Search

Objectives The aim of this study was to report the 2-year results of the SURTAVI (Surgical Replacement and Transcatheter Aortic Valve Implantation) trial and confirm the interim Bayesian analysis. Background Transcatheter aortic valve replacement (TAVR) with a self-expanding valve was noninferior to surgery in patients with severe aortic stenosis and intermediate operative risk using Bayesian statistical methods. Novel Bayesian designs have been used to shorten the time to primary endpoint analysis in randomized clinical trials, although the predictive value of Bayesian analysis compared with frequentist approaches remains debated. Methods The SURTAVI trial randomized 1,660 patients. An interim analysis was performed 1 year after the 1,400th patient was treated to estimate the primary 2-year endpoint of all-cause mortality or disabling strokes for all patients. Results The Kaplan-Meier rate for the complete 2-year primary endpoint was 12.7% in the TAVR group and 12.6% in the surgery group (0.0% difference; 95% confidence interval: −3.4% to 3.5%), compared with 12.6% with TAVR and 14.0% with surgery (−1.4% difference; Bayesian credible interval: −5.2% to 2.3%) in the interim Bayesian analysis. A comparison of individual clinical, hemodynamic, and quality-of-life endpoints using Bayesian and frequentist methods found no significant differences. Conclusions The complete analysis of all patients with aortic stenosis at intermediate risk for surgery in the SURTAVI trial confirmed the noninferiority, with respect to the frequency of all-cause mortality or disabling stroke, of TAVR to surgery, as determined in the interim Bayesian analysis. Follow-up will extend out to 10 years.

Objectives Oral steroids are routinely administered in the United States for prophylaxis of iodinated contrast media hypersensitivity (ICMH). We studied the impact of short-term steroid use in diabetic patients with ICMH undergoing nonemergent coronary angiography. Methods We retrospectively analyzed records of diabetic patients with and without ICMH who underwent nonemergent coronary angiography at our center. Primary study endpoint was 30-day major adverse cardiac events (MACE) and secondary endpoints were pre- and postprocedure fasting blood glucose (FBG), highest in hospital blood glucose, pre- and postprocedure systolic blood pressure (SBP), and use of intravenous insulin and antihypertensive medications. Results A total of 88 diabetics with ICMH (study group) and 76 diabetics without ICMH (control group) undergoing angiography were enrolled. Demographics and hemoglobin A1c values were similar in both groups. Preprocedural FBG was significantly higher in the study group. The study group had significantly higher post angiography FBG (239.93 + 96.88 mg/dl vs. 156.6 + 59.88 mg/dl) and greater use of intravenous (IV) insulin (67.27% vs. 32.43%). Further, those who received steroids had significantly higher systolic SBP postprocedure (146.16 + 25.35 mmHg vs. 130.8 + 21.59 mmHg), a higher incidence of severe hypertension and use of IV antihypertensive medications (80.95% vs. 19.05%) periprocedurally. There were no differences in 30-day MACE between groups. Conclusion Short-term steroid use for ICMH results in a significant increase in surrogate markers for adverse clinical events after coronary procedures. Study findings highlight the need for better periprocedural management of these patients and to limit steroid prophylaxis to those with only true ICMH.

Introduction: Statins have shown mortality benefit in peripheral artery disease (PAD), their impact in end-stage renal disease (ESRD) patients with PAD is not well studied. Hypothesis: Does statin utilization have any impact on mortality in ESRD patients with PAD? Methods: We included ESRD Medicare beneficiaries from the United states Renal Database (Jan 1 st 2006 to May 31 st 2017) with PAD within 6 months of incident dialysis. Medicare part D claims were used to determine STU during the follow-up period. Fractional polynomial regression across varying % of STU was generated to predict 2-year mortality. Results: Out of 45,424 ESRD patients with PAD, 62.3% received no statins while the rest had at least some duration of STU. ST was bimodally distributed, with median utilization of 0% (IQR= 0-90%). Mortality was 41.7% over a median follow-up of 472 days. Univariate association of STU on mortality yielded odds ratio (OR) of 0.99 (95% CI = 0.992-0.993; p Conclusions: Statin utilization in ESRD patients is associated with only borderline statistically significant reduction in mortality (≈0.1%) of unclear clinical implications

