Impact of Combined Pre and Postcapillary Pulmonary Hypertension on Survival after Transcatheter Aortic Valve Implantation.

We aimed to evaluate the association between pulmonary hypertension (PH) hemodynamic classification and all-cause mortality in patients with symptomatic severe aortic stenosis (AS) undergoing transcatheter aortic valve implantation (TAVI). PH is common and associated with post-TAVI outcomes in patients with severe AS. Although PH in these patients is primarily driven by elevated left-sided pressures (postcapillary PH), some patients develop increased pulmonary vascular resistance (PVR) configuring the combined pre- and postcapillary PH (CpcPH). We analyzed severe AS patients with mean pulmonary artery pressure (mPAP) measured by right heart catheterization (RHC) before TAVI between 2011 and 2017. PH hemodynamic classification was defined as: No PH (mPAP < 25 mm Hg); precapillary PH (mPAP ≥ 25 mm Hg, pulmonary capillary wedge pressure (PCWP) ≤15 mm Hg); isolated postcapillary PH (IpcPH; mPAP ≥ 25 mm Hg, PCWP > 15 mm Hg, PVR ≤ 3 Wood units (WU); CpcPH (mPAP ≥ 25 mm Hg, PCWP > 15 mm Hg, PVR > 3 WU). Kaplan-Meier and Cox regression analyses were used to test the association of PH hemodynamic classification with post-TAVI all-cause mortality. We examined 561 patients (mean age 82 ± 8 years, 51% men, mean LVEF 54 ± 14%). The prevalence of no PH was 201 (36%); precapillary PH, 59 (10%); IpcPH, 189 (34%); and CpcPH, 112 (20%). During a median follow-up of 30 months, 240 all-cause deaths occurred. Patients with CpcPH had higher mortality than those with no-PH even after adjustment for baseline characteristics (Hazard ratio 1.56, 95% confidence interval 1.06 to 2.29, p = 0.025). There was no survival difference among patients with non-PH, precapillary PH and IpcPH. In conclusion, for patients with symptomatic severe AS treated with TAVI, CcpPH is independently associated with long-term all-cause mortality despite successful TAVI.

Mitral Regurgitation in Low-Flow, Low-Gradient Aortic Stenosis Patients Undergoing TAVR: Insights From the TOPAS-TAVI Registry.

OBJECTIVES: This study sought to determine the incidence, clinical impact, and changes over time of mitral regurgitation (MR) in patients with low-flow, low-gradient aortic stenosis (LFLG-AS) undergoing transcatheter aortic valve replacement (TAVR). BACKGROUND: Few data exist on the clinical impact and changes in severity over time of MR in patients with LFLG-AS undergoing TAVR. METHODS: A total of 308 TAVR candidates with LFLG-AS were included. Patients were categorized according to MR severity at baseline, and presence of MR improvement at 12-month follow-up. Clinical outcomes were assessed at 1 and 12 months (+ echocardiography), and yearly thereafter. RESULTS: Baseline mild and moderate-to-severe MR were present in 118 (38.3%) and 115 (37.3%) patients, respectively. MR was of functional and mixed etiology in 77.2% and 22.7% of patients, respectively. A total of 131 patients (42.5%) died after a median follow-up of 2 (1 to 3) years. Baseline moderate-or-greater MR had no impact on mortality (hazard ratio [HR]: 1.34; 95% confidence interval [CI]: 0.72 to 2.48) or heart failure hospitalization (HR: 1.02; 95% CI: 0.49 to 2.10). At 1-year follow-up, MR improved in 44.3% of patients and remained unchanged/worsened in 55.7%. The lack of MR improvement was associated with a higher risk of all-cause and cardiac mortality (HR: 2.02; 95% CI: 1.29 to 3.17; HR: 3.03; 95% CI: 1.27 to 7.23, respectively), rehospitalization for cardiac causes (HR: 1.50; 95% CI: 1.04 to 2.15), and an increased overall-mortality/heart failure rehospitalization (HR: 1.94; 95% CI: 1.25 to 3.02). A higher baseline left ventricular end-diastolic diameter and a higher increase in left ventricular ejection fraction were found to be independent predictors of MR improvement at 1-year follow-up (odds ratio: 0.69; 95% CI: 0.51 to 0.94; and odds ratio: 0.81; 95% CI: 0.67 to 0.96, respectively). CONCLUSIONS: Most TAVR candidates with LFLG-AS had some degree of MR, of functional origin in most cases. MR improved in about one-half of patients, with larger left ventricular size and a higher increase in left ventricular ejection fraction post-TAVR determining MR improvement over time. The lack of MR improvement at 1 year was associated with poorer outcomes.

