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Low ejection fraction (EF) and low flow as determined by an echocardiographic stroke volume index (SVi) <35 mL/m2 are associated with low transvalvular gradients and increased mortality in both severe aortic stenosis (AS) and post–transcatheter aortic valve replacement (TAVR). Absence of an elevated echocardiographic transaortic gradient post-TAVR is considered a marker of procedural success despite the absence of data on its impact on mortality. The authors sought to examine the association of invasive and echocardiographic gradients post-TAVR with all-cause mortality in relation to flow and EF. In a multicenter retrospective registry of patients undergoing TAVR, Cox models with regression splines explored the relationship between invasive and echocardiographic gradients post-TAVR with 2-year mortality. An invasive gradient <5 mm Hg was considered low, between ≥5 and <10 mm Hg was considered intermediate, and ≥10 mm Hg was considered high. An echocardiographic gradient <10 mm Hg was considered low, ≥10 and <20 mm Hg was considered intermediate, and ≥20 mm Hg was considered high. Higher mortality occurred in low echocardiographic gradients at discharge relative to intermediate gradients (P < 0.001), and low gradient was associated with lower EF and echocardiographic SVi (P < 0.001 and P < 0.008, respectively). Lower mortality occurred in low invasive gradients relative to intermediate gradients (P = 0.012) with no difference in EF and echocardiographic SVi between groups (P = 0.089 and P = 0.947, respectively). There were insufficient observations to determine the impact of high echocardiographic and invasive gradients on mortality. In this large retrospective analysis, the impact of transaortic gradients on mortality after TAVR was not linear and complex, showing opposite results among echocardiographic and invasive measurements in low-gradient patients. [Display omitted] [ABSTRACT FROM AUTHOR]

The cardiovascular and renal systems share an intimate physiological relationship, wherein a perturbance in one system may have an adverse effect on the other. Since the burden of renal disease increases with age, there is a considerable interest in the pathophysiology of kidney disease in the geriatric patient population. This review will explore the physiological dynamics behind the increased susceptibility to kidney disease in this population. A better understanding of these pathophysiological changes may lead to improved prevention and management strategies. [ABSTRACT FROM AUTHOR]

The Amulet IDE Trial is an ongoing, prospective, randomized, multi-national trial, designed to evaluate the safety and effectiveness of the AMPLATZER Amulet Left Atrial Appendage Occluder for stroke prevention in comparison to the WATCHMAN Left Atrial Appendage Closure Device in patients with non-valvular atrial fibrillation. METHODS: Non-valvular atrial fibrillation patients at high risk of stroke (CHADS2 score ≥2 or a CHA2DS2-VASc score of ≥3) who are suitable candidates for left atrial appendage occlusion (LAAO) will be fully informed and requested to participate in the trial. A total of 1878 patients at up to 150 sites worldwide will be randomized in a 1:1 ratio between the AMPLATZER Amulet device (investigational) and the Boston Scientific WATCHMAN device (control). Each patient will be followed for 5 years, with follow-up assessments at discharge, 45 days, 3, 6, 9, 12, 18, and 24 months and then annually. The trial has three primary endpoints: A composite of procedure-related complications, or all-cause death, or major bleeding through 12 months (safety); a composite of ischemic stroke or systemic embolism through 18 months (effectiveness); and effective device LAAO, defined as residual jet around the device ≤5 mm at the 45-day visit (mechanism of action). SUMMARY: The Amulet IDE Trial is the first randomized head-to-head LAAO device trial and will provide data for the AMPLATZER Amulet occluder in a population with a high risk of stroke and bleeding. [ABSTRACT FROM AUTHOR]

