The utilization of single versus double Perclose devices for transfemoral aortic valve replacement access site closure: Insights from Cleveland Clinic Aortic Valve Center.

INTRODUCTION: Percutaneous femoral access is the preferred access route for transcatheter aortic valve replacement (TAVR). The majority of experienced TAVR centers use two 6F Perclose ProGlide™ devices to close the primary vascular access site, deployed prior to upsizing sheath size with closure completed at the end of the case (the "preclose" approach). A strategy of utilizing a single Perclose device to preclose may have advantages including fewer complications, complexity, and cost, but the safety of this is unknown. This study examines in the safety and efficacy of using a single Perclose versus double Perclose for perclosure of large bore access during TAVR. METHODS: Patients undergoing Transfemoral (TF) TAVR from January 2014 to December 2017 within the Cleveland Clinic Aortic Valve Center were identified. A retrospective review of medical charts was conducted. Vascular complications were defined according to the VARC-2 criteria. RESULTS: A total of 740 patients were included; 487 (65.8%) received a single Perclose device while 253 (34.2%) received double Perclose devices. Baseline characteristics were similar with no differences between the single versus double Perclose groups, respectively. The access sheath size was similar in both groups with (14, 16, and 18 F) being the most common sizes utilized. Of the total 487 patients with single Perclose, 75.6% needed additional closure device (AngioSeal). With double Perclose strategy, additional closure device (AngioSeal) was used in 40.3% patients with 470 (63.5%) patients being successfully perclosed. Vascular complication rates including hematoma, stenosis requiring stenting, pseudoaneurysm, and other major vascular complications were similar between both groups. CONCLUSION: Single 6F ProGlide use for preclosure is a safe strategy for TF TAVR using the S3 valve. Additional closure device was not needed in almost one-quarter of the patients. When necessary, residual bleeding can be controlled with the AngioSeal Device at the end of the procedure. This single device preclose strategy can help to reduce the cost of TAVR procedure without increasing risk.

Advances in Imaging and Targeted Therapies for Recurrent Pericarditis: A Review.

Importance: Pericarditis is the most common form of pericardial disease. Recurrence of pericarditis affects 15% to 30% of patients after the initial episode of pericarditis. Up to 50% of patients with the first recurrence have additional recurrences. These patients often progress to have colchicine-resistant and corticosteroid-dependent disease. Rapidly evolving cardiac magnetic resonance imaging techniques and novel targeted therapies have paved the way for imaging-guided therapy for recurrent pericarditis. However, the optimal application of these recent advances remains unclear. Observations: A search was conducted using the PubMed and Cochrane databases for English-language studies, management guidelines, meta-analyses, and review articles published until April 2022 on recurrent pericarditis. Following the 2015 European Society of Cardiology guidelines for the diagnosis and management of pericardial diseases, new clinical trials and registry data have emerged that demonstrate the efficacy of interleukin-1 blockers in recurrent pericarditis. In addition, new observational data have come to light supporting the use of cardiac magnetic resonance imaging in the diagnosis, risk stratification, and management of such patients. Conclusions and Relevance: Advances in imaging and targeted therapies have led to a paradigm shift in the management of recurrent pericarditis. This narrative review summarizes the established and emerging data on the diagnosis and treatment of recurrent pericarditis with special emphasis on the role of cardiac magnetic resonance imaging and interleukin-1 blockers in the current era of tailored therapy for recurrent pericarditis.

Postdischarge-to-30-Day Mortality Among Patients Receiving MitraClip: A Systematic Review and Meta-Analysis.

