Safety and Feasibility of an Implanted Inferior Vena Cava Sensor for Accurate Volume Assessment: FUTURE-HF2 Trial.

BACKGROUND: A novel implantable sensor has been designed to accurately measure inferior vena cava (IVC) area to allow daily monitoring of IVC area and collapse to predict congestion in heart failure (HF). METHODS: A prospective, multicenter, single arm, Early Feasibility Study enrolled 15 HF patients (irrespective of ejection fraction) with a HF event in the previous 12 months, an elevated NT-proBNP, and receiving ≥40 mg of furosemide equivalent. Primary endpoints included successful deployment without procedure-related (30 days) or sensor-related complications (three months) and successful data transmission to a secure database (3 months). Accuracy of sensor-derived IVC area, patient adherence, NYHA classification, and KCCQ were assessed from baseline to three months. Patient-specific signal alterations were correlated with clinical presentation to guide interventions. RESULTS: Fifteen patients underwent implantation (66±12 years; 47% female; 27% HFpEF, NT-ProBNP 2569 (median, IQR: (1674-5187)) ng/L; 87% NYHA Class III). All patients met the primary safety and effectiveness endpoints. Sensor-derived IVC area showed excellent agreement with concurrent CT (R2=0.99, mean absolute error=11.15 mm2). Median adherence to daily readings was 98% (IQR: 86-100%) per patient-month. A significant improvement was seen in NYHA class and a non-significant improvement was observed for KCCQ. CONCLUSIONS: Implantation of a novel IVC sensor (FIRE1) was feasible, uncomplicated, and safe. Sensor outputs aligned with clinical presentation and improvements in clinical outcomes. Future investigation to establish the IVC sensor remote management of HF is strongly warranted.

Utility of rapid atrial pacing before and after TAVR with balloon-expandable valve in predicting permanent pacemaker implantation.

BACKGROUND: High-grade or complete atrioventricular block (AVB) requiring permanent pacemaker (PPM) implantation is a known complication of transcatheter aortic valve replacement (TAVR). Wenckebach AVB induced by rapid atrial pacing (RAP) after TAVR was previously demonstrated in an observational analysis to be an independent predictor for PPM. We sought to investigate the utility of both pre- and post-TAVR RAP in predicting PPM implantation. METHODS: In a single-center, prospective study, 421 patients underwent TAVR with balloon-expandable valves (BEV) between April 2020 and August 2021. Intraprocedural RAP was performed in patients without a pre-existing pacemaker, atrial fibrillation/flutter, or intraprocedural complete AVB to assess for RAP-induced Wenckebach AVB. The primary outcome was PPM within 30 days after TAVR. RESULTS: RAP was performed in 253 patients, of whom 91.3% underwent post-TAVR RAP and 61.2% underwent pre-TAVR RAP. The overall PPM implantation rate at 30 days was 9.9%. Although there was a numerically higher rate of PPM at 30 days in patients with RAP-induced Wenckebach AVB, it did not reach statistical significance (13.3% vs. 8.4%, p = 0.23). In a multivariable analysis, RAP-induced Wenckebach was not an independent predictor for PPM implantation at 30 days after TAVR. PPM rates at 30 days were comparable in patients with or without pre-TAVR pacing-induced Wenckebach AVB (11.8% vs. 8.2%, p = 0.51) and post-TAVR pacing-induced Wenckebach AVB (10.2% vs. 5.8%, p = 0.25). CONCLUSION: In patients who underwent TAVR with BEV, there were no statistically significant differences in PPM implantation rates at 30 days regardless of the presence or absence of RAP-induced Wenckebach AVB. Due to conflicting results between the present study and the prior observational analysis, future studies with larger sample sizes are warranted to determine the role of RAP during TAVR as a risk-stratification tool for significant AVB requiring PPM after TAVR.

In-hospital outcomes of TAVR patients with a bundle branch block: Insights from the National Inpatient Sample 2011-2018.

