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BACKGROUND: Among patients with stable coronary disease and moderate or severe ischemia, whether clinical outcomes are better in those who receive an invasive intervention plus medical therapy than in those who receive medical therapy alone is uncertain. METHODS: We randomly assigned 5179 patients with moderate or severe ischemia to an initial invasive strategy (angiography and revascularization when feasible) and medical therapy or to an initial conservative strategy of medical therapy alone and angiography if medical therapy failed. The primary outcome was a composite of death from cardiovascular causes, myocardial infarction, or hospitalization for unstable angina, heart failure, or resuscitated cardiac arrest. A key secondary outcome was death from cardiovascular causes or myocardial infarction. RESULTS: Over a median of 3.2 years, 318 primary outcome events occurred in the invasive-strategy group and 352 occurred in the conservative-strategy group. At 6 months, the cumulative event rate was 5.3% in the invasive-strategy group and 3.4% in the conservative-strategy group (difference, 1.9 percentage points; 95% confidence interval [CI], 0.8 to 3.0); at 5 years, the cumulative event rate was 16.4% and 18.2%, respectively (difference, -1.8 percentage points; 95% CI, -4.7 to 1.0). Results were similar with respect to the key secondary outcome. The incidence of the primary outcome was sensitive to the definition of myocardial infarction; a secondary analysis yielded more procedural myocardial infarctions of uncertain clinical importance. There were 145 deaths in the invasive-strategy group and 144 deaths in the conservative-strategy group (hazard ratio, 1.05; 95% CI, 0.83 to 1.32). CONCLUSIONS: Among patients with stable coronary disease and moderate or severe ischemia, we did not find evidence that an initial invasive strategy, as compared with an initial conservative strategy, reduced the risk of ischemic cardiovascular events or death from any cause over a median of 3.2 years. The trial findings were sensitive to the definition of myocardial infarction that was used. (Funded by the National Heart, Lung, and Blood Institute and others; ISCHEMIA ClinicalTrials.gov number, NCT01471522.).

Background Previous studies from the Low Risk TAVR (LRT) trial demonstrated that transcatheter aortic valve replacement (TAVR) is safe and feasible in low-risk patients, with excellent 30-day and 1-year outcomes. The objective of this study was to report clinical outcomes and the impact of 30-day hypoattenuated leaflet thickening (HALT) on structural valve deterioration (SVD) 2 years after TAVR. Methods The LRT trial was the first Food and Drug Administration-approved Investigational Device Exemption trial in the United States to evaluate the safety and feasibility of TAVR in low-risk patients with symptomatic severe tricuspid aortic stenosis (AS). Valve hemodynamics and SVD by echo were recorded 30 days, 1 year, and 2 years post-TAVR. Results The LRT trial enrolled 200 low-risk patients to receive TAVR. Their mean age was 73.6 years and 61.5% were men. At 2-year follow-up, the mortality rate was 4.2%; the cardiovascular death rate was 1.6%. The disabling stroke rate was 1.1%, permanent pacemaker implantation rate was 8.6%, and 4 patients (2.2%) presented with endocarditis (2 between years 1 and 2). Of the 14% of TAVR subjects who had evidence of HALT at 30 days, there was no impact on valve hemodynamics, endocarditis or stroke at 2 years. Conclusions TAVR for low-risk patients with symptomatic severe tricuspid AS is safe at 2 years. The presence of HALT at 30 days did not impact the early hemodynamic improvements nor the durability of the valve structure.

Graphical abstract, Highlights • VSD after MI is a rare and often fatal complication. • Echocardiography is essential in the diagnosis and management of these patients. • Though urgent surgical repair is recommended, operative risk is often high. • VA ECMO and percutaneous closure under echocardiographic guidance are alternatives. • Echocardiography can identify persistent AV closure and stasis in the aortic root.

Background Cardiac implantable electronic devices (CIED) are sometimes required after alcohol septal ablation (ASA) for hypertrophic cardiomyopathy (HCM). The primary objectives of this study were to characterize the incidence, timing, and predictors of CIED placement after ASA for HCM. Methods Patients were identified from the 2010-2015 Nationwide Readmissions Databases. Incidence, timing and independent predictors of CIED placement, as well as 30-day readmission rates were examined. Results There were 1296 patients (national estimate = 2864) with HCM who underwent ASA. CIED were implanted in 322 (25% overall; 14% permanent pacemaker, 11% implantable cardioverter defibrillator) during the index hospitalization. Of these, 21%, 23%, 21%, and 18% occurred on postprocedure day 0, 1, 2, and 3, respectively. Only 17 (1.3%) patients underwent CIED implantation between discharge and 30-day follow up. Independent predictors of index hospitalization CIED implantation included older age, diabetes, heart failure, nonelective index hospital admission and hospitalization at a privately owned hospital. Nonelective 30-day readmission rates among those who did and did not undergo CIED placement during their index hospitalization, were 6.8% and 7.9%, respectively (p = .53); median time to readmission was also similar between groups. Conclusions One in four HCM patients undergoing ASA underwent CIED implantation during their index hospitalization; nearly 2/3rd during the first 48 h postprocedure. Private hospital ownership independently predicted CIED placement. More data are needed to better understand the unexpectedly high rates of CIED placement, earlier than anticipated timing of implantation and differential rates by hospital ownership.

Patients with heart transplants who present with severe aortic stenosis may be deemed high-risk surgical candidates due to immunosuppression and multiple comorbid conditions. Appropriately selected patients may be successfully treated with transcatheter aortic valve replacement. (Level of Difficulty: Advanced.), Central Illustration, Patients with heart transplants who present with severe aortic stenosis may be deemed high-risk surgical candidates due to immunosuppression and…

Objectives The aim of this study was to evaluate clinical outcomes and transcatheter heart valve hemodynamic parameters after transcatheter aortic valve replacement (TAVR) in low-risk patients with bicuspid aortic stenosis (AS). Background TAVR is approved for low-risk patients in the United States. However, patients with bicuspid AS were excluded from the randomized cohorts of the pivotal low-risk trials. Methods The LRT (Low Risk TAVR) trial was an investigator-initiated, prospective, multicenter study and was the first and only U.S. Food and Drug Administration–approved investigational device exemption trial to evaluate the feasibility of TAVR with either balloon-expandable or self-expanding valves in low-risk patients with bicuspid AS. The primary endpoint was all-cause mortality at 30 days. Baseline and follow-up echocardiography and computed tomography to detect leaflet thickening were analyzed in an independent core laboratory. Results Sixty-one low-risk patients with symptomatic, severe AS and bicuspid aortic valves (78.3% Sievers type 1 morphology) underwent TAVR at 6 centers from 2016 to 2019. The mean age was 68.6 years, and 42.6% were men. At 30 days, there was zero mortality and no disabling strokes. The rate of new permanent pacemaker implantation was 13.1%; just 1 patient had a moderate paravalvular leak at 30 days. Hypoattenuated leaflet thickening was observed in 10% of patients at 30 days. Conclusions TAVR appears to be safe in patients with bicuspid AS, with short length of hospital stay, zero mortality, and no disabling strokes at 30 days. Subclinical leaflet thrombosis was observed in a minority of patients at 30 days but did not appear to be associated with clinical events.

