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• Patients experiencing loss of pulse pressure (LOPP) during high-risk percutaneous coronary intervention (HR-PCI) are transiently dependent on mechanical circulatory support (MCS) devices. • LOPP during HR-PCI with Impella was common and occurred more frequently in patients with cardiomyopathy and low systolic blood pressure. LOPP was strongly associated with higher 90-day major adverse cardiac and cerebrovascular events, acute kidney injury, and mortality. • The ongoing randomized PROTECT-IV trial will determine whether Impella CP support during HR-PCI improves early and late clinical outcomes compared with the standard of care. The trial includes a right heart catheterization substudy that should help to define the role of invasive hemodynamics in stratifying and managing patients undergoing HR-PCI. Patients experiencing loss of pulse pressure (LOPP) during high-risk percutaneous coronary intervention (HR-PCI) are transiently dependent on mechanical circulatory support devices. We sought to define the frequency and clinic outcomes of patients who experience LOPP during HR-PCI. Patients enrolled in the PROTECT III study and had automated Impella controller logs capturing real-time hemodynamics were included in this analysis. A LOPP event was defined as a mean pulse pressure on Impella of <20 mm Hg for ≥5 seconds during PCI. Clinical characteristics and outcomes were then compared between those with and without LOPP. Logistic regression identified clinical and hemodynamic predictors of LOPP. We included 302 patients, of whom 148 patients (49%) experienced LOPP. Age, sex, and comorbidities were similar in patients with and without LOPP. Mean baseline systolic blood pressure (118.6 mm Hg vs 129.8 mm Hg; P <.001) and mean arterial pressure (86.9 mm Hg vs 91.6 mm Hg; P =.011) were lower in patients with LOPP, whereas heart rate (78 bpm vs 73 bpm; P =.012) was higher. Anatomical complexity was similar between groups. Patients with LOPP were more likely to experience major adverse cardiac and cerebrovascular events (23.5% vs 8.8%; P =.002), acute kidney injury (10.1% vs 2.6%; P =.030), and death (20.2% vs 7.9%; P =.008) within 90 days. A low baseline systolic blood pressure and cardiomyopathy were the strongest predictors of LOPP (P =.003 and P =.001, respectively). LOPP on Impella during HR-PCI was common and occurred more frequently in patients with cardiomyopathy and a low systolic blood pressure. LOPP was strongly associated with higher 90-day major adverse cardiac and cerebrovascular events, acute kidney injury, and mortality. Condensed Abstract We sought to define the frequency and clinic outcomes of patients who experience LOPP during high-risk percutaneous coronary intervention (HR-PCI). We included 302 patients, of whom 148 (49%) experienced LOPP. Patients with LOPP were more likely to experience major adverse cardiac and cerebrovascular events (23.5% vs 8.8%; P =.002), acute kidney injury (10.1% vs 2.6%; P =.030), and death (20.2% vs 7.9%; P =.008) within 90 days. A low baseline systolic blood pressure and cardiomyopathy were the strongest predictors of LOPP (P =.003 and P =.001, respectively). [ABSTRACT FROM AUTHOR]

