On May 7, 2022, the “RDN Always On: ACC 2022 Interpretation Conference on the Latest Clinical Data of Radiofrequency Ablation of Renal Artery Sympathetic Nerve Ablation”, hosted by China Cardiovascular Health Alliance and co-organized by Medtronic, was successfully held. By interpreting the latest clinical research data of RDN, we are exploring new technologies for blood pressure control. The meeting was chaired by Professor Huo Yong from Peking University First Hospital, Professor Sun Ningling from Peking University People’s Hospital, and Professor Yuan Zuyi from the First Affiliated Hospital of Xi’an Jiaotong University , Professor Feng Yingqing from Guangdong Provincial People’s Hospital, Professor Lu Chengzhi from Tianjin First Central Hospital, and Professor Shu Yan from Sichuan Provincial People’s Hospital attended and participated in the study. This meeting was chaired by Professor Zhang Yi from Shanghai Tenth People’s Hospital.
Radiofrequency ablation of renal artery sympathetic nerve (hereinafter referred to as “RDN”) is a minimally invasive procedure A revolutionary innovative therapy for pressure. RDN uses radiofrequency energy to ablate the sensual nerves distributed outside the renal artery, which blocks the abnormally excited signal conduction between the brain and sympathetic nerves in patients with hypertension to a certain extent, and achieves the effect of long-term blood pressure reduction in one minimally invasive operation. With the presentation of the three-year results of the SPYRAL HTN-ON MED Pilot study at the 71st American College of Cardiology Annual Scientific Session (ACC 2022), RDN therapy has gained renewed interest.
According to the experience and summary of the early SMPLICITY HTN series of clinical studies, the new generation of SPYRAL HTN series of clinical studies led by Medtronic and the Global Symplicity Registry Efficacy, safety and durability of RDN therapy were demonstrated. The long-term follow-up data of RDN therapy published in ACC 2022 is a prespecified analysis of the SPYRAL HTN-ON MED Pilot clinical study published in The Lancet in 2018. To compare blood pressure changes, antihypertensive drug use, and safety between the RDN group and the sham-operated control group during up to 36 months of follow-up.
The SPYRAL HTN-ON MED Pilot clinical study is a multicenter, prospective, randomized, sham-operated controlled trial of high blood pressure patients who are stable on 1-3 antihypertensive drugs. blood pressure patients. The study used the next-generation Symplicity Spyral™ renal artery sympathetic multipolar radiofrequency ablation catheter and performed complete ablation of the main and branches of the renal artery to reduce sympathetic nerve activity. The primary end point was the change in 24-hour ambulatory systolic blood pressure and the incidence of major adverse events at 6 months postoperatively.
Data published in 2018 have shown the efficacy of RDN therapy at 6 months after the primary endpoint, and this data further demonstrates that RDN therapy is even more effective after surgery. At 36 months, it still showed a -10 mm Hg antihypertensive effect independent of drug effect (RDN group-18.7 mm Hg vs. sham-operated control group-8.6 mm Hg, p em>=0.004, with a statistical difference), and had a lower drug load than the sham-operated control group, and the antihypertensive effect was 24/7 continuous online, even during the morning rush hour. In addition, nearly twice as many patients in the RDN group successfully controlled 24-hour ambulatory systolic blood pressure levels to <140 mm Hg at year 3 compared to the sham control group (83.3 % in the RDN group vs. 43.8 % in the sham group, < em>P=0.002).
As a revolutionary innovative interventional treatment for hypertension, RDN therapy has also been shown to have long-term safety Good, no device or procedure-related complications occurred during the 36-month follow-up, and there was no significant difference in renal function-related indicators between the RDN group and the control group.
The release of the long-term follow-up data of SPYRAL HTN-ON MED Pilot adds a higher level of randomized controlled clinical evidence for the long-term efficacy and safety of RDN therapy. RDN therapy has clinically meaningful and sustained antihypertensive effects, and will further reduce the risk of cardiovascular events by 20% and the risk of stroke by 27%. For RDN therapy, the European Society of Hypertension issued a position statement document in 2021, suggesting that RDN therapy is an evidence-based medicine-based hypertension treatment option that can effectively lower blood pressure, and is an important part of current drug therapy and lifestyle choices. Modal intervention complements the two treatment modalities.