Objectives This study sought to evaluate clinical outcomes and transcatheter heart valve hemodynamics at 1 year after transcatheter aortic valve replacement (TAVR) in low-risk patients. Background Early results from the LRT (Low Risk TAVR) trial demonstrated that TAVR is safe in patients with symptomatic severe aortic stenosis who are at low risk for surgical valve replacement. Methods The LRT trial was an investigator-initiated, prospective, multicenter study and was the first Food and Drug Administration–approved Investigational Device Exemption trial to evaluate feasibility of TAVR in low-risk patients. The primary endpoint was all-cause mortality at 30 days. Secondary endpoints included clinical outcomes and valve hemodynamics at 1 year. Results The LRT trial enrolled 200 low-risk patients with symptomatic severe AS to undergo TAVR at 11 centers. Mean age was 73.6 years and 61.5% were men. At 30 days, there was zero mortality, zero disabling stroke, and low permanent pacemaker implantation rate (5.0%). At 1-year follow-up, mortality was 3.0%, stroke rate was 2.1%, and permanent pacemaker implantation rate was 7.3%. Two (1.0%) subjects underwent surgical reintervention for endocarditis. Of the 14% of TAVR subjects who had evidence of hypoattenuated leaflet thickening at 30 days, there was no impact on valve hemodynamics at 1 year, but the stroke rate was numerically higher (3.8% vs. 1.9%; p = 0.53). Conclusions TAVR in low-risk patients with symptomatic severe aortic stenosis appears to be safe at 1 year. Hypoattenuated leaflet thickening, observed in a minority of TAVR patients at 30 days, did not have an impact on valve hemodynamics in the longer term.

Background Previous studies have demonstrated that intramyocardial human CD34+ cells may relieve symptoms and improve clinical outcomes in chronic refractory angina unresponsive to optimal medical therapy or not amenable to revascularization. Methods We performed a meta-analysis of randomized controlled trials (RCTs) to evaluate the impact of human CD34+ cells compared with placebo in chronic refractory angina. Primary efficacy outcomes in our analysis were angina frequency and exercise time. Primary safety outcomes included major adverse cardiovascular events such as myocardial infarction (MI), stroke and death. Results Three eligible randomized trials including 269 patients (placebo = 90, CD34+ = 179) were included. Dose of auto-CD34+ cells ranged from 5 × 104 to 5 × 105 cells/kg. Follow-up ranged from 6 to 24 months. In a pooled analysis, administration of CD34+ cells decreased the risk of all-cause mortality [OR 0.24, 95% CI (0.08–0.73), p = 0.01], reduced angina frequency [mean difference −2.91, 95% CI (−4.57 to −1.25), p = 0.0006] and improved exercise time [mean difference 58.62 s, 95% CI (21.19 to 96.06), p = 0.02] compared with control group. However, there was no significant difference in the risk of myocardial infarction (MI) and stroke between groups. Conclusion In a meta-analysis, intra-myocardial CD34+ cell therapy was superior to placebo in improving risk of all – cause mortality, angina frequency with an increase in exercise time, without a significant increase in adverse events. This analysis supports further trials of CD34+ cell therapy for ischemic heart disease.

OBJECTIVES We sought to report details of the incidence, organisms, clinical course, and outcomes of prosthetic valve endocarditis (PVE) after transcatheter aortic valve replacement (TAVR) in low-risk patients. BACKGROUND PVE remains a rare but devastating complication of aortic valve replacement. Data regarding PVE after TAVR in low-risk patients are lacking. METHODS We performed a detailed review of all patients in the low-risk TAVR trials who underwent TAVR from 2016 to 2020 and were adjudicated to have definitive PVE by the independent Clinical Events Committee. RESULTS We analyzed 396 low-risk patients who underwent TAVR (including 72 with bicuspid valves). PVE occurred in 11 patients at a median 379 days (210, 528) from TAVR. The incidence within the first 30 days was 0%; days 31-365, 1.5%; and after day 365, 2.8%. The most common organism identified was Streptococcus (n = 4/11). Early PVE (≤ 365 days) occurred in five patients, of whom three demonstrated evidence of embolic stroke and two underwent surgical aortic valve re-intervention. Late PVE (> 365 days) occurred in six patients, of whom thee demonstrated evidence of embolic stroke and only one underwent surgical aortic valve re-intervention. Of the six patients with evidence of embolic stroke, two died, two were discharged to rehabilitation, and two were discharged home with home care. CONCLUSIONS PVE was infrequent following TAVR in low-risk patients but was associated with substantial morbidity and mortality. Embolic stroke complicated the majority of PVE cases, contributing to worse outcomes in these patients. Efforts must be undertaken to minimize PVE in TAVR.

Background/Purpose This sub-analysis of the prospective Low Risk TAVR (LRT) trial determined anatomical characteristics associated with hypoattenuated leaflet thickening (HALT), which may contribute to early transcatheter heart valve (THV) degeneration. Methods/Materials The LRT trial enrolled 200 low-risk patients between February 2016 and February 2018. All subjects underwent baseline and 30-day CT studies, analyzed by an independent core laboratory. Additional measurements, namely THV expansion, eccentricity, depth, and commissural alignment, were made by consensus of three independent readers. HALT was observed only in the Sapien 3 THV, so Evolut valves were excluded from this analysis. Results In the LRT trial, 177 subjects received Sapien 3 THVs, of whom 167 (94.3%) had interpretable 30-day CTs and were eligible for this analysis. Twenty-six subjects had HALT (15.6%). Baseline characteristics were similar between groups. There was no difference in THV size implanted and baseline aortic-root geometry between groups. In patients who developed HALT, THV implantation depth was shallower than in patients who did not develop HALT (2.6±1.1 mm HALT versus 3.3±1.8 mm no-HALT, p=0.03). There were more patients in the HALT group with commissural malalignment (40% vs. 28%; p=0.25), but this did not reach statistical significance. In a univariable regression model, no predetermined variable were shown to independently predict the development of HALT. Conclusions This study did not find anatomical or THV implantation characteristics that predicted the development of HALT at 30 days. This study cannot exclude subtle effects or interaction between factors because of the small number of events. Summary This sub-analysis of the prospective Low Risk TAVR trial found that hypoattenuated leaflet thickening (HALT) was associated with shallower transcatheter heart valve implantation. No predictors of HALT were found in a univariable regression analysis.

Importance After percutaneous coronary intervention (PCI), patients withCYP2C19*2or*3loss-of-function (LOF) variants treated with clopidogrel have increased risk of ischemic events. Whether genotype-guided selection of oral P2Y12 inhibitor therapy improves ischemic outcomes is unknown. Objective To determine the effect of a genotype-guided oral P2Y12 inhibitor strategy on ischemic outcomes inCYP2C19LOF carriers after PCI. Design, Setting, and Participants Open-label randomized clinical trial of 5302 patients undergoing PCI for acute coronary syndromes (ACS) or stable coronary artery disease (CAD). Patients were enrolled at 40 centers in the US, Canada, South Korea, and Mexico from May 2013 through October 2018; final date of follow-up was October 2019. Interventions Patients randomized to the genotype-guided group (n = 2652) underwent point-of-care genotyping.CYP2C19LOF carriers were prescribed ticagrelor and noncarriers clopidogrel. Patients randomized to the conventional group (n = 2650) were prescribed clopidogrel and underwent genotyping after 12 months. Main Outcomes and Measures The primary end point was a composite of cardiovascular death, myocardial infarction, stroke, stent thrombosis, and severe recurrent ischemia at 12 months. A secondary end point was major or minor bleeding at 12 months. The primary analysis was in patients withCYP2C19LOF variants, and secondary analysis included all randomized patients. The trial had 85% power to detect a minimum hazard ratio of 0.50. Results Among 5302 patients randomized (median age, 62 years; 25% women), 82% had ACS and 18% had stable CAD; 94% completed the trial. Of 1849 withCYP2C19LOF variants, 764 of 903 (85%) assigned to genotype-guided therapy received ticagrelor, and 932 of 946 (99%) assigned to conventional therapy received clopidogrel. The primary end point occurred in 35 of 903CYP2C19LOF carriers (4.0%) in the genotype-guided therapy group and 54 of 946 (5.9%) in the conventional therapy group at 12 months (hazard ratio [HR], 0.66 [95% CI, 0.43-1.02];P = .06). None of the 11 prespecified secondary end points showed significant differences, including major or minor bleeding inCYP2C19LOF carriers in the genotype-guided group (1.9%) vs the conventional therapy group (1.6%) at 12 months (HR, 1.22 [95% CI, 0.60-2.51];P = .58). Among all randomized patients, the primary end point occurred in 113 of 2641 (4.4%) in the genotype-guided group and 135 of 2635 (5.3%) in the conventional group (HR, 0.84 [95% CI, 0.65-1.07];P = .16). Conclusions and Relevance AmongCYP2C19LOF carriers with ACS and stable CAD undergoing PCI, genotype-guided selection of an oral P2Y12 inhibitor, compared with conventional clopidogrel therapy without point-of-care genotyping, resulted in no statistically significant difference in a composite end point of cardiovascular death, myocardial infarction, stroke, stent thrombosis, and severe recurrent ischemia based on the prespecified analysis plan and the treatment effect that the study was powered to detect at 12 months. Trial Registration ClinicalTrials.gov Identifier:NCT01742117