Association of Structural and Functional Cardiac Changes With Transcatheter Aortic Valve Replacement Outcomes in Patients With Aortic Stenosis.

Importance: Severe aortic stenosis causes pressure overload of the left ventricle, resulting in progressive cardiac dysfunction that can extend beyond the left ventricle. A staging system for aortic stenosis has been recently proposed that quantifies the extent of structural and functional cardiac changes in aortic stenosis. Objectives: To confirm the reproducibility of a proposed staging system and expand the study findings by performing a survival analysis and to evaluate the association of aortic stenosis staging with both cardiac and noncardiac post-transcatheter aortic valve replacement (TAVR) readmissions. Design, Setting, and Participants: A cohort analysis was conducted involving patients with severe aortic stenosis who underwent TAVR at the University of Pittsburgh Medical Center between July 1, 2011, and January 31, 2017. Patients who had undergone TAVR for valve-in-valve procedures and had an incomplete or unavailable baseline echocardiogram study for review were excluded. Clinical, laboratorial, and procedural data were collected from the Society of Thoracic Surgeons database and augmented by electronic medical record review. Exposures: The aortic stenosis staging system is based on echocardiographic markers of abnormal cardiac function. The stages are as follows: stage 1 (left ventricle changes - increased left ventricular mass index; early mitral inflow to early diastolic mitral annulus velocity (E/e') >14; and left ventricular ejection fraction <50%), stage 2 (left atrial or mitral changes - left atrial volume index >34 mL/m2; moderate to severe mitral regurgitation; and atrial fibrillation), stage 3 (pulmonary artery or tricuspid changes - pulmonary artery systolic pressure ≥60 mm Hg; moderate to severe tricuspid regurgitation), and stage 4 (right ventricle changes - moderate to severe right ventricle dysfunction). Main Outcomes and Measures: Primary outcome was post-TAVR all-cause mortality. Secondary outcomes were composite outcomes of all-cause mortality and post-TAVR all-cause and cardiac-cause readmissions. Results: A total of 689 consecutive patients (351 [50.9%] were male, with a mean [SD] age of 82.4 [7.6] years) were included. The prevalence of stage 1 was 13%; stage 2, 62%; stage 3, 21%; and stage 4, 4%. Patients with higher staging had a greater burden of comorbidities as captured by the Society of Thoracic Surgeons Predicted Risk of Mortality (STS-PROM). Despite adjustment for STS-PROM, a graded association was found between aortic stenosis staging and all-cause mortality (hazard ratio [HR] stage 2 vs stage 1: 1.37 [95% CI, 0.81-2.31; P = .25]; stage 3 vs stage 1: 2.24 [95% CI, 1.28-3.92; P = .005]; and stage 4 vs stage 1: 2.83 [95% CI, 1.39-5.76; P = .004]). Stage 3 patients had higher post-TAVR readmission rates for both cardiac (HR, 1.84; 95% CI, 1.13-3.00; P = .01) and noncardiac causes. Conclusions and Relevance: Aortic stenosis staging appears to show a strong graded association between the extent of cardiac changes and post-TAVR all-cause mortality; such staging may improve patient care, risk stratification, assessment of prognosis, and shared decision making for patients undergoing TAVR.

Right ventricle to pulmonary artery coupling in patients undergoing transcatheter aortic valve implantation.

OBJECTIVES: To evaluate the prognostic value of the ratio between tricuspid annular plane systolic excursion (TAPSE)-pulmonary artery systolic pressure (PASP) as a determinant of right ventricular to pulmonary artery (RV-PA) coupling in patients undergoing transcatheter aortic valve replacement (TAVI). BACKGROUND: RV function and pulmonary hypertension (PH) are both prognostically important in patients receiving TAVI. RV-PA coupling has been shown to be prognostic important in patients with heart failure but not previously evaluated in TAVI patients. METHODS: Consecutive patients with severe aortic stenosis who received TAVI from July 2011 through January 2016 and with comprehensive baseline echocardiogram were included. All individual echocardiographic images and Doppler data were independently reviewed and blinded to the clinical information and outcomes. Cox models quantified the effect of TAPSE/PASP quartiles on subsequent all-cause mortality while adjusting for confounders. RESULTS: A total of 457 patients were included with mean age of 82.8±7.2 years, left ventricular ejection fraction (LVEF) 54%±13%, PASP 44±17 mm Hg. TAPSE/PASP quartiles showed a dose-response relationship with survival. This remained significant (HR for lowest quartile vs highest quartile=2.21, 95% CI 1.07 to 4.57, p=0.03) after adjusting for age, atrial fibrillation, LVEF, stroke volume index, Society of Thoracic Surgeons Predicted Risk of Mortality. CONCLUSION: Baseline TAPSE/PASP ratio is associated with all-cause mortality in TAVI patients as it evaluates RV systolic performance at a given degree of afterload. Incorporation of right-side unit into the risk stratification may improve optimal selection of patients for TAVI.