Background: MitraClip (MC) implantation is the recommended treatment for severe symptomatic mitral regurgitation in patients not responding to medical therapy and at prohibitive surgical risk. It is important to quantify immediate mortality during postdischarge-to-30-day period so as to improve the procedural outcomes. Hence, we aim to identify the incidence of postdischarge-to-30-day mortality and its associated predictors using the technique of meta-analysis. Methods: We searched Medline, Embase, and Cochrane CENTRAL databases from inception until July 3, 2019 for studies reporting mortality prior to discharge, at 30 days and 1 year after MC implantation. The primary outcome was postdischarge-to-30-day all-cause mortality. Results: Of 2394 references, 15 studies enrolling 7498 patients were included. Random effects analysis showed that all-cause cumulative inpatient, 30-day, and 1-year mortality was 2.40% (2.08, 2.77; I2 = 0%), 4.31% (3.64, 5.09, I2 = 41.9%), and 20.71% (18.32; 23.33, I2 = 81.5%), respectively. The postdischarge-to-30-day mortality was 1.70% (95% confidence interval: 1.0, 2.70; I2 = 84%). A total of 71.50% of deaths (95% confidence interval: 36.80-91.50, I2 = 63%) in the postdischarge-to-30-day period were due to cardiac etiology. On meta-regression, pre-MC left ventricular ejection fraction (p = 0.003), Log.Euroscore (p = 0.047), Society of Thoracic Surgeons Predicted Risk of Mortality (p < 0.001), and prolonged ventilation >48 ​hours (p < 0.001) were found to be its significant predictors. Conclusions: Our meta-analysis reports an additional mortality of ∼2% immediately after MC implantation during the postdischarge-to-30-day period. Majority of deaths occurred due to cardiac causes. Pre-MC left ventricular ejection fraction, Log.Euroscore, Society of Thoracic Surgeons Predicted Risk of Mortality score, and prolonged ventilation were found to be its significant predictors. Further studies are needed to better understand the causes of this early mortality to maximize benefits of this important therapy.

Effect of High-Density Lipoprotein Cholesterol Levels on Overall Survival and Major Adverse Cardiovascular and Cerebrovascular Events.

Several studies designed to augment high density lipoprotein (HDL) levels have so far been unsuccessful in reducing rates of major adverse cardiovascular and cerebrovascular events (MACCE). In this study, we report the effect of HDL-C levels on overall survival outcomes and rates of MACCE following percutaneous coronary intervention (PCI). We reviewed patients who underwent PCI at the Cleveland Clinic from 2005 to 2017 and followed them through the end of 2018. Restricted cubic splines incorporated into Cox proportional hazard regression models were used to assess the outcomes. The HDL-C level associated with the lowest mortality was used as a reference value.15,633 patients underwent PCI during the study period, of which 70% were male, 81% were white, and 73% were on statins. The mean age at the time of procedure was 65.8 ± 11.8 years. After adjusting for demographics, co-morbidities, lipid profile, statin use, and date of procedure, our model demonstrated a U-shaped association between HDL-C and overall mortality, with HDL-C levels of 30-50 mg/dl associated with the most favorable outcomes, and HDL-C levels < 30 mg/dl or > 50 mg/dl associated with worse outcomes. A sensitivity analysis in men yielded a similar U-shaped association. In conclusion, our study shows that both low and high levels of HDL-C are associated with worse overall survival, with no effect on rates of MACCE in PCI patients. Further studies are required to understand the mechanism of this association between elevated HDL-C levels with increased overall mortality in patients with atherosclerotic cardiovascular disease (ASCVD).

Coronary artery aneurysms: outcomes following medical, percutaneous interventional and surgical management.

BACKGROUND: Coronary artery aneurysms (CAAs) are increasingly diagnosed on coronary angiography; however, controversies persist regarding their optimal management. In the present study, we analysed the long-term outcomes of patients with CAAs following three different management strategies. METHODS: We performed a retrospective review of patient records with documented CAA diagnosis between 2000 and 2005. Patients were divided into three groups: medical management versus percutaneous coronary intervention (PCI) versus coronary artery bypass grafting (CABG). We analysed the rate of major cardiovascular and cerebrovascular events (MACCEs) over a period of 10 years. RESULTS: We identified 458 patients with CAAs (mean age 78±10.5 years, 74.5% men) who received medical therapy (N=230) or underwent PCI (N=52) or CABG (N=176). The incidence of CAAs was 0.7% of the total catheterisation reports. The left anterior descending was the most common coronary artery involved (38%). The median follow-up time was 62 months. The total number of MACCE during follow-up was 155 (33.8%); 91 (39.6%) in the medical management group vs 46 (26.1%) in the CABG group vs 18 (34.6%) in the PCI group (p=0.02). Kaplan-Meier survival analysis showed that CABG was associated with better MACCE-free survival (p log-rank=0.03) than medical management. These results were confirmed on univariate Cox regression, but not multivariate regression (OR 0.773 (0.526 to 1.136); p=0.19). Both Kaplan-Meier survival and regression analyses showed that dual antiplatelet therapy (DAPT) and anticoagulation were not associated with significant improvement in MACCE rates. CONCLUSION: Our analysis showed similar long-term MACCE risks in patients with CAA undergoing medical, percutaneous and surgical management. Further, DAPT and anticoagulation were not associated with significant benefits in terms of MACCE rates. These results should be interpreted with caution considering the small size and potential for selection bias and should be confirmed in large, randomised trials.