INTRODUCTION: Data on the outcomes following transcatheter aortic valve replacement (TAVR) in patients with a bundle branch block (BBB) remains limited. METHODS: We studied the outcomes of TAVR patients with a BBB from the National Inpatient Sample (NIS) database between 2011 and 2018 using ICD-9-CM and ICD-10-CM codes. RESULTS: Between 2011 and 2018, 194,237 patients underwent TAVR, where 1.7% (n = 3,232) had a right BBB (RBBB) and 13.7% (n = 26,689) had a left BBB (LBBB). Patients with a RBBB and LBBB had a higher rate of new permanent pacemaker (PPM) implantation (31.5% - RBBB, 15.7% LBBB vs. 10.2% - no BBB). RBBB was associated with a significantly longer median length of stay (5 days) and total hospitalization cost ($53,669) compared with LBBB (3 days and $47,552) and no BBB (3 days and $47,171). Trend analysis revealed lower rates of PPM implantation and reduced lengths of stay and costs across all comparison groups. CONCLUSION: In conclusion, patients undergoing TAVR with a BBB are associated with higher new rates of PPM implantation. RBBB is the strongest independent predictor for new PPM implantation following TAVR. Rates of new PPM implantation in TAVR patients with and without a BBB have improved over time including reductions in length of stay and hospital costs. Further study is needed to reduce the risks of PPM implantation in TAVR patients.

Transcatheter cerebral embolic protection during WATCHMAN procedure in two patients with persistent left atrial appendage thrombus: Case report with review of the literature.

Percutaneous left atrial appendage closure (LAAC) has been increasingly used in patients with atrial fibrillation who are poor candidates for long-term oral anticoagulation. The presence of a left atrial appendage (LAA) thrombus is a contraindication for percutaneous LAAC. Despite oral anticoagulation, persistent thrombus is not uncommon. We describe the use of transcatheter cerebral embolic protection with the Sentinel cerebral protection system during LAAC using WATCHMAN in two atrial fibrillation patients who had persistent LAA thrombus despite oral anticoagulation.

New approaches to inhibiting platelets and coagulation.

Ischemic heart disease and stroke are major causes of death and morbidity worldwide. Coronary and cerebrovascular events are a consequence of thrombus formation caused by atherosclerotic plaque rupture or embolism, both of which result from platelet activation and aggregation and thrombin-mediated fibrin generation via the coagulation cascade. Current and emerging antiplatelet and anticoagulant agents are evolving rapidly. The use of aspirin for primary prevention continues to be controversial, as are the doses appropriate for secondary prevention. Development of new oral and intravenous adenosine diphosphate P2Y12 inhibitors and novel antiplatelet agents continues to transform the landscape of antiplatelet therapy. Oral anticoagulation has advanced with the use of direct thrombin and factor Xa inhibitors that do not require therapeutic monitoring. In this review, we discuss the pharmacology and growing clinical evidence for traditional and new antiplatelet and anticoagulant therapies.

Impact of intravascular ultrasound on the long-term clinical outcomes in the treatment of coronary ostial lesions.

OBJECTIVES: To evaluate the long-term outcomes of patients with ostial lesions who underwent percutaneous coronary intervention (PCI) with and without the use of intravascular ultrasound (IVUS). BACKGROUND: A higher rate of adverse cardiac events is associated with PCI of ostial lesions as compared with nonostial disease. METHODS: From 7/2002 to 8/2010, 225 patients with 233 coronary ostial lesions underwent PCI with (n = 82) and without (n = 143) IVUS guidance. Ostial lesions included both native aorto-ostial or major coronary vessel (left anterior descending, left circumflex, and ramus intermedius) lesions. Clinical outcomes [cardiovascular death, myocardial infarction (MI), and target lesion revascularization (TLR)] at a mean follow-up of 4.2 ± 2.5 years were compared between patients undergoing PCI of an ostial lesion with and without use of IVUS using univariate and propensity score adjusted analyses. RESULTS: Aorto-ostial lesions (n = 109) comprised 47% of lesions, whereas the remaining lesions (53%) involved major coronary vessels. After propensity score adjustment, IVUS use was associated with lower rates of the composite of cardiovascular death, MI, or TLR (HR 0.54, 95% CI 0.29-0.99; P = 0.04), composite MI or TLR (HR 0.39, 95% CI 0.18-0.83; P = 0.01), and MI (HR 0.31, 95% CI 0.11-0.85; P = 0.02) as compared with no IVUS. The use of IVUS was also associated with a trend towards a lower rate of TLR (HR 0.42, 95% CI 0.17-1.02; P = 0.06). CONCLUSIONS: PCI of coronary ostial lesions with the use of IVUS was associated with significantly lower rates of adverse cardiac events.

