Turnpike Catheter failure, causes and mechanisms: Insights from the MAUDE database.

Background: The Turnpike catheters (Teleflex, Wayne, PA, USA) is a microcatheter that was approved by the Food and Drug Administration in November 2014 to be used to access discrete regions of the coronary and peripheral vasculature. Methods: The Manufacturer and User Facility Device Experience (MAUDE) database was queried for reports of the Turnpike catheters from March 2015 through August 2021. Results: A total of 216 reports were found during the study period. After excluding duplicate reports (n = 21), our final cohort included 195 reports. The most common failure mode was catheter tip break or detachment (83%, n = 165) which was significantly associated with over-torquing (p-value = 0.025). The most common clinical consequence was the entrapment of the catheter (33%, n = 65), followed by vessel injury (7.8% n = 15) and vessel occlusion (3.6%, n = 7). Most patients had no consequences (47.0%, n = 93) or recovered (11%, n = 22). A total of 4 deaths were reported. 35.8% of reports (n = 69) specified the presence of severe calcification in the target vessel. Over torquing by interventionists was reported in 33.2% of events (n = 64). Conclusion: Despite clinical trials demonstrating the safety of the Turnpike catheters, complications can still occur. These data serve to inform operators about potentional risks and complications associated with the use of the device. Physicians should avoid over-torqueing which seems to be the most common mechanism for device complications

Clinical and angiographic success and safety comparison of coronary intravascular lithotripsy: An updated meta-analysis

Background Intravascular lithotripsy (IVL) can be used to assist stent deployment in severe coronary artery calcifications (CAC). Methods Studies employing IVL for CAC lesions were included. The primary outcomes included clinical and angiographic success. The secondary outcomes, including lumen gain, maximum calcium thickness, and calcium angle at the final angiography site, minimal lumen area site, and minimal stent area site, were analyzed by the random-effects model to calculate the pooled standardized mean difference. Tertiary outcomes included safety event ratios. Results Seven studies (760 patients) were included. The primary outcomes: pooled clinical and angiographic success event ratio parentage of IVL was 94.4% and 94.8%, respectively. On a random effect model for standard inverse variance for secondary outcomes showed: minimal lumen diameter increase with IVL was 4.68 mm (p-value < 0.0001, 95% CI 1.69–5.32); diameter decrease in the stenotic area after IVL session was −5.23 mm (95 CI –22.6–12.8). At the minimal lumen area (MLA) and final minimal stent area (MSA) sites, mean lumen area gain was 1.42 mm2 (95% CI 1.06–1.63; p < 0.00001) and 1.34 mm2 (95% CI 0.71–1.43; p < 0.00001), respectively. IVL reduced calcium thickness at the MLA site (SMD −0.22; 95% CI −0.40–0.04; P = 0.02); calcium angle was not affected at the MLA site. The tertiary outcomes: most common complication was major adverse cardiovascular events (n = 48/669), and least common complication was abrupt closure of the vessel (n = 1/669). Conclusions Evidence suggests that IVL safely and effectively facilitates stent deployment with high angiographic and clinical success rates in treating severely calcified coronary lesions

Cardiovascular outcomes and trends of Transcatheter vs. Surgical aortic valve replacement among octogenarians with heart failure: A Propensity Matched national cohort analysis.

Background: Heart failure (HF) is a complex clinical syndrome with symptoms and signs that result from any structural or functional impairment of ventricular filling or ejection of blood. Limited data is available regarding the in-hospital outcomes of TAVR compared to SAVR in the octogenarian population with HF. Methods: The National Inpatient Sample (NIS) database was used to compare TAVR versus SAVR among octogenarians with HF. The primary outcome was in-hospital mortality. The secondary outcome included acute kidney injury (AKI), cerebrovascular accident (CVA), post-procedural stroke, major bleeding, blood transfusions, sudden cardiac arrest (SCA), cardiogenic shock (CS), and mechanical circulatory support (MCS). Results: A total of 74,995 octogenarian patients with HF (TAVR-HF n = 64,890 (86.5%); SAVR n = 10,105 (13.5%)) were included. The median age of patients in TAVR-HF and SAVR-HF was 86 (83-89) and 82 (81-84) respectively. TAVR-HF had lower percentage in-hospital mortality (1.8% vs. 6.9%;p < 0.001), CVA (2.5% vs. 3.6%; p = 0.009), SCA (9.9% vs. 20.2%; p < 0.001), AKI (17.4% vs. 40.8%); p < 0.001), major transfusion (26.4% vs 67.3%; p < 0.001), CS (1.8% vs 9.8%; p < 0.001), and MCS (0.8% vs 7.3%; p < 0.001) when compared to SAVR-HF. Additionally, post-procedural stroke and major bleeding showed no significant difference. The median unmatched total charges for TAVR-HF and SAVR-HF were 194,561$and 246,100$ respectively. Conclusion: In this nationwide observational analysis, TAVR is associated with an improved safety profile for octogenarians with heart failure (both preserved and reduced ejection fraction) compared to SAVR

