Review of Pathophysiology of Cardiogenic Shock and Escalation of Mechanical Circulatory Support Devices.

PURPOSE OF REVIEW: Cardiogenic shock (CS) is a complex clinical entity that continues to carry a high risk of mortality. The landscape of CS management has changed with the advent of several temporary mechanical circulatory support (MCS) devices designed to provide hemodynamic support. It remains challenging to understand the role of different temporary MCS devices in patients with CS, as many of these patients are critically ill, requiring complex care with multiple MCS device options. Each temporary MCS device can provide different types and levels of hemodynamic support. It is important to understand the risk/benefit profile of each one of them for appropriate device selection in patients with CS. RECENT FINDINGS: MCS may be beneficial in CS patients through augmentation of cardiac output with subsequent improvement of systemic perfusion. Selecting the optimal MCS device depends on several variables including the underlying etiology of CS, clinical strategy of MCS use (bridge to recovery, bridge to transplant or durable MCS, or abridge to decision), amount of hemodynamic support needed, associated respiratory failure, and institutional preference. Furthermore, it is even more challenging to determine the appropriate time to escalate from one MCS device to another or combine different MCS devices. In this review, we discuss the current available data published in the literature on the management of CS and propose a standardized approach for escalation of MCS devices in patients with CS. Shock teams can play an important role to help in hemodynamic-guided management and algorithm-based step-by-step approach in early initiation and escalation of temporary MCS devices at different stages of CS. It is important to define the etiology of CS, and stage of shock and recognize univentricular vs biventricular shock for appropriate device selection and escalation of therapy.

Contemporary post-marketing adverse events and modes of failure related to VASCADE Vascular Closure System: The utility of the MAUDE database.

OBJECTIVES: To analyze post-marketing surveillance data from the United States Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database for the VASCADE Vascular Closure System (Cardiva Medical Inc., Santa Clara, CA). BACKGROUND: The VASCADE Vascular Closure System is a closure device for femoral arterial and venous access-site closure that was approved by the FDA in 2013. However, post-marketing data and experience on the most commonly reported complications and modes of failure associated with the VASCADE Vascular Closure System are limited. METHODS: Post-marketing surveillance data from the FDA MAUDE database from October 2013 through March 2020 were analyzed, yielding 201 reports. RESULTS: Of the 201 reports of major complications involving VASCADE devices, 156 reports involved either injury (145) or death (11) related to the device. Of the 145 injury reports, bleeding was the most common adverse outcome described (85), followed by pseudoaneurysm (29) and pulselessness of an extremity (21). The device malfunction incidents (41 reports) were reported in three main categories, with deployment failure being the most commonly reported complication. CONCLUSIONS: Our analysis of the MAUDE database demonstrates that in contemporary post-marketing practice, physicians should be well-trained and educated to use the VASCADE closure device because improper utilization is a common cause of device failure, and complications with the VASCADE device can have profound clinical implications.

Right transradial coronary angiography in the setting of tortuous brachiocephalic/thoracic aorta ("elephant head"): Impact on fluoroscopy time and contrast use.

OBJECTIVES: Assess the impact on fluoroscopy time and contrast use in patients with tortuous brachiocephalic/thoracic aortas undergoing right transradial coronary angiography (RTCA) and provide strategies to manage. BACKGROUND: Unfavorable anatomy with severe brachiocephalic/thoracic tortuosity, referred to as an "elephant head," remains a significant obstacle for RTCA. METHODS: We reviewed the coronary angiograms of patients who underwent RTCA and had tortuous aortas. Angiography was attempted first using a universal catheter (Tiger) and switched to a left coronary specific catheter (Judkins Left [JL]) if challenging. Fluoroscopy time, contrast volume, and greatest distance from the patient's midline to the catheter in the aorta were recorded. RESULTS: Forty-nine patients (62.6 ± 12.0 years, 69.4% male) were included. Fifteen (30.6%) patients underwent successful angiography with a Tiger catheter; 34 (69.4%) patients required switching to JL catheter. The average distance of Tiger catheters to the midline of the spine was 0.78 ± 0.41 cm versus 1.28 ± 0.44 cm (p = .001) in JL catheters. Tiger catheter use resulted in less fluoroscopy time (6.48 ± 4.73 min) and contrast use (58.87 ± 43.53 ml) than in cases switched to JL (13.26 ± 10.76 min [p = .026]; 86.5 ± 69.95 ml [(p = .017]). CONCLUSIONS: For patients undergoing RTCA with significant brachiocephalic/thoracic aorta tortuosity, "elephant head," a Tiger catheter can be used efficiently for curvatures <1 cm from the middle of the spine. We propose that for curvatures >1 cm, operators should consider immediately switching to a JL catheter.