Risk model for estimating the 1-year risk of deferred lesion intervention following deferred revascularization after fractional flow reserve assessment.

AIMS: Although lesions deferred revascularization following fractional flow reserve (FFR) assessment have a low risk of adverse cardiac events, variability in risk for deferred lesion intervention (DLI) has not been previously evaluated. The aim of this study was to develop a prediction model to estimate 1-year risk of DLI for coronary lesions where revascularization was not performed following FFR assessment. METHODS AND RESULTS: A prediction model for DLI was developed from a cohort of 721 patients with 882 coronary lesions where revascularization was deferred based on FFR between 10/2002 and 7/2010. Deferred lesion intervention was defined as any revascularization of a lesion previously deferred following FFR. The final DLI model was developed using stepwise Cox regression and validated using bootstrapping techniques. An algorithm was constructed to predict the 1-year risk of DLI. During a mean (±SD) follow-up period of 4.0 ± 2.3 years, 18% of lesions deferred after FFR underwent DLI; the 1-year incidence of DLI was 5.3%, while the predicted risk of DLI varied from 1 to 40%. The final Cox model included the FFR value, age, current or former smoking, history of coronary artery disease (CAD) or prior percutaneous coronary intervention, multi-vessel CAD, and serum creatinine. The c statistic for the DLI prediction model was 0.66 (95% confidence interval, CI: 0.61-0.70). CONCLUSION: Patients deferred revascularization based on FFR have variation in their risk for DLI. A clinical prediction model consisting of five clinical variables and the FFR value can help predict the risk of DLI in the first year following FFR assessment.

Early vs. late transcatheter aortic valve replacement in acute heart failure hospitalizations: A comparative nationwide analysis.

BACKGROUND: Severe aortic stenosis (AS) is the most common valvular disease in the USA. Patients undergoing urgent or emergent transcatheter aortic valve replacement (TAVR) have worse clinical outcomes than those undergoing non-urgent procedures. No studies have examined the impact of procedural TAVR timing on outcomes in AS complicated by acute heart failure (AHF). AIMS: We aimed to evaluate differences in in-hospital mortality and clinical outcomes between early (<48 h) vs. late (≥48 h) TAVR in patients hospitalized with AHF using a real-world US database. METHODS: We queried the National Inpatient Sample database to identify hospitalizations with a diagnosis of AHF, aortic valve disease, and a TAVR procedure (2015-2020). The associations between TAVR timing and clinical outcomes were examined using logistic regression model. RESULTS: A total of 25,290 weighted AHF hospitalizations were identified, of which 6855 patients (27.1 %) underwent early TAVR, and 18,435 (72.9 %) late TAVR. Late TAVR patients had higher in-hospital mortality rate (2.2 % vs. 2.8 %, p < 0.01) on unadjusted analysis but no significant difference following adjustment for demographic, clinical, and hospital characteristics [aOR 1.00 (0.82-1.23)]. Late TAVR was associated with higher odds of cardiac arrest (aOR 1.50, 95 % CI: 1.18-1.90) and use of mechanical circulatory support (aOR 2.05, 95 % CI: 1.68-2.51). Late TAVR was associated with longer hospital stay (11 days vs. 4 days, p < 0.01) and higher costs ($72,851 vs. $53,209, p < 0.01). CONCLUSION: Early TAVR was conducted in approximately 25 % of the AS patients admitted with AHF, showing improved in-hospital outcomes before adjustment, with no significant differences observed after adjustment.

