植入性監視器可以改善心臟衰竭病患預後


  Nov. 22, 2005(達拉斯訊)-研究者表示,一種可以不必住院、且持續測量心臟內壓力的植入性血行動力學監視器,相較於僅接受標準療法,可以改善紐約心臟協會(NYHA)分級III/IV級心臟衰竭病患的預後。
  
  這項the Chronicle Offers Management to Patients with Advanced Signs and Symptoms of Heart Failure(COMPASS-HF)臨床試驗的六個月追蹤結果顯示,除了最好的內科療法之外,加上不需住院的監測儀器,相較於僅接受內科療法,可以降低33%心臟衰竭惡化的機率。
  
  首席研究者,伯明罕阿拉巴馬大學心臟疾病部門主任Robert C. Bourge醫師表示,這項發表於美國心臟醫學會2005科技座談的單盲、隨機分派試驗也顯示,遠端監視血行動力學、以及心臟衰竭病患使用植入性監視器的好處。
  
  Bourge醫師向Medscape表示,植入性血行動力學監視器(Chronicle;明尼蘇達州明尼亞波利Medtronic公司製造)經由皮下植入,類似心臟節律器,具有一個延伸至右心室外流徑的壓力感受導程;該監視器持續追蹤心內壓力、體溫、病患活動力與心跳速度,而且所監測到數據接著從病患住家透過網路傳送到醫師診間。
  
  COMPASS-HF試驗主要是探討,根據持續監測已接受最好內科療法心臟衰竭病患的心臟內壓力,是否可以降低病患的發病率;這項試驗隨機分派274位接受標準心臟衰竭治療,包括標準藥物與裝置療法、每日測量體重、並且定期就診的病患,分別接受標準照護(控制組)、以及接受標準療法加上持續監測血行動力學參數(實驗組)。
  
  目前的分析已經收納了200位完成6個月後續追蹤的病患(99位為控制組、101位為實驗組);其中85%的病患於收納時為NYHA分級III的心臟衰竭。
  
  Bourge醫師與其同事表示,相較於控制組,接受監測病患的臨床改善綜合指數,包括NYHA分級變化、重大臨床事件與住院率都顯著地改善(46%相較於35%)。
  
  除此之外,實驗組相較於控制組病患,發生以臨床改善綜合指數評估的心臟衰竭惡化機率較低(34%相較於51%;P=.035)。
  
  隨機分派接受監測的病患因為心臟衰竭相關狀況而住院的機率較低(27.7%相較於44.4%)、死亡率同樣較低(5.9%相較於8.1%);研究者同時表示,實驗組中46.5%病患的NYHA分級改善,相較於控制組的38.5%,而實驗組中有3.0%病患惡化,相較於控制組的5.2%。
  
  夏洛特維爾維吉尼亞大學健康系統心臟衰竭/心臟移植計畫醫療主任James D. Bergin醫師表示,治療組中,比較少病患因為心臟衰竭相關問題住院代表這項療法是具有潛力的。
  
  他向Medscape表示,但這項試驗是單盲的,使得主觀性試驗終點會比較難加以闡釋;如果可以將受試者數目增加,並且透過雙盲的方式進行將會更好。
  
  這項試驗由Medtronic公司贊助,該公司為Chronicle監視器的製造廠商。

Implantable Monitor Improves O

By
Medscape Medical News

Nov. 22, 2005 (Dallas) — An implantable hemodynamic monitoring device that continuously measures intracardiac pressure on an outpatient basis can improve outcomes among New York Heart Association (NYHA) class III/IV patients by 33% compared with standard medical care alone, researchers report.

Six-month follow-up results from the Chronicle Offers Management to Patients with Advanced Signs and Symptoms of Heart Failure (COMPASS-HF) trial also demonstrated that use of the ambulatory monitoring device on top of optimal therapy was associated with a 33% reduction in worsening HF compared with optimal therapy alone.

The results of the single-blinded, randomized controlled study, presented here at the American Heart Association 2005 Scientific Sessions, "demonstrate the benefits of remotely monitoring hemodynamics and congestion in heart failure patients using an implantable monitor," said principal investigator Robert C. Bourge, MD, director of the division of cardiovascular disease at the University of Alabama at Birmingham.

Dr. Bourge told Medscape that the implantable hemodynamic monitor (Chronicle; Medtronic, Minneapolis, Minnesota) is implanted subcutaneously, similar to a pacemaker, with a pressure-sensing lead extending into the right ventricular outflow tract. The monitor continuously tracks intracardiac pressure, body temperature, patient activity, and heart rate, and the measurements are then transmitted from the patient's home to the clinician's office via a secure online connection.
COMPASS-HF was designed to determine whether a management strategy based on continuously monitored intracardiac pressures in patients with heart failure already receiving optimal medical care improves patient morbidity. The study randomized 274 patients receiving standard heart failure care, including standard drug and device therapy, daily weight measurements, and regular access to heart failure clinicians, to standard care alone (control group) or standard care complemented by continuous hemodynamic monitoring (monitor group).

The current analysis included 200 patients (99 control and 101 monitor) that completed six-month follow-up; 85% of patients enrolled had NYHA functional class III heart failure at baseline.

Dr. Bourge and colleagues reported that improvement in the clinical composite score, which took into account changes in NYHA class, major clinical events, and hospitalizations, was higher in the monitor patients compared with controls (46% vs 35%, respectively).

In addition, significantly fewer patients in the monitor group than in the control group experienced worsening heart failure, as measured by the clinical composite score (34% vs 51%, respectively; P = .035).

Patients randomized to the monitor group had fewer incidents of hospitalization for heart failure–related conditions (27.7% vs 44.4%) and fewer deaths (5.9% vs 8.1%). Investigators also reported that NYHA class improved in 46.5% of patients in the monitor group, compared with 38.5% of controls, and worsened in 3.0% of monitor patients vs 5.2% of controls.

James D. Bergin, MD, medical director of the heart failure/cardiac transplant program at the University of Virginia Health System in Charlottesville, said that "the fewer number of patients hospitalized in the treated group does suggest the technique may hold promise. 

"But the study was single-blinded, which makes subjective end points a little more difficult [to interpret]," he told Medscape. "It would be nice to see this applied to a larger group in a double-blind fashion."

The trial was supported by Medtronic, the maker of the Chronicle monitor.

AHA 2005 Scientific Sessions: Abstract 3015, Presented Nov. 14, 2005.

Reviewed by Ariana Del Negro

    
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