that underlie these adverse trends, and (3) potential solutions to these problems.

Summary. Background: The REG2 anticoagulation system consists of pegnivacogin, a subcutaneously administered aptamer factor IXa inhibitor, and its intravenous control agent, anivamersen. Objectives: To assess the safety, tolerability and pharmacokinetic and pharmacodynamic responses of REG2. Patients/Methods: In this phase 1a study, 36 healthy volunteers were enrolled into five cohorts and given one dose of pegnivacogin. Cohorts 1 (n = 6) and 1A (n = 4) received 0.5 mg kg−1; cohort 2 (n = 6) received 1.0 mg kg−1; cohort 3 (n = 6) received 3.0 mg kg−1; and cohort 4 (n = 8) received 2.0 mg kg−1. In cohorts 1–3, two subjects were randomized to placebo. Cohort 4 subjects were subsequently randomized to single-dose (n = 4) or multidose (n = 4) anivamersen. Results: The mean maximum observed concentrations of pegnivacogin in cohorts 1, 1A, 2 and 3 at median time were 5.16 μg mL−1 at 84 h, 5.19 μg mL−1 at 72 h, 9.32 μg mL−1 at 90 h, and 32.5 μg mL−1 at 84 h, respectively. The maximum relative activated partial thromboplastin time and time needed to achieve this were 1.18 at 2 days, 1.16 at 2 days, 1.27 at 3 days, and 1.85 at 2 days, respectively. The calculated mean half-life and mean residence times of pegnivacogin were 6.12 days and 9.6 days, respectively. There was rapid reversal with intravenous anivamersen, although subsequent reaccumulation of pegnivacogin was observed. Conclusions: In our first-in-human study, REG2 was well tolerated and provided dose-proportional anticoagulation for several days after a single subcutaneous dose, with complete, although transient, reversal by its control agent. This study demonstrates the first application of a subcutaneously administered aptamer, and represents a potential advance in aptamer therapeutics.

KILO tested 2 novel weight-based eptifibatide dosing strategies compared with standard dosing in obese patients undergoing elective percutaneous coronary intervention (PCI). Eptifibatide dosing is weight adjusted for patients up to 121 kg. Patients above this weight receive the same maximal dose, although it is unknown if this provides adequate eptifibatide concentration or platelet inhibition.Sixty-seven patients weighing ≥125 kg undergoing elective PCI were randomized to 1 of 3 eptifibatide dosing regimens: standard dosing using a weight of 121 kg, actual body weight (ABW)-based dosing with no upper limit, or ideal body weight (IBW)-based dosing. Boluses of 180 μg/kg were given 10 minutes apart, followed by a 2.0 μg/kg per minute infusion. Plasma eptifibatide concentrations were drawn at 12 to 18 hours after initiating the infusion. Platelet aggregation was assessed at baseline and 10 minutes after the second bolus.Sixty-seven patients were randomized to standard (n = 22), ABW (n = 23), or IBW (n = 22) dosing. The median (25th, 75th) steady-state plasma eptifibatide concentrations were 1,740 ng/mL (1,350, 2,350), 1,780 ng/mL (1,510, 2,350), and 1,055 ng/mL (738, 1,405), respectively (P.001). Ten-minute median (25th, 75th) platelet aggregation units were 7 (0, 21), 2 (0, 8), and 14 (8, 20), respectively (P = .001).Actual body weight eptifibatide dosing leads to higher plasma concentrations and greater platelet inhibition than standard or IBW dosing in obese patients undergoing PCI. Current recommendations for eptifibatide dosing may be inadequate in patients121 kg. Further study is warranted to define the optimal dosing of eptifibatide and other medications in obese patients.

The prevalence of aortic and mitral valve disease in the US population is growing at an alarming rate, yet many patients with valvular heart disease remain undiagnosed and untreated. Empowering primary care physicians (PCPs) to use handheld echocardiography (HHE) to screen for valve disease at the

A 60-year-old man with end-stage heart failure underwent orthotopic heart transplantation. Before transplantation, he had elevated pulmonary artery (PA) pressures (60/17 mm Hg, mean PA 35 mm Hg) and pulmonary vascular resistance (PVR) (6.6 Wood units). Following transplantation, he initially did

A 33-year-old woman was evaluated for palpitations and a continuous murmur. Echocardiography demonstrated a dilated vascular structure posterior to the aortic root. Coronary angiography revealed a coronary–cameral fistula originating from the left main coronary artery emptying into the right

Acute myocarditis often mimics acute myocardial infarction (MI) and can present a diagnostic dilemma. A 16-year-old healthy female presented with vomiting, malaise and bradycardia. Workup revealed inferolateral ST-elevation and troponin >200 ng/mL. She was transferred to pediatric intensive care

Medicare has proposed bundled payment for coronary artery bypass surgery (CABG) and acute myocardial infarction with or without percutaneous coronary intervention (AMI/PCI). The 90 day bundled payment window encompasses home health and rehabilitation, and may lead to financial challenges for health