CRTにおいて代替のリード位置は安全である（Presentation #3025）

SEPTAL CRT：心臓再同期療法のリード位置として中部中隔は安全である
SEPTAL CRT: Mid-septal location is safe for lead position in cardiac resynchronization therapy

心臓再同期療法（CRT）を施行される心不全患者において、右室（RV）リードの中部中隔への留置は従来の心尖部への留置と比較し予後が同等である、との研究結果が2014年European Society of Cardiology Congressホットラインセッションで発表された。SEPTAL-CRTスタディは、25のヨーロッパの施設で施行された、前向き、多施設、ランダム化トライアルである。研究者らはCRT患者263人（平均年齢63.4歳）を、RVリードを従来の心尖部に留置する群（132人）、または中部中隔に留置する群（131人）にランダムに割り付けた。左室リードは従来通り冠静脈洞に留置した。このスタディの主な目的は、左室収縮末期容積（LVESV）変化に関してRVリードの中隔留置が心尖部留置に劣らないことを示すことであった。6か月後の追跡時点でベースラインからのLVESV減少は中隔群と心尖部群とで同等であった（それぞれ-25対-29 mL；p=0.79）。臨床上の予後も両群間で差がなかった。RVリードの中部中隔留置では挿入の成功率および合併症率も従来の留置部位の場合と同等であった。

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In heart failure patients undergoing cardiac resynchronization therapy (CRT), right ventricular (RV) lead placement in the mid-septum as compared to the conventional apical position results in similar outcomes, according to the SEPTAL-CRT study.

The findings, presented as a Hot Line at the ESC Congress 2014, have potentially important implications for many heart failure patients.

"CRT is currently only successful in about two thirds of heart failure patients, and the optimal location of the RV lead is still a matter of debate," said study investigator Christophe Leclercq, MD, from Rennes University, France.

"Conventional lead placement in the apex of the right ventricle can induce cardiac dyssynchrony and thus increase morbidity and mortality. Therefore, knowing that we have an alternative position for RV lead placement means there is potentially a way to improve the CRT success rate."

The SEPTAL-CRT study was conducted at 25 European centers and randomized 263 CRT patients (mean age 63.4 years) to either conventional RV lead positioning in the apex (n=132), or positioning in the mid-septum (n=131).  The left ventricle (LV) lead was inserted conventionally, into the coronary sinus.

The main objective of the study was to demonstrate that the RV septal position was not inferior to the apical position in terms of changes in the left ventricular end systolic volume (LVESV) – the volume of blood in the ventricle at the end of contraction.

At six months follow-up there was a similar decrease in LVESV from baseline in both the septal and apical groups (-25 vs. -29 ml respectively; p=0.79).

There were also no differences between groups in clinical outcome, with both showing the same benefit in the six-mile walk test and the Milton Packer score, a composite score of death, hospitalization for heart failure, New York Heart Association class and global assessment.

The mid-septal position of the RV lead was also associated with the same implantation success and complication rates as the conventional position.

"The SEPTAL-CRT trial is the first prospective, multicenter, randomized trial demonstrating the non inferiority of the mid-septal location as compared to the conventional apical location of the right ventricular lead in CRT patients on left ventricular reverse remodeling," concluded Professor Leclercq. "The implantation success rate was similar in both groups, and the clinical outcome was also similar at one year. Therefore both implantation sites are appropriate and could be used for CRT."

The study was sponsored by grants from Boston Scientific.

Professor Leclercq disclosed relationships with Boston Scientific, Medtronic, Sorin, St. Jude Medical Inc., and Biotronik.