Friday September 6th in London, an important symposium specifically focused on the clinical discussion of aortic dissection took place: Interdisciplinary Aortic Dissection Symposium. A large concentration of professionals specialized in the field debated the diagnosis, treatment, and clinical outcomes related to this pathology. The discussion highlighted that there is still no consensus on the indication for treatment, and especially no clear and universally recognized guidelines.
It therefore appears evident, as expressed by the medical community, that there is a need for more structured clinical data. Our reflection is therefore directed towards the industry and the support it could and should provide in this context. Let’s now look at a quick summary of the topics discussed and their respective conclusions.
Aortic Dissection
Aortic dissections are among the most serious conditions within the spectrum of aortic diseases. Although they are less common compared to other aortic pathologies, such as aortic aneurysms, they represent a medical emergency due to their high mortality rate and the need for immediate intervention.
Incidence of Aortic Dissections
The incidence of aortic dissections is relatively low, but their severity makes them clinically significant. Here are some key data points regarding the incidence of aortic dissections:
1. Annual Incidence: The estimated incidence of aortic dissections is about 3-6 cases per 100,000 people per year. This figure can vary depending on the population studied and the diagnostic criteria used.
2. Distribution by Sex and Age:
• Sex: Men are affected by aortic dissection more frequently than women, with a ratio of approximately 2:1. This may be due to differences in risk factors, such as hypertension and smoking habits, which are more prevalent in men.
• Age: Aortic dissection occurs more frequently in adults over the age of 60, although it can also occur in younger individuals, especially in the presence of predisposing conditions such as Marfan syndrome, Ehlers-Danlos syndrome, or other connective tissue disorders.
3. Classification of Aortic Dissections:
• Type A Dissection: This form, which involves the ascending aorta, accounts for about 60-70% of all aortic dissection cases. It is associated with a high mortality rate and often requires immediate surgical intervention.
• Type B Dissection: Involves the descending aorta and accounts for the remaining 30-40% of cases. Management of this form can be more variable, including both medical therapy and interventional approaches (such as endovascular stenting).
Components of a Clinically Significant Study Protocol
To establish the most meaningful study protocol for the treatment of aortic dissections with endografts (stent grafts), it is essential to consider a series of key elements that ensure its methodological robustness and clinical relevance. An effective study protocol should aim to evaluate not only the efficacy and safety of the treatment but also the long-term impact on survival, quality of life, and management of complications. Below are the main components that would provide clinical significance to a study protocol for the treatment of aortic dissections with endografts:
1. Study Design: Randomized Controlled Trial (RCT)
A randomized controlled trial (RCT) is considered the gold standard in clinical research because it reduces the risk of bias. An RCT could compare endograft treatment with other standard treatments, such as conservative medical therapy or open surgery, for complicated type B aortic dissections.
2. Well-Defined Inclusion and Exclusion Criteria
It is important to establish clear criteria for including patients with complicated type B aortic dissections (e.g., patients with persistent pain, risk of rupture, organ ischemia, or expansion of the false lumen) and excluding those with contraindications for endograft treatment (e.g., unsuitable aortic anatomy or severe comorbidities that preclude intervention).
3. Adequate Sample Size
To achieve statistical significance, the protocol must include a sufficient number of participants. An adequate sample size reduces the risk of type I (false positive) and type II (false negative) errors, ensuring that the results are robust and generalizable to the broader population.
4. Multiple and Well-Defined Clinical Outcomes
Primary and secondary outcomes should include:
– Short- and Long-Term Survival Rates: Evaluate mortality at 30 days, 1 year, 5 years, and 10 years.
– Complications Associated with Endografts (Endoleak, Stent Migration, Aortic Rupture): Monitoring of endoleaks (types I, II, III), stent migration, and other prosthesis-related complications.
– Quality of Life: Measured using validated tools such as the SF-36 or EQ-5D questionnaires to understand the impact of treatment on patients’ daily lives.
– Need for Retreatment or Secondary Interventions: Frequency of additional interventions required to manage complications or disease progression.
5. Extended Follow-Up Duration
A prolonged follow-up is essential to evaluate the durability of the endograft and detect long-term complications. Ideally, the follow-up should last at least 5-10 years to provide meaningful data on long-term survival and management of complications.
