Propensity Score-matched Patients Research Articles

Viral eradication reduces all-cause mortality in patients with chronic hepatitis C virus infection who had received direct-acting antiviral therapy.

The impact of hepatitis C virus (HCV) eradication via direct-acting antiviral (DAA) therapy on overall mortality, particularly non-liver-related mortality, is understudied. We recruited 4180 patients with chronic HCV infection who achieved sustained virological response (SVR) (HCV eradication) through DAA therapy (n = 2501, SVR group) or who did not receive antiviral therapy (n = 1679, non-SVR group); 1236 from each group were chosen using propensity score matching. Causes of death and all-cause mortality, including non-liver-related diseases, were investigated. Of the 4180 patients, 592 died during the follow-up period. In the SVR group, the mortality rates from liver-related and non-liver-related diseases were 16.5% and 83.5%, respectively. Compared to the non-SVR group, mortality rates from liver-related and non-liver-related diseases were 50.1% and 49.9%, respectively (p < .001). In non-cirrhotic patients, multivariable analysis revealed that SVR was an independent factor associated with both liver-related (hazard ratio [HR], .251; 95% confidence interval [CI], .092-.686) and non-liver-related (HR, .641; 95% CI, .415-.990) mortalities. In cirrhotic patients, multivariable analysis revealed that SVR remained an independent factor significantly associated with liver-related mortality (HR, .151; 95% CI, .081-.279). In propensity score-matched patients, the eradication of HCV (SVR group) decreased both liver-related (p < .001) and non-liver-related mortality (p = .008) rates compared to persistent HCV infection (non-SVR group). The elimination of HCV via DAA therapy reduced not only liver-related mortality but also non-liver-related mortality in patients with chronic HCV.

Evaluation of Etomidate Use and Association with Mortality Compared with Ketamine Among Critically Ill Patients.

Uncertainty remains regarding the risks associated with single dose use of etomidate. To assess use of etomidate in critically ill patients and compare outcomes for patients who received etomidate versus ketamine. We assessed patients who received invasive mechanical ventilation (IMV), admitted to an ICU in the Premier Healthcare Database, 2008-2021. The exposure was receipt of etomidate on the day of IMV initiation and the main outcome was hospital mortality. Using multivariable regression we compared patients who received IMV within the first two days of hospitalization who received etomidate with propensity-score matched patients who received ketamine. We also assessed whether receipt of corticosteroids in the days after intubation modified the association between etomidate and mortality. Of 1,689,945 patients who received IMV, nearly half (738,855; 43.7%) received etomidate. Among those who received IMV in the first two days of hospitalization, we established 22,273 matched pairs given either etomidate or ketamine. In the primary analysis, receipt of etomidate was associated with greater hospital mortality relative to ketamine (21.6% vs 18.7%; absolute risk difference: 2.8%, 95% CI 2.1%, 3.6%; adjusted odds ratio: 1.28, 95% CI 1.21,1.34). This was consistent across subgroups and sensitivity analyses. We found no attenuation of the association with mortality with receipt of corticosteroids in the days following etomidate use. Use of etomidate on the day of IMV initiation is common and associated with a higher odds of hospital mortality compared with ketamine. This finding is independent of subsequent treatment with corticosteroids.

Early reapplication of prone position during venovenous ECMO for acute respiratory distress syndrome: a prospective observational study and propensity-matched analysis

BackgroundA combination of prone positioning (PP) and venovenous extracorporeal membrane oxygenation (VV-ECMO) is safe, feasible, and associated with potentially improved survival for severe acute respiratory distress syndrome (ARDS). However, whether ARDS patients, especially non-COVID-19 patients, placed in PP before VV-ECMO should continue PP after a VV-ECMO connection is unknown. This study aimed to test the hypothesis that early use of PP during VV-ECMO could increase the proportion of patients successfully weaned from ECMO support in severe ARDS patients who received PP before ECMO.MethodsIn this prospective observational study, patients with severe ARDS who were treated with VV-ECMO were divided into two groups: the prone group and the supine group, based on whether early PP was combined with VV-ECMO. The proportion of patients successfully weaned from VV-ECMO and 60-day mortality were analyzed before and after propensity score matching.ResultsA total of 165 patients were enrolled, 50 in the prone and 115 in the supine group. Thirty-two (64%) and 61 (53%) patients were successfully weaned from ECMO in the prone and the supine groups, respectively. The proportion of patients successfully weaned from VV-ECMO in the prone group tended to be higher, albeit not statistically significant. During PP, there was a significant increase in partial pressure of arterial oxygen (PaO2) without a change in ventilator or ECMO settings. Tidal impedance shifted significantly to the dorsal region, and lung ultrasound scores significantly decreased in the anterior and posterior regions. Forty-five propensity score-matched patients were included in each group. In this matched sample, the prone group had a higher proportion of patients successfully weaned from VV-ECMO (64.4% vs. 42.2%; P = 0.035) and lower 60-day mortality (37.8% vs. 60.0%; P = 0.035).ConclusionsPatients with severe ARDS placed in PP before VV-ECMO should continue PP after VV-ECMO support. This approach could increase the probability of successful weaning from VV-ECMO.Trial RegistrationClinicalTrials.Gov: NCT04139733. Registered 23 October 2019.