Cangrelor vs. glycoprotein IIb/IIIa inhibitors during percutaneous coronary intervention.

BACKGROUND: To date, there are no real-world studies comparing cangrelor to glycoprotein IIb/IIIa inhibitors (GPI) during percutaneous coronary intervention (PCI). Thus, we performed this study to evaluate the safety and effectiveness of cangrelor compared to GPI during PCI. METHODS: We identified patients who underwent PCI at our institution who received either cangrelor or GPI during PCI. Patients already on GPI or cangrelor prior to PCI or who received both cangrelor and GPI were excluded. Baseline demographics and clinical outcomes were extracted. Major bleeding is defined as a composite of major hematoma >4 cm, hematocrit drop >15, and gastrointestinal bleeding. RESULTS: A total of 2072 patients received adjunctive antiplatelet therapy during PCI (cangrelor [n=478]; GPI [n=1594]). Patients' mean age was 61±12 years. Most (66%) presented with acute coronary syndrome. Patients who received cangrelor were older and had a higher percentage of acute coronary syndrome and lower baseline hematocrit in comparison with patients who received GPI. Procedural success was achieved in 94% of patients, with no difference between groups. Major bleeding events (1.7% vs. 5.1%, P=.001), any vascular complication rates, and hospital length of stay were significantly lower in the cangrelor group. In-hospital ischemic events did not differ between groups. On regression analysis, patients on cangrelor were noted to have significantly lower major bleeding events (OR 0.23; 95% CI, 0.09-0.59). CONCLUSIONS: Balancing ischemic and bleeding risks with adjunctive antiplatelet drugs is of prime importance during PCI. Our real-world analysis shows that cangrelor is safe and effective when compared to GPI during PCI.

National trends and 30-day readmission rates for next-day-discharge transcatheter aortic valve replacement: An analysis from the Nationwide Readmissions Database, 2012-2016.

Transcatheter aortic valve replacement (TAVR) has evolved toward a minimalist approach, resulting in shorter hospital stays. Real-world trends of next-day discharge (NDD) TAVR are unknown. This study aimed to evaluate underlying trends and readmissions of NDD TAVR. METHODS: This study was derived from the Nationwide Readmissions Database from 2012 to 2016. International Classification of Diseases, Ninth and Tenth Revisions, codes were used to identify patients. Any discharge within 1 day of admission was identified as NDD. NDD TAVR trends over the years were analyzed, and any admissions within 30 days were considered readmissions. A hierarchical logistic regression model was used to identify predictors of readmission. RESULTS: Of 49,742 TAVR procedures, 3,104 were NDD. The percentage of NDD TAVR increased from 1.5% (46/3,051) in 2012 to 12.2% (2,393/19,613) in 2016. However, the 30-day readmission rate remained the same over the years (8.6%). The patients' mean age was 80.3 ±â€¯8.4 years. Major readmission causes were heart-failure exacerbation (16%), infections (9%), and procedural complications (8%). In 2016, there were significantly higher late conduction disorder and gastrointestinal bleeding readmission rates than in 2012-2015. Significant predictors of readmission were anemia, baseline conduction disease, cardiac arrhythmias, heart failure, chronic kidney disease, chronic obstructive pulmonary disease, neoplastic disorders, and discharge to facility. CONCLUSIONS: The percentage of NDD TAVR increased over the years; however, readmission rates remained the same, with a higher rate of conduction abnormality-related hospitalizations in 2016. Careful discharge planning that includes identification of baseline factors that predict readmission and knowledge of etiologies may further prevent 30-day readmissions.