Open Surgical Access for Transfemoral TAVR Should Not Be a Contraindication for Conscious Sedation.

OBJECTIVES: The use of monitored anesthesia care (MAC) for transcatheter aortic valve replacement (TAVR) is gaining favor in the United States, although general anesthesia (GA) continues to be common for these procedures. Open surgical cutdown for transfemoral TAVR has been a relative contraindication for TAVR with MAC at most centers. The objective of this study was to review the authors' results of transfemoral TAVR performed in patients with open surgical cutdown with the use of MAC. DESIGN: Retrospective study design from a prospectively recorded database. SETTING: Tertiary academic (teaching) hospital. PARTICIPANTS: Two hundred eighty-two patients undergoing transfemoral TAVR with open surgical cutdown under MAC from 2015 to 2017. INTERVENTIONS: Transfemoral TAVR under MAC with surgical cutdown for femoral vascular access. MEASUREMENTS AND MAIN RESULTS: The study cohort consisted of 282 patients with severe aortic stenosis (mean area 0.65 [± 0.16] cm2, mean gradient of 48.9 [±13.3] mmHg, and mean age of 82.7 [± 7.31] years). Eleven (3.9%) patients required conversion to GA. First postoperative pain score (0-10) was 2.9 and highest postoperative pain score was 4.6. Major and minor vascular complications occurred in 2 (0.7%) and 6 (2.1%) patients, respectively. Twenty-nine (10.3%) patients were readmitted within 30 days, and 6 (2.1%) patients had in-hospital mortality. CONCLUSIONS: Open surgical cutdown for transfemoral TAVR can be performed safely using MAC and ilioinguinal block with low rates of conversion to general anesthesia and acceptable postoperative outcomes and pain scores.

Outcomes From Transcatheter Aortic Valve Replacement in Patients With Low-Flow, Low-Gradient Aortic Stenosis and Left Ventricular Ejection Fraction Less Than 30%: A Substudy From the TOPAS-TAVI Registry.

Importance: In low-flow, low-gradient aortic stenosis (LFLG AS), the severity of left ventricular dysfunction remains a key factor in the evaluation of aortic valve replacement. Objective: To evaluate the clinical outcomes and changes in left ventricular ejection fraction (LVEF) after transcatheter aortic valve replacement (TAVR) in patients with LFLG AS and severe left ventricular dysfunction. Design, Setting, and Participants: This multicenter registry is a substudy of the True or Pseudo-Severe Aortic Stenosis-TAVI registry that included patients with classic LFLG AS, defined as a mean transvalvular gradient less than 35 mm Hg, an effective orifice area less than 1.0 cm2, and an LVEF of 40% or less. Patients were divided in groups with very low (<30%) LVEF and low (30%-40%) LVEF. Dobutamine stress echocardiography (DSE) was performed before TAVR in a subset with very low LVEF, and presence of contractile reserve was defined as an increase of 20% or more in stroke volume. Clinical outcomes were assessed at 1 and 12 months and yearly thereafter, and echocardiography was performed at 1-year follow-up. Retrospective data were collected from 2007 to 2013 and prospective data from January 2013 to March 2018. Data were analyzed from March to October 2018. Exposures: Transcatheter aortic valve replacement in patients with LFLG AS. Main Outcomes and Measures: Changes in LVEF over time; periprocedural and late mortality. Results: A total of 293 patients were included, including 128 (43.7%) with very low LVEF and 165 with low LVEF (56.3%). Their mean (SD) age was 80 (7) years, and most (214 [73.0%]) were men. The mean (SD) LVEF in the very low LVEF group was 22% (5%), compared with 37% (7%) in the low LVEF group (P < .001). There were no differences between groups in rates of periprocedural mortality and late mortality (median [interquartile range], 23 [6-38] months). Patients with very low LVEF displayed a greater increase in LVEF at the 1-year follow-up examination (mean absolute increase, 11.9% [95% CI, 8.8%-15.1%]), than the low LVEF group (3.6% [95% CI, 1.1%-6.1%]; P < .001). In 92 patients with very low LVEF who had preprocedural DSE, results showed a lack of contractile reserve in 45 (49%), but this had no effect on clinical outcomes or changes in LVEF over time. Conclusions and Relevance: In patients with LFLG AS and severe left ventricular dysfunction, TAVR was associated with similar clinical outcomes as in counterparts with milder left ventricular dysfunction. The TAVR procedure was associated with a significant increase in LVEF, irrespective of contractile reserve. These results support TAVR for LFLG AS, irrespective of the severity of left ventricular dysfunction and DSE results.