Right ventricular dysfunction (RVD) complicates 30%–40% of cases in acute myocardial infarction (AMI) and cardiogenic shock (CS). There are sparse data on the effects of RVD on outcomes and the impact of providing early left ventricular (LV) mechanical circulatory support (MCS) on RV function and hemodynamics. Between July 2016 and December 2020, 80 sites participated in the study. All centers agreed to treat patients with AMI-CS using a standard protocol emphasizing invasive hemodynamic monitoring and rapid initiation of LV-MCS. RVD was defined as a right atrial (RA) pressure of >12 mm Hg and a pulmonary artery pulsatility index (PAPI) of <1 within 24 hours of the index procedure. The primary outcome was survival to discharge. In a subgroup analysis, data available from the Automated Impella Controller console was used to analyze diastolic suction alarms from LV placement signal and its relation to RVD. A total of 361 patients were included in the analysis, of whom 28% had RVD. The median age was 64 years (interquartile range 55–72 years), 22.7% were female and 75.7% were White. There was no difference in age, sex, or comorbidities between those with or without RVD. Patients with RVD had a higher probability of active CPR during LV-MCS implant (14.7% vs 6.3%), Society for Cardiovascular Angiography and Interventions stage E shock (39.2% vs 23.2%), and higher admission lactate levels (5.1 mg/dL vs 3.0 mg/dL). Survival to discharge was significantly lower among those with RVD (61.8% vs 73.4%, odds ratio 0.89, 95% confidence interval 0.36–0.95, P =.031). This association remained significant in the multivariate analysis. There was no significant difference in hemodynamic variables within 24 hours of LV-MCS support among those with or without RVD. At 24 hours, patients with a CPO of >0.6 W and a PAPi of >1 had a trend toward better survival to discharge compared with those with a CPO of ≤0.6 W and a PAPi of ≤1 (77.1% vs 54.6%, P =.092). Patients with RVD were significantly more likely to have diastolic suction alarms within 24 hours of LV-MCS initiation. RVD in AMI-CS is common and associated with worse survival to discharge. Early LV-MCS decreases filling pressures rapidly within the first 24 hours and decreases the rate of RVD. Achieving a CPO of >0.6 W and a PAPi of >1 within 24 hours is associated with high survival. Diastolic suction alarms may have usefulness as an early marker of RVD. [ABSTRACT FROM AUTHOR]

Right ventricular dysfunction (RVD) is an important prognostic factor in several cardiac conditions, including acute and chronic heart failure. The impact of baseline RVD on clinical outcomes of patients undergoing high-risk percutaneous coronary intervention (HRPCI) supported by Impella is unknown. Patients from the single-arm, multicenter PROTECT III study of Impella-supported HRPCI were stratified based on the presence or absence of RVD. RVD was quantitatively assessed by an echocardiography core laboratory and was defined as fractional area change < 35%, tricuspid annular plane systolic excursion < 17 mm or pulsed-wave Doppler S-wave of the lateral tricuspid annulus < 9.5 cm/s. Procedural outcomes, 90-day major adverse cardiac and cerebrovascular events (MACCE: the composite of all-cause mortality, myocardial infarction, stroke/TIA, and repeat revascularization), and 1-year mortality were assessed. Of the 239 patients who underwent RV function assessment, 124 were found to have RVD. Lower left ventricular ejection fraction, higher blood urea nitrogen levels, and more severe RV dilation were independently associated with RVD. The incidence of hypotensive episodes during PCI, the proportion of patients requiring prolonged Impella support, the completeness of revascularization, and the rate of in-hospital mortality did not differ significantly between patients with vs without RVD. However, 90-day MACCE rates were higher in those with RVD, and RVD was a robust predictor of 1-year mortality in multivariable Cox-regression analyses. In patients undergoing HRPCI with Impella, RVD was associated with more advanced biventricular failure. The use of Impella support during HRPCI facilitated effective revascularization, even in those with concomitant RVD. Nevertheless, RVD was associated with unfavorable long-term prognoses. In the PROTECT III study, among the 239 patients undergoing high-risk percutaneous coronary intervention (HRPCI) with Impella, 48% demonstrated normal right ventricular (RV) function, while 52% exhibited RV dysfunction, based on quantitative imaging. Both groups displayed a comparable extent of revascularization, as evaluated by the SYNTAX Score pre- and post-procedure, and similar in-hospital mortality rates. However, patients with RV dysfunction experienced higher rates of 90-day major adverse cardiac and cerebrovascular events (MACCE) as well as higher 1-year mortality rates. [Display omitted] [ABSTRACT FROM AUTHOR]