Hyperkalemia and risk of chronic kidney disease progression: A propensity score matched analysis.

Hyperkalemia is a known complication of chronic kidney disease (CKD); however, it is not known whether hyperkalemia directly contributes to CKD progression and the risk of death. Clarifying the extent to which hyperkalemia is associated with CKD progression and mortality can inform clinical practice and guide future research. The objective of this study was to quantify the risks of CKD progression and mortality associated with hyperkalemia in patients with stages 3b/4 CKD. This was a real-world, exact and propensity score-matched, observational cohort study using data (January 2016-December 2021) from Optum's deidentified Market Clarity Data, a large US integrated insurance claims/electronic medical record database. The study included matched adult patients with stages 3b/4 CKD with and without hyperkalemia, not regularly treated with an intestinal potassium (K+) binder. Measured outcomes were CKD progression and all-cause mortality. CKD progression was defined as diagnosis of CKD stage 4 (if stage 3b at index), CKD stage 5 or kidney failure, or receipt of dialysis or kidney transplantation. After matching, there were 6,619 patients in each of the hyperkalemia and non-hyperkalemia cohorts, with a mean (standard deviation) follow-up time of 2.12 (1.42) years. Use of any renin-angiotensin-aldosterone system inhibitors (RAASi) during baseline was common (75.9%) and most patients had CKD stage 3b (71.2%). Patients with hyperkalemia had a 1.60-fold (95% confidence interval [CI] 1.50, 1.71) higher risk of CKD progression and a 1.09-fold (1.02, 1.16) higher risk of all-cause mortality relative to patients without hyperkalemia. Relative risks of CKD progression associated with hyperkalemia were similar within the subset of patients receiving RAASi and across CKD stages, and when alternative definitions of CKD progression were used. Patients with CKD stages 3b/4 and hyperkalemia experienced significantly higher risks of CKD progression and all-cause mortality than propensity score-matched patients without hyperkalemia.

Correlation between tumor budding and the long-term follow-up outcomes after endoscopic submucosal dissection for superficial esophageal squamous cell carcinoma.

The effect of tumor budding (TB) on the prognosis of patients with esophageal squamous cell carcinoma (ESCC) after endoscopic submucosal dissection (ESD) remains unclear. We evaluated the long-term outcomes of patients with superficial ESCC after ESD and the risk factors of TB for the long-term prognosis. We conducted a retrospective study in a Chinese hospital. All patients with ESCC treated by ESD and reported TB were included consecutively. Comparative analyses were conducted in three parts: specimen analysis, follow-up analyses of unmatched patients, and propensity score-matched (PSM) patients. Cox proportional hazard regression models were constructed to identify risk factors for overall survival and recurrence-free survival (RFS). A total of 437 patients were enrolled [154TB and 283 no tumor budding (NTB)], and 258 patients (52TB and 206 NTB) were included in the follow-up analysis. Results showed that the invasion depth, differentiation type, and positive vascular invasion (all p < 0.001) of the TB group were significantly different from the NTB group. The all-cause mortality and the median RFS time between the two groups were comparable. RFS rate at 5years were 84.6% and 80.6%, respectively (p = 0.43). Cox analyses identified that having other cancers but not TB, as a risk factor independently associated with overall survival and RFS after ESD. TB tends to be associated with invasion depth, differentiation type, and positive vascular invasion. However, it might not affect the long-term outcomes of patients with superficial ESCC after ESD when other high-risk factors are negative.

Postoperative Complications and Readmission Rates in Robotic-Assisted Versus Manual Total Knee Arthroplasty: Large, Propensity Score-Matched Patient Cohorts.

There is a paucity of research comparing postoperative complication rates between manual total knee arthroplasty (M-TKA) and robotic-assisted total knee arthroplasty (RA-TKA). This study aims to compare 90-day postoperative complication, readmission, and emergency department rates between RA-TKA and M-TKA. A retrospective review of a multihospital database identified patients who underwent TKA between January 2016 and May 2023. Surgeons who used the robotic-assisted surgery technique in <10% or >90% of their cases annually were excluded. This resulted in 15,999 cases (8,853 RA-TKAs; 7,146 M-TKAs) from 282 surgeons. RA-TKA and M-TKA cohorts were one-to-one matched based on patient sex, age, body mass index, hospital setting, surgeon experience, primary payer, and anesthesia type. Each cohort consisted of 7,146 patients (N = 14,292). 90-day revisits, specifically readmissions, readmissions with >23 hours of observation, and ED visit rates were compared between cohorts. Complications were classified according to the Clinical Classification Software schema and compared between cohorts. Mann-Whitney U, chi-squared, and Fisher exact tests, along with Bonferroni correction, were used to statistically compare cohorts. All-cause 90-day readmission rates were 2.4% for RA-TKA and 2.6% for M-TKA (P = 0.36). RA-TKA had fewer revisits (RA-TKA: 7.8%; M-TKA: 8.8%, P = 0.027) and rates of readmission with >23 hours of observation (RA-TKA: 1.4%; M-TKA: 2.0%, P = 0.003). RA-TKA had fewer hospital revisits due to joint stiffness (RA-TKA: 17 revisits; M-TKA: 42 revisits, P = 0.002) and chronic pain (RA-TKA: 1 revisit; M-TKA: 8 revisits, P = 0.039). Fewer readmissions were observed for acute injuries (lower extremity muscle/tendon strains) in the RA-TKA cohort (RA-TKA: 1; M-TKA: 9, P = 0.021). RA-TKA had fewer ED visits due to hematomas (RA-TKA: 0 visits; M-TKA: 7 visits, P = 0.016). In this retrospective matched cohort analysis, RA-TKA was associated with markedly fewer revisits and readmissions with >23 hours of observation compared with M-TKA. No differences in all-cause 90-day readmission were observed between cohorts. Level III. Retrospective review.