Micropuncture technique for femoral access is associated with lower vascular complications compared to standard needle.

OBJECTIVES: We compared access-site complications with a Micropuncture 21-gauge (G) needle to a standard 18G needle in patients undergoing femoral-access percutaneous coronary intervention (PCI). BACKGROUND: Vascular access-site complications are the most common complication after cardiac catheterization. These complications increase patient morbidity and mortality, along with healthcare costs. METHODS: We retrospectively analyzed a cohort of 17,844 consecutive patients undergoing PCI. Micropuncture access was used in 2344 patients and a standard 18G needle in 15,500 patients. Primary endpoints included vascular perforation or limb ischemia requiring repair, retroperitoneal bleeding, pseudoaneurysm, arteriovenous fistula, groin hematoma (>4 cm). RESULTS: Patients undergoing PCI with Micropuncture were at higher risk: they were on anticoagulation (557 [23.7%] vs. 1,590 [10.2%], p < .001), used steroids more frequently (131 [5.6%] vs. 638 [4.1%], p < .001) and required the use of an intra-aortic balloon pump more often (191 [(8.1%] vs. 896 [5.7%], p < .001). Overall, the access-site complications rate was lower using Micropuncture (58 [2.5%]) versus standard needle (558 [3.6%], p = .005). The Micropuncture group had a significantly lower rate of hematoma than standard needle (32 [1.4%] vs. 309 [1.9%], p = .03). There was no significant difference in the rate of limb ischemia (1 [0.04%] vs. 12 [0.07%], p = .56), perforation (2 [0.08%] vs. 14 [0.09%], p = .93), retroperitoneal bleeding (3 [0.12%] vs. 18 [0.11%], p = .87), pseudoaneurysm (18 [0.76%] vs. 170 [1.09%], p = .14), and arteriovenous fistula (2 [0.08%] vs. 35 [0.22%], p = .16), comparing the Micropuncture group to a standard needle, respectively. CONCLUSIONS: Femoral access using a Micropuncture reduced the rate of vascular complications with significant reduction in the rate of groin hematomas.

Real-world experience of suture-based closure devices: Insights from the FDA Manufacturer and User Facility Device Experience.

OBJECTIVES: We analyzed post-marketing surveillance data from the United States Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database for suture-based vascular closure devices (VCDs) - Perclose ProGlide (Abbott, Chicago, Illinois) and Prostar XL (Abbott). BACKGROUND: Suture-based VCDs are mostly used for large-bore femoral arterial access-site closure. Real-world, contemporary experience on the most commonly reported complications and modes of failure associated with these devices is limited. METHODS: Post-marketing surveillance data from the FDA MAUDE database, for the ProGlide system and for the Prostar XL system, were analyzed, yielding 827 Perclose ProGlide reports and 175 Prostar XL reports. RESULTS: Of the 827 reports of major complications involving the Perclose ProGlide devices, 404 reports involved injury, and one involved death related to the device. In the Prostar XL analysis, 94 reports involved injury, and one involved death. Bleeding from vessel injury was the most common adverse outcome described with both devices, followed by hematoma and thrombus. Surgical repair was the most commonly used treatment strategy. In terms of device malfunction, suture-related malfunction (212 reports) was most commonly seen in the Perclose ProGlide group, while failed deployment was most commonly seen in the Prostar XL group. CONCLUSIONS: Our analysis of the MAUDE database demonstrates that in real-world practice, suture-based VCDs were found to be associated with complications, including vascular injury, difficulties with the device itself, and even death. Ongoing user education and pre-procedural patient selection are important to minimize risks associated with suture-based vascular closure devices.