Background: The Impella percutaneous ventricular assist device (PVAD) rapidly deploys mechanical circulatory support (MCS) in patients with acute myocardial infarction complicated by cardiogenic shock (AMICS). We present findings from a quality improvement (IQ) registry for US patients with AMICS who received Impella devices.Methods and Results: From January 2009 to December 2016, 46,949 patients from 1010US hospitals were entered into the IQ registry; of these, 15,259 had AMICS. Limited de-identified patient information, product performance, and survival to explantation were recorded. Of those with AMICS, 51% survived to explantation of PVAD. There was a significant difference between survival at explantation with quintile volume at hospitals (range: 0-100%; 30% survival rate in lowest quintile vs. 76% in top quintile; P<.0001). Use of the Impella device as first-line treatment pre-PCI was associated with a 59% survival rate, compared with 52% when used as a salvage strategy (P<.001). The survival rate among those who received hemodynamic monitoring with pulmonary artery catheters was 63% as compared with 49% in those who did not (P<.0001). Overall institutional Impella volume was related to survival (56% survival at sites with >7/year vs. 51% at sites with ≤1; P<.001).Conclusions: In this early clinical experience with Impella support for AMICS, wide variation in outcomes existed across centers. Survival was higher when Impella was used as first support strategy, when invasive hemodynamic monitoring was used, and at centers with higher Impella implantation volume. [ABSTRACT FROM AUTHOR]

Objectives Patients with symptomatic severe aortic stenosis and severe mitral regurgitation or severe tricuspid regurgitation were excluded from the major transcatheter aortic valve replacement trials. We studied these 2 subgroups in patients at extreme risk for surgery in the prospective, nonrandomized, single-arm CoreValve US Expanded Use Study. Methods The primary end point was all-cause mortality or major stroke at 1 year. A favorable medical benefit was defined as a Kansas City Cardiomyopathy Questionnaire overall summary score greater than 45 at 6 months and greater than 60 at 1 year and with a less than 10-point decrease from baseline. Results There were 53 patients in each group. Baseline characteristics for the severe mitral regurgitation and severe tricuspid regurgitation cohorts were age 84.2 ± 6.4 years and 84.9 ± 6.5 years; male, 29 (54.7%) and 22 (41.5%), and mean Society of Thoracic Surgeons score 9.9% ± 5.0% and 9.2% ± 4.0%, respectively. Improvement in valve regurgitation from baseline to 1 year occurred in 72.7% of the patients with severe mitral regurgitation and in 61.8% of patients with severe tricuspid regurgitation. A favorable medical benefit occurred in 31 of 47 patients (66.0%) with severe mitral regurgitation and 33 of 47 patients (70.2%) with severe tricuspid regurgitation at 6 months, and in 25 of 44 patients (56.8%) with severe mitral regurgitation and 24 of 45 patients (53.3%) with severe tricuspid regurgitation at 1 year. All-cause mortality or major stroke for the severe mitral regurgitation and severe tricuspid regurgitation cohorts were 11.3% and 3.8% at 30 days and 21.0% and 19.2% at 1 year, respectively. There were no major strokes in either group at 1 year. Conclusions Transcatheter aortic valve replacement in patients with severe mitral regurgitation or severe tricuspid regurgitation is reasonable and safe and leads to improvement in atrioventricular valve regurgitation. [ABSTRACT FROM AUTHOR]

Management of patients requiring temporary, mechanical hemodynamic support during high- risk percutaneous coronary intervention (PCI) or in cardiogenic shock is rapidly evolving. With the availability of the Impella 2.5, CP, 5.0, LD, and RP percutaneous mechanical circulatory support devices, there is a need for continued surveillance of outcomes. Three factors underline the importance of a registry for these populations. First, large randomized trials of hemodynamic support, involving cardiogenic shock, are challenging to conduct. Second, there is increasing interest in the use of registries to provide "real-world" experience and to allow the flexibility to evaluate individual patient uses and outcomes. Third, current, large databases have not captured the specific impact of mechanical support treatment of cardiogenic shock. The predecessor to the catheter-based ventricular assist devices registry, known as USpella, began in 2009 with paper data acquisition but beginning in 2011 transferred to electronic data capture, enrolling 3,339 patients through 2016. Throughout, registry data have been used to assess the outcomes of Impella therapy, leading to 8 publications and 4 Food and Drug Administration premarket approvals covering multiple indications and Impella devices. Going forward, the registry will continue to assess not only in-hospital outcomes but long-term follow-up to 1 year. In addition, data management will be enhanced to assess quality and clinical experiences. The registry will also provide a mechanism for postmarketing surveillance. This manuscript reviews the ongoing catheter-based ventricular assist devices registry design, management, and contributions of the registry data. The upgraded registry will provide a more robust opportunity to assess acute and late outcomes of current and future device use worldwide.Condensed Abstract: The current catheter-based ventricular assist devices registry is an international database documenting outcomes with temporary Impella hemodynamic support. The registry has supported 8 publications and 4 Food and Drug Administration premarket approvals since its inception in 2009. The current registry is more robust containing outcomes up to 1 year postprocedure. [ABSTRACT FROM AUTHOR]