Background: An increasing body of evidence suggests that packed red blood cell (PRBC) transfusion may be associated with increased morbidity and mortality after transcatheter and surgical aortic valve replacement. It remains unclear whether PRBC transfusion is a surrogate marker or truly an independent risk factor for mortality after aortic valve replacement in different populations. Methods: The Surgical Replacement and Transcatheter Aortic Valve Implantation (SURTAVI) trial randomized 1660 patients with symptomatic, severe aortic stenosis at intermediate risk for operative death to transcatheter aortic valve replacement or surgical aortic valve replacement. Baseline characteristics and outcomes including all-cause and cardiovascular mortality at 30 days and thereafter were compared between participants with and participants without PRBC transfusion. Cox proportional hazards models with time-varying covariates were fitted to estimate the effect of PRBC transfusion on mortality after adjustment for comorbidities and procedural complications. Results: Patients receiving PRBC were older, more commonly female and frail, with more comorbidities. The Society of Thoracic Surgeons Predicted Risk of Mortality baseline score was higher in the transfused group. After adjustment for these differences, PRBC transfusion was associated with mortality at 30 days, but not thereafter. The effect of PRBC on mortality (hazard ratio 1.04; 95% confidence interval, 0.96 to 1.11; P = .304) at 30 days was not independent of procedural complications (hazard ratio 21.04; 95% CI, 7.26 to 60.95; P < .001). Conclusions: Poor health status, procedural complications, PRBC transfusion, and mortality are correlated with each other. Transfusion of PRBC did not independently increase risk for mortality. In this intermediate-risk population, transfusion appears to be a risk marker of chronic conditions and periprocedural complications as opposed to a risk factor for postprocedural mortality. (Clinical trial registration: www.clinicaltrials.gov NCT01586910.)

Transcatheter aortic valve implantation (TAVI) has comparable outcomes with surgical aortic valve replacement (SAVR) in symptomatic patients with severe aortic stenosis, including those at low risk for surgery. Less is known about TAVI outcomes in asymptomatic patients. This analysis compares clinical, hemodynamic, and quality of life (QOL) outcomes after TAVI or SAVR for low-risk asymptomatic patients. The randomized Evolut Low Risk trial enrolled asymptomatic patients treated with TAVI (n = 76) and SAVR (n = 62). New York Heart Association functional class I identified patients without symptoms. Clinical outcomes, echocardiographic findings, and QOL in both groups were compared 30 days and 12 months after AVR. Asymptomatic patients had a mean Society of Thoracic Surgeons score of 1.7 ± 0.6, 73% were men, and mean age was 74.2 ± 5.8 years. The composite end point of all-cause mortality or disabling stroke was similar at 12 months in patients with TAVI (1.3%) and SAVR (6.5%; p = 0.11), although patients with SAVR tended to have higher rates of all-cause mortality (4.8%) compared with patients with TAVI (0.0%, p = 0.05). Patients with TAVI had lower mean aortic valve gradients (8.1 ± 3.2 mm Hg) and larger mean effective orifice area (2.3 ± 0.6 mm Hg) than patients with SAVR (10.8 ± 3.8; p0.001 and 1.9 ± 0.6; p = 0.001, respectively), and showed significant improvement in Kansas City Cardiomyopathy Questionnaire scores from baseline to 30 days (∆12.1 ± 23.6; p0.001), whereas patients with SAVR did not (∆2.2 ± 20.3; p = 0.398). Patients with TAVI and SAVR had a significant improvement in QOL by 12 months compared with baseline. In conclusion, low risk asymptomatic patients with severe aortic stenosis who underwent TAVI had comparable clinical outcomes to SAVR, with superior valve performance and faster QOL improvement.

Background The CoreValve U.S. Pivotal High Risk Trial was the first randomized trial to show superior 1-year mortality of transcatheter aortic valve replacement (TAVR) compared with surgical aortic valve replacement (SAVR) among high operative mortality–risk patients. Objectives The authors sought to compare TAVR to SAVR for mid-term 5-year outcomes of safety, performance, and durability. Methods Surgical high-risk patients were randomized (1:1) to TAVR with the self-expanding bioprosthesis or SAVR. VARC-1 (Valve Academic Research Consortium I) definitions were applied. Severe hemodynamic structural valve deterioration was defined as a mean gradient ≥40 mm Hg or a change in gradient ≥20 mm Hg or new severe aortic regurgitation. Five-year follow-up was planned. Results A total of 797 patients were randomized at 45 U.S. centers, of whom 750 underwent an attempted implant (TAVR = 391, SAVR = 359). The overall mean age was 83 years, and the STS score was 7.4%. All-cause mortality rates at 5 years were 55.3% for TAVR and 55.4% for SAVR. Subgroup analysis showed no differences in mortality. Major stroke rates were 12.3% for TAVR and 13.2% for SAVR. Mean aortic valve gradients were 7.1 ± 3.6 mm Hg for TAVR and 10.9 ± 5.7 mm Hg for SAVR. No clinically significant valve thrombosis was observed. Freedom from severe SVD was 99.2% for TAVR and 98.3% for SAVR (p = 0.32), and freedom from valve reintervention was 97.0% for TAVR and 98.9% for SAVR (p = 0.04). A permanent pacemaker was implanted in 33.0% of TAVR and 19.8% of SAVR patients at 5 years. Conclusions This study shows similar mid-term survival and stroke rates in high-risk patients following TAVR or SAVR. Severe structural valve deterioration and valve reinterventions were uncommon. (Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement; NCT01240902 )