Short-term outcomes associated with inpatient ventricular tachycardia catheter ablation.

BACKGROUND: Utilization of catheter ablation of ventricular tachycardia (VT) has steadily increased in recent years. Exploring short-term outcomes is vital in health care planning and resource allocation. METHODS: The Nationwide Readmissions Database from 2010 to 2014 was queried using the ICD-9 codes for VT (427.1) and catheter ablation (37.34) to identify study population. Incidence, causes of 30-day readmission, in-hospital complications as well as predictors of 30-day readmissions, complications, and cost of care were analyzed. RESULTS: Among 11 725 patients who survived to discharge after index admission for VT ablation, 1911 (16.3%) were readmitted within 30 days. Paroxysmal VT was the most common cause of 30-day readmission (39.51%). Dyslipidemia, chronic kidney disease (CKD), previous CABG, congestive heart failure (CHF), chronic pulmonary disease, and anemia predicted increased risk of 30-day readmissions. The overall in-hospital complication rate was 8.2% with vascular and cardiac complications being the most common. Co-existing CKD and CHF and the need for mechanical circulatory support (MCS) predicted higher complication rates. Similarly increasing age, CKD, CHF, anemia, in-hospital use of MCS or left heart catheterization, teaching hospital, and disposition to nursing facilities predicted higher cost. CONCLUSION: Approximately one in six patients was readmitted after VT ablation, with paroxysmal VT being the most common cause of the readmission. A complication rate of 8.2% was noted. We also identified a predictive model for increased risk of readmission, complication, and factors influencing the cost of care that can be utilized to improve the outcomes related to VT ablation.

An updated systematic review and meta-analysis of early outcomes after left atrial appendage occlusion.

BACKGROUND: Left atrial appendage occlusion (LAAO) is a promising intervention for stroke prevention in patients with non-valvular atrial fibrillation (NVAF). Early outcomes following LAAO have been published in many studies with variable results. OBJECTIVE: This updated meta-analysis aims to provide a summary of the early outcomes of LAAO. METHODS: Medline/Pubmed, Ovid Journals, Clinical trials, Abstract meetings, Cochrane databases were searched from January 1st, 1999 to November 30th, 2016. RESULTS: This meta-analysis included 49 studies involving 12 415 patients. The median age was 73.5 years (IQR 72-75 years) and 43% were males. Hypertension and diabetes were present in 36% and 15% of the population, respectively. There was a prior history of stroke and congestive heart failure in 14% and 18% of the population, respectively. The median CHADS2 score was 2.9 (IQR 2.6-3.3) and the median HASBLED score was 3.3 (IQR 3-4). LAAO implantation was successful in 96.3% of patients (95.40-97.08, I2 = 76.1%). The pooled proportion of all-cause mortality was 0.28% (0.19-0.38, I2 = 0%). The pooled proportion of all-cause stroke was 0.31% (0.22-0.42, I2 = 9.4%), major bleeding requiring transfusion was 1.71% (1.13-2.41, I2 = 73.2%), and pericardial effusion was 3.25% (2.46-4.14, I2 = 79%). Sub analysis of randomized clinical trials comparing LAAO devices to warfarin showed lower mortality (P = 0.03) with similar bleeding risk (P = 0.20) with LAAO. CONCLUSIONS: This meta-analysis concludes that LAAO occlusion is a safe and effective stroke prevention strategy in patients with NVAF.

Permanent pacemaker implantation and paravalvular leak rates following sutureless aortic valve operations.