Cardiovascular Outcomes and Trends of Transcatheter vs. Surgical Aortic Valve Replacement Among Octogenarians With Heart Failure: A Propensity Matched National Cohort Analysis

Background: Heart failure (HF) is a complex clinical syndrome with symptoms and signs that result from any structural or functional impairment of ventricular filling or ejection of blood. Limited data is available regarding the in-hospital outcomes of TAVR compared to SAVR in the octogenarian population with HF. Methods: The National Inpatient Sample (NIS) database was used to compare TAVR versus SAVR among octogenarians with HF. The primary outcome was in-hospital mortality. The secondary outcome included acute kidney injury (AKI), cerebrovascular accident (CVA), post-procedural stroke, major bleeding, blood transfusions, sudden cardiac arrest (SCA), cardiogenic shock (CS), and mechanical circulatory support (MCS). Results: A total of 74,995 octogenarian patients with HF (TAVR-HF n = 64,890 (86.5%); SAVR n = 10,105 (13.5%)) were included. The median age of patients in TAVR-HF and SAVR-HF was 86 (83-89) and 82 (81-84) respectively. TAVR-HF had lower percentage in-hospital mortality (1.8% vs. 6.9%;p \u3c 0.001), CVA (2.5% vs. 3.6%; p = 0.009), SCA (9.9% vs. 20.2%; p \u3c 0.001), AKI (17.4% vs. 40.8%); p \u3c 0.001), major transfusion (26.4% vs 67.3%; p \u3c 0.001), CS (1.8% vs 9.8%; p \u3c 0.001), and MCS (0.8% vs 7.3%; p \u3c 0.001) when compared to SAVR-HF. Additionally, post-procedural stroke and major bleeding showed no significant difference. The median unmatched total charges for TAVR-HF and SAVR-HF were 194,561$and 246,100$ respectively. Conclusion: In this nationwide observational analysis, TAVR is associated with an improved safety profile for octogenarians with heart failure (both preserved and reduced ejection fraction) compared to SAVR

Cardiovascular Outcomes of Transradial Versus Transfemoral Percutaneous Coronary Intervention in End-Stage Renal Disease: A Regression-Based Comparison

Background: Limited data is available on the comparison of outcomes of transradial (TR) and transfemoral (TF) access for percutaneous coronary intervention (PCI) in patients with end-stage stage renal disease (ESRD). Methods: Online databases were queried to compare cardiovascular outcomes among TR. and TF in ESRD patients. The outcomes assessed included differences in mortality, cerebrovascular accidents (CVA), periprocedural myocardial infarction (MI), bleeding, transfusion, and periprocedural cardiogenic shock (CS). Unadjusted odds ratios (OR) were calculated using a random-effect effect model. Results: A total of 6 studies including 7,607 patients (TR-PCI = 1,288; TF-PCI = 6,319) were included. The overall mean age was 67.7 years, while the mean age for TR-PCI and TF-PCI was 69.7 years and 67.9 years, respectively. TR-PCI was associated with lower incidence of mortality (OR 0.46 95 % CI 0.30-0.70, p \u3c 0.05, I2 0.00 %), bleeding (OR 0.45 95 % CI 0.29, 0.68, p \u3c 0.05, I2 3.48 %), and transfusion requirement (OR 0.52 95 % CI 0.40, 0.67, p \u3c 0.05, I2 0.00 %) (Fig. 1). There were no differences among TR-PCI and TF-PCI for periprocedural MI, periprocedural CS, and CVA outcomes. Conclusion: TR access was associated with lower mortality, bleeding, and transfusion requirement as compared to TF access in patients with ESRD undergoing PCI

Clinical and angiographic success and safety comparison of coronary intravascular lithotripsy: An updated meta-analysis