Surgical cut down for vascular access with conscious sedation for transcatheter aortic valve replacement: the best of both worlds?

OBJECTIVES: Despite the established efficacy of transcatheter aortic valve replacement for aortic valve replacement, vascular complications remain a major cause of procedural morbidity and mortality. In this study, we evaluate the use of femoral artery cut down with conscious sedation and report outcomes and complications associated with this approach. METHODS: Our study included 282 patients undergoing transcatheter aortic valve replacement with conscious sedation and surgical cut down for femoral access between 2015 and 2017. Data were prospectively recorded in the local institutional database and were retrospectively accessed. Descriptive statistics are presented, and a Kaplan-Meier time-to-event plot was used to estimate 1-year survival. RESULTS: The mean age of the patients was 82.7 ± 7.31 years and consisted of 146 (52%) women. Echocardiographic data demonstrated a severe aortic stenosis with a mean area of 0.65 ± 0.16 cm2 and a mean gradient of 48.9 ± 13.3 mmHg. STS-PROM for the cohort was 7.2%, representing an intermediate risk group. Six (2.2%) patients died within 30 days after transcatheter aortic valve replacement. Major vascular complications occurred in 2 (0.7%) patients and minor vascular complications occurred in 6 (2.2%) patients in our cohort. Wound complications were observed in 2 (0.7%) patients. CONCLUSIONS: We demonstrate that the use of conscious sedation and surgical cut down for femoral arterial access resulted in a major vascular complication rate of less than 1% and low in-hospital mortality rates without any significant increase in wound complications.

Transcatheter Aortic Valve Replacement in Patients With Low-Flow, Low-Gradient Aortic Stenosis: The TOPAS-TAVI Registry.

BACKGROUND: Few data exist on patients with low-flow, low-gradient aortic stenosis (LFLG-AS) undergoing transcatheter aortic valve replacement (TAVR). Also, very scarce data exist on the usefulness of dobutamine stress echocardiography (DSE) before TAVR in these patients. OBJECTIVES: The authors sought to evaluate clinical outcomes and changes in left ventricular ejection fraction (LVEF) following TAVR in patients with classical LFLG-AS. METHODS: This multicenter registry included 287 patients with LFLG-AS undergoing TAVR. DSE was performed before TAVR in 234 patients and the presence of contractile reserve was defined as an increase of ≥20% in stroke volume. Transthoracic echocardiography was repeated at hospital discharge and at 1-year follow-up. Clinical follow-up was obtained at 1 and 12 months, and yearly thereafter. RESULTS: The median Society of Thoracic Surgeons score of the study population was 7.7% (interquartile range 5.3% to 12.0%), and the mean LVEF and transvalvular gradient were 30.1 ± 9.7% and 25.4 ± 6.6 mm Hg, respectively. The presence of contractile reserve was observed in 45% of patients at DSE. Mortality rates were 3.8%, 20.1%, and 32.3% at 30 days, 1 year, and 2 years, respectively. On multivariable analysis, chronic obstructive pulmonary disease (p = 0.022) and lower hemoglobin values (p < 0.001) were associated with all-cause mortality. Lower hemoglobin values (p = 0.004) and moderate-to-severe aortic regurgitation post-TAVR (p = 0.018) were predictors of the composite of mortality and rehospitalization due to heart failure. LVEF increased by 8.3% (95% confidence interval: 6% to 11%) at 1-year follow-up, and the lack of prior coronary artery bypass graft (p = 0.004), a lower LVEF at baseline (p < 0.001), and a lower stroke volume index at baseline (p = 0.019) were associated with greater increase in LVEF. The absence of contractile reserve at baseline DSE was not associated with any negative effect on clinical outcomes or LVEF changes at follow-up. CONCLUSIONS: TAVR was associated with good periprocedural outcomes in patients with LFLG-AS. However, approximately one-third of LFLG-AS TAVR recipients died at 2-year follow-up, with pulmonary disease, anemia, and residual paravalvular leaks associated with poorer outcomes. LVEF improved following TAVR, but DSE failed to predict clinical outcomes or LVEF changes over time. (Multicenter Prospective Study of Low-Flow Low-Gradient Aortic Stenosis [TOPAS Study]; NCT01835028).

