The V-LAP System for Remote Left Atrial Pressure Monitoring of Patients With Heart Failure: Remote Left Atrial Pressure Monitoring.

OBJECTIVE: Patients with heart failure (HF) are at an increased risk of hospital admissions. The aim of this report is to describe the feasibility, safety and accuracy of a novel wireless left atrial pressure (LAP) monitoring system in patients with HF. METHODS: The V-LAP Left Atrium Monitoring systEm for Patients With Chronic sysTOlic & Diastolic Congestive heart Failure (VECTOR-HF) study is a prospective, multicenter, single-arm, open-label, first-in human clinical trial to assess the safety, performance and usability of the V-LAP system (Vectorious Medical Technologies) in patients with New York Heart Association class III HF. The device was implanted in the interatrial septum via a percutaneous, trans-septal approach guided by fluoroscopy and echocardiography. Primary endpoints included the successful deployment of the implant, the ability to perform initial pressure measurements and safety outcomes. RESULTS: To date, 24 patients have received implants of the LAP-monitoring device. No device-related complications have occurred. LAP was reported accurately, agreeing well with wedge pressure at 3 months (Lin concordance correlation coefficient = 0.850). After 6 months, New York Heart Association class improved in 40% of the patients (95% CI = 16.4%-63.5%), while the 6-minute walk test distance had not changed significantly (313.9 ± 144.9 vs 232.5 ± 129.9 meters; P = 0.076). CONCLUSION: The V-LAP left atrium monitoring system appears to be safe and accurate.

Safety, usability, and performance of a wireless left atrial pressure monitoring system in patients with heart failure: the VECTOR-HF trial.

AIMS: In heart failure (HF), implantable haemodynamic monitoring devices have been shown to optimize therapy, anticipating clinical decompensation and preventing hospitalization. Direct left-sided haemodynamic sensors offer theoretical benefits beyond pulmonary artery pressure monitoring systems. We evaluated the safety, usability, and performance of a novel left atrial pressure (LAP) monitoring system in HF patients. METHODS AND RESULTS: The VECTOR-HF study (NCT03775161) was a first-in-human, prospective, multicentre, single-arm, clinical trial enrolling 30 patients with HF. The device consisted of an interatrial positioned leadless sensor, able to transmit LAP data wirelessly. After 3 months, a right heart catheterization was performed to correlate mean pulmonary capillary wedge pressure (PCWP) with simultaneous mean LAP obtained from the device. Remote LAP measurements were then used to guide patient management. The miniaturized device was successfully implanted in all 30 patients, without acute major adverse cardiac and neurological events (MACNE). At 3 months, freedom from short-term MACNE was 97%. Agreement between sensor-calculated LAP and PCWP was consistent, with a mean difference of -0.22 ± 4.92 mmHg, the correlation coefficient and the Lin's concordance correlation coefficient values were equal to 0.79 (p < 0.0001) and 0.776 (95% confidence interval 0.582-0.886), respectively. Preliminary experience with V-LAP-based HF management was associated with significant improvements in New York Heart Association (NYHA) functional class (32% of patients reached NYHA class II at 6 months, p < 0.005; 60% of patients at 12 months, p < 0.005) and 6-min walk test distance (from 244.59 ± 119.59 m at baseline to 311.78 ± 129.88 m after 6 months, p < 0.05, and 343.95 ± 146.15 m after 12 months, p < 0.05). CONCLUSION: The V-LAP™ monitoring system proved to be generally safe and provided a good correlation with invasive PCWP. Initial evidence also suggests possible improvement in HF clinical symptoms.

Temporal trends of acute kidney injury in patients undergoing percutaneous coronary intervention over a span of 12 years.

BACKGROUND: AKI is a known complication of PCI and is associated with higher rates of adverse events. We assessed temporal trends in rates of AKI, factors associated with risk of AKI and prognosis. METHODS: From a prospective registry of patients undergoing PCI at two hospitals of the Rabin Medical Center, 15,153 consecutive patients were assessed at two time periods: 2006-2012 and 2012-2018. AKI was defined as either a relative elevation of ≥25% in serum creatinine or an absolute elevation of ≥0.5 mg/dl in serum creatinine at 48 h post PCI. RESULTS: Data for 7913 patients from 2006 to 2012 and 7240 during 2012-2018 was available for analysis. Mean age was 65.0 ± 11.9y and 66.0 ± 12.3y (p < 0.001) and baseline creatinine was 1.08 ± 0.87 mg/dl and 1.15 ± 0.97 mg/dl, respectively (p < 0.001). Rates of AKI were 11.1% in the early and 7.3% in the late period (p < 0.001). Following adjustment, risk of AKI was lower in the late period (OR- 0.72; 95% CI 0.61-0.85, p < 0.001). AKI was associated with increased MACE (HR 1.62; 95% CI 1.44-1.82, p < 0.001 for the early period and HR 2.11; 95% CI 1.80-2.46, P < 0.001 for the late period) and death (HR 1.86; 95% CI 1.64-2.11, p < 0.001; HR 2.4; 95% CI 2.02-2.86; p < 0.001) in both time periods. CONCLUSIONS: Over time, there was an improvement in the rates of post-PCI AKI. Increased adverse outcomes were evident at both periods. Further research is warranted, to further reduce peri-procedural AKI which is associated with impaired prognosis.