Coronary Angiography in Patients With Out-of-Hospital Cardiac Arrest Without ST-Segment Elevation: A Systematic Review and Meta-Analysis.

OBJECTIVES: The authors conducted a meta-analysis to study clinical outcomes in patients who underwent early versus nonearly coronary angiography (CAG) in the setting of out-of-hospital cardiac arrest (OHCA) without ST-segment elevation. BACKGROUND: The benefit of performing early CAG in patients with OHCA without STE remains disputed. METHODS: MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials were searched according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines from inception until February 21, 2020. Early and nonearly CAG patients were identified on the basis of the definitions mentioned in respective published studies. The primary outcome studied was 30-day mortality. Secondary outcomes were neurological status and the rate of percutaneous coronary intervention (PCI) following cardiac arrest. RESULTS: Of 4,516 references, 11 studies enrolling 3,581 patients were included in the final meta-analysis. Random-effects analysis showed no differences in 30-day mortality (risk ratio [RR]: 0.86; 95% confidence interval [CI]: 0.71 to 1.04; p = 0.12; I2 = 74%), neurological status (RR: 1.08; 95% CI: 0.94 to 1.24; p = 0.28; I2 = 69%), and rate of PCI (RR: 1.22; 95% CI: 0.94 to 1.59; p = 0.13; I2 = 67%) between the 2 groups. Diabetes mellitus, chronic renal failure, previous PCI, and lactate level were found to be significant predictors of 30-day mortality on meta-regression (p < 0.05). CONCLUSIONS: This analysis shows that there is no significant difference in 30-day mortality, neurological status, or rate of PCI among patients with OHCA without STE treated with early versus nonearly CAG. Thirty-day mortality is determined by presentation comorbidities rather than revascularization.

Incidence of Stress Cardiomyopathy During the Coronavirus Disease 2019 Pandemic.

Importance: The coronavirus disease 2019 (COVID-19) pandemic has resulted in severe psychological, social, and economic stress in people's lives. It is not known whether the stress of the pandemic is associated with an increase in the incidence of stress cardiomyopathy. Objective: To determine the incidence and outcomes of stress cardiomyopathy during the COVID-19 pandemic compared with before the pandemic. Design, Setting, and Participants: This retrospective cohort study at cardiac catheterization laboratories with primary percutaneous coronary intervention capability at 2 hospitals in the Cleveland Clinic health system in Northeast Ohio examined the incidence of stress cardiomyopathy (also known as Takotsubo syndrome) in patients presenting with acute coronary syndrome who underwent coronary arteriography. Patients presenting during the COVID-19 pandemic, between March 1 and April 30, 2020, were compared with 4 control groups of patients with acute coronary syndrome presenting prior to the pandemic across 4 distinct timelines: March to April 2018, January to February 2019, March to April 2019, and January to February 2020. Data were analyzed in May 2020. Exposures: Patients were divided into 5 groups based on the date of their clinical presentation in relation to the COVID-19 pandemic. Main Outcomes and Measures: Incidence of stress cardiomyopathy. Results: Among 1914 patient presenting with acute coronary syndrome, 1656 patients (median [interquartile range] age, 67 [59-74]; 1094 [66.1%] men) presented during the pre-COVID-19 period (390 patients in March-April 2018, 309 patients in January-February 2019, 679 patients in March-April 2019, and 278 patients in January-February 2020), and 258 patients (median [interquartile range] age, 67 [57-75]; 175 [67.8%] men) presented during the COVID-19 pandemic period (ie, March-April 2020). There was a significant increase in the incidence of stress cardiomyopathy during the COVID-19 period, with a total of 20 patients with stress cardiomyopathy (incidence proportion, 7.8%), compared with prepandemic timelines, which ranged from 5 to 12 patients with stress cardiomyopathy (incidence proportion range, 1.5%-1.8%). The rate ratio comparing the COVID-19 pandemic period to the combined prepandemic period was 4.58 (95% CI, 4.11-5.11; P < .001). All patients during the COVID-19 pandemic had negative reverse transcription-polymerase chain reaction test results for COVID-19. Patients with stress cardiomyopathy during the COVID-19 pandemic had a longer median (interquartile range) hospital length of stay compared with those hospitalized in the prepandemic period (COVID-19 period: 8 [6-9] days; March-April 2018: 4 [3-4] days; January-February 2019: 5 [3-6] days; March-April 2019: 4 [4-8] days; January-February: 5 [4-5] days; P = .006). There were no significant differences between the COVID-19 period and the overall pre-COVID-19 period in mortality (1 patient [5.0%] vs 1 patient [3.6%], respectively; P = .81) or 30-day rehospitalization (4 patients [22.2%] vs 6 patients [21.4%], respectively; P = .90). Conclusions and Relevance: This study found that there was a significant increase in the incidence of stress cardiomyopathy during the COVID-19 pandemic when compared with prepandemic periods.