Rates and Predictors of Structural Valve Degeneration and Failure of Trifecta Bioprosthetic Valve Over a 5-year Follow-up Period: A Single-center Experience.

Introduction: The Trifecta bioprosthetic valve has been commonly used for surgical aortic valve replacement (SAVR). Multiple studies have been done to define the rate of structural valve degeneration (SVD) and failure (SVF), but the outcomes are still debatable. Therefore, we aim to conduct this single-center study to estimate the rate and predictors of SVD/SVF. Methodology: This retrospective observational cohort single-center study was conducted between 2014 and 2019 among Trifecta SAVR patients. Data were patient's characteristics collected from electronic medical records at baseline and follow-up (3-5 years). Statistical analysis was performed with a significance level of P ≤ 0.05. Results: A total of 271 eligible patients were identified. Most of our sample were males (57.9%), with a mean age of 71.1 ± 10.6 years. The mean baseline preoperative ejection fraction (EF) was 53.0%, with no change (P = 0.88) in the immediate postoperative EF (53.6%). A most recent follow-up EF revealed a significant increase of EF (55.2%), P = 0.01. Furthermore, there was a significant increase from peak velocity to PVMRE (mean difference [MD] ± standard error of mean (SEM) [0.15 ± 0.04], P < 0.01), an increase in pressure gradient (PGIPE) to PGMRE (MD ± SEM [1.70 ± 0.49], P < 0.01), and a decrease in Doppler velocity index (DVIIPE) to DVIMRE (MD ± SEM [-0.037 ± 0.01], P = 0.01). Regarding the SVF rate, 13 (4.8%) patients had failed valves requiring replacement throughout the study period. Conclusions: Over a 5-year follow-up period, 4.8% had SVF with an SVD of 23.2%, with the majority of SVD not being clinically significant except in six patients. These results corroborate with a previously published study suggesting a bad clinical outcome of Trifecta valve placement.

Clinical Validation of a Machine-Learned, Point-of-Care System to IDENTIFY Functionally Significant Coronary Artery Disease.

Many clinical studies have shown wide performance variation in tests to identify coronary artery disease (CAD). Coronary computed tomography angiography (CCTA) has been identified as an effective rule-out test but is not widely available in the USA, particularly so in rural areas. Patients in rural areas are underserved in the healthcare system as compared to urban areas, rendering it a priority population to target with highly accessible diagnostics. We previously developed a machine-learned algorithm to identify the presence of CAD (defined by functional significance) in patients with symptoms without the use of radiation or stress. The algorithm requires 215 s temporally synchronized photoplethysmographic and orthogonal voltage gradient signals acquired at rest. The purpose of the present work is to validate the performance of the algorithm in a frozen state (i.e., no retraining) in a large, blinded dataset from the IDENTIFY trial. IDENTIFY is a multicenter, selectively blinded, non-randomized, prospective, repository study to acquire signals with paired metadata from subjects with symptoms indicative of CAD within seven days prior to either left heart catheterization or CCTA. The algorithm's sensitivity and specificity were validated using a set of unseen patient signals (n = 1816). Pre-specified endpoints were chosen to demonstrate a rule-out performance comparable to CCTA. The ROC-AUC in the validation set was 0.80 (95% CI: 0.78-0.82). This performance was maintained in both male and female subgroups. At the pre-specified cut point, the sensitivity was 0.85 (95% CI: 0.82-0.88), and the specificity was 0.58 (95% CI: 0.54-0.62), passing the pre-specified endpoints. Assuming a 4% disease prevalence, the NPV was 0.99. Algorithm performance is comparable to tertiary center testing using CCTA. Selection of a suitable cut-point results in the same sensitivity and specificity performance in females as in males. Therefore, a medical device embedding this algorithm may address an unmet need for a non-invasive, front-line point-of-care test for CAD (without any radiation or stress), thus offering significant benefits to the patient, physician, and healthcare system.

