Angiographic Characteristics and Clinical Outcomes in Patients With Chronic Kidney Disease Undergoing Impella-Supported High-Risk Percutaneous Coronary Intervention: Insights From the cVAD PROTECT III Study.

BACKGROUND: Prior studies have found that patients with chronic kidney disease (CKD) have worse outcomes following percutaneous coronary intervention (PCI). There are no data about patients with advanced CKD undergoing Impella-supported high-risk PCI. We, therefore, aimed to evaluate angiographic characteristics and clinical outcomes in patients with CKD who received Impella-supported high-risk PCI as part of the catheter-based ventricular assist device PROTECT III study (A Prospective, Multi-Center, Randomized Controlled Trial of the IMPELLA RECOVER LP 2.5 System Versus Intra Aortic Balloon Pump [IABP] in Patients Undergoing Non Emergent High Risk PCI). METHODS: Patients enrolled in the PROTECT III study were analyzed according to their baseline estimated glomerular filtration rate (eGFR). The primary outcome was 90-day major adverse cardiovascular and cerebrovascular events (the composite of all-cause death, myocardial infarction, stroke/transient ischemic attack, and repeat revascularization). RESULTS: Of 1237 enrolled patients, 1052 patients with complete eGFR baseline assessment were evaluated: 586 with eGFR ≥60 mL/min per 1.73 m2, 190 with eGFR ≥45 to <60, 105 with eGFR ≥30 to <45, and 171 with eGFR <30 or on dialysis. Patients with lower eGFR (all groups with eGFR <60) were more frequently females and had a higher prevalence of hypertension, diabetes, anemia, and peripheral artery disease. The baseline Synergy Between PCI With Taxus and Cardiac Surgery score was similar between groups (28.2±12.6 for all groups). Patients with lower eGFR were more likely to have severe coronary calcifications and higher usage of atherectomy. There were no differences in individual PCI-related coronary complications between groups, but the rates of overall PCI complications were less frequent among patients with lower eGFR. Major adverse cardiovascular and cerebrovascular events at 90 days and 1-year mortality were significantly higher among patients with eGFR <30 mL/min per 1.73 m2 or on dialysis. CONCLUSIONS: Patients with advanced CKD undergoing Impella-assisted high-risk PCI tend to have higher baseline comorbidities, severe coronary calcification, and higher atherectomy usage, yet CKD was not associated with a higher rate of immediate PCI-related complications. However, 90-day major adverse cardiovascular and cerebrovascular events and 1-year mortality were significantly higher among patients with eGFR<30 mL/min per 1.73 m2 or on dialysis. Future studies of strategies to improve intermediate and long-term outcomes of these high-risk patients are warranted. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04136392.

Influence of left ventricular ejection fraction in patients undergoing contemporary pLVAD-supported high-risk PCI.

BACKGROUND: Left ventricular (LV) systolic dysfunction worsens outcomes in patients undergoing percutaneous coronary intervention (PCI). The objective of this study, therefore, was to evaluate outcomes of pLVAD-supported high-risk PCI (HRPCI) patients according to LV ejection fraction (LVEF). METHODS: Patients from the PROTECT III study undergoing pLVAD-supported HRPCI were stratified according to baseline LVEF: severe LV dysfunction (LVEF <30%), mild and moderate LV dysfunction (LVEF ≥30% to <50%), or preserved LV function (LVEF ≥50%). Major adverse cardiovascular and cerebrovascular events (MACCE: composite of all-cause death, myocardial infarction, stroke/transient ischemic attack, and repeat revascularization), and PCI-related complications were assessed at 90 days and mortality was assessed at 1-year. RESULTS: From March 2017 to March 2020, 940 patients had evaluable baseline LVEF recorded in the study database. Patients with preserved LV function were older, more frequently presented with myocardial infarction, and underwent more left main PCI and atherectomy. Immediate PCI-related coronary complications were infrequent (2.7%, overall), similar between groups (P = 0.98), and not associated with LVEF. Unadjusted 90-day MACCE rates were similar among LVEF groups; however, as a continuous variable, LVEF was associated with both 90-day MACCE (adj.HR per 5% 0.89, 95% CI [0.80, 0.98], P = 0.018) and 1-year mortality (adj.HR per 5% 0.84 [0.78, 0.90], P <0.0001). CONCLUSIONS: Patients who underwent pLVAD-supported HRPCI exhibited low incidence of PCI-related complications, regardless of baseline LVEF. However, LVEF was associated with 90-day MACCE and 1-year mortality.