Introduction: The Emory risk score has been developed to predict new pacemaker implantation in patients undergoing TAVR procedures. There is limited data on assessing risk of early versus late pacemaker implantation in these patients. Hypothesis: The Emory risk score is similar for patients with both early and late pacemaker implantation in TAVR patients. Methods: A single center observational study was performed at our tertiary care center. All patients who underwent pacemaker implantation after TAVR procedures were included. Patients were categorized as early or late if they had pacemaker implantation within the same admission versus implantation post discharge. Standard statistical tests were used for analysis with two-sided p value Results: A total of 97 patients were studied between January 2017 to April 2020. The mean age was 77.5 ± 7 years and females were 41.2%. At baseline patients with early implantation of pacemakers (n=66) had a higher proportion of underlying RBBB (45.2% vs 23.3%, p=0.43), higher valve size as well as a higher incidence of valve oversizing > 146% (43.9 % vs 19.4 %, p =0.23)when compared to patients with late pacemakers(n=31). There was no difference between patient characteristics, baseline comorbidities, pre procedural ECG parameters as well as use of beta blocking agents. Late pacemaker implantations were associated with a overall lower Emory Risk score (1.06±1.41 vs 1.70±1.35, p =0.037). Conclusions: The Emory Risk score is significantly different for early and late pacemaker implantation. Further studies are needed evaluate risk of late pacemaker implantation.

Background Paravalvular regurgitation (PVR) following transcatheter aortic valve replacement (TAVR) is associated with increased morbidity and mortality. PVR continues to plague TAVR jeopardizing long-term results. New device iterations, such as the self-expandable Evolut PRO valve, aim to decrease PVR while maintaining optimal hemodynamics. This study sought to evaluate clinical and hemodynamic performance of the Evolut PRO system at 3 years. Methods The Evolut PRO US Clinical Study included 60 patients at high or extreme surgical risk undergoing TAVR with the Evolut PRO valve at 8 centers in the United States. Clinical outcomes were evaluated using Valve Academic Research Consortium (VARC)-2 criteria and included all-cause mortality, cardiovascular mortality , disabling stroke and valve complications. An independent core laboratory centrally assessed all echocardiographic measures. Results At 3 years, all-cause mortality was 25.8% (cardiovascular mortality 16.5%) and the disabling stroke rate was 10.7%. There were no cases of repeat valve intervention, endocarditis or coronary obstruction . Valve thrombosis was identified in 1 patient 2 years post-procedure and was treated medically. Hemodynamics at 3 years included a mean gradient of 7.2 ± 4.5 mm Hg, an effective orifice area of 2.0 ± 0.5 cm 2 , and 88.2% of patients had no or trace PVR. The remaining patients had mild PVR. Most of the surviving patients (80.6%) had New York Heart Association class I symptoms at 3 years. Conclusion Outcomes at 3-years following TAVR with a contemporary self-expanding prosthesis are favorable, with no signal of valve deterioration , excellent hemodynamics including very low prevalence of PVR.

Introduction: Stroke after transcatheter aortic valve replacement (TAVR) is a significant cause of morbidity and mortality. It increases the risk of mortality threefold, within one year of TAVR. It is also associated with significant disability and increased health care costs. A validated risk prediction tool for stroke one year after TAVR may be useful in risk stratification to guide decisions at the point of clinical care and in research. The objective of this study was to assess the calibration and discriminative ability of the R 2 CHA 2 DS 2 VASc, CHA 2 DS 2 VASc, R 2 CHADS 2 , and CHADS 2 scores for predicting stroke within one year of TAVR. Methods: This was a retrospective cohort study using data from a midwestern academic center TAVR program. Patients who underwent TAVR from 2012 to the first quarter of 2018 who had one-year follow-up data were included in the study. The model discrimination and calibration were assessed using the area under the receiver operating characteristic curve (c-statistic) and the Hosmer-Lemeshow test respectively. Results: Six hundred and sixty four patients met the inclusion criteria and 3.4% had stroke within one year of undergoing TAVR. They had a median age of 81 years and a mean STS score of 6.3. The R 2 CHA 2 DS 2 VASc, CHA 2 DS 2 VASc, R 2 CHADS 2 , and CHADS 2 scores had c-statistics of 0.591, 0.596, 0.607, and 0.622, respectively. The Hosmer-Lemeshow χ 2 p-values were 0.762, 0.422, 0.463 and 0.146 respectively. Conclusion: The CHADS 2 score had the best discriminative ability for stroke prediction one year after TAVR. All the four scores were well calibrated.