The delayed southern migration of a transcatheter aortic valve.

Transcatheter aortic valve replacement has emerged as a favourable alternative in patients with severe symptomatic aortic stenosis who are at intermediate and/or high risk for open aortic valve replacement. While transcatheter aortic valve replacement has been shown to be a safe alternative to surgical aortic valve replacement in those populations, the procedure is not without risks. Transcatheter heart valve migration can occur, albeit rarely, in an acute, subacute and delayed fashion. This complication can have fatal consequences if not managed appropriately. We describe a patient who underwent a transcatheter aortic valve replacement and had evidence of transcatheter heart valve subacute migration into the left ventricular outflow tract.

Outcomes of persistent pulmonary hypertension following transcatheter aortic valve replacement.

OBJECTIVES: To determine the prevalence and factors associated with persistent pulmonary hypertension (PH) following transcatheter aortic valve replacement (TAVR) and its relationship with long-term mortality. METHODS: Consecutive patients who underwent TAVR from July 2011 through January 2016 were studied. The prevalence of baseline PH (mean pulmonary artery pressure ≥25 mm Hg on right heart catheterisation) and the prevalence and the predictors of persistent≥moderate PH (pulmonary artery systolic pressure (PASP)>45 mm Hg on 1 month post-TAVR transthoracic Doppler echocardiography) were collected. Cox models quantified the effect of persistent PH on subsequent mortality while adjusting for confounders. RESULTS: Of the 407 TAVR patients, 273 (67%) had PH at baseline. Of these, 102 (25%) had persistent≥moderate PH. Mortality at 2 years in patients with no baseline PH versus those with PH improvement (follow-up PASP≤45 mm Hg) versus those with persistent≥moderate PH was 15.4%, 16.6% and 31.3%, respectively (p=0.049). After adjusting for Society of Thoracic Surgeons Predicted Risk of Mortality and baseline right ventricular function (using tricuspid annular plane systolic excursion), persistent≥moderate PH remained associated with all-cause mortality (HR=1.82, 95% CI 1.06 to 3.12, p=0.03). Baseline characteristics associated with increased likelihood of persistent≥moderate PH were ≥moderate tricuspid regurgitation, ≥moderate mitral regurgitation, atrial fibrillation/flutter, early (E) to late (A) ventricular filling velocities (E/A ratio) and left atrial volume index. CONCLUSIONS: Persistency of even moderate or greater PH at 1 month post-TAVR is common and associated with higher all-cause mortality.

Subclavian/Axillary Access for Self-Expanding Transcatheter Aortic Valve Replacement Renders Equivalent Outcomes as Transfemoral.

BACKGROUND: Iliofemoral arterial disease can preclude transfemoral (TF) transcatheter aortic valve replacement (TF-TAVR). Transthoracic access by direct aortic or a transapical approach imparts a greater risk of complications and death than TF access. We hypothesized that subclavian/axillary arterial (SCA) access offers equivalent risks and outcomes as TF access. METHODS: The outcomes of 202 patients from the CoreValve (Medtronic, Minneapolis, MN) United States Pivotal Trial Program treated with SCA access were propensity matched with patients treated with TF access and analyzed. RESULTS: Matching was successful, with no significant baseline differences in the SCA group and the TF group, except the SCA group had more past or present smokers (79.2% vs 61.4%, p < 0.001) and fewer patients with anemia requiring transfusion (18.5% vs 27.5%, p = 0.04). SCA patients experienced a significantly longer time from enrollment to procedure (8.6 ± 19.1 vs 5.3 ± 6.3 days; p = 0.02), likely the result of case planning. Significant differences in procedural outcomes include less post-TAVR balloon dilation (17.9% vs 26.7%, p = 0.03) and more general anesthesia (99.0% vs 89.6%, p < 0.001) for the SCA accesses. There were no differences in procedure time (57.8 ± 45.3 vs 57.5 ± 32.1 min, p = 0.94) or Valve Academic Research Consortium I-defined procedure success between groups (p = 0.89). Event rates at 30 days or 1 year were similar, with a trend toward fewer pacemakers with SCA accesses. CONCLUSIONS: Major morbidity and mortality rates SCA-TAVR are equivalent to TF-TAVR. The SCA should be the preferred secondary access site for TAVR because it offers procedural and clinical outcomes comparable to TF-TAVR and applies to most patients who are not TF candidates.