Relationship Between Fluid Administration During the First Three Hours of Sepsis Resuscitation and Mortality: A Multicenter Observational Study.

Background Timely and effective fluid resuscitation is vital for stabilizing sepsis while avoiding volume overload. We aimed to assess how the administration of a 30 mL/kg bolus fluid affects patients with sepsis within three hours of clinical outcomes. Methods This multicenter observational study included adult patients diagnosed with sepsis in 17 intensive care units at tertiary hospitals in Japan between July 2019 and August 2020. The clinical outcomes of patients with sepsis who received ≥30 mL/kg bolus fluid within three hours (30 × 3 group) were compared with those who received <30 mL/kg fluid (non-30 × 3 group). Results Of 172 eligible patients, 74 (43.0%) belonged to the 30 × 3 group, and 98 (57.0%) belonged to the non-30 × 3 group. The median Sequential Organ Failure Assessment score was 9 (interquartile range (Q1-Q3): 7-11) in the 30 × 3 group and 7 (Q1-Q3: 4-9) in the non-30 × 3 group (P < 0.01). The 28-day mortality rate was 29.7% in the 30 × 3 group and 12.2% in the non-30 × 3 group (P < 0.01). However, the adjusted odds ratio by the inverse probability of treatment weighting analysis with propensity score for the 28-day mortality rate of the 30 × 3 group compared with that in the non-30 × 3 group was 2.17 (95% confidence interval: 0.85-5.54). Among the propensity score-matched patients, the 28-day mortality rate was 30% in the 30 × 3 (n = 70) and non-30 × 3 (n = 95) groups, respectively (P = 0.72). Conclusions Patients with sepsis who received the 30 mL/kg bolus fluid within three hours experienced more severe clinical outcomes. However, it was not associated with the increased odds of the 28-day mortality.

Two-Year Outcomes of Primary Prophylactic Use of Defibrillators for Ischemic and Non-Ischemic Cardiomyopathy - Propensity Score-Matched Analysis From the Nippon Storm Study.

In 2016, the DANISH study reported negative results regarding the efficacy of implantable cardioverter-defibrillators (ICDs) in patients with non-ischemic cardiomyopathy (NICM) and reduced left ventricular ejection fraction (LVEF). In this study we determined the efficacy of using ICDs for primary prophylaxis in patients with NICM.Methods and Results: We selected 1,274 patients with underlying cardiac disease who were enrolled in the Nippon Storm Study. We analyzed the data of 451 patients with LVEF ≤35% due to NICM or ischemic cardiomyopathy (ICM) who underwent ICD implantation for primary prophylaxis (men, 78%; age, 65±12 years; LVEF, 25±6.4%; cardiac resynchronization therapy, 73%; ICM, 33%). After propensity score matching, we compared the baseline covariates between groups: NICM (132 patients) and ICM (132 patients). The 2-year appropriate ICD therapy risks were 27.7% and 12.2% in the NICM and ICM groups, respectively (hazard ratio, 0.390 [95% confidence interval, 0.218-0.701]; P=0.002). This subanalysis of propensity score-matched patients from the Nippon Storm Study revealed that the risk of appropriate ICD therapy was significantly higher in patients with NICM than in those with ICM.

Acute kidney injury in cancer patients receiving anti-vascular endothelial growth factor monoclonal antibody vs. immune checkpoint inhibitors: a retrospective real-world study

BackgroundAnti-vascular endothelial growth factor monoclonal antibody (anti-VEGF) or immune checkpoint inhibitors (ICIs) combined with chemotherapy are commonly administered to cancer patients. Although cancer patients receiving anti-VEGF or ICIs have been reported to experience an increased risk of acute kidney injury (AKI), comparative studies on the AKI incidence have not been evaluated.MethodsCancer patients receiving anti-VEGF or ICIs were retrospectively selected from the hospital information system of the First Affiliated Hospital of Wenzhou Medical University between Jan, 2020 and Dec, 2022 and were divided into two groups according to the treatment regimen: anti-VEGF group and ICIs group. The baseline characteristics were propensity-score matched. The primary outcome was sustained AKI. A comparison of cumulative incidence of sustained AKI was performed by Kaplan-Meier curves and log-rank test. Risks for outcomes were assessed using Cox proportional regression.ResultsA total of 1581 cancer patients receiving anti-VEGF (n = 696) or ICIs (n = 885) were included in the primary analysis. The ICIs group had a higher cumulative incidence of sustained AKI within one year than the anti-VEGF group (26.8% vs. 17.8%, P < 0.001). Among 1392 propensity score matched patients, ICIs therapy (n = 696) was associated with an increased risk of sustained AKI events in the entire population (HR 2.0; 95%CI 1.3 to 2.5; P = 0.001) and especially in those with genitourinary cancer (HR 4.2; 95%CI 1.3 to 13.2; P = 0.015). Baseline serum albumin level (> 35 g/l) was an important risk factor for a lower incidence of sustained AKI in the anti-VEGF group (HR 0.5; 95%CI 0.3 to 0.9; P = 0.027) and the ICIs group (HR 0.3; 95%CI 0.2 to 0.5; P < 0.001).ConclusionsAmong cancer patients in this real-world study, treatment with ICIs increased incidence of sustained AKI in one year. Baseline serum albumin level was an important risk factor for sustained AKI. The risk factors for sustained AKI differed between the anti-VEGF group and the ICIs group.Trial RegistrationThe study has been registered at ClinicalTrials.gov (NCT06119347) on 11/06/2023.