Background The ACC/AHA guidelines recommend low-dose dobutamine challenge for hemodynamic assessment of the severity of AS in patients with low flow, low gradient aortic stenosis with reduced ejection fraction (EF) (LFLG-AS; stage D2). Inherent pitfalls of echocardiography could result in inaccurate aortic valve areas (AVA), which have downstream prognostic implications. Data on the safety and efficacy of coronary pressure wire and fluid-filled catheter use for low dose dobutamine infusion is sparse. Methods We retrospectively analyzed 39 consecutive patients with EF on echocardiography who underwent simultaneous right and left heart catheterization . Hemodynamic assessments were performed at baseline and at every increment in the dobutamine infusion rate (The infusion was continued until maximal dose of dobutamine or a mean AV gradient > 40 mm Hg was attained. The occurrence of sustained ventricular arrhythmias , symptomatic hypotension or intolerable symptoms leading to cessation of infusion was recorded. Transient ischemic attacks (TIAs) or clinically apparent strokes periprocedurally or up to 30 days after the procedure were recorded. Results Dobutamine challenge confirmed true AS in 26 patients (67%) and pseudosevere AS in 34%. No sustained arrhythmias, hypotension or cessation of infusion from intolerable symptoms were observed. No clinical strokes or TIAs were observed up to 30 days after procedure in any of these patients. Conclusions Hemodynamic assessment of AS using a pressure wire with dobutamine challenge is a safe and effective tool in identifying truly severe AS in patients with LFLG-AS with reduced EF.

Background This analysis evaluates the relationship of annular size to hemodynamics and the incidence of prosthesis-patient mismatch (PPM) in surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR) patients. Methods The CoreValve US Pivotal High Risk Trial, described previously, compared TAVR using a self-expanding valve with SAVR. Multislice computed tomography was used to categorize TAVR and SAVR subjects according to annular perimeter-derived diameter: large (≥26 mm), medium (23 to Results At all postprocedure visits, mean gradients were significantly lower for TAVR compared with SAVR in small and medium size annuli (p Conclusions Annular size has a significant effect on hemodynamics and the incidence of PPM in SAVR subjects, not observed in TAVR subjects. With respect to annular size, TAVR results in better hemodynamics and less PPM for annuli less than 26 mm and should be strongly considered when choosing a tissue valve for small and medium size annuli.

BACKGROUND Over the last decade, there has been a significant increase in the use of percutaneous left ventricular assist devices(p-LVADs). p-LVADs are being increasingly used during complex coronary interventions and for acute cardiogenic shock. These large bore percutaneous devices have a higher risk of vascular complications. We examined the vascular complication rates from the use of p-LVAD in a national database. METHODS We conducted a secondary analysis of the National In-patient Sample (NIS) dataset from 2005 till 2015. We used the ICD-9-CM procedure codes 37.68 and 37.62 for p-LVAD placement regardless of indications. We investigated common vascular complications, defining them by the validated ICD 9 CM codes. χ2 test and t test were used for categorical and continuous variables, respectively for comparison. RESULTS A total of 31,263 p-LVAD placements were identified during the period studied. A majority of patients were male (72.68%) and 64.44% were white. The overall incidence of vascular complications was 13.53%, out of which 56% required surgical treatment. Acute limb thromboembolism and bleeding requiring transfusion accounted for 27.6% and 21.8% of all vascular complications. Occurrence of a vascular complication was associated with significantly higher in-hospital mortality (37.77% vs. 29.95%, p

In patients with severe aortic stenosis at increased risk for surgery, self-expanding transcatheter aortic valve replacement (TAVR) is associated with improved 2-year survival compared with surgery.This study sought to determine whether this clinical benefit was sustained over time.Patients with severe aortic stenosis deemed at increased risk for surgery by a multidisciplinary heart team were randomized 1:1 to TAVR or open surgical valve replacement (SAVR). Three-year clinical and echocardiographic outcomes were obtained in those patients with an attempted procedure.A total of 797 patients underwent randomization at 45 U.S. centers; 750 patients underwent an attempted procedure. Three-year all-cause mortality or stroke was significantly lower in TAVR patients (37.3% vs. 46.7% in SAVR; p = 0.006). Adverse clinical outcome components were also reduced in TAVR patients compared with SAVR patients, including all-cause mortality (32.9% vs. 39.1%, respectively; p = 0.068), all stroke (12.6% vs. 19.0%, respectively; p = 0.034), and major adverse cardiovascular or cerebrovascular events (40.2% vs. 47.9%, respectively; p = 0.025). At 3 years aortic valve hemodynamics were better with TAVR patients (mean aortic valve gradient 7.62 ± 3.57 mm Hg vs. 11.40 ± 6.81 mm Hg in SAVR; p0.001), although moderate or severe residual aortic regurgitation was higher in TAVR patients (6.8% vs. 0.0% in SAVR; p0.001). There was no clinical evidence of valve thrombosis in either group.Patients with severe aortic stenosis at increased risk for surgery had improved 3-year clinical outcomes after TAVR compared with surgery. Aortic valve hemodynamics were more favorable in TAVR patients without differences in structural valve deterioration. (Safety and Efficacy Study of the Medtronic CoreValve(®) System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement; NCT01240902).