Objectives: To assess post-procedural outcomes when Impella 2.5 percutaneous left ventricular assist device (pLVAD) support is initiated either prior to or after percutaneous coronary intervention (PCI) on unprotected left main coronary artery (ULMCA) culprit lesion in the context of acute myocardial infarction cardiogenic shock (AMICS).Background: Initiation of Impella 2.5 pLVAD prior to PCI is associated with significant survival benefit in the setting of AMICS. Outcomes of those presenting with a ULMCA culprit lesion in this setting have not been well characterized.Methods: Thirty-six consecutive patients in the cVAD Registry supported with Impella 2.5 pLVAD for AMICS who underwent PCI on ULMCA culprit lesion were included in our multicenter study.Results: The average age was 69.8 ± 14.2 years, 77.8% were male, 72.7% were in CS at admission, 44.4% sustained one or multiple cardiac arrests, and 30.6% had anoxic brain injury. Baseline characteristics were comparable between the Pre-PCI group (n = 20) and Post-PCI group (n = 16). Non-ST segment elevation myocardial infarction and greater coronary disease burden were significantly more frequent in the Pre-PCI group but they had significantly better survival to discharge (55.0% vs 18.8%, P = 0.041). Kaplan-Meier 30-day survival analysis showed very poor survival in Post-PCI group (48.1% vs 12.5%, Log-Rank P = 0.004).Conclusions: Initiation of Impella 2.5 pLVAD prior to as compared with after PCI of ULMCA for AMICS culprit lesion is associated with significant early survival. As previously described, patients supported after PCI appear to have very poor survival at 30 days. [ABSTRACT FROM AUTHOR]

Background End-stage renal disease (ESRD) poses unique challenges in the treatment of patients with severe aortic stenosis. Although surgical valve replacement in ESRD patients has been associated with increased mortality, the outcomes from transcatheter aortic valve replacement (TAVR) are not clearly defined. Methods The CoreValve US Expanded Use Study is a prospective, nonrandomized study of TAVR in extreme-risk patients with comorbidities excluding them from the Pivotal Trial. We report on patients with ESRD. The primary endpoint was a composite of all-cause mortality or major stroke at 1 year. Results Ninety-six patients with ESRD underwent TAVR with the CoreValve (Medtronic, Minneapolis, MN) and have reached 1-year follow-up. Mean Society of Thoracic Surgeons Predicted Risk of Mortality score was 16.2% ± 8.4%. The rate of all-cause mortality or major stroke at 1 year was 30.3%. The all-cause mortality rate was 5.3% at 30 days and 30.3% at 1 year. The rate at 1 year of any stroke or transient ischemic attack was 2.1%; major vascular injury was 5.2%; and new permanent pacemaker was 26.8%. Valve performance improved postprocedure and remained improved at 1 year (effective orifice area 1.71 cm 2 , mean gradient 9.33 mm Hg) Conclusions Early mortality in patients with ESRD is comparable to previously published data on extreme-risk patients without ESRD, but our data suggest a higher mortality rate at 1 year for ESRD patients, likely due to comorbid conditions. Stroke and major vascular injury are infrequent, and improved valve hemodynamics are maintained at 1 year. [ABSTRACT FROM AUTHOR]

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 (<21 kg/m²), 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. [ABSTRACT FROM AUTHOR]

