Prospective Evaluation of Extracorporeal Shockwave Lithotripsy in Renal and Upper Ureteric Stone Treatment: Clinical Assessment and Results.

INTRODUCTION: Extracorporeal shockwave lithotripsy (ESWL) is a widely accepted non-invasive treatment for renal and upper ureteric stones smaller than 2 cm due to its safety and efficacy. Despite advancements in minimally invasive techniques, extracorporeal shockwave lithotripsy remains an important modality. AIMS AND OBJECTIVE: This prospective observational study aimed to evaluate the outcomes of ESWL in managing renal and upper ureteric stones measuring less than 2 cm in terms of stone clearance. MATERIAL AND METHODS: In a study conducted at a university-affiliated tertiary care hospital, 119 patients with renal and upper ureteric stones underwent extracorporeal shockwave lithotripsy over a 12-month period. Data on patient demographics, stone characteristics, treatment procedures, and complications were collected. Follow-up assessments were performed at two-week intervals for up to two months post-treatment. RESULTS: The mean age of patients was 39.78 years, with a mean stone size of 1.2 cm. Right kidney stones were more prevalent (61.3% [n=76]). Complications included fever (19.3% [n=23]), gross haematuria (24.3% [n=29]), and steinstrasse (21.8% [n=26]). The success rate of extracorporeal shockwave lithotripsy was 81.5% (n=97), with 18.5% (n=22) of patients requiring surgical intervention due to incomplete fragmentation or residual fragments >4 mm. Stone size and density played significant roles in treatment success. CONCLUSION: Despite advancements in minimally invasive techniques, ESWL retains its significance as a noninvasive and effective treatment option for renal and upper ureteric stones smaller than 2 cm. Its success depends on various factors, including the stone site, size, and composition. ESWL offers advantages such as minimal morbidity, shorter hospital stays, and better patient compliance. Complications such as steinstrasse are manageable with conservative measures or ancillary procedures. While ESWL may be losing ground in some cases, its noninvasive nature and favourable outcomes make it a valuable option in the armamentarium for stone management.

Evaluation of pharmacist-led transition of care program in patients with acute coronary syndrome.

BACKGROUND: Guideline-directed medical therapies (GDMTs), initiated in-hospital and continued during the transition to outpatient care, are paramount to successful outcomes for patients with acute coronary syndrome (ACS). Incomplete discharge medication prescribing and delayed follow-up lead to worse cardiovascular outcomes. OBJECTIVES: We investigated a system of care using inpatient and outpatient clinical pharmacists to close GDMT gaps, ensure seamless transition to outpatient care, improve patient education, and optimize therapies. METHODS: We conducted a pre-post cohort analysis of patients with ACS pre- versus post-intervention to compare process metrics and key outcomes using electronic health record data. RESULTS: There were 181 and 135 patients in the pre- and post-intervention cohorts, respectively. Patients post-intervention were significantly more likely to have appropriately-timed follow-up visits scheduled with cardiology (79% vs. 51%, P < 0.0001) and primary care (57% vs. 43%, P = 0.01), to be discharged with prescriptions for P2Y12 inhibitors (87% vs. 64%, P < 0.0001), high dose statins (86% vs. 70%, P = 0.001), and beta blockers (87% vs. 76%, P = 0.01), and significantly less likely to have 30-day all-cause hospital readmissions (4% vs. 12%, P = 0.02) and emergency department (ED) visits (10% vs. 18%, P = 0.04). CONCLUSIONS: The integration of advanced practicing pharmacists into a cardiology team at transition and post-hospitalization resulted in improved rates of posthospital follow-up visits, optimization of GDMT medications, and significantly lower 30-day hospital readmission and ED utilization.

Severe Bradycardia Leading to Hemodynamic Instability Associated with Remdesivir Use in a Patient with COVID-19 Pneumonia.

Remdesivir (RDV) is an approved treatment for hospitalized patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. There is limited literature on the cardiac adverse effects of RDV. We report a case of a patient who developed hemodynamically unstable bradycardia after the initiation of RDV that resolved after discontinuing RDV.

Outcomes of Patients Undergoing Cardiac Catheterization After a Three-Day Holiday Weekend Versus a Two-Day Weekend.