Stroke after transcatheter aortic valve replacement (TAVR) increases the risk of 1-year mortality 3-fold. A tool for predicting 1-year stroke after TAVR is lacking. The purpose of this study was to develop a new risk score for predicting 1-year stroke after TAVR and compare its performance with

OBJECTIVES To assess the prognostic significance of high vs. low grade coronary artery ectasia (CAE) and the impact of antithrombotic or anticoagulant therapy on adverse cardiac outcomes. BACKGROUND There is paucity of knowledge on the impact of angiographic characteristics in CAE or that of antithrombotic or anticoagulant therapy on outcomes. METHODS AND RESULTS In this retrospective study, we reviewed angiograms and medical records of all cases of confirmed CAE (2001-2011). Extent of CAE was categorized using the Markis classification. Types 1 and 2 were categorized as high-grade and types 3 and 4 as low-grade CAE. Angiographic flow was recorded as normal or sluggish (

Objectives This study sought to compare the health status outcomes for patients treated with either self-expanding transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (AVR). Background In patients at increased surgical risk, TAVR with a self-expanding bioprosthesis is associated with improved 1-year survival compared with AVR. However, elderly patients may be just as concerned with quality-of-life improvement as with prolonged survival as a goal of treatment. Methods Between 2011 and 2012, 795 patients with severe aortic stenosis at increased surgical risk were randomized to TAVR or AVR in the CoreValve US Pivotal Trial. Health status was assessed at baseline, 1 month, 6 months, and 1 year using the Kansas City Cardiomyopathy Questionnaire, Medical Outcomes Study Short-Form 12 Questionnaire, and EuroQOL 5-dimension questionnaire; growth curve models were used to examine changes over time. Results Over the 1-year follow-up period, disease-specific and generic health status improved substantially for both treatment groups. At 1 month, there was a significant interaction between the benefit of TAVR over AVR and access site. Among surviving patients eligible for iliofemoral (IF) access, there was a clinically relevant early benefit with TAVR across all disease-specific and generic health status measures. Among the non-IF cohort, however, most health status measures were similar for TAVR and AVR, although there was a trend toward early benefit with TAVR on the Short-Form 12 Questionnaire’s physical health scale. There were no consistent differences in health status between TAVR and AVR at the later time points. Conclusions Health status improved substantially in surviving patients with increased surgical risk who were treated with either self-expanding TAVR or AVR. TAVR via the IF route was associated with better early health status compared with AVR, but there was no early health status benefit with non-IF TAVR compared with AVR. (Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement; NCT01240902 )

Objectives This study sought to evaluate the Medtronic Evolut PRO Transcatheter Aortic Valve System in patients with severe symptomatic aortic stenosis. Background A next-generation self-expanding transcatheter aortic valve was designed with an external pericardial wrap with the intent to reduce paravalvular leak while maintaining the benefits of a low-profile, self-expanding, and repositionable supra-annular valve. Methods The Medtronic Evolut PRO Clinical Study included 60 patients undergoing transcatheter aortic valve replacement with the Evolut PRO valve at 8 investigational sites in the United States. Clinical outcomes at 30 days were evaluated using Valve Academic Research Consortium-2 criteria. The 2 primary safety endpoints were the incidence of all-cause mortality at 30 days and the incidence of disabling stroke at 30 days. The primary efficacy endpoint was the proportion of patients with no or trace prosthetic valve regurgitation at 30 days. An independent echocardiographic core laboratory (Mayo Clinic, Rochester, Minnesota) was used to adjudicate all echocardiographic assessments. Results All 60 patients received the Evolut PRO valve. At 30 days, 1 patient (1.7%) died and 1 patient (1.7%) experienced a nonfatal disabling stroke. Paravalvular regurgitation at 30 days was absent or trace in 72.4% of patients and was mild in the remainder of patients, with no patients having worse than mild paravavlular leak. The mean atrioventricular gradient was 6.4 ± 2.1 mm Hg and effective orifice area was 2.0 ± 0.5 cm2 at 30 days. Conclusions The safety and efficacy results of this study support the use of the Evolut PRO System for the treatment of severe symptomatic aortic stenosis in patients who are at increased surgical risk, resulting in excellent hemodynamics and minimal paravalvular leak (The Medtronic TAVR 2.0 US Clinical Study; NCT02738853)