In this review, we summarize both contrast fractional flow reserve (cFFR) and computed tomography fractional flow reserve (CT-FFR) as novel modalities to evaluate the hemodynamic significance of coronary artery stenoses and to guide percutaneous coronary intervention (PCI). Implementation of cFFR can reduce the time, cost, effort, and patient discomfort associated with traditional adenosine FFR. Clinical outcomes following cFFR-guided revascularization are currently under investigation. Emerging data on the use of CT-FFR in patients with acute coronary syndromes may increase the use of this technology in acute settings, while virtual stenting applications to model the hemodynamic results of stent placement may help optimize PCI planning. Using contrast media already available for traditional angiography, cFFR yields results that are highly reproducible and correlate more closely with traditional adenosine FFR than the distal/aortic pressure ratio (Pd/Pa) or the instantaneous wave-free ratio (iFR). Based upon computational fluid dynamics, CT-FFR provides a non-invasive estimate of the traditional adenosine FFR and predicts ischemia more accurately than nuclear imaging. Therefore, CT-FFR has begun to take on a gatekeeper role to minimize unnecessary invasive angiography.

Infective endocarditis (IE) of prosthetic or bioprosthetic heart valves is a serious complication associated with significant morbidity and mortality. Data on the incidence, risk factors, and outcomes of IE after transcatheter aortic valve implantation (TAVI) in the United States are limited. We used the 2013 to 2014 Nationwide Readmissions Databases to determine the incidence of early IE after TAVI and surgical aortic valve replacement (SAVR) in the US. Clinical characteristics, independent predictors, and outcomes of patients with IE post-TAVI were examined. In 29,306 TAVI and 66,077 SAVR patients, the incidence rates of early IE were 1.7% (95% confidence interval [CI] 1.5% to 1.9%) and 2.5% (95% CI 2.3% to 2.9%) per person-year, respectively. In a propensity-matched cohort of 15,138 TAVI and 15,030 SAVR patients (weighted), there were no significant differences in the incidence rates of IE (1.7% [95% CI 1.4% to 2.0%] vs 1.9% [95% CI 1.6% to 2.2%] per person-year, log-rank p = 0.29) or in the median (interquartile range) time to IE (91 [48 to 146] vs 92 [61 to 214] days, p = 0.13). Staphylococcus (30.4%), Streptococcus (29.9%), and Enterococcus (20.5%) were the most common causative organisms of IE post-TAVI. Younger age, history of heart failure, need for permanent pacemaker placement, cardiac arrest, major bleeding, and sepsis during the index TAVI hospitalization were independently associated with an increased risk of IE. In-hospital mortality rate during readmission for IE was 15.6%. In conclusion, in a nationally representative cohort of TAVI patients in the US, the incidence rate of early IE was 1.7% per person-year. Age, co-morbid conditions, invasive procedures, and complications during the index hospitalization were associated with incident IE post-TAVI.

Background Transcatheter aortic valve replacement (TAVR) is now the standard of care for patients with symptomatic severe aortic stenosis who are extreme, high, or intermediate risk for surgical aortic valve replacement (SAVR). Objectives The authors sought to evaluate TAVR in a prospective multicenter trial involving low-risk patients. Methods The Low Risk TAVR (Feasibility of Transcatheter Aortic Valve Replacement in Low-Risk Patients With Symptomatic, Severe Aortic Stenosis) trial was the first U.S. Food and Drug Administration–approved Investigational Device Exemption trial to enroll in the United States. This investigator-led trial was a prospective, multicenter, unblinded, comparison to historical controls from the Society of Thoracic Surgeons (STS) database. The primary endpoint was all-cause mortality at 30 days. Results The authors enrolled 200 low-risk patients with symptomatic severe aortic stenosis at 11 centers to undergo TAVR. The authors compared outcomes with an inverse probability weighting–adjusted control cohort of 719 patients who underwent SAVR at the same institutions using the STS database. At 30 days, there was zero all-cause mortality in the TAVR group versus 1.7% mortality in the SAVR group. There was zero in-hospital stroke rate in the TAVR group versus 0.6% stroke in the SAVR group. Permanent pacemaker implantation rates were similar between TAVR and SAVR (5.0% vs. 4.5%). The rates of new-onset atrial fibrillation (3.0%) and length of stay (2.0 ± 1.1 days) were low in the TAVR group. One patient (0.5%) in the TAVR group had >mild paravalvular leak at 30 days. Fourteen percent of TAVR patients had evidence of subclinical leaflet thrombosis at 30 days. Conclusions TAVR is safe in low-risk patients with symptomatic severe aortic stenosis, with low procedural complication rates, short hospital length of stay, zero mortality, and zero disabling stroke at 30 days. Subclinical leaflet thrombosis was observed in a minority of TAVR patients at 30 days. (Feasibility of Transcatheter Aortic Valve Replacement in Low-Risk Patients With Symptomatic, Severe Aortic Stenosis [Low Risk TAVR; NCT02628899)

Improved procedural techniques and process of care initiatives have decreased length of stay (LOS) after primary percutaneous coronary intervention (PPCI) for ST-elevation myocardial infarction (STEMI). However, there remains a subset of patients who continue to require longer LOS. We used the 2005 to 2014 National Inpatient Sample databases to identify all hospitalizations for PPCI for STEMI in patients ≥18 years of age. Hospitalizations in which patients were discharged home alive were included. Multivariable linear and logistic regression models were used to examine temporal trends in LOS and to identify independent predictors of longer LOS (LOS >3 days). In 678,545 hospitalizations for PPCI for STEMI, mean ± standard error of mean LOS decreased significantly from 3.3 (±0.04) days to 2.7 (±0.02) days (ptrend 3 days from 31.9% in 2005 to 16.9% in 2014 (p

Objectives This study sought to determine whether higher maximal activated clotting time (ACT) during transradial (TR) percutaneous coronary intervention (PCI) is associated with greater bleeding risk. Background Higher maximal ACT during transfemoral (TF) PCI has been associated with a greater bleeding risk. It is unclear whether this relationship exists in the setting of TR PCI. Methods Among 14,637 patients undergoing TR or TF PCI with unfractionated heparin monotherapy, the study related maximal ACT to the risk of major bleeding. In secondary analyses, the study related maximal ACT to composites of in-hospital death, myocardial infarction (MI), or stroke and in-hospital death, MI, or urgent target vessel revascularization. Multivariable logistic regression was employed to compare outcomes in the third with the first and second maximal ACT tertiles. Results More major bleeding occurred at ACT >290 s versus ≤290 s following TF (7.7% vs. 5.8%; p = 0.006) but not TR PCI (1.7% vs. 2.4%; p = 0.18). After adjustment, major bleeding risk remained significantly higher at ACT >290 s versus ACT ≤290 s among TF (odds ratio: 1.28; 95% confidence interval: 1.02 to 1.62; p = 0.036) but not TR PCI (odds ratio: 0.72; 95% confidence interval: 0.42 to 1.22; p = 0.22). Maximal ACT was not related to the incidence of composite death, MI, or stroke or death, MI, or urgent target vessel revascularization following TF or TR PCI. Conclusions Higher maximal ACT is associated with a greater risk of major bleeding following TF PCI than TR PCI.