Sex Differences in pLVAD-Assisted High-Risk Percutaneous Coronary Intervention: Insights From the PROTECT III Study.

BACKGROUND: Prior studies have found that female patients have worse outcomes following high-risk percutaneous coronary intervention (HRPCI). OBJECTIVES: The authors sought to evaluate sex-based differences in patient and procedural characteristics, clinical outcomes, and safety of Impella-supported HRPCI in the PROTECT III study. METHODS: We evaluated sex-based differences in the PROTECT III study; a prospective, multicenter, observational study of patients undergoing Impella-supported HRPCI. The primary outcome was 90-day major adverse cardiac and cerebrovascular events (MACCE)-the composite of all-cause death, myocardial infarction, stroke/transient ischemic attack, and repeat revascularization. RESULTS: From March 2017 to March 2020, 1,237 patients (27% female) were enrolled. Female patients were older, more often Black, more often anemic, and had more prior strokes and worse renal function, but higher ejection fractions compared to male patients. Preprocedural SYNTAX score was similar between sexes (28.0 ± 12.3). Female patients were more likely to present with acute myocardial infarction (40.7% vs 33.2%; P = 0.02) and more often had femoral access used for PCI and nonfemoral access used for Impella device implantation. Female patients had higher rates of immediate PCI-related coronary complications (4.2% vs 2.1%; P = 0.004) and a greater drop in SYNTAX score post-procedure (-22.6 vs -21.0; P = 0.04). There were no sex differences in 90-day MACCE, vascular complications requiring surgery, major bleeding, or acute limb ischemia. After adjustment using propensity matching and multivariable regression, immediate PCI-related complications was the only safety or clinical outcome that was significantly different by sex. CONCLUSIONS: In this study, rates of 90-day MACCE compared favorably to prior cohorts of HRPCI patients and there was no significant sex differences. (The PROTECT III Study is a substudy of The Global cVAD Study [cVAD]; NCT04136392).

Hemoptysis: unilateral pulmonary artery atresia? a case report.

BACKGROUND: Asymptomatic, isolated cases of unilateral pulmonary artery atresia may present in adulthood with symptoms such as recurrent respiratory infections, dyspnea, hemoptysis, and pulmonary hypertension. Unlike previously reported patients that underwent surgical management for this pathology, the patient in this report had no chronic history of recurrent respiratory infections, dyspnea, or pulmonary hypertension, making a diagnosis prior to extensive imaging difficult. CASE PRESENTATION: A 55-year-old male presented to our emergency department (ED) with a 3-day history of recurrent cough with 2-3 tablespoons of hemoptysis per episode, chills, and occasional wheezing. A computed tomography angiography (CTA) was performed, which identified a congenital absence of the left pulmonary artery and a right-sided aortic arch. Hypertrophied left intercostal and bronchial arteries were noted to be perfusing the left lung. V/Q scan confirmed a heterogeneous distribution of gas throughout both lung fields with 97% perfusion to the right lung, but no visualization of the left lung on the perfusion images. Given extensive collateral blood supply to the left lung, interventional radiology performed a GELFOAM® embolization of the hypertrophied left bronchial artery and two parasitized arteries from the left subclavian artery to minimize intra-operative blood loss. This was immediately followed by a left thoracotomy, pneumonectomy, intercostal muscle flap placement, and bronchoscopy. The procedure was 360 min long with a total of 1500 cc blood loss that was salvaged and re-infused. No additional blood products were administered. The patient remained intubated post-operatively and was transferred to the surgical intensive care unit. His postoperative course was complicated by troponin leak, rhabdomyolysis, delirium, and ileus, all of which resolved over time. He was discharged home on postoperative day seven and continues to do well one-year later. CONCLUSIONS: The patient in this report presented with several episodes of isolated hemoptysis but unlike previously reported cases of unilateral pulmonary artery atresia, he had no history of recurrent respiratory infections, dyspnea, or pulmonary hypertension. Although unilateral pulmonary artery atresia is a rare diagnosis, in patients with unexplained, isolated hemoptysis, further examination of the vasculature may be warranted, and surgical management may be beneficial in appropriate, symptomatic patients.

Coronary Obstruction From TAVR in Native Aortic Stenosis: Development and Validation of Multivariate Prediction Model.