Cardiac amyloidosis is prevalent in older patients with aortic stenosis and carries worse prognosis.

BACKGROUND: Non-invasive cardiac imaging allows detection of cardiac amyloidosis (CA) in patients with aortic stenosis (AS). Our objective was to estimate the prevalence of clinically suspected CA in patients with moderate and severe AS referred for cardiovascular magnetic resonance (CMR) in age and gender categories, and assess associations between AS-CA and all-cause mortality. METHODS: We retrospectively identified consecutive AS patients defined by echocardiography referred for further CMR assessment of valvular, myocardial, and aortic disease. CMR identified CA based on typical late-gadolinium enhancement (LGE) patterns, and ancillary clinical evaluation identified suspected CA. Survival analysis with the Log rank test and Cox regression compared associations between CA and mortality. RESULTS: There were 113 patients (median age 74 years, Q1-Q3: 62-82 years), 96 (85%) with severe AS. Suspected CA was present in 9 patients (8%) all > 80 years. Among those over the median age of 74 years, the prevalence of CA was 9/57 (16%), and excluding women, the prevalence was 8/25 (32%). Low-flow, low-gradient physiology was very common in CA (7/9 patients or 78%). Over a median follow-up of 18 months, 40 deaths (35%) occurred. Mortality in AS + CA patients was higher than AS alone (56% vs. 20% at 1-year, log rank 15.0, P < 0.0001). Adjusting for aortic valve replacement modeled as a time-dependent covariate, Society of Thoracic Surgery predicted risk of mortality, left ventricular ejection fraction, CA remained associated with all-cause mortality (HR = 2.92, 95% CI = 1.09-7.86, P = 0.03). CONCLUSIONS: Suspected CA appears prevalent among older male patients with AS, especially with low flow, low gradient AS, and associates with all-cause mortality. The importance of screening for CA in older AS patients and optimal treatment strategies in those with CA warrant further investigation, especially in the era of transcatheter aortic valve implantation.

Assessment of P2Y12 inhibitor usage and switching in acute coronary syndrome patients undergoing percutaneous coronary revascularization.

BACKGROUND: Dual antiplatelet therapy is recommended for patients with acute coronary syndrome (ACS) that undergo percutaneous coronary intervention (PCI). However, the effect of switching P2Y12 inhibitors between the loading dose and therapy after discharge is not well described. METHODS: This post-hoc analysis of a prospectively collected registry included 3219 consecutive ACS patients who underwent PCI. Patients were categorized into four groups: clopidogrel at load and discharge (C-C), loading dose of clopidogrel and discharged on prasugrel/ticagrelor (C-PT), loading dose of prasugrel/ticagrelor and discharged on clopidogrel (PT-C), and prasugrel/ticagrelor at load and discharge (PT-PT). RESULTS: While 77.6% of patients received the C-C treatment regimen and 13.6% received the PT-PT strategy, the strategy of P2Y12 switching was fairly common with 6.2% in the PT-C group and 2.6% in the C-PT group. While C-C was the most common treatment regimen, PT-C and PT-PT were more commonly used in STEMI patients than in NSTEMI or unstable angina patients. A significantly lower unadjusted incidence of the composite outcome (death, MI, and repeat revascularization) was appreciated in both the PT-C (1.0%) and PT-PT (2.3%) groups than the C-C group (4.0%). Propensity-score matched analysis still showed significantly reduced risk (HR=0.22, 95% CI 0.05-0.93, p=0.04) in the PT-C group vs. a matched group of C-C controls. CONCLUSIONS: The strategy of utilizing a newer P2Y12 inhibitor and then switching to clopidogrel in ACS patients following PCI is used with some frequency in routine clinical practice and further studies should evaluate the safety and efficacy of such a strategy.

Meta-Analysis of Perioperative Stroke and Mortality in Transcatheter Aortic Valve Implantation.

