Transcatheter aortic valve implantation in patients with high-risk symptomatic native aortic regurgitation (ALIGN-AR): a prospective, multicentre, single-arm study.

BACKGROUND: Surgery remains the only recommended intervention for patients with native aortic regurgitation. A transcatheter therapy to treat patients at high risk for mortality and complications with surgical aortic valve replacement represents an unmet need. Commercial transcatheter heart valves in pure aortic regurgitation are hampered by unacceptable rates of embolisation and paravalvular regurgitation. The Trilogy transcatheter heart valve (JenaValve Technology, Irvine, CA, USA) provides a treatment option for these patients. We report outcomes with transfemoral transcatheter aortic valve implantation (TAVI) in patients with pure aortic regurgitation using this dedicated transcatheter heart valve. METHODS: The ALIGN-AR trial is a prospective, multicentre, single-arm study. We recruited symptomatic patients (aged ≥18 years) with moderate-to-severe or severe aortic regurgitation at high risk for mortality and complications after surgical aortic valve replacement at 20 US sites for treatment with the Trilogy transcatheter heart valve. The 30-day composite primary safety endpoint was compared for non-inferiority with a prespecified performance goal of 40·5%. The primary efficacy endpoint was 1-year all-cause mortality compared for non-inferiority with a performance goal of 25%. This trial is registered with ClinicalTrials.gov, NCT04415047, and is ongoing. FINDINGS: Between June 8, 2018, and Aug 29, 2022, we screened 346 patients. We excluded 166 (48%) patients and enrolled 180 (52%) patients with symptomatic aortic regurgitation deemed high risk by the heart team and independent screening committee assessments. The mean age of the study population was 75·5 years (SD 10·8), and 85 (47%) were female, 95 (53%) were male, and 131 (73%) were White. Technical success was achieved in 171 (95%) patients. At 30 days, four (2%) deaths, two (1%) disabling strokes, and two (1%) non-disabling strokes occurred. Using standard Valve Academic Research Consortium-2 definitions, the primary safety endpoint was achieved, with events occurring in 48 (27% [97·5% CI 19·2-34·0]) patients (pnon-inferiority<0·0001), with new pacemaker implantation in 36 (24%) patients. The primary efficacy endpoint was achieved, with mortality in 14 (7·8% [3·3-12·3]) patients at 1 year (pnon-inferiority<0·0001). INTERPRETATION: This study shows the safety and effectiveness of treating native aortic regurgitation using a dedicated transcatheter heart valve to treat patients with symptomatic moderate-to-severe or severe aortic regurgitation who are at high risk for mortality or complications after surgical aortic valve replacement. The observed short-term clinical and haemodynamic outcomes are promising as are signs of left ventricular remodelling, but long-term follow-up is necessary. FUNDING: JenaValve Technology.

Clinical journey for patients with aortic regurgitation: A retrospective observational study from a multicenter database.

BACKGROUND: Data using real-world assessments of aortic regurgitation (AR) severity to identify rates of Heart Valve Team evaluation and aortic valve replacement (AVR), as well as mortality among untreated patients, are lacking. The present study assessed these trends in care and outcomes for real-world patients with documented AR. METHODS: Using a deidentified data set (January 2018-March 2023) representing 1,002,853 patients >18 years of age from 25 US institutions participating in the egnite Database (egnite, Inc.) with appropriate permissions, patients were classified by AR severity in echocardiographic reports. Rates of evaluation by the Heart Valve Team, AVR, and all-cause mortality without AVR were examined using Kaplan-Meier estimates and compared using the log-rank test. RESULTS: Within the data set, 845,113 patients had AR severity documented. For moderate-to-severe or severe AR, respectively, 2-year rates (95% confidence interval) of evaluation by the Heart Valve Team (43.5% [41.7%-45.3%] and 65.4% [63.3%-67.4%]) and AVR (19.4% [17.6%-21.1%] and 46.5% [44.2%-48.8%]) were low. Mortality at 2 years without AVR increased with greater AR severity, up to 20.7% for severe AR (p < 0.001). In exploratory analyses, 2-year mortality for untreated patients with left ventricular end-systolic dimension index > 25 mm/m2 was similar for moderate (34.3% [29.2%-39.1%]) and severe (37.2% [24.9%-47.5%]) AR. CONCLUSIONS: Moderate or greater AR is associated with poor clinical outcomes among untreated patients at 2 years. Rates of Heart Valve Team evaluation and AVR were low for those with moderate or greater AR, suggesting that earlier referral to the Heart Valve Team could be beneficial.