Long-term clinical outcomes with the use of a modified provisional jailed-balloon stenting technique for the treatment of nonleft main coronary bifurcation lesions.

OBJECTIVES: To assess the long-term clinical outcomes associated with treatment of nonleft main coronary bifurcation lesions using a modified provisional jailed-balloon technique (JBT). BACKGROUND: Percutaneous coronary intervention (PCI) of bifurcation lesions is associated with a higher risk of adverse events, including the risk of side branch (SB) loss during main branch (MB) stenting. METHODS: From 4/2003 to 8/2010, 406 patients with 424 nonleft main coronary bifurcation lesions underwent PCI with (n = 95) and without (n = 311) the use of JBT. Rates of SB loss and long term clinical outcomes [death, myocardial infarction (MI), and target lesion revascularization (TLR)] were compared between patients undergoing PCI with and without JBT using univariate and propensity score adjusted and matched analyses. RESULTS: The majority of patients presented with acute coronary syndrome (63%) and 90% of lesions were Medina class 1,1,1. Patients were followed for a mean of 2.7 ± 2.1 years. After propensity score matching (n = 81 in each group), JBT was associated with a significantly lower composite rate of death, MI, or TLR (HR 0.22, 95% CI 0.06-0.76; P = 0.02) and TLR (HR 0.20, 95% 0.04-0.92; P = 0.04) compared with no JBT. Permanent SB loss was significantly lower in the JBT group compared with no JBT group (OR 0.22, 95% CI 0.10-0.49; P = 0.0001). CONCLUSIONS: The use of JBT for the treatment of nonleft main coronary bifurcation lesions was associated with significantly lower rates of SB loss and major adverse cardiac events at late follow-up.

Outcomes of Bioprosthetic Valve Fracture in Patients Undergoing Valve-in-Valve TAVR.

BACKGROUND: Valve-in-valve (VIV) transcatheter aortic valve replacement (TAVR) is increasingly used to treat degenerated surgical bioprostheses. Bioprosthetic valve fracture (BVF) has been shown to improve hemodynamic status in VIV TAVR in case series. However, the safety and efficacy of BVF are unknown. OBJECTIVES: The primary objective of this study was to assess the safety and efficacy of VIV TAVR using SAPIEN 3 and SAPIEN 3 Ultra valves with or without BVF using data from the Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry. METHODS: The primary outcome was in-hospital mortality. Secondary outcomes included echocardiography-derived valve gradient and aortic valve area. Inverse probability of treatment weighting was used to adjust for baseline characteristics. RESULTS: A total of 2,975 patients underwent VIV TAVR from December 15, 2020, to March 31, 2022. BVF was attempted in 619 patients (21%). In adjusted analyses, attempted BVF was associated with higher in-hospital mortality (OR: 2.51; 95% CI: 1.30-4.84) and life-threatening bleeding (OR: 2.55; 95% CI: 1.44-4.50). At discharge, VIV TAVR with attempted BVF was associated with larger aortic valve area (1.6 cm2 vs 1.4 cm2; P < 0.01) and lower mean gradient (16.3 mm Hg vs 19.2 mm Hg; P < 0.01). When BVF was compared with no BVF according to timing (before vs after transcatheter heart valve implantation), BVF after transcatheter heart valve implantation was associated with improved hemodynamic status and similar mortality. CONCLUSIONS: BVF as an adjunct to VIV TAVR with the SAPIEN 3 and SAPIEN 3 Ultra valves is associated with a higher risk for in-hospital mortality and significant bleeding and modest improvements in echocardiography-derived hemodynamic status. The timing of BVF is an important determinant of safety and efficacy.

Same-Day Discharge after Percutaneous Left Atrial Appendage Closure: Insights from the Nationwide Readmission Database 2015-2019.

