Meta-analysis comparing valve-in-valve TAVR and redo-SAVR in patients with degenerated bioprosthetic aortic valve.

INTRODUCTION: The comparative efficacy and safety of valve-in-valve transcatheter aortic valve replacement (ViV-TAVR) and redo-surgical AVR (redo-SAVR) in patients with degenerated bioprosthetic aortic valves remain unknown. METHOD: Digital databases were searched to identify relevant articles. Unadjusted odds ratios for dichotomous outcomes were calculated using a random effect model. A total of 11 studies comprising 8326 patients (ViV-TAVR = 4083 and redo-SAVR = 4243) were included. RESULTS: The mean age of patients undergoing ViV-TAVR was older, 76 years compared to 73 years for those undergoing SAVR. The baseline characteristics for patients in ViV-TAVR vs. redo-SAVR groups were comparable. At 30-days, the odds of all-cause mortality (OR 0.45, 95% CI 0.30-0.68, p = .0002), cardiovascular mortality (OR 0.44, 95% CI 0.26-0.73, p = .001) and major bleeding (OR 0.29, 95% CI 0.15-0.54, p = .0001) were significantly lower in patients undergoing ViV-TAVR compared to redo-SAVR. There were no significant differences in the odds of cerebrovascular accidents (OR 0.91, 95% CI 0.52-1.58, p = .74), myocardial infarction (OR 0.92, 95% CI 0.44-1.92, p = .83) and permanent pacemaker implantation (PPM) (OR 0.54, 95% CI 0.27-1.07, p = .08) between the two groups. During mid to long-term follow up (6-months to 5-years), there were no significant differences between ViV-TAVR and redo-SAVR for all-cause mortality, cardiovascular mortality and stroke. ViV-TAVR was, however, associated with higher risk of prosthesis-patient mismatch and greater transvalvular pressure gradient post-implantation. CONCLUSION: ViV-TAVR compared to redo-SAVR appears to be associated with significant improvement in short term mortality and major bleeding. For mid to long-term follow up, the outcomes were similar for both groups.

Systematic review and meta-analysis comparing Manta device and Perclose device for closure of large bore arterial access.

Data comparing MANTA device with Perclose device for large bore arterial access closure is limited. We performed meta-analysis to compare safety and efficacy of the two devices in large (⩾14 Fr sheath) arteriotomy closure post-TAVR. Relevant studies were identified via PubMed, Cochrane, and EMBASE databases until June, 2022. Data was analyzed using random effect model to calculate relative odds of VARC-2 defined access-site complications and short-term (in-hospital or 30-day) mortality. A total of 12 studies (2 RCT and 10 observational studies) comprising 2339 patients were included. The odds of major vascular complications (OR 0.99, 95% CI 0.51-1.92; p = 0.98); life threatening and major bleeding (OR 0.77, 95% CI 0.45-1.33; p = 0.35); minor vascular complications (OR 1.37, 95% CI 0.63-2.99; p = 0.43); minor bleeding (OR 0.94, 95% CI 0.57-1.56; p = 0.82); device failure (OR 0.74, 95% CI 0.49-1.11; p = 0.14); hematoma formation (OR 0.76, 95% CI 0.33-1.75; p = 0.52); dissection, stenosis, occlusion, or pseudoaneurysm (OR 1.08, 95% CI 0.71-1.62; p = 0.73) and short-term mortality (OR 1.01, 95% CI 0.55-1.84; p = 0.98) between both devices were similar. MANTA device has a similar efficacy and safety profile compared to Perclose device.

Angiographic-only or intravascular ultrasound-guided approach for left-main coronary artery intervention: a systematic review and meta-analysis.

INTRODUCTION: The use of intravascular ultrasound (IVUS) in percutaneous revascularization of left-main coronary artery disease (LMCAD) warrants further exploration. We aimed to collate all available data on the merits of IVUS in LMCAD to help decision-making. METHODS: The MEDLINE, Embase, and Cochrane databases were queried for relevant randomized controlled trials (RCTs) and observational cohort studies (OCS). The data were analyzed using random-effects model to calculate unadjusted odds ratio (OR) between IVUS-guided and angiography-only LMCA revascularization. RESULTS: A total of 14 studies (2 RCTs and 12 OCS), comprising 18944 patients, were included. The pooled odds of all-cause mortality (OR 0.57, 95%CI 0.46-0.70, p = <0.00001), cardiovascular mortality (OR 0.37, 95%CI 0.26-0.54, p = <0.00001), left-main revascularization (OR 0.63, 95%CI 0.45-0.89, p = 0.009) and myocardial infarction (OR 0.80, 95% CI 0.66-0.97, p = 0.02) were significantly lower with IVUS-guidance. There was no difference observed in the odds of the stent thrombosis (OR 0.57, 95% CI 0.31-1.05, p = 0.07) and stroke (OR 1.7, 95%CI 0.56-5.14, p = 0.35) between the two groups. A subgroup analysis based on the study design and follow-up duration mirrored the pooled estimates. CONCLUSION: IVUS-guided LMCA intervention is associated with overall improved cardiovascular outcomes than the angiography-only approach. This needs to be tested in a large randomized controlled trial.

