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.

Atrial Giant Cell Myocarditis as a Cause of Heart Failure: Diagnostic Pathway and Successful Treatment.

We present a patient with acute heart failure and new onset atrial fibrillation secondary to giant cell myocarditis with lone atrial involvement. The diagnosis was managed with cardiac magnetic resonance and confirmed by interventionally guided biopsy. In the future, diagnosis could be managed noninvasively for this rare entity as the gold standard. (Level of Difficulty: Advanced.).

Results of the ALSTER BP real-world registry on renal denervation employing the Symplicity system.

AIMS: To prove the efficacy and safety of renal sympathetic denervation as a new treatment option for patients suffering from resistant hypertension in a real-world setting. METHODS AND RESULTS: This single-centre real-world registry included 93 patients who underwent renal denervation employing the Symplicity system. Patients were followed for six months. The patient cohort was divided into early responders with a reduction of office systolic blood pressure >10 mmHg three months after the procedure (n=53, 57%), late responders (six months after the procedure, n=16, 17%) and non-responders (n=24, 26%). After six months, systolic blood pressure was lowered by 46±2.9 mmHg (mean±SEM, p<0.001), 31±3.4 mmHg (p<0.001) and 7.1±3.3 mmHg (p=0.79, ns), respectively. Ambulatory blood pressure monitoring also showed a significant reduction in the early responder group (20±5.7 mmHg, p=0.002). We subjected eight patients to a re-do procedure which led to a significant reduction of blood pressure in another five patients after six months (63%). One patient in this cohort developed a one-sided renal artery stenosis associated with an increase in blood pressure. CONCLUSIONS: This real-world analysis of renal sympathetic denervation confirms the procedure to be safe and efficient in the majority of patients. Non-responders may profit from a second ablation, arguing in favour of the hypothesis that the procedure did not destroy sufficient amounts of sympathetic innervation in these patients. However, repeated denervations may also increase side effects.

Bone defects caused by high-energy injuries, bone loss, infected nonunions, and nonunions.

Bone defects represent a difficult problem for the clinician. They entail a sustained increase in hospitalization, risk of complications, and associated increase in expenses. This article discusses bone defects caused by high-energy injuries, bone loss, infected nonunions, and nonunions.

Continuous psoas and sciatic block after knee arthroplasty: good effects compared to epidural analgesia or i.v. opioid analgesia: a prospective study of 63 patients.

INTRODUCTION: For endoprosthetic knee surgery, intensive postoperative pain therapy is necessary. We therefore evaluated whether the combination of continuous psoas compartment and sciatic analgesia (PSC) is as effective as epidural analgesia (EPI) and whether it provides better analgesia than patient-controlled intravenous analgesia with piritramide (PCA). METHODS: We studied 63 patients who underwent total knee arthroplasty (TKA). The PSC group received a combination of continuous psoas and sciatic nerve block, the EPI group an epidural analgesia, and the PCA group an intravenous patient-controlled piritramide pump. Pain scores, satisfaction, flexion and side effects were recorded. RESULTS: Pain scores (0-10) were higher in the PCA group (on movement, day 1/day 2: 7.0/6.5) than in the EPI group (5.0/5.0) and the PSC group (4.0/3.5). Postoperative opioid consumption over 48 h was higher in the PCA group (51 mg) than in the EPI group (0 mg) and the PSC group (0 mg). There were no differences in functional recovery. Pruritus occurred more frequently in the PCA and EPI groups than in the PSC group. Patients receiving a PSC and EPI were more satisfied than those treated with PCA. INTERPRETATION: Analgesia with PSC catheters or EPI catheter is superior to PCA regarding pain levels, analgesic requirements, and patient satisfaction. There was no difference in functional outcome between the 3 groups.