Data on the feasibility of same-day discharge (SDD) following percutaneous left atrial appendage closure (LAAC) remain limited. We analyzed the US Nationwide Readmission Database from quarter four of 2015 to 2019 to study the safety and feasibility of SDD after LAAC. After excluding non-elective cases and in-hospital deaths, a total of 54,880 cases of LAAC were performed during the study period. Following LAAC, 2% (n=1077) of patients underwent SDD, 88% (n=48,428) underwent next-day discharge (NDD), 5.2% (n=2881) were discharged on the second day (ScD), and 4.5% of patients (n = 2494) were discharged 3 or more days after LAAC. There was no difference in 30-day readmission rates between SDD and NDD (7.3% [n=79] vs 7.4% [n=3585], P=0.94). The hospitalization costs were significantly lower for SDD compared with NDD ($22,963 vs $27,079, P≤0.01). SDD discharge following percutaneous LAAC appears to be safe and is associated with lower hospitalization costs. Further prospective studies are needed to determine the safety and feasibility of SDD with percutaneous LAAC.

Cerebral Embolic Protection during Transcatheter Aortic Valve Implantation: Updated Systematic Review and Meta-Analysis.

In patient undergoing transcatheter aortic valve implantation (TAVI), stroke remains a potentially devastating complication associated with significant morbidity, and mortality. To reduce the risk of stroke, cerebral protection devices (CPD) were developed to prevent debris from embolizing to the brain during TAVI. We performed a systematic review and meta-analysis to determine the safety and efficacy of CPD in TAVI. The MEDLINE (PubMed, Ovid) and Cochrane databases were queried with various combinations of medical subject headings to identify relevant articles. Statistical analysis was performed using a random-effects model to calculate unadjusted odds ratio (OR), including subgroup analyses based on follow-up duration, study design, and type of CPD. Using a pooled analysis, CPD was associated with a significant reduction in major adverse cardiovascular events MACE (OR 0.75, 95% CI 0.70-0.81, P < 0.01), mortality (OR 0.65, 95% CI 0.58-0.74, P < 0.01) and stroke (OR 0.84, 95% CI 0.76-0.93, P < 0.01) in patients undergoing TAVI. Similarly, on MRI volume per lesion were lower for patients with CPD use. No significant difference was observed in acute kidney injury (OR 0.75, 95% CI 0.42-1.37, P = 0.68), bleeding (OR 0.92, 95% CI 0.71-1.20, P = 0.55) or vascular complications (OR 0.90, 95% CI 0.62-1.31, P = 0.6) for patients undergoing TAVI with CPD. In conclusion, CPD device use in TAVI is associated with a reduction of MACE, mortality, and stroke compared with patients undergoing TAVI without CPD. However, the significant reduction in mortality is driven mainly by observational studies.

Clinical outcomes using a platelet function-guided approach for secondary prevention in patients with ischemic stroke or transient ischemic attack.

BACKGROUND AND PURPOSE: Antiplatelet therapy nonresponse is associated with worse clinical outcomes. We studied the clinical outcomes associated with platelet function-guided modifications in antiplatelet therapy in patients with ischemic stroke or transient ischemic attack. METHODS: From January 2005 to August 2007, 324 patients with ischemic stroke underwent platelet function testing using platelet aggregometry. Aspirin nonresponse was defined as a mean platelet aggregation ≥20% with 0.5 mg/mL arachidonic acid and/or ≥70% with 5 µmol/L adenosine diphosphate. Clopidogrel nonresponse was defined as a mean platelet aggregation ≥40% with 5 µmol/L adenosine diphosphate. A modification was any increase in antiplatelet therapy occurring after testing. Clinical outcomes were compared between patients with and without platelet function-guided antiplatelet therapy modifications using univariate and propensity score-adjusted analyses. RESULTS: In patients with ischemic stroke or transient ischemic attack, 43% (n=128) and 35% (n=54) were nonresponders to aspirin and clopidogrel, respectively. After platelet function testing, antiplatelet therapy was increased in 23% of patients (n=73). After propensity score matching (n=61 in each group), antiplatelet therapy modification was associated with significantly increased rates of death, ischemic events, or bleeding (hazard ratio, 2.24; 95% CI, 1.12-4.47; P=0.02) compared with no modification in antiplatelet therapy and a trend toward increased bleeding (hazard ratio, 3.56; 95% CI, 0.98-12.95; P=0.05). No differences in ischemic events were observed. CONCLUSIONS: Platelet function-guided modification in antiplatelet therapy after an ischemic stroke or transient ischemic attack was associated with significantly higher rates of adverse clinical outcomes.