Background--Multidetector computed tomography is useful for determining the appropriate transcatheter heart valve (THV) size in patients with severe aortic stenosis who are suboptimal surgical candidates. The relationship between adherence to the recommended CoreValve sizing algorithm and clinical outcomes is not known. Methods and Results--We evaluated 1023 patients with severe aortic stenosis deemed high or extreme risk for surgery treated with the CoreValve THV. All patients underwent preprocedural multidetector computed tomography, and the scans were reviewed at a central analysis center using standardized software. Compliance to a recommended sizing algorithm was used to identify patients with below-range, in-range, and above-range THV sizing. A device annular sizing ratio (DAR) was also calculated based on the native annulus perimeter and perimeter of the selected THV. Clinical end points included the presence of paravalvular aortic regurgitation evaluated by an independent echocardiographic laboratory. Adherence to the sizing algorithm was highest with a 31-mm THV (92.6%) and lowest with the 23-mm THV (38.5%). Below-range sizing was associated with a higher rate of moderate or severe paravalvular aortic regurgitation (15.3%) than in-range (6.5%) or above-range (10.0%; P<0.001) sizing. Higher DARs were associated with lower rates of moderate or severe paravalvular aortic regurgitation: DAR ≤10%, 17.6%; DAR 10% to 15%, 9.9%; DAR 15% to 20%, 6.3%; and DAR >20%, 4.9%; P<0.001. There was no increase in clinical events associated with higher DARs. Conclusions--Adherence to a sizing algorithm guided by multidetector computed tomography resulted in lower rates of paravalvular aortic regurgitation after self-expanding transcatheter valve replacement without an increase in complications. [ABSTRACT FROM AUTHOR]

Objectives To evaluate the periprocedural characteristics and outcomes of patients supported with Impella 2.5 prior to percutaneous coronary intervention (pre-PCI) versus those who received it after PCI (post-PCI) in the setting of cardiogenic shock (CS) complicating an acute myocardial infarction (AMI). Background Early mechanical circulatory support may improve outcome in the setting of CS complicating an AMI. However, the optimal timing to initiate hemodynamic support has not been well characterized. Methods Data from 154 consecutive patients who underwent PCI and Impella 2.5 support from 38 US hospitals participating in the USpella Registry were included in our study. The primary end-point was survival to discharge. Secondary end-points included assessment of patients' hemodynamics and in-hospital complications. A multivariate regression model was used to identify independent predictors for mortality. Results Both groups were comparable except for diabetes (P = 0.02), peripheral vascular disease (P = 0.008), chronic obstructive pulmonary disease (P = 0.05), and prior stroke (P = 0.04), all of which were more prevalent in the pre-PCI group. Patients in the pre-PCI group had more lesions (P = 0.006) and vessels (P = 0.01) treated. These patients had also significantly better survival to discharge compared to patients in the post-PCI group (65.1% vs.40.7%, P = 0.003). Survival remained favorable for the pre-PCI group after adjusting for potential confounding variables. Initiation of support prior to PCI with Impella 2.5 was an independent predictor of in-hospital survival (Odds ratio 0.37, 95% confidence interval: 0.17-0.79, P = 0.01) in multivariate analysis. The incidence of in-hospital complications included in the secondary end-point was similar between the 2 groups. Conclusions The results of our study suggest that early initiation of hemodynamic support prior to PCI with Impella 2.5 is associated with more complete revascularization and improved survival in the setting of refractory CS complicating an AMI. (J Interven Cardiol 2014;27:1-11) [ABSTRACT FROM AUTHOR]