Clinical outcomes of patients with diabetes mellitus and acute ST-elevation myocardial infarction following fibrinolytic therapy: a nationwide inpatient sample (NIS) database analysis.

The impact of diabetes mellitus (DM) on clinical outcomes of acute ST-segment elevation myocardial infarction (STEMI) following fibrinolytic therapy remains uncertain. We queried the National Inpatient Sample (NIS) for STEMI patients who received fibrinolytic therapy. Categorical and continuous variables were compared using the unadjusted odds ratio (uOR) and t-test analysis, respectively. A binary logistic regression model was used to control the outcomes for patient demographics, procedural characteristics, and baseline comorbidities. A total of 111,155 (no-DM 84,146, DM 27,009) were included. The unadjusted odds of in-hospital mortality (8.4% vs. 6.8%, uOR 1.25, 95% CI 1.19-1.31, P = <0.0001) and cardiogenic shock (7.7% vs. 6.2%, uOR 1.26, 95% CI 1.20-1.33, P = <0.0001) were significantly higher in patients with DM compared to those with no DM, respectively. The odds for major bleeding and cardiopulmonary arrest were significantly lower for in diabetes. The adjusted pooled estimates mirrored the unadjusted findings. Diabetic patients receiving fibrinolytic therapy for STEMI might have higher odds of all-cause mortality and cardiogenic shock compared to non-diabetic patients.

Meta-Analysis Comparing Transcatheter Aortic Valve Implantation to Surgical Aortic Valve Replacement in Low Surgical Risk Patients.

Transcatheter aortic valve implantation (TAVI) is recommended for inoperable and high risk surgical patients with severe aortic stenosis. It is noninferior to surgical aortic valve replacement (SAVR) in intermediate risk candidates. TAVI is currently being assessed for low surgical risk individuals. We performed a meta-analysis of randomized controlled trials (RCTs) and matched observational studies between TAVI and SAVR in low surgical risk patients. The primary outcomes were short-term and mid-term mortality and neurologic events. Secondary outcomes were other periprocedure complications. A total of 8 studies (3 RCTs and 5 matched observational studies) totaling 6,686 patients were included. No difference was seen in short-term mortality and neurologic events (risk ratio [RR] 0.68, 95% confidence interval [CI] 0.45 to 1.03, p 0.07 and RR 0.76, 95% CI 0.52 to 1.13, p 0.18) as well as mid-term mortality and neurologic events (RR 0.89, 95% CI 0.54 to 1.47, p 0.65 and RR 1.04, 95% CI 0.55 to 1.97, p 0.9) between the 2 groups. Reduced risk of new onset atrial fibrillation (RR 0.14, 95% CI 0.08 to 0.25, p <0.00001), acute kidney injury (RR 0.43, 95 CI 0.23 to 0.82, p 0.01), and bleeding (RR 0.43, 95% CI 0.27 to 0.69, p 0.0005) whereas increased risk of ≥ moderate aortic regurgitation (RR 6.53, 95% CI 3.48 to 12.24, p <0.00001), pacemaker or defibrillator implantation (RR 3.11, 95% CI 1.96 to 4.94, p <0.00001) and vascular complications (RR 5.29, 95% CI 1.58 to 17.70, p 0.007) was noted in TAVI arm. In conclusion, TAVI is comparable to SAVR in terms of short-term and mid-term mortality and neurologic events in low surgical risk patients. The risk of periprocedure events is variable.

Immune Checkpoint Inhibitor Induced Diabetes Mellitus Treated with Insulin and Metformin: Evolution of Diabetes Management in the Era of Immunotherapy.

Immune checkpoint inhibitors (ICPIs) are a breakthrough therapy in oncology and have been approved by the Food and Drug Administration for the treatment of several malignancies. ICPIs have been reported to cause immune-mediated damage of islet cells leading to ICPI-induced type 1 diabetes mellitus (T1DM). These reports described patients presenting with severe diabetic ketoacidosis (DKA). We present a case of a 69-year-old Caucasian male with type 2 diabetes suffering from non-small cell lung cancer and undergoing treatment with pembrolizumab, an anti-programmed cell death protein-1 antibody, who presented to our emergency department with complaints of nausea, vomiting, polyuria, and polydipsia. He was found to have high anion gap metabolic acidosis with ketosis and elevated blood glucose levels consistent with DKA. Lab workup was consistent with T1DM. Despite being on a tailored insulin regimen, his blood glucose remained elevated, necessitating the addition of metformin to his regimen which effectively controlled his blood glucose.