Primary results of the SAVAL randomized trial of a paclitaxel-eluting nitinol stent versus percutaneous transluminal angioplasty in infrapopliteal arteries.

BACKGROUND: Effective and durable options for infrapopliteal artery revascularization for patients with chronic limb-threatening ischemia (CLTI) are limited. METHODS: The SAVAL trial is a prospective, multicenter, randomized trial of patients with CLTI and infrapopliteal artery lesions with total lesion length ⩽ 140 mm, stenosis ⩾ 70%, and Rutherford category 4-5 assigned 2:1 to treatment with the SAVAL self-expandable paclitaxel drug-eluting stent (DES) or percutaneous transluminal angioplasty (PTA) with an uncoated balloon. The primary effectiveness endpoint was primary vessel patency (i.e., core lab-adjudicated duplex ultrasound-based flow at 12 months in the absence of clinically driven target lesion revascularization or surgical bypass of the target lesion). The primary safety endpoint was the 12-month major adverse event (MAE)-free rate; MAEs were defined as a composite of above-ankle index limb amputation, major reintervention, and 30-day mortality. The endpoints were prespecified for superiority (effectiveness) and noninferiority (safety) at a one-sided significance level of 2.5%. RESULTS: A total of 201 patients were enrolled and randomly assigned to treatment (N = 130 DES, N = 71 PTA). Target lesion length was 68.1 ± 35.2 mm for the DES group and 68.7 ± 49.2 mm for the PTA group, and 31.0% and 27.6% of patients, respectively, had occlusions. The 12-month primary patency rates were 68.0% for the DES group and 76.0% for the PTA group (Psuperiority = 0.8552). The MAE-free rates were 91.6% and 95.3%, respectively (Pnoninferiority = 0.0433). CONCLUSION: The SAVAL trial did not show benefit related to effectiveness and safety with the nitinol DES compared with PTA in infrapopliteal artery lesions up to 140 mm in length. Continued innovation to provide optimal treatments for CLTI is needed. (ClinicalTrials.gov Identifier: NCT03551496).

Improved outcomes in patients with severely depressed LVEF undergoing percutaneous coronary intervention with contemporary practices.

BACKGROUND: Contemporary practices for hemodynamically supported high-risk percutaneous coronary intervention have evolved over the last decade. This study sought to compare outcomes of the prospective, multicenter, PROTECT III study to historic patients treated with Impella in the PROTECT II randomized controlled trial. METHODS: Of 1,134 patients enrolled in PROTECT III from March 2017 to March 2020, 504 were "PROTECT II-like" (met eligibility for PROTECT II randomized controlled trial) and are referred to as PROTECT III for comparative analysis. Major adverse cardiac and cerebrovascular events (MACCE), comprising all-cause mortality, stroke/transient ischemic attack, myocardial infarction, and repeat revascularization, were compared at hospital discharge and 90 days. RESULTS: Compared with PROTECT II (N = 216), PROTECT III patients were less often Caucasian (77.1% vs 83.8%, P = .045), with less prior CABG (13.7% vs 39.4%; P < .001) and prior myocardial infarction (40.7% vs 69.3%; P < .001). More PROTECT III patients underwent rotational atherectomy (37.1% vs 14.8%, P < .001) and duration of support was longer (median 1.6 vs 1.3 hours; p<0.001), with greater improvement achieved in myocardial ischemia jeopardy scores (7.0±2.4 vs 4.4±2.9; P < .001) and SYNTAX scores (21.4±10.8 vs 15.7±9.5; P < .001). In-hospital bleeding requiring transfusion was significantly lower in PROTECT III (1.8% vs 9.3%; P < .001), as was procedural hypotension (2.2% vs 10.1%; P < .001) and cardiopulmonary resuscitation or ventricular arrhythmia (1.6% vs 6.9%; P < .001). At 90 days, MACCE was 15.1% and 21.9% in PROTECT III and PROTECT II, respectively (p=0.037). Following propensity score matching, Kaplan-Meier analysis showed improved 90-day MACCE rates in PROTECT III (10.4% vs 16.9%, P = .048). CONCLUSIONS: The PROTECT III study demonstrates improved completeness of revascularization, less bleeding, and improved 90-day clinical outcomes compared to PROTECT II for Impella-supported high-risk percutaneous coronary intervention among patients with severely depressed LVEF.