Comparable results in total knee arthroplasty using the ROSA knee system versus the conventional technique:Aretrospective propensity-matched cohort study.

Robotic-assisted total knee arthroplasty (RA-TKA) is an increasingly popular alternative that may increase the accuracy of conventional TKA techniques. This study aims to evaluate RA-TKA accuracy and compare its radiographic and clinical outcomes to conventional TKA (cTKA). A retrospective examination of patients with bi- or tricompartmental knee osteoarthritis who underwent RA-TKA (RObotic Surgical Assistant system) or cTKA and were prospectively documented in the TKA registry. Accuracy was assessed using standardized radiographic implant position evaluations, namely femoral and tibial coronal angles and femoral and tibial sagittal angles. Baseline demographics, surgery details and 6- and 12-month post-TKA patient-reported outcomes (PROMs; e.g., Oxford Knee Score [OKS] and Core Outcome Measures Index) were compared between RA-TKA and propensity score-matched cTKA patients. Overall correlation between preset and 6-week postoperative angle measurements for RA-TKA was low with significant differences noted only for mean tibial sagittal angles (84.6° [RA-TKA] vs. 82.3° [cTKA]) (p < 0.001). The study groups were demographically similar, although RA-TKA patients had slightly longer operative times and higher blood loss but shorter inpatient stays. There were sustainable improvements in all PROMs already at 6 months, yet RA-TKA patients had significantly higher OKS values over their conventional counterparts at this time point. Radiological and clinical outcomes were comparable between RA-TKA and cTKA. The robotic-assisted system demonstrated higher accuracy in the coronal than sagittal plane and RA-TKA patients achieved better short-term outcomes for pain and disability. While both methods are similar in the hands of a skilled surgeon, long-term studies are necessary to establish clear method superiority. Therapeutic, Level III.

Drug-Coated Balloon Angioplasty in Patients Undergoing Complex Percutaneous Coronary Intervention

BackgroundThere are limited clinical data on drug-coated balloon (DCB)-based percutaneous coronary intervention (PCI) compared with drug-eluting stent (DES)-only PCI in patients with complex coronary artery lesions. ObjectivesThe goal of the current study was to investigate the efficacy of DCB in patients undergoing PCI for complex coronary artery lesions. MethodsFrom an institutional registry of patients with de novo complex coronary artery lesions, 126 patients treated with DCB-based PCI were compared with 234 propensity score–matched patients treated with DES-only PCI. Complex coronary artery lesions were defined as the presence of at least 1 of the following: bifurcation, chronic total occlusion, unprotected left main disease, long lesion ≥38 mm, multivessel disease, lesion requiring ≥3 devices, or severe calcification. The primary endpoint was target vessel failure (TVF) at 2 years, a composite of cardiac death, target vessel–related myocardial infarction, and target vessel revascularization. ResultsBaseline characteristics were comparable between the 2 groups. DCB-based PCI showed a comparable risk of TVF vs DES-based PCI (7.6% vs 8.1%; HR: 0.81; 95% CI: 0.33-1.99; P = 0.638). The risks of cardiac death (5.0% vs 5.7%; HR: 0.78; 95% CI: 0.24-2.49), target vessel–related myocardial infarction (0.9% vs 1.3%; HR: 2.65; 95% CI: 0.26-27.06), and target vessel revascularization (3.5% vs 2.0%; HR: 1.30; 95% CI: 0.30-5.67) were also comparable between the 2 groups. ConclusionsDCB-based PCI showed comparable risks of TVF vs those of DES-only PCI in patients with complex coronary artery lesions. DCB might be considered as a suitable alternative device to DES in patients undergoing complex PCI. (Long-term Outcomes and Prognostic Factors in Patient Undergoing CABG or PCI; NCT03870815)

Effects of ACE inhibitor/ARB therapy and long COVID on kidney disease: a retrospective cohort study using real-world data.

