Features and Limitations of Robotically Assisted Percutaneous Coronary Intervention (R-PCI): A Systematic Review of R-PCI.

Background: Ischaemic heart disease is one of the major drivers of cardiovascular death in Europe. Since the first percutaneous coronary intervention (PCI) in 1977, developments and innovations in cardiology have made PCI the treatment of choice for stenotic coronary artery disease. To address the occupational hazards related to chronic exposure to radiation and wear and tear from heavy lead-based radioprotective aprons, the concept of robotically assisted PCI (R-PCI) was introduced in 2005. Aim: To explore the features and limitations of R-PCI, we first discuss the concept and evolution of R-PCI platforms and then systematically review the available clinical data. Methods: A systematic review has been performed across the Pubmed, Embase and Cochrane databases in order to assess the efficacy and safety of R-PCI. Secondary endpoints, such as operator and patient exposure to radiation, contrast volume used and procedural time, were assessed when available. Results: In selected patients, R-PCI provides high technical and clinical success rates, ranging from 81 to 98.8% and from 93.3 to 100%, respectively. In-hospital and 1-year MACE rates ranged from 0 to 10.4% and 4.8 to 10.5%, respectively. R-PCI is able to significantly reduce the operator's exposure to radiation. Further research analysing the patient's and cath lab staff's exposure to radiation is needed. Therapy escalation with R-PCI seems to be limited to complex lesions. R-PCI procedures add approximately 10 min to the procedural time. Conclusions: The efficacy and safety of R-PCI have been proven, and R-PCI is able to significantly reduce occupational hazards for the first operator. The lack of adoption in the community of interventional cardiologists may be explained by the fact that current generations of R-PCI platforms are limited by their incompatibility with advanced interventional devices and techniques needed for escalation in complex interventions.

Exploring Potential Referral Pathways for Renal Artery Denervation and Developing a Centre of Excellence in Ireland.

Arterial hypertension is one of the most significant and prevalent risk factors for cardiovascular disease. Despite widespread awareness of the condition, as well as a multitude of available antihypertensive drug classes, rates of uncontrolled hypertension remain high on a global scale. Frequently, poor compliance with anti-hypertensive medication plays a big role in patients' inability to attain adequate blood pressure control. In individuals with resistant and/or uncontrolled hypertension, renal denervation is an emerging device-based therapy that has shown to be efficacious and safe in reducing blood pressure in several sham controlled trials. Additionally, it represents a treatment option for patients intolerant to oral pharmacotherapy. University Hospital Galway has been performing renal denervation procedures over the past number of years within multicentre, international sham-controlled trials and registries. Representing a novel and emerging antihypertensive treatment option, sources of referral for renal denervation are diverse and multiple; thus, there is an unmet need for standardised referral structures in Ireland. Herein, we review current and developing referral pathways for renal denervation at our institution, and discuss streamlined patient management and requirements to establish a centre of excellence.

Does renal denervation require cardiovascular outcome-driven data?

Hypertension is a major driver of cardiovascular disease with a prevalence of 32-34% in adults worldwide. This poses a formidable unmet challenge for healthcare systems, highlighting the need for enhanced treatment strategies. Since 2017, eight major sham-controlled randomised controlled trials have examined the effectiveness and safety of renal denervation (RDN) as therapy for BP control. Although most trials demonstrated a reduction in systolic 24-hour/daytime ambulatory BP compared to control groups, open to discussion is whether major adverse cardiovascular events (MACE)-driven RDN trials are necessary or whether the proof of BP reduction as a surrogate for better cardiovascular outcomes is sufficient. We conducted an analysis of the statistical methods used in various trials to assess endpoint definitions and determine the necessity for MACE-driven outcome data. Such comprehensive analysis provides further evidence to confidently conclude that RDN significantly reduces blood pressure compared to sham controls. Importantly, this enables the interpolation of RDN trial endpoints with other studies that report on outcome data, such as pharmacological trials which demonstrate a significant reduction in MACE risk with a decrease in BP. Moreover, limitations associated with directly evaluating outcome data further support the use of BP as a surrogate endpoint. For example, conducting lengthier trials with larger numbers of participants to ensure robust statistical power presents a substantial challenge to evaluating outcome data. Thus, in light of the crucial need to tackle hypertension, there are notable advantages of considering BP as a surrogate for outcome data.