Post hoc closure of large bore vascular access using the MANTA closure device.

Successful closure of large bore vascular access (≥12 Fr) is facilitated by the MANTA vascular closure device; however, it requires a critical first step of measuring "skin to arterial wall" depth of the access site using the depth locator before dilating the vessel above 8 Fr. It may be challenging at times to acquire the deployment depth at the onset of the procedure due to case urgency, delayed closure, or when large bore access is obtained at a different institution. We discuss a novel technique of measuring the deployment depth and successful delayed closure of large bore arterial access using the MANTA closure device.

Mechanical circulatory support in acute myocardial infarction and cardiogenic shock: Challenges and importance of randomized control trials.

BACKGROUND: Acute myocardial infarction (AMI) complicated by cardiogenic shock (CS) is associated with significant morbidity and mortality. METHODS: We provide an overview of previously conducted studies on the use of mechanical circulatory support (MCS) devices in the treatment of AMI-CS and difficulties which may be encountered in conducting such trials in the United States. RESULTS: Well powered randomized control trials are difficult to conduct in a critically ill patient population due to physician preferences, perceived lack of equipoise and challenges obtaining informed consent. CONCLUSIONS: With growth in utilization of MCS devices in patients with AMI-CS, efforts to perform well-powered, randomized control trials must be undertaken.

The Single-access for Hi-risk PCI (SHiP) technique.

Currently, the Impella CP (Abiomed, Danvers, Massachusetts) percutaneous ventricular assist catheter requires implantation through a 14 French sheath. Additional arterial access is commonly obtained to perform therapeutic or diagnostic procedures. Multiple arterial access requires time and results in increased risk for vascular complications. Some patients may have limited arterial access. We describe the Single-access for Hi-risk PCI (SHiP) technique to allow for rapid and safer single access utilizing only the Impella access site. After the Impella catheter is placed in the standard fashion, a micropuncture needle is used to pierce the hemostasis valve of the Impella insertion sheath. After dilating the hemostasis valve and exchanging for a 0.035″ wire, up to a 7 French sheath can be inserted for PCI within the 14 French access sheath and alongside the 9 French portion of the Impella catheter. After PCI, the sheath is removed. We report on a case series of 17 patients using this technique. There were no instances of bleeding during the procedure or after removal of the PCI sheath, and no evidence of disruption of the Impella sheath.

Cardiac procedural deferral during the coronavirus (COVID-19) pandemic.