The association between angiotensin-converting enzyme inhibitors (ACEIs) or angiotensin II receptor blockers (ARBs) and severe acute respiratory syndrome coronavirus 2 susceptibility, particularly via ACE-2 receptor upregulation in the kidneys, raises concerns about potential kidney disease risks in long coronavirus disease (COVID) patients. This study explores the association of ACEI/ARB therapy on acute kidney injury (AKI), chronic kidney disease (CKD) and all-cause mortality in patients with and without long COVID. A retrospective cohort study using TriNetX datasets was conducted, with diagnoses of long COVID via International Classification of Diseases, Tenth Revision (ICD-10) codes and prescription for ACEI/ARB as the classification of four cohorts: long COVID ACEI/ARB users (LCAUs), long COVID ACEI/ARB non-users (LCANs), non-long COVID ACEI/ARB users (NLCAUs) and non-long COVID ACEI/ARB non-users (NLCANs). Multivariable stratified Cox proportional hazards regression models assessed the adjusted hazard ratios (aHRs) across groups. Additional analyses were conducted, including time-dependent exposure analysis and comparison with an active comparator, calcium channel blockers. Our study included 18 168 long COVID and 181 680 propensity score-matched non-long COVID patients from October 2021 to October 2023. ACEI/ARB use did not significantly affect the risk of AKI or CKD when comparing LCAUs with LCANs and NLCAUs with NLCANs. However, a protective effect against all-cause mortality was observed {aHR 0.79 [95% confidence interval (CI) 0.65-0.93]} in the NLCAU group compared with the NLCAN group. Conversely, long COVID was associated with increased risks of CKD [aHR 1.49 (95% CI 1.03-2.14)] and all-cause mortality [aHR 1.49 (95% CI 1.00-2.23)] when comparing LCANs with NLCANs. The additional analyses support the primary findings. ACEI/ARB treatment does not increase the incidence of CKD or AKI, regardless of long COVID status. However, long COVID itself is associated with increasing risks of kidney diseases and all-cause mortality.

Implant-Positioning and Patient Factors Associated with Acromial and Scapular Spine Fractures After Reverse Shoulder Arthroplasty

Background: This study aimed to identify implant positioning parameters and patient factors contributing to acromial stress fractures (ASFs) and scapular spine stress fractures (SSFs) following reverse shoulder arthroplasty (RSA). Methods: In a multicenter retrospective study, the cases of patients who underwent RSA from June 2013 to May 2019 and had a minimum 3-month follow-up were reviewed. The study involved 24 surgeons, from 15 U.S. institutions, who were members of the American Shoulder and Elbow Surgeons (ASES). Study parameters were defined through the Delphi method, requiring 75% agreement among surgeons for consensus. Multivariable logistic regression identified factors linked to ASFs and SSFs. Radiographic data, including the lateralization shoulder angle (LSA), distalization shoulder angle (DSA), and lateral humeral offset (LHO), were collected in a 2:1 control-to-fracture ratio and analyzed to evaluate their association with ASFs/SSFs. Results: Among 6,320 patients, the overall stress fracture rate was 3.8% (180 ASFs [2.8%] and 59 SSFs [0.9%]). ASF risk factors included inflammatory arthritis (odds ratio [OR] = 2.29, p &lt; 0.001), a massive rotator cuff tear (OR = 2.05, p = 0.010), osteoporosis (OR = 2.00, p &lt; 0.001), prior shoulder surgery (OR = 1.82, p &lt; 0.001), cuff tear arthropathy (OR = 1.76, p = 0.002), female sex (OR = 1.74, p = 0.003), older age (OR = 1.02, p = 0.018), and greater total glenoid lateral offset (OR = 1.06, p = 0.025). Revision surgery (versus primary surgery) was associated with a reduced ASF risk (OR = 0.38, p = 0.019). SSF risk factors included female sex (OR = 2.45, p = 0.009), rotator cuff disease (OR = 2.36, p = 0.003), osteoporosis (OR = 2.18, p = 0.009), and inflammatory arthritis (OR = 2.04, p = 0.024). Radiographic analysis of propensity score-matched patients showed that a greater increase in the LSA (ΔLSA) from preoperatively to postoperatively (OR = 1.42, p = 0.005) and a greater postoperative LSA (OR = 1.76, p = 0.009) increased stress fracture risk, while increased LHO (OR = 0.74, p = 0.031) reduced it. Distalization (ΔDSA and postoperative DSA) showed no significant association with stress fracture prevalence. Conclusions: Patient factors associated with poor bone density and rotator cuff deficiency appear to be the strongest predictors of ASFs and SSFs after RSA. Final implant positioning, to a lesser degree, may also affect ASF and SSF prevalence in at-risk patients, as increased humeral lateralization was found to be associated with lower fracture rates whereas excessive glenoid-sided and global lateralization were associated with higher fracture rates. Level of Evidence: Prognostic Level III. See Instructions for Authors for a complete description of levels of evidence.

Cardiovascular risk in patients with acromegaly vs. non-functioning pituitary adenoma following pituitary surgery: an active-comparator cohort study.