BACKGROUND: Permanent pacemaker (PPM) implantation and paravalvular leak (PVL) rates after sutureless aortic valve replacement (SuAVR) vary widely. The aim of this meta-analysis was to examine the incidence of new PPM implantation and PVL after SuAVR. METHODS: Studies evaluating PPM implantation and PVL rates after SuAVR were searched in Medline/PubMed, Ovid Journals, Clinicaltrials.gov, Cochrane central register of controlled trials and database. Studies with a sample size ≥10 were included in this analysis. Pooled proportions were calculated using both the fixed and random-effects models. The heterogeneity among studies was tested using I2 statistic. The study design was written in accordance with PRISMA guidelines. RESULTS: Thirty studies involving 3993 patients with a median follow-up of 12 months were included. The median age was 77 years and males constituted 50%. There was a history of stroke and coronary artery disease in 6% and 31% of the population. Pooled proportions demonstrate a cumulative postoperative PPM rate of 8.5% (95% confidence interval [CI] 7.6-9.5%, I2 = 68.8%) and the overall rate of any PVL was 4.2% (95%CI 3.4-5%, I2 = 76.1%) across all major SuAVR devices. The rate of severe PVL was only 0.4% (95%CI 0.2-0.7%, I2 = 0%) at discharge and 0.5% (95%CI 0.2-0.9%, I2 = 0%) at 12 months. CONCLUSIONS: In SuAVR prostheses implanted in this meta-analysis, the postoperative permanent pacemaker rate was higher (8.5%) than reported for non-SuAVR prosthesis. While the overall PVL rate was 4.2%, the incidence of severe PVL was only 0.4% at discharge and remained stable at 0.5% at 12 months.

Usefulness of Temporary Pacing in Patients With New Left Bundle Branch Block During Transcatheter Aortic Valve Implantation.

New-onset left bundle branch block (NLBBB) is the most common complication after transcatheter aortic valve implantation (TAVI). Expert consensus recommends temporary transvenous pacemaker (TTVP) support for 24 hours in these patients. To date, no study has examined TTVP use during the index hospitalization in detail. Therefore, we aimed to assess TTVP use in patients with TAVI who developed NLBBB. In this prospective observational study, we performed a detailed analysis of 24-hour telemetry in patients who developed NLBBB during TAVI. Baseline characteristics and procedural and postprocedural data were recorded. The primary outcome was pacing by the TTVP. We evaluated inappropriate TTVP use, electrophysiology study findings, permanent pacemaker (PPM) implantation, and NLBBB resolution. A total of 83 patients (74.4 ± 8.7 years, 41% female) developed NLBBB during TAVI. During index hospitalization, 1 patient (1%) required TTVP because of complete heart block and received a PPM. Five of the 83 (6%) patients were inappropriately paced, and 1 patient (1%) had ventricular fibrillation, likely secondary to TTVP. A total of 34 patients (41%) underwent electrophysiology study during hospitalization, with 4 of 83 (5%) subsequently receiving a PPM. One (1%) patient died during hospitalization, and 9 patients were lost to follow-up because of the COVID-19 pandemic. Of the remaining 73 patients with a 30-day follow-up, NLBBB had resolved in 36 (49%) at 30 days, and 2 (3%) were readmitted with complete heart block and received PPM. In conclusion, in patients with TAVI who develop NLBBB, temporary pacing is rarely necessary, may carry additional risks to the patient, and prolong hospitalization time.

Impact of Baseline Imaging of Non-Culprit Coronary Lesions on Adverse Events: Insight From LRP Study.