We aimed to examine factors impacting variability in cardiac procedural deferral during the COVID-19 pandemic and assess cardiologists' perspectives regarding its implications. Unprecedented cardiac procedural deferral was implemented nationwide during the COVID-19 pandemic. A web-based survey was administered by Society for Cardiovascular Angiography and Interventions and the American College of Cardiology Interventional Council to cardiac catheterization laboratory (CCL) directors and interventional cardiologists across the United States during the COVID-19 pandemic. Among 414 total responses, 48 states and 360 unique cardiac catheterization laboratories were represented, with mean inpatient COVID-19 burden 16.4 ± 21.9%. There was a spectrum of deferral by procedure type, varying by both severity of COVID-19 burden and procedural urgency (p < .001). Percutaneous coronary intervention volumes dropped by 55% (p < .0001) and transcatheter aortic valve replacement volumes dropped by 64% (p = .004), with cardiologists reporting an increase in late presenting ST-elevation myocardial infarctions and deaths among patients waiting for transcatheter aortic valve replacement. Almost 1/3 of catheterization laboratories had at least one interventionalist testing positive for COVID-19. Salary reductions did not influence procedural deferral or speed of reinstituting normal volumes. Pandemic preparedness improved significantly over time, with the most pressing current problems focused on inadequate testing and staff health risks. During the COVID-19 pandemic, cardiac procedural deferrals were associated with procedural urgency and severity of hospital COVID-19 burden. Yet patients did not appear to be similarly influenced, with cardiologists reporting increases in late presenting ST-elevation myocardial infarctions independent of local COVID-19 burden. The safety and importance of seeking healthcare during this pandemic deserves emphasis.

Frailty and related outcomes in patients undergoing transcatheter valve therapies in a nationwide cohort.

AIMS: We sought to identify the prevalence and related outcomes of frail individuals undergoing transcatheter mitral valve repair and transcatheter aortic valve replacement (TAVR). METHODS AND RESULTS: Patients aged 65 and older were included in the study if they had at least one procedural code for transcatheter mitral valve repair or TAVR between 1 January 2016 and 31 December 2016 in the Centers for Medicare and Medicaid Services Medicare Provider and Review database. The Hospital Frailty Risk Score, an International Classification of Diseases, Tenth Revision (ICD-10) claims-based score, was used to identify frailty and the primary outcome was all-cause 1-year mortality. A total of 3746 (11.6%) patients underwent transcatheter mitral valve repair and 28 531 (88.4%) underwent TAVR. In the transcatheter mitral valve repair and TAVR populations, respectively, there were 1903 (50.8%) and 14 938 (52.4%) patients defined as low risk for frailty (score <5), 1476 (39.4%) and 11 268 (39.5%) defined as intermediate risk (score 5-15), and 367 (9.8%) and 2325 (8.1%) defined as high risk (score >15). One-year mortality was 12.8% in low-risk patients, 29.7% in intermediate-risk patients, and 40.9% in high-risk patients undergoing transcatheter mitral valve repair (log rank P < 0.001). In patients undergoing TAVR, 1-year mortality rates were 7.6% in low-risk patients, 17.6% in intermediate-risk patients, and 30.1% in high-risk patients (log rank P < 0.001). CONCLUSIONS: This study successfully identified individuals at greater risk of short- and long-term mortality after undergoing transcatheter valve therapies in an elderly population in the USA using the ICD-10 claims-based Hospital Frailty Risk Score.

Design and rationale of a randomized noninferiority trial to evaluate the SurVeil drug-coated balloon in subjects with stenotic lesions of the femoropopliteal artery - the TRANSCEND study.

BACKGROUND: Drug-coated balloons (DCBs), developed to reduce restenosis after percutaneous intervention in peripheral arterial disease (PAD), have been shown to be safe and efficacious, particularly in treating PAD affecting the femoropopliteal segment. The SurVeil DCB uses an excipient intended to optimize both the uniformity and transfer of paclitaxel to the vessel wall, allowing for efficient drug loading and lower systemic exposure than currently available DCBs, Heretofore, clinical outcomes have not previously been compared to other DCBs. STUDY DESIGN AND OBJECTIVES: This prospective, multicenter, international, randomized, single-blind, trial will compare 1:1 the SurVeil DCB with the IN.PACT Admiral DCB for treatment of patients with Rutherford classification 2 to 4 due to femoral and/or popliteal arterial disease. The trial will randomize 446 subjects (with reference vessel diameter 4-7 mm and total lesion length ≤180 mm). Subjects will be followed for 60 months. The primary efficacy endpoint is 1 year primary patency, defined as composite freedom from clinically-driven target-lesion revascularization (TLR) and binary restenosis (core lab-adjudicated duplex ultrasound peak systolic velocity ratio ≥2.4, or ≥50% stenosis via angiography). The primary safety endpoint is composite freedom from device- and procedure-related death through 30 days and freedom from target limb major amputation and clinically-driven target vessel revascularization through 12 months. The primary analysis is a test of noninferiority of the SurVeil vs. IN.PACT Admiral on the primary efficacy and safety endpoints according to absolute deltas of 15.0% and 10.0%, respectively. CONCLUSION: The Randomized And Controlled Noninferiority Trial to Evaluate Safety and Clinical Efficacy of the SurVeil DCB in the Treatment of Subjects with Stenotic Lesions of the Femoropopliteal Artery Compared to the Medtronic IN.PACT Admiral (TRANSCEND) study will assess safety and efficacy of the SurVeil DCB relative to a commonly used DCB.