Antiplatelet therapy and proton pump inhibition: cause for concern?

PURPOSE OF REVIEW: To review the current evidence on the clinical significance of the drug-drug interactions between the available antiplatelet agents and proton pump inhibitors (PPIs). RECENT FINDINGS: Gastrointestinal bleeding is associated with higher rates of morbidity and mortality following a myocardial infarction. PPIs are commonly used to prevent gastrointestinal bleeding. PPIs can attenuate metabolism of clopidogrel to its active metabolite by inhibiting various hepatic CYP450 enzymes, mainly CYP2C19. Concomitant use of a PPI with clopidogrel reduces clopidogrel active metabolite generation and subsequent platelet inhibition. In observational studies, the clinical significance of this drug-drug interaction is mixed. Evidence from the only randomized trial studying the clinical implications of the PPI-clopidogrel interaction did not demonstrate any difference in cardiovascular outcomes but did show a reduction in gastrointestinal bleeding with use of a PPI. SUMMARY: The drug-drug interaction between antiplatelet agents and PPIs at the enzymatic level does not seem to result in worse clinical outcomes. The risk of gastrointestinal bleeding with antiplatelet therapy is substantial. Clinicians should use PPIs in selected high-risk patients to prevent gastrointestinal bleeding.

A modified provisional stenting approach to coronary bifurcation lesions: clinical application of the "jailed-balloon technique".

OBJECTIVES: To demonstrate the application of a novel provisional side branch (SB) stenting strategy for coronary bifurcation lesions using a "jailed-balloon" technique (JBT). BACKGROUND: Adverse cardiac events are higher for percutaneous coronary intervention (PCI) of bifurcation lesions. Recent studies support the use of provisional SB stenting, but a risk of SB closure and a higher rate of target lesion revascularization (TLR) remain important limitations. METHODS: From December 2007 to August 2010, 100 patients with 102 bifurcation lesions underwent PCI using the JBT. Baseline and postprocedural quantitative coronary angiography (QCA) analysis were performed. Procedural and immediate clinical outcomes were reviewed. RESULTS: The majority of patients presented with acute coronary syndrome (68%) and had Medina class 1,1,1 bifurcation lesions (91%). TIMI 3 flow was established in 100% of main branch and 99% of SB lesions. QCA revealed preservation of the bifurcation angle after PCI (pre-PCI: 59.6 ± 30.0; post-PCI: 63.3 ± 26.8, P = 0.41). Nine patients (9%) had lesions that required rewiring and two patients (2%) required provisional stenting of the SB. SB loss occurred in one patient (1%). The jailed-balloon or wire was not entrapped during any PCI. One patient (1%) suffered a periprocedural myocardial infarction (MI). CONCLUSIONS: Provisional stenting of complex coronary bifurcation lesions using a JBT is associated with a high procedural success rate, improved SB patency, and a low rate of immediate cardiac events. Further study is warranted to evaluate the role of JBT in improving long-term clinical outcomes in PCI of complex bifurcation lesions.

Right aortic arch with common origin of right carotid and left innominate artery: A case report.

Aortic arch anomalies are rare congenital malformations with an incidence of approximately 1-3%. Right aortic arch is an anatomical variant with an incidence of <0.1% associated with various congenital heart diseases. We present a case of a 26-year-old female patient with a right aortic arch with a common origin of right carotid and left innominate artery.