BACKGROUND: Transcatheter aortic valve replacement (TAVR)-related coronary artery obstruction prediction remains unsatisfactory despite high mortality and novel preventive therapies. OBJECTIVES: This study sought to develop a predictive model for TAVR-related coronary obstruction in native aortic stenosis. METHODS: Preprocedure computed tomography and fluoroscopy images of patients in whom TAVR caused coronary artery obstruction were collected. Central laboratories made measurements, which were compared with unobstructed patients from a single-center database. A multivariate model was developed and validated against a 1:1 propensity-matched subselection of the unobstructed cohort. RESULTS: Sixty patients with angiographically confirmed coronary obstruction and 1,381 without obstruction were included. In-hospital death was higher in the obstruction cohort (26.7% vs 0.7%; P < 0.001). Annular area and perimeter, coronary height, sinus width, and sinotubular junction height and width were all significantly smaller in the obstructed cohort. Obstruction was most common on the left side (78.3%) and at the level of the coronary artery ostium (92.1%). Coronary artery height and sinus width, but not annulus area, were significant risk factors for obstruction by logistic regression but performed poorly in predicting obstruction. The new multivariate model (coronary obstruction IF cusp height > coronary height, AND virtual valve-to-coronary distance ≤4 mm OR culprit leaflet calcium volume >600 mm3) performed well, with an area under the curve of 0.93 (sensitivity = 0.93, specificity = 0.84) for the left coronary artery and 0.94 (sensitivity = 0.92, specificity = 0.96) for the right. CONCLUSIONS: A novel computed tomography-based multivariate prediction model that can be implemented routinely in real-world practice predicted coronary artery obstruction from TAVR in native aortic stenosis.

Cardiogenic Shock From Heart Failure Versus Acute Myocardial Infarction: Clinical Characteristics, Hospital Course, and 1-Year Outcomes.

BACKGROUND: Little is known about clinical characteristics, hospital course, and longitudinal outcomes of patients with cardiogenic shock (CS) related to heart failure (HF-CS) compared to acute myocardial infarction (AMI; CS related to AMI [AMI-CS]). METHODS: We examined in-hospital and 1-year outcomes of 520 (219 AMI-CS, 301 HF-CS) consecutive patients with CS (January 3, 2017-December 31, 2019) in a single-center registry. RESULTS: Mean age was 61.5±13.5 years, 71% were male, 22% were Black patients, and 63% had chronic kidney disease. The HF-CS cohort was younger (58.5 versus 65.6 years, P<0.001), had fewer cardiac arrests (15.9% versus 35.2%, P<0.001), less vasopressor utilization (61.8% versus 82.2%, P<0.001), higher pulmonary artery pulsatility index (2.14 versus 1.51, P<0.01), lower cardiac power output (0.64 versus 0.77 W, P<0.01) and higher pulmonary capillary wedge pressure (25.4 versus 22.2 mm Hg, P<0.001) than patients with AMI-CS. Patients with HF-CS received less temporary mechanical circulatory support (34.9% versus 76.3% P<0.001) and experienced lower rates of major bleeding (17.3% versus 26.0%, P=0.02) and in-hospital mortality (23.9% versus 39.3%, P<0.001). Postdischarge, 133 AMI-CS and 229 patients with HF-CS experienced similar rates of 30-day readmission (19.5% versus 24.5%, P=0.30) and major adverse cardiac and cerebrovascular events (23.3% versus 28.8%, P=0.45). Patients with HF-CS had lower 1-year mortality (n=123, 42.6%) compared to the patients with AMI-CS (n=110, 52.9%, P=0.03). Cumulative 1-year mortality was also lower in patients with HF-CS (log-rank test, P=0.04). CONCLUSIONS: Patients with HF-CS were younger, and despite lower cardiac power output and higher pulmonary capillary wedge pressure, less likely to receive vasopressors or temporary mechanical circulatory support. Although patients with HF-CS had lower in-hospital and 1-year mortality, both cohorts experienced similarly high rates of postdischarge major adverse cardiovascular and cerebrovascular events and 30-day readmission, highlighting that both cohorts warrant careful long-term follow-up. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT03378739.

Enhancing occupational safety in the X-ray laboratory.