BACKGROUND/PURPOSE: Intravascular ultrasound (IVUS) and near-infrared spectroscopy (NIRS) can identify vulnerable coronary atherosclerotic plaques. We aimed to compare the presence or absence of baseline intravascular imaging of non-culprit lesions and their subsequent adverse events. METHODS/MATERIALS: We identified patients from the Lipid Rich Plaque (LRP) study who had a non-culprit-lesion adverse event and divided them into 2 cohorts: those with lesions detected with NIRS-IVUS imaging at baseline and those with lesions not imaged at baseline. RESULTS: Overall, 73 patients had an adverse event (99 coronary segments) during the 24-month follow-up period. Among them, 41 patients (56.2%) had a non-culprit-lesion adverse event related to a coronary segment imaged at baseline, and 32 patients (43.8%) had a non-culprit-lesion adverse event adjudicated to a segment that was not scanned at baseline. Angiographic core laboratory analysis suggested that unscanned lesions were more often in the right coronary artery (~50%); branches of the left coronary artery, i.e., diagonal or left obtuse marginal arteries (~20%); smaller vessels; or more tortuous vessels; and less often in the left anterior descending or distal locations. There was a weak trend for acute severe events (adjudicated myocardial infarction and acute coronary syndrome) in patients with lesions not scanned at baseline (50.0% versus 36.6%, p = 0.250). CONCLUSIONS: In patients with follow-up non-culprit-lesion adverse events, nearly half were not imaged with NIRS-IVUS at baseline. Because events related to non-imaged lesions were at least as severe as events related to imaged lesions, future clinical trials and clinical protocols should be designed to minimize this issue. CLINICAL TRIAL REGISTRATION: The Lipid-Rich Plaque Study (LRP), https://clinicaltrials.gov/ct2/show/NCT02033694, NCT02033694.

Impact of Left Ventricular Outflow Tract Calcification on Outcomes Following Transcatheter Aortic Valve Replacement.

BACKGROUND: We aimed to determine left ventricular outflow tract (LVOT) calcification impact following transcatheter aortic valve replacement (TAVR) with contemporary transcatheter heart valves. Recent studies reported a higher rate of 2-year mortality with greater than moderate LVOT calcium, but they have not established a reliable and validated method to assess the degree of valve calcification and utilized first-generation valves for their analyses. MATERIALS/METHODS: We conducted a retrospective analysis of patients who underwent TAVR at our institution from 2013 through 2017 with available valves. LVOT calcification quantification was assessed as a continuous variable. RESULTS: We included 273 patients: 179 had a non-calcified LVOT (NOLVOTCA) and 96 had a calcified LVOT (LVOTCA). Balloon post-dilatation (BPD) was utilized in 31.3% of LVOTCA vs. 19% of NOLVOTCA (p = 0.029). The Evolut R valve was used in 40.6% vs. 23.4% (p = 0.002), while the Sapien 3 was used in 59.4% vs. 76.6% (p = 0.004), for the LVOTCA and NOLVOTCA, respectively. Paravalvular leak (PVL) at hospital discharge was higher in LVOTCA (47.5%) versus NOLVOTCA (29.1%; p = 0.004). All-cause mortality (11.5% vs. 10.1%; p = 0.5) and need for permanent pacemaker implantation were similar between the groups. There was a positive trend between LVOT calcification volume and the probability of any PVL (OR 1.012; 95% CI, 0.99-1.02). CONCLUSIONS: TAVR performed in patients with calcified LVOT is safe, but LVOT calcification adversely impacts TAVR outcomes, with a higher PVL rate despite greater usage of BPD. Calcium quantification did not predict any PVL degree post-TAVR.

Meta-Analysis of Usefulness of Antiplatelet Therapy in Ischemic Stroke or Transient Ischemic Attack.