Background: Intravascular lithotripsy (IVL) can be used to assist stent deployment in severe coronary artery calcifications (CAC). Methods: Studies employing IVL for CAC lesions were included. The primary outcomes included clinical and angiographic success. The secondary outcomes, including lumen gain, maximum calcium thickness, and calcium angle at the final angiography site, minimal lumen area site, and minimal stent area site, were analyzed by the random-effects model to calculate the pooled standardized mean difference. Tertiary outcomes included safety event ratios. Results: Seven studies (760 patients) were included. The primary outcomes: pooled clinical and angiographic success event ratio parentage of IVL was 94.4% and 94.8%, respectively. On a random effect model for standard inverse variance for secondary outcomes showed: minimal lumen diameter increase with IVL was 4.68 mm (p-value \u3c 0.0001, 95% CI 1.69-5.32); diameter decrease in the stenotic area after IVL session was -5.23 mm (95 CI -22.6-12.8). At the minimal lumen area (MLA) and final minimal stent area (MSA) sites, mean lumen area gain was 1.42 mm2 (95% CI 1.06-1.63; p \u3c 0.00001) and 1.34 mm2 (95% CI 0.71-1.43; p \u3c 0.00001), respectively. IVL reduced calcium thickness at the MLA site (SMD -0.22; 95% CI -0.40-0.04; P = 0.02); calcium angle was not affected at the MLA site. The tertiary outcomes: most common complication was major adverse cardiovascular events (n = 48/669), and least common complication was abrupt closure of the vessel (n = 1/669). Conclusions: Evidence suggests that IVL safely and effectively facilitates stent deployment with high angiographic and clinical success rates in treating severely calcified coronary lesions

Partial vena cava occlusion (VCO) to counteract refractory heart failure: A new era in interventional heart failure strategy.

Background: Patients with acute decompensated heart failure are prone to recurrent exacerbation leading to poor quality of life when they do not respond to an optimal medical regimen. Due to the lack of linear positive inotropy response to increasing preload in heart failure patients, increasing preload is associated with poor outcomes. Partial occlusion of either IVC or SVC is a proposed novel treatment that can improve cardiac function or quality of life by altering preload/pressure in heart failure (HF) patients unresponsive to diuretics. Methods: PubMed, Ovid (MEDLINE), and Cochrane database we searched using the MeSH terms including Superior vena cava occlusion, Inferior vena cava occlusion, Heart failure exacerbation. The inclusion criteria included studies that enrolled patients \u3e 18 years with diagnosed NYHA II-IV HF with reduced ejection fraction (HFrEF) on optimal medical treatment (OMT). Results: The analysis involved two studies with 14 patients; the mean age was 64.4 ± 10 and 100% males. The difference in the mean pulmonary pressures between pre-and-post VCO devices were 1.56 (95% CI 0.66-2.46, p-value = 0.006). There was no heterogeneity among the study of mean pulmonary pressures. With the use of VC occlusion devices, the mean difference in pulmonary artery systolic pressure decreased by 1.70 (95% CI 0.68-2.71, p-value = 0.001) (Fig. 1B). The heterogeneity of mean pressure was minimal 14%. Conclusion: In conclusion, VCO can help decrease pulmonary pressure that can indirectly prevent heart failure exacerbations and possibly hospitalization in this cohort of patients

Comparative safety of percutaneous ventricular assist device and intra-aortic balloon pump in acute myocardial infarction-induced cardiogenic shock

Background The relative safety of percutaneous left ventricular assist device (pVAD) and intra-aortic balloon pump (IABP) in patients with cardiogenic shock after acute myocardial infarction remain unknown.Methods Multiple databases were searched to identify articles comparing pVAD and IABP. An unadjusted OR was used to calculate hard clinical outcomes and mortality differences on a random effect model.Results Seven studies comprising 26 726 patients (1110 in the pVAD group and 25 616 in the IABP group) were included. The odds of all-cause mortality (OR 0.57, 95% CI 0.47 to 0.68, p=&lt;0.00001) and need for revascularisation (OR 0.16, 95% CI, 0.07 to 0.38, p=&lt;0.0001) were significantly reduced in patients receiving pVAD compared with IABP. The odds of stroke (OR 1.12, 95% CI 0.14 to 9.17, p=0.91), acute limb ischaemia (OR=2.48, 95% CI 0.39 to 15.66, p=0.33) and major bleeding (OR 0.36, 95% CI 0.01 to 25.39, p=0.64) were not significantly different between the two groups. A sensitivity analysis based on the exclusion of the study with the largest weight showed no difference in the mortality difference between the two mechanical circulatory support devices.Conclusions In patients with acute myocardial infarction complicated by cardiogenic shock, there is no significant difference in the adjusted risk of all-cause mortality, major bleeding, stroke and limb ischaemia between the devices. Randomised trials are warranted to investigate further the safety and efficacy of these devices in patients with cardiogenic shock