Given the increased cardio-metabolic risk in patients with acromegaly, this study compared cardiovascular outcomes, mortality, and in-hospital outcomes between patients with acromegaly and non-functioning pituitary adenoma (NFPA) following pituitary surgery. This was a nationwide cohort study using data from hospitalized patients with acromegaly or NFPA undergoing pituitary surgery in Switzerland between January 2012 and December 2021. Using 1:3 propensity score matching, eligible acromegaly patients were paired with NFPA patients who underwent pituitary surgery, respectively. The primary outcome comprised a composite of cardiovascular events (myocardial infarction, cardiac arrest, ischemic stroke, hospitalization for heart failure, unstable angina pectoris, cardiac arrhythmias, intracranial hemorrhage, hospitalization for hypertensive crisis) and all-cause mortality. Secondary outcomes included individual components of the primary outcome, surgical re-operation, and various hospital-associated outcomes. Among 231 propensity score-matched patients with acromegaly and 491 with NFPA, the incidence rate of the primary outcome was 8.18 versus 12.73 per 1,000 person-years (hazard ratio [HR], 0.64; [95% confidence interval [CI], 0.31-1.32]). Mortality rates were numerically lower in acromegaly patients (2.43 vs. 7.05 deaths per 1,000 person-years; HR, 0.34; [95% CI, 0.10-1.17]). Individual components of the primary outcome and in-hospital outcomes showed no significant differences between the groups. This cohort study did not find an increased risk of cardiovascular outcomes and mortality in patients with acromegaly undergoing pituitary surgery compared to surgically treated NFPA patients. These findings suggest that there is no legacy effect regarding higher cardio-metabolic risk in individuals with acromegaly once they receive surgical treatment.

Pulsed field vs very high-power short-duration radiofrequency ablation for atrial fibrillation: Results of a multicenter, real-world experience

BackgroundPulsed field ablation (PFA) and very high-power short-duration (vHPSD) radiofrequency ablation are the most recently introduced technologies for atrial fibrillation (AF) ablation. The procedural performance, safety, and effectiveness of PFA vs vHPSD are currently unknown. ObjectiveThe study aimed to compare PFA with vHPSD for the treatment of paroxysmal or persistent AF. MethodsWe conducted an observational, multicenter study enrolling 534 consecutive patients (63 ± 9 years; 36% female) with paroxysmal (n = 368 [69%]) or persistent (n = 166 [31%]) AF undergoing ablation by either PFA (Farapulse; n = 192) or vHPSD (90 W/4 seconds; QDOT Micro; n = 342) between 2020 and 2023. Atrial tachyarrhythmia recurrence after a 1-month blanking period was the primary efficacy end point and was assessed both overall and in propensity score–matched patients. The primary safety end point was a composite of procedure-related complications. ResultsSuccessful pulmonary vein isolation was achieved in all patients, with shorter procedure duration (PFA,70 minutes; vHPSD, 100 minutes; P < .001) but longer fluoroscopy time (PFA, 15 minutes; vHPSD, 7 minutes; P < .001) in the PFA group. PFA was associated with more frequent use of general anesthesia (P < .001). Primary safety outcome events occurred in 19 patients (3.5%), with similar prevalence in both groups (PFA, 4%; vHPSD, 3%; P = .745). After a median follow-up of 12 (9–12) months, survival free from recurrent atrial tachyarrhythmia was similar between the PFA and vHPSD groups, both overall (12-month estimate: PFA, 75%; vHPSD, 76%; log-rank P = .73) and in propensity score–matched patients (n = 342; 12-month estimate: PFA, 75%; vHPSD, 77%; log-rank P = .980). ConclusionIn a large, multicenter experience, PFA was associated with more common use of general anesthesia, shorter procedural times, and longer fluoroscopy exposure compared with vHPSD ablation, with both techniques displaying superimposable safety and efficacy.

Hybrid therapy with ablation + subcutaneous ICD for secondary prevention of sudden cardiac death in ischemic heart disease

Abstract Background The aim of the prospective Ventricular Tachycardia Ablation- Subcutaneous ICD (VTAbl-SICD) Trial was to provide data on the efficacy and safety of a novel hybrid management strategy that combines VT ablation (VTAbl) with S-ICD implantation in patients who present with scar-related VT. The rate of appropriate therapy in patients with S-ICD may be a quite fairest surrogate of true residual sudden death (SD) risk compared to transvenous ICD (TV-ICD). More specific data on ischemic heart disease – the prominent cause of VT with the better results of VTAbl – may give arguments for questioning current practices in the future. Methods 32 patients with post ischemic scar-related sustained VT/VF were included. Patients underwent VTAbl with subsequent (or previous prophylactic n=8) S-ICD implant and were followed for 2-years. We evaluate the occurrence of appropriate and ICD therapies once ablated, as well as cardiovascular (CV) readmissions or death. We also compared to 64 propensity-score matched patients implanted with a secondary prevention TV-ICD (enrolled in the Ranolazine in High-Risk Patients With Implanted Cardioverter-Defibrillators (RAID) trial). Results Mean age was 57±12 years (28 males, 87%) (53% hypertension, 31% diabetes and 47% congestive heart failure with NYHA 1.6±1). Mean LVEF was 39±9%.There were no major complications associated with the ablation and implant procedures. Propensity-score matched patients implanted with a secondary prevention TV-ICD displayed similar clinical characteristics. At 16.5±8.6 months FU, appropriate ICD therapy occurred in 5 patients (15%) in the VTAbl-SICD group, significantly lower compared to the TV-ICD group (34 pts, 53%) (p&amp;lt;0.001). This corresponded to 2-year cumulative probability of 20% vs. 71% in the VTAbl-SICD vs. TV-ICD groups, respectively (log-rank p&amp;lt;0.001; Figure 1) and a significant 83% reduction in the risk of appropriate ICD therapy associated with VTAbl-SICD (HR= 0.17 [95% CI 0.07 - 0.39; p&amp;lt;0.001). Two of the patients who received appropriate ICD therapy in the VTAbl-SICD group may have had unrecognized transient causes of VT (torsades de pointes or unrecognized ischemia), letting 3 out of 32 (10%) with possible aborted SD caused by VT recurrences. There were no cases of untreated symptomatic VT. The rate of CV readmissions was similar in the VTAbl-SICD (41%) vs. TV-ICD group (44%) (p=0.7), whereas mortality was significantly lower in the VTAbl-SICD- vs.TV-ICD- group (0% vs. 17%, respectively; p&amp;lt;0.001) Conclusions Our findings suggest that VT ablation in ischemic heart disease patients allow reaching a low residual true risk for SD, which should now be evaluated in terms of cost-effectiveness compared to ablation + S-ICD implantation. Concommitant S-ICD implantation seems to be a safe alternative to TV-ICD without ablation.Appropriate ICD therapy-free KM