Percutaneous coronary intervention (PCI) followed by transcatheter aortic valve replacement (TAVR) is an alternative to surgery in patients with severe aortic stenosis (AS) and coronary artery disease (CAD). In many, the coronary arteries are severely calcified and best treated with rotational atherectomy (RA). However, RA is not routinely performed in severe AS patients due to safety concerns. There is a paucity of data on the safety of RA in severe AS patients with calcific CAD.We retrospectively analyzed the medical records of 29 patients with severe AS who underwent elective RA-facilitated PCI at our center between January 1, 2011 and December 31, 2015.Twenty-nine patients (mean age, 79.8 ± 8.8 years) were enrolled. Mean aortic valve area was 0.71 ± 0.20 cm², mean aortic valve gradient was 40.32 ± 9.88 mm Hg. All PCIs were successful (mean diameter stenosis, 86.3 ± 7.6%; mean burr size, 1.62 ± 0.19 mm). Nineteen patients (65.5%) required temporary pacemaker. Eight patients (27.6%) required vasopressors during PCI. There was a significant reduction in systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), and heart rate (HR) during RA, but without clinical events. No procedure was aborted and there were no deaths or clinical myocardial infarctions.RA-facilitated PCI can be safely performed in elderly patients with severe AS and severely calcified CAD with low risk of complications. There was a significant but transient drop in SBP, DBP, MAP, and HR during RA. However, this was not associated with clinically significant adverse events.

Ankle-brachial index (ABI) is conventionally derived as the ratio of higher of the 2 systolic ankle blood pressures to the higher brachial pressure (HABI method). Alternatively, ABI may be derived using the lower of the 2 systolic ankle pressures (LABI method). The objective of this study was to assess the utility and difference between 2 techniques in predicting peripheral artery disease (PAD). Participants who underwent both ABI measurement and arteriography from July 2005 to June 2010 were reviewed. Angiographic disease burden was scored semiquantitatively (0=50%, 1=50% to 75%, and 2=75% stenosis of any lower extremity arterial segment), and PAD by angiography was defined as50% stenosis of any 1 lower extremity arterial segment. A combined PAD disease score was calculated for each leg. A total of 130 patients were enrolled (260 limbs). The ABI was0.9 (abnormal) in 68% of patients by HABI method and in 84% by LABI. LABI method had higher sensitivity and overall accuracy to detect PAD compared with the HABI method. Regression analysis showed that an abnormal ABI detected by LABI method is more likely to predict angiographic PAD and total PAD burden compared with HABI. Moreover, abnormal ABI by LABI method had higher sensitivity and accuracy to detect PAD in patients with diabetes and below knee PAD compared with the HABI method. In conclusion, ABI determined by the LABI method has higher sensitivity and is a better predictor of PAD compared with the conventional (HABI) method.

BACKGROUND We compared transcatheter aortic-valve replacement (TAVR), using a self-expanding transcatheter aortic-valve bioprosthesis, with surgical aortic-valve replacement in patients with severe aortic stenosis and an increased risk of death during surgery. METHODS We recruited patients with severe aortic stenosis who were at increased surgical risk as determined by the heart team at each study center. Risk assessment included the Society of Thoracic Surgeons Predictor Risk of Mortality estimate and consideration of other key risk factors. Eligible patients were randomly assigned in a 1:1 ratio to TAVR with the self-expanding transcatheter valve (TAVR group) or to surgical aortic-valve replacement (surgical group). The primary end point was the rate of death from any cause at 1 year, evaluated with the use of both noninferiority and superiority testing. RESULTS A total of 795 patients underwent randomization at 45 centers in the United States. In the as-treated analysis, the rate of death from any cause at 1 year was significantly lower in the TAVR group than in the surgical group (14.2% vs. 19.1%), with an absolute reduction in risk of 4.9 percentage points (upper boundary of the 95% confidence interval, −0.4; P