A prior Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry–based analysis reported similar 1-year clinical outcomes with small (20-mm) vs large (≥23-mm) balloon-expandable valves (BEV). The aim of this study was to describe mid-term 3-year clinical outcomes for small vs large BEV and the relationship between discharge echocardiographic mean gradient (MG) and different definitions of prothesis-patient mismatch (PPM) with clinical outcomes. Using the TVT Registry with Centers for Medicare and Medicaid Services linkage, a propensity-matched analysis of patients receiving 20- vs ≥23-mm BEVs was performed. Spline curves and Kaplan-Meier plots with adjusted HRs determined the relationship between MG and 3-year mortality. In total, 316,091 patients were analyzed; after propensity matching, 8,100 pairs of each group were compared. The 20-mm BEV was associated with higher MGs compared with ≥23-mm BEVs (16.2 ± 7.2 mm Hg vs 11.8 ± 5.7 mm Hg; P < 0.0001). At 3 years, there was no difference in mortality between 20- and ≥23-mm BEVs (31.5% vs 32.5%, respectively; HR: 0.97; 95% CI: 0.90-1.05). Compared with an MG of 10 to 30 mm Hg, an MG <10 mm Hg (HR: 1.25; 95% CI:1.22-1.27) was associated with increased 3-year mortality. Measured severe PPM and predicted no PPM were associated with increased 3-year mortality (33.5% vs 32.9% vs 32.1%; P < 0.0001) and (33.5% vs 31.1% vs 30%; P < 0.0001), respectively. Low MG and severe measured PPM were associated with lower left ventricular ejection fraction (LVEF). Patients with small-prosthesis BEVs (20 mm) had identical 3-year survival as those with larger (≥23-mm) BEV valves. Severe measured PPM and low MG (<10 mm Hg), but not predicted severe PPM, were associated with lower LVEF and increased mortality, suggesting that LVEF is the culprit for worse outcomes. [Display omitted] [ABSTRACT FROM AUTHOR]

Tricuspid regurgitation (TR) is highly prevalent in the transcatheter aortic valve replacement (TAVR) population, but clear management guidelines are lacking. The aims of this study were to elucidate the prevalence and consequences of severe TR in patients with aortic stenosis undergoing TAVR and to examine the change in TR post-TAVR, including predictors of improvement and its impact on longer term mortality. Using Centers for Medicare and Medicaid Services–linked TVT (Transcatheter Valve Therapy) Registry data, a propensity-matched analysis was performed among patients undergoing TAVR with baseline mild, moderate, or severe TR. Kaplan-Meier estimates were used to assess the impact of TR on 3-year mortality. Multivariable analysis identified predictors of 30-day TR improvement. Of the 312,320 included patients, 84% had mild, 13% moderate, and 3% severe TR. In a propensity-matched cohort, severe baseline TR was associated with higher in-hospital mortality (2.5% vs 2.1% for moderate TR and 1.8% for mild TR; P = 0.009), higher 1-year mortality (24% vs 19.6% for moderate TR and 16.6% for mild TR; P < 0.0001), and 3-year mortality (54.2% vs 48.5% for moderate TR and 43.3% for mild TR; P < 0.0001). Among the patients with severe TR at baseline, 76.4% improved to moderate or less TR 30 days after TAVR. Baseline mitral regurgitation moderate or greater, preserved ejection fraction, higher aortic valve gradient, and better kidney function predicted TR improvement after TAVR. However, severe 30-day residual TR was associated with higher 1-year mortality (27.4% vs 18.7% for moderate TR and 16.8% for mild TR; P < 0.0001). Severe baseline and 30-day residual TR after TAVR are associated with increased mortality up to 3 years. This analysis identifies a higher risk group that could be evaluated for the recently approved tricuspid interventions. [Display omitted] [ABSTRACT FROM AUTHOR]

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). 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. 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). 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. [Display omitted] [ABSTRACT FROM AUTHOR]