Unilateral Access Is Safe and Facilitates Peripheral Bailout During Transfemoral-Approach Transcatheter Aortic Valve Replacement.

OBJECTIVES: The aim of this study was to compare the rate and trend of vascular complications when placing a second arterial sheath in the contralateral femoral artery during transcatheter aortic valve replacement (TAVR) unilaterally versus bilaterally. BACKGROUND: Vascular complications occur in approximately 5% to 8% of TAVR procedures. Many operators place a second arterial sheath in the contralateral femoral artery to perform aortic root angiography. The authors surmised that placing the second sheath ipsilateral and distal to the delivery sheath would be an easier option with similar safety. METHODS: The Cleveland Clinic Aortic Valve Center TAVR database was accessed, and data for patients undergoing transfemoral TAVR (TF-TAVR) from January 2014 to December 2017 were analyzed retrospectively. The primary outcome was the rate of peripheral vascular complications. RESULTS: A total of 1,208 patients who underwent TF-TAVR were included in this study. One thousand seven patients (83.36%) underwent bilateral femoral access, and 201 patients (16.64%) underwent TF-TAVR using a unilateral femoral approach. Over the study duration, use of the unilateral access approach trended upward significantly, reaching 43.7% of total cases in 2017. A gradual decline in access site-related vascular complications was observed, from 13.7% in 2014 to 7.4% in 2017. After propensity-score matching, peripheral vascular complications were similar between bilateral access and unilateral access (10.8% vs. 8.6%) (p = 0.543). CONCLUSIONS: There was a significant decline in vascular complications from 2014 to 2017. Unilateral-access TF-TAVR provided similar safety compared with bilateral-access TF-TAVR and is a more accessible approach for managing access site-related complications and possibly achieving better patient satisfaction.

Meta-analysis of the Impact of Avoiding Balloon Predilation in Transcatheter Aortic Valve Implantation.

Balloon predilation (BPD) has been an integral part of transcatheter aortic valve implantation (TAVI) since inception. We sought to investigate the effect of avoiding BPD on outcomes of TAVI across different valve types. Articles were included if outcomes of TAVI without BPD were reported. Pooled meta-analysis used a random effects model and reported odds ratios (ORs). Twenty-one studies with 10,752 patients were pooled for analysis. Age and gender were well matched between NoBPD and BPD groups. There was no difference in mortality, stroke, bleeding, and acute kidney injury. NoBPD showed lower pacemaker rates (OR 0.84, 95% confidence interval [CI] 0.72 to 0.97), vascular complications (OR 0.77, 95% CI 0.62 to 0.95), and early safety at 30 days (OR 0.81, 95% CI 0.66 to 0.99). For balloon-expandable valves, lower rates of aortic regurgitation (OR 0.73, 95% CI 0.53 to 0.99) and early safety (OR 0.68, 95% CI 0.55 to 0.85) were seen. Self-expanding valves showed lower pacemaker (OR 0.80, 95% CI 0.66 to 0.97) and vascular complications (OR 0.70, 95% CI 0.50 to 0.99), with a trend toward higher postdilation (OR 1.51, 95% CI 0.85 to 2.67). TAVI without BPD is safe and effective. NoBPD is associated with fewer vascular complications, less aortic regurgitation, and fewer pacemaker requirements and composite early safety end points.