OBJECTIVES: The study aim is to determine whether invasive cardiac procedures following a 3-day (holiday) weekend have worse outcomes compared with procedures following a 2-day (normal) weekend. BACKGROUND: Catheterization laboratory schedules after 3-day holiday weekends tend to be overloaded with urgent procedures for patients who have waited up to 3 days. We hypothesized that this would be reflected by more procedural complications in patients undergoing procedures after a 3-day weekend. METHODS: Invasive cardiac procedures that occurred after a weekend at Geisinger Medical Center from July 2012 to December 2019 were included. Baseline characteristics, presentation, periprocedural variables, adverse events, and clinical outcomes were compared between catheterizations on the day following a 2-day weekend and catheterizations following a 3-day weekend. Independent correlates of adverse events were identified by logistic regression analysis. RESULTS: We identified 13,704 invasive cardiac procedures performed after a weekend, of which 722 occurred after a 3-day (holiday) weekend. Baseline demographics, presentation, and case volumes were similar between the 2 groups. Procedures after a 3-day weekend were not associated with any differences in in-hospital mortality, myocardial infarction, or stroke compared with those after a standard 2-day weekend. By univariate analysis, procedural complications were more frequent after a 3-day weekend (15.1% vs 12.3%; P=.03), but this difference was not significant on multivariate analysis (odds ratio, 1.22; P=.30). CONCLUSIONS: Cardiac catheterization procedures performed after a 3-day weekend were not associated with differences in in-patient mortality, myocardial infarction, stroke, or procedural complications.

Preventing Coronary Obstruction During Transcatheter Aortic Valve Replacement: Results From the Multicenter International BASILICA Registry.

OBJECTIVES: This study sought to determine the safety of the BASILICA (bioprosthetic or native aortic scallop intentional laceration to prevent iatrogenic coronary artery obstruction) procedure. BACKGROUND: Transcatheter aortic valve replacement causes coronary artery obstruction in 0.7% of cases, with 40% to 50% mortality. BASILICA is a procedure to prevent coronary obstruction. Safety and feasibility in a large patient cohort is lacking. METHODS: The international BASILICA registry was a retrospective, multicenter, real-world registry of patients at risk of coronary artery obstruction undergoing BASILICA and transcatheter aortic valve replacement. Valve Academic Research Consortium-2 definitions were used to adjudicate events. RESULTS: Between June 2017 and December 2020, 214 patients were included from 25 centers in North America and Europe; 72.8% had bioprosthetic aortic valves and 78.5% underwent solo BASILICA. Leaflet traversal was successful in 94.9% and leaflet laceration in 94.4%. Partial or complete coronary artery obstruction was seen in 4.7%. Procedure success, defined as successful BASILICA traversal and laceration without mortality, coronary obstruction, or emergency intervention, was achieved in 86.9%. Thirty-day mortality was 2.8% and stroke was 2.8%, with 0.5% disabling stroke. Thirty-day death and disabling stroke were seen in 3.4%. Valve Academic Research Consortium-2 composite safety was achieved in 82.8%. One-year survival was 83.9%. Outcomes were similar between solo and doppio BASILICA, between native and bioprosthetic valves, and with the use of cerebral embolic protection. CONCLUSIONS: BASILICA is safe, with low reported rates of stroke and death. BASILICA is feasible in the real-world setting, with a high procedure success rate and low rates of coronary artery obstruction.

Prognostic implications of prior contrast reaction in patients with emergency premedication before undergoing percutaneous coronary intervention.

BACKGROUND: Patients with iodinated contrast material (ICM) adverse reactions are at increased risk for breakthrough reactions. Previous studies suggest that the severity of a prior ICM adverse reaction corresponds to the severity of a repeat reaction. OBJECTIVE: We investigated whether the severity of prior ICM adverse reactions in patients receiving emergency premedication therapy prior to PCI predicts outcomes. METHODS: A retrospective observational study of percutaneous coronary intervention (PCI) encounters between January 1, 2005, and May 30, 2018, was conducted at Geisinger Medical Center. Patients with ICM adverse reactions premedicated with an emergency premedication regimen prior to PCI were included in the study. PCIs were stratified based on the severity of the index ICM adverse reactions; PCIs with a prior severe reaction were compared to PCIs with a prior mild-moderate reaction. RESULTS: We evaluated 604 PCI, of these, 144 (23.8%) had prior severe reactions and 460 (76.2%) had mild-to-moderate reactions. Nine patients had breakthrough reactions, of which seven were of the same or decreased severity in comparison to the index reactions. The overall breakthrough reactions occurred in 1 of 144 patients (0.7%) with an initial severe reaction and in 8 of 460 (1.7%) with an initial mild/moderate reaction (p = 0.69). Outcomes including length of hospital stay and 30-day mortality were similar for PCI with or without severe index ICM reactions. CONCLUSION: Frequency and severity of breakthrough reaction and clinical outcomes in patients treated with emergency premedication regimen prior to PCI were independent of the severity of index ICM reactions.