Transcatheter aortic valve implantation (TAVI) is a rapidly evolving safe method with decreasing incidence of perioperative stroke. There is a void in literature concerning the impact of stroke after TAVI in predicting 30-day stroke-related mortality. The primary aim of this meta-analysis was to determine whether perioperative stroke increases risk of stroke-related mortality after TAVI. Online databases, using relevant keywords, and additional related records were searched to retrieve articles involving TAVI and stroke after TAVI. Data were extracted from the finalized studies and analyzed to generate a summary odds ratio (OR) of stroke-related mortality after TAVI. The stroke rate and stroke-related mortality rate in the total patient population were 3.07% (893 of 29,043) and 12.27% (252 of 2,053), respectively. The all-cause mortality rate was 7.07% (2,053 of 29,043). Summary OR of stroke-related mortality after TAVI was estimated to be 6.45 (95% confidence interval 3.90 to 10.66, p <0.0001). Subgroup analyses were performed among age, approach, and valve type. Only 1 subgroup, transapical TAVI, was not significantly associated with stroke-related mortality (OR 1.97, 95% confidence interval, 0.43 to 7.43, p = 0.42). A metaregression was conducted among females, New York Heart Association class III/IV status, previous stroke, valve type, and implantation route. All failed to exhibit any significant associations with the OR. In conclusion, perioperative strokes after TAVI are associated with >6 times greater risk of 30-day stroke-related mortality. Transapical TAVI is not associated with increased stroke-related mortality in patients who suffer from perioperative stroke. Preventative measures need to be taken to alleviate the elevated rates of stroke after TAVI and subsequent direct mortality.

The risk and extent of neurologic events are equivalent for high-risk patients treated with transcatheter or surgical aortic valve replacement.

OBJECTIVES: This study was designed to characterize the incidence of new clinically detectable neurologic events, or any comparative change in indices of higher cognitive function following transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) within the framework of a prospective, randomized clinical trial for high-risk patients. METHODS: High-risk patients (predicted SAVR mortality 15%) with severe aortic stenosis (n = 750) were randomized 1:1 to TAVR or SAVR and underwent evaluation using the National Institutes of Health Stroke Scale (NIHSS) and modified Rankin Scale assessment at each follow-up and any suspected event. Neurologic outcomes were ascertained by a neurologist and further evaluated by Mini-Mental State Examination (MMSE), visual fields testing, gait assessment, hand function, writing evaluation, and drawing assessment. RESULTS: The 30-day, 1-year, and 2-year stroke rates were 4.9%, 8.7%, and 10.9%, respectively, for TAVR and 6.2%, 12.5%, and 16.6%, respectively, for SAVR (P = .46, .11, and .05, respectively). All-cause mortality in patients with a major stroke was 83.3% for TAVR and 54.5% for SAVR at 2 years (P = .29). Late major stroke was disproportionately higher (23.8% at 2 years) among patients with poor iliofemoral access randomized to SAVR. Peripheral vascular disease and falls within 6 months predicted early stroke, and severe aortic calcification and high Charlson score (≥5) predicted 1-year stroke post-TAVR. NIHSS and MMSE scores trended higher after SAVR than after TAVR. Lack of dual antiplatelet therapy use during and after TAVR was associated with early stroke. CONCLUSIONS: This study defines an equivalent postprocedural stroke risk, stroke extent, and degree of cognitive change after TAVR or SAVR in a high-risk population, and also defines several predictors of stroke after TAVR.

Right Ventricular Function and Prognosis in Patients with Low-Flow, Low-Gradient Severe Aortic Stenosis.