Massive pulmonary embolism: embolectomy or extracorporeal membrane oxygenation?

PURPOSE OF REVIEW: To highlight updates on the use of extracorporeal membrane oxygenation (ECMO) and surgical embolectomy in the treatment of massive pulmonary embolism. RECENT FINDINGS: Outcomes for surgical embolectomy for massive pulmonary embolism have improved in the recent past. More contemporary therapeutic options include catheter embolectomy, which although offer less invasive means of treating this condition, need further study. The use of ECMO as either a bridge or mainstay of treatment in patients with contraindications to fibrinolysis and surgical embolectomy, or have failed initial fibrinolysis, has increased, with data suggesting improved outcomes with earlier implementation in selected patients. SUMMARY: Although surgical embolectomy continues to be the initial treatment of choice in massive pulmonary embolism with contraindications or failed fibrinolysis, the use of ECMO in these high-risk patients provides an important tool in managing this often fatal condition.

Quality of Care at Hospitals Identified as Outliers in Publicly Reported Mortality Statistics for Percutaneous Coronary Intervention.

BACKGROUND: Public reporting of percutaneous coronary intervention (PCI) outcomes may create disincentives for physicians to provide care for critically ill patients, particularly at institutions with worse clinical outcomes. We thus sought to evaluate the procedural management and in-hospital outcomes of patients treated for acute myocardial infarction before and after a hospital had been publicly identified as a negative outlier. METHODS: Using state reports, we identified hospitals that were recognized as negative PCI outliers in 2 states (Massachusetts and New York) from 2002 to 2012. State hospitalization files were used to identify all patients with an acute myocardial infarction within these states. Procedural management and in-hospital outcomes were compared among patients treated at outlier hospitals before and after public report of outlier status. Patients at nonoutlier institutions were used to control for temporal trends. RESULTS: Among 86 hospitals, 31 were reported as outliers for excess mortality. Outlier facilities were larger, treating more patients with acute myocardial infarction and performing more PCIs than nonoutlier hospitals (P<0.05 for each). Among 507 672 patients with acute myocardial infarction hospitalized at these institutions, 108 428 (21%) were treated at an outlier hospital after public report. The likelihood of PCI at outlier (relative risk [RR], 1.13; 95% confidence interval [CI], 1.12-1.15) and nonoutlier institutions (RR, 1.13; 95% CI, 1.11-1.14) increased in a similar fashion (interaction P=0.50) after public report of outlier status. The likelihood of in-hospital mortality decreased at outlier institutions (RR, 0.83; 95% CI, 0.81-0.85) after public report, and to a lesser degree at nonoutlier institutions (RR, 0.90; 95% CI, 0.87-0.92; interaction P<0.001). Among patients that underwent PCI, in-hospital mortality decreased at outlier institutions after public recognition of outlier status in comparison with prior (RR, 0.72; 9% CI, 0.66-0.79), a decline that exceeded the reduction at nonoutlier institutions (RR, 0.87; 95% CI, 0.80-0.96; interaction P<0.001). CONCLUSIONS: Large hospitals with higher clinical volume are more likely to be designated as negative outliers. The rates of percutaneous revascularization increased similarly at outlier and nonoutlier institutions after report of outlier status. After outlier designation, in-hospital mortality declined at outlier institutions to a greater extent than was observed at nonoutlier facilities.

