Brijeshwar Maini

Transcatheter aortic-valve replacement with a self-expanding prosthesis.

BACKGROUNDnWe 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.nnnMETHODSnWe 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.nnnRESULTSnA 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<0.001 for noninferiority; P = 0.04 for superiority). The results were similar in the intention-to-treat analysis. In a hierarchical testing procedure, TAVR was noninferior with respect to echocardiographic indexes of valve stenosis, functional status, and quality of life. Exploratory analyses suggested a reduction in the rate of major adverse cardiovascular and cerebrovascular events and no increase in the risk of stroke.nnnCONCLUSIONSnIn patients with severe aortic stenosis who are at increased surgical risk, TAVR with a self-expanding transcatheter aortic-valve bioprosthesis was associated with a significantly higher rate of survival at 1 year than surgical aortic-valve replacement. (Funded by Medtronic; U.S. CoreValve High Risk Study ClinicalTrials.gov number, NCT01240902.).

2-Year Outcomes in Patients Undergoing Surgical or Self-Expanding Transcatheter Aortic Valve Replacement

BACKGROUNDnThe U.S. pivotal trial for the self-expanding valve found that among patients with severe aortic stenosis at increased risk for surgery, the 1-year survival rate was 4.9 percentage points higher in patients treated with a self-expanding transcatheter aortic valve bioprosthesis than in those treated with a surgical bioprosthesis.nnnOBJECTIVESnLonger-term clinical outcomes were examined to confirm if this mortality benefit is sustained.nnnMETHODSnPatients with severe aortic stenosis who were at increased surgical risk were recruited. Eligible patients were randomly assigned in a 1:1 ratio to transcatheter aortic valve replacement with the self-expanding transcatheter valve (transcatheter aortic valve replacement [TAVR] group) or to aortic valve replacement with a surgical bioprosthesis (surgical group). The 2-year clinical and echocardiographic outcomes were evaluated in these patients.nnnRESULTSnA total of 797 patients underwent randomization at 45 centers in the United States. The rate of 2-year all-cause mortality was significantly lower in the TAVR group (22.2%) than in the surgical group (28.6%; log-rank test pxa0< 0.05) in the as-treated cohort, with an absolute reduction in risk of 6.5 percentage points. Similar results were foundxa0in the intention-to-treat cohort (log-rank test pxa0< 0.05). The rate of 2-year death or major stroke was significantly lower in the TAVR group (24.2%) than in the surgical group (32.5%; log-rank test pxa0= 0.01).nnnCONCLUSIONSnIn patients with severe aortic stenosis who are at increased surgical risk, the higher rate of survival with a self-expanding TAVR compared with surgery was sustained at 2 years. (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).

Detection of Lipid-Core Plaques by Intracoronary Near-Infrared Spectroscopy Identifies High Risk of Periprocedural Myocardial Infarction

Background— Percutaneous coronary intervention (PCI) is associated with periprocedural myocardial infarction (MI) in 3% to 15% of cases (depending on the definition used). In many cases, these MIs result from distal embolization of lipid-core plaque (LCP) constituents. Prospective identification of LCP with catheter-based near-infrared spectroscopy (NIRS) may predict an increased risk of periprocedural MI and facilitate development of preventive measures. Methods and Results— The present study analyzed the relationship between the presence of a large LCP (detected by NIRS) and periprocedural MI. Patients with stable preprocedural cardiac biomarkers undergoing stenting were identified from the COLOR Registry, an ongoing prospective observational study of patients undergoing NIRS before PCI. The extent of LCP in the treatment zone was calculated as the maximal lipid-core burden index (LCBI) measured by NIRS for each of the 4-mm longitudinal segments in the treatment zone. A periprocedural MI was defined as new cardiac biomarker elevation above 3× upper limit of normal. A total of 62 patients undergoing stenting met eligibility criteria. A large LCP (defined as a maxLCBI4 mm ≥500) was present in 14 of 62 lesions (22.6%), and periprocedural MI was documented in 9 of 62 (14.5%) of cases. Periprocedural MI occurred in 7 of 14 patients (50%) with a maxLCBI4 mm ≥500, compared with 2 of 48 patients (4.2%) patients with a lower maxLCBI4 mm (P=0.0002). Conclusions— NIRS provides rapid, automated detection of extensive LCPs that are associated with a high risk of periprocedural MI, presumably due to embolization of plaque contents during coronary intervention.

