麻豆传媒

ORLANDO -- Hemodynamic self-monitoring via a trans-septal implant was associated with early complications but a potential signal for fewer heart failure rehospitalizations in the troubled LAPTOP-HF trial.

When patients regularly managed their own diuretic dosage -- based on their physician's instructions and left atrial pressure measurements -- they had 92.4% odds of 12-month freedom from major adverse events (with a lower 95% CI limit exceeding the pre-specified performance criteria of 80%), , of The Ohio State University in Columbus, told the audience at the Heart Failure Society of America conference here.

Furthermore, hemodynamic monitoring was associated with greater efficacy than daily medication reminders given to the control group (0.40 events per patient-year for treatment group versus 0.70 for controls, HR 0.57, P=0.003).

"Results show study-related major adverse cardiovascular and neurological events occurred early and in close proximity to implant and did not increase over time," Abraham noted, though he emphasized that they study was terminated early and did not randomize enough people.

Cited as a reason for early termination was a cluster of implant-related trans-septal complications, namely cardiac perforations that required pericardiocentesis or surgical repair. The data safety monitoring board suggested the "totality of the results indicated a very low likelihood of achieving the primary efficacy endpoint in the face of evidence of upfront risk to patients," he noted.

"While hypothesis-generating and not definitive, LAPTOP-HF findings support the results of the CHAMPION trial and the potential efficacy of pressure-guided physician directed, patient self-management in New York Heart Association (NYHA) Class III heart failure patients at risk for heart failure re-hospitalization," he concluded.

Yet of the University of Texas Southwestern Medical Center in Dallas, advocated caution. "The risks of the current technology of direct left atrial pressure monitoring appear to be too high," he said during his commentary.

The prospective trial was terminated when 486 out of the planned 730 patients had been randomized to hemodynamic monitoring (n=241) or standard daily medication reminders (n=245). Patient characteristics were well-balanced between arms. Patients were enrolled after a prior heart failure hospitalization or if they had persistently elevated B-type natriuretic peptide levels.

Clinicians provided specific instructions to the hemodynamic monitoring group: After device implantation, they were to take a pre-determined dosage of furosemide (Lasix) depending on regular left atrial pressure readings. Patients used a phone-like device for RF telemetry that was linked to record-keeping software.

To cut their losses, the investigators changed their primary endpoints of LAPTOP-HF to enable comparison with the CHAMPION trial. They ended up with cumulative hazard ratios for heart failure rehospitalization very similar to those of CHAMPION.

Drazner commented that the exclusion of sicker patients introduced a potential source of bias; and that the reported LAPTOP-HF analysis was not intention-to-treat data.

However, he left room for a potential benefit from hemodynamic monitoring: "The analysis presented was 12 months, not the full study duration," he said, and "the benefit of left atrial pressure monitoring appears greater in earlier than later phases."