Favorable 6-month outcomes from the CLASP IID Registry (Edwards PASCAL transcatheter valve repair system pivotal clinical trial) demonstrated that mitral valve transcatheter edge-to-edge repair with the PASCAL transcatheter valve repair system is safe and beneficial for treating prohibitive surgical risk degenerative mitral regurgitation (DMR) patients with complex mitral valve anatomy. The authors sought to assess 1-year safety, echocardiographic and clinical outcomes from the CLASP IID Registry. Patients with 3+ or 4+ DMR who were at prohibitive surgical risk, had complex mitral valve anatomy based on the MitraClip Instructions for Use, and deemed suitable for treatment with the PASCAL system were enrolled prospectively. Safety, clinical, echocardiographic, functional, and quality-of-life outcomes were assessed at 1 year. Study oversight included a central screening committee, echocardiographic core laboratory, and clinical events committee. Ninety-eight patients were enrolled. One-year Kaplan-Meier (KM) estimates of freedom from composite major adverse events, all-cause mortality, and heart failure hospitalization were 83.5%, 89.3%, and 91.5%, respectively. Significant mitral regurgitation (MR) reduction was achieved at 1 year (P < 0.001 vs baseline) including 93.2% at MR ≤2+ and 57.6% at MR ≤1+ with improvements in related echocardiographic measures. NYHA functional class and Kansas City Cardiomyopathy Questionnaire score also improved significantly (P < 0.001 vs baseline). At 1 year, treatment with the PASCAL system demonstrated safety and significant MR reduction, with continued improvement in clinical, echocardiographic, functional, and quality-of-life outcomes, illustrating the value of the PASCAL system in the treatment of prohibitive surgical risk patients with 3+ or 4+ DMR and complex mitral valve anatomy. [Display omitted] [ABSTRACT FROM AUTHOR]

Prior studies have found that female patients have worse outcomes following high-risk percutaneous coronary intervention (HRPCI). 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. 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. 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. 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) [Display omitted] [ABSTRACT FROM AUTHOR]

Despite successful primary percutaneous coronary intervention (PCI) in ST-elevation myocardial infarction (STEMI), myocardial salvage is often suboptimal, resulting in large infarct size and increased rates of heart failure and mortality. Unloading of the left ventricle (LV) before primary PCI may reduce infarct size and improve prognosis. STEMI-DTU (NCT03947619) is a prospective, randomized, multicenter trial designed to compare mechanical LV unloading with the Impella CP device for 30 minutes prior to primary PCI to primary PCI alone without LV unloading. The trial aims to enroll approximately 668 subjects, with a potential sample size adaptation, with anterior STEMI with a primary end point of infarct size as a percent of LV mass evaluated by cardiac magnetic resonance at 3-5 days after PCI. The key secondary efficacy end point is a hierarchical composite of the 1-year rates of cardiovascular mortality, cardiogenic shock ≥24 hours after PCI, use of a surgical left ventricular assist device or heart transplant, heart failure, intra-cardiac defibrillator or chronic resynchronization therapy placement, and infarct size at 3 to 5 days post-PCI. The key secondary safety end point is Impella CP-related major bleeding or major vascular complications within 30 days. Clinical follow-up is planned for 5 years. STEMI-DTU is a large-scale, prospective, randomized trial evaluating whether mechanical unloading of the LV by the Impella CP prior to primary PCI reduces infarct size and improves prognosis in patients with STEMI compared to primary PCI alone without LV unloading. [ABSTRACT FROM AUTHOR]