In vivo characterization of coronary plaques: novel findings from comparing greyscale and virtual histology intravascular ultrasound and near-infrared spectroscopy.

AIMSnTo test the hypothesis that near-infrared spectroscopy (NIRS) combined with intravascular ultrasound (IVUS) would provide novel information of human coronary plaque characterization.nnnMETHODS AND RESULTSnGreyscale-IVUS, virtual histology (VH)-IVUS, and NIRS were compared in 131 native lesions (66 vessels) that were interrogated during catheterization by all three modalities. Greyscale-IVUS detected attenuated and echolucent plaques correlated with NIRS-detected lipid-rich areas. Attenuated plaques contained the highest NIRS probability of lipid core, followed by echolucent plaques. By VH-IVUS, 93.5% of attenuated plaques contained confluent necrotic core (NC) and were classified as VH-derived fibroatheromas (FAs). Although 75.0% of echolucent plaques were classified as VH-FAs, VH-NC was seen surrounding an echolucent zone, but not within any echolucent zone; and echolucent zones themselves contained fibrofatty and/or fibrous tissue. All calcified plaques with arc >90° contained >10% VH-NC (range 16.0-41.2%) and were classified as calcified VH-FAs, but only 58.5% contained NIRS-detected lipid core. A positive relationship between VH-derived %NC and NIRS-derived lipid core burden index was found in non-calcified plaques, but not in calcified plaques.nnnCONCLUSIONnCombining NIRS with IVUS contributes to the understanding of plaque characterization in vivo. Further studies are warranted to determine whether combining NIRS and IVUS will contribute to the assessment of high-risk plaques to predict outcomes in patients with coronary artery disease.

Real-world use of the Impella 2.5 circulatory support system in complex high-risk percutaneous coronary intervention: The USpella Registry

Objectives: We report on the real‐world, multicenter experience of the Impella 2.5 circulatory support system during high‐risk PCI, a subset of the larger USpella Registry. Background: Standard of care for most patients with compromised ventricular function with multivessel or high‐risk coronary lesions has been coronary artery bypass grafting. In poor operative candidates, high‐risk PCI is increasingly considered, despite an increased risk for periprocedural hemodynamic compromise. Methods: 175 consecutive patients who underwent high‐risk PCI with prophylactic support of the Impella 2.5 were evaluated. The primary safety endpoint was the incidence of major adverse cardiac events (MACE) at 30 days. Secondary endpoints included safety and efficacy related to the device and patient outcomes, including survival at 12 months. Results: Overall angiographic revascularization was successful in 99% of patients and in 90% of those with multivessel revascularization, resulting in a reduction of the mean SYNTAX score post‐PCI from 36 ± 15 to 18 ± 15 (P < 0.0001) and an improvement of the ejection fraction (from 31 ± 15% to 36 ± 14%, P < 0.0001). In 51% of patients, the functional status improved by one or more NYHA class (P < 0.001). At 30‐day follow‐up, the rate of MACE was 8%, and survival was 96%, 91%, and 88% at 30 days, 6 months, and 12 months, respectively. Conclusions: The use of Impella 2.5 in high‐risk PCI appeared feasible and safe in the real‐world setting. The utilization of the Impella 2.5 was successful, resulting in favorable short‐ and midterm angiographic, procedural and clinical outcomes.