6. Use of Advanced Imaging Techniques for Outcome Assessment
Radiological imaging (CT with contrast, MRI, transesophageal echocardiography) should be used to accurately assess the position of the graft, thrombosis of the false lumen, size of the true lumen, and presence of endoleaks or other complications. These outcomes should be assessed at regular time points (e.g., at 1, 3, 6, 12 months, and then annually).
7. Subgroup Analysis
Subgroup analyses are useful to determine which patients benefit most from endograft intervention, such as by age, presence of comorbidities, aortic anatomical characteristics, or type of dissection (chronic vs. acute).
8. Cost-Effectiveness Evaluation
A cost-effectiveness analysis comparing endograft treatment with available alternatives could provide an important perspective for the healthcare system, especially considering limited resources and the need for optimal allocation.
Conclusion
A clinical study protocol for the treatment of aortic dissections with endografts that includes a randomized controlled design, well-defined inclusion/exclusion criteria, adequate sample size, relevant and well-defined clinical outcomes, prolonged follow-up, and detailed assessments through imaging and cost-effectiveness analysis would have significant clinical relevance. This approach would allow for the collection of solid data to guide clinical decisions, improve patient outcomes, and optimize the use of healthcare resources.
About CCi
CCi is specialized in harmonizing the clinical needs of the medical community with the research efforts of corporate R&D to foster collaborations for the improvement and development of technologies and/or methodologies in the medical field.
CCi is strongly focused on clinical marketing.
We believe that medicine does not need slogans or “advertising,” but rather solid and concrete scientific foundations on which to build the future.
Clinical marketing is extremely important for a company that wants to penetrate the medical devices market. This sector is highly regulated, characterized by strong competition, rapid technological advancement, and purchasing decisions that are heavily influenced by healthcare professionals, hospitals, and public health systems. Here are some reasons why clinical marketing is crucial:
1. Communicating Clinical Value and Product Effectiveness
Clinical marketing focuses on clearly communicating the clinical value, benefits, and effectiveness of medical devices. This includes scientific data, clinical studies, and evidence demonstrating the superiority or uniqueness of the device compared to competitors. Healthcare professionals, who are the primary decision-makers, require solid proof of a device’s effectiveness and safety before adopting it into their clinical practice.
2. Continuous Education and Training
Companies operating in the medical device sector must continuously educate and train doctors, nurses, and other healthcare professionals on the correct use of their products, new technologies, and application methods. Well-structured clinical marketing strategies include seminars, symposia, workshops, certified training courses, and practical demonstrations that help build trust and competence among potential users.
3. Building Relationships with Key Opinion Leaders (KOLs)
Clinical marketing often involves building strong relationships with Key Opinion Leaders (KOLs) and influential professionals in the medical field. These experts play a crucial role in evaluating, testing, and promoting new medical devices. Their endorsement and support can significantly influence the adoption of the product by other clinicians and healthcare institutions.
4. Differentiation in a Competitive Market
The medical device market is highly competitive. Clinical marketing enables companies to differentiate their products not only based on technical features but also in terms of clinical outcomes, patient benefits, and cost-effectiveness. Strategies may include highlighting positive clinical experiences, publishing in peer-reviewed journals, and presenting at medical conferences.
5. Support for Market Access and Regulatory Compliance
Clinical marketing can also support market access by facilitating understanding and adherence to local, national, and international regulations. A company must demonstrate that its device is not only effective and safe but also compliant with current regulations. Clinical marketing strategies that incorporate market research and interactions with regulatory bodies can accelerate the approval process and improve the company’s competitive position.
6. Engagement of Patients and Stakeholders
Clinical marketing is not limited to healthcare professionals; it can also involve patients and other stakeholders in the healthcare system. Educating patients on the benefits of medical devices, especially those used for managing chronic conditions or improving quality of life, can increase demand and indirectly influence decision-makers.
7. Increasing Brand Credibility and Trust
A clinical marketing approach enhances the credibility and trust in the company’s brand. Actively participating in clinical studies, publishing research results, and collaborating with renowned academic institutions and hospitals build a solid and respected image within the medical community.
Conclusion
Clinical marketing is essential for the success of a company seeking to enter and establish itself in the medical devices market. Through continuous education, communication of clinical value, building relationships with KOLs and stakeholders, and supporting regulatory compliance, companies can build a strong presence and effectively differentiate themselves in a highly competitive and regulated sector.
Are you ready to massively penetrate the market by linking your brand to the concept of an exclusive partner for clinically proven scientific progress?
CCi is ready to support you!