Recurrent Hospitalization Among Patients With Atrial Fibrillation Undergoing Intracoronary Stenting Treated With 2 Treatment Strategies of Rivaroxaban or a Dose-Adjusted Oral Vitamin K Antagonist Treatment Strategy.

BACKGROUND: Patients with atrial fibrillation who undergo intracoronary stenting traditionally are treated with a vitamin K antagonist (VKA) plus dual antiplatelet therapy (DAPT), yet this treatment leads to high risks of bleeding. We hypothesized that a regimen of rivaroxaban plus a P2Y12 inhibitor monotherapy or rivaroxaban plus DAPT could reduce bleeding and thereby have a favorable impact on all-cause mortality and the need for rehospitalization. METHODS: Stented subjects with nonvalvular atrial fibrillation (n=2124) were randomized 1:1:1 to administration of reduced-dose rivaroxaban 15 mg daily plus a P2Y12 inhibitor for 12 months (group 1); rivaroxaban 2.5 mg twice daily with stratification to a prespecified duration of DAPT of 1, 6, or 12 months (group 2); or the reference arm of dose-adjusted VKA daily with a similar DAPT stratification (group 3). The present post hoc analysis assessed the end point of all-cause mortality or recurrent hospitalization for an adverse event, which was further classified as the result of bleeding, a cardiovascular cause, or another cause blinded to treatment assignment. RESULTS: The risk of all-cause mortality or recurrent hospitalization was 34.9% in group 1 (hazard ratio=0.79; 95% confidence interval, 0.66-0.94; P=0.008 versus group 3; number needed to treat=15), 31.9% in group 2 (hazard ratio=0.75; 95% confidence interval, 0.62-0.90; P=0.002 versus group 3; number needed to treat=10), and 41.9% in group 3 (VKA+DAPT). Both all-cause death plus hospitalization potentially resulting from bleeding (group 1=8.6% [P=0.032 versus group 3], group 2=8.0% [P=0.012 versus group 3], and group 3=12.4%) and all-cause death plus rehospitalization potentially resulting from a cardiovascular cause (group 1=21.4% [P=0.001 versus group 3], group 2=21.7% [P=0.011 versus group 3], and group 3=29.3%) were reduced in the rivaroxaban arms compared with the VKA arm, but other forms of rehospitalization were not. CONCLUSIONS: Among patients with atrial fibrillation undergoing intracoronary stenting, administration of either rivaroxaban 15 mg daily plus P2Y12 inhibitor monotherapy or 2.5 mg rivaroxaban twice daily plus DAPT was associated with a reduced risk of all-cause mortality or recurrent hospitalization for adverse events compared with standard-of-care VKA plus DAPT. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01830543.

Factors associated with performing urgent coronary angiography in out-of-hospital cardiac arrest patients.

OBJECTIVES: Factors associated with performing urgent coronary angiography (UCA) in patients with out-of-hospital cardiac arrest (OHCA) were identified. BACKGROUND: Current guidelines for resuscitated OHCA patients recommend UCA if there is ST-elevation on post-arrest electrocardiogram or high suspicion of acute myocardial infarction. Some have advocated for UCA in all OHCA regardless of suspected etiology. The reasons for variations in performing UCA are not well understood. METHODS: A retrospective analysis of subjects presenting with resuscitated OHCA to a single academic medical center from 12/15/2007 to 8/31/2014 was conducted. Demographic and clinical characteristics of patients undergoing UCA, defined as angiography within 6 hr of presentation, were compared with those not undergoing UCA. Logistic regression was used to determine predictors of UCA. RESULTS: A total of 323 resuscitated OHCA patients (mean age, 64 years; women, 35%) were included in the analysis; 107 (33.1%) underwent coronary angiography during their hospitalization and 66 (20.4%) underwent UCA. Multivariable adjusted factors associated with UCA were ST-elevation [odds ratio (OR) 14.66, 95% confidence interval (CI) 6.28-34.24, P < 0.001], initial shockable rhythm (OR 3.69, 95% CI 1.52-8.97, P = 0.004), and history of coronary artery disease (CAD) (OR 3.37, 95% CI 1.43-7.95, P = 0.005). Higher age (OR 0.71 per decade, 95% CI 0.55-0.92, P = 0.01) and obvious non-cardiac cause of arrest (OR 0.08, 95% CI 0.02-0.38, P = 0.001) were negatively associated with UCA. CONCLUSIONS: In resuscitated out-of-hospital cardiac arrest patients, ST-elevation, shockable rhythm, and history of CAD were associated with performing urgent coronary angiography; older patients and those with obvious non-cardiac causes of arrest were negatively associated.