Background: The economic burden of heart disease is heavy and growing. As advanced technologies for treating heart disease become available, decision makers need to be able to assess the relative value of such options against existing standards of care. Objectives: To compare the clinical and economic benefits of a percutaneous ventricular assist device (pVAD) versus an intra-aortic balloon pump (IABP) observed during the 90-day duration of the PROTECT II clinical trial, and to supplement these findings with a simulation of the longer-term value of this technology through the use of a Markov model to estimate the incremental cost-effectiveness of a pVAD relative to an IABP, in terms of quality-adjusted life-years (QALYs). Methods: Hospital bills were collected for patients enrolled in the PROTECT II trial who received hemodynamic support for high-risk percutaneous coronary intervention (PCI) provided by a pVAD (Impella 2.5) versus a conventional IABP during a 90-day episode of care (EOC). Length of stay, charges, and costs were analyzed for the index admissions, intensive care unit confinements, readmissions, and overall EOC. In addition, a probabilistic Markov model was used to project these parameters and their impact on a patient's quality of life for up to 10 years in relation to a pVAD versus an IABP. Results: Hospital costs for the index admission were lower for the IABP compared with the pVAD ($33,684 vs $47,667; P <.001), whereas readmission length of stay and costs were lower for the pVAD versus the IABP (5 days vs 7 days; and $11,007 vs $21,834, respectively; P <.001). The total 90-day hospital charges were similar for the pVAD and the IABP ($172,564 vs $172,758, respectively; P = .785); however, the total 90-day EOC cost was lower for the IABP than for the pVAD ($44,032 vs $53,171, respectively; P <.001). The median hospital days for the entire EOC were 7 days for the pVAD versus 9 days for the IABP (P = .008). Critical care stays were considerably shorter for a pVAD than for an IABP on readmissions (3.88 days vs 7.00 days; P = .145). Reduction in major adverse cardiovascular and cerebrovascular events resulted in a projected gain of 0.26 QALYs over 10 years, yielding an incremental cost-effectiveness ratio of $39,389/QALY. Conclusions: For high-risk patients with advanced heart failure undergoing PCI, the new pVAD reduced major adverse events, critical care and readmission length of stay, and readmission cost over the 90-day EOC, and was determined to be cost-effective over the long-term. These findings can assist decision makers in forming value-based judgments with regard to new hemodynamic support strategies. [ABSTRACT FROM AUTHOR]

Contrast-induced acute kidney injury (CI-AKI) is an important consideration in patients undergoing cardiac catheterization. There has been a continuous strive to decrease morbidity and improve procedural safety. This review will address the pathophysiology, predictors, and clinical management of CI-AKI with a concise overview of the pathophysiology and a suggested association with left atrial appendage closure. Minimizing contrast administration and intravenous fluid hydration are the cornerstones of an effective preventive strategy. A few adjunctive pharmacotherapies hold promise, but there are no consensus recommendations on prophylactic therapies. [ABSTRACT FROM AUTHOR]

Periprocedural imaging assessment for percutaneous Left Atrial Appendage (LAA) transcatheter occlusion can be obtained by utilizing different imaging modalities including fluoroscopy, magnetic resonance imaging (MRI), computed tomography (CT), and ultrasound imaging. Given the complex and variable morphology of the left atrial appendage, it is crucial to obtain the most accurate LAA dimensions to prevent intra-procedural device changes, recapture maneuvers, and prolonged procedure time. We therefore sought to examine the accuracy of the most commonly utilized imaging modalities in LAA occlusion. Institutional Review Board (IRB) approval was waived as we only reviewed published data. By utilizing PUBMED which is an integrated online website to list the published literature based on its relevance, we retrieved thirty-two articles on the accuracy of most commonly used imaging modalities for pre-procedural assessment of the left atrial appendage morphology, namely, two-dimensional transesophageal echocardiography, three-dimensional transesophageal echocardiography, computed tomography, and three-dimensional printing. There is strong evidence that real-time three-dimensional transesophageal echocardiography is more accurate than two-dimensional transesophageal echocardiography. Three-dimensional computed tomography has recently emerged as an imaging modality and it showed exceptional accuracy when merged with three-dimensional printing technology. However, real time three-dimensional transesophageal echocardiography may be considered the preferred imaging modality as it can provide accurate measurements without requiring radiation exposure or contrast administration. We will present the most common imaging modality used for LAA assessment and will provide an algorithmic approach including preprocedural, periprocedural, intraprocedural, and postprocedural. [ABSTRACT FROM AUTHOR]

The article presents a case study of a 83-year-old woman nonvalvular persistent atrial fibrillation, underwent computed tomography of chest which shows the left atrial filling defect and she was found the risks of recurrent thrombus formation and stroke.