Coronary and Structural Heart Disease Interventions During COVID-19 Pandemic: A Road Map for Clinicians and Health Care Delivery Systems.

BACKGROUND: Because of the COVID-19 pandemic, cath labs have had to modify their workflow for elective and urgent patients. METHODS: We surveyed 16 physicians across 3 hospitals in our healthcare system to address COVID-19 related concerns in the management of interventional and structural heart disease patients, and to formulate system wide criteria for deferring cases till after the pandemic. RESULTS: Our survey yielded common concerns centered on the need to protect patients, cath lab staff and physicians from unnecessary exposure to COVID-19; for COVID-19 testing prior to arrival to the cath lab; for clear communication between the referring physician and the interventionalist; but there was initial uncertainty among physicians regarding the optimal management of ST elevation myocardial infarction (STEMI; percutaneous coronary intervention versus thrombolytics). Patients with stable angina and hemodynamically stable acute coronary syndromes were deemed suitable for initial medical management, except when they had large ischemic burden. Most transcatheter aortic valve implantations (TAVI) were felt appropriate for postponement except in symptomatic patients with aortic valve area <0.5 cm2 or recent hospitalization for heart failure (HF). Most percutaneous mitral valve repair (pMVR) procedures were felt appropriate for postponement except in patients with HF. All left atrial appendage closure (LAAC) and patent foramen ovale (PFO)/atrial septal defect (ASD) closure procedures were felt appropriate for postponement. CONCLUSION: Our survey of an experienced team of clinicians yielded concise guidelines to direct the management of CAD and structural heart disease patients during the initial phases of the COVID-19 pandemic.

Efficiency, Safety, and Quality of Life After Transcatheter Aortic Valve Implantation Performed With Moderate Sedation Versus General Anesthesia.

There is growing interest in "minimalist" transcatheter aortic valve implantation (M-TAVI), performed with conscious sedation instead of general anesthesia (GA-TAVI). We assessed the impact of M-TAVI on procedural efficiency, long-term safety, and quality of life (QoL) in 477 patients with severe aortic stenosis (82 years, women 50%, STS 5.0), who underwent M-TAVI (n = 278) or GA-TAVI (n = 199). M-TAVI patients were less likely to have NYHA Class ≥3, valve-in-valve TAVI, and receive self-expanding valves. M-TAVI was completed without conversion to GA in 269 (97%) patients. M-TAVI was more efficient that GA-TAVI including shorter lengths of stay (2 vs 3 days, p <0.0001), higher likelihood of being discharged home (87% vs 72%, p <0.0001), less use of blood transfusions (10% vs 22%, p = 0.0008), inotropes (13% vs 32%, p <0.0001), contrast volume (50 vs 90 ml, p <0.0001), fluoroscopy time (20 vs 24 minute, p <0.0001), and need for >1 valves (0.4 vs 5.5%, p = 0.0004). At 1-month, death/stroke (M-TAVI vs GA-TAVI 4.0 vs 6.5%) and a "safety composite" end point (death, stroke, transient ischemic attack, myocardial infarction, new dialysis, major vascular complication, major or life-threatening bleeding, and new pacemaker: 17.6% vs 21.1%) were similar (p = NS for both). At a median follow-up of 365 days, survival curves showed similar incidence of death/stroke as well as the safety composite end point between the groups. QoL scores were similar at baseline and 1-month after TAVI. In multivariable analyses, M-TAVI showed significant improvements in all parameters of procedural efficiency. In conclusion, M-TAVI is more efficient than GA-TAVI, with similar safety at 1-month and long-term, and similar QoL scores at 1 month.

Applying the Seattle Heart Failure Model in the Office Setting in the Era of Electronic Medical Records.

BACKGROUND: Prediction models such as the Seattle Heart Failure Model (SHFM) can help guide management of heart failure (HF) patients, but the SHFM has not been validated in the office environment. This retrospective cohort study assessed the predictive performance of the SHFM among patients with new or pre-existing HF in the context of an office visit.Methods and Results:SHFM elements were ascertained through electronic medical records at an office visit. The primary outcome was all-cause mortality. A "warranty period" for the baseline SHFM risk estimate was sought by examining predictive performance over time through a series of landmark analyses. Discrimination and calibration were estimated according to the proposed warranty period. Low- and high-risk thresholds were proposed based on the distribution of SHFM estimates. Among 26,851 HF patients, 14,380 (54%) died over a mean 4.7-year follow-up period. The SHFM lost predictive performance over time, with C=0.69 and C<0.65 within 3 and beyond 12 months from baseline respectively. The diminishing predictive value was attributed to modifiable SHFM elements. Discrimination (C=0.66) and calibration for 12-month mortality were acceptable. A low-risk threshold of ∼5% mortality risk within 12 months reflects the 10% of HF patients in the office setting with the lowest risk. CONCLUSIONS: The SHFM has utility in the office environment.