Despite more than 80% of interventional operators reporting one or more orthopedic injuries attributed to the X-ray laboratory, there has been limited adoption of various strategies and equipment to minimize these injuries. A comprehensive review of these methods to reduce musculoskeletal strain is lacking in the current literature, and is essential in order to ensure a long, healthy, and productive interventional career.

Pulmonary Venous Waveforms Predict Rehospitalization and Mortality After Percutaneous Mitral Valve Repair.

OBJECTIVES: In this study, the authors hypothesized that intraprocedural improvement of pulmonary venous (PV) waveforms are predictive of improved outcomes. In this report, they analyzed intraprocedural invasive and echocardiographic changes with respect to rehospitalization and mortality. BACKGROUND: The effects of hemodynamic changes during percutaneous mitral valve repair (PMVR) with MitraClip (Abbott Vascular, Santa Clara, California) are incompletely characterized. METHODS: The authors retrospectively reviewed records and intraprocedural transesophageal echocardiograms of 115 consecutive patients (age 76 ± 12 years) who underwent PMVR for mitral regurgitation (MR) from May 2013 to January 2017 at Emory University Hospital. They assessed intraprocedural PV waveforms for improvement in morphology, measured change in MR grade by semiquantitative methods, evaluated invasive changes in left atrial pressure (LAP) and V-wave, and compared with 30-day and 1-year rehospitalization and all-cause mortality. RESULTS: Ninety-three cases (80%) had PV waveforms before and after clip placement sufficient for analysis, of which 67 (73%) demonstrated intraprocedural improvement in PV morphology and 25 (27%) did not. At 24 months, 57 (85%) of those with PV improvement were living, compared with only 10 (40%) of those without improvement. Proportional hazards models demonstrated a significant survival advantage in those with PV improvement (hazard ratio [HR]: 0.28, 95% confidence interval [CI]: 0.08 to 0.93, p = 0.038). By multivariable analysis, PV improvement predicted reduced 1-year cardiac rehospitalization (odds ratio [OR]: 0.18, p = 0.044). Intraprocedural assessment of MR grade and invasive hemodynamics did not consistently predict mortality and rehospitalization. CONCLUSIONS: PV waveforms are important markers of procedural success after PMVR. Our data show intraprocedural PV waveforms may predict rehospitalization and mortality after PMVR. A larger, multicenter cohort will be important to clarify this relationship.

Contemporary evaluation of mitral regurgitation - 3D echocardiography, cardiac magnetic resonance, and procedural planning.

INTRODUCTION: Mitral regurgitation is one of the more common forms of valvular heart disease. Given the expansion of therapies for structural heart disease, new therapies for mitral regurgitation are emerging. An accurate description and classification of mitral disease is important to understand pathology and provide recommendations for therapy. Areas covered: In the modern evaluation of mitral regurgitation, 3-dimensional echocardiography (3DE) and cardiac magnetic resonance imaging (CMR) play important roles which overcome the prior limitations of 2-dimensional echocardiography. Specifically, an advanced evaluation with these techniques allows accurate characterization of the anatomic etiology of mitral regurgitation and quantification of severity. Furthermore, the role of 3DE during intraprocedural guidance, 'interventional echocardiography,' is expanding. Expert commentary: In our review, we demonstrate a complete diagnostic evaluation of mitral valve dysfunction by 3DE and CMR and describe current implications for invasive therapy and procedural guidance.

End-stage renal disease and severe aortic stenosis: Does valve replacement improve one-year outcomes?

