Clinical Evidence: Transcatheter PAB in HFrEF

30+patients in the ContraBand™ study

30 monthsmean follow-up (longest beyond 48 months)

FDABreakthrough Device Designation

Key findings from the ContraBand™ study (interim analysis)

ContraBand™ is the earlier name of the UPright™ System.

30.3 → 21.5 mmHgmean PCWP at a matched workload of 20W, baseline to 6 months

+48%cardiac output reserve during exercise, baseline to 6 months

+16.6 pointsKCCQ overall summary score, baseline to 12 months

+67.7 msix-minute walk distance, baseline to 12 months

Exercise hemodynamics · 6 months

Filling pressures and cardiac output during exercise

Pulmonary capillary wedge pressure (PCWP)

30.3 → 21.5 mmHg

PCWP is an invasive surrogate for left ventricular filling pressure. Its rise during exercise is a key driver of exertional symptoms in heart failure.

At 6 months, mean PCWP at a matched workload of 20W fell from 30.3 to 21.5 mmHg, a reduction of 8.8 mmHg (29%; p<0.01).

Population mean, in patients with paired baseline and 6-month invasive exercise hemodynamics.

PCWP during exercise (mmHg)

Mean invasive measurement at matched workload, paired patients, baseline vs 6 months

Baseline6 months

Cardiac output reserve

Patients recruit more cardiac output during exercise, with a smaller rise in filling pressure (PCWP).

At 6 months, cardiac output reserve from rest to peak exercise was 48% greater than at baseline, and the rise in filling pressure was 37% smaller.

Population mean, rest to peak (symptom-limited) exercise, in patients with paired baseline and 6-month invasive exercise hemodynamics.

More exercise at a lower pressure cost

Before treatmentAfter treatment (6 months)

+48%larger rise in cardiac output from rest to peak exercise

−37%smaller rise in PCWP, rest to peak exercise

Functional capacity and quality of life · 12 months

Quality of life and walking distance at 12 months

Quality of life: Kansas City Cardiomyopathy Questionnaire (KCCQ)

+16.6 points

The KCCQ is a 23-item, self-administered questionnaire that measures the patient's own perception of their health status, including symptoms, physical limitation and quality of life. Scores range from 0 to 100; higher is better.

At 12 months, the KCCQ overall summary score rose from 61.5 to 78.1 (p<0.001).

KCCQ overall summary score

Mean score, paired patients

Functional capacity: six-minute walk test (6MWT)

+67.7 m

The six-minute walk test measures the distance a patient can walk in six minutes, a submaximal measure of functional exercise capacity.

At 12 months, six-minute walk distance increased from 346.8 m to 414.5 m, a gain of 67.7 m (p<0.001).

Six-minute walk distance

Mean distance in meters, paired patients

Left ventricular volumes · 12 months

Reduction in LV volumes

LV end-diastolic and end-systolic volume

−18.7 mL LVEDV · −14.1 mL LVESV

Left ventricular volumes, measured by echocardiography and read by an independent core laboratory, are markers of ventricular remodeling.

At 12 months, mean LVEDV decreased from 222.8 to 204.1 mL (p<0.05) and mean LVESV from 158.7 to 144.6 mL.

LVEDV

Mean, mL

LVESV

Mean, mL

ContraBand™ Safety & Feasibility Study, interim analysis of an ongoing study, data on file, Restore Medical. Paired analysis: patients with data at both time points. p-values from paired t-tests, shown where p<0.05.

Study oversight

Independent analysis, comprehensive follow-up

Every patient is followed with echocardiography, CT and invasive hemodynamic assessment of the right and left heart.

Restore Medical monitors all patients for safety throughout follow-up, which now averages 30 months (longest beyond 48 months).

Detailed study data are available to healthcare professionals on request. Contact us

Hemodynamic tracings and CT

CRF Imaging Core Labs

Independent core laboratories of the Cardiovascular Research Foundation, United States. crf.org

Echocardiography

Cardiac Imaging Core Lab

Independent core laboratory of Baylor Scott & White Research Institute, United States. bswhealth.com

References

1. Bruckheimer E, et al. Transcatheter Pulmonary Artery Banding for HFrEF. Initial Results: Exercise Hemodynamics From the Ongoing First-in-Human Trial. JACC: Basic to Translational Science. 2024;9(4):445-447. doi:10.1016/j.jacbts.2024.02.008
2. ContraBand™ Safety & Feasibility Study, data on file, Restore Medical Ltd.

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