Trends and Outcomes After Same-Day Discharge After Percutaneous Coronary Interventions.

BACKGROUND: Despite the demonstrated safety of the same-day discharge (SDD) after percutaneous coronary intervention (PCI), uptake of this program has been relatively poor in the United States. We evaluated the temporal trends and variations in the utilization of SDD after PCI during the contemporary era. In addition, we evaluated the predictors of SDD (compared with next-day discharge) and the causes of readmission in these 2 patient cohorts. METHODS AND RESULTS: Data were extracted from State Ambulatory Surgical Database and State Inpatient Database from Florida and New York ranging from 2009 to 2013. All adults undergoing PCI in an outpatient setting were included. Data were merged with the directory available from the American Hospital Association to obtain detailed information on hospital-related characteristics. Unplanned readmissions within 7 and 30 days constituted the coprimary outcomes. There was modest increase in the proportion of SDD after PCI from 2.5% in 2009 to 7.4% in 2013 (P-trend <0.001). SDD was more frequently used among male and younger patients with fewer comorbidities. There were considerable differences in the discharge practices among the different hospital types. Larger hospitals, teaching hospitals, and high PCI volume hospitals had higher utilization of SDD compared with their respective counterparts. SDD and next-day discharge cohorts had similar rates of unplanned readmissions, in-hospital mortality, and acute myocardial infarction during follow-up. Furthermore, uninsured patients had significantly lower odds of SDD along with higher incidence of unplanned readmission within 30 days after PCI compared with insured patients. CONCLUSIONS: During 2009 to 2013, there has been a modest increase in SDD after PCI. Several demographic and clinical characteristics play critical role in determination of SDD after PCI. There were significant disparities in discharge practices between different sex, racial, and insurance-based strata.

Changing Trends of Atherosclerotic Risk Factors Among Patients With Acute Myocardial Infarction and Acute Ischemic Stroke.

We aimed to evaluate the secular trends in demographics, risk factors, and clinical characteristics of patients presenting with acute myocardial infarction (AMI) or acute ischemic stroke (AIS), using a large nationally representative data set of in-hospital admissions. We used the 2003 to 2013 Nationwide Inpatient Sample. All admissions with primary diagnosis of AMI or AIS were included. Across 2003 to 2013, a total of 1,360,660 patients with AMI and 937,425 patients with AIS were included in the study. We noted a progressive reduction in the mean age of patients presenting with AMI and AIS (p trend <0.001 for all groups), implying that the burden of young patients with these acute syndromes is progressively increasing. In addition, there was a progressive increase in the proportion of patients who are uninsured among patients presenting with AMI and AIS. Furthermore, despite a progressively younger age at presentation, there was an observed increase in the prevalence of atherosclerotic risk factors including hypertension, hyperlipidemia, diabetes, smoking, and obesity among patients presenting with AMI or AIS during 2003 to 2013. Significant disparities were noted in the prevalence of risk factors among various demographic and geographical cohorts. Low socioeconomic status as well as uninsured patients had a significantly higher prevalence of preventable risk factors like smoking and obesity as compared to the high socioeconomic status and insured patients, respectively. In conclusion, there have been significant changes in the risk factor profile of patients presenting with AMI and AIS over the last decade.

Burden of Readmissions Among Patients With Critical Limb Ischemia.

BACKGROUND: Readmissions constitute a major health care burden among critical limb ischemia (CLI) patients. OBJECTIVES: This study aimed to determine the incidence of readmission and factors affecting readmission in CLI patients. METHODS: All adult hospitalizations with a diagnosis code for CLI were included from State Inpatient Databases from Florida (2009 to 2013), New York (2010 to 2013), and California (2009 to 2011). Data were merged with the directory available from the American Hospital Association to obtain detailed information on hospital-related characteristics. Geographic and routing analysis was performed to evaluate the effect of travel time to the hospital on readmission rate. RESULTS: Overall, 695,782 admissions from 212,241 patients were analyzed. Of these, 284,189 were admissions with a principal diagnosis of CLI (primary CLI admissions). All-cause readmission rates at 30 days and 6 months were 27.1% and 56.6%, respectively. The majority of these were unplanned readmissions. Unplanned readmission rates at 30 days and 6 months were 23.6% and 47.7%, respectively. The major predictors of 6-month unplanned readmissions included age, female sex, black/Hispanic race, prior amputation, Charlson comorbidity index, and need for home health care or rehabilitation facility upon discharge. Patients covered by private insurance were least likely to have a readmission compared with Medicaid/no insurance and Medicare populations. Travel time to the hospital was inversely associated with 6-month unplanned readmission rates. There was a significant interaction between travel time and major amputation as well as travel time and revascularization strategy; however, the inverse association between travel time and unplanned readmission rate was evident in all subgroups. Furthermore, length of stay during index hospitalization was directly associated with the likelihood of 6-month unplanned readmission (odds ratio for log-transformed length of stay: 2.39 [99% confidence interval: 2.31 to 2.47]). CONCLUSIONS: Readmission among patients with CLI is high, the majority of them being unplanned readmissions. Several demographic, clinical, and socioeconomic factors play important roles in predicting readmissions.