Cost implications of intraprocedural thrombotic events and bleeding in percutaneous coronary intervention: Results from the CHAMPION PHOENIX ECONOMICS Study.

BACKGROUND: Despite improvements in percutaneous coronary intervention (PCI), intraprocedural thrombotic events (IPTE) and bleeding complications occur and are prognostically important. These have not been included in prior economic studies. METHODS: PHOENIX ECONOMICS was a substudy of the CHAMPION PHOENIX trial, evaluating cangrelor during PCI. Hospital bills were reviewed from 1,171 patients enrolled at 22 of 63 US sites. Costs were estimated using standard methods including resource-based accounting, hospital billing data, and the Medicare fee schedule. Bleeding and IPTE, defined as abrupt vessel closure (transient or sustained), new/suspected thrombus, new clot on wire/catheter, no reflow, side-branch occlusion, procedural stent thrombosis or urgent need for CABG were identified. Costs were calculated according to whether a complication occurred and type of event. Multivariate analyses were used to estimate the incremental costs of IPTE and postprocedural events. RESULTS: IPTE occurred in 4.3% and were associated with higher catheterization laboratory and overall index hospitalization costs by $2,734 (95%CI $1,117, $4,351; P = 0.001) and $6,354 (95% CI $4,122, $8,586; P < 0.001), respectively. IPTE were associated with MI (35.4% vs. 3.6%; P < 0.001), out-of-laboratory stent thrombosis (4.2% vs. 0.1%; 0 = 0.005), ischemia driven revascularization (12.5% vs. 0.3%; P < 0.001), but not mortality (2.1% vs. 0.2%; P = 0.12) vs. no procedural thrombotic complication. By comparison, ACUITY minor bleeding increased hospitalization cost by $1,416 (95%CI = 312, $2,519; P = 0.012). ACUITY major bleeding increased cost of hospitalization by $7,894 (95%CI $4,154, $11,635; P < 0.001). CONCLUSIONS: IPTE and bleeding complications, though infrequent, are associated with substantial increased cost. These complications should be collected in economic assessments of PCI.

Trends in Treatment and Mortality for Mesenteric Ischemia in the United States from 2000 to 2012.

BACKGROUND: It is unknown whether increased endovascular treatment of chronic mesenteric ischemia has led to decreases in open surgery, acute mesenteric ischemia, or overall mortality. The present study evaluates the trends in endovascular and open treatment over time for chronic and acute mesenteric ischemia. METHODS: We identified patients with chronic or acute mesenteric ischemia in the Nationwide Inpatient Sample and Center for Disease Control and Prevention database from 2000 to 2012. Trends in revascularization, mortality, and total deaths were evaluated over time. Data were adjusted to account for population growth. RESULTS: There were 14,810 revascularizations for chronic mesenteric ischemia (10,453 endovascular and 4,358 open) and 11,294 revascularizations for acute mesenteric ischemia (4,983 endovascular and 6,311 open). Endovascular treatment increased for both chronic (0.6-4.5/million, P < 0.01) and acute mesenteric ischemia (0.6-1.8/million, P < 0.01). However, concurrent declines in open surgery did not occur (chronic: 1-1.1/million, acute: 1.8-1.7/million). Among patients with acute mesenteric ischemia, the proportion with atrial fibrillation (18%) and frequency of embolectomy (1/million per year) remained stable. In-hospital mortality rates decreased for both endovascular (chronic: 8-3%, P < 0.01; acute: 28-17%, P < 0.01) and open treatment (chronic: 21-9%, P < 0.01; acute: 40-25%, P < 0.01). Annual population-based mortality remained stable for chronic mesenteric ischemia (0.7-0.6 deaths per million/year), but decreased for acute mesenteric ischemia (12.9-5.3 deaths per million/year, P < 0.01). CONCLUSIONS: Population mortality from acute mesenteric ischemia declined from 2000 to 2012, correlated with dramatic increases in endovascular intervention for chronic mesenteric ischemia, and in spite of a stable rate of embolization. However, open surgery for both chronic and acute ischemia remained stable.