Objectives The authors sought to examine outcomes and identify independent predictors of mortality among patients undergoing urgent/emergent transcatheter aortic valve replacement (TAVR). Background Data on urgent/emergent TAVR as a rescue therapy for decompensated severe aortic stenosis (AS) are limited. Methods The Society of Thoracic Surgeons and the American College of Cardiology Transcatheter Valve Therapy (STS/ACC TVT) Registry linked with Centers for Medicare & Medicaid Services claims was used to identify patients who underwent urgent/emergent versus elective TAVR between November 2011 and June 2016. Outcomes assessed were device success rate, in-hospital major adverse events, and 30-day and 1-year mortality. Independent predictors of mortality after urgent/emergent TAVR were examined. Results Of 40,042 patients who underwent TAVR, 3,952 (9.9%) were urgent/emergent (median STS PROM score 11.8 [interquartile range: 7.6 to 17.9]). Device success rate was statistically lower, but not clinically different after urgent/emergent versus elective TAVR (92.6% vs. 93.7%; p = 0.007). Rates of major and/or life-threatening bleeding, major vascular complications, myocardial infarction, stroke, new permanent pacemaker placement, conversion to SAVR, and paravalvular regurgitation were similar between the 2 groups. Compared with elective TAVR, patients undergoing urgent/emergent TAVR had higher rates of acute kidney injury and/or new dialysis (8.2% vs. 4.2%; p Conclusions Urgent/emergent TAVR is feasible with acceptable outcomes and may be a reasonable option in a selected group of patients with severe AS.

Development of membranous ventricular septal defects (VSD) is a rare complication of transcatheter aortic valve replacements (TAVR), and is recognized using intraoperative and postoperative imaging. We present two cases of this rare but serious complication; one was successfully managed conservatively and the other with valve-in-valve therapy. Management strategies for post-TAVR VSDs varies, but should be individualized to the clinical scenario. We performed a literature search and sought to identify various risk factors which may predispose patients to the development of VSD after TAVR.

Transcatheter aortic valve replacement (TAVR) is now an accepted pathway for aortic valve replacement for patients who are at prohibitive, severe and intermediate risk for traditional aortic valve surgery. However, with this rising uptrend and adaptation of this new technology, vascular complications and their management remain an Achilles heel for percutaneous aortic valve replacement. The vascular complications are an independent predictor of mortality for patients undergoing TAVR. Early recognition of these complications and appropriate management is paramount. In this article, we review the most commonly encountered vascular complications associated with currently approved TAVR devices and their optimal percutaneous management techniques.

Background: This analysis evaluated echocardiographic predictors of hypoattenuated leaflet thickening (HALT) in low-risk patients undergoing transcatheter aortic valve replacement and assessed 1-year clinical and hemodynamic consequences. HALT by computed tomography may be associated with early valve degeneration and increased neurological events. Methods: Echocardiograms were performed at baseline, discharge, 30 days, and 1 year post-procedure. Four-dimensional contrast-enhanced computed tomography assessed HALT at 30 days. Independent core laboratories analyzed images. Doppler hemodynamic parameters were tested in a univariable regression model to identify HALT predictors. One-year clinical and hemodynamic outcomes were compared between HALT (+) and (−) patients. Results: Analysis included 170 patients with Sapien 3 valves and diagnostic 30-day computed tomographies, of whom 27 (16%) had HALT. Baseline characteristics were similar between groups. After transcatheter aortic valve replacement, aortic flow was nonsignificantly reduced in patients who developed HALT. Regression analysis did not show significant association between baseline or discharge valve hemodynamics and development of HALT at 30 days. Patients with HALT had smaller aortic valve areas (1.4±0.4 versus 1.7±0.5 cm 2 ; P =0.018) and Doppler velocity index (0.4±0.1 versus 0.5±0.1; P =0.003) than those without HALT at 30 days but not at 1 year. There was no difference in aortic mean gradient at 30 days. There was no difference between the groups in New York Heart Association class, 6-minute walk distance, and mortality at 1 year. Conclusions: There were no early hemodynamic predictors of HALT. At 30 days, patients with HALT had worse valve hemodynamics than those without HALT, but hemodynamic and clinical outcomes at 1 year were similar. Clinical Trial Registration: URL: http://www.clinicaltrials.gov . Unique identifier: NCT02628899.

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).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.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.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.TAVR may present challenges to future coronary access and aortic valve reintervention in a substantial number of low-risk patients.

Objective Determine the rates, reasons, predictors, and costs of 30-day readmissions following transcatheter mitral valve repair (TMVR) versus surgical mitral valve repair (SMVR) in the United States. Background Data on 30-day readmissions after TMVR are limited. Methods High-risk patients with mitral regurgitation (MR) undergoing TMVR or SMVR were identified from the 2014-2015 Nationwide Readmissions Databases. Multivariable stepwise regression models were used to identify independent predictors of 30-day readmission. Risk of 30-day readmission was compared between the two groups using univariate and propensity score adjusted regression models. Results Among 8,912 patients undergoing mitral valve repair during 2014-2015 (national estimate 17,809), we identified 7,510 (84.7%) that underwent SMVR and 1,402 (15.3%) that underwent TMVR. Thirty-day readmission rates after SMVR and TMVR were 10.7% and 11.7%, respectively (unadjusted OR 1.11, 95% CI 0.89-1.39, p = .35). After propensity score adjustment, TMVR was associated with a lower risk of 30-day readmissions compared with SMVR (adjusted OR 0.70, 95% CI 0.51-0.95, p = .02). Heart failure and arrhythmias were the leading cardiac reasons for readmission. Anemia and fluid and electrolyte disorder were independent predictors of 30-day readmission after TMVR. Demographics, comorbidities, and length of stay were independent predictors of 30-day readmission after SMVR. Conclusions One in 10 patients are readmitted within 30 days following TMVR or SMVR. Approximately half of the readmissions are for cardiac reasons. The predictors of 30-day readmission are different among patients undergoing TMVR and SMVR, but can be easily screened for to identify patients at highest risk for readmission.

Severe aortic stenosis (AS) and heart failure (HF) represent an important and high-risk group of patients who are often referred for transcatheter aortic valve replacement (TAVR) due to high risk for surgical intervention. Thus far, randomized controlled trials have shown comparable outcomes between TAVR and surgical aortic valve replacement in patients with severe AS and heart failure with reduced ejection fraction. In the current review, we will discuss (1) the pathophysiology of HF in patients with severe AS, (2) role of imaging modalities in management, (3) role of biomarkers of HF on prognosis, (4) impact of other valvular heart diseases, (5) evidence from the contemporary trials on the role of TAVR in patients with severe AS and HF, and (6) future directions and research.