Background: Severe coronary artery calcification has been associated with stent underexpansion, procedural complications, and increased rates of early and late adverse clinical events in patients undergoing percutaneous coronary intervention. To date, no lesion preparation strategy has been shown to definitively improve outcomes of percutaneous coronary intervention for calcified coronary artery lesions.Study Design and Objectives: ECLIPSE (NCT03108456) is a prospective, randomized, multicenter trial designed to evaluate two different vessel preparation strategies in severely calcified coronary artery lesions. The routine use of the Diamondback 360 Coronary Orbital Atherectomy System is compared with conventional balloon angioplasty prior to drug-eluting stent implantation. The trial aims to enroll approximately 2000 subjects with a primary clinical endpoint of target vessel failure, defined as the composite of cardiac death, target vessel-related myocardial infarction, or ischemia-driven target vessel revascularization assessed at 1 year. The co-primary endpoint is the acute post-procedural in-stent minimal cross-sectional area as assessed by optical coherence tomography in a 500-subject cohort. Enrollment is anticipated to complete in 2022 with total clinical follow-up planned for 2 years.Conclusions: ECLIPSE is a large-scale, prospective randomized trial powered to demonstrate whether a vessel preparation strategy of routine orbital atherectomy system is superior to conventional balloon angioplasty prior to implantation of drug-eluting stents in severely calcified coronary artery lesions. [ABSTRACT FROM AUTHOR]

Up to 20 % of patients presenting with acute heart failure and cardiogenic shock have a structural etiology. Despite efforts in timely management, mortality rates remain alarmingly high, ranging from 50 % to 80 %. Surgical intervention is often the definitive treatment for structural heart disease; however, many patients are considered high risk or unsuitable candidates for such procedures. Consequently, there has been a paradigm shift towards the development of novel percutaneous management strategies and temporizing interventions. This article aims to provide a comprehensive review of the pathophysiology of valvular and structural heart conditions presenting in cardiogenic shock, focusing on the evolving landscape of mechanical circulatory support devices and other management modalities. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

The study compared 1-year outcomes between transcatheter aortic valve replacement (TAVR) patients with bicuspid aortic valve (BAV) morphology and clinically similar patients having tricuspid aortic valve (TAV) morphology. There are limited prospective data on TAVR using the SAPIEN 3 device in low-surgical-risk patients with severe, symptomatic aortic stenosis and bicuspid anatomy. Low-risk, severe aortic stenosis patients with BAV were candidates for the PARTNER 3 (Placement of Aortic Transcatheter Valves 3) (P3) bicuspid registry or the P3 bicuspid continued access protocol. Patients treated in these registries were pooled and propensity score matched to TAV patients from the P3 randomized TAVR trial. Outcomes were compared between groups. The primary endpoint was the 1-year composite rate of death, stroke, and cardiovascular rehospitalization. Of 320 total submitted BAV patients, 169 (53%) were treated, and most were Sievers type 1. The remaining 151 patients were excluded caused by anatomic or clinical criteria. Propensity score matching with the P3 TAVR cohort (496 patients) yielded 148 pairs. There were no differences in baseline clinical characteristics; however, BAV patients had larger annuli and they experienced longer procedure duration. There was no difference in the primary endpoint between BAV and TAV (10.9% vs 10.2%; P = 0.80) or in the rates of the individual components (death: 0.7% vs 1.4%; P = 0.58; stroke: 2.1% vs 2.0%; P = 0.99; cardiovascular rehospitalization: 9.6% vs 9.5%; P = 0.96). Among highly select bicuspid aortic stenosis low-surgical-risk patients without extensive raphe or subannular calcification, TAVR with the SAPIEN 3 valve demonstrated similar outcomes to a matched cohort of patients with tricuspid aortic stenosis. [Display omitted] [ABSTRACT FROM AUTHOR]