Background— The risk for stroke after transcatheter aortic valve replacement (TAVR) is an important concern. Identification of predictors for stroke is likely to be a critical factor aiding patient selection and management as TAVR use becomes widespread. Methods and Results— Patients enrolled in the CoreValve US Extreme Risk and High Risk Pivotal Trials or Continued Access Study treated with the self-expanding CoreValve bioprosthesis were included in this analysis. The 1-year stroke rate after TAVR was 8.4%. Analysis of the stroke hazard rate identified an early phase (0–10 days; 4.1% of strokes) and a late phase (11–365 days; 4.3% of strokes). Baseline predictors of early stroke included National Institutes of Health stroke scale score >0, prior stroke, prior transient ischemic attack, peripheral vascular disease, absence of prior coronary artery bypass surgery, angina, low body mass index (2 ), and falls within the past 6 months. Significant procedural predictors were total time in the catheterization laboratory or operating room, delivery catheter in the body time, rapid pacing used during valvuloplasty, and repositioning of the prosthesis. Predictors of stroke between 11 and 365 days were small body surface area, severe aortic calcification, and falls within the past 6 months. There were no significant imaging predictors of early or late stroke. Conclusions— Predictors of early stroke after TAVR included clinical and procedural factors; predictors of later stroke were limited to patient but not anatomic characteristics. These findings indicate that further refinement of imaging to identify anatomic factors predisposing to embolization may help improve stroke prediction in patients undergoing TAVR. Clinical Trial Registrations— URL: http://www.clinicaltrials.gov . Unique identifiers: NCT01240902, NCT01531374.

Transcatheter aortic valve replacement (TAVR) is now a well-accepted alternative to surgical AVR (SAVR) for patients with symptomatic aortic stenosis at increased operative risk. There is interest in whether TAVR would benefit patients at lower risk.The Society of Thoracic Surgeons Predicted Risk of Mortality (STS PROM) has trended downward in US TAVR trials and the STS/American College of Cardiology Transcatheter Valve Therapy Registry. We hypothesized that if the Society of Thoracic Surgeons Predicted Risk of Mortality (STS PROM) alone is sufficient to define decreased risk, the contribution to survival based on the degree of invasiveness of the TAVR procedure will decrease, making it more difficult to show improved survival and benefit over SAVR.The CoreValve US Pivotal High Risk Trial was a multicenter, randomized, noninferiority trial. This retrospective analysis evaluated patients who underwent an attempted implant and had an STS PROM of 7% or less. The trial was performed at 45 US sites. Patients had severe aortic stenosis and were at increased surgical risk based on their STS PROM score and other risk factors.Eligible patients were randomly assigned (1:1) to self-expanding TAVR or to SAVR.We retrospectively stratified patients by the overall median STS PROM score (7%) and analyzed clinical outcomes and quality of life using the Kansas City Cardiomyopathy Questionnaire in patients with an STS PROM score of 7% or less.The mean (SD) ages were 81.5 (7.6) years for the TAVR group and 81.2 years (6.6) for the SAVR group. A little more than half were men (57.9% in the TAVR group and 55.8% in the SAVR group). Of 750 patients who underwent attempted implantation, 383 (202 TAVR and 181 SAVR) had an STS PROM of 7% or less (median [interquartile range]: TAVR, 5.3% [4.3%-6.1%]; SAVR, 5.3% [4.1%-5.9%]). Two-year all-cause mortality for TAVR vs SAVR was 15.0% (95% CI, 8.9-10.0) vs 26.3% (95% CI, 19.7-33.0) (log rank P = .01). The 2-year rate of stroke for TAVR vs SAVR was 11.3% vs 15.1% (log rank P = .50). Quality of life by the Kansas City Cardiomyopathy Questionnaire summary score showed significant and equivalent increases in both groups at 2 years (mean [SD] TAVR, 20.0 [25.0]; SAVR, 18.6 [23.6]; P = .71; both P .001 compared with baseline). Medical benefit, defined as alive with a Kansas City Cardiomyopathy Questionnaire summary score of at least 60 and a less than 10-point decrease from baseline, was similar between groups at 2 years (TAVR, 51.0%; SAVR, 44.4%; P = .28).Self-expanding TAVR compares favorably with SAVR in high-risk patients with STS PROM scores traditionally considered intermediate risk.Clinicaltrials.gov Identifier: NCT01240902.

This study assessed the safety of intravenous adenosine infusion during fractional flow reserve (FFR) evaluation of intermediate coronary lesions in severe aortic stenosis (AS). In severe AS, the extent of underlying coronary artery disease (CAD) can be an important determinant for deciding between surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR). Hemodynamic assessment of coronary lesion severity using FFR may reduce the extent of revascularization needed and make TAVR more feasible in higher-risk patients (compared with coronary artery bypass surgery with SAVR).We retrospectively analyzed the demographic, clinical, and hemodynamic parameters of 72 patients with severe AS who underwent FFR procedure with intravenous adenosine infusion for hemodynamic assessment of intermediate coronary artery lesions. Severe AS patients were elderly, predominantly male, and had a high prevalence of peripheral arterial disease, prior myocardial infarction, left ventricular hypertrophy, and chronic kidney disease. Mean aortic valve area in these patients was 0.71 ± 0.24 cm². No patient with severe AS required discontinuation of the adenosine and all patients tolerated the infusion well. We observed a statistically significant reduction in systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), and heart rate (HR) during adenosine infusion compared with the baseline values. However, no clinically significant adverse events occurred.In elderly patients with severe AS, adenosine infusion is safe and well tolerated during FFR evaluation of intermediate coronary lesions. There was a significantly greater drop in SBP, DBP, MAP, and HR with adenosine infusion as compared with baseline values. This, however, was not associated with clinically significant adverse events.