The efficacy of early administration of dual antiplatelet therapy (DAPT) for secondary prevention after acute ischemic stroke or transient ischemic attack (TIA) is uncertain. This systematic review and meta-analysis compares the safety and efficacy of early administration (<24 hours) of DAPT (using either clopidogrel or ticagrelor with aspirin) versus single antiplatelet therapy (SAPT; aspirin alone) in acute non-cardioembolic ischemic stroke or TIA, incorporating data from large randomized controlled trials. Published trials fulfilling our criteria were identified from an electronic search of MEDLINE, with key words including: "clopidogrel or ticagrelor", "aspirin", "ischemic stroke", "transient ischemic attack", and "randomized controlled trial". Included were 3 randomized controlled trials of 21,067 patients assessing early administration (<24 hours from symptom onset) of DAPT versus SAPT in non-cardioembolic acute ischemic stroke or TIA. Our efficacy outcomes were ischemic stroke and all-cause mortality. Our safety outcome was severe bleeding. We performed a meta-analysis to pool results with a hierarchical Bayesian random-effects model. Dual antiplatelet therapy significantly reduced the risk of ischemic stroke (hazard ratio [HR], 0.73; 95% credible interval [CrI]: 0.54, 0.97), while increasing the risk of severe bleeding (HR, 2.48; 95% CrI: 1.07, 5.26). There was a non-significant numerical trend toward increased mortality with DAPT (HR, 1.29; 95% CrI: 0.73, 2.23). These observations were robust under the sensitivity analysis. In the present systematic review and meta-analysis of randomized controlled trials, DAPT reduced the risk of ischemic stroke at the cost of an increase in severe bleeding. Additional trials examining the ideal timing of DAPT administration are needed to thoroughly investigate the role, if any, of routine DAPT in patients with non-cardioembolic ischemic stroke or high-risk TIA.

A Patient-Level, Pooled Analysis of Mortality Rates With the Passeo-18 Lux Paclitaxel Drug-Coated Balloon in Peripheral Arterial Disease.

BACKGROUND: Recent meta-analyses have raised concerns about mortality with paclitaxel drug-coated balloons (DCB). This pooled, patient-level analysis of the BIOLUX P-I, P-II, and P-III studies was performed to evaluate the safety and efficacy of Passeo-18 Lux DCB. MATERIALS AND METHODS: Individual patient-level demographic, clinical, diagnostic, and procedural data from the BIOLUX P-I, BIOLUX P-II, and BIOLUX P-III studies were pooled in a common database. Clinical safety (all-cause mortality and cardiovascular mortality) and efficacy (any amputation, target lesion/vessel revascularization) were extracted. Cox proportional modeling was used to assess the effect of critical limb ischemia at the time of enrollment and the occurrence of new amputation as a time-dependent variable on mortality. RESULTS: A total of 1009 patients were included in the analysis. Sixty-six patients were treated with percutaneous transluminal angioplasty (PTA) and 943 underwent DCB angioplasty. The cumulative incidence of all-cause mortality did not differ between the groups (PTA 6.7%, DCB 6.7%, p = 0.65). The composite efficacy endpoint of freedom from any amputation and target lesion/vessel revascularization was superior in the DCB arm compared to PTA [PTA 28.8%, DCB 16.7%, p = 0.02]. Both in unadjusted and adjusted Cox proportional models (adjusted for critical limb ischemia and amputation), the use of DCB was not associated with any mortality at 1 year. CONCLUSIONS: Our patient-level analysis shows that overall, the use of the Passeo-18 Lux paclitaxel DCB in infrainguinal arteries was not associated with increased mortality at 1 year and reinforces the efficacy of DCB angioplasty in preventing amputation or the need for reintervention.

Transcatheter Aortic Valve Replacement in Low-Risk Bicuspid and Tricuspid Patients: Meta-Analysis.