The TRISCEND study (Edwards EVOQUE Tricuspid Valve Replacement: Investigation of Safety and Clinical Efficacy after Replacement of Tricuspid Valve with Transcatheter Device) is evaluating the safety and performance of transfemoral transcatheter tricuspid valve replacement in patients with clinically significant tricuspid regurgitation (TR) and elevated surgical risk. Transcatheter valve replacement could lead to a paradigm shift in treating TR and improving patient quality of life. In the prospective, single-arm, multicenter TRISCEND study, patients with symptomatic moderate or greater TR, despite medical therapy, underwent percutaneous transcatheter tricuspid valve replacement with the EVOQUE system. A composite rate of major adverse events, echocardiographic parameters, and clinical, functional, and quality-of-life measures were assessed at 30 days. Fifty-six patients (mean age of 79.3 years, 76.8% female, 91.1% TR severe or greater, 91.1% atrial fibrillation, and 87.5% New York Heart Association functional class III or IV) were treated. At 30 days, TR was reduced to mild or less in 98%. The composite major adverse events rate was 26.8% at 30 days caused by 1 cardiovascular death in a patient with a failed procedure, 2 reinterventions after device embolization, 1 major access site or vascular complication, and 15 severe bleeds, of which none were life-threatening or fatal. No myocardial infarction, stroke, renal failure, major cardiac structural complications, or device-related pulmonary embolism were observed. New York Heart Association significantly improved to functional class I or II (78.8%; P < 0.001), 6-minute walk distance improved 49.8 m (P < 0.001), and Kansas City Cardiomyopathy Questionnaire score improved 19 points (P < 0.001). Early experience with the transfemoral EVOQUE system in patients with clinically significant TR demonstrated technical feasibility, acceptable safety, TR reduction, and symptomatic improvement at 30 days. The TRISCEND II randomized trial (NCT04482062) is underway. [Display omitted] [ABSTRACT FROM AUTHOR]

This study sought to evaluate the differences in cardiogenic shock patient characteristics in trial patients and real-life patients. Cardiogenic shock (CS) is a leading cause of mortality in patients presenting with acute myocardial infarction (AMI). However, the enrollment of patients into clinical trials is challenging and may not be representative of real-world patients. We performed a systematic review of studies in patients presenting with AMI-related CS and compared patient characteristics of those enrolled into randomized controlled trials (RCTs) with those in registries. We included 14 RCTs (n = 2,154) and 12 registries (n = 133,617). RCTs included more men (73% vs 67.7%, P < 0.001) compared with registries. Patients enrolled in RCTs had fewer comorbidities, including less hypertension (61.6% vs 65.9%, P < 0.001), dyslipidemia (36.4% vs 53.6%, P < 0.001), a history of stroke or transient ischemic attack (7.1% vs 10.7%, P < 0.001), and prior coronary artery bypass graft surgery (5.4% vs 7.5%, P < 0.001). Patients enrolled in RCTs also had lower lactate levels (4.7 ± 2.3 mmol/L vs 5.9 ± 1.9 mmol/L, P < 0.001) and higher mean arterial pressure (73.0 ± 8.8 mm Hg vs 62.5 ± 12.2 mm Hg, P < 0.001). Percutaneous coronary intervention (97.5% vs 58.4%, P < 0.001) and extracorporeal membrane oxygenation (11.6% vs 3.4%, P < 0.001) were used more often in RCTs. The in-hospital mortality (23.9% vs 38.4%, P < 0.001) and 30-day mortality (39.9% vs 45.9%, P < 0.001) were lower in RCT patients. RCTs in AMI-related CS tend to enroll fewer women and lower-risk patients compared with registries. Patients enrolled in RCTs are more likely to receive aggressive treatment with percutaneous coronary intervention and extracorporeal membrane oxygenation and have lower in-hospital and 30-day mortality. [Display omitted] [ABSTRACT FROM AUTHOR]

Transfemoral is the most widely used access to perform transcatheter aortic valve replacement (TAVR). However, alternative access is needed in up to 21% of patients with TAVR because of a myriad of factors. The authors provide a comprehensive review on alternative access for TAVR, discussing the relevant data and providing the pros and cons of each access route. [ABSTRACT FROM AUTHOR]