Bleeding complications of triple antithrombotic therapy after percutaneous coronary interventions.

BACKGROUND: 5% of patients undergoing coronary stenting have an indication for anticoagulation. The aim of our study was to determine the bleeding rates and complications in patients on triple oral antithrombotic therapy (TOAT) after coronary stenting. METHODS: We studied patients who underwent coronary stenting in our institution between 2003-2013 and were started on TOAT. Bleeding was the primary outcome. RESULTS: Totally, 999 patients were treated with TOAT with a median follow up of 127 days. All patients were treated with warfarin as an anticoagulant. 267 patients (26.7%) developed a total of 331 bleeding events. 100 patients had bleeding during the first 30 days of therapy. Major bleeding, minor bleeding, bleeding requiring medical attention, and minimal bleeding developed in 2.9%, 3.3%, 17.2%, and 3.3% of the patients respectively as their most significant bleeding event. Patients with anticoagulation initiated at time of stenting had a significantly higher bleeding rate compared to those already on chronic anticoagulation [adjusted HR (95% CI): 1.37 (1.03-1.79), P = 0.03]. The bleeding likelihood was significantly higher for patients with drug-eluted stents (DES) compared to bare-metal stents (BMS) [adjusted OR (95% CI): 1.52 (1.14 - 2.04), P < 0.05]. Patients with atrial fibrillation had an increased rate of bleeding after 6 month of initiation of TOAT with significantly worse outcomes. CONCLUSIONS: TOAT after coronary stenting is associated with high bleeding rates. Patients with AF had worse outcomes. Patients with newly initiated anticoagulation at time of stenting bleed significantly more than people already on chronic anticoagulation prior to stenting. © 2016 Wiley Periodicals, Inc.

Insights Into Timing, Risk Factors, and Outcomes of Stroke and Transient Ischemic Attack After Transcatheter Aortic Valve Replacement in the PARTNER Trial (Placement of Aortic Transcatheter Valves).

BACKGROUND: Prior studies of stroke and transient ischemic attack (TIA) after transcatheter aortic valve replacement (TAVR) are limited by reporting and follow-up variability. This is a comprehensive analysis of time-related incidence, risk factors, and outcomes of these events. METHODS AND RESULTS: From April 2007 to February 2012, 2621 patients, aged 84±7.2 years, underwent transfemoral (TF; 1521) or transapical (TA; 1100) TAVR in the PARTNER trial (Placement of Aortic Transcatheter Valves; as-treated), including the continued access registry. Stroke and TIA were identified by protocol and adjudicated by a Clinical Events Committee. Within 30 days of TAVR, 87 (3.3%) patients experienced a stroke (TF 58 [3.8%]; TA 29 [2.7%]; P=0.09), 85% within 1 week. Instantaneous stroke risk peaked on day 2, then fell to a low prolonged risk of 0.8% by 1 to 2 weeks. Within 30 days, 13 (0.50%) patients experienced a TIA (TF 10 [0.67%]; TA 3 [0.27%]; P>0.17). Stroke and TIA were associated with lower 1-year survival than expected (TF 47% after stroke versus 82%, and 64% after TIA versus 83%; TA 53% after stroke versus 80%, and 64% after TIA versus 83%). Risk factors for early stroke after TA-TAVR included more postdilatations, pure aortic stenosis without regurgitation, and possibly more pacing runs, earlier date of procedure, and no dual antiplatelet therapy; high pre-TAVR aortic peak gradient was a risk factor for stroke early after TF-TAVR. CONCLUSIONS: Risk of stroke or TIA is highest early after TAVR and is associated with increased 1-year mortality. Modifications of TAVR, emboli-prevention devices, and better intraprocedural pharmacological protection may mitigate this risk. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00530894.