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Related Concept Videos

Bioavailability Study Design: Healthy Subjects Versus Patients01:15

Bioavailability Study Design: Healthy Subjects Versus Patients

Bioavailability studies are essential for evaluating a drug's therapeutic efficacy and understanding its absorption patterns under various physiological conditions. Conducting such studies on target patient populations provides more relevant data by simulating real-world disease states. However, practical challenges often necessitate the use of young, healthy adult volunteers as study subjects.Patients may exhibit altered drug absorption patterns due to the effects of the disease itself,...
Bioavailability Study Design: Single Versus Multiple Dose Studies01:11

Bioavailability Study Design: Single Versus Multiple Dose Studies

Bioavailability studies are essential for understanding how a drug is absorbed, distributed, metabolized, and excreted in the body. These studies assess the extent and rate at which the active pharmaceutical agent becomes available at the site of action. The design of bioavailability studies can involve single-dose or multiple-dose regimens, each with distinct advantages and limitations.Single-dose studies are the preferred approach due to their simplicity and reduced drug exposure for...
Therapeutic Drug Monitoring: Affecting Factors01:29

Therapeutic Drug Monitoring: Affecting Factors

Therapeutic Drug Monitoring (TDM) is the clinical practice of measuring specific drug levels in a patient's blood or body tissues to manage and optimize therapy. TDM is crucial for drugs with narrow therapeutic windows, like warfarin and phenytoin, where incorrect doses can lead to treatment failure or severe side effects. This monitoring ensures the dosage administered is within a safe and effective range. The factors affecting therapeutic drug monitoring include:Patient-Specific Factors:a.
Clinical Trials: Overview01:11

Clinical Trials: Overview

Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
Acute Coronary Syndrome III: Diagnostic Studies01:30

Acute Coronary Syndrome III: Diagnostic Studies

Diagnosing acute coronary syndrome or ACS begins with a thorough patient history. Notable symptoms include central, crushing chest pain radiating to the left arm, neck, jaw, or back, along with shortness of breath, sweating (diaphoresis), nausea, vomiting, dizziness, and palpitations.It is crucial to note any history of cardiac illnesses and assess risk factors, including age, gender, smoking, hypertension, diabetes, hyperlipidemia, and a sedentary lifestyle.During physical examination, vital...
Bioequivalence studies: Biowaivers01:13

Bioequivalence studies: Biowaivers

In certain scenarios, in vitro dissolution tests can replace in vivo bioequivalence studies. This is particularly true when a drug product, though available in varying strengths, maintains proportional similarity in its active and inactive ingredients. In such cases, the need for in vivo bioequivalence studies for lower strength variants may be waived, provided dissolution tests and in vivo studies on the highest strength yield satisfactory results.Bioequivalence can be indicated through...

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Related Experiment Video

Updated: May 9, 2026

Upper-extremity Approach for Secondary Access in Transfemoral Transcatheter Aortic Valve Implantation
06:04

Upper-extremity Approach for Secondary Access in Transfemoral Transcatheter Aortic Valve Implantation

Published on: August 8, 2025

Gender differences in patients undergoing TAVI: a multicentre study.

Fabrizio D'Ascenzo1, Anna Gonella, Claudio Moretti

  • 1Division of Cardiology, San Giovanni Battista Molinette, University of Turin, Turin, Italy.

Eurointervention : Journal of Europcr in Collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology
|July 23, 2013
PubMed
Summary
This summary is machine-generated.

Transcatheter aortic valve implantation (TAVI) is effective for severe aortic stenosis in high-risk patients. While female patients had more bleeding events, TAVI outcomes were similar regardless of gender.

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Area of Science:

  • Cardiology
  • Interventional Cardiology
  • Cardiovascular Surgery

Background:

  • Surgical valve replacement for severe aortic stenosis has shown worse outcomes in females.
  • Contrasting data exist regarding gender differences in transcatheter aortic valve implantation (TAVI).

Purpose of the Study:

  • To investigate gender-based outcomes in patients with severe symptomatic aortic stenosis undergoing TAVI.
  • To identify predictors of mortality following TAVI, with a focus on gender-specific complications.

Main Methods:

  • A retrospective study included 377 patients (161 male, 216 female) undergoing TAVI from 2007-2011.
  • Patients were divided into male and female cohorts.
  • Endpoints were adjudicated using VARC definitions, with 30-day and long-term follow-up.

Main Results:

  • Female patients had higher rates of overall and life-threatening bleeding (p=0.024 and p=0.016, respectively), even after multivariate analysis.
  • Cardiovascular death rates at 30 days were similar between genders (6.0% vs. 8.1%).
  • At long-term follow-up, no significant gender differences in endpoints were observed; only life-threatening bleeding predicted death (OR 8.2).

Conclusions:

  • TAVI is a safe and effective strategy for high-surgical-risk patients with severe aortic stenosis, irrespective of gender.
  • Female patients experienced higher rates of life-threatening bleeding, identified as the sole independent predictor of mortality.