With regard to the data published in this ACC 2022, the chairman of the meeting and the experts also commented on the long-term efficacy and safety of RDN therapy, the applicable patient population, as well as the positioning and future of RDN therapy The direction of development has been expressed.
Dark the clouds and see the sun, big coffee decrypts RDN
Professor Sun Ningling RDN therapy: During the past 15 years of development, rapid development has been achieved in terms of methods and techniques, patient selection, doctor allocation, and teamwork between hypertension centers and interventional centers. At the same time, the treatment of RDN therapy has become more and more accurate. with valid. The current treatment methods for hypertension are mainly based on lifestyle intervention and drug treatment, but there are certain limitations. Therefore, the emergence of non-drug treatments provides a new option for hypertension treatment. RDN therapy has proven its efficacy and safety through clinical data. Whether it is for first-degree hypertension, poorly controlled hypertension, or refractory hypertension, it can help promote an improvement in the rate of hypertension management and compliance in the future. . For the development of RDN therapy, wider popularization and training is also needed to improve the application skills of RDN therapy.
Professor Shu Yanjiu: In terms of current clinical research data and experience, RDN therapy has shown clinically meaningful antihypertensive effects in different populations, different treatment backgrounds and different follow-up periods. The publication of the three-year follow-up data of the SPYRAL HTN-ON MED Pilot study further proves that RDN therapy has a -10 mmHg antihypertensive effect that is independent of the effect of drugs, and it is continuously online for 24 hours and has long-term efficacy without rebound. Especially for the high incidence of hypertension in the young and middle-aged population in my country, and it is difficult to carry out long-term lifestyle intervention or long-term adherence to taking drugs, RDN therapy can become a new alternative blood pressure method. Help reduce the incidence of cardiovascular events such as stroke. At the same time, with the innovation of RDN devices and the optimization of ablation strategies, operations will be performed more efficiently in the future, benefiting patients.
Professor Lu Chengzhi: With the deepening understanding of the anatomical characteristics of the sympathetic nerve distribution around the renal artery, the current ablation strategy for RDN therapy requires simultaneous ablation of the main and branches of the renal artery to achieve a better antihypertensive effect. With the innovation and upgrading of RDN therapy related devices, the current generation of multipolar radiofrequency ablation catheters can easily achieve complete ablation of the distal end of each renal artery branch. Based on safety follow-up data from the SPYRAL HTN series, there were no device- or procedure-related safety events with RDN, either immediately after surgery or 3 years after surgery. The GSR real-world registry study also showed that RDN therapy did not accelerate the reduction of eGFR in patients, even in CKD patients, suggesting that the safety of RDN therapy is relatively definite, and RDN therapy can also be explored in the future for patients with hypertension and CKD.
Professor Yuan Zuyi’s therapy: It has been developed for fifteen years, and it was mainly used for refractory hypertension in the early stage. With the progress of GSR real-world clinical registration research, RDN therapy has also shown antihypertensive effects in patients with different types of hypertension, such as those with ISH, CKD, and AF. The causes of hypertension are complex and diverse. In the early stage of RDN therapy, patients with refractory hypertension, hypertensive drug intolerance, or poor drug compliance, and patients who are unwilling to take drugs can be preferentially selected. It can also be recommended for patients with high or distributed sympathetic activity, such as those who are young, have a fast heartbeat, or have metabolic syndrome. With the accumulation of RDN therapy experience, RDN therapy can be extended to more patient populations in the future.
Professor Feng Yingqing:According to the clinical research design of ON MED and OFF MED in the SPYRAL HTN series of studies, it can be seen that the scope of application of RDN therapy has expanded from the initial refractory hypertension to the current use of 1-3 hypertension drugs. In patients with poorly controlled blood pressure, clinical studies have also demonstrated the efficacy and safety of RDN therapy in these patient populations, similar to a blood pressure drug. At present, the medication rate of hypertensive patients is less than 50%, and RDN therapy can help reduce the burden of medication tablets in hypertensive patients (Pill Burden), thereby improving patients’ medication compliance and acceptance. RDN therapy can be recommended for patients with more sympathetic nerves, such as young patients, patients with hypertension and obesity or diabetes. At the same time, according to the recommendations of many international societies, the application of RDN therapy should follow the principle of consultation and decision-making between doctors and patients.
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