Effect of Early Initiation of Mechanical Circulatory Support on Survival in Cardiogenic Shock

The role and timing of percutaneous mechanical circulatory support (MCS) devices in the treatment of acute myocardial infarction complicated by cardiogenic shock (AMICS) are not well understood. We sought to evaluate patient characteristics and predictors of outcomes in patients presenting with AMICS supported with an axial flow percutaneous MCS device; 287 consecutive unselected patients enrolled in the catheter-based ventricular assist device registry presenting with AMICS who underwent percutaneous coronary intervention (PCI) were included in this analysis. All patients were supported with either the Impella 2.5 or Impella CP. Mean patient age was 66 ± 12.5xa0years, 76% were men, and mean left ventricular ejection fraction was 25 ± 12%. Before receiving MCS, 80% of patients required inotropes or vasopressors and 40% were supported with intra-aortic balloon pump; 9% of patients were under active cardiopulmonary resuscitation at the time of MCS implantation. Survival to discharge was 44%. In a multivariate analysis, early implantation of a MCS device before PCI (pxa0= 0.04) and before requiring inotropes and vasopressors (pxa0= 0.05) was associated with increased survival. Survival was 66% when MCS was initiated <1.25xa0hours from shock onset, 37% when initiated within 1.25 to 4.25xa0hours, and 26% when initiated after 4.25xa0hours (pxa0= 0.017). Survival was 68%, 46%, 35%, 35%, and 26% for patients requiring 0, 1, 2, 3, and ≥4 inotropes before MCS support, respectively (pxa0<0.001). In conclusion, MCS implantation early after shock onset, before initiation of inotropes or vasopressors and before PCI, is independently associated with improved survival in patients presenting with AMICS.

Percutaneous cardiac assist devices compared with surgical hemodynamic support alternatives: cost-effectiveness in the emergent setting.

This study evaluates the cost‐effectiveness of percutaneous cardiac assist device (pVAD) therapy in the emergent setting compared with traditional surgical hemodynamic support alternatives. Background: Previous research has demonstrated the cost‐effectiveness of pVAD hemodynamic support for patients undergoing high‐risk percutaneous coronary intervention. For patients in cardiogenic shock (CS), use of pVAD therapy has been shown to reduce length of stay (LOS). Methods: National utilization and outcome data from the 2010–2011 MedPAR and state‐sponsored all‐payer databases were collected for patients with an acute myocardial infarction complicated by CS who were treated with either a pVAD (nu2009=u2009883) or with traditional surgical hemodynamic support alternatives (ECMO and extracorporeal VAD) (nu2009=u2009305). Results: Discharge survival was greater with pVADs than with surgical alternatives (56% vs. 42%, Pu2009<u20090.001) and was achieved with a strong trend toward reduced LOS (13.2 and 17.9 days, respectively, Pu2009=u20090.055) and a significantly lower cost of the index admission (

Device-Related Thrombus After Left Atrial Appendage Closure: Incidence, Predictors, and Outcomes

90,929 and

Analysis of outcomes for 15,259 US patients with acute myocardial infarction cardiogenic shock (AMICS) supported with the Impella device

144,257, respectively, Pu2009<u20090.001). Cost‐effectiveness analysis based on the national data demonstrated that pVAD achieved improved outcomes at lower cost. Data were also collected for similar patients who underwent protocol‐guided pVAD therapy (using Impella 2.5) at PinnacleHealth, between 2009 and 2011 (nu2009=u200930). At this site, the survival rate increased to 60%, length of hospitalization was shortened to 6 days, and admission costs were lowered to

PERCUTANEOUS CARDIAC ASSIST DEVICES COMPARED WITH SURGICAL HEMODYNAMIC SUPPORT ALTERNATIVES: COST–EFFECTIVENESS IN THE EMERGENT SETTING

53,850 relative to the surgical alternatives strategy. Conclusions: For patients in CS requiring emergent hemodynamic support, pVAD therapy offers a less invasive alternative that can be deployed sooner, resulting in better outcomes, shorter LOS, lower costs and with no incremental cost, and a survival benefit when compared with traditional surgical hemodynamic support alternatives. PVAD therapy (and Impella 2.5 in particular) is emerging as a dominant strategy for this challenging patient population.