BACKGROUND: Most pivotal transcatheter aortic valve replacement (TAVR) trials have excluded patients with bicuspid aortic stenosis (AS). This study compared TAVR in low-risk patients with bicuspid AS to those with tricuspid AS, incorporating data from prospective trials. METHODS: We selected prospective US low-risk TAVR trials containing a bicuspid arm for this meta-analysis, examining outcomes at 30 days. Study results were pooled using a hierarchical Bayesian random-effects model. RESULTS: Included were 3 Food and Drug Administration (FDA)-approved investigational device exemption (IDE) trials that enrolled a total of 1810 low-risk patients with symptomatic severe AS for TAVR. We compared 380 bicuspid patients with 1430 tricuspid patients. Event rates at 30 days overall were low, with similar mortality (odds ratio [OR], 0.38; 95% credible interval [CrI]: 0.08, 1.78; I2, 0%), non-disabling stroke (OR, 0.45; 95% CrI: 0.15, 1.07; I2, 9%), and permanent pacemaker implantation (OR, 0.86; 95% CrI: 0.41, 1.47; I2, 59%). There were statistically significant differences in disabling stroke (OR, 0.16; 95% CrI: 0.01, 0.90; I2, NA) and coronary obstruction (OR, 0.21; 95% CrI: 0.05, 0.91) that disappeared after sensitivity analysis by adding a single event to the tricuspid arm. Hemodynamics were similar at 30 days. CONCLUSIONS: Preliminary data from the FDA-approved IDE trials of low-risk patients with bicuspid AS undergoing TAVR demonstrated 30-day outcomes comparable to low-risk tricuspid patients, except for a trend toward higher stroke in bicuspid patients. Randomized trials are warranted to reassure the safety and long-term outcome of TAVR in patients with severe bicuspid AS.

Implications of Left Ventricular Function on Short-Term Outcomes in COVID-19 Patients With Myocardial Injury.

BACKGROUND: Myocardial injury is a complication of coronavirus disease 2019 (COVID-19). We describe a large multi-center experience of COVID-19 patients with myocardial injury, examining the prognostic role left ventricular function plays on short-term outcomes. METHODS/MATERIALS: We included adult COVID-19 patients admitted to our health system with evidence of myocardial injury and who underwent a transthoracic echocardiogram (TTE) during index admission. Patients were dichotomized into those with reduced ejection fraction (EF; <50%) and preserved EF (≥50%). RESULTS: Across our 11-hospital system, 5032 adult patients were admitted with COVID-19 from March-September 2020. Of these, 235 had evidence of myocardial injury (troponin ≥1 ng/mL). Included were 134 patients who underwent TTE, of whom 43.3% (n = 58) had reduced EF and 56.7% (n = 76) preserved EF. A subset of 6 patients had newly reduced EF, with 5 demonstrating evidence of stress cardiomyopathy and subsequently dying. Overall, mortality was high in those with reduced EF and preserved EF (in-hospital: 34.5% vs. 28.9%; p = 0.494; 6 months: 63.6% vs. 50.0%; p = 0.167; Kaplan-Meier estimates: p = 0.2886). Readmissions were frequent in both groups (30 days: 22.2% vs. 26.0%; p = 0.162; 6 months: 52.0% vs. 54.5%; p = 0.839). CONCLUSIONS: Many COVID-19 patients admitted with evidence of myocardial injury did not undergo TTE. For those who did, short-term mortality was high. Patients who survived hospitalization had frequent readmissions. In patients with newly reduced EF, most had evidence of stress cardiomyopathy and expired. Larger studies are needed to fully evaluate the prognosis of COVID-19 patients with evidence of myocardial injury and left ventricular dysfunction.

Usefulness of Antiplatelet Therapy After Transcatheter Aortic Valve Implantation.

The rationale for dual antiplatelet therapy (DAPT) after transcatheter aortic valve implantation (TAVI) is to facilitate endothelialization of metallic struts of the transcatheter heart valve and to prevent thrombosis that could lead to thromboembolic events. Based on expert consensus, current societal guidelines recommend DAPT for 1 to 6 months after TAVI with weak evidence. Although the pivotal TAVI trials mandated this regimen, the evidence for the efficacy of DAPT to prevent transcatheter heart valve thrombosis is limited to 3 small trials and a handful of observational studies. Multiple coronary trials have demonstrated that DAPT is associated with increased bleeding in comparison with single antiplatelet therapy, especially in elderly patients. TAVI patients are predominantly elderly and frequently have risk factors that predispose them to bleeding. Herein, we summarize the evidence for antiplatelet therapy after TAVI and explore the theoretical benefit of DAPT to prevent thromboembolic events versus the risk of increased bleeding.