BACKGROUND: Treatment for patients with end-stage renal disease (ESRD) and severe aortic stenosis (AS) includes balloon aortic valvuloplasty (BAV), surgical (SAVR), or transcatheter (TAVR) aortic valve replacement. We compared outcomes among these strategies. METHODS: A retrospective review of patients with ESRD undergoing treatment for severe AS between 07/2007 and 06/2015 was performed at our center. Patients were classified based on treatment: BAV-only, TAVR, or SAVR. Baseline characteristics and 30-day outcomes were compared among groups. A 1-year survival analysis was performed. RESULTS: Of 85 patients, 25 (29.4%) underwent BAV, 30 (35.3%) TAVR, and 30 (35.3%) SAVR. Patients in the SAVR group, compared to the BAV or TAVR patients, were younger (63 vs. 74 vs. 71 years, P = 0.02) and had less prior stroke (3.3% vs. 12.0% vs. 30.0%, P = 0.008). While all BAV patients had NYHA class III/IV, 93.3% and 76.7% of patients had NYHA class III/IV in the TAVR and SAVR group, respectively (P = 0.001). BAV patients were less likely to have atrial fibrillation than TAVR or SAVR patients (16.0% vs. 43.3% vs. 50.0%, P = 0.03). All patients were high risk, but there was a statistical trend to lower STS scores in the SAVR group (8.6% vs. 13.5% vs. 13.5%, P = 0.08). There was no significant difference in 30-day mortality (16.7% vs. 10.0% vs. 10.0%, P = 0.74), but BAV treated patients had an increased 1-year mortality compared to those treated with TAVR or SAVR (87.0% vs. 32.0%, vs. 36.7%, P=<0.001). Independent predictors of 1-year mortality were a higher STS score (HR 1.026, 95%CI 1.002-1.051) and BAV-only strategy (BAV vs. TAVR: HR 3.961, 95%CI 1.595-9.840), but dialysis duration and type, and SAVR versus TAVR were not. CONCLUSIONS: Patients with ESRD and severe AS have a similar and higher survival with TAVR or SAVR when compared to BAV at 1-year. These results may influence patient care decisions favoring valve replacement in AS patients with ESRD. © 2016 Wiley Periodicals, Inc.

Should We Perform Carotid Doppler Screening Before Surgical or Transcatheter Aortic Valve Replacement?

BACKGROUND: Screening for internal carotid artery stenosis (ICAS) with Doppler ultrasound is commonly used before cardiovascular surgery. Nevertheless, the relationship between ICAS and procedure-related stroke in isolated aortic valve replacement is unclear. METHODS: We retrospectively reviewed patients with artery stenosis who underwent ICAS screening before surgical (SAVR) or transcatheter aortic valve replacement (TAVR) between January 2007 and August 2014. Logistic regression models were used to determine the relation between post-procedure stroke and total (sum of left and right ICAS) and maximal unilateral ICAS. Age, sex, history of atrial fibrillation, cerebrovascular disease and diabetes, left ventricular ejection fraction, and procedure type were considered as covariates. Two-subgroup analyses were performed in patients who underwent TAVR and SAVR, adjusting for procedure specific details. RESULTS: A total of 996 patients underwent ICAS screening before TAVR (n = 467) or SAVR (n = 529). The prevalence of at least ≥70% ICAS was 5.2% (n = 52) and incidence of 30-day stroke was 3.4% (n = 34). Eight patients who underwent carotid intervention before valve replacement and 6 patients with poor Doppler images were excluded from the final analysis. We found no statistically significant association between stroke and either the total or maximal unilateral ICAS for all patients (p = 0.13 and p = 0.39, respectively) or those undergoing TAVR (p = 0.27 and p = 0.63, respectively) or SAVR (p = 0.21 and p = 0.36, respectively). CONCLUSIONS: We found no statistically significant association between ICAS severity procedure-related stroke after aortic valve replacement. This suggests that universal carotid Doppler screening before isolated TAVR or SAVR is unnecessary.

In vivo lipid core plaque modification with percutaneous coronary revascularization: a near-infrared spectroscopy study.

BACKGROUND: Coronary revascularization is associated with no-reflow phenomenon and elevation of cardiac biomarkers. This may occur due to plaque modification. We used near-infrared spectroscopy (NIRS) to evaluate lipid core plaque (LCP) modification with coronary revascularization and its correlation with periprocedural myocardial infarction. METHODS: Patients presenting to the cardiac catheterization laboratory who underwent NIRS, NIRS/intravascular ultrasound (IVUS) were reviewed and their lipid core burden index (LCBI) was assessed. Using fuzzy c-means clustering algorithm, the coronary was divided into three zones and the lipid burden was recalculated. Its correlation to postprocedure troponin elevation and outcomes with a mean follow-up of 42 months were studied. RESULTS: A total of 77 coronaries were evaluated. There was an overall decrease in the LCBI after percutaneous revascularization (P<.0001). Using fuzzy c-means clustering algorithm, there was always a decrease in the lipid burden at the site of the percutaneous revascularization (P<.0001). Postprocedure troponin elevation was only noted in patients with an axial shifting of the LCP. There was no difference in long-term outcomes due to the degree of reduction of lipid burden or its axial. CONCLUSIONS: Plaque modification may be performed successfully using interventional methods and can be evaluated with NIRS. Axial plaque shifting is an acute prognostic marker for postprocedure myocardial infarction.