Ablation of hemodynamically unstable ventricular tachycardia guided by ultra-high density pacemapping and PASO correlation map, a multi-center clinical trial

Abstract Background Due to hemodynamic instability during ventricular tachycardia (VT), obtaining a complete electroanatomic map is often difficult if not impossible. Pace-mapping has progressed but still lacks precision and may not reveal sufficient details for complete ablation of the potential critical isthmus. Purpose We hypothesized that a novel strategy of combining ultra-high density (HD) pace-mapping using the PASO algorithm and Carto system to match the induced/clinical VT may aid in the reconstruction of the VT critical isthmus and effective VT ablation leading to reduce the risks of VT recurrence. Methods This was a prospective, multi-center trial conducted between January 2021 and July 2023. We enrolled 30 patients with ischemic heart disease and scar mediated recurrent VT clinically indicated for ablation. Following induction of clinical VT, we performed ultra-HD pace-mapping (5-10 mm distance between pacing points) of the identified ventricular substrate. Using PASO Module, a pacing correlation map (PCM) was constructed based on the percentage match to the induced VT. Using the PCM and the measured stimulation to electrogram intervals, the potential VT critical isthmus was reconstructed. Radiofrequency ablation was carried out to completely transect the delineated isthmus. Post ablation, repeat HD mapping and ablation was performed, until the PASO % correlation dropped from &amp;gt;93% to &amp;lt;70%, indicating at least uni-directional (orthodromic to the perceived VT circuit) conduction block through the ablation line. Follow-up data, including ICD interrogations were collected via chart review. Outcomes were compared to 60 propensity-score matched patients with an ICD who were enrolled in the Ranolazine in High-Risk Patients with Implanted Cardioverter-Defibrillators (RAID) trial who did not undergo VT ablation and served as the control group. The primary endpoint was the first occurrence of any VT at 1-year of follow-up. Results Patients enrolled had a mean age of 69 ± 9 years and 13% were women. Propensity matched patients from the RAID trial had similar baseline clinical characteristics to patients who underwent VT ablation (Table). At 1 year follow up, there was a significantly lower cumulative probability of VT/VF recurrent events in the patients who underwent PCM guided ablation as compared with the control group (17% vs 69%, respectively; log-rank p&amp;lt;0.001 Figure). There were no serious procedure related complications with all patients remaining free of adverse events or death at 30 days. Conclusion Our findings suggest that ablation for unstable or unmappable VT is enhanced by ultra-high density pace-mapping to reconstruct the potential VT circuit and is associated with a significantly lower rate of recurrent VT as compared with patients managed with aggressive and escalating medical therapy.Cumulative probability of ICD therapyBaseline clinical characteristics

Radiofrequency catheter ablation using QDOT MICRO: single-center experience in treating outflow tract premature ventricular complexes

Abstract Aims This study sought to examine the efficacy of radiofrequency catheter ablation (RFCA) for premature ventricular complexes (PVCs) originating from the outflow tracts. The investigation utilized the QDOT MICRO™ (QDOT) catheter, known for enabling a temperature-controlled ablation strategy. Methods and results The study began in November 2022 at a single center. All patients (n=100, 57% male, mean age 49±18) were prospectively and consecutively enrolled and underwent PVCs ablation with QDOT-MICRO™ catheter. The procedural and efficacy data of the study population were compared with those of a control group composed of a cohort of 100 propensity score-matched patients who underwent the same procedure with the ThermoCool® SmartTouch® Catheter using the Ablation Index strategy. Acute procedural success was defined as the elimination of the targeted PVCs at the termination of the procedure. Clinical success was defined as at least an 80% decrease in PVCs burden. Follow-up visits with 24- to 48-h Holter monitoring were performed at baseline and 1, 3, and every 3 months thereafter. Both patients with follow-up &amp;lt;6 months and non-outflow tracts PVCs were excluded. In the study cohort, the average PVCs burden was 21,13% (IQR: 12,50, 24,44) and the RVOT PVCs were 58% (n=58). The mean procedure and fluoroscopy times were 113±103 and 18±15, respectively, and significantly differ between both groups (p=0.02 and p&amp;lt;0.001, respectively). Signals detected by the microelectrodes at the effective site of ablation differed significantly from those recorded by the standard bipolar electrodes (p&amp;lt;0.001). No major complication occurred during the procedures, and there was no procedure-related mortality. The freedom from PVCs recurrences was 86% in the QDOT group and 84% in the STSF group.Freedom from PVCs recurrences at a mean follow-up of 11.5±1.6 months did not significantly differ between both groups (86% vs 84%, respectively; p=0.65). Conclusion This study suggests that RFCA using the QDOT MICRO™ catheter is not only effective but also comparable to the standard approach for treating outflow tract PVCs. Moreover, the study highlights shorter fluoroscopy and procedure times, reinforcing the catheter's efficiency and safety. The use of microelectrodes proved beneficial in enhancing precision in RF delivery.