BACKGROUND: Patients with low left ventricular ejection fractions and low-flow, low-gradient aortic stenosis (AS) represent a challenging cohort with high morbidity and mortality. The prevalence and clinical impact of right ventricular dysfunction (RVD) on risk stratification and prognosis in these patients is unknown. METHODS: A retrospective analysis was performed of 65 patients with low-flow, low-gradient AS who underwent low-dose dobutamine stress echocardiography to determine AS severity and to ascertain flow reserve status (≥20% stroke volume increase). Clinical, demographic, and imaging data were prospectively collected. Per guidelines, RVD was defined as tricuspid annular plane systolic excursion < 16 mm in the apical four-chamber view and measured at baseline. Cox proportional hazards modeling was used to risk-adjust comparisons for the end point of all-cause mortality. RESULTS: The mean age was 74 ± 9 years, the mean left ventricular ejection fraction was 29 ± 10%, the mean indexed aortic valve (AV) area was 0.49 ± 0.1 cm(2)/m(2), and the mean AV gradient 22 ± 7 mm Hg. RVD was present in 37 patients (57% of the study cohort). After a median follow-up period of 13 months (interquartile range, 5-30 months), there were 29 AV replacements and 30 deaths. The presence of RVD (hazard ratio, 2.86; 95% CI, 1.21-6.75; P = .02) was an independent risk factor associated with all-cause mortality despite many adjustments for potential clinical and echocardiographic confounders such as AV replacement, Society of Thoracic Surgeons Predicted Risk of Mortality score, severity of tricuspid regurgitation, and left ventricular global longitudinal strain. CONCLUSIONS: Baseline RVD is prevalent in patients with low-flow, low-gradient AS undergoing dobutamine stress echocardiography. Quantification of right ventricular systolic function in these complex patients provides important prognostic value and risk stratification adjunctive to Society of Thoracic Surgeons Predicted Risk of Mortality score and should be incorporated into the decision-making process.

Clinical utility of regadenoson for assessing fractional flow reserve.

OBJECTIVES: The aim of this study was to evaluate the efficacy of regadenoson, in comparison with adenosine, for assessing fractional flow reserve (FFR) of intermediate coronary artery stenoses (CAS). BACKGROUND: Fractional flow reserve is an established invasive method for assessing the physiological significance of CAS. Regadenoson, a selective A(2A) receptor agonist, is an approved hyperemic agent for pharmacological stress imaging, but its role for measuring FFR is unknown. METHODS: This prospective, single-center study enrolled 25 consecutive patients with intermediate CAS discovered during elective angiography (25 lesions). In each patient, FFR of the CAS was measured first by IV adenosine (140 µg/kg/min), followed by IV regadenoson (400 µg bolus). The intrapatient FFR correlation between adenosine and regadenoson was evaluated. RESULTS: The mean age was 63 ± 11 years, and mean left ventricular ejection fraction was 58 ± 11%. Most patients were male (52%) and had hypertension (84%) and dyslipidemia (84%), with 24% having diabetes mellitus and 20% chronic obstructive pulmonary disease. The CAS was visually estimated during angiography (mean 58 ± 9%) and most often found in the left anterior descending coronary artery (48%). A strong, linear correlation of FFR was noted with adenosine and regadenoson (r = 0.985, p < 0.001). A hemodynamically significant lesion (FFR ≤ 0.80) was present in 52% with no reclassification of significance between adenosine and regadenoson. No serious events occurred with administration of either drug. CONCLUSIONS: Our results suggest that a single IV bolus of regadenoson is as effective as an intravenous infusion of adenosine for measuring FFR and, given its ease of use, should be considered for FFR measurement in the catheterization laboratory.

Paclitaxel-eluting versus sirolimus-eluting stents in diabetes mellitus: a report from the National Heart, Lung, and Blood Institute Dynamic Registry.

BACKGROUND: Diabetes is a powerful predictor of adverse events in patients undergoing percutaneous coronary intervention. Drug-eluting stents reduce restenosis rates compared with bare metal stents; however, controversy remains regarding which drug-eluting stents provides greater benefit in patients with diabetes. Accordingly, we compared the safety and efficacy of sirolimus-eluting stents (SES) with paclitaxel-eluting stents (PES) among diabetic patients in a contemporary registry. METHODS AND RESULTS: Using the National Heart, Lung, and Blood Institute Dynamic Registry, we evaluated 2-year outcomes of diabetic patients undergoing percutaneous coronary interventions with SES (n=677) and PES (n=328). Clinical and demographic characteristics, including age, body mass index, insulin use, left ventricular function, and aspirin/clopidogrel use postprocedure, did not differ significantly between the groups except that PES-treated patients had a greater frequency of hypertension and hyperlipidemia. At the 2-year follow-up, no significant differences were observed between PES and SES with regard to safety or efficacy end points. PES- and SES-treated patients had similar rates of death (10.7% versus 8.2%, P=0.20), death and myocardial infarction (14.9% versus 13.6%, P=0.55), repeat revascularization (14.8% versus 17.8%, P=0.36), and stent thrombosis (1.3% versus 1.3%, P=0.95). After adjustment, no significant differences between the 2 stent types in any outcome were observed. CONCLUSIONS: PES and SES are equally efficacious and have similar safety profiles in diabetic patients undergoing percutaneous coronary interventions in clinical practice.