Safety and Efficacy of Direct Oral Anticoagulants Versus Warfarin Following WATCHMAN in High-Risk Patients.

Background: In the pivotal WATCHMAN trials, warfarin was used exclusively for postprocedural anticoagulation following left atrial appendage closure. We sought to investigate the safety and efficacy of direct oral anticoagulants (DOACs) in high-risk patients with atrial fibrillation who underwent left atrial appendage closure with WATCHMAN. Methods: This was a retrospective study of 318 patients who underwent the WATCHMAN procedure in a tertiary referral center (June 2016-September 2020). We compared the outcomes of patients who were discharged on DOACs versus warfarin after the WATCHMAN procedure. The primary outcome was the composite of any bleeding, thromboembolism, or cardiovascular death through 7 â€‹days and 45 â€‹days after the procedure. Results: The final analysis included 301 patients, of whom 82.4% (248/301) were discharged on DOACs and 17.6% (53/301) were discharged on warfarin. The mean CHA2DS2-VASc and HAS-BLED scores were 4.9 â€‹± â€‹1.6 and 2.9 â€‹± â€‹0.9, respectively. The primary composite outcome was similar between the DOAC and warfarin groups through 7 â€‹days (3.2% vs 5.6%; adjusted odds ratio [OR], 0.65; 95% confidence interval [CI], 0.13-3.17; P â€‹= â€‹.59) and 45 days after procedure (10.1% vs 11.3%; adjusted OR, 1.18; 95% CI, 0.41-3.45; P â€‹= â€‹.76). Major bleeding (5.2% vs 9.5%; P â€‹= â€‹.34) and all-cause readmission (12.5% vs 16.9%; P â€‹= â€‹.85) at 45 â€‹days were comparable between the DOAC and warfarin groups. The overall incidence of device-related thrombus and significant peri-device flow at 45 â€‹days were low (<0.5%). Conclusions: In high-risk patients with atrial fibrillation, the primary composite outcome of any bleeding, thromboembolism, or cardiovascular death through 7 â€‹days and 45 â€‹days following WATCHMAN implantation was similar in patients receiving DOACs versus warfarin.

Same-Day Discharge After Transcatheter Aortic Valve Implantation: Insights from the Nationwide Readmission Database 2015 to 2019.

Background There is a paucity of data on the feasibility of same-day discharge (SDD) following transcatheter aortic valve implantation (TAVI) at a national level. Methods and Results This study used data from the Nationwide Readmission Database from the fourth quarter of 2015 through 2019 and identified patients undergoing TAVI using the claim code 02RF3. A total of 158 591 weighted hospitalizations for TAVI were included in the analysis. Of the patients undergoing TAVI, 961 (0.6%) experienced SDD. Non-SDDs included 65 814 (41.5%) patients who underwent TAVI who were discharged the next day, and 91 816 (57.9%) discharged on the second or third day. The 30-day readmission rate for SDD after TAVI was similar to non-SDD TAVI (9.8% versus 8.9%, P=0.31). The cumulative incidence of 30-day readmissions for SDD was higher compared with next-day discharge (log-rank P=0.01) but comparable to second- or third-day discharge (log-rank P=0.66). At 30 days, no differences were observed in major or minor vascular complications, heart failure, or ischemic stroke for SDD compared with non-SDD. Acute kidney injury, pacemaker implantation, and bleeding complications were lower with SDD. Predictors associated with SDD included age <85 years, male sex, and prior pacemaker placement, whereas left bundle-branch block, right bundle-branch block, second-degree heart block, heart failure, prior percutaneous coronary intervention, and atrial fibrillation were negatively associated with SDD. Conclusions SDD following TAVI is associated with similar 30-day readmission and complication rates compared with non-SDD. Further prospective studies are needed to assess the safety and feasibility of SDD after TAVI.