Real-world evidence of survival benefit of remdesivir: study of 419 propensity score-matched patients hospitalized over the alpha and delta waves of COVID-19 in New Orleans, LA.

The direct acting antiviral remdesivir (RDV) has shown promising results in randomized clinical trials. This study is a unique report of real clinical practice RDV administration for COVID-19 from alpha through delta variant circulation in New Orleans, Louisiana (NOLA). Patients in NOLA have among US worst pre-COVID health outcomes, and the region was an early epicenter for severe COVID. Data were directly extracted from electronic medical records through REACHnet. Of 9,106 adults with COVID, 1,928 were admitted to inpatient care within 7 days of diagnosis. The propensity score is based upon 22 selected covariates, related to both RDV assignment and outcome of interest. RDV and non-RDV patients were matched 1:1 with replacement, by location and calendar period of admission. Primary and secondary endpoints were, death from any cause and inpatient discharge, within 28 and 14 days after inpatient admission. Of 448 patients treated with RDV, 419 (94%) were successfully matched to a non-RDV patient. 145 (35%) patients received RDV for < 5 days, 235 (56%) for 5 days, and 39 (9%) for > 5 days. 96% of those on RDV received it within 2 days of admission. RDV was more frequently prescribed in patients with pneumonia (standardized difference: 0.75), respiratory failure, hypoxemia, or dependence on supplemental oxygen (0.69), and obesity (0.35) within 5 days prior to RDV initiation or corresponding day in non-RDV patients (index day). RDV patients were numerically more likely to be on steroids within 5 days prior to index day (86 vs. 82%) and within 7 days after inpatient admission (96 vs. 87%). RDV was significantly associated with lower risk of death within 14 days after admission (hazard ratio [HR]: 0.37, 95% CI: 0.19 to 0.69, p = 0.002) but not within 28 days (HR: 0.62, 95% CI: 0.36 to 1.07, p = 0.08). Discharge within 14 days of admission was significantly more likely for RDV patients (p < 0.001) and numerically more likely within 28 days after admission (p = 0.06). Overall, our findings support recommendation of RDV administration for COVID-19 in a highly comorbid, highly impoverished population representative of both Black and White subjects in the US Gulf South.

Outcomes of transcatheter aortic valve replacement in patients with history of chest wall irradiation: Propensity matched analysis of five years data from national inpatient sample (2016–2020)

IntroductionChest radiotherapy has been utilized to treat intra-thoracic and mediastinal tumors. Chest wall irradiation (C-XRT) survivors frequently develop valvular disease, including aortic stenosis, which eventually requires valve replacement. Previous trials have shown worse outcomes with surgical aortic valve replacement. However, transcatheter aortic valve replacement (TAVR) outcomes-related data in patients with C-XRT is limited. MethodsThe national inpatient sample (NIS) database was queried from 2016 to 2020 to identify adult hospitalizations with TAVR, which were dichotomized based on a history of C-XRT using ICD-10-CM codes. Propensity score matching was performed to derive age, sex, hospital characteristics, and co-morbidities matched controls without a history of C-XRT. The outcomes studied were inpatient mortality and complications, mean length of stay (LOS), and total hospital charge (THC). Multivariate logistic and linear regression were used to analyze the outcomes. ResultsOf 296,670 patients who underwent TAVR between 2016 and 2020, 515 had a history of C-XRT. Upon propensity score matching in patients undergoing TAVR, Patients with a history of C-XRT showed significantly lower adjusted odds of in-hospital mortality (adjusted odd ratio [aOR] 0.04, 95 % CI [0.003–0.57], p = 0.017), lower mean LOS by 1.6 days (−1.88 to −1.26 days, p < 0.001) and reduced mean THC (−$74,720, [−$88,784 to -$60,655], p < 0.001). Additionally, patients with C-XRT had significantly lower adjusted odds of inpatient complications, mainly acute myocardial infarction, cerebrovascular events, acute respiratory failure, acute kidney injury, need for vasopressors and cardiopulmonary resuscitation, whereas similar odds of complications, including a requirement of intubation, mechanical ventilation, hemodialysis, and cardiogenic shock. ConclusionOur analysis showed reduced adjusted odds of in-hospital mortality, length of stay, total hospital charges, and inpatient complications in patients undergoing TAVR with a history of C-XRT. TAVR appears to be a safe and viable alternative in this population subgroup.