Usually 25% of the myocardium is replaced by amyloid deposition for symptoms to appear with congestive heart failure being the most common presentation of cardiac amyloidosis. In the clinical workup of patients with diastolic heart failure and myocardial hypertrophy, cardiac amyloidosis is an important differential diagnosis. Once congestive heart failure occurs, the median survival is less than six months in untreated patients, and is the most common cause of death. 2

Steroid prophylaxis prior to coronary angiography is routine in patients with contrast allergy (CA). We aimed to assess the impact of steroid use in diabetic patients with CA undergoing elective angiography. We retrospectively analyzed records of diabetics with and without CA who underwent

The effect of dual antiplatelet therapy (DAPT) or oral anticoagulation on long term incidence of acute coronary syndromes (ACS) in patients with coronary artery ectasia (CAE) and no significant occlusive CAD is not well known. We retrospectively analyzed 317 consecutive cases of CAE. CAE patients

Though percutaneous closure of atrial septal defect (ASD) or patent foramen (PFO) has been available for several years, it has remained controversial due to lack of strong outcomes data and lack of uniform acceptance by the neurology community. We sought to determine nationwide trends in the use of

An intracameral or intracavitary course for a coronary artery is a rare anomaly. Nevertheless, it carries a significant impact for invasive cardiac procedures that require right atrial catheterization, pacemaker implantation, or electrophysiologic study such as radiofrequency ablation. If a coronary artery were to be damaged within the atrial chamber by catheter manipulation at the time of heart catheterization, serious complications might ensue. We describe the first reported case of an intracameral right coronary artery identified with multidetector 64-slice coronary computed tomographic angiography performed prior to pulmonary venous antral isolation for atrial fibrillation.

Oral anticoagulation (OAC) is essential in patients with atrial fibrillation (AF). Interestingly coronary artery disease coexists in 20-30% of these patients.[1,2] Balancing the risk of bleeding and thromboembolism is very important for the management of patients on OAC, especially than when such patients require percutaneous coronary intervention (PCI). Lack of data and clear societal guidelines for peri-procedural and post-procedural management of anticoagulated patients has resulted in diverse clinical practices among clinicians, hospitals, and countries. Furthermore with expanding number of available oral antiplatelet and anticoagulant agents, the uncertainty regarding optimal combination therapy in this growing pool of the patients with overlapping clinical indications is also growing. Given the high proportion of patients with atherothrombosis and requiring OAC for conditions particularly like AF, it is important that physicians are aware of the clinical implications and management of these overlapping syndromes. In this article we discuss; this evolving dilemma of peri-procedural and post-procedural management of anticoagulated patient's, burden of the disease, available data, risk factors that could identify high risk patients and propose a well-balanced management strategy.

Background: Current guidelines discourage aortic stenosis (AS) evaluation by direct pressure measurement if echocardiography (echo) is adequate. However several studies show sizable differences between echo and catheterization (cath) lab measurements. Dobutamine Challenge is recommended for

Background: Clinical presentation, natural history of coronary artery ectasia (CAE) and prognostic implications of its anatomic classification of are not well known. Methods: We retrospectively analyzed 376 consecutive cases of CAE and angiographically categorized them using the Markis

Background: Percutaneous coronary intervention (PCI) followed by transcatheter valve replacement is an alternative for patients with severe aortic stenosis (SAS) and coronary artery disease (CAD). In many, the coronaries are calcific and best treated with rotational or orbital atherectomy (RA or OA

Background: Current guidelines discourage aortic stenosis (AS) evaluation by direct pressure measurement if echocardiography (echo) is adequate. However several studies show sizable discrepancies between echo and catheterization (cath) lab measurements. We wanted to investigate the impact of both

Current guidelines discourage aortic stenosis (AS) evaluation by direct pressure measurement if echocardiography (echo) is adequate. However several studies show sizable differences between echo and catheterization (cath) lab measurements. Low flow/ low gradient (LF/LG) severe aortic stenosis (AS)

A 72-year-old male with a previous medical history consistent with chronic systolic heart failure presented for frequent episodes of generalized fatigue and shortness of air for the past week. The patient noted that his symptoms started a few days after he began a new anti-fungal medication. The initial echocardiogram is shown below.