Cardiogenic shock (CS) is a condition associated with high mortality rates in which prognostication is uncertain for a variety of reasons, including its myriad causes, its rapidly evolving clinical course and the plethora of established and emerging therapies for the condition. A number of validated risk scores are available for CS prognostication; however, many of these are tedious to use, are designed for application in a variety of populations and fail to incorporate contemporary hemodynamic parameters and contemporary mechanical circulatory support interventions that can affect outcomes. It is important to separate patients with CS who may recover with conservative pharmacological therapies from those in who may require advanced therapies to survive; it is equally important to identify quickly those who will succumb despite any therapy. An ideal risk-prediction model would balance incorporation of key hemodynamic parameters while still allowing dynamic use in multiple scenarios, from aiding with early decision making to device weaning. Herein, we discuss currently available CS risk scores, perform a detailed analysis of the variables in each of these scores that are most predictive of CS outcomes and explore a framework for the development of novel risk scores that consider emerging therapies and paradigms for this challenging clinical entity. [ABSTRACT FROM AUTHOR]

Coronary artery disease is a condition in which the coronary arteries (which supply the heart with blood) become narrowed to the extent that they no longer provide sufficient blood to the heart. This often results from the build-up of fatty atherosclerotic deposits in the coronary arteries; these deposits may inhibit blood flow, causing damage to the heart muscle. A common treatment for coronary artery disease is percutaneous transluminal coronary angioplasty (PTCA), a procedure in which an inflatable balloon is introduced into the occluded region of a coronary artery and inflated, stretching the artery enough to restore near-normal blood flow. A complication that frequently accompanies PTCA is the formation or dislodging of a clot during the trauma imposed on the arterial wall when it is stretched. The administration of clot-dissolving or clot-inhibiting drugs at the time of PTCA is one way of dealing with this problem; however, increased risks, such as hemorrhage, accompany this adjunctive therapy. To determine the safety and efficacy of urokinase (a clot-dissolving enzyme), 89 of 462 patients who underwent PTCA were treated with urokinase. Urokinase was administered as treatment for chest pain (26 percent), intracoronary clot formation (34 percent), disease afflicting the inner lining of the artery (intimal dissection; 27 percent), abrupt closure (10 percent), and clot formation in a vein grafted to bypass the coronary artery (3 percent). The urokinase-treated patients were compared with 167 patients with similar profiles who had not received urokinase. PTCA success rates were similar in both groups. Adverse cardiac events were less prevalent in the urokinase-treated patients with intracoronary clot formation, but more prevalent in urokinase-treated patients with intimal dissection. The outcomes of patients who had received urokinase for other reasons were similar to controls with respect to adverse cardiac events. These results suggest that urokinase may be beneficial in patients with intracoronary clots who are undergoing PTCA. (Consumer Summary produced by Reliance Medical Information, Inc.)

Transcaval transcatheter aortic valve replacement (TC-TAVR) is an alternative approach to transcatheter aortic valve replacement involving deployment of the bioprosthetic valve via a conduit created from the inferior vena cava to the descending aorta in patients for whom the traditional transfemoral approach is not feasible. By analyzing the largest known cohort of TC-TAVR patients, the authors wished to compare hospital length of stay and post-procedure outcomes between patients who underwent the procedure under deep sedation (DS) and patients who underwent general anesthesia with an endotracheal tube. Retrospective, single-center study. Henry Ford Hospital in Detroit, MI. Patients undergoing TC-TAVR from 2015 to 2018. Seventy-nine patients were included in the analysis, which consisted of 38 under general anesthesia with an endotracheal tube and 41 under DS. The sample was divided into a general anesthesia (GA) group and DS group. There were no significant differences in implant success rate or post-procedure outcomes, including in-hospital mortality (p = 0.999) and major vascular complication rate (p = 0.481), between the two groups. Patients in the GA group stayed a median of 24 hours longer in the intensive care unit (ICU) (p < 0.001) and one day longer in the hospital (p = 0.046) after the procedure compared to patients in the DS group. The median procedure time was significantly lower (135 minutes) in the DS group compared to the GA group (167 minutes, p < 0.001). Patients undergoing TC-TAVR under DS had similar postoperative outcomes and shorter post-procedure hospital and ICU lengths of stay compared to general anesthesia. In the authors' experience, DS is the preferred anesthetic technique for TC-TAVR. [ABSTRACT FROM AUTHOR]