Should We Screen for Coronary Heart Disease in Asymptomatic Persons?: Grand Rounds Discussion From Beth Israel Deaconess Medical Center.

In March 2015, the American College of Physicians (ACP) released a clinical guideline on the value of screening for coronary heart disease (CHD) in asymptomatic persons. The guideline authors found that results of screening studies are unlikely to change patient management or the intensity of risk factor reduction strategies. Most events occur in patients who are at low to intermediate risk for CHD; and in low-risk asymptomatic patients, percutaneous coronary intervention in "screen-positive" patients does not improve outcomes and creates unnecessary risks. As a result, the ACP recommended against screening for asymptomatic patients who are at low risk for CHD. Instead, it recommended a focus on proven strategies, such as treatment of hypertension and hypercholesterolemia, to reduce risk in appropriately selected asymptomatic persons. Two discussants weigh the evidence for and against screening for CHD in asymptomatic patients with varying degrees of risk and provide recommendations for a specific patient who is uncertain whether to proceed to screening.

Bivalirudin is associated with improved clinical and economic outcomes in heart failure patients undergoing percutaneous coronary intervention: Results from an observational database.

BACKGROUND: Outcomes with bivalirudin compare favorably with heparin ± GPIIb/IIIa receptor inhibition (heparin ± GPI) during percutaneous coronary intervention (PCI). Patients with congestive heart failure (CHF) have increased risk for complications. The objective was to investigate clinical and economic outcomes for bivalirudin ± GPI vs. heparin ± GPI among PCI patients with CHF. METHODS: Using the Premier Hospital Database, PCI patients with CHF were stratified by anticoagulant: bivalirudin, bivalirudin ± GPI, heparin and heparin ± GPI. The probability of receiving bivalirudin ± GPI was estimated using individual and hospital variables. Using propensity scores, each bivalirudin ± GPI patient was matched to a heparin ± GPI patient. The primary outcome was in-hospital death. Bleeding rates, transfusion, length of stay and in-hospital cost were ascertained. RESULTS: Overall, 116,313 patients at 315 hospitals received bivalirudin (n = 45,559) bivalirudin + GPI (n = 8,115), heparin (n = 27,972) or heparin + GPI (n = 34,667). Patients had STEMI (21.2%), NSTEMI (29.1%), unstable angina (16.6%), stable angina (5.7%) or other ischemic heart disease (24.2%). Of these, 79.1% of bivalirudin patients matched, resulting in 84,948 analyzed patients. Compared with heparin ± GPI patients, bivalirudin ± GPI patients had fewer deaths (3.3% vs. 3.9%; p < 0.0001), less clinically apparent bleeding (10.2% vs. 11.4%; p < 0.0001), clinically apparent bleeding with transfusion (2.7% vs. 3.2%, p <0.0001), and transfusion (8.5% vs. 9.8%, p < 0.0001). Patients receiving bivalirudin had shorter length of stay (6.3 vs. 6.8 days; p < 0.0001) and lower in-hospital cost (mean $26,706 vs. $27,166 [median $19,414 vs. $19,798]; p < 0.0001). In conclusion, this is the largest retrospective analysis of PCI patients with CHF and demonstrates bivalirudin ± GPI compared with heparin ± GPI is associated with lower inpatient rates of death, bleeding, and cost.