First‐in‐human experience with occlusion of the superior vena cava to reduce cardiac filling pressures in congestive heart failure

Abstract

Background Acutely decompensated heart failure remains a major clinical problem. Volume overload promotes cardiac and renal dysfunction and is associated with increased morbidity and mortality in heart failure. We hypothesized that transient occlusion of the superior vena cava (SVC) will reduce cardiac filling pressures without reducing cardiac output or systemic blood pressure. The objective of this proof of concept study was to provide initial evidence of safety and feasibility of transient SVC occlusion in patients with acutely decompensated heart failure and reduced ejection fraction. Methods and Results In eight patients with systolic heart failure, SVC occlusion was performed using a commercially available occlusion balloon. Five minutes of SVC occlusion reduced biventricular filling pressures without decreasing systemic blood pressure or total cardiac output. In three of the eight patients, a second 10‐minutes occlusion had similar hemodynamic effects. SVC occlusion was well‐tolerated without development of new symptoms, new neurologic deficits, or any adverse events including stroke, heart attack, or reported SVC injury or thrombosis at 7 days of follow up. Conclusion We report the first clinical experience with transient SVC occlusion as a potentially new therapeutic approach to rapidly reduce cardiac filling pressures in heart failure. No prohibitive safety signal was identified and further testing to establish the clinical utility of transient SVC occlusion for acute decompensated heart failure is justified.

Partial vena cava occlusion (VCO) to counteract refractory heart failure: A new era in interventional heart failure strategy

“…However, in all three animal studies in Kapur et al, SVC occlusion increased IJ pressure, reduced RA, mean PA, PCWP pressure; CO remained stable. One potential concern is the impact of elevated jugular venous pressure on the cerebral function, but no neurologic deficits were identified during or up to 7 days of follow-up after SVC occlusion [ 1 ].…”

“…The study found that mean pulmonary artery pressures dropped significantly with occlusion with no additional neurological or cardiovascular complications. The study found that IVC obstruction lowers left ventricular filling pressure, decreasing cardiac workload, and improving myocardial contractility [ 1 ]. Another study by Kapur et al used an SVC occlusion device called Precardia to occlude the SVC [ 2 ] intermittently.…”

“…Due to the lack of linear positive inotropy response to increasing preload in heart failure patients, increasing preload is associated with poor outcomes. Partial occlusion of either IVC or SVC is a proposed novel treatment that can improve cardiac function or quality of life by altering preload/pressure in heart failure (HF) patients unresponsive to diuretics [ 1 , 2 ]. This meta-analysis evaluates the degree of change in pressures with vena cava occlusion in patients with heart failure.…”

Novel Therapeutic Devices in Heart Failure

“…Prior studies have also reported its safety in the preclinical model, in terms of thrombotic events, strokes or neurologic deficits. No examined animal has experienced increased cerebral oedema or thrombotic event [ 49 ].…”

Intermittent Occlusion of the Superior Vena Cava to Improve Hemodynamics in Patients With Acutely Decompensated Heart Failure: The VENUS-HF Early Feasibility Study

“…We previously tested the effect of transient SVC occlusion in patients with ADHF and observed a rapid and significant reduction in cardiac filling pressures without reduced systemic blood pressure or cardiac output. 15 Based on these observations and subsequent preclinical testing, 16 a catheter-mounted balloon occlusion and pump console device, known as the preCARDIA system, was developed for intermittent occlusion of the SVC to reduce cardiac filling pressures and facilitate decongestion in patients with ADHF (Figure 1). The VENUS-HF study is the first study testing the feasibility and safety of intermittent SVC occlusion with the preCARDIA system to reduce cardiac filling pressures in patients with ADHF and venous congestion.…”