Background Referral rates and outcomes of cardiac rehabilitation have not been evaluated in patients with transcatheter aortic valve replacement or compared with surgical aortic valve replacement. Method A retrospective cohort study was conducted in 488 patients who underwent transcatheter aortic valve replacement ( n = 199) and surgical aortic valve replacement ( n = 289) from a university-based statewide transcatheter aortic valve replacement/surgical aortic valve replacement program during 2015–2017. Cardiac rehabilitation consisted of supervised exercise, diet education, and stress and depression management. We compared changes from baseline in exercise duration and intensity during cardiac rehabilitation sessions, quality-of-life (36-Item Short-Form Health Survey), and psychosocial measures (anxiety, depression, mood, social support, and diet) between transcatheter aortic valve replacement and surgical aortic valve replacement patients using t-test and chi-square analyses. Results Of 488 patients, cardiac rehabilitation referral rates were similar at 41% (transcatheter aortic valve replacement 81/199 versus surgical aortic valve replacement 117/289), but enrollment rates were lower in transcatheter aortic valve replacement (27/199, 14%) versus surgical aortic valve replacement (102/289, 35%, p Conclusion Cardiac rehabilitation enrollment was low in transcatheter aortic valve replacement patients versus surgical aortic valve replacement patients despite similar referral rates. Improvement in functional and quality-of-life performance was achieved in both transcatheter aortic valve replacement and surgical aortic valve replacement. Future studies should address obstacles for enrollment of transcatheter aortic valve replacement patients.

Background We evaluated the association between postprocedural packed red blood cell transfusion and morbidity and mortality among patients undergoing transcatheter aortic valve replacement. Methods We retrospectively analyzed 429 patients with severe aortic stenosis who underwent transcatheter aortic valve replacement. Propensity-score adjusted multivariable logistic and Cox regression models were used to determine the association of packed red blood cell transfusion with the composite endpoint of death, myocardial infarction, and stroke at 30 days and in hospital, and 1-year mortality. Results Patients receiving transfusions had a higher 30-day and in-hospital incidence of death, myocardial infarction, or stroke when compared with patients who did not receive transfusions (hazard ratio 2.03, 95% confidence interval: 1.02 to 4.07, p = 0.045; and hazard ratio 2.46, 95% confidence interval: 1.12 to 5.41, p = 0.025, respectively). Postprocedural transfusion was independently associated with 1-year mortality (hazard ratio 2.65, 95% confidence interval: 1.21 to 5.80, p = 0.015). Conclusions Packed red blood cell transfusion for patients undergoing transcatheter aortic valve replacement is associated with an increased incidence of adverse outcomes during hospitalization and at 30-day and 1-year follow-up.

The authors sought to examine outcomes and identify independent predictors of mortality among patients undergoing urgent/emergent transcatheter aortic valve replacement (TAVR).Data on urgent/emergent TAVR as a rescue therapy for decompensated severe aortic stenosis (AS) are limited.The Society of Thoracic Surgeons and the American College of Cardiology Transcatheter Valve Therapy (STS/ACC TVT) Registry linked with Centers for MedicareMedicaid Services claims was used to identify patients who underwent urgent/emergent versus elective TAVR between November 2011 and June 2016. Outcomes assessed were device success rate, in-hospital major adverse events, and 30-day and 1-year mortality. Independent predictors of mortality after urgent/emergent TAVR were examined.Of 40,042 patients who underwent TAVR, 3,952 (9.9%) were urgent/emergent (median STS PROM score 11.8 [interquartile range: 7.6 to 17.9]). Device success rate was statistically lower, but not clinically different after urgent/emergent versus elective TAVR (92.6% vs. 93.7%; p = 0.007). Rates of major and/or life-threatening bleeding, major vascular complications, myocardial infarction, stroke, new permanent pacemaker placement, conversion to SAVR, and paravalvular regurgitation were similar between the 2 groups. Compared with elective TAVR, patients undergoing urgent/emergent TAVR had higher rates of acute kidney injury and/or new dialysis (8.2% vs. 4.2%; p 0.001), 30-day mortality (8.7% vs. 4.3%, adjusted hazard ratio: 1.28, 95% confidence interval: 1.10 to 1.48), and 1-year mortality (29.1% vs. 17.5%, adjusted hazard ratio: 1.20, 95% confidence interval: 1.10 to 1.31). In patients undergoing urgent/emergent TAVR, non-femoral access and cardiopulmonary bypass were associated with increased risk, whereas use of balloon-expandable valve was associated with decreased risk of 30-day and 1-year mortality.Urgent/emergent TAVR is feasible with acceptable outcomes and may be a reasonable option in a selected group of patients with severe AS.

Background: We sought to evaluate the association between post-procedural packed red blood cell (PRBC) transfusion following transcatheter aortic valve replacement (TAVR) and 30-day all-cause readmission. We assessed incidence, causes and predictors of 30-day readmission. Methods: We retrospectively analyzed 417 patients who underwent TAVR and survived the index hospitalization. A propensity-score adjusted multivariable logistic regression model was utilized to relate PRBC transfusion to 30-day readmission and to identify predictors of 30-day readmission. Results: The overall 30-day readmission rate was 19.4% and was for non-cardiac causes in 54.3% of patients. Of patients who received PRBC transfusion and those who were not transfused, 30.9% and 21.7% were readmitted within 30 days, respectively (p = 0.08). After propensity adjustment, the odds of readmission were not different among transfused and non-transfused patients (1.33 [95% CI 0.74, 2.40, p = 0.34]). However, among non-anemic patients, transfusion was associated with a greater likelihood of readmission (50% vs. 11.8%, OR 4.92 [95% CI 1.74, 13.91], p = 0.003), in contrast to anemic patients in whom it was not (OR 0.96, [95% CI 0.53, 1.73], p = 0.89; interaction p = 0.002). Independent predictors of 30-day readmission included history of atrial fibrillation (OR: 2.06; CI: 1.23, 3.46, p = 0.006), urgent TAVR procedure (OR: 2.29; CI: 1.20, 4.38, p = 0.020), discharge to nursing home or rehabilitation facility (OR: 1.95; CI: 1.11, 3.44, p = 0.014) and any post-operative complication (OR: 2.08; CI: 1.19, 3.63, p = 0.007). Conclusions: Pre-procedure atrial fibrillation and urgent procedures are novel predictors of early readmission following TAVR. PRBC transfusion did not independently predict 30-day readmission following TAVR.

Creation of an arteriovenous access for hemodialysis can provoke a sequence of events that significantly affects cardiovascular hemodynamics. We present a 78-year-old man with end-stage renal disease and concomitant coronary artery disease previously requiring coronary artery bypass grafting including a left internal mammary graft to the left anterior descending artery, ischemic cardiomyopathy with left ventricular systolic dysfunction, and severe aortic stenosis who developed hypotension unresponsive to medical therapy after recent angioplasty of his ipsilateral arteriovenous fistula for high-grade outflow stenosis. This case highlights the long-term effects of dialysis access on the cardiovascular system, with special emphasis on complications such as high-output cardiac failure and coronary artery steal syndrome. Banding of the arteriovenous fistula provided symptomatic relief with a decrease in cardiac output. Avoidance of arteriovenous access creation on the ipsilateral upper extremity in patients with a left internal mammary artery bypass graft may prevent coronary artery steal syndrome.

Objectives To examine temporal trends, predictors, and outcomes of red blood cell (RBC) transfusion in patients undergoing transcatheter aortic valve replacement (TAVR) in the United States. Methods We used the National Inpatient Sample databases to identify TAVR procedures performed between January 2012 and September 2015 in the United States. Patients were propensity matched (within the strata of overt and no bleeding) on the likelihood of receiving RBC transfusion, and in-hospital outcomes were compared between the 2 groups in the matched cohort. Results Among 46,710 TAVR procedures performed during the study period, rates of RBC transfusion were 17.3% (95% confidence interval [CI], 16.1%-18.5%). RBC transfusion rates decreased significantly from 29.5% during the first quarter of 2012 to 10.8% during the third quarter of 2015 (P Conclusions RBC transfusion is associated with worse clinical outcomes in TAVR patients without bleeding, but not in those with overt bleeding. The utility and optimal threshold for RBC transfusion in TAVR patients, especially among those with overt bleeding, warrants further prospective investigation.

Objectives The aim of this study was to identify clinical, procedural, and angiographic correlates of late/very late drug-eluting stent (DES) thrombosis as well as to determine the clinical outcomes of these events. Background Late/very late DES thromboses are a poorly studied phenomenon, partly due to the relative infrequency of these events, even in large cohort studies. Methods In the DESERT (International Drug-Eluting Stent Event Registry of Thrombosis), a retrospective, case-control registry, 492 cases of late/very late definite DES thrombosis from 21 international sites were matched in a 1:1 fashion with controls without stent thrombosis (ST). Controls were matched according to 2 criteria: same enrolling institution and date of initial DES implantation. Baseline and procedural variables were collected, and clinical follow-up was obtained for patients with ST as long as 1 year after the event. Offline quantitative coronary angiography was performed for a subset of 378 case-control pairs. Results The majority of ST events occurred after 1 year (75%) and continued to occur for as long as 7.3 years. The clinical presentation of late/very late ST events was mainly myocardial infarction (66.7% ST-segment elevation myocardial infarction and 22.0% non–ST-segment elevation myocardial infarction); in-hospital mortality was 3.8%. A minority of patients (30%) with ST were receiving dual-antiplatelet therapy at the time of the event. Independent clinical correlates of late/very late ST were younger age, African-American race, current smoking, multivessel disease, longer stented length, overlapping stents, and percutaneous coronary intervention of vein graft lesions. Independent angiographic correlates for late/very late ST were lesions within the left anterior descending artery or a bypass graft, thrombus, and a larger residual diameter stenosis after the initial DES implantation. Despite the large sample of ST cases, all identified correlates of late/very late ST had weak associations with subsequent ST (all odds ratios Conclusions Despite a large sample of ST cases and use of limited matching to maximize the identification of predictive factors associated with late/very late ST, the variables associated with the development of late/very late ST were only weakly predictive of subsequent events. Additionally, a relatively low observed mortality rate of ST in this series may reflect a different pathophysiology of these late/very late events compared with acute/subacute ST. (Drug Eluting Stent Registry of Thrombosis [DESERT]; NCT00812552 ).

In patients with acute heart failure (AHF), dyspnea relief is the most immediate goal. Renal dysfunction, diuretic resistance, and hyponatremia represent treatment impediments.It was hypothesized that the addition of tolvaptan to a background diuretic improved dyspnea early in patients selected for an enhanced vasopressin antagonism response.In a double-blind trial, patients were randomized to tolvaptan 30 mg/day or placebo. Study entry required hospitalization within the previous 36 h, active dyspnea, and any of the following: 1) estimated glomerular filtration rate 60 ml/min/1.73 mWe randomized 250 patients. There was no difference in the primary endpoint of day 1 dyspnea reduction, despite significantly greater weight reduction with tolvaptan (-2.4 ± 2.1 kg vs. -0.9 ± 1.8 kg; p 0.001). At day 3, dyspnea reduction was greater with tolvaptan (p = 0.01). There were 2 significant treatment-by-subgroup interactions: patients without elevated jugular venous pressure and those without ascites showed directional favorability of tolvaptan over placebo for the primary endpoint compared with patients with these findings.Despite rapid and persistent weight loss with tolvaptan compared with placebo, in patients with AHF who were selected for greater potential benefit from vasopressin receptor inhibition, tolvaptan was not associated with greater early improvement in dyspnea. Apparent subsequent differences in dyspnea warrant further exploration of the temporal relationship between diuresis and dyspnea relief and a possible clinical role for tolvaptan. (Randomized, Double-Blind, Placebo Controlled Study of the Short Term Clinical Effects of Tolvaptan in Patients Hospitalized for Worsening Heart Failure With Challenging Volume Management [SECRET of CHF]; NCT01584557).

Background— Readmissions after cardiac procedures are common and contribute to increased healthcare utilization and costs. Data on 30-day readmissions after transcatheter aortic valve replacement (TAVR) are limited. Methods and Results— Patients undergoing TAVR ( International Classification of Diseases -Ninth Revision-CM codes 35.05 and 35.06) between January and November 2013 who survived the index hospitalization were identified in the Nationwide Readmissions Database. Incidence, predictors, causes, and costs of 30-day readmissions were analyzed. Of 12 221 TAVR patients, 2188 (17.9%) were readmitted within 30 days. Length of stay >5 days during index hospitalization (hazard ratio [HR], 1.47; 95% confidence interval [CI], 1.24–1.73), acute kidney injury (HR, 1.23; 95% CI, 1.05–1.44), >4 Elixhauser comorbidities (HR, 1.22; 95% CI, 1.03–1.46), transapical TAVR (HR, 1.21; 95% CI, 1.05–1.39), chronic kidney disease (HR, 1.20; 95% CI, 1.04–1.39), chronic lung disease (HR, 1.16; 95% CI, 1.01–1.34), and discharge to skilled nursing facility (HR, 1.16; 95% CI, 1.01–1.34) were independent predictors of 30-day readmission. Readmissions were because of noncardiac causes in 61.8% of cases and because of cardiac causes in 38.2% of cases. Respiratory (14.7%), infections (12.8%), bleeding (7.6%), and peripheral vascular disease (4.3%) were the most common noncardiac causes, whereas heart failure (22.5%) and arrhythmias (6.6%) were the most common cardiac causes of readmission. Median length of stay and cost of readmissions were 4 days (interquartile range, 2–7 days) and $8302 (interquartile range, $5229–16 021), respectively. Conclusions— Thirty-day readmissions after TAVR are frequent and are related to baseline comorbidities, TAVR access site, and post-procedure complications. Awareness of these predictors can help identify and target high-risk patients for interventions to reduce readmissions and costs.

In randomized trials, longer drug-eluting stent (DES) length has been associated with adverse clinical events. We used data from the EVENT registry to examine the impact of DES length on outcomes in routine clinical practice. We identified 5,425 unselected consecutive patients from the EVENT registry who had a single vessel treated with DES for nonemergency indications from 2004 through 2007. The association between stented length and short- and long-term outcomes was analyzed in ordinal categories (15, 15 to 19, 20 to 24, and24 mm) and as a continuous variable. There were few differences in baseline characteristics across categories. At 1 year, there was a stepwise increase in major adverse cardiac events (composite of death, myocardial infarction [MI], and target lesion revascularization [TLR]) with increasing stent length (8.0%, 10.1%, 11.8%, and 14.8%, p0.001) and a similar relation with TLR (3.0%, 3.1%, 3.3%, and 5.0%, p = 0.02). After adjusting for demographic, clinical, angiographic, and treatment characteristics, longer stent length remained associated with 1-year major adverse cardiac events (adjusted hazard ratio 1.17 per 10-mm increase stent length) and TLR (hazard ratio 1.20 per 10 mm), but not with stent thrombosis. In conclusion, longer DES length is associated with increased adverse events, predominantly periprocedural MI, but also an increased rate of TLR.

To evaluate whether the improved outcomes with newer generation drug-eluting stents (DES) utilising thin-strut stents are consistent among different patient and angiographic subgroups.Clinical outcomes over three years were collected in the SPIRIT III trial comparing the XIENCE V® everolimus-eluting stents (EES) (Abbott Vascular, Santa Clara, CA, USA) to the TAXUS® paclitaxel-eluting stents (PES) (Boston Scientific, Natick, MA, USA). Potential predictors of adverse clinical outcomes were assessed using demographic, clinical, and procedural variables by logistic and Cox regression analyses. For three-year target vessel failure, the independent predictors identified by Cox regression were number of vessels treated (HR=2.19 [1.50, 3.19], p0.0001), HbA1c (%) (HR=1.17 [1.05, 1.29], p=0.004), total cholesterol (200 mg/dl) (HR=1.63 [1.13, 2.36], p=0.009), and female gender (HR=1.42 [1.01, 2.01], p=0.05). Logistic regression analysis identified the same predictors except for the female gender. The clinical results with EES compared to PES were consistent among the multiple subgroups examined with the possible exception of patients with diabetes.Clinical factors and stent type were the most important multivariable predictors of adverse clinical outcomes in this contemporary trial of first versus second generation DES. The benefit of the EES compared to the PES was consistent across a wide range of patient and angiographic subgroups with the possible exception of patients with diabetes.

The precise cause of takotsubo cardiomyopathy (TC) remains controversial. Plaque rupture with transient thrombotic occlusion of a transapical left anterior descending coronary artery (LAD) has been advanced as a potential mechanism. To explore this hypothesis, the investigators analyzed data from 11 patients prospectively enrolled in the Rhode Island Takotsubo Cardiomyopathy Registry who underwent coronary angiography and intravascular ultrasound evaluation of the LAD during their initial presentation. Despite the presence of nonobstructive coronary artery disease, no culprit lesion was identified in any patient. Similarly, the course of the LAD failed to account for the characteristic left ventricular apical ballooning seen in TC. In conclusion, an atherosclerotic coronary lesion in the LAD causing an aborted myocardial infarction may not be the primary underlying cause of TC, and nonobstructive coronary artery disease and TC may coexist without a direct causal association.

Objectives: The purpose of this study was to investigate long-term 3-year clinical outcomes of an everolimus-eluting stent (EES) versus a paclitaxel-eluting stent (PES). Background Compared with PES, EES reduced target vessel failure and major adverse cardiac events at 2 years. Whether the benefits of EES are sustained at 3 years has not been reported. Methods In the SPIRIT II (A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions) and SPIRIT III (A Clinical Evaluation of the Investigational Device XIENCE V Everolimus Eluting Coronary Stent System [EECSS] in the Treatment of Subjects With De Novo Native Coronary Artery Lesions) trials, 1,302 patients were randomly assigned to EES (n = 892) or PES (n = 410). We report the 3-year clinical follow-up of this patient-level pooled analysis. Results At 3 years, EES compared with PES resulted in a significant reduction in myocardial infarction (3.8% vs. 6.7%; relative risk [RR]: 0.56; 95% confidence interval [CI]: 0.34 to 0.94; p = 0.04), and target lesion revascularization (6.8% vs. 12.7%; RR: 0.53; 95% CI: 0.37 to 0.77; p = 0.001). Everolimus-eluting stents resulted in a significant reduction in target vessel failure (13.7% vs. 19.5%; RR: 0.70; 95% CI: 0.54 to 0.92; p = 0.01), and major adverse cardiac events (9.1% vs. 16.3%; RR: 0.56; 95% CI: 0.41 to 0.76; p = 0.0004). The cumulative rates of Academic Research Consortiumdefined definite or probable stent thrombosis were 1.2% in EES patients and 1.9% in PES patients (RR: 0.64; 95% CI: 0.25 to 1.68; p = 0.43). Conclusions In this patient-level pooled analysis, EES compared with PES resulted in a significant and persistent reduction in target vessel failure and major adverse cardiac events at 3 years due to fewer myocardial infarction and ischemic target lesion revascularization events, which is consistent with superior safety and efficacy of the EES platform. (A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions [SPIRIT II]; NCT00180310) (SPIRIT III: A Clinical Evaluation of the Investigational Device XIENCE V Everolimus Eluting Coronary Stent System [EECSS] in the Treatment of Subjects With De Novo Native Coronary Artery Lesions [SPIRIT III]; NCT00180479)

Data on urgent/emergent transcatheter aortic valve replacement (TAVR) as a rescue therapy for decompensated severe aortic stenosis (AS) are limited. The STS/ACC TVT Registry linked with Centers for Medicare and Medicaid Services claims was used to identify patients who underwent urgent/emergent vs

Objective: This study evaluates the safety and efficacy of the XIENCE V® 4.0 mm stent for the treatment of de novo native coronary artery lesions. Background: In the SPIRIT III trial, the XIENCE V® everolimus-eluting stent (EES), compared with the TAXUS EXPRESS2 paclitaxel-eluting stent (PES) in 2.5–3.75 mm diameter coronary arteries, resulted in reduced angiographic late loss (LL), noninferior rates of target vessel failure (TVF), and fewer major adverse cardiac events (MACE). Methods: The SPIRIT III 4.0 mm registry was a concurrent arm of the SPIRIT III trial consisting of 69 nonrandomized patients with lesions ≤28 mm in length and reference vessel diameter 3.75–4.25 mm treated with a 4.0 mm EES. The primary endpoint was 8-month in-segment LL compared with the randomized PES arm. Results: In-segment LL was 0.17 ± 0.38 mm in the 4.0 mm EES registry compared with 0.28 ± 0.48 mm in the PES arm (P < 0.0001 for noninferiority). The 1-year rates of ischemia-driven TVF (cardiac death, myocardial infarction [MI], or target vessel revascularization) and MACE (cardiac death, MI, or target lesion revascularization [TLR]) were numerically, but not statistically, lower in the 4.0 mm EES patients compared with the randomized PES patients (5.9 vs. 11.3%, P = 0.27 and 5.9 vs. 10.3%, P = 0.36, respectively). There was no difference in 8-month LL or 1-year TVF or MACE between the 4.0 mm EES and randomized EES patients. Conclusions: In large coronary arteries, the 4.0 mm EES results in low rates of LL at 8 months and adverse clinical events at 1 year. © 2009 Wiley-Liss, Inc.

The aim of this study was to determine correlates of acute/subacute coronary stent thrombosis among unselected patients treated in the era of routine dual antiplatelet therapy and specifically to investigate the influence of prophylactic administration of glycoprotein IIb/IIIa (GpIIb-IIIa) inhibitors and use of clopidogrel versus ticlopidine on the development of coronary stent thrombosis (ST).Because of a relative infrequency of ST events and relatively uniform practice patterns within randomized trials, previous studies have had a limited ability to address whether the use of different antiplatelet regimens at the time of coronary stenting is associated with differences in ST.We performed a multicenter, case-control study to evaluate clinical, angiographic, and pharmacologic/procedural correlates of ST. Between 1996 and 2000, all cases of angiographically-confirmed ST (n = 145) among patients receiving dual antiplatelet therapy were identified from 10 participating clinical sites and were matched with a control without ST randomly selected from the same institution.Multivariable conditional logistic regression identified higher pre-procedure platelet count, stenting for acute myocardial infarction, use of a coil or self-expanding stent, and overt angiographic thrombus prior to the procedure, as independent predictors of ST (all P.05). After adjusting for these factors, the use of clopidogrel (vs ticlopidine) was independently associated with an increased risk of ST (OR 2.1, 95% CI 1.0-4.1, P = .04). The use of prophylactic glycoprotein IIb/IIIa inhibitors was not associated with reduced ST in the overall analysis, but appeared to confer some protection against ST within the first 24 hours post procedure (OR 0.5 [95% CI 0.2-1.1] for ST during first day, OR 1.7 [95% CI 0.7-4.3] for ST on subsequent days).Both biologic and pharmacologic factors are independently associated with acute/subacute ST. The association between clopidogrel use (vs ticlopidine) and increased ST in this analysis requires confirmation in adequately powered clinical trials and suggests a potential role for newer and more potent antiplatelet agents.

With the approval of transcatheter aortic valve replacement (TAVR) for patients with severe symptomatic aortic stenosis at intermediate surgical risk, TAVR volume is projected to increase exponentially in the United States. The 30-day readmission rate for TAVR was recently reported at 17.9%. The association between institutional TAVR volume and the 30-day readmission metric has not been examined.To assess the association between hospital TAVR volume and 30-day readmission.In this observational study, we used the 2014 Nationwide Readmissions Database to identify hospitals with established TAVR programs (performing at least 5 TAVRs in the first quarter of 2014). Based on annual TAVR volume, hospitals were classified as low (50), medium (≥50 to100), and high (≥100) volume. Rates, causes, and costs of 30-day readmissions were compared between low-, medium-, and high-volume hospitals. Data were analyzed from November to December 2016.Transcatheter aortic valve replacement.Thirty-day readmissions.Of 129 hospitals included in this study, 20 (15.5%) were categorized as low volume, 47 (36.4%) as medium volume, and 62 (48.1%) as high volume. Of 16 252 index TAVR procedures, 663 (4.1%), 3067 (18.9%), and 12 522 (77.0%) were performed at low-, medium-, and high-volume hospitals, respectively. Thirty-day readmission rates were significantly lower in high-volume compared with medium-volume (adjusted odds ratio, 0.76; 95% CI, 0.68-0.85; P .001) and low-volume (adjusted odds ratio, 0.75; 95% CI, 0.60-0.92; P = .007) hospitals. Noncardiac readmissions were more common in low-volume hospitals (65.6% vs 60.6% in high-volume hospitals), whereas cardiac readmissions were more common in high-volume hospitals (39.4% vs 34.4% in low-volume hospitals). There were no significant differences in length of stay and costs per readmission among the 3 groups (mean [SD], 5.5 [5.0] days vs 5.9 [7.5] days vs 6.0 [5.8] days; P = .74, and $13 886 [18 333] vs $14 135 [17 939] vs $13 432 [15 725]; P = .63, respectively).We report for the first time, to our knowledge, an inverse association between hospital TAVR volume and 30-day readmissions. Lower readmission at higher-volume hospitals was associated with significantly lower cost to the health care system.

Background: Infective endocarditis (IE) is a serious complication in patients with prosthetic heart valves. There are limited available data on the incidence, clinical predictors, and outcomes of IE after transcatheter aortic valve replacement (TAVR) in the United States. Methods: Patients

Sodium bicarbonate has been proposed for protection of the kidney from contrast-induced AKI (CIAKI). However, the effects of bicarbonate on long-term important clinical outcomes are uncertain.In a prospective, double-blind, multicenter randomized clinical trial, 391 patients with an eGFR45 ml/min per 1.73 m(2) undergoing elective coronary or peripheral angiography were randomized to an infusion with a high dose of isotonic sodium bicarbonate (target 2.0 mEq/kg) or a similar molar amount of isotonic sodium chloride. The primary outcome was a composite of mortality, dialysis, or a sustained 20% reduction in eGFR at 6 months.There were 391 patients enrolled between March 2010 and May 2012. The incidence of the primary outcome was 14.9% in the bicarbonate group and 16.3% in the control group in the intention-to-treat population (P=0.78). There was also no difference in the incidence of CIAKI between the treatment groups (14.5% versus 12.1%, respectively; P=0.20). CIAKI was associated with a higher incidence of sustained loss of kidney function at 6 months compared with those without CIAKI (21.2% versus 7.7%, respectively; P=0.06).High-dose sodium bicarbonate infusion in patients with eGFR45 ml/min per 1.73 m(2) undergoing angiography did not demonstrate a difference in incidence of the composite of death, dialysis, or sustained 6-month reduction in eGFR or CIAKI compared with sodium chloride.

OBJECTIVES This registry collected the 30-day and 9-month clinical outcomes of patients whose coronary stent implantation was suboptimal, and compared them with the cohort of patients with “optimal” stenting in the randomized portion of the STent Anti-thrombotic Regimen Study (STARS) trial. BACKGROUND Although “optimal” stenting combined with an aspirin and ticlopidine regimen carries a low (0.5%) incidence of subacute stent thrombosis, only limited data are available for patients in whom stents are deployed suboptimally. METHODS In the STARS, 312 (15.9%) of 1,965 patients enrolled were excluded from participation in the randomized trial based on a perceived “suboptimal” result of coronary stenting. Of these, 265 patients met prespecified criteria for suboptimal stenting, and were followed in a parallel registry, which was compared with the randomized STARS optimal stenting cohort. The primary end point was a 30-day composite of death, emergent target lesion revascularization, angiographic thrombosis of the target vessel without revascularization and nonfatal myocardial infarction (MI)unrelated to direct procedural complications. RESULTS Registry patients had a similar frequency of the primary end point compared with the overall randomized cohort (3.0% vs. 2.2%), with this end point correlating to use of multiple stents, smaller final lumen diameter and absence of ticlopidine from the poststent regimen. Overall 30-day mortality (1.1% vs. 0.06%, p = 0.009) and periprocedural non-Q wave MI (8.7% vs. 4.2%, p = 0.003) were more frequent in registry patients, and appeared to be related to acute procedural complications. Clinical restenosis was significantly higher for registry patients (26.8% vs. 16.0%, p = 0.001), relating to greater prevalence of independent predictors such as smaller final lumen diameter and multiple stent use. CONCLUSIONS In the STARS registry, the inability to perform optimal stenting correlated with smaller final lumen diameter and longer stent length. With ticlopidine-containing regimens, the acute clinical results of “suboptimal” stent deployment are clinically acceptable, although they are not quite as good as those of optimal stenting using similar drug therapy.

In patients with symptomatic severe aortic stenosis, surgical aortic valve replacement (SAVR) improves survival, quality of life, and functional status compared with medical therapy. Based on the results of the randomized PARTNER Trial, Transcatheter Aortic Valve Replacement (TAVR) using the Edwards Sapien balloon expandable valve is now available in the United States for patients who are either inoperable due to anatomic concerns or severe medical co-morbidities, or as an alternative in patients considered high risk for SAVR. Fifty-six patients have been treated with TAVR at Rhode Island Hospital from March 2012 through October 2013 with similar outcomes to The PARTNER Trial and several large European registries. Second- generation valves and lower profile delivery systems designed to reduce the incidence of vascular complications, stroke, and perivalvular leak; and extension of TAVR to intermediate risk surgical patients, are under investigation.

Objectives We sought to compare the clinical outcomes after perctuaneous coronary revascularization of large coronary arteries using drug-eluting (DES) or bare-metal (BMS) stents. Background In de novo native coronary lesions with reference diameters of 2.5–3.5 mm, DES reduce target lesion revascularization (TLR) with no increase in death or myocardial infarction (MI). The relative efficacy of DES in larger coronary artery lesions is less certain. Methods From the prospective Evaluation of Drug-Eluting Stents and Ischemic Events registry, we identified patients undergoing stenting of de novo lesions in native coronary arteries 3.5–5.0 mm in diameter (n = 1,485). In-hospital and 1-year clinical outcomes were compared for BMS (n = 282) and DES (n = 1,203) patients, using propensity stratification to adjust for differences in potential confounding factors. Results Most patient characteristics were similar for the two groups, but BMS patients were more likely to have been treated in the setting of ST elevation MI, whereas DES patients had more bifurcation lesions, smaller vessels, and longer total stent lengths. In risk-adjusted analyses, the composite endpoint of 1-year death, MI or TLR was similar for BMS and DES (standardized rate: 11.9% vs. 8.5%, P = 0.10). DES was associated with a 62% reduction in the risk of TLR, although the absolute difference in event rates was small (standardized rates 4.6% vs. 1.8%, P = 0.016). Conclusions Among relatively unselected patients undergoing PCI of large native coronary arteries, use of DES was associated with a modest reduction in rates of TLR, with a neutral effect on other ischemic endpoints